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 .
Applicant’s election without traverse of Group II, claims 11-19, in the reply filed on 11 November 2025 is acknowledged.
Status of the Claims
Claims 1-10 and 20 have been withdrawn.
Claims 11-19 are presented for examination on the merits.
Claim Rejections - 35 USC § 102
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 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) 11-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAlexander et al. (US2007/0166395).
McAlexander discloses medical graft products, including multilaminate, having two or more regions with difference properties (porosity, strength). A hydrated ECM material is lyophilized while being shielded, covered or compressed [0006,0021]. The remoldable material can be first freezed before being lyophilized [0029], especially the freezing step take place while compressing parts of the laminated material [0039-0044]. The covering material can be Teflon or acetyl resin or a suitable fabric [0040], after the covering is complete, the hydrated material is frozen. The final construct is characterized by collapsed area (Fig.2-7) corresponding to the compressed ECM and more open matrix (no compression during the process). The construct can present a latice pattern (crisscross or crosshatch for example [0038], the compression step takes place by compressing the structure (multilayer) between plastic or metallic segments [0037],[0042].
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.
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) 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over McAlexander et al. (US2007/0166395) and Dhanaraj et al. (US2015/0258142) and Ward et al. (US2020/0188077).
McAlexander et al. is cited for the teaching put forth above.
Dhanaraj et al. discloses : a medical graft device made of ECM : decellularized pleural membranes (example 1) were laminated together, various layers of membranes being placed one above each other (up to 4 layers). Below and above the laminated construct, Teflon sheet were placed and then the construct was laminated under vacuum while applying pressure (example 3). A knitted mesh could also be placed between the layers 2 and 3 of the laminate [0044]. After the step of lamination, the construct was further lyophilized (example 4).
Ward et al. discloses a tissue graft comprising two or more layers of ECM [0018] without the use of any synthetic material for holding the layers together [0015]. Layers are interlocked with each other by a system of holes and lugs [0017,0019,0022],[0063]. After the lamination step (not further defined), the construct is removed from the mold and can eventually be further lyophilized [0099].
It would have been obvious to one of ordinary skill in the art at the time filing date of the instant Application to make a medical graft device employing the steps of the claimed method which appear to be commonly-employed techniques as taught by the cited references. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
While cited references fail to explicitly disclose that the sheets are in a specific orientation i.e., a staggered orientation or a cross-bar configuration, such adjustment of these and/or other particular conventional working conditions is deemed merely a matter of judicious selection, design choice, and routine optimization which is well within the purview of the skilled artisan. As there is a finite number of orientations of the two sheets, it would have been well within the purview of the skilled practitioner to employ an number of possibilities including staggered and cross-bar configuration with a reasonable expectation of success.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655