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 .
Status of Claims
The amendments to the claims filed August 6, 2026 are acknowledged and entered. Claims 1-8, 11-12, 16-17, 19, 21, 26-28 and 39-41 are pending.
Priority
This application is a 371 of PCT/US2022/080832, filed December 2, 2022, which claims benefit of 63/285,841, filed December 3, 2021.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see e.g. [00372]-[00382], hyperlinks for references; they appear to be listed throughout pages 113-122). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to because the text in Figure 1 is illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
The restriction requirement mailed June 3, 2026 has been reconsidered and is hereby withdrawn.
Claim Rejections - 35 USC § 112a
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.
Claim 1-8, 11-12, 16-17, 19, 21, 26-28 and 39-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a psychiatric disorder or a method of reducing the symptoms of a psychiatric disorder wherein the psychiatric disorder is selected from alcohol use disorder (AUD) or post-traumatic stress disorder (PTSD) does not reasonably provide enablement for
Treating a psychiatric disorder generally;
Reducing the severity of symptoms of a psychiatric disorder generally
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
Nature of the Invention and Breath of the Claims
Instant claim 1 is drawn to a method of treating a psychiatric disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one or more compounds selected from pibrentasvir, glecaprevir, and velpatasvir, or pharmaceutically acceptable salts thereof, wherein the subject has not been diagnosed as having hepatitis C virus.
Claims 2-8 , 11-12, 16-17, 19, 21 and 26-28 depend from claim 1 and include the treatment of a psychiatric disorder or a broad class of psychiatric disorder (e.g. substance use disorder).
Claims 39-40 are drawn to a method of reducing the severity of one or more symptoms of a psychiatric disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one or more compounds selected from pibrentasvir, glecaprevir, and velpatasvir, or pharmaceutically acceptable salts thereof, wherein the subject has not been diagnosed as having hepatitis C virus.
Claim 41 is drawn to a method of treating a psychiatric disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one or more compounds selected from pibrentasvir, glecaprevir, and velpatasvir, or pharmaceutically acceptable salts thereof, wherein the psychiatric disorder is one or more selected from attention-deficit/hyperactivity disorder, autism spectrum disorder, conduct disorder, disruptive mood dysregulation disorder, an eating disorder, gender dysphoria, internet gaming disorder, obsessive-compulsive disorder, a paraphilic disorder, a personality disorder, posttraumatic stress disorder, a sleep-wake disorder, a specific learning disorder, a social communication disorder, a substance-use disorder, and a somatic symptom disorder.
Applicant teaches pibrentasvir, glecaprevir, and velpatasvir are known hepatitis C medications (see [0049]-[0051]).
Claims 1 and 39 do not require any particular psychiatric disorder and a scope limiting definition of psychiatric disorders is not provided in the specification. The method of claims 1 and 39 broadly would be understood to include the treatment of any known psychiatric disorder (e.g. any condition listed in the table of contents of the DSM-5).
Claim 41 is more narrowly drawn to the explicitly recited conditions.
All of the claimed methods require the administration of a compound that is known in the prior art for the treatment of hepatitis C infection.
The state of the prior art
The DSM-5 teaches there are hundreds of different psychiatric disorders all of which are recognized as separate conditions with different diagnostic criteria and treatment requirement. Classes of disorder broadly include intellectual disabilities, communication disorders, Autism spectrum disorder, ADHD, specific learning disorder, motor disorders, other neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, catatonia, bipolar and related disorders, depressive disorders, anxiety disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, feeding and eating disorders, elimination disorders, sleep-wake disorders, breathing-related sleep disorders, parasomnias, sexual dysfunctions, gender dysphoria, disruptive, impulse-control, and conduct disorders, substance-related and addictive disorders (which includes all alcohol related disorders, caffeine related disorders, hallucinogen related disorders, cannabis related disorders, inhalant related disorders, opioid related disorders, sedative-, hypnotic, or anxiolytic related disorders, stimulant related disorders, tobacco related disorders and other substance related disorders), non-substance related disorders (e.g. gambling), neurocognitive disorders, personality disorders, other personality disorders, paraphilic disorders, and other mental disorders (See DSM-5 Table of Contents). A person skilled in the art readily understands that these classes of psychiatric disorders are distinct in terms of cause, effect and treatment. A person skilled in the art further recognizes that the symptoms of these highly varied disorders are also highly varied. For instance, the Mayo clinic teaches PTSD symptoms include intrusive memories, avoidance behavior, negative changes in thinking and mood and changes to physical and emotional reactions. By contrast schizophrenia symptoms include delusions, hallucinations, disorganized speech and thinking, extremely disorganized or unusual motor behavior. Symptoms of gambling disorder include problems with gambling (e.g. preoccupation with gambling, asking others to bailing one out of financial trouble) (see attached Mayo Clinic descriptions of PTSD, schizophrenia and compulsive gambling).
Applicant teaches the compounds of the claims (pibrentasvir, glecaprevir, and velpatasvir) are known as antiviral medications for the treatment of Hepatitis C infection (see the instant specification at paragraphs [0049]-[0051]. The state of the prior art reference Back et al. (J Viral Hepat 2019, 26, 951-960) teaches glecaprevir and pibrentasvir are used to treat patients with chronic HCV infection that also have a psychiatric disorder (Title and Abstract). However, the state of the prior art does not appear to be aware that these medications or this class of medications are useful for the treatment of a psychiatric condition.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides evidence to suggest that these hepatitis C medications may be useful in the treatment of PTSD and AUD (see Examples beginning at page 43).
However, no evidence is provided to suggest that these anti-viral medications generally treat a psychiatric disorder. No guidance is provided (e.g. mechanistic basis for how the method works) which could form the basis for treating other psychiatric conditions embraced by the claim. Indeed Applicant teaches the biological mechanism by which DAAs could have a psychiatric effect is unclear (see [00233]). Moreover, Applicant states that these effects are unexpected (see specification at [00232]). In the present case, AUD and PTSD are distinct conditions and there is simply no evidence in the record to suggest that these conditions are models for the hundreds of other psychiatric conditions embraced by the claims. Treatment of a psychiatric condition with the compounds of the claims is unpredictable.
Similarly, no evidence is provided to suggest that a hepatitis C medication reduces the severity of all psychiatric symptoms which are highly varied and unrelated. Such an effect as is claimed is unpredictable.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here and one skilled in the art could not practice the full scope of the claimed invention without undue and unreasonable experimentation. This rejection could be overcome by amending the claims to require that the psychiatric disorder to be treated is PTSD or AUD, and to require that the psychiatric disorder for which symptom severity is reduced is PTSD or AUD.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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 Murray can be reached on (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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October 2, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
