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 .
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 1-9 and 11-16 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 expressing polypeptide comprising instant SEQ ID NO: 1 in Chlamydomonas reinhardtii, does not reasonably provide enablement for expressing the polypeptide in any other organism. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to methods for improving the resistance to oxidative stress and/or photoinhibition of host organisms or for improving biomass productivity of host organisms and/or prevailing over other competing organisms, wherein the host organism expresses a polypeptide comprising SEQ ID NO: 1, or a nucleic acid encoding for the polypeptide comprising SEQ ID NO: 1, or an expression vector comprising a nucleic acid encoding for the polypeptide comprising SEQ ID NO:1.
Instant claims encompass expression of the polypeptide of SEQ ID NO: 1 in a variety of organisms.
Instant specification teaches that astaxanthin can be produced in a number of organisms such as bacteria, yeast and high plants by expression of ketolases (see paragraph [0023]), but preferably should be expressed in unicellular photosynthetic organism, most preferably in Chlamydomonas reinhardtii (see paragraph [0041]). Working example demonstrates expression in only one organism, Chlamydomonas reinhardtii (see paragraph [0057]).
There is no evidence in prior art that ketolases can be expressed in any possible organism.
The guidance provided in the specification is limited to expression of ketolases in only limited number of organisms.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to express ketolase in any possible organism as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
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 4 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 4 recites polypeptide comprising SEQ ID NO: 5. SEQ ID NO: 5 is a nucleic acid and not a polypeptide.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perozeni et al (Plant Biology Journal, 25 February 2020, 18: 2053-2067, cited from IDS) and in further view of GenBank (AYH63702.1, 2018, cited from IDS).
Perozeni teach methods of expressing beta-carotene ketolase in Chlamydomonas reinhardtii (see Abstract), such expression is carried out using pOpt2_mVenus_Paro vector (see page 2056, Figure 2). Expression can be carried out in very high light conditions as in claims 11-13 in the presence of 3% CO2 (see Figure 5). Additional enzyme, canthaxanthin, can be used in the method (see first column on page 2054). Further Perezoni teach beta-carotene ketolase polypeptide from Chlamydomonas reinhardtii (see Figure 1C) and optimization of the gene encoding such polypeptide such as omission of 166 amino acids at the C-terminus and fusion to YFP (see pages 2056-2057).
Perezoni do not teach peptides of instant SEQ ID NOs: 1-2 or nucleic acid of SEQ ID NO: 5.
GenBank AYH63702.1 teach a beta-carotene ketolase polypeptide sequence (see page 1), which is 99% identical to instant SEQ ID NO: 1.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to derive polypeptides of SEQ ID NOs: 1-2 and nucleic acid of SEQ ID NO: 5 based on teachings of Perezoni and GenBank AYH63702.1. One of the ordinary skill in the art would be motivated to do so, because Perezoni teach modifications to optimize beta-carotene ketolase polypeptide, which can be introduced into GenBank AYH63702.1 sequence, arriving at instant SEQ ID NOs: 1-2 and 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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, Jennifer Dunston can be reached at (571)272-2916. 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.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
Prosecution Insights