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 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 12 May 2026 has been entered.
Claim Status
Claims 17, 21, 23-29, 31-34, 38-39 and 43-75 are currently pending in the instant application.
Information Disclosure Statement
The information disclosure statement filed 12 May 2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The IDS which was filed 12 May 2026 also contains 11 cited references, which have been provided, but for which the citations do not comply with 37 CFR 1.98(b)(5). Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, date and place of publication. Some of the citations include a date, but do not indication where they were published, who the publisher is or where the publication could be found. Some of the citations do not have any date or publisher or place of publication. Some of the citations appear to be for posters (possibly a poster session at a research meeting) but there is no date or indication of where the poster was presented (i.e. published). Even if Applicant corrects the deficiency related to the size fee assertion, all the cited references will be lined through because they do not comply with 37 CFR 1.98 for the reasons provided above.
No initialed/signed/dated IDS is being returned at this time.
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 39, 43, 46, 51, 55, 60, 64-68, 70, 71 and 73 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 39, 46, 55, 60, 66, 73 recite the broad recitation Parkinson’s disease, and the claims also recite Parkinson’s disease dementia which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 43 recites the limitation "wherein the anti-α-synuclein antibody comprises an M428L mutation". There is insufficient antecedent basis for this limitation in the claim. Claim 43 depends from claim 27 (which indicates an isotype subtype) which depends from claim 26 (no additional limitation on the anti-α-synuclein antibody) which depends from claim 17 which recites an anti-α-synuclein antibody or an antigen-binding fragment thereof. The specification at page 7 states “[u]nless otherwise stated herein, the term of antibody includes antibodies comprising 2 full-length heavy chains and 2 full-length light chains, and their derivatives, variants, fragments, and mutants”. Therefore, the recitation of “anti-α-synuclein antibody” does not necessarily provide for an Fc region which contains the CH2 domain, which would be necessary for the M428L mutation to be present. Claims 64 and 71 are also indefinite for the same rationale as applied to claim 43.
Claim 51 recites the limitation “wherein the two heavy chains of the anti-α-synuclein antibody comprise knob-in-hole mutations”. There is insufficient antecedent basis for this limitation because, based on the definition in the specification for “antibody”, there is no requirement that the antibody of claim 28 (which depends from claim 26 which depends on claim 17) the has two heavy chains as it could be a single chain antibody. Claim 70 is also indefinite for the same rationale as applied to claim 51.
Claims 65, 67 and 68 are indefinite for depending on an indefinite claim.
Allowable Subject Matter
Claims 17, 21, 23-29, 31-34, 38, 44-45, 47-50, 52-54, 56-59, 61-63, 69, 72 and 74-75 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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