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 .
Formal matters
1. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675.
Response to Amendment
2. Claim 22 has been amended and claims 32-34 added as requested in the amendment filed on August 19, 2026. Following the amendment, claims 22-34 are pending in the instant application.
3. Claims 23 and 24 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 24, 2025.
4. Claims 22 and 25-34 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on August 19, 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 below as well.
Claim Objections
7. Claims 31-34 are objected to because of the following informalities:
The claims recite acronyms without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for. Appropriate correction is suggested.
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.
8. Claims 22 and 25-30, as amended, and new claims 31-34 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.
9. Claim 22 stands rejected as being indefinite for reasons of record in Paper mailed on March 19, 2026. Applicant is advised that amendment to the claim did not obviate the rejection. Briefly, the amendment provided a point of reference to compare the intended result of administration of the therapeutically effective amount of the anti-CD3 antibody. However, it remains not obvious what stands for a meaningful comparison point, such as what represents that level of activation of microglia prior to commencement of intra-nasal administration. The specification does not describe what parameters stand for the term “microglia activation,” such as units to measure activation, or lack thereof, for example. Therefore, one of skill in the art would not know what active steps are intended to be practiced to support the limitation “wherein administering […].” This renders the claim indefinite.
10. Similarly, new claims 31-34, are indefinite insofar as they recite limitation “sufficient to decrease [or increase] microglial expression of […].” Applicant is advised that because the instant specification fails to provide any meaningful information regarding critical levels of expression of the recited markers specifically associated with a normal or pathological state, or means of assessment of the markers, a skilled practitioner would not know what steps to practice to satisfy the claims’ limitations and achieve the intended result of administering of anti-CD3 antibody. This further raises issues under 112(a), first paragraph, lack of enablement and lack of written description.
11. Also, the terms “to decrease” or “to increase” in claims 31-34 are relative terms which render the claims indefinite. These terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
12. Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
13. Claims 25-30 are indefinite for being dependent from indefinite claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
14. Claim(s) 22 and 27-30 stand rejected under 35 U.S.C. 103 as being unpatentable over Kuhn et al. for reasons of record in Paper mailed on March 19, 2026.
Applicant argues at pp. 7-8 of the Response that the Office has not provided any explanation of reasons to practice the disclosure of Kuhn et al. or expectation of success. Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
Claim 22 is broadly drawn to a method of administering an anti-CD3 antibody, Foralumab, intra-nasally, to a subject to alleviate a sign or symptom of an ischemic related disease or injury. Kuhn et al. teach clinical intra-nasal administration of Foralumab to treat autoimmune diseases, colitis, atherosclerosis, IBD and inflammatory diseases, see the whole paper. By broadest reasonable interpretation and consistent with the knowledge in the relevant art —the shared pathology in ischemic diseases and chronic inflammation, such as persistent systemic inflammation that drives endothelial injury, atherogenesis and thrombosis leading to ischemic events of myocardial infraction and ischemic stroke— treatment of at least inflammatory diseases meets the limitation of treatment of a sign or symptom of an ischemic related disease or injury, absent evidence to the contrary. The limitations describing the resulting effect of such administration —reduces microglia activation—are currently subject of the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, indefiniteness, and therefore are not the subject of interpretation for purposes of the instant art rejection.
For reasons of record fully explained earleri and reasons above, the rejection is maintained.
Conclusion
15. No claim is allowed.
16. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
September 1, 2026
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