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 .
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.
Claim Status
Applicant’s arguments and amendments dated 10/14/25 have been received and entered in the application.
Claims 1-4, 10, 12 are currently pending and examined on the merits.
Claims 1, 10 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
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.
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) 1-4, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Publication No. 2018/0037623 (hereinafter Novartis) in view of Bellavia et al., (Sept 2018) Engineered exosomes: A new promise for the management of musculoskeletal diseases. BBA General Subjects, 1862(9) pp. 1893-1901 (hereinafter Bellavia) as evidenced by Sahu et al., (2021) Regulation of aged skeletal muscle regeneration by circulating extracellular vesicles. Nat Aging. 1(12): 1148-1161 (cited on IDS dated 7/25/24, hereinafter Sahu).
Regarding claims 1, 3-4, 10, Novartis discloses methods for treating age-related conditions, such as muscle atrophy, by administering an alpha-Klotho polypeptide or nucleic acid encoding the alpha-Klotho polypeptide to subjects in need thereof (Abstract, [0012], [0014], [0073], [0078]-[0079], [0257], claims 21, 24). The composition may be administered using any suitable means, including intramuscular injection ([0387]-[0390]).
Regarding claims 2, 12, Novartis further teaches said mammal is a human ([0073]).
Novartis does not disclose that the α-Klotho polypeptide or nucleic acid encoding α-Klotho is loaded within exosomes or vesicles.
Bellavia reviews the use of engineered exosomes in the management of musculoskeletal diseases (Abstract). Bellavia explains that exosomes have emerged as an advantageous delivery vector due to their high physiochemical stability, good biocompatibility, excellent safety profile, and the ability to interact directly with target cells (Introduction, Exosomes: characteristics and potentialities). Exosomes have been successfully utilized to deliver multiple types of components, including drugs, microRNAs, and proteins (Exosomes in regenerative medicine, Table 1). In particular MSC-derived exosomes have been utilized to accelerate muscle regeneration and repair skeletal muscle injuries (Exosomes in muscle regeneration). Bellavia suggests that MSC-derived exosomes with enhanced myo-regenerative effects are an advantageous therapeutic tool for muscle injuries (Exosomes in muscle regeneration, Conclusions).
As both Novartis and Bellavia are both in the field of treating musculoskeletal conditions, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the exosomes of Bellavia for delivery of the α-Klotho polypeptide or nucleic acid encoding α-Klotho of Novartis, as Bellavia explains that exosomes are a highly advantageous delivery vehicle for treatment of musculoskeletal conditions to promote regeneration of muscle cells.
The combination does not disclose increasing muscle force of an injured muscle within the subject. However, as per MPEP §2112 the claiming of a new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. As evidenced by Sahu, administration of extracellular vesicles engineered to express a α-Klotho mRNA improves muscle regeneration, including muscle force (Klotho transcripts are abundant in young, but not old, EVs, Functional and histological analysis of muscle regeneration, Fig. 7). The prior art discloses that intramuscular injection of alpha-Klotho significantly enhances growth of muscle mass (i.e., muscle regeneration) after dexamethasone-induced muscle atrophy as compared to a control (Bellavia: [0271], [0284], [0293], [0387]-[0390], Fig.10), and that that MSC-derived exosomes accelerate muscle regeneration by increasing angiogenesis and reducing fibrosis (Exosomes in muscle regeneration, Conclusions).
Response to Arguments
Applicant’s arguments and amendments dated 10/14/25 have been fully considered but are moot in part due to the new grounds of rejection necessitated by applicant’s amendments and not persuasive in part as explained in detail below.
Claim(s) 1-4, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Novartis) in view of Bellavia, as evidenced by Sahu.
Applicant argues that none of the cited references discloses or suggests that that one of ordinary skill in the art should increase muscle force by intramuscularly administering the vesicles or exosomes of the present claims (Response p5-6).
In response, the combination discloses administering exosomes for delivery of an α-Klotho polypeptide or nucleic acid encoding α-Klotho for treatment of musculoskeletal conditions to promote regeneration of muscle cells (See art rejections supra). The improvement in muscle force following administration is merely a new function of the methods disclosed by the combination as evidenced by Sahu. As per MPEP §2112 the claiming of a new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Therefore, the combination is deemed to obviate the claims as presented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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