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 14 has been canceled. Claims 1-13, 15-21 are still at issue and are present for examination.
Applicants' arguments filed on 7/24/26, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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, 4-13, 15-21 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. Claim 1 (and its dependent claims 4-13, 15-21) is directed to a genus of genetically modified Hydrogenovibrio bacteria family, kits comprising it and a method of use thereof, wherein said genus of modified bacteria is inadequately described in the disclosure.
The disclosure fails to teach which members of the genus of Hydrogenovibrio are likely to be genetically modified to produce one or more heterologous [proteins as recited in claim 1. Further, no information about how similar the growth and transformation/transfection conditions (such as temperature, salinity, pressure, etc.) of each member of said Hydrogenovibrio genus members are. Further, regarding a method of use of said genus, the specification merely describes culturing conditions for H. Marinus and no information about culturing conditions applicable for fermentation of other members of the genus Hydrogenovibrio is provided.
Given the fact that the Hydrogenovibrio genus has members such as Hydrogenovibrio crunogenus, Hydrogenovibrio halophilus , Hydrogenovibrio kuenenii and Hydrogenovibrio thermophilus etc., some more information as to which specific transformation/transfection conditions are most appropriate for each species to ensure successful expression of heterologous proteins and which fermentation conditions to utilize to ensure proper cell growth, such as temperature, pressure, stirring rate, etc. deems necessary that is currently lacking in the disclosure. All applicant provides is information about genetic modification and growth of Hydrogenovibrio marinus (H. marinus), a single species, which is totally inadequate to fully describe the genus of products claimed (see claims 1, 4-13, 15) and methods of use thereof (see claims 16-21).
Further, applicant himself/herself in his/her response, page 8, admits that applicant’s new method which includes electroporation of H. marinus in the presence of ecotine is the first time that successful transformation of such species has been reported and said response is merely restricted to transformation of H. marinus.
Therefore, based on the information provided, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the effective filing of this application.
Since the genus of genetically modified Hydrogenovibrio bacteria is inadequately described (see claims 4-9), kits comprising said product (claim 15), methods of use of said product (claims 10-13) and methods of preparing said generic product (claims 16-21) are also inadequately described.
Allowable Subject Matter
Claims 2-3 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. This is because a genetically modified H. marinus capable of producing one or more heterologous proteins is free of prior art. Further, the prior art fails to suggest such specifically claimed product.
Conclusion
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 MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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