DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. The amendment, filed 12/17/25, has been entered. Claims 1-6 are pending and under examination. Claims 1, 4, 5, and 6 are amended.
Withdrawal of Objections/Rejections
3. The following are withdrawn from the Office Action, filed 10/08/25:
The objection to claims 4, 5 and 6, found on page 2 at paragraph 4, is withdrawn in light of Applicant’s amendments thereto.
The rejection of claims 5-6 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement (biological deposit), found on page 3 at paragraph 6, is withdrawn in light of Applicant’s submission of the required statement by an attorney of record: the specific biological materials have been deposited under the Budapest Treaty and the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent; see Remarks, page 4.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Iwama et al. 2014 (Fatty Aldehyde Dehydrogenase Multigene Family Involved in the Assimilation of n-Alkanes in Yarrowia lipolytica; The Journal of Biological Chemistry 289 (48):33275-33286), found on page 5 at paragraph 9, is withdrawn in light of Applicant’s amendments thereto (i.e. eliminating SEQ ID NO:5 as an option).
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Iwama et al. 2014 (Fatty Aldehyde Dehydrogenase Multigene Family Involved in the Assimilation of n-Alkanes in Yarrowia lipolytica; The Journal of Biological Chemistry 289 (48):33275-33286), found on page 5 at paragraph 9, is withdrawn in light of Applicant’s amendments thereto (i.e. eliminating SEQ ID NO:5 as an option).
Maintained Objection
4. Claim 1 is objected to because of the following informalities: improper use of an acronym/abbreviation. Acronyms and abbreviations must be spelled out and/or defined upon first use, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves); therefore each of EcAldH must be properly explained/defined. Appropriate correction is required.
Applicant’s Response
5. Applicant states EcAldH is already defined in the preamble of claim 1 ("an aldehyde dehydrogenase (EcAldH) gene"); see Remarks, page 4. However, this explanation does not properly address the Ec part of the EcAldH abbreviation which appears to refer to a particular aldehyde dehydrogenase of Escherichia coli. Therefore appropriate correction and/or clarification is still required.
New Rejection: Claim Rejections - 35 USC § 101
6. 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.
7. Claims 1-3 and 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nature-based product (e.g. naturally occurring microbial strains) without significantly more.
The claims recite a furfural-resistant strain comprising a gene encoding an aldehyde dehydrogenase gene, wherein the aldehyde dehydrogenase gene comprises at least one gene sequence selected from the group consisting of a nucleotide sequence of SEQ ID NO: 1; a nucleotide sequence of SEQ ID NO:2; a nucleotide sequence of SEQ ID NO: 3; and a nucleotide sequence of SEQ ID NO: 4, which reads on naturally occurring strains of bacteria (e.g. SEQ ID NO: 1 in Escherichia coli) and yeast (e.g. SEQ ID NO: 4 in Yarrowia lipolytica) as evidenced by the alignments provided in the art rejections below.
The judicial exception is not integrated into a practical application because the naturally occurring microorganisms do not appear to be markedly different from their naturally occurring counterparts, in their natural states, since they do not appear to be modified. Therefore, although the product claims are directed to a statutory category (i.e. Step 1 is yes), they are also directed to a judicial exception (i.e. nature-based products; Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is no).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 1, 2, 3, 5 or 6. Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
New Rejections: Claim Rejections - 35 USC § 102 and 103
8. 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 (i.e., changing from AIA to pre-AIA ) 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.
9. 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.
10. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
11. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
12. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 102
13. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurihara et al. 2005 (A Novel Putrescine Utilization Pathway Involves g-Glutamylated Intermediates of Escherichia coli K-12; The Journal of Biological Chemistry 280(6): 4602-4608).
Kurihara teach E. coli bacterial strains having a 100% match to instant SEQ ID NO: 1 as evidenced by the following alignment:
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With regards to furfural resistance, MPEP 2112.01 states that products of identical chemical composition cannot have mutually exclusive properties because a chemical composition and its properties are inseparable; therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In addition, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention; see Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In the instant case, because Kurihara teaches bacterial strains with the same structural features, any functional properties, including furfural resistance, must necessarily present, whether the prior art recognized those properties or not.
Accordingly, Kurihara anticipates the invention as claimed.
Claim Rejections - 35 USC § 102 and 103
14. Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lubuta et al. 2018 (GenEmbl direct submission of Yarrowia genome; CP028449).
With regards to claim 1, Lubuta teaches Yarrowia lipolytica yeast strains comprising a 100% sequence match to instant SEQ ID NO: 4, as evidenced by the following alignment of a Yarrowia draft genome:
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With regards to furfural resistance, MPEP 2112.01 states that products of identical chemical composition cannot have mutually exclusive properties because a chemical composition and its properties are inseparable; therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In addition, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention; see Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). Thus, because Lubuta teaches a strain with the required structural feature (i.e. SEQ ID NO: 4), then furfural resistance necessarily must be present whether they recognized the functional property or not.
With regards to specific process steps in dependent claims 2, 3 and 4; it is noted that product-by-process claims are not limited to the manipulation of the recited steps, but only the structure implied by those steps. MPEP 2113 states that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, it is the Office’s position that the Yarrowia lipolytica of the prior art (1) appear to be substantially identical to the claimed Yarrowia lipolytica (i.e. it is the same species and has the same required nucleic acid sequence of SEQ ID NO: 4) and (2) the recited method steps do not appear to impart distinctive structural characteristics to the final product. MPEP 2113 also states that the Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion; see In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Accordingly, the burden now shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product; see In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983); Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989).
With regards to dependent claims 5 and 6, while the prior art does not specifically teach the Yarrowia lipolytica is a strain deposited and having the accession number KCTC15376BP (see claim 5) or KCTC15377BP (see claim 6); the strains are deemed to be the same, or substantially the same, as evidenced by, for example, the same Latin name: Yarrowia lipolytica. Therefore, absence convincing evidence to the contrary, Lubuta anticipates the invention as claimed because the genetically modified Yarrowia lipolytica and its functional properties cannot be separated; see MPEP 2112.01. Further, MPEP 2112.01 also states that “When the PTO shows a sound basis for believing that the inventions of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alternatively, it would have been prima facie obvious to substitute one Yarrowia lipolytica yeast strain for another for the same purpose as desired. Therefore, Lubuta teaches, or at least renders obvious, the yeast strains, as claimed, because (1) Yarrowia lipolytica cannot be separated from its properties, and/or (2) the prior art teaches a product that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the Yarrowia lipolytica strain) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
January 8, 2026