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 August 3, 2026 is acknowledged. Claims 1-4 and 6-21 are pending in the application. Claim 7 has been withdrawn from consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 3, 2026 has been entered.
Claim Objections
Claims 3 and 19-21 are objected to because of the following informalities:
In claim 3 at line 2, it is suggested to remove the hyphen “-“ after “by” and before “Differential”.
Claims 19-21 have the status identifier of “New”. However, these claims have been previously added in the immediate prior version of the claims dated January 7, 2026.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 1-4, 6, and 8-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Edwards et al. US 4060203 (hereinafter “Edwards”).
With respect to claim 1, Edwards relates to a protein composition wherein the protein has been preserved to a great extent in its native condition and has little protein denaturation. The protein composition is obtained from lupin, broad beans, chick peas, cow peas, field beans, kidney beans, lentils, lima beans or ming beans (pulses) (Abstract; C2, L51-54; and C3, L53-57).
Regarding the recitation of a protein content of at least 60 wt% based on dry matter in claim 1, Edwards teaches the protein composition comprises 60-90% protein on a dry basis (C3, L51-53).
Regarding the recitation of a nitrogen solubility index at a pH ranging from 4.5 to 5.5 of at most 20% and a nitrogen solubility index at pH of 3.5 of at least 20% as measured on an aqueous composition comprising 3 wt% of said pulse protein composition based on the total weight of the aqueous composition, a denaturation enthalpy of at least 4.5 (∆H J/g) measured by Differential scanning calorimetry, and an emulsion capacity of at least 600g oil/g protein at room temperature in claim 1, it is noted that the claimed nitrogen solubility index, denaturation enthalpy, and emulsion capacity relate to characteristics, functions, and properties of the claimed pulse protein composition. Where Applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the Examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
Absent any clear and convincing evidence to the contrary, it is reasonable to assert that the protein composition of Edwards displays the claimed nitrogen solubility index, denaturation enthalpy, and emulsion capacity since the instant specification indicates that the protein is kept as native as possible (or as less denatured as possible) (P2, L11-14), and Edwards teaches the protein in the composition has been preserved to a great extent in its native condition and has little protein denaturation, the protein molecular size of the protein composition is large enough to ensure high response of its functional properties when used in a foodstuff, and the protein composition has very good functional properties such as nitrogen dispersibility index (C2, L23-28; C3, L53-57; and C4, L1-3).
Alternatively, 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 processing parameters through routine experimentation in Edwards with the expectation of successfully preparing a functional product of desirable functional properties. One of ordinary skill in the art would have been motivated to do so because Edwards teaches the functional behaviors of the protein composition are directly connected to the protein molecular size and level of denaturation which are a result of processing parameters, such as temperature, during the preparation of the protein composition and can be adjusted (C1, L17-18 and 27-34; and C3, L57-C4, L1), and the claimed nitrogen solubility index, denaturation enthalpy, and emulsion capacity of the protein composition are not seen as critical in absence of unexpected results. 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).
Applicant is also reminded that 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).
With respect to claims 2-4 and 6, Edwards is relied upon for the teaching of the pulse protein composition of claim 1 as addressed above.
Regarding the recitation of characterized in that by having a nitrogen solubility index at a pH of at least 7 of at least 70% in claim 2, characterized in that by having an enthalpy of at least 5.5 measured by Differential scanning calorimetry in claim 3, having a viscosity below 2000 cP at pH 6.5 in claim 4, and characterized in that the pulse protein composition has a gel strength of at most 150 g in claim 6, it is noted that the claimed nitrogen solubility index, enthalpy, viscosity, and gel strength relate to characteristics, functions, and properties of the claimed pulse protein composition. Where Applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the Examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
Absent any clear and convincing evidence to the contrary, it is reasonable to assert that the protein composition of Edwards displays the claimed nitrogen solubility index, enthalpy, viscosity, and gel strength since the instant specification indicates that the protein is kept as native as possible (or as less denatured as possible) (P2, L11-14), and Edwards teaches the protein in the composition has been preserved to a great extent in its native condition and has little protein denaturation, the protein molecular size of the protein composition is large enough to ensure high response of its functional properties when used in a foodstuff, and the protein composition has very good functional properties such as nitrogen dispersibility index and gel formation (C2, L23-28; C3, L53-57; and C4, L1-3).
Alternatively, 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 processing parameters through routine experimentation in Edwards with the expectation of successfully preparing a functional product of desirable functional properties. One of ordinary skill in the art would have been motivated to do so because Edwards teaches the functional behaviors of the protein composition are directly connected to the protein molecular size and level of denaturation which are a result of processing parameters, such as temperature, during the preparation of the protein composition and can be adjusted (C1, L17-18 and 27-34; and C3, L57-C4, L1), and the claimed nitrogen solubility index, enthalpy, viscosity, and gel strength of the protein composition are not seen as critical in absence of unexpected results. 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).
Applicant is also reminded that 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).
Claims 8-13 and 19-21 relate to a pulse protein composition obtained by a method. Applicant is reminded that “[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, 227 USPQ 964,966). 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 unobvious different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113).
Additionally, "[t]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
With respect to independent claim 13 and dependent claims 8-12 and 19-21, it is Examiner’s position that the broadest reasonable interpretation of the product encompassed by these product-by-process claims includes a milled, pulse protein composition, and the steps of hydrating, leaving, and removing as claimed do not appear to impart distinctive structural characteristics to the final product.
Edwards relates to a milled protein composition wherein the protein has been preserved to a great extent in its native condition and has little protein denaturation. The protein composition is obtained from lupin, broad beans, chick peas, cow peas, field beans, kidney beans, lentils, lima beans or ming beans (pulses) (Abstract; C1, L27-30; C2, L51-54; and C3, L53-57).
Thus, it is reasonable to assert that the milled protein composition of Edwards is substantially similar to the presently claimed pulse protein composition, absent any clear and convincing evidence to the contrary. Applicant is reminded that 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).
With respect to claim 14, Edwards relates to a food system comprising a protein composition. The protein composition is obtained from lupin, broad beans, chick peas, cow peas, field beans, kidney beans, lentils, lima beans or ming beans (pulses) (C2, L51-54; and C3, L57-60).
Regarding the recitation of comprising the pulse protein composition according to claim 1 in claim 14, Edwards teaches the food system comprises a protein composition (C3, L57-60). Additionally, Edwards is relied upon for the teaching of the pulse protein composition of claim 1 as addressed above. Thus, the teachings of Edwards meet the presently claimed invention.
With respect to claim 15, Edwards relates to food comprising a protein composition. The protein composition is obtained from lupin, broad beans, chick peas, cow peas, field beans, kidney beans, lentils, lima beans or ming beans (pulses) (C2, L51-54; and C3, L57-60).
Regarding the recitation of comprising the pulse protein composition according to claim 1, wherein the food or feed product is one of the listed components in claim 15, Edwards teaches food comprising a protein composition, and the food may be a meat product, bread, etc. (C3, L57-60; and C4, L3). Additionally, Edwards is relied upon for the teaching of the pulse protein composition of claim 1 as addressed above. Thus, the teachings of Edwards meet the presently claimed invention.
With respect to claims 16, 17, and 18, Edwards is relied upon for the teaching of the pulse protein composition of claim 1 as addressed above.
Regarding the recitation of characterized in that by having a nitrogen solubility index at a pH of at least 7 of at least 80% in claim 16, having a viscosity below 1800 cP at pH 6.5 in claim 17, and of characterized in that the pulse protein composition has a gel strength of at most 130 g in claim 18, it is noted that the claimed nitrogen solubility index, viscosity, and gel strength relate to characteristics, functions, and properties of the claimed pulse protein composition. Where Applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the Examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
Absent any clear and convincing evidence to the contrary, it is reasonable to assert that the protein composition of Edwards displays the claimed nitrogen solubility index, viscosity, and gel strength since the instant specification indicates that the protein is kept as native as possible (or as less denatured as possible) (P2, L11-14), and Edwards teaches the protein in the composition has been preserved to a great extent in its native condition and has little protein denaturation, the protein molecular size of the protein composition is large enough to ensure high response of its functional properties when used in a foodstuff, and the protein composition has very good functional properties such as nitrogen dispersibility index and gel formation (C2, L23-28; C3, L53-57; and C4, L1-3).
Alternatively, 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 processing parameters through routine experimentation in Edwards with the expectation of successfully preparing a functional product of desirable functional properties. One of ordinary skill in the art would have been motivated to do so because Edwards teaches the functional behaviors of the protein composition are directly connected to the protein molecular size and level of denaturation which are a result of processing parameters, such as temperature, during the preparation of the protein composition and can be adjusted (C1, L17-18 and 27-34; and C3, L57-C4, L1), and the claimed nitrogen solubility index, viscosity, and gel strength of the protein composition are not seen as critical in absence of unexpected results. 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).
Applicant is also reminded that 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).
Response to Arguments
Applicant’s remarks filed August 3, 2026 are acknowledged.
Applicant’s arguments with respect to the 35 USC 102/103 rejection of claims 8-13 and 19-21 over Shima and the 35 USC 103 rejection of claims 1-6 and 14-18 over Shima in the previous Office Action have been fully considered and are persuasive (P6-P11). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Edwards. As addressed above, Edwards teaches a protein composition that is substantially similar to that as presently claimed.
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