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 in the Request for Continued Examination, filed May 26, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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). The study suggests that curcumin may be used as an adjunctive therapy for individuals seeking a combination of conventional and alternative medicine without clinically significant side effects or adverse events (Discussion).
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 dose 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 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 filed on 5/26/2026 have been fully considered but are not persuasive.
Regarding Applicant’s argument that Ao does not disclose the claimed components all in one composition, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). Where Ao in view of Suskind teach a composition comprising pectin/beta-glucan, Lactobacillus rhamnosus, glutamine, DHA, and curcumin in dosages that overlap with those instantly claimed, it would have been obvious for one of ordinary skill in the art to have formulated a composition comprising said components in said dosages because the combination is suggested.
Regarding Applicant’s arguments with respect to Suskind, as a threshold matter, Applicant’s assertion that “The Office Action asserts that based on this teaching, a person of ordinary skill in the art would have been taught to use the highest tolerated dose because it is the highest tolerated dose” appears to be inaccurate. The previously mailed Office Action, dated 2/23/26, concluded that it would have been obvious to include curcumin “in an amount of up to 2 grams since this is the highest tolerated dose”. As such, it can be seen that the Office Action did not conclude that it would have been obvious to use the highest dose specifically, but amounts ranging up to it.
Regarding Applicant’s argument that the overlap between Ao and Suskind is little, the Examiner submits that there is indeed sufficient overlap between the two references where Suskind provides strong motivation for one of ordinary skill in the art to use a recommended dosage range of curcumin for pediatric patients. One of ordinary skill in the art would seriously consider the tolerance of a patient to an active’s dosage prior to administration especially when considering the fact that the composition of Ao is directed to pediatric subjects (i.e., patients with ages that overlap with those of Suskind). One of ordinary skill in the art would not administer an active in amounts that are greater than the tolerated dose for a specific clinical population for the purpose of avoiding undesirable side effects and adverse events. To the contrary, they would be strongly motivated to administer the active within the tolerated dosage range desiring to achieve a therapeutic effect while avoiding the aforementioned side effects. This is especially true when the cited reference discloses that said tolerated dose was found for pediatric patients in ages that overlap with the target patient population of the primary composition. This is further supported by Suskind suggesting the use of curcumin in combination therapy where they disclose that the study suggests that curcumin may be used as an adjunctive therapy for individuals seeking a combination of conventional and alternative medicine without clinically significant side effects or adverse events.
Regarding Applicant pointing to the alleged criticality of the amounts cited in Table 4 of the instant specification, and the Faucher publication, the Examiner submits that the claims must be “commensurate in scope” with the showing. See MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02 and 716.02(b) I-II.
For instance, Applicant’s claim 11 requires from 5 g to 30 g of glutamine, 0.05 x 106 to 100 x 1010 CFU of Lactobacillus rhamnosus, from 0.8 g to 1.4 g of omega-3, and 0.8 g to 1.4 g of curcumin. However, for example, the compositions of Table 4 contain several additional unrecited actives of the same class as these aforementioned components. Furthermore, the amounts recited in Table 4 are extremely specific in comparison to the broad recitations of the claim. The same issue is found in the Faucher publication where Faucher discloses a very specific combination of amounts/components in comparison to the very broad recitation of the instant claim. As such, a trend cannot be reasonably established. Therefore, the probative value of the data cannot be reasonably extended across the full breadth of the claimed ranges since a trend cannot be reasonably determined. As such, Applicant’s data is not commensurate in scope with the instant claims.
Regarding Applicant’s arguments that there is no indication that Suskind's curcumin would operate effectively in combination, as discussed above, Suskind suggests the use of curcumin in combination therapy where they disclose that the study suggests that curcumin may be used as an adjunctive therapy for individuals seeking a combination of conventional and alternative medicine without clinically significant side effects or adverse events.
Regarding Applicant’s arguments that the combination of Ao in view of Suskind amounts to picking and choosing from different references, Applicant is reminded that a skilled artisan is not an automaton, but a person having ordinary skill in the art and is capable of fitting teachings of multiple prior art documents together like pieces of a puzzle. See MPEP § 2143.03. Therefore, a skilled artisan would be highly capable of combining the teachings of Ao and Suskind to arrive at the claimed composition and dosage of curcumin in view of the strong motivation Suskind provides. Since the cited prior art teaches each of the instantly recited limitations, a prima facie case of obviousness is established.
Regarding Applicant’s arguments that a reasonable expectation of success is not articulated with respect to the routine optimization rejection, one of ordinary skill in the art would have had a reasonable expectation of success when adjusting the amounts of nutrients since the composition is nutritional in purpose and 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 which makes such amounts a result effective variable.
Regarding Applicant’s arguments with respect to improper hindsight, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, where Ao teaches a composition comprising pectin/beta-glucan, Lactobacillus rhamnosus, glutamine, DHA, and curcumin and Suskind provides strong motivation for one of ordinary skill in the art to use curcumin in dosages that overlap with those instantly claimed, it would have been obvious for one of ordinary skill in the art to have formulated a composition comprising said components in said dosages. Accordingly, no improper hindsight was used in the conclusion of obviousness in the rejection of record.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 11, 14, and 16-20 are rejected.
Claims 21, 24, and 26-30 are withdrawn.
No claims are allowed.
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
/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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