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 .
Election/Restrictions
Applicant’s election of the following species: (A) the species of claims 3 and 5, (B) λ cos and P1 pac, (C) a reporter gene (e.g., antibiotic resistance gene), and (D) two different bacteria of claim 16 in the reply filed on 2/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of the Claims
Claims 4, 6-8, and 17 have been withdrawn as being directed to a non-elected species. Claims 1-3, 5, 9-16 and 18-20 are under examination at this time.
Specification
Applicant should update the first paragraph of the specification to provide the correct status of application numbers 17/406437 and 16/444576 (i.e., patented).
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see, for example, page 38). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claims 9 and 20 are objected to because of the following informalities: Claim 9 should recite “further comprising a step”. Claim 20 should recite “and/or helper phage” instead of “and/or phage helper phage”. 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.
Claims 1-3, 5, 9-16 and 18 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant claims are directed to a method for preparing a population of at least two different bacterial delivery vehicles containing the same payload, comprising introducing a payload into production bacteria, wherein said payload comprises:
(i) a nucleic acid sequence of interest under the control of a promoter; and
(ii) at least two orthogonal bacterial virus packaging sites that allow packaging of said payload into said at least two different bacterial delivery vehicles.
The claimed method is for preparing a population of at least two different bacterial delivery vehicles (e.g., bacteriophages). However, it is not clear how the bacterial delivery vehicles are prepared solely from introducing i) a nucleic acid sequence of interest, and ii) at least two packaging sites into a production bacteria.
Without additional components (e.g., capsid or coat proteins and other components to produce a bacterial delivery vehicle or bacteriophage), one of ordinary skill in the art cannot make and/or use the claimed invention.
Claim Rejections - 35 USC § 103
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 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 19 is rejected under 35 U.S.C. 103 as being unpatentable over Aakvik et al. (WO 2007/141540; published December 13, 2007; cited by applicant).
The claims are directed to kit comprising:
-a payload comprising:
(i) a nucleic acid sequence of interest under the control of a promoter; and
(ii) at least two orthogonal bacterial virus packaging sites that allow packaging of said payload into said at least two different bacterial delivery vehicles; and .
-production bacterial cells suitable for packaged payload production.
Aakvik et al. teaches that combined fosmid and BAC vectors are a preferred feature of the present invention. Thus, the vector of the invention is preferably a BAC vector containing or comprising a cos site. Such a vector may be used for both BAC cloning of larger or very large inserts and for cosmid cloning of smaller inserts of 30-40kb (see page 12, lines 1-4).
The BAC vector can comprise a P1 packaging (pac) site. See page 8, lines 1-12) where Aakvik et al. describes a BAC system based on P1 artificial chromosome (PAC), which is a sub-set of BACs. Aakvik et al. also teaches that the vector can comprise a gene of interest (an insert) under the control of a promoter (see page 12, lines 20-27 and page 15, lines 8-15).
Aakvik et al. also teaches that the vectors can be introduced into a desired bacterial host cell, e.g., by transformation (see page 16, lines 24-28).
Aakvik et al. does not teach a kit comprising the BAC vectors and a bacterial host cell. However, the concept of packaging components into a kit is well known and routine in the art.
Further, it would have been obvious to one of ordinary skill in the art at the time the invention was made to package components into a kit. One would be motivated to do this for commercial exploitation of the invention by providing convenience for the end user. Thus, the claimed invention is obvious over Aakvik et al.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Aakvik et al. (WO 2007/141540; published December 13, 2007; cited by applicant) as applied to claim 19 above and further in view of Quiles-Puchalt et al. (PNAS, 2014, 111(16):6016-6021).
The instant claims are directed to the kit of claim 19 further comprising a satellite phage and/or a helper phage to promote packaging of the payload.
The teachings of Aakvik et al. are outline above and incorporated herein. Aakvik et al. does not teach a satellite or helper phage. However, Quiles-Puchalt et al. teaches the use of pac-type helper phages or cos-type helper phages that package DNA into bacteriophages.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the kit a helper phage to promote packaging of the sequence of interest. One would have been motivated to do so and there would have been a reasonable expectation of success given the teachings of Quiles-Puchalt et al. regarding the use of helper phages and given the state of the art regarding packaging of DNA in phages using cos and pac sites.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached on M to Th 6:30 am to 6:00 pm.
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, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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