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 .
Title
The Title of the invention is not descriptive. A new Title is required that is clearly indicative of the invention to which the claims are directed.
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The claimed invention is directed to
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and not the entirety of what is set forth in Title as filed.
Specification
The disclosure is objected to because of the following informalities: please update the priority statement at the beginning of the Specification.
Appropriate correction is required.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
When there are drawings, there shall be a “brief description of the several views of the drawings” (See 37 C.F.R. 1.74.).
The section heading “BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)” is missing.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes (US 5,413,804).
Regarding Claim 1, Rhodes (‘804) teaches a process for aggregating whey protein, the process comprising: obtaining a whey protein solution containing native whey protein, the whey protein solution having a concentration of about 13wt% to about 18wt% total solids (See Examples, where the whey protein concentrate used has a solids content of around 14%.).; adjusting a mineral balance of the whey protein solution by adding CaCl2 to the whey protein solution (See col. 11, l. 20+.); adjusting a pH of the whey protein solution to a pH value comprises between 5.6 and about 6.2 (See col. 10, l. 55+, col. 16, l. 61+ and col. 28, para. 1 where it would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date that cheese whey having a pH of 5.9 can be used in the process to provide a product that is usable as intended.); subsequent the adjusting the pH of the whey protein solution, denaturing at least a portion of the native whey protein present in the whey protein solution to obtain a denatured whey protein mixture, the denatured whey protein mixture containing water insoluble whey protein material, the denaturing of the at least a portion of the native whey protein present in the whey protein solution including heating the whey protein solution; separating the water insoluble whey protein material from the denatured whey protein mixture by filtering the water insoluble whey protein material from the denatured whey protein mixture by using a cloth filter, a mesh or screen separator, a clarifier, or a perforated conveyor belt; extruding the water insoluble whey protein material to obtain extruded whey protein material; and cutting the extruded whey protein material to obtain whey protein aggregates (See FIG-1, col. 7, l. 35+, col. 9, l. 45+ where a fat substitute is produced from whey protein concentrate, which is denatured and agglomerated in a step involving temperature denaturation by direct steam injection and acidification to form a macroscopic curd which first floats on the liquid whey and then settles to the bottom. The settled curd is transported by means of auger/spiral agitators to a door of a cooker where the curd is expelled. The curd is transported with false bottom carts to a chopper, wherein during transport whey continues to drain. In the chopper the curd is broken up to give a fat-substitute product having a particle size between 1-1 0 μm.),
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however, fails to expressly disclose denaturing and extrusion.
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to heat the solution at a temperature and time to provide an effectively denatured product that can be used as intended.
Rhodes (‘804) teaches a step involving an auger/spiral agitator for transporting insoluble curd, wherein it is indicated that the extrusion process may simply help to transfer the viscous material to the shearing process (See paras. 41, 73, 80.). Where the extruder merely serves to transport the insoluble whey protein, no specific structure is accomplished by the use of an extruder in comparison as compared to the auger/spiral agitator as taught by Rhodes (‘804). Therefore, use of an extruder instead of auger/spiral agitator for transportation would have been foreseeable and within the skill set of a person having ordinary skill in the art prior to the earliest effective filing date.
Regarding Claim 2, Rhodes (‘804) teaches the method discussed above, however, fails to expressly disclose wherein heating the whey protein solution includes heating the whey protein solution to a temperature from about 90 °C to about 92 °C for a duration of about 10 minutes to about 15 minutes.
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to heat the solution at a temperature and time that to provide an effectively denatured product that can be used as intended.
Regarding Claim 3, Rhodes (‘804) teaches wherein obtaining the whey protein solution includes: preparing the whey protein solution by mixing whey protein concentrate powder to obtain the whey protein solution (See Examples.).
Regarding Claim 4, Rhodes (‘804) teaches wherein obtaining the whey protein solution includes: preparing the whey protein solution by mixing whey protein retentate in water to obtain the whey protein solution (See Examples.).
Regarding Claim 5, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein mixing is conducted for about 15 minutes at a temperature of about 60° C.
Heating to 60°C accelerates hydration would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to heat and to provide a product that is usable as intended.
Regarding Claim 6, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein mixing is conducted for about 15 minutes at a temperature of about 60° C.
Heating to 60°C accelerates hydration would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to heat and to provide a product that is usable as intended.
Regarding Claim 7, Rhodes (‘804) teaches comprising adjusting a mineral balance of whey protein solution (See col. 11, 20+ where the addition of CaCl2 during the heat-denaturation process and outlines that by adjusting the ionic strength precipitation may be enhanced. Addition of CaCl2 therefore would have been foreseeable and obvious prior to the earliest effective filing date.).
Regarding Claim 8, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein adding CaCl2 to the whey protein solution includes adding from about 1400 ppm to about 1600 ppm of CaCl2 to the whey protein solution.
It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to provide a product with an effective amount of CaCl2 to provide a product that is usable as intended.
Regarding Claim 9, Rhodes (‘804) teaches wherein adjusting the pH of the whey protein solution includes adding lactic acid to the whey protein solution (See col. 16, l. 61+.).
Regarding Claim 10, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose hydrating the whey protein solution at a temperature of about 60° C for a duration of about 20 minutes.
Heating to 60 °C accelerates hydration therefore it would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to heat to provide a product that is usable as intended.
Regarding Claim 11, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein heating the whey protein solution includes injecting steam into the whey protein solution
Rhodes (‘804) teaches (See FIG-1 and Examples.) where heating is by a heating tank for heating the whey by means of direct steam injection, a false bottom carts device allowing dripping off liquids from the wet curd transported out of the heating chamber. It would have been foreseeable and obvious to a person having ordinary skill in the art prior to the earliest effective filing date to inject steam in the way as claimed to provide an effectively denatured product that can be used as intended.
Regarding Claim 12, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein cutting the extruded whey protein material includes subjecting the whey protein material to a shearing process.
Rhodes (‘804) teaches a step involving an auger/spiral agitator is included for transporting the insoluble curd.
Rhodes (‘804) teaches a step involving an auger/spiral agitator is included for transporting the insoluble curd, wherein it is indicated that the extrusion process may simply help to transfer the viscous material to the shearing process (See paras. 41, 73, 80.). Where the extruder merely serves to transport the insoluble whey protein, no specific structure is accomplished by the use of an extruder in comparison as compared to the auger/spiral agitator as taught by Rhodes (‘804). Therefore, use of an extruder instead of auger/spiral agitator for transportation would have been foreseeable and within the skill set of a person having ordinary skill in the art prior to the earliest effective filing date.
Regarding Claim 13, Rhodes (‘804) teaches the process discussed above, however, fails to expressly disclose wherein thee whey protein aggregates are output whey protein aggregates, the shearing process includes subjecting the extruded whey protein material to a first shearing step to obtain intermediate whey protein aggregates and subjecting the intermediate whey protein aggregates to a second shearing step to obtain the output whey protein aggregates, the output whey aggregates being smaller than the intermediate whey aggregates.
Rhodes (‘804) teaches a step involving an auger/spiral agitator for transporting insoluble curd, wherein it is indicated that the extrusion process may simply help to transfer the viscous material to the shearing process (See paras. 41, 73, 80.). Where the extruder merely serves to transport the insoluble whey protein, no specific structure is accomplished by the use of an extruder in comparison as compared to the auger/spiral agitator as taught by Rhodes (‘804). Therefore, use of an extruder instead of auger/spiral agitator for transportation would have been foreseeable and within the skill set of a person having ordinary skill in the art prior to the earliest effective filing date.
Regarding Claim 14, Rhodes (‘804) teaches cooling the whey protein aggregates to a temperature of about 10° C to obtain cooled whey protein aggregates (See Col. 9, l. 52+.).
Regarding Claim 15, Rhodes (‘804) teaches comprising storing the whey protein aggregates (See col. 9, l. 52+.).
Double Patenting
Claim 2 is directed to the same invention as that of claim 1 of commonly assigned US 11,968,991.
Claim 2 of this application includes all of the limitations of independent claim 1 which in combination is the same as claim 1 of US 11,968,991.
Under 35 U.S.C. 101, more than one patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
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, 3-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,968,991. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims at issue are not identical, they are not patentably distinct from each other because the same invention is disclosed in various combinations of claims and the properties being inherent as the materials and end use are the same.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T O'HERN whose telephone number is (571)272-6385. The examiner can normally be reached M-Th 5:00 am - 3:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached on 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENT T O'HERN/ Primary Examiner, Art Unit 1793
March 9, 2026
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