*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 May 8, 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withdrawn. Claim 32 was amended. Claims 16, 27, 28, and 31-33 are examined.
Withdrawn Claim Rejections - 35 USC § 112
Rejection of claim 32 is withdrawn because it was obviated with claim amendments.
Maintained 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 comprising 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 003 8). 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 warming sensates include capsaicin and
nonivamide, among others, wherein the warming 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 100 g of the final beverage product ( column 4 lines 6-14 ). Example 1 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.%
nonivamide 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.
Maintained 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.
Response to Arguments
Applicant’s response dated May 8, 2026 was fully considered but it is not found persuasive for the following reasons.
Arguments that none of the cited references individually teach a combination of arginine and nonivamide are not sufficient of obviate the rejection because an obviousness rejection does not require all of the claimed elements to be in the same reference in order to be proper. The rejection clearly explains which claimed limitations are absent from Constantine and how those deficiencies are met with the secondary references.
Arguments regarding Moriyama’s purpose for using arginine are not persuasive because prior art’s reason does not have to be the same as applicant’s reason in order for modification of the prior art to be proper.
Arguments regarding Spence’s preferred warming sensates and the purpose of using said warming senesates in a masking composition are not persuasive because Spence was relied upon for known concentrations of warming sensates in beverages. It is irrelevant that Spence teachings warming sensates that are not nonivamide.
In response to applicant's argument that the cited references occupy different technical areas, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all cited references are related to beverages where the primary reference teaches combining a warming sensate with amino acids, and it would have been obvious to look to the secondary references for known warming sensates and amino acids that are useful in beverages and arrive at the claimed invention. The selection of a known material based on its suitability for its intended purpose supports obviousness. The benefits observed by the applicant, such as promoting satiety, would have been present in the prior art composition because the prior art composition meets all of the structural requirements of the instantly claimed composition.
Argument that Lin does not teach that capsaicin and nonivamide are interchangeable to achieve the needed organoleptic purposes of Constantine, and merely lists capsaicin and nonivamide in a list of warming sensates, is not sufficient to overcome the rejection because both are known as warming sensates suitable for use in a beverage and that is sufficient for an obviousness rejection. Applicant is essentially arguing that unless Constantine teaches nonivamide then it would not have been obvious to use nonivamide in Constantine’s beverage, which is not the standard for obviousness.
Argument against Moriyama’s purpose of using free arginine is not persuasive because prior art’s purpose does not have to be the same as applicant’s for an obviousness rejection to be proper. Constantine teaches using amino acids in the beverage, and benefits of using free arginine in a beverage were known from Moriyama, which provides motivation to use free arginine in Constantine’s beverage.
Arguments directed to the teachings of Spence are not persuasive because the rejection is made over a consumable product (i.e. a beverage) as a whole and not over a component that is used to make the consumable product. This is clear from because the rejection states that it would have been obvious to make a beverage as taught by Constantine followed by modifications of Constantine’s beverage in view of the teachings of secondary references that also teach components and their corresponding amounts that are known to be used in a beverage. The claimed combination agent is found obvious over a beverage composition as a whole. The preamble “combination agent” does not limit the claimed composition by any structure and any prior art composition that contains the claimed components reads on the claimed “combination agent”. Thus, examiner’s calculation of the lowest concentration of warming agent in the beverage composition is proper, and the calculated range overlaps with the claimed range.
Double patenting rejection is maintained because applicant requested the rejection to be held in abeyance.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617
Prosecution Insights