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 .
This action is responsive to papers filed 04/27/2026.
Claims 1 and 8 have been amended. Claims 2, 4, 7, and 9-12 have been newly canceled and no claims have been newly added.
Claims 1, 3, 5-6, and 8 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, 5-6, and 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
Claims 1, 3, 5-6, and 8 are drawn to a method of preparing a tissue gel for transplantation. The phrase “for transplantation” is with regard to the final product produced by the method and is interpreted as requiring that the final product be in form suitable for such intended use. Baring evidence to the contrary, any method that includes the claimed method steps and structural elements is deemed to be meet this intended use provided that there is nothing in the final product produced that would render it unsuitable for transplantation.
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.
Claim(s) 1, 3, 5-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al (US 2016/0152946-newly cited) in view of Boso et al (Materials published May 2020-newly cited).
Regarding claims 1, 5, 6, and 8, Choi disclose a method of producing a cell culture by a step of stretching an elastic substrate and a step of loading a composition containing microfibrils onto the stretched elastic substrate and a step of restoring the elastic substrate (page 1 para 14). Choi disclose wherein the microfibril is one or more of a natural polymer fiber such as collagen, as long as the directionality of the fiber can be used in culturing cells (page para 62). The composition containing microfibrils may further contain one or more types of cells, such as muscle cells (page 3 para 63-64). The microfibrils may be aligned to be perpendicular to the stretching direction of the elastic substrate (page 4 para 75, page 6 para 107). The composition containing microfibrils may be cured partially as the stretched state of the elastic substrate is maintained and then restored (removing the tensile force)(page 4 para 83, page 6 para 112, 115-116) and the method may further include a step of gelling the composition containing the microfibrils at a temperature of 30-40˚C for10 minutes to an hour (allowing the composition to crosslink) (page 4 para 85) and then incubating in culture medium (culturing) for 1 to 5 days at an incubation temperature of 30-40˚C (page 4 para 86). The elastic substrate is PDMS (page 4 para 91).
While Choi does not specifically state that the final 3D scaffold product is intended for transplantation, they do teach and suggest that transplanting engineered tissue comprising cells embedded in a hydrogel is a suitable and beneficial application of such constructs (page 1 para 7), and thus one of ordinary skill in the art would have been motivated to adapt the process and product to provide for the therapeutic use of transplantation with a reasonable expectation of success.
While Choi disclose wherein the composition contain a natural polymer containing collagen and muscle cells, Choi do not specifically include wherein the composition contains decellularized skeletal muscle extracellular matrix loaded with skeletal muscle progenitor cells.
Boso disclose extracellular matrix-derived hydrogels for different skeletal muscle tissue replacements (Title, abstract, page 16 section 8). Boso teach and suggest that there is a need for engineered skeletal muscle-like tissue made from SKM ECM (pages 1-2 Introduction, page 16 section 8). Boso disclose that cell-laden hydrogels possess the ability to recapitulate the cellular environment of SKM and include the use of decellularized ECM (dECM)-based hydrogels, specifically dECM of SKM (pages 5-6, section 3, pages 7-9 section 3.4). Collagen is a major ECM component (page 6 section 3.1 Natural hydrogels). Myogenic progenitors are a suggested cell type (page 11 section 5.1) and mechanical stimulation (such as stretching) is indicated as a fundamental element of myogenic cells and plays a critical role in the regulation of SKM mass, tissue ECM remodeling and homeostasis (page 14 section 6.1).
One of ordinary skill in the art would have been motivated to utilize decellularized skeletal muscle extracellular matrix (dECM SKM) loaded with skeletal muscle progenitor cells in the method of Choi because Boso teach and suggest that there is a need for engineered skeletal muscle-like tissue made from SKM ECM (pages 1-2 Introduction, page 16 section 8). One of ordinary skill in the art would have had a reasonable expectation of success because Choi indicate that natural polymer materials such as collagen and cells such as muscle cells are suitable for use in their method and Boso also suggests that mechanical stimulation, such as stretching, is beneficial for myogenic cells.
Regarding claim 3, while Boso are silent with regard to the concentration of the proteins in their decellularized extracellular matrix they are using decellularized extracellular matrix from the same tissue as claimed (skeletal muscle) and are directed to obtaining a product that more closely replicates the in vivo environment and thus the claimed concentrations would be easily obtainable through routine optimization and experimentation.
With regard to the concentrations of the proteins in the decellularized extracellular matrix from skeletal muscle tissue in the composition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells cultured on the matrix substrate would have been affected by these concentrations.
Therefore, the combined teachings of Choi et al and Boso et al render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cheng et al., “Decellularized Tissue and Cell-Derived Extracellular Matrices as Scaffolds for Orthopaedic Tissue Engineering”, Biotechnol Adv., 2014 ; 32(2): pp. 462–484.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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