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 SEQ ID NO: 51 SCN9A, pain, zinc finger protein, transcription repression, KRAB, and Protoxin-II in the reply filed on 3/26/26 is acknowledged.
Drawings
The drawings filed on 7/28/23 are objected to because they are not fully legible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 8, 10, 11, 13, 18, and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 1 requires a sequence encoding any epigenetic modulator that regulates transcription of one or more target molecules. However, the specification does not adequately describe the structure required for the sequence to encode any possible epigenetic modulator that regulates transcription of one or more target molecules.
Instant claim 2 reuqir3es for the target molecule to be associated with an ion channel. However, the specification does not adequately describe the genus of target molecules that have any possible association with any ion channel
Instant claim 4 reuqir3es for the target molecule to be associated with a pain disorder. However, the specification does not adequately describe the genus of target molecules that have any possible association with any possible pain disorder. The specification in fact does not adequately describe the genus of disorders that are “pain disorders”.
Instant claim 10 requires for the modulator to comprises a domain having transcription repression activity. However, the specification does not adequately describe the structure required for the domain to have transcription repression activity.
Claim 13 requires for the modulated to comprise KRAB or any variant thereof. The specification does not adequately describe variants of KRAB that function as epigenetic modulators. The specification does not adequately describe the level of tryp of variance permitted for the compound to function as an epigenetic modulator.
Claim 18 requires Protoxin-II or any variant thereof. The specification d9es not adequately describe variants of Protoxin-II that function as Protoxin-II. The specification does not adequately describe the level of tryp of variance permitted for the compound to function as Protoxin-II.
The species of the specification are not representative of the entire claimed genus.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for each of the recited genuses that have the required structure to function a required. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
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.
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.
Claim(s) 1-4, 6, 8, 10, 11, 13, 18, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mali et al. (WO 2020/210542 A1), in view of Mingozzi et al. (US 12,171,843 B2), and Wright (Synthesis of Truncated Analogues of ProTx-II as a Novel Form of Pain Relief. Doctoral thesis , UCL University College London, 2015, pages 1-257).
Mali et al. teach epigenetic based approaches and methods using genome editing constructs comprising a zinc finger fused with a repressor domain and/or a dCas9 fused with a repressor domain to treat and manage pain in subjects in need of treatment thereof (abstract) (instant claims 4, 8, and 10).
Mali et al. teach a nucleic acid ([0007] The disclosure also provides a polynucleotide encoding one or more components of the recombinant gene repressor complex described above and herein. In one embodiment, the polynucleotide is codon optimized for expression in a human cell) comprising a sequence encoding a nucleic acid binding domain, a sequence encoding an epigenetic modulator that regulates transcription of one or more target molecules ([0006] The disclosure provides recombinant gene repressor complex comprising a nuclease inactivated Cas9 (dCas9) protein fused to a transcription repressor and associated with at least one guide RNA (gRNA), wherein the gRNA specifically hybridizes to a target nucleic acid sequence), and a promoter ([0008] The disclosure also provides a vector or vector system comprising a polynucleotide of the disclosure encoding one or more components to generate a recombinant gene repressor complex of the disclosure. In one embodiment, the polynucleotide is operably linked to a promoter, wherein the promoter is a Nav1.7 promoter of a neuron-specific promoter).
Mali et al. does not teach that the promoter comprises a sequence at least 90% identical to instant SEQ ID NO: 51.
However, it would have been obvious for the promoter to comprise a sequence at least 90% identical to instant SEQ ID NO: 51 because Mingozzi et al. teach transcription regulatory elements to drive gene expression comprising a promoter to drive expression in a tissue-selective manner (abstract). Mingozzi et al. teach that hSYN is a neuron-selective promoter (column 6).
Mingozzi et al. teach a hSYN promoter sequence that is 468 nucleotides in length and comprises nucleotides 2-449 of instant SEQ ID NO: 51 (448 nucleotides of instant SEQ ID NO: 51).
us-18-274-978-51.align150.rni
RESULT 5
US-16-968-196-3
Sequence 3, US/16968196
Patent No. 12171843
GENERAL INFORMATION
APPLICANT: GENETHON et al.
TITLE OF INVENTION: HYBRID REGULATORY ELEMENTS
FILE REFERENCE: B2684PC00
CURRENT APPLICATION NUMBER: US/16/968,196
CURRENT FILING DATE: 2020-08-07
NUMBER OF SEQ ID NOS: 25
SEQ ID NO 3
LENGTH: 468
TYPE: DNA
ORGANISM: artificial
FEATURE:
OTHER INFORMATION: hSYN promoter
Query Match 99.8%; Score 448; Length 468;
Best Local Similarity 100.0%;
Matches 448; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
It would have been obvious to select the promoter of Mingozzi et al. for the construct of Mali et al. because each teach that the promoter can be a neuron-selective promoter. It would have been obvious to select the hSYN promoter as a matter of design choice when selecting a neuron-selective promoter with a reasonable expectation of success (instant claim 1).
Mali et al. teaches that the gRNA specifically hybridizes to a target nucleic acid sequence encoding a gene product SCN9A [0006] (instant claims 2 and 3).
Mali et al. teach: [0012] The disclosure also provides an epigenetic-based method to treat or manage chronic pain in a subject comprising administering an effective amount of a complex or a construct as described herein and above (instant claims 4 and 6). Mali et al. teach that the pain is trigeminal neuralgia [0013] (instant claim 33).
Mali et al. teach: [0006] the transcriptional repressor domain is a KRAB domain (instant claim 11).
Mali et al. teach: [0008] the vector comprises a nucleic acid encoding a KRAB sequence of SEQ ID NO:7 or a sequence that is at least 90% identical thereto and can repress transcription (instant claim 13).
Although Mali et al. teaches incorporation of a delivery vehicle into the composition including a liposome or poloxamer [0082], Mali et al. does not teach incorporation of Protoxin-II.
It would have been obvious to incorporate Protoxin-II with the motivation of pain relief because Protoxin-II and the delivery construct both have the same intended function of pain relief. Wright teaches that ProTx-II is an inhibitor of Nav1.7 and treats chronic pain (pages 20, 32, and 33). Wright teaches the PROTX-II peptide sequence (page 33) for delivery to treat chronic pain. Therefore, it would have been obvious to incorporate the peptide with a reasonable expectation of chronic pain treatment.
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 1-4, 6, 8, 10, 11, 13, 18, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15, 16, 20, 25, 33, 39-41, 43, 44, 47, and 67-69 of copending Application No. 18/907,287 (reference application), in view of Mali et al. (WO 2020/210542 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of application ‘287 are directed to an epigenetic modulator comprising a zinc finger protein linked to a repressor domain, wherein the zinc finger has affinity for SCN9A. Application ‘287 recites the incorporation of protoxin, and the treatment of pain.
It would have been obvious to incorporate a promoter because Mali et al. teach epigenetic based approaches and methods using genome editing constructs comprising a zinc finger fused with a repressor domain and/or a dCas9 fused with a repressor domain to treat and manage pain in subjects in need of treatment thereof (abstract) (instant claims 4, 8, and 10). Mali et al. teach a nucleic acid ([0007] The disclosure also provides a polynucleotide encoding one or more components of the recombinant gene repressor complex described above and herein. In one embodiment, the polynucleotide is codon optimized for expression in a human cell) comprising a sequence encoding a nucleic acid binding domain, a sequence encoding an epigenetic modulator that regulates transcription of one or more target molecules ([0006] The disclosure provides recombinant gene repressor complex comprising a nuclease inactivated Cas9 (dCas9) protein fused to a transcription repressor and associated with at least one guide RNA (gRNA), wherein the gRNA specifically hybridizes to a target nucleic acid sequence), and a promoter ([0008] The disclosure also provides a vector or vector system comprising a polynucleotide of the disclosure encoding one or more components to generate a recombinant gene repressor complex of the disclosure. In one embodiment, the polynucleotide is operably linked to a promoter, wherein the promoter is a Nav1.7 promoter of a neuron-specific promoter).
The claims are obvious variations of each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
Prosecution Insights