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 Amendment filed on October 30, 2025, has been received and entered.
Claim Disposition
3. Claims 2-6, 10-12 and 16 have been cancelled. Claims 21-26 have been added. Claims 1, 7-9, 13-15 and 17-26 are pending. Claims 1-2, 7-9, 13-15 and 17-20 are under examination.
Claim objection
4. Claims 1-2, 7-9, 13-15 and 17-26 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “…and/or [[and or]]……”.The dependent claims hereto are also included.
For clarity it is suggested that claim 21-26 are amended to add a comma (,) after the claim number and before the ‘wherein clause”, see claim 21 (C. necator, wherein) and claim 22 (…of claim 21, wherein…), for example.
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.
5. Claims 1-2, 7-9, 13-15 and 17-26 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 strain of Cupriavidus necator comprising a transgene encoding a heterologous desaturase enzyme, wherein the heterologous desaturase enzyme is selected from a group provided in claim 1… and synthesizes at least one unsaturated C18 fatty acid (provided in a Markush), however, no structure function correlation was made. The claimed invention is not adequately described because no correlation is made between structure and function for the foreign gene and its expression products. It is well established in the art that several different genes can encode the same protein and the claimed invention encompasses a large variable genus of foreign transgenes that could encode the heterologous enzymes. The claims are also directed to optimization of the transgene, thus the ordinary skilled worker needs to have a glimpse of the structure that is optimized and for applicant demonstrate possession. The claims also encompasses modified strains of the organism that can include adaptive laboratory evolution or genetic modification, neither of which is described.
There are no indicia in the claimed limitations regarding the structure of the heterologous genes. The invention recites that the genes are from a cyanobacteria or a eukaryote which is extremely broad and has a large variable genus not adequately described. It is noted that new claim 21 recites that the strain produces an unsaturated fatty acid that is not natively produced in the C. necator, thus should be adequately described. Further, the gene is recited as codon optimized but not identified. The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. The claimed invention is recited as optionally having adaptive laboratory evolution or genetic modifications which are also not identified or described adequately. The claimed invention requires any of the list of enzymes with no origin or structure, however, claim 1 is not limited by these. There is no structure-function correlation provided for the second transgene that is also heterologous and the third one (see claims 19-20 for example). The claimed invention is overly broad and encompasses large variable genus of genes, enzymes, desaturases and modifications. 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 fusion protein that encompasses mutants and fragments with no asserted activity.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objection/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 112 (first paragraph) remains and has been amended to reflect changes made to the claims. Applicant traverses the rejection stating that claim 1 has been amended and also assert that specific heterologous desaturase enzymes are claimed. This argument is not persuasive because the claims are overly broad, no structure function correlation is made. The claimed invention remains directed to a large variable genus of transgene, thus maintained.
Conclusion
7. No claims are presently allowable.
8. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
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.
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, Robert Mondesi can be reached on (408) 918-7584. 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.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652