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
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant’s submission filed on 07/01/2026 has been entered.
Claim Status
Claims 1-24 are pending examination.
Priority Status
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Applicant claims no foreign priority; the effective filing date is 04/12/2023.
Examiner Responses to Arguments/Amendments
The issues raised in the prior Office Action mailed, are addressed below:
I. Independent Claim 1 –
“A method of reducing suicidal ideation and suicidal behavior in a person,
the method comprising orally administering twice-a-day (BID) a single unit dose comprising nefazodone hydrochloride and risperidone,
wherein the person is suffering from a psychiatric disorder having a Global Impression of Severity of Suicidality-revised (CGI-SS-r) score of >2,
wherein, the method comprises a period of acute therapy, followed by a period of ongoing maintenance,
the strength of the unit doses administered during the acute therapy differs from the strength of the unit doses administered during the maintenance therapy,
the strength of the unit doses administered during the maintenance therapy can vary,
the acute therapy comprises a loading dose, and
the period of ongoing maintenance is long-term and continuous.”
III. Claim Rejections under 35 USC § 103 –
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over P. Migaly in
US 7,973,043 B2 (hereinafter “Pat’043”) in view of H. Rozjabek, et al., (hereinafter “Rozjabek”) as evidenced by PubChem (nefazodone hydrochloride).
Applicant' s arguments, filed 07/01/2026, with respect to claims have been fully considered but they are not persuasive.
With respect to Applicant’s argument that the Examiner has not met the burden for establishing prima facie finding of obvious this argument has been considered but is not found to be persuasive for the following reasons:
As stated in the prior Office Action, it is the Examiner’s opinion that the art discloses the matter of the claims.
Applicant has not satisfied their burden of proof when overcoming a prima facie obviousness rejection. Applicant’s response fails to provide objective evidence of criticality, such as a 37 C.F.R. § 1.132 Declaration. Applicant must show unexpected results, such as a vastly improved safety profile or completely unforeseen therapeutic synergy. Applicant has not submitted side-by-side comparative data showing that the claimed invention possesses unexpectedly improved properties or functional advantages over the closest prior art.
In that matter, the Examiner has made the case for a single dosage unit as indicated in col. 6, lns. 16-58 (see below) of Pat’043. The Examiner has shown the art is good for the claims in reciting “orally administering twice-a-day (BID) a single unit dose.”
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With respect to the claims reciting “a single dosage unit, administered twice-a-day, comprising nefazodone hydrochloride and risperidone,” it is understood by KSR-Prong A – both medications are known in the art, as well as their mechanism of action, for being used by a person suffering from a psychiatric disorder.
Both nefazodone hydrochloride and risperidone share important receptor-binding profiles. Nefazodone is a SARI (serotonin antagonist and reuptake inhibitor), while risperidone is an atypical antipsychotic that acts as a potent 5-HT2A and dopamine receptor antagonist. Nefazodone (Patent’043; col. 8, lns. 7-22) and risperidone (Patent’043; col. 8, lns. 56-63) combination is known in the prior art, as the elements are combined using techniques that are standard or known. Combining 5-HT2A antagonists is a recognized and established strategy in psychiatry. It is often used to supplement antidepressant therapy, treat treatment-resistant depression, or mitigate specific side effects induced by the antipsychotic.
The nefazodone-risperidone combination product (as indicated by the prior art) does not produce a new or unexpected function in treating a patient in need. Its combination restates the key benefits of the combination already known. Nefazodone's moderate affinity for α1 receptors complements risperidone's, which is also an α1 antagonist. Nefazodone lacks affinity for muscarinic and dopaminergic receptors, and so it does not add to the anticholinergic load (e.g., dry mouth, constipation) or worsen the D2 antagonism produced by risperidone.
Nefazodone is used for treatment-resistant depression (col. 8, lns. 7-22), and adding an antipsychotic like risperidone can boost the overall antidepressant effect. Risperidone (col. 8, lns. 56-60) is effective for schizophrenia, bipolar mania, and, when combined with antidepressants, can help manage irritability, aggression, or psychotic symptoms.
Nefazodone and risperidone treat distinct psychiatric conditions by uniquely binding to overlapping, but different, neurotransmitter receptors. This combination manages suicidal thoughts by targeting distinct psychiatric symptoms such as: Nefazodone as a SARI, alleviates deep depressive, anxious, and insomnia symptoms by blocking 5-HT2A receptors and inhibiting serotonin reuptake. Risperidone, an atypical antipsychotic, targets severe agitation, impulsive aggression, and psychosis via dual D₂ and 5-HT2A antagonism.
Applicant’s arguments regarding the alleged criticality of the Global Impression of Severity of Suicidality-revised (CGI-SS-r) score are unpersuasive. It is well established that differences in parameters will not support patentability unless there is evidence indicating such concentration, temperature, or proportion is critical. Here, Applicant has provided no objective evidence, comparative test data, or expert declarations demonstrating that the claimed feature yields unexpected results or functions in a fundamentally different manner than the prior art. Merely alleging criticality in the remarks without empirical support is insufficient to rebut the prima facie case of obviousness.
Therefore, Applicant’s argument is not persuasive.
With respect to Applicant’s argument stating: “References, alone or in combination, do not teach every limitation of the invention, as presently claimed. The cited references fail to satisfy the "all claim limitations taught or suggested" prong because multiple elements of amended claim 1 are neither disclosed nor suggested when Rozjabek (2022) and Migaly (US 7,973,043) are read alone or in combination.”
Examiner disagrees. In response to the argument over the combination of references and Global Impression of Severity of Suicidality-revised (CGI-SS-r) score. It is understood by KSR-Prong A – both medications are known in the art, as well as their mechanism of action, and how their unique receptor affinities manage specific psychiatric symptoms by a person suffering from a psychiatric disorder. Nefazodone is a SARI (serotonin antagonist and reuptake inhibitor), while risperidone is an atypical antipsychotic that acts as a potent 5-HT2A and dopamine receptor antagonist. Nefazodone (Patent’043; col. 8, lns. 7-22) and risperidone’s (Patent’043; col. 8, lns. 56-63) combination is known in the prior art, as the elements are combined using techniques that are standard or known.
Also, it would be prima facie obvious to combine risperidone (an established antipsychotic) with nefazodone (an established antidepressant) to treat complex psychiatric comorbidities (e.g., treatment-resistant depression or schizophrenia with anxiety).
The prior art establishes overlapping therapeutic windows and dosing for both compounds independently. Merely optimizing the dosage, adjusting the formulation to a standard delivery method, or co-administering the two known APIs does not yield unexpected results. The claimed invention represents the predictable result of combining known pharmacological agents.
Therefore, Applicant’s argument is not persuasive.
With respect to Applicant’s argument stating: “the Office has not provided an articulated reason with rational underpinning that would have led a person of ordinary skill in the art to select nefazodone hydrochloride and risperidone, co- formulate them in a BID single unit dose, administer the product to a person having a CGI-SS-r score of >2, and use the particular acute/loading and long-term continuous maintenance regimen recited in the claims.”
Examiner disagrees. In response to Applicants argument over the drug combination & the Global Impression of Severity of Suicidality-revised (CGI-SS-r), first please refer to the responses above.
In addition, for one to co-formulate nefazodone hydrochloride and risperidone into a BID single-unit dose for a patient with a Clinical Global Impressions-Severity of Illness (CGI-S) or similar score of (>2), one in the art would rely on pharmacological complementarity, pharmacokinetic matching, and recognized clinical treatment guidelines for complex psychiatric presentations. One who would use this combination would know these drugs treat treatment-resistant depression or suicidal ideation/thoughts with comorbid depressive or anxious symptoms by leveraging complementary mechanisms. Hence, a CGI-S score of 2, or higher indicates symptoms that require more than monotherapy. Supplementing a chief antipsychotic (like risperidone) with a broad-spectrum antidepressant (like nefazodone) is an established clinical strategy to resolve treatment-refractory mood and psychotic symptoms.
Finally, as one in the art understands these specific drugs are highly compatible for a fixed-ratio, co-formulated BID (twice-daily) single unit dose. First, nefazodone has a short half-life (roughly 2 to 4 hours) and is administered BID. Risperidone requires BID dosing due to rapid clearance, particularly in active or fast-metabolizing patients. Combining two drugs that both require twice-daily administration solves pill burden while matching the pharmacokinetic profile at the site. It delivers the medication predictably every 12 hours CGI-S score greater than 2 translates to "Mildly Ill" or worse. This indicates that the patients in this range have complex, overlapping symptom clusters (for example, treatment-resistant negative symptoms) and that mono-therapy would not be as effective. In administering this co-formulated BID dose several issues are addressed at once. There is the psychotic/hyper-dopaminergic dimensions (via risperidone) managed and the mood/serotonergic dimensions (via nefazodone) simultaneously managed.
Therefore, Applicant’s argument is not persuasive.
With respect to Applicant’s argument stating “The Office Action further acknowledges that "there is not a CGI-SS-r score associated with the nefazodone- risperidone combination." These admissions are material because the claims are not merely directed to treating depression with an antidepressant/antipsychotic or dopamine system
Examiner disagrees. In response to the nefazodone-risperidone combination, when considering the co-formulation of nefazodone hydrochloride (an antidepressant) and risperidone (an antipsychotic) into a single-unit twice-daily (BID) dose, the motivation centers on pharmacokinetic alignment and pharmacodynamic complementarity.
As stated above, both nefazodone hydrochloride and risperidone share important receptor-binding profiles. Nefazodone is a SARI (serotonin antagonist and reuptake inhibitor), while risperidone is an atypical antipsychotic that acts as a potent 5-HT2A and dopamine receptor antagonist. Nefazodone (Patent’043; col. 8, lns. 7-22) and risperidone (Patent’043; col. 8, lns. 56-63) combination is known in the prior art, as the elements are combined using techniques that are standard or known. Combining 5-HT2A antagonists is a recognized and established strategy in psychiatry. It is often used to supplement antidepressant therapy, treat treatment-resistant depression, or mitigate specific side effects induced by the antipsychotic.
Its combination restates the key benefits of data known. Nefazodone's reasonable affinity for α1 receptors complements risperidone's, which is also an α1 antagonist. Nefazodone lacks affinity for muscarinic and dopaminergic receptors, and so it does not add to the anticholinergic load or worsen the D2 antagonism produced by risperidone. Also, because both drugs share similar plasma half-lives and require twice-daily dosing to maintain therapeutic efficacy and avoid peak-dose side effects, co-formulating them into a single unit dose administered every 12 hours ensures steady-state concentrations align.
In conclusion, the Examiner has stated rationale used for establishing the 35 U.S.C. 103 rejection. In addition, the 35 USC § 103 rejection prior art recites the acute loading phase (col. 11, lns. 55-67) transitioning to long-term continuous maintenance (col. 15, lns. 20-56), both which reads upon the Applicant’s Claims.
Hence, Applicant’s argument is not persuasive.
The 35 USC § 103 rejection is maintained.
IV. Maintained Rejections –
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.
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) 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over P. Migaly in US 7,973,043 B2 (for Claims 1-16; 20-24; hereinafter “’043”) in view of H. Rozjabek, et. al in “Assessing the meaningful change threshold of Quality of Life in Depression Scale…” (for Claims 17-19 & 21; hereinafter “Rozjabek”) as evidenced by PubChem (Nefazodone hydrochloride).
With respect to Claim 1-5, Patent ’043 teaches “the method comprises administering an effective amount of an antipsychotic medication or dopamine system stabilizer in combination with a newer antidepressant, to patients who have not been diagnosed as treatment-resistant, or bipolar disorder, and who do not have psychotic symptoms. Preferably the antipsychotic medication is an atypical antipsychotic. In one embodiment, the antidepressant is a selective serotonin reuptake inhibitor. Furthermore, this combination may specifically target the prevention of suicide” (col. 4, lns. 20-26). Patent ’043 further teaches embodiments of specific antidepressants including selective serotonin reuptake inhibitors such as nefazodone (nefazodone-Serzone; col. 8, lns. 5-18) This reads on the claims since nefazodone hydrochloride is also known as Serzone (as evidenced by PubChem, Nefazodone hydrochloride). Patent ’043 further teaches atypical antipsychotics which include risperidone (col. 8, lns. 56-63).
Patent ’043 continues teaching with respect to Claim 1 , “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 (which reads on orally administering twice-a-day (BID) a unit dose since it is based on physician recommendation; col. 6, lns. 16-58).
Patent ’043 continues teaching with respect to Claim 1, two examples in which the subjects are suffering from a psychiatric disorder and illustrates the invention as a method of acute therapy following by maintenance period, change in dosage strength and period of ongoing maintenance (col. 10, lns. 45-67 to col. 11, lns. 1-54).
Patent ’043 fails to teach the use of the Global Impression of Severity of Suicidality-revised (CGI-SS-r) however it must be noted that Patent ’043 does teach that the patient population suffering from this 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 (in Claims 1-5) teaches “The CGI-SS-r is included in Module 7 of the Suicide Ideation and Behavior Assessment Tool (SIBAT)… 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 Patent ’043 and Rozjabek as both teach the scope of the claims in dealing with treating psychiatric disorders to reduce suicidal ideation. Patent ’043 and Rozjabek include relevant data on psychiatric disorders (as cited above) 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 there is motivation to combine these prior arts because use of these methods helps to aid in the reduction of suicide ideation in patients suffering from this psychiatric disorder. 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.
This additionally indicates that though there is not a CGI-SS-r score associated with the nefazodone-risperidone combination, there are still key motivations:
To treat patients who were not just experiencing suicidal thoughts, but were actively and significantly suicidal (mildly suicidal to extremely suicidal). The >2 cut-off is designed to select patients with adequate "therapeutic windows" to show a response.
This threshold is also strategy to enhance sensitivity of studies to detect accurate treatment effects by enrollment of a population with at least, "mild" level of active risk.
A lower threshold may also have too many patients with "Normal, not at all suicidal" (score of 1) ratings, which results in a plateau effect where further improvement isn’t possible. This yields a reduced ability to show differences between treatments and placebos.
In the intended population, with suicidality studies, methods are often targeting patients with major depressive disorder who have acute suicidal ideation. A CGI-SS-r captures patients who are experiencing at least questionable or minimal suicidal thoughts, allowing for the analysis of rapid reduction in suicide risk within hours or days.
With the above included, an obvious motivation is that there is a guarantee there is focus on a symptomatic population rather than a healthy one,. This allows for an honest assessment of the medication's capacity to reduce suicidal severity.
With respect to claims 6-16, Patent ’043 teaches:
Claim 6: wherein the person is suffering from a psychiatric disorder for at least 6 weeks (col. 3, lns. 59-64).
Claim 7: which effectively reduces the incidence of suicidal ideation and suicidal behavior in a person suffering from a major depressive episode (col. 7, lns. 34-54).
Claim 8: which effectively reduces the severity of depressive symptoms in the person (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-54).
Claim 9: wherein the person is afflicted with treatment-refractory depression (also known as treatment-resistant depression; col. 3, lns. 59-64; which reads).
Claim 10: wherein the person was previously prescribed an antipsychotic drug (risperidone; col. 8, lns. 56-63).
Claim 11: wherein the person was previously prescribed an antidepressant drug (SSRI – nefazodone - Serzone; col. 8, lns. 5-18).
Claim 12: wherein the person is afflicted with treatment-refractory depression (also known as treatment-resistant depression; col. 3, lns. 59-64).
Claim 13: wherein treatment 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 14: wherein the treatment 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 in reducing suicidal ideation and suicidal behavior (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67).
Claim 15: wherein the unit dose is an oral tablet, an oral capsule, an oral soluble film, an oral solution, an oral suspension, an oral powder, or oral granules (col. 6, lns. 45-65).
Claim 16: wherein the unit dose is an oral solid (col. 6, lns. 45-65).
Patent ’043 teaches several embodiments of antidepressant/antipsychotic combinations, it also continues teaching Claims 20 -24 in the following:
Claim 20: wherein the unit dose comprises 50-300 mg nefazodone hydrochloride (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67, which details a patient receiving an SSRI of 50 mg that reads on the claim range) and 0.20-1.0 mg risperidone (col. 6, lns. 30-31; for risperidone 0.5-1 mg -which reads within the claim range).
Claim 21: wherein the unit dose is a scored tablet comprising 50-300 mg nefazodone hydrochloride (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67, which details a patient receiving an SSRI of 50 mg that reads on the claim range) and 0.20-1.0 mg risperidone (col. 6, lns. 30-31; for risperidone 0.5-1 mg -which reads within the claim range).
Claim 22: wherein the period of acute therapy is up to 2 weeks (Examples 1 & 2; col. 10, lns. 45-67 to col. 11, lns. 1-67; acute therapy for Example 2 patient started under care of physician for 2 weeks, col. 11, lns. 5-55).
Claim 23: wherein the period of acute therapy is up to 1 month (Examples 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).
Claim 24: wherein the long-term and continuous period of ongoing maintenance is at least 6 months (Examples 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).
Though Patent ’043 fails to teach all of the limitation of Claim 21, wherein the unit dose is a scored tablet - the patent does teach that suitable dosage forms can range from “two tablets each containing one drug to be administered in a single dose form, it further teaches the medication components can various methods to form a delivery system whether within the same delivery system or concomitate use…. (single) capsule, tablet (including "sprinkle", fast dissolving, "melt away"(col. 6, lns. 45-65).” Under BRI this indicates that the tablet can be in any manner desired by the physician to maximize taking necessary medication for the patient, including scoring the tablets.
For Claims 17-19: wherein, wherein during the period of treatment, or at the conclusion thereof, the person experiences an improvement of ( >2 units) – (>4 units) in the Global Impression of Severity of Suicidality-revised (CGI-SS-r) evaluation score, Rozjabek teaches the following:
Rozjabek teaches “The CGI-SS-r is included in Module 7 of the Suicide Ideation and Behavior Assessment Tool (SIBAT)… 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).” A physician maintaining care over their patient would check this scale to consistently see improvement to the medication treatment being given as well as to whether there is need to adjust or optimize the treatment for the patient based on their assessment of the antidepressant/antipsychotic therapeutic use in their lives.
It would therefore be obvious to combine Patent ’043 and Rozjabek as both teach the scope of the claims in dealing with treating psychiatric disorders to reduce suicidal ideation. Patent ’043 and Rozjabek include relevant data on psychiatric disorders (as cited above) 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 there is motivation to combine these prior arts because use of these methods helps to aid in the reduction of suicide ideation in patients suffering from this psychiatric disorder. 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.
Conclusion
Claim(s) 1-24 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.
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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