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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 26 January 2026 is acknowledged. Accordingly, claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 6 is objected to because of the following informalities: “xanthum” should be recited as --- xanthan ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “glycerrizin” should be recited as --- glycyrrhizin ---. Appropriate correction is required.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Horcajada et al. (EP 2981253 B1, 01/06/2021, IDS reference 03/03/2026) (hereinafter Horcajada).
Horcajada discloses a nutritional composition comprising bioactive substance such as vitamins A and C ([0043]; [0057]), a blend of different fibers including xanthan gum and guar gum in hydrolyzed or non-hydrolyzed form ([0056]), lecithin ([0060]), and may additionally include glucooligosaccharides, xylooligosaccharides ([0054]), and amylose starch ([0059]). The composition may be formulated in the form of tablets ([0068]). Effective amounts of a composition will vary with the particular composition, route of administration, and/or age and condition of recipient ([0037]).
Together these would provide compositions as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). See also MPEP § 2144.06(I), supporting combining known ingredients for their known functions is generally obvious.
Although Horcajada does not explicitly recite the ranges of the components, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so it would have been obvious to determine workable ranges to arrive at the claimed amounts in weight percentages. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 7, as noted by Para. [0054] of the instant specification: the mannose/galactose (M/G) ratio of fenugreek, guar, tara, and locust bean gums are 1.0-1.1/1.0, 1.6-1.8/1.0, 3.0/1.0, and 3.9-4.0/1.0, respectively. Thus the guar gum of Horcajada meets the limitations as instantly claimed.
Regarding claims 8 and 10, although Horcajada does not explicitly recite the weight ratios of the components, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed weight ratios of the components through routine experimentation based on the desired amounts suitable for the intended population as taught by Horcajada. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 12-14, reciting properties of a powder, it is not necessary for Horcajada to disclose the recited particle size of said powder since claim 11, from which it depends, as currently recited, does not require the nutraceutical composition in the form of a powder. Claim 11 recites wherein the nutraceutical formulation may be in the form of a powder, granules, syrup, tablets, capsules, or spherical beads. which Horcajada discloses by disclosing wherein the composition may be formulated as tablets. Moreover, in any case, the selection of appropriate powder particle sizes would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed particle sizes in mesh or nm. "[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." See MPEP § 2144.05(II)(A).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,785,380; claims 1-7 of U.S. Patent No. 9,855,308; claims 1-10 of U.S. Patent No. 10,624,942; and claims 1-11 of U.S. Patent No. 11,241,462 in view of Horcajada et al. (EP 2981253 B1, 01/06/2021, IDS reference 03/03/2026) (hereinafter Horcajada).
The pending claims differ from the patented claims insofar as reciting a hydrolyzed galactomannan and further ingredients of instant claim 15.
However, these features are known. As noted in the current rejections, the teachings of Horcajada render obvious claims 1-15.
Therefore, as claims 1-12 of U.S. Patent No. 8,785,380, claims 1-7 of U.S. Patent No. 9,855,308, claims 1-10 of U.S. Patent No. 10,624,942, claims 1-11 of U.S. Patent No. 11,241,462, and Horcajada all disclose powdered nutritional compositions compositions comprising fibers and galactomannans, it would have been prima facie obvious to one of ordinary skill in the art to have modified the patented applications and to include the teachings of Horcajada as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Citation of the State of the Art and Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsuda et al. (US 2006/0188633 A1, 08/24/2006), directed to a water soluble dietary fiber-containing composition comprising a thickening polysaccharide.
Spence et al. (US 2011/0027412 A1, 02/03/2011), directed to a composition for promoting gastrointestinal and/or cardiovascular health comprising dietary fibers..
Paliyath et al. (US 2022/0018038 A1, 01/20/2022) and (US 2022/0008349 A1, 01/13/2022), directed to plant tissue-derived nanoparticles and food powder.
Urakabe (WO 2018/181380 A1, 10/04/2018), directed to health food containing an edible composition for intestinal bacteria.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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