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 .
Applicant’s amendment and reply filed November 13, 2025 have been received and entered into the case. Claims 6 – 8 and 18 – 21 are canceled; claims 1 – 5, 9 – 17 and 22 are pending; claims 3 – 5, 11, 16 – 17 and 22 are withdrawn; claims 1 – 2, 9 – 10 and 12 – 15 have been considered on the merits insofar as they read on the elected species.
Information Disclosure Statement
The information disclosure statements filed July 25, August 26, September 29, November 3 and November 14, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 12 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claim is drawn to a method for preparing glucaric acid, the method comprising contacting glucose with a mutant galactose oxidase (GAO) to form an intermediate followed by contacting the intermediate with a metal catalyst to form the glucaric acid.
The specification fails to disclose or enable a method wherein galactose oxide will form glucaric acid. In paragraph 0041, the specification discloses glucose “may be contacted with a galactose oxidase (GAO) variant under conditions suitable for oxidation of the C6 alcohol to an aldehyde generating D-glucohexodialdose,” which is an oxidized glucose product. However, the variant (mutant) does not product glucaric acid as recited in claim 12. Rather, the D-glucohexodialdose is contacted with glucose oxidase (GOX) to produce additional intermediate L-guluronic acid-δ-2,6-lactone which is further reacted with a metal catalyst to produce glucaric acid. In this regard, the claimed subject matter explicitly contradicts the specification. Further, the specification provides no direction or working examples from which one practicing the invention would reasonably make and use the claimed invention without undue experimentation. Although the specification discloses several galactose oxidase mutants, none of these mutants are shown to bind to glucose such that they produce glucaric acid as claimed. Moreover, the specification fails to demonstrate the claimed subject matter can be successfully carried out, resulting in a significant amount of experimentation to determine whether any such mutants can be used in a method for preparing glucaric acid as currently claimed.
Response to Arguments
Applicant argues that the amended claims are limited to mutant galactose oxidase which is enabled at paragraph 0041 of the specification.
However, this argument fails to persuade. As stated above, the cited paragraph discloses glucose “may be contacted with a galactose oxidase (GAO) variant under conditions suitable for oxidation of the C6 alcohol to an aldehyde generating D-glucohexodialdose,” which is an oxidized glucose product. However, the variant (mutant) does not product glucaric acid as recited in claim 12. Rather, the D-glucohexodialdose is contacted with glucose oxidase (GOX) to produce additional intermediate L-guluronic acid-δ-2,6-lactone which is further reacted with a metal catalyst to produce glucaric acid. Moreover, the claim remains at odds with the teachings of the specification in that glucaric acid is not produced by a mutant GAO alone.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 as being anticipated by Taketoshi et al. (2013) are withdrawn due to amendment. Specifically, the amendment requiring contacting glucose with a mutant GAO.
Applicant argues that the reference does not teach the method wherein a mutant GAO is contacted with glucose. Examiner agrees.
Claim Rejections - 35 USC § 103
Previous rejections under 35 U.S.C. 103 as being unpatentable over Taketoshi et al. (2013) in view of Solmi et al. (2017) are withdrawn due to amendment. Specifically, the amendment requiring contacting glucose with a mutant GAO.
Applicant argues that the reference does not teach the method wherein a mutant GAO is contacted with glucose. Examiner agrees. While the prior art teaches preparing gluconic acid (an oxidized glucose product) comprising contacting glucose with glucose oxidase and gold (metal) catalyst (abstract), the prior art does not teach or suggest the method utilizing mutant GAO to first act on glucose.
Double Patenting
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 – 2, 9 – 10 and 12 – 15 reamin provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 4 – 19, 23 – 25 of copending Application No. 17/910,849 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to the same chemoenzymatic process for producing oxidized glucose products with the same galactose oxidase and metal catalysts, at the same temperature and with the same purity of products.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 12 – 15 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7 of copending Application No. 18/580 308 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to the same chemoenzymatic process for producing oxidized glucose products with the same galactose oxidase and metal catalysts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant acknowledges the provisional rejections.
No claims are allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/RUTH A DAVIS/Primary Examiner, Art Unit 1699