DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 12/18/25 has been entered in full. Claims 1, 4-5 and 10-11 are amended. Claims 1-13 are pending.
Applicants' election without traverse of Invention I, claims 1-11 was previously acknowledged. Claims 12 and 13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The election of “antibody inhibitor of SEMA7A” as the species of inhibitor was also previously acknowledged. The elected inhibitor reads on each claim in the elected invention.
Claims 1-11 are under consideration, as they read upon the elected species.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (8/18/25).
The objection to the Drawings at pages 2-3 is withdrawn in view of the replacement sheet for Sheet 8 (Figure 6i) filed on 12/18/25.
The objections to the specification at page 2 are withdrawn in view of the amendments to the specification.
The objections to claims 1-11 at page 3 are withdrawn in view of the amendments to the claims.
The rejection of claims 4-5 and 10-11 at pages 3-4 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
Maintained Rejections
Claim Rejections - 35 USC § 112(a), written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.-The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was set forth at pages 5-10 of the 8/18/25 Office Action.
Applicants’ arguments (12/18/25; pages 7-8) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
In the response, Applicants argue that specification as originally filed supports the written description of “an inhibitor of SEMA7A” because the invention relies on identifying “a biological principle”, i.e., “SEMA7A inhibition as a therapeutic mechanism for treating or preventing post-ischemic tissue injury”, rather than identifying “a specific molecular species” (page 8). Applicants further argue that “[f]unctional claim language is permissible in method-of-treatment claims when the pathway to inhibition is fully elucidated and when the specification provides sufficient guidance for the skilled person to identify working members of the genus” (page 8).
This argument has been fully considered but is not found persuasive because as set forth in the rejection of record, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition". Such applies not only to a product but also to a method of use relying on the functionality of a product. See MPEP 2163, which describes the decision in the Univ. of Rochester v. G.D. Searle & Co:
“The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").”
Applicants further argue that the specification “discloses multiple classes of inhibitors”, which demonstrates contemplation of “a genus of inhibitor agents rather than a single inhibitor type”, and further provides “representative experimental data demonstrating functional inhibition of SEMA7A by antibodies”, which is sufficient to support a broader genus because the target protein SEMA7A “is well characterized and the mechanism of action is mechanistically explained” (page 8).
This argument has been fully considered but is not found persuasive because envisioning “classes” of inhibitors that may exist does not demonstrate possession of such classes of inhibitors, which are necessary for practicing the claimed method. Instead each class is merely a conceptual subgenus representing a varied structures that have the required functionality, without any description of what separates them from other structures in the same class that do not have the required functionality. Specifically with respect to SEMA7A inhibitors that are antibodies, which is the elected species under consideration, the Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of a target protein (e.g., SEMA7A) or the functional of said target is not in and of itself sufficient to provide a written description of the genus of antibodies that bind to said target and/or interfere with its functionality.
Applicants further argue that the skilled artisan, given the disclosure, “would readily appreciate that numerous classes of inhibitory agents—beyond antibodies---can be generated using routine techniques” (page 8)
This argument has been fully considered but is not found persuasive because per MPEP 2163, "An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed". Thus, adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Thus, disclosure of one or more candidate compounds and a description of “routine techniques” to identify which of the candidates has a certain functionality, e.g., inhibition of SEMA7A, is only a plan for obtaining one or more requisite inhibitors to be administered in the claimed method of treatment, and thus is not adequate to provide written description for the inhibitors.
Conclusion
No claims are allowed.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674