Patent Application 17311684 - METHODS COMPOSITIONS AND KITS FOR TREATING

Title: METHODS, COMPOSITIONS AND KITS FOR TREATING MULTIPLE SCLEROSIS AND OTHER DISORDERS

Application Information

Invention Title: METHODS, COMPOSITIONS AND KITS FOR TREATING MULTIPLE SCLEROSIS AND OTHER DISORDERS
Application Number: 17311684
Submission Date: 2025-04-10T00:00:00.000Z
Effective Filing Date: 2021-06-07T00:00:00.000Z
Filing Date: 2021-06-07T00:00:00.000Z
National Class: 514
National Sub-Class: 183000
Examiner Employee Number: 83496
Art Unit: 1614
Tech Center: 1600

Rejection Summary

102 Rejections: 1
103 Rejections: 0

Cited Patents

No patents were cited in this rejection.

Office Action Text

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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/18/2025 has been entered.

Election/Restrictions
Applicant’s election of Group II in the reply filed on 3/25/2024 remains acknowledged.
Applicant’s election of:
(i) bryostatin-1 as recited in claim 12 [sic, construed as claim 13];
(ii-a-1) relapsing-remitting MS as recited in claim 16,
in the reply filed on 3/25/2024 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Claims 14-15, 22, 50-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/25/2024.

Response to Arguments
Applicant’s arguments, see p. 6, filed 2/18/2025, with respect to the rejection(s) of claim(s) 1, 13, 16 under 35 USC 102 and of claims 1, 13, 16, 38, 48-49 under 35 USC 103 have been fully considered and are persuasive in view of the In re Katz type Declaration filed by Paul M. Kim on 2/18/2025. The declaration documents the additional named authors on the Kornberg document Matthew D. Smith and Hasti Atashi Shirazi, carried out work under the general instruction and supervision of one or more inventors, participating in performing experiments, collecting and calculating data, and drafting the manuscript as later published as the Kornberg document; and that the named authors that are also instant inventors invented the subject matter that is disclosed in Kornberg. This establishes that Kornberg is not by others, and has been withdrawn as applicable prior art. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as set forth below.

Claim Rejections - 35 USC § 102
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 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.

Claim(s) 1, 13, 38, 48 is/are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Alkon (WO 2017/062924 A1; 2017 Oct; filed 2016, priority 2015).
Alkon teaches PKC activators, chosen, from, inter alia, Applicant elected bryostatin-1, a bryostatin [040], [060], also first named in Table 1, Bryologs, [132], claims 6-7. Alkon claims a dosing regimen for improving or enhancing a cognitive ability of a subject comprising administering to the subject a therapeutically effective amount of a PKC activator (claim 1). Among the subjects in need of treatment for a neurodegenerative disorder (claim 2) are subjects where the neurodegenerative disorder is chosen from, inter alia, multiple sclerosis (claim 3).
Alkon also claims a method for improving or enhancing a cognitive ability of a subject, comprising administering a PKC activator (claim 9), where the neurodegenerative disorder is chosen from, inter alia, multiple sclerosis (claim 11); PKC activator is chosen from, inter alia, macrocyclic lactones and bryologs (claim 13); where the macrocyclic lactone is bryostatin (claim 14), where the bryostatin is chosen from, inter alia, bryostatin-1 (claim 15). Alcon clearly teaches administering therapeutically effective amount of a bryostatin, including Applicant elected bryostatin-1 to subjects including those having MS.
Regarding claim 38, subject includes a human in need of treatment with a PKC activator [030].

Claim Objections
Claims 16, 49 are objected to as being dependent upon a rejected base claim.

Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614

/TIMOTHY P THOMAS/ Primary Examiner, Art Unit 1614