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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 26, 2026 has been entered.
In that response, claims 21-33 and 41-47 were amended. Claims 21-33 and 41-47 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 is objected to because of the following informalities: double commas after “(PEG)”. “Poly vinylpyrrolidone” is more conventionally written as “polyvinylpyrrolidone” or “poly(vinylpyrrolidone)”. Appropriate correction is required.
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 21-33 and 41-47 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 electrospun polymer fiber fragments having an average diameter of 500 nm (paras.00110-11; see title; abstract; paras.0076-91, 0110-22; Figs. 5A, 5B, 6B and accompanying text). The micronized nanofiber fragments were “mixed with adipose derived mesenchymal stem cells…” (para.00112) and loaded into syringes (paras.00114-22). 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), or used to fill a tissue defect (para.0085). Johnson teaches a gel injection medium (paras.0077, 0080, 0083). The electrospun polylactic acid fiber fragments can be mixed with other powders (para.0089).
Regarding “wherein the plurality of particles include the nanofiber matrix of the electrospun graft material” now in claim 21, Johnson shows in Figures 5A and 5B the “images of micronized electrospun textile fragments dispersed in water” (para.00111). “Figures 6A depicts a micrograph of the suspension of micronized nanofiber fragments immediately after the addition of the stem cells.” (Para.00112). Figure 6A shows a cluster of nanofiber fragments 610 and a cell embedded in the suspension of micronized nanofiber fragments 620 (see below). All of these figures show distinct fibers which retain their electrospun structure or “matrix”, after micronization by “cryoshearing” (para.00111).
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Regarding claims 23-25 and 47, Johnson teaches using a combination of the recited polymers at ratios within the range in claim 23 (para.0047).
Regarding claims 31 and 32, Johnson teaches loading and evacuating vials using different sized syringe tips which comprises a “sorting”.
Johnson does not specifically teach an example electrospun graft material comprising a plurality of electrospun fibers formed by electrospinning a first and a second fiber compositions which are different as now recited in claim 21.
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). Also
Johnson does not expressly teach a sheet of electrospun graft material in claim 22. However the claims at hand are drawn to a plurality of particles formed from electrospun graft material. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP §2113 (citations omitted). Here the electrospun graft material is formed into particles; therefore whether the material prior to forming the particles is a sheet or otherwise is not seen as yielding different particles.
Johnson does not expressly teach applying the electrospun nanofiber fragments onto a suture line and using them in combination with an electrospun graft material as in claims 28, 45, and 46.
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 28 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 claims 45 and 46, the skilled person would have been motivated to use the electrospun nanofiber fragments in combination with an 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
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 February 26, 2026 have been fully considered but they are not persuasive. Applicant argues that neither Johnson nor Kayuha teach or suggest “wherein the plurality of particles include the nanofiber matrix of the electrospun graft material”, and Ito evidences electrospun nanofiber mats that had undergone milling do not retain the initial morphology. (Remarks, 6-8, February 26, 2026.)
In response it is noted that as discussed above Johnson shows in Figures 5A and 5B the “images of micronized electrospun textile fragments dispersed in water” (para.00111). “Figures 6A depicts a micrograph of the suspension of micronized nanofiber fragments immediately after the addition of the stem cells.” (Para.00112). Figure 6A shows a cluster of nanofiber fragments 610 and a cell embedded in the suspension of micronized nanofiber fragments 620 (see below). All of these figures show distinct fibers which retain their electrospun structure or “matrix”, after micronization by “cryoshearing” (para.00111). Ito attests to a change in morphology of its electrospun fibers which contained D-mannitol and polyvinyl alcohol, neither of which are among the substances contemplated in the disclosure here, after milling.
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 21-33 and 41-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-27, 29, 30, and 33-43 of copending Application No. 19353328 (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”. However both claim sets recite the same resorbable polymers and therefore they would hydrolyze into the recited byproducts when applied to a tissue site.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-33 and 41-47 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 21-33 and 41-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-43 of copending Application No. 19353408 (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; wherein the plurality of particles comprise a nanofiber matrix, and the first fiber composition and the second fiber composition each have a mean fiber diameter of less than 5 um. The ‘408 application’s 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”. However Johnson teaches electrospun polymer fiber fragments having an average diameter of 500 nm (paras.00110-11; see title; abstract; paras.0076-91, 0110-22; Figs. 5A, 5B, 6B). The micronized nanofiber fragments have an average pore diameter (para.0068) within the range in the ‘408 application’s claims. Furthermore both claim sets are drawn to particles configured to improve wound healing and therefore the skilled artisan would have been motivate to provide an architecture consistent with the extracellular matrix.
Response to Arguments
Applicants requested reconsideration of the double patenting rejection(s) in light of the amendments. (Remarks, 9.)
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
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
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