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 1-7 filed 07/16/2024 are pending in the application and are hereby examined on the merits.
Claim Objections
Claim 6 objected to because of the following informalities: “YI” should be written out with full name Yellowness Index for the first occurrence. 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 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 that the method “comprises the steps consisting in” steps (i)-(vi), which has both “comprises” and “consisting” in one clause. It is unclear whether the scope of the claim comprises the steps or only consists of the steps. Appropriate correction is required.
Claim 1 recites “preparing a starch milk” that has a certain dry matter content in step (i). It is unclear what the starch milk is referring to. Is it a slurry of starch in water, an aqueous solution or solvent? Clarification is required.
Claim 1 recites “preferably between 35 and 37% by weight”. The phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed subject matter. See MPEP 2173.05(d). It is noted that step (ii) of claim 1 and claims 3-4 recites “preferably”, and claims 2-4 recite “more preferentially” or “even more preferentially” thus are rejected for the same reason. Appropriate correction is required.
Claim 1 step (iv) recites dying until reaching an equilibrium moisture content of 10-12%. It is unclear what is dried. Similarly, in step (v) it is unclear what is heated. Clarification is required.
Claim 1 step (vi) recites “resuspending”. The phrase renders the claim indefinite because claim 1 does not recite a suspending step earlier. Clarification is required.
Claims 2-7 ultimately depend from claim 1 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 3 recites “wherein the rise in temperature of the dry starch obtained in step (iv)”, “the delta T”, and “the product at the outlet of the reactor”. There is insufficient antecedent basis for the limitation of the rise, the dry starch, the delta T, the product, or the outlet of the reactor in the claim. Further, it does not appear that step (iv) requires a rise in the temperature where it recites “drying”. The examiner notes that para. 0068-0070 of the instant specification recites that the turbo dryer is for step (v), thus for the purpose of examination, claim 3 is interpreted to limit step (v) of claim 1. Appropriate correction is required.
Claim 3 recites “turbo-dryer type devices”. The phrase “type” renders the claim indefinite because the addition of the word "type" to an otherwise definite expression (e.g., turbo-dryer) extends the scope of the expression so as to render it indefinite. See MPEP 2173.05(b)III E. It is noted claim 4 recites “the reaction fluidized bed type” thus is rejected for the same reason. Clarification is required.
Claim 4 recites “wherein the rise in temperature of the dry starch obtained in step (iv) is carried out in devices of the reaction fluidized bed type”. There is insufficient antecedent basis for the limitation the rise, the dry starch, or the reaction fluidized bed type in the claim. Further, it does not appear that step (iv) requires a rise in the temperature where it recites “drying”. The examiner notes that para. 0068-0070 of the instant specification recites that the fluidized bed reaction system is for step (v), thus for the purpose of examination, claim 4 is interpreted to limit step (v) of claim 1. Appropriate correction is required.
Claim 5 recites a free or bound citrate content in percent form. It is unclear whether the percent is weight percent. Appropriate correction is required.
Claim 6 depends from claim 1 and recites “The blend of at least two-heated starches according to claim 1”. However, given that claim 1 is directed to a method, it is unclear what the claim 6 is drawn to. For the purpose of examination, claim 6 is interpreted to mean the method of claim 1, wherein the blend of at least two heat-modified starches has a coloring expressed as an L* value between 80 and 90, and a YI value of between 15 and 20. Appropriate correction is required.
Claim 7 is drawn to a use of a heat-modified starch, without any steps as to how the use is to be practiced. Therefore, it is unclear what steps must be present in order to meet the claim.
Claim 7 recites “in particular in soups and sauces, and in dairy products”. The phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required.
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. The claim does not fall within at least one of the four categories of patent eligible subject matter because a claim directed to a “use” is considered to be an improper definition of a process per MPEP § 2173.05(q).
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 1-2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lane US Patent Application Publication No. 2020/0207877 A1 (hereinafter referred to as Lane) in view of Shi US Patent No. 6,277,186 B1 (hereinafter referred to as Shi) and Thomas US Patent No. 6,221,420 B1 (cited in the IDS submitted 07/16/2024, hereinafter referred to as Thomas).
Regarding claims 1-2, Lane teaches a method of preparing a heat-modified (e.g., thermally inhibited) granular starch from one or more of corn, waxy corn, tapioca, potato, waxy potato, rice, waxy rice, pea, fava bean, etc. (0013; 0019), the method comprising preparing a starch milk (e.g., a starch slurry that has 35-50% solids, 0029), and adding a citrate buffer to the starch slurry and maintaining a contact time of 0.25 hours to 24 hours so as to adjust the pH of the starch slurry to 4-6 (0030-0033) thus inherently a citrate buffer having the same pH is prepared; dehydrating the pH adjusted starch slurry to a low moisture content to below 5% (or below 1%) (0036); and dry heating the pH adjusted dehydrated starch at above 150 °C for 0.05-4 hours to obtain the thermally inhibited starch (0037-0038), for example, 155-180 °C for 30-200 min (0049).
The dry matter content, the contact time, the heating temperature, and the residency time as disclosed by Lane overlap with or fall within the ranges as recited in the claim 1. 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).
Lane teaches preparing the thermally inhibited starch from one or more of the starches above but does not explicitly teach mixing two starches of different botanical origins to make the starch slurry. Lane is further silent regarding drying the pH adjusted starch slurry to a moisture content of 10-12%.
Shi in the same field of endeavor teaches a process of preparing thermally inhibited starches comprising making a slurry of a starch from corn, pea, potato, wheat, rice, tapioca, etc. (column 2, line 40-42; column 3, line 51-52); adjusting the pH of the starch slurry (column 4, line 12-15); drying the pH adjusted slurry to 2-15% (column 4, line 21-36); dehydrating the dried pH to anhydrous or substantially anhydrous (for example, less than 1%) (column 4, line 37-40; column 5, line 1-3); and heat treating the dehydrated starch at a temperature and for a time sufficient to inhibit the starch, for example, 120-180 °C for 0.5-24 hours (column 5, line 27-39). Further, Shi teaches that starch blend can be used to make the starch slurry (column 7, line 21; column 2, line 65).
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 Lane by comprising two starches such as those that are from different species to make a slurry with reasonable expectation of success, for the reason that prior art has established that it is suitable to make thermally inhibited starches from a starch blend.
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 Lane by subjecting the pH adjusted starch slurry to a drying step to reduce the moisture content to 2-15% prior to the dehydrating step with reasonable expectation of success, for the reason that prior art has established that it is suitable to dry the pH adjusted starch slurry before dehydrating.
The moisture content as disclosed by Shi encompasses the range as recited in claim 1. 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).
Lane in view of Shi teaches preparing the thermally inhibited starch comprising making a starch slurry, adjusting the pH, drying, dehydrating and heating, but is silent regarding resuspending and adjusting the pH of the thermally inhibited starch.
Thomas in the same field of endeavor teaches a method of making a thermally-inhibited granular starch comprising making a starch slurry, adjusting the pH, drying and heating to obtain thermally inhibited starch (column 6, line 1-30). Further, Thomas teaches purifying the thermally inhibited starch by slurring in water, washing, adjusting the pH and drying (column 8, line 59-67).
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 Lane by subjecting the thermally inhibited starch to the post inhibition steps as disclosed by Thomas for purifying the thermally inhibited starch.
Regarding claim 4, Lane as recited above teaches dry heating the pH adjusted dehydrated starch at 155-180 °C for 30-200 min. Further, Lane mentions using a fluidized bed reactor (0052).
Regarding claim 5, Lane in view of Shi and Thomas as recited above teaches the method of making the blend of two heat-modified starches of distinct botanical origins. The free or bound citrate content in the final thermally inhibited starch blend will depend on the amount of citrate buffer added to the starch slurry. In the instant case, Lane teaches that in any embodiment using a citrate buffer and/or citric acid in the pH adjustment step, the total citrate and citric acid content of the slurry is less than about 5% by weight of the starch , or less than about 4% or less than about 3% or less than about 2% or less than about 1% or between greater than 0% to about 4% or about 0.1% to about 3% or about 0.1% to about 2% or about 0.1% to about 1% or about 0.5% to about 2% or about 0.6% to about 2% or about 0.8% to about 2% or about 0.9% to about 2% or about 1% to about 2% or about 1% or the starch (0031). It thus logically follows that the amount of citrate (free or bound) as recited in the claim is encompassed by the prior art.
Regarding claim 6, Lane in view of Shi and Thomas teaches what has been recited above but does not explicitly teach the whiteness/brightness of the thermally inhibited starch blend expressed as L*, or the Yellow index of the blend. However, from the disclosure of Lane (0023-0025; 0047-0049), it appears that the whiteness of the thermally inhibited starch is related to the level of the inhibition, in particular, higher degree of thermal inhibition in starch generally leads to a lower whiteness value as measured by Hunter L value. Note that higher degree of inhabitation incudes a higher heating temperature combined with longer heating time (see 0047-0049). To this end, given that prior art teaches a dry heating condition (e.g., time and temperature) that is consistent with that recited in claim 1, it logically follows that the whiteness value expressed as CIE L* for the thermally inhibited starch blend as disclosed by prior art will encompass the range as recited in claim 6. Similarly, the YI value as recited in claim 6 is also encompassed by prior art (note that YI of starch measures the deviation of a starch sample from an ideal white or transparent state toward yellow). See In re Best.
Regarding claim 7, Lane teaches that the thermally inhibited starch is used as a thickening agent in food products (0062).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Shi and Thomas as applied to claim 1 above, and further in view of Bock US Patent Application Publication No. 2020/0308311 A1 (hereinafter referred to as Bock).
Regarding claim 3, Lane as recited above teaches dry heating the pH adjusted dehydrated starch at above 150 °C (for example 120-200 °C) for 0.05-4 hours (0037-0038). Further, Lane mentions using a fluidized bed reactor (0052), thus being silent regarding a turbo dryer.
Bock in the same field of endeavor teaches that a continuous turbo dryer with a delta T between 15-25 °C can be used to heat-modify a pH adjusted dehydrated starch (0030; 0048-0052; 0066-0067).
It is noted that prior art (e.g., Lane) contains a method of heating (fluidized bed type heating) that is different from the claimed method (e.g., continuous turbo dryer type heating), however, both types of heating are known in the art of making a thermally inhibited starch, therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one for another and the result of the substitution would have been predictable. See MEPE 2143 B, Simple substitution of one known element for another to obtain predictable results.
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, 5 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-8 of copending Application No. 18/263,474 in view of Shi US Patent No. 6,277,186 B1 (hereinafter referred to as Shi). It is noted that claims 1-2 and 4-8 of ‘186 teaches the method of instant claim 1 and the product of instant claim 5 except that the starch is a blend of starch from different species. Shi in the same field of endeavor teaches a process of preparing thermally inhibited starches comprising making a slurry of a starch from corn, pea, potato, wheat, rice, tapioca, etc. (column 2, line 40-42; column 3, line 51-52); adjusting the pH of the starch slurry (column 4, line 12-15); drying the pH adjusted slurry to 2-15% (column 4, line 21-36); dehydrating the dried pH to anhydrous or substantially anhydrous (for example, less than 1%) (column 4, line 37-40; column 5, line 1-3); and heat treating the dehydrated starch at a temperature and for a time sufficient to inhibit the starch, for example, 120-180 °C for 0.5-24 hours (column 5, line 27-39). Further, Shi teaches that starch blend can be used to make the starch slurry (column 7, line 21; column 2, line 65). 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 ‘186 by comprising two starches such as those that are from different species to make a slurry with reasonable expectation of success, for the reason that prior art has established that it is suitable to make thermally inhibited starches from a starch blend.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
