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 .
DETAILED ACTION
Non-Final Rejection
Claim Status
Claims 1 and 20 are independent claims.
Claims 1-30 are currently pending.
Priority Status
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Applicant claims NO foreign priority; the effective filing date is 04/12/2023.
Information Disclosure Statement
All references have been considered in the three (3) IDS(s) filed 03/05/2025, 06/13/2025, and 05/15/2026 unless marked with a strikethrough.
Drawings
The Instant Application had zero submissions of (0) drawing(s) for examination.
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.
112(a) for Written Description –
Claims 1-6, 16-30 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 written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Level of skill and knowledge:
The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which specific mechanism of action, combination of inhibitors influence the desired pharmacological activity and which diseases would benefit from this activity.
State of the art & predictability or unpredictability of the art:
Chadda RK, Gupta A. Looking into biological markers of suicidal behaviours (Indian J Med Res. 2019 Oct;150(4):328-331; hereinafter “Chadda”).
MacDonald K, Krishnan A, Cervenka E, Hu G, Guadagno E, Trakadis Y. Biomarkers for major depressive and bipolar disorders using metabolomics: A systematic review (Am J Med Genet B Neuropsychiatr Genet. 2019 Mar;180(2):122-137; hereinafter “MacDonald”).
In the instant case, the claims are drawn to a method of treating a person suffering from a psychiatric disorder, the method comprising orally administering to the person a unit dose comprising nefazodone hydrochloride, risperidone, and one or more pharmaceutical excipients, for a period of time effective to treat the psychiatric disorder.
As disclosed in Chadda, the genus of the "psychiatric disorder" contains various diseases with different etiologies. Unlike many diseases, “clinical risk assessment is largely based on the subjective report of the patient's experience, which has its own limitations with likelihood of under-reporting (col. 1, para. 3). There is no single blood test or brain scan that confirms a psychological diagnosis.
For this reason, biochemical etiologies across example psychiatric disorders (as seen in MacDonald), such as Major Depressive Disorder (MDD), Bipolar Disorder, Substance Use Disorders, Suicidal Behavior disorder (SBD) and Treatment-Resistant Depression (TRD), involve dysregulations in neurotransmitter systems (serotonin, dopamine, glutamate), the hypothalamic-pituitary-adrenal (HPA) axis, and neuroinflammatory responses are also distinctive. Use of Applicant’s composition with nefazodone/risperidone has not been defined or demonstrated by Applicant to “treat all psychiatric disorders.”
The biochemical and molecular markers reflect complex, overlapping changes in inflammation, monoamine systems, and the HPA axis. For instance (Chadda: pg. 328, col. 2 - pg. 329, col. 2):
Major Depressive Disorder (MDD): Elevated levels of pro-inflammatory markers such as Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), and C-reactive protein (CRP) and dysregulation in the HPA axis causes hyperactivity which results in elevated cortisol levels and a changed cortisol awakening response (CAR).
Bipolar Disorder: Associated with altered glutamatergic, dopaminergic, and cellular energy metabolism pathways. Elevated striatal dopamine (DA) transmission mediates manic phases, whereas depressive phases are tied to frontal cortical hypo-dopaminergia (reduced dopamine activity in the brain,). Studies indicate dysregulated calcium signaling and aberrant inflammatory profiles (e.g., higher neutrophil counts).
Substance Use Disorders (SUD): Repeated substance exposure causes prolonged alterations in the mesolimbic dopamine pathway, dampening natural reward systems, alongside a heightened baseline stress response (CRH system) and blunted serotonin transmission.
Suicidal Behavior Disorder: Strongly linked to reduced cerebrospinal fluid (CSF) levels of serotonin's primary metabolite, 5-HIAA. Lower levels of the 5-HIAA in the cerebrospinal fluid altered 5-HT1A receptor binding, and lower tryptophan levels. Elevated peripheral blood markers, particularly Interleukin-1β (IL-1β), are significantly associated with suicide-related behaviors.
Treatment-Resistant Depression (TRD): It is associated with persistent high-sensitivity C-reactive protein (hs-CRP) and distinct cellular metabolism markers, while cortisol levels may unexpectedly drop compared to typical MDD.
Based on the art above establishing the unpredictability and different etiologies, Applicant has not established a structure/function correlation between various member of the genus of psychiatric disorders with this specific combination of drugs that act through specific mechanisms. For example, stated in para. [0021], “The unit dose can be administered to a person for the treatment of a psychiatric disorder. The psychiatric disorder can include, e.g., suicidal behavior, suicidal ideation, and/or major depressive disorder (MDD). This includes persons at risk of committing suicide, persons having recently attempted to commit suicide, and/or persons having a history of suicide attempts.” It is understood this can include a multitude of psychiatric disorders to which would or would not be treated with Applicant’s combination.
Existence of working examples/Specification:
Within the Instant Specification (paras. [0048] - [0049]), gives Tables of antipsychotics and antidepressants that can be paired, based on a patient’s individual treatment. In the working examples though, only two (2) examples, with complicated medical history that does not indicate what the baseline is in regards to the patient, and the criteria set up to allow such distinction despite the interaction with other medications. There is the single specified amount in the manufacturing of the composition, three (3) dosage strengths, 2 dosage forms of administration, and 2 dosing regimens.
The specification claims a pharmaceutical composition made by a specific process that avoids typical prior art limitations; however, the specification does not provide more working examples, analytical testing, or data verifying that this manufacturing process yields the claimed composition reliably or unexpectedly. There is no comparison data to assess the Applicant’s claim of distinct results.
The Instant Specification discloses two (2) case studies geared to patients with overlapping psychiatric diseases, Major Depressive Disorder & Borderline Personality Disorder and Bipolar Disorder. It does not have a representative number of examples for the claim of treating various psychiatric disorders that within the class of psychiatric diseases.
Overall Conclusion:
With some of the already established prior art in the field, the articles above disclose markers of suicidal behaviors which would aid a subject in need of such treatment with a composition comprising the API’s of nefazodone, risperidone and an excipient as listed in the Claims.
Diverse approaches have been used to identify quantifiable biological correlates, consistently associated with suicide vulnerability. The most prominent biochemical approaches which have yielded valuable information are in the fields of neurotransmitter systems, hypothalamic-pituitary-adrenal (HPA) axis, neuroinflammatory indices, neurotrophic factors and lipoproteins (Chadda, pg. 329, col. 2, para. 2 - pg. 330, col. 1, para. 2). None of this is described in detail to determine possession of the invention, nor enough working examples to thoroughly demonstrate the critical aspect indicating an unexpected result from what is already known in the field of art.
The description requirement of the patent statue requires a description of an invention,
not an indication of a result that one might achieve if one made that invention. See In re Wilder,
736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the
specification does “little more than outlin[e] goals appellants hope the claimed invention
achieves and the problems the invention will hopefully ameliorate.”)
Accordingly, it is deemed that the specification fails to provide adequate written description for the method of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
In this case, given the status of the prior art established by the references, the lack of
structure/function correlation relating to the functional limitations, and the lack of a
representative number of examples, the independent Claims 1 and 20 are rejected for lack of written description.
Dependent Claims 2-6, 16-30, do not resolve these issues, since these claims do not further limit or provide further structure towards a resolution.
Accordingly, these claims are also rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Graham vs. Deere, Test for Obviousness
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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over P. Migaly in US 7,973,043 B2 (hereinafter “Pat’043”) as evidenced by PubChem references on Risperidone and Nefazodone hydrochloride, and further evidenced by FDA references on Serzone & Risperidone.
With respect to Claim 1, Pat’043 teaches a method of treating a person suffering from a psychiatric disorder (col. 4, lns. 15-26), the method comprising orally administering to the person a unit dose comprising nefazodone hydrochloride, risperidone, and one or more pharmaceutical excipients, for a period of time effective to treat the psychiatric disorder. Pat’043 further teaches oral embodiments of antidepressants including SARI’s (serotonin-2 antagonist-reuptake inhibitors) as nefazodone (nefazodone-Serzone; col. 8, lns. 5-18) and its salts. This reads on the claims since nefazodone hydrochloride is also known as Serzone (as also seen by PubChem & FDA, Nefazodone hydrochloride). Patent’043 further teaches its combination with atypical antipsychotics which include risperidone (col. 8, lns. 56-63) and added excipients or inactive components (col. 6, lns. 53-59).
Pat’043 continues teaching, with respect to Claim 1, examples in which the subjects suffer from a psychiatric disorder and illustrates the method of acute therapy following a maintenance period, change in dosage strength and period of ongoing maintenance (col. 10, lns. 45-67 to col. 11, lns. 1-54).
Pat’043 fails to teach an embodiment containing both API’s of nefazodone and risperidone.
However, the combination of an antipsychotic with an antidepressant (Pat’043 abstract) is a routine practice to address co-morbid conditions, or treatment-resistant depression, which ranges to patients susceptible to suicidal ideas or thoughts from their psychiatric disorder (Pat’043: col. 21, lns. 50-55). A skilled artisan would have been motivated to co-administer these drugs to achieve a broader spectrum of therapeutic effects as seen through Pat’043.
Nefazodone is known as a potent inhibitor of the hepatic cytochrome P450 3A4 (CYP3A4) enzyme (seen in PubChem & FDA-Serzone). It is also a well-known phenylpiperazine antidepressant used to treat major depressive disorder. Risperidone is also a well-known atypical antipsychotic (seen in PubChem & FDA-1Risperidone) used to treat schizophrenia, and bipolar disorder.
Based on the teachings of the above art, one would be aware, nefazodone is an FDA-approved antidepressant (FDA-Serazone) and risperidone is an FDA-approved atypical antipsychotic (FDA-Risperidone). Because the administration of these drugs is independently known, it is prima facie obvious (KSR-Prong A) to combine risperidone and nefazodone hydrochloride for psychiatric conditions where co-morbidities like anxiety and depression co-exist.
Pat’043 continues teaching Claims 2-21:
Claims 2 & 20: wherein the nefazodone hydrochloride is present in 100-300 mg (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67, details a patient receiving an effective amount of antidepressant at various mg of the claim range).
Claims 3, 20 & 21: wherein the risperidone is present in 0.25-1.0 mg (col. 6, lns. 30-31; for risperidone 0.5-1 mg -which reads within the claim range).
Claims 4 & 21: wherein the nefazodone hydrochloride is present in 125-275 mg (Ex.1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67, details a patient receiving an effective amount of antidepressant at various mg of the claim range) and the risperidone is present in 0.25-0.75 mg (col. 6, lns. 30-31; for risperidone 0.5-1 mg -which reads within the claim range).
Pat’043 states “Determination of the appropriate dosage is well within the ability of one skilled in the art; antidepressants and antipsychotics have been prescribed for years. When used in the combination of the present invention, dosage of the anti-depressant will be similar to the dosage amount needed when prescribed alone, while the amount of antipsychotic drug needed will be somewhat less than the amount used when that class of drug is prescribed alone for a patient experiencing psychotic symptoms. (col. 6, lns. 16-24)”
As such, the dosage is viewed as a result-effective concentration. One can use routine optimization to arrive at different concentrations of nefazodone hydrochloride and risperidone through motivation and suggestion listed in the prior arts. The references suggest varying dosages to optimize patient outcomes, establishing these as result-effective variables. Hence, variables that alter the rate of reactivity, the production of effects and the final result of desired activation/inhibition, treating/ameliorating symptoms desired is result effective. Because the prior art teaches the use and effectiveness of nefazodone hydrochloride and risperidone, optimizing their respective concentrations to determine the most effective ratio is a routine adjustment within the skill of one in the art.
In this case, using the dosing ranges and method of administration as taught by Pat’043 would lead to safe ranges in the treatment in humans. One skilled in the art would expect success because dosage is result-effective. The claimed dosage has not been shown to achieve a different, unexpected outcome rather than just a predictable, proportional change.
The structural and functional characteristics of both nefazodone hydrochloride and risperidone are well-documented in the prior art, and their co-administration or combination does not present unpredictable or unexpected pharmacological results.
Pat’043 continues teaching:
Claim 5: which effectively reduces symptoms associated with the psychiatric disorder (col. 6, lns. 11-14: teaches the amount of drug necessary to provide a therapeutic benefit, reading on relief from symptoms with a psychiatric disorder).
Claim 6: wherein the psychiatric disorder comprises at least one of suicidal behavior, suicidal ideation, and major depressive disorder (MDD) (col. 7, lns. 34-65).
Claims 7, 20 & 26: which effectively reduces the incidence of suicidal ideation and suicidal behavior in a person suffering from a major depressive episode (col. 5, lns. 66-67 to col. 6, lns. 1-2).
Claims 8 & 26: which effectively reduces the incidence of suicidal behavior in a person suffering from a major depressive episode (col. 10, ln. 63 to col. 11, ln. 5).
Claims 9, 20 & 26: which effectively reduces the incidence of suicidal ideation in a person suffering from a major depressive episode (col. 11, lns. 6-34).
Claims 10 & 26: which effectively reduces the severity of depressive symptoms in the person (col. 5, lns. 66-67 to col. 6, lns. 1-2).
Claim 11: wherein the person is afflicted with treatment-refractory depression ((also known as treatment-resistant depression; col. 3, lns. 59-64; col. 13, lns. 20-44).
Claim 12: wherein the unit dose is an oral liquid (col. 6, lns. 54-65; indicates that oral solution for dose delivery).
Claim 13: wherein the unit dose is an oral solution, an oral suspension, an oral powder, or oral granules (col. 6, lns. 54-65).
Claim 14: wherein the unit dose is an oral solid (col. 6, lns. 54-65; sublingual indicates that oral dose delivery).
Claim 15: wherein the unit dose is an oral tablet, an oral capsule, or an oral soluble film (col. 6, lns. 54-65).
Claim 16: wherein the unit dose is orally administered to the person twice a day (BID) (which reads on orally administering twice-a-day (BID) a unit dose since it is based on physician recommendation; col. 6, lns. 16-58).
Claim 17: wherein treatment of the psychiatric disorder comprises acute therapy, such that the unit dose is administered in a hospital emergency department, psychiatric hospital, urgent care center, or other short-term stay facility (col. 6, lns. 5-10).
Claim 18: wherein the treatment of the psychiatric disorder comprises maintenance therapy, such that the unit dose is a maintenance drug, orally administered on a regular, recurring, and long-term basis to the person in outpatient care as an ongoing maintenance of the psychiatric disorder.
Pat’043 teaches that treatment for treatment of the psychiatric disorder commonly involves a structured tapering or an ongoing maintenance regimen to prevent relapse after the acute phase is resolved. It would be obvious to include a maintenance phase as taught by Pat’043, in order to maintain therapeutic effectiveness over a prolonged period. One in the art would have expected the combined acute-and-maintenance dose regimen to produce the successful management of the psychiatric disorder with a predictable success.
In regards to Claims 23-25, Pat’043 teaches dosing found in the Instant Case:
Claim 23: wherein the person was previously prescribed an antipsychotic drug mg (col. 6, lns. 30-31; for risperidone 0.5-1 mg -which reads within the claim range).
Claim 24: wherein the person was previously prescribed an antidepressant drug (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67, details a patient receiving an effective amount of antidepressant at various mg of the claim range).
Claim 25: wherein the person is afflicted with treatment-refractory depression (also known as treatment-resistant depression; col. 3, lns. 59-64; col. 13, lns. 20-44).
In regards to Claims 19 & 27-30, with respect to dosage, acute therapy, maintenance therapy and dosage amounts:
Claims 19, 27-30: wherein treatment of the psychiatric disorder comprises:
(i) acute therapy month (Ex. 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67; acute therapy for Example 2 patient continued for two months, col. 11, lns. 5-55), such that the unit dose is administered in a hospital emergency department, psychiatric hospital, urgent care center, or other short-term stay facility, and (ii) maintenance therapy (Ex. 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67; acute therapy for Example 1 & 2 patient continued for at least 12 months, col. 11, lns. 35-43), such that the unit dose is a maintenance drug, orally administered on a regular, recurring, and long-term basis to the person in outpatient care as an ongoing maintenance of the psychiatric disorder.
Pat’043 teaches that treatment for treatment of the psychiatric disorder commonly involves a structured tapering or an ongoing maintenance regimen to prevent relapse after the acute phase is resolved. It would be obvious to include a maintenance phase as taught by Pat’043, in order to maintain therapeutic effectiveness over a prolonged period. One in the art would have expected the combined acute-and-maintenance dose regimen to produce the successful management of the psychiatric disorder with a predictable success.
Pat’043 also teaches:
Claim 29: …wherein (iii) the acute therapy comprises administering a daily amount nefazodone hydrochloride greater than the daily amount of nefazodone hydrochloride administered during the maintenance therapy; and (iv) the acute therapy comprises administering a daily amount risperidone greater than the daily amount of risperidone administered during the maintenance therapy.
Claim 30: …wherein (iii) the first unit dose comprises an amount of nefazodone hydrochloride greater than the amount of nefazodone hydrochloride present in the second unit dose; and(iv) the first unit dose comprises an amount of risperidone greater than the amount of risperidone present in the second unit dose.
Based on the above and what is already taught within the prior art, it would have been prima facie obvious to arrive at the claimed dosages for the following reasons: Methods for administering Nefazodone Hydrochloride for the treatment of depression are well-established in the art. Within the art, listed above, the claimed dosages of 100-300 mg for nefazodone hydrochloride and 0.5-1 mg for risperidone overlap with prior art-recognized therapeutic ranges. However, it would have been prima facie obvious to one having ordinary skill in the art to arrive at an overlapping range because according to MPEP 2144.05
Overlapping ranges:
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
Based on the prior art in the field and the prior motivation to combine a known antidepressant and known atypical antipsychotic, to optimize treatment efficacy while minimizing adverse effects is routine. Dosage titration is a standard and expected practice in psychopharmacology. Because the pharmacological properties, safety profiles, and mechanisms of action of both active ingredients are well-documented in the prior art, one would have reasonable expectation of success in combining these known agents through KSR-Prong A (the prior art reference is in same field of utility and is analogous art.
There is reasonable expectation of success in combining these agents at standard therapeutic doses to treat overlapping psychiatric conditions. In the Instant case, identifying a newly discovered property (such improving efficacy) is just a characteristic result of a known combination.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over P. Migaly in US 7,973,043 B2 (hereinafter “Pat’043”) as evidenced by PubChem references on Risperidone and Nefazodone hydrochloride, and further evidenced by FDA references on Serzone & Risperidone, in view of H. Rozjabek (J Patient Rep Outcomes. 2022 Jul 10;6(1):74; hereinafter “Rozjabek”).
The teachings of Pat’043 are disclosed above and at least those teachings are incorporated by reference herein. Pat’043 teaches the administering of oral tablet to a person suffering from a psychiatric disorder for Claim 22.
Pat’043 fails to teach the use of the Global Impression of Severity of Suicidality-revised (CGI-SS-r) however it must be noted Pat’043 does teach the patient population suffering from this psychiatric disorder would be under the care of a physician(s) or health care provider(s) indicating that the physician prescribing the treatment is trained to use this test or others similarly used in the field of art.
Rozjabek teaches “The CGI-SS-r in Module 7 summarizes the clinician’s overall impression of severity of suicidality on a 7-point scale (0-normal, 1-questionably, 2-mildly, 3-moderately, 4-markedly, 5-severely, and 6-most extremely suicidal) based on the totality of information available to the clinician, including information from the completed modules of the SIBAT. The category ratings in the CGI-SS-r are directly interpretable as different levels of suicidality and a 1-point change in a CGI scale is consistent with a clinically observable change (pg. 3, col. 2, para. 1).”
It would therefore be obvious to combine Pat’043 and Rozjabek to teach the range for those dealing with treating psychiatric disorders to reduce suicidal ideation. Pat’043 and Rozjabek include relevant data on psychiatric disorders treating persons suffering from various types of depression, including major depressive disorder, who are at risk for suicide (col. 3, lns. 45-51).
As seen in KSR – Prong A, because the pharmacological properties, safety profiles, and mechanisms of action of both active ingredients are well-documented in the prior art, one would have reasonable expectation of success in combining these known agents as the prior art references are in same field of utility and are analogous art.
There is motivation to combine these prior arts because these methods aid in the reduction of suicide ideation in patients suffering from these psychiatric disorders. Since combining prior art elements according to known methods yields predictable results, one skilled in the art could have combined the elements by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Conclusions
Claims 1-30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 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, Clinton A. Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights