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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 26, 2026, has been entered.
Response to Amendment
2. Claim 14 has been amended, claims 1, 2, 11-13 and 27 canceled and claims 29 and 30 added as requested in the amendment filed on August 26, 2026. Following the amendment, claims 14, 24-26, 29 and 30 are pending in the instant application.
3. Claims 14, 24-26, 29 and 30 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on August 26, 2026 have been fully considered but found to be not persuasive for reasons set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 29 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claim 29 is indefinite because it recites functional language. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, claim 29, which limits the subject matter of independent claim 14 by reciting the result of the procedure—administration results in improvement in TMS—defines the subject matter by functional language. While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by recitation of the results of the same procedure as in claim 14.
8. Claim 30 is rejected as being incomplete for being dependent from a cancelled claim. See MPEP § 608.01(n), V.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claim(s) 14, 24-26, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 9,598,495 in view of Gluhm et al. for reasons of record in section 5 of Paper mailed on March 10, 2026 and section 10 of Paper mailed on June 01, 2026.
Applicant traverses the rejection at pp. 6-10 of the Response. Specifically, Applicant argues that, “[T]he pending claims define the subjects treated by the claimed method as subjects having HD or determined to have HD and having a MoCA score specifically in the range of 19-25 and/or a TFC score of 11. It is clear from a reading of the specification as a whole and the specific language of claim 14 that only that particular subset of HD subjects is selected and treated by the claimed method. It is that subset of subjects that exhibit the recited treatment outcomes. The term "if," as used in claim 14, is a conditional instruction that means perform the action, i.e., administer the antibody, only when a specific condition is met, i.e., the MoCA and/or TFC score meets the claim requirement. The term "if" sets the situation that must be true for the action to occur,” p. 6.
Applicant further explains the results of the working examples of the instant disclosure, pp. 7-8. At p. 9, Applicant submits that, “Nothing in the cited prior art suggests that HD subjects having a TFC score of 12 or 13 and/or a MoCA score ≥ 26 experience little or no therapeutic benefit from treatment with the recited antibodies, while subjects having a TFC score of 11 and/or a MoCA score in the range of 19-25 experience improved motor function and/or cognition when treated with the recited antibodies. The '495 patent discloses that anti-SEMA4D antibody treatment provides therapeutic benefit to subjects with neurodegenerative disorders in general, which includes subjects with HD but does not distinguish between HD subjects on the basis of the stage of the disease, such as by MoCA score or TFC score and therefore, does not disclose or suggest treatment of those HD subjects that are likely to benefit from treatment and those that will not benefit.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
As fully explained earlier, the ‘495 patent teaches the active ingredient of the treatment protocol— an antibody to SEMA4D, wherein the antibody is identified by reference to the SEQ ID NOS: 6, 7, 8, 14, 15 and 16, identical product to the instant claims—and its use in treating neurodegenerative disorders and Huntington’s disease (HD) specifically. Thus, at the time of filing of the instant patent application, methods of treating of the same pathology, HD, by administration of the identical antibody and following the same treatment protocol have been fully disclosed. The only difference between the cited art and the instant claims is the requirement to submit the subjects with HD to well-known cognitive tests, MoCA and TFC. After the testing, the claimed method requires to proceed with the same known treatment and expect specific results, which Applicant has recently discovered. Examiner maintains that adding a test does not support novelty of the method of treatment, which remains fully disclosed at the time of filing of the instant patent application. Applicant’s reasoning that the later research allowed a discovery that some of the HD patients, those tested by known cognitive assessment tests, had better or specific clinical outcome than the rest of the treated population does not change anything in the protocol disclosed within ‘495 patent. The HD patients, including those who are, as claimed here, tested and selected, are treated by the same protocol by administering the same product as in ‘495 patent, although now with appreciation why some patients experience different outcome of the treatment.
MPEP 2141.02, I, The Claimed Invention as a Whole Must be Considered, states that, “In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983). Further, MPEP 2141.02, V, Disclosed Inherent properties are Part of “As a Whole” Inquiry”, “In determining whether the invention as a whole would have been obvious under 35 U.S.C. 103, we must first delineate the invention as a whole. In delineating the invention as a whole, we look not only to the subject matter which is literally recited in the claim in question... but also to those properties of the subject matter which are inherent in the subject matter and are disclosed in the specification. . . Just as we look to a chemical and its properties when we examine the obviousness of a composition of matter claim, it is this invention as a whole, and not some part of it, which must be obvious under 35 U.S.C. 103." In re Antonie, 559 F.2d 618, 620, 195 USPQ 6,8 (CCPA 1977) (emphasis in original) (citations omitted). See also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
The cited references do not explicitly teach that a population of HD patients with a certain MoCA score and TFC score, when treated by the method disclosed within the ‘495 patent, produces the results recited within the instant claims. However, such a result would be an inherent property of practicing the method taught by the prior art. It is well settled that “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The Examiner maintains that the active method steps encompassed by the instant claims are indistinguishable from those of the prior art. Thus, an enhanced treatment outcome experienced by those having or determined to have Huntington’s disease treated by administration of the antibody to SEMA4D must be an inherent result of practicing the method taught by the ‘495. The Examiner maintains that in essence, the claims are drawn to the scientific explanation of the methods disclosed by the prior art.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
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.
10. Claims 14, 24-26, 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,598,495 for reasons of record in section 6 of Paper mailed on March 09, 2026 and in section 11 of Paper mailed on June 01, 2026. Applicant argues that because the patented claims did not suggest testing, the inventions are patentably distinct, p. 10. Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
The patented claims describe a method of treatment, which recites administration of an identical substance to treat the identical pathology, and using an open language comprising. The Examiner maintains that the instant claims are drawn to the same invention for which patent protection has been already granted.
11. Claims 14, 24-26, 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,800,853 for reasons of record in section 7 of Paper mailed on March 09, 2026 and section 12 of Paper mailed on June 01, 2026. At pp. 10-11, Applicant argues, similarly to above, that the patented claims do not disclose or suggest assessing an HD subject prior to treatment. Applicant’s argument has been fully considered but found to be not persuasive for reasons of record fully explained earlier and above. Furthermore, by broadest reasonable interpretation, the instant claims do not explicitly require or suggest not to treat those patients with the score that does not meet the limitations of the claims. The Examiner maintains that the instant claims encompass a method of treating the same pathology, Huntington’s disease, by administration of the same antibody for which patent protection has been already granted.
12. Claims 14, 24-26, 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,385,136.
Claims 14, 24-26, 29 and 30 are directed to methods of treatment of the same pathology, HD specifically, by administration of the same antibody as in patented claims of the ‘136 document.
Conclusion
13. No claim is allowed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
September 15, 2026
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