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 amendment and argument of 12/23/25 are entered.
Claims 1-4 are amended.
Claims 17-18 are newly presented.
Claims 1-18 are pending.
Election/Restrictions
The species elections are now withdrawn, as the particular combination is not found.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
In light of the amendments requiring amounts sufficient for transdermal light, the rejections of record against Claim(s) 1-8 and 11-16 under 35 U.S.C. 102(a)(1) as being anticipated by Towne, et al. (2013) “Optogenetic control of targeted peripheral axons in freely moving animals”, PLoS One, e72691 (10 pages), cited by Applicant, in IDS of 10/25/22, reference No. 5 of the non-patent literature documents, are withdrawn.
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) 1-8 and 11-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Iyer, et al. (2014) “Virally mediated optogenetic excitation and inhibition of pain in freely moving nontransgenic mice”, Nature Biotechnology, 32(3): 274-81 (IDS of 10/25/22, NPL reference 1).
Claim 1: Iyer teaches transfection of sciatic nerve with AAV viruses encoding excitatory opsin enabled light-inducible stimulation of acute pain, place aversion and optogenetically mediated reductions in withdrawal thresholds to mechanical and thermal stimuli (e.g., ABSTRACT). Similar deliveries were made of inhibitory opsin enabled light-inducible inhibition of acute pain and reversed mechanical allodynia and thermal hypergesia (e.g., Id.). Light was derlivered transdermally, allowing these behaviors to be induced in freely moving animals (e.g., Id.) Such was carried out in mice (e.g., TITLE). The light was applied trans-dermally through the skin (e.g., p. 275, col. 1).
Claim 2: as a sensor, the investigator utilized their eyes to sense the movement of the footpad affected or filming the mice to assay movement, and (e.g., p. 280).
Claim 3: in at least some experiments, the same animal had multiple trials (e.g., p. 280, first paragraph). Thus the light source is reset for each trial, and is therefore caused by the feedback of the mouse’s movement being observed, which is the signal.
Claim 4: In addition to the above, the promoter utilized is the human synapsin-1 promoter, which is a pan-neuronal human promoter (e.g., p. 274, col. 2, last paragraph).
Claims 5-7: the vectors are packed as an AAV6 virus (e.g., p. 279, col. 1, penultimate paragraph).
Claim 8: the vector is pAAV-hSyn-hChR2(H134)R-EYFP (e.g., Id.).
Claim 11: As mice weight about 30grams, and Iyer teaches 3E10 and 3E11 genomes being injected (p. 279, col. 2, paragraph 1), absent reason to believe otherwise, the appropriate amount is injected.
Claim 12: intrasciatic injection is taught (e.g, p. 279, col. 1, penultimate paragraph), which is, absent reason to believe otherwise, sub-epineurial, at the least.
Claim 13: Absent reason to believe otherwise, the distance from a dermal surface in these mice, is within about 4cm.
Claim 14: ChR2(H134R) is utilized.
Claim 15: the hSyn promoter is utilized (e.g., supra in claim 8).
Claim 16: pain is tested, so the nerves must be nocioceptive.
Claims 17-18: as above, abswent reason to believe otherwise, the distinct is within about 2 mm of the skin/dermal surface of the animal.
Claims Free of the Art
Claims 9-10 are free of the Art. To wit, while the Art typically utilized concentrations of AAV particles in the range of 10E11-10E13, the Art did not disclose any concentration of 10E14 viral genomes per milliliter. However, Applicant had obtained the same from Virotek (e.g., paragraph 59). Thus, the Artisan would not have found injecting at these stock concentrations and volumes predictable at the time of Applicant’s disclosure.
Claims 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 9-10 are objected to.
Claims 1-8 and 11-18 are rejected.
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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638