DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on April 14, 2026, has been entered.
Status of Claims
The indicated allowability of claims 1, 3-12, 15, 17, and 20 is withdrawn in view of the newly discovered reference(s) to NPL No. 1 of the IDS filed April 14, 2026. Rejections based on the newly cited reference(s) follow.
In view of the withdrawal of the indicated allowability of the claims, then the status of the claims is as follows:
Claims 1-20 are pending.
Claims 3-14 and 16-19 are withdrawn.
Claims 1, 2, 15, and 20 are examined on the merits.
Response to Arguments
Applicant’s arguments, filed January 26, 2026, with respect to the rejection under 35 U.S.C. 112(b) of claims 15 and 20, and the rejection under 35 U.S.C. 103 of claims 1, 2, 15, and 20 as being unpatentable over Perin, have been fully considered and are persuasive. In particular, the rejection under 35 U.S.C. 112(b) has been overcome by the amendment to claim 15. Also, the rejection under 35 U.S.C. 103 has been overcome by the argument that the claimed ASTAOMEGA strain has a particular set of 504 mutations that are not explicitly disclosed in Perin; also, since the mutations introduced by EMS are randomly distributed across the genome, it cannot be concluded that any of the 49 mutant strains obtained by Perin have the particular set of 504 mutations that characterized the claimed strain. Therefore, these rejections have been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of NPL No. 1 of the IDS filed April 14, 2026. Additionally, Applicant’s arguments are unpersuasive with respect to the rejection under 35 U.S.C. 112(b) of claim 2. See the rejection under 35 U.S.C. 112(b) below for the Examiner’s response to Applicant’s arguments.
Drawings
The drawings are objected to because Figures 2C, 2G, and 2M have incomplete text. Regarding FIG. 2C, the text under the heading “REF” of the third column at line 25 starts off with “CTGCGAG,” but the text is cut off at the end. Regarding FIG. 2G, the text under the heading “Annotation” of the seventh column (Variant effect column) at line 2 is cut off at the beginning and the end because it recites “ense_variant&splice_region_va.” It is unclear whether that recitation should start off with “missense” and end with “variant.” Regarding FIG. 2M, the text under the heading “REF” of the third column at line 5 includes “GAGGGA,” but the text is cut off at the beginning and the end.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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.
Claim 2 is indefinite because it is unclear what are the 504 mutations illustrated in Figures 2A-2N. First, Figures 2C, 2G, and 2M are not completely legible. It is difficult to discern some of the text characters – see the objection to the drawings above. Moreover, the mutations are unclear. No sequence is provided for the wild-type algal strain. The claimed strain was obtained by performing random chemical mutagenesis on a wild-type algal strain which is Nannochloropsis gaditana CCAP849/5 (i.e. CCAP 849/5) (page 12, third paragraph of the specification). However, no specific sequence of N. gaditana CCAP 849/5 was provided that serves as the reference sequence on which the mutations are applied according to Figures 2A-2N. On the other hand, in the Remarks filed January 26, 2026, Applicant asserts that the reference genome “Nannochloropsis gaditana” is publicly available in different databases, and the sequence herein used was reported in Corteggiani Caprinelli, E. et al (Mol. Plant. 7, 323-335 (2014)). However, this is not supported by the specification as filed. There is no reference to the Corteggiani Caprinelli paper in the specification.
Furthermore, it is unclear what are the mutations based on the headings and subheadings of Figure 2A-2N. Page 7, last paragraph through page 8, first paragraph of the Remarks filed January 26, 2026, define the heading and subheadings, which create further confusion regarding each mutation. There are no reference sequence(s) to make sense of chromosome number (#CHROM) and thus the specific positions in the chromosome (POS). With respect to the HGVS notation under the “Variant substitution” column, since the reference sequence(s) have not been filed, then the entries of that column are confusing for interpretation of each mutation. The mutations set forth in the “Variant substitution” column use different positions than in the “POS” column, thus creating further confusion. For instance, the first entry of Figure 2A recites position 12414 in the “POS” column, but then refers to position 2138 in the “HGVS.c” column. Even with the explanation of the headings and subheadings in the Remarks filed January 26, 2026, the scope of the 504 mutations is still unclear. For the purpose of applying prior art, any 504 mutations to a sequence of N. gaditana CCAP 849/5 are being considered as meeting instant claim 2.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 2, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL No. 1 of the IDS filed April 14, 2026 (‘NPL NO. 1.’ The true costs of health habits_ASTAOMEGA Project_Results in Brief, CORDIS-EU research results, November 13, 2019, https://cordis.europa.eu/article/id/411502-the-true-costs-of-ourhealthy-habits [retrieved 14-04-2026], 6 pp.).
NPL No. 1 discloses Nannochloropsis gaditana of the ASTAOMEGA system which accumulates high levels of the omega-3 fatty acid eicosapentaenoic acid (EPA) and also produces the antioxidant astaxanthin (page 2, second paragraph). Additionally, the selected strain has a high biomass productivity (page 3, first full paragraph).
Though NPL No. 1 does not expressly disclose that the strain is the claimed mutant algal strain ASTAOMEGA, the strain of NPL No. 1 appears to be the claimed strain because the strain of NPL NO. 1 is of the species Nannochloropsis gaditana, produces both astaxanthin and EPA like the claimed strain (page 21, third to fourth paragraphs of the originally filed specification), and is described as being of the ASTAOMEGA system. Therefore, NPL NO. 1 renders obvious instant claim 1.
Regarding instant claim 2, since NPL NO. 1 renders obvious the claimed mutant algal strain ASTAOMEGA, then its strain necessarily comprise the claimed 504 mutations to a sequence of the wildtype Nannochloropsis gaditana strain 849/5. The claimed mutations are an inherent characteristic of the claimed mutant algal strain. Thus, instant claim 2 is rendered obvious.
Regarding instant claims 15 and 20, NPL No. 1 discloses a high biomass productivity of the N. gaditana strain, and used it as a basis to produce both astaxanthin and EPA (page 3, first full paragraph). The teaching of a high biomass productivity sets forth an algal biomass of the N. gaditana strain of NPL No.1 (renders obvious the mutant algal strain of instant claim 1). In order to produce the algal biomass, it would have been obvious to the person of ordinary skill in the art that the strain of NPL No. 1 is cultured. Since the strain of NPL No. 1 produces both astaxanthin and EPA (directed to an omega-3 fatty acid), then culturing the strain of NPL No. 1 to produce the biomass in turn produces astaxanthin and omega-3 fatty acids. Therefore, instant claim 15 is rendered obvious. Regarding instant claim 20, it is directed to an intended use. The biomass of the N. gaditana strain of NPL No. 1 would have been suitable for the claimed intended use as feed. Therefore, instant claim 20 is rendered obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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