DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 04 March 2026 in which claims 2, 8-14, 17, 19, 20 were canceled, claims 1 and 4 were amended to change the scope and breadth of the claims, and claims 21-29 were newly added.
Claims 1, 3-7, 15, 16, 18 and 21-29 are pending in the current application and are examined on the merits herein.
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 .
Withdrawn Objections & Rejections
Applicant’s amendment, filed 04 March 2026, with respect to the objection of claims 7 and 17, has been fully considered and is persuasive because claim 17 (a duplicate of claim 7), has been canceled. The objection is hereby withdrawn.
Applicant’s amendment, filed 04 March 2026, with respect to the rejection of claim 4 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive because claim 4 has been amended to delete “, preferably at least 70%”. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn.
Applicant’s amendment and arguments, filed 04 March 2026, with respect to the rejections of claims 2, 3 and 15 under 35 U.S.C. 103 as being unpatentable over Sanchez et al., Thompson et al. and Olsen et al., has been fully considered and is persuasive.
Applicant contends Olsen teaches using a spray dyer in the fiber process stream, and not in the starch process stream (see page 6-7 of the Remarks filed 04 March 2026).
The rejection is hereby withdrawn.
Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 05 September 2025, where the limitations in pending claims 1 and 4 as amended now have been changed and claims 21-29have been newly added. Therefore, rejections from the previous Office Action, dated 05 September 2025, have been modified and are listed below.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The recitation “wherein the digestive-resistant starch composition comprises at least 60% Type 2 resistant starch by weight” in claim 27 fails to further limit claim 26, because claim 26 already recites this wherein clause.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant's arguments filed 04 March 2026 have been fully considered but they are not persuasive.
Applicant contends Tan refers to the usage of spray drying on potato powder that contains starch, not extracted potato starch. Applicant argues this material may have different morphology and rheology, affecting the final material and how it reacts to the spray drying process overall.
The above arguments have been considered, but they are not persuasive. While Tan is concerned with spray drying potato powder, Tan expressly teaches the usage of spray drying to prevent the starch from gelatinizing (see e.g. p.483, first and third para; section 2.4.6 Gelatinization degree of starches in spray-dried powder).
Sanchez et al. also teach the method used to isolate starch from plants should prevent gelatinization. As noted in the previous Office Action, Sanchez et al. teach “When vacuum filters are used, the high moisture content of the starch requires low temperatures with long drying periods to prevent starch gelatinization (p.56, last para).”. Sanchez et al. also teach “cassava starch has a high solubility, similar to that of potato starch” (p.39, last para). Sanchez et al. teach potato starch is preferable over corn starch and other starches because it has high gel consistency, and the viscosity decreases upon further heating and stirring (p.124). It’s low gelatinization temperature and excellent flexible film formation are additional favorable properties.
Thus, gelatinization is a consideration when manufacturing starch from plants. Accordingly, the ordinary artisan would have looked to the teaching from Tan et al., which found spray-drying is a solution to preventing starch from gelatinizing.
One having ordinary skill in the art would have been motivated to combine spray drying with convection drying because Sanchez et al. teach the use of hot air to rapidly dry starch, and Tan et al. teach spray-drying incorporates convection drying.
The rejection is hereby maintained.
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.
Claim(s) 1, 3-7, 15, 16, 18, 21, 22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez et al. (Technical Guide for the Production and Analysis of Cassava Starch, 2007, cited in previous Office Action) in view of Thompson et al. (Trends in Food Science & Technology, 2000, vol. 11, pp. 245-253, cited in previous Office Action) and further in view of Tan et al. (Food Research International, published online August 2018, vol. 116, pp. 483-491, cited in previous Office Action).
Starch and starch products are used in both food and non-food industries (p.44, last para). Sanchez et al. teach starch can be used to prepare resistant starch, which promote the growth of microorganisms beneficial to the colon (p.48). Sanchez et al. teach manufacturing starch, the method comprises washing and peeling the roots of yucca to remove soil and impurities; grating or disintegrating to release starch granules and straining or extracting; centrifugation; drying to obtain starch with a moisture content of 12-13 percent (see p.49-50 translation; see p.54-55 for a description of the mechanized extraction technology; and specifically, p.56, last paragraph). The grated mass is pumped to sieves (fig. 32), then centrifugal separators (primary and secondary), (p.55-57).
Drying can be done artificially or using the sun (p.50, Drying). Drying can take place using a vacuum dehydrator; pneumatic dryer; air drying (convection drying, i.e. heated air); and cyclone (p.56). When vacuum filters are used, the high moisture content of the starch requires low temperatures with long drying periods to prevent starch gelatinization (p.56, last para). In modern plants, however, starch is dried in pneumatic dryers with short residence times and rapid water evaporation (figure 38; p.56, last para). The starch is conveyed and dried by a stream of hot air (i.e. convection drying).
Sanchez et al. teach starch comes from tubers (potato) and roots (cassava), (p.33, first para). Starch granules from tubers are oval/spherical, 5-100 µm in diameter, with a 20% amylose content, has a gelation temperature of 64 °C, and has a tendency to produce a clear cohesive gel when cooked (see Table 3, p.36). Yuca root similarly has oval shaped starch granules, are 4-35 µm in diameter, with a 17% amylose content, a gelation temperature of 63 °C, has a tendency to produce a clear cohesive gel when cooked.
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At page 123, it is clear the google translation for “board” is tubers/potato from Solanum tuberosum.
Sanchez et al. further teach starch from tubers and roots are similar in that they both exhibit a significant increase in viscosity during cooking; and exhibit higher peak viscosity than those from corn and wheat (p.38, Behavior of different starches). Potato, cassava, and waxy maize starches have a greater water adsorption capacity, faster hydration rates, and disintegrate more rapidly. Sanchez et al. also teach “cassava starch has a high solubility, similar to that of potato starch” (p.39, last para). Sanchez et al. teach potato starch is preferable over corn starch and other starches because it has high gel consistency, and the viscosity decreases upon further heating and stirring (p.124). It’s low gelatinization temperature and excellent flexible film formation are additional favorable properties.
While Sanchez et al. teach manufacturing starch from roots, Sanchez et al. do not expressly disclose “providing an edible tuber” (claim 1). Sanchez et al. do not expressly disclose spray drying the starch (present claims 1 and 3).
Thompson et al. review strategies for increasing the proportion of types 2 and 3 resistant starch (RS) in a starch-containing ingredient (abstract and p.245). Thompson et al. teach people vary in their tolerance to RS, making it necessary to prepare products having varying amounts of RS (p.245). RS type 2 is resistant to digestion due to the refractory nature of starch granules (p.247, second para). Native starch granules from potato are highly resistant to digestion (p.247, Type 2 RS).
Thompson et al. teach various combinations of temperature, moisture and time may be employed to enhance RS levels while maintaining discrete granule structure (p.248, Enhancement of RS levels in granular starch). Granules may be either caused to swell without loss of integrity and the constituent molecules allowed to retrograde to form RS, or the granule may be subjected to conditions that alter RS levels without gelatinization or melting. The latter strategy could be considered to enhance type 2 RS. This latter strategy is known as “hydrothermal treatment” and includes treatment at moisture levels below 35%.
Thompson et al. teach overall considerations for manufacturing RS should include physical functionality, processing stability, and nutritional functionality (p.251, last para). The physical functionality is required for appropriate physical characteristics of the food, such as texture, water holding capacity, etc. The processing stability of RS is important in order to preserve the nutritional functionality of the RS-containing ingredient. The nutritional functionality can involve both resistance to digestion in the small intestine and resistance to fermentation in the colon.
Tan et al. teach converting potato into dried powder for use as a functional ingredient is a known approach to increase consumption of potato, since preservation, transportation and storage of fresh potato is difficult (p.483, first para). One challenge for drying potatoes is that it gelatinizes during heating. Spray-drying is a known drying method to produce powdered-products in food industry, including for heat-sensitive materials since the residence time is short enough to prevent the material from heat induced deterioration (p.483, second para). Tan et al. hypothesize spray drying might implement short time heat processing to inactivate the polyphenol oxidase (PPO) in potato and to prevent starch from gelatinization at the same time. Tan et al. then confirmed spray-drying potato by pre-experimental results (Attachment 1). Tan et al. also teach the use of convective heat and mass transfer (p.484, first para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture starch from an edible tuber, wherein the edible tuber is Solanum tuberosum.
One having ordinary skill in the art would have been motivated to apply the method described by Sanchez et al. to tubers from Solanum tuberosum, because Sanchez et al. teach potato starch is preferable over corn starch and other starches because it has high gel consistency, and the viscosity decreases upon further heating and stirring (p.124). Its low gelatinization temperature and excellent flexible film formation are additional favorable properties.
See MEP 2144.06 (II) “In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents.”.
The ordinary artisan would have had a reasonable expectation of success because Cassava and Solanum tuberosum starch granules have similar physical properties and behave similarly under heat. Sanchez et al. teach starch from tubers and roots are similar in that they both exhibit a significant increase in viscosity during cooking; exhibit higher peak viscosity than those from corn and wheat, have a greater water adsorption capacity, faster hydration rates, disintegrate more rapidly, and “cassava starch has a high solubility, similar to that of potato starch”. Thus, Sanchez et al. teach cassava root and Solanum tuberosum tubers are equivalent sources of starch.
The ordinary artisan would have been motivated to increase the content of RS from potato because Thompson et al. teach it is a source of type 2 RS, and people vary in their tolerance to RS, making it necessary to prepare products having varying amounts of RS. The ordinary artisan would have been motivated to optimize the drying and heating conditions applied to potato starch, because Thompson et al. teach various combinations of temperature, moisture and time may be employed to enhance RS levels while maintaining discrete granule structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to spray dry potato starch that is resistant starch type 2, because spray drying uses short heat times that is sufficient to inactivate PPO, while simultaneously prevents starch from gelatinizing.
The ordinary artisan would have had a reasonable expectation of success because Tan et al. confirmed the use of spray-drying as reported in their pre-experimental results.
One having ordinary skill in the art would have been motivated to combine spray drying with convection drying because Sanchez et al. teach the use of hot air to rapidly dry starch, and Tan et al. teach spray-drying incorporates convection drying.
The claimed process is no more than a selective combination of prior art teachings done in a manner obvious to one of ordinary skill in the art since each step of the process appears to be relatively complete in itself and there is no indication of an interaction between steps of such a type that would lead one of ordinary skill in the art to doubt that a substitution of alternative steps known to the art could be made. In re Mostovych, 144 USPQ 38 (1964).
The recitation “wherein the digestive-resistant starch composition comprises at least 60% resistant starch (type 2) by weight” in claim 4 is a property of the starch obtained from performing the claimed method steps (as evidenced by Example 3 of the present Specification).
Similarly, the recitation “wherein the digestive-resistant starch composition stimulates short-chain fatty acid production upon administration to a subject” in claim 5 is a property of the starch produced by the process of claim 1.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Closest Prior Art
With respect to claims 23 and 26-29, Safarik et al. (American Institute of Physics, 2010, vol. 1311, no. 1, pp. 146-151, cited in PTO-892) teach the use of magnetic separators to remove/isolate protein from potato starch waste water. However, there is no teaching, suggestion or motivation to pass dried starch through a magnetic separator in step (f) as recited in claims 23 and 26 to obtain a digestive-resistant starch.
Conclusion
Claim(s) 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 26, 29 and 29 are allowable.
Claims 1, 3-7, 15, 16, 18, 21, 22, 24, 25 and 27 remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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