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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 7/16/2026 in response to the Non-Final Rejection mailed on 4/20/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-23, 25-28, 30-32 are pending.
Claims 24, 29 are cancelled.
Claims 27-28, 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-23, 25-26, 32 are pending and examined on the merits.
Withdrawal of Election/Restrictions
Applicant’s election without traverse of Group I (claim 1-26) in the reply filed on 2/27/2026 is acknowledged. The restriction requirement of claim 29 is withdrawn in view of Applicant’s cancellation of claim 29.
Withdrawn Rejections
The written description rejection of claim 24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant’s cancellation of claim 24.
The scope of enablement rejection of claims 1-22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant’s amendment of claims 1, 2, 27 to recite ‘at least 90% sequence identity,’ claims 20-21 to recite ‘at least 95% sequence identity.’
The rejection of claims 13, 15-16, 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s amendment of claims 15-16 to delete the recitation ‘nitrogen deficient condition,’ and antecedent basis of claims 13, 15-16, 26 for the recitation ‘the corresponding control algal cell’ in independent claim 1 which recites ‘a corresponding control algal organism.’
Maintained 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.
The rejection of claims 1-23, 25-26, 32 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 is maintained. The rejection has been modified to address the recitation ‘a recombinant algal organism comprising a deletion, disruption… of: a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 90% sequence identity to SEQ ID NO: 1’ recited in the instant application claims 1, 23, cancellation of claim 24 and new claim 32. 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, 32 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 90% sequence identity to SEQ ID NO: 1; or a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 90% 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. It is unclear what encompasses the terms ‘deletion’ and ‘disruption’ when the limitations that immediately follows said terms recites ‘a gene encoding a protein kinase-like domain….having 90% sequence identity to SEQ ID NO:1’ as the gene that is 90% identical to SEQ ID NO: 1 will necessarily be comprised of a ‘deletion’ and/or ‘disrupted.’
Claims 23, 25-26 are drawn to a recombinant algal organism comprising a deletion, disruption, or inactivation to: a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 90% sequence identity to SEQ ID NO: 9; or a gene encoding a protein kinase-like domain having a nucleic acid sequence having at least 90% sequence identity to SEQ ID NO: 8; and wherein the recombinant algal organism exhibits higher biomass productivity and higher lipid productivity versus a corresponding control algal organism not having the genetic modification. It is unclear what encompasses the terms ‘deletion’ and ‘disruption’ when the limitations that immediately follows said terms recites ‘a gene encoding a protein kinase-like domain….having 90% sequence identity to SEQ ID NO:9’ as the gene that is 90% identical to SEQ ID NO: 9 will necessarily be comprised of a ‘deletion’ and/or ‘disrupted.’
In this case, the specification discloses the following representative recombinant algal organism comprising a deletion or disruption, of a gene encoding a protein kinase-like domain as encompassed by the claims (i.e. a deletion of one or more amino acids of the encoded protein kinase-like domain, or the disruption can be an insertion of a stop codon in the gene encoding the kinase-like protein). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of ‘deletions’ and/or ‘disruptions’ of a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 90% sequence identity to SEQ ID NO: 1 and 9. The breadth of the claims encompasses any deletions and/or insertions that are beyond the scope of the claimed limitations as a sequence that is 90% identical to SEQ ID NO: 1 and 9 would necessarily have some sort of ‘deletion’ and/or ‘disruption.’
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 any additional deletions and/or disruptions that encompasses a gene encoding a protein kinase-like domain that has a polypeptide sequence having at least 90% sequence identity to SEQ ID NO: 1 and SEQ ID NO: 9 as said gene would necessarily be comprised of deletions and/or disruptions.
RESPONSE TO REMARKS: Beginning on p. 7 of Applicant’s remarks, Applicant contends that the rejection has been addressed by amendment. In summary, Applicant contends that amending claims to recite a 90% sequence identity to SEQ ID NO: 1 and 9 necessitates withdrawal of the rejection.
The argument is found to be not persuasive. Examiner contends that it is unclear what encompasses the terms ‘deletion’ and ‘disruption’ when the limitations that immediately follows said terms recites a gene encoding a protein kinase-like domain….having 90% sequence identity to SEQ ID NO:1 and 9 as the gene that is 90% identical to SEQ ID NO: 1 and 9 will necessarily be comprised of a ‘deletion’ and/or ‘disrupted.’ Clarification is requested.
Conclusion
Status of Claims
Claims 1-23, 25-26, 32 are pending.
Claims 24, 29 are cancelled.
Claims 27-28, 30-31 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.
Claims 1-23, 25-26, 32 are rejected.
No claims are in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656
