Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This action is in response to papers filed March 9, 2026. Applicant’s reply to the restriction/election requirement of January 9, 2026 has been entered. Claims 14-25, 29, 31, and 35-45 have been canceled. Claims 1-13, 26-28, 30, and 32-34 are pending.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2022/076620, filed September 16, 2022 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 63/245,591, filed September 17, 2021 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8 and 10-13, is hereby acknowledged. Applicant’s elections of i) “neutral” as the species of side chain pendant group charge, ii) “zwitterionic” as the species of side chain pendant group character, iii) “sulfobetaine group” as the species of zwitterionic pendant group, iv) “PEG group” as the species of hydrophilic pendant group, v) “C1-20 alkyl group” as the species of hydrophobic pendant group, vi) “methacrylate monomer” as the species of backbone monomer, vii) “silk fibroin” as the species of silk protein, viii) “small molecule” as the species of active agent, ix) “oxidizing the silk protein film” as the species of means of enriching the silk protein film, and x) “reversible addition fragmentation chain transfer (RAFT)” as the species of means of polymerizing backbone monomers are all also acknowledged. The Examiner has determined that claims 1-4, 10, and 11 read on the elected subject matter.
***It is noted that Applicant first elected “zwitterionic for the side chain pendant group character” on page 4 of the present response, but then later Applicant attempts to nullify this species election by stating on page 5 of the present response that they are somehow more broadly entitled to this species plus other disclosed species, including any combination species. In effect, Applicant’s response appears to be non-compliant. Applicant must elect a single disclosed species of pendant group. In the interest of furthering compact prosecution, since Applicant specifically stated that “zwitterionic” was their elected species of pendant group, this is being accepted as the actual election of species for further prosecution on the merits. Therefore, Applicant elected “zwitterionic”, not the combination of “zwitterionic and active agent”, and certainly not any one or all of the recited species, which would nullify any species election at all.
The traversal is on the grounds that “the Heichel et al. publication does not qualify as prior art under 35 U.S.C. §102(a)(1)”; that “the Heichel et al. publication was first published on October 28, 2020, which is less than one year before the effective filing date of the instant application”; that “a Declaration under 37 CFR §1.30(a) by Kelly A. Burke…establishes that the inventive entity of the Heichel et al. publication…overlaps with the inventive entity of the instant application”; that “the subject matter relied upon by the Examiner in Heichel…was conceived solely by Kelly A. Burke and Douglas H. Adamson, both coinventors of the instant application”; and hence “the Heichel et al. publication constitutes a disclosure of Applicant’s own inventive work within the meaning of 35 USC §102(b)(1)(A), and therefore is excluded as prior art”.
This is not found persuasive because of the following:
1. It is noted that the International Searching Authority (ISA) has determined that Applicant’s claims lack unity in view of the Heichel reference. Specifically, the ISA has determined that the identified groups “do not relate to a single special technical feature under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical feature” since “this shared technical feature is anticipated by…Heichel et al.”.
2. PCT rules that govern the ISA are not superseded by America Invents Act (AIA ) provisions. The Heichel reference was published before the effective filing date of the present application. The ISA has determined that Heichel et al. disclose the special technical feature common to the identified groups, and thus that this linking feature was known at the time of filing. ISA’s determination that claims lack unity a posteriori is not nullified by a declaration under 37 CFR 1.130. The linking feature among the groups was known at the time of filing the present application, and thus it cannot serve as a special technical feature, regardless of who invented it or whether Heichel was published less than one year before the effective filing date of the present application.
3. Even assuming, arguendo, that Heichel is now disqualified as a valid reference for establishing a lack of unity, it is noted that the claims still lack unity a posteriori. The special technical feature common to groups I-III, i.e. “a composition comprising a silk protein film with a plurality of hydroxyl groups, and a brush-like polymer attached to the silk protein film comprising a plurality of repeating units” is also described in other prior art references, e.g. Zhang et al. J. Controlled Release. 2011; 152: e266-e267.
Accordingly, claims 5-9, 12, 13, 26-28, 30, and 32-34 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction/election requirement is still deemed proper, maintained, and is therefore made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on March 9, 2026. Claims 1-4, 10, and 11 are currently under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients or structural features. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader in rather broad, generic terms that the invention is a silk protein film that has somehow been functionalized. This is nothing new to the art at all. Moreover, the abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
3. The opening phrase “materials, methods, and techniques herein relate to relate to” not only contains an extraneous “relate to” but should be deleted altogether as not containing anything of real substance.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 11, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 stipulates that the silk protein film is “enriched with a plurality of hydroxyl groups”, which renders the claim indefinite. The term “enriched with” is arbitrary and subjective, and is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain what requisite structural formula, or what requisite number of hydroxyl groups, constitutes being “enriched” with hydroxyl groups. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, it is noted that the elected species of silk protein is silk fibroin, which contains hydroxyl groups, and hence silk fibroin is deemed to meet this limitation of “enriched” with hydroxyl groups.
Claims 2-4, 10, and 11 are indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, which depends from claim 1, stipulates in a wherein clause that each side chain’s pendant group is either neutral, positively charged, negatively charged, or some combination of these. As anyone of ordinary skill in the art would recognize, this is already understood from claim 1, since these represent all the possible options that exist in nature. Hence, claim 2 does not further limit claim 1 from which it depends.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (J. Controlled Release. 2011; 152: e266-e267), in view of Sin et al. (ACS Applied Mater Interfaces. 2014; 6: 861-873).
Applicant Claims
Applicant’s elected subject matter is directed to a composition comprising i) a silk fibroin film, and ii) a brush-like polymer attached to the silk fibroin film comprising repeating units comprising a methacrylate backbone and a sulfobetaine (i.e. zwitterionic) pendant group; wherein the brush-like polymer is present on the silk fibroin film at a density of 1-3 chains/nm2.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Zhang et al. disclose a composition comprising i) a silk fibroin film, and ii) a brush-like polymer attached to the silk fibroin film comprising repeating units comprising e.g. 2-hydroxyethyl methacrylate (HEMA, i.e. a methacrylate backbone and a pendant group); wherein the silk fibroin film with p(HEMA) grafted surface resisted attachment and growth of cells, and has applications in wound dressings and wound healing.
Sin et al. disclose a composition comprising i) a substrate, and ii) a brush-like polymer attached to the substrate comprising repeating units comprising a methacrylate backbone and a sulfobetaine (i.e. zwitterionic) pendant group; wherein the P(SBMA) grafted surface resisted attachment and growth of cells and also exhibited marked antibacterial efficacy, and wherein these properties could be optimized by adjusting the chain polymer density to a greater grafting coverage (see e.g. abstract).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Zhang et al. do not explicitly disclose that the brush-like polymer comprises a methacrylate backbone and a sulfobetaine (i.e. zwitterionic) pendant group. This deficiency is cured by the teachings of Sin et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Zhang et al. and Sin et al., outlined supra, to devise Applicant’s claimed composition.
Zhang et al. disclose a composition comprising i) a silk fibroin film, and ii) a brush-like polymer attached to the silk fibroin film comprising repeating units comprising e.g. 2-hydroxyethyl methacrylate (HEMA, i.e. a methacrylate backbone and a pendant group); wherein the silk fibroin film with p(HEMA) grafted surface resisted attachment and growth of cells, and has applications in wound dressings and wound healing. Since Sin et al. disclose that substrates grafted with a zwitterionic brush-like polymer comprising repeating units comprising a methacrylate backbone and a sulfobetaine pendant group not only resisted attachment and growth of cells but also exhibited marked antibacterial efficacy, one of ordinary skill in the art would thus be motivated to graft Zhang’s silk fibroin substrate with a zwitterionic brush-like polymer comprising repeating units comprising a methacrylate backbone and a sulfobetaine pendant group, with the reasonable expectation that the resulting composition will not only resist attachment and growth of cells but also exhibit marked antibacterial efficacy, and thus can be successfully applied in applications such as wound dressings and healing.
One of ordinary skill in the art would readily know that, generally, brush-like polymers are present on a substrate most commonly at a density within the range of about 0.1-0.8 chains/nm2. However, as Sin et al. teach, a P(SBMA) grafted surface resisted attachment and growth of cells and also exhibited marked antibacterial efficacy, and these properties could be optimized by adjusting the chain polymer density to a greater grafting coverage. Hence, it would have been within the skill of the ordinary mechanic in the art to optimize the P(SBMA) density on the silk fibroin film to thus arrive at a density of about 1-3 chains/nm2, with a reasonable expectation that the resulting density will result in a grafted surface that successfully resists attachment and growth of cells and also exhibits marked antibacterial efficacy.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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