Office Action Analysis — App 19456196 (public record)
Full Analysis

Office Action Response Analysis · Non-Final (CTNF)

App. No. 19/456,196

Art Unit
3731
Examiner
KOTIS, JOSHUA G
Mailed
07/27/2026
Response period stated in the OA
“3 MONTHS FROM THE MAILING DATE OF THIS COMMUNICATION”
Rejections
§112(b) ×1§102 ×1§103 ×3
Claims
9 rejected · 6 objected
Generated
Aug 10, 2026

The independent-claim combination attack (Argument 1) and the two construction contests (Arguments 6 and 5) present the most durable argue-first postures because each targets an articulated-reasoning gap or a claim-construction/BRI question the examiner has not foreclosed on the record — and none of the top six rests on a doctrinally losing theory (each definiteness point is correctly framed on the examination standard, and none argues the §112(b)/§103 pairing is improper). Counsel may wish to weigh that several arguments (1's ordered arrangement, 2's inspect-before-cut, 3's repeat-cycle, 4's fixed relationship) turn on Kim's detailed description and figures that are truncated in the record, so confirming the full Kim disclosure before committing to an argue-only path is a threshold consideration, and where a term or geometry cannot be anchored in the specification an amendment to a determinate limitation may be the more efficient lever. Given this examiner's documented interview propensity, counsel may also consider whether the construction points (Arguments 6 and 5) are better advanced in an interview than solely on paper.

Examiner Joshua Kotis (AU 3731): allowance rate 78% (n=314); avg 2.03 OAs to allowance; interviews held in 69% of cases, and when an interview was held allowance followed 97% of the time (correlation, not causation); RCE filed in 33% of cases. Based on n=315 applications; USPTO public data, 2016-01-01..2022-12-31. Correlational — it informs, it never decides.

Generated on a published USPTO office action — no confidential disclosure involved. First-pass analysis for attorney review — not a drafted response.

1.

Indicated Allowable Subject Matter & Examiner Interview

Examiner interview (MPEP 713) — a consideration. The strongest candidate arguments below are close calls (see the likely examiner responses in the Argument Bank), so an examiner interview to test the arguments and probe what would put the case in condition for allowance may be worth weighing before filing a written response.

2.

Per-Claim Strategy

An at-a-glance recommendation per rejected claim, composed deterministically from the analysis below. A triage summary for counsel to weigh, not a decision.

ClaimRejectionsRecommended pathBasisFallback amendmentConfidence
Claim 1§112(b) (indefiniteness)§102 (anticipation)ArgueStrategy check: re-ranked — The current top for claim 1 (rank 5, 'generally horizontal') is a §112(b) definiteness point that cannot withdraw the §102 anticipation, so it cannot carry the claim; only the axis-geometry attack (rank 8) reaches the operative rejection, and its mapping-defeating potential outweighs the definiteness point despite the verify-first flag.Missing element (#2)high
Claim 2§112(b) (indefiniteness)§102 (anticipation)ArgueStrategy check: re-ranked — The current top (rank 7, 'the step of' recitation) only addresses §112(b); the substantive rejection is §102 inherited from claim 1, which falls only via the axis-geometry attack now ranked 8.Definiteness rebuttal (#8)moderate
Claim 3§112(b) (indefiniteness)§102 (anticipation)Review — no argument identifiedStrategy check: re-ranked — No argument is currently ranked as claim 3's top substantive path; its §112 and §102 rejections both resolve only if claim 1's anticipation fails via the axis-geometry attack (rank 8).low
Claim 4§112(b) (indefiniteness)§102 (anticipation)§103 (obviousness)ArgueStrategy check: re-ranked — The current top (rank 4, In re Japikse rebuttal) only addresses the fixed-relationship limitation under the §103 alternative and leaves the §102 mapping intact; the axis-geometry attack disposes of both Kim-based rejections.Definiteness rebuttal (#3)high
Claim 5§112(b) (indefiniteness)§103 (obviousness)ArgueConclusory rationale (#5)moderate
Claim 6§112(b) (indefiniteness)§103 (obviousness)ArgueStrategy check: re-ranked — The current top for claim 6 (rank 2, Kim 2006 purpose) does not reach claim 6's own 'feeding from the inspection station to the platform' limitation; the rank-1 Holmes-downstream/feed-from-station deficiency squarely targets that limitation and should govern claim 6 as it does claim 10.Conclusory rationale (#5)moderate
Claim 7§112(b) (indefiniteness)§102 (anticipation)Review — no argument identifiedStrategy check: re-ranked — No argument is tagged as claim 7's top substantive path; its rejections resolve only if claim 1's anticipation falls via the axis-geometry attack (rank 8).low
Claim 8§112(b) (indefiniteness)§103 (obviousness)ArgueStrategy check: re-ranked — The current top (rank 3, extend/repeat conclusory) is graded fragile — the examiner can characterize re-extending pins and re-running the disclosed apparatus as predictable operation needing no motivation — whereas the axis-geometry attack defeats the base reference entirely.Conclusory rationale (#7)low
Claim 9§112(b) (indefiniteness)§103 (obviousness)ArgueStrategy check: re-ranked — The current top (rank 3, repeat-the-process rationale) is fragile against the KSR predictable-operation comeback; the axis-geometry attack on the base reference is the more dispositive path.Conclusory rationale (#7)low
Claims 10–15§112(b) (indefiniteness)§103 (obviousness)ArgueMischaracterized reference (#1)moderate
3.

Argument Bank

Candidate arguments for counsel, ranked strongest-first — brainstorming inputs for counsel to evaluate, not a drafted response.

1

Holmes' verification is downstream, not an upstream station feeding the winding platform (claim 10)

Mischaracterized referenceClaim 10Claim 11Claim 12Claim 13Claim 14Claim 15Rebuts: §103 rejection of claims 10, 11, 12, 13, 14, 15

feeding a leading end of the strip of pouches from the automated inspection station along a platform and between two generally horizontal pins

Holmes (fully grounded) expressly places its verification system DOWNSTREAM of the dispenser and describes it monitoring pouches as they are spooled onto the take-up roll or dispensed — i.e., at or after roll formation — not as an upstream station that feeds a strip INTO a separate winding platform. Kim 2013's introduction plate feeds the strip from the body to the winding unit, not from an inspection station. Claim 10 requires inspection FIRST (step a) and then feeding the strip FROM the automated inspection station to the winding pins, which neither grounded reference discloses in that ordered arrangement. For counsel to weigh whether the examiner's statement that the modified device 'would readily feed the strip of pouches from the inspection station... to the platform' is a disclosed arrangement or an unsupported assertion supplied only by hindsight (this overlaps with OA3's flag that the positional relationship 'appears to be assertion rather than a disclosed arrangement').

  • Holmes claim 2: 'The automatic packager of claim 1 , wherein the verification system is provided downstream of the dispenser.'
  • Holmes description: 'The verification system 200 provides a final check of the filled pouches before the pouches are distributed. The verification system 200 is provided downstream of the dispenser (that is, the manifold 150 and the receptacle 160)...'
  • Kim Technical Solution: 'The drug package introducing unit comprises an introduction plate extending from one side of the body to the drug package winding unit to link the one side of the body with the drug package winding unit'
  • Office action: '...as the modification readily leads one to incorporate an inspection station in a packaging section (to form "P" of Kim; as taught by Holmes) upstream of the winding apparatus (1) of Kim.'
MPEP § 2143.01 — a §103 combination must rest on articulated reasoning with a rational underpinning, not hindsight; see also § 2145 (attacking the combination as a whole) and § 2141.02 (reference considered in its entirety).

⚠ Risk The examiner will likely respond that relocating an inspection station upstream of winding is a predictable rearrangement and that Holmes' inspection concept is not tied to a specific location. Prosecution-history-estoppel caution: arguing the invention requires inspection strictly upstream of and feeding into the winding platform characterizes the claim in a way that may narrow scope in the file wrapper.

Likely examiner response survives — moderate

The rejection is a §103 combination, so a single reference need not show inspection-then-feed arranged as in claim 10; under KSR / MPEP § 2143 bodily incorporation of Holmes into Kim is not required. Kim 2013 already supplies the introduction plate that feeds the strip to the winding unit, and Holmes supplies an inspection of the filled/sealed pouches before they are distributed. An examiner can articulate that a PHOSITA integrating Holmes' pre-distribution verification into Kim's line would position the inspection before the winding stage — so that the same introduction-plate feed Kim already discloses becomes a feed 'from' the inspection station. Holmes' label 'downstream of the dispenser' does not foreclose being upstream of the winding platform; those describe two different reference points, and the ordered claim language (inspect, then feed) can be met by the combined architecture rather than by either reference alone.

How to adjust The live gap is the ARTICULATED reasoning for the specific ordered arrangement — inspect each pouch first, then feed the strip out of the inspection station into the winding platform — not the mere absence of the arrangement in one reference (attacking references singly is a losing posture per MPEP § 2145). Press that the OA's statement the modified device 'would readily feed the strip... to platform 11' is a bare conclusion lacking a rational underpinning (MPEP § 2143.01), and that placing inspection upstream of winding may change Holmes' principle of operation (its verification is a final check before distribution). If the examiner can supply a clean quality-control motivation for inspect-before-wind, consider an amendment tightening the 'from the inspection station' feed geometry to a structurally distinct upstream station.

2

VERIFY-FIRST: distinct-/parallel-axis geometry not present in the retrieved Kim text (claims 1, 10)

Missing elementClaim 1Claim 10

Strategy check: re-ranked from #8 — The current top for claim 1 (rank 5, 'generally horizontal') is a §112(b) definiteness point that cannot withdraw the §102 anticipation, so it cannot carry the claim; only the axis-geometry attack (rank 8) reaches the operative rejection, and its mapping-defeating potential outweighs the definiteness point despite the verify-first flag.

a drive unit having an output axis of rotation that is different than the first axis of rotation ... and a linear actuator that defines a second axis that is parallel to but different from the first axis and the output axis

The examiner maps these limitations to Kim's pulley 233, ¶¶0089/0094/0153, numerals 231/253/257, and an annotated Fig. 3b. The Kim detailed description containing those passages is NOT in the record provided; the retrieved Kim claims recite only 'a bobbin rotating part to rotate the drug bobbin part' and a 'backward and forward movement part' without specifying any axis offsets. Because the relied-on passages are absent from the record, this CANNOT yet be declared a confirmed absence — counsel should OBTAIN AND VERIFY Kim's full detailed description and Figs. 3a-3d before asserting the §102 case fails on the offset-output-axis and parallel-second-axis geometry. If verification shows Kim does not disclose the claimed axis arrangement, this would go to the heart of the anticipation rejection of independent claim 1; until verified it must sort below every fully-grounded argument above.

  • Kim retrieved claim 1: 'a bobbin rotating part to rotate the drug bobbin part; and a bobbin backward and forward movement part to move the drug bobbin part forward or backward.'
  • Office action: 'the "a bobbin rotation driving unit 231" is connected to the bobbin housing by pulley 233 which thereby will rotate about different axis; Para. 0089, 0094, 0153.'
  • OA2/OA3 note: the provided Kim text does not contain the detailed description with reference numerals (e.g., 11, 210a/210b, 231, 233, 257) or the cited paragraphs/figures.
MPEP § 2131 — anticipation requires that a single reference disclose every element arranged as in the claim.Evidence needed: Obtain and review Kim (US 2013/0264376) full detailed description and Figs. 3a-3d to confirm whether the distinct-output-axis and parallel-second-axis geometry is actually disclosed before relying on this distinction.

Risk If Kim's Figs. 3a-3d and ¶¶0089/0094/0153 do disclose the offset output axis and parallel second axis, this argument evaporates. Do NOT assert the limitation is missing until the full Kim disclosure is reviewed — a premature absence assertion the reference contradicts would damage credibility.

3

'Fixed relative to' has a reasonably certain construction (claims 4, 13)

Definiteness rebuttalClaim 4Claim 13Rebuts: §112(b) rejection of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

the drive unit is fixed relative to the linear actuator and the pins

The examiner reads 'fixed relative to' as inconsistent with the pins moving between extended and retracted states while the drive unit and actuator are wall-mounted. For counsel to weigh arguing that under BRI 'fixed relative to' denotes a fixed mounting/kinematic relationship in a given operative state or in a particular degree of freedom, not that the pins are immobile in all respects, so the scope is reasonably certain under § 2173.02. Notably the examiner himself applied a determinate interpretation in the prior-art mapping ('when linear actuator/driving unit 257 is not actuated, the drive unit 231 and the pins are readily fixed'), which supports that the term is amenable to a single reasonable construction rather than being irreducibly unclear.

  • Office action (claim 4): 'it is unclear to how the drive unit is fixed relative to the pins as the pins are shown as moving between an extended and retracted state (Figures 7-10) while the drive unit (i.e. motor 60) and linear actuator (36) are fixed to a wall (32).'
  • Office action (§102 claim 4): 'note when linear actuator/driving unit 257 is not actuated, the drive unit 231 and the pins are readily fixed relative to the drive unit 231.'
MPEP § 2173.02 — claim construction under BRI; § 2173.06 — compact prosecution (a paired art rejection is proper).Evidence needed: Point to the as-filed specification passages (not in the provided record) that define the fixed drive-unit relationship.

⚠ Risk The examiner may respond that the availability of two readings itself shows a Miyazaki plural-construction problem. Do not argue the §112(b)+§102 pairing is inconsistent — that is a losing point. Prosecution-history-estoppel caution: adopting a narrowing construction of 'fixed relative to' could estop a broader reading.

Likely examiner response survives — strong

An examiner could invoke the Miyazaki prong of MPEP § 2173.02 — that 'fixed relative to' is amenable to more than one plausible construction (fixed in all respects versus fixed only in a particular state or degree of freedom) — and argue the term conflicts with pins that move between extended and retracted positions, so the scope is not reasonably certain. The examiner may also say that applying a determinate interpretation in the prior-art mapping was done under compact prosecution's 'reasonable interpretation' directive (MPEP § 2173.06(II)) and does not concede the term is definite.

How to adjust This is the best-positioned construction contest: the record shows the examiner himself applied a single determinate reading ('when linear actuator/driving unit 257 is not actuated, the drive unit 231 and the pins are readily fixed'), which cuts hard against a Miyazaki 'multiple plausible constructions' finding. Press that the examiner's own operative-state reading demonstrates a single reasonable construction, and reinforce with spec support for the fixed mounting/kinematic relationship. A win here may also moot Argument 4. Well suited to an interview.

4

'Generally horizontal' is a definite term of approximation under the examination standard (claims 1, 10)

Definiteness rebuttalClaim 1Claim 10Rebuts: §112(b) rejection of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

between two generally horizontal pins

The examiner found 'generally horizontal' indefinite under §112(b) because it is unclear what variations from horizontal the word 'generally' encompasses. Under the examination standard (MPEP § 2173.02; In re Packard; Ex parte Miyazaki), a term of approximation is permissible where a PHOSITA can ascertain its scope with reasonable certainty. For counsel to weigh arguing that 'generally horizontal' conveys an orientation that is horizontal within ordinary manufacturing tolerances relative to the platform, and to point to the specification's description of the pins and platform to supply the reference frame. This is a construction contest and does not challenge the propriety of the paired §102/§103 rejection (compact prosecution permits both).

  • Office action (claim 1): 'This limitation renders the claim indefinite as it is not clear what "generally horizontal" is intending to encompass. Specifically it is unclear what variations from "horizontal" the term "generally" is encompassing.'
MPEP § 2173.02 — In re Packard / Ex parte Miyazaki examination standard for definiteness; § 2173.05(b) — terms of degree.Evidence needed: Identify the as-filed specification passages (not present in the provided record) that supply a reference frame / tolerance standard for 'generally horizontal.'

⚠ Risk The examiner may maintain that no standard for measuring 'generally' is supplied and invite amendment to a definite orientation. Do NOT cite Nautilus 'reasonable certainty' — that is the litigation standard. Prosecution-history-estoppel caution: narrowing 'generally horizontal' to a specific orientation could estop a later broader reading.

Likely examiner response survives — moderate

Under In re Packard / MPEP § 2173.02, 'generally horizontal' contains a term of approximation whose boundary is unclear — it does not identify what angular deviation from horizontal 'generally' permits — and an examiner can maintain the indefiniteness finding unless the specification supplies an ascertainable reference frame or tolerance. Pointing to the spec's description of the pins and platform only helps if that description actually fixes the orientation; if the spec uses the same approximation language without a metric, the Packard 'unclear term' prong is not overcome, and attorney argument that a PHOSITA would understand ordinary manufacturing tolerances is not itself record support.

How to adjust Correctly framed on the examination standard (Packard/Miyazaki, not Nautilus) — keep it there. Shore it up by pin-citing the specification passages that supply the horizontal reference frame for the pins relative to the platform; terms of approximation are routinely definite when the spec anchors them. Given this examiner's high interview rate (69%, with allowance following 97% of interviewed cases — correlation only), a term-of-approximation construction point is well suited to an interview. If the spec supplies no reference frame, amendment to a determinate orientation may be cleaner than arguing.

5

Kim 2006 addresses a different purpose (excising defective packets), undercutting the inspect-before-cut rationale (claims 5-6)

Conclusory rationaleClaim 5Claim 6Rebuts: §103 rejection of claims 5, 6

the step of inspecting contents of each pouch of the strip of pouches prior to step (c), the inspecting being carried out by an automated inspection station

Kim 2006 (fully grounded) is directed to detecting and REMOVING defective packets from an already-formed, conveyed series: a cutter (60) cuts the packet judged defective and a separating/discharging device (70) collects it. Its cutting therefore serves defect excision, a different function than claim 5's cutting step (c), which forms a strip SEGMENT having a lagging end. The examiner's rationale that inspecting before cutting lets 'the noted defective pouches... be readily removed by the cutting after inspection' appears to conflate Kim 2006's defect-excision cut with Kim 2013's segment-forming cut. Combined with Argument 1 (Holmes' inspection is downstream), for counsel to weigh whether the three-reference combination supplies an articulated rational underpinning for inspecting each pouch of a strip prior to the segment-forming cut, or whether the motivation is conclusory.

  • Kim 2006 abstract: 'A medicine inspection system for detecting a defective medicine packet from a series of packaged medicine packets is disclosed.'
  • Kim 2006 claim 6: 'a medicine packet cutter installed at the side of the conveyor and cutting the medicine packet determined as a defective medicine packet by the image reader by a cutter blade moving up and down.'
  • Office action rationale: '...by inspecting the pouches prior to cutting, the noted defective pouches can be readily removed by the cutting after inspection as taught by Kim 2006 (Para. 0059, 0060, 0094).'
MPEP § 2143.01 / § 2145 — articulated reasoning required and combination considered as a whole; § 2141.02 — a reference must be read in its entirety, including its actual purpose.

⚠ Risk The examiner may respond that Holmes alone supplies the inspection step and Kim 2006 is merely cumulative on 'inspect before cut,' so any purpose mismatch is harmless. Prosecution-history-estoppel caution: arguing the claimed cut differs in purpose from Kim 2006's defect-excision cut may narrow the construction of 'cutting.'

Likely examiner response survives — moderate

A reference's different stated purpose does not defeat obviousness; Kim 2006 is relied on for its teaching to inspect pouch/packet contents before a cutting operation, and the claim's cutting step (c) does not recite any purpose that distinguishes it from a cut. An examiner can respond that arguing Kim 2006 serves defect-excision attacks the reference individually while the rejection rests on the combination (MPEP § 2145): Kim 2013 supplies the segment-forming cut, Kim 2006 supplies the inspect-before-cut sequence and a quality-control motivation, and combining known elements to yield the predictable result of not winding defective pouches is a proper § 2143(A) rationale. That Kim 2006's own cut removes a defective packet is exemplary of why inspecting before cutting is beneficial, not a limitation on the teaching.

How to adjust Do not rest on Kim 2006's different function alone. The stronger line is that the examiner's stated rationale conflates two structurally different cuts — Kim 2006's excision cut on an already-formed conveyed series versus Kim 2013's boundary/segment-forming cut — so the reasoning that 'defective pouches can be readily removed by the cutting after inspection' does not actually explain why a PHOSITA would inspect EACH pouch of a strip before the segment-forming cut (MPEP § 2143.01, rational underpinning). Frame it as a gap in the articulated reasoning tying inspection to the specific claimed cut, and pair with Argument 1's architecture point rather than as a standalone teaching-away.

6

In re Japikse 'rearrangement' rationale for the fixed drive-unit relationship may lack a rational underpinning (claims 4, 13)

Conclusory rationaleClaim 4Claim 13

the drive unit is fixed relative to the linear actuator and the pins

The alternative §103 basis rests on In re Japikse (rearranging parts is routine) coupled with the assertion that applicant 'has not disclosed any criticality.' For counsel to weigh whether the claimed fixed relationship is a mere rearrangement of Kim's existing parts or a functional relationship that changes operation, since the Japikse rationale requires that the rearrangement not modify how the device operates. This argument is secondary to resolving the §112(b) construction of the same limitation (Argument 6); a construction win there may moot the need to reach the Japikse point.

  • Office action: 'it would have been obvious... to have arranged the drive unit and/or the linear actuator to comprise such a relatively fixed arrangement, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.'
MPEP § 2144.04(VI)(C) — rearrangement of parts; § 2143.01 — rational underpinning required.Evidence needed: A § 1.132 declaration (if counsel elects to contest rather than amend) showing the fixed drive-unit relationship produces a functional difference / criticality rather than a mere rearrangement.

Risk Absent a showing that the fixed relationship yields a functional difference, the examiner will maintain Japikse and note the admitted lack of disclosed criticality. If counsel elects to contest rather than amend, a declaration may be required.

Likely examiner response survives — moderate

Under In re Japikse, rearrangement of parts that does not change how the device operates is prima facie obvious, and the applicant bears the burden to show criticality of the claimed fixed drive-unit relationship; attorney argument that it is a 'functional relationship' is not evidence (MPEP § 2145). Absent a showing that fixing the drive unit relative to the actuator and pins changes operation or yields an unexpected result, an examiner can maintain the Japikse rationale as articulated.

How to adjust The Japikse rationale requires that the rearrangement NOT modify how the device operates — so the productive lever is a concrete showing (from the spec, or a § 1.132 declaration) that the fixed relationship changes the actuator/pin kinematics, not a bare assertion of functionality. As the argument itself notes, this is secondary to the §112(b) construction of the same term (Argument 6): a construction win there may moot the need to reach Japikse. Sequence it behind Argument 6.

7

Conclusory 'repeat the process' rationale for extending pins and re-running the cycle (claims 8-9, 14-15)

Conclusory rationaleClaim 8Claim 9Claim 14Claim 15

the step of extending the first and second pins after step (e) ... and repeating steps (a)-(e) for a subsequent strip of pouches

The examiner supports the extend-pins-and-repeat limitations solely on Kim's general statement that it winds and cuts several packages of drugs. For counsel to weigh whether this is an articulated rational underpinning for the specific claimed sequence — re-extending the pins to the extended position after retraction/disengagement, then repeating the full feed-wind-cut-retract cycle — or a conclusory assertion. Note that the 'extending' step depends on Kim's retract/extend pin mechanism, which itself rests on the truncated detailed-description passages flagged in Argument 8; counsel should confirm that disclosure. This is a lower-priority, combination-rationale attack secondary to the independent-claim challenges.

  • Office action: 'Kim outlines winding and cutting several packages of drugs (see Para. 0001). Therefore, it would have been obvious... to have extended the pins and repeated the steps outlined in Claim 1...'
  • Kim retrieved claim 1: 'a bobbin rotating part to rotate the drug bobbin part; and a bobbin backward and forward movement part to move the drug bobbin part forward or backward.'
MPEP § 2143.01 — the reasoning to modify must be articulated with a rational underpinning.

⚠ Risk Repetition of a disclosed cyclic process is frequently treated as within routine skill, so this is likely a weak standalone attack; the examiner will point to Kim's stated multi-package operation. Minimal prosecution-history-estoppel exposure.

Likely examiner response fragile — the comeback likely defeats it

Kim 2013 expressly states it winds and cuts several packages of drugs, so cyclic repetition of the feed-wind-cut sequence is inherent in a machine designed to process multiple rolls, and re-extending retractable pins to begin the next cycle is the ordinary operation of the very retract/extend mechanism Kim already discloses (MPEP § 2143(A), predictable result). An examiner can characterize 'extend the pins and repeat steps (a)-(e)' as nothing more than running the disclosed apparatus again, which needs no separate motivation.

How to adjust This limitation likely rises or falls with the underlying pin retract/extend disclosure, which OA2/OA3 flag as resting on Kim's truncated detailed description not in the record. Before pressing, counsel should confirm from Kim's full detailed description whether the extend-after-retract-then-repeat sequence is actually disclosed; if it is, the conclusory-rationale attack has little to hold. Treat as a secondary/dependent-claim point contingent on the independent-claim outcome, or reserve for amendment adding cycle-specific structure.

8

'The step of' recitations introduce and define the step in the same clause (claims 2, 5, 8, 11, 14)

Definiteness rebuttalClaim 2Claim 5Claim 8Claim 11Claim 14Rebuts: §112(b) rejection of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

further comprising the step of securing / inspecting / extending ... [the lagging end / contents / the pins]

The examiner rejected these recitations for lack of antecedent basis, reading 'the step of' as a back-reference to a previously defined step. For counsel to weigh arguing that each recitation both INTRODUCES and DEFINES its step within the same clause (e.g., 'the step of securing the lagging end...'), so the scope is reasonably certain and no antecedent is required. This is the weakest of the indefiniteness grounds and the cleanest resolution is a minor amendment (e.g., deleting the article) that does not narrow scope; for counsel to weigh argument versus amendment for compact prosecution.

  • Office action (claim 2): 'the claim recites "the step of securing", however, this step lacks antecedent basis within the claim and therefore renders the claim indefinite.'
MPEP § 2173.02 — examination definiteness standard; § 2173.05(e) — lack of antecedent basis.

⚠ Risk The examiner is likely to maintain the formality; the downside of a minor amendment is low. Minimal prosecution-history-estoppel exposure if only the article is deleted.

4.

Examiner's Characterization of the Cited Art

Note

What each cited reference actually discloses, checked against what the examiner said it teaches — limited to the reference text available to the analysis.

Kim (US 2013/0264376)

US 2013/0264376Claim text retrieved

Kim discloses a drug package winding apparatus that introduces a continuously-packaged strip of drug packs via an introduction plate to a winding unit, winds the strip around a drug bobbin part having two winding members arranged up and down, cuts the boundary between packs, attaches a sticker to the cut end portion to make a bundle, and discharges the wound roll. The bobbin part is rotated by a bobbin rotating part and can be moved forward/backward (and left/right) by dedicated movement parts, with a 'separation position' where the wound roll is separated from the winding members as the bobbin moves rearward. The available text is limited to the abstract, claims, and portions of the description (Technical Field, Background, Disclosure/objects, and Technical Solution prose); it does NOT contain the detailed description with the reference numerals (e.g., 11, 210a/210b, 231, 233, 257) or the specific paragraph/figure citations the examiner relies upon.

Claim elementExaminer assertsReference disclosesEvidence
Claim 1(a) — feeding a leading end along a platform and between two generally horizontal pins, with a first pin above the platform and a second pin below the platform (mapped to introduction plate 11 and winding members 210a/210b; Fig. 7, ¶0149)Kim's introduction plate 11 is the platform and winding members 210a/210b are the two generally horizontal pins, with one pin extending above and one below the platform, per Fig. 7 and ¶0149.Partially supportedAvailable text supports a platform and two vertically-arranged members: "an introduction plate extending from one side of the body to the drug package winding unit" and "two winding members that are arranged up and down," with "A space between the upper and lower winding members maintains a level with respect to the introduction plate." However, the specific above/below-the-platform geometry the examiner draws from Fig. 7 and ¶0149 (and the numerals 11/210a/210b) is not present in the available claims/abstract/excerpt; the full specification and drawings should be checked.
Claim 1(b) — rotating the pins about a first axis, driven by a drive unit having an output axis of rotation different than the first axis (mapped to bobbin rotation driving unit 231 connected by pulley 233; Fig. 3b, ¶0089, 0094, 0153)A bobbin rotation driving unit 231 connected by pulley 233 rotates the bobbin about a first axis while the driving unit's output axis is different from the first axis.Partially supportedThe general rotation is supported: "a bobbin rotating part to rotate the drug bobbin part." The specific assertion of a separate output axis distinct from the first axis (via pulley 233, ¶0089/0094/0153, Fig. 3b) is not found in the available text (claims/abstract/excerpt), which does not disclose the numerals or the axis relationship; the detailed description and Fig. 3b should be checked.
Claim 1(e) — with a linear actuator defining a second axis parallel to but different from the first axis and the output axis, retracting the pins to disengage the coiled strip segment (mapped to backward and forward driving unit 257; Annotated Fig. 3b, ¶0164)A backward and forward driving unit 257 defines a second axis parallel to (but different from) the first and output axes and retracts the pins to disengage the coiled roll.Partially supportedDisengagement by rearward movement is supported: "a bobbin backward and forward movement part to move the drug bobbin part forward or backward" and "a separation position where a wound drug package roll is separated from the upper and lower winding members ... as the drug bobbin part is moved to the rear portion of the body." The specific 'second axis parallel to but different from the first axis and the output axis' geometry (from Annotated Fig. 3b, ¶0164) is not found in the available text; the detailed description and figures should be checked. Note also that Kim describes the winding members themselves moving/pivoting, which counsel may weigh against a simple retraction-only characterization.
Claim 10 steps (b)-(f) — same mappings as claim 1(a)-(e)Kim discloses the same feeding, rotating, cutting, continuing rotation, and retracting limitations as mapped for claim 1.Partially supportedSee the claim 1(a)-(e) findings above: feeding/platform, general rotation, cutting, and rearward-separation disengagement are corroborated in the available prose, while the specific axis-relationship geometry (output axis different from first axis; second axis parallel to both) and the 'continuing until lagging end reaches pins' sequence are not found in the available claims/abstract/excerpt and depend on figures/paragraphs outside the provided text.
Claim 1(d) — continuing to rotate the pins until the lagging end reaches the pins to form a coiled strip segment (¶0076, 0163)Rotation continues until the lagging end reaches the pins, forming a coiled segment, with the sticker/lagging end attached to the wound package.Not found in available textThe available text does not contain this specific sequence (continuing rotation until the lagging end reaches the pins). The cited ¶0076 and ¶0163 are outside the provided excerpt; the full specification should be checked.
Claim 4 — the drive unit is fixed relative to the linear actuator and the pins (mapped to 231 fixed relative to 257 and 210a/210b when 257 is not actuated)When the backward/forward driving unit 257 is not actuated, drive unit 231 and the pins are fixed relative to one another.Not found in available textThe available text does not describe the relative-fixation relationship among the rotating drive, the forward/backward movement unit, and the winding members. Indeed the available text shows multiple relative movements (bobbin moves forward/backward and left/right, and the upper winding member pivots up and returns via a "leaf-spring member"), which counsel may weigh against a fixed-relationship reading. The specific 'fixed relative' assertion is not found in the provided text; the detailed description should be checked. (This element is also the subject of the examiner's own §112 indefiniteness rejection.)
Claim 13 (§103) — drive unit fixed relative to linear actuator and pinsSame as claim 4; alternatively obvious to rearrange parts to a fixed relationship (In re Japikse).Not found in available textAs with claim 4, the fixed-relationship arrangement is not described in the available text, which instead shows multiple relative movements of the bobbin and winding members; the full specification should be checked.
Claim 3 — securing the lagging end with tape (mapped to sticker S; ¶0163)The sticker S constitutes 'tape.'Partially supportedThe available text describes a "sticker" (unwound from a release paper), not "tape": e.g., "a wound sticker roll formed by winding a release paper to which stickers ... are consecutively attached." Whether a 'sticker' reads on the claimed 'tape' is a claim-construction point for counsel to weigh; the text supports 'sticker' but does not use the term 'tape.'
Claims 8-9 (§103) — extending the pins after step (e) and repeating steps (a)-(e) for a subsequent strip (rationale from ¶0001, producing rolls for different patients)Kim outlines winding and cutting several packages of drugs, so it would be obvious to extend the pins and repeat the method to produce subsequent wound rolls for different patients.Partially supportedThe underlying teaching of handling multiple patient packages is supported: Technical Field states the apparatus is "capable of winding and cutting the packages of drugs, which are continuously packaged in large quantity based on prescriptions, according to patients." The specific act of 'extending the pins after retraction and repeating the steps' is an examiner obviousness rationale, not an express disclosure found in the available text; whether the express repeat/extend sequence appears is for the full specification to confirm.
Claims 11-12 (§103) — securing lagging end with sticker S / sticker as tapeSame as claims 2-3: sticker S secures the lagging end and constitutes tape.Partially supportedSecuring via sticker is supported (Abstract; Technical Field 'make a bundle'); the equation of 'sticker' with 'tape' is a construction point, as the text uses only 'sticker.' See claim 2/3 findings.
Claim 1(c) — cutting the strip at a desired location to form a strip segment having a lagging end (mapped to cutting via element 30; ¶0076, 0113)Kim's cutting unit (30) cuts the strip to form a strip segment with a lagging end ('the end portion').SupportedAbstract: "a drug package cutting unit to cut a boundary between one side pack and an opposite side pack" and "attach a sticker to an end portion of the drug package cut." The existence of a cutting unit producing a cut end portion is supported; the numeral 30 and ¶0076/0113 are not in the available text but the concept is corroborated.
Claim 2 — securing the lagging end of the strip segment to a remaining portion (mapped to sticker S; ¶0163)The end portion is attached with sticker S, securing the lagging end to the wound package.SupportedAbstract: "a sticker attaching unit to attach a sticker to an end portion of the drug package cut," and Technical Field: "attaching a sticker to the cut drug package to make a bundle of a wound drug package roll." Concept of a sticker securing/bundling the end portion is supported.
Claim 7 — each pouch contains one or more medicaments (¶0073)The packs contain a 'dose of drugs.'SupportedClaim 1/Abstract: "a single pack having a dose of drugs." Directly supported.

Holmes (US 2023/0211912)

US 2023/0211912Claim text retrieved

Holmes discloses an automatic pharmacy packager (100) with a packaging unit (120) that dispenses pharmaceuticals into pouches formed and heat-sealed from two feed stock rolls, and a verification system (200) that checks the filled pouches using a camera system (visible and infrared), a heat source, a visible light source, and an electronic processor. The verification system is expressly positioned downstream of the dispenser and performs a 'final check of the filled pouches before the pouches are distributed,' capturing images to inspect pouch contents (including through opaque foil via IR/heat). In Holmes, pouches are filled and sealed and, in at least some examples, wrapped/spooled onto a take-up roll, and the verification system monitors and checks the pouches as they are spooled or dispensed.

Claim elementExaminer assertsReference disclosesEvidence
feeding the leading end of the strip from the (automated) inspection station to the platform — i.e., inspection located upstream of the winding/coiling and prior to cuttingAs modified, Kim would feed the strip of pouches from the inspection station upstream to platform 11; the inspection station is incorporated in the packaging section upstream of the winding apparatus.Partially supportedHolmes affirmatively places its verification system DOWNSTREAM of the dispenser and inspects pouches AFTER they are filled and sealed, and in at least some examples AFTER spooling: "The verification system 200 is provided downstream of the dispenser" and "Once filled and sealed, the pouches are wrapped around the take-up roll ... the verification system 200 to monitor and check the pouches as they are spooled onto the take-up roll or dispensed." For counsel to weigh under MPEP § 2141.02 (reference considered in its entirety): Holmes' own arrangement (verification after sealing/spooling) differs from the claimed inspection upstream of and prior to the cutting/coiling; the examiner leans on Kim 2006 rather than Holmes for the 'prior to cutting' placement.
inspecting contents of each pouch of a strip of pouches, carried out by an automated inspection station (claims 5-6 step; claim 10 step (a))Holmes teaches inspection device 200 for inspecting contents of each pouch 300, carried out by an automated inspection station 200 (Para. 0031, 0040-0041, Figs. 5a-5b).Supported"The verification system 200 provides a final check of the filled pouches before the pouches are distributed"; verification uses a camera system and electronic processor (claims 1, 11; Fig. 4 control system 400). Note: the examiner's specific paragraph numbers (¶0031, ¶0040-0041) cannot be verified against the available excerpt, which lacks paragraph numbering, but the substantive teaching of automated inspection of pouch contents is present.
motivation — improperly filled pouches can be readily discarded prior to distribution (Para. 0041)By modifying Kim in this manner, improperly filled pouches can be readily discarded prior to distribution as taught by Holmes (Para. 0041).Not found in available textThe available excerpt describes a 'final check ... before the pouches are distributed' but does not contain an express teaching of discarding improperly filled pouches; the excerpt is truncated at 'The pouches then pass the camera' before reaching the content the examiner attributes to ¶0040-0041. The full specification should be checked for the discard/rejection teaching.
inspecting prior to discharge from the packaging machineHolmes inspects contents of each pouch prior to discharge of the pouch 300 from a packaging machine 100.Supported"The verification system 200 provides a final check of the filled pouches before the pouches are distributed."

Kim 2006 (US 2006/0271237)

Kim 2006 discloses a system for detecting a defective medicine packet from a series of continuously-connected medicine packets. A conveyor (10) moves the series past a camera (20) with a backlight (21), and an image reader (30) extracts packet information from printed characters and analyzes tablet number/condition to determine whether a packet is defective. Where a packet is judged defective, a cutter (60) with an up/down cutter blade cuts that packet, and a separating/discharging device (70) with a shutter separates and collects the defective packet from the normal packets. The system is directed to detecting and removing DEFECTIVE packets, not to forming a coiled roll segment.

Claim elementExaminer assertsReference disclosesEvidence
inspecting pouches at an inspection station (20, 30) to determine if the pouches are defectiveKim 2006 teaches inspecting the pouches (P) at an inspection station (20, 30) and determines if the pouches are defective (Para. 0047-0053).SupportedAvailable text describes camera (20) capturing images and image reader (30) that "compares and analyzes the tablet conditions with the medicine packet information to determined whether the number of tablets is correct and the tablets are damaged or not." (The specific cited paragraph numbers 0047-0053 are not present in the truncated excerpt, but the substance is affirmatively in the available text.)
the inspecting occurs prior to a cutting step (at 60)Kim 2006 teaches that the inspecting (via 20, 30) occurs prior to a cutting step (at 60).SupportedAvailable text: cutter (60) is described "cutting the medicine packet determined as a defective medicine packet by the image reader 30" — the cut is triggered by, and therefore follows, the image reader's determination. For counsel to weigh: in Kim 2006 the cutting severs a DEFECTIVE packet for removal, a different cutting purpose than applicant's cutting to form a strip segment.
combination rationale — pouches inspected 'at a high rate' and defective pouches 'readily removed by the cutting after inspection'By modifying Kim 2013' in this manner, the pouches can be inspected at a high rate and further, by inspecting the pouches prior to cutting, the noted defective pouches can be readily removed by the cutting after inspection as taught by Kim 2006' (Para. 0059, 0060, 0094).Partially supportedThe 'defective pouches removed by the cutting after inspection' portion is affirmatively supported (cutter 60 cuts the packet 'determined as a defective medicine packet,' and device 70 separates/collects it). The 'inspected at a high rate' / speed advantage is NOT found in the available text; the cited paragraphs (0059, 0060, 0094) fall beyond the truncated excerpt and cannot be verified from the text provided — the full specification should be checked. For counsel: the cited passages describe cutting to REMOVE defective packets, not cutting to define a coiled strip segment at a desired location.
5.

Element-by-Element Claim Chart

Claim 1 — §102 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
feeding a leading end of a strip of pouches along a platform and between two generally horizontal pins located adjacent the platform and in an extended position, with a first pin extending above the platform and a second pin extending below the platformKimArguably disclosedThe available Kim text supports a strip fed along an introduction plate to a bobbin part having upper/lower winding members maintaining a level with the plate — conceptually one member above and one below. However, the examiner's specific supports (Fig. 7; ¶¶0088, 0149; reference numerals 11, 210a/210b) are NOT present in the provided Kim text, whose detailed description is truncated (per OA2). Also note the pending independent §112(b) rejection of 'generally horizontal' — a scope question for counsel to weigh, separate from the art.Kim, Abstract (drug package introduced via body/introducing unit); Kim, Technical Solution ('A space between the upper and lower winding members maintains a level with respect to the introduction plate.'); Kim, claim 7 (bobbin housing with 'two winding members that are arranged up and down')
rotating the pins about a first axis of rotation to capture the leading end and to form a coiled strip radially outwardly of the pins, the rotation being driven by a drive unit having an output axis of rotation that is different than the first axis of rotationKimArguably disclosedThe available Kim text discloses a bobbin rotating part that rotates the bobbin, but does NOT describe an output axis distinct from the rotation axis. The examiner's basis for the different-output-axis limitation (pulley 233; ¶¶0089, 0094, 0153; annotated Fig. 3b) does not appear in the provided reference text (detailed description truncated per OA2). For counsel: verify whether Kim's full detailed description discloses a drive output axis offset from the bobbin's rotation axis before treating this limitation as met.Kim, claim 1 ('a bobbin rotating part to rotate the drug bobbin part'); Kim, Technical Solution ('a bobbin rotating part to rotate the drug bobbin part')
cutting the strip at a desired location to form a strip segment having a lagging endKimDisclosedKim expressly discloses a cutting unit that cuts the strip; the concept of a resulting cut end ('end portion') is present. The examiner's specific pin-cites (element 30; ¶¶0076, 0113) are not in the available text but the cutting concept is squarely disclosed in the retrieved claims/abstract.Kim, Abstract ('a drug package cutting unit to cut a boundary between one side pack and an opposite side pack'); Kim, claim 1 (drug package cutting unit)
continuing to rotate the pins until the lagging end reaches the pins to form a coiled strip segmentKimArguably disclosedKim winds the strip and attaches a sticker to the cut end portion, implying the trailing/cut end is wound in. The specific 'continuing to rotate until the lagging end reaches the pins' sequence and the examiner's cites (¶¶0076, 0163) are not verbatim in the available text — the timing detail should be verified against the full detailed description.Kim, Abstract (winding then cutting then attaching sticker to the end portion to make a bundle); Kim, claim 1 (winding unit winds the introduced package)
with a linear actuator that defines a second axis parallel to but different from the first axis and the output axis, retracting the pins into a retracted position to disengage the coiled strip segment from the pinsKimArguably disclosedKim discloses a backward/forward movement part and a 'separation position' where the wound roll separates from the winding members as the bobbin moves rearward. Two arguable points for counsel: (1) Kim appears to move the whole bobbin part rearward to separate the roll, whereas the claim recites 'retracting the pins into a retracted position' — whether moving the bobbin reads on retracting the pins is contestable; (2) the 'second axis parallel to but different from the first axis and the output axis' rests on the examiner's annotated Fig. 3b and guide rail 253, none of which appears in the available Kim text. Verify the geometry against the full detailed description.Kim, claim 1 ('a bobbin backward and forward movement part to move the drug bobbin part forward or backward'); Kim, claim 6 (backward and forward driving unit, guide rail, seating plate); Kim, claim 10 ('a separation position where a wound drug package roll is separated from the upper and lower winding members ... as the drug bobbin part is moved to the rear portion of the body')
Claim 2 — §102 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
securing the lagging end of the strip segment to a remaining portion of the strip segmentKimArguably disclosedKim attaches a sticker to the cut end portion to 'make a bundle of a wound drug package roll' (Technical Field), which supports securing the end. Whether attaching a sticker to make a bundle equates to securing the lagging end to a 'remaining portion of the strip segment' is a mapping point for counsel. Note the pending §112(b) rejection ('the step of securing' — antecedent basis) is a separate formal issue.Kim, Abstract ('a sticker attaching unit to attach a sticker to an end portion of the drug package cut by the drug package cutting unit'); Kim, claim 1 (sticker attaching unit)
Claim 3 — §102 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
the securing step comprises securing the lagging end of the strip with tapeKimArguably disclosedThe examiner equates Kim's 'sticker' with 'tape.' Whether a sticker (a release-paper-backed label per Kim claim 25) is 'tape' within the claim's scope is contestable and a claim-construction point for counsel. The examiner's cite (¶0163) is not in the available text, but the sticker concept is disclosed in the retrieved claims.Kim, Abstract (sticker attaching unit / sticker); Kim, claim 25 (release paper to which stickers are attached)
Claim 4 — §102 (Kim); §103 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
the drive unit is fixed relative to the linear actuator and the pinsKimArguably taughtRejected two ways: (i) §102 on the theory the drive unit is fixed relative to the actuator and pins 'when driving unit 257 is not actuated,' and (ii) §103 in the alternative under In re Japikse (rearranging parts). For counsel: the examiner ALSO rejected this same limitation under §112(b) as indefinite in light of the specification (pins move between extended/retracted per Figs. 7-10 while motor 60 and actuator 36 are wall-mounted) — the examiner's own indefiniteness position sits in tension with a firm anticipation mapping. The 'fixed relative ... when not actuated' reading and the specific numerals (231, 257) are not verifiable in the available Kim text.Kim, claim 1 (bobbin rotating part; bobbin backward and forward movement part); Kim, claim 6 (backward and forward driving unit)
Claim 5 — §103 (Kim 2013 in view of Holmes and Kim 2006)
Status glyphClaim elementStatusDisclosure / notesLocation
inspecting contents of each pouch of the strip of pouches prior to step (c) [the cutting]Kim (2013), Holmes, Kim 2006Arguably taughtCombination-based. Holmes supplies inspecting pouch contents; Kim 2006 supplies inspection of the strip and a downstream cutter. For counsel: the 'prior to cutting' sequence relies on Kim 2006, whose cutting (element 60, up/down blade) is for excising DEFECTIVE packets (OA2), not for forming a coiled roll segment as in claim 5 — the ordering-of-operations rationale and the motivation to combine are contestable even though the individual inspecting act is disclosed. Holmes' verification is positioned downstream of the dispenser/during spooling, which counsel may argue is not 'prior to' the roll-forming cut. Note pending §112(b) ('the step of inspecting' antecedent basis) as a separate formal issue.Holmes, claim 1 (verification system with camera inspecting filled pouches); Holmes, claim 2 ('the verification system is provided downstream of the dispenser'); Holmes, DETAILED DESCRIPTION ('The verification system 200 provides a final check of the filled pouches before the pouches are distributed.'); Kim 2006, claim 1 (image reader determines whether tablet number is correct / tablets damaged); Kim 2006, claim 6 (cutter cuts the packet determined defective)
Claim 7 — §102 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
each of the pouches contains one or more medicamentsKimDisclosedSquarely disclosed in the retrieved Kim claims/abstract — each pack holds a dose of drugs.Kim, Abstract ('packaging a great amount of drugs in a unit of a single pack having a dose of drugs'); Kim, claim 1 ('a dose of drugs')
Claim 8 — §103 (Kim)
Status glyphClaim elementStatusDisclosure / notesLocation
extending the first and second pins after step (e) [after retracting]KimArguably taught§103-only. Kim does not expressly disclose re-extending the pins after separation; the examiner relies on Kim's teaching of winding/cutting several packages (¶0001, not in available text but reflected in the Background/Disclosure describing repeated per-patient winding). Kim claim 10's insertion/winding/separation position cycle supports an arguable inference that the bobbin returns forward to receive the next strip. Whether that discloses/renders obvious 'extending the pins' is a point for counsel. Note pending §112(b) ('the step of extending' antecedent basis).Kim, claim 10 ('an insertion position, where the one side of the drug package is inserted between the upper and lower winding members as the drug bobbin part is provided at the front portion of the body and the upper winding member is moved up'); Kim, Disclosure/objects ('to wind and cut a drug package' for multiple patients)
Claim 10 — §103 (Kim in view of Holmes)
Status glyphClaim elementStatusDisclosure / notesLocation
inspecting contents of each pouch, each containing one or more medicaments, carried out with an automated inspection stationKim, HolmesArguably taughtKim supplies the medicament-containing pouches; Holmes supplies an automated inspection/verification station. Motivation per examiner: discard improperly filled pouches (Holmes ¶0041). The inspecting act itself is disclosed by Holmes.Holmes, claim 1 (verification system with camera system inspecting filled pouches); Holmes, DETAILED DESCRIPTION (verification system 200 provides a final check of filled pouches); Kim, claim 1 (dose of drugs in each pack)
feeding a leading end of the strip of pouches FROM the automated inspection station along a platform and between two generally horizontal pins ... (first pin above, second pin below the platform)Kim, HolmesArguably taughtKey combination weakness for counsel: Holmes places its verification system DOWNSTREAM of the dispenser and monitors pouches as they are spooled/dispensed (OA2), i.e., at/after the take-up stage — not clearly as an upstream station that then feeds the strip TO a separate winding platform. The examiner asserts the modified apparatus 'would readily feed the strip from the inspection station ... to platform 11,' but neither Kim nor Holmes is shown in the available text to disclose feeding a strip out of an inspection station and into a downstream winding platform. Contestable positional/architectural mismatch. Both references fully grounded.Holmes, claim 2 ('the verification system is provided downstream of the dispenser'); Holmes, DETAILED DESCRIPTION (pouches wrapped/spooled onto take-up roll; verification monitors pouches as spooled or dispensed); Kim, Technical Solution (introduction plate feeding to winding unit)
rotating the pins about a first axis, drive unit output axis different from first axis; cutting; continuing rotation until lagging end reaches pins; retracting with linear actuator defining a parallel second axis (claim 10 steps (c)-(f))KimArguably taughtThese steps mirror claim 1 elements (b)-(e); see the claim 1 chart for the same arguably_taught analysis and the same verify-first caveats on the distinct-output-axis and parallel-second-axis geometry (examiner's ¶¶0089/0094/0153 and annotated Fig. 3b are not in the available Kim text). OMITTED CLAIMS (8-chart cap): claim 6 (automated inspection station + feeding from station) is subsumed by the claim 10 inspection analysis above; claim 9 (repeating steps a–e) parallels claim 8; claims 11-12 parallel claims 2-3; claim 13 parallels claim 4; claims 14-15 parallel claims 8-9 (examiner's claim 14-15 text is truncated in the record per OA1). Counsel should chart 6, 9, and 11-15 by analogy if needed.Kim, claim 1 (bobbin rotating part; cutting unit; backward and forward movement part); Kim, claim 10 (separation position)

Elements not shown by the cited art (2)

  • Claim 1 — “a drive unit having an output axis of rotation that is different than the first axis of rotation; and a linear actuator that defines a second axis parallel to but different from the first axis and the output axis”: VERIFY-FIRST candidate, not a confirmed absence. Kim is graded fully grounded (claim text retrieved), but the provided Kim text is limited to the abstract, claims, and portions of the description (per OA2) and does NOT contain the passages the examiner relies on for these distinct-axis/parallel-axis limitations (pulley 233; ¶¶0089, 0094, 0153; annotated Fig. 3b; numerals 231/253/257). The retrieved Kim claims describe only 'a bobbin rotating part to rotate the drug bobbin part' and a 'backward and forward movement part' without specifying axis offsets. Because Kim's detailed description is truncated in the record, this limitation cannot be affirmatively declared missing — counsel should obtain and review Kim's full detailed description/Figs. 3a-3d to confirm whether the offset-output-axis and parallel-second-axis geometry is actually disclosed before asserting the anticipation case fails on this element.
  • Claim 10 — “feeding a leading end of the strip of pouches FROM the automated inspection station along a platform to the winding pins (i.e., an inspection station positioned upstream of and feeding into the winding platform)”: Prima-facie-combination-failure candidate on fully-grounded references. Holmes (fully grounded) discloses its verification system 'downstream of the dispenser' (claim 2) that monitors pouches 'as they are spooled or dispensed' — i.e., at/after the take-up/roll-forming stage, not as an upstream station feeding the strip into a separate winding platform. Kim's introduction plate feeds from the body/dispenser, not from an inspection station. Neither asserted reference, on the available text, discloses feeding the strip out of an inspection station and into a downstream winding platform; the examiner's statement that the modified device 'would readily feed the strip from the inspection station to platform 11' appears to be assertion rather than a disclosed arrangement. For counsel to weigh whether the Kim+Holmes combination supplies this positional relationship or whether the motivation/architecture rationale is deficient.
6.

Rejection Map

§112(b)Indefiniteness — claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Multiple indefiniteness grounds: (1) Claims 1 and 10 — 'generally horizontal' is indefinite; unclear what variations from 'horizontal' the term 'generally' encompasses. (2) Claims 2 and 11 — 'the step of securing' lacks antecedent basis. (3) Claim 5 — 'the step of inspecting' lacks antecedent basis. (4) Claims 8 and 14 — 'the step of extending' lacks antecedent basis. (5) Claims 4 and 13 — 'the drive unit is fixed relative to the linear actuator and the pins' is indefinite because the pins move between extended and retracted states (Figs. 7-10) while the drive unit (motor 60) and linear actuator (36) are fixed to a wall (32), making the claimed fixed relationship unclear. (6) Claims 3, 6-7, 9, 12, and 15 are rejected as depending from at least one indefinite claim.

§102Anticipation — claims 1, 2, 3, 4, 7

KimUS 2013/0264376

Kim anticipates under 102(a)(1) and (a)(2). Claim 1: (a) feeding strip of pouches P along introduction plate 11 between winding members 210a, 210b, with one pin above and one below the platform (Fig. 7, Para. 0149); (b) rotating pins via bobbin rotation driving unit 231 connected by pulley 233 about a different output axis (Fig. 3b, Para. 0089, 0094, 0153); (c) cutting strip via element 30 (Fig. 2a, Para. 0076, 0113); (d) continuing rotation until lagging end reaches pins (Para. 0076, 0163); (e) retracting pins via backward and forward driving unit 257, which defines a parallel second axis (Annotated Fig. 3b, Para. 0164). Claim 2: sticker S secures lagging end (Para. 0163). Claim 3: sticker S is tape (Para. 0163). Claim 4: drive unit 231 is fixed relative to linear actuator 257 and pins 210a/210b when driving unit 257 is not actuated. Claim 7: pouches contain dose of drugs (Para. 0073).

§103Obviousness — claims 4, 8, 9MPEP §2143(G)

KimUS 2013/0264376

Claim 4 (alternative to 102): Assuming arguendo the drive unit is not fixed relative to the linear actuator and pins, it would be obvious to arrange them in such a fixed relationship since rearranging parts involves only routine skill in the art (In re Japikse, 86 USPQ 70), and applicant disclosed no criticality for the limitation. Claims 8-9: Kim does not explicitly disclose extending the pins after step (e) and repeating steps (a)-(e) for a subsequent strip. However, Kim outlines winding and cutting several packages of drugs (Para. 0001). Therefore it would be obvious to extend the pins and repeat the steps to produce subsequent wound package rolls for different patients.

§103Obviousness — claims 5, 6MPEP §2143(G)

Kim 2013US 2013/0264376HolmesUS 2023/0211912Kim 2006US 2006/0271237

Kim 2013 does not disclose inspecting pouch contents prior to cutting or an automated inspection station. Holmes teaches inspection device 200 for inspecting contents of each pouch 300 prior to discharge from packaging machine 100, carried out by automated inspection station 200 (Para. 0031, 0040-0041, Figs. 5a-5b). Obvious to incorporate Holmes' inspection into Kim 2013 so improperly filled pouches can be discarded prior to distribution (Holmes Para. 0041). Kim 2006 teaches inspecting pouches at stations 20, 30 to determine if defective (Para. 0047-0053), with inspection prior to cutting at 60. Obvious to incorporate inspection prior to cutting as taught by Kim 2006 so defective pouches can be removed by cutting after inspection (Kim 2006 Para. 0059, 0060, 0094). As modified, the strip would be fed from the inspection station to platform 11 of Kim 2013.

§103Obviousness — claims 10, 11, 12, 13, 14, 15MPEP §2143(G)

KimUS 2013/0264376HolmesUS 2023/0211912

Kim discloses steps (b)-(f) of claim 10 as mapped for claim 1, but does not disclose step (a) — inspecting pouch contents with an automated inspection station. Holmes teaches inspection device 200 for inspecting pouch contents (Para. 0031, 0040-0041). Obvious to incorporate Holmes' inspection into Kim to discard improperly filled pouches (Holmes Para. 0041). As modified, the strip feeds from the inspection station upstream to platform 11. Claim 11: securing lagging end with sticker S (Para. 0163). Claim 12: sticker S is tape (Para. 0163). Claim 13: drive unit 231 fixed relative to linear actuator 257 and pins when not actuated; alternatively, rearranging parts obvious per In re Japikse. Claims 14-15: text of examiner's analysis appears truncated in the record but parallels the treatment of claims 8-9 (extending pins after retraction and repeating the method for a subsequent strip).

References Cited

7.

Record & Grounding

Grounding Summary

Note

How each cited reference was grounded. A reference the analysis could only read through the office action’s characterization is flagged — its findings are limited to what the examiner said, not the reference itself.

DRUG PACKAGE WINDING APPARATUSUS20130264376
Claim text retrieved
VERIFICATION SYSTEM FOR A PHARMACY PACKAGING SYSTEMUS20230211912
Claim text retrieved
System for detecting medicine packetUS20060271237
Claim text retrieved

Data Egress Log

Note

Your uploads stay in-boundary. External retrieval was limited to public patent-number lookups: 3 fetches. No claim text, no client material left the environment.

Documents processed
  • c6d5b37b-4c36-4324-b886-23366d4213db.pdfoffice action
  • 63f176a5-ab5a-46ee-8790-37ed7a268fab.pdfclaims
Processed in-boundary — never transmitted externally.

Obviousness Framework

Field of endeavor
Automated pharmaceutical packaging — specifically methods for forming a coiled/wound segment from a continuous strip of medicament-filled pouches, including feeding, winding on pins, cutting, and disengaging the wound roll, optionally with pouch-content inspection.
PHOSITA
For argument purposes (a proposed construction, not a factual finding): a person with a bachelor's-level degree in mechanical, manufacturing, or packaging engineering (or equivalent hands-on experience) working with automated pharmacy strip/pouch packaging equipment, familiar with strip feeding, winding/coiling mechanisms, cutting stations, actuator and drive-train layouts, and — to the extent inspection is claimed — with machine-vision/verification stations used to check filled pouches. Counsel should adjust the level of skill and the weight given to inspection experience to fit the record and the specification.A construction for argument — not asserted as fact.
ReferenceAnalogous artRationale
Kim (US 2013/0264376)AnalogousSame field of endeavor. Kim is expressly a 'drug package winding apparatus' directed to 'winding and cutting the packages of drugs... according to patients, and attaching a sticker to the cut drug package to make a bundle of a wound drug package roll' (Kim, Technical Field). This is the identical field as the claimed method of forming a coiled segment of a strip of medicament pouches.
Holmes (US 2023/0211912)AnalogousSame field of endeavor (pharmacy packaging) and reasonably pertinent to inspecting filled pouches. Holmes discloses an 'automatic packager for pharmaceuticals' with a 'verification system' that provides, per its description, 'a final check of the filled pouches before the pouches are distributed.' For counsel to note (analysis): Holmes' verification is 'provided downstream of the dispenser' and checks pouches 'as the pouches are spooled onto the take-up roll or dispensed' — its disclosed placement/purpose differs from the claimed pre-cutting, upstream-of-winding inspection, which bears on the combination analysis below rather than on analogous-art status.
Kim 2006 (US 2006/0271237)ContestableArguably same field (handling a series of connected medicine packets) and pertinent to inspecting/cutting pouches. However, for counsel to weigh: Kim 2006 is directed to 'detecting a defective medicine packet from a series of packaged medicine packets' — its cutter 'cut[s] the medicine packet determined as a defective medicine packet' and a separating/discharging device 'separat[es] the defective medicine packet... from the normal medicine packets.' The problem Kim 2006 addresses (defect detection and removal of individual bad packets) is different from the inventor's problem (forming a coiled roll segment). Whether it is 'reasonably pertinent to the particular problem' the inventor faced (MPEP § 2141.01(a), prong 2) is contestable.

§103, claims 4, 8, 9 over Kim alone. Claim 4 (alternative to the §102 anticipation): if the drive unit is not 'fixed relative to' the linear actuator and pins, it would have been obvious to so arrange them as mere rearrangement of parts (In re Japikse). Claims 8-9: extending the pins after step (e) and repeating steps (a)-(e) for a subsequent strip, asserted obvious because Kim winds and cuts several packages.

Kim (US 2013/0264376)

Motivation asserted For claim 4: rearranging parts of an invention involves only routine skill (In re Japikse, 86 USPQ 70), and applicant disclosed no criticality for the fixed relationship. For claims 8-9: Kim outlines winding and cutting several packages of drugs (Para. 0001), so repeating the method to produce subsequent wound rolls for different patients would have been obvious.

  • Othermoderate

    Grounding gap for counsel to confirm: OA2 states that the provided Kim text 'does NOT contain the detailed description with the reference numerals (e.g., 11, 210a/210b, 231, 233, 257) or the specific paragraph/figure citations the examiner relies upon.' The examiner's claim-4 arrangement theory rests on which structures (drive unit 231, actuator 257, pins 210a/210b) move relative to one another; that factual predicate cannot be verified against the record as provided and should be checked against the full Kim disclosure before relying on any rebuttal.

  • Conclusory motivationmoderate

    For claim 4, the In re Japikse 'rearrangement of parts' rationale is a per se-style assertion; MPEP § 2143.01 requires an articulated reason with rational underpinning for why a PHOSITA would adopt the specific fixed relationship. There is internal tension for counsel to exploit: the same limitation is simultaneously rejected under §112(b) as indefinite (the examiner says it is 'unclear... what the claimed relationship is intending to encompass'), yet the §103 rejection presumes a definite arrangement obvious to achieve — the examiner has not reconciled how a relationship it deems unclear can be found obvious to arrive at.

  • Conclusory motivationweak

    For claims 8-9, the citation is to Kim's background (Para. 0001) describing that packages are 'continuously packaged in large quantity based on prescriptions.' Counsel may weigh whether that generic background supplies an articulated reason to (i) re-extend the pins after retraction and (ii) repeat the full cycle, versus being a conclusory duplication rationale. This weakness is comparatively thin because repeating a per-patient winding cycle is arguably the reference's core purpose.

§103, claims 5-6 over Kim 2013 in view of Holmes and further in view of Kim 2006. Kim 2013 lacks a step of inspecting pouch contents prior to cutting via an automated inspection station and feeding from that station to the platform; Holmes supplies the automated inspection station and Kim 2006 supplies the placement of inspection prior to cutting.

Kim (US 2013/0264376) + Holmes (US 2023/0211912) + Kim 2006 (US 2006/0271237)

Motivation asserted Incorporate Holmes' inspection station into Kim 2013 so that 'improperly filled pouches can be readily discarded prior to distribution' (Holmes Para. 0041); and locate the inspection prior to cutting per Kim 2006 so defective pouches 'can be readily removed by the cutting after inspection' (Kim 2006 Para. 0059, 0060, 0094).

  • Destroys principle of operationmoderate

    Holmes' verification system is disclosed as 'provided downstream of the dispenser' performing 'a final check of the filled pouches before the pouches are distributed,' monitoring pouches 'as the pouches are spooled onto the take-up roll or dispensed' (analysis: i.e., at or after the winding/take-up stage). The claims require inspecting each pouch and then feeding the leading end from the inspection station to the platform ahead of the winding pins — i.e., upstream of winding. Counsel may argue the examiner's relocation of Holmes' final, downstream verification to a pre-winding position reworks how Holmes' system is arranged to function, and the examiner has not articulated why that relocation preserves Holmes' operation.

  • Hindsight reconstructionmoderate

    The rationale conflates two functionally different cutting operations. Kim 2006 cuts to excise and discard an individual DEFECTIVE packet ('cutting the medicine packet determined as a defective medicine packet'), whereas Kim 2013's cutting separates a completed per-patient roll ('cut a boundary between one side pack and an opposite side pack'). The examiner's statement that defective pouches 'can be readily removed by the cutting after inspection' appears to borrow Kim 2006's defect-removal purpose to justify placing inspection before Kim 2013's roll-separation cut — a linkage counsel may characterize as supplied by the applicant's own claim structure rather than by the references (MPEP § 2143.01).

  • Conclusory motivationmoderate

    For counsel to weigh: the rejection stacks three references and asserts, without a step-by-step articulated rationale, that a PHOSITA would (a) add Holmes' camera/heat/IR verification station, (b) move it upstream, and (c) sequence it before cutting per Kim 2006. Each modification needs its own rational underpinning under MPEP § 2143/§ 2143.01; a generalized 'inspection stations are well known' statement may be insufficient standing alone.

  • Otherweak

    Grounding note for counsel: as flagged in OA2, the provided Kim 2013 text does not contain the detailed reference numerals or paragraph/figure citations the examiner relies on (including 'platform 11'); the assertion that the modified system would 'feed the strip of pouches from the inspection station... to the platform (11 of Kim 2013')' should be verified against the full disclosure before it is challenged or conceded.

§103, claims 10-15 over Kim in view of Holmes. Kim discloses claim 10 steps (b)-(f) as mapped for claim 1 but lacks step (a) — inspecting pouch contents with an automated inspection station with the leading end fed from that station. Holmes supplies the automated inspection station. Dependent claims 11-15 track claims 2-4/8-9 (securing with sticker/tape; drive-unit-fixed relationship with In re Japikse fallback; extending pins and repeating the method).

Kim (US 2013/0264376) + Holmes (US 2023/0211912)

Motivation asserted Incorporate Holmes' automated inspection station into Kim so 'improperly filled pouches can be readily discarded prior to distribution' (Holmes Para. 0041); as modified, Kim would feed the strip from the inspection station upstream to platform 11.

  • Destroys principle of operationmoderate

    Same concern as in the claims 5-6 rejection: claim 10 requires the leading end of the strip to be fed FROM the automated inspection station to the platform (inspection upstream of winding), but Holmes discloses its verification system as a downstream 'final check... before the pouches are distributed,' operating as pouches are spooled or dispensed. Counsel may argue the examiner relocates Holmes' downstream final-verification function to an upstream feed position without articulating why Holmes' operation is preserved.

  • Conclusory motivationmoderate

    The motivation ('improperly filled pouches can be readily discarded prior to distribution') is drawn from Holmes' own purpose, but the rejection does not articulate why a PHOSITA would restructure Kim's introduction/feed path to place inspection before winding rather than adopting Holmes' disclosed downstream placement. Under MPEP § 2143.01 the reasoning must rest on a rational underpinning tied to the references' actual teachings.

  • Conclusory motivationmoderate

    For claim 13, the rejection repeats the In re Japikse 'rearrangement of parts' fallback used for claim 4, carrying the same conclusory-rationale and §112(b)-tension concerns identified above; counsel should treat it in parallel.

  • Othermoderate

    Record completeness flag for counsel: OA1 itself states the examiner's analysis of claims 14-15 'appears truncated in the record' and merely 'parallels' the claims 8-9 treatment. Because the articulated reasoning for these dependent claims is not fully present in the provided record, counsel should confirm what rationale the examiner actually gave before responding, rather than assuming the parallel.

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