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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/26 has been entered.
Election/Restrictions
Claims 5, 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/18/23.
Response to Amendment
The declaration under 37 CFR 1.132 filed 1/23/26 is insufficient to overcome the rejection of claims 1-3, 6-9, 18-20 based upon Choromanski et al as set forth in the last Office action because: the experimental examples are not commensurate with the overlap in protein ranges between Chrormanski et al and the present claims. Claim 1 requires 20-40% protein, while Choromanski et al used 0.5-30% protein. Applicant only tested an example at approximately 38% protein (paragraph 14) which was outside the protein range used by Choromanski et al. Also, applicant’s specification discussed the Choromanski et al reference on page 2, lines 10-15 of the specification, and only acknowledged a gritty sensation at protein values over 30%. Clearly, applicant needs to provide further test examples in the range of 20-30% protein for the product of Choromanski et al. Further, paragraph 15 of the declaration appears to attribute the differences in grittiness/pastiness to the particle size. However, the claims do not require any particular particle size. It also is not clear if the particle size is referring to protein particles, or chocolate particles, or some other type of particle. It is further noted that Choromanski et al also conducted a triangular test with a blind panel and concluded that the product “does not significantly alter the rheological behaviour of the chocolate” and “the trained panel was unable to tell the difference between a traditional milk chocolate and a chocolate… according to the present invention” (paragraph 0165-0176).
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 1-3, 6-9, 18-20 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.
Claims 1, 20 recite the product “does not exhibit perceptible grittiness and does not exhibit a pasty mouthfeel”. Claim 18 also recites “no perceptible difference in grittiness or pasty mouthfeel”. It is not clear what level or degree of grittiness/pasty would be “perceptible”. It is not clear what types of texture would be considered “pasty” or gritty. It is not clear if these values would require a particular particle size, or not.
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.
Claims 1-3, 6-9, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Choromanski et al [US 2012/0294986A1] in view of Rumbaut et al [US 2010/0196574A1] and Luccas et al [US 2009/0311409A1].
Choromansi et al teach confectionary products with pea protein (title) comprising a milk chocolate or white chocolate product (paragraph 0019, 0030), the product containing 0.5-30% pea proteins (paragraph 0015; claim 1), the optional use of 0-30% milk proteins (paragraph 0091, 0093), a chocolate example having 11% pea protein, 24% cocoa butter, and a Casson viscosity of 0.7 Pa*s (page 8, Table 6, paragraph 0165), the replacement of milk proteins with pea proteins NOT significantly altering the rheological behavior such as viscosity of Casson’s model (paragraph 0057), the test chocolate having a higher protein content than the control chocolate (paragraph 0176), a trained panel being unable to tell the difference between traditional milk chocolate and the chocolate using pea protein in a blind triangular test with trained panelists (paragraph 0174), an emulsifier in the form of lecithin (page 8, Table 5)
Choromanski et al do not explicitly recite a Casson viscosity of less than 6 Pa*s (claim 1), or 1-6 Pa*s (claim 2), 3-6 Pa*s (claim 8).
Regarding claim 20, this is a product-by-process claim. MPEP 2113 states:
I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding "interbonded by interfusion" to limit structure of the claimed composite and noting that terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched" are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an integral structure," and discussing several cases since Garnero that held "limitations to convey structure even when they also describe a process of manufacture").
II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be "essentially free of alkali metal." The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not "essentially free of alkali metal" and therefore a different and nonobvious product.).
See also Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art disclosed human nerve growth factor (b-NGF) isolated from human placental tissue. The claim was directed to b-NGF produced through genetic engineering techniques. The factor produced seemed to be substantially the same whether isolated from tissue or produced through genetic engineering. While the applicant questioned the purity of the prior art factor, no concrete evidence of an nonobvious difference was presented. The Board stated that the dispositive issue is whether the claimed factor exhibits any unexpected properties compared with the factor disclosed by the prior art. The Board further stated that the applicant should have made some comparison between the two factors to establish unexpected properties since the materials appeared to be identical or only slightly different.).
Rumbaut et al teach a chocolate product (abstract) possessing a Casson viscosity of 500-4500 mPa*s or 0.5-4.5 Pa*s, and more preferably 1500-3500 mPa*s or 1.5-3.5 Pa*s (paragraph 0029).
Luccas et al teach a chocolate composition comprising cocoa and proteinaceous fat-substitute (abstract; paragraph 0031), the composition including 25-40% cocoa, 2-10% fat-substitute protein, and 10-30% milk (paragraph 0056); and a Casson viscosity of 4-11 Pa*s (paragraph 0073).
It would have been obvious to one of ordinary skill in the art to incorporate the claimed Casson viscosity levels into the invention of Choromanski et al, in view of Rumbaut et al and Luccas et al, since all are directed to chocolate products, since Choromanski et al already included a chocolate example having 11% pea protein and a Casson viscosity of 0.7 Pa*s (page 8, Table 6, paragraph 0165) but simply did not mention any further values for Casson viscosity for other protein amounts, since chocolate products with increased protein levels commonly possessed a Casson viscosity of 4-11 Pa*s as shown by Luccas et al, since chocolate products commonly possessed a Casson viscosity of 500-4500 mPa*s or 0.5-4.5 Pa*s, and more preferably 1500-3500 mPa*s or 1.5-3.5 Pa*s (paragraph 0029) as shown by Rumbaut et al, since Choromanski et al also disclosed the replacement of milk proteins with pea proteins NOT significantly altering the rheological behavior such as viscosity of Casson’s model (paragraph 0057), and since the claimed Casson viscosity values would have been used during the course of normal experimentation and optimization procedures due to factors such as the desired end use of the chocolate product, the desired type of chocolate product, and/or the desired final texture and taste qualities of the chocolate product of Choromanski et al, in view of Luccas et al and Rumbaut et al.
In conclusion, all of the claimed elements/features were known in the prior art and one skilled in the art could have combined the elements/features as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 1/23/26 have been fully considered but they are not persuasive.
The declaration under 37 CFR 1.132 filed 1/23/26 is insufficient to overcome the rejection of claims 1-3, 6-9, 18-20 based upon Choromanski et al as set forth in the last Office action because: the experimental examples are not commensurate with the overlap in protein ranges between Chrormanski et al and the present claims. Claim 1 requires 20-40% protein, while Choromanski et al used 0.5-30% protein. Applicant only tested an example at approximately 38% protein (paragraph 14) which was outside the protein range used by Choromanski et al (ie 0.5-30% protein). Also, applicant’s specification discussed the Choromanski et al reference on page 2, lines 10-15 of the specification, and only acknowledged a gritty sensation at protein values over 30%. Clearly, applicant needs to provide further test examples in the range of 20-30% protein for the product of Choromanski et al. Further, paragraph 15 of the declaration appears to attribute the differences in grittiness/pastiness to the particle size. However, the claims do not require any particular particle size. It also is not clear if the particle size is referring to protein particles, or chocolate particles, or some other type of particle. It is further noted that Choromanski et al also conducted a triangular test with a blind panel and concluded that the product “does not significantly alter the rheological behaviour of the chocolate” and “the trained panel was unable to tell the difference between a traditional milk chocolate and a chocolate… according to the present invention” (paragraph 0165-0176).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DREW E BECKER whose telephone number is (571)272-1396. The examiner can normally be reached 8am-5pm Monday-Friday.
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/DREW E BECKER/Primary Examiner, Art Unit 1792