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 May 21, 2026. In that response, claims 24-40 were amended. Claims 24-40 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 24 objected to because of the following informalities: after “wherein”, a colon and a line break appear unnecessary, with un-indented clauses following them. 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 24-40 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 24 recites “hybrid-scale fiber matrix”, whose meaning is indefinite. The disclosure states as follows.
Embodiments provided herein facilitate repairing biological tissue or reinforcing biomedical material based on a biomedical patch (e.g., graft, hybrid-scale fiber matrix or matrices, sheet) including a plurality of fibers, such as shown in FIG. 1. Such fibers may have a very small cross-sectional diameter (e.g., from 1-3000 nanometers, from 1-1000 nanometers, from 1 nanometer - 10 millimeters) and, accordingly, may be referred to as hybrid-scale fiber matrices and/or microfibers. (Specification, para.[0019].)
The above passage does not clearly define “hybrid-scale fiber matrix”. The term “hybrid” implies a combination of two different things. “Hybrid-scale” thus implies a combination of two different scales. However the passage states “a very small cross-sectional diameter (e.g., from 1-3000 nanometers, from 1-1000 nanometers, from 1 nanometer - 10 millimeters)”. “1 nanometer-10 millimeters” ranges from nanoscale to millimeter scale and thus could arguably be “hybrid-scale”. However the range of 1-1000 nanometers, at the least, is nanoscale only. Therefore it is curious why the underlined “accordingly” is present at all. Further confusion then arises whether the “hybrid-scale fiber matrix” has to also display the functions, i.e., “facilitate repairing biological tissue or reinforcing biomedical material based on a biomedical patch (e.g., graft, hybrid-scale fiber matrix or matrices, sheet) including a plurality of fibers, such as shown in FIG. 1”.
“Hybrid-scale fiber matrix” does not appear to be a term whose meaning is established. Several publications since 2021 use the term; however they appear related to a product named Restrata®, marketed by Applicant Acera Surgical, Inc. (e.g., Fernandez, L., et al., Synthetic Hybrid-Scale Fiber Matrix in the Trauma and Acute Care Surgical Practice, Wounds 2021;33(9):237–244). While the publication uses the term “hybrid-scale fiber matrix”, it does not elaborate or define the term but simply refers to Restrata®.
Therefore it is determined that the metes and bounds of claim 24 could not be ascertained. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
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 24-40 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. Claims 24 recites “the plurality of particles having an average diameter of less than 5000 µm” which lacks written description support.
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) Claim 24 as a whole covers a method of tissue repair comprising applying a plurality of particles to a wound wherein the particle comprise two fiber resorbable polymer compositions and “the plurality of particles having an average diameter of less than 5000 µm”.
(2) The entire application has been reviewed to understand how applicant provides support for the claimed invention including “the plurality of particles having an average diameter of less than 5000 µm”. The average diameter has been discussed for the fiber, i.e., fiber diameter, but not for the particles made from the fibers. The discussion most relevant to “the plurality of particles having an average diameter of less than 5000 µm” concerns D50 (Specification para.[0049]). However D50 is the median diameter, not an average diameter. The median and the average are distinct concepts. An embodiment of a plurality of particles could have D50 of 4999 µm and an average diameter vastly greater than 5000 µm.
(3) Consequently it is determined that there is not 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.
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 MacEwan (US 2017/0326270).
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). Johnson shows in Figures 5A and 5B the “images of micronized electrospun textile fragments dispersed in water” (para.00111 (emphasis added)). “The micronized electrospun textile fragments depicted in FIGS. 5A and 5B had an average diameter of 500 nm and an average length of about 500 μm” (id.).
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.
MacEwan teaches non-woven graft materials for wound repair comprising “at least two distinct fiber compositions composed of different polymeric materials” (abstract) such as poly(lactic-co-glycolic acid) (PLGA) and polydioxanone, prepared by electrospinning (title; abstract; paras.0001, 0011-13, 0027-28, 0030, 0033, 0036-40, 0055-58, Example 1; claims 1-20). The fibers have a mean fiber diameter of less than 5 µm (para.0038).
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 which are different as in claim 21. The skilled person would have been motivated to do so because both are drawn to electrospun polymeric fibrous implants comprising two or more polymers. “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). Here both Johnson and MacEwan teaches the polymers in claims 24, 25, and 47 as suitable for electrospinning. Furthermore MacEwan teaches, “two or more distinct types of fiber compositions , each of which possesses independent mechanical, chemical and/or biological properties” provide benefits: “inclusion of one fiber composition can stabilize the resulting non-woven graft material, while the other fiber composition can improve stability, free-shrinkage properties, mechanical properties, and resorption rate of the non-woven graft material” for better wound healing” (para.0027).
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).
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed May 21, 2026 have been fully considered but they are not persuasive. Applicant states “the Office action appears to be conflating the diameter fibers…and the diameter of particles”, and neither Johnson nor Kayuha discloses a plurality of particles having an average diameter of less than 5000 µm. (Remarks, 8, May 21, 2026.)
First, there is no “conflating”. The line breaks and indentions in claim 24 filed 01/21/2026 (for which amendment markings are omitted in the claim listing filed May 21, 2026), the inconsistent use of “the plurality of particles…” in lines 3-6 as compared to lines 8 and 9, and the lack of an “and” at the end of line 5, support “an average diameter of less than 5000 µm” as referring to the fiber diameter rather than the plurality of particles. The indefiniteness rejection at page 6 of the Office action indicates the absence of “conflating”. Moreover as noted above here “the plurality of particles” which have an average diameter of less than 5000 µm is not disclosed.
Johnson on the other hand shows in Figures 5A and 5B the “images of micronized electrospun textile fragments dispersed in water” (para.00111 (emphasis added)). “The micronized electrospun textile fragments depicted in FIGS. 5A and 5B had an average diameter of 500 nm and an average length of about 500 μm” (id.).
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.
Response to Arguments
Applicants requested reconsideration of the double patenting rejection(s) in light of the amendments. (Remarks, 6.)
The provisional 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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