DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 08/13/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims: (1) the objection to claim 3 has been withdrawn; (2) the 35 U.S.C. §112(b) rejections of claims 6 and 9 have been withdrawn; and (3) the 35 U.S.C. §103 rejection of claim 2 over Bataller and Hoffman as evidenced by Kammerlehner has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 3-11
Withdrawn claims: None
Previously cancelled claims: None
Newly cancelled claims: 2
Amended claims: 1, 3-11
New claims: None
Claims currently under consideration: 1, 3-11
Currently rejected claims: 1, 3-11
Allowed claims: None
Claim Objections
Claim 3 is objected to because of the following informalities:
In claim 3, the phrase “wherein the ratio” should be read as “wherein the weight ratio”.
Appropriate correction is required.
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, 3-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Carrington-Bataller (US 2016/0157504), hereinafter referred to as “Bataller”, in view of Hoffman (Hoffman, W., "Effects of microparticulated whey proteins on the consistency of low-fat quark preparations", Institute for Process Engineering of the Federal Institute for Milk Research, D 24103 Kiel, Federal Republic of Germany, Vol. 9, No. 6, (1994), pp. 312-315; IDS citation; English translation relied on for citations) as evidenced by Kammerlehner (Kammerlehner, J., “Simplesse 100® - Dry Simplesse 100®. Specific products made from whey to upgrade food”, Munchen, DE, vol. 114, No. 29, 1993, pages 848-850, 852; IDS citation; English translation relied on for citations).
Regarding claim 1, Bataller teaches a spoonable (corresponding to spreadable) fermented cream cheese composition of the quark types (corresponding to cream cheese made from pasteurized cultured milk per page 2, lines 11-13 of the present specification) [0002], [0027], [0049]. Bataller teaches that the composition comprises about 10 wt.% to about 20 wt.% protein with respect to the total weight of the composition (Table 2 below [0051]), which overlaps the claimed protein concentration. Bataller also teaches that the composition has a pH of about 4.5 to about 5.0 [0051], which overlaps the claimed pH range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I.
Bataller teaches that the protein in the composition is dairy protein [0020], which consists of casein and milk serum proteins (corresponding to whey) in a weight ratio of casein to milk serum proteins of less than about 80:20, such as about 70:30 [0030], which given the ±10% or ±20% deviation implied by the term “about” [0062], overlaps the claimed ratio. The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I. Bataller teaches that the milk serum proteins may be provided by a dairy protein powder from a cheesemaking process [0026]; and that the powder may provide at least about 50 wt.% of the total protein to the composition [0020]. Bataller also teaches that the composition contains no more than 14 wt.% fat and has similar texture and organoleptic characteristics of conventional cream cheese [0006], [0017].
Bataller does not teach that the milk serum proteins comprise at least 20 wt.% denatured serum proteins in the form of microparticles with respect to the total weight of the serum proteins.
However, Hoffman discloses a milk serum protein powder (corresponding to Simplesse 100) that is used in low-fat or fat-free variants of cheese such as quark (page 1, paragraph under “1. Introduction”) to substitute the missing fat in the cheese in order to improve the flavor and texture (corresponding to upgrade) of the cheese (page 1, paragraph under “1. Introduction”). The protein powder contains denatured serum proteins as evidenced by Kammerlehner (page 1, 1st paragraph under “Manufacturing Characteristics”). Hoffman teaches that the milk serum proteins in the protein powder are microparticulated milk serum proteins (page 1, paragraph under “1. Introduction”).
It would have been obvious for a person of ordinary skill in the art to have modified the composition of Bataller to include denatured microparticulate milk serum proteins as taught by Hoffman. Since Bataller teaches that the milk serum proteins may be provided by a dairy protein powder from a cheesemaking process [0026] and that the composition contains no more than 14 wt.% fat while having similar texture and organoleptic characteristics of conventional cream cheese [0006], [0017], but does not disclose a specific protein powder capable of achieving such a goal, a skilled practitioner would have been motivated to consult an additional reference such as Hoffman in order to determine a suitable milk protein powder which may be used in low-fat and fat-free quark cream cheese compositions to obtain flavor and texture similar to conventional full-fat quark cream cheese. Therefore, the incorporation of denatured microparticulate milk serum proteins is rendered obvious.
In regard to at least 20 wt.% of the milk serum proteins being denatured microparticulate milk serum proteins, Bataller discloses that the protein in the composition consists of casein and milk serum proteins in a weight ratio of casein to milk serum proteins of less than about 80:20; and that the protein powder may provide at least about 50 wt.% of the total protein to the composition [0020]. Therefore, Bataller at least suggests a concentration range of denatured microparticulate milk serum proteins which overlaps the claimed at least 20 wt.% of the milk serum proteins (e.g., the protein powder providing 50 wt.% of the casein and whey in the composition means that the powder provides half of the whey in the casein to whey ratio of 80:20 and thus 50 wt.% of the whey would be denatured microparticulate whey). The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I.
Regarding claim 3, Bataller teaches the invention as described above in claim 1, including the weight ratio of casein to milk serum protein may be less than about 80:20 [0030], which overlaps the claimed ratio. The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I.
Regarding claim 4, Bataller teaches the invention as described above in claim 1, including that the protein in the composition consists of casein and milk serum proteins in a weight ratio of casein to milk serum proteins of less than about 80:20; and that the protein powder may provide at least about 50 wt.% of the total protein to the composition [0020]. Therefore, Bataller at least suggests a concentration range of denatured microparticulated milk serum proteins which overlaps the claimed at least 20 wt.% of the milk serum proteins (e.g., the protein powder providing 50 wt.% of the casein and whey in the composition means that the powder provides half of the whey in the casein to whey ratio of 80:20 and thus 50 wt.% of the whey would be denatured microparticulate whey). The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I.
Regarding claim 5, modified Bataller teaches the invention as described above in claim 1, including the microparticulate serum proteins are Simplesse 100 (Hoffman, page 1, paragraph under “1. Introduction”), wherein the mean diameter of the microparticulate protein is 1 micron as evidenced by Kammerlehner (page 1, paragraph under “Manufacturing Characteristics”). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP §2144.05.I.
Regarding claim 6, Bataller teaches the invention as described above in claim 1, including the composition comprising 10-20 wt.%, such as 12-15 wt.% protein with respect to the total weight of the composition (Table 2 below [0051]), which overlaps the claimed protein concentration. The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I.
Regarding claim 7, Bataller teaches the invention as described above in claim 1, including the composition comprising 0-10 wt.% carbohydrates (corresponding to sugar) with respect to the total weight of the composition (Table 2 below [0051]), which encompasses the claimed carbohydrate concentration. The selection of a value within the encompassing range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 8, Bataller teaches the invention as described above in claim 1, including the composition comprising less than 14 wt.% fat with respect to the total weight of the composition [0006], which encompasses the claimed fat concentration. The selection of a value within the encompassing range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 9, Bataller teaches the invention as described above in claim 1, including the composition comprising lactic acid bacteria (corresponding to inoculated with a lactic acid culture) [0038], texturing agents (corresponding to emulsifiers and stabilizers), dyes (corresponding to colorants), and/or flavourings [0033].
Regarding claim 11, Bataller teaches the invention as described above in claim 1. Bataller does not disclose that the composition is for use in the nutritional supplementation of sporting or elderly persons. However, statements reciting the purpose or intended use of the claimed invention which do not result in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art do not limit the claim and do not distinguish over the prior art apparatus (or process). See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) and cases cited therein, as it has been held that the recitation of a new intended use for an old product does not make a claim to that old product patentable. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). MPEP § 2111.02, §2112.02, §2114-2115. Therefore, the claim is rendered obvious by the disclosure of the invention of present claim 1 in the cited combination of prior art references.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bataller (US 2016/0157504; previously cited) in view of Hoffman (Hoffman, W., "Effects of microparticulated whey proteins on the consistency of low-fat quark preparations", Institute for Process Engineering of the Federal Institute for Milk Research, D 24103 Kiel, Federal Republic of Germany, Vol. 9, No. 6, (1994), pp. 312-315; IDS citation; English translation relied on for citations) as evidenced by Kammerlehner (Kammerlehner, J., “Simplesse 100® - Dry Simplesse 100®. Specific products made from whey to upgrade food”, Munchen, DE, vol. 114, No. 29, 1993, pages 848-850, 852; IDS citation; English translation relied on for citations) as applied to claim 1 above, and further in view of Brighenti (Brighenti et al., “Characterization of the Rheological, Textural, and Sensory Properties of Samples of Commercial US Cream Cheese with Different Fat Contents”, 2008, J. Dairy Sci., vol. 91, pages 4501-4517; previously cited).
Regarding claim 10, Bataller teaches the invention as described above in claim 1, including the composition is a high protein cream cheese comprising no more than 14 wt.% fat [0006] and various optional ingredients such as stabilizers [0033]. Bataller also teaches that the composition may be made by different conventional cream cheesemaking and hybrid cream cheesemaking processes [0038]-[0039]. Bataller does not disclose that the composition has the viscosity recited in present claim 10.
However, Brighenti discloses that many processing factors affect the structure, texture, and rheology of cream cheese (page 4502, 1st column, 3rd paragraph). Brighenti also teaches that structure, texture, and rheology are influenced by an increase in the levels of total solids, an increase in gel-forming protein, an increase in the levels of fat, and the addition of different types of stabilizers (page 4502, 1st column, 3rd paragraph). Viscosity is characteristic considered to be included under structure, texture, and rheology characteristics.
It would have been obvious for a person of ordinary skill in the art to have modified the viscosity of the composition of Bataller as taught by Brighenti. Since Bataller discloses that the composition is a high protein cream cheese comprising no more than 14 wt.% fat [0006] and optionally stabilizers [0033], wherein the composition may be made by different conventional cream cheesemaking and hybrid cream cheesemaking processes [0038]-[0039], a skilled practitioner would understand that these factors would influence the viscosity of the composition. As the viscosity is a variable that can be modified, among others, by adjusting the concentrations of ingredients and processing conditions of the composition, the claimed viscosity would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed viscosity cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the viscosity in the composition to obtain the desired texture in the composition (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Therefore, the claimed viscosity is rendered obvious.
Response to Arguments
Claim Objections: Applicant canceled claim 2; therefore, its objection is moot. Applicant did not amend claim 3 to address the objection; therefore, the objection of claim 3 is maintained as written herein.
Claim Rejections – 35 U.S.C. §112(b) of claims 6 and 9: Applicant amended claims 6 and 9 to fully address the rejections; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-9 and 11 over Bataller and Hoffman as evidenced by Kammerlehner; claim 10 over Bataller, Hoffman, and Brighenti as evidenced by Kammerlehner: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant canceled claim 2. Applicant argued that Bataller teaches away from the claimed pH range of less than or equal to 4.6 as Bataller discloses in [0036] that a pH of about 4.3 to about 4.6 causes casein to precipitate out of solution, which creates a grainy texture. Applicant stated that Bataller seeks to solve the problem of casein precipitation by raising the pH of the overall blend to above pH 4.6 as disclosed in [0049]. Due to this reasoning, Applicant argued that a skilled practitioner would be motivated to operate at the higher end of the disclosed pH range and be discouraged from operating at a pH of 4.6 or below (Applicant’s Remarks, page 5, 1st paragraph – page 6, 1st paragraph).
However, the Examiner points out that the pH of above 4.6 disclosed in [0049] of Bataller refers to the pH of a blend of curd and retentate/cultured dairy liquid (Fig. 4-5; [0007], [0024]-[0025]). The pH of above 4.6 discussed in [0049] of Bataller does not refer to the pH of the final cream cheese composition. Bataller explicitly states in [0051] that the pH range of the final cream cheese composition may be from about 4.5 to about 4.2, which overlaps the claimed pH range of the final cream cheese composition. This disclosure provides sufficient motivation for a skilled practitioner to operate within a pH range which includes values within the claimed pH range.
Applicant then argued that Hoffman discloses using microparticulated whey proteins as a fat substitute in low-fat quark while Bataller discloses that its composition is not fat-free and contains up to 14% fat. Applicant argued that a skilled practitioner would not have reason to incorporate a fat substitute from Hoffman into the fat-containing composition of Bataller, particularly wherein Bataller already has a solution for achieving a smooth texture (Applicant’s Remarks, page 6, 2nd paragraph).
However, the Examiner points out that the term “low-fat” does not mean there is an absence of any fat in a composition; and that Hoffman does not disclose a threshold for determining what level of fat is considered “low-fat”. The Examiner also points out that Bataller discloses that there is fat present in its composition, but that the amount of fat is not more than 14% [0006], thereby disclosing a fat concentration from greater than 0 wt.% to a maximum of 14 wt.%. This fat concentration range includes amounts of fat which may be considered as being “low” (e.g., Hoffman discloses that less than 1% fat falls within the range of “low-fat” in the 1st paragraph under “Materials and Methods” on page 1). Furthermore, a skilled practitioner would be motivated to use the microparticulated whey of Hoffman in the composition of Bataller to maintain or improve the smooth texture of the composition while still adding the desired whey protein.
Applicant then argued that Bataller discourages the addition of whey protein as a solution to the texture problem as [0026] of Bataller states that “in some instances, the whey protein sources may be less than desired”. Applicant stated that this position is supported by the grainy texture resulting from the addition of whey protein as seen in Compositions 1 and 3 in Table 1 of Bataller’s experiments (Applicant’s Remarks, page 6, 3rd -4th paragraphs).
However, the Examiner points out that the results of Compositions 1 and 3 exemplify the use of using high protein powders alone in the composition (i.e., using protein powders without retentate/cultured diary liquid) as described in [0033] and Fig. 1 of Bataller. This method of using high protein powders alone is a comparative method and thus, is not the method disclosed by Bataller as Bataller requires the addition of retentate/cultured dairy liquid to the composition to hydrate the protein powder in the composition (Figs. 2-5; [0007]; Composition 4 of Table 1). Furthermore, the phrase “in some instances” in the phrase “in some instances the whey protein sources may be less than desired” in [0026] does not mean “in every instance”. As such, while Bataller may desire to exclude whey protein sources from some of its compositions, Bataller also indicates a desire to include whey protein sources in other compositions, especially wherein Bataller also discloses in [0026] that “Alternatively whey sources may be native whey proteins”.
Applicant then argued that Bataller consistently discloses a casein to whey ratio of 80/20 and only discloses a passing, non-preferred mention of a ratio of casein to whey of 70/30 in [0030]. Applicant stated that Bataller is built upon maximizing the casein content in order to achieved the desired cream cheese texture in teaching that the starting cheese curd, cultured dairy liquid, and added protein powders should have a ratio of casein to whey of about 80/20 or higher. For this reason, Applicant argued that Bataller teaches away from the claimed casein to whey ratio. Applicant argued that a skilled practitioner would have no motivation to lower the casein to whey ratio of Bataller to be within the claimed range (Applicant’s Remarks, page 7, 1st – 4th paragraphs; page 8, 3rd-4th paragraphs).
However, the Examiner points out that Bataller discloses that the starting cheese curd, cultured dairy liquid, and added protein powders “may” have a casein to whey ratio of about 80:20, wherein the term “may” does not mean that the ingredients must have a casein to whey ratio of about 80:20. The Examiner also points out that the term “about” in the phrase “about 80:20” may imply a deviation of up to ±20% [0062]. Therefore, when Bataller states that the casein to whey ratio may be “about 80:20”, Bataller is disclosing a casein to whey ratio from 64:56 to 96:4, which encompasses the claimed range. Furthermore, Bataller explicitly states in [0030] that “In at some alternative embodiments, the ratio of casein to whey may be less than about 80:20, such as about 78:22, about 75:25, and about 70:30”. Even if the Applicant considers this disclosure to be a passing, non-preferred mention of a casein to whey ratio, the Examiner points out that it is still a disclosure of a casein to whey ratio. “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments” especially wherein “such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). ” MPEP 2123.II. Therefore, Bataller explicitly discloses a composition comprising a casein to whey ratio which falls within the claimed range; and does not teach away from the claimed casein to whey ratio or require modification to reach the claimed casein to whey ratio.
Applicant then argued that Table 1 of the present specification demonstrates that embodiments of the claimed invention reveal the criticality of the casein to whey ratio as the total protein of the composition increases. Applicant stated that the present invention shows that the casein to whey ratio must be decreased (i.e., the proportion of microparticulated whey must be increased) in order to keep the compositions viscosity below the acceptability limit of 7 Pa/s. Applicant argued a skilled practitioner reading Bataller would have no reason to suspect this phenomenon (Applicant’s Remarks, page 8, 1st-2nd paragraphs).
However, the Examiner points out that only claim 10 requires the composition to have a viscosity below 7 Pa/s; therefore, Applicant’s arguments are moot with respect to all the other claims. The Examiner points out that only the embodiments comprising 13% proteins and 14% proteins provide comparisons between compositions comprising differing ratios of casein to whey (i.e., microparticulated whey) while maintaining the same protein content (i.e., MP13% ratio case/PS 70/30 is compared with MP13% ratio case/PS 50/50; MP14% ratio case/PS 70/30 is compared with MP14% ratio case/PS 50/50). These embodiments do not show criticality of the claimed casein to whey ratio as they only use casein to whey ratios that are within the claimed range. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” MPEP §716.02(d)II. Therefore, criticality of the claimed casein to whey ratio has not been demonstrated so that Applicant’s arguments are unpersuasive. The rejections of the claims stand as written herein. The rejection of claim 2 is withdrawn due to the cancellation of the claim.
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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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791