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 Objections
In claim 6, the “to” after demineralizing in line 4 appears to be a typo.
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.
Claim(s) 1, 4, 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tamaki et al (US 2021/0017243) in view of Eriksen et al (US 2014/0377439), or alternately, Eriksen in view of Tamaki.
At the outset, applicant defines condensation and demineralization as removing water and other components by ultrafiltration or microfiltration among several other processes.
Tamaki teaches in [0006] that process of heat-treating milk whey at 80oC or more to produce whey protein aggregate and then ultrafiltering using > 50,000 Da mol wt. cut-off membrane to recover GMP in permeate is known in the art. Applicant also has a similar citation in [0004]. Therefore, applicant’s claim 1 of using membrane of 50,000 Da or more membrane to ultrafilter microparticulated GMP is prima facie obvious, if not anticipated.
Tamaki teaches a process for making GMP as permeate in high concentration (28% or more) with respect to the total solids (working examples). Membrane – see [0070]. Molecular weight cut-off 30,000-100,000 (overlapping range,) which meets the claim requirements. The process is diafiltration (see the figure and [0127]). The source materials are raw milk [0056] and whey proteins (examples.) Tamaki fails to teach the d50 particle size of the microparticulated whey, and the heat and shear treatment for microparticulation.
However, it is observed that applicant’s claimed invention is disclosed as producing GMP from “MP whey,” and that while GMP is known to be produced from whey [0003] – [0005], “… any technique of separating GMP from the MP whey has not been reported so far.” That is, applicant is essentially applying known methods of making GMP from whey, wherein the whey is micropartiulated.
In a similar art of making GMP product using membrane process etc., Eriksen teaches microparticulating whey protein using heat and controlled shear to obtain the particle sizes as claimed ([0088]-[0090] and the figures. In [0087]-[0090], Eriksen also teaches that whey should be subjected to microparticulation to denature the protein and make it ideal for use. Also, Eriksen in [0087] implies that micropaticluated whey is a commonly available source for whey. In [0110-0111], Eriksen teaches ultrafiltration and diafiltration to obtain CGMP. Therefore, using such whey for producing GMP would have been prima facie obvious. Also, it would have been obvious to one of ordinary skill to have whey microparticulated to have it denatured and ready for use as taught by Eriksen in the teaching of Tamaki.
Removing lactose, minerals, etc. as claimed – see [0087] of Tamaki.
Food additive – [0004].
Eriksen in view of Tamaki: Erikesen teaches obtaining CGMP from microparticulated whey using ultra- and diafiltration in [0111] but provides no details. Therefore, it would have been obvious to one of ordinary skill in the art to obtain such details from the literature such as Tamaki.
Response to Arguments
Applicant's arguments filed 6/5/26 have been fully considered but they are not persuasive.
Argument:
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This is addressed in the rejection. The remaining arguments are simply attacking the references individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, the claims are directed at diafiltration of microparticulated whey solution. The office has shown clearly that such process is known in the art and obvious using Tamaki and Eriksen.
The following rationales from MPEP 2143 would apply:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Conclusion
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
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