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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 in the reply filed on March 16, 2026 is acknowledged. The traversal is on the ground(s) that Group II, claim 8 which is a food or beverage comprising the protein composition of Group I should be with Group I as it is an obvious variant thereof. This is not found persuasive because Group I does not require an edible product, and nonedible compositions such as pet chews or anti-microbial coatings could also read on the composition. A protein and salt composition can be used in many ways and do not require use in a food as argued. Additionally, it is noted that the search of group II is further different from that of group I as it does not require the specific ratios required by group I because it is a composition comprising the plant protein composition and thus may have additional proteins and/or salts, such that the final product does not have the same ratios required by Group I.
The requirement is still deemed proper and is therefore made FINAL. Claims 8-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
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 1-7 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.
Claim 1 recites the limitation "the added orthophosphate salt" in line 3. It is unclear as to if the term refers to an orthophosphate salt which would be inherent in the alkaline orthophosphate salt composition, or if the term is meant to refer to the alkaline orthophosphate salt composition, or to some other component that may be “added”. Claim 3 is rejected for substantially the same reasons.
Claim 4 depends from claim 1 and recites “the composition” and it is unclear as to if this is referring to the “plant protein composition” or the “alkaline orthophosphate salt composition” recited in claim 1.
The terms “neutral” and “hot” in claim 5 are relative terms which render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to if neutral is related to temperature, pH, or some other parameter, and as to what would and would not be considered neutral. It is also unclear as to what threshold is used to determine what is and what is not “hot” water.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as obvious over Ito (WO 2020/007940).
Regarding a plant protein composition comprising a dried plant protein isolate comprising at least 70% protein as recited in claim 1, Ito teaches a plant protein composition comprising a dried protein composition (abstract, page 7 lines 6-11 and 18, and page 8 lines 6-10). Ito does not generically disclose the form of the dried protein composition as an isolate with at least 70% protein, however does exemplify it as a pea protein isolate Nutralys® S85F which contained greater than 70% protein (see example tables and page 10 lines 8-9). Thus, it would have been encompassed, or at least obvious for the dried protein taught by Ito to be in the form exemplified, i.e. as a pea protein isolate with greater than 70% protein. Where there is no generic disclosure, it would have been encompassed or at least an obvious suggestion of the prior art to use the form of the disclosed ingredients found in the examples.
Regarding the protein composition as comprising an alkaline orthophosphate salt composition, wherein the added salt to protein content by dry weight of 3-98% as recited in claim 1, to the alkaline orthophosphate salt composition as comprising 5-100% trisodium phosphate and/or tripotassium phosphate as recited in claim 2, or further comprising 5-95% hexametaphosphate sodium or potassium salt as recited in claim 3, as discussed above, the limitations recited in claims 1 and 3 are unclear. Regardless, Ito teaches that the protein composition comprises 0.008-33% dry weight potassium metaphosphate which can be in the hexamer form (page 5 line 19 through page 6 line 3 and claim 2), and thus encompasses potassium hexametaphosphate which is disclosed as an alkaline phosphate salt (instant specification paragraph 48). Ito further teaches that the composition may further comprises sodium hexametaphosphate, wherein the amount of sodium metaphosphate and potassium metaphosphate is from 0.01-8% dry weight of the composition (page 6 lines 6, 10 and 25-27), and which is disclosed as an alkaline phosphate salt (instant specification paragraph 48). As there are no other ingredients required besides the dry protein (all), the percentages disclosed by Ito thus encompass the amount of said salt by dry weight of the composition. Furthermore, Ito further exemplifies the composition as comprising by dry weight about 6% (0.2/3.5 total dry ingredients) tripotassium phosphate or trisodium phosphate (Example 5, specifically including the tables tests 2 and 3). Ito discloses overlapping ranges to those claimed, thus, the claimed limitations are considered encompassed or alternatively obvious over the teachings of the prior art. It is noted that Ito discloses that the inclusion of the salts affected the solubility, bitterness, acidity, and sandiness of the resulting product (Example 5, specifically including the tables tests 2 and 3), thus it would have been further obvious to modify the amount of each respective salt depending on the properties desired in the respective end product. Furthermore, 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.
Regarding the composition as having an aqueous solubility at a pH7 of at least 20% as recited in claim 4, Applicant has described the product with parameters which cannot be measured by the office for prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability purposes. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facie case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different. In the instant case as Ito teaches of a product with an overlapping composition to that as claimed and disclosed, i.e. a plant protein comprising 3-98% alkaline orthophosphate salts, one of ordinary skill in the art would expect the product to have the same properties as claimed. Also see instant specification paragraphs 53 and 54 which states the solubility is a result of the composition. The position is further supported as Ito teaches the composition is soluble and dissolves easily and/or rapidly (page 6 lines 31-32 and Example 5, test 2).
Regarding the plant protein isolate as a neutral extracted plant protein isolate prepared by extraction with hot water as recited in claim 5, as discussed above, the claimed limitations are unclear. Regardless, the claimed limitation is a product by process limitation and thus is considered as much as it affects the final product. “[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). In the instant case, as the parameters claimed are unclear, the claimed product by process would impart a protein isolate component to the claimed composition. As discussed above, the teachings of Ito encompass or at least make obvious a protein isolate, and thus the claimed product is considered at least obvious over the product of the prior art.
Regarding claims 6 and 7, Ito teaches that the protein is preferably a pea protein (page 7 lines 10-12).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 13, 14, 16-18, and 21 of U.S. Patent No. 11,825,861 (‘861). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Regarding claims 1 and 6-7, ‘861 claims a pea protein composition comprising a dried pea protein isolate with at least 70% protein and 3-98% dry weight of an added alkaline orthophosphate salt (claim 13).
Regarding claim 2, ‘861 claims the alkaline phosphate comprises 5-100% trisodium phosphate and/or tripotassium phosphate (claim 14).
Regarding claim 3, ‘861 claims the alkaline salt further comprises 5-95% hexametaphosphate sodium and/or potassium salt (claim 16).
Regarding claim 4, ‘861 claims the composition as an aqueous solubility at a pH of 7 of at least 20% (claim 18).
Regarding claim 5, ‘861 claims the plant protein is a neutral extracted plant protein extracted with hot water (claim 21).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: XU US 8776728 teaches a pet chew comprising a plant protein and orthophosphate salt.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792
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