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 .
Claims 1-13 are pending in the instant application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
1. Claims 1-6 are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1-6 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Claims 1-6 are directed to naturally occurring bacteria. Applicants specification (page 7) sets forth that the microorganism of the instant invention includes “all wild-type” microorganisms.
The claims drawn to naturally occurring bacteria and are not patent eligible merely because they have been isolated.
Serber et al (WO 2018/226964) disclose of isolated Corynebacterium glutamicum microorganisms. (See abstract; claim 71). Serber et al further disclose the Corynebacterium to comprise a polypeptide comprising SEQ ID NO: 3 of the instant invention, encoded by SEQ ID NO: 4 of the instant invention. (See SEQ ID NO: 197 & 58).
Accordingly, the instant claims encompass naturally occurring microorganisms and are thereby deemed to be a judicial exception.
The Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a “product of nature” exception. (Emphasis added). As the Court explained, the modified bacterium was patentable because the patent claim was not to a “hitherto unknown natural phenomenon,” but instead had “markedly different characteristics from any found in nature,” due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.
Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is “central” to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that “discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection.” In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was “the first mammal ever cloned from an adult somatic cell.” Despite acknowledging that the method used to create the claimed clones “constituted a breakthrough in scientific discovery”, the court relied on Chakrabarty in holding the claims ineligible because “Dolly herself is an exact genetic replica of anothersheep and does not possess ‘markedly different characteristics from any [farm animals]found in nature.’” Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671.
As the Corynebacterium of the instant invention remains identical to the naturally occurring Corynebacterium, the instantly claimed microorganisms are deemed to be a naturally occurring judicial exception.
Claim Rejections - 35 USC § 102
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.
2. Claim(s) 1-2, 5-9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moeckel et al.
The claims are drawn to a Corynebacterium sp. microorganism with weakened activity of LacI family DNA-bidning transcriptional regulator protein.
Moeckel et al (US Publication 2002/0151001) disclose of Corynebacterium glutamicum microorganisms having weakened activity of a ccpAI gene encoding a ccpAI protein, which is a LacI family DNA-binding transcriptional regulator protein. (See paragraphs [0039], [0059] and claim 8. Moeckel et al further disclose of attenuating the ccpAI gene. (See claim 8). Moeckel et al further disclose of overexpressing and producing L-amino acids including L-glutamic acid. (See paragraph [0009]; claim 12 & 19-20).
Accordingly, Moeckel et al disclose of each and every limitation of the instantly filed claims.
3. Claim(s) 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serber et al.
The claims are drawn to a Corynebacterium sp. microorganism with weakened activity of LacI family DNA-bidning transcriptional regulator protein.
Serber et al (WO 2018/226964) disclose of Corynebacterium glutamicum microorganisms comprising the LacI DNA-binding transcriptional regulator protein identified as SEQ ID NO: 3 of the instant invention. (See SEQ ID NO: 197). Serber et al further disclose of the gene encoding the protein identified as SEQ ID NO: 4 of the instant invention. (See SEQ ID NO: 58). Serber et al further disclose of producing L-amino acids. (See claim 32).
It is noted that Serber et al do not characterize the production of L-amino acids to specifically recite L-glutamic acid. However, products of identical chemical composition cannot have mutually exclusive properties. A composition and its properties are inseparable. Therefore, if the prior art teaches the identical structure, (Corynebacterium glutamicum comprising the LacI DNA binding protein comprising SEQ ID NO: 3 and producing L-amino acids) the properties applicant discloses and/or claims (production of L-glutamic acid) are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Serber et al disclose of each and every limitation of the instantly filed claims.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 December 12, 2025