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
Response to Amendment
1. Claims 1, 2, 12, 14, 25 and 27 have been amended and claims 3-10, 15-23 and 28 canceled as requested in the amendment filed on April 17, 2026. Following the amendment, claims 1, 2, 11-14 and 24-27 are pending in the instant application.
2. Claims 1, 2, 11-14 and 24-27 are under examination in the instant office action.
3. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
4. Applicant’s arguments filed on April 17, 2026 have been fully considered but found to be not persuasive for reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
5. Claims 1, 2, 11-13 and 24-26, as amended, 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.
6. Claim 1, as currently presented, is indefinite in recitation of “treatment of said subjects results in improvement in detection of changes in cognition and/or motor function.” Briefly, it is not clear and cannot be determined from the claim or the specification as filed whether the limitation encompasses improvement in detection of changes or an actual improvement in cognition and/or motor function.
7. Claims 11-13, dependent from claim 1, and claims 24-26, dependent from claim 14, wherein both claims 1 and 14 are now limited to one specific antibody, are indefinite wherein they recite 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, claims 11-13 and 24-26 further limit the antibody of the base claims 1 and 14 to the antibodies that are defined by functional language—inhibits SEMA4D binding to its receptor, or to a specific receptor or inhibits signal transduction. 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 a requirement to perform the recited functions. Since the claims fail to meet the criteria set forth in MPEP 2173.05(g), then the claims are rejected as being indefinite.
8. Claim 2 is indefinite for being dependent from indefinite claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Claims 1 and 11-13 stand rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter for reasons of record in section 4 of Paper mailed on March 09, 2026.
At p. 7 of the Response, Applicant traverses the rejection on premises that, “[T]he MoCA assessment is designed to evaluate a person's cognitive abilities across multiple
domains, including memory, attention, language, executive function, visuospatial skills,
abstraction, delayed recall, and orientation. Testing requires the subject to make physical and
cognitive connections within test parameters. Administration of such testing and the testing perse are not abstract concepts. […] The TFC is used as an endpoint in clinical trials and is recognized by the FDA as a critical outcome measure in clinical HD trials. These parameters are primarily physical and administration of such testing and the testing per
se are not abstract concepts.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
As far as the test recited within claim 1 encompasses “evaluation of memory, attention, language, executive function, visuospatial skills, abstraction, delayed recall, and orientation,” The Examiner maintains that the test is limited to mental steps of communication with a person under testing and as such is not patentable under 35 U.S.C. 101. Any testing that comprises physical assessment of a person that is suspected or having Huntington’s disease, when recited within claimed subject matter, sets forth a judicial exception by reciting natural body reaction during process of a naturally occurring pathology of HD. Note that limitations that describe how the person under treatment will be treated and results that are expected to be achieved do not change the scope of the claimed invention because they represent descriptive intention and not actual active physical steps of the method.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
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.
10. Claim(s) 14 and 24-27 stand 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.
Applicant traverses the rejection at pp. 8-10 of the Response. Specifically, Applicant argues that, “[T]he pending claims have been amended to define the subjects selected for and administered treatment as having or suspected of having HD and having a MoCA score specifically in the range of 19-25 and/or a TFC score of 11. As disclosed in the Examples and as shown in Figures 2 and 3 of the specification as filed, HD subjects that have a MoCA score in the range or 19-25 that are treated with an anti-SEMA4D antibody as recited exhibit an enhanced decrease, slowing or reversal of cognitive decline and/or an enhanced decrease in motor impairment as compared to treatment of subjects having or suspected of having HD and having a MoCA score of > 26.” Applicant further submits that, “[T]he specification also discloses that HD subjects having a TFC of 11 demonstrate a significant treatment benefit compared to HD subjects having a TFC of 12 or 13. […] Applicant's studies disclosed in Example 1 demonstrate that HD subjects that have a slightly more advanced disease as shown by a TFC score 11, show a treatment benefit compared to subjects with a TFC score of 12 or 13. As shown in Figure 1, treatment benefit over a period of 17 months was observed in subjects with a TFC score of 11 (treatment versus placebo) compared to those subjects with a TFC score of 12-13 who demonstrated no detectable difference in the Clinical Global Impression of Change over the same time period.” Applicant explains that, “[T]he '495 patent does not disclose or suggest assessing a HD subject prior to treatment to determine the stage of the disease and does not disclose or suggest using information regarding the stage of the disease to determine whether or not to treat the subject with the recited anti-SEMA4D antibody.” 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—and its use in treating neurodegenerative disorders while explaining the mechanism of acting upon semaphoring-4D binding to its receptor. The disorders include Huntington’s disease (HD) specifically. The many benefits of the antibody treatment are explained as at least promoting myelination, restoring astrocyte-mediated trophic support of oligodendrocyte precursor cells, protecting inhibitory neurons from degeneration, and preventing injury to blood-brain barrier. Thus, at the time of filing of the instant patent application, methods of treating of HD by administration of the identical antibody have been fully disclosed. The Examiner maintains that adding a test, that at the time of filing of the instant patent application was well-described as useful specifically in association with HD, would be fully within the technical grasp of an ordinary practitioner. Those under treatment by administration of the antibody, as described within the ‘495 patent, would benefit from the treatment protocol the same way as described by the ‘495 patent, regardless of the test assessment. The Examiner maintains that would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent application to administer a known test for HD and proceed with a known method of treatment. The result of the procedure would be reasonably expected to result “in a decrease, reduction, slowing or reversal of cognitive decline and/or an enhanced decrease in motor impairment,” even if not fully appreciated when practiced.
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.
11. Claims 14 and 24-27 stand 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. Applicant argues at p. 11 of the Response that, “the '495 claims do not disclose or suggest determining the MoCA and TFC
scores of the HD subjects and administering anti-SEMA4D antibodies only to those HD subjects that have a MoCA score of 19-25 and/or a TFC score of 11. Nor do the '495 patent claims suggest that the treatment outcome is different for this subset of subjects compared to HD subjects having a MoCA score of 26 and higher or a TFC score of 12 or 13. Claims 1-10 of the '495 patent do not disclose or suggest a method of maximizing treatment outcome by identifying and treating those HD subjects that are most likely to benefit from the recited treatment.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
First, the instant claims do not require for the subjects to be treated only when the MoCA score is of a specific value. Next, there is no requirement of maximizing treatment outcome to anticipate the claimed subject matter. The Examiner maintains that claims 14 and 24-27 are drawn to the method of treating the same pathology, Huntington’s, by administration of the same antibody for which patent protection has been already granted.
12. Claims 14 and 24-27 stand 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. At pp. 11-12, Applicant argues, similarly to above, that the patented claims “do not disclose or suggest assessing a HD subject prior to treatment to determine the stage of the disease and using that information to determine whether or not treat the subject.” Applicant’s argument has been fully considered but found to be not persuasive because, first, the instant claims do not recite or suggest not to treat those patients with the score that does not meet the limitations of the claims. The Examiner maintains that claims 14 and 24-27 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.
13. Claims 14 and 24-27 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/168,002 (reference application) for reasons of record in section 9 of Paper mailed on March 09, 2026. Applicant argues at pp. 12-13 of the Response, that the claims of the ‘002 patent application do not disclose or suggest determining the MoCa score of the subject prior to administration of the treatment “in order to determine whether or not the subject is likely to benefit from anti-SEMA4D antibody treatment.” While this has been fully considered, the argument is not persuasive because, as fully explained earlier, claims 14 and 24-27 by broadest reasonable interpretation are limited to a step of testing and a step of administering of the antibody, wherein the step of administering the antibody is the same as of the ‘002 claims. There is nothing in the instant claims that recites a different dose, route of administration or distinct regimen so to distinguish the treatment from the one recited within the ‘002 claims. The Examiner maintains that because the claims of the ‘002 patent application encompass treatment of Huntington’s disease by administration of an anti-SEMA4D antibody and another therapeutic agent, wherein the instant claims encompass treatment of Huntington’s comprising administration of the same an anti-SEMA4D antibody, then the claims are patentably indistinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
14. No claim is allowed.
15. 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
May 6, 2026
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