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 . Claims included in prosecution are claims 11, 14, and 16-20.
Previous Rejections
Applicants' arguments, filed 10/30/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 11 is objected to because of the following informalities: “UFC” in line 5 should be recited as --- CFU ---. Appropriate correction is required.
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.
1. Claims 11, 14, and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites “wherein glutamine, Lactobacillus rhamnosus and curcumin act synergistically”.
The instant specification teaches a nutraceutical or pharmaceutical composition comprising one or more sources of fiber, glutamine, Lactobacillus rhamnosus, one or more sources of omega-3, and curcumin. The instant specification makes reference to synergism in relation to a prior art teaching of a composition comprising silybin; quercetin; curcumin, or turmeric rhizome extract; and/or vitamin E.
However, the instant specification does not offer sufficient description of the common structural elements or identifying characteristics that constitute a synergistic relationship/combination between glutamine, Lactobacillus rhamnosus, and curcumin. There is no description of structural elements of a relationship/combination between glutamine, Lactobacillus rhamnosus, and curcumin that are sufficient to distinguish the claimed combination of glutamine, Lactobacillus rhamnosus, and curcumin from other combinations comprising said components. Furthermore, the instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics. Furthermore, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize the glutamine, Lactobacillus rhamnosus, and curcumin combination as synergistic. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed a synergistic combination of glutamine, Lactobacillus rhamnosus, and curcumin.
Since no basis has been found to support the new claim limitation in the specification, the claims are rejected as incorporating new matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 11, 14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ao et al. (US 2014/0271979, Sep. 18, 2014) (hereinafter Ao) in view of Suskind et al. (J Pediatr Gastroenterol Nutr. Mar. 2013; 56(3): 277–279) (hereinafter Suskind).
Ao discloses anti-regurgitation nutritional compositions for pediatric subjects (Abstract). The composition comprises at least one hydrolyzed protein source; a lipid component; at least one pre-gelatinized starch; at least one pectin; and at least one additional carbohydrate. The nutritional composition may further include at least one prebiotic, at least one probiotic, at least one additional phytonutrient component, at least one long-chain polyunsaturated
fatty acid (LCPUFA), and/or an amount of β-glucan (¶ [0007]). In a particular embodiment, the nutritional composition is protein-free and contains free amino acids as a main protein equivalent source. Suitable amino acids include glutamine which may be included in amounts of up to about 5 g per 100 kcal of composition (¶ [0061]). Suitable probiotics include Lactobacillus rhamnosus GG which may be included in an amount of about 1 x 106 to about 1 x 1010 CFU per 100 kcal (¶ [0088-0089]). Suitable LCPUFAs include docosahexaenoic acid (DHA) (¶ [0098]). LFPUFAs maybe included in an amount of at least about 5 mg per 100 kcal (¶ [0100]). Suitable phytonutrients for use include curcumin (¶ [0129]). Nutrients may be delivered as part
of the composition for the purpose of meeting nutritional needs and/or in order to optimize the nutritional status in a subject (¶ [0149]). The composition may be utilized in a staged nutritional feeding regimen for a pediatric subject, which includes a plurality of different nutritional compositions according to the invention. Each nutritional composition comprises a hydrolyzed protein, at least one pre-gelatinized starch, and at least one pectin. In certain embodiments, the nutritional compositions of the feeding regimen may also include a source of long chain polyunsaturated fatty acid or any other ingredient described. Said compositions may be administered once per day or via several administrations throughout the course of a day (¶ [0155]).
Ao differs from the instant claims insofar as not disclosing the amount of curcumin utilized in the composition.
However, Suskind discloses that tolerability study to assess increasing dosages of curcumin pediatric subjects tolerated doses of curcumin up to 2 grams (Results).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Ao to contain curcumin in an amount of up to 2 grams since this is the highest tolerated does by pediatric subjects as taught by Suskind.
Regarding claim 11 reciting a dosage of glutamine (i.e., 5 g to 30 g), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, suitable amino acids include glutamine which may be included in amounts of up to about 5 g. Accordingly, because the range recited in the instant claims overlaps with the amount disclosed by Ao, the amount disclosed by Ao meets the instantly recited limitation.
Regarding claim 11 reciting a dosage of Lactobacillus rhamnosus (i.e., 0.05 x 106 to 100 x 1010 CFU), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Ao discloses that suitable probiotics include Lactobacillus rhamnosus GG which may be included in an amount of about 1 x 106 to about 1 x 1010 CFU. Accordingly, because the range recited in the instant claims overlaps with the range disclosed by Ao, the range disclosed by Ao meets the instantly recited limitation.
Regarding claim 11 reciting a dosage of omega-3 sources (i.e., 0.8 g to 1.4 g), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Ao discloses that suitable LCPUFAs include docosahexaenoic acid (DHA) which may be included in an amount of at least about 5 mg. Accordingly, because the range recited in the instant claims overlaps with the range disclosed by Ao, the range disclosed by Ao meets the instantly recited limitation.
Regarding claim 11 reciting fiber sources such as starches, pectin, and beta-glucans, as discussed above, Ao discloses wherein the composition comprises at least one pre-gelatinized starch; at least one pectin; and/or an amount of β-glucan. Accordingly, a composition comprising such components would have been obvious.
Regarding claim 11 and 20 reciting synergetic use for treating intestinal dysbiosis, this is merely a recitation of the intended use of the claimed composition. Since the composition of Ao in view Suskind is substantially the same as the claimed composition, comprising substantially the same components, one of ordinary skill in the art would reasonably conclude that the composition of Ao in view Suskind would be suitable for treating intestinal dysbiosis, whether the prior art discloses such use or not.
Regarding claims 11 and 14 reciting sources of omega-3 such as docosahexaenoic acid, as discussed above, Ao discloses wherein suitable LCPUFAs include docosahexaenoic acid. Accordingly, a composition comprising docosahexaenoic acid would have been obvious.
Regarding claims 16-19 reciting different parts comprising different components, as discussed above, Ao discloses wherein composition may be utilized in a staged nutritional feeding regimen for a pediatric subject, which includes a plurality of different nutritional compositions according to the invention. Each nutritional composition comprises a hydrolyzed protein, at least one pre-gelatinized starch, and at least one pectin. In certain embodiments, the nutritional compositions of the feeding regimen may also include a source of long chain polyunsaturated fatty acid or any other ingredient described. As such it would have been obvious for one of ordinary skill in the art to have formulated Ao’s compositions to contain three stages/compositions, a first stage/composition comprising the source(s) of dietary fibers and glutamine, a second stage/composition comprising the probiotic(s), a third comprising the source(s) of omega-3, the antioxidant(s) being included in the first module of the composition and/or in the third module of the composition since Ao discloses wherein the one or more stage/composition may comprise any of these components.
Regarding the amounts recited in instant claims 17-19, where 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. See MPEP 2144.05(II)(A). As discussed above, Ao discloses that nutrients may be delivered as part of the composition for the purpose of meeting nutritional needs and/or in order to optimize the nutritional status in a subject. Accordingly, amounts of nutrients included in the composition are a result effective variable, since amounts directly impact the nutritional needs/status in a subject. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of fiber/glutamine/omega-3 to yield the desired nutritional needs/status (i.e., therapeutic effect) in a subject.
Therefore, the combined teachings of Ao and Suskind render obvious claims 11, 14, and 16-20.
Response to Arguments
Applicant’s arguments with respect to claims 11, 14, and 16-20 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. Ao in view of Suskind which teach a composition comprising, among other components, pectin/beta-glucan, Lactobacillus rhamnosus, glutamine, DHA, and curcumin were applied to meet the new limitations reciting specific dosages of Lactobacillus rhamnosus, glutamine, omega-3 sources, and curcumin.
Conclusion
Claims 11, 14, and 16-20 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612