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 .
This action is in response to the papers filed March 11, 2026.
Claims 1-2, 6, 9-11, 13-20, 22-25 and 40-41 are pending in the application.
Applicant's election with traverse of Group I in the reply filed on 03/11/2026 is acknowledged. The traversal is on the ground(s) that there is not a serious search burden present between the two inventions.
This has been found persuasive and the restriction requirement has been withdrawn.
Therefore, Claims 1-2, 6, 9-11, 13-20, 22-25 and 40-41 are examined on the merits.
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.
Claim Rejections - 35 USC § 112
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 1-2, 6, 9-11, 13-20, and 22-25 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 1 and 2 recite methods of treatment wounds and promotion of wound healing “comprising administering a composition comprising one or more 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.
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 1-2, 6, 9-11, 13-18, 22 and 23 are rejected 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)
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 adipose stem cell derived exosomes to a wound of a subject (p. 301, 2nd column; Objective and Approach).
Regarding claim 6, 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, Cooper teaches that the exosomes are human adipose stem cell (hASC) exosomes (p. 300-301, bridging paragraph; p. 301, 1st full paragraph).
Regarding claim 10 and 11, Cooper teaches the human adipose stem cell (hASC) exosomes comprise large amounts of MALAT1 lncRNA (p. 302, 2nd column).
Regarding claim 13 and 14, 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, 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, Cooper states that dermal fibroblasts take up MALAT1 which is packaged by the exosomes (p. 307, 1st paragraph; p. 299, Results).
Regarding claim 17, 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 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 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.
Regarding claim 22, Cooper teaches a topical administration (p. 302, 2nd column).
Regarding claim 23, Cooper teaches adipose stem cell derived exosomes express CD9, CD63, and CD81 (p. 301, exosome isolation).
Therefore, the invention is anticipated by Cooper.
Claims 1-2, 9-11, 15 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel (US2018/0360888)
Regarding claims 1 and 2, Patel teaches a method of promoting wound healing and treating a wound comprising: administering a composition comprising one or more adipose stem cell derived exosomes to a wound of a subject (para. 0046, 0047, 0059, 0097).
Regarding claim 9, Patel teaches that the exosomes are human adipose stem cell (hASC) exosomes (para. 0004, 0056).
Regarding claim 10 and 11, Patel teaches the human adipose stem cell (hASC) exosomes comprise MALAT1 and GAS5 lncRNA (para. 0011, 0130, Figure 4A-B).
Regarding claim 15, cell free is interpreted to mean only exosomes are in the composition administered with no other cells. Patel teaches the exosomes are isolated from human adipose stem cell (hASC) (para. 0031, 0048, 0098).
Regarding claim 23, Patel teaches adipose stem cell derived exosomes express CD9, CD63, and CD81 (para. 0127).
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)
Therefore, the invention is anticipated by Patel.
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.
Claim 1-2, 6, 9-11, 13-18, 22, 23 and 40-41 are 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)
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 adipose stem cell derived exosomes to a wound of a subject (p. 301, 2nd column; Objective and Approach).
Regarding claim 6, 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, Cooper teaches that the exosomes are human adipose stem cell (hASC) exosomes from subcutaneous adipose (p. 300-301, bridging paragraph; p. 301, 1st full paragraph).
Regarding claim 10 and 11, Cooper teaches the human adipose stem cell (hASC) exosomes comprise large amounts of MALAT1 lncRNA (p. 302, 2nd column).
Regarding claim 13 and 14, 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, 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, Cooper states that dermal fibroblasts take up MALAT1 which is packaged by the exosomes (p. 307, 1st paragraph; p. 299, Results).
Regarding claim 17, 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 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 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, the same method steps yield the same predictable results with a reasonable expectation of success.
Regarding claim 22, Cooper teaches a topical administration (p. 302, 2nd column).
Regarding claim 23, Cooper teaches adipose stem cell derived exosomes express CD9, CD63, and CD81 (p. 301, exosome isolation).
Regarding claim 40, Cooper does not teach that GAS5 and/or MALATI are overexpressed. However, Cooper does teach that depletion of MALAT1 in exosomes and conditioned media show significant reduction in cell migration. Since MALAT1 is secreted into exosomes, a purified population of exosomes was applied to HDF where they enhanced cell migration in a similar manner to FGF-2 or basic fibroblast growth factor (bFGF) in ECIS wound healing assays (p. 299, Results).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to overexpress MALAT1 in the subcutaneous adipose derived stem cell exosomes of Cooper with a reasonable expectation of success. An artisan would have been motivated to overexpress MALAT1 in exosomes as Cooper teaches depletion of MALAT1 in exosomes and conditioned media show significant reduction in cell migration.
Regarding claim 41, 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
Conclusion
No claims are allowed.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631