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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of
Application No. 62/209,800 filed 08/25/2015. Based on the filing receipt, the effective filing
date of this application is August 25, 2015 which is the filing date of Application No. 62/209,800.
Status of Claims
Claims 1-38 and 40 are cancelled.
Claims 39 and 41-54 are pending and examined herein.
Withdrawn Rejections/Objections
The objections to claims 41-43 due to informalities has been withdrawn, necessitated by amendments filed 02/06/2026. The claims have been amended to adopt the examiner’s suggested wording regarding the ATCC accession numbers.
The rejection of claims 39 and 45-54 on the grounds of 35 U.S.C. 112(a) has been withdrawn, necessitated by amendments filed 02/06/2026. Independent claim 39 has been amended to include the limitations of claim 40 from the previous set of claims, which narrows the claimed invention to subject matter sufficiently described in the specification.
The rejection of claims 40 and 44 on the grounds of 35 U.S.C. 112(b) has been withdrawn, necessitated by amendments filed 02/06/2026. The claims have been amended to remove the parenthetical narrow limitations that contributed to the indefiniteness.
The rejection of claims 39 and 41-54 under 35 U.S.C. 103 is withdrawn due to the persuasiveness of the applicant’s arguments on p. 6 of the Remarks filed 02/06/2026. The applicant argues that Chilcote (US 20130317199 A1, published 2013-11-18, cited in PTO-892 dated 12/05/2025) does not provide an enabling disclosure because Chilcote does not provide sequences or a deposit of antibody 23E8 to permit its production. Note also that this specification discloses, “The cell line designated JH19.23E8.2.32.22, producing the antibody 23E8 having the ATCC accession number PTA-122711 has been deposited on December 9, 2015 at the ATCC” (see, para. [0031]). The office agrees that Chilcote does not provide an enabling disclosure because the cell line producing the antibody 23E8 was not deposited until after the publication of Chilcote.
Maintained Rejections
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 39 and 41-54 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, and 37-38 of U.S. Patent No. 10,852,309 (referred hereto as ‘309) in view of Chilcote (US 20130317199 A1). The rejections discussed below have been modified, necessitated by amendments filed 02/06/2026. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a method of detecting alpha-synuclein phosphorylated at serine 129 (PS129 alpha-synuclein), comprising: (a) contacting a sample with a capture antibody that preferentially binds to PS129 alpha-synuclein and a reporter antibody that specifically binds to an epitope within residues 40-55 of alpha-synuclein, wherein the capture antibody comprises the Kabat CDRs of 11A5 (ATCC accession number PTA-8222) and the reporter antibody comprises the Kabat CDRs of 23E8 (ATCC accession number PTA-122711); wherein if PS129 alpha-synuclein is present in the sample, the capture antibody and reporter antibody bind to the PS129 alpha-synuclein forming a sandwich complex; and (b) detecting the reporter antibody that binds to the PS129 alpha-synuclein in step (a), if any, to indicate presence or absence of the PS129 alpha-synuclein. ’309 teaches all the components of a kit for detecting alpha-synuclein phosphorylated at serine 129 (PS129 alpha-synuclein), comprising: a capture antibody that preferentially binds to PS129 alpha-synuclein and a reporter antibody that specifically binds to an epitope within residues 40-55 of alpha-synuclein, as in claim 39 (see, e.g., claim 1 of ‘309). ‘309 teaches wherein the capture antibody comprises the Kabat CDRs of 11A5 (ATCC accession number PTA-8222) and the reporter antibody comprises the Kabat CDRs of 23E8 (ATCC accession number PTA-122711), as in claims 39 and 42-43 (see, e.g., claim 2 of ‘309). ‘309 teaches wherein the reporter antibody is a chimeric, veneered, or humanized form of 23E8 (ATCC accession number PTA-122711), as in claim 44 (see, e.g., claim 37 and 38 of ‘309). ‘309 teaches wherein the capture antibody is bound to a solid phase, specifically a magnetic particle, as in claims 45-49 (see, e.g., claims 3-5 of ‘309). ‘309 teaches wherein the reporter antibody is fluorescently labeled, as in claims 50 and 51 (see, e.g., claim 8 of ‘309).
‘309 fails to teach the linker is biotin. ‘309 fails to teach a secondary labeling reagent for labeling of the reporter antibody, such as an anti-idiotypic antibody, as in claims 52 and 53. ‘309 fails to teach a chart or a correspondence regime correlating a signal from the reporter antibody with a level of alpha-synuclein phosphorylated at serine 129 (PS129 alpha-synuclein) in a sample, as in claim 54.
However, in a patent application publication on methods for detecting alpha-synuclein, Chilcote rectifies these deficiencies. Chilcote teaches the linker is biotin, as in claim 49 (see, e.g., para. [0082]). Chilcote teaches the secondary labeling reagent for labeling the reporter antibody, such as an anti-idiotypic antibody, as in claims 52 and 53 (see, e.g., para. [0096]). Chilcote teaches the kit comprises a chart or a correspondence regime, as in claim 54 (see, e.g., para. [0096]).
‘309 and Chilcote are analogous to the field of the claimed invention because they are both in the field of alpha-synuclein detection. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to substitute the linker of Chilcote into the method of ‘309. An artisan would be motivated to do so because Chilcote discloses that “antibodies can be joined to a linker molecule, such as biotin for attachment to a surface” (see para. [0082]). An artisan would have a reasonable expectation of success given the discussed disclosures.
One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the secondary labeling reagent of Chilcote to the method of ‘309. An artisan would be motivated to do so because Chilcote discloses that secondary labeling reagents, such as an anti-idiotypic antibody is typical in such assays (see, e.g., para. [0079]). An artisan would have a reasonable expectation of success given the discussed disclosures.
One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the chart or other correspondence regime of Chilcote to the method of ‘309. An artisan would be motivated to do so because Chilcote discloses that that the chart or correspondence regime can be used for “correlating levels of measured label with levels of antibodies to alpha-SN” (see, e.g., para. [0096]). An artisan would have a reasonable expectation of success given the discussed disclosures.
Therefore, the patent claims anticipate the claims of this application.
Response to Arguments
Nonstatutory Double Patenting Rejections of Claims 39 and 41-54:
While the office acknowledges the applicant’s request for abeyance regarding the double patenting rejections, the rejections will remain on the record until a terminal disclaimer is provided.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C SVEIVEN whose telephone number is (703)756-4653. The examiner can normally be reached Monday to Friday - 8AM to 5PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678