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 .
Priority
The instant application claims benefit to PCT/US23/62666 (filed on 02/15/2023) PCT/US2023/062666 (filed 02/15/2023) and US Provisional Application No. 63310976 (filed 02/16/2022) and is acknowledged. The instant claims herein are examined using the effective filing date of 02/16/2022 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 04/09/2025 was properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) was considered.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 41-58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 41-58 either explicitly recite the limitation “at least about” or depend from a claim that requires the “at least about limitation”. The term “at least about” in the claims is
indefinite because the recitation of “at least” sets a lower limit but “about” does not set a lower limit.
Thus, the claims are indefinite.
Claim 54 recites “the percentage of the alpha-guaiene is at least greater than about 15% of the total guaiene products”. The term “at least greater than about 15%” renders the claim indefinite because the term “at least greater” sets a lower limit but “about” does not set a lower limit. For example, the term “at least greater” encompasses percentages ≥ 15% but the term “about” encompasses percentages below 15% (e.g., 14.8%). Please note that claim 55 is also indefinite due to dependency on indefinite claim 54.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1, 41, 45-46, 50-58 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 written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, 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 inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
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). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
Independent claim 1 (and thus the dependent claims) recite “an engineered polypeptide encoding a guaiene synthase, wherein the engineered polypeptide comprises an amino acid sequence at least about 85% identical to SEQ ID NO:4 and wherein the amino acid sequence comprises a deletion of amino acids corresponding to positions 60-64 of SEQ ID NO:4.”. Claim 41 recites “the engineered polypeptide comprises an amino acid sequence at least about 90% identical to SEQ ID NO:8.” Claim 45 requires “a cell expressing the engineered polypeptide of claim 1”. Claim 45 requires “the engineered polypeptide comprises an amino acid sequence at least about 90% identical to SEQ ID NO:8.” Claim 50-53 (respectively) requires the cell to be a microbial cell, yeast or E. coli, of S. cerevisiae. Claim 56-57 require a nucleic acid molecule encoding the polypeptide of claim 1 and the nucleic acid molecule comprising the sequence of SEQ ID NO: 7.
The specification recites that alpha-guaiene synthases are sesquiterpene synthases known as rate-limiting enzymes in biosynthetic pathways and catalyze the formation of alpha-guaiene (see paragraph 0044-45). The examiner has interpreted the claim to require any amino acid sequence having at least 85% sequence identity to SEQ ID NO: 4, include the deletion of amino acids at positions 60-64, and that must retain functional capacity as a guaiene synthase. This is problematic because the specification fails to teach an art-recognized correlation between structure and function between the ability of the guaiene synthase to perform its function at 85%+ sequence identity.
In support of the claimed genus of enzymes, the specification discloses engineering of guaiene synthase by deleting amino acids 60-64 in SchTPS3 from Stellera chamjasme L. before being introduced into different background strains shown in Table 1, resulting in a 16-fold increase in activity of alpha-guaiene synthase (see Example 2-3, Fig. 2-3). Applicant also demonstrates large scale production of alpha-guaiene using the engineered strains harboring the full length SEQ ID NO: 8 (which was mutated from instant SEQ ID NO: 4. However, there is no disclosure in the specification that demonstrates the use of any guaiene synthase amino acid sequence having 85% identity to SEQ ID NO:4 and the claimed deletions for the production of alpha-guanine in recombinant cells. The use of full length of the engineered SEQ ID NO: 8 cannot reasonably be extrapolated and applied to support possession of the entire claimed genus of enzymes useful for increased production of alpha-guaiene, because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
There is also no disclosure as to what structure(s) must be present or retained on the claimed genus of enzymes that would result in a functional guaiene synthase for use in the claimed invention. Applicant has not provided any information or steps as to how one of ordinary skill would obtain any sufficient distinguishing structure-function relationship with respect to the broad genus as claimed. This data cannot be extrapolated to any and all possible synthase enzymes as instantly claimed. For example, SEQ ID NO: 4 (the wildtype synthase) is 553 amino acids long. 85% sequence identity to the sequence would allow for the addition, substitution, or deletion of at least 83 amino acids anywhere along the sequence and still retain functional capacity as a guaiene synthase. Even with knowledge in the art regarding modification of amino acids, one of ordinary skill would not reasonably know, based on the disclosure provided, what structures or functions are required for the outcome of creating a functional fragment of superoxide dismutase without a recognized correlation between structure and function.
The specification, then, is considered devoid of sufficiently detailed, relevant, identifying characteristics demonstrating that Applicant was in possession of the claimed genus of superoxide dismutase enzyme fragments, i.e., additional complete or partial structures, other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure, or some combination thereof demonstrating possession of the claimed genus.
Examiner’s Note
The instant claims recite “An engineered polypeptide encoding a guaiene synthase, wherein the engineered polypeptide comprises an amino acid sequence at least about 85% identical to SEQ ID NO:4 and wherein the amino acid sequence comprises a deletion of amino acids corresponding to positions 60-64 of SEQ ID NO:4.” The examiner notes that SEQ ID NO: 8 (as recited in the dependent claims) contains the deletion of amino acids 60-64 as required by the instant claims. The closest prior art of record (Phillips et al US 20210254107 A1) discloses enzymes, polynucleotides encoding said enzymes, and recombinant microbial host cells (or microbial host strains including mutated alpha-guaiene synthases used to produce alpha-guaiene and rotundone (see abstract; claims, throughout). Phillips et al also teaches various sequences of the guaiene synthase including SEQ ID NO: 1-21 containing one or more amino acid substitutions at positions selected from 72, 273, 290, 368, 371, 374, 377, 381, 382, 399, 406, 419, 433, 442, 443, 454, 512, and 522 (see claim 6) and more specifically T72I, M273L, R290K, F368M, I371L, S374A, R377V, Y381W, F382L, I399V, F406L, L419T, V433I, Y442L, I443M, E454K, F512L, and K522D relative to SEQ ID NO: 8 (see claim 7). The prior art fails to adequately provide a PHOSITA the necessary teaching, suggestion or motivation to delete amino acids at position 60-64 in the amino acid sequence of SEQ ID NO:4 (the wildtype guaiene synthase). As such, after a search of SEQ ID NO: 8, the sequence has been deemed free of the prior art. Please note that while no prior art rejections have been made, the claims are not allowable for the reasons set forth in the rejections above.
Conclusion
NO CLAIMS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights