DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election of a PPT promoter and archaerhodopsin-3 in the reply filed on August 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 36-55 are currently pending in the instant application. Upon further consideration, the restriction requirement among the different promoters and the different genes is withdrawn. Accordingly, claims 36-55 are under examination on the merits in the instant case.
Drawings
The drawings are objected to because not all Figures are clearly legible. See for instance Figures 3 and 6 in the replacement drawings filed on May 3, 2024. Note that the patent application content should be in black font for legibility. That is, all application papers must be clearly legible using black colored font text and black lines. See MPEP §608.01. Applicant is required to review all Figures and make appropriate corrections for clear legibility.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 61/321,117, 13/637,977, and 16/455,077, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘117 application is completely silent regarding a sequence encoding “rhodopsin”, “blue opsin”, and “red opsin”. The ’117 application is also insufficient to describe the claimed method that uses a vector structure comprising “more” than one of the recited promoters including “both of a Scn10a promoter and TPRV1 promoter.” In fact, it is noted that none of the aforementioned prior-filed applications provide adequate written description for the claimed method comprising using “a vanilloid receptor subtype 1 (TRPV1) promoter”. That is, the prior-filed applications are completely silent regarding the TRPV1 promoter.
Accordingly, claims 36-55 are not entitled to the benefit of any of the priority filing dates and therefore, the effective filing date for claims 36-55 will be the instant application’s filing date, which is August 23, 2023.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 36-55 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Horsager et al. (US 2013/0225664 A1).
Horsager discloses a method of relieving chronic neuropathic pain in a subject in need thereof comprising “optically silencing pain-associated neurotransmission” comprising transducing a nociceptive neuron of the DRG with an “sc-rAAV1 or sc-rAAV8” comprising a PPT promoter or an Scn10a promoter operably linked to a gene encoding a light-sensitive protein including archaerhodopsin-3 (Arch), followed by a step of directly exposing the DRG neurons transduced with the rAAV to “green light”, wherein “the rheobase was increased to approximately 3.5 nanoamps” in the green light-exposed DRG neurons transduced with the rAAV, wherein “said method provides significant analgesia for chronic neuropathic pain without off-target effects” such as “general central nervous system depression.” See paragraphs 0167-0168; claims 1-39.
Accordingly, claims 36-55 are described by Horsager et al.
Claims 36-40, 42, 44, 46-49, 53, and 55 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Li et al. (Brain Research, 2015, 1609:12-20).
Li teaches that light-induced pain inhibition in a subject having chronic pain can be provided by locally injecting nociceptive DRG neurons with a recombinant virus (e.g., AAV5, AAV8) comprising a TRPV1 promoter operably linked to a inhibitory light-sensitive pump such as archaerhodopsin from Halorubrum strain TP00 (ArchT) and “Archaerhodopsin-3 (Arch)”, wherein the local injection is followed by the light stimulation/exposure to the “green laser (532 nm)”, wherein “Arch can induce powerful, transient and repetitive silencing of neurons in response to pulses of light.” See pages 13-15.
Since the active method steps of Li are patentably indistinguishable from those recited in the instant claims, it necessarily follows that Li’s method would inherently provide “an increase in rheobase for the DRG neurons expressing the opsin” and would also inherently “not provide off-target effects” and “not provide general central nervous system depression”, absent objective evidence to the contrary. Note that the aforementioned limitations are merely recited as a natural consequence of the active method steps.
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine and/or compare the specific natural results of the instantly claimed method versus Li’s method. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed method is different from the one taught by Li, thereby establishing that Li’s method cannot provide the natural, inherent results recited in the claims, hence establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989).
Accordingly, claims 36-40, 42, 44, 46-49, 53, and 55 are described by Li et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 36-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,771,763 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the ‘763 patent claims drawn to a method for relieving neuropathic pain comprising intrathecal injection of an AAV (sc-AAV1, sc-AAV8) vector encoding Arch operably linked to one of the PPT, Scn10a, and TRPV1 promoters into a subject’s DRG neurons, which are exposed to 495-570 nm light. Since the active method steps of the ’763 patent claims are patentably indistinguishable from those recited in the instant claims, it necessarily follows that practicing the method of the ‘763 patent claims would inherently result in “an increase in rheobase for the DRG neurons expressing the opsin”, absent objective evidence to the contrary, wherein the aforementioned limitation recited in the instant claims is written as a mere consequence of performing the recited method steps, not as an additional active method step.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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