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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed July 27, 2026.
Claims 1-2, 6, 9-11, 13-20, 22-25 and 40-41 are pending in the application. Claims 1-2, 9-10, 15-17, 23-24, and 40-41 are amended, no new claims are added, and no claims are canceled as set forth in the claim set filed 07/27/2026.
Applicant's election with traverse of Group I in the reply filed on 03/11/2026 was previously acknowledged. However, the restriction requirement has been previously withdrawn in the office action filed 03/26/2026.
Therefore, claims 1-2, 6, 9-11, 13-20, 22-25 and 40-41 are examined on the merits.
Claim Objections
The amendment to the claims filed on 07/27/2026 does not comply with the requirements of 37 CFR 1.121(c) because changes in withdrawn claims filed on 07/27/2026 was not completely marked with respect to the previously presented claims, filed on 03/11/2026. Specifically, withdrawn claims 40-41 were previously rejoined and are not identified with the proper status in the claim listing. Amendments to the claims filed on or after 03/11/2026 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
Any further claim amendments must comply with 37 CFR 1.121(c) or they may not be entered.
Priority
Applicant’s claim for the benefit of a prior-filed parent provisional applications 63/388,119 filed 07/11/2022, and 63/331,582 filed 04/15/2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is April 15, 2022.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 102
The rejection of claims 1-2, 6, 9-11, 13-18, 22 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Cooper (Advances in Wound Care, Volume 7, Issue 9, September 2018, Pages 299-308; IDS reference filed 08/31/2023) is withdrawn.
Applicant’s arguments and amendments filed 07/7/2026 have been considered and are persuasive. Applicant has amended the claims to specify an omental source for ADSCs not previously addressed, therefore a new rejection has been set forth to address the new limitation.
The rejection of claims 1-2, 9-11, 15 and 23-25 under 35 U.S.C. 102(a)(1) as being anticipated by Patel (US2018/0360888) is withdrawn.
Applicant’s arguments and amendments filed 07/7/2026 have been considered and are persuasive. Applicant has amended the claims to specify an omental source for ADSCs not previously addressed, therefore a new rejection has been set forth to address the new limitation.
Claim Rejections - 35 USC § 103
In view of Applicants’ amendment, the rejection of claims 40 and 41 under 35 U.S.C. 103 as being unpatentable over Cooper (Advances in Wound Care, Volume 7, Issue 9, September 2018, Pages 299-308; IDS reference filed 08/31/2023) has been withdrawn.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot
Maintained objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112
Claims 1-2, 6, 9-11, 13-20, and 22-25 remain 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.
This rejection has been modified as necessitated by Applicant’s arguments and amendments filed 07/27/2026.
Claims 1 and 2 recite methods of treatment wounds and promotion of wound healing “comprising administering a composition comprising one or more omental derived adipose stem cell derived exosomes to a wound of a subject.”
The current scope would encompass any number of administration routes. The specification states “include, but are not limited to: oral administration, transdermal administration, administration by inhalation, nasal administration, topical administration, intravaginal administration, ophthalmic administration, intraaural administration, intracerebral administration, rectal administration, sublingual administration, buccal administration, and parenteral administration, including injectable such as intravenous administration, intra-arterial administration, intramuscular administration, and subcutaneous administration,” (para. 0030). However, the specification only shows examples of topical administration (para. 022). Therefore, the claims lack adequate written description of the administration step.
Sun (Front Med. 2024 April ; 18(2): 258–284) reviews the optimization parameters for exosomal therapies and states that local, topical, intravenous, inhalation, and oral administration may all be effective in treating diseases (p. 271, 2nd column). However, due to the poor oral bioavailability, further studies are needed to characterize the efficacy of this delivery method and the current study shows that inhalation is mainly used for lung disease (p. 271, 2nd column). Local application, local administration and systemic intravenous administration of exosomes all play a positive role in wound healing but studies have shown
that the therapeutic effect of intravenous injection and local application is superior to that of local injection (p. 272, 1st column). Thus, Sun demonstrates in 2024 that such administration routes such as oral and inhalation within the broad genus claimed may not be suitable for wounds and that not all known modes of administration have the same effectiveness in treating wound healing. Therefore, the entire genus of administration routes may not have the same function and provides a level of unpredictability.
Applicant generally claims a method, encompassing any route of administration as a genus in order to produce the treatment of wounds or promote wound healing, however the specification does not provide adequate written description for the entire scope of these limitations and thus the claims.
In response to Applicant’s arguments and amendments filed 07/27/2026 regarding the Written Description rejection,
Applicant argues in the 07/26/2026 Remarks that the Action confirms that a large concrete list of administration routes and thus, there is adequate written description for the administration routes. This is not persuasive.
The examiner disagrees with this position. The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,' to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). MPEP 2163 states that “An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991. There is not a reduction to practice of the entire breadth of administration routes included in a laundry list within the specification. Therefore, the claims lack adequate written description.
Claim Rejections - 35 USC § 103
Claim 1-2, 6, 9-11, 13-20, 22, and 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Cooper (Advances in Wound Care, Volume 7, Issue 9, September 2018, Pages 299-308; IDS reference filed 08/31/2023) in view of Patel2 (US Pub 2017/0321277) (Please note that claims 19-20 were inadvertently not included in the heading of the rejection though these claims were properly rejected in the body of the 103 as reflected at page 9 of the previous action filed on 03/26/2026).
This rejection is modified as necessitated by Applicant’s arguments and amendments filed 07/27/2026.
Regarding claims 1 and 2, Cooper teaches a method of promoting wound healing and treating a wound comprising: administering a composition comprising one or more subcutaneous adipose stem cell derived exosomes to a wound of a subject (p. 301, 2nd column; Objective and Approach).
However, Cooper does not teach that the adipose stem cells are derived from omental fat.
Patel2 teaches an omental derived adipose stem cell and a subcutaneous adipose derived stem cell wherein exosomes are collected from the conditioned media (para. 0173-0178). The omental exosomes comprise lncRNA GAS5 and MALAT1 (para. 0021-22, Figure 13-14). As the exosomes are purified based on CD9, CD63 and CD81 magnetic beads (para. 0178), it is interpreted that the exosomes express these markers.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to obtain exosomes from omental fat stem cells as taught by Patel2 rather than subcutaneous fat as taught in Cooper with a reasonable expectation of success to treat wounds. An artisan would have been motivated to do so as Patel2 teaches obtaining exosomes from both omental and subcutaneous stem cell sources.
Regarding claim 6, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches the exosomes were administered to a dermal wound caused by an excision of skin which is utilized to model chronic recalcitrant wounds (p. 301, 2nd column, Introduction).
Regarding claim 9, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches that the exosomes are obtained from human adipose (p. 300-301, bridging paragraph; p. 301, 1st full paragraph).
Regarding claim 10 and 11, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches the human adipose stem cell (hASC) exosomes comprise large amounts of MALAT1 lncRNA (p. 302, 2nd column). Patel2 teaches human adipose stem cells comprise MALAT1 and GAS5 (Fig. 13-14).
Regarding claim 13 and 14, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches that the model is utilized to resemble ischemic wounds which have impaired wound healing in recalcitrant wounds which have prolonged inflammatory phases (Introducton, 1st column).
Regarding claim 15, the combination of Cooper and Patel2 make obvious claim 1. Cell free is interpreted to mean only exosomes are in the composition administered with no other cells. Cooper teaches the exosomes are isolated from conditioned media (p. 302, 2nd column; p. 301, 1st full paragraph).
Regarding claim 16, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper states that dermal fibroblasts take up MALAT1 which is packaged by the exosomes (p. 307, 1st paragraph; p. 299, Results).
Regarding claim 17, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches an exosomal cargo capable of stimulating HDF migration which is largely dependent on MALAT1, a lncRNA that normally functions in the nucleus for splicing of pre-RNA (p. 307, 1st paragraph). The distribution of the exosomes within the fibroblasts is an inherent property of the exosomes. As the exosomes are the same as the present invention, the characteristics are additionally the same.
Regarding claim 18, the combination of Cooper and Patel2 make obvious claim 1. Moreover, the instant specification states in paragraph 0046: “accelerated wound closure can mean a faster wound closure compared to a wound that receives no treatment.” Cooper teaches exosomes derived from hADSC were found to accelerate cutaneous wound healing (p. 302, 2nd column).
Regarding claims 19 and 20, the combination of Cooper and Patel2 make obvious claim 1. Moreover, the increase of IL1 and IL6 as well as TLR7,CCL17 and ITGB2 is an inherent characteristic which would naturally result from the administration of the claimed exosomes. As each and every method step is taught by Cooper with the same exosomes taught by Patel2, the same method steps yield the same predictable results with a reasonable expectation of success.
Regarding claim 22, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches a topical administration (p. 302, 2nd column).
Regarding claim 23, the combination of Cooper and Patel2 make obvious claim 1. Moreover, Cooper teaches adipose stem cell derived exosomes express CD9, CD63, and CD81 (p. 301, exosome isolation).
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date
In response to Applicant’s arguments and amendments regarding the 103 rejection over Cooper,
Applicant’s arguments and amendments filed 07/27/2026 have been considered. Applicant argues that Cooper does not describe the newly claimed limitation of an omental source of the adipose tissues.
The Examiner agrees that the new limitation was not described by Cooper. Therefore, the rejection has been modified in light of Patel2 to address this new limitation.
New objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 102
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.
Claims 40 and 41 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel2 (US2017/0321277)
Regarding claims 40 and 41, Patel2 teaches an omental derived adipose stem cell wherein exosomes are collected from the conditioned media (para. 0173-0178). These exosomes comprise lncRNA GAS5 and MALAT1 (para. 0021-22, Figure 13-14). As the exosomes are purified based on CD9, CD63 and CD81 magnetic beads (para. 0178), it is interpreted that the exosomes express these markers.
Therefore, Patel2 anticipates the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claims 24 and 25 are newly rejected under 35 U.S.C. 103 as being unpatentable over Cooper (Advances in Wound Care, Volume 7, Issue 9, September 2018, Pages 299-308; IDS reference filed 08/31/2023) in view of Patel2 (US2017/0321277) as applied to claim 1 above, and further in view of Patel (US2018/0360888)
As discussed in the above 103 rejection and incorporated herein in its entirety, the combination of Cooper and Patel2 make obvious a method of wound healing comprising administering exosomes isolated from omental derived adipose stem cells.
Regarding claims 24 and 25, the instant specification discloses: "In some aspects, the adipose stem cell derived exosome comprises a labeling moiety. In some aspects, the labeling moiety can be a fluorescent marker" (para. 0070). Patel teaches GFP labelled hASC exosomes (i.e. targeting moiety expressed on the surface; a peptide which binds to a moiety present on the cell to be targeted) (para. 0023, 0176)
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to label the exosomes with moieties such as GFP as taught by Patel with a reasonable expectation of success. Patel demonstrates that labeling moieties are known in the art to be utilized with exosomes for labeling purposes.
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date.
Conclusion
No claims are allowed.
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.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
