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 .
Applicants’ amendment to the claims filed on 2/27/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-31 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claim 1-26) in the reply filed on 2/27/2026 is acknowledged.
Claims 1-26 are pending and examined on the merits.
Claims 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgement is made of this non-provisional application No. 18/386,502 filed on 11/4/2022, which claims domestic priority to U.S. provisional application 63/422,815, filed on 11/4/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/1/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 11/2/2023 is acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 112
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 1-26 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.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states 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 applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claims 1-22 are drawn to a recombinant algal organism comprising a deletion, disruption, or inactivation of: a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; or a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; wherein the recombinant algal organism exhibits higher biomass productivity and higher lipid productivity versus a corresponding control algal organism not having the deletion, disruption, or inactivation. The structure and function of a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1 is a large number of sequences as it is unknown the amino acid sequences of the remaining 20% of the protein. Additionally, the structure and function of a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3 is a large number of sequences as it is unknown the amino acid sequences of the remaining 20% of the nucleic acid.
Claim 2 is drawn to the recombinant algal organism of claim 1, having a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1. The structure and function of a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1 is a large number of sequences as it is unknown the amino acid sequences of the remaining 15% of the protein.
Claim 3 is drawn to the recombinant algal organism of claim 1, having a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3. The structure and function of a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3 is a large number of sequences as it is unknown the amino acid sequences of the remaining 15% of the nucleic acid.
In this case, the specification discloses the following representative recombinant algal organism comprising a deletion, disruption, or inactivation of a gene encoding a protein kinase-like domain as encompassed by the claims (i.e. a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1; a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3; a polypeptide sequence having at least 90% sequence identity to SEQ ID NOs: 1 or 9; a nucleic acid sequence having at least 90% sequence identity to SEQ ID NO: 2 or SEQ ID NO: 3). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of amino acids that are the remaining claimed protein kinase-like domain. The breadth of the claims encompass any polypeptide sequence beyond a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; any polypeptide sequence beyond a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1. The breadth of the claims encompass any nucleotides beyond a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; any polypeptide sequence beyond a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3: any nucleotides beyond a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3 as the claimed gene encoding a protein kinase-like domain.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to teach which amino acids and nucleotides out of the numerous possibilities comprising gene encoding a protein kinase-like domain.
Accordingly, one of skill in the art would not accept the disclosure of a recombinant algal organism comprising a deletion, disruption, or inactivation of a gene encoding a protein kinase-like domain comprising a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1; a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3 as being representative of all protein kinase-like domains as encompassed by the claims. As such, the specification, taken with the pre-existing knowledge in the art of CRISPR nuclease, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a gene encoding a protein kinase-like domain (a polypeptide sequence having at least 90% or 95% sequence identity to SEQ ID NOs: 1 or 9; a nucleic acid sequence having at least 90% sequence identity to SEQ ID NO: 2 or SEQ ID NO: 3), does not reasonably provide enablement for all genes encoding a protein kinase-like domain with a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1; nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3 as the remaining 15%-20% of the polypeptide sequence and 20% of the nucleic acid sequence are a large number of sequences. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) as follows: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The Factors considered to be most relevant to the instant rejection are addressed in detail below.
(A)The breadth of the claims
Claims 1-22 are drawn to a recombinant algal organism comprising a deletion, disruption, or inactivation of: a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1; or a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3; wherein the recombinant algal organism exhibits higher biomass productivity and higher lipid productivity versus a corresponding control algal organism not having the deletion, disruption, or inactivation. The structure and function of a polypeptide sequence having at least 80% sequence identity to SEQ ID NO: 1 is a large number of sequences as it is unknown the amino acid sequences of the remaining 20% of the protein. Additionally, the structure and function of a nucleic acid sequence having at least 80% sequence identity to SEQ ID NO: 2 or 3 is a large number of sequences as it is unknown the amino acid sequences of the remaining 20% of the nucleic acid.
Claim 2 is drawn to the recombinant algal organism of claim 1, having a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1. The structure and function of a polypeptide sequence having at least 85% sequence identity to SEQ ID NO: 1 is a large number of sequences as it is unknown the amino acid sequences of the remaining 15% of the protein.
Claim 3 is drawn to the recombinant algal organism of claim 1, having a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3. The structure and function of a nucleic acid sequence having at least 85% sequence identity to SEQ ID NO: 3 is a large number of sequences as it is unknown the amino acid sequences of the remaining 15% of the nucleic acid.
B) The nature of the invention; C)The state of the prior art; (D) The level of one of ordinary skill; and (E) The level of predictability in the art: As noted above, the scope of the claimed amino acids of the gene encoding a protein kinase-like domain is a large number of sequences. Furthermore, the scope of the claimed nucleic acids of the gene encoding a protein kinase-like domain is a large number of sequences. The structure of the claimed gene encoding a protein kinase-like domain exhibiting higher biomass productivity and higher lipid productivity abilities encompass a large number of sequences.
It is well-known in the prior art that the amino acid sequence of a polypeptide determines the polypeptide’s functional properties. The positions within a protein's sequence where modifications can be made with a reasonable expectation of success in obtaining a polypeptide having the desired activity/utility are limited in any protein and the result of such modifications is highly unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g., multiple substitutions. The reference of Singh et al. (Current Protein and Peptide Science, 2017; examiner cited) reviews various protein engineering methods and discloses that despite the availability of an ever-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 p. 7, column 1, top]. The reference of Zhang et al. (Structure, 2018; examiner cited) discloses that a mutation of a residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide [p. 1475, column 1].
It is well-known in the art that even a single amino acid alteration can alter the folding of a polypeptide. See, e.g., MPEP 2144.08.II.A.4.(c), which states, “[i]n the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (“the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.” Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989)). The effect of a conservative substitution on protein function depends on the nature of the substitution and its location in the chain. Although at some locations a conservative substitution may be benign, in some proteins only one amino acid is allowed at a given position. For example, the gain or loss of even one methyl group can destabilize the structure if close packing is required in the interior of domains. James Darnell et al., Molecular Cell Biology 51 (2d ed. 1990).”
(F) The amount of direction provided by the inventor and (G) The existence of working examples: The specification discloses the following working examples of genes encoding a protein kinase-like domain (i.e. SEQ ID NO: 1-3). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of sequences comprising a gene encoding a protein kinase-like domain exhibiting higher biomass productivity and higher lipid productivity. Other than the above disclosed species, there is no prior-art or disclosed teaching as to a gene encoding a protein kinase-like domain through genetic modification of genes encoding proteins or post-translational modifications, etc. via any modification technique such as deletion, mutation, etc. exhibiting higher biomass productivity and higher lipid productivity. Other than these working examples, the specification fails to disclose any other working examples of a gene encoding a protein kinase-like domain that exhibits higher biomass productivity and higher lipid productivity.
In view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability, and the state of the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention. Applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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 13, 15-16, 26 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.
Regarding claims 15-16, the phrase "nitrogen deficient condition" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The phrase “nitrogen deficient conditions” is indefinite because the term “deficient” is relative term. It is not clear if the items/phrases followed by this phrase are to be considered as claim limitations. Applicant have not specified a measurable way to define “nitrogen deficient” condition. Appropriate correction is suggested. See MPEP § 2173.05(d). Appropriate correction is suggested.
Claims 13, 15-16, 26 recites the limitation "the corresponding control algal cell" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of corresponding control algal cell in independent claims 1, 23. It is suggested that Applicant amend the claim to maintain consistency of either plural or singular. Appropriate correction is suggested.
Conclusion
Status of Claims
Claims 1-26 are pending and examined on the merits.
Claims 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b)
Claims 1-26 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. 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.
/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights