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 .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 21 August 2025 has been entered.
Priority
2. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 62/728,384 filed 07 September 2018.
Withdrawn Rejections
3. The rejection of claims 2, 5, and 15 as obvious over Bellorini et al (Bellorini et al., 2018, EURL Evaluation Report—cited on the Information Disclosure Statement dated 30 July 2021), Moon et al (Moon et al., 2010, US 2010/0273222 A1—cited previously), and Serber et al (Serber et al., 2017, US 2017/0159045 A1—cited previously) is withdrawn in view of the amendments to claim 2, which now specifically recites “but for structural alterations: (a) insertion of a promoter in front of the cg1383 start codon; (b) replacement of the native phoU promoter; (c) replacement of the native cg3210 promoter; and (d) replacement of the native cg0800 promoter.” Said rejection has been withdrawn in view of the modified rejection below.
4. The rejection of claims 2, 6, and 19 as obvious over Bellorini et al (Bellorini et al., 2018, EURL Evaluation Report—cited on the Information Disclosure Statement dated 30 July 2021), Bott and Brocker (Bott and Brocker, 2012, Appl Microbiol Biotechnol—cited previously), Becker et al (Becker et al., 2011, Metabolic Engineering—cited previously), Shimizu (Shimizu, 2014, Metabolites—cited previously), and Serber et al (Serber et al., 2017, US 2017/0159045 A1—cited previously) is withdrawn in view of the amendments to claim 2, which now specifically recites “but for structural alterations: (a) insertion of a promoter in front of the cg1383 start codon; (b) replacement of the native phoU promoter; (c) replacement of the native cg3210 promoter; and (d) replacement of the native cg0800 promoter.” Said rejection has been withdrawn in view of the modified rejection below.
5. The rejection of claims 2, 7, and 22 as obvious over Bellorini et al (Bellorini et al., 2018, EURL Evaluation Report—cited on Information Disclosure Statement dated 30 July 2021) and Baumgart et al. (Baumgart et al., 2016, Journal of Bacteriology—cited previously), and Serber et al (Serber et al., 2017, US 2017/0159045 A1—cited previously) is withdrawn in view of the amendments to claim 2, which now specifically recites “but for structural alterations: (a) insertion of a promoter in front of the cg1383 start codon; (b) replacement of the native phoU promoter; (c) replacement of the native cg3210 promoter; and (d) replacement of the native cg0800 promoter.” Said rejection has been withdrawn in view of the modified rejection below.
6. The rejection of claims 2, 8, and 24 as obvious over Bellorini et al (Bellorini et al., 2018, EURL Evaluation Report—cited on Information Disclosure Statement dated 30 July 2021) and Radmacher and Eggeling (Radmacher and Eggeling, 2007, Appl Microbiol Biotechnol—cited previously), and Serber et al (Serber et al., 2017, US 2017/0159045 A1—cited previously) is withdrawn in view of the amendments to claim 2, which now specifically recites “but for structural alterations: (a) insertion of a promoter in front of the cg1383 start codon; (b) replacement of the native phoU promoter; (c) replacement of the native cg3210 promoter; and (d) replacement of the native cg0800 promoter.” Said rejection has been withdrawn in view of the modified rejection below.
New Rejections—necessitated by amendments
Claim Rejections - 35 USC § 112(a)
7. 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.
Written Description:
8. Claims 2 and 15 are 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.
The claims are drawn to a Corynebacterium having a bacterial genome consisting essentially of the genome of the bacterium deposited as NRRL B-67439 but for structural alterations: (a) insertion of a promoter in front of the cg1383, specifically the promoter Pcg0007_30 (SEQ ID NO: 20) (claim 15), (b) replacement of the native phoU promoter, (c) replacement of the native cg3210 promoter, and (d) replacement of the native cg0800 promoter.
MPEP 2163(1):
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en bane); Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
9. The claims are drawn to a Corynebacterium having a bacterial genome consisting essentially of the genome of the bacterium deposited as NRRL B-67439 but for structural alterations: (a) insertion of a promoter in front of the cg1383, specifically the promoter Pcg0007_30 (SEQ ID NO: 20) (claim 15), (b) replacement of the native phoU promoter, (c) replacement of the native cg3210 promoter, and (d) replacement of the native cg0800 promoter. The specification does not describe a mutant with all four of the claimed alterations. At most the specification describes the utilization of the Pcg007_30 (SEQ ID NO: 20) promoter sequence to modulate each of the genes listed in the base claim: cg1383, phoU, cg3210, and cg0800. The specification fails to describe any Corynebacterium with more than a single perturbation, let alone four. How a mutant Corynebacterium will grow, survive, and/or produce the desired industrial product with all of the genetic alterations claimed, together, is unpredictable. Here the specification is incomplete and it mandates that those skilled in the art must then figure out how to use the claimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of a Corynebacterium with four genomic alterations, where specifically the Pcg007_30 (SEQ ID NO: 20) is utilized to perterbate the cg1383, phoU, cg3210, and cg0800 gene locales. The courts have established:
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013):
A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an ufinished invention.” Id.
Applicant’s Arguments and Examiner’s Rebuttal:
The applicant traverses the previous rejections of record of claims 2 and 15 over Bellorini, Moon, and Serber, claim 2 over Bellorini, Bott, Becker, Shimizu, and Serber, claim 2 over Bellorini, Baumgart, and Serber, and claim 2 over Bellorini, Radmacher, and Serber.
The applicant argues that the amendments to claim 2 to require four structural alterations, where specifically, the insertion of Pcg0007_30 (SEQ ID NO: 20) in front of the cg1383 start codon, replacement of the native phoU promoter, replacement of the native cg3210 promoter, and replacement of the native cg0800 promoter is not taught by the prior art rejections. The examiner agrees, and the examiner withdrew the previous rejections of record in lieu of the 35 U.S.C. 112(a) written description rejection, since the specification does not describe a mutant Corynebacterium with all four structural alterations.
The examiner does not find the arguments presented by the Applicant persuasive, and for these reasons, the rejections of record above apply.
Conclusion
10. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656