DETAILED ACTION
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 election without traverse of Group I (Invention I) in the reply filed on 12/01/2025 is acknowledged. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-5 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of modified microorganisms comprising any genetic modification that suppresses a genus of transcription factors of any amino acid sequence and structure that controls expression of genus of pyruvate dehydrogenases, wherein the microorganism has a production pathway of a C6 compound, and herein the C6 compound is at least one compound selected from the group consisting of adipic acid, hexamethylenediamine, 1,6-hexanediol, 6-aminohexanoic acid, 6-amino-1-hexanol, 6- hydroxyhexanoic acid, 3-oxoadipic acid, 3-hydroxyadipic acid, and 2,3-dehydroadipic acid. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Prather et al. (Curr Opin Biotechnol. 2008 Oct;19(5):468-74; PTO 892) teaches numerous challenges associated with constructing de novo metabolic pathways, including selection of the appropriate enzymes in a multi-step pathway, compatibility of the enzymes with the expression host and with each other, and the requirement to engineer one or more of the enzymes to achieve the desired activity on a given substrate [see p. 472, columns 1-2]. Prather et al. specifically teach that “while synthetic biology provides a complementary framework for de novo pathway design, it is unclear how well some of the core principles, for example, Abstraction, can be implemented [see p. 472, column 2, top]. The reference of Kizer et al. (Appl Environ Microbiol. 2008 May;74(10):3229-41; PTO 892), which teaches that producing complex chemicals using synthetic metabolic pathways in microbial hosts is often complicated by deleterious interactions between pathway intermediates and the host cell metabolism [see p. 3229, abstract], noting that “… embedding a novel biochemical pathway in the metabolic network of a host cell can disrupt the subtle regulatory mechanisms that the cell has evolved over the millennia" [see p. 3229, column 1] and “[w]hile it can be relatively simple to determine that an engineered synthetic biochemical pathway is not functioning in the heterologous host, it is often a far more challenging task to determine exactly what is causing the problem” [p. 3237, column 2]. The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; PTO 892) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; PTO 892) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). However, the reference teachings only provide guidance for searching and screening for genus of modified microorganisms comprising any genetic modification that suppresses a genus of transcription factors of any amino acid sequence and structure that controls expression of genus of pyruvate dehydrogenases.
The specification as originally filed does not disclose a representative number of species of modified microorganisms having any chemical and/or biological properties and capable of producing any of the recited C6 compounds where any genetic modification is performed to suppress any transcription factor that controls expression of any pyruvate dehydrogenase. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with any transcription factor that controls expression of any pyruvate dehydrogenase.
. Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants at the time the application was filed were in possession of the claimed genus of modified microorganisms comprising any genetic modification that suppresses a genus of transcription factors of any amino acid sequence and structure that controls expression of genus of pyruvate dehydrogenases, wherein the microorganism has a production pathway of a C6 compound, and herein the C6 compound is at least one compound selected from the group consisting of adipic acid, hexamethylenediamine, 1,6-hexanediol, 6-aminohexanoic acid, 6-amino-1-hexanol, 6- hydroxyhexanoic acid, 3-oxoadipic acid, 3-hydroxyadipic acid, and 2,3-dehydroadipic acid.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20230392112 (2023-12-07; PTO 892).
US20230392112 teaches genetically modified microorganisms including mutant Serratia and Escherichia microorganisms that can produce 3-hydroxyadipic acid and/or α-hydromuconic acid in high yields, and the genetically modified microorganism, where the genetically modified microorganism is a microorganism having an ability to produce 3-hydroxyadipic acid and/or α-hydromuconic acid, in which the reaction to generate acetyl-CoA from pyruvic acid is enhanced and function of pyruvate kinase and/or phosphotransferase system is reduced (see entire publication and claims especially paragraphs [0020]- [0047]).
US20230392112 teaches in paragraphs [0091], [0116], [0126], [0135] and Examples 3-5 mutant Serratia microorganism with reduced function of the pyruvate dehydrogenase complex where transcriptional repressor pdhR, a gene coding for the pyruvate dehydrogenase complex transcriptional repressor of Serratia microorganism (SEQ ID NO: 36) which was deleted to prepare mutant Serratia microorganism with increased expression of pyruvate dehydrogenase complex (PDHc)
US20230392112 teaches in paragraphs [0169]- [0177] and Examples 8-10 the preparation of mutant Escherichia microorganism with reduced function of pyruvate dehydrogenase complex transcriptional repressor pdhR which is a gene coding for the pyruvate dehydrogenase complex transcriptional repressor of Escherichia microorganisms (NCBI Gene ID: 944827) which was deleted to prepare mutant an Escherichia microorganism with increased expression of PDHc. Thus, the reference teachings anticipate the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652