DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The status of the claims stands as follows:
Pending claims: 1-9
Withdrawn claims: None
Cancelled claims: None
Claims currently under consideration: 1-9
Currently rejected claims: 1-9
Allowed claims: None
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/595,017, filed on 11/05/2021.
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.
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 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Maynard (US 2018/0116270) in view of Expasy (“ENZYME entry: EC 3.4.24.28”, March 2019, Expasy, https://web.archive.org/web/20190322211433/https://enzyme.expasy.org/EC/3.4.24.28).
Regarding claims 1, 6, and 9, Maynard teaches a method of preparing a whey protein hydrolysate, wherein the method comprises (a) providing a whey protein solution comprising whey protein isolate and water [0042], [0047]-[0048], [0051] as recited in present claims 1 and 6. Maynard teaches that whey protein isolate comprises more than 95 wt.% whey protein [0047]. Therefore, a solution containing whey protein isolate and water would contain more than 95 wt.% whey protein based on the total solid content of the solution, which falls within the claimed concentration recited in step (a) of present claim 1.
Maynard teaches that the method then comprises (b) subjecting the whey protein solution to enzymatic hydrolysis, wherein the enzymatic hydrolysis is performed by an enzyme combination comprising a bacillolysin having EC Number: 3.4.24.28 from Bacillus; bromelain from Ananas comosus; and a leucyl aminopeptidase from Aspergillus oryzae [0018], [0057]-[0058], [0061], [0068], [0070] as recited in present claims 1 and 9. Maynard teaches that the method then comprises (c) stopping enzymatic hydrolysis by inactivating the enzymes when the extent of hydrolysis is greater than 95% [0030], [0078], [0082]. This extent of hydrolysis is considered to fall within the claimed degree of hydrolysis (DH) range recited in step (c) of present claim 1. Maynard teaches that after step (c), the obtained whey protein hydrolysate may be concentrated and/or dried [0079]. Therefore, Maynard teaches that the method may not comprise ultrafiltration of the whey protein hydrolysate obtained in step (c).
Maynard teaches that the bacillolysin having EC Number: 3.4.24.28 is from Bacillus species [0068]. Maynard does not teach that the bacillolysin is from Bacillus amyloliquefaciens as recited in present claims 1 and 9.
However, Expasy teaches that bacillolysin having EC Number: 3.4.24.28 may be obtained from several Bacillus species including B. amyloliquefaciens (1st bullet under “Comment(s)”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Maynard to include using bacillolysin from B. amyloliquefaciens as taught by Expasy. Since Maynard discloses that the bacillolysin has EC Number: 3.4.24.28 and is obtained from Bacillus species [0068] and Expasy discloses that bacillolysin having EC Number: 3.4.24.28 may be obtained from several Bacillus species including B. amyloliquefaciens (1st bullet under “Comment(s)”), the combination of Maynard and Expasy provides a finite number of identified, predictable solutions with a reasonable expectation of success, particularly wherein the Applicant of the present invention has not demonstrated criticality of the claimed source of bacillolysin. MPEP §2143.I.E. Therefore, the combination of Maynard and Expasy renders the claimed enzyme combination (iii) as recited in present claims 1 and 9 obvious.
Regarding claim 2, Maynard teaches the invention as described above in claim 1, including the method further comprises concentrating and/or drying the whey protein hydrolysate in step (c) [0079].
Regarding claim 3, Maynard teaches the invention as described above in claim 1, including the whey protein solution of step (a) contains water and whey protein isolate wherein the whey protein isolate comprises more than 95 wt.% whey protein [0047], [0051]. Since water does not contain lipids and the whey protein isolate contains less than 5 wt.% of other ingredients, the whey protein solution of Maynard comprising the water and whey protein isolate comprises less than 5 wt.% of lipids based on the solid content of the solution, which falls within the claimed concentration range.
Regarding claim 4, Maynard teaches the invention as described above in claim 1, including the enzymatic hydrolysis in step (b) is performed at a temperature of from about 40°C to about 60° such as about 55°C [0072], which falls within the claimed temperature range.
Regarding claim 5, Maynard teaches the invention as described above in claim 1, including the inactivation of enzymes in step (c) is by heating to a temperature above 75°C, such as 90°C [0078], [0101], which falls withing the claimed temperature range.
Regarding claim 7, Maynard teaches the invention as described above in claim 1, including the whey protein solution comprises protein in an amount of 2-30 wt.% of the whey protein solution [0049], which falls within the claimed concentration range.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kragh (US 2018/0291360).
Regarding claims 1 and 8, Kragh teaches a method of preparing a whey protein hydrolysate comprising (a) providing whey protein which may be in the form of a 10 wt.% whey protein solution comprising whey protein isolate (corresponding to a suspension of whey protein isolate) [0017], [0121], [0306]. Whey protein isolate contains at least 90 wt.%. Therefore, the whey protein solution of Kragh comprises at least 90 wt.% whey protein based on the solid content of the solution which falls within the concentration range recited in step (a) of present claim 1. Kragh teaches that the method then comprises (b) subjecting the whey protein solution to enzymatic hydrolysis, wherein the enzymatic hydrolysis is performed with one of the following enzyme combinations: (i) a serine endopeptidase from Bacillus (corresponding to “ALCALASE ®”), a serine endopeptidase from Aspergillus (corresponding to “Allzyme FD”), and a trypsin-like protease; (ii) a serine endopeptidase from Bacillus (corresponding to “ALCALASE®”), a serine endopeptidase from Aspergillus (corresponding to “Allzyme FD”), and a leucyl aminopeptidase which may be from Aspergillus; or (iii) a bacillolysin from Bacillus amyloliquefaciens (corresponding to “NEUTRASE®”), bromelain, and leucyl aminopeptidase which may be from Aspergillus [0067], [0072], [0084] as recited in present claim 1.
Kragh teaches that the method then comprises (c) stopping the enzymatic hydrolysis by inactivating the enzymes when the DH is increased by at least about 5% of the DH when compared to any suitable basis such as relative to the DH of a type 1 aminopeptidase [0090]. Kragh teaches that the DH within this range may be 23% (page 39, Table 1, row labeled “WPI”, column labeled “0.1”). Therefore, Kragh is considered to teach that a range of DH which at least overlaps the DH ranges recited by present claims 1 and 8.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
Kragh teaches that the method may not comprise ultrafiltration of the whey protein hydrolysate obtained in step (c) [0306] as recited in present claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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/KELLY P KERSHAW/Examiner, Art Unit 1791
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