DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 12/09/2025 to claims 1, 3-5, 8, and 10 have been entered. Claims 2, 6, and 7 are canceled. Claims 1, 3-5, and 7-31 remain pending, of which claims 1, 3-5, and 8-12 are being considered on their merits. Claims 13-31 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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.
Claims 1, 3-5, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tector III et al. (US 2017/0311579; provided in the IDS dated 12/19/2022).
Tector III teaches genetically modified pigs with reduced α(l,3) galactosyltransferase, CMAH and β4GalNT2 expression and methods of making porcine organs, tissues and cells therein (¶0014-0015; see Example 2 for detailed methods of making triple knockout transgenic pigs and Examples 18-19 for working examples directed towards liver and kidney xenografts), reading in-part on claims 1 and 3. In a separate embodiment, Tector III teaches obtaining nerve tissue for xenografting (¶0068-0069), reading in-part on claims 1 and 3. Tector III teaches a xenograft comprising generic cells (¶0068) and Schwann cells obtained from the porcine triple transgenic animals (¶0070), reading on claim 1. Tector III teaches obtaining nerve tissue from the brain (e.g. central nervous system) or the spinal cord (e.g. peripheral nervous system), reading on claims 4 and 5 respectively. Tector III teaches obtaining the xenograft from prenatal (i.e. fetal), neonatal or immature (i.e. juvenile), or fully mature (i.e. adult) transgenic animals (¶0068), reading on claim 10.
Regarding claim 1, Tector III does not teach a nerve xenograft for implanting in a human patient, the nerve xenograft comprising nerve tissue derived from a genetically engineered non-human organism in a single embodiment. However, It would have been obvious to a person of ordinary skill in the art before the invention was filed to obtain a nerve xenograft from the triple transgenic pigs of Tector III which lack in-part alpha 1,3-galactose epitopes. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because and the skilled artisan would have been motivated to do so because Tector III expressly considers the combination of a xenograft predictably obtained from nerve tissue as a desirable tissue source from the triple transgenic pigs further taught by Tector III. See M.P.E.P. § 2143 (I)(A), in that combining prior art elements according to known methods to yield predictable results must be held prima facie obvious absent any showing of nonobviousness to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tector III as applied to claim 1 above, and further in view of Whitworth et al. (J Hand Surg Br (1996), 21(4), 514-522).
The teachings of Tector III are relied upon as set forth above. Tector III further teaches treating subjects in need of organ, tissue, or cellular xenotransplantation by administering organs, tissue, transfusion products, and/or cells to said subjects (¶0068-0069), reading in-part on claim 9.
Regarding claim 9, Tector III does not teach a nerve xenograft further comprising nerve growth factor (NGF).
Whitworth teaches that adding nerve growth factor (NGF) to a graft composition comprising fibronectin mats and then administering the NGF graft composition to a site of injury in a subject produces an increase in the rate and volume of axonal and Schwann cell regeneration (Abstract; p515, subheading “Surgical Procedures” for a rodent model of sciatic nerve injury and graft administration; p517, subheading “Rate and volume of axonal regeneration” and “Schwann cell penetration and volume of regeneration” on p517-519), reading on claim 9.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to add the NGF of Whitworth to the nerve xenograft of Tector III. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Tector III and Whitworth are directed towards nerve graft compositions and because Tector III envisions treating subjects in need thereof. The skilled artisan would have been motivated to do so because Whitworth teaches that the addition of NGF would predictably improve upon the nerve xenograft composition of Tector III as the addition would increase in the rate and volume of axonal and Schwann cell regeneration when administered to a subject in need of sciatic nerve repair thereof.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tector III as applied to claim 1 above, and further in view of Squintani et al. (J Neurosurg (2013), 119, 907-913).
The teachings of Tector III are relied upon as set forth above. Tector III further teaches treating subjects in need of organ, tissue, or cellular xenotransplantation by administering organs, tissue, transfusion products, and/or cells to said subjects (¶0068-0069), reading in-part on claim 11.
Regarding claim 11, Tector III does not teach a nerve xenograft further cryogenically frozen.
Squintani teaches a composition comprising cryopreserved cadaveric nerve allografts (paragraph spanning p908-909), and wherein surgical administration of cryopreserved cadaveric nerve allografts to subjects in need of treatment thereof improves motor function post-operatively (Abstract and p909, the paragraph starting “The results of clinical examinations…”), reading on claim 11. Squintani teaches that the mean length of cryopreservation of the grafts before surgical implantation was 9 months (p909, paragraph starting “Allografts were usually collected…”), reading on claim 11.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further cryogenically freeze the nerve xenograft composition of Tector III in view of Squintani. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Tector III and Squintani are directed towards nerve graft compositions and because Tector III envisions treating subjects in need thereof. The skilled artisan would have been motivated to do so because Squintani teaches that cryopreserved nerve grafts are capable of treating nerve injury in subjects, and so the cryopreserving would be predictably advantageous to store the nerve xenografts of Tector III until such time as they were needed to treat subjects in need of treatment thereof as envisioned by Tector III.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tector III as applied to claim 1 above, and further in view of Dubuisson et al. (Experimental Neurology (1997), 148, 378-387).
The teachings of Tector III are relied upon as set forth above. Tector III further teaches treating subjects in need of organ, tissue, or cellular xenotransplantation by administering organs, tissue, transfusion products, and/or cells to said subjects (¶0068-0069), reading in-part on claim 12.
Regarding claim 12, Tector III does not teach a fresh (i.e. freshly obtained) nerve xenograft.
Dubuisson teaches that a composition comprising a fresh nerve allograft is capable of treating nerve injury in subjects in need of treatment thereof (Abstract ), reading on claim 12.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to freshly obtain the nerve xenograft composition of Tector III in view of Dubuisson. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Tector III and Dubuisson are directed towards nerve graft compositions and because Tector III envisions treating subjects in need thereof. The skilled artisan would have been motivated to do so because Dubuisson teaches that a freshly obtained nerve allograft is capable of treating nerve injury in subjects in need of treatment thereof, and so freshly obtaining the nerve xenografts of Tector III would be predictably advantageous to then treat subjects in need thereof as envisioned by Tector III.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-10 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 6-7 of the reply, Applicant alleges there would be no reasonable expectation of success to generate a nerve xenograft according to Tector III. This is not found persuasive of error because Applicant is alleging error over the preamble statement of intended use and which does not limit the structure of the claimed composition. As such and absent any showing to the contrary or narrowing claim amendments, the composition of Tector III is reasonably presumed to be capable of functioning as a nerve xenograft in generic downstream methods of administering said nerve xenograft to human patient(s). See M.P.E.P. § 2111.02 and 2111.04. That the nerve xenograft envisioned by Tector III may be less than optimal as alleged is not persuasive because Applicant is not claiming the downstream and non-elected methods of use of the composition of claim 1.
On pages 8-9 of the reply, Applicant alleges that Tector III does not teach the combination of nerve tissue and Schwann cells. This is not persuasive because Tector III is not applied under 35 U.S.C. § 102, but under 35 U.S.C. § 103 and envisions the combination of nerve tissue and Schwann cells as cited above. The claimed invention becomes obvious when Tector III is considered as a whole for the reasons given above
Conclusion
No claims are allowed. No claims are free of the art.
THIS ACTION IS MADE FINAL. 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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653