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
Claims 1-17 are currently pending and examined on the merits.
Information Disclosure Statement
Two IDS were received on 1/13/25. All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
Claim Objections
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 1 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 9 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 16 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
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.
Claims 2-6, 8 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-3, 8 recite the limitation "the materials comprising collagen-containing tissue matrix". There is insufficient antecedent basis for this limitation in the claim.
Claims 4-6 recite the limitation "the collagen-containing tissue matrices". There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah et al (PCT Publication No. WO 2010/002799, cited on IDS dated 1/13/15, hereinafter Shah)
Regarding claims 1, 4, 8, Shah discloses a laminate construct comprising layers of extracellular matrix (ECM) which are adhered to one another with transglutaminase (p9 ln 17-24). Shah discloses obtaining a collagen-containing tissue sheet from the abdominal wall of an animal including the subserous fascia and subserous fat (p3 ln 14-23, p5 ln 11-p6 ln 12). At least some of the subserous fat is removed to produce a collagenous layer of tissue (p3 ln 14-23, p6 ln 14-29). The collagenous tissue is then decellularized and treated to remove remaining fat (p3 ln 14-23, claim 18). The resultant ECM material may retain certain bioactive components and retains the collagenous structure (p11 ln 9-p12 ln 2). In some embodiments, the ECM may be subjected to processes that expand the material, such as by partially denaturing the collagen (p14 ln 1-p15 ln 7, p15 ln 16-p17 ln 11).
Regarding claims 2-3, 7, Shah discloses that the ECM material may also be used to manufacture compositions or devices of any suitable form, such as porous solid foams (e.g., sponges), and sheets (p17 ln 11-14).
Therefore, every limitation of claims 1-4, 7-8 is present in Shah, and the subject matter is anticipated.
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) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah as applied to claims 1-4, 7-8 above, and in view of Stachel et al (Cross-linking of type I collagen with microbial transglutaminase: identification of cross-linking sites. Biomacromolecules, Vol. 11, No. 3 (2011) pages 698-705., cited on IDS dated 6/14/21, hereinafter Stachel).
Regarding claims 9-10, 12, Shah discloses that in some embodiments, two or more layers of the ECM material may be laminated together, such as by treating the layers with transglutaminase (p9 ln 17-24, p18 ln 4-30). Shah explains that layers may advantageously overlap to form a sheet that has a larger surface area than the individual layers, and that the overlapping layers may form a region with improved strength and stability (p18 ln 4-30).
Regarding claim 11, Shah does not explicitly disclose that the layers are joined together by bonds formed between the gamma-carboxamide groups of glutamine residues with primary amino acids. However, Shah discloses that the layers may be bonded together with transglutaminase. Thus, it is implicit that the layers of Shah would likewise by joined together by bonds formed between the gamma-carboxamide groups of glutamine residues with primary amino acids.
Regarding claims 13-14, Shah discloses that the ECM material may also be used to manufacture compositions or devices of any suitable form, such as porous solid foams (e.g., sponges), and sheets (p17 ln 11-14).
Regarding claim 15, Shah discloses that the obtaining the collagen-containing tissue sheet from the abdominal wall (p3 ln 14-23, p5 ln 11-p6 ln 12).
Shah also does not explicitly disclose that the collagen tissue matrix is partially denatured prior to contact with the transglutaminase; that the two treatments may be combined.
Stachel examines the ability of transglutaminase to stabilize collagen-based materials (Abstract). Stachel explains that transglutaminase is able to cross-link collagen-based materials significantly better when the collagen-based material is at least partially denatured (Discussion, Conclusion).
As both Shah and Stachel are directed methods of treating collagen-based materials with transglutaminase 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 incorporate the teachings of Stachel into Shah to ensure sufficient cross-linking (i.e., adherence) of the first material to the second material in creating a laminated tissue graft.
Claim(s) 5-6, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Stachel as applied to claims 1-4, and 9-15 above, and in further view of Xu et al (US Publication No. 2015/0282925, hereinafter Xu)
Regarding claims 5-6, 16-17, the combination does not disclose that the tissue may be obtained from muscle tissue.
Xu discloses methods of making decellularized muscle matrices for therapeutic implants (Abstract). Xu discloses obtaining a sample of muscle tissue, and decellularizing (para 16, 40, 47, 56). Preferably, the muscle tissue contains collagen and other ECM components (para 30). In some embodiments, the decellularized muscle matrix may be joined to other decellularized matrices using methods known in the art (Abstract, para 5-6, 19, 36-37, 56-57). Xu explains that forming a bilayer or multilayer implant stabilizes and strengthens the resultant construct (para 19). The resultant construct may be used to treat a variety of muscle defects and related conditions, such as hernia (para 7, 20, 64).
As both Shah and Xu are directed to methods of making multi-layer decellularized ECM constructs for therapeutic purposes, 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 utilize the tissue types disclosed in Xu in the methods of the combination for more effective treatment of certain conditions, such as hernia
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 at (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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1/13/25/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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