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
Status of Claims
Claims 60-86 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 69-86 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, the claims do not recite something significantly different than a judicial exception.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
The examiner has determined that the claimed processes have not transformed unpatentable abstract ideas into patent eligible applications of those abstract ideas. As such, it is concluded that the processes instantly claimed are not patent eligible based upon the analysis set forth below. Also see M.P.E.P. § 2106.
STEP 1: Are the claims to a process, machine, manufacture, or composition of matter? YES.
The claims are drawn to a process having contingent limitations. Thus, the claimed process are directed to two embodiments: 1) a process comprising a step of assessment (mental process) only if the patient is not cognitively impaired, does not have poor or slow cognition, difficulty making decisions, or reduced information processing speed, and 2) a process comprising a step of assessment and a step of treatment with (4-benzylpiperazin-1-yl)-[2- (3-methylbutylamino)pyridin-3-yl]methanone if the patient is cognitively impaired, have poor or slow cognition, difficulty making decisions, or reduced information processing speed. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition precedent is not met. See MPEP 2111.04 II.
STEP 2A: Are the claims directed to a law of nature, natural phenomenon, or an abstract idea? YES.
The first embodiment as stated above only comprises a step of assessing (i.e., determining whether or not the patient is cognitively impaired, have poor or slow cognition, difficulty making decisions, or reduced information processing speed). It is a mental process that a neurologist should follow when testing a patient for cognitive function. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. See MPEP 2106.04 IIC and III.
If the patient is determined to be not cognitively impaired, have no poor or slow cognition, no difficulty making decisions, or no reduced information processing speed upon the assessment step, no active step of administration is taken. In that case, the claims simply recite mental process which is done by a neurologist. Thus, the claims are directed to an abstract idea without additional elements that integrate the judicial exception into a practical application.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
For the first embodiment, there is no additional element or active step other than the mental process. In other words, the instant claims do not recite additional elements that amount to significantly more than the judicial exception.
The “assessing" step simply tells a neurologist to determine known criteria for cognitive functions, through whatever process the doctor or laboratory wishes to use. These measurements are well-known in the art. As such, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by the doctors who work in the field.
For the reasons stated above, it is determined that the instant claims as a whole are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 65-66 and 83-84 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 65-66 recite “the human patient suffers from cognitive impairment, poor or slow cognition or difficulty making decisions”. Thus, it appears that the human patient can suffer from “slow cognition” or “difficulty making decisions” only without cognitive impairment or poor cognition since they are alternatively recited. However, claim 60 from they are dependent recites that the patient has objectively determined-cognitive impairment or poor cognition. As such, claims 65-66 fail to further limit the subject matter of claim 60.
Claims 83-84 recite “the human patient suffers from cognitive impairment, poor or slow cognition or difficulty making decisions”. Thus, it appears that the human patient can suffer from “difficulty making decisions” or “poor or slow cognition” only without cognitive impairment they are alternatively recited. However, claim 78 from they are dependednt recites that the patient has objectively determined-cognitive impairment. As such, claims 83-84 fail to further limit the subject matter of claim 78.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 60-86 are rejected under 35 U.S.C. 103 as being unpatentable over Mclntyre et al. (EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2017, VOL. 26, NO. 6, 767–770; cited in the IDS filed on 1/29/2025) in view of WO2019/222629 (hereafter, Johe; cited in the IDS filed on 1/29/2025) in further view of Ionescu et al. (Translational Psychiatry volume 7, page e068, 2017; cited in the IDS filed on 1/29/2025).
Mclntyre et al. disclose NSI-189 phosphate is a multi-domain neurogenic compound with pro-cognitive and antidepressant effects (title and abstract). NSI-189 is (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone and the route of administration for NSI-189 is via oral, available in compressed tablets (p768, Box 1 and 3.1. pharmacokinetics). Mclntyre et al. further disclose NSI-189 stimulates neurogenesis of human hippocampus-derived neural stem cells in vitro and stimulates neurogenesis in murine hippocampus in vivo (abstract). Mclntyre et al. teach that NSI-189 is capable of mitigating depressive symptoms and improveing cognitive function in adults with DSM-5-defined Major Depressive Disorder (MDD) (abstract).
Also, Mclntyre et al. disclose a phase 1B, randomized, double-blinded, placebo-controlled, multiple-dose escalation study of NSI-189 phosphate, wherein adult patients aged 16-60 with DSM-4-TR-defiend with MDD were treated with NSI-189 in a dose of 40 mg QD, 40 mg BID (40 mg twice a day), or 50 mg TID (p769, 3.4. Clinical). The results of the clinical study showed that treatment with NSI-189 was associated with significant improvements in depressive symptomatology and improvements in depressive symptoms were maintained through the follow-up period (day 54). Mclntyre et al. further disclose that using the Massachusetts General Hospital Cognition and Physical Functioning Questionnaire, a self- rated measure of cognitive and physical functioning, there was significant improvement in NSI-189-treated subjects compared to placebo-treated subjects (p769, 3.4. Clinical, col 2, para 2).
Mclntyre et al. are silent that the patient has objectively determined-cognitive impairment or poor cognition. Also, Mclntyre et al. do not specifically teach the combination with an antidepressant. As to claims 62, 71, and 80, Mclntyre et al. do not specifically teach that the patient has been treated with the antidepressant but failed to response to it alone.
Johe teaches the use of NSI-189 (
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) for ameliorating cognitive and/or motor deficiencies associated with Alzheimer’s disease (abstract and claims 1 and 4). Thus, the patient having cognitive and/or motor deficiencies associated with Alzheimer’s disease is those having objectively-determined cognitive impairment or poor cognition as claimed. Johe also teaches that the compounds may also be administered in combination with other active agents either in the same composition or sequentially ([0027]). Johe further discloses that cognitive and motor deficiencies (impairment) can be measured by a number of procedure well known in the art. Johe further discloses that in human subjects, a particularly useful diagnostic is measurement by CogScreen, a computer-administered cognitive test for evaluation of the neurocognitive functioning of pilots and which has also played a key role in the FDA drug approval and labeling process and this includes analysis of Shifting Attention Test-Arrow Color Accuracy a measure of executive functioning; Shifting Attention Test-Arrow Direction Reaction Time Correct, a measure of attention; Symbol Digit Coding-Delayed Recall Accuracy, a measure of memory and Shifting Attention Test-Instruction Number Incorrect, which is a measure of working memory ([0017]). In addition, Johe discloses that among these used in laboratory models are Barnes maze performance which tests learning and memory, an object recognition test which tests memory, a learning Rota-Rod test that measures motor skills and additional tests that are known in the art ([0019]). Using these tests for measuring the improvement in cognitive functions implicitly discloses that the patient having cognitive and/or motor deficiencies associated with Alzheimer’s disease suffers from reduced information processing speed, reduced attention, memory, learning, or working memory as claimed.
Ionescu et al. teaches that while there are several classes of approved antidepressant treatments for depression such as selective serotonin reuptake inhibitors, tricyclic antidepressants and monoamine oxidase inhibitors, about a third of patients do not respond to these medications, thus it is imperative for drug discovery to continue towards the development of novel and rapidly acting compounds, especially for patients with treatment-resistant depression (abstract). Ionescu et al. further teach that antidepressant monotherapy alone may not always be enough to treat depression and thus augmentation strategies with other classes of medications can be a useful option (p1, col 2, para 3). For example, olanzapine/fluoxetine combination therapy is approved for patients with treatment-resistant depression (p1, col 2, para 3). Also, Ionescu et al. teaches that evidence exists to suggest that decreased hippocampal volume may be involved in the pathophysiology of depression and reversal of this deficit may be an important target for the development of novel antidepressants (p6, col 1 para 2). In addition, Ionescu et al. disclose that NSI-189 with neurogenic properties has potential as a novel antidepressant and further disclose administering NSI-189 in a dose of 40 mg b.i.d. for treating MDD (p6, col 1 para 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use NSI-189 for treating MDD in a patient having objectively determined cognitive impairment or poor cognition because NSI-189 is taught to a neurogenic compound with both pro-cognitive and antidepressant effects as evidenced by Mclntyre et al. Also, Johe already discloses NSI-189 is effective for ameliorating cognitive impairment in a patient having objectively determined cognitive impairment or poor cognition such as those with Alzheimer’s disease. In addition, Ionescu et al. teach that the neurogenic effects of NSI-189 are beneficial for treating depression because decreased hippocampal volume may be involved in the pathophysiology of depression. Thus, one of ordinary skill in the art would have been motivated to do so on the reasonable expectation that NSI-189 would be effective for improving depressive symptoms and cognitive function in those having both MDD and cognitive impairment.
As to the combination with an antidepressant and claims 62-64, 71-73, and 80-82, it was well known in the art that a third of patients do not respond to conventional antidepressant such as selective serotonin reuptake inhibitors, tricyclic antidepressants and monoamine oxidase inhibitors and the combination of antidepressant such as fluoxetine with other classes of medications could be a useful option for treating depression as evidenced by Ionescu et al. Also, Johe teaches that NSI-189 may be administered in combination with other active agents either in the same composition or sequentially. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use NSI-189 in combination with a known antidepressant taught by Ionescu et al. in the treatment of depressive symptoms, especially for those who do not response to monotherapy of such antidepressant. The skilled artisan would have been motivated to do so on the reasonable expectation that NSI-189 and the antidepressant would provide combined effects through different action mechanisms as evidenced by Ionescu et al. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As to assessing step recited in 69, 74-78 and 83-86, implicitly in any disclosure of giving a treatment to a patient with a condition is first determining (assessing) that the patient has the condition. Therefore, the subject under treatment has been identified prior to applying the treatment. A person of ordinary skill in the art is a healthcare provider which first identify patients with a condition and then treats them with an appropriate drug. This is what a person of ordinary skill in the corresponding art does. In this case, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess whether the patient has cognitive impairment or poor cognition using known cognitive tests such as reaction time test, working memory test, or learning and memory test taught by Johe for identifying a patient who suffers from cognitive impairments including reduced information processing speed, and reduced attention, memory, learning, and working memory. Once the patient is identified to be in need of the treatment of NSI-189 for improving cognitive functions as well as depression, the skilled artisan would have initiated the treatment with NSI-189 with a reasonable expectation of success.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 60-86 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6-7, 9-10, 17-18, and 33-45 of copending application 17/805374.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘374 application are also drawn to a method of treating major depressive disorder in a human patient comprising: (a) objectively assessing whether the patient has poor cognition; (b) upon an assessment from step (a) that the patient has poor cognition, initiating oral administration to the patient of 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. Also, the dependent claims of ‘374 application recite that the patient is concurrently treated with a second antidepressant medication and the patient was, prior to treatment with (4-benzylpiperazin-1-yl)-[2-(3- methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof, treated with one or more antidepressants such as serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, mirtazapine, and bupropion, and continues treatment with the one or more antidepressants during treatment with the (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof (see claims 10, 42 and 44).
Thus, the instant claims are either anticipated by or would have been obvious over the claims of ‘374 application.
Claims 60-86 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of copending application 18/528486.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘486 application are also drawn to a method of treating major depressive disorder in a human patient having objectively determined impaired learning and memory (cognitive impairment) comprising orally administrating to the patient of 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. Also, the dependent claims of ‘486 application recite that the patient is concurrently treated with a standard of care antidepressant.
Thus, the instant claims are either anticipated by or would have been obvious over the claims of the co-pending application.
Claims 60-86 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 60-72 of copending application 18/892030
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘030 application are also drawn to a method of treating major depressive disorder in a human patient having impaired verbal memory (cognitive impairment) as objective determined comprising orally administrating to the patient of from about 80 mg of (4-benzylpiperazin-1-yl)-[2- (3-methylbutylamino)pyridin-3-yl]methanone or a pharmaceutically acceptable salt thereof daily. Also, the dependent claims of ‘030 application recite that the patient is concurrently treated with a second antidepressant medication (see claim 66).
Thus, the instant claims would have been obvious over the claims of the co-pending application.
Claims 60-86 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US patent 12208096 in view of Ionescu et al. (Translational Psychiatry volume 7, page e068, 2017; cited in the IDS filed on 1/29/2025).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of selecting a treatment for major depressive disorder in a human patient comprising: (a) objectively assessing whether the patient has impaired learning and/or memory (cognitive impairment); (b) upon an assessment from step (a) that the patient has impaired learning and/or memory, initiating oral administration to the patient of 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. While the claims of the patent are silent about administering an antidepressant with the claimed compound, it was well known in the art that a third of patients do not respond to conventional antidepressant such as selective serotonin reuptake inhibitors, tricyclic antidepressants and monoamine oxidase inhibitors and the combination of antidepressant such as fluoxetine with other classes of medications could be a useful option for treating depression as evidenced by Ionescu et al. (abstract and p1, col 2, para 3). In addition, Ionescu et al. disclose that NSI-189 with neurogenic properties has potential as a novel antidepressant and further disclose administering NSI-189 in a dose of 40 mg b.i.d. for treating MDD (p6, col 1 para 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the claimed compound in combination with a known antidepressant taught by Ionescu et al. in the treatment of major depressive symptoms, especially for those who do not response to monotherapy of such antidepressant. The skilled artisan would have been motivated to do so on the reasonable expectation that the claimed compound and the antidepressant would provide combined effects through different action mechanisms as evidenced by Ionescu et al. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Thus, the instant claims would have been obvious over the claims of the patent.
Conclusion
No claims are allowed.
This is a continuation of Applicant's earlier Application No. 18/670599. All claims are drawn to the same invention claimed in the earlier application and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BONG-SOOK BAEK/
Primary Examiner, Art Unit 1611
Prosecution Insights