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 .
Restriction/Election
Applicant’s election without traverse of Group I, Claims 1-30 in the reply filed on 10/29/2025 is acknowledged. Claims 33 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-8 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gautam (US 2008/0020098 A1).
Regarding Claims 1 and 30, Gautam teaches a method for making a product which is extruded protein (Abstract). The product is made by blending a protein concentrate, such as whey protein [0033], with an extrusion component, such as emulsifiers [0041]. The components are mixed (which forms a dough, e.g. [0061]) and combined with a supercritical fluid prior to extrusion [0029]. The extruded product is dried (Abstract).
Regarding the limitation that the extrusion step is effective to inhibit protein-protein interactions in the protein concentrate, given that Gautam teaches all the limitations of the extrusion step, the method of Gautam is interpreted to inhibit protein-protein interactions as claimed.
Gautam teaches that the final product has a puffed and expanded texture [0050], as set forth in the instant Specification at [0004] for an “orally dissolving” product. Gautam additionally teaches the limitations of blending, extruding, and drying as set forth in the claim. Therefore, Gautam teaches an “orally dissolving” product as claimed.
Regarding Claim 2, Gautam teaches the use of whey protein concentrate derived from milk [0033].
Regarding Claim 3, Gautam teaches the use of emulsifiers [0041].
Regarding Claims 4 and 5, given that the limitations of Claim 3 have been met, the limitations of Claim 4 and 5 have also been met. Regardless, Gautam teaches the use of sucrose [0043].
Regarding Claim 6, given that the limitations of Claim 3 have been met, the limitations of Claim 6 have also been met. Regardless, Gautam teaches the use of monoglycerides and lecithin [0041].
Regarding Claim 7 and 8, given that the limitations of Claim 3 have been met, the limitations of Claim 7-8 have also been met.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9, 10, 15-17, 20, 21, 23-26, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Gautam.
Regarding Claim 9, Gautam teaches greater than 50% protein, which encompasses the claimed range(s) [0057]. Gautam additionally teaches 0-20% sugar [0041], which encompasses the claimed range. Gautam additionally teaches .03-0.3% emulsifiers [0041], which lies within the claimed range. Gautam additionally teaches 15-40% moisture prior to extrusion [0059], which encompasses the claimed range.
Gautam teaches the use of a “processing aid” [0040], which is interpreted to meet the limitation of a dispersing agent as claimed. Gautam does not teach a specific amount of processing aid, or dispersing agent. However, 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. See MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 10, note that the claimed amounts correspond to a mixture comprising 84% protein, 13.5% saccharide, 1% lecithin, 1% distilled monoglycerides, and 0.5% dispersing agent.
Gautam teaches greater than 50% protein [0057]. Gautam additionally teaches 0-20% sugar, which is a saccharide [0041]. Gautam additionally teaches .03-0.3% emulsifiers, including lecithin and distilled monoglycerides [0041].
It would have been obvious to have selected any amount (i.e. mass) of protein, saccharide, and emulsifiers in a protein dough for extrusion. One would have been motivated to make such a modification to create, e.g. different batch sizes for extrusion. Since Gautam teaches a composition comprising the same relative amounts of each ingredient as set forth in the Claim, the amounts set forth in the Claim are made obvious.
Regarding the amount of dispersing agent, Gautam teaches the use of a “processing aid” [0040], which is interpreted to meet the limitation of a dispersing agent as claimed. Gautam does not teach a specific amount of processing aid, or dispersing agent. However, 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. See MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claims 15 and 16, Gautam teaches that the supercritical fluid may be at a pressure of at least 72.9 atm, which is 7.4 MPa, which encompasses the claimed range(s) [0051].
Regarding Claim 17, Gautam teaches that the temperature in the extruder is less than 80 °C [0050], which encompasses the claimed range.
Regarding Claim 20, Gautam teaches that the supercritical fluid is carbon dioxide [0050].
Regarding Claim 21, Gautam teaches that the components of the dough are blended without water, which is dry blending [0059].
Regarding Claims 23 and 24, Gautam teaches that the temperature of the extruder is set from 70-130 °C [0059]. Absent evidence to the contrary, the extruded dough is interpreted to exit the extruder 70-130 °C, which encompasses the claimed range.
Regarding Claim 25, Gautam teaches drying via a belt/conveyor drier or a fluid bed dryer [0049], which is interpreted to meet the limitation of a “conventional oven” drier.
Regarding Claim 26, Gautam teaches that an extruded protein product can be dried to less than 12% moisture [0004], which overlaps the claimed range.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to dry to the levels as taught by Gautam, since Gautam teaches that drying to such a level is known in the art.
Regarding Claim 28, Gautam teaches that the final product has a puffed and expanded texture [0050], as set forth in the instant Specification at [0004] for an “orally dissolving” product. Gautam additionally teaches the limitations of blending, extruding, and drying as set forth in the claim. Therefore, the product of Gautam is interpreted to be a “fast orally dissolving” product as claimed.
Note that 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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Regarding Claim 29, Gautam teaches that the product comprises, e.g. greater than 50% protein (Abstract), which is interpreted to meet the limitation of “protein-rich”. Note that the instant Specification at [0109] teaches a protein rich product can have a protein content of 65% or greater. The protein content of the product of Gautam therefore encompasses the claimed range.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gautam in view of Rizvi (US 2011/0014328).
Regarding Claims 11 and 12, Gautam teaches the method as describe above in regards to Claim 1 but does not discuss specific process conditions such as feed rate.
Rizvi teaches a method for producing a protein extrudate product with supercritical fluid. Rizvi teaches a feed rate of 35 kg/h [0097] in the extruder. Rizvi teaches that such process conditions are appropriate for producing an extruded whey protein product.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to select the feed rate as claimed. One would have been motivated to make such a modification since Rizvi teaches that these process conditions are appropriate for a protein product extruded with supercritical fluid.
Claims 13, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gautam in view of Rizvi (2) (US 5120559)
Regarding Claim 13, Gautam teaches the method as describe above in regards to Claim 1 but does not discuss specific process conditions such as screw speed or supercritical fluid pressure. Gautam teaches to the teachings of Rizvi (2) [0050] for typical process embodiments.
Rizvi (2) teaches a screw speed of 200 rpm (Column 6, Line 19) for a product extruded with supercritical fluid.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to utilize the process conditions of Rizvi in the method of Gautam. One would have been motivated to make such a modification since Gautam points to Rizvi as providing typical process embodiments.
Regarding Claim 14, Gautam teaches the method as describe above in regards to Claim 1 but does not discuss specific process conditions such as screw speed. Gautam teaches to the teachings of Rizvi (2) [0050] for typical process embodiments.
Rizvi (2) teaches that process parameters such as feed rate and screw speed are selected to prevent backflow in an extruder and provide sufficient pressure to prevent supercritical fluid expansion within the extruder (Column 5, Lines 20-27). One of ordinary skill therefore would have been able to have adjusted process parameters such as screw speed to arrive at the speed as claimed through no more than routine experimentation. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 18, Gautam teaches the method as describe above in regards to Claim 1 but does not discuss specific process conditions such as the amount of injected supercritical fluid. Gautam teaches to the teachings of Rizvi [0050] for typical process embodiments.
Rizvi (2) teaches that the amount of injected supercritical fluid controls the extent of puffing and expansion of the product (Column 2, Lines 23-25).
Therefore, one of ordinary skill would have been able to have adjusted the amount of supercritical fluid to have arrived at the amount of supercritical fluid as claimed through no more than routine experimentation. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gautam in view of Rizvi and Rizvi (3) (US 5417992).
Regarding Claim 19, Gautam teaches the method as discussed above in regards to Claim 1 but does not discuss a specific amount of water injected during the process.
Rizvi teaches that a process for an extruded protein product processed with a supercritical fluid may utilize a feed rate of 35 kg/h [0097]. Rizvi teaches that such process conditions are appropriate for producing an extruded whey protein product.
Rizvi (3) teaches a product extruded with supercritical CO2. Rizvi teaches that water is added at 20-35% of the weight of the product. Rizvi (3) teaches that such an amount of moisture provides for an appropriate temperature of the product (Column 6, Lines 8-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify Gautaum to utilize a product feed rate of 35 kg/h as taught by Rizvi, and additionally to include an amount of water as taught by Rizvi (3) at 20-35% of the product. One having ordinary skill would therefore include an amount of water at (20%)*(35 kg/h) to (35%)*(35 kg/h) = 7 to 12.25 kg/h of water, which is ”about” 14 kg/h as claimed. One would have been motivated to make such a modification since Rizvi teaches process conditions for an extruded product, and Rizvi (3) additionally teaches that the water feed rate as claimed provides appropriate process conditions for an extruded product.
Additionally, note that water feed rate is a known process variable commonly adjusted in extruded food products. One of ordinary skill would have been able to have adjusted the water feed rate to have arrived at the amount of water as claimed through no more than routine experimentation. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gautam in view of Banaszek (“A Best Practice Guide for Ribbon Blenders”, July 2019).
Regarding Claim 22, Gautam teaches dry blending but does not specify ribbon blending for any period of time.
Banaszek teaches that ribbon blending is commonly used for blending dry ingredients such as protein (Page 2, “Common ribbon blender processes”).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to utilize a ribbon blender to blend the dry materials of Gautaum, since Banaszek teaches that ribbon blending is a known method for blending dry materials.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gautam in view of Schong (Dry heating of whey proteins" DOI:10.1016/j.foodres.2017.08.057, August 2017).
Regarding Claim 27, Gautam teaches drying but does not specify a temperature.
Schong teaches that drying whey protein products at temperatures below 75 °C prevents denaturing of the whey proteins (Page 31, Column 2, Paragraph 1), which overlaps the claimed temperature(s).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to dry a product comprising whey proteins at the temperatures as claimed. One would have been motivated to make such a modification to prevent denaturing of proteins.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH LIU whose telephone number is (571)270-5685. The examiner can normally be reached 12-8 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.L./ Examiner, Art Unit 1791
/Nikki H. Dees/ Supervisory Patent Examiner, Art Unit 1791