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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,060,339. The instant claims and reference claims overlap substantially. The intended use of a pharmaceutical composition does not carry patentabilty weight.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,435,051. The reference compounds are fully embraced by the instant claims. A later genus claim is not patentable over an earlier species claim, In re Berg, 46 USPQ2d 1226, 1233. See also In re KAUFFMAN, II, 68 USPQ 178.
Although the claims at issue are not identical, they are not patentably distinct from each other because one skilled in the art can select any of the compounds of the pharmaceutical compositions in the reference claims and arrive at the pharmaceutical compositions comprising the same compound of the instant claims. A pill is a pill no matter what it is used for.
Claims 4-11 are duplicates as they each depend on claim 1. Different intended uses are given no material weight in such claims. Note In re Tuominen 213 USPQ 89.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
The claims are drawn to pharmaceutical compositions for the prevention or treatment of mental disorder generally (claims 1-3); prevention or treatment of the metal disorder wherein the mental disorder is substance-related and addictive disorder (claim 4); prevention or treatment of substance-related and addictive disorder wherein the substance-related and addictive disorder is induced by a substance selected from alcohol; anxiolytics and sedatives (including benzodiazepines, zolpidem, propofol, ketamine, esketamine, phenobarbital); caffeine; cannabis (including marijuana, synthetic cannabis); hallucinogens (including LSD, phencyclidine, psilocybin); inhalants (including paint thinners, some adhesives); opioids (including fentanyl, morphine, oxycodone, pethidine, methadone, hydromorphone, hydrocodone, oxymorphone, codeine, heroin); stimulants (including methamphetamine, ecstasy, amphetamines, cocaine); cigarette; and others (including appetite suppressants such as phentermine, phendimetrazine, diethylpropion and mazindol; synthetic anabolic steroids; other commonly abused substances) (claim 5); prevention or treatment of mental disorder according to Claim 4, which is for treating or attenuating withdrawal symptoms of the substance inducing the substance-related and addictive disorder (claim 6); prevention or treatment of mental disorder according to Claim 4, which is used in combination with an anti-addiction agent including a drug of substitution or a drug of replacement (Claim 7); prevention or treatment of mental disorder according to Claim 7, wherein the anti-addiction agent is at least one selected from naloxone, naltrexone, nalmefene, disulfiram, acamprosate, topiramate, risperidone, paliperidone, ondansetron, fluoxetine, sertraline, paroxetine, citalopram, fluvoxamine, venlafaxine, duloxetine, mirtazapine and bupropion (Claim 8); prevention or treatment of mental disorder according to Claim 4, which is for preventing recurrence or reducing the likelihood of recurrence of abuse of the substance inducing the substance-related and addictive disorder in a patient attempting to discontinue use of the substance inducing the substance-related and addictive disorder (Claim 9); prevention or treatment of mental disorder according to Claim 1, wherein the mental disorder is depressive disorder or anxiety disorder (claim 10); and prevention or treatment of mental disorder according to Claim 1, wherein the mental disorder is post-traumatic stress disorder (claim 11).
The treatment, much less prevention, of these disorders cannot be possibly enabled.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
1) The nature of the invention: The claims are drawn to pharmaceutical compositions for use in preventing or treating a myriad of mental disorders.
2) The state of the prior art: There are no known compounds of similar structure which have been demonstrated to treat any or prevent any and all of these diseases. For example, the notion that a compound could be effective against substance-related and addictive disorder in general is absolutely contrary to our current understanding of how chemical dependencies operate. There is not, and probably never will be, a pharmacological treatment for “substance addiction” generally. That is because this is not a single disease or cluster of related disorders, but in fact, a collection with relatively little in common. Addiction to barbiturates, alcohol, cocaine, opiates, amphetamines, benzodiazepines, nicotine, etc. all involve different parts of the CNS system, different receptors in the body. For example, cocaine binds at the dopamine reuptake transmitter. Heroin addiction, for example, arises from binding at the opiate receptors, cigarette addiction from some interaction at the nicotinic acid receptors, many tranquilizers involve the benzodiazepine receptor, alcohol involves yet another system, etc. All attempts to find a pharmaceutical to treat substance addictions generally have thus failed.
There are no known compounds which have been demonstrated to prevent or treat mental disorders because these are extremely varied in origin and nature of effect. The origins, symptoms and the nature of many mental disorders are different one from the other. Many are untreatable to this day.
Mental disorders vary in how they affect the body and its functions. Diseases such as Cerebral palsy, and Parkinson's disease affect the movement of the patient. Diseases such as Alzheimer's disease affect the memory of the patient.
Mental disorders such as Depression, Meningitis (viral, bacteria, or fungi infection), Encephalitis (viral infection), Rett syndrome, Tinnitus, Narcolepsy, Shy-Drager syndrome, Charcot-Marie-Tooth disease, Tarsal tunnel syndrome, Psychosis, Memory loss, Mental retardation, Autism, Migraine, Tension headache, Multiple sclerosis, etc. are different one from the other. The symptoms and nature of these diseases are also different one from the other. Some are hereditary (Charcot-Marie-Tooth disease). Since the origin and nature of neurological disorders vary extremely one from the other, it is impossible to treat them in general.
3) The predictability or lack thereof in the art: Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
4) The amount of direction or guidance present and 5) the presence or absence of working examples: There are no doses present to direct one to prevent or treat any and all of the disorders embraced by the claims. As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
Applicants must teach the skilled practitioner, in this case a physician, how to prevent or treat amental disorders generally.
6) The breadth of the claims: The claims are drawn to disorders that are not related and whose prevention is unknown.
7) The quantity of experimentation would be an undue burden to one skilled in the pharmaceutical arts since there is inadequate guidance given to the skilled artisan for the many reasons stated above.
Thus, factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instant case for the instant method claims.
The scope of uses embraced by the claims is not remotely enabled. Applicants need to limit the claims to those disorders that are known to be treated. It is presumed in the prevention of disorders claimed herein there is a way of identifying those people who may develop any kind of the disorders recited. There is no evidence of record which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the disorders claimed herein.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221', Ex parte Jovanovics, 211 USPQ 907., MPEP 2164.05(a).
The claims are enabled for treating morphine or cocaine addiction, depression, anxiety and PTSD.
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.
Claim 5 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.
The claim has terms and phrases in parenthesis which begin with “including.” These render the claim indefinite because the metes and bounds are not known. Are the terms in parenthesis part of the claim limitations? The term “including” renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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 H. 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.
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.
September 26, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
