DETAILED ACTION
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 .
Status of the Claims
Acknowledgement is made of the response filed on March 9, 2026. In that response, claims 24-27, 29, 30, and 33-43 were amended and claims 28, 31, and 32 were cancelled. Claims 24-27, 29, 30, and 33-43 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 25 is objected to because of the following informalities: the last wherein clause recites “the one or more… selected from the group consisting of monomers and oligomers comprising: lactic acid, glycolic acid,… and 2-hydroxyethoxyacetic acid”. The last “and” here indicates all of the acids as “the group consisting of” modifies “monomers and oligomers”. Unless the claim is requiring that the byproducts comprise all of the acids recited an appropriate correction is required.
Claim Rejections - 35 USC § 112
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 24-27, 29, 30, and 33-43 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.
The term “topical tissue defect” in claim 25 is a relative term which renders the claim indefinite. The term “topical tissue defect” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree of the depth that is considered “topical”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
First it is noted that the exact claim phrase is “…configured to be applied to a topical tissue defect”. It recites configuring for application “to a topical tissue defect”; it does not recite or require topical application or administration, i.e., directly onto skin or mucous membrane. In other words, configuration for injection into an area under skin to fill a facial wrinkle, which is a “topical tissue defect”, is encompassed by the claim phrase.
The disclosure does not specifically use the term “topical tissue defect”. The disclosure discusses repairing “skin wounds” at length (Specification, paras.[0005]-[0006], [0061]), and mentions repairing the epidermis among numerous other tissues (Specification, para.[0054]). However “topical tissue defect” is not discussed expressly. Such defects would include wrinkles, sagging skin, uneven texture, acne scars, etc., yet none is mentioned or contemplated in Applicant’s disclosure. On the other hand the disclosure refers extensively to repairing defects of types of tissue that are not “topical”, e.g., dura mater, pericardium, gastrointestinal tract repair, etc. (Specification, para.[0054]).
For the purposes of examination now this claim term is construed as “configured to be applied to a topical tissue defect” is interpreted as including injections, skin grafts, and other which are not topical dosage forms.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-27, 29, 30, and 33-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically in independent claim 24, the universe of resorbable polymers wherein the one or more the “acidic byproducts” comprise “lactic acid, glycolic acid, 6-hydroxycaproic acid, 4-hydroxybutyrate, [and/or] 2-hydroxyethoxyacetic acid” have not been described adequately. Also the one or more acidic byproducts which are “configured to create an acidic microenvironment configured to improve wound healing” have not been described adequately.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(1) Here claim 24 as a whole covers particles configured to improve wound healing, comprising: an average diameter of less than 5000 um; a fiber matrix; and a first and a second fiber compositions, each comprising a resorbable polymer; wherein the first and second fiber compositions are configured to break down into one or more of five acidic byproducts when applied to a tissue site. “Configured to break down” means any resorbable polymer that comprises any one or more of the five recited acidic byproducts as a constituent monomer. The five acidic byproducts are: “lactic acid, glycolic acid, 6-hydroxycaproic acid, 4-hydroxybutyrate, 2-hydroxyethoxyacetic acid”. Further, the one or more “acidic byproducts” are “configured to create an acidic microenvironment” which itself is “configured to improve wound healing”.
(2) The entire application has been reviewed to understand how applicant provides support for the claimed invention including each element. It is noted that the concept of the resorbable polymer breaking down “into one or more acidic byproducts when applied to a tissue site” is not expressly discussed the disclosure. It was known prior to the effective filing of this application that resorbable polymers hydrolyze into constituent acids when placed in a biological, i.e., aqueous, environment. Lactic acid and glycolic acid for example are end products of commonly-used biodegradable polymers in biomedical applications. Polydioxanone is known to hydrolyze to form (2-hydroxyethoxy) acetic acid. However the term “break down into …acidic byproducts when applied to a tissue site” in claim 24 is not limited to “hydrolysis”. For example simultaneously applying a non-polar active agent to the tissue site could cause non-hydrolytic “break down”. The disclosure does not elaborate on “acidic byproducts” and also the nature of “break down”.
Furthermore the “acidic microenvironment” which are “configured to create an acidic microenvironment configured to improve wound healing” as recited in claim 24 lacks adequate disclosure. The claim recites not just the creation of an “acidic microenvironment” by the “acidic byproducts” of biodegradable polymers, but the specific functions they are “configured to” perform, i.e., “improve wound healing”. In the disclosure there is no discussion of any acidic microenvironment, let alone their “configuration” to improve wound healing.
Also the disclosure does not adequately inform the universe of polymers which “break down” to any one or a combination of the “lactic acid, glycolic acid, 6-hydroxycaproic acid, 4-hydroxybutyrate, and 2-hydroxyethoxyacetic acid”. Applicant discloses some resorbable polymers (Specification, para.[0030]), all known in prior art. However as noted above the disclosure does not contemplate their “acidic byproducts” or their biological effects. There is also no disclosure of the polymers other than those in para.[0030] , e.g., poly(ethyl glyoxylate) which breaks down into glyoxylic acid. Moreover there is also no disclosure of the universe of polymers which would break down into any one or a combination of the five “acidic byproducts”. Note that the “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(3) Therefore, it is determined that there is insufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention in claims 24-27, 29, 30, and 33-43 as a whole at the time the application was filed.
Response to Arguments
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive. Applicant argues that cite prior art references to argue that the polymers disclosed in paragraph [0032] degrade into the acidic byproducts in claim 24. (Remarks, 7-8, March 9, 2026.)
Paragraph [0032] of the Specification as filed refers to a suitable ratio of polymers. Furthermore at issue is not whether the polymers degrade into the acidic byproducts recited; rather the disclosure is found inadequate because the Specification merely lists a small subset of polymers which are known in prior art that would degrade to produce the acidic byproducts. The claims however are not limited to those known polymers. A universe of polymers, known and yet to be discovered, are encompassed by the language of claim 24.
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 24-27, 29, 30, and 33-43 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (WO 2015/153011A1) in view of MacEwan (US 2017/0326270).
Johnson teaches implantable electrospun resorbable polymer fiber fragments having a particle diameter of about 0.1 µm to about 10 µm (paras.0007, 00110-11; see title; abstract; paras. 0018, 0076-91, 0110-22; Figs. 5A, 5B, 6B). Each fragment comprises “at least one polymer” (abstract; see, e.g.,paras.0005-08; claims 1, 12-14, 16). Johnson teaches using a combination of resorbable polymers such as polylactic acid (PLA), polyglycolic acid (PGA), polydioxanone which breaks down into 2-hydroxyethoxyacetic acid, at ratios within the range in claim 25 (para.0047). These would “break down” via hydrolysis into the “acidic byproducts” in claims 24 and 33-35. Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted). Figure 1 shows inter-fiber spacing 130 formed between adjacent windings, such as between winding 125a and 125b, such inter-fiber spacings 130 having “a diameter of about 2 microns to about 5 microns” and therefore having a size within the range in claim 29 (para.0059, Fig. 1; see Fig.3B showing interconnected pores having sizes well under 200 µm).
Further regarding claim 24, and regarding claims 38-42, the electrospun polymer fiber fragments can be added to a carrier medium and “applied topically onto a wound” (para.0083), injected into a joint or otherwise used to treat “tissue injuries such as muscle tears,…” (para.0084), “mixed with adipose derived mesenchymal stem cells…” (para.00112) and loaded into syringes (paras.00114-22), or used to fill a tissue defect including wrinkles (para. 0085). Wounds, muscle tears, and wrinkles comprise a “topical tissue defect” now in claim 24. Johnson teaches a gel injection medium (paras.0077, 0080, 0083). Electrospun polylactic acid fiber fragments can be mixed with other powders (para.0089).
Regarding “wherein the one or more acidic byproducts are …configured to improve wound healing”, to the extent that the limitation it is supported in the disclosure merely by referring to wound healing without any specific disclosure on the “configured to…”, Johnson as noted above teaches application to wound healing.
Johnson does not specifically teach an example particle formed from electrospun graft material comprising fibers of a first and a second fiber compositions as recited in claim 24.
MacEwan teaches “non-woven graft materials for use in specialized surgical procedures such as neurosurgical procedures, wound repair, oral surgery, dermal repair and regeneration, …” (para.0001; see entire document, title; abstract; claims 1-5, 9-12, 14). The material comprises “at least two distinct fiber compositions composed of different polymeric materials” (para.0001), specifically including the combination of a first non-woven fiber composition comprising poly(lactic-co-glycolic acid) (PLGA) and a second non-woven fiber composition comprising polydioxanone (PDO) (paras.0010, 0046). MacEwan also teaches other polymers that hydrolyze into the acidic byproducts recited in claim 24 (paras.0011, 0037).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Johnson and MacEwan and prepare Johnson’s electrospun polymer fiber fragments formed by electrospinning a first and a second fiber compositions as in claim 24, such as the combination of PLGA and PDO or the others that MacEwan teaches. The skilled person would have been motivated to do so because both are drawn to electrospun polymeric fibrous implants comprising two or more polymers, and MacEwan teaches that the combination of electrospun fibers of PLGA and PDO “on-biologic tissue substitute designed to provide optimal strength, handling, and suturability, while reducing local inflammation to provide improved wound healing and tissue regeneration” (para.0040).
Johnson does not expressly teach applying the electrospun nanofiber fragments onto a suture line or using them in combination with an electrospun graft material as in claims 37 and 43.
However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to do so. The skilled person would have been motivated to apply the electrospun nanofiber fragments onto a suture line because Johnson teaches combining the electrospun nanofiber fragments with suitable carrier materials (paras.0089), “a method for making a biocompatible suture, comprising electrospinning a polymer solution onto a receiving surface, forming one or more non-overlapping nanofiber threads, removing the nanofiber threads from the receiving surface, and cutting the nanofiber threads into one or more biocompatible sutures” (abstract), and that mesenchymal “stem cells quickly attach, proliferate, and produce extracellular matrix on the nanofibers” which would improve wound healing. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” MPEP §2144.06 (I) (citations omitted).
Regarding claim 43, the skilled person would have been motivated to use the electrospun nanofiber fragments in combination with the electrospun graft material because Johnson teaches applying the nanofiber fragments topically to a wound (para.0083), and also teaches electrospun sutures and textiles for tissue repair (paras.0048, 0069, 0073, 0078-79).
Response to Arguments
Applicant’s arguments with respect to claim(s) 24-27, 29, 30, and 33-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-27, 29, 30, and 33-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12263269.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a plurality of particles configured to improve wound healing, the plurality of particles comprising: an average diameter of less than 5000 μm, wherein the plurality of particles include the nanofiber matrix structure. The differences are that the ‘269 patent’s claims further recite the plurality of particles are formed from an electrospun graft material, wherein the electrospun graft material possesses a hybrid-scale fiber structure, and breaking down a sheet of the electrospun graft material to form the particles and hybrid-scale fiber structure. Hybrid-scale is fiber diameter of 1-3000 nm (col.4 lines 53-56, col.8 lines 65-67). Therefore those claims anticipate the claims here.
Claims 24-27, 29, 30, and 33-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-43 of copending Application No. 19353408 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets are drawn to a plurality of particles configured to improve wound healing, comprising: a first fiber composition and a second fiber composition, wherein the first and second fiber composition each independently comprise a resorbable polymer; an average diameter of less than 5000 um; wherein the plurality of particles comprise a nanofiber matrix. The ’408 application’s claims further recite the mean fiber diameter and an architecture resembling a native extracellular matrix. However it would have been prima facie obvious to provide such an architecture since both claim sets are drawn to wound healing. Furthermore it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to apply Johnson because it is drawn to electrospun polymeric fibrous implants comprising two or more polymers, which are broken down into particles and comprise the fiber diameters in the present claims for diverse tissue healing and therapeutic applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 24-27, 29, 30, and 33-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-43 of copending Application No. 19353396 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets are drawn to a plurality of particles comprising: a first fiber composition and a second fiber composition, wherein the first and second fiber composition each independently comprise a resorbable polymer; an average diameter of less than 5000 um; wherein: the plurality of particles comprise a nanofiber matrix, and the plurality of particles are configured to improve wound healing. The ’396 application’s claims are drawn to a method of tissue repair in an individual in need thereof by using the plurality of particles; however the present claims recite “configured to improve wound healing” and therefore a skilled artisan would have been motivated to use the particles to repair a wounded tissue.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 24-27, 29, 30, and 33-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-33 and 41-47 of copending Application No. 19093009 (reference application) in view of Johnson (WO 2015/153011A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets are drawn to a plurality of particles configured to improve wound healing, comprising: a first fiber composition and a second fiber composition, wherein the first and second fiber composition each independently comprise a resorbable polymer; an average diameter of less than 5000 um. The ‘009 application’s claims further recite electrospun graft material, and the present claims further recite he plurality of particles comprise a plurality of pores comprising a mean pore size of from about 10 um2 to about 10,000 um and a mean fiber diameter of less than 5 um, However Johnson teaches the same. It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to apply Johnson because it is drawn to electrospun polymeric fibrous implants comprising two or more polymers, which are broken down into particles and comprise the pore sizes and fiber diameters in the present claims for diverse tissue healing and therapeutic applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed March 9, 2026 included a request to reconsider the obviousness-type double patenting rejections.
The double patenting rejection(s) is/are maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejection(s).
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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