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 .
Status of the Claims
The amendment of 08/11/2025 has been entered. Claims 1-24 are pending (claim set as filed on 08/11/2025). Claims 9-14, 18, and new claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. It is noted that new claims 21-24 are drawn to a use of a probiotic composition in the preparation of probiotic formulations.
Claims 1-8, 15-17, and 19-20 are currently under examination and were examined on their merits.
Priority
This application filed on 10/06/2022 claims priority to PCT application no. PCT/CN2021/086312, filed on 04/10/2021, and claims foreign priority to application no. CN202010281549.8, filed on 04/10/2020. Acknowledgment is made of Applicant' s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. 1.56).
Withdrawn Objections/Rejections
The rejections of claims 1-8 under 35 U.S.C. 103 set forth in the previous Office action are withdrawn in light of the amendment filed on 08/11/2025, which narrowed the scope of base claim 1 and altered the limitations in claims 3-6. New rejections have been presented as discussed below.
Claim Interpretation
The preamble of base claims 1 and 15 recites "for treating rapid eye movement sleep behavior disorder", which is considered intended use. Claim 8 further specifies the intended use.
MPEP 2111.01 (II) states:
“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Dependent claim 7 and independent claim 19 recite process steps for obtaining the product ‘probiotic composition’ of claims 1 and 19, respectively. Dependent claim 17 recites process steps for obtaining the product ‘probiotic formulation’. Therefore, the product ‘probiotic composition’ in claims 7 and 19, and the product ‘probiotic formulation’ are considered product-by-process limitations, since the claimed products are obtained by process steps. The MPEP states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)” (see MPEP 2113 (I)).
As discussed above, claims 7, 17, and 19 are directed to a product claim, and thus, the method of making the product does not impart a structural limitation absent evidence to the contrary (see MPEP 2113 (I)). As such, patentable weight is given to the product and no patentable weight is given to the process steps recited in claims 7, 17, and 19.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8, and 19-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a combination of judicial exceptions without significantly more. The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972
(2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S.,132 S.
Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an
eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must
(a) not be directed to a judicial exception or must (b) contain additional elements that
amount to significantly more than the judicial exception itself.
'Directed to a judicial exception' analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Base claims 1 and 19 recite a probiotic composition. Probiotic compositions occur in nature, and are therefore a natural phenomenon. Claims 1 and 19-20 recite ‘Bacillus licheniformis’, ‘Bifidobacterium longum’, ‘Lactobacillus acidophilus’, and ‘Enterococcus faecalis’ (“The Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis used in the present disclosure are strains well known to those skilled in the art.”; page 6, lines 9-11). The instant specification does not further describe said microorganisms as genetically modified or mutated, which therefore read on natural microorganisms absent evidence to the contrary. Natural microorganisms are considered natural phenomena. Further the recited concentrations do not change the bacteria. Claims 2 and 19 further recite ‘adjuvants’ wherein ‘adjuvant’ reads on dietary fiber or lactose (specification, page 3, lines 28-29 and page 10, lines 20-21), which are natural phenomena. Claim 19 recites a food composition or supplement which read on water which is a natural phenomenon (see specification, page 6, lines 1-8).
The above listed microorganisms, probiotic composition, adjuvant, and food composition or supplement are directed to natural products that do not interact to yield significantly more.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No additional elements are cited that would integrate the judicial exception into a practical application.
'Significantly more' analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not include any additional elements other than the judicial exceptions.
Therefore, the claims are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 15-17, and 19-20 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Lathan et al. (WO 2011/017040 A1, published on 02/10/2011), hereinafter ‘Lathan’, as evidenced by Carabin et al. (“Evaluation of Safety of Inulin and Oligofructose as Dietary Fiber”, published in Dec 1999, Regulatory Toxicology and Pharmacology Vol. 30, pages 268-282), hereinafter ‘Carabin’.
Lathan’s general disclosure relates to “Nutritional compositions including fiber blends having a stable amount of probiotics and methods of making the nutritional compositions” (see entire document, including abstract).
Regarding claims 1, 7-8, pertaining to a probiotic composition, Lathan teaches a probiotic composition comprising Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis (“In a general embodiment, the present disclosure provides a nutritional composition including a fiber blend having a mixture of agglomerated fiber particulates and one or more probiotics.”, “Specific examples of suitable probiotics are: …, Bacillus licheniformis, …,Bifidobacterium longum, …, Enterococcus faecalis, Lactobacillus acidophilus,”; paragraphs [0004], [0027]).
Regarding claims 1, 8 and 15, it is noted that treating rapid eye movement sleep behavior disorder (instant claim 1), wherein the rapid eye movement sleep behavior disorder comprises idiopathic rapid eye movement sleep behavior disorder and/or rapid eye movement sleep behavior disorder in Parkinson’s disease (instant claim 8), is considered intended use, as discussed above under Claim Interpretation. Since the intended use ‘treating rapid eye movement sleep behavior disorder’ does not impart a structural limitation on the product itself, no patentable weight is given to ‘treating rapid eye movement sleep behavior disorder’ in claim 1 and to the species of rapid eye movement sleep behavior disorder listed in claim 8.
Regarding claim 2, pertaining to adjuvants, Lathan teaches the probiotic composition further comprising adjuvants (“In a general embodiment, the fiber blends include one or more fibers and one or more probiotics.”, “The fibers can include …, inulin, …, pectins,”, “The nutritional compositions of the present disclosure can optionally include conventional food additives, such as any of emulsifies, stabilizes, sweeteners, flavorings, coloring agents, preservatives, chelating agents, osmotic agents, buffers or agents for pH adjustment, acidulants, thickeners, texturizers”; paragraphs [0017], [0023], [0042]). It is noted that inulin and pectin are dietary fibers, as evidenced by Carabin (“Inulin and oligofructose are soluble, fermentable dietary fibers”, “Dietary fiber belongs to the broad category of carbohydrates. They can be classified into soluble (e.g., gums, pectins)”; page 268, right column, paragraph 2; page 280, right column, paragraph 5). Dietary fiber, emulsifiers, osmotic agents, and agents for pH adjustment read on ‘adjuvants’ as described in the instant specification (see specification, page 3, lines 28-32).
Regarding claims 7, 17, and 19, it is noted that the probiotic composition (instant claims 7 and 19) and the probiotic formulation (instant claim 17) is considered a product-by-process limitation, as discussed above under Claim Interpretation, and the method of making the product does not impart a structural limitation absent evidence to the contrary (see MPEP 2113 (I)). Therefore, weight is given to the products ‘probiotic composition’ and ‘probiotic formulation’, and not to the process steps recited in claims 7,17, and 19.
Regarding claims 15 and 17, pertaining to a probiotic formulation, Lathan teaches a probiotic formulation comprising Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis (“the present disclosure provides a nutritional composition including a fiber blend having a mixture of agglomerated fiber particulates and one or more probiotics.”, “Specific examples of suitable probiotics are: …, Bacillus licheniformis, …,Bifidobacterium longum, …, Enterococcus faecalis, Lactobacillus acidophilus,”; paragraphs [0004], [0027]) as well as adjuvants used for preparing the probiotic composition as a probiotic dosage form (“The probiotic(s) to be used can be initially premixed with some of the raw fiber powder (…) to separate the probiotics before mixing with the agglomerated fiber particulates. This allows the probiotics to be evenly distributed throughout the agglomerated fiber particulates. The premixed probiotic and raw fiber powder are then mixed with the previously formed agglomerated fiber particulates to form the fiber blend”, “The fiber blend can readily be incorporated into any suitable pharmaceutical or nutritional formulations (…), dietary supplements, functional foods and beverage products”, “the nutritional composition is in an administerable form”, “The fibers can include …, inulin, …, pectins,”, “The nutritional compositions of the present disclosure can optionally include conventional food additives, such as any of emulsifies, stabilizes, sweeteners, flavorings, coloring agents, preservatives, chelating agents, osmotic agents, buffers or agents for pH adjustment, acidulants, thickeners, texturizers”; paragraphs [0017], [0032], [0035], [0042], see abstract and claim 11). It is noted that inulin and pectin are dietary fibers, as evidenced by Carabin (“Inulin and oligofructose are soluble, fermentable dietary fibers”, “Dietary fiber belongs to the broad category of carbohydrates. They can be classified into soluble (e.g., gums, pectins)”; page 268, right column, paragraph 2; page 280, right column, paragraph 5). Dietary fiber, emulsifiers, osmotic agents, and agents for pH adjustment read on ‘adjuvants’ as described in the instant specification (see specification, page 3, lines 28-32).
Regarding claim 19, pertaining to a food composition or supplement, Lathan teaches a food composition or supplement comprising a probiotic composition (“In a general embodiment, the present disclosure provides a nutritional composition including a fiber blend having a mixture of agglomerated fiber particulates and one or more probiotics”, “The nutritional composition can be in an administerable form such as pharmaceutical formulations, nutritional formulations, dietary supplements, functional foods and beverage products”, “Specific examples of suitable probiotics are: …, Bacillus licheniformis, …,Bifidobacterium longum, …, Enterococcus faecalis, Lactobacillus acidophilus,”; paragraphs [0004], [0027]; see abstract), as well as adjuvants (“In a general embodiment, the fiber blends include one or more fibers and one or more probiotics.”, “The fibers can include …, inulin, …, pectins,”, “The nutritional compositions of the present disclosure can optionally include conventional food additives, such as any of emulsifies, stabilizes, sweeteners, flavorings, coloring agents, preservatives, chelating agents, osmotic agents, buffers or agents for pH adjustment, acidulants, thickeners, texturizers”; paragraphs [0017], [0023], [0042]). It is noted that inulin and pectin are dietary fibers, as evidenced by Carabin (“Inulin and oligofructose are soluble, fermentable dietary fibers”, “Dietary fiber belongs to the broad category of carbohydrates. They can be classified into soluble (e.g., gums, pectins)”; page 268, right column, paragraph 2; page 280, right column, paragraph 5). Dietary fiber, emulsifiers, osmotic agents, and agents for pH adjustment read on ‘adjuvants’ as described in the instant specification (see specification, page 3, lines 28-32). .
Additionally, Lathan teaches wherein the probiotic composition comprises 4.74 x 108 cfu/g of probiotic (“Fiber blend #2 including agglomerated fiber particles and probiotic…CFU/g… 4.74E+08"; see Table 1 on page 11), and that “if the concentration of viable probiotics in the food product does not exceed a certain threshold value, the beneficial effect of the probiotics is not provided” (paragraph [0003]). Lathan further teaches wherein probiotics “beneficially affect a host by improving a host’s intestinal microbial balance”, and “inhibit or influence the growth and/or metabolism of pathogenic bacteria in the intestinal tract”, and “may also activate the immune function of the host” (see paragraph [0002]).
From Lathan’s teachings one would not immediately envisage a probiotic composition comprising a probiotic composition specifically comprising Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis (instant claims 1, 7-8, 15-17, and 19). Lathan further does not teach wherein the viable count of Bacillus licheniformis in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Bacillus licheniformis in the probiotic composition is not less than 10.0x108 CFU/g (instant claim 3), wherein the viable count of Bifidobacterium longum in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Bifidobacterium longum in the probiotic composition is not less than 4.0x108 CFU/g (instant claim 4), wherein the viable count of Lactobacillus acidophilus in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Lactobacillus acidophilus in the probiotic composition is not less than 1.0×108 CFU/g (instant claim 5), wherein the viable count of Enterococcus faecalis in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Enterococcus faecalis in the probiotic composition is not less than 0.5×108 CFU/g (instant claim 6).
While Lathan does not expressly teach wherein a probiotic composition comprises Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis (instant claims 1, 7-8, 15, 17, and 19), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified Lathan’s composition with Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis, as taught by Lathan, in order to create a probiotic composition comprising Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. One would have been motivated to do so, in order to create a superior probiotic composition that beneficially affects a host (see Lathan above). A skilled artisan would have reasonably expected success in combining Lathan’s probiotic composition with Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis, as taught by Lathan since Lathan suggests all four bacterial strains for a probiotic composition (see paragraph [0027]). Further, since the claims recite comprising language, one would have been motivated to add all the suggested bacterial strains including Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis in the probiotic composition because Lathan clearly teaches the incorporation of several probiotic strains (see paragraph [0004]).
While modified Lathan does not teach wherein the viable count of Bacillus licheniformis in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Bacillus licheniformis in the probiotic composition is not less than 10.0x108 CFU/g (instant claim 3), wherein the viable count of Bifidobacterium longum in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), the viable count of Bifidobacterium longum in the probiotic composition is not less than 4.0x108 CFU/g (instant claim 4), wherein the viable count of Lactobacillus acidophilus in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Lactobacillus acidophilus in the probiotic composition is not less than 1.0×108 CFU/g (instant claim 5), wherein the viable count of Enterococcus faecalis in the probiotic composition is not less than 1×107 CFU/g (instant claims 1, 16, and 20), wherein the viable count of Enterococcus faecalis in the probiotic composition is not less than 0.5×108 CFU/g (instant claim 6), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Lathan’s probiotic composition with Lathan’s teachings on the concentration of colony forming units in the probiotic composition, in order to create a probiotic composition wherein the viable count of Bacillus licheniformis in the probiotic composition is not less than 1×107 CFU/g or not less than 10.0x108 CFU/g, wherein the viable count of Bifidobacterium longum in the probiotic composition is not less than 1×107 CFU/g or not less than 4.0x108 CFU/g, wherein the viable count of Lactobacillus acidophilus in the probiotic composition is not less than 1×107 CFU/g or not less than 1.0x108 CFU/g, wherein the viable count of Enterococcus faecalis in the probiotic composition is not less than 1×107 CFU/g, or not less than 0.5x108 CFU/g. One would have been motivated to do so in order to optimize the probiotic composition for use in a host due to its beneficial effects (see Lathan, paragraphs [0002]-[0003]). A skilled artisan would have reasonably expected success in combining modified Lathan’s probiotic composition with Lathan’s teachings on the concentration of colony forming units in the probiotic composition, since Lathan teaches the necessity of a sufficient concentration of viable probiotic in a product for ensuring beneficial effects provided by said probiotic (see paragraph [0003]).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955). See MPEP § 2144.05 part II A.
While modified Lathan et al. does not teach the process steps recited in instant claims 7, 17, and 19, the probiotic composition in claims 7 and 19 and the probiotic formulation in claim 17 are considered product-by-process limitations, as discussed above under Claim Interpretation, and the method of making the product does not impart a structural limitation absent evidence to the contrary (see MPEP 2113 (I)). Therefore, weight is given to the product ‘probiotic composition’ or ‘probiotic formulation’, and not to the process steps recited in claims 7, 17, and 19. As such, the probiotic composition product in claims 7 and 19, and the probiotic formulation product in claim 17 are unpatentable over modified Lathan’s probiotic products as discussed above.
Response to Arguments
Applicant has traversed the previous rejections of claims 1-6, 8, and 19-20 under 35 U.S.C. 101 (remarks, pages 7-11), and of claims 1-8, 15-17, and 19-20 under 35 U.S.C. 103 (remarks, pages 12-14). As discussed above, the previous rejections of claims of claims 1-8 under 35 U.S.C. 103 have been withdrawn, and new rejections have been presented in light of Applicant’s amendment of 08/11/2025. Lathan are still relied upon in the above rejections. Applicant's arguments filed on 08/11/2025 have been fully considered but they are not persuasive.
In Applicant’s reply, regarding the rejections of claims 1-6, 8, and 19-20 under 35 U.S.C. 101, Applicant states that “there is no naturally occurring counterpart to the claimed combination (the components do not occur together in nature), and further describes that “None of the four claimed substances can treat rapid eye movement sleep behavior disorder in nature. When the 4 substances are combined, however, they can treat rapid eye movement sleep behavior disorder.” (remarks, page 8, paragraph 4, - page 9, paragraph 1).
The Examiner responds that the claimed combination is a combination of bacteria that occur in nature and the combination itself does not appear to have a markedly different characteristic.
The specification does not provide evidence that there is a synergistic effect between the recited bacteria within the composition, since only compositions comprising three or all four recited strains were tested for treating rapid eye movement sleep behavior disorder, and is silent on testing individual strains (“Test group 1 (intervention group): the probiotic formulation was obtained in Example 1 of the present disclosure. Test group 2 (intervention group): each capsule contained a probiotic capsule containing 10x107 CFU of Bifidobacterium longum, 10x107 CFU of Lactobacillus acidophilus, and 10x107 CFU of Enterococcus faecalis”, “Example 1 Preparation of the probiotic formulation in the present disclosure (1) Dried and lyophilized bacterial powders of Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis and adjuvants were mixed to obtain a homogeneous mixture”; see test method in efficacy trial 1 on page 14, lines 1-7, and example 1 on page 10, lines 17-20; see also test method in efficacy trial 2 on page 24, lines 20-21, and example 4 on page 11, lines 22-23).
It is further noted that the concentration of a bacterium does not change the function and characteristic of the bacterium, and thus, the recited bacteria are natural phenomenona independent from their concentration (see MPEP 2106.04(c) I.B).
In Applicant’s reply, regarding the rejections of claims 1-8, 15-17, and 19-20 under 35 U.S.C. 103, Applicant states that “Lathan never focuses on the specific combination of these four particular strains claimed by the applicant” (remarks, page 12).
The Examiner responds that, as discussed above under Claim Rejections - 35 USC § 103, the instant claims recite comprising language, and one would have been motivated to add all the bacterial strains suggested by Lathan, including Bacillus licheniformis, Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis in the probiotic composition because Lathan clearly teaches the incorporation of several probiotic strains (see paragraph [0004]).
Applicant further describes that Lathan “fails to disclose or suggest any minimum viable count requirements for specific bacterial species” (remarks, page 12).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to modify the viable cell count of the bacterial species, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Lathan provides viable cell counts for probiotic strains (Lathan, see Table 1), and Lathan further provides motivation to modify the viable cell count by disclosing the necessity of having a sufficient amount of viable cells for having a probiotic effect (paragraphs [0002]-[0003]).
Applicant states that “The clinical data presented in the description provides compelling evidence of an unexpected synergistic effect arising from the specific combination of these four strains at the claimed viable counts” (remarks, page 13).
The Examiner responds that, as discussed above, the specification does not provide evidence that there is a synergistic effect between the microbes within the composition, since only compositions comprising three or all four recited strains were tested for treating rapid eye movement sleep behavior disorder (see test method in efficacy trial 1 on page 14, lines 1-7, and example 1 on page 10, lines 17-20; see test method in efficacy trial 2 on page 24, lines 20-21, and example 4 on page 11, lines 22-23). The specification is silent on individual strains being tested as probiotics for the treatment of Rapid eye movement sleep behavior disorder, and as such it is not evident if the claimed composition has a stronger health effect compared to the sum of individual health effects provided by a treatment with individual strains.
Conclusion
No claims are 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653