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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 May 2026 has been entered.
Response to Amendment
All rejections not repeated in this Office Action have been withdrawn.
Claims 1-4, 12, 14-17, 19-20, 22-23, 26, 29-32, 34, and 36 are currently pending. Claims 12, 14-17, 19-20, 22-23, 26, 29-32, 34, and 36 have been withdrawn due to being drawn to the non-elected invention.
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.
Regarding Claim 3, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 3 recites the broad recitation “70-100% denatured whey protein”, and the claim also recites “80-90% denatured whey protein” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhaskar et al. (US 2017/0164645 A1- cited in IDS filed 4/5/23) in view of Dyck (WO 2008/05592 A1).
Regarding Claims 1-4, Bhaskar discloses a calcium depleted milk protein concentrate (see abstract) that has between 15-45% of the calcium removed (see abstract), which overlaps with the ranges of Claims 1 and 2, wherein the MPC is greater than 70% w/w milk protein (reads on the range “greater than 80%” of claim 1 and “greater than 85%” of Claim 4, paragraph 16). While ‘milk protein concentrate’ includes both whey and casein proteins, Bhaskar does not specifically recite that about 50-100% of the whey protein is denatured. Dyck is relied on to teach a method of improving the taste of milk products (see abstract), where it has been experimentally determined that the taste is favorably influenced when the microparticulated whey proteins have a degree of denaturation of at least 80% (meets the limitation of Claim 3).
Therefore, since both Bhaskar and Dyck are directed to milk protein products having whey protein, it would have been obvious to one of ordinary skill in the art to modify the whey component of the milk protein concentrate to have the structures taught by Dyck for the purpose of improving the taste of the milk product. 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).
Response to Arguments
Applicant’s arguments in the response filed 29 May 2026 has been considered, but is found not persuasive for the following reasons:
Applicant argues on the basis that a skilled artisan would not have been motivated to modify the MPC of Bhaskar with the denatured microparticulated whey of Dyck to arrive at the claimed invention with the requisite expectation of success. That is, Applicant argued that Bhaskar is not concerned with modifying the flavor of a product using the MPC (page 6 of the remarks), and Dyck has no teaching with respect to the effect of denaturation of whey protein outside the context of its microparticulated whey, therefore a skilled artisan would not have the requisite, specific reason to modify the MPC of Baskar with the isolated and modified whey protein of Dyck. The argument is not persuasive because Bhaskar explicitly recites adding minor components such as flavouring (paragraph 31), thereby suggesting that one of ordinary skill in the art considers the flavor of the composition as a whole. Therefore, it is maintained that one of ordinary skill in the art would look into the Dyck reference to modify the whey protein to denatured microparticulated whey protein for its effect on flavour.
Applicant also argued that Dyck has no teaching or suggestion that its microparticulated whey could provide any advantage in Bhaskar (page 7 of the remarks). However, as noted above, it is maintained that Dyck provides the advantage of improved milk flavour.
Applicant argued that modifying the MPC of Bhaskar with the denatured and microparticulated whey of Dyck would produce a different product thus changing the way that Bhaskar operates by increasing the complexity and expense (page 7 of the remarks). Applicant’s argument is not persuasive because the fact that the Dyck reference exist would suggest that one of ordinary skill in the art would pursue the endeavors taught by Dyck. Furthermore, there is no evidence within the Bhaskar reference that would teach away from using microparticulated or denatured whey protein, nor any evidence that would teach away from increasing expenses or complexity. Also, it is not clear that modifying with Dyck would increase the cost of production. That is, the claims are directed to a composition claim and not a method of making; therefore, there is no requirement to make a denatured and microparticulated whey protein product. In other words, substituting the whey component of Bhaskar may simply involve sourcing denatured and microparticulated whey.
Applicant argued that the combination would produce a product that is different and unsuited for its intended purpose because Bhaskar is directed to a low-viscosity product and that Dyck’s large and heavy whey microparticles would fall out of solution and sediment in the MPC product of Bhaskar (Page 8 of the remarks). However, the argument is not persuasive because there is no evidence to suggest that microparticulated and denatured whey protein would fall out of solution and sediment in the MPC product of Bhaskar. Rather, since Dyck is directed to a liquid formulation, Dyck suggest that microparticulated whey protein is stable in liquid formulation that mimics the mouth feel of regular milk (page 2, fifth paragraph). In fact, evidentiary reference Food Navigator suggests the contrary such that microparticulated whey proteins can be added as an ingredient at high concentrations with no adverse effects during processing and that the small protein particle size is critical for good suspendability in beverage application to obtain a long shelf life with no sedimentation (page 3, third paragraph, <https://www.foodnavigator.com/News/Promotional-features/Way-forward-with-whey-protein/>). For these reasons, the prior art is maintained.
Declarant’s arguments in the declaration filed 29 May 2026 has been considered, but is found not persuasive for reasons discussed above.
That is, Declarant argues that one of ordinary skill in the art would not combine Bhaskar with the microparticulated denatured whey process of Dyck since it would require multiple lines, holding steps, and specific equipment to obtain the microparticulated whey product. The argument is not persuasive because since the claim is not directed to a method of making, and there is no requirement to make microparticulated whey with the requisite equipment. Rather, the claims are directed to a composition, and Dyck presents motivation to one of ordinary skill in the art to use denatured and microparticulated whey protein for the purpose of improving the flavors of a dairy composition. Since Bhaskar is directed to a dairy composition comprising whey protein, it would have been obvious to one of ordinary skill in the art to substitute the whey component with denatured and microparticulated whey for the purpose of improving the taste of the dairy composition. Furthermore, one may source the microparticulated whey and is not required by the claim to involve a process of producing denatured whey protein. Therefore, all arguments directed to the increased expenses by the Dyck reference are not persuasive.
Declarant also argued that the incorporation of microparticulated whey protein would produce a large and dense fraction of whey microparticles that would likely sediment out of solution during storage thereby being shelf-life defect. As presented above with respect to evidentiary reference Food Navigator, it is found that microparticulated whey proteins can be added as an ingredient at high concentrations with no adverse effects during processing and that the small protein particle size is critical for good suspendability in beverage application to obtain a long shelf life with no sedimentation (page 3, third paragraph, <https://www.foodnavigator.com/News/Promotional-features/Way-forward-with-whey-protein/>). For these reasons, the combination is maintained.
Declarant also argued that the microparticulated whey protein would increase the viscosity of Bhaskar which desires a low viscosity for medical applications. However, the argument is not persuasive because as suggested by Dyck discloses a dairy product that resembles milk (taste to match that of pasteurized milk, see abstract), and Food Navigator indicating its usage in the beverage industry (page 3, third paragraph), there is no evidence to suggest that the microparticulated whey protein of Dyck would increase the viscosity to unsatisfactory levels (Note that Bhaskar discloses up to 200 cP, paragraph 60). For these reasons, the prior art has been maintained.
Conclusion
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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792