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 .
CONTINUING DATA
This application is a 371 of PCT/EP2022/025037 02/03/2022
FOREIGN APPLICATIONS
FRANCE 2101079 02/04/2021
Claims 1-7 are pending.
Specification
The specification is objected to because there is no Brief Description of the Drawings section.
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 7 is 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 pre-AIA the applicant regards as the invention.
Claim 7 provides for the use of a thermally modified starch, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 1 recites a starch produced via “the acid process.” “The acid process” is unclear because it is not defined in the specification and it is not clear which acid process is “the” acid process.
Claim 4 depends from claim 1 and recites “the starches.” There is insufficient antecedent basis for this limitation in the claim because claim 1 recites a starch but not multiple starches.
Claims 5 and 7 recite “correcting the pH.” This limitation is unclear because it is unclear what sort of pH adjustment is required, whether it is an increase or a decrease, or which pH is to be obtained by the correction. The specification does not define correcting the pH.
Claim 6 depends from claim 5 and recites “the starches.” There is insufficient antecedent basis for this limitation in the claim because claim 5 recites a starch but not multiple starches.
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.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Claim 7 recites the use of a thermally modified starch, but does not set forth any steps involved in the use.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah (WO 2020/139997, cited on IDS).
Shah discloses a thermally modified starch (see abstract) which is prepared by the steps of preparing a starch slurry comprising 30-60% starch, adding into the slurry sodium citrate and citric acid powder to obtain pH of from about 5 to about 6.5, soaking the starch slurry with the citrate and citric acid for about 15 minutes to 24 hours, drying the starch to a moisture content of less than about 5% and heating the dried starch to temperature above 120 degrees C, about 120-200 degrees C. Shah discloses that the starch may be washed in water or aqueous solution prior to a starch slurry or after thermally inhibiting for one or more cycles (see paragraph 0020,0029-0032,0035-0038, 0042, 0045. Shah discloses the use of the thermally modified starch as thickening agent in sauces. (see paragraph 0061,0062).
Claim 7 is a product-by-process claim. “[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). 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.). See MPEP 2113. Claim 7 only requires the use of a starch capable of being produced by the recited method. Claim 7 does not require the starch to have the characteristics recited in claim 1. It is considered that Shah’s product is capable of being produced by the steps recited in current claim 7 because Shah’s product is also prepared by thermal treatment of a moistened starch in citrate buffer.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/263,474 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in each are drawn to a thermally modified starch having a free citrate content of less than 0.05% and a fixed citrate content range which overlaps. The sedimentation volumes recited in each application overlap. The coloring values in each application overlap. Each application claims a process for preparing the starch which differs in the amount of water present (20% moisture versus 30-40% solids content) and a heating temperature (170 degrees C versus at least 160 degree C). 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. In this instance, the fixed citrate ranges, sedimentation volumes, and coloring values of the starches in the reference application and the current application overlap. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” MPEP 2144.05. In this instance, the skilled artisan would have discovered the workable ranges of water content in the reaction by routine experimentation.
The reference application is silent about the lowering of gelatinization temperature, but lowering of gelatinization temperature is an inherent property of the reference application starch because each starch is prepared by a substantially similar process which differs only in potentially the amount of water present.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/729,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a blend of at least two different starches (wherein it has a free citrate content of less than 0.05% and a bound citrate content of between 0.05 and 0.15%) and a method of preparing the blend. The current claims require only one starch, but do not exclude an additional starch. The reference claims recite a similar process to the one recited in the current claims, but the reference claims require a blend of starches and the pH (4-6 versus 4), moisture content (10 to 12 versus 13), and heating temperature (150 versus 170) differ. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” or do not overlap but are merely close, a prima facie case of obviousness exists. MPEP 2144.05. In this instance, the pH, moisture content, and heating temperature in the reference application and the current application overlap or are close. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” MPEP 2144.05. In this instance, the skilled artisan would have discovered the workable ranges of water content in the reaction by routine experimentation.
The reference application is silent about the lowering of gelatinization temperature, but lowering of gelatinization temperature is an inherent property of the reference application starch because each starch is prepared by a substantially similar process which differs only in potentially the amount of water present.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The closest prior art is Shah (cited above). Shah is silent about the free citrate content and fixed citrate content of the starch, and the current specification Table 5 shows that commercial products prepared by the prior art method have a higher free citrate content than is claimed. Shah does not teach or suggest step (vi) in claim 5.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693