DETAILED ACTION
A non-final Office action was mailed 22 August 2024 (“Office Action”).
Applicant’s reply to the Office Action was received 5 February 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1, 3, 8–11, 13, 14, 18–22, 24–29, 31, and 36–38 are pending.
Claims 2, 4–7, 12, 15–17, 23, 30, and 32–35 are canceled.
Claims 1, 11, 20, and 29 are amended.
Claims 37 and 38 are new.
Benefit of Earlier Filing Date
The instant application was filed 13 February 2023 and claims the benefit of an earlier filing date of U.S. Prov. Pat. App. Serial No. 63/309,874, filed 14 February 2022. Applicant’s claim is acknowledged.
Status of Rejections and Objections
Unless repeated herein, any objection or rejection in the Office action is withdrawn.
Claim Objections
Claims 1, 8, 11, 13, 14, 19, 21, 24, 25, 28, 31, 36, and 37 are objected to for using improper capitalization. Trademarks may not be improperly used in claims. (MPEP § 2173.05(u)). In this case, the capitalization of Roluperidone appears to be a typographical error rather than a reference to a trademark because it is a common names for the compound 1H-isoindol-1-one,2-[ [1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2). The capitalization of a common name is not necessary or proper.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
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.
Claims 9–11, 14, 21, and 26 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A claim is indefinite when it contains words or phrases whose meaning is unclear. For example, a claim may be indefinite when it recites a subjective term and the specification does not supply an objective standard for measuring the scope of the term. MPEP § 2173.05(b)(IV). A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893 (CCPA 1970). As another example, a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claims 9 and 26 recite, “the schizophrenia patient does not manifest any behavior which puts the patient, or those around the patient, at risk of bodily harm.”
The specification does not provide an objective standard for what is or is not “behavior which puts the patient, or those around the patient, at risk of bodily harm.” As such, the claim is indefinite because a person having ordinary skill in the art would not be able to determine the scope of the claim.
Claim 10 recites, “the schizophrenia patient has low levels of symptoms related to . . .”
Claim 11 recites, “the schizophrenia patient does not experience a high level of depression or anxiety . . .”
The terms “low levels” and “high level” are relative terms and a clear standard or interpretive frame of reference for the term is not provided in any of the claims or in the specification. The specification discusses the PANSS scale (¶93), but because some claims refer to that scale while other claims do not, it is unclear what low levels and high level refer to.
Claim 14 recites, “(i) negative symptoms that are moderate to severe; or (ii) a PANSS negative subscore that is greater than 20.”
The term “moderate to severe” is a relative term and a clear standard or interpretive frame of reference for the term is not provided in any of the claims or in the specification. The specification discusses the PANSS scale (¶93), but because claim 14 recites “a PANSS negative subscore that is greater than 20” as an alternative to “negative symptoms that are moderate to severe,” it is unclear what moderate to severe refers to a PANSS score or some other standard.
Claim 21 recites, “the schizophrenia patient having moderate to severe negative symptoms.”
The term “moderate to severe” is a relative term and a clear standard or interpretive frame of reference for the term is not provided in any of the claims or in the specification. The specification discusses the PANSS scale (¶93), but because dependent claim 22 recites “a PANSS negative subscore that is greater than 20,” it is unclear whether moderate to severe refers to a PANSS score or some other standard.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claims 1, 3, 8–10, 13, 14, 18, 19, 21, 22, 24–29, 31, 36, and 37 are rejected under 35 U.S.C. § 103 as being unpatentable over Strauss et al., Schizophrenia Bulletin (2020), 46(4), 964–970 (“Strauss”) in view of Applicant admissions.
Claim Interpretation
Claim 1 recites: “A method of preventing relapse in a schizophrenia patient, wherein the method comprises administering a therapeutically effective amount of Roluperidone to the schizophrenia patient, wherein the schizophrenia patient has positive symptoms that are stable before starting treatment with Roluperidone or does not have positive symptoms before starting treatment with Roluperidone.”
The specification states, “Relapse may be characterized by the acute increase in positive and/or negative symptoms.” (Spec., ¶115).
Claim 1 defines the patient as having positive symptoms that are stable before starting treatment with roluperidone or not having positive symptoms before starting treatment with roluperidone. Accordingly, the scope of the claim excludes patients having positive symptoms that are not stable before starting treatment with roluperidone. And the scope of the claim includes patients having negative symptoms as long as the patient also has no positive symptoms or positive symptoms that are stable before starting treatment with roluperidone.
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Strauss states: “Results of a phase 2b trial indicate that roluperidone . . . exerts a significant improvement on negative symptoms in schizophrenia patients.” (Strauss, p.966).
Applicant acknowledges: “Strauss discloses that roluperidone demonstrates efficacy in the treatment of [negative symptoms].” (Remarks, p.7).
The background section of the instant specification states that most individuals with schizophrenia suffer from positive symptoms and negative symptoms: “According to the World Health Organization, schizophrenia affects about 1% of the general population. Most individuals affected by schizophrenia suffer from psychosis or positive symptoms, negative symptoms and cognitive impairment.” (Spec., ¶4).
Strauss discloses administering a daily dose of roluperidone orally in an amount of 32 mg/day, 64 mg/day, or placebo, in a 1:1:1 ratio. (Strauss, p.965, Table 1).
Strauss states: “Participants included individuals with schizophrenia.” (Strauss, p.966).
Strauss states: “Two hundred forty-four patients between the ages of 18 and 60 entered the trial.” (Id.).
Strauss discloses the patients selected for this study to be clinically stable and exhibiting negative symptoms for 3 months prior to entering the study, in addition to these patients displaying low levels (<4 on the PANSS) of symptoms related to agitation, impulse control, hostility, suspiciousness, or uncooperativeness and poor impulse control. (Id.).
Strauss discloses the patients selected displayed negative symptoms for 3 months prior to entering the study and being treated with roluperidone in addition to the patients having a negative symptom score greater or equal to 20 on the PANSS scale for at least 3 months prior to entering the study. (Id.).
Strauss states eligible patients were withdrawn from depot antipsychotics for longer than one month before oral administration of roluperidone. (Id.).
Ascertaining the differences between the prior art and the claims at issue
Strauss is silent with respect to whether the patients exhibited an absence of positive symptoms or positive symptoms that were stable before starting treatment.
Strauss is silent regarding preventing relapse.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application includes numerous studies and results therefrom, but the evidence does not appear to indicate obviousness or nonobviousness in the context of this rejection.
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed method because Strauss discloses the administration of roluperidone to patients within the scope of the claim. Although Strauss reports on the treatment of negative symptoms, one of ordinary skill in the art would have been a reasonable expectation of success in administering the same drug for the prevention of the negative symptoms if administered before the onset of the acute event.
Allowable Subject Matter
Claims 20 and 38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 20 and 38 narrow the definition of relapse relative to claims 1 and 21, respectively, such that it does not include preventing negative symptoms.
Conclusion
No claims are allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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