DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendments filed on May 5, 2026 and June 3, 2024, have been received and entered.
3. Applicant's election without traverse of Group I (claims 1-7), on May 5, 2026, is acknowledged.
Claim Disposition
4. Claims 1-21 are pending. Claims 1-7 are under examination. Claim 8-21 are withdrawn as directed to a non-elected invention, further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Drawings
5. The drawings filed on February 1, 2024, are accepted by the examiner.
Information Disclosure Statement
6. To date no Information Disclosure Statement has been filed. Applicant is reminded of the duty to disclose.
Specification Objection
7. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "A method for increasing lipid production of Cyanobacteria with Antibiotics".
Appropriate correction required.
Claim Objection
8. Claims 1-7 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “……production of Cyanobacteria, comprising:
growing cultures of the Cyanobacteria……..”. The dependent claims hereto are also included.
Claims 2 and 3 are objected to because the organism names are not italicized, and the organism name is not spelled out.
For clarity it is suggested that claims 3-7 are amended to recite “of” in lieu of “according to”.
For clarity it is suggested that claim 7 is amended to delete “includes” and instead recite “wherein the lipid production further comprises production of one or more unsaturated fatty acids, polyunsaturated fatty acids and monounsaturated”.
Appropriate correction is required.
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.
9. Claims 1-7 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) contain 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 claimed invention is directed to a method for increasing lipid production of Cyanobacteria comprising growing cultures of the cyanobacteria in presence of non-lethal levels of antibiotics. The claimed invention is directed to a large variable genus of any antibiotics, any cyanobacteria and any level the could be potentially non-lethal. The claimed invention is not adequately described because there are no indicia as to what levels are considered non-lethal or optimal antibiotic concentration with any antibiotic and microorganism in the large genus of cyanobacteria. The art generally recognizes that morphology of the cyanobacteria affects resistance to antibiotics. This means that not all antibiotics are effective in having an effect on all cyanobacteria. In addition, the invention encompasses any fatty acids production to be included. The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states 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). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of structures, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the genes, proteins and virus.
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.
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.
10. Claims 1-7 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.
Claim 1 and the dependent claims hereto are indefinite for the recitation of “non-lethal levels” without informing the ordinary skilled worker what level is ideal or regarded as non-lethal and that works with the method to produce the result of ‘increasing lipid production’ and in what specific organism in the large genus of Cyanobacteria, especially in view of well-established art that determined that excreted antibiotics from human and animal is detrimental to bacteria.
Claim 6 is indefinite for the recitation of “optimal antibiotic concentration’ and no parameters are provided. Claim 1 from which it depends requires a non-lethal level which is not provided, thus unclear what is construed as optimal and claim 1 does not require lactate dehydrogenase activity.
Basis For NonStatutory Double Patenting
11. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
12. Claims 1-7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7 and 9-10 of U.S. Application No. 18/592,932. An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The instant application claims are directed to a method for increasing lipid production of cyanobacteria comprising growing cultures of said cyanobacteria in the presence of non-lethal levels of antibiotics. The copending application claims are drawn to a method for increasing pigmentation and/or bioproduct in cyanobacteria comprising growing cultures of said cyanobacteria in the presence of non-lethal levels of antibiotics (dependent claims and the specification define bioproduct as lipid production). The two sets of claims differ because the copending claims recite ‘pigmentation”, however, the copending application recites the same product ‘lipid’ and is written in the alternative. Note that claim 1 of the instant claims is a genus over the species disclosed in claim 1 of the copending application. The depending claims align with each other since they recite similar embodiments.
Although the scope of the two sets of claims differs, the two sets of claims are an obvious variation of each other, thus prima facie obvious. This is a provisional obvious type double patenting rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
13. Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (Environmental Pollution, October 20, 2022 (received), January 31, 2023 (available online), 322, 121171, pages 1-9).
The claimed invention is directed to a method for increasing lipid production of Cyanoabacteria in the presence of non-lethal levels of antibiotics.
Fang et al. disclose in Cyanobacteria, each antibiotic induced hormetic responses, such as increase in cell density, dry cell weight, and photosynthetic activity; upregulation of photosynthesis-related proteins; and elevation of lipid expression by up to 2.05-fold. Under antibiotic stress, the two cyanobacterial species preferred to store energy in the form of lipids rather than ATP, with fructose- bisphosphate aldolase playing an essential role in lipid synthesis. The downregulation of lipid transporters also facilitated lipid accumulation in Synechococcus sp. In general, the two non-toxic cyanobacterial species achieved a good combination of lipid deposition and antibiotic treatment performance, especially in Chroococcus sp. exposed to sulfamethoxazole (see abstract and page 1). Therefore, the limitations of the claim is met by the reference.
Conclusion
14. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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