The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-7, are pending in this application.
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.
Claim 1, is rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. The claim is drawn to a list of diseases or disorders not treated. Appropriate corrections are required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-7, are rejected under 35 U.S.C. 103(a) as being unpatentable over Vardanyan et al., US 2018/0021322 A1, further in view of Klassen et al., J. Affective Dis. (2010) 124:1-8.
Vardanyan et al., teaches the following compound (page 3) is opioid antagonist
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useful for treating opioid detoxification and/or opioid withdrawal (pp. 6, lines 8-9); it modulates the effects of opioid or cocaine abuse, the development of opioid tolerance or drug dependency. Vardanyan et al., teaches the compound is useful for treating, Parkinson’s disease, dyskinesia, hypertension, and scleroderma, [0009]. The dose is 0.01-500 mg/day, [0057], [0059], which may be changed depending on severity of disease, age and relative health of the subject, potency of the drug, route and form of administration, preference and experience of the medical practitioner, etc. The prior art teaches a POSA can ascertain the dose without undue experiment or by following the guidelines set forth by the prior art, [0056]-[0057] or known in the art. See also the entire document.
The prior art does not teach compound 1, but the compound by Vandanyan et al.,
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and compound 1, involve replacement of methyl with H or vice versa. Hydrogen and alkyl are art recognized equivalents. In re Lincoln, 126 USPQ 477, 53 USPQ 40 (CCPA, 1942); In re Druey, 319 F.2d 237, 138 USPQ 39 (CCPA, 1963); In re Lohr, 317 F.2d 388, 137 USPQ 548 (CCPA, 1963); In re Hoehsema, 399 F.2d 269, 158 USPQ 598 (CCPA, 1968); In re Wood, 582 F.2d 638, 199 USPQ 137 (CCPA, 1978); In re Hoke, 560 F.2d 436, 195 USPQ 148 (CCPA, 1977); Ex parte Fauque, 121 USPQ 425 (POBA, 1954); Ex parte Henkel, 130 USPQ 474, (POBA, 1960).
Having known the compounds are equivalents, are expected to have similar chemical and/or biological properties, and knowing that compound 1, has advantage over standard-of-care drugs, a POSA would have known and be motivated to administer compound 1, at the time the invention was made. There is reasonable expectation of success because applicant use compound 1 exactly as taught by the prior arts.
A showing of sufficiently close structural relationship is enough to create an expectation of similar properties, in light of the totality of prior arts, that the new compound will have "similar properties" to the old. Motivation is found in the expectation that similar compounds would have similar properties. A disclosure of new property does not defeat such expectation. Dillon, 16 USPQ2d, 1897 (Fed Cir, 1990). Applicant must show the prior art’s compound does not have the new property. Dillon, 16 USPQ2d, 1897 (Fed Cir, 1990), In re Shetty, 195 USPQ 753 (CCPA, 1977).
Applicant who claims a compound, which is structurally similar to a prior art’s compound must rebut the presumed expectation that structurally similar compounds have similar properties. In re Wilder, 195 USPQ 426 (CCPA, 1977). In the instant, compound 1, and the compound by Vardanyan et al., have the same utilities.
Vardanyan et al., also does not teach treatment of bipolar disorder and ADHD. However, the invention is obvious from the prior art in view of Klassen et al., because Vardanyan et al., teaches treatment of depression, anxiety disorder (AD) and panic disorders. Klassen et al., teaches comorbidity of ADHD with depression, AD, bipolar disorder (BD), alcohol and/or substance abuse. See the entire document, particularly the introduction. Therefore, a POSA would have known and be motivated to try treatment of ADHD and BD with compound 1, at the time the invention was made with reasonable expectation of success.
Establishing a dose or dosing regimen is not patentable significant under the US patent practice. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum workable range or amount”. In re Aller, 105 USPQ 232, 235 (CCPA, 1955). It takes no more than routine practice for Clinicians to establish dosing regimen.
The claims are not allowable over the combination of the prior arts and knowledge known in the art.
IDS
No IDS was filed in this application. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." See the MPEP 2000 and 37 CFR 1.97, 1.98. The references and English translations of all foreign documents must be submitted.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625
September 9, 2025
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