Office Action Analysis — App 19540347 (public record)

Candidate arguments for counsel, ranked strongest-first. Each names the limitation it hangs on, the argument for the record with pin-cites, the MPEP frame, and the strongest response the examiner is likely to give (an adversarial pass, so counsel sees the rebuttal before the examiner sends it). These are brainstorming inputs for counsel to evaluate — not a drafted response.

1. [Definiteness rebuttal]: Definiteness of 'highly hydrophilic' and 'a large percentage' — construction lever for claims 10 and 18

Strategy check: re-ranked from #4 — The globally top-ranked argument (rank 1, volume-split rationale) does not touch claim 10's unique §112(b) hurdle; rank 3 (definiteness lever) is the only argument addressing it and is therefore the claim-specific lead for claims carrying the indefiniteness rejection.

Claims addressed: 10, 18

Limitation hook: the superficial domain is highly hydrophilic and possess a large percentage of zwitterionic moieties

The examiner rejects 'highly hydrophilic' and 'a large percentage' as relative terms with no standard in the specification, applying Datamize. For counsel to weigh: under the examination standard (In re Packard / MPEP § 2173.02, not the litigation Nautilus 'reasonable certainty' test), the question is whether the term's meaning is unclear or amenable to more than one plausible construction under BRI. Counsel should review the as-filed specification for any operational description tying 'a large percentage' of zwitterionic moieties to a comparative distribution (the claims themselves recite that the subsurface 'comprises predominately' the primary network, which may supply a comparative frame). If the specification supplies context sufficient to bound the terms, that defeats the Packard prong; if it does not, an amendment to a comparative or quantitative recitation is likely the cleaner path. This is a record-grounded rebuttal path, but its strength depends on specification support counsel must confirm.

Supporting evidence:

• Office action: 'The terms "highly hydrophilic" and "a large percentage" ... is a relative term which renders the claim indefinite ... the specification does not provide a standard for ascertaining the requisite degree'
• Claim 10: 'the superficial domain is highly hydrophilic and possess a large percentage of zwitterionic moieties, while the subsurface comprises predominately of the primary polymer network'
• Office action citing Datamize, LLC v. Plumtree Software, Inc.

Doctrine: MPEP § 2173.02 / In re Packard / Ex parte Miyazaki — examination-standard definiteness (challenge via BRI/clarity or amend); do NOT cite Nautilus as the governing test

Risk: The examiner will likely maintain that neither the claim nor the spec provides a numerical or otherwise objective boundary and that 'predominately' is itself relative. If the spec lacks a standard, arguing clarity may fail and amendment may be required. Prosecution-history caution: any argument construing 'a large percentage' by reference to specific ranges (e.g. Alm's 2-20 mol%) risks importing that range as a scope-limiting admission into the file wrapper.

Likely examiner response (argument survives — moderate): The examiner could maintain under In re Packard / MPEP § 2173.02 that 'highly hydrophilic' and 'a large percentage' are textbook relative terms of degree with no reference point or standard in the specification, so their meaning is unclear on the examination (BRI) standard, and could add that the separate 'comprises predominately the primary network' recitation addresses a different limitation and supplies no numerical or comparative bound for the zwitterionic-moiety percentage or the degree of hydrophilicity.

How to adjust: Survival turns entirely on whether the as-filed specification supplies an operational or comparative frame that bounds these terms — counsel must confirm this in the record before pressing. If the spec ties 'a large percentage' or 'highly hydrophilic' to a measurable comparison or threshold, the Packard 'unclear term' prong can be contested; if not, amending to a comparative or quantitative recitation is likely the cleaner path than arguing. The argument correctly cites Packard/§ 2173.02 rather than Nautilus — keep it that way.

2. [Conclusory rationale]: Routine-optimization rationale for the >64%/<36% volume split lacks a result-effective-variable predicate

Claims addressed: 1, 14

Limitation hook: a core region comprising more than 64% of the volume ... and a surface region comprising less than 36% of the volume of the indwelling medical device

The office action expressly concedes that Alm does not teach the claimed volume fractions and supplies them only through a routine-optimization theory, characterizing the split as 'entirely arbitrary' and 'merely optimizing the teachings of Alm' under In re Aller and MPEP 2144.05(II)(A). For counsel to weigh: the optimization doctrine applies only where the general conditions of the claim are disclosed AND the variable being optimized is recognized in the art as a result-effective variable; the office action does not identify any teaching that the core/surface volume ratio is a recognized result-effective variable, and instead reasons that because the specification does not label the values 'unexpected,' they must be arbitrary. That reasoning inverts the examiner's burden — the absence of an unexpected-results characterization is not itself a disclosure that the ratio is result-effective. This is a candidate attack on whether a prima facie case of obviousness was articulated with a rational underpinning, for counsel to develop.

Supporting evidence:

• Office action: 'Alm et al. do not expressly teach a core region comprising more than 64% of the volume ... with a surface region ... comprising less than 36% of the volume'
• Office action: 'the limitation appears entirely arbitrary and is merely optimizing the teachings of Alm et al.' (citing In re Aller, MPEP 2144.05(II)(A))
• Office action: 'the instant specification does not characterize the limitation ... as unexpected or surprising'

Doctrine: MPEP § 2143.01 / § 2144.05(II)(A) — routine-optimization requires a recognized result-effective variable and articulated reasoning; a conclusory 'arbitrary/judicious selection' assertion is legally insufficient; see also § 2145

Risk: The examiner will likely respond that Alm teaches varying monomer concentration/loading time to create a guest-polymer gradient (¶[0155], [0235]) and that adjusting the amount of IPN necessarily adjusts the volume split, making the ratio inherently result-effective. Counsel should be prepared to distinguish a gradient in guest-polymer density from a defined core/surface volume ratio. Prosecution-history caution: framing the volume split as critical/non-arbitrary in the response may invite an examiner demand for evidence and could narrow claim scope in the file wrapper.

Likely examiner response (argument survives — strong): The examiner could respond that the core/surface volume proportion is not truly arbitrary but is a variable that necessarily affects the device's surface and bulk properties, and could supplement the record (potentially as a new ground) by pointing to Alm's own gradient/graduated structure teachings to show the proportion between the modified surface zone and the unmodified core is recognized as affecting lubricity/hydrophilicity — thereby supplying the result-effective-variable predicate MPEP 2144.05(II)(B) requires. The examiner could also invoke that where the general conditions (a core region and a surface region of differing composition) are disclosed, discovering the optimum proportion is a matter of routine optimization, and that the specification's silence on criticality supports the position.

How to adjust: This holds because, on the current record, the office action concedes Alm does not teach the fractions and characterizes them as 'arbitrary' — which cuts against, not toward, result-effective status. Shore it up by keeping the burden framed on the examiner: an RE-variable finding needs an articulated prior-art teaching that the ratio affects a recognized result, and 'not labeled unexpected' is not that teaching. Because Alm is unverified, counsel should confirm Alm does not itself disclose the proportion as outcome-driving; if it does, the examiner can cure the gap and the posture shifts toward amending to a proportion with disclosed criticality/unexpected-results evidence (§ 1.132).

3. [Missing element]: Verify-first: whether any single reference discloses the specific >64%/<36% volume fractions

Claims addressed: 1

Limitation hook: a core region comprising more than 64% of the volume ... and a surface region comprising less than 36% of the volume

The office action concedes on its face that Alm does not expressly teach the >64% core / <36% surface volume fractions, and no other asserted reference is characterized as disclosing them. For counsel to weigh: this is a candidate missing-element pressure point, but because Alm and Antoni were never retrieved, the distinction cannot be confirmed as a true missing element from the reference text — the ONLY sound posture is verify-first. Counsel should obtain the actual Alm disclosure (including any embodiments quantifying core/surface proportions or gradient depth) and Antoni's coating-thickness/volume teachings before relying on this as an absent limitation; if confirmed absent from every reference, it dovetails with the rank-1 rationale attack. This finding is provisional and non-dispositive.

Supporting evidence:

• Office action concession: 'Alm et al. do not expressly teach a core region comprising more than 64% of the volume ... [or] a surface region ... comprising less than 36% of the volume'
• Claim 1 volume-fraction limitation

Doctrine: MPEP § 2141.02 — differences between the prior art and the claims; the claimed invention as a whole must be reached by the art or a properly supported modification

Risk: The examiner will maintain that the volume split is reached by routine optimization regardless of express disclosure, so a bare 'missing element' framing may be met with the same optimization rationale. VERIFY-FIRST: Alm/Antoni text not retrieved — do not present this as dispositive. Prosecution-history caution: characterizing the ratio as a distinguishing feature may narrow scope if later amended around it.

Evidence needed: Retrieve Alm (US20210338905) and Antoni (WO2014118382) full text to confirm whether either discloses the claimed core/surface volume fractions.

Likely examiner response (argument survives — moderate): The examiner could point out that this is a §103 rejection, not §102, so a 'missing element' framing is not dispositive — the office action never claimed Alm expressly discloses the fractions; it supplied them by routine optimization. As long as the optimization rationale stands, the conceded absence of the fractions from any single reference does not by itself defeat the rejection.

How to adjust: As a standalone missing-element attack this is limited because §103 permits supplying the limitation by rationale rather than express disclosure. Its real value is to dovetail with rank 1: the conceded absence is what forces the examiner onto the optimization theory, so the fractions' absence and the missing RE-variable predicate are two halves of one attack. Merge it into rank 1 rather than pressing it separately, and preserve verify-first because Alm/Antoni text is not in the record (Alm may quantify gradient depth/proportion).

4. [Improper hindsight]: Combination rationale (Alm + Antoni) rests on hindsight and the applicant's own figure

Claims addressed: 1, 14

Limitation hook: the surface region comprising an interpenetrated polymer network ... wherein the interpenetrated polymer network has a thickness of more than 100 nm

The office action's motivation to arrive at the claimed thickness and volume split leans on the observation that 'Figure 3a of Alm et al. closely resembles Applicant's own diagram' and that measuring the IPN to reach 100 nm is 'merely routine.' For counsel to weigh: pointing to the resemblance between a reference figure and the applicant's own Figure 1 as the reason to make the modification is a hallmark of hindsight reconstruction — the rational underpinning must come from the prior art's own teachings and the problem faced, not from the applicant's disclosure used as a template. The office action does not articulate why a PHOSITA, starting from Alm and Antoni alone and without the applicant's specification, would select this particular thickness and volume allocation. This is a candidate challenge to the sufficiency of the articulated reasoning, for counsel to develop.

Supporting evidence:

• Office action: 'Figure 3a of Alm et al. closely resembles Applicant's own diagram and Alm et al. teach and suggest overlapping wall thickness. It is then merely routine optimization to measure the interpenetrated polymer network thickness to arrive at 100 nm'
• Office action motivation section reproducing Applicant's Figure 1 (lower panel) alongside Alm Figure 3a

Doctrine: MPEP § 2143.01 / § 2145 — the reasoning to combine must rest on a rational underpinning drawn from the art, not from the applicant's disclosure (impermissible hindsight)

Risk: The examiner will likely respond that the motivation is independently supported by Antoni's controllable-thickness teaching and Alm's overlapping wall-thickness ranges, not merely the figure resemblance. Counsel should address those independent bases rather than the figure comment alone. Prosecution-history caution: none significant beyond ordinary characterization risk.

Likely examiner response (argument survives — moderate): The examiner could recast the motivation without leaning on the applicant's figure — arguing that the figure resemblance was merely corroborative and that the actual rationale rests on Alm's and Antoni's own teachings plus routine measurement of an IPN thickness, so the reasoning has an independent rational underpinning that survives removing the figure reference. The examiner could characterize the modification as combining known IPN/coating elements to yield a predictable lubricious surface (MPEP 2143(A)/(C)).

How to adjust: The hindsight point is real where the ONLY articulated bridge to the specific thickness/volume allocation is the resemblance to the applicant's Figure 1, but it is vulnerable because an examiner can often restate the motivation from the references. Strengthen by tying the challenge to the specific selection the office action never explains from the prior art alone (why THIS thickness and THIS volume split), and pair it with the rank-1 RE-variable gap so the combined attack targets the sufficiency of the articulated reasoning as a whole rather than the figure comment alone. Preserve verify-first since Alm/Antoni text is not in the record.

5. [Missing element]: Verify-first: first/second solution component allocation in method claim 14 assembled from separate passages

Claims addressed: 14, 15, 16

Limitation hook: the first solution comprises hydrophobic monomers, radical initiator, and a solvent ... the second solution comprises hydrophilic monomers, catalyst and a solvent

The office action appears to assemble the first-solution composition (hydrophobic monomers + radical initiator + solvent) from separate Alm passages — Example 12 for hydrophobic monomer and solvent and ¶[0453] for an initiator — and the second-solution composition across Alm Example 12 and Wang ¶[0010], rather than from a single embodiment reciting the claimed allocation of components between a swelling solution and a polymerization solution. For counsel to weigh: whether any single asserted teaching discloses the claimed division of components between the two sequential solutions is a candidate gap, but this is a §103 combination (not §102), so the inquiry is whether the combination is properly motivated and whether the components are allocated as claimed. Because Alm and Wang were not retrieved, the actual composition and sequence of their solutions cannot be confirmed — verify-first before relying on this. Provisional and non-dispositive; it ranks below the record-grounded rationale and construction points above.

Supporting evidence:

• Office action: Example 12 relied on for hydrophobic DEPDC in hexane and hydrophilic HEMA in EtOH/THF; ¶[0453] relied on separately for '0.5 mol % of an initiator'
• Office action: Wang ¶[0010] relied on for the swelling-then-transfer-to-reaction-mixture sequence
• Claim 14 allocation of hydrophobic monomers/radical initiator to the first solution and hydrophilic monomers/catalyst to the second solution

Doctrine: MPEP § 2143 / § 2145 — a §103 combination must be articulated; attacking the allocation goes to whether the combination as a whole yields the claimed method, not to any single reference in isolation

Risk: The examiner will respond that §103 permits assembling teachings across references and that Wang supplies the two-step swell/polymerize sequence with an initiator. VERIFY-FIRST: Alm and Wang text not retrieved; cannot confirm the allocation gap. Prosecution-history caution: emphasizing a specific component-to-solution mapping may narrow method-claim scope.

Evidence needed: Retrieve Alm (US20210338905) Example 12 and ¶[0453], and Wang (US20020052448) ¶[0010]-[0011] to confirm the actual composition and sequence of the swelling and polymerization solutions.

6. [Claim construction]: Boundary construction: 'more than 100 nm' versus Antoni's 'at least 0.1 μm' and the office action's nm/mm arithmetic

Claims addressed: 1, 14

Limitation hook: wherein the interpenetrated polymer network has a thickness of more than 100 nm

The claim recites a thickness of 'more than 100 nm,' while the office action quotes Antoni as teaching a hydrophilic coating 'at least 0.1 μm thick' — i.e., 100 nm inclusive, which reaches the boundary but not necessarily 'more than' it. For counsel to weigh: whether 'at least 0.1 μm' discloses 'more than 100 nm' is a boundary/construction question. Separately, the office action's own conversions appear internally inconsistent — it equates 0.01 mm with '10 nm' and 0.1 mm with '100 nm' when reciting Alm's wall-thickness range (¶[0213]), which is arithmetically off by orders of magnitude and may undercut the asserted overlap between Alm's wall-thickness range and the claimed IPN thickness. Because Antoni and Alm were not retrieved, counsel should obtain and verify Antoni's exact thickness language and Alm's ¶[0213] range before pressing this; the arithmetic inconsistency, however, is visible on the face of the office action.

Supporting evidence:

• Office action: 'the hydrophilic coating is at least 0.1 μm thick (Page 24, lines 12-19), hence more than 100 nm'
• Office action: 'The wall thickness can be from about 0.01 mm (10 nm) to about 5 mm or from about 0.1 mm (100 nm) to about 3 mm [0213]' (note: 0.1 mm = 100,000 nm, not 100 nm)
• Claim 1: 'the interpenetrated polymer network has a thickness of more than 100 nm'

Doctrine: MPEP § 2111 / § 2173.02 — claim scope under BRI; boundary of an open-ended numeric limitation relative to the reference's disclosed range

Risk: The examiner will likely respond that 'at least 0.1 μm' includes values above 100 nm and that under routine optimization any value in the range is reachable, and may correct the nm/mm typo as harmless. VERIFY-FIRST: Antoni's and Alm's exact figures were not retrieved; confirm them before relying on this distinction. This is provisional and non-dispositive.

Evidence needed: Retrieve and verify Antoni page 24 thickness language and Alm ¶[0213] wall-thickness range to confirm the boundary and arithmetic points.

Likely examiner response (⚠ fragile — the comeback likely defeats it): The examiner has a strong direct rebuttal: 'at least 0.1 μm' means 0.1 μm OR GREATER, so it expressly encompasses thicknesses greater than 100 nm and therefore reads on 'more than 100 nm' — the boundary distinction counsel draws collapses because 'at least' is inclusive of everything above the lower bound. The examiner could treat the nm/mm conversion typos as harmless clerical errors in the Alm wall-thickness recitation that do not affect the Antoni-based thickness mapping.

How to adjust: The 'reaches the boundary but not more than it' framing is weak because 'at least 0.1 μm' plainly includes values exceeding 100 nm, so this is unlikely to defeat the mapping. The arithmetic inconsistency in the office action's Alm ¶[0213] conversions is visible on its face but is a correctable clerical point, not a merits defect. Steer counsel to verify Antoni's and Alm's actual thickness language first; if the goal is a genuine distinction, an amendment to a quantitative bound clearly above what the references teach is a cleaner path than pressing the boundary reading. Do not lead with this argument.

7. [Secondary considerations]: Optional evidentiary path: unexpected results tied to the claimed volume split / durable zwitterionic surface

Claims addressed: 1, 14

Limitation hook: a core region comprising more than 64% of the volume ... a surface region comprising less than 36% of the volume ... interpenetrated polymer network has a thickness of more than 100 nm

The office action affirmatively notes that 'the instant specification does not characterize the limitation ... as unexpected or surprising' and uses that absence to support the arbitrariness/routine-optimization theory. For counsel to weigh: this invites an evidentiary response — if the confined IPN surface region (per the specification's stated goal of 'a durable zwitterionic surface while maintaining the integrity of the primary polymer network beneath,' ¶[0071]) produces a benefit a PHOSITA would not have expected relative to Alm/Antoni, that could rebut the optimization rationale. Such a showing carries weight only with a nexus to the specific claimed volume fractions and thickness and generally requires a § 1.132 declaration, not attorney argument. This is a supporting/optional path, not a standalone distinction.

Supporting evidence:

• Office action: 'the instant specification does not characterize the limitation ... as unexpected or surprising'
• Specification ¶[0071] (reproduced in office action): 'This method achieves a durable zwitterionic surface while maintaining the integrity of the primary polymer network beneath.'

Doctrine: MPEP § 2145 — unexpected results / objective indicia require evidence and a nexus commensurate with the claims

Risk: The examiner will likely require that any unexpected-results showing be commensurate in scope with the claimed ranges and tied specifically to the >64%/<36% split rather than to zwitterionic surfaces generally (which Alm already teaches). Without a declaration this argument carries no weight. Prosecution-history caution: a declaration emphasizing criticality of the ranges can create estoppel limiting later scope.

Evidence needed: A § 1.132 declaration establishing unexpected results with a nexus to the claimed core/surface volume fractions and >100 nm IPN thickness, commensurate in scope with the claims.