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 .
Response to Amendment/Status of Claims
Receipt of Arguments/Remarks filed on 06/05/2026 is acknowledged. Claims 2-8,12 and 15 were cancelled. Claims 1,9-11,13 and 14 were amended. Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/13/2026.
Claims 1,9-11,13 and 14 are under examination.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 03/16/2022 (IN202221014245). The foreign priority documents were electronically retrieved by USPTO on 06/08/2026.
Withdrawn Objections and Rejections
Applicant’s arguments and amendments, see page 7, filed 06/05/2026, with respect to Figures 13-16 not being identified by SEQ ID NO have been fully considered and are persuasive due to the submission of replacement drawings and substitute specification providing sequence identifiers for the nucleotide sequences. The objection to the drawings and specification regarding the lack of sequence identifiers has been withdrawn.
Applicant’s arguments and amendments, see page 8, filed 06/05/2026, with respect to the objection to the drawings filed 03/13/2023 including color, as well as the incorrect labeling of each view of figures 1-4 and 6-9 have been fully considered and are persuasive due to providing replacement drawings correcting the issues. The objections to the drawings have been withdrawn.
Applicant’s arguments and amendments, see page 8, filed 06/05/2026, with respect to the objection to claims 1,4,5,6,7,9,10,11,13 and 14 have been fully considered and are persuasive due to the cancelation of claims 4-7 and amendments to claims 1,9-11,13 and 14 correcting the typos. The objections to the claims have been withdrawn.
Applicant’s arguments and amendments, see page 8, filed 06/05/2026, with respect to the 35 U.S.C. 112(b) rejection of claims 2-11 and 13-15 have been fully considered and are persuasive due to the amendments to claims 9-11,13 and 14 to recite “the mutant algae”, and cancelation of the other claims. The 35 U.S.C. 112(b) rejection of claims 2-11 and 13-15 has been withdrawn.
Applicant’s arguments and amendments, see pages 9-10, filed 06/05/2026, with respect to the 35 U.S.C. 103 rejection of claims 1,8 and 15 have been fully considered and are persuasive due to the amendments to claim 1 limiting the algae to Picochlorum spp. and defining the mutant algae as having one or more specific mutations in the genes which is not taught by Sim et al. in view of Van Ginkel et al. The 35 U.S.C. 103 rejection of claims 1,8 and 15 has been withdrawn.
Rejection Necessitated by Amendment
Written Description Rejection
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 1,9-11,13 and 14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims 1,9-11,13 and 14 encompasses a genus of mutant algae variants belonging to Picochlorum spp. resistant to a salicylanilide based drug selected from the group consisting of niclosamide, oxyclozanide, rafoxanide and closantel having improved productivity and improved photosynthetic efficiency compared to wild type algae. Amended claim 1 recites wherein the mutant algae comprises at least one selected from: (a) an insertion-deletion mutation at about the 730 nucleotide position and at about the 1070 nucleotide position in a gene encoding putative proton symporter protein 3;(b) a frameshift mutation at about the 200 nucleotide position in a gene encoding putative cytochrome p450 protein 4;(c) about a 350 bp insertion at about the 255 nucleotide position and about a 220 bp insertion at about the 1275 nucleotide position, respectively in the reading frame of a gene encoding putative aquaporin protein 1; or (d) about a 340 bp insertion at about the 250 nucleotide position in the reading frame of a gene encoding putative aquaporin protein 2. This encompasses a genus of variants as instantly claimed. The claims do not recite a specific nucleotide sequence for each gene encoding the protein that shows the structure of the gene containing the specific mutation(s) that performs the function, as the claims recite for example, “at about the 730 nucleotide position and at about the 1070 nucleotide position”, or “about a 350 bp insertion at about the 255 nucleotide position and about a 220 bp insertion at about the 1275 nucleotide position”.
Regarding the state of the art, Sim et al. (US 20180100206, Published 12 April 2018), teach that as one of the methods of improving photosynthetic efficiency of microalgae, a method of decreasing a chlorophyll antenna size has been used (paragraph 0005). Sim et al. teach that 100 or more genes participate in and regulate photosynthesis mechanism which is one of the most complicated biochemical mechanisms and a large number of proteins and coenzymes are required for an electron transport system, carbon dioxide fixation and synthesis of photosynthetic pigments (paragraph 0005). Therefore, Sim et al. teach the large genus of genes, proteins and enzymes involved in photosynthesis, and which has complicated biochemical mechanisms.
The instant specification discloses that the wild type agal cells are Picochlorum strain (page 6, lines 25-27). The instant specification discloses the mutant algae comprises at least 2 mutations in a gene encoding putative proton symporter protein 3, as set forth in SEQ ID NO: 1 (page 8, lines 21-23) and the mutant algae comprises an insertion-deletion mutation at about 730 nucleotide position and at about 1070 nucleotide position in the gene (page 8, lines 27-30); the mutant algae comprises at least one mutation in a gene encoding putative cytochrome P450 protein 4 as set forth in SEQ ID NO: 3 and comprises a frameshift mutation at about 200 nucleotide position in the gene (page 9, lines 1-10); the mutant algae comprises at least 500 base pair insertion in a gene encoding putative aquaporin protein 1 in reading frame, and in an embodiment the putative aquaporin protein 1 of the mutant algae is set forth as SEQ ID NO: 5 (page 9, lines 16-20); and the mutant algae comprises about 340 bp insertion at about 250 nucleotide position in reading frame of a gene encoding putative aquaporin protein 2 and in an embodiment the gene encoding putative aquaporin protein 2 of the mutant algae is set forth as SEQ ID NO: 7 (page 9 lines 32-34, to page 10 line 1).
Instant Example 1 discloses that the wild type cells were treated with EMS for 1 hour, and the salicylanilide based drug they were exposed to was Niclosamide (Example 1, page 18). Figure 5 shows improved volumetric productivity of the mutant algae compared to wild type algae based on about 1,2 and 5 ppm of Niclosamide, and shows the mutant algae is resistant to salicylanilide based drug such as Niclosamide compared to wild type algae. Figures 11 and 12 show improved volumetric productivity of the mutant algae compared to wild type algae at about 2 and 5 ppm of Niclosamide, oxyclozonide, Rafoxanide and Closantel and that the mutant algae are resistant to salicylanilide based drug compared to wild type algae. Figures 8 and 9 show improved growth of the mutant algae at about 2 and 5 ppm of Niclosamide, oxyclozonide, Rafoxanide and Closantel that the mutant algae are resistant to salicylanilide based drug compared to wild type algae. Figure 6 shows improved photosynthetic efficiency/health of the mutant algae at about 1,2 and 5 ppm of Niclosamide, and Table 1 page 12 shows that the mutant algae has improved nitrogen content in presence of salicylanilide based drug such as Niclosamide and is found to be about 10-14% higher in the mutant algae comprised to wild type algae.
The specification discloses the microalgae species as Picochlorum, SEQ ID NOs: 1,3,5 and 7 as the nucleotide sequence comprising mutations of each gene, as well as the salicylanilide based drug being Niclosamide, oxyclozonide, Rafoxanide or Closantel which meet the written description and enablement provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. However, claims 1,9-11,13 and 14 are directed to encompass a genus of Picochlorum algae variants comprising at least one mutation in each of the recited genes which only correspond in some undefined way to specifically instantly disclosed species of mutations in the recited genes and comprising the recited functions. The recited genus of mutations in the recited genes do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus’s encompassed by the claim. Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed nucleotide sequences of SEQ ID NO: 1 representing the mutation in a gene encoding putative proton symporter protein 3, SEQ ID NO: 3 representing the mutation in a gene encoding putative cytochrome P450 protein 4, SEQ ID NO: 5 representing the mutation in a gene encoding putative aquaporin protein 1, and SEQ ID NO: 7 representing the mutation in a gene encoding putative aquaporin protein 2, the skilled artisan cannot envision the detailed chemical structure of the encompassed species of mutants in each of the recited genes encoding the proteins, because no reference sequence identifier is given, the claims recite approximate nucleotide positions and approximate lengths of insertions (about), and are not limited to just these mutations since the claims use the language “comprising”. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
The specification does not disclose a core structure of the genus of mutations for each gene that would result in the functional limitations of the mutant algae being resistant to a salicylanilide based drug and having improved productivity and improved photosynthetic efficiency as compared to wild type algae in the presence of a salicylanilide based drug, or wherein the nitrogen content in the algae is improved by at least 10% as compared to wild type algae, or wherein the algae has at least 2 fold reduced atp depletion as compared to wild type algae. The specification does not disclose a sufficient number of species of microalgae that have the recited mutations in the specific genes that result in the recited functional limitations above. For example, the specification only describes SEQ ID NO: 1 as the sequence comprising a specific mutation in the gene encoding putative proton symporter protein 3, and does not describe any other nucleotide sequences having an insertion-deletion mutation in other positions that would fall within the “about the 730 nucleotide position and at about the 1070 nucleotide position”. It is not clear if there could be additional mutations in other positions other than what is provided for by SEQ ID NO: 1 and still have the recited functions (having improved productivity and improved photosynthetic efficiency, and being resistant to a salicylanilide based drug).
Therefore, only SEQ ID NO: 1 representing the mutation in a gene encoding putative proton symporter protein 3, SEQ ID NO: 3 representing the mutation in a gene encoding putative cytochrome P450 protein 4, SEQ ID NO: 5 representing the mutation in a gene encoding putative aquaporin protein 1, and SEQ ID NO: 7 representing the mutation in a gene encoding putative aquaporin protein 2, but not the full breadth of the claim(s) meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Response to Arguments
Applicant's arguments and amendments, filed 06/05/2026 have been fully considered but they are not persuasive.
Applicant states on page 9 of response that claim 1 has been amended to recite Picochlorum spp. as the algae, define the salicylanilide based drug as being selected from the group consisting of niclosamide, oxyclozanide, rafoxanide and closantel, and define the mutations and genes comprising the mutations in the claimed mutant algae as now recited in claim 1 and therefore believes the amendments carried out now are in line with the description.
While the amendments to the claims greatly help narrow the species, and limiting to Picochlorum spp. as the algae, and defining the salicylanilide based drug as being selected from the group consisting of niclosamide, oxyclozanide, rafoxanide and closantel has brought those components in line with what there is written support for, the Written Description rejection stated that regarding the nucleotide sequences that had support in the specification for the specific mutations in each gene was SEQ ID NOs: 1,3,5 and 7 respectively. Since the claims recite that the mutant algae “comprises at least one selected from”, the mutant algae may contain other mutations, and may contain one or more of the recited mutations listed. Each of (a),(b),(c) and (d) also describe each mutation using language that recites “about” pertaining to nucleotide positions and the length of insertions. However, the specification only shows the complete structure of SEQ ID NO: 1 as pertaining to the mutation in a gene encoding putative proton symporter protein 3, SEQ ID NO: 3 representing the mutation in a gene encoding putative cytochrome P450 protein 4, SEQ ID NO: 5 representing the mutation in a gene encoding putative aquaporin protein 1, and SEQ ID NO: 7 representing the mutation in a gene encoding putative aquaporin protein 2. No other nucleotide sequences showing mutations encompassed by the claims are shown, and therefore for these reasons pertaining to the genus of the recited mutations, the written description rejection is maintained for claims 1,9-11,13 and 14.
Conclusion
Claims 1,9-11,13 and 14 are rejected.
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 STEPHANIE L SULLIVAN whose telephone number is (703)756-4671. The examiner can normally be reached Monday-Friday, 7:30-3:30 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, Ram R Shukla can be reached at 571-272-0735. 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.
/STEPHANIE L SULLIVAN/Examiner, Art Unit 1635
/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
Prosecution Insights