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 .
Claim Status
Claims 1, 4-7, and 10-11 are pending in the current application, Claims 2-3 and 8-9 have been cancelled. Claim 11 is a newly added claim.
Claim Rejections - 35 USC § 112
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 11 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. With regard to Claim 11, the claims states, “wherein the at least one masking agent consists of the combination of maltodextrin and gum Arabic”. Claim 11 is dependent on claim 1 which states, “wherein the at least one masking agent consists of the combination of maltodextrin and gum Arabic”. Thus, Claim 11 just repeats a limitation presented in claim 1 and therefore does not further limit the claim. 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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-6, and, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gallardo et al. (herein referred to as Gallardo, CN 106659221 A).
With regard to Claim 1, Gallardo teaches a nutrient delivery system including a pod and a nutritional powder. The nutritional powder comprises at least hydrolyzed protein proteins in an amount of about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90% weight % ([0129]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Gallardo teaches the nutritional powder comprises at least one masking agent for reducing any bitter taste associated with the resulting nutritional formula ([0004]). Gallardo teaches the amount of masking agent in the nutritional powder may vary depending on the specific masking agent selected, other ingredients in the nutritional powder (such as the type and amount of hydrolyzed protein), and other nutritional powder or product target variables. However, the amount is typically up to about 70% by weight of the powder, including up to about 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10% or 5% by weight of the powder ([0189]-[0190]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Gallardo teaches the masking agent(s) are a combination of maltodextrin ([0031]) and gum Arabic ([0184]-[0185]).
Gallardo teaches the composition does not adversely affect the palatability of the food or beverage once dissolved or dispersed therein ([0047], [0256]-[0262]). In addition, Gallardo teaches the composition is capable of rapidly dissolving or dispersing in a food or beverage having a temperature of 60℃ ([0084]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.);
With regard to Claim 4, Gallardo teaches the nutritional powder comprises substantially 83% w/w of hydrolysed protein(s) and substantially 17% w/w of masking agent(s) ([0129], [0189]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
With regard to Claim 5, Gallardo teaches the hydrolysed protein component is hydrolysed whey protein ([0141]) comprising between about 80 - 90% protein on a dry basis ([0129], [0067]).
With regard to Claim 6, Gallardo teaches the hydrolysed whey protein has a degree of hydrolysis of between about 30 - 40% ([0131]). See MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
With regard to Claim 10, Gallardo teaches the composition comprises hydrolysed whey protein in an amount of 83% w/w, ([0129], [0141]) and a masking agent in an amount of about 17 % w/w ([0189]-[0190]). Gallardo teaches the nutritional powder also includes at least one masking agent ([0187]) and the amount of masking agent in the nutritional powder may vary depending on the specific masking agent selected, other ingredients in the nutritional powder (such as the type and amount of hydrolyzed protein), and other nutritional powder or product target variables ([0189]). Gallardo teaches suitable masking agents include maltodextrin ([0031]) and gum Arabic ([0184]-[0185]). Gallardo teaches other suitable masking agents include artificial sweeteners ([0188]). One with ordinary skill in the art would recognize artificial sweeteners are a common food flavoring agent.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of maltodextrin, gum Arabic, and flavoring component within the masking agent through routine experimentation in order to achieved the desired flavor profile and in accordance with the specific masking agent selected, other ingredients in the nutritional powder (such as the type and amount of hydrolyzed protein), and other nutritional powder or product target variables ([0189]). See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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 Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");
With regard to Claim 11, Gallardo teaches the masking agent(s) are a combination of maltodextrin ([0031]) and gum Arabic ([0184]-[0185]).
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gallardo (CN 106659221 A) in view of Hisashi et al. (herein referred to as Hisashi, AU 2009332369 A1)
With regard to Claim 7, Gallardo teaches whey protein is a good source of branched-chain amino acids ([0141]). However, Gallardo is silent to the hydrolysed whey protein comprises at least 20% branched chain amino acids (BCAAs).
Hisashi teaches muscle-building agent comprising a whey protein hydrolysate (abstract). Hisashi teaches the muscle-building agent comprises a whey protein hydrolysate as the active ingredient having a branched-chain amino acid content of 20% or more (Claim 1). Hisashi teaches branched-chain amino acids are involved in muscle synthesis ([0003]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Gallardo in view of Hisashi to incorporate hydrolysed whey protein which comprises at least 20% branched chain amino acids (BCAAs) in order to assist in muscle synthesis ([0003]).
Response to Arguments
Applicant's arguments filed 5 December 2025 have been fully considered but they are not persuasive.
Applicant argues that in contrast to amended claim 1 Gallardo discloses extremely broad ranges of hydrolysed protein components and masking agents and that these broad disclosures contain no suggestion that would lead one with ordinary skill in the art to select the narrow and specific concentrations ranges cited in amended claim 1. This argument is not found to be persuasive in view of MPEP 2144.05(I) which clearly teaches In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Therefore, regardless of the “broadness” of the ranges taught by Gallardo, because Gallardo clearly teaches the claimed ranges in amended claim 1 than the reference teaches the limitation. Thus, the applicants argument is not found to be persuasive.
Applicant argues that the concentration ranges and combination of maltodextrin and gum Arabic show unexpected results. This argument is not found to be persuasive because arguments presented by applicant cannot take the place of evidence, The examiner would like to point to MPEP 716.01(C) which states Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. This this case, the applicant points to Example 1-4 and the specification page 8 lines 13-22. Examples 1-4 merely show compositions and provide no data which corresponds to the claimed unexpected results. The same can be said about applicant’s specification page 8 lines 13-22, there is not data presented here to support the claimed unexpected results. Therefore, the data presented in these cited sections do not support the claimed the “unexpected permit rapid dispersion or dissolution at temperatures at or above 60℃ and maintain palatability by effectively reducing bitterness” and thus applicants argument is not found to be persuasive. The examiner points would like to highlight MPEP 716.02(b)(I) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); and MPEP 716.02(II) which states "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
Applicant argues Gallardo does not teach or suggest that any particular range of composition of hydrolysed protein component and masking agent associated to maintain palatability and dissolution or dispersion at temperatures of 60℃ or greater. This argument is not persuasive because as stated above Gallardo teaches the claimed ranges of components and teaches the composition is capable of rapidly dissolving or dispersing in a food or beverage having a temperature of 60℃ ([0084]). Thus, applicants argument is not found to be persuasive.
The argument above with regard to Gallardo’s “broad generic ranges” also is applicable to applicants arguments with regard to Claim 4. Gallardo clearly teaches the claimed amount in claim 4 and thus the reference teaches the limitation regardless of the “broadness” of the disclosure. Therefore, the applicants argument is not found to be persuasive.
The argument above with regard to Gallardo’s “broad generic ranges” also is applicable to applicants arguments with regard to Claim 5. Gallardo clearly teaches the claimed amount in claim 5 and thus the reference teaches the limitation regardless of the “broadness” of the disclosure. Therefore, the applicants argument is not found to be persuasive. The examiner would also like to note that Claim 5 is rejected in view of Gallardo not Gallardo in view of Hisashi as shown on page 7 of applicants arguments.
The argument above with regard to Gallardo’s “broad generic ranges” also is applicable to applicants arguments with regard to Claim 6. Gallardo clearly teaches the claimed amount in claim 6 and thus the reference teaches the limitation regardless of the “broadness” of the disclosure. Therefore, the applicants argument is not found to be persuasive. The examiner would also like to note that Claim 6 is rejected in view of Gallardo not Gallardo in view of Hisashi as shown on page 8 of applicants arguments.
With regard to Claim 7, applicant argues that Hisashi does not provide any teaching or suggestion of a protein composition comprising a hydrolysed whey protein comprising at least 20% branched-chain amino acids and masking agents in the specific composition ranges recited in amended independent claim 1. This argument is not found to be persuasive because Gallardo teaches the specific composition ranges recited in the amended independent claim 1 and the rapid dispersion at temperatures of 60℃, as discussed above, and Hisashi teaches a whey protein hydrolysate as the active ingredient having a branched-chain amino acid content of 20% or more (Hisashi, Claim 1) and provides ample motivation to combine to assist in muscle synthesis (Hisahsi, [0003]). Thus, applicant argument is not found to be persuasive.
The argument above with regard to Gallardo’s “broad generic ranges” also is applicable to applicants arguments with regard to Claim 10. Gallardo clearly teaches the claimed amounts in claim 10 and thus the reference teaches the limitation regardless of the “broadness” of the disclosure. Therefore, the applicants argument is not found to be persuasive. The examiner would also like to note that Claim 10 is rejected in view of Gallardo not Gallardo in view of Hisashi as shown on page 9 of applicants arguments.
Conclusion
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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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792