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 .
Claims 1-20 are pending. Claims 1-4, 6-14, 16-17 and 19-20 are under examination. Claims 5, 15 and 18 are withdrawn.
Election/Restrictions
Applicant's election with traverse of the species Bifidobacterium adolescentis and anxiety disorder in the reply filed on 06/09/2026 is acknowledged. The traversal is on the ground(s) that no serious burden would exist on the examiner if restriction was not required. Applicant states that the species identified in the claims are sufficiently related such that a thorough search for the subject matter of the elected invention would encompass a search for the subject matter of the non-elected invention and to avoid duplicative examination and unnecessary delay and expense and examination on the merits of all the claims 1-20 is respectfully requested.
Applicants traversal has been carefully considered but is not found persuasive because the species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. The methods use different GABA producing probiotic bacteria and each probiotic bacteria has distinct physical and biochemical characteristics. The disorders being treated all have different etiology and pathology. Therefore, for example, prior art against one species of bacterium will not apply to a different species of bacteria. Furthermore, for example, prior art against epilepsy may not apply to anxiety. These species are not obvious variants of each other based on the current record.
In addition, there is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species require a different field of search e.g. searching different classes and subclasses and also require employing different search strategies and also employing different search queries.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 15 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2026.
Information Disclosure Statement
The information disclosure statement filed 11/26/2024 has been considered and an initialed copy is enclosed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 13-14, 16 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikolaevich et al. RU2614110 03-22-2017.
Claim 1: Nikolaevich et al disclose a method of treating a mental health disorder in a subject in need thereof, the method comprising: administering to the subject a composition comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA). See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art disclosure that GABA producing strains have a psychotropic effect allowing them to be attributed to psychobiotics and preclinical evaluations show that certain psychobiotics have activity that reduces symptoms of depression and anxiety. Effects can be mediated through the vagus nerve, spinal cord, and neuroendocrine system.
Claim 2: Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Claim 3: Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Claim 6: Nikolaevich et al disclose the mental health disorder includes anxiety disorder and depression. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Claim 7: Nikolaevich disclose the same administration step, thus the composition increases GABA within a body of the subject. Nikolaevich disclose the B. adolescentis produces GABA. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Claim 13: Nikolaevich disclose the same administration step, thus administration of the composition decreases a responsiveness of a nerve cell.
Claim 14. Nikolaevich disclose a method of treating a disorder in a subject in need thereof, the method comprising: administering to the subject a probiotic comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA); wherein the probiotic is administered at least one time. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Claim 16. Nikolaevich disclose the bacterium is Bifidobacterium adolescentis.
Claim 19. Nikolaevich disclose the bacterium is administered to treat anxiety or depression which is necessarily an administration at least one time daily.
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 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Nikolaevich et al. RU2614110 03-22-2017.
Nikolaevich et al disclose a method of treating a mental health disorder in a subject in need thereof, the method comprising: administering to the subject a composition comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA). See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art disclosure that GABA producing strains have a psychotropic effect allowing them to be attributed to psychobiotics and preclinical evaluations show that certain psychobiotics have activity that reduces symptoms of depression and anxiety. Effects can be mediated through the vagus nerve, spinal cord, and neuroendocrine system.
Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose the mental health disorder includes anxiety disorder and depression. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al does not disclose the composition is administered by oral administration.
However, Nikolaevich et al disclose a number of studies have shown that administering bifidobacteria orally to animals (mice and rats) relieves symptoms of anxiety and depressive-like behavior, and also reduces stress hormones. See two paragraphs above summary of the invention.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified Nikolaevich et al such that the composition is administered orally, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Nikolaevich et al disclose a number of studies have shown that administering bifidobacteria orally to animals (mice and rats) relieves symptoms of anxiety and depressive-like behavior, and also reduces stress hormones.
Claim(s) 1, 9, 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolaevich et al. RU2614110 03-22-2017 in view of Dyrmann et al. WO 2016030504 03-03-2016.
Nikolaevich et al disclose a method of treating a mental health disorder in a subject in need thereof, the method comprising: administering to the subject a composition comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA). See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art disclosure that GABA producing strains have a psychotropic effect allowing them to be attributed to psychobiotics and preclinical evaluations show that certain psychobiotics have activity that reduces symptoms of depression and anxiety. Effects can be mediated through the vagus nerve, spinal cord, and neuroendocrine system.
Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose the mental health disorder includes anxiety disorder and depression. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al does not disclose the B. adolescentis is provided at a concentration of between about 103 CFUs to about 1010 CFUs.
Nikolaevich et al does not disclose the composition further comprises FOS, GOS inulin or a combination thereof.
Dyrmann et al disclose probiotic compositions comprising B. adolescentis for treatment of anxiety, mood disorders, major depressive disorders etc. See abstract, p. 14 lines 1-6, lines 31-39.
Dyrmann et al disclose said probiotic compositions can further comprise FOS, GOS inulin or a combination thereof which are only partially digested by humans and act as fiber and the probiotic composition can comprises at least 105 CFU, at least 107 CFU , at least 109 CFU or at least 1012 CFU. See p. 20 lines 16-24, p. 21 lines 25-32, p. 22 lines 6-10 and p. 23 lines 4-9.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have included FOS, GOS inulin or a combination thereof in the composition of Nikolaevich and used a concentration of the B. adolescentis at least 105 CFU, at least 107 CFU , at least 109 CFU or at least 1012 CFU in the composition of Nikolaevich, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Dyrmann et al disclose that probiotic compositions comprising B. adolescentis for treatment of anxiety, mood disorders, major depressive disorders etc. can further comprise FOS, GOS inulin or a combination thereof as a source of fiber and the probiotic composition can further comprises at least 105 CFU, at least 107 CFU , at least 109 CFU or at least 1012 CFU of B. adolescentis.
Claim(s) 1 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolaevich et al. RU2614110 03-22-2017 in view of Tissot-Favre et al. WO 2013/025399 2/21/2013.
Nikolaevich et al disclose a method of treating a mental health disorder in a subject in need thereof, the method comprising: administering to the subject a composition comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA). See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art disclosure that GABA producing strains have a psychotropic effect allowing them to be attributed to psychobiotics and preclinical evaluations show that certain psychobiotics have activity that reduces symptoms of depression and anxiety. Effects can be mediated through the vagus nerve, spinal cord, and neuroendocrine system.
Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose the mental health disorder includes anxiety disorder and depression. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose a number of studies have shown that administering bifidobacteria orally to animals (mice and rats) relieves symptoms of anxiety and depressive-like behavior, and also reduces stress hormones. See two paragraphs above summary of the invention.
Nikolaevich et al does not disclose the composition comprises benzodiazepines.
Tissot-Favre et al discloses that compositions used for managing stress (paragraph 2, 5, 8, 27, ) can comprise sedatives such a benzodiazepines, antidepressants such as SSRIs (paragraph 66) and probiotics such as B. adolescentis (see paragraph 69-70).
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have included sedatives such a benzodiazepine and antidepressants such as SSRIs in the composition of Nikolaevich et al, as taught by Tissot-Favre et al, resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Tissot-Favre et al disclose that compositions used for managing stress can comprise sedatives such a benzodiazepines, antidepressants such as SSRIs and probiotics such as B. adolescentis.
Claim(s) 1, 4, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nikolaevich et al. RU2614110 03-22-2017 in view of Savaiano, Dennis. Bifidobacterium adolescentis IVS-1 capsule in Lactose Intolerance - Clinical Trials Registry - ICH GCP. Retrieved from https://ichgcp.net/clinical-trials-registry/NCT05668486.
Nikolaevich et al disclose a method of treating a mental health disorder in a subject in need thereof, the method comprising: administering to the subject a composition comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA). See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art disclosure that GABA producing strains have a psychotropic effect allowing them to be attributed to psychobiotics and preclinical evaluations show that certain psychobiotics have activity that reduces symptoms of depression and anxiety. Effects can be mediated through the vagus nerve, spinal cord, and neuroendocrine system. We believe that the development of psychobiotics (strains and drugs based on them) is very timely and necessary.
Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose the bacterium is Bifidobacterium adolescentis. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich et al disclose the mental health disorder includes anxiety disorder and depression. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich disclose a method of treating a disorder in a subject in need thereof, the method comprising: administering to the subject a probiotic comprising a therapeutically effective amount of a bacterium capable of producing γ-aminobutyric acid (GABA); wherein the probiotic is administered at least one time. See under abstract, field of invention, summary of the invention, example 1 selection of strains producing GABA, example 2 the selection of strain B. adolescentis 150 - producer of GABA, state of the art.
Nikolaevich disclose the bacterium is Bifidobacterium adolescentis.
Nikolaevich disclose the bacterium is administered to treat anxiety or depression which is necessarily an administration at least one time daily.
Nikolaevich et al does not disclose the Bifidobacterium adolescentis is Bifidobacterium adolescentis IVS-1.
Savaiano disclose Bifidobacterium adolescentis IVS-1, is a strain of the bacterial species Bifidobacterium adolescentis that has been thoroughly characterized and that it is deposited with the American Type Culture Collection (ATCC®) under Patent Deposit Designation as PTA-120614. Savaiano disclose B. adolescentis IVS-1 is part of the broader group of bacteria within the genus and is also long considered to contribute to a healthy gastrointestinal tract in infants as well as adults. See under study overview.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have included Bifidobacterium adolescentis IVS-1 in the composition of Nikolaevich et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Savaiano disclose Bifidobacterium adolescentis IVS-1, is a strain of the bacterial species Bifidobacterium adolescentis that has been thoroughly characterized and is considered to contribute to a healthy gastrointestinal tract in infants as well as adults.
Status of Claims
Claims 1-4, 6-14, 16-17 and 19-20 are rejected. Claims 5, 15 and 18 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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