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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/27/2025 has been entered.
Election/Restrictions
Applicant’s election of Group V, without traverse, and the autoantigen species: RRMS and NM_152729.2 aka SEQ ID NO: 1, BC024289.1 aka SEQ ID NO: 2, BC020233.1 aka SEQ ID NO: 3, BC030813.1 aka SEQ ID NO: 4, NM_144606.1 aka SEQ ID NO: 5, and NM_145253.1 aka SEQ ID NO: 6, with traverse, filed 3/10/22, is acknowledged. Applicant argues: Thus, Applicant respectfully requests that in addition to RRMS, embodiments encompassing both RRMS and SPMS are examined. Applicant is advised the request above is not actually an argument as it contains no reasoning.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-24 and 28 and are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/2024.
Claims 25-27 and 29-31 are under consideration in the instant Office Action.
Withdrawn Rejections
The rejection of claims 25-27 and 29-31 under 35 U.S.C. 112(a) as containing 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one skilled in the relevant art that the inventor, at the time the application was filed, had possession of antigens is withdrawn in view of the claim amendments.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 25-27 and 29-31 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention, specifically:
The newly amended claims 25-27 and 29-31 have removed citation of GenBank accession nos. and added SEQ ID NOs to identify the antigens but place these sequence identifiers in parenthesis. The claims are found unclear in the use of SEQ ID NOs in parenthesis. The fact that the SEQ ID NOs are in parenthesis make it is unclear what is being set forth. This is being interpreted as the phrase "for example" which renders the claim indefinite because it is unclear whether the limitations following the parenthesis are part of the claimed invention. Further, the new identifiers are still confusing and unclear what they are referring to since they are found within the parenthesis and only allowed used use of parenthesis in claim is to indicate abbreviations of terminology.
Accordingly, the metes and bounds of the claims cannot be determined.
Response to Arguments
Applicant's arguments filed 3/27/2025 have been fully considered and found persuasive but a new rejection is needed over the new claim amendments as discussed above.
New Rejections
Claim Rejections - 35 USC § 102
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.
(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.
Claims 25-27 and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagele US2013/0157888 (IDS 8/18/2022).
Nagele teaches kits with autoantigens, which are diagnostic for neurodegenerative diseases, immobilized on a substrate and include microarrays and include the substrate as a nitrocellulose-coated glass slide (see Nagele’s claims 9-20 and [0037], [0040], [0042] and[0062]) and reads on instant claims 25, 29 and 31. Nagele teaches that the assays are performed by methods known in the art in which the one or more autoantigens are contacted with the biological sample under conditions that allow the formation of an immunocomplex of an autoantigen and an antibody, and detecting the immunocomplex (see [0045], [0062]) and reads on instant claim 25. Nagele teaches that neurodegenerative diseases include multiple sclerosis (MS: see [0048-0050]) and reads on instant claims 25 and 29. Nagele teaches the antigens include BC030813.1, cDNA clone MGC:22645 IMAGE :4700961, complete eds (see page 33, top of Table 7) which is the antigen set forth as IGK@protein in SEQ ID NO: 4 and reads on in instant claims 25 and 30. Nagele also teaches the antigen Interferon, alpha-inducible protein 6 (IFI6; see page 54) and reads on instant claim 26. Nagele also teaches the antigen NM_004987.3 LIM and senescent cell antigen-like-containing domain protein 1 which is the antigen set forth as LIM and senescent cell antigen-like-containing domain protein 1 in SEQ ID NO:17 and tripartite motif-containing 21 (TRIM21) which is SEQ ID NO:18 and reads on instant claim 27.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Barrett et al., US2019/0192691 (instant PTO-892). Barrett teaches kit and antigens that include SEQ ID NO: 454 (instant SEQ ID NO: 1); SEQ ID NO: 32483 (instant SEQ ID NO:5 ); SEQ ID NO: 94406 (instant SEQ ID NO: 6); SEQ ID NO: 55891 (instant SEQ ID NO:7) and SEQ ID NO: 13460 ( instant SEQ ID NO:10);
Advisory Information
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675