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 July 24, 2026. Applicant’s response to the restriction/election requirement of May 28, 2026 has been entered. Claims 4, 6, 10, 14, 23, 28, 29, 32, 35, and 43 have been amended; and claims 3, 5, 7-9, 11-13, 15-17, 19, 20, 22, 24, 25, 27, 30, 31, 33, 34, 38, 39, and 44 have been canceled. Claims 1, 2, 4, 6, 10, 14, 18, 21, 23, 26, 28, 29, 32, 35-37, and 40-43 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed U.S. Provisional Patent Application Nos. 63/460,832 and 63/526,646, filed April 20, 2023 and July 13, 2023, respectively, under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 4, 6, 10, 14, and 36, is acknowledged. Applicant’s elections of i) “hyaluronic acid” as the species of polymeric fiber constituent, and ii) “hyaluronic acid” as the species of hydrogel polymeric constituent are both also acknowledged. The Examiner has determined that claims 1, 2, 4, 6, 10, 14, and 36 read on the elected subject matter.
Accordingly, claims 18, 21, 23, 26, 28, 29, 32, 35, 37, and 40-43 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on July 24, 2026. Claims 1, 2, 4, 6, 10, 14, and 36 are 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. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs that the invention is a hydrogel comprising polymeric fibers, that is “stable”. Hydrogels comprising polymers are not new to the art at all, but rather have been well known for decades if not centuries. Indeed, the abstract does not properly inform the reader what the invention actually is, e.g. the specific requisite polymers and other specific requisite constituents in the specific requisite amounts.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art (e.g. “improved”). However, this is precisely what the abstract does, and pretty much exclusively what the abstract does. Applicant is advised that the abstract is not intended to be a promotional advertisement for the product.
4. The abstract contains English grammatical errors. For example, “hydrogels systems” and “provided are…method of preparation”. Applicant is advised to carefully review the abstract and correct any English grammatical errors present in the abstract.
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).
Drawings
The drawings are objected to because they are not in compliance with 37 CFR 1.84(u)(1) and 1.84(u)(2), which state, in part, that “partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.”, and that “numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 6 and 14 are objected to because of the following:
1. Claims 6 and 14 recite the element “poly(acrylamide)” twice, and also recite the element “polyvinylpyrrolidone” twice.
Appropriate correction is required.
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, 2, 4, 6, 10, 14, and 36 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.
Claims 1 and 36 (i.e. via claim 26) stipulate that the scaffold is “stable”, which is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “stable”, and what necessarily delineates a “stable” scaffold from a “not stable” scaffold. For example, does “stable” mean the scaffold does not explode? Or does “stable” mean the scaffold is not degraded by more than 10% at temperatures at or above 125 F? Or what?
Claims 6 and 14 are indefinite for the following reasons:
1. Claims 6 and 14 recite at least one broad limitation together with at least one narrower limitation that falls within the broad limitation, in the alternative in the same claim. For example, claims 6 and 14 recite “carbohydrate” and also recite “polysaccharide”, and also recite “alginate”. Another example is “polypeptide” with “collagen” and “gelatin”. Another example is “an extracellular matrix derived hydrogel” with “collagen” and “hyaluronic acid”. Applicant is advised to find all such examples and make the appropriate amendments.
2. The element “a self-assembled peptide or peptide amphiphile” is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter, and which subset of all peptides are “self- assembled” or “peptide amphiphile” and which are not. Indeed, whether any particular peptide is “self-assembled” would depend, in part, on the prevailing physical and chemical conditions and environment present, which are also not defined by the claim. Moreover, a peptide amphiphile is not necessarily a polymer. For example, a peptide amphiphile can be a non-polymeric surfactant.
3. The notion that polymeric fibers can comprise “an extracellular matrix-derived hydrogel” appears to be incongruous. The cart appears to be before the horse. While an extracellular matrix derived hydrogel may comprise polymeric fibers, polymeric fibers do not comprise an extracellular matrix derived hydrogel. One of ordinary skill in the art thus cannot make heads or tails out of the claimed subject matter.
Claims 2, 4, 6, 10, and 14 are (also) indefinite for depending from an indefinite claim.
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, 2, 4, 6, 10, 14, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (U.S. Patent Application Pub. No. 2018/0200407).
Applicant Claims
Applicant’s elected subject matter is directed to a “scaffold” comprising polymeric fibers and hydrogel microparticles; wherein the polymeric fibers comprise hyaluronic acid, have a length of at least 35 µm, have an aspect ratio of at least 30, and are not cross-linked; wherein the hydrogel microparticles comprise hyaluronic acid; and wherein the “scaffold” is “stable” and has a porosity of at least 30%.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Sun discloses a “scaffold” comprising polymeric fibers and hydrogel microparticles; wherein the polymeric fibers have a diameter of 2-250 µm and a length of 100-3000 µm (i.e. at least 35 µm), and are not cross-linked; and wherein the “scaffold” is “stable”, comprises matrix material from e.g. skin, and has a porosity of 90-99% (i.e. at least 30%) (abstract; paragraphs 0001, 0005-0008, 0010, 0011, 0017, 0028, 0029).
Ascertainment of the Difference Between the Scope and Content of the Prior Art and the Claims (MPEP §2141.02)
Sun does not explicitly disclose that the polymeric fiber aspect ratio is at least 30, and that the polymeric fibers and the hydrogel microparticles each comprise hyaluronic acid. These deficiencies are cured by the teachings of Sun and the general knowledge of one of ordinary skill in the art.
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 employ the teachings of Sun, outlined supra, to devise Applicant’s presently claimed scaffold.
Sun discloses a “scaffold” comprising polymeric fibers and hydrogel microparticles; wherein the polymeric fibers have a diameter of 2-250 µm and a length of 100-3000 µm (i.e. at least 35 µm), and are not cross-linked; and wherein the “scaffold” is “stable”, comprises matrix material from e.g. skin, has a porosity of 90-99% (i.e. at least 30%), and is employed in applications that require the scaffold to have biological activity. Since one of ordinary skill in the art would generally and readily know that matrix materials from skin primarily include collagen and hyaluronic acid, and since Sun discloses that the combination of collagen and hyaluronic acid exhibits improved biological activity compared to collagen alone, one of ordinary skill in the art would thus be motivated to employ hyaluronic acid as a polymeric fiber material and also to employ hyaluronic acid as a hydrogel microparticle material, with the reasonable expectation that the resulting scaffold will exhibit excellent biological activity.
Moreover, Sun discloses that polymeric fibers have a diameter of 2-250 µm and a length of 100-3000 µm. At the minimum length of 100 µm and the minimum diameter of 2 µm, the aspect ratio is thus 50 (i.e. at least 30).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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