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 .
Election/Restrictions
Applicant’s election without traverse of poly(lactic-co-glycolic acid) as the first fiber composition and poly(dioxanone) as the second fiber composition in the reply filed on January 21, 2026 is acknowledged. In view of the art cited below (Johnson & Kayuha), the species election requirement is hereby withdrawn.
Claim Objections
Claims 25-43 are objected to because of the following informalities: “Claim ..” should be in lowercase. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement filed October 16, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. NPL numbers 2, 3, and 18 were not found in the submissions as listed.
Also a number of documents (all under 100 pages) such as NPL numbers 11-13 and 32-34 are split up into several files without identification, requiring guesswork to identify the correct parts thereof. The listing for NPL number 12 has been corrected.
Furthermore it is unclear why some of the foreign references are listed, e.g., number 13 concerns wellbore ranging, number 12, a “system for managing sale of one or more items”, and number 5 concerns semiconductor memory. Applicant is requested to explain their relevance.
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.
Claim 38 is 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 “a mean pore size of from about 10 µm2 to about 300 µm2 ” in claim 38 has 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).
Here claim 38 as a whole covers particles comprising two fiber compositions, each fiber composition comprising a resorbable polymer, an average particle diameter of under 5000 µm, a nanofiber matrix, a mean pore size of about 10 µm2 to about 300 µm2.
The entire application has been reviewed to understand how applicant provides support for the claimed invention including each element and/or step. There is no express disclosure of “plurality of particles comprise a plurality of pores comprising a mean pore size of from about 10 µm2 to about 300 µm2 ” in claim 38. The disclosure regarding pore size concerns “non-woven graft material”, which “has interconnecting pores having a pore size in the range of from about 10 μm2 to about 10,000 μm2”, with “[p]articularly suitable embodiments hav[ing] a pore size of less than 300 μm2” (Specification para. [0036]). It is acknowledged that these pore sizes would yield “mean” pore sizes within the range; however, “mean” is a mathematical parameter of a range that is not identical to the range: one range of values and a much wider range could comprise the same mean. There is no discussion of the mean or average pore size in the disclosure. Furthermore, although the disclosure states that the particles, which are formed by breaking down the graft material “maintain the same fiber diameter and pore size” (Specification para. [0046]), the mean or the average of the pore size would change once the electrospun graft material is broken down into particles.
Therefore, it is determined that there is insufficient 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.
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 24-43 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Applicant states, “‘nanofibers’ refer to very small diameter fibers having an average diameter not greater than 2000 nanometers, than 1000 nanometers, and suitably, not greater than 1500 nanometers (nm)” (Specification [0024]). In the present instance, claim 24 recites the broad recitation “mean fiber diameter of less than 5000 um”, and the claim also recites “nanofiber” in “nanofiber matrix”, i.e., average diameter not greater than 2000 nm, 1000 nm, or 1500 nm, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
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 24-43 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (WO 2015/153011A1) in view of Kayuha (US 2015/0086607).
Regarding claims 24, 30-35, 38, and 39, Johnson teaches electrospun polymer fiber fragments which 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), or used to fill a tissue defect including wrinkles (para. 0085). The implantable electrospun resorbable polymer fiber fragments have an average fiber diameter 500 nm (i.e., nanofiber matrix), and a particle diameter of about 0.1 µm to about 10 µm (paras.0007, 00110-12; see title; abstract; paras. 0018, 0076-91, 0110-22; Figs. 5A, 5B, 6B). The Figure 3B shows interconnected pores having sizes well under 200 µm in all dimensions, and therefore having a mean within or close to the range in claim 38 (see paras.0096, 0058). Suitable polymers for forming the fiber particles include PLGA, poly(dioxanone), and the others in claims 40-42 (paras.0062, 0095).
Johnson teaches a incorporating the particles in a gel injection medium (paras.0077, 0080, 0083). The micronized nanofiber fragments can be “mixed with adipose derived mesenchymal stem cells…” (para.00112) or other powders (para.0089), and loaded into syringes (paras.00114-22). It is noted that “irregularly-shaped” in claim 35 is interpreted as a shape other than “circular, spherical, square, rectangular, diamond, star,” (Specification para.[0045]). “Joint structures, such as knee meniscus, cruciate ligament,…” (para.0084) would comprise “irregularly-shaped wounds” in claim 35.
Regarding claims 25-28, Johnson does not expressly teach pouring or packing the particles into one or more layers. However doing so would have been prima facie obvious for one having ordinary skill in the art before the effective filing date because Johnson teaches suspending the fragments in various carrier medium including “saline …, a gel, a powder, an aerosol, or any combination thereof” (para.0083). Such suspensions can be injected “intravenously, intramuscularly, subcutaneously, or intraperintoneally”, as well as applied or inserted topically, or implanted(id. para.0089; see paras. 0025, 0084-86). A solution, gel, or powder medium would allow “packing, spreading…or pouring” of the particles onto a wound in one or more layers. Johnson further teaches filling voids such as beneath skin wrinkle and sphincter voids, and use as an embolization agent (paras.0085-86) which would comprise about 100 µm to 700 µm. 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).
Johnson does not teach an example particle formed from electrospun graft material comprising fibers specifically of two polymer compositions as recited in claim 24, or the combination elected on January 21, 2026 and recited in claim 42.
Kayuha is drawn to a “synthetic construct suitable for implantation into a biological organism that includes at least one polymer scaffold; wherein the at least one polymer scaffold includes at least one layer of polymer fibers that have been deposited by electrospinning;…” (abstract). Kayuha expressly teaches that one “embodiment provides a graft that varies in compliance from the arterial side to the venous side in a manner as to reduce the mismatch in compliance between the sides through different fiber orientations; different materials; …; or combinations thereof” (para.0034; see para.0025: “assembling a composite structure of different materials…”; claims 21, 32). Kayuha expressly teaches, “[d]rugs, antibiotics, growth factors, …may be embedded in the fibers… [m]ultiple polymers may be co-electrospun to produce individual fibers of each polymer or the polymers may be mixed in solution to produce fibers of mixed polymers” (para.0035). Like Johnson, Kayuha teaches the polymers in instant claims 40-42 and polydioxanone nanofibered graft materials (claims 7, 18).
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 Kayuha and prepare Johnson’s electrospun polymer fiber fragments formed by electrospinning a first and a second fiber compositions as in claims 24 and 42. 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 Kayuha expressly teaches producing individual fibers of each polymer which would allow “reducing the mismatch in compliance between the [arterial and venous] sides” when the implant is deployed, and enable “assembling a composite structure of different materials and/or different fiber orientations … to control and direct cell orientation and differentiation” (para.0025). Both Johnson and Kayuha teach the polymer fiber compositions in claims 40-42. “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 it is noted that a “chemical composition and its properties are inseparable”. MPEP § 2112.01(II). Because Johnson and Kayuha teach the polymer fiber compositions in claims 40-42, they would hydrolyze to the acidic byproducts in claim 43.
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 29, 36, and 37.
However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to do so. Regarding claim 29 the skilled person would have been motivated to apply the electrospun nanofiber fragments onto a suture line because Johnson teaches “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; see para.0009), and that mesenchymal “stem cells quickly attach, proliferate, and produce extracellular matrix on the nanofibers” which would improve wound healing. Therefore the skilled person would have been motivated to apply Johnson’s fiber fragments onto suture lines to improve would healing at the site of the suture.
Regarding claims 36 and 37, the skilled person would have been motivated to use the electrospun nanofiber fragments in combination with an electrospun sheet 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).
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 24-43 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 and comprises a first and a second fiber compositions. The differences are that the ‘269 patent’s claims further recite the plurality of particles are formed from an electrospun graft material, 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) which is less than the 5 µm and the pore size here. Therefore those claims anticipate the claims here. The present claims recite a method of tissue repair by applying the plurality of particles configured to improve wound healing, however the ‘269 patent’s claims are also drawn to particles configured to improve wound healing.
Claims 24-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24 and 29-43 of copending Application No. 19/353328 (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 ’328 application’s claims further recite “the first and second fiber compositions are configured to break down into one or more acidic byproducts when applied to a tissue site, and the one or more acidic byproducts are selected from the group consisting of monomers and oligomers comprising: lactic acid, glycolic acid, 6-hydroxycaproic acid, caproic acid, 4-hydroxybutyrate, 2-hydroxyethoxyacetic acid, glyoxylic acid, and oxalic acid” which appears in instant claim 43. However both claim sets recite the same resorbable polymers and therefore they would hydrolyze into the recited byproducts when applied to a tissue site. The instant 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 24-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-43 of copending Application No. 19/353408 (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 instant 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 24-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 22, 24-33, and 41-47 of copending Application No. 19/093009 (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 present claims further recite “the plurality of particles comprise a plurality of pores comprising a mean pore size of from about 10 um2 to about 10,000 um2, and the plurality of particles have an architecture resembling a native extracellular matrix”. Therefore the present claims anticipate those of the ‘009 application. The instant 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.
Conclusion
No claim is allowed.
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