DETAILED ACTION
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
Claims 1-21 are pending in the instant application. Claims 3-4, 7, 10-13, 15-17 and 21 are amended and claims 22-59 are cancelled via the amendment filed December 4th, 2023.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 12/04/2023, 05/21/2024 and 09/20/2024 were considered by the Examiner.
Claim Rejections - 35 USC § 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.
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 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or 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). In the present instance, claim 10 recites the broad recitations “Cogstate battery”, “CANTAB”, and “Penn Computerized Neurocognitive Battery” and the claim also recites “(which can include the following subtests: Behavioral Pattern Separation Object Test, Continuous Paired Associate Learning Test, Face Name Associative Memory Exam, Groton Maze Learning Test and its Delayed Recall and Delayed Reverse Recall versions, International Shopping List, One Card Learning Test)”, “(which can include the following subtests: Delayed Matching to Sample, Pattern Recognition Memory, Verbal Paired Associates, Paired Associates Learning, Verbal Recognition Memory)” and “(which can include the following subtests: Penn Word Memory Task, Penn Face Memory Task, Visual Object Learning Test)”
which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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) 1-9 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johe et al (US 2015/0359792 A1, published December 17th, 2015) in view of Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014) and Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Johe teaches a method to treat major depressive disorder (MDD) in a human subject, which method comprises administering to said subject an amount of a compound formula (1):
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wherein the amount is of 10mg to 130mg per day (claim 1).
This compound above is (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone of instant claim 1. Johe also teaches that the compound is administered in an oral dosage form (claim 10).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Johe does not explicitly that the MDD subject is a subject having objectively determined impaired leaning and/or memory. Johe also does not explicitly teach that the patient displays a low aperiodic exponent in an EEG.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Johe does teach that the method of treating MDD also includes evaluating the subject with the Cognitive and Physical Functioning Questionnaire (CPFQ) (claim 6). Johe also teaches that depressed patients, after being administered the compound of formula (1), showered clinically meaningful reductions in depressive and cognitive systems across all measures against placebo (paragraph [0022]).
Further, Lam teaches that cognitive dysfunction refers to deficits in attention, verbal and nonverbal learning, short-term and working memory, visual and auditory processing, problem solving, processing speed, and motor functioning. Cognitive dysfunction may be a primary mediator of functional impairment in MDD. Cognitive complaints are core symptoms of acute MDEs, and diminished ability to think or concentrate and (or) indecisiveness are criterion items for the diagnosis of MDD (page 649, paragraph 2). Lahm further teaches that 94% of patients with MDD report cognitive complaints during acute depressive episodes (page 649, paragraph 3).
Regarding claims 1, as Johe teaches a method of treating major depressive disorder (MDD) in a human subject with administering (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone in an amount of 10mg to 130mg one of ordinary skill in the art would have been motivated to alter the method to include patients who have objectively determined impaired learning and/or memory as Johe also teaches that the subjects are given a cognitive function questionnaire and Lam teaches that deficits in verbal learning and memory are symptoms of MDD and 94% of MDD patients have these deficits.
Regarding claims 2, as seen above, Lam teaches that verbal learning deficits are present in patients with MDD.
Regarding claim 3-6, Johe teaches that the patients with MDD are evaluated with an EEG (claim 7). Further, Arnett teaches that flatter aperiodic slope has been associated with poorer performance on tasks of working memory and processing speed, suggesting reduced cognitive efficiency (page 1547, left column, paragraph 2). As such, one of ordinary skill would recognize that as MDD patients have cognitive deficiency’s that evaluating the patients with MDD with an EEG, a low aperiodic exponent would also be present.
Regarding claims 7-8, Johe teaches that the compound is administered in an amount of 40-90mg/day (claim 3).
Regarding claim 9, as seen above, Lam teaches that verbal learning deficits are present in patients with MDD.
Regarding claim 11, Johe teaches a study wherein the compound above was administered to patients not concurrently treated with a second antidepressant medication (paragraph [0024]).
Regarding claim 19, as Johe teaches a method of treating MDD with (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone and Lam teaches that those with MDD also face cognitive deficits such as impaired learning and memory, one of ordinary skill in the art would have been motivated alter the method of Johe to include assessing for cognitive impairment as Lam teaches that the two are strongly associated with each other.
Regarding claim 20, as seen abpve, Lam teaches that verbal learning deficits are present in patients with MDD.
Regarding claim 21, as MDD and impaired learning and memory are associated with each other, as seen above, one of ordinary skill in the art would recognize that the method of treating MDD as taught by Johe may not apply to those without impaired memory and learning.
Claim(s) 1-11 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johe et al (US 2015/0359792 A1, published December 17th, 2015) in view of Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014) and Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), as applied to claims 1-9, 11 and 19-20 above, and in further view of Gonzalez et al (Int J Geriatr Psychiatry 2003; 18: 1021–1028).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Johe teaches a method for treating major depression disorder, as seen in the 103 rejection above. However, Neither Johe nor Lam describe the type of testing used to determine that the subject suffers from impaired learning or memory.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Johe, Lam and Arnett do not explicitly teach the specific test used to display impaired learning and/or memory in the subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Gonzalez teaches that the Rey’s Auditory Verbal Learning Test-RAVLT was established in a group of patients with subjective memory complaints (page 1021, right column, paragraph 1). Gonzalez further teaches that RAVLT correlates with other measures of learning and memory such as the California Verbal Learning Test (Crossen and Wiens, 1994; Spreen and Strauss, 1998) and is sensitive to verbal memory deficits in a variety of patient groups (page 1022, left column, paragraph 2).
Regarding claim 10, as the method of claim 1 has been rendered obvious in the rejection above, one of ordinary skill in the art would have been motivated to assess the impaired learning and/or memory with the RAVLT as Gonzalez teaches that the test is widely used and holds advantageous.
Claim(s) 1-9, 11 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johe et al (US 2015/0359792 A1, published December 17th, 2015) in view of Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014) and Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), as applied to claims 1-9, 11 and 19-20 and in further view of Tran et al (Canadian Agency for Drugs and Technologies in Health; 2020 Jan 30).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Johe teaches a method for treating major depression disorder, as seen in the 103 rejection above. However, Johe does not clarify if the subject to be treated is concurrently treated with a second antidepressant medication.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Johe, Lam and Arnett do not explicitly teach that the subject to be treated with (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone is concurrently treated with a second antidepressant medication.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Tran teaches that quetiapine, aripiprazole and brexpiprazole are approved for add-on treatment for therapy in patients with major depressive disorder (context and policy issues).
Regarding claims 12 and 16, as Johe teaches a method of treating MDD with 4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone and Tran teaches that that quetiapine, aripiprazole and brexpiprazole are approved for add-on treatment for therapy in patients with major depressive disorder, one of ordinary skill in the art could recognize that a patient with MDD would benefit from the treatment of 4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridine-3-yl]methanone and the additional add-on drugs.
Regarding claims 13 and 15, Tran teaches that MDD patients show inconsistency’s when treated with quetiapine monotherapy, and adult patients present with treatment-resistant depression when treated with quetiapine (depressive symptoms).
Regarding claim 14, as seen above, Tran teaches that quetiapine, aripiprazole and brexpiprazole are approved for treatment for therapy in patients with major depressive disorder.
Regarding claims 17-18, as seen above, Tran teaches that the drugs are quetiapine, aripiprazole and brexpiprazole.
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 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62-88 of copending Application No. 19/052,783 (reference application) in view of Johe et al (US 2015/0359792 A1, published December 17th, 2015), Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014), Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), Gonzalez et al (Int J Geriatr Psychiatry 2003; 18: 1021–1028) and Tran et al (Canadian Agency for Drugs and Technologies in Health; 2020 Jan 30).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims a method of treating a major depressive episode in a human patient with bipolar disorder with depression who has been and is currently undergoing treatment with an antipsychotic medication, a mood stabilizer, or any combination thereof, the method comprising:
(a) objectively assessing whether the patient has impaired learning and/or memory; and
(b) upon an assessment from step (a) that the patient has impaired learning and/or memory, (i) initiating oral administration to the patient of from about 40 to about 240 mg of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylanin)pyridin-3-yl]methann or a pharmaceutically acceptable salt thereof daily, and (ii) continuing administration of the antipsychotic medication, mood stabilizer, or combination thereof (claim 62).
The copending application further claims that the patient has impaired learning and/or memory as objectively determined by poor immediate recall in a verbal memory test (claim 68).
As the copending claims are directed to a method of treating major depressive disorder or a symptom thereof in a subject with impaired learning or memory, the copending claims are obvious variants of the instant claims for the same reasons as listed in the 103 rejections above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-72 of copending Application No. 18/892,030 (reference application) in view of Johe et al (US 2015/0359792 A1, published December 17th, 2015), Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014), Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), Gonzalez et al (Int J Geriatr Psychiatry 2003; 18: 1021–1028) and Tran et al (Canadian Agency for Drugs and Technologies in Health; 2020 Jan 30).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims a method for treating major depressive disorder in a human patient having impaired verbal memory comprising oral administering to the patient about 80 mg of (4- benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanon or a pharmaceutically
acceptable salt thereof daily (claim 60).
As the copending claims are directed to a method of treating major depressive disorder or a symptom thereof in a subject with impaired learning or memory, the copending claims are obvious variants of the instant claims for the same reasons as listed in the 103 rejections above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,208,096 B2c in view of Johe et al (US 2015/0359792 A1, published December 17th, 2015), Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014), Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), Gonzalez et al (Int J Geriatr Psychiatry 2003; 18: 1021–1028) and Tran et al (Canadian Agency for Drugs and Technologies in Health; 2020 Jan 30).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims A method of treating major depressive disorder in a human patient comprising the steps of: (a) prescribing to the patient from about 40 to about 240 mg of (4-benzylpiperazin-1- yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof daily, the prescribing being performed in response to (i) marketing of the (4-benzylpiperazin-1- yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof as providing effective treatment of major depressive disorder in patients having objectively
determined impaired learning and/or memory and (ii) an objective determination that the patient has impaired learning and/or memory; and (b) orally administering the prescribed (4-benzylpiperazin-1-yl)-[2-(3- methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof to the patient.
As the patent claims are directed to a method of treating major depressive disorder or a symptom thereof in a subject with impaired learning or memory, the patent claims are obvious variants of the instant claims for the same reasons as listed in the 103 rejections above.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,233,059 B2 in view of Johe et al (US 2015/0359792 A1, published December 17th, 2015), Lam et al (The Canadian Journal of Psychiatry, Vol 59, No 12, December 2014), Arnett et al (J Neurophysiology 128: 1546-1554, published 11/16/2022), Gonzalez et al (Int J Geriatr Psychiatry 2003; 18: 1021–1028) and Tran et al (Canadian Agency for Drugs and Technologies in Health; 2020 Jan 30).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method of treating a major depressive episode in a human patient with
bipolar disorder with depression who has been and is currently undergoing treatment with a mood stabilizer, the method comprising: (a) objectively assessing whether the patient has impaired learning and/or memory; and (b) upon an assessment from step (a) that the patient has impaired learning and/or memory, (i) initiating oral administration to the patient of from about 40 to about 240 mg of (4-
benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yljmethanone or a pharmaceutically acceptable salt thereof daily, and (ii) continuing administration of the mood stabilizer (claim 16).
As the patent claims are directed to a method of treating major depressive disorder or a symptom thereof in a subject with impaired learning or memory, the patent claims are obvious variants of the instant claims for the same reasons as listed in the 103 rejections above.
Conclusion
No claim is allowed.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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