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 .
The examiner acknowledges receipt of amendment and remarks filed 06/30/2026 and IDS filed 07/02/2026.
Claim 10 is amended. The status identifier should be ---currently amended --- and not “previously presented.” Applicant is encouraged to use proper status identifiers for all claims in all future filings.
Claims 10-20 are pending.
Priority
This application is a 371 of PCT/US2021/054547 filed 10/12/2021, which claims benefit of 63/234,567 filed 08/18/2021 and 63/091240 filed 10/13/2020.
Information Disclosure Statement
The IDS filed 07/02/2026 has been considered by the examiner.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive. On pages 5 of 8 to 7 of 8, applicant argues a) that claim 10 is patentable over combination of Behfar, Gao and Huebner because the claims as amended apply PEP exosome composition to injured peripheral tissue and Behfar does not; that the characterization in the office action that it would be predictable to promote growth of peripheral nervous tissue by application of PEP and surgical glue to intravaginal and intrauterine tissues ignores the plain meaning of the claim that the PEP exosome composition is applied to injured peripheral nervous tissue. b) Behfar does not disclose applying PEP exosome to injured peripheral nervous tissue and that extrinsic evidence is required to make clear that the missing descriptive matter is necessarily present; that the mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency. c) That Behfar’s application of PEP to injured vaginal tissue or uterine tissue would still fail to inherently describe applying the composition to injured peripheral nervous tissue and that application of PEP to vaginal tissue to treat injury to vaginal tissue may happen in the absence of any injury to peripheral nervous tissue. d) That Gao and Huebner do not cure the deficiencies of Behfar.
Response: Firstly, treating injured peripheral nervous system is newly added to the claim 10. Also, the last office action mailed 04/08/2026 addressed injured peripheral tissue in addressing claim 10. a) Claim 10 is not patentable over the combination of Behfar, Gao and Huebner because BEHFAR topically applies therapeutic composition comprising PEP and surgical glue or tissue adhesive namely thrombin glue and hyaluronic acid suitable excipient to promote rapid aggregation for filling surgical or fistulizing defects (page 13, lines 28-29) and treat myocardial infarction (page 15, line 29) and also teaches effects of PEP on wound closure and wound healing (page 6, lines 9 and 10; page 15, lines 29-31; page 17, lines 16-29; Fig. 6). Wound is endowed with peripheral nervous tissue. Thus b), because wound is an injury, Behfar discloses applying PEP exosome to injured peripheral nervous tissue which is intrinsic to the teaching of Behfar the citation that the mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency is not applicable here. c) Behfar’s application of PEP to injured vaginal tissue or uterine tissue and to wound is descriptive of applying the composition to injured peripheral nervous tissue because wound is an injury and wound contains peripheral nervous tissue. Application of PEP to vaginal tissue is also treating injury to vaginal tissue and applicant’s argument is not a demonstration of absence of peripheral nervous tissue in vaginal tissue. d) Gao and Huebner were relied upon as evidentiary references that peripheral nervous tissues are autograft or allograft (see at least the first 4 lines under Results at the left column of page 1004 and Table 1 on page 1005 of Gao) and that axons are part of peripheral nervous system (Huebner).
Therefore, claim 10 and the claims dependent therefrom are not patentable over Behfar as evidenced by Gao and Huebner.
The rejection is maintained and reiterated herein below.
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.
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.
Claim(s) 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over BEHFAR et al. (WO 2019118817 Al) as evidenced by Gao et al. "Nerve autografts and tissue-engineered materials for the repair of peripheral nerve injuries: a 5-year bibliometric analysis" in NEURAL REGENERATION RESEARCH, June 2015, Volume 10, issue 6, pp 1003-1008 (for claims 11 and 12) and as evidenced by Huebner et al., “Axon Regeneration in the Peripheral and Central Nervous Systems,” in Results Probl Cell Differ. 2009; 48: 339-351 (NIH Public Access Author Manuscript) that axons are part of peripheral nervous system and axons are known to transmit impulses for claim 17 (Britannica, Axon | Neurons, Nerve Fibers & Signaling | Britannica, 2026) for reasons of record and with minor modification to address injured peripheral nervous tissue.
Based on the addition of injured to claim 1, BEHFAR’s teaching that PEP is effective for wound closure and wound healing (page 6, lines 9 and 10; page 15, lines 29-31; page 17, lines 16-29; Fig. 6) is also described here. Wound is endowed with peripheral nervous tissue. Wound is an injury and BEHFAR discloses applying PEP exosome to injured peripheral nervous tissue (see the whole document with emphasis on (page 6, lines 9 and 10; page 15, lines 29-31; page 17, lines 16-29; Fig. 6).
BEHFAR teaches composition comprising purified exosome product and pharmaceutically acceptable carrier (page 2, line 18; page 12, lines 5-22) and thrombin glue is a suitable excipient that promotes rapid aggregation for filling surgical or fistulizing defects (page 13, lines 28-29) with the thrombin glue meeting the limitation of surgical glue; the purified exosome product is spherical or spheroid having diameter of greater than 300 nm (See the whole document with emphasis on page 1, lines 11-17; page 11, lines 10-11 ). BEHFAR teaches that the diameter of the spheroid is no more than 300 nm(page 11, lines 10 and 11) meeting the requirement of claim 13 that the diameter is no greater than 300 nm; BEHFAR also teaches that the diameter of the spheroid to have diameter of is at least 20 nm, 25 nm, 30 nm, 35 nm, 40 nm, 45 nm, 50 nm, …80 nm (page 11, lines 14-17). Spheroid having a diameter of 20 nm meets the limitation of claim 14 because 110-90 = 20 nm; spheroid having a diameter of 60 nm meets the limitation of claim 15 because 110-50 = 60 nm; spheroid having a diameter of 800 nm meets the limitation of claim 16 because 110-30 = 80 nm. BEHFAR further teaches that the purified exosome product (PEP) comprises 6 x 1011 particles/ml (Fig. 14, page 21, line 9) which is a specific point within the claimed range of 1 x 1011 to 1 x 1013 thereby meeting the requirement of claim 18. For claim 19, BEHFAR does not teach the PEP to comprise from 1 x 1012 to 1 x 1013 exosomes. However, looking to the teaching of BEHFAR that the PEP is 6 x 1011 particles/ml, it would have been obvious to the person of ordinary skill in the art to adjust the specimen volume to achieve amount of PEP exosomes within the specified range in the course of routine optimization that would predictably be effective in treating patients in need of treatment. For claim 20, BEHFAR teaches method of preparing the PEP by methods that include cryodesiccation/freezing and thawing (see the whole document with emphasis on at least page 2, lines 3-13); and when stored frozen, the material is thawed under controlled conditions at a rate of from 0.1 oC to 5 oC per minute (page 8, lines 4-5).
For claim 10, it is the composition comprising PEP and surgical glue or tissue adhesive applied to an injured peripheral nervous tissue that treats injured peripheral nervous tissue. BEHFAR topically applies therapeutic composition comprising PEP and surgical glue or tissue adhesive namely thrombin glue and hyaluronic acid suitable excipient to promote rapid aggregation for filling surgical or fistulizing defects (page 13, lines 28-29) and treat myocardial infarction (page 15, line 29) --- topical application to intravaginal or intrauterine tissues (page 12, lines 27-28), the myocardium and vaginal and uterine tissues have peripheral nervous tissues. Because it is the application of the exosome composition that results in treating injured peripheral nervous tissue, it would be reasonable to expect that the application of the therapeutic composition of BEHFAR comprising PEP and surgical glue to intravaginal and intrauterine tissues would predictably treat injured peripheral nervous tissue.
Peripheral nervous tissues are autograft or allograft (see at least the first 4 lines under Results at the left column of page 1004 and Table 1 on page 1005 of Gao). Therefore, for claims 11 and 12, before the effective date of the invention, a person of ordinary skill in the art would reasonably expect that the peripheral nervous tissue would predictably be autograft or allograft tissue.
For claim 17, peripheral nervous cells are part of the peripheral nervous system, and the peripheral nervous cells have axons (see the whole document of Huebner) that are part of the nerve cell carrying impulses away from the cell body (Britannica, Axon | Neurons, Nerve Fibers & Signaling | Britannica). Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect that application of the PEP to the peripheral nervous tissue would be application to the axons within the peripheral nervous tissue such that it would be expected to predictably carry impulses to effect the expected result of promoting growth/regeneration.
Therefore, BEHFAR as evidenced by Gao, Huebner and Britannica, Axon | Neurons, Nerve Fibers & Signaling | Britannica) renders claims 10-20 prima facie obvious.
Prior art cited by applicant in 1449:
Mao et al., “Gingiva-Derived Mesenchymal Stem Cell-Extracellular Vesicles Activate Schwann Cell Repair Phenotype and Promote Nerve Regeneration” in Tissue Engineering & Regenerative Medicine International Society, Vol. 25, Nos. 11 and 12, 2019 cited by applicant in 1449 filed 03/27/2026, teaches that local application of gingiva-derived mesenchymal stem cell-extracellular vesicles (GMSC EV) effects repair/regeneration/growth of injured peripheral nervous tissue (see the whole document).
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). The recitation of “treating injured peripheral nervous tissue” led to the citing of page 6, lines 9 and 10; page 15, lines 29-31; page 17, lines 16-29; and Fig. 6 of BEHFAR that disclose application of composition comprising PEP to wound for effective wound closure and healing.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights