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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/29/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 03/29/2024.
Election/Restrictions
Applicant's election with traverse of Group I and the species of cells for claim 7, weakness or asymmetry in tongue muscle for claim 12, cancer of the upper aerodigestive tract for claims 13 and 25, muscle function for claim 14, injected at the site of the head and/or neck muscle injury or muscle loss for claim 17, and cancer of the upper aerodigestive tract for claim 21, in the reply filed on 04/22/2026 is acknowledged. The traversal is on the ground(s) that the applicant believes there to be unity of invention because the special feature of Group I is also in Group II. This is not found persuasive because although there may be unity of invention, unity is broken because the special technical feature is already disclosed in the prior art as discussed in the previous action.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/22/2026.
Claims 1-21 are being examined on the merits.
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 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Karen Christman and Jessica Dequach (From IDS, WO2013036708A2).
Regarding claims 1, 5, 15 and 19, Christman teaches of a method of injecting or implanting in a subject with peripheral artery disease an effective amount of a composition comprising decellularized extracellular matrix derived from skeletal muscle tissue (see claim 1) and teaches wherein said effective amount is an amount that increases muscle mass in the area of the injection or implantation of the treated subject (see claim 12). The ECM composition as described herein can help regenerate defective or absent skeletal muscle and restore muscle mass and function (see 0035).
Regarding claim 2, Christman teaches the composition to be delivered as a liquid (see claim 48).
Regarding claim 3, Christman teaches wherein the composition transforms into a gel form after delivery (see claim 49).
Regarding claim 4, Christman teaches wherein said composition is delivered as a powder (see claim 10).
Regarding claims 6-7 and 16, Christman teaches hydrogels derived from decellularized ECMs and combined with cells (see 0083).
Regarding claim 8, Christman teaches that the skeletal muscle ECM best mimics the natural skeletal muscle environment, it improves cell survival and retention upon injection at the site of the injured tissue, thus encouraging tissue regeneration (see 0039).
Regarding claim 9, Christman teaches wherein the composition degrades three months following injection (see claim 2).
Regarding claim 10, Christman teaches wherein the composition degrades one month following injection (see claim 2).
Regarding claims 11 and 18, Christman teaches wherein the ECM concentration can be 1-20 mg/mL, or 2-8 mg/mL (see 0046).
Regarding claim 12, pertaining to wherein the head and/or neck muscle injury or muscle loss in weakness or asymmetry in at least one facial muscle being tongue muscle, applying the method for increasing muscle mass by using and treating muscle injury by administering the same composition would inherently have the same effects unless given some evidence that this indeed is not the case.
Regarding claims 13 and 21, Christman teaches wherein skeletal muscle loss can be due to injury or tumor (see 0010).
Regarding claim 14, Christman teaches wherein the composition is for tissue damage, as well as for restoring muscle mass and function (see 0035).
Regarding claim 17, Christman teaches injecting the composition as a liquid into a desired site in the patient (see 0054).
Christman does not specifically teach that the method is for treating head and/or neck muscle injury however Christman teaches the method can be for repairing muscle damage to skeletal muscle tissue and so using it on the head and/or neck would have been obvious to any person having ordinary skill in the art before the effective filing date because skeletal muscle exists in both the head and neck. It would have also been obvious to administer the composition to a subject periodically at an interval of once per, day, week, month and year as this optimization is well within the purview of any skilled artisan. Christman also teaches the muscle injury can be due to tumors and so expecting the method to treat injuries from cancers of the upper aerodigestive tract would also have been prima facie obvious. It would have also been obvious administer the composition to patients having asymmetry of muscle mass in their tongue because the composition is known to improve skeletal muscle mass and function and so expecting the treatment to fix asymmetrical muscle mass loss is also prima facie obvious.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gail Naughton et. al. (WO2016176620A1).
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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