DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the application filed on April 1, 2024.
Status of Application
Claims 1-6 are pending. Claims 1-6 are presented for examination.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Each claim recites “a-beta-glucanase enzyme,” which should read “a beta-glucanase enzyme.”
Each claim recites “Carica papaya” which should be italicized since it is a scientific name.
Each claim recites “alpha amylase,” which should read “alpha-amylase.”
Any and all recitations of “Stabilized Rice Bran” should not be capitalized.
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 1-6 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.
Claims 1 and 2 recite “greater than 0.86 to 2.78 percent as-is protein” which renders the claim indefinite as the language is ambiguous. The claim recites a range immediately after reciting “greater than” – this is unclear as it cannot be ascertained if the applicant is intending to claim a range with a lower and upper limit or claim “greater than 2.78 percent.” For the purposes of examination, the claim will be interpreted as “comprises from 0.86 to 2.78 percent as-is protein.”
Claims 1 and 2 refer to percentages, “percent as-is protein” and “percent as-is fat,” without defining the base unit. The claim limitation is unclear as to whether the percentage is based on weight, volume, molar, etc., and as such, the claims fail to distinctly claim the subject matter of the invention and is therefore rendered indefinite. For the purposes of examination, the claim will be interpreted as percent by weight.
Claims 4 and 6 recite both “papain protease” and “papaya protease,” which renders the claims indefinite as it is not clear what the difference is between the two. Both proteases seem to be referring to the same protease because “papaya protease” is commonly known as papain protease. The instant specification at [0026] uses a commercial product as the protease enzyme and states that the biological source of this protease enzyme is Carica papaya. Thus, neither the claims nor the specification give a definition as to each protease or explain how or why they are different. If “papain protease” and “papaya protease” are the same protease, it would be redundant to claim both proteases.
Claims 3 and 5 are rejected as being dependent on a rejected base claim.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-6 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6 of prior U.S. Patent No. 8,945,642. Patented claims 1-3 correspond directly to pending claims 1, 3, and 4, respectively, while patented claims 4-6 correspond directly to pending claims 2, 5, and 6, respectively. This is a statutory double patenting rejection.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,238,134. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 1 is limited to a nutritionally enhanced isolate of stabilized rice bran comprising 0.86-2.78% protein and 0.93-2.5% fat. Claims 1-3 of U.S. Patent No. 10,238,134 are limited to a nutritionally enhanced isolate of stabilized rice brain wherein the stabilized rice bran is treated with the mixture of enzymes as presently claimed and the stabilized rice bran isolate comprises the same amount of protein and/or fat. Therefore, instant claim 1 is an obvious version of claims 1-3 of U.S. Patent No. 10,238,134.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,039,633. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 1-6 are limited to a nutritionally enhanced isolate of stabilized rice bran and the method of producing the same, wherein a slurry is heated to a first temperature from 57°C to 97°C to activate the enzymes used and then the slurry is heated to a second temperature from 68°C to 108°C to inactivate the enzymes. Claims 1-6 of U.S. Patent No. 11,039,633 are limited to a nutritionally enhanced isolate of stabilized rice bran and the method of producing the same, wherein a slurry is heated sufficiently to activate the combination of enzymes used. Since enzymes used have a known optimum temperature for activation, selecting a range of temperatures to activate the enzymes would have been conventional wisdom in the art. On the other hand, as known in the art, inactivation of enzymes, by increasing the temperature, is also a conventional process. Therefore, it would have been obvious to select a temperature range for enzyme activation and a temperature range for enzyme inactivation as presently claimed.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,944,113. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims 1-6 are limited to a nutritionally enhanced isolate of stabilized rice bran and the method of producing the same, wherein the slurry has a pH in the range of 6 to 7. Claims 1-6 of U.S. Patent No. 11,944,113 are limited to a nutritionally enhanced isolate of stabilized rice bran and the method of producing the same, but the pH of the slurry is not specified. Since the isolate of the instant claims and the isolate of the patented claims are substantially similar and are produced by the same method, it would have been expected that the intermediate slurries would also possess the same, if not substantially similar, pH values.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791