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 .
Applicant’s response filed 03/16/2026 has been received and entered into the case. Claims 4, 5, 8-10, 12-16, 18-23 are pending and have been considered on the merits. All arguments and amendments have been considered.
Response to Amendment
In the interest of compact prosecution, the claims will be examined herein; however, it is noted that the amendment to the claims filed on 3/16/2026 does not comply with the requirements of 37 CFR 1.121(c) because canceled claim 17 includes all text, and no claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”, see 4) below. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Terminal Disclaimer
The terminal disclaimer filed on 3/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of prior patent number US12551517 and the full statutory term of any patent granted on pending reference Application number 18799195 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The Double patenting rejection over US12551517 and Application No. 18799195 have been withdrawn in light of the approved Terminal Disclaimer filed on 3/16/2026.
Maintained rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 5, 8-10, 12-16, 18-23 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating symptoms of mental health or symptoms of a mental illness and chronic stress wherein the symptoms of mental health are anxiety, mood swings and/or depression, does not reasonably provide enablement for the treating the scope of mental illnesses, symptoms which affect mental health or a condition associated with chronic stress encompassed by the claims, other than anxiety and/or depression. It is noted that applicants have amended the claims to include that the mental illness is a mood disorder, an anxiety disorder or depression or combinations thereof; however, the scope of the claims encompasses illnesses, symptoms and conditions for which applicants have neither direction or guidance presented in the specification, to treat with respect to the method as instantly claimed.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The claims are drawn to a method of treating mental illness, a symptom affecting mental health or a condition associated with chronic stress, wherein the mental illness is a mood disorder, an anxiety disorder or depression or combinations thereof, which including any mood disorder, any symptom which would affect one’s mental health and any condition associated with chronic stress. While the person of ordinary skill in the art would have a reasonable expectation of successfully treating symptoms associated mental health, mental illness or a condition associated with chronic stress wherein the symptoms of mental health are anxiety, stress and/or depression as disclosed in the present application, he or she would not have such an expectation for treating the scope of disorders, symptoms of mental health or conditions associated with chronic stress encompassed by the claims. For example, conditions associated with chronic stress encompass a broad range of conditions which can include muscle pains, high blood pressure, increased heart rate, chronic fatigue, weight gain or loss, while mental illness includes bipolar disorder, Schizophrenia, eating disorders, PTSD and cognitive disorders including Autism spectrum disorders and Alzheimer’s, for example, each having different symptoms and treatment. Applicant has not demonstrated treating the scope of disorders, symptoms and conditions encompassed by the claims.
The field is still in its infancy stages, but the art has shown that probiotics are capable of mitigating some mental illness symptoms, such as depression (Johnson et al. (cited in parent 16954659), Abstract, Exploring the Role and Potential of Probiotics in the Field of Mental Health: Major Depressive Disorder, Nutrients 2021, 13, 1728, doi.org/10.3390/nu13051728). The prior art generally attributes probiotic influence on mental health through the gut-brain axis (applicants specification page 2). The gut-brain axis is known in the art to influence mood, and some physiological symptoms like anxiety or depression. However, the prior art also understands diagnosing, and treating mental illness is very challenging and unpredictable because there is no identifiable common pathway or central disease mechanism involved in the occurrence of mental disorders (Johnson Page 4 paragraph 3 sentence 2-3). Mental disorders are known to be a constellation of symptoms (Johnson Page 4 paragraph 3 last sentence), and investigations into the mechanisms of probiotic effect on mental disorders is specific to each mental disorder (Johnson Page 5 paragraph 2 last sentence). Therefore, the art is highly unpredictable, and one skilled in the art would not be able to reasonably use the present invention to treat any other mental illness and/or symptom affecting mental health other than mental illnesses with symptoms other than anxiety and/or depression.
Applying the above test to the facts of record, it is determined that 1) no declaration under 37 C.F.R. 1.132 or other relevant evidence has been made of record establishing the amount of experimentation necessary, 2) insufficient direction or guidance is presented in the specification with respect to a method for treatment of the scope of mood disorders, symptoms and conditions, and 3) presence or absence of working examples. Applicants’ examples use only mice exposed to chronic stress and regarding applicants elected L. plantarum strain LP124186, the specification teaches “Treatment with L. plantarum LP12418: [0178] Reduced the loss of body weight as compared to chronically stressed mice in a non-significant manner. [0179] Very significantly but partially reduced the anxiety-like state in mice in the elevated plus maze test and in the open field test. [0180] Showed no effect on recognition long-term memory deficit in mice compared to chronically stressed mice. [0181] Showed a very significant antidepressant-like effect observed as behavioral despair in the forced swim test, compared to chronically stressed mice. [0182] Showed no effect on plasma corticosterone levels.” And “Treatment with Either L. Paracasei Lpc-37, L. Plantarum LP12418, L. Plantarum, or LP12407: [0200] Had no effect on the loss of body weight as compared to chronically stressed mice [0201] Very significantly and fully alleviated anxiety-like state in mice in the elevated-plus maze test. [0202] Very significantly and fully alleviated anxiety-like state in mice in the open-field procedure. [0203] Very significantly and fully alleviated the recognition long-term memory deficit in mice compared to chronically stressed mice. [0204] Very significantly and fully alleviated the depression-like behavior observed by a behavioral despair in the forced swim test paradigm, compared to the chronically stressed group treated with vehicle alone [0205] Showed differential effect on corticosterone, ACTH and BDNF concentrations.” Thus, applicants’ specification provides working examples and evidence of the invention being used to treat anxiety and depression symptoms caused by chronic stress; however, there is no guidance or examples in the specification demonstrating that the invention can be used to treat any and all mental illnesses, symptoms of general mental health or conditions of chronic stress other than anxiety and/or depression.
The relative skill of those in the art is commonly recognized as quite high (post-doctoral level). While the level of skill in the art is high, the unpredictability of the art, lack of guidance, broad scope of the claims encompassing treating a broad scope of illness and symptoms and poorly developed state of the art would require that undue and excessive experimentation would have to be conducted by the skilled artisan in order to practice the claimed invention.
The specification requires the skilled artisan to practice trial and error experimentation in a method to treat numerous mood disorders, symptoms which affect one’s mental health and conditions associated with chronic stress. Given the above analysis of the factors which the courts have determined are critical in determining whether a claimed invention is enabled, it must be considered that undue and excessive experimentation would have to be conducted by the skilled artisan in order to practice the claimed invention.
New rejection necessitated by amendment
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 15 and its dependent claims 4,5, 8-10, 12-16, 18-23 are 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.
Claim 15 reads “A method for treating mental illness, a symptom affecting mental health or a condition associated with chronic stress or both in a mammal in need thereof, wherein the mental illness is a mood disorder, an anxiety disorder or depression or a combination of the foregoing…” however, the addition of the term “or both” fails to particularly point to what is included in “both” as the claim is drawn to three “treatments”, i.e. treatment of mental illness, treatment of a symptom affecting mental health or treatment of a condition associated with chronic stress. Therefore, it is not clear what “or both” refers to.
Response to Arguments
Applicant's arguments filed 3/16/2026 have been fully considered but they are not persuasive. Regarding the 112(a) rejection, applicants argue that incorporating the features of claim 17 into claim 15 overcomes the enablement rejection as the specification is enabling for treating “symptoms” such as anxiety, mood swings and/or depression. While the “symptoms” of anxiety, mood swings and/or depression were indicated to be enabled, the scope of illness, symptoms which affect mental health or a condition associated with chronic stress encompassed by the claims are not enabled.
Conclusion
Before the effective filing date of the claimed invention, the claimed and deposited L. plantarum LP12418 DSM32655 or LP121407 DSM 32654 strains were not known and were not taught in the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. EP2937424 to Tsai et al., Nimgampalle et al. (J. Clin Diag. Res., 2017), Davis et al. (Sci. Reports, 2016, vol. 6, p. 1-11), Vitetta (WO2016/065419), and Bengmark WO2005/077391.
EP2937424 teaches a method of treating stress-induced disorders and symptoms thereof including anxiety, depression and IBS (associated with stress) in a mammal in need thereof, comprising administering to said mammal in need thereof a composition comprising Lactobacillus plantarum PS128 (abstract, 0001, 0009-0012, 0018, 0020, 0021, 0023, Ex. 3, 0036-0048, Ex. 4, 0054-0060). EP424 teaches treating gastrointestinal disorders including irritable bowel syndrome (IBS) associated with stress (0006-0010, 0016, 0018, 0020, 0021, Ex. 5). The composition is orally administered (0023) to treat a disorder, and thus it would obvious to formulate the probiotic composition for oral use including as a food product, dietary supplement, pharmaceutical composition or medicament (according to claim 23).
Nimgampalle teaches administering L. plantarum to subjects in need thereof for treating a symptom affecting mental health wherein the illness and symptom results in diminished cognitive function, i.e. administering to an Alzheimer’s rat model and preforming cognitive behavior tests (p. 2, 3rd and 5th parag, p. 3, whole page). The reference teaches that the administration ameliorated cognition deficit and restored acetylcholine deficits (abstract, results section of abstract). The reference teaches that LAB are beneficial probiotic bacteria for restoring gut microbiome and functions of immune and neuro modulation, including protection against memory deficits, having antioxidant activity and improving learning and memory ability (intro. p. 1, 2nd col, 1st parag.). Administration of L. plantarum to the Alzheimer’s model significantly improved gross behavioral activity and learning skills, increased ACh in the brain and ameliorates memory impairment (p. 3, whole page, Table/Fig. 3, 4, p. 4-5).
Davis teaches the treatment of stress and anxiety disorders in a subject in need thereof comprising administering L. plantarum. Davis teaches that probiotic Lactobacillus is an alternative approach to regulating the gut microbiota affecting the innate immune system and central nervous system, which is associated with the dysregulation in systems in the brain of stress and anxiety disorders, manifesting in behaviors and neurological systems and well as the digestive tract (p. 1, whole page). Davis teach that zebrafish are a model species for neurobehavioral studies and exhibit behaviors in human neurological disorders including anxiety, learning, fear, sociability and psychosis, thus demonstrating a clear translatability to humans and rodents (p. 1, last parag.-p. 2, 1st parag.). The administration of L. plantarum to zebrafish reduced anxiety-related behaviors when validated in a tank diving behavior test and modulated GABAergic and serontonergic pathways (p. 3, L. plant. Alters anxiety section, p. 5, Fig. 4) and protects against stress-induced dysbiosis of the gut microbiota (p. 4, last parag., Discussion section p. 6-7).
Vitetta (WO2016/065419) teaches a method of treating depression and anxiety or disorders related thereto (abstract, 0010, 0024-0026, 0074, 0075) comprising administering a composition comprising one or more probiotic bacteria, wherein the one or more probiotic bacteria may include L. plantarum and L. paracasei (0018, 0019, 0044, 0045, 0089).
Bengmark (WO2005/077391) teaches methods of treating stress-induced disorders including depression and reduced mood (p. 4, lines 26) comprising administering to a mammal a formulation comprising L. paracasei and L. plantarum (p. 1, lines 5-24, p. 3, lines 3-23, p. 5, lines 6-25, p. 8, lines 5-9).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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