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 .
DETAILED ACTION
1. Claims 1, 5 are amended. New claims 11-15 are added. Claim 10 is withdrawn. Claims 1, 5, 9, 11-15 are under consideration.
Priority
2. The submission of the certified English translations of the priority documents is noted.
Claim Objections
3. (previous objection, withdrawn) Claims 1, 8 were objected to because of informalities
Applicant contends: claim 1 has been amended; claim 8 is canceled.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. (new, necessitated by amendment) Claims 1, 5, 9, 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1, 5, 9, 11-15 as submitted 7/25/2025.
Claim 1 recites “the promoter”. It is not clear which promoter is being referred to, as claim 1 previously recites a Rous Sarcoma Virus promoter and “at least one promoter operably linked…”, reading on at least two promoters.
Claim Rejections - 35 USC § 103
5. (previous rejection, withdrawn) Claims 1-9 were rejected under 35 U.S.C. 103 as being unpatentable over Ennist et al. (US20050186178)(cited in applicant’s IDS submitted 1/5/2024) in view of Kamizono et al. (U.S. Patent No. 8142770)(cited in applicant’s IDS submitted 1/5/2024) and Flotte et al. (US20080003204; previously cited).
Applicant contends: a prima facie case of obviousness has not been established; the combination could not lead to the recited oncolytic virus; Kamizono et al. and Flotte et al. both to not disclose an operable linkage between any promoter and any immunity-inducing gene; none of Ennist et al., Kamizono et al. or Flotte et al. disclose an RSV promoter driving expression of a non-viral immunity-inducing gene for use in oncolytic virotherapy; a key feature of Ennist et al. is the use of E2F promoter linked to E1A gene; one of skill in the art would have to replace the E2F promoter of Ennist et al. with the survivin promoter of Kamizono et al.; there cannot be a motivation to combine Ennist et al. and Kamizono et al.; replacing this key feature of Ennist et al. would render the invention of Ennist et al. unsuited for its purpose; one of ordinary skill in the art would expect different promoters to have different strengths; Ennist et al. clearly emphasizes the strength of the E2F promoter; Flotte et al. does not disclose the operable linkage of any promoter with the E1A gene; Flotte et al. teaches away from use of RSV promoter; Flotte et al. is directed to non-proliferative vectors; the claims are directed to results of a surprisingly superior nature; inventors retained survivin promoter to maximize oncolytic effect; neither Ennist et al., Kamizono et al. nor Flotte et al. describe the problem caused by excess production by oncolytic virus; inventors discovered problem of excess amount of the immunity-inducing factor and solved it with combination of three elements, survivin promoter, RSV promoter, GM-CSF; Example 5 shows that adenovirus comprising survivin promoter linked to E1A and RSV promoter drops viability of cancer cells to less than 20%; Example 6 shows synergistic effect between the survivin promoter and RSV promoter.
Upon further consideration, applicant’s arguments are considered and the rejection is withdrawn.
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.
6. (previous rejection, maintained; withdrawn as to canceled claims 2-4, 6-8; new, necessitated by amendment as to claims 11-15) Claims 1, 5, 9, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Arima et al. (WO2011118819; previously cited)(See also the attached English translation of WO201118819; previously cited)) in view of Flotte et al. (US20080003204)(cited above).
See claims 1, 5, 9, 11-15 as submitted 7/25/2025.
Applicant contends: Arima et al. and Flotte et al. do not disclose operable linkage between any promoter and any immunity-inducing gene, let alone RSV promoter linked to GM-CSF; neither Arima et al. nor Flotte et al. describe the problem caused by excess production of immunity inducing factors; a skilled person could not have arrived at the present invention and the claimed invention produces a surprisingly superior result.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
It is reiterated that Arima et al. teaches: wherein the therapeutic gene can be placed under the control of “any” promoter (p. 3). Further, as to claims 11-15, Arima et al. already teaches: adenovirus vector (p. 4)(as recited in claims 11, 15); additionally CMV E1B gene (p. 4)(as recited in claims 12, 15); as well as E1B lacking 19Kda region (E1Bdelta19)(p. 4)(as recited in claims 13, 14, 15); vector with E1A gene linked to survivin; linked E1B gene, reporter gene linked to promoter (CMV)(p. 4); promoter controlling E1A (survivin promoter) and the E1B gene, but the expression of the E1A gene and E1B is controlled (p. 4)(interpreted as reading upon wherein CMV promoter and E1B are downstream as recited in claim 15).
Response to Arguments
Turning to applicant’s arguments, first, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is reiterated that Arima et al. teaches: wherein the therapeutic gene can be placed under the control of “any” promoter (p. 3); as well as therapeutic gene such as GM-CSF (p. 3).
In response to applicant's argument that neither Arima et al. nor Flotte et al. describe the problem caused by excess production of immunity inducing factors, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Further, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is maintained and extended for reasons of record.
Conclusion
7. No claims are allowed.
8. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671
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