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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/17/2024 have been considered by the Examiner.
Election Acknowledged
Applicant's election with traverse of the invention of Group I encompassing claims 1-11 and the species of ‘enhancer’ in the reply filed on 11/17/2025 is acknowledged. The traversal is on the ground(s) that Groups I, II and II would not pose a serious burden on the examiner as al Groups would require an overlapping search. This is not found persuasive because the claims of Group I does not require a linkage to a promoter or a terminal repeat sequence (as required by Group II) and does not require a nucleic acid of any specific sequence (as required by Group III).The Examiner maintains that these compositions/methods are sufficiently different and would require a different search and examination protocol. Further, prior art which may anticipate or render obvious one method would neither anticipate nor render obvious the other.
Applicant’s arguments regarding the election of species have been considered. However, in view of identified prior art which describes the species identified in the action mailed 9/15/2025, this requirement is considered moot and is withdrawn.
The requirement regarding the restriction is however deemed proper and is therefore made FINAL.
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.
Claims 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haider et al. (US 2016/0015783) in view of Burford et al. (US 2003/0092119).
Haider describes a method for administering gene modifiers for treating ocular disease, the method comprising administering a therapeutically effective amount of a composition comprising a) a nucleic acid, e.g. RNA, DNA (see [0026]), encoding a nuclear hormone receptor (see [0004, 0005, 0046] and claim 1) (see instant claim 1(a)) such as the nucleic acid encoding RORA (see [0005] and claim 11; see instant claims 9 and 10) and b) a delivery vehicle (see claim 25). Exemplified delivery vehicles include viral vectors like adeno-associated viruses or adenovirus delivery systems (see [0071, 0073]) (see instant claims 1(b), 2 and 3), as well as non-viral vectors such as lipid nanoparticles and biodegradable polymer complexes (e.g. PLGA nanoparticles) (see [0081] and claim 25) (see instant claims 7 and 8). Haider teaches that the nucleic acid encoding the nuclear hormone receptor may be recombinant (see [0026, 0070]) (see instant claim 1(a)). Moreover, Haider teaches that the method may include expression control enhancers such as a CMV enhancer (see [0076]) (see instant claims 4 and 6) and/or polyadenylation moieties such as SV40 and/or polyA from bovine growth hormone (see [0076]) (see instant claims 4 and 5).
Haider fails to teach the method of administering the composition as being for ameliorating or treating a neurological condition (e.g. epilepsy).
Burford, like Haider, is directed to methods of administering compositions comprising nucleic acids encoding a nuclear hormone receptor via a carrier vehicle such as adenoviruses (see abstract and [0163, 0167]). It is taught that the nuclear hormone receptors are a protein superfamily that act as both receptors and transcriptional regulators that serves a wide array of biological processes including homeostasis, cell proliferation and cell differentiation. The method may be useful in the treatment of a variety of neuropathies and developmental disorders such as epilepsy (a ‘neurological condition or disease’) (see [0240]) (see instant claims 1 and 11). It would have been obvious to modify Haider’s method to encompass the treatment of other known diseases, e.g. epilepsy, as such diseases were known to be responsive to nuclear hormone receptor gene therapy (see Burford). Thus, one would have a reasonable expectation for success in combining the prior art methods to arrive a method such as that claimed. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in absence of evidence to the contrary.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/080078 in view of Burford et al. (US 2003/0092119).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims in all the applications are drawn to a method of administering a human nuclear hormone receptor gene and a delivery vehicle for the treatment of a neurological condition/disease. The delivery vehicle may be an adenovirus capsid such as AAV5 (see [0079] of published specification) and the method may include non-viral delivery vehicles, promoters and enhancers such as those claimed (see specification). The reference claims do not describe a method of treating neurological condition such as epilepsy. Burford is directed to methods of administering a human nuclear hormone receptor gene via a viral delivery vehicle such as adenovirus. Burford’s method is taught to be useful in the treatment of neurological conditions such as epilepsy (see [0007]). It would have been obvious to modify the reference application to be used in methods of treating neurological conditions with a reasonable expectation for success. Thus, the scope of the claims are overlapping and the differences considered obvious.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611