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 .
Claims 1-25, of record 5/29/2024, are pending and subject to prosecution.
Priority
The instant application is a national stage entry of PCT/US2022/051424 (filed 11/30/2022). Acknowledgement is made of the applicant’s claim for benefit to provisional application 63/284987 (filed 12/1/2021).
Specification
The use of the terms Restorelle, Tween, Triton-X, Alexa Fluor, Click-iT, ProLong, and Betadine, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities:
The abbreviation “PEP” should be written out as “purified exosome product” when it first appears.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites the limitation “PEP”, which is interpreted as a purified exosome product prepared by isolating exosomes from plasma by filtration and ultracentrifugation and subjecting the composition to lyophilization, consistent with ¶0023 of the instant application’s PG Pub.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 9-16, and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kisby et al. (Master’s Thesis, 2020).
Kisby teaches the regeneration of vaginal tissue in an animal model of surgical mesh exposure using exosomes (See page 10, ¶1-3 and 8 and page 11, ¶1).
Regarding claims 1-4, 9-16, and 21-25: Kisby teaches that polypropylene meshes were surgically implanted into vaginal tissue in pigs to create a mesh exposure model (See page 10, ¶3 and 6). The meshes were 1 × 1 cm, 2 × 2 cm, or 3 × 3 cm (which reads on “at least 1 cm by 1 cm in size”) (See page 10, ¶6 and page 14, ¶3). In some animals, surgical closure was performed in a second procedure (See page 14, ¶4). Reconstituted PEP was injected deep to the surgical mesh and closure (if performed) was injected (which reads on “administered once”) into the vaginal tissue below the exposed mesh (See page 14, ¶4; page 15, ¶1; and fig. 1). The injections read on “administering PEP to tissue adjacent to an area of exposed surgical mesh” and “injecting PEP at one or more sites within the treated area”. PEP was reconstituted in sterile water with collagen (which reads on “an extracellular matrix component”) (See page 15, full ¶1). Animals treated with PEP (with or without surgical closure) exhibited more prominent mesh exposure resolution and increased epithelial thickness, proliferation, and vascularization (which reads on “in an amount effective to treat”, “an amount effective to increase proliferation of epithelium to decrease the area of exposed surgical mesh, increase thickness of epithelium… or increase vascularization of epithelium”, and “increased cellular proliferation, increased epithelial thickness, increased vascularization”) compared to surgical closure-only controls (which reads on “an untreated mesh exposure”) (See page 18, ¶2-3; page 19, ¶1-2; and page 20, ¶1-2). The control group exhibited via microscopic evaluation poorly regenerated basement membrane and scar formation in contrast to the intact basement membrane and maintained cell junctions (which read on “reduced scar formation”) in the PEP-treated groups, although PEP plus surgical reclosure reduced the length of epithelial disruption versus PEP alone (See page 19, full ¶1 and fig. 2-3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kisby (Master’s Thesis, 2020) in view of Behfar et al. (WO 2019118817 A1), of record in IDS dated 8/19/2024.
The teachings of Kisby are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 5-7 and 17-19: Following the discussion of claims 1-4, 9-16, and 21-25, Kisby teaches the administration of PEP for resolving exposure of surgical mesh but does not teach multiple administrations.
Behfar et al. teach methods of making and using purified exosome products (See Abstract). PEP can be formulated into therapeutic compositions and can be administered in a single dose or multiple doses (which reads on “more than once” and “from 2 to 4 administrations”), such as weekly doses (which reads on “at an interval of about seven days between administrations”) (See page 12, line 23-25 and page 15, line 23-31).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Kisby to comprise the multiple dose schedule disclosed by Behfar et al. One would be motivated to make this modification because Behfar et al. teach that weekly administrations may be preferred for applications such as wound healing (See page 15, line 29-31). There would be a reasonable expectation of success in doing so because injections on a weekly basis could be readily performed.
Regarding claims 8 and 20: Following the discussion of claims 1-7, 9-19, and 21-25, Kisby does not expressly teach the number of exosomes delivered by injection, however, 2.5 ml of a 20% PEP gel solution was delivered per injection (See page 14, ¶4 and page 15, ¶1).
Behfar et al. teach 6 × 1011 total particles measured per ml of a 100% PEP solution that had been diluted 1000-fold (i.e., a 0.1% solution) (See page 29, line 9-14 and fig. 14), which suggests that the 20% solution of Kisby would comprise approximately 1.2 × 1014 exosomes per ml. The 2.5 ml injection volumes of reconstituted PEP taught by Kisby would thus read on “an amount effective to deliver at least 1012 PEP exosomes”.
Citation of Prior Art
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure. The examiner notes that Kisby et al. (Female Pelvic Medicine & Reconstructive Surgery, 2019) teach PEP-induced vaginal epithelial regeneration in a porcine mesh exposure model (See S111-S112). Meshes ranging from 1-3 cm2 were implanted, and pigs underwent surgical reclosure and/or PEP injection. PEP treatment resulted in re-epithelialization, with regenerated tissue structure similar to healthy vaginal epithelium.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
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