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 4, 5, 8-10, 12-23 are pending and have been considered on the merits herein.
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, 12-23 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 scope of mental illnesses, symptoms which affect mental health and/or a condition associated with chronic stress encompassed by the claims, other than anxiety and/or depression. 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 and or a condition associated with chronic stress, including any mental illness, 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 mental illness, symptoms of mental health and/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 illnesses, 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 mental illnesses, 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.
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 4, 5, 8-10, 12-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12551517. Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions are drawn to methods of treating mental illness, a symptom thereof comprising administering to a mammal in need thereof a composition comprising L. plantarum, particularly strain LP12418 DSM 32655 or LP121407 DSM 32654 and L. paracasei Lpc-37. Independent claim 15 of the instant application is drawn to the composition comprising L. plantarum and particularly strain LP12418 DSM 32655 or LP121407 DSM 32654 to treat, while dependent claims 9, 10, and 22 additionally include L. paracasei, particularly strain Lpc-37, required by patented claims 1, 5 and 8. While instant claim 15 is directed to a broad limitation of treating mental illness and/or a symptom thereof, dependent claims 17-19 are narrowly drawn to the mental illness and symptoms being a mood disorder, an anxiety disorder, and/or depression and anxiety, mood swings, and a mental illness resulting in diminished cognitive function meeting the limitations of patented claims 1-4. The compositions are administered in the form of a food product, a dietary supplement or a pharmaceutical composition. Thus, the examined claims would be anticipated by the reference claims.
Claims 4, 5, 8-10, 12-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-18 of copending Application No. 18799195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because treating mental illness, a symptom affecting mental health and/or a condition associated with chronic stress comprising administering to a mammal in need thereof a composition comprising L. plantarum, particularly strain LP12418 DSM 32655 or LP121407 DSM 32654. The claimed inventions differ in that reference claim 11 of US’195 includes that the L. plantarum strains may be selected from the group consisting of LP12418 DSM 32655, LP121407 DSM 32654, or L. plantarum strain LP12151 DSM 32721; however, the instant claims are drawn to a composition “comprising” and thus, the instant claims would not exclude an additional L. plantarum (LP12151 DSM 32721) strain. Additionally, the compositions of claimed inventions further include L. paracasei Lpc-37, and may include other bacterial strains. The compositions are administered to treat mood disorders, anxiety disorders and/or depression and illness resulting in diminished cognitive function, and the symptoms treated include anxiety, mood swings and/or depression and GI disorders including IBS. The compositions are in the form of a food product, a dietary supplement or a pharmaceutical composition and may be spray-dried or freeze-dried and comprising a cryoprotectant. Thus, the examined claims would be obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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). 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.
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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