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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed March 11, 2025 is acknowledged.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 5-11
Withdrawn claims:
None
Previously canceled claims:
None
Newly canceled claims:
2-4, 12-20
Amended claims:
1, 5-11
New claims:
None
Claims currently under consideration:
1, 5-11
Currently rejected claims:
1, 5-11
Allowed claims:
None
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 10, the limitation requiring the steam to be applied to the interior of the drum dryer does not have support in the original disclosure. MPEP 2163 I(B) states, “To comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, 365, or 386, each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure.” Express, implicit, nor inherent support for the limitation of steam being applied to the interior of the drum dryer. The original disclosure merely recites that the starch is heated by application of steam to the drum dryer (p. 9, lines 22-23). Furthermore, because the instant specification does not disclose that the drum dryer is specifically the conductive type of drum dryer, there is no implicit support for the steam to be applied to the interior of the drum dryer.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Berckmans (US 2015/0374015 A1) in view of Shah (US 5,718,770), and Majzoobi (“Physical properties of pregelatinized and granular cold water swelling maize starches in presence of acetic acid”, 2015).
Regarding claim 1, Berckmans teaches a process for the preparation of pregelatinized starch (a process for modifying starches to produce a pregelatinized starch product, [0001]) comprising the steps of:
Providing an aqueous medium having a pH in the range of -1.0 to 7.5 (an aqueous starch slurry having a pH preferably between 4 to 8, [0022], where the slurry is aqueous and thus would necessarily have water as the “aqueous medium”, where it is recognized that water has a pH around 7, which falls within the claimed range)
A starch composition having a pH in the range of between 4.0 and 6.5 (an aqueous starch slurry having a pH preferably between 4 to 8, [0022], where “4 to 8” overlaps with any of the claimed range of “between 4.0 and 6.5”), wherein the starch composition has the aqueous medium as continuous phase (starch is dispersed in a colloidal suspension, [0023]) and contains between 20 and 60 wt.% expressed as percentage of dry matter on total weight of the starch composition, of particles of starch and/or flour (solids content preferably between 20 to 35%, [0023], where “20 to 35%” falls within the claimed range of “20 and 60 wt.%”); and
Pregelatinizing the starch composition in a pregelatinization step (any reactor is suitable for carrying out the process provided superheated steam is homogenously distributed, including rotary drum dryers [0025] and direct heat rotary drum, where the product is conveyed through a rotating tube with gas enabling heat and mass exchange, [0032]).
Berckmans further teaches wherein the process comprises a physical modification step prior to the mixing step, wherein the physical modification step is a thermal inhibition step for thermally inhibiting a starch and/or flour and wherein the starch and/or flour used in the mixing step is the thermally inhibited starch and/or thermally inhibited flour (using thermal inhibition as a physical modification [0020]).
With respect to the above overlapping numerical ranges, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Berckmans does not teach mixing the starch and/or flour with the aqueous medium in a mixing step to form a starch composition.
However, Shah teaches a process for producing pregelatinized granular starches and flours (title). Specifically, Shah teaches providing an aqueous medium (water, col. 2 lines 27 – 30) and mixing the starch and/or flour with the aqueous medium in a mixing step to form a starch composition (starch or flour is slurried in water, col. 2 lines 27 – 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the process for pregelatinizing starch as taught by Berckmans and perform the mixing step of Shah to obtain an aqueous starch slurry. One of ordinary skill in the art would have understood that the starch and aqueous medium of Berckmans must have been mixed together to form the resulting slurry, as the mixing is shown in Shah. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Berckmans as modified by Shah does not teach wherein during the pregelatinization step the starch composition is dried during one pass on the drum dryer and allowing the pregelatinized starch and/or pregelatinized flour to cool to a temperature of at most 80[Symbol font/0xB0]C, and storing the obtained pregelatinized starch and/or pregelatinized flour at a temperature of at most 60[Symbol font/0xB0]C.
However, Majzoobi teaches that pregelatinized starch is commonly produced by drum drying, which is achieved using a single or twin drum drier, where the starch slurry is poured onto a hot drum and then scraped off with a sharp blade (p. 375, right-hand column, ¶ 2). Majzoobi also teaches physical properties of pregelatinized and granular cold water swelling maize starches in presence of acetic acid. Specifically, Majzoobi teaches allowing the pregelatinized starch and/or pregelatinized flour to cool to a temperature of at most 80[Symbol font/0xB0]C (starch is stored at 22[Symbol font/0xB0]C, page 376, paragraph 2.2, therefore it necessarily follows that the pregelatinized starch must be cooled below 80[Symbol font/0xB0]C, which would fall within the claimed range); and storing the obtained pregelatinized starch and/or pregelatinized flour at a temperature of at most 60[Symbol font/0xB0]C (storing pregelatinized starch obtained from drum drying at 22[Symbol font/0xB0]C, page 376, paragraph 2.2, where 22[Symbol font/0xB0]C falls within any of the claimed ranges of “at most 60[Symbol font/0xB0]C”).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pregelatinization process of Berckmans with the use of a drum dryer taught by Majzoobi and the reactor with steam distribution. One would be motivated to make this modification because, as taught by Majzoobi, drum drying is an easy and economical method for production of pregelatinized starch (p. 375, right-hand column, ¶ 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Berckmans in view of Shah by cooling and storing the dried pregelatinized starch at 22[Symbol font/0xB0]C as taught by Majzoobi. One of ordinary skill in the art would be motivated to make this modification as it is well known in the art that storing the pregelatinized starch will preserve the pregelatinized starch for further uses. Additionally, if the pregelatinized starch is stored at 22[Symbol font/0xB0]C, it necessarily follows that the pregelatinized starch must be cooled below 80[Symbol font/0xB0]C.
Regarding claim 5, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans also teaches wherein the starch is derived from a waxy starch and/or waxy flour (waxy maize starches used in Example 1, [0082]).
Regarding claim 6, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans further teaches wherein the starch is selected from maize (i.e., corn), wheat, rice, sorghum, barley, rye, and any mixtures thereof (examples of starches include corn, sorghum, barley, wheat, rice, etc. [0020]).
Regarding claim 7, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans further teaches wherein the starch is derived from rice (example of starch includes rice [0020]).
Regarding claim 8, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans does not teach the moisture content of the pregelatinized starch falling between 0 and 30 wt.%.
However, Shah additionally teaches wherein the pregelatinizing step is performed such that the obtained pregelatinized starch has a moisture content lying between 0 wt.% and 30 wt.% (pregelatinized starch dried to 2 – 15% moisture content, col. 2 lines 33 – 35, where “2 – 15%” falls within the claimed ranges of “0 wt.% to 30 wt.%”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pregelatinized starch resulting in modified Berckmans such that the resulting starch has a moisture content of 2 – 15% as taught by Shah. This simple substitution of one known element for another would yield a predictable result of a pregelatinized starch powder. MPEP §2143(I)(B). With respect to the claimed ranges, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I
Regarding claim 9, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans as modified by Shah also teaches wherein: in the mixing step, the pH of the starch composition is brought to a value between 4.0 and 6.5 minutes (pH of Berckmans was modified above in claim 1 to be the overlapping portion of the claimed “more preferably between 4.0 and 6.5, [0022]).
Berckmans does not teach the pH of the starch composition being adjusted within 90 minutes of the mixing step after mixing of the starch and/or flour with the aqueous medium.
However, Majzoobi teaches stirring the starch and water mixture for 2 -3 minutes (page 376 paragraph 2.2), which falls within the claimed “within 90 minutes after the mixing of the starch and/or flour with the aqueous medium.”).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mixing step in modified Berckmans with the mixing time of 2 – 3 minutes as taught by Majzoobi, as Majzoobi teaches that a mixing time of 2 – 3 minutes is known in the art. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious, see MPEP §2143(I)(D).
Regarding claim 10, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans also teaches wherein in the pregelatinization step, said composition is heated using a drum dryer by the application of steam to the drum dryer (use of superheated steam with reaction chamber, for example a drum dryer, [0042]). Berckmans also teaches that the steam treatment is carried out in a reaction chamber, where said reaction chamber has at least one inlet and one outlet for the superheated steam (Abstract). Therefore, it logically follows that steam is applied to the interior of the drum dryer.
Regarding claim 11, Berckmans as modified by Shah and Majzoobi teach all elements of claim 1 as described above. Berckmans does not teach wherein in the mixing step the starch and/or flour is the largest dry matter constituent.
However, Shah teaches wherein the mixing step the starch and/or flour is the largest dry matter constituent (col. 7 lines 34 – 37). Shah teaches a slurry composition comprising 30 – 40% starch, water, and 5% sodium carbonate solution as needed for adjusting pH. Based on the described mixture, the starch would be the largest dry matter constituent present in the starch slurry.
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the present application to modify the starch slurry as taught by modified Berckmans to be composed of the starch slurry composition outlined in Shah, which would result in the starch and/or flour being the largest dry matter constituent. One of ordinary skill would be able to make this simple substitution and expect to obtain the desired results of a pregelatinized starch, MPEP §2143(I)(B).
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1, 5-11 over Berckmans, Shah, and Majzoobi: Applicant’s arguments filed September 4, 2025 have been fully considered but they are not persuasive.
Applicant argued that a drum dryer uses conductive drying whereas a rotary drum dryer as described by the prior art utilizes convective drying (Remarks, p. 4, ¶ 3-4).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., conductive drum drying) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, MPEP §2111 states that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. Claim 1 states that the “composition is heated using a drum dryer, while rotating the drum”. Under broadest reasonable interpretation, the claim limitation encompasses any equipment that contains a drum and rotates. Because rotary dryers are known in the art as “rotary drum dryer”, the language “drum dryer while rotating” encompasses the “rotary drum dryer” of Berckmans.
Applicant argued that the method of Berckmans differs from the present invention because the effect of the difference in drying and pH results in a pregelatinized product with improves high shear stability (Remarks, p. 5, ¶ 1-3, p. 7, ¶ 4- p. 8, ¶ 5; 132 Affidavit, ¶ (6)-(13)).
This argument has been considered. However, the data provided is not commensurate in scope with the claimed invention. MPEP §716.02(d) states “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” The data provided in the instant specification and 132 Affidavit is not a sufficient number of tests inside and outside of the claimed range to show the criticality of the range. Furthermore, no experiments were done comparing a conductive drum dryer that the applicant alleges to use to a convective rotary dryer as taught by the prior art. Therefore, the data provided by 132 Affidavit is not persuasive to teach unexpected results.
Applicant argued that Berckmans does not teach anything about the stability of the gel when the gel is subjected to extreme shear prior to the rheological evaluation (Remarks, p. 5, ¶ 3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., stability of gel when subjected to extreme shear) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argued that Berckmans teaches away from the use of drum drying (Remarks, p. 5, ¶ 4- p. 6, ¶ 1).
This argument has been considered. However, MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) and “The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ‘The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.’” Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998). Because Berckmans teaches that the method may be performed with any suitable reactor, Berckmans is sufficient for all that is relied upon.
Applicant argued that Berckmans is silent about the pH range for a starch composition and about the fact that unexpected results on shear stability can be obtained when tradition drum drying technology is applied (Remarks, p. 6, ¶ 2-3).
This argument has been considered. However, as stated above, Berckmans teaches an aqueous starch slurry having a pH preferably between 4 to 8 for pregelatinizing, [0022] and any reactor is suitable for carrying out the process provided superheated steam is homogenously distributed, including rotary drum dryers [0025] and direct heat rotary drum, where the product is conveyed through a rotating tube with gas enabling heat and mass exchange, [0032]. Therefore, Berckmans does teach the pH of a starch composition that is treated using a drum. Although Berckmans doesn’t teach the result of shear stability, MPEP §2112.01(I) states “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).” Therefore, because the starch of Berckmans in view of Shah and Majzoobi is made by substantially the same process as the claimed invention, a prima facie case of obviousness has been established.
Applicant argued that Berckmans teaches that the starch composition is pregelatinized by being brought into contact with steam whereas the claimed invention the starch composition is dried during a pass on the drum dryer, not inside the drum (remarks, p. 6, ¶ 4-6).
This argument has been considered. However, Berckmans is not relied upon to teach that the starch in on the drum, not inside. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Berckmans is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant argued that Shah teaches that pregelatinization was performed in a spray dryer similar to Berckmans and does not teach the technology of claim 1 (Remarks, p. 7, ¶ 1).
This argument has been considered. However, Shah is not relied upon to teach drum drying. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Shah is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant argued that the present application is not obvious when one adds the teaching of Majzoobi because Majzoobi does not teach that the starch composition should be at a pH range between 4.0 and 6.5 as required by claim 1 (Remarks, p. 7, ¶ 2).
This argument has been considered. However, Majzoobi is not relied upon to teach the pH of the claimed invention. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Majzoobi is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant argued that Berckmans is different than the claimed invention, and would not have been obvious to combine the elements based on fundamentally different principals (Remarks, p. 7, ¶ 3).
This argument has been considered. However, the Examiner maintains that the combination of reference as described above would have been obvious to one of ordinary skill before the effective filing date of the claimed invention. Berckmans is not solely relied upon to teach the claimed invention. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejections of claims 1 and 5-11 have been maintained herein.
Conclusion
THIS ACTION IS MADE FINAL. 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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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793