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 two claim sets filed June 28, 2023 are acknowledged. Claims 1-16 are pending in the application. Claim 16 has been withdrawn from consideration (see below).
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-15, in the reply filed on October 21, 2025 is acknowledged. The traversal is on the grounds that Fazio does not specifically disclose or suggest a dairy creamer with a fat content not lower than 10.5 wt% and a carbohydrate content equal to or lower than 0.10 wt%, and these specific unobvious ranges provide the special technical effect required for providing Unity of Invention.
However, this is not found persuasive. As previously addressed, the shared feature of a dairy creamer with a fat content not lower than 10.5 wt% and a carbohydrate content equal to or lower than 0.10 wt%, which is interpreted to include creamers that do not contain carbohydrate, was known prior to the filing thereof of the international application as demonstrated in Fazio. Fazio relates to a dairy creamer composition comprising from about 5% to about 45% by weight of an edible fat component which encompasses the claimed fat range, nonfat dry milk proteins, emulsifier, emulsion stabilizers, and silent with respect to carbohydrates being required which is interpreted as no carbohydrate present (Abstract; C2, L25-34; C4, L46-47; C6, L12-13).
Thus, the requirement is still deemed proper and is therefore made FINAL.
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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 recites “the steps of” at line 2. This recitation lacks antecedent basis as there is no previous recitation of “steps” in the claim. Therefore, the scope of claim 1 is indefinite. For the purpose of the examination, the recitation of “comprising the steps of:” at line 2 of claim 1 (emphasis added) is interpreted as “comprising:”
Claims 2-15 are not specifically discussed but are rejected due to their dependence on claim 1.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Aird et al. US 200402240224069 (hereinafter “Aird”) in view of Zoltai et al. US 7700145 (hereinafter “Zoltai”).
With respect to claim 1, Aird teaches a process of making a dairy additive for food (Abstract and paragraphs [0021], [0116], and [0117]).
Regarding the recitation “for producing a dairy creamer …” 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 “comprising : a) providing a volume of skim milk having a protein content ranging from 2.5 to 4.5 wt% and a carbohydrate content ranging from 4.5 to 5.5 wt%” in claim 1, Aird teaches providing a volume of skim milk having a protein content ranging from 2-6 wt% and encompasses the presently claimed range of protein (paragraphs [0029], [0096], [0136], and [0148]). 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).
However, Aird does not expressly disclose the carbohydrate content of the skim milk.
Zoltai teaches a method of making a dairy product. The product comprises skim milk. The skim milk comprises a carbohydrate content of approximately 5% (Abstract; C4, L52-57; and C4, L67-C5, L2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any portions of the disclosed range, including the instantly claimed carbohydrate content, from the range disclosed in the prior art reference with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Aird and Zoltai similarly teach the preparation of dairy based products comprising skim milk and Zoltai teaches the skim milk provides dairy flavor and protein to the dairy product (C4, L65-66). There would have been a reasonable expectation of success. "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages " In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Regarding the recitation of b) concentrating the skim milk by ultrafiltration and collecting the obtained protein-enriched retentate in claim 1, Aird teaches concentrating the skim milk by ultrafiltration and obtaining a retentate. Ultrafiltration concentrates the total protein content in the skim milk (paragraphs [0016], [0027], [0044], [0072], [0080], [0096], [0098], [0137] and [0149]; and Fig. 1).
Regarding the recitation of c) diluting the protein-enriched retentate with enough water to reach at least 80 vol% of the initial volume of skim milk to obtain a diluted fraction having a reduced carbohydrate content in claim 1, Aird teaches adding water to the ultrafiltration retentate. Aird also teaches ultrafiltration is used to remove lactose (carbohydrate) (paragraphs [0016], [0027], [0044], [0059], [0063], [0073], and [0138]; and Fig. 1).
Aird does not expressly disclose adding enough water to reach at least 80 vol% of the initial volume of skim milk. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the quantity of water added in the method of Aird with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Aird teaches the moisture content may be adjusted upwards by the addition of water in order to contribute to the nutritional composition, functionality and/or flavor characteristics of the final food product (paragraphs [0063] and [0073]) 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 recitation of d) optionally repeating one or more times steps b) and c) on the diluted fraction resulting from step c) to further reduce the carbohydrate content of the diluted fraction in claim 1, Aird teaches modifying the protein containing material by concentrating by ultrafiltration, obtaining a retentate, and adding water to the retentate in order to alter the lactose content of the protein containing material and performing the modifications at any step in the process (paragraphs [0016], [0027], [0059], [0063], [0072], [0073], and [0080]).
Regarding the recitation of e) concentrating the diluted fraction resulting from step c) or d) by ultrafiltration and collecting the obtained protein-enriched retentate in claim 1, Aird teaches concentrating the diluted retentate by ultrafiltration and obtaining a retentate. Ultrafiltration concentrates the total protein content in the material (paragraphs [0016], [0027], [0077], [0079], and [0080]); and Fig. 1).
Regarding the recitation of f) diluting the protein-enriched retentate resulting from step e) with enough water to provide a diluted fraction having a protein content ranging from 2.5 to 4.5 wt% in claim 1, Aird teaches diluting the obtained retentate with water to obtain a protein content ranging from 2-6 wt% and encompasses the presently claimed protein range (paragraphs [0016], [0027], [0063], and [0074]; and Fig. 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).
Regarding the recitation of g) adding cream to the diluted fraction resulting from step f) to provide a dairy creamer that has a fat content not lower than 10.5% by weight in clam 1, Aird teaches adding cream to diluted product to obtain a dairy based food product with a fat content that does not exceed 55% (paragraphs [0016], [0021], [0027], [0054], [0082], and [0085]; and Fig. 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).
Regarding the recitation of h) optionally adding a stabilizing salt and/or a flavor to the dairy creamer; i) heat treating the dairy creamer; j) optionally homogenizing the dairy creamer; and k) packaging the dairy creamer in claim 1, Aird teaches optionally adding flavor to the dairy based product, heat treating the dairy based product, optionally homogenizing the product, and packaging the product (paragraphs [0038], [0085], [0087], [0100], [0102], [0113], and Fig. 1).
Regarding the recitation of for producing a dairy creamer that has a fat content not lower than 10.5 wt% and a carbohydrate content equal to or lower than 3.3 wt% in claim 1, it is noted that this recitation relates the resulting effect of practicing the claimed method. 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. Additionally, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) and MPEP 2111.04.
Absent any clear and convincing evidence to the contrary, the method would naturally arrive at these claimed features since modified Aird teaches a method that is substantially similar to the presently claimed method as addressed above and Aird teaches ultrafiltration removes the lactose (carbohydrate) content of the composition (removal to achieve less than 6 wt% lactose in the final product) as well as increasing the fat content with the addition of cream to obtain a product with a fat content that does not exceed 55% (paragraphs [0016], [0021], [0053], [0054], [0058], [0059], [0080], [0082], and [0085]; and Fig. 1).
With respect to claims 2 and 3, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the carbohydrate content of the dairy creamer ranges from 0 wt% to 3.0 wt% or 0 wt% to 0.5 wt% in claims 2 and 3, respectively, Aird does not expressly disclose these limitations.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the quantity of carbohydrate in the method of Aird with the expectation of successfully preparing a functional dairy based product. One of ordinary skill in the art would have been motivated to do so because Aird teaches ultrafiltration removes the lactose (carbohydrate) content of the composition (removal to achieve less than 6 wt% lactose in the final product) (paragraphs [0058], [0059], and [0080]) 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 4, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the fat content of the dairy creamer ranges from 10.5 wt% to 18 wt% in claim 4, modified Aird teaches this limitation since Aird teaches adding cream to diluted product to obtain a product with a fat content that does not exceed 55% (paragraphs [0016], [0027], [0053], [0054], [0082], [0085], and Fig. 1). The range of Aird encompasses 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 5, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the concentrating step b and/or e) is performed by ultrafiltration at a temperature ranging from 30 to 55°C and at a pressure ranging from 0.5 to 10 bar in claim 5, Aird teaches ultrafiltration is performed at a temperature range of from 0 to 60⁰C (paragraph [0079]) and encompasses 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).
Additionally, it is reasonable to assert that ultrafiltration in Aird is performed at standard pressure of 1 bar since Aird is silent with respect to adjusting the pressure during ultrafiltration (paragraph [0079]). Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the pressure during ultrafiltration with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Aird teaches modifications, such as pressure conditions, can be used to produce a final product of desired nutritional composition, functional, and/or flavor characteristics (paragraphs [0015]-[0016]), 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 6, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the concentrating step b and/or e) is performed with a concentration factor of 2 to 4 in claim 6, modified Aird teaches this limitation since Aird teaches concentrating with a concentration factor of approximately 4.2 in one embodiment (paragraphs [0122] and [0173]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (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.)
With respect to claims 7 and 8, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the diluted fraction obtained in step f) has a carbohydrate content ranging from 0 wt% to 3.0 wt% or 0 wt% to 0.5 wt% in claims 7 and 8, respectively, Aird does not expressly disclose these limitations.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the quantity of carbohydrate in the method of Aird with the expectation of successfully preparing a functional dairy based product. One of ordinary skill in the art would have been motivated to do so because Aird teaches ultrafiltration removes the lactose (carbohydrate) content of the composition (removal to achieve less than 6 wt% lactose in the final product) (paragraphs [0058], [0059], and [0080]) 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 claims 9 and 10, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the diluted fraction obtained in step f) contains from 0 to 1.0 wt% or 0 to 0.10 wt% fat in claims 9 and 10, respectively, modified Aird teaches these limitation since Aird teaches the fat content of the diluted material is between 0.05 and 5% in one embodiment (paragraphs [0016], [0027], [0063], and [0074]; and Fig. 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 11, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the diluted fraction obtained in step f) contains from 5 to 15 wt% of total solids in claim 11, modified Aird teaches this limitation since Aird teaches the material has a total solids of up to 28% (paragraph [0079]) and encompasses 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 claims 12 and 13, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the cream has a fat content of at least 30 wt% or ranging from 30 wt% to 40 wt% in claims 12 and 13, respectively, modified Aird teaches these limitations since Aird teaches the cream has a fat content of 35-80% (paragraph [0082]) and overlaps with the presently claimed ranges. 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 14, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the stabilizing salt is selected from the group consisting of sodium or potassium salt of citrate, sodium or potassium salt of phosphate, sodium or potassium salt of di- or poly-phosphate, and combinations thereof in claim 14, modified Aird meets the claimed limitation since Aird is silent with respect to the salts listed in claim 14, and the stabilizing salt is an optional component in claim 1.
With respect to claim 15, modified Aird teaches the process of claim 1 as addressed above.
Regarding the recitation of wherein the heat treating step comprises performing pasteurization and/or ultra-high temperature (UHT) procedures n claim 15, modified Aird teaches this limitation since Aird teaches pasteurization and heat treating the product at a suitable temperature above 50⁰C to reduce microorganism activity (paragraphs [0079] and [0102]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYNESHA L. MCCLAIN whose telephone number is (571)270-1153. The examiner can normally be reached Monday-Friday 10 AM - 6:30 PM ET.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793