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 .
Response to Amendments
Applicant’s amendments to the claims of May 5, 2026, in response to the Office Action of February 5, 2026, are acknowledged.
Response to Arguments
The Double Patenting Rejection is withdrawn in view of the filing and approval of a Terminal Disclaimer on May 4, 2026.
Applicant’s amendments to the claims of May 5, 2026, narrow the scope of the claimed core formulas and obviate the §112 rejections for Scope of Enablement and Written Description.
The examiner notes that the elected species are: blepharitis and 2-phenyl-cycloproanamine. While claim 114 refers to a diseased causes by Demodex infestation, dependent claim 143 makes clear that the claims are inclusive of treating blepharitis (as the condition caused by Demodex) with 2-phenyl-cyclopropamine.
The combination of prior art teaches that topical administration of 2-phenyl-cyclopropamine as well as other phenylcyclopropylamine compounds, analogs or derivatives, can be used to treat and/or prevent blepharitis and other skin inflammatory conditions. The mode of action is through LSD1 inhibition. Topical administration includes to the skin in the form of a lotion, cream, ointment, gel, paste or other topical form. Even further, Maes teaches treating any structure of the eye or eyelid. See par. 71.Thus, Maes alone is teaching administration of the claimed agent to a subject with blepharitis (i.e., the elected species of condition).
Elston teaches us that the prevalence of Demodex infestation is nearly 95% of individuals above 71%. They are also found in 69% of 31 to 50 year olds. As noted in the previous action, most (i.e., 58%) of these individuals have clinical blepharitis. Other articles indicate that more than two-thirds of all cases of blepharitis are caused by Demodex. See Evidentiary reference Page, “Multidisciplinary perspectives in Demodex blepharitis: A new view of treatment from clinical, payer, and patient perspectives,” JMCP October 2024, Volume 30, Number 10-a.
Claim 114 includes inhibiting Demodex or preventing or treating a disease caused by Demodex. The examiner notes that this includes a subject with blepharitis caused by Demodex. Thus, when the claimed agent is taught to be administered topically or orally, or otherwise to the elected subject (i.e. one having Demodex blepharitis), it would have an effect of inhibiting Demodex even if it was not recognized as doing so. The claimed subject population remains broad because although they can have blepharitis or a susceptible to blepharitis caused by Demodex. Even healthy individuals have Demodex mites and have some level of susceptibility to an infestation.
As such, the rejection of record is maintained because the claimed subject is taught to be administered the claimed agent through various topical and systemic routes of administration. Even if a specific dosage were required to achieve such inhibition, there is no dosage or route of administration claimed and it would appear that an optimized dosage of an LSD1 inhibitor would have some ameliorating effect on preventing or treating Demodex blepharitis.
Status of the Claims
Claims 114 and 125-143 are pending. Claims 132 and 133 and preliminarily withdrawn. Claims 114, 125-131, and 134-143 are examined.
Claim Rejections - 35 USC § 103
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.
Claims 114 and 125-143 are rejected under 35 U.S.C. 103 as obvious over Maes et al., (US2014/0329833), as evidenced by STN CAS RN: 54-97-7 (1984), and in view of Elston et al., “Demodex mites,” Clinics in Dermatology (2014) 32, 739-743.
Maes teaches prevention and treatment of inflammatory conditions by administration of an LSD1 inhibitor such as 2-cyclylcylopropan-1-amine derivative, a phenelzine derivative and a propargylamine derivative. See Abstract. Routes of administration including topical, lotions, creams, gels, pastes, ointments, and others. See par. 294. The method includes treatment and prevention by administering an LSD1 inhibitor to treat conditions including a chronic skin inflammatory disease, psoriasis, atopic dermatitis, and others. Inflammatory conditions include ocular inflammation including blepharitis, conjunctivitis, and dry eye. See par. 71. The LSD1 inhibitor can be a phenylcyclopropylamine derivative or analog. See par. 78. More preferably, the compound is a 2-phenylcyclopropan-1-amine compound. See par. 78.
As evidenced by the STN database record of Nov 16 1984, 2-phenylcyclopropan-1-amine is the elected species compound V-C.
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Further, Elston teaches that demodex mites cause chronic inflammatory eruptions and is associated with chronic blepharitis. Further, 58% experience clinical blepharitis. See p741, 2nd full par.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods because it is treating such conditions with a claimed agent is explicitly motivated. Further one would have a reasonable and predictable expectation of success in treating blepharitis and conjunctivitis, among other conditions, by topically administering 2-phenylcyclopropan-1-amine as a preferred LSD1 inhibitor that is also an MAO inhibitor as taught. Further, blepharitis is known to be an inflammatory condition that is often caused by demodex. Inflammation and chronic inflammatory conditions are taught to be treated by the claimed API when topically applied. Blepharitis is typically caused by Demodex and is a chronic inflammatory condition. Moreover, the combination of prior art teaches that topical administration of 2-phenyl-cyclopropamine as well as other phenylcyclopropylamine compounds, analogs or derivatives, can be used to treat and/or prevent blepharitis and other skin inflammatory conditions. The mode of action is through LSD1 inhibition. Maes teaches treating any structure of the eye or eyelid. See par. 71.Thus, Maes alone is teaching administration of the claimed agent to a subject with blepharitis (i.e., the elected species of condition).
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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