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 .
112(a) Rejections Withdrawn
The rejection of claims 21-40 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment narrows the scope of the claim set such that it is now enabled.
112(b) Rejections Withdrawn
The rejections of claims 21-40 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, have been overcome by inventor’s amendment. With respect to claims 21, 23-30, 33 and 40, the amendment clarifies the claims as appropriate. With respect to the remaining claims (indefinite from indefinite), the rejection is moot.
Claim Rejections - 35 USC § 112(b), NEW
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 22-29 and 31-33 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.
There is insufficient antecedent basis for the limitation “…and pharmaceutically acceptable salts, esters, and solvates thereof…” in the claims.
Claim 30 is 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.
There is insufficient antecedent basis for the limitation “…tranylcypromine hydrochloride [emphasis added]…” in the claim.
102 Rejections Withdrawn
The rejection of claims 21, 22, 24, and 34-40 under 35 USC 102(a)(2), outlined in the previous Office Action (diosmetin), has been overcome by inventor’s amendment. The amendment narrows the scope of the claim set such that it no longer reads on the cited art.
Markush Search
Inventor having overcome the outstanding art rejection, the search was therefore expanded as called for under Markush examination practice, a compound-by-compound search, to include a single additional species. That species is: quinidine.
All claimed but as yet unexamined subject matter which does not read on the above species is hereby withdrawn from consideration, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matter will be rejoined, as appropriate, as the Markush examination progresses.
Claim Rejections - 35 USC § 102, NEW
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21, 26, 27, 29 and 33-40, in so far as they read on the species defined above (quinidine), are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by WO 2022/212399 A1 (which claims priority to 30 March 2021).
The reference teaches a method of reducing or eliminating Demodex mites in or on an individual which will then reduce clinical signs and symptoms, and provide transmission prophylaxis, of viral infections associated with these organisms (abstract; page 1, [0002]). That is, the reference teaches “[a] method of inhibiting and/or killing Demodex on a subject and/or to prevent and/or treat a disease of the subject caused by Demodex infection…”. Quinidine is explicitly taught (page 13, [0037]; page 26, [0086]; page 80, claim 11). Topical administration to hair follicles, skin, eyes, eyelids, eyelashes, or meibomian glands, i.e. where Demodex is known to exist, is explicitly taught (page 7, [0018]; page 56, [0222]). Transdermal and intraocular topical administrations are explicitly taught (page 51, [0203]). Such topical transdermal application will intrinsically encompass conventional formulations to achieve such an end such as lotions, ointments, gels, etc. Likewise, such topical intraocular application will intrinsically encompass conventional formulations to achieve such an end such as eye drops, eye ointments, ophthalmic gels, etc.
Claims 38-40 included in this rejection because the claims simply list eye and skin diseases, for instance, and associated symptoms, which are already known in the art to be associated with Demodex colonization – note inventor’s summary of the pertinent art in the BACKGROUND section of the instant specification (page 1, 2nd full paragraph). That is, the limitations of the claims are already intrinsic to Demodex colonization.
Allowable Subject Matter
As noted in the previous Office Action, the elected species (tranylcypromine HCL) being free of the prior art, any claim, or portion of a claim, drawn exclusively to this species would constitute allowable subject matter.
Conclusion
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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/19/2026
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