DETAILED ACTION
This Action is in response to the communication filed on 07/10/2025.
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 .
Status of the Claims
Claims 1-12, and new claim 17 are pending.
Claims 4-11 remain withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim.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 07/10/2025.
Claims 1-3, 12, 17 are under consideration as they read on the elected species.
Claim Objections
Claims 12 and 17 are objected to because the claims recite “Dynamin 2 activity, expression or function in a level…” which could be more clearly written as “Dynamin 2 activity, expression or function to a level…”
Appropriate correction or clarification is required.
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.
(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.
Claims 1-3, 12, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamada et al. (Biomed. Biophys. Res. Comm. (2009) 390(4):1142-1148; of record).
***It is noted that the claims have been changed from “A method for the treatment of centrouclear myopathy in a subject in need thereof…” to “An inhibitor of Dynamin 2 (DNM2) for use in the treatment of a centronuclear myopathy…” (See claim 1). Accordingly the claims have been changed from a process to a product, specifically an inhibitor of Dynamin 2 (DNM2). Accordingly, the new ground of rejection is necessitated by the amendment.
It is noted that claims 1, 2, 3, and 12 are drawn to a product, specifically a DNM2 inhibitor and include the recitation of the intended use of the product. For instance, claim 1 recites “An inhibitor of Dynamin 2 (DNM2) for use in treatment of a centrouclear myopathy…” Claim 2 recites, “The inhibitor of Dynamin 2 for use according to claim 1…” Claim 3 recites, “The inhibitor of Dynamin 2 for use according to claim 1 or 2…” and Claim 12 recites, “The inhibitor of Dynamin 2 for use according to claim 1…”
Intended used does not impart patentable weight to a product. See MPEP §2111.02 which states in part that, ‘During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
In this case, the claims are drawn to product (not a process) and the recited intended use (“for treatment of a centronuclear myopathy”) does not result in a structural difference to the claimed product. The only structural limitation of claim 1 is that the dynamin 2 inhibitor must be one that is selected from the group consisting of an antibody directed against Dynamin 2, a nucleic acid molecule interfering specifically with Dynamin 2 expression, and a small molecule inhibiting the Dynamin 2 activity, expression or function. It is noted that the elected species is the small molecule 3-Hydroxynaphthalene-2-carboxylic acid (3,4-dihydroxy-benzylidene)hydrazide. Therefore, the only structural limitation to the claimed inhibitor of claim 1 is that the inhibitor must be small molecule inhibitor of Dynamin 2.
The only structural limitation to the inhibitor of claim 2 is that the inhibitor must be 3-Hydroxynaphthalene-2-carboxylic acid (3,4-dihydroxy-benzylidene)hydrazide (the elected species).
Claim 3 only further limits the type of centronuclear myopathy that is treated by the intended use and does not set forth any structural limitations to the Dynamin 2 inhibitor.
Claim 12 is drawn to the inhibitor of Dynamin 2 for use according to claim 1, wherein the inhibitor is administered in an amount sufficient to reduce the Dynamin 2 expression or the Dynamin 2 activity, expression or function in a level equal to or less than the normal level. It is noted that the wherein clause of claim 12 only further limits the intended use of the Dynamin2 inhibitor (i.e., is sets forth further limitations with respect to the amount administered in the intended use) and does not set forth any structural limitations to the Dynamin 2 inhibitor.
Claim 17 is drawn to the inhibitor of claim 12 but only further limits the amount of inhibitor administered to an amount sufficient to reduce the Dynamin 2 expression or the Dynamin 2 activity, expression or function in a level less than the normal level.
Therefore, claims 3, 12 and 17 only further limit the intended use of the inhibitor and do not add any structural limitations to the Dynamin 2 inhibitor of claim 1 or claim 2. Accordingly, prior art that teaches the elected small molecule inhibitor (3-Hydroxynaphthalene-2-carboxylic acid (3,4-dihydroxy-benzylidene)hydrazide) anticipates the instant claims.
Yamada teaches 3-Hydroxynaphthalene-2-carboxylic acid (3,4-dihydroxy-benzylidene)hydrazide, also known as Dynasore, is a DNM2 inhibitor (e.g., see abstract, page 1144 and Figure 3; page 1145 paragraph bridging columns 1-2).
Therefore, Yamada anticipates the instant claims because it teaches a Dynamin 2 inhibitor which meets all of the structural limitations of the claims.
Response to Arguments
As indicated above, the claims have been changed from a method for treatment to an inhibitor of DNM2 (a product). Upon search and consideration of the amended claims, it was determined that the claims are anticipated by the prior art for the reasons indicate above. Accordingly, the rejection of claims under 35 U.S.C. 103 has been withdrawn.
Applicant’s arguments with respect to the rejection of claims under 35 U.S.C. 103 are moot in view of the withdrawal of the rejection. It is noted that a new ground of rejection under 35 U.S.C. 102(a)(1) has been set forth for the reasons indicated above.
Conclusion
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.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637