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 .
Summary
Claims 52-71 are pending in this office action. All pending claims are under examination in this application.
Priority
The current application filed on March 22, 2023 is a continuation of 15/937,619, filed Marcy 27, 2018 which is a divisional of 14/649,973, filed June 5, 2015 which is a 371 of PCT/US2013/073582, filed December 6, 2013, which in turn claims domestic priority to a provisional patent application 61/734,472, filed on December 7, 2012.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on December 19, 2022 is acknowledged. A signed copy of 1449 is attached to this office action.
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 62-64 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 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 claims are drawn to a genus of host cells that comprise one or more genetic modifications that enhance the ability of the methylotrophic host cell to grow on an electrolytically generated C1 compound relative to a corresponding methylotrophic host cell lacking the one or more genetic modifications.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, and any combination thereof. In this case, none of these factors are present, just the function of enhancing the ability to grow on a C1 compound. The specification does not identify any specific genetic modifications that would impart the claimed property. Such modifications are discussed at paragraphs [00197]-[00200]. Those paragraphs discuss what kind of genetic modifications might enhance the ability of the methylotrophic host cell to grow on an electrolytically generated C1 compound but there are no specific genetic modifications disclosed. This amounts to an explanation of how to go about experimenting to find out what such modifications might be but none of them have been reduced to practice and applicant clearly does not have possession of such modified host cells.
Accordingly, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states, “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 it 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), As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, 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) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’ s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Therefore, only amino acid designated by SEQ ID NO: 2, but not the full breadth of the claim meets the written description provision of 35 U. S.C. 112, first paragraph. Applicant is reminded that Vas-cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision.
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.
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.
Claims 52, 55 , 57, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Pyle et al.
Pyle et al. US 20090087890 A1 2009-04-02 teach host cells comprising E-alpha-bisabolene synthase, AAS47689, see Table I, paragraph 120. The sequence is presumed to be the same as SEQ ID No. 4 since it is the same protein as claimed.
This teaching does not constitute anticipation because there is nothing specifically directing one of ordinary skill in the art to select this specific example of a host cell, however, it would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to select said host cell with the expectation of being able to use it to make E-alpha-bisabolene.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Pyle et al. in view of Knoll et al., Journal of Biotechnology 132 (2007) 167–179.
The teachings of Pyle et al. are outlined above.
Knoll et al. teach the importance of high cell density for fermentation processes.
It would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to run the fermentation of Pyle et al. in a high-cell-density bioreactor in order to achieve the excellent results taught by Knoll.et al.
Claims 52 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Gokarn et al. 8076120 which teaches host cells comprising seq id no 129 which encodes a protein that is 99.8% identical to seq id no 5, see attached sequence search result.
This teaching does not constitute anticipation because there is nothing specifically directing one of ordinary skill in the art to select this specific example of a host cell, however, it would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to select said host cell with the expectation of being able to use it to make 3-hydroxy propionyl-CoA.
Claims 52 and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Pyle et al. in view of Sharpe et al.
The teachings of Pyle et al. are outlined above.
Sharpe et al. teach methylotrophs that can be modified; they specifically use paracoccus as the host cell, see claim 23.
It would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to select paracoccus as the host cell to modify in accordance with the teachings of Pyle et al. with the expectation of being able to use it to make E-alpha-bisabolene. Such expectation is reasonable since paracoccus is itself methylotrophic.
Allowable Subject Matter
Claims 53, 54, 65 and 68-71 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No prior art was found that teaches seq ids 1 or 3 or host cells containing said sequences. Therefore, these claims are allowable over the prior art.
Conclusion
No claim is allowed.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615