DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1-19 have been canceled.
Claims 20-39 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 30-36, in the reply filed on 7/21/2025 is acknowledged.
Claims 20-29 and 37-39 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 30-36 are being examined in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 33, line 1, the recitation of “the decellularized muscle matrix” is indefinite. Claim 33 is dependent from claim 30, which recites “at least one decellularized muscle matrix”. It is unclear what / which decellularized muscle matrix is being recited in claim 33. Applicant may amend claim 33 to recite “the at least one decellularized muscle matrix” to overcome the rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 30-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Christman et al (WO 2010/039823 A2; 4/8/2010.) in view of Wagers et al (Cell. 2005;122:659-667.).
The instant claims recite a muscle implant comprising at least one decellularized muscle matrix that contains at least some of the myofibers normally found in an unprocessed muscle sample.
Christman teaches a composition comprising decellularized extracellular matrix derived from skeletal muscle tissue, wherein the composition is an implant (para 0022). Christman teaches the composition is in a gel form (para 0018), wherein the gel can potentially conform to any three-dimensional shape (para 00108). Christman teaches the decellularized tissue is lyophilized (para 00160). Christman does not teach alpha-galactose moieties and bioburden. Therefore, the decellularized muscle matrix lacks substantially all alpha-galactose moieties, and the muscle implant substantially lacks bioburden.
Christman does not teach the composition comprises the claimed amount of myofibers normally found in an unprocessed muscle sample (claims 30 and 32).
However, Christman does teach the muscle fibers (myofibers) in native skeletal muscle are closely packed together in an extracellular three-dimensional matrix to form an organized tissue with high cell density and cellular orientation to generate longitudinal contraction (para 0091). Christman does teach the skeletal muscle matrix can be injected into skeletal muscle for skeletal muscle tissue engineering (para 0096). Christman does teach the skeletal muscle extracellular matrix can be used to deliver cells, such as skeletal myoblast or other muscle relevant cell types in the extracellular matrix. At the time of the claimed invention, it was well-known in the art that myofibers are essential for muscle function. In support, Wagers teaches adult skeletal muscle generates force in a controlled and directed manner through the contraction of highly specialized, postmitotic, multinucleated myofibers, and lifelong muscle function relies on maintenance and regeneration of myofibers (p.659 col left – para 1).
Thus, at the time of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an optimized amount of myofibers normally found in an unprocessed muscle sample, since Christman and Wagers both disclose that skeletal muscle development and function rely significantly on the integrity and proper development of myofibers. In addition, Christman discloses an implantable decellularized extracellular matrix derived from skeletal muscle tissue that can be used to deliver muscle relevant cell types for skeletal muscle tissue engineering, and Wagers discloses that lifelong muscle function relies on maintenance and regeneration of myofibers. Therefore, one of ordinary skill in the art would use the implantable decellularized extracellular matrix derived from skeletal muscle tissue as taught in Christman to deliver muscle relevant cell types such as myofibers, in an optimized amount, for skeletal muscle tissue engineering. Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to incorporate an optimized amount of myofibers normally found in an unprocessed muscle sample, with a reasonable expectation for successfully obtaining a composition comprising decellularized extracellular matrix derived from skeletal muscle tissue.
References cited above do not teach the at least one decellularized muscle matrix is at least two or at least three decellularized muscle matrices (claim 31).
However, Christman does teach decellularized muscle matrices for treating, repairing or regenerating defective, diseased damaged or ischemic cells, tissues or organs (Abstract), wherein cardiac tissue, skeletal muscle, and liver of both rat and porcine origin are decellularized (para 00154).
Thus, at the time of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine multiple decellularized muscle matrices for treating, repairing or regenerating defective, diseased damaged or ischemic cells, tissues or organs, since Christman discloses decellularized muscle matrices and their therapeutic uses, wherein said decellularized muscle matrices include decellularized cardiac tissue and skeletal muscle of both rat and porcine origin. Therefore, one of ordinary skill in the art would have been motivated by Christman to combine multiple decellularized muscle matrices for the same purpose – treating, repairing or regenerating defective, diseased damaged or ischemic cells, tissues or organs. Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to combine multiple decellularized muscle matrices for treating, repairing or regenerating defective, diseased damaged or ischemic cells, tissues or organs, with a reasonable expectation of success.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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