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 .
Claim status
Claims 1-12 filed 08/25/2023 are pending in the application and are hereby examined on the merits.
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, 2, 3, 4, 5, 6, 7, 8, 10, 11 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/547,980 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 and 11 of ‘980 encompass all the limitation of instant claims 1-2; claims 3-5 of ‘980 teaches the limitation of instant claims 3-5; claim 6 of ‘980 teaches the limitation of instant claim 6; claims 7-8 of ‘980 teaches the limitation of instant claims 7-8; claim 10 of ‘980 teaches the limitation of instant claim 10; and claims 12-13 of ‘980 teaches the limitation of instant claims 11-12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claim 11 broadly recites a protease, however, a protease can be naturally occurring. This judicial exception is not integrated into a practical application because although claim 11 recites a stretchability improver for a stretchable cheese alternative including a plant protein and starch, such a recitation is merely the intended use of a protease which does not impart any material characteristic to the enzyme. Further, claim 12 recites a peptidase which also can be naturally occurring. Furthermore, the combination of two naturally occurring enzymes produces no new species, no new substances, no change, and no enlargement of the range of their utility. Each enzyme appears to have the same effect it always had. Each of the enzyme appears to perform in their natural way. Their use in combination does not improve in any way their natural functioning. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited.
Claim Objections
Claims 4-5 are objected to because of the following informalities: the genus or species for the bacteria should be written in italic form. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “a step of treating with a peptidase” should read “a step of treating the material composition with a peptidase”. Appropriate correction is required. Appropriate correction is required.
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 2 and 5 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 2 recites a ratio of the starch to the plant protein. It is unclear whether the ratio is for the material composition or for the stretchable cheese alternative. Given that para. [0020] of the instant specification recites that in the material composition the content of the starch per 1 part of the plant protein is 0.1-5 parts by weight, or preferably 0.1-0.6 parts by weight, it is interpreted that the ratio as recited in claim 2 is for the material composition. Appropriate correction is required.
Claim 5 recites “these species in the genus Geobacillus”. It is unclear what the limitation means. Is it the same species as for the Bacillus as recited in the claim? Clarification is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-5, 7-8 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holz-Schietinger US Patent Application Publication No. 2015/0305361 A1 (cited in the IDS submitted 08/25/2023, hereinafter referred to as Holz-Schietinger).
Regarding claim 1, Holz-Schietinger teaches a method of producing a stretchable cheese alternative (e.g., cheese replica, see Abstract) (0023; 0033; 0083) comprising a step of treating a material composition (e.g., a non-dairy cheese source which is an emulsion) comprising plant protein (0093-0094) and starch such as corn starch, potato starch and a gum (0140; 0238) with a protease (0176).
Regarding claim 3-5, Holz-Schietinger teaches that the protease is bacterial-derived protease such as a protease derived from Bacillus licheniformis (0180).
Regarding claim 7, Holz-Schietinger further teaches treating the material composition with a peptidase (0179).
Regarding claim 8, Holz-Schietinger teaches that the plant protein is a pea protein, chickpea protein and/or a lentil protein (0040).
Regarding claims 11-12, Holz-Schietinger as recited above teaches a protease combined with a peptidase for making a cheese alternative that comprises a plant protein and starch. Further, Holz-Schietinger teaches that the stretchability of the cheese replica is modified by the protease, thus reading the preamble language about a “stretchability improver”.
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 2, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Holz-Schietinger as applied to claim 1 above.
Regarding claim 2, Holz-Schietinger as recited above teaches that the non-dairy cheese source comprises a plant protein and starch but does not expressly teach the ratio of the two. The ratio of the two depends on the amount of the plant protein and the amount of the starch in the non-dairy cheese source. In the instant case, Holz-Schietinger teaches that the non-dairy cheese source is an emulsion comprising plant protein provided as a protein solution, and fat (0093; 0101), that the plant protein could account for 100% of the protein content of the protein solution (0101), and that the total protein content of the protein solution is about 0.1- 20% or more than 20% (w/v) (0101). Further, Holz-Schietinger teaches that sugar such as starch function to modify the flavor, melting characteristic and stretchability of the cheese replica (0083; 0140; 0238). Therefore, one of the ordinary skill in the art would have been motivated to manipulate the amount of starch in the non-dairy cheese source so as to ensure that the final cheese replica has desired flavor profile, melting characteristic and stretchability. As such, the ratio as recited in the claim is merely an obvious variant of the prior art.
Regarding claim 6, Holz-Schietinger as recited above teaches a protease but is silent regarding the protease activity unit. What Holz-Schietinger teaches is that the flavor profile and stretchability property of the cheese replica can be modulated by the protease through adjusting the amount of the protease (0083; 0177). Thus given that the enzyme activity unit will govern the amount of an enzyme that is used, one of ordinary skill in the art would have been motivated to choose a protease having a desired activity so as to ensure that the amount of protease is sufficient to improve the flavor profile and stretchability of the cheese replica. As such, the protease activity unit as recited in the claim is merely an obvious variant of the prior art.
Regarding claim 9, Holz-Schietinger teaches that the non-dairy cheese source is an emulsion comprising plant protein provided as a protein solution, and fat (0093; 0101), that the plant protein could account for 100% of the protein content of the protein solution (0101), that the total protein content of the protein solution is about 0.1- 20% or more than 20% (w/v) (0101), and that the emulsion is prepared by admixing the protein solution with the fat a ratio of 1:10 to 10:1 (w/w), therefore, assuming a density of ~ 1 g/ml for the protein solution, Holz-Schietinger teaches a plant protein concentration that at least overlaps with the range as recited in claim 9. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Holz-Schietinger teaches as applied to claim 1 above, and further in view of Grzanich US Patent Application Publication No. 2017/0172169 A1 (hereinafter referred to as Grzanich).
Regarding claim 10, Holz-Schietinger as recited above teaches that a corn starch or potato starch thus being silent regarding tapioca starch.
In the same field of endeavor, Grzanich teaches that corn starch, potato starch and tapioca starch is suitable starch used to make a cheese replica (e.g., a soy-based cheese) that comprises a plant protein, an oil and a microbial strain (0004; 0006).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Holz-Schietinger by substituting tapioca starch for corn starch or potato starch in the non-dairy cheese source of Holz-Schietinger with reasonable expectation of success, for the reason that prior art has established that all these three types of starch are art-recognized starch suitable for making a plant-based cheese and one of ordinary skill in the art would have been motivated to substitute one for another. Substituting equivalents known for the same purpose is prima facie obvious. See MPEP 2144.06 II. See also MPEP 2144.07. which states that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791