DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
Applicant has amended claim 1 to add the limitation “wherein administering an effective dosage regimen of the multistrain probiotic formulation to the subject, wherein the effective dosage regimen comprises administering 1 to 2 doses per day of the multistrain probiotic formulation, for 6-8 weeks, wherein the subject is predisposed to treatment-resistant depression (TRD) associated with early-life stress and chronic stress, wherein the multistrain probiotic formulation is administered subsequent to the occurrence of early-life stress and chronic stress”, as well as claims 2, 11-12, 14, 16-17, 25-27, and 29-31 to correct minor informalities or address improper dependency form. Moreover, claims 3, 9, and 28 have been canceled.
No new matter has been added.
Priority
Applicant claims the benefits of foreign priority based on an application filed in India on 6/23/20222. However, applicant has not filed a certified copy of the IN202341018673 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to because the text in the graphs of Figure 8 is too small to read legibly and the lines/bars are not well defined. 37 C.F.R. 1.84 section (p)(3) requires that “Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height”, while section (l) states “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined”. See MPEP § 608.02(V).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is defective because the file size in the “Reference to Sequence Listing” section added to the specification on 7/01/2024 is in kilobytes (i.e., it should expressed in terms of bytes).
Required response - Applicant must provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
RE: Objections to the claims
The minor informalities in claims 11-12, 14, 27, and 30 have been corrected. Thus, the claim objections have been withdrawn.
Claim 28 has been canceled, thereby rendering the objection on said claim moot.
New objections
Claim 1 is objected to because of the following informalities: (i) unnecessary capitalization of a common noun and (ii) missing words in the first ‘wherein’ clause. To rectify these minor informalities, the term “Glutamine” should be amended to “glutamine” and the phrase “wherein administering an effective dosage regimen” should be amended to “wherein the administering step comprises an effective dosage regimen”.
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.
RE: Rejection of claim 2 under 35 U.S.C. 112(a)
Applicant has submitted an affidavit stating that the deposited biological materials were deposited under the Budapest Treaty and will be released to the public irrevocably and without restrictions. Hence, the rejection has been withdrawn.
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.
RE: Rejection of claim 29 under 35 U.S.C. 112(b)
Claim 29 has been amended such that it clearly sets forth its dependency on claim 1 rather than on itself. The rejection has therefore been withdrawn.
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.
RE: Rejection of claim 29 under 35 U.S.C. 112(d)
The dependency of claim 29 has been changed to claim 1. Since claim 29 now has proper dependent form, the rejection has been withdrawn.
New rejections
Claims 7-8 are rejected under 35 U.S.C. 112(d) 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.
The claims require that the multistrain probiotic formulation is administered to the subject “for at least 6 weeks” (claim 7) or “for 6 – 8 weeks” (claim 8). However, the parent claim already specifies administering it for 6-8 weeks. Claim 7 therefore broadens the scope of claim 1’s subject matter, while claim 8 merely maintains the scope.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
RE: Rejection of claims 1-6, 10, and 12-31 under 35 U.S.C. 102(a)(1) over Venkataraman
Trvaersal of rejections is based on Venkataraman failing to teach administration of the disclosed multi-strain probiotic formulation for a dosage period of 6-8 weeks. Referring to applicant’s definition of the term “treatment-resistant depression” (pages 12-13 of specification), it is also argued that said prior art does not particularly teach that the subject being treated is “predisposed to treatment-resistant depression associated with early-life stress and chronic stress”, nor that the administration is performed “subsequent to the occurrence of early-life stress and chronic stress”.
The traversal has been fully considered and is found persuasive. The cited primary reference does not teach using the disclosed probiotic formulation for 6-8 weeks as now required in the amended claims. Thus, the rejections of record have been withdrawn.
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, 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.
RE: Rejection of claims 7-9 and 11 under 35 U.S.C. 103 over Venkataraman in view of Mousset et al.
Applicant contends that Mousset et al. fails to cure the deficiencies of Venkataraman et al. as it does not disclose the specified probiotic formulation and does not teach administering said formulation to the specified subject. There is allegedly no reasonable expectation of success because neither one of the cited references teaches using the probiotic formulation after the occurrence of said stressors for 6-8 weeks. Extending the treatment period from 4 weeks to 6-8 weeks is asserted to be not a matter of routine optimization or simple substitution given that synergistic production of the neurotransmitter gamma-aminobutyric acid (GABA) in an animal TRD model and other benefits were unexpectedly found by the applicant.
All arguments have been fully considered. It is conceded that none of the cited prior art explicitly teaches administering the recited multistrain probiotic formulation specifically to the subject for 6-8 weeks. But according to Venkataraman et al., the bacterial strains in the disclosed multi-strain probiotic formulation (the same strains tested by the applicant and recited in claim 2) were selected for their ability to produce GABA. GABA is derived from glutamine and GABA-producing bacterial strains are known to possess anti-depressant like effects (first three par. in left col., page 13). Thus, there is reasonable expectation that administering a formulation comprising GABA-producing bacterial strains would help treat depression. More importantly, Venkataraman et al. experimentally demonstrates that administering twice daily the disclosed multi-strain probiotic formulation containing GABA-producing bacterial strains to students led to reduction in stress, depression, anxiety, and serum cortisol level (Figure 2, page 15), some of which are symptoms of TRD according to the applicant (claim 16). Since the treatment started 2 weeks before examination and the baseline scores already indicate moderate stress, high anxiety, and elevated serum cortisol level (second par. in left col. and Table 1, page 16), the students would be considered predisposed to TRD associated with early-life stress and chronic stress. And even though the treatment only lasted for a total of 4 weeks, Venkataraman et al. states that previous studies show that probiotic administration for 6 or 8 weeks prevented the onset of stress and improved scores for depression, anxiety, and stress (last par. in left col. and first par. in right col., page 16). It is routine in the art to treat depression with probiotics and glutamine for more than 4 weeks such as for 2 months or 8 weeks as substantiated by Mousset et al.. Thus, it would have been obvious to prolong the Venkataraman et al.’s administration period to 6 or 8 weeks and have reasonable expectation that the reduced symptoms would be sustained.
Moreover, it should be noted that one aspect of the claimed method is “preventing… at least one symptom of treatment-resistant depression (TRD) in a subject”. Applicant describes “treating or preventing” as including preventing the development of TRD or onset of a depressive episode or symptoms thereof (lines 23-29, page 12 of specification) and claim 1 defines the subject as being “predisposed to treatment-resistant depression (TRD) associated with early-life stress and chronic stress”. In this context, the term “preventing” is therefore considered to mean the subject is not required to have TRD or exhibit a TRD symptom.
With regards to the assertion of unexpected results, they are not commensurate in scope with the claims. Claim 1 broadly recites six different species of bacteria as components but only one particular strain was assessed for each species. Applicant also only evaluated the effects of one amount for each bacterial strain in the multistrain probiotic formulation at a specific ratio (second par., page 35). The observed results cannot therefore be extended to other amounts/ratios and other bacterial strains. Furthermore, applicant only tested one dosage regimen. Without any point of comparison, it cannot be determined that the claimed dosage regimen of administering 1-2 doses per day for 6-8 weeks is critical to the claimed invention.
Hence, obviousness of the claims still stands but the prior art rejections have been modified to address all claim limitations.
Modified rejections
Claims 1-2, 4-8, 10-27, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Venkataraman et al. (Probiotics and Antimicrobial Proteins 2021, Vol. 13, pages 12-18; hereafter “Venkataraman”) in view of Mousset et al. (Pub. No. WO 2021005310 A1; hereafter “Mousset”).
Regarding claims 1-2, 4-8, 11-13 and 16: The daily, oral administration of between 106 to 1012 CFUs per dose, once or twice a day, of a multi-probiotic formulation comprising: Bacillus coagulans (Unique IS-2 MTCC 5260), Lactobacillus rhamnosus (UBL R-58 MTCC 5402), Bifidobacterium lactis (UBBLa-70 MTCC 5400), Lactobacillus plantarum (UBLP-40 MTCC 5380), Bifidobacterium breve (UBBr-01 MTCC 25081) Bifidobacterium infantis (UBBI-01 MTCC 25124) and 100-500 mg of Glutamine subsequent to the occurrence of early-life stress and chronic stress; for the purpose of preventing, treating or ameliorating at least one symptom of Treatment-Resistant Depression (TRD), wherein TRD is induced by chronic stress or early-life stress and also comprises one or more of the following symptoms: irritability, mood swings, depressed mood, disturbed sleep, listlessness, cognitive changes, short term memory loss, anxiousness, restlessness, tension, and anhedonia. The probiotics are also administered at a ratio of 2:2:2:2:1:1 as a food, supplement, or pharmaceutically acceptable composition.
Venkataraman teaches the twice daily oral administration of the same multi-strain probiotic formulation comprising identical strains in the same ratio and a dose of 2 or 1x109 CFUs per dose and 250 mg of glutamine, in the form of a pharmaceutically acceptable composition (capsule for oral administration), with the effect of decreasing score on the Perceived Stress Scale (PSS), Depression Anxiety Stress Scale (DASS) and the State-Trait Anxiety Inventory (STAI) questionnaire, as well as reductions to serum cortisol levels (abstract). The disclosed multi-strain probiotic formulation was administered to 18-24 year old students 2 weeks before the examination and ended 2 weeks later. Since students at this age range have been exposed to exam stress for years, this administration timing can be considered to meet the requirement that the multistrain probiotic formulation is administered subsequent to the occurrence of early-life stress and chronic stress.
Venkataraman differs from that the claimed invention in that it only teaches an administration period of 4 weeks. It does not explicitly teach that the multistrain probiotic formulation is administered for “6-8 weeks” or as an adjunct to standard medical treatment for depression.
However, Mousset teaches the administration of a probiotic composition comprising glutamine, extract of curcuma and Lactobacillus rhamnosus (Abstract in page 1 of the English translation) and one or more probiotics selected from preferably but not limited to, lactobacilli, bifidobacteria, bacillus, streptococci, enterococci, propionibacteria or saccaromycetes (last two par. in page 15 of the English translation) for the treatment or prevention of anxiety disorders and/or mood disorders, in particular depression (abstract). Mousset also teaches the composition above being administered alongside standard medical treatments for depression including as an adjunct (last five paragraphs before the Examples section in page 25 of the English translation). Mousset further teaches the administration of their multistrain probiotic formulation for the treatment or prevention of depression for “about 24 hours, about 2 days, about 5 days, about 10 days, about 15 days, about 30 days or 1 month, about 2 months, about 4 months, about 6 months, or about 1 year”.
It would have been obvious for one of ordinary skill in the art to extend the treatment period of 4 weeks taught in Venkataraman to any of the administration durations taught in Mousset which includes “about 2 months” which would reasonably include anywhere from 6 to 8 weeks. One would have been motivated to do so since a longer dosage period requires the subject to purchase more of the multistrain probiotic composition while likely having even further benefits to the subject’s mental health. It would have also been obvious to administer the multistrain probiotic formulation of Venkataraman as an adjunct to standard medical treatment as taught in Mousset with the expectation of success, and one would have been motivated to do so since this would expand the subject group taught in Venkataraman, which explicitly excluded individuals with diagnoses of psychological disorders, or that were on medication.
Regarding claims 10, 14-15, 17-27, and 29-31: wherein the multistrain probiotic formulation does or does not have the following effects:
10) does not affect metabolic activity or locomotor activity,
14) alleviates TRD symptoms by increasing gut eubiosis,
15 & 28-29) leads to an increase in goblet cells and improved crypt-to-villi ratio in the colon and a restoration of levels of tight junction (TJ) proteins,
17) a decrease of anhedonia,
18) alleviates TRD symptoms by modulating levels of tryptophan metabolites,
19) increasing levels of 5-HT,
20) restoring the elevated levels of L-tryptophan, L-kynurenine, kynurenic acid and 3-hydroxyanthranilic acid in the circulatory system,
21 & 22) reversing accumulation of neurotoxic metabolites associated with anxiety and depression: 3-hydroxyanthranilic acid,
23 & 24) decrease the levels of short chain fatty acids associated with anxiety and depression: acetate, propionate and or butyrate,
25) decreasing levels of proinflammatory cytokines,
26 & 27) reversing the elevated mRNA expression levels of TNA-alpha and C-reactive protein associated with anxiety and depression and dopamine levels in the hippocampus and or frontal cortex,
30) reverses the decrease in BDNF levels
31) reverses the decrease in Firmicutes to Bacteroidetes ratio in subjects showing symptoms of TRD.
Venkataraman teaches the administration of the exact same species of bacteria in a multistrain probiotic formulation, recited in claim 1, with 250 mg of glutamine to subjects with anxiety (as determined by the baseline STAI score of 48.58 +/- 8.25). The effects claimed in the instant application are inherent effects of administering this particular composition and thus must have been present in the subjects treated in the double-blind clinical trial of Venkataraman even if they were not explicitly observed during that trial.
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.
RE: Nonstatutory double patenting over U.S. Application No. 18/427867
The terminal disclaimer (TD) filed on 6/25/2026 was disapproved since it is unclear and it incorrectly lists the application number of the instant application instead of the co-pending application number. Moreover, the co-pending application was recently allowed. Applicant should therefore submit a new TD to disclaim the entire term or any terminal part of the term of U.S. patent 12,629,398.
Accordingly, the nonstatutory double patenting rejections have been modified to account for the cancelation of some claims and issuance of the co-pending application as a patent.
Modified rejections
Claims 1-2, 4-8, 10, 12-27, and 29-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, and 12-17 of U.S. Patent 12,629,398.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 and 10 of the U.S. patent recite the administration of the exact same composition to an overlapping subject group at the same ratio of bacterial strains for the same durations and dose and also in the same form of food product supplement or pharmaceutically acceptable composition as the instant application. Claims 16-17 of the U.S. patent recite the same inherent efficacies as claim 15 (increase in goblet cells and improved crypt to villi ratio) and claims 25-27 (decrease in inflammatory cytokines, TNF-alpha and C-reactive protein) of the instant application.
Regarding claims 1-2, 4-8, 12-13 and 16: The daily, oral administration of between 106 to 1012 CFUs per dose, once or twice a day, of a multi-probiotic formulation comprising: Bacillus coagulans (Unique IS-2 MTCC 5260), Lactobacillus rhamnosus (UBL R-58 MTCC 5402), Bifidobacterium lactis (UBBLa-70 MTCC 5400), Lactobacillus plantarum (UBLP-40 MTCC 5380), Bifidobacterium breve (UBBr-01 MTCC 25081) Bifidobacterium infantis (UBBI-01 MTCC 25124) and 100-500 mg of Glutamine; for the purpose of preventing, treating or ameliorating at least one symptom of Treatment-Resistant Depression (TRD), wherein TRD is induced by chronic stress or early-life stress and also comprises one or more of the following symptoms: irritability, mood swings, depressed mood, disturbed sleep, listlessness, cognitive changes, short term memory loss, anxiousness, restlessness, tension, and anhedonia . Also the probiotics are administered in a ratio of 2:2:2:2:1:1 as a food, supplement or pharmaceutically acceptable composition.
Claims 1-8 and 10 of the U.S. patent encompass the limitations of claims 1-2, 4-8, 12-13, and 16 of the instant application because they recite administering the exact same composition to an overlapping group of subjects for the same durations at the same dose and ratios of probiotic strains, in the same form (food, supplement or pharmaceutically acceptable composition). The limitation of oral administration of claim 12 of the instant application is encompassed by the administration of the multistrain probiotic as a food product in claim 10 of the U.S. patent since food is consumed orally. The subject groups are considered overlapping because both applications recite a method of preventing a symptom of either TRD of instant application or Obsessive Compulsive Disorder (OCD) of the U.S. patent. This does not limit the subject group in either case because preventing a symptom of a condition does not require that the subject have the condition or even be at risk of the condition, the subject would simply need to benefit from the prevention of one of those symptoms. Thus, further recitations of specific symptoms of either condition do not affect the scope of the subject group since any subject could benefit from the prevention of those symptoms.
Regarding claims 10, 14-15, 17-27, and 29-31: wherein the multistrain probiotic formulation does or does not have the following effects:
10) does not affect metabolic activity or locomotor activity,
14) alleviates TRD symptoms by increasing gut eubiosis,
15 & 28-29) leads to an increase in goblet cells and improved crypt-to-villi ratio in the colon and a restoration of levels of tight junction (TJ) proteins,
17) a decrease of anhedonia,
18) alleviates TRD symptoms by modulating levels of tryptophan metabolites,
19) increasing levels of 5-HT,
20) restoring the elevated levels of L-tryptophan, L-kynurenine, kynurenic acid and 3-hydroxyanthranilic acid in the circulatory system,
21 & 22) reversing accumulation of neurotoxic metabolites associated with anxiety and depression: 3-hydroxyanthranilic acid,
23 & 24) decrease the levels of short chain fatty acids associated with anxiety and depression: acetate, propionate and or butyrate,
25) decreasing levels of proinflammatory cytokines,
26 & 27) reversing the elevated mRNA expression levels of TNA-alpha and C-reactive protein associated with anxiety and depression and dopamine levels in the hippocampus and or frontal cortex,
30) reverses the decrease in BDNF levels
31) reverses the decrease in Firmicutes to Bacteroidetes ratio in subjects showing symptoms of TRD.
Claims 1-8, 10, and 16-17 of the U.S. patent encompass the limitations of claims 10, 14-15, 17-27, and 29-31 of the instant application because they recite administering the exact same composition to an overlapping group of subjects for the same durations at the same dose and ratios of probiotic strains, in the same form (food, supplement or pharmaceutically acceptable composition). The effects of the multistrain probiotic formulation recited in the instant application are inherent effects of administering the composition to a subject and thus are necessarily present in the methods of the U.S. patent.
Conclusion
No claim is allowed.
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 MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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 L. 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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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
