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 .
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Claims 4, 6-8, and 17 have been withdrawn as being directed to a non-elected species.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 are under examination at this time.
Withdrawn Rejections
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Aakvik et al. (WO 2007/141540; published December 13, 2007; cited by applicant) has been withdrawn in view of the cancelation of claim 19.
The rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Aakvik et al. (WO 2007/141540; published December 13, 2007; cited by applicant) and further in view of Quiles-Puchalt et al. (PNAS, 2014, 111(16):6016-6021) has been withdrawn in view of the cancelation of claim 20.
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 legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of 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 that express the capsid or coat proteins of a first bacterial virus particle and of a second bacterial virus particle,
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.
State of the prior art. At the time the invention was made, it was known that bacteriophages target host bacteria by using specific tail fibers to recognize and bind to unique chemical receptor molecules on the outer surface of the bacterial cell (see Stone et al., Viruses, 2019 Jun 18,11(6):567).
Guidance in the specification. The specification defines bacterial delivery vehicles i) as bacterial viruses (paragraph [0017]), and ii) as capable of targeting two different bacteria or the same bacteria to introduce the payload into the bacteria (paragraphs [0018] and [0019]).
Working examples. The examples use 3 different E. coli production strains.
CY2120b is an engineered Escherichia coli strain that carries a modified lambda (λ) bacteriophage prophage, making it a lambda lysogen1.
C600(186)Δcos is an engineered lysogenic strain of Escherichia coli C600 harboring a prophage of coliphage 186 that has been modified to remove or mutate its wild-type cos site.
KL739 is an E. coli strain that functions as a P1 lysogen.
A lysogen is a bacterial cell that carries the dormant bacteriophage genome (called a prophage) integrated into its own chromosome or existing as a plasmid (see, for example, Howard-Varona et al., The ISME Journal, 2017, 11:1511–1520). Thus, each of the three lysogens used in the examples contained a bacteriophage genome, which, when induced, will produce a functional bacteriophage.
Amount of experimentation. 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 linked to a promoter, and ii) at least two packaging sites into a production bacteria that express the capsid or coat proteins of a first bacterial virus particle and of a second bacterial virus particle.
Without additional components, such as tail fibers, which target and bind the bacteriophage to its host, and other components encoded by the bacteriophage genome that are needed to produce a complete and functioning bacteriophage, one of ordinary skill in the art cannot make and/or use the claimed invention. Further, it is not clear how bacteriophage capsid proteins alone can target and bind to bacterial host cells for delivery of the cargo.
Given the state of the art and the lack of guidance in the specification, it would require undue experimentation for one skilled in the art to use the claimed composition and method.
Response to Arguments
In the reply dated 7/10/2026, applicant first argues that the claims have been amended to recite that the production bacteria express the capsid or coat proteins of the bacteriophages. Applicant’s arguments have been fully considered and not found persuasive for the reasons above.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 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.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
1 A lysogen is a bacterial cell that carries the dormant DNA of a virus (called a prophage) integrated into its own chromosome or existing as a plasmid.
