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 .
The amendment filed March 26, 2025 is acknowledged. Claims 1, 2, 4-8, and 12-26 are pending in the application. Claims 3, 9, 10, and 11 have been cancelled.
Claim Objections
Claims 1, 12-15 and 23-26 are objected to because of the following informalities:
In claim 1 at line 19, it is suggested to add “and” after “same,”.
In claim 12 at line 19, it is suggested to add “and” after “same,”.
In claim 13 at line 20, it is suggested to add “and” after “same,”.
In claim 14 at line 19, it is suggested to add “and” after “same,”.
In claim 15 at line 20, it is suggested to add “and” after “same,”.
Applicant is also advised that should claims 12, 13, 23, and 24 be found allowable, claims 14, 15, 25, and 26, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-8, and 12-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 has been amended to recite “… pentanOL content of 0 to 40% …pentanAL content of 5 to 60%” at lines 18-21 (emphasis added). The instant specification fails to provide support for this limitation. See paragraph [0034] and the recitation of “pentanAL content of 40% or less, preferably 0 to 40%” (emphasis added) and paragraph [0036] and the recitation of “pentanOL content of 60% or less, preferably 5 to 60%”.
Claims 2 and 4-8 are not specifically discussed but are rejected due to the dependence on claim 1.
Independent claim 12 has been amended to recite “… pentanOL content of 0 to 40% …pentanAL content of 5 to 60%” at lines 18-21 (emphasis added). The instant specification fails to provide support for this limitation. See paragraph [0034] and the recitation of “pentanAL content of 40% or less, preferably 0 to 40%” (emphasis added) and paragraph [0036] and the recitation of “pentanOL content of 60% or less, preferably 5 to 60%”.
Independent claim 13 has been amended to recite “… pentanOL content of 0 to 40% …pentanAL content of 5 to 60%” at lines 19-22 (emphasis added). The instant specification fails to provide support for this limitation. See paragraph [0034] and the recitation of “pentanAL content of 40% or less, preferably 0 to 40%” (emphasis added) and paragraph [0036] and the recitation of “pentanOL content of 60% or less, preferably 5 to 60%”.
Independent claim 14 has been amended to recite “… pentanOL content of 0 to 40% …pentanAL content of 5 to 60%” at lines 18-21 (emphasis added). The instant specification fails to provide support for this limitation. See paragraph [0034] and the recitation of “pentanAL content of 40% or less, preferably 0 to 40%” (emphasis added) and paragraph [0036] and the recitation of “pentanOL content of 60% or less, preferably 5 to 60%”.
Independent claim 15 has been amended to recite “… pentanOL content of 0 to 40% …pentanAL content of 5 to 60%” at lines 19-22 (emphasis added). The instant specification fails to provide support for this limitation. See paragraph [0034] and the recitation of “pentanAL content of 40% or less, preferably 0 to 40%” (emphasis added) and paragraph [0036] and the recitation of “pentanOL content of 60% or less, preferably 5 to 60%”.
Claims 16-21 are not specifically discussed but are rejected due to the dependence on claim 1.
Claim 22 recites “the milk raw material produced by the production method has a change ratio in aminoacetophenone content of 0 to 40%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 3-5. However, the instant specification does not provide support for the entire range of aminoacetophenone of 0 to 40% as claimed. See paragraph [0138] and the recitation of “the aminoacetophenone content of the reductive liquid (Brix: 5%) of the MPC powder (NF membrane, 1.2 times) was changed very little (changed (decreased) by 40%) as compared with the untreated MPC reductive liquid (Brix: 5%)).
Claim 23 recites “the milk raw material produced by the production method has a change ratio in aminoacetophenone content of 0 to 40%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 3-5. However, the instant specification does not provide support for the entire range of aminoacetophenone of 0 to 40% as claimed. See paragraph [0138] and the recitation of “the aminoacetophenone content of the reductive liquid (Brix: 5%) of the MPC powder (NF membrane, 1.2 times) was changed very little (changed (decreased) by 40%) as compared with the untreated MPC reductive liquid (Brix: 5%)).
Claim 24 recites “the milk raw material produced by the production method has a change ratio in aminoacetophenone content of 0 to 40%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 3-5. However, the instant specification does not provide support for the entire range of aminoacetophenone of 0 to 40% as claimed. See paragraph [0138] and the recitation of “the aminoacetophenone content of the reductive liquid (Brix: 5%) of the MPC powder (NF membrane, 1.2 times) was changed very little (changed (decreased) by 40%) as compared with the untreated MPC reductive liquid (Brix: 5%)).
Claim 25 recites “the milk raw material produced by the production method has a change ratio in aminoacetophenone content of 0 to 40%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 3-5. However, the instant specification does not provide support for the entire range of aminoacetophenone of 0 to 40% as claimed. See paragraph [0138] and the recitation of “the aminoacetophenone content of the reductive liquid (Brix: 5%) of the MPC powder (NF membrane, 1.2 times) was changed very little (changed (decreased) by 40%) as compared with the untreated MPC reductive liquid (Brix: 5%)).
Claim 26 recites “the milk raw material produced by the production method has a change ratio in aminoacetophenone content of 0 to 40%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 3-5. However, the instant specification does not provide support for the entire range of aminoacetophenone of 0 to 40% as claimed. See paragraph [0138] and the recitation of “the aminoacetophenone content of the reductive liquid (Brix: 5%) of the MPC powder (NF membrane, 1.2 times) was changed very little (changed (decreased) by 40%) as compared with the untreated MPC reductive liquid (Brix: 5%)).
Accordingly, there is no indication that Applicant had possession of the presently claimed invention at the time of the filing the instant application.
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.
Claims 1, 2, 4-8, and 12-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 has been amended to recite “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22 of claim 1 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claims 2 and 4-8 are not specifically discussed but are rejected due to the dependence on claim 1.
Independent claim 12 has been amended to recite “the production method” at lines 11, 14, 17, and 20. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of claim 12 is indefinite. For the purpose of the examination, the recitation of “the production method” at lines 11, 14, 17, and 20 of claim 12 is interpreted as “the method”.
Independent claim 12 has been amended to recite “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22 of claim 12 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Independent claim 13 has been amended to recite “the production method” at lines 12, 15, 18, and 21. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of claim 13 is indefinite. For the purpose of the examination, the recitation of “the production method” at lines 12, 15, 18, and 21 of claim 13 is interpreted as “the method”.
Independent claim 13 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 13-14, 16-17, 19-20, and 22-23. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 13-14, 16-17, 19-20, and 22-23 of claim 13 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Independent claim 14 has been amended to recite “the production method” at lines 11, 14, 17, and 20. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of claim 14 is indefinite. For the purpose of the examination, the recitation of “the production method” at lines 11, 14, 17, and 20 of claim 14 is interpreted as “the method”.
Independent claim 14 has been amended to recite “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 12-13, 15-16, 18-19, and 21-22 of claim 14 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Independent claim 15 has been amended to recite “the production method” at lines 12, 15, 18, and 21. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of claim 15 is indefinite. For the purpose of the examination, the recitation of “the production method” at lines 12, 15, 18, and 21 of claim 15 is interpreted as “the method”.
Independent claim 15 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 13-14, 16-17, 19-20, and 22-23. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 13-14, 16-17, 19-20, and 22-23 of claim 15 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claims 16-21 are not specifically discussed but are rejected due to the dependence on claim 1.
Claim 22 recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5 of claim 22 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claim 23 recites “the production method” at line 3. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “the production method” at line 3 of claim 23 is interpreted as “the method”.
Claim 23 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5 of claim 23 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claim 24 recites “the production method” at line 3. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “the production method” at line 3 of claim 24 is interpreted as “the method”.
Claim 24 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5 of claim 24 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claim 24 further recites “the liquid high-protein milk raw material” at lines 6-7, 9, 12-13, 15-16, 18, 21-22, and 24, and this claim depends upon claim 13. However, this limitation lacks antecedent basis as there is no mention of a liquid high-protein milk raw material anywhere in claim 13. Therefore, the scope of claim 24 is indefinite. For the purpose of the examination, the recitation of “the liquid high-protein milk raw material” at lines 6-7, 9, 12-13, 15-16, 18, 21-22, and 24 of claim 24 is interpreted as “the solid high-protein milk raw material” (emphasis added).
Claim 25 recites “the production method” at line 3. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “the production method” at line 3 of claim 25 is interpreted as “the method”.
Claim 25 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5 of claim 25 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claim 26 recites “the production method” at line 3. This recitation lacks antecedent basis as there is no mention of a production method anywhere in the claim. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “the production method” at line 3 of claim 26 is interpreted as “the method”.
Claim 26 also recites “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5. It is unclear what is intended by this limitation. More specifically, it is uncertain what the phrase “to the same” refers to and what it encompasses. Therefore, the scope of the claim is indefinite. For the purpose of the examination, the recitation of “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same” at lines 4-5 of claim 26 is interpreted as “compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material”(emphasis added).
Claim 26 further recites “the liquid high-protein milk raw material” at lines 6-7, 9, 12-13, 15-16, 18, 21-22, and 24, and this claim depends upon claim 15. However, this limitation lacks antecedent basis as there is no mention of a liquid high-protein milk raw material anywhere in claim 15. Therefore, the scope of claim 26 is indefinite. For the purpose of the examination, the recitation of “the liquid high-protein milk raw material” at lines 6-7, 9, 12-13, 15-16, 18, 21-22, and 24 of claim 26 is interpreted as “the solid high-protein milk raw material” (emphasis added).
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, 2, 4-8, and 12-26 are rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. WO 2015059248 (hereinafter “Mikkelsen”).
With respect to claim 1, Mikkelsen teaches a method of making compositions with a high content of protein (Abstract; and P26, L4).
Regarding the recitation of “for producing a liquid high-protein milk raw material” in the preamble of claim 1, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: a step of preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 1, Mikkelsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of at least 60% (w/w) on a dry weight basis (P2, L34-35; P26, L6-7; and P68, L5-7).
Regarding the limitation of comprising a step of subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 1, Mikkelsen teaches subjecting the aqueous whey protein composition to nanofiltration (P26, L12-17).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 1, Mikkelsen teaches the whey protein concentrate solution has a lactose content of .45% (P69, Table 1). Additionally, the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise 1-20% (w/w) of carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34). Thus, Mikkelsen teaches a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is about 2 to about 44 ( = 1% / .45% to 20% / .45%) as a refractive sugar content. As set forth in MPEP 2144.05, in the case where the claimed range “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.). Also, the claimed range and the prior art range are close enough that one skilled in the art would have expected them to have the same properties of improved milk flavor (P61, L15-16 and P74, L11). Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Regarding the limitation of wherein the milk raw material produced by the production method has an improved refreshing feeling and reduced protein odor as recited in claim 1, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Mikkelsen positively recites all of the claimed process steps as addressed above, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the production method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 1, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Mikkelsen positively recites all of the claimed process steps as addressed above, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11). Additionally, the functional language is not considered to confer patentability to the claim.
With respect to claim 2, Mikkelsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 2, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the milk raw material used for preparing the high-protein milk fluid has a protein content of 60% by mass or more in the total solid content as recited in claim 2, Mikkelsen teaches the solution of whey protein contains a total amount of protein of at least 60% (w/w) on a dry weight basis (P19, L36-37).
With respect to claim 4, Mikkelsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 4, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein a concentration of the total solid content in the high-protein milk fluid is 2 to 20% by mass as recited in claim 4, Mikkelsen teaches the solids content of the protein composition is in the range of 2-30% (w/w) and overlaps with the presently claimed range (P29, L19-20). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With respect to claim 5, Mikkelsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 5, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein a concentration of protein in the high-protein milk fluid is 1.5 to 18% by mass as recited in claim 5, Mikkelsen teaches the concentration of protein in the product is at least 4% (w/w) and overlaps with the presently claimed range (P28, L12-13). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With respect to claim 6, Mikkelsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 6, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the liquid high-protein milk raw material is a liquid milk protein concentrate (MPC) or a liquid whey protein concentrate (WPC) as recited in claim 6, Mikkelsen teaches whey protein concentrates and milk protein concentrates may be used (P39, L40-P40, L2; and P68, L5-7).
With respect to claim 7, Mikkelsen teaches a method of making compositions with a high content of protein by drying (Abstract; P25, L34-36; and P26, L4).
Regarding the recitation of “for producing a solid high-protein milk raw material obtained through a drying treatment” in the preamble of claim 7, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: a step of further subjecting the liquid high-protein milk raw material produced by the production method according to claim 1 to the drying treatment as recited in claim 7, Mikkelsen is relied upon for the teaching of the method of claim 1 as addressed above, and Mikkelsen further teaches subjecting the product to drying (P25, L34-36; and P26, L24-25).
With respect to claim 8, Mikkelsen is relied upon for the teaching of the method of claim 7.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 8, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the solid high-protein milk raw material is a solid milk protein concentrate (MPC) or a solid whey protein concentrate (WPC) as recited in claim 8, Mikkelsen teaches whey protein concentrates and milk protein concentrates (P39, L40-P40, L2; and P68, L5-7).
With respect to claim 12, Mikkelsen teaches a method of making compositions with improved milky flavor (Abstract; P26, L4; and P61, L15-16).
Regarding the recitation of “for improving a refreshing feeling of a milk raw material” in the preamble of claim 12, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 12, Mikkelsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of at least 60% (w/w) on a dry weight basis (P2, L34-35; P26, L6-7; and P68, L5-7).
Regarding the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane to obtain a liquid high-protein milk raw material as recited in claim 12, Mikkelsen teaches subjecting the aqueous whey protein composition to nanofiltration (P26, L12-17).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 12, Mikkelsen teaches the whey protein concentrate solution has a lactose content of .45% (P69, Table 1). Additionally, the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise 1-20% (w/w) of carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34). Thus, Mikkelsen teaches a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is about 2 to about 44 ( = 1% / .45% to 20% / .45%) as a refractive sugar content. As set forth in MPEP 2144.05, in the case where the claimed range “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.). Also, the claimed range and the prior art range are close enough that one skilled in the art would have expected them to have the same properties of improved milk flavor (P61, L15-16 and P74, L11). Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 12, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Mikkelsen positively recites all of the claimed process steps as addressed above, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 12, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Mikkelsen positively recites all of the claimed process steps as addressed above, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11). Additionally, the functional language is not considered to confer patentability to the claim.
With respect to claim 13, Mikkelsen teaches a method of making compositions with improved milky flavor (Abstract; P26, L4; and P61, L15-16).
Regarding the recitation of “for improving a refreshing feeling of a milk raw material” in the preamble of claim 13, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 13, Mikkelsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of at least 60% (w/w) on a dry weight basis (P2, L34-35; P26, L6-7; and P68, L5-7).
Regarding the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 13, Mikkelsen teaches subjecting the aqueous whey protein composition to nanofiltration (P26, L12-17).
Regarding the limitation of then to drying treatment to obtain a solid high-protein milk raw material as recited in claim 13, Mikkelsen further teaches subjecting the product to drying (P25, L34-36; and P26, L24-25).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 13, Mikkelsen teaches the whey protein concentrate solution has a lactose content of .45% (P69, Table 1). Additionally, the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise 1-20% (w/w) of carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34). Thus, Mikkelsen teaches a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is about 2 to about 44 ( = 1% / .45% to 20% / .45%) as a refractive sugar content. As set forth in MPEP 2144.05, in the case where the claimed range “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.). Also, the claimed range and the prior art range are close enough that one skilled in the art would have expected them to have the same properties of improved milk flavor (P61, L15-16 and P74, L11). Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 13, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Mikkelsen positively recites all of the claimed process steps as addressed above, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 13, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Mikkelsen positively recites all of the claimed process steps as addressed above, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11). Additionally, the functional language is not considered to confer patentability to the claim.
With respect to claim 14, Mikkelsen teaches a method of making compositions with less off-taste (Abstract; P26, L4; and P74, L11).
Regarding the recitation of “for reducing a protein odor of a milk raw material” in the preamble of claim 14, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 14, Mikkelsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of at least 60% (w/w) on a dry weight basis (P2, L34-35; P26, L6-7; and P68, L5-7).
Regarding the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane to obtain a liquid high-protein milk raw material as recited in claim 14, Mikkelsen teaches subjecting the aqueous whey protein composition to nanofiltration (P26, L12-17).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 14, Mikkelsen teaches the whey protein concentrate solution has a lactose content of .45% (P69, Table 1). Additionally, the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise 1-20% (w/w) of carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34). Thus, Mikkelsen teaches a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is about 2 to about 44 ( = 1% / .45% to 20% / .45%) as a refractive sugar content. As set forth in MPEP 2144.05, in the case where the claimed range “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.). Also, the claimed range and the prior art range are close enough that one skilled in the art would have expected them to have the same properties of improved milk flavor (P61, L15-16 and P74, L11). Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 14, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Mikkelsen positively recites all of the claimed process steps as addressed above, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 14, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Mikkelsen positively recites all of the claimed process steps as addressed above, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11). Additionally, the functional language is not considered to confer patentability to the claim.
With respect to claim 15, Mikkelsen teaches a method of making compositions with less off-taste (Abstract; P26, L4; and P74, L11).
Regarding the recitation of “for reducing a protein odor of a milk raw material” in the preamble of claim 15, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 15, Mikkelsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of at least 60% (w/w) on a dry weight basis (P2, L34-35; P26, L6-7; and P68, L5-7).
Regarding the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 15, Mikkelsen teaches subjecting the aqueous whey protein composition to nanofiltration (P26, L12-17).
Regarding the limitation of then to drying treatment to obtain a solid high-protein milk raw material as recited in claim 15, Mikkelsen further teaches subjecting the product to drying (P25, L34-36; and P26, L24-25).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 15, Mikkelsen teaches the whey protein concentrate solution has a lactose content of .45% (P69, Table 1). Additionally, the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise 1-20% (w/w) of carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34). Thus, Mikkelsen teaches a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is about 2 to about 44 ( = 1% / .45% to 20% / .45%) as a refractive sugar content. As set forth in MPEP 2144.05, in the case where the claimed range “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.). Also, the claimed range and the prior art range are close enough that one skilled in the art would have expected them to have the same properties of improved milk flavor (P61, L15-16 and P74, L11). Applicant is reminded a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); and In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Regarding the limitation of wherein the milk raw material produced by the production method has an improved refreshing feeling and reduced protein odor as recited in claim 15, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Mikkelsen positively recites all of the claimed process steps as addressed above, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 15, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Mikkelsen positively recites all of the claimed process steps as addressed above, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11). Additionally, the functional language is not considered to confer patentability to the claim.
With respect to claim 16, Mikkelsen teaches preparing foods and beverages (P27, L29-30; and P28, L1-7).
Regarding the recitation of “for producing a food or drink” in the preamble of claim 16, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising a step of including the milk raw material produced by the production method according to claim 1 in the food or drink as recited in claim 16, Mikkelsen teaches the method of claim 1 as addressed above as well as using the produced product in food and beverage products (P27, L29-30; P28, L1-7).
With respect to claim 17, Mikkelsen is relied upon for the teaching of the method of claim 16.
Regarding the recitation of “for producing a food or drink” in the preamble of claim 17, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the food or drink is sterilized as recited in claim 17, Mikkelsen teaches pasteurizing the foods and beverages (P54, L35-39).
With respect to claim 18, Mikkelsen is relied upon for the teaching of the method of claim 16.
Regarding the recitation of “for producing a food or drink” in the preamble of claim 18, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the food or drink is packed in a container as recited in claim 18, Mikkelsen teaches packing the foods and beverages in a container (P57, L36-P58, L1).
With respect to claim 19, Mikkelsen teaches foods and beverages (P27, L29-30; and P28, L1-7).
Regarding the limitation of containing the milk raw material produced by the production method according to claim 1 as recited in claim 19, Mikkelsen teaches the method of claim 1 as addressed above as well as using the produced product in food and beverage products (P27, L29-30; and P28, L1-7).
With respect to claim 20, Mikkelsen is relied upon for the teaching of the food or drink of claim 19.
Regarding the limitation of wherein the food or drink is sterilized as recited in claim 20, Mikkelsen teaches pasteurizing the foods and beverages (P54, L35-39).
With respect to claim 21, Mikkelsen is relied upon for the teaching of the food or drink of claim 19.
Regarding the limitation of wherein the food or drink is packed in a container as recited in claim 21, Mikkelsen teaches packing the foods and beverages in a container (P57, L36-P58, L1).
With respect to claim 22, Mikkelsen is relied upon for the teaching of the method of claim 1.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 22, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at the claimed feature(s) since Mikkelsen positively recites all of the claimed process steps as addressed above in claim 1, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11).
With respect to claim 23, Mikkelsen is relied upon for the teaching of the method of claim 12.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 23, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at the claimed feature(s) since Mikkelsen positively recites all of the claimed process steps as addressed above in claim 12, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11).
With respect to claim 24, Mikkelsen is relied upon for the teaching of the method of claim 13.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 24, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at the claimed feature(s) since Mikkelsen positively recites all of the claimed process steps as addressed above in claim 13, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11).
With respect to claim 25, Mikkelsen is relied upon for the teaching of the method of claim 14.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 25, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at the claimed feature(s) since Mikkelsen positively recites all of the claimed process steps as addressed above in claim 14, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11).
With respect to claim 26, Mikkelsen is relied upon for the teaching of the method of claim 15.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 26, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at the claimed feature(s) since Mikkelsen positively recites all of the claimed process steps as addressed above in claim 15, and Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11).
Claims 1, 2, 4-8, and 12-26 are rejected under 35 U.S.C. 103 as being unpatentable over Paulsen et al. US 20040156969 (hereinafter “Paulsen”).
With respect to claim 1, Paulsen teaches a method of making protein compositions (Abstract; and paragraph [0002]).
Regarding the recitation of “for producing a liquid high-protein milk raw material” in the preamble of claim 1, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: a step of preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 1, Paulsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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 the limitation of comprising a step of subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 1, Paulsen teaches subjecting the aqueous whey protein composition to nanofiltration (paragraphs [0038]-[0039]).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 1, Paulsen does not expressly disclose this limitation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration ratio as a refractive sugar content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of wherein the milk raw material produced by the production method has an improved refreshing feeling and reduced protein odor as recited in claim 1, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Paulsen positively recites all of the claimed process steps as addressed above, Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the production method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 1, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above, and the functional language is not considered to confer patentability to the claim.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 2, Paulsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 2, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the milk raw material used for preparing the high-protein milk fluid has a protein content of 60% by mass or more in the total solid content as recited in claim 2, Paulsen teaches the solution of whey protein contains a total amount of protein of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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).
With respect to claim 4, Paulsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 4, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein a concentration of the total solid content in the high-protein milk fluid is 2 to 20% by mass as recited in claim 4, Paulsen teaches the solids content of the protein composition is in the range of about 15% to about 25% and overlaps with the presently claimed range (paragraph [0031]). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With respect to claim 5, Paulsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 5, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein a concentration of protein in the high-protein milk fluid is 1.5 to 18% by mass as recited in claim 5, Paulsen teaches the concentration of protein in the product is at least 10% and overlaps with the presently claimed range (paragraph [0030] and P4-P5, Table 1). As set forth in MPEP 2144.05, in the case where the claimed range “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).
With respect to claim 6, Paulsen is relied upon for the teaching of the method of claim 1.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 6, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the liquid high-protein milk raw material is a liquid milk protein concentrate (MPC) or a liquid whey protein concentrate (WPC) as recited in claim 6, Paulsen teaches whey protein concentrates may be used (paragraphs [0022], [0024], and [0030]).
With respect to claim 7, Paulson teaches a method of making whey protein compositions by drying (Abstract; and paragraph [0040]).
Regarding the recitation of “for producing a solid high-protein milk raw material obtained through a drying treatment” in the preamble of claim 7, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: a step of further subjecting the liquid high-protein milk raw material produced by the production method according to claim 1 to the drying treatment as recited in claim 7, Paulsen is relied upon for the teaching of the method of claim 1 as addressed above, and Paulsen further teaches subjecting the product to drying (paragraph [0040]).
With respect to claim 8, Paulsen is relied upon for the teaching of the method of claim 7.
Regarding the recitation of “for producing a milk raw material” in the preamble of claim 8, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the solid high-protein milk raw material is a solid milk protein concentrate (MPC) or a solid whey protein concentrate (WPC) as recited in claim 8, Paulsen teaches whey protein concentrates (Abstract; and paragraphs [0022], [0024], [0030], and [0038]-[0039]).
With respect to claim 12, Paulsen teaches a method of making compositions with enhanced organoleptic characteristics (Abstract; paragraphs [0008], [0019], [0022], and [0038]).
Regarding the recitation of “for improving a refreshing feeling of a milk raw material” in the preamble of claim 12, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 12, Paulsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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 the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane to obtain a liquid high-protein milk raw material as recited in claim 12, Paulsen teaches subjecting the aqueous whey protein composition to nanofiltration (paragraphs [0038]-[0039]).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 12, Paulsen does not expressly disclose this limitation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration ratio as a refractive sugar content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 12, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Paulsen positively recites all of the claimed process steps as addressed above, Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 12, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above, and the functional language is not considered to confer patentability to the claim.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 13, Paulsen teaches a method of making compositions with enhanced organoleptic characteristics (Abstract; paragraphs [0008], [0019], [0022], and [0038]).
Regarding the recitation of “for improving a refreshing feeling of a milk raw material” in the preamble of claim 13, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 13, Paulsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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 the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 13, Paulsen teaches subjecting the aqueous whey protein composition to nanofiltration (paragraphs [0038]-[0039]).
Regarding the limitation of then to drying treatment to obtain a solid high-protein milk raw material as recited in claim 13, Paulsen further teaches subjecting the product to drying (paragraph [0040]).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 13, Paulsen does not expressly disclose this limitation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration ratio as a refractive sugar content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 13, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Paulsen positively recites all of the claimed process steps as addressed above, Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 13, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above, and the functional language is not considered to confer patentability to the claim.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 14, Paulsen teaches a method of making compositions with less off-flavors (Abstract; and paragraphs [0038], [0039], and [0048]).
Regarding the recitation of “for reducing a protein odor of a milk raw material” in the preamble of claim 14, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 14, Paulsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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 the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane to obtain a liquid high-protein milk raw material as recited in claim 14, Paulsen teaches subjecting the aqueous whey protein composition to nanofiltration (paragraphs [0038]-[0039]).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 14, Paulsen does not expressly disclose this limitation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration ratio as a refractive sugar content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of wherein the milk raw material produced by the method has an improved refreshing feeling and reduced protein odor as recited in claim 14, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Paulsen positively recites all of the claimed process steps as addressed above, Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 14, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above, and the functional language is not considered to confer patentability to the claim.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 15, Paulsen teaches a method of making compositions with less off-flavors (Abstract; and paragraphs [0038], [0039], and [0048]).
Regarding the recitation of “for reducing a protein odor of a milk raw material” in the preamble of claim 15, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising: preparing a high-protein milk fluid having a protein content of 60% by mass or more in the total solid content from a milk raw material as recited in claim 15, Paulsen teaches preparing an aqueous solution of whey protein concentrate having a protein content of about 50% to about 100% (paragraphs [0030] and [0031]) and overlaps with the presently claimed range. As set forth in MPEP 2144.05, in the case where the claimed range “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 the limitation of comprising subjecting the milk fluid to concentration processing using a nanofiltration membrane as recited in claim 15, Paulsen teaches subjecting the aqueous whey protein composition to nanofiltration (paragraphs [0038]-[0039]).
Regarding the limitation of then to drying treatment to obtain a solid high-protein milk raw material as recited in claim 15, Paulsen further teaches subjecting the product to drying (paragraph [0040]).
Regarding the limitation of wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as recited in claim 15, Paulsen does not expressly disclose this limitation. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentration ratio as a refractive sugar content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Regarding the limitation of wherein the milk raw material produced by the production method has an improved refreshing feeling and reduced protein odor as recited in claim 15, the produced product having an improved refreshing feeling and a reduced protein odor would naturally occur from said method since Paulsen positively recites all of the claimed process steps as addressed above, Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling and reduced protein odor of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary.
Regarding the limitations of wherein the milk raw material produced by the method has a change ratio in dimethyl disulfide content of 20 to 90%, nonanal content of 0 to 40%, pentanol content of 0 to 40%, and pentanal content of 5 to 60%, compared with the high-protein milk fluid after adjusting the refractive sugar content to the same value as the refractive sugar content of the milk raw material in claim 15, it is noted that these limitations relate to functional language. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above, and the functional language is not considered to confer patentability to the claim.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 16, Paulsen teaches preparing foods and beverages (paragraphs [0008], [0010], [0011], [0022], and [0041]).
Regarding the recitation of “for producing a food or drink” in the preamble of claim 16, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of comprising a step of including the milk raw material produced by the production method according to claim 1 in the food or drink as recited in claim 16, Paulsen teaches the method of claim 1 as addressed above as well as using the produced product in food and beverage products (paragraphs [0008], [0010], [0011], [0022], and [0041]).
With respect to claim 17, Paulsen is relied upon for the teaching of the method of claim 16.
Regarding the recitation of “for producing a food or drink” in the preamble of claim 17, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the food or drink is sterilized as recited in claim 17, Paulsen teaches pasteurizing the foods and beverages (paragraph [0028]).
With respect to claim 18, Paulsen is relied upon for the teaching of the method of claim 16.
Regarding the recitation of “for producing a food or drink” in the preamble of claim 18, it is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the limitation of wherein the food or drink is packed in a container as recited in claim 18, Paulsen teaches packing the foods and beverages in a container (paragraphs [0050] and [0061]).
With respect to claim 19, Paulsen teaches foods and beverages (paragraphs [0008], [0010], [0011], [0022], and [0041]).
Regarding the limitation of containing the milk raw material produced by the production method according to claim 1 as recited in claim 19, Paulsen teaches the method of claim 1 as addressed above as well as using the produced product in food and beverage products (paragraphs [0008], [0010], [0011], [0022], and [0041]).
With respect to claim 20, Paulsen is relied upon for the teaching of the food or drink of claim 19.
Regarding the limitation of wherein the food or drink is sterilized as recited in claim 20, Paulsen teaches pasteurizing the foods and beverages (paragraph [0028]).
With respect to claim 21, Paulsen is relied upon for the teaching of the food or drink of claim 19.
Regarding the limitation of wherein the food or drink is packed in a container as recited in claim 21, Paulsen teaches packing the foods and beverages in a container (paragraphs [0050] and [0061]).
With respect to claim 22, Paulsen is relied upon for the teaching of the method of claim 1.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 22, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above in claim 1.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of change in aminoacetophenone content, carbohydrate concentration, sodium concentration, potassium concentration, magnesium concentration, calcium concentration, phosphorus concentration, and/or chlorine concentration in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 23, Mikkelsen is relied upon for the teaching of the method of claim 12.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 23, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above in claim 12.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of change in aminoacetophenone content, carbohydrate concentration, sodium concentration, potassium concentration, magnesium concentration, calcium concentration, phosphorus concentration, and/or chlorine concentration in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 24, Mikkelsen is relied upon for the teaching of the method of claim 13.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 24, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above in claim 13.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of change in aminoacetophenone content, carbohydrate concentration, sodium concentration, potassium concentration, magnesium concentration, calcium concentration, phosphorus concentration, and/or chlorine concentration in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 25, Mikkelsen is relied upon for the teaching of the method of claim 14.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 25, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above in claim 14.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of change in aminoacetophenone content, carbohydrate concentration, sodium concentration, potassium concentration, magnesium concentration, calcium concentration, phosphorus concentration, and/or chlorine concentration in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 26, Mikkelsen is relied upon for the teaching of the method of claim 15.
Regarding the limitation of wherein the method satisfies at least one of numbers 1-8 in claim 26, it is noted that these limitations relate to characteristics of the produced product. Applicant is reminded that language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect: (A) statements of intended use or field of use, including statements of purpose or intended use in the preamble, (B) "adapted to" or "adapted for" clauses, (C) "wherein" or "whereby" clauses, (D) contingent limitations, (E) printed matter, or (F) terms with associated functional language. See MPEP 2103 and 2111.04. Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since Paulsen positively recites all of the claimed process steps as addressed above in claim 15.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of change in aminoacetophenone content, carbohydrate concentration, sodium concentration, potassium concentration, magnesium concentration, calcium concentration, phosphorus concentration, and/or chlorine concentration in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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. There would have been a reasonable expectation of success. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Response to Arguments
Applicant’s remarks filed March 26, 2025 are acknowledged.
Due to the amendments to the claims, the 35 USC 112 rejection in the previous Office Action has been withdrawn (P13-P14). However, the 35 USC 112 rejection and claim objections above are necessitated by the amendments made to the claims.
Applicant’s arguments with respect to Mikkelsen and Paulsen have been fully considered, but they are unpersuasive (P14-P18).
Applicant respectfully submits that the effects of the claimed invention, i.e., improving refreshing feeling and reducing protein odor in the milk raw material by subjecting the milk fluid to concentration processing using a nanofiltration membrane, wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content, and adjusting the parameters of the aroma components (dimethyl disulfide, nonanal, pentanol, pentanal), are remarkable and beyond the expectation of those having ordinary skill in the art. The refractive sugar content is affected not only by lactose, but also by all dissolved substances in the milk fluid and the refractive sugar content should be determined based on data of the contents of all the dissolved substances. The claimed variable was not recognized in the prior art to be a result-effective variable and thus cannot be optimized in view of Mikkelsen. Mikkelsen fails to disclose or suggest subjecting the milk fluid to concentration processing using a nanofiltration membrane, wherein a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content, and adjusting the amount of the aroma components (dimethyl disulfide, nonanal, pentanol, pentanal) to the presently specified ranges in order to improve the refreshing feeling and reduce the protein odor simultaneously in the milk raw material. Paulsen fails to disclose or suggest that a concentration ratio of retentate liquid in subjecting the high-protein milk fluid to concentration processing using the nanofiltration membrane is 1.1 times or more to 1.7 times or less as a refractive sugar content as required in the present claims. As explained in the rejection above, the refractive sugar content is affected not only by sugar, but also by all dissolved substances in the milk fluid and thus the content of total carbohydrates in the product (retentate) of Paulsen would not teach or suggest the concentration processing ratio required in the present claims. Paulsen fails to disclose or suggest adjusting the amount of the aroma components (dimethyl disulfide, nonanal, pentanol, pentanal) to the presently specified ranges in order to improve the refreshing feeling and reduce the protein odor simultaneously in the milk raw material. This fact further shows that the claimed variables were not recognized in the prior art to be result-effective variables and thus cannot be optimized in view of Paulsen.
Examiner disagrees. Mikkelsen and Paulsen teach the claimed methods, and a prima facie case of obviousness has been established. As addressed above, Mikkelsen teaches the product (retentate) may comprise one or more carbohydrate(s) native to the whey protein composition, such as lactose, and the product may comprise carbohydrate which may be inherent to the product (lactose) or added to reach the desired sweetness of taste (P26, L18-19, P30, L39-40; and P37, L26-28 and 30-34, emphasis added). While Paulsen does not expressly disclose the concentration ratio of the retentate liquid, it would have been obvious to one of ordinary skill in the art before to optimize the concentration through routine optimization because Paulsen teaches the product (retentate) comprises about 1-2% total carbohydrates, nanofiltering the whey protein concentrate solution to enhance the characteristics, and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Additionally, the produced product having the properties of improved refreshing feeling and reduced protein odor as well as the claimed aroma components (dimethyl disulfide, nonanal, pentanol, and pentanal) would naturally occur from said method since Mikkelsen and Paulsen positively recite all of the claimed process steps as previously demonstrated, Mikkelsen teaches the product has improved milk flavor and less off-taste (P61, L15-16 and P74, L11), Paulsen teaches the product has enhanced organoleptic characteristics and decreased off flavors (paragraphs [0008], [0019], [0022], [0038], [0039], and [0048]), and the improved refreshing feeling, reduced protein odor, and the particular aroma components of the product is an intended result of the claimed process, absent any clear and convincing evidence to the contrary. As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977). Also, it would have been obvious to one of ordinary skill in the art to optimize the change ratio in dimethyl disulfide content, nonanal content, pentanol content, and pentanal content in the method of Paulsen through routine optimization with the expectation of successfully preparing a functional product because Paulsen teaches nanofiltering the whey protein concentrate solution to enhance the characteristics and adjusting the processing conditions of nanofiltration to optimize the process and obtain an organoleptically desirable whey protein product (paragraphs [0008], [0010], [0019], [0022], [0036], and [0044]-[0045]), and it is understood that, 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
Further, Applicant has not demonstrated that the methods of Mikkelsen and Paulsen are incapable of arriving at a milk raw material with the claimed properties. Applicant is reminded if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc).
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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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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