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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Response to Amendment
The amendments received 05/20/2026 have been entered. Claims 16-21 and 23-29 are pending. Any objection or rejection previously set forth in the Office Action mailed 01/20/2026 not maintained herein has been overcome by amendment and is withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
Claims 16-21 and 23-29 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.
Claims 16-21 and 23-29 directly or indirectly recite “isomers… thereof”. The term “isomers” renders the claims indefinite as isomers also includes constitutional isomers, i.e., isomers with the same type and number of atoms but in a different configuration. It is unclear which isomers are within the scope of the claims, nor can it be ascertained whether every constitutional isomer would have the same properties as the claimed compounds. Correction is required.
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.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama et al. (2008; IDS filed 01/07/2022), further in view of Sarkar et al. (Cell Death and Differentiation; 2009), Nguyen (Universite de Bretagne Occidentale - Brest; 2013), and Lorenzen (Humboldt-Universität zu Berlin; 2006). All references have been previously cited.
Hatakeyama et al. discloses a method of treating dementia patients with Alzheimer’s disease comprising administering to the patients azelastine hydrochloride (p. 59) which resulted in improved psychological symptoms (p. 59, col. 1 – p. 60).
Hatakeyama et al. does not teach combining azelastine with another compound. These limitations are obvious over Sarkar et al., Nguyen, and Lorenzen.
Nguyen teaches that flunarizine has activity against yeast and mammalian PRPSc formation (p. 135). Nguyen additionally discloses that flunarizine inhibits PFAR (p. 137-138) and that its antiprion activity is linked to its activity as an antihistamine (H1 receptor antagonist) (p. 139-140).
It would have been prima facie obvious to combine azelastine with flunarizine. One would have been motivated to do so, with reasonable expectation of success, as the aforementioned compounds have properties that would be expected to enhance the effects of azelastine by reducing protein aggregates and have been suggested for treating protein misfolding disorders such as Alzheimer’s disease.
Response to Arguments
Applicant's arguments filed 05/20/2026 have been fully considered but they are not persuasive.
35 U.S.C. 112(b)
Regarding the rejection under 35 U.S.C. 112(b) over the term “isomers”, Applicant argues that claim 16 has been amended to identify the compounds as inhibitors of PFAR, such that the compounds recited in the claim necessarily retain the function of PFAR inhibition. However, this is not persuasive. An isomer that retains the function of a compound does not convey the degree to which the function is retained, nor does it allow one of ordinary skill in the art to envisage what structures would maintain even a modicum of the function of the parent compound. Examiner additionally notes that claims 27-29 have not been amended to recite that the compounds are PFAR inhibitors and are thus still directed toward the recited compounds and isomers thereof generally. A compound may have multiple functions, and the definition in the specification which states “here the inhibition of PFAR” (p. 8) does not make clear that the scope of the claims is only limited to those retaining the function of inhibiting PFAR, nor does setting forth that the compounds are PFAR inhibitors clearly indicate that PFAR inhibition would be retained. The language may be more broadly interpreted as exemplary, which suggests that other functions are possible. The rejection is maintained.
35 U.S.C. 103
While Applicant argues that the synergy of ebastine in combination with flunarizine is unexpected, the scope of the claims is broader than that of the results pointed to by Applicant. Per MPEP 716.02(d), unexpected results must be commensurate in scope with the claimed invention. The claims are directed toward a composition comprising at least two different compounds selected from ebastine and flunarizine, ebastine and loperamide, and azelastine and flunarizine. The scope of the claims includes any concentration of the aforementioned compounds, not just those that are synergistic. One of ordinary skill in the art would not be able to extrapolate from the tested combinations and amounts that all concentrations would result in a synergistic combination.
The rejections are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 05/27/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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