*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 February 12, 2026 is acknowledged.
Priority
This application is a 371 of PCT/EP2019/051301 filed on 01/18/2019.
Claim Status
Claims 1, 3-7, 9, 10, and 12-28 are pending. Claims 24-28 were newly added and read on the elected invention. Claims 2, 8, and 11 were cancelled. Claims 1 and 7 were amended. Claims 4, 9, 10, 12, 13, 16, 18-20, 22, and 23 remain withdrawn. Claims 1, 3, 5-7, 14, 15, 17, 21, and 24-28 are examined.
Withdrawn Claim Objections
Objections to claim 1 are withdrawn because objections were obviated with claim amendments.
Withdrawn ClaimRejections-35 USC§ 112(a), (b), and (d)
Rejections of claims 1, 3, 5-7, 14, 15, 17, and 21 are withdrawn because rejections were obviated with claim amendments.
New Claim Rejections – 35 USC § 112
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 does not further limit claim 1 because the range of amounts (at least 0.1 g) of L-arginine in claim 5 is broader than the range of amounts (at least 0.5 g) of L-arginine in claim 1. This rejection is necessitated by amendment of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New Claim Rejections - 35 USC§ 103
Necessitated by Amendment
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.
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, 3, 5-7, 14, 15, 17, 21, and 24-28 are rejected under 35 U.S.C. 103 as being
unpatentable over Constantine (US 2009/0162483 Al Published June 25, 2009), Lin (US
2015/0238613 A Published August 27, 2015), Moriyama (US 5,229,390 Date of Patent July 20,
1993), Martin (US 2004/0253227 Al, Published December 16, 2004), and Spence (US 2007/0036733 Al Published February 15, 2007).
The claims encompass a combination agent comprising (a) nonivamide, (b) free arginine, its isomers, or derivatives, (c) whey protein isolate, and (d) caramel aroma.
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 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 Mortyama 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 1 teaches formulations comprising
1.2g, 3 g, and 2g of arginine per 100 mL of composition (paragraph bridging columns 4 and 5).
Constantine, Lin, and Moriyama do not teach caramel aroma.
The teachings of Martin are related to a protein beverage (Abstract). The beverage
comprises a flavoring selected from caramel, among others (paragraph 0033).
The teachings of Constantine, Lin, Moriyama, and Martin 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 about 2.2
to about 3.5 weight percent of a whey protein isolate, a flavoring agent in a concentration from
about 0.1 to about 8.0 wt.%, capsaicin as a warming agent in a concentration of 0.01-10 wt.%,
and amino acids, where the concentrations are based on the total weight of the composition; with
a reasonable expectation of success because Constantine teaches a sports beverage comprising
said components in said concentration ranges.
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 would have been obvious with a reasonable
expectation of success because the two are recognized in the art as equivalent. It would have
been obvious to have varied the amount of the warming agent in the range of 0.005-10 wt.%
because Lin teaches using the warming sensates in a concentration of 0.005-2 wt. % and
Constantine teaches using the warming sensates in a range of 0.01-10 wt. %. Thus, according to
the state of the art 0.005 wt.% is the lowest concentration and 10 wt.% is the highest
concentration of warming agent in a beverage composition.
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 0.l g to 25 g per total 100g of the final beverage
product because Moriyama teaches beverage compositions containing 0.1-25 g of essential
ingredient where arginine is considered an essential ingredient. Thus, Moriyama teaches arginine
in a concentration of 0.1-25 wt. % based on the total weight of the beverage composition.
Nonivamide would have been present in a concentration of 0.005-10 wt.% and arginine
would have been present in a concentration of 0.1-25 wt. %.
It would have been obvious to have formed Constantine's beverage with caramel flavor,
with a reasonable expectation of success because it was known from Martin that caramel flavor
is suitable for flavoring a protein beverage. Constantine teaches various flavoring agents in the
beverage and teaches using 0.1-8 wt.% of flavoring agent, and it would have been obvious to
have varied the concentration of caramel flavor in the range of 0.1-8 wt. %.
The teachings of Constantine, Lin, Moriyama, and Martin are relied upon as summarized
above. The combination of references teaches concentration ranges of each component ranges
that overlap with the claimed ranges or ranges that are close enough. However, the rejection is
further made over Spence to show that warming sensates were known to be used in a
concentration range that overlaps with the instantly claimed range.
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 Spence and Constantine modified with Lin, Moriyama, and Martin 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 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. The weight ratio of nonivamide to arginine would be from 0.00001:25 to 10:0.1, which is equivalent to a range of from 1:2,500,000 to 1:0.01. The claimed range of weight ratios in claims 1 and 27 are obvious because they overlap with the prior art range.
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.
Constantine's modified sports beverage comprises:
-0.00001-10 wt.% nonivamide, which renders the one or more first saturating
components obvious. The claimed concentration range is obvious because it overlaps with
concentration range of the prior art. Constantine teaches a concentration of warming agent of
0.01-10 wt.%, Lin teaches a concentration range of warming agent of 0.005-2 wt.%, and Spence
teaches a concentration range of warming sensate of 0.00001-0.0125 wt.%. Thus, among the
three references, the prior art teaches a warming agent in a concentration of 0.00001-10 wt. %.
MPEP 2144.05(11);
- 0.1-25 wt.% of free arginine, which renders the claimed concentration range of 5-20
wt. % obvious;
- 2.2-3.5 wt.% whey protein isolate, which renders the one or more second saturation
component(s) obvious, the claimed range is obvious because it encompasses the prior art range;
and
-0.1-8 wt.% caramel flavor, the claimed range is obvious because it overlaps with the
prior art range.
Regarding claim 3, whey protein isolate meets the limitation of a protein from milk.
Claim 3 teaches a genus of proteins from milk, and whey protein isolate is species of milk
proteins.
Regarding claims 1 and 5, it would have been obvious to have formed 100 mL of Constantine's composition with 0.1-25 g of L-arginine, with a reasonable expectation of success because Moriyama teaches 100 mL beverage compositions containing 0.1-25 g of an essential ingredient where L-arginine is an essential ingredient. A 100 mL beverage could be considered a regularly consumable amount. Thus, the claimed amount range of at least 0.1 g and at least 0.5 g of L-arginine in a regularly consumable amount is obvious because it encompasses 0.1-25 g.
Regarding claim 6, 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 14, the prior art composition is a beverage, which is an orally
consumable preparation.
Regarding claim 15, it would have been obvious to have formed the beverage to comprise
85-96 wt. % water and 4-15 wt. % of the combination of remaining components including whey
protein isolate, arginine, nonivamide, and caramel flavor, with a reasonable expectation of
success because Constantine teaches an example of a beverage composition which comprises 85-
96 wt.% water and 4-16 wt.% of all remaining components (paragraph 0128). The claimed
concentration range 1-80 wt.% of the combination of whey protein isolate, arginine,
nonivamide, and caramel flavor is obvious because it encompasses 4-16 wt. %.
Regarding claims 17 and 21, the claims are met because prior art teaches whey protein
isolate.
Regarding claim 24, the claimed range is obvious because it overlaps with 0.00001-10 wt.% nonivamide.
Regarding claim 25, the claimed range is obvious because it overlaps with 0.1-25 wt.% of free arginine.
Regarding claim 26, the claimed range is obvious because it overlaps with 0.1-25 g of L-arginine.
Regarding claim 28, prior art teaches nonivamide.
Response to Arguments
Applicant's arguments submitted in the remarks dated February 12, 2026, were fully
considered but are not persuasive for the following reasons.
Arguments related to concentrations of warming sensates are not persuasive because the combination of references teaches a range that overlaps with the instantly claimed range. 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. The purpose of nonivamide in the prior art and its purpose in combination with arginine does not have to be the same as applicant’s for an obviousness rejection to be proper.
Applicant’s argument related to the use of component (a) at a subthreshold (subsensory) dose is not persuasive because applicant has not presented evidence that the claimed range is considered subsensory or subthreshold. Paragraphs 0042-0044 were reviewed and the paragraphs do not support what the applicant is arguing.
Paragraph 0036 teaches “In all embodiments of the first saturation component, the first saturation component or a mixture of more than one of the first saturation components is preferred to exhibit only a subthreshold odor or taste value in the feed concentration, i.e., preferably the first saturation component or a mixture of more than one of the first saturation components is used around the detection threshold or lower.”. Based on this teaching, it is not clear where the distinction is between the detection threshold or lower in applicant’s concentration ranges.
Arguments against Moriyama and Martin are not persuasive because it is irrelevant that the purpose of arginine is not same as applicant’s purpose and that all of the claimed limitations are not present in the two references. The rejection is made over multiple references.
Arguments against the quantitative limitations are not persuasive because the combination of references teaches ranges of concentrations and amounts that overlap with the instantly claimed concentrations and amounts. The ratio based on concentrations was calculated and it overlaps with the claimed range of ratios. Applicant did not show any evidence that the claimed concentration is subsensory.
Arguments that the cited references address divergent technical goals and operate in incompatible dosing regimens is not persuasive because applicant’s reason for combining prior art references does not have to be the same as suggested by prior art for an obviousness rejection.
In response to applicant's argument that a person having ordinary skill in the art working from any of these references would not be led to the problem solved by the present invention – namely reducing subjective hunger and energy intake by TRPV1-enabled arginine regimen, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant’s argument regarding that reducing TRPV1 agonists into the sub-threshold 0.1-10 ppm regime would eliminate their intended function is not persuasive because the applicant did not provide any evidence that 0.1-10 ppm is a sub-threshold dose. The prior art actually teaches a concentration range that overlaps with the claimed range.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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). All claimed limitations are present in the prior art and motivation to combine and modify prior art references is present in the prior art.
Applicant argued that the claimed composition has unexpected properties and referred to the declaration by Jakob P. Ley.
The declaration and the supporting document were fully considered but are not persuasive because they do not meet the requirements set forth in MPEP 716.02.
The claims are not commensurate in scope with the compositions that provided the asserted unexpected result. Figure 1 on page 4 of the reference describes contents of the four compositions NV control, ARG, WPH, and WPH+ARG, where each composition contains specific components in specific amounts. NV control contains glucose and nonivamide. ARG contains glucose, nonivamide, and L-arginine hydrochloride. WPH contains glucose,
nonivamide, wheat protein hydrolysate, and free L-arginine hydrochloride. Presently claimed composition requires one or more first saturating component(s) in a range of concentrations and selected from a list of compounds, free arginine or its isomers or derivatives in a range of concentrations and amounts, and a range of weight ratios of the two; and optional components. The applicant did not provide sufficient evidence to show that the skilled artisan would have expected the asserted unexpected results to occur over the entire breadth of the claims.
The applicant observed the effects of the different compositions and concluded that the effects are unexpected. It is not clear why the applicant considers the data unexpected in view of the prior art.
Additionally, one of ordinary skill in the art would not be able to determine a trend in the
exemplified data which would allow the artisan to reasonably extend the probative value thereof.
Applicant's statement that the observed effects, such as serotonin increase, ghrelin
suppression, reduced energy intake, reduction in subjective hunger, natural appetite, and total
caloric intake are surprising is not persuasive because applicant did not provide evidence
supporting the conclusion.
Applicant's statement that the results show unexpected effects of the combination of
nonivamide and arginine is not convincing. Applicant tested ARG composition, which contains
nonivamide and arginine; WPH composition, which contains wheat protein hydrolysate and
nonivamide; and ARG+WPH composition, which contains arginine, wheat protein hydrolysate,
and nonivamide. It is not clear how the applicant arrived at the conclusion that combination of
arginine and nonivamide has unexpected properties since applicant did not test arginine and
nonivamide separately. It is required to test each component separately and in combination in
order to be able to determine whether or not the combination produces an unexpected result.
None of the tested compositions contain arginine without nonivamide.
Applicant's statement that adding arginine causes significant decrease in actual energy
intake is not sufficient to obviate the grounds of rejection because it is not clear why the
applicant arrived at this conclusion. There is no evidence on the record that would have led the
skilled artisan to conclude that administering arginine would not reduce hunger or decrease
actual energy intake. Compositions WPH and ARG are chemically different and a person skilled
in the art would not have expected them to have the same effect on hunger and satiety.
Any differences between the claimed invention and the prior art may be
expected to result in some differences in properties. The issue is whether the properties differ to
such an extent that the difference is really unexpected.
Applicant's conclusion that the having arginine in large excess relative to the first
saturating component results in a surprising effect is not persuasive because the applicant did not
show that the claimed ratio is critical. As noted above, a weight ratio of two components can be
obtained from many different combinations of weights of the two components. Applicant's
examples are based on a limited number of combinations of the two components, which are not
sufficient to show that the asserted unexpected result would have occurred over the entire
breadth of the claimed range of weight ratios. To establish unexpected results over a claimed
range, applicants should compare a sufficient number of tests both inside and outside the claimed
range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197
(CCPA 1960).
Applicant argued that applicant is not required to test each individual component in isolation to demonstrate unexpected results, and referred to the experimental design in the specification and Exhibit A to provide probative comparative evidence demonstrating an unexpected synergistic effect.
The argument is not persuasive because in order to demonstrate synergy applicant is required to show the effect of each component individually and together. That is the only way to show that the effect of the combination is greater than the additive effect of the two, which is required for synergy. In the instant case, the effect of arginine alone is unknown and it cannot be determined whether the asserted unexpected result of the combination is due to arginine or the combination of arginine and nonivamide.
Applicant’s argument that none of the applied references suggest any effect on appetite or energy intake associated with arginine alone or sub-sensory TRPV1 modulation can produce a satiety effect, is not persuasive prior art is not required to teach this in order to render the claimed composition obvious. The claimed composition was found to be obvious over the cited references and Office’s reasons for combining prior art elements to arrive at the claimed invention does not have to be the same as applicant’s reasons. Additionally, since the prior art composition meets all of the structural limitations of the claimed composition the prior art composition would have exhibited the same properties when tested under the same conditions as claimed composition.
Applicant’s argument regarding a significant change in performance associated with the claimed invention and that the office cannot ignore the demonstration of results by asserting that chemical differences might be expected to yield difference properties, is not persuasive because the issue is that the applicant did not show that the results are unexpected.
Conclusion
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.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617