Office Action Analysis — App 19463301 (public record)
Full Analysis

Office Action Response Analysis · Non-Final (CTNF)

App. No. 19/463,301

Art Unit
3731
Examiner
TANZIM IMAM
Mailed
08/11/2026
Response period stated in the OA
“3 months from the mailing date of this communication (08/11/2026)”
Rejections
§112(a) ×1§112(b) ×1§102 ×1§103 ×2
Claims
20 rejected · 20 canceled
Generated
Aug 22, 2026

Several of the top arguments are verification-dependent or correctable rather than merits-dispositive: the Prommersberger point (rank 1) turns on a citation the examiner can fix, and the Schmid point (rank 4) turns on obtaining the full reference — counsel may wish to resolve both factual predicates (obtain the intended Prommersberger surgical reference and the complete Schmid text) before committing to an argue posture. The most durable record-based merits point is the Erneta motivation tension (rank 2, supported by rank 3's framing), which stands on the actual reference text but has a ready examiner rebuttal distinguishing standard from fast-absorbing polyglactin 910, so counsel should weigh whether narrowing the mapping or amending strengthens it. Given the §112 items (rank 5, and the rank-6 antecedent-basis defects) are formal and largely amendment-curable, and given this examiner's documented interview propensity, counsel may consider a combined posture — verify the mis-cited/truncated references, press the surviving merits tension, and clean up the §112 defects by amendment — as considerations for counsel to weigh rather than a recommended position.

Examiner Tanzim Imam (AU 3731): allowance rate 74% (n=348); avg 1.8 OAs to allowance; interviews held in 37% of cases, and when an interview was held allowance followed 92% of the time (correlation, not causation); RCE filed in 37% of cases. Based on n=348 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 21Other§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claims 22, 23§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 24Other§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 25§103 (obviousness)ArgueMissing element (#2)—high
Claim 26§103 (obviousness)ArgueTeaching away (#1)—high
Claims 27, 28§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 29§112(a) (written description / enablement)§112(b) (indefiniteness)§102 (anticipation)ArgueWritten-description rebuttal (#4)—low
Claim 30§112(b) (indefiniteness)§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 31Other§112(b) (indefiniteness)§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claims 32, 33Other§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 34§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 35§112(b) (indefiniteness)§103 (obviousness)ArgueMissing element (#2)—high
Claim 36Other§112(b) (indefiniteness)§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 37Other§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 38§103 (obviousness)ArgueMissing element (#2)—high
Claim 39§112(b) (indefiniteness)§102 (anticipation)ArgueMischaracterized reference (#3)—low
Claim 40§102 (anticipation)ArgueMischaracterized reference (#3)—low
3.

Argument Bank

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

1

Erneta's own Background contradicts the examiner's 'high strength' motivation for polyglactin 910

Teaching awayClaim 26Rebuts: §103 rejection of claim 26

the reinforcement strands comprise polyglactin 910

The examiner combines Erneta to make the reinforcement strands comprise polyglactin 910 on the stated rationale that doing so makes them 'commercially available, fast absorbing, and high strength.' But Erneta's own Background frames the fast-absorbing polyglactin 910 product (VICRYL RAPIDE) as a low-strength deficiency the invention seeks to overcome — it states the fast-absorbing product 'exhibits a tensile strength of about 60 percent of the standard absorbing counterpart.' A reference considered in its entirety, including passages that discredit the very property the examiner relies on, undercuts the articulated motivation to combine (MPEP § 2141.02, § 2145). The 'high strength' underpinning is therefore contradicted by the reference itself, making the stated rationale conclusory or self-defeating as applied (MPEP § 2143.01). This weakness is independent of, and in addition to, the Prommersberger base-reference problem on which claim 26 also depends.

  • Erneta Background: "Commercially available braided fast absorbing suture sold by ETHICON, Inc., ... and known as VICRYL RAPIDE™ (polyglactin 910) Suture exhibits a tensile strength of about 60 percent of the standard absorbing counterpart, Coated VICRYL™ (polyglactin 910) Suture."
  • OA1 Rejection 6 rationale: Erneta relied on "to make them commercially available, fast absorbing, and high strength"
  • OA2 reality check: the Background "frames the fast-absorbing polyglactin 910 product as having reduced strength (about 60 percent of the standard counterpart)"
MPEP § 2145 (teaching away) and § 2141.02 (reference considered in its entirety); see also § 2143.01 (articulated, non-conclusory rationale)

Risk The examiner may reframe the motivation around 'fast absorbing' and 'commercially available' rather than strength, or argue that ~60% strength is still adequate for a strand within a reinforced adjunct. PHE caution: characterizing polyglactin 910 as low-strength on the record could later estop counsel from arguing the claimed strands provide superior strength — weigh whether that concession is acceptable.

Likely examiner response◐ survives — moderate

The examiner can respond that the claim term is 'polyglactin 910,' a genus, and the Erneta Background describes TWO polyglactin 910 products — the fast-absorbing VICRYL RAPIDE (~60% tensile strength) AND the standard-absorbing Coated VICRYL, the higher-strength counterpart. The 60% figure characterizes only the fast-absorbing variant, so the examiner can rest the 'high strength' rationale on standard polyglactin 910 (Coated VICRYL) while relying on polyglactin 910 generally as a known, commercially available, absorbable suture material. A material described as retaining ~60% strength is not necessarily criticized, discredited, or discouraged for use in reinforcement strands (MPEP 2141.02 requires actual discouragement of the claimed path); a comparative strength statement in a Background is not a teaching away from using the genus. The examiner can also note 'commercially available' and 'fast absorbing' remain unrebutted rationales even if 'high strength' is trimmed.

How to adjust Pin down exactly which polyglactin 910 property and which product the examiner's articulated rationale relies on. If the rejection's motivation is tied to the fast-absorbing property, the ~60% strength passage is a genuine internal contradiction worth pressing (MPEP 2143.01/2145). If the examiner can retreat to standard polyglactin 910, this becomes a narrower point — consider whether the claim scope or the specific mapping lets counsel confine the examiner to the fast-absorbing variant. Develop jointly with rank 3, which supplies the evidentiary framing that the passage describes a deficiency.

2

Cited Prommersberger document (US 2007/0175235) is an ice-bagging machine that teaches no reinforcement strands

Missing elementClaim 25Claim 35Claim 38Claim 26

the third layer / reinforcement layer includes a plurality of reinforcement strands

The §103 rejection of claims 25, 35, and 38 rests entirely on 'Prommersberger' supplying the reinforcement-strand limitation, but the document actually retrieved under the examiner's cited number US 2007/0175235 is titled 'Apparatus and method for bagging ice' and is directed to icemakers, hoppers, slider boxes, bagging assemblies, and heat sealers — it discloses nothing about surgical staplers, tissue adjuncts, layers, or reinforcement strands (analysis of the retrieved claims 1-46 and Abstract). Because this reference is fully grounded and the retrieved subject matter is a categorically different field, the reinforcement-strand teaching the examiner attributes to it is absent from the document at that number, so the prima facie §103 case as applied to the retrieved document has no factual support (MPEP § 2143). The same defect cascades to claim 26, which depends on the Prommersberger-supplied strands as its base. Separately, an ice-bagging apparatus is neither in the field of surgical fastening adjuncts nor reasonably pertinent to the inventor's problem, raising a non-analogous-art issue under MPEP § 2141.01(a). This appears to be a publication-number/identity mismatch, so counsel should obtain and verify the examiner's intended Prommersberger surgical reference before finalizing this distinction.

  • Retrieved US 2007/0175235 Abstract: "An ice-bagging apparatus that provides an establishment with the ability to automatically and expeditiously produce, bag and store bags of ice"
  • Retrieved US 2007/0175235 claim 1: "An ice-bagging apparatus, comprising: means for producing ice; means for bagging the produced ice; and means for dispensing the bagged ice."
  • OA2 reality check: "The available text ... contains nothing about surgical staplers, tissue adjuncts, buttress material, layers, sutures, or reinforcement strands ... an apparent identity mismatch"
MPEP § 2143 — a §103 rationale must rest on the prior art actually teaching the limitation; see also § 2141.01(a) (analogous art)

Risk The examiner will most likely respond that the wrong publication number was cited and issue a corrected citation to the intended surgical Prommersberger reference, which may fully cure the defect; counsel should treat this as a mismatch to press for correction, not a merits win. Verify the intended reference's actual teaching before relying on the distinction. No PHE concern since no claim scope is being characterized.

Likely examiner response◐ survives — moderate

The most realistic examiner response is that US 2007/0175235 is a clerical/typographical citation error, not a substantive defect — the surname 'Prommersberger et al.' and the mapped teaching (a surgical adjunct reinforcement layer with a plurality of reinforcement strands) identify the intended reference well enough that the examiner can correct the publication number and reissue or clarify the rejection. Under compact-prosecution practice the examiner would likely fix the record (and, given this examiner's 37% interview rate with a 92% post-interview allowance correlation, may propose resolving it in an interview) rather than withdraw the rejection on the merits. The non-analogous-art point attaches only to the ice-bagging document that was mis-fetched; once the intended surgical Prommersberger reference is on the record, the same-field / reasonably-pertinent inquiry (MPEP 2141.01(a)) resets to that document. So the 'the retrieved document teaches nothing about strands' point, while literally correct, does not reach the reinforcement-strand teaching the examiner actually intends to apply.

How to adjust Preserve this as a procedural/record-integrity point (the applied document does not support the mapping and the prima facie case as literally stated lacks factual support, MPEP 2143), which forces a corrected action and buys time — but do not build the substantive case on it. Counsel should obtain the intended Prommersberger surgical reference and pre-analyze whether it actually discloses a plurality of reinforcement strands and whether it is analogous; the durable win, if any, is on that document's content, not on the mis-cited number. An interview to confirm the intended reference fits this examiner's documented pattern.

3

Schmid passages relied on for the core adjunct limitations are not present in the retrieved text

Mischaracterized referenceClaim 21Claim 32Claim 37Claim 22Claim 23Claim 24Claim 27Claim 28Claim 33Claim 34Claim 36Claim 39Claim 40Claim 30Claim 31Rebuts: §102 rejection of claims 21, 22, 23, 24, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 39, 40

a second layer that abuts the first layer and comprises polydioxanone; a first layer that comprises foam; an adhesive layer configured to adhere the adjunct to a surgical fastening surface

The §102 rejection of the independent claims maps Schmid ¶0515 (foam first layer; polydioxanone second layer), ¶¶0514-0515 (reinforcing third layer), and ¶0520 (adhesive layer), together with reference numerals 1010-1014 and 1031/1032. The available Schmid text, however, comprises the abstract, claims 1-20, and the brief description of the drawings only, and it is truncated after the drawing descriptions — the specific paragraphs and reference numerals the examiner relies upon are not present in the retrieved excerpt, and FIGS. 18A-18D are described only as diagramming 'the deformation of a surgical staple positioned within a collapsible staple cartridge body.' The available text therefore does not confirm that Schmid discloses a foam first layer, a polydioxanone second layer, a reinforcing third layer, and an adhesive layer arranged as claimed. Anticipation requires that a single reference disclose every element arranged as in the claim (MPEP § 2131), so counsel should obtain the full Schmid publication and verify each mapped passage before conceding the §102 mapping; if the cited passages do not read as the examiner asserts, the anticipation rejection of every dependent claim falls with the independent claims.

  • Schmid brief description: "FIGS. 18A-18D diagram the deformation of a surgical staple positioned within a collapsible staple cartridge body in accordance with at least one embodiment"
  • OA2 reality check: "The detailed-description paragraphs the examiner relies upon (¶¶0514, 0515, 0520) and the specific reference numerals for a multilayer adjunct (1010, 1011, 1012, 1013, 1014) and adhesive/fastening surface (1031, 1032) are NOT present in the available text, which is truncated after the drawing descriptions."
MPEP § 2131 — anticipation requires every element in a single reference arranged as claimed; verify the mapped passagesEvidence needed: Obtain the complete Schmid US 2013/0075448 specification and confirm the text of ¶¶0514, 0515, 0520 and the mapping of numerals 1010-1014, 1031, 1032 to the claimed foam/polydioxanone/reinforcement/adhesive layers.

Risk This is a verification posture, not a confirmed missing element — the passages may well appear in the full Schmid publication, in which case the mapping stands; it must rank below the fully-confirmed Prommersberger and Erneta points. The examiner will simply point to the full specification. Do not assert the teaching is absent; frame it as obtain-and-verify. No PHE concern unless counsel later characterizes the layers narrowly.

Likely examiner response⚠ fragile — the comeback likely defeats it

The examiner will point out that the truncation is in counsel's retrieved copy, not in the Schmid publication itself — absence from an incomplete excerpt is not absence from the reference. The OA cites specific detailed-description paragraphs (¶¶0514, 0515, 0520) and reference numerals (1010-1014, 1031/1032) that exist in the full document; the examiner can reproduce them. Framed as 'these passages are not present,' the argument is a verification gap, not a merits rebuttal, and the examiner can close it by quoting the full text. Anticipation stands or falls on what the complete Schmid discloses arranged as claimed (MPEP 2131), which the examiner asserts it does.

How to adjust Treat this as a mandatory verification step, not an argument to file as-is. Obtain the full Schmid publication and read ¶¶0514, 0515, 0520 and numerals 1010-1014/1031-1032 against the independent-claim elements (foam first layer, polydioxanone second layer, reinforcing third layer, adhesive layer) with attention to the 'arranged as in the claim' requirement (MPEP 2131). If the passages confirm the mapping, pivot to a BRI/arrangement attack on the merits; only if a mapped element is genuinely absent does the missing-element attack become dispositive — and if so, it would reach every dependent claim tied to the independents, so the stakes justify the verification.

4

Claim 29 written-description (new matter) rejection — verify spec support or address by amendment

Written-description rebuttalClaim 29Rebuts: §112(a) rejection of claim 29

the fifth layer and the second layer are separated by ... the first layer

The examiner rejects claim 29 under §112(a) as new matter, stating that the specification (Figs. 24-26 and ¶0142 of the PGPub) shows the fifth layer 3040 and second layer 3030 are only separated by the third layer 3020+3022 and the adhesive layer 3050, never by the first layer. The correct §112(a) lever is to identify where the as-filed specification actually conveys possession of a first-layer separation, not to attack the rejection as improper (MPEP § 2163). Counsel should review the as-filed disclosure to determine whether any embodiment supports the 'first layer' separation as recited; if none does, this element is best addressed by amendment rather than argument, consistent with the examiner's own suggested narrowing of the alternative list. This limitation also overlaps a §112(b) antecedent-basis issue ('the fifth layer' with no antecedent), reinforcing that the cleanest path is likely amendment.

  • OA1 Rejection 2 rationale: the limitation "is not disclosed in any part of the instant application ... the fifth layer 3040 and the second layer 3030 are only separated by the third layer 3020+3022 and the adhesive layer 3050"
  • OA1 Rejection 3: "Claim 29 recites the limitation 'the fifth layer' ... There is insufficient antecedent basis"
MPEP § 2163 — written description requires the specification to convey possession as of filingEvidence needed: Review the as-filed specification and drawings to determine whether any disclosed embodiment supports separation of the fourth/fifth layer from the second layer by the first layer.

⚠ Risk The as-filed specification is not in the record before this analysis, so the availability of support cannot be confirmed; if the spec does not describe a first-layer separation, arguing possession will fail and amendment is the safer path. PHE caution: any amendment narrowing the separation options will create estoppel as to the surrendered alternative.

Likely examiner response⚠ fragile — the comeback likely defeats it

The examiner can reaffirm that the as-filed disclosure (Figs. 24-26; ¶0142 of the PGPub) shows the fifth layer (3040) and second layer (3030) separated only by the third layer (3020+3022) and the adhesive layer (3050) — never by the first layer — so the recited 'first layer' separation is unsupported new matter (MPEP 2163), and the claim independently lacks antecedent basis for 'the fifth layer' (MPEP 2173/2181). The examiner can note that possession must appear in the specification, and attorney argument cannot substitute for a disclosed embodiment showing the claimed separation.

How to adjust The argument as written already reaches the correct posture — identify actual as-filed support rather than attacking the WD rejection as improper (and it correctly avoids arguing the §112(a)/§112(b) pairing is duplicative). As an argue-to-preserve path it is fragile: if no embodiment conveys the first-layer separation, amendment is the cleaner cure, which also resolves the overlapping antecedent-basis defect. Counsel should search the as-filed spec for any first-layer-separation embodiment first; absent one, treat as amend-first.

5

Erneta's polyglactin 910 disclosure is Background prior art describing other products, not Erneta's invention

Mischaracterized referenceClaim 26Rebuts: §103 rejection of claim 26

the reinforcement strands comprise polyglactin 910

The examiner cites Erneta ¶0011 for reinforcement strands 'comprising polyglactin 910,' but in the retrieved Erneta text the polyglactin 910 language appears only in the Background as a description of two pre-existing commercial ETHICON products (VICRYL RAPIDE and Coated VICRYL), not as part of Erneta's own claimed contribution. Erneta's actual invention is a different absorbable polymer blend of a higher- and a lower-molecular-weight lactide/glycolide component, at least one end-capped with a carboxylic acid group (Erneta claim 1). Counsel may weigh whether reliance on a reference's characterization of a third party's product — offered to illustrate a problem — is the strongest footing for the motivation to combine, particularly where that same passage describes the product as strength-deficient. This point reinforces the rank-2 teaching-away argument and should be developed together with it.

  • Erneta claim 1: "a mixture of a first polymeric component and a second polymeric component, wherein the first polymeric component has a weight average molecular weight higher than the weight average molecular weight of the second polymeric component, and wherein at least one of said components is at least partially end-capped by a carboxylic acid group."
  • OA2 reality check: "The specific 'polyglactin 910' language the examiner relies on does not appear in the reference's inventive claims; it appears in the Background as a description of two existing commercial ETHICON products"
MPEP § 2141.02 (reference read in its entirety) and § 2143.01 (rational underpinning)

Risk The examiner can respond that Background prior-art disclosures are fully available as §103 teachings regardless of whether they are part of the reference's inventive claims, which is generally correct — so this is a framing/support point rather than a standalone defeater. Pair it with the teaching-away argument rather than relying on it alone.

Likely examiner response⚠ fragile — the comeback likely defeats it

This is a known losing framing: a reference's Background/admitted-prior-art discussion is fully available for whatever it teaches, and it is immaterial that the polyglactin 910 language describes a third party's commercial product rather than Erneta's own claimed blend. A §103 rejection may rely on any portion of a reference's disclosure, not only its inventive claims; the examiner will simply reaffirm that Erneta discloses polyglactin 910 as a known suture material. Attacking the teaching because of WHERE in the document it appears does not negate the disclosure's existence.

How to adjust Do not press this as a standalone 'wrong section of the reference' argument — it will draw a correction. Its only real value is evidentiary support for rank 2: the same Background passage that discloses polyglactin 910 also frames the fast-absorbing product as strength-deficient, which is what undercuts the motivation. Fold it into rank 2 as context, not as an independent basis.

6

§112(b) antecedent-basis defects — scope ascertainable but best cured by amendment

Definiteness rebuttalClaim 29Claim 30Claim 31Claim 35Claim 36Claim 39Rebuts: §112(b) rejection of claims 29, 30, 31, 35, 36, 39

antecedent-basis terms: 'the fifth layer' (cl. 29), 'the adjunct of claim 1' (cl. 30), 'the third layer' (cl. 35), 'the second layer'/'the fourth layer' (cl. 36), 'spaced apart from the first layer by the second layer' (cl. 39)

The §112(b) rejections identify genuine antecedent-basis and internal-consistency defects (e.g., claim 30's reference to 'the adjunct of claim 1' where the parent should be claim 21, and claim 39's recitation that a layer is spaced apart from the first layer 'by the second layer,' which the examiner reads as nonsensical). The examiner supplied a reasonable interpretation for each term, which tends to show the claim scope is ascertainable under the broadest-reasonable-interpretation standard (MPEP § 2173.02 / In re Packard) — a possible definiteness_rebuttal foothold. However, because these are formal antecedent-basis errors, the cleaner and lower-risk path for counsel is correction by amendment rather than argument. Counsel should not argue that the simultaneous §112(b) and §102/§103 rejections are inconsistent — compact prosecution expressly permits applying prior art to an indefinite claim under a reasonable interpretation (MPEP § 2173.06(II)).

  • OA1 Rejection 3: "Claim 30 recites the limitation 'the adjunct of claim 1' ... interpreting ... as 'the adjunct of claim 21'"
  • OA1 Rejection 3: "Claim 39 recites ... 'at least a portion of the second layer is spaced apart from the first layer by the second layer' ... It is unclear ... how the second layer can possibly be spaced apart from the first layer by itself"
MPEP § 2173.02 / In re Packard / Ex parte Miyazaki (examination definiteness standard, not Nautilus); § 2173.06(II) (compact prosecution)

⚠ Risk Arguing definiteness rather than amending invites the examiner to maintain the antecedent-basis objections; the examiner's reasonable interpretations do not eliminate the formal defect. Do not cite Nautilus 'reasonable certainty' as the governing standard in prosecution. Amendment is likely the efficient resolution; any narrowing amendment carries the usual estoppel considerations.

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.

Schmid (US 2013/0075448)

US 2013/0075448Claim text retrieved

The available text (abstract, claims 1-20, and the brief description of the drawings) describes a staple cartridge for a surgical stapler having a collapsible/descendible cartridge deck with apertures, staples whose legs extend into the apertures, guides/supports on the deck surface that slidably receive staple legs, and, in various embodiments, a compressible tissue thickness compensator positioned above the deck surface. Figures 18A-18D are described only as diagramming 'the deformation of a surgical staple positioned within a collapsible staple cartridge body.' The detailed-description paragraphs the examiner relies upon (¶¶0514, 0515, 0520) and the specific reference numerals for a multilayer adjunct (1010, 1011, 1012, 1013, 1014) and adhesive/fastening surface (1031, 1032) are NOT present in the available text, which is truncated after the drawing descriptions.

Claim elementExaminer assertsReference disclosesEvidence
first layer 1014 that comprises foam (claims 21, 32, 37)Schmid discloses a first/body layer 1014 comprising foam at ¶0515 lines 20-21.Not found in available textThe available text does not contain ¶0515 or reference numeral 1014. The abstract and claims mention a 'tissue thickness compensator' but do not state it comprises foam. The full specification should be checked for ¶0515.
second/supplemental layer 1013 that abuts the first layer and comprises polydioxanone (claims 21, 32, 37)Schmid discloses a second layer 1013 abutting the first layer and comprising polydioxanone at ¶0515 lines 26-30.Not found in available textThe available text does not contain ¶0515, reference numeral 1013, or any mention of polydioxanone. The full specification should be checked.
third/reinforcement layer 1012 spanning across at least a portion of the first layer and configured to reinforce it (claims 21, 32, 37)Schmid discloses a third layer 1012 spanning across and reinforcing the first layer at ¶¶0514-0515 and Figs. 18A-18D.Not found in available textThe available text does not contain ¶¶0514-0515 or reference numeral 1012; the Fig. 18A-18D description refers only to 'deformation of a surgical staple positioned within a collapsible staple cartridge body,' not a distinct reinforcement layer. The full specification should be checked.
adhesive layer configured to abut and adhere the adjunct to a surgical fastening surface 1031 (claims 21, 32, 37)Schmid discloses an adhesive (¶0520 lines 8-11) adhering the adjunct to fastening surface 1031.Not found in available textThe available text does not contain ¶0520, reference numeral 1031, or any mention of an adhesive. The full specification should be checked.
fourth layer 1011 overlying the second layer and the adhesive layer (claims 27, 28, 29, 36, 40)Schmid discloses a fourth/fifth layer 1011 that overlies the second layer 1013 and the adhesive layer.Not found in available textThe available text does not contain reference numeral 1011, ¶0520, or any description of a fourth overlying layer. The full specification should be checked.
second layer overlies the first layer / third layer spaced from first by second layer (claims 22, 23, 39)Apparent from Figure 18A that layer 1013 overlies 1014 and layer 1012 is spaced from 1014 by 1013.Not found in available textThe relative arrangement of numbered layers 1012/1013/1014 depends on Figure 18A detail and description not present in the available text (the Fig. 18A-18D description refers only to staple deformation within a cartridge body). The full specification and figures should be checked.
third/reinforcement layer spans at least a majority of a length and width of the first/body layer (claims 24, 33)Clear from Figures 18A-18D that layer 1012 spans a majority of the length and width of layer 1014.Not found in available textThe available text does not contain the layer reference numerals or dimensional detail; Figs. 18A-18D are cross-sectional/deformation diagrams per the drawing description, and the underlying paragraphs are absent. The full specification should be checked.
reinforcement layer spaced apart from body layer by supplemental layer (claim 34)Apparent from Figure 18A.Not found in available textThe available text does not contain the Figure 18A detail or the layer numerals needed to verify this arrangement. The full specification should be checked.
adjunct configured to be pierced by surgical fasteners (staples 1020) (claims 21, 32, 37)The adjunct is pierced by staples 1020, apparent from Figs. 18A-18D and ¶0515.Partially supportedThe Fig. 18A-18D description confirms 'the deformation of a surgical staple positioned within a collapsible staple cartridge body' and claim 1 recites staple legs that 'at least partially extend into said apertures,' so staples interacting with a cartridge body is disclosed; however, the specific characterization of staples piercing a discrete multilayer adjunct rests on ¶0515 and numeral 1020, which are not in the available text.
cartridge body 1030 with a deck having a plurality of openings/grooves 1032 housing staples (claim 37)Schmid discloses a body 1030 with a deck, plurality of openings/grooves 1032, and staples 1020 housed within the openings (¶0517).Partially supportedThe abstract and claim 1 disclose 'a deck, comprising: a deck surface; a plurality of apertures extending through said deck, wherein said legs of said staples at least partially extend into said apertures'—supporting a deck with openings housing staple legs; the specific numerals 1030/1032 and ¶0517 are not in the available text. The full specification should be checked.
first jaw 1040 and second jaw 1030 cooperating to clamp and fasten tissue (claim 30)Schmid discloses a first jaw 1040 and a second jaw 1030 that cooperate to clamp and fasten tissue with staples 1020 (¶¶0517-0518).Partially supportedClaim 20 in the available text recites 'an anvil movable between an unfired position and a fired position' and 'a staple cartridge support,' which corresponds to cooperating jaw structures; however, the specific numerals 1030/1040 and ¶¶0517-0518 are not in the available text. The full specification should be checked.
knife 172 actuatable to sever tissue and part of the adjunct (claim 31)Schmid discloses a knife 172 actuatable to sever tissue and part of the adjunct (¶¶0493, 0496, Figs. 18A-18D).Partially supportedThe drawing descriptions for Figs. 4-5 refer to a 'knife bar' advancing through the end effector, supporting that a cutting member is disclosed; the specific numeral 172 and ¶¶0493, 0496 are not in the available text. The full specification should be checked.

Prommersberger (US 2007/0175235, as cited by examiner) — NOTE: the text fetched under this publication number is titled 'Apparatus and method for bagging ice'

US 2007/0175235Claim text retrieved

The text available under publication number US 2007/0175235 describes an ice-bagging apparatus — a machine having an icemaker, a hopper with an agitator, a slider box and slider tray, a bagging assembly, heat sealers, a rotator, and a control panel, directed to automatically producing, bagging, and storing bags of ice while reducing 'bridging/fusing' of ice particles (Abstract; Technical Field; Brief Summary). The available text (claims, abstract, and detailed-description excerpt) contains nothing about surgical staplers, tissue adjuncts, buttress material, layers, sutures, or reinforcement strands. There is an apparent identity mismatch between the reference the examiner characterizes as 'Prommersberger et al.' teaching a surgical adjunct layer and the document actually retrieved under US 2007/0175235; counsel should verify the correct publication number and obtain the true Prommersberger text.

Claim elementExaminer assertsReference disclosesEvidence
third layer / reinforcement layer that includes a plurality of reinforcement strands (claims 25, 35, 38)Prommersberger teaches providing a layer (360 in Fig. 3C) of an adjunct (350) with a plurality of reinforcement strands (381) (Col. 7 ll. 15-19) to provide additional support and assist in preventing tears during stapling (Col. 2 ll. 30-34).MischaracterizedThe text available under US 2007/0175235 is an ice-bagging apparatus (Abstract; Technical Field: "an ice-bagging apparatus and method"); it affirmatively describes an unrelated machine and contains no adjunct, no layer 360, no strands 381, no Fig. 3C, and no stapling teaching. The cited pin-cites (Col. 7 ll. 15-19; Col. 2 ll. 30-34; Fig. 3C) do not correspond to any content in the retrieved document. This is a reference-identity discrepancy for counsel to verify; the available text does not contain the asserted teaching and describes materially different subject matter.
underlying rationale to combine (additional support / preventing tears during stapling)Reinforcement strands would provide additional support to the adjunct and assist in preventing tears during stapling (attributed to Prommersberger Col. 2 ll. 30-34).Not found in available textthe available text does not contain this — the retrieved US 2007/0175235 text discusses reducing 'bridging/fusing of ice particles' (Background; Brief Summary), not tissue support or tear prevention during stapling; nothing in the available text supplies the asserted motivation.

Erneta (US 2013/0315963)

US 2013/0315963Claim text retrieved

The reference's own invention is a novel absorbable polymer blend of a higher-molecular-weight first component and a lower-molecular-weight second component, at least one at least partially end-capped by a carboxylic acid group, used to make medical devices (especially sutures) that combine fast absorption with high initial mechanical strength. The specific 'polyglactin 910' language the examiner relies on does not appear in the reference's inventive claims; it appears in the Background as a description of two existing commercial ETHICON products — VICRYL RAPIDE (a fast-absorbing polyglactin 910 suture) and Coated VICRYL (its standard-absorbing polyglactin 910 counterpart). Notably, the Background frames the fast-absorbing polyglactin 910 product as having reduced strength (about 60 percent of the standard counterpart) — i.e., as a deficiency the invention seeks to overcome, not as an example of a 'high strength' material.

Claim elementExaminer assertsReference disclosesEvidence
motivation — polyglactin 910 is high strengthModifying the strands to comprise polyglactin 910 would make the reinforcement strands high strength.MischaracterizedThe available text states the fast-absorbing polyglactin 910 product "exhibits a tensile strength of about 60 percent of the standard absorbing counterpart," and that "sutures that are touted as fast absorbing are often lower in initial strength than their standard absorbing suture counterparts." The reference presents fast-absorbing polyglactin 910 as a reduced-strength material and frames improving on that deficiency as the object of its invention — the opposite of the examiner's 'high strength' rationale.
reinforcement strands comprising polyglactin 910Erneta teaches reinforcement strands (the 'sutures' described in ¶0011) comprising polyglactin 910 (¶0011).Partially supportedThe available text discloses polyglactin 910 sutures only as background commercial products: "VICRYL RAPIDE™ (polyglactin 910) Suture... Coated VICRYL™ (polyglactin 910) Suture." It supports that polyglactin 910 sutures exist and are known, but the reference's own invention is a distinct engineered PLGA blend, not polyglactin 910; the polyglactin 910 disclosure is in the Background rather than in the inventive teaching.
motivation — polyglactin 910 is commercially availableModifying the strands to comprise polyglactin 910 would make the reinforcement strands commercially available.Supported"Commercially available braided fast absorbing suture sold by ETHICON, Inc.... VICRYL RAPIDE™ (polyglactin 910) Suture..."
motivation — polyglactin 910 is fast absorbingModifying the strands to comprise polyglactin 910 would make the reinforcement strands fast absorbing.Supported"Commercially available braided fast absorbing suture... VICRYL RAPIDE™ (polyglactin 910) Suture..." — the polyglactin 910 product is expressly described as fast absorbing.

Shelton, IV (US 2012/0080344)

US 2012/0080344Claim text retrieved

The available text (claims and abstract only) teaches a fastener/staple cartridge having a compressible, collapsible, and/or crushable cartridge body with staples/fasteners embedded or positioned within it, plus a detachably/releasably affixed support pan (or retainer), and in some embodiments staple drivers positioned between the pan and the staples. The cartridge body can be comprised of compressible foam (claims 11, 20) or a hemostatic material (claim 12). Note: in the office action this reference is listed in the Conclusion as prior art 'made of record and not relied upon' — i.e., it forms no part of any § 102 or § 103 rejection.

Claim elementExaminer assertsReference disclosesEvidence
An adjunct (6670) having a first layer (6671) that comprises foamShelton, IV teaches an adjunct (6670 in Figure 212) having a first layer (6671 in Figure 212) that comprises foam, citing Paragraph 0509 lines 1-4.Not found in available textThe examiner relies on Figure 212 and ¶[0509], neither of which is present in the available text (claims and abstract only). The available text does recite that the cartridge body is 'comprised of compressible foam' (claims 11, 20), but it does not use the term 'adjunct,' does not identify a discrete 'first layer' element numbered 6671, and does not contain Figure 212 or ¶[0509]. The full specification should be checked before drawing any conclusion.
A second layer (6672) that abuts the first layer and comprises polydioxanoneShelton, IV teaches a second layer (6672 in Figure 212) that abuts the first layer (6671) and comprises polydioxanone, citing Paragraph 0509 lines 5-7 and Figure 212.Not found in available textThe available text does not contain this. The word 'polydioxanone' does not appear in the claims or abstract; the only body-material recitations in the available text are 'compressible foam' (claims 11, 20) and 'hemostatic material' (claim 12). Figure 212 and ¶[0509] are outside the available text. The full specification should be checked.
The adjunct does not have any other layersThe examiner asserts that the adjunct (6670) of Shelton, IV 'does not have any other layers.'Not found in available textThis is a negative characterization about the contents of Figure 212 / the embodiment at ¶[0509], neither of which is in the available text. The available text (claims/abstract) does describe additional structural elements in various embodiments — e.g., a support pan/retainer and staple drivers positioned between the pan and the staples (claims 8, 17) — but whether the specific '6670' embodiment has additional layers cannot be confirmed or contradicted from the claims and abstract alone. The full specification should be checked.
5.

Element-by-Element Claim Chart

Claim 21 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
an adjunct configured for use with a surgical fastening deviceSchmidArguably disclosed(analysis) Schmid's retrieved text discloses a 'compressible tissue thickness compensator' above the deck, which is conceptually an adjunct/buttress. The examiner's specific reference numeral 1010 and the multilayer detailed description are not present in the retrieved excerpt (abstract, claims 1-20, drawing descriptions only), which is truncated. Verify-first as to the specific mapping.Schmid, claims 2 & 14 ('a compressible tissue thickness compensator positioned above said deck surface'); Schmid, Fig. 18A-18D description ('diagram the deformation of a surgical staple positioned within a collapsible staple cartridge body'); OA §102 rationale mapping adjunct 1010 (examiner cite, unverified)
a first layer that comprises foamSchmidArguably disclosed(analysis) Per OA2, Schmid ¶0515 and numeral 1014 are NOT in the retrieved text; the retrieved claims describe a 'compressible' compensator but do not specify a foam material. Counsel should obtain and verify Schmid ¶0515 before accepting the 'foam' mapping. (Foam cartridge bodies are separately shown in Shelton '344 claims 11/20, but Shelton is expressly 'not relied upon' in any rejection.)Schmid, claims 2 & 14 (compressible tissue thickness compensator); OA §102 rationale citing 1014 / ¶0515 (examiner cite, unverified in retrieved text)
a second layer that abuts the first layer and comprises polydioxanoneSchmidArguably disclosed(analysis) This is the weakest link in the retrieved record: the word 'polydioxanone' does not appear anywhere in the available Schmid text (abstract, claims 1-20, drawing descriptions), and the cited ¶0515 is truncated/unavailable per OA2. Because Schmid is graded fully grounded but the cited passage was not retrieved, the honest posture is verify-first — obtain the full Schmid detailed description and confirm the polydioxanone teaching before relying on this element.OA §102 rationale citing 1013 / ¶0515 (examiner cite, unverified in retrieved text)
a third layer that spans across at least a portion of the first layer and is [thereby] configured to reinforce the first layerSchmidArguably disclosed(analysis) Numeral 1012 and ¶¶0514-0515 are not in the retrieved excerpt; Fig. 18A-18D is described only as diagramming staple deformation within a collapsible cartridge body, not a discrete reinforcement layer. Verify against full Schmid text.OA §102 rationale citing 1012 / ¶¶0514-0515, Figs. 18A-18D (examiner cite, unverified in retrieved text)
an adhesive layer configured to abut and [thereby] adhere the adjunct to a surgical fastening surface of the surgical fastening deviceSchmidArguably disclosed(analysis) ¶0520 and numeral 1031 are not present in the retrieved text. The 'adhesive layer' teaching cannot be confirmed from the available excerpt; verify-first.OA §102 rationale citing 'adhesive' at ¶0520 lines 8-11 and fastening surface 1031 (examiner cite, unverified in retrieved text)
wherein the adjunct is configured to be pierced by surgical fasteners of the surgical fastening deviceSchmidArguably disclosed(analysis) The general concept — staples interacting with/passing into the compensator — is consistent with Schmid's retrieved claims 1 and 3. The specific numeral mapping (1020) is from the truncated portion.Schmid, claim 1 (staple legs 'at least partially extend into said apertures' and are 'deformed by the anvil'); Schmid, claim 3 (guides 'extend into said tissue thickness compensator'); OA §102 rationale citing staples 1020, Figs. 18A-18D
Claim 24 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
the third layer spans across at least a majority of a length and at least a majority of a width of the first layerSchmidArguably disclosed(analysis) The examiner rests this dimensional limitation on Figs. 18A-18D, which the retrieved drawing description characterizes only as diagramming staple deformation — it does not, on its face, establish a reinforcement layer spanning a majority of length and width. Whether the figures support the 'majority of length/width' read is contestable and should be checked against the full Schmid disclosure. Claim 24 also carries the §-objection informality ('length and' → 'length of the first layer and').OA §102 rationale citing Figs. 18A-18D (examiner cite); Schmid, Fig. 18A-18D description ('diagram the deformation of a surgical staple positioned within a collapsible staple cartridge body')
Claim 25 — §103 (Schmid in view of Prommersberger)
Status glyphClaim elementStatusDisclosure / notesLocation
the third layer includes a plurality of reinforcement strandsSchmid, PrommersbergerNot taught(analysis) IDENTITY MISMATCH (per OA2): the document actually retrieved under US 2007/0175235 is 'Apparatus and method for bagging ice' — an icemaker/hopper/bagging machine — and contains nothing about surgical staplers, adjuncts, layers, or reinforcement strands. This reference is graded FULLY GROUNDED, and its retrieved subject matter is a categorically different field, so the reinforcement-strand teaching the examiner attributes to 'Prommersberger' is not supported by the document at this publication number. The likely explanation is that the examiner's Prommersberger surgical reference bears a different publication number; counsel should obtain and verify the correct Prommersberger document before treating the reinforcement-strand teaching as established. Same Prommersberger reinforcement-strand issue applies to claims 35 (claim 32 chain) and 38 (claim 37 chain), which are omitted from separate charting for the 8-claim cap.US 2007/0175235, Abstract ('An ice-bagging apparatus...'); US 2007/0175235, claims 1-46 (all directed to ice-making/bagging apparatus); OA §103 rationale citing Prommersberger layer 360, strands 381, Fig. 3C, Col. 7 ll. 15-19, Col. 2 ll. 30-34 (examiner cite)
Claim 26 — §103 (Schmid in view of Prommersberger and Erneta)
Status glyphClaim elementStatusDisclosure / notesLocation
the reinforcement strands comprise polyglactin 910Schmid, Prommersberger, ErnetaArguably taught(analysis) Two contestable points for counsel to weigh. (1) Per OA2, 'polyglactin 910' appears in Erneta only in the Background as a description of two pre-existing commercial ETHICON products (VICRYL RAPIDE and Coated VICRYL), not in Erneta's inventive claims. (2) The examiner's stated motivation — that polyglactin 910 makes the strands 'commercially available, fast absorbing, and high strength' — is in tension with Erneta's own framing, which describes the fast-absorbing polyglactin 910 product (VICRYL RAPIDE) as exhibiting only ~60% of the standard counterpart's tensile strength, i.e., as a strength DEFICIENCY the invention seeks to overcome (potential teaching-away angle as to the 'high strength' rationale, §103/MPEP 2143-2145, for counsel). Also note this element rides on top of the Prommersberger identity mismatch (see claim 25), so the §103 base itself requires verification.Erneta, Background ('known as VICRYL RAPIDE™ (polyglactin 910) Suture exhibits a tensile strength of about 60 percent of the standard absorbing counterpart, Coated VICRYL™ (polyglactin 910) Suture'); OA §103 rationale citing Erneta ¶0011 (examiner cite)
Claim 27 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
the adjunct further comprising a fourth layerSchmidArguably disclosed(analysis) Numeral 1011 and the Fig. 18A layer-stack detail are not present in the retrieved Schmid excerpt; verify-first as to the existence and identity of a discrete 'fourth layer.' Note the downstream §112 issues the examiner raised on this chain: claim 29 (§112(a) new matter for 'the first layer' separation and §112(b) 'the fifth layer' lacking antecedent basis) and claim 28 depend from claim 27.OA §102 rationale citing fourth layer 1011, Fig. 18A (examiner cite, unverified in retrieved text)
Claim 30 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
a first jawSchmidArguably disclosed(analysis) Schmid's retrieved claim 20 describes an end effector with an anvil and a staple cartridge support; the cartridge-support structure maps to a jaw conceptually. Numeral 1040 is from the truncated portion.Schmid, claim 20 ('a staple cartridge support comprising a plurality of stationary staple supports'); OA §102 rationale citing 1040
a second jaw configured to cooperate with the first jaw to clamp and fasten tissue with a plurality of surgical fastenersSchmidArguably disclosed(analysis) The anvil + cartridge-support clamping/deforming arrangement is in Schmid's retrieved claims 1 and 20. Supportable at the concept level; specific numeral 1030 is from the truncated portion.Schmid, claim 20 ('an anvil movable between an unfired position and a fired position'); Schmid, claim 1 (staple legs 'deformed by the anvil of the surgical stapler'); OA §102 rationale citing 1030
the adjunct of claim [21] adhered to a fastening surface of one of the jaws by the adhesive layerSchmidArguably disclosed(analysis) This element imports the entire claim-21 multilayer + adhesive mapping, all of which rests on the truncated/unverified Schmid ¶¶0514-0520 and numerals 1010-1014/1031 (see claim 21 notes). Verify-first. Separately, the examiner raised a §112(b) antecedent-basis issue: claim 30 recites 'the adjunct of claim 1,' which the examiner reads as intended to be 'claim 21' — a drafting point for counsel.OA §102 rationale citing adjunct 1010, adhesive at ¶0520, fastening surface 1031 (examiner cite, unverified in retrieved text)
wherein the surgical fastening device is operable to drive the surgical fasteners through the adjunct and into the tissue such that the adjunct supports the surgical fasteners relative to the tissueSchmidArguably disclosed(analysis) Driving staples through the compensator into tissue is consistent with Schmid's retrieved claims 1 and 3; the specific 'supports the surgical fasteners relative to the tissue' language is the examiner's characterization drawn from the truncated ¶¶0517-0518.Schmid, claim 1 (deck 'collapsible toward said bases of said staples between an unfired position and a fired position when said staple legs are deformed by the anvil'); Schmid, claim 3 (guides 'extend into said tissue thickness compensator')
Claim 32 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
a body layer that comprises foamSchmidArguably disclosed(analysis) Same substance as claim 21(a) with relabeled 'body layer'; foam material and ¶0515 not in retrieved text — verify-first.Schmid, claims 2 & 14 (compressible tissue thickness compensator); OA §102 rationale citing 1014 / ¶0515 (examiner cite, unverified)
a supplemental layer that abuts the body layer and comprises polydioxanoneSchmidArguably disclosed(analysis) Same substance as claim 21(b); 'polydioxanone' does not appear anywhere in the retrieved Schmid text — this is the strongest verify-first point for the independent adjunct claims.OA §102 rationale citing 1013 / ¶0515 (examiner cite, unverified)
a reinforcement layer that spans across at least a portion of the body layer and is configured to reinforce the body layerSchmidArguably disclosed(analysis) Same substance as claim 21(c). Note §112(b) issues the examiner flagged in the claim-32 chain: claim 35 ('the third layer' → 'the reinforcement layer') and claim 36 ('the second layer'/'the fourth layer' antecedent basis).OA §102 rationale citing 1012 / ¶¶0514-0515, Figs. 18A-18D (examiner cite, unverified)
an adhesive layer configured to abut and [thereby] adhere the adjunct to a surgical fastening surfaceSchmidArguably disclosed(analysis) Same substance as claim 21(d); ¶0520/1031 not in retrieved text — verify-first.OA §102 rationale citing adhesive at ¶0520, fastening surface 1031 (examiner cite, unverified)
wherein the adjunct is configured to be pierced by surgical fasteners of the surgical fastening deviceSchmidArguably disclosed(analysis) Same substance as claim 21 final clause; concept supported by retrieved Schmid claims 1 and 3.Schmid, claim 1 (staple legs extend into apertures and are deformed by anvil); Schmid, claim 3 (guides extend into the tissue thickness compensator)
Claim 37 — §102 (Schmid)
Status glyphClaim elementStatusDisclosure / notesLocation
a body having a deck configured to compress tissue, the deck having a plurality of openingsSchmidArguably disclosed(analysis) The deck-with-apertures structure is directly present in Schmid's retrieved claims 1 and 13; more solidly supportable than the multilayer-adjunct elements. 'Configured to compress tissue' tracks the collapsible/compensator function. Claim 37 carries the §-objection informality ('is thereby configured' → 'is configured').Schmid, claim 1 ('a deck, comprising: a deck surface; a plurality of apertures extending through said deck'); Schmid, claim 13 ('a cartridge deck, comprising: a deck surface; a plurality of apertures'); OA §102 rationale citing deck of 1030, grooves 1032
a plurality of surgical fasteners housed within the openingsSchmidArguably disclosed(analysis) Staples with legs in the deck apertures are in Schmid's retrieved claims 1 and 13. 'Housed within the openings' is the examiner's characterization; the retrieved claims speak of legs extending/sliding into apertures rather than the staple bodies being housed there — a scope nuance for counsel.Schmid, claim 1 (staple legs 'at least partially extend into said apertures'); Schmid, claim 13 (legs 'configured to slide within said apertures'); OA §102 rationale citing staples 1020 in grooves 1032
an adjunct secured to the deck including (i) a foam first layer, (ii) a polydioxanone second layer abutting the first, (iii) a reinforcing third layer, and (iv) a fourth layer that adheres the adjunct to the deckSchmidArguably disclosed(analysis) The four-layer adjunct stack — foam, polydioxanone, reinforcement, adhesive — imports the same truncated/unverified Schmid ¶¶0514-0520 and numerals 1010-1014 discussed for claim 21. Verify-first, with the polydioxanone sub-element the least corroborated by the retrieved text.Schmid, claims 2 & 14 (compressible tissue thickness compensator above the deck); OA §102 rationale citing 1010/1011/1012/1013/1014, ¶¶0514-0515, ¶0520 (examiner cite, unverified in retrieved text)
wherein the adjunct is configured to be pierced by the surgical fastenersSchmidArguably disclosed(analysis) Concept supported by retrieved Schmid claims 1 and 3. OMITTED-CLAIM NOTE (8-claim cap): claims 22, 23, 28, 29, 31, 33, 34, 35, 36, 38, 39, 40 were not separately charted. Their examiner mappings are substantively duplicative of charted claims — 23/34/39 (third/reinforcement layer spaced from first/body layer by second/supplemental layer) mirror the layer-stack read; 33 mirrors claim 24; 28/36/40 (a further layer 1011 overlying the second layer and the adhesive/fourth layer) mirror claim 27; 35 and 38 share the Prommersberger reinforcement-strand identity-mismatch issue charted at claim 25; 31 depends from claim 30 and adds knife 172 (examiner cites the truncated ¶¶0493/0496); and claims 29, 30, 31, 35, 36, 39 additionally carry the §112(a)/§112(b) issues summarized in the rejection map for counsel.Schmid, claim 1 (staple legs deformed by anvil after extending into apertures); Schmid, claim 3 (guides extend into the tissue thickness compensator)

Elements not shown by the cited art (4)

  • Claim 25 — “the third layer includes a plurality of reinforcement strands”: The sole reference asserted to supply this limitation is 'Prommersberger,' but the document actually retrieved under the examiner's cited number US 2007/0175235 is 'Apparatus and method for bagging ice' (Abstract; claims 1-46), which concerns icemakers, hoppers, bagging assemblies, and heat sealers and discloses nothing about surgical staplers, adjunct layers, or reinforcement strands. Because this reference is graded FULLY GROUNDED and its retrieved subject matter is a categorically different field, the reinforcement-strand teaching is not supported by the document at that publication number. This is an apparent publication-number/identity mismatch (a §103 prima-facie-case-failure candidate as applied to the retrieved document), NOT a definitive holding — counsel must obtain and verify the examiner's intended Prommersberger surgical reference before relying on this distinction.
  • Claim 35 — “the reinforcement layer includes a plurality of reinforcement strands (examiner-interpreted from 'the third layer')”: Same asserted reference and same identity mismatch as claim 25: the document retrieved under US 2007/0175235 is an ice-bagging apparatus and does not disclose reinforcement strands. Prima-facie-failure candidate for the §103 rejection of this element as applied to the retrieved document, subject to verifying the correct Prommersberger reference.
  • Claim 38 — “the third layer includes a plurality of reinforcement strands (surgical fastener cartridge chain)”: Same asserted reference and same identity mismatch as claim 25: the document retrieved under US 2007/0175235 (ice-bagging apparatus) supplies no reinforcement-strand teaching. Prima-facie-failure candidate for the §103 rejection of this element as applied to the retrieved document, subject to verifying the correct Prommersberger reference.
  • Claim 26 — “the reinforcement strands comprise polyglactin 910 (with the examiner's asserted 'high strength' motivation)”: This element is NOT flatly missing from the record — Erneta's Background does mention polyglactin 910 (VICRYL RAPIDE / Coated VICRYL). It is listed here as a prima-facie-case concern for two reasons counsel should weigh: (1) it depends on the Prommersberger reinforcement-strand base, which is subject to the identity-mismatch problem above; and (2) the examiner's 'high strength' rationale is contradicted by Erneta's own Background, which describes the fast-absorbing polyglactin 910 product (VICRYL RAPIDE) as having only ~60% of the standard counterpart's tensile strength — a potential teaching-away against the stated motivation to combine (§103/MPEP 2143-2145).
6.

Rejection Map

OtherRejection — claims 21, 24, 31, 32, 33, 36, 37

Claim objections for informalities: Claim 21 — 'comprising:' should read 'the adjunct comprising:', 'is thereby' should read 'is', 'and thereby adhere' should read 'and adhere'. Claim 24 — 'length and' should read 'length of the first layer and'. Claim 31 — 'sever tissue' should read 'sever the tissue'. Claim 32 — 'comprising:' should read 'the adjunct comprising:', 'and thereby adhere' should read 'and adhere'. Claim 33 — 'where the' should read 'wherein the', 'length and' should read 'length of the body layer and'. Claim 36 — 'a fifth layer' should read 'an additional layer' because first through fourth layers were not previously recited. Claim 37 — 'is thereby configured' should read 'is configured'.

§112(a)Written description / enablement — claims 29

Claim 29 recites 'the fifth layer and the second layer are separated by…the first layer' (lines 1-2). The examiner states this limitation is not disclosed in the instant application. Citing Figures 24-26 and Paragraph 0142 of the PGPub, the examiner states the fifth layer 3040 and second layer 3030 are only separated by the third layer 3020+3022 and the adhesive layer 3050, never by the first layer. The limitation constitutes new matter. The examiner suggests changing 'the first layer, the third layer, or the adhesive layer' to 'the third layer or the adhesive layer'.

§112(b)Indefiniteness — claims 29, 30, 31, 35, 36, 39

Multiple indefiniteness issues: Claim 29 — 'the fifth layer' lacks antecedent basis (claim 27 introduces only a fourth layer); examiner interprets as 'the fourth layer'. Claim 30 — recites 'the adjunct of claim 1' which lacks antecedent basis; examiner interprets as 'the adjunct of claim 21'. Claim 35 — recites 'the third layer' which lacks antecedent basis (claim 32 uses 'reinforcement layer'); examiner interprets as 'the reinforcement layer'. Claim 36 — recites 'the second layer' (no antecedent; examiner interprets as 'the supplemental layer') and 'the fourth layer' (no antecedent; examiner interprets as 'the adhesive layer'). Claim 39 — recites 'at least a portion of the second layer is spaced apart from the first layer by the second layer,' which is nonsensical; examiner interprets as 'at least a portion of the third layer is spaced apart from the first layer by the second layer'. Claim 31 — indefinite by dependence from claim 30.

§102Anticipation — claims 21, 22, 23, 24, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 39, 40

SchmidUS 2013/0075448

Schmid discloses adjunct 1010 (Figure 18A) with: first layer 1014 comprising foam (¶0515); second layer 1013 abutting the first layer and comprising polydioxanone (¶0515); third layer 1012 spanning across the first layer and reinforcing it (¶¶0514-0515, Figs. 18A-18D); adhesive layer (¶0520 lines 8-11) adhering adjunct to fastening surface 1031; adjunct pierced by staples 1020. Fourth layer 1011 overlies second layer 1013 and the adhesive layer. For claims 30-31, Schmid discloses jaws 1040/1030, staples 1020, knife 172, and the adjunct adhered to the fastening surface. For claim 37, Schmid discloses cartridge body 1030 with deck, grooves 1032, staples 1020, and adjunct 1010 with the four-layer structure secured to the deck. For dependent claims: claim 22 (second layer overlies first); claim 23 (third layer spaced from first by second); claim 24 (third layer spans majority of length and width of first); claims 27-29 (fourth layer 1011); claims 33-34 (reinforcement layer spans majority/spaced apart); claim 36 (fifth layer 1011 overlies second layer and adhesive); claim 39 (interpreted: third layer spaced from first by second); claim 40 (fifth layer 1011 overlies second layer and fourth layer).

§103Obviousness — claims 25, 35, 38MPEP §2143(A)

SchmidUS 2013/0075448PrommersbergerUS 2007/0175235

Schmid discloses all limitations except that the third layer (or reinforcement layer) includes a plurality of reinforcement strands. Prommersberger teaches providing layer 360 (Figure 3C) of an adjunct 350 with reinforcement strands 381 (Col. 7 lines 15-19) to provide additional support and assist in preventing tears during stapling (Col. 2 lines 30-34). The examiner concludes it would have been obvious to modify Schmid's third layer to include reinforcement strands for additional support and tear prevention.

§103Obviousness — claims 26MPEP §2143(B)

SchmidUS 2013/0075448PrommersbergerUS 2007/0175235ErnetaUS 2013/0315963

Schmid in view of Prommersberger teaches all limitations except that the reinforcement strands comprise polyglactin 910. Erneta teaches reinforcement strands (sutures described in ¶0011) comprising polyglactin 910 (¶0011) to make them commercially available, fast absorbing, and high strength. The examiner concludes it would have been obvious to modify the reinforcement strands to comprise polyglactin 910 for those benefits.

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.

STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENTUS20130075448
Claim text retrieved
Apparatus and method for bagging iceUS20070175235
Claim text retrieved
Mechanically Strong Absorbable Polymeric Blend Compositions of Precisely Controllable Absorption Rates, Processing Methods, And Products TherefromUS20130315963
Claim text retrieved
Implantable fastener cartridge comprising a support retainerUS20120080344
Claim text retrieved

Data Egress Log

Note

Your uploads stay in-boundary. External retrieval was limited to public patent-number lookups: 4 fetches. No claim text, no client material left the environment.

Patents fetched by number
US20130075448US20070175235US20130315963US20120080344
Documents processed
  • c351276e-b6a0-4a77-85e7-ff3b851b419d.pdfoffice action
  • 743768da-a944-4b5a-a70d-4a50444ee013.pdfclaims
Processed in-boundary — never transmitted externally.

Automated consistency checks

Deterministic checks run over the analysis before assembly — automated heuristics, not legal conclusions.

  • ⚠ Unverified quotation in Argument Bank (Cited Prommersberger document (US 2007/0175235) is an ice-bagging machine that teaches no reinforcement strands): "The available text ... contains nothing about surgical staplers, tissue adjuncts, buttress material, layers, sutures,…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Erneta's own Background contradicts the examiner's 'high strength' motivation for polyglactin 910): "Commercially available braided fast absorbing suture sold by ETHICON, Inc., ... and known as VICRYL RAPIDE™ (polyglac…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Erneta's own Background contradicts the examiner's 'high strength' motivation for polyglactin 910): "to make them commercially available, fast absorbing, and high strength" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Erneta's own Background contradicts the examiner's 'high strength' motivation for polyglactin 910): "frames the fast-absorbing polyglactin 910 product as having reduced strength (about 60 percent of the standard counte…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Erneta's polyglactin 910 disclosure is Background prior art describing other products, not Erneta's invention): "The specific 'polyglactin 910' language the examiner relies on does not appear in the reference's inventive claims; i…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Schmid passages relied on for the core adjunct limitations are not present in the retrieved text): "The detailed-description paragraphs the examiner relies upon (¶¶0514, 0515, 0520) and the specific reference numerals…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Claim 29 written-description (new matter) rejection — verify spec support or address by amendment): "is not disclosed in any part of the instant application ... the fifth layer 3040 and the second layer 3030 are only s…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (Claim 29 written-description (new matter) rejection — verify spec support or address by amendment): "Claim 29 recites the limitation 'the fifth layer' ... There is insufficient antecedent basis" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (§112(b) antecedent-basis defects — scope ascertainable but best cured by amendment): "Claim 30 recites the limitation 'the adjunct of claim 1' ... interpreting ... as 'the adjunct of claim 21'" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.
  • ⚠ Unverified quotation in Argument Bank (§112(b) antecedent-basis defects — scope ascertainable but best cured by amendment): "Claim 39 recites ... 'at least a portion of the second layer is spaced apart from the first layer by the second layer…" does not appear verbatim in the record (office action, claims, specification, or reference text). Rephrase it as analysis or correct the quote before relying on it.

Obviousness Framework

Field of endeavor
Surgical fastening devices and their consumables — specifically staple/fastener cartridges and multilayer tissue adjuncts (buttress-type materials) that are pierced by staples and support the fastened tissue.
PHOSITA
A reasonable construction FOR ARGUMENT PURPOSES (not a factual finding, and not attributed to the examiner, who articulated no PHOSITA level in the office action): a person with a bachelor's-level degree in mechanical or biomedical engineering (or equivalent) plus a few years of practical experience designing surgical stapling instruments and/or the biomaterials used with them, familiar with staple-cartridge deck/anvil mechanics, compressible foam adjuncts, and absorbable polymers such as polydioxanone and polyglactin used in surgical implants. Counsel may wish to adjust the level up or down and should note the office action itself supplies no explicit PHOSITA definition.A construction for argument — not asserted as fact.
ReferenceAnalogous artRationale
Schmid (US 2013/0075448)AnalogousSame field of endeavor. The available Schmid text (abstract, claims, drawing descriptions) is directed to a staple cartridge for a surgical stapler with a collapsible deck, staples, and a compressible tissue thickness compensator — squarely within surgical fastening devices and adjuncts. Note (analysis): the specific detailed-description paragraphs and reference numerals the examiner relies on (¶¶0514, 0515, 0520; numerals 1010-1014, 1031, 1032) are NOT present in the retrieved text, so the analogous-art status is clear even though the substantive mapping cannot be verified from the record.
Prommersberger (US 2007/0175235)ContestableSerious identity mismatch on the record. Per the OA2 reality check, the text actually retrieved under US 2007/0175235 is titled 'Apparatus and method for bagging ice' and describes an icemaker, hopper, slider box, bagging assembly, and control panel — with 'nothing about surgical staplers, tissue adjuncts, buttress material, layers, sutures, or reinforcement strands' (OA2 summary). If that document is what the publication number designates, it is neither in the same field of endeavor as surgical adjuncts nor reasonably pertinent to the inventor's problem of reinforcing a stapled tissue adjunct, and would be NON-ANALOGOUS under both prongs of MPEP § 2141.01(a). Counsel must first verify the correct publication number and obtain the true Prommersberger surgical-adjunct text; if the true reference is a surgical buttress/adjunct disclosure, it would likely be analogous, but that cannot be confirmed from the present record.
Erneta (US 2013/0315963)ContestableErneta concerns absorbable polymer blends for medical devices, especially sutures — a materials field adjacent to, but not identical with, surgical staplers/adjuncts. Whether it is 'reasonably pertinent to the particular problem' the inventor faced (reinforcing a stapled tissue adjunct) is arguable; a PHOSITA reinforcing an adjunct with absorbable strands might consult suture-material art, but the record's polyglactin 910 discussion appears only in Erneta's Background describing pre-existing commercial products rather than in its inventive teaching. Counsel to weigh the pertinence framing from the inventor's perspective under MPEP § 2141.01(a).
Shelton, IV (US 2012/0080344)AnalogousSame field — a staple/fastener cartridge with a compressible foam cartridge body and support pan. Noted only for completeness: the office action lists this reference in the Conclusion as prior art 'made of record and not relied upon,' so it forms no part of any §102 or §103 rejection and no combination analysis is required.

§103 rejection of claims 25, 35, and 38 over Schmid in view of Prommersberger. Theory: Schmid discloses the entire multilayer adjunct except that the third/reinforcement layer includes a plurality of reinforcement strands, and Prommersberger supplies reinforcement strands (381 in Fig. 3C) in an adjunct layer.

Schmid + Prommersberger

Motivation asserted To provide additional support to the adjunct and assist in preventing tears during stapling (examiner citing Prommersberger Col. 2 lines 30-34 and Col. 7 lines 15-19).

  • Otherstrong

    The document retrieved under the cited publication number (US 2007/0175235) is, per the OA2 reality check, an ice-bagging apparatus that contains 'nothing about surgical staplers, tissue adjuncts, buttress material, layers, sutures, or reinforcement strands.' On the present record there is thus no text supporting the examiner's characterization of Prommersberger as teaching reinforcement strands 381 in an adjunct layer 360 — the secondary reference as retrieved does not disclose the element it is cited for. Counsel should first confirm the publication number and obtain the true reference before treating this as dispositive, because the mismatch may be a clerical citation error rather than an absence of teaching in the intended document. (analysis)

  • No reasonable expectation of successmoderate

    If the retrieved ice-bagging text is in fact the reference, it is drawn from a wholly unrelated mechanical field, and a PHOSITA in surgical adjuncts would have no reason to look to it and no basis to expect success in transplanting anything from it into Schmid's adjunct — implicating the analogous-art requirement of MPEP § 2141.01(a) and the reasonable-expectation-of-success requirement of MPEP § 2143.02. This weakness is entirely contingent on the identity question and evaporates if the true Prommersberger surgical text is a proper adjunct/buttress disclosure. (analysis)

  • Othermoderate

    The examiner's characterization of the primary reference cannot be verified from the record: the OA2 check confirms the Schmid detailed-description paragraphs (¶¶0514, 0515, 0520) and adjunct numerals (1010-1014) relied upon for the base limitations are not present in the retrieved Schmid text. Counsel to weigh whether the underlying §102 mapping that this §103 builds upon is confirmable before the motivation analysis is even reached. (analysis)

§103 rejection of claim 26 over Schmid in view of Prommersberger and further in view of Erneta. Theory: the combination of Schmid and Prommersberger supplies the reinforcement strands, and Erneta supplies that the strands comprise polyglactin 910.

Schmid + Prommersberger + Erneta

Motivation asserted To make the reinforcement strands commercially available, fast absorbing, and high strength (examiner citing Erneta ¶0011).

  • Teaching awaystrong

    The examiner's stated rationale is that polyglactin 910 strands would be 'fast absorbing, and high strength,' but per the OA2 reality check the polyglactin 910 discussion appears only in Erneta's Background, which frames the fast-absorbing polyglactin 910 product (VICRYL RAPIDE) as exhibiting only about 60 percent of the strength of its standard-absorbing counterpart — i.e., as a strength DEFICIENCY the invention seeks to overcome. Counsel may argue Erneta actually associates fast-absorbing polyglactin 910 with reduced strength, undercutting (and arguably contradicting) the examiner's 'fast absorbing and high strength' motivation. (analysis)

  • Conclusory motivationmoderate

    The polyglactin 910 language on which the rejection rests is not part of Erneta's inventive teaching; per OA2 it appears only in the Background as a description of two pre-existing ETHICON commercial products. Counsel to weigh whether using a reference's background characterization of the prior art, rather than its own inventive disclosure, supplies the articulated rational underpinning required by MPEP § 2143.01, or whether the motivation is a conclusory pick of a named material. (analysis)

  • Othermoderate

    Claim 26 depends from claim 25, so this three-reference combination inherits the Prommersberger identity-mismatch problem noted for the §103 rejection of claims 25/35/38: on the present record the middle reference supplying the 'reinforcement strands' element is an ice-bagging document. If that link fails or is unverifiable, the further modification to specify polyglactin 910 has no adjunct-strand to modify. Contingent on resolving the publication-number question. (analysis)

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