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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Claim Status and formal matters
This action is in response to papers filed 12/30/2025.
Claims 11, 15, 19, 23, 29,32, 36, 40, 66, 74-79, 87-89 are pending.
Claim 23 has been amended.
Applicant’s election of group I, in vitro, determining/genotyping, position 99,219 SEQ ID NO 3 in the reply filed on 3/27/2025 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)).
Claims 11, 15, , 19, 32, 36, 40, 66, 73-79, 87-89 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/ invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/27/2025.
Claims 23, 29, are being examined.
The 101 rejection has been withdrawn in view of the amendment.
Priority
The instant application was filed 11/12/2021 is a Continuation of 16881167 , filed 05/22/2020, and claims priority from provisional application 62851296 , filed 05/22/2019.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required Claim 23 has been amended to recite, “6:158081105 :G:T located in the SYNJ2 gene. Review and searching of the specification did not reveal antecedent basis for this limitation.
Response to Arguments
This is a new grounds of objection necessitated by amendment.
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 23 and 29 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.
MPEP 2163 IB New or amended claims section II
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04
Claim 23 has been amended to recite, “Synaptojanin-2 (SYNJ2) variant 6:158081105:G:T located in the SYNJ2 gene”” when the patient has a genotype not comprising the SYNJ2 variant 46:158081105:G:T, then administering to the patient D-methionine, a combination of ebselen and allopurinol, or resveratrol in a standard dosage amount.” The response asserts support can be found throughout the specification. Review and searching of the specification did not reveal antecedent basis for the limitation. The specification generally discusses the use of a greater than standard dosage in the presence of loss of function mutation, this does not provide basis for the limitations of the claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 has been amended to recite, “when the patient has a genotype not comprising the SYNJ2 variantloss.” Review of the specification did not reveal antecedent basis for SYNJ2 variant
Further claim 23 recites, “standard dose” and “greater than standard dose.” The recitation of standard is a relative term which suggests there is non-standard doses. The specification and claims fail to provide any standard to differentiate a standard dose from a non-standard dose. Thus the metes and bounds are unclear.
Response to Arguments
This is a new grounds of rejection necessitated by amendment.
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.
Claim(s) 23, 29, 35 and 43is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahl (WO2009094713) and Submitted SNP(ss) Details: ss104378217(https://www.ncbi.nlm.nih.gov/projects/SNP/snp_ss.cgi?subsnp_id=ss104378217, 9/10/2008) and Campbell (Hearing Research 226 (2007) 92–103).
This rejection is set forth as it is unclear what is required of SYNJ2 variant
With regards to claim 23, Dahl teaches, “0023] Accordingly, the present invention provides a method for identifying a sensory neuropathy in an individual, said method comprising screening for a mutation in a gene or gene expression product associated with the Synaptojanin-2 (Synj2) pathway, which mutation is indicative of a sensory neuropathy or risk of developing same, wherein the presence of the mutation provides an indication of the sensory neuropathy.” (0158). Dahl teaches, “[0103] The present invention further contemplates a method of treating an individual with a sensory neuropathy such as a hearing condition.” Dahl teaches, “0027] The present invention is directed to any mutation in Synj2 (or its gene product) associated with deafness or other sensory including peripheral neuropathy. The present invention is also directed to any mutation in Synj2 [heterozygous or homozygous] (or its gene product) associated with deafness, alone or in combination with any mutation(s) in gene(s) associated with deafness such as connexin26, cdh23, pendrin, myosin7a, usherin or TMCl (or their gene products) or a site of interaction between Synj2 and one or more of connexin (including other connexin genes such as connexin26), cdh23, pendrin, usherin, and/or TMCl or genes associated with deafness or other sensory neuropathy. The present invention also encompasses any mutation in any gene in the phosphoinositide signaling pathway (Synj2 pathway) associated or linked with a sensory including peripheral neuropathy. Examples of genes in addition to those listed above include FIG4, MTMR2, SBF2, FGD4, SPASTI, ZIN and Synjl.” Dahl teaches, “0002] The present invention relates generally to the detection and treatment of a sensory defect including peripheral neuropathy in a mammal, including a human. More particularly, the present invention provides diagnostic assays and therapeutic targets for hearing impairment and other sensory defects including peripheral neuropathies. “
Dahl does not specifically teach rs2256014 or treating with the recited treatments.
However, ss104378217 teaches PGI sequencing of rs2256014.
Campbell teaches, “Thus far in animal studies, as reviewed in this paper, D-met has shown efficacy in protecting against cisplatin-induced, carboplatin-induced, aminoglycoside induced ototoxicity and permanent noise-induced hearing loss. The additional experiments presented in this paper provide further support for future clinical trials.” (page 100, 1st column, bottom)
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to examine any variant in SYNJ2 including in subjects with hearing loss and treat the subject with a standard dose of D-methionine. The artisan would be motivated to examine all mutations in SYNJ2 as Dahl claims A method for identifying a sensory neuropathy in an individual, said method comprising screening for a mutation in a gene or gene expression product associated with the Synaptojanin-2 (Synj2) pathway, which mutation is indicative of a sensory neuropathy or risk of developing same, wherein the presence of the mutation provides an indication of the sensory neuropathy, which includes hearing loss. The artisan would be motivated to treat with D- methionine as Campbell teaches it treats numerous types of hearing loss. Thea artisan would have a reasonable expectation of success as the artisan is merely suing known methods to detect known sequences in known genes associated with hearing loss in subjects with hearing loss and treating with known treatments for hearing loss.
With regards to claim 29, ss104378217 teaches PGI sequencing
Response to Arguments
The response traverses the rejection asserting, “Neither Dahl nor Campbell teaches or suggests the claim-recited variant. And while Submitted SNP purports an NCBI submission date of Sep. 10, 2008 for information allegedly related to the existence of a single nucleotide polymorphism (SNP) identified as BGI_rs2256014, this submission did not include, for example, any further information about the SNP's allele frequency or functional or medical significance. Absent this information, the skilled artisan would not have been motivated to treat patients carrying this SNP in any particular way, let alone with a regimen that includes administration of D-methionine, a combination of ebselen and allopurinol, or resveratrol in an amount that is greater than the standard dosage amount. Without the detailed studies provided in the instant application, the skilled artisan would have had to confront the possibility that the variant might have a positive gain-of-function effect, in which case not more but less therapeutic should be administered to a patient carrying the variant. Or, alternatively, the variant might not have any medical implications at all, in which case the treatment should be the same, regardless of the patient's genotype.” This argument has been thoroughly reviewed but is not considered persuasive as the claim does not require a specific allele as indicated in the 112 rejections and the beginning of the art rejection. Further Dahl suggests mutations in Synaptojanin-2 (Synj2) pathway, which mutation is indicative of a sensory neuropathy or risk of developing same. Dahl teaches sensory neuropathy encompasses hearing loss. Thus the claims are obvious in view of the breadth of the claims.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/Primary Examiner, Art Unit 1683
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