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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-8, 19-27, 29 and 30 in the reply filed on 8 August 2025 is acknowledged. Claims 9-18 and 28 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103
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.
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 1-8 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen USPGPub 20230051969 and Manso “Angiotensin I Converting Enzyme–Inhibitory Activity of Bovine, Ovine, and Caprine κ-Casein Macropeptides and Their Tryptic Hydrolysates” J. of Food Protection, Volume 66, Issue 9, 1 September 2003, Pages 1686-1692.
Regarding claims 1-3, Nielsen teaches a denatured whey protein composition [0226] for use in food products [0001] comprising:
70-89 wt% protein on a dry weight basis [0094]
30-90 wt% beta-lactoglobulin relative to total protein [0095]
0-25 wt% GMP [0097]
Nielsen discloses that at least 99 wt% of the beta-lactoglobulin is denatured [0226] and therefore greater than 50 wt% of the total proteins must necessarily be denatured given the beta-lactoglobulin content disclosed.
Nielsen is silent regarding enzymatically hydrolyzed GMP.
Manso “Angiotensin I converting enzyme (ACE) is a key enzyme in the physiological regulation of blood pressure. This dipeptide- liberating carboxypeptidase catalyzes the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, together with the inactivation of the vasodilator bradykinin, and thus the inhibition of ACE results in a decrease in blood pressure (20). Peptide sequences capable of blocking ACE have been investigated with the aim of finding natural substances that act against hypertension.” (Pg. 1686) Manso teaches that peptides produced from the hydrolysis of GMP exhibit ACE inhibitory activity at a level which “justifies their use as food components”. (1691)
Nielsen and Manso are both directed to whey protein food compositions. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have included hydrolyzed GMP as taught by Manso in the whey protein composition of Nielsen in order to produce a food product with the beneficial property of ACE inhibitory activity.
Nielsen teaches a GMP content of 0-25 wt%. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have replaced this component with hydrolyzed GMP as taught by Manso because of the superiority of hydrolyzed GMP for ACE inhibition compared to native GMP. This substitution would have resulted in a composition of no native GMP and 0-25% hydrolyzed GMP. Therefore, the modification of Nielsen with Manso would have produced a composition wherein the proportions of protein, native GMP, hydrolyzed GMP and denatured whey protein that overlap or encompass the proportions of present claims 1 and 3. The level of hydrolyzed GMP present in such a substitution would provide a proteolysis index that overlaps or encompasses the range recited in claim 1. 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) Therefore, the modification of Nielsen with Manso renders obvious the limitations of claims 1-3.
Regarding claims 4-6, Nielsen teaches particle sizes of 150-900 nm. [0459]
Regarding claims 7 and 8, Nielsen teaches a fat content of at most 8 wt% which overlaps with the present claims. [0209] 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)
Regarding claim 29, Nielsen teaches a food product as recited in claim 1 which also reads on claim 29.
Claims 19-27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen USPGPub 20230051969.
Regarding claims 19 and 21-24, Nielsen teaches a denatured whey protein composition [0226] for use in food products [0001] comprising:
70-89 wt% protein on a dry weight basis [0094]
30-90 wt% beta-lactoglobulin relative to total protein [0095]
4-35 wt% alpha-lactalbumin
0-25 wt% GMP [0097]
Nielsen teaches a fat content of at most 8 wt% [0209]
Nielsen discloses that at least 99 wt% of the beta-lactoglobulin is denatured [0226] and therefore greater than 50 wt% of the total proteins must necessarily be denatured given the beta-lactoglobulin content disclosed.
The proportions of the components of Nielsen overlap or encompass the proportions and ratios of claims 19 and 21-24. 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)
Regarding claim 20, the limitations of this claim are product-by-process limitations that do not impart any material characteristics to the claimed composition because claim 19 already recites that the final composition comprises greater than 50 wt% denatured whey protein so the content of denatured whey protein prior to denaturation that is less than in the final product does not affect the properties of the final product.
Regarding claims 25-27, Nielsen teaches particle sizes of 150-1000 nm and a polydispersity index of at most 0.05. [0429,0432] Therefore, the particles of Nielsen reads on claims 25-27.
Regarding claim 30, Nielsen teaches a food product as recited in claim 19 which also reads on claim 30.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-7, 19 and 25-27 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7, 15 and 18-20 of prior U.S. Patent No. 11825860. This is a statutory 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 1-7 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 11 and 18 of U.S. Patent No. 12349701. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent teach the limitations of the present claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793