-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 .
Applicant’s response dated January 20, 2026 is acknowledged.
Priority
This application is a continuation of 17/423,400 dated 07/15/2021, which is a 371 of PCT/EP2019/051301 filed on 01/18/2019.
Claim Status
Claims 16-33 are pending. Claims 1-15 were canceled. Claims 17-26, 29, and 30 are withdrawn. Claims 16, 27, 28, and 31-33 are examined.
Election/Restriction
Applicant’s election with traverse of Group I (Claims 16-28 and 31-33), drawn to a combination agent in the reply filed on January 20, 2026, is acknowledged.
Applicant’s election without traverse of the species of the combination agent in which the optional components c and d are not required, is acknowledged.
Claims 16, 27, 28, and 31-33 read on the elected species.
1.The traversal is on the grounds that there is unity of invention because a reference was not provided showing that the common technical feature among the groups is known in the art.
This argument is not persuasive because instant applicant is not a 371 and thus the rules for breaking unity do not apply to the restriction requirement.
2.Applicant traversed the restriction between Groups I and II by arguing that the claimed product cannot be used in a materially different process or that the claimed process cannot be practiced with another product.
This argument is not persuasive because it was shown that the claimed product be used in a materially different process such as in a method of making an orally consumable preparation or food.
3.Applicant traversed the restriction between Groups I and III by arguing that claim 30 necessarily produces the same product of claim 16 and the product is not made using a materially different process.
This argument is not persuasive because claim 30 is a method of using the product of claim 16, and not a method of making product of claim 16. The restriction is proper because it was shown that the product of claim 16 can be used in a materially different process such as in a method of reducing appetite, providing feeling of satiety, reducing energy intake and reducing body weight where the product is administered to a subject in need thereof.
4.Applicant traversed the restriction requirement by arguing that there would not be a serious burden in examining all the groups because all groups fall under the same classification, and searching the product necessarily identifies the art relevant to the methods. Searching the methods would not add search intensive technical features. A restriction does not reduce search burden and therefore is not justified.
This argument is not persuasive because having the same or different classification is not the only criteria that determines whether or not there is a serious burden in examine all the groups. Examining product claims and method claims requires different search strategies and considerations. A search of the product does not have to take method steps into consideration. A search of the product may recover prior art that is relevant to methods of using the product, however additional searching is required to address the claimed method steps. Method claims also require additional considerations beyond searching, such as enablement.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 17-26, 29, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims. Please note that after a final requirement for restriction, the Applicants, in addition to making any response due on the remainder of the action, may petition the Commissioner to review the requirement. Petition may be deferred until after final action on or allowance of claims to the invention elected, but must be filed not later than appeal. A petition will not be considered if reconsideration of the requirement was not requested. (See § 1.181.).
Response to the restriction requirement of November 20, 2025 was timely filed.
Claims 16, 27, 28, and 31-33 are examined on the merits.
Claim Rejections – 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 is indefinite because it recites an improper Markush language and the alternatives form which the preparation is selected are not clear. The claim recites that the preparation is selected from the group consisting of followed by a list that contains “insects or insect products”, “eggs or egg products”, “partial or complete protein hydrolysate, or physico-chemically, enzymatically or fermentatively modified proteins”, “fat- and oil-based products”, “other ready-to-serve meals and soups”, which renders the claim indefinite because it is not clear what elements are alternatives. It is recommended to amend the claim by listing the alternatives and separating each alternative with a comma without using multiple occurrences of “and” and “or”, such as “selected from the group consisting of A, B, and C”.
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 CPR 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.
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.
Claims 16, 27, 28, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over
Constantine (US 2009/0162483 Al Published June 25, 2009 – of record in IDS dated 09/16/2025), Lin (US 2015/0238613 A Published August 27, 2015 – of record in IDS dated 09/16/2025), Moriyama (US 5,229,390 Date of Patent July 20, 1993 – of record in IDS dated 09/16/2025), and Spence (US 2007/0036733 Al Published February 15, 2007).
The claims encompass a combination agent comprising (a) nonivamide and (b) free arginine, its isomers, or derivatives.
The teachings of Constantine are related to sports beverage compositions in liquid drink
form for optimizing muscle performance during exercise (Abstract). One embodiment includes a
sports beverage composition comprises about 2.2 to about 3.5 weight percent of a whey protein
isolate based on the total weight of the composition; and a flavoring agent (paragraph 0012). The
particular amount of the flavoring agent effective for imparting flavor characteristics to the
composition will depend upon several factors including the flavor, the flavor impression, and the
like (paragraph 0038). Suitable amounts of the flavoring agent can be selected by one of ordinary
skill in the art without undue experimentation using guidelines provided. In one embodiment, the
flavoring agent can be present in a beverage composition from about 0.1 to about 8.0 wt.%
based on the total weight of the beverage composition (paragraph 0039). In some embodiments,
the composition may include amino acids (paragraph 0063). The compositions further comprise
sensates including warming agents (paragraphs 0100·-0102) such as capsaicin (paragraph 0103).
Sesantes are present in a concentration of 0.01-10 wt. % of the beverage composition (paragraph
0106).
Constantine does not teach nonivamide.
The teachings of Lin are related to compositions with reduced bitter taste (title).
Compositions include beverages (paragraph 0024). The compositions comprise sensates such as
warming sensates (paragraph 0092). Examples of wam1ing sensates include capsaicin and
nonivamide, among others, wherein the \va.rming sensates are present in a concentration of
0.005-2 wt.% (paragraph 0096).
Constantine and Lin do not teach free arginine or its isomers or derivatives.
The teachings of Moriyama are related to an edible composition comprising an amino
acid capable of accelerating a release of glucagon. The composition is useful in the enhanced
mobilization of depot body fats through physical activity such as sports (Abstract). The
composition includes a beverage (column 2 lines 30-38). The preferred amino acid is arginine in
free form or salt form (column 2 lines 39-45). The beverage contains various dietetically
acceptable vehicles and additives in addition to the essential ingredients including amino acids
(column 3 lines 18-54). The essential ingredient in the final product is suitably 0.1-25 g per 100g
of the final beverage product (column 4 lines 6-14). Example l teaches formulations comprising
1.2g, 3g, and 2g of arginine per 100 mL of composition (table bridging columns 4 and 5).
Constantine, Lin, and Moriyama do not teach a concentration range of the warming sensates that overlaps with the claimed range of nonivamide.
The teachings of Spence are related to masking compositions that include warming
sensate (Abstract). The amount of warming sensate ranges from about 0.001 to about 5% by
weight based on the total weight of the sensate masking composition (paragraph 0021). The
sensate masking composition ranges from about 0.001 to 0.25% of the total weight of the
consumed composition (paragraph 0023). The sensate masking composition may be applied to
all types of beverages (paragraph 0024).
The teachings of Constantine, Lin, and Moriyama are related to a beverage and it
would have been obvious to have combined their teachings because they are in the same field of
endeavor. It would have been prima facie obvious to a person of ordinary skill in the art before
the effective filing date of the claimed invention to have formed a beverage comprising capsaicin as a warming agent in a concentration of 0.01-10 wt. % and an amino acid, where the concentration is based on the total weight of the composition; with a reasonable expectation of success because Constantine teaches a sports beverage comprising capsaicin as a warming agent in a concentration of 0.01-10 wt. % and an amino acid, where the concentration is based on the total weight of the composition.
It would have been obvious to have modified the beverage of Constantine by replacing
capsaicin with nonivamide, with a reasonable expectation of success because it was known from
Lin that capsaicin and nonivamide are known warming agents suitable for use in beverages and
replacing one warming agent with another to obtain predictable result would have been obvious
because the two are recognized in the art as equivalent.
It would have been obvious to have selected arginine as the amino acid in Constantine's
beverage, with a reasonable expectation of success because it was known from Moriyama that
arginine in free form is a suitable amino acid for use in a beverage. One of skill would have been
motivated to use arginine because it was known for accelerating the release of glucagon during
physical activity such as playing sports, and the purpose of Constantine is to form a sports
beverage that optimizes muscle performance during exercise, speeds up the uptake of glucose
into the muscle cells during exercise, increases the efficiency of every gram of every
carbohydrate consumed during exercise, replenishes glycogen stores in the muscle, and speeds
the uptake of glycogen into muscle (paragraph 0024 of Constantine). It would have been obvious
to have added arginine in a concentration of 1.2 wt. %, 3 wt. %, 2 wt. %, or 6 wt. % because
Moriyama teaches beverage compositions containing 1.2 g, 3 g, and 2 g of arginine per 100 mL
of composition (example 1), and a 100 mL composition comprising 6.25 g of L-arginine
(example 2 column 6 lines 15·-30).
The teachings of Spence and Constantine modified with Lin and Moriyama are
related to beverage compositions comprising warming sensates and it would have been obvious
to have combined their teachings because they are in the same field of endeavor. It would have
been prima facie obvious to a person of ordinary skill in the art before the effective filing date of
the claimed invention to have further modified Constantine's composition by varying the concentration of warming sensates from 0.00001 wt.% and up to 10 wt.%, with a reasonable expectation of success because Spence teaches that a consumed composition comprises 0.001-0.25 wt.% of a sensate masking composition wherein the sensate masking composition contains a warming sensate in a concentration of 0.001-5% by weight. Thus, according to the teachings of Spence the lowest amount of a warming sensate in the consumed composition would be 0.00001 wt.% based on the total weight of the consumed composition. The upper end of the range 10 wt. % was known from Constantine.
Combining prior art elements according to known methods to obtain predictable results
supports obviousness. The selection of a known material based on its suitability for its intended
use supports obviousness.
Regarding claim 16, Constantine's modified sports beverage comprises 0.00001-10 wt.%
nonivarnide and 6.25 wt. % arginine. The claimed range of nonivamide is obvious because it overlaps with 0.00001-10 wt.%. The claimed range of arginine is obvious because it encompasses 6.25 wt. %.
Regarding claim 27, it would have been obvious to have used water as a carrier, with a
reasonable expectation of success because Constantine teaches that the composition comprises
water (paragraph 0009).
Regarding claim 28, the claimed range of arginine is obvious because it encompasses 6.25 wt. %.
Regarding claims 31 and 32, Constantine teaches a beverage and it is apparent from the reference as a whole that the beverage does not require alcohol, therefore it is a non-alcoholic beverage.
Regarding claim 33, the combination agent comprising nonivamide (6.25 wt. %) and arginine (0.00001-10 wt. %) renders the claimed concentration range obvious because the claimed range encompasses the combined concentrations of nonivamide and arginine.
Double Patenting Rejection
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 16, 27, 28, and 31-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 9, 10, and 12-23 of copending Application No. 17/423,400 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending claims are drawn to a combination agent comprising 0.1-10 ppm of nonivamide and 5-20 wt. % of free arginine, and carrier; and an orally consumable preparation or food ingredient comprising said combination agent and wherein the combination agent is present in a concentration of 1-80 wt. % based on the total weight of the orally consumable preparation. The orally consumable product reads on a snack food.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617