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 .
Response to Amendment
1. Claims 4, 8, 10, 14 and 15 have been amended, claims 1-3 canceled and claim 28 added as requested in the amendment filed on January 23, 2026. Following the amendment, claims 4-8, 10-15, 18, 19, 21, 22, 25, 26 and 28 are pending in the instant application.
2. Claims 5-7, 11-13, 18, 19, 21, 22, 25 and 26 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 11, 2025.
3. Newly submitted claim 28 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claim does not recite the elected species as a single antibody embodiment.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 28 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
4. Claims 4, 8, 10, 14 and 15 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on January 23, 2026 have been fully considered but found to be not persuasive for reasons set forth below.
7. Claims 4, 8, 10, 14 and 15 stand rejected on the basis that it contains an improper Markush grouping of alternatives for reasons of record in section 4 of Paper mailed on October 23, 2025.
Applicant traverses the rejection at pp. 14-16 of the Response. Specifically, Applicant submits that the antibodies recited within claim 4 share a single structural similarity, which is they have “overall antibody structure, and bind α-Synuclein.” Applicant explains that, “all of the isolated monoclonal antibodies are antibodies against α-Synuclein. Furthermore, all the antibodies recited in the claims showed discrimination toward Lewy bodies over normal synaptic neuropil in immunohistochemistry staining assays […]. All the recited antibodies also displayed the ability to reduce α-Synuclein pathology in cultured primary neurons.”
Applicant’s arguments have been fully considered but found to be not persuasive for the following reasons.
As fully explained earlier, the Markush grouping of fourteen different antibodies in one claim is improper because the antibodies do not share both a single structural similarity and a common use. Applicant’s argument that the common structure that defines these fourteen independent and distinct molecular embodiments—common binding epitope, α-Synuclein—is not persuasive because the antibodies, as products or molecular compounds, do not comprise α-Synuclein. These antibodies are characterized by their ability to bind to α-Synuclein; however, they do not share α-Synuclein as a common structure.
Claim 4 encompasses a set of fourteen different anti-α-Synuclein antibodies. MPEP § 2117, II, states that a Markush grouping is proper if “[T]he alternatives defined by the Markush group are either alternative chemical compounds as a whole (e.g., if a claim includes a compound R-OH wherein R is selected from the group consisting of methyl, propyl, and butyl, then the alternatives are methanol, propanol, or butanol) or in the context of a combination or process, the alternatives from which a selection is to be made (e.g., the alternatives in a list following the phrase "selected from the group consisting of"). The alternatives (1) share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class, and (2) share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent in the context of the claimed invention,” emphasis added. Further, section A, “Single Structural Similarity” – Members of a Physical, Chemical, or Art-Recognized Class, explains that, “Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”. In the instant case, the Markush grouping of alternatives is not proper because the fourteen recited antibodies do not share a singular structural similarity that supports a common functional utility. Further, the Markush grouping of alternatives is not proper because the recited antibodies do not belong to a recognized physical class or recognized chemical class or to the same art-recognized class with respect to their asserted utility. There is no expectation from the knowledge in the art that all antibodies will behave in the same way in the context of the claimed invention, which is being suitable for clinical administration to treat synucleopathic disease(s).
Appellant’s citation of In re Harnish, p. 15, appears to be misplaced because in that case the claims recited compounds with a common structural component—coumarin. This is not the case here.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
For reasons of record explained earlier and reasons above, the rejection is maintained.
Conclusion
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
February 18, 2026