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 .
Applicant’s reply and amendments to the claims have ameliorated the objections to the specification and the rejection under 35 USC 112(b).
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.
Claims 1-7 and 9-11 remain rejected under 35 U.S.C. 103 as being unpatentable over Lanthier et al. (Vaccine. 2011; 29 (44): 7849-7856), Chen (CN 111671891), English translation provided, and Musana et al. (Clinical Medicine and Research. 2004; 2 (4): 256-259).
In reply to the rejection of record, applicant points to Example 1 of Chen, stating that the mice were administered the live influenza virus intranasally or intramuscularly while the oseltamivir was administered orally, and achieved only partial protection.
Applicant’s arguments and a review of Example 1 of Chen have been fully considered, but are found unpersuasive. In the seventh section under “Disclosure of the invention”, Chen teaches (underlining for convenience):
…And fifthly, the split-packaged live vaccine and the split-packaged antiviral drug are combined and packaged to form the live vaccine, a part of samples are randomly extracted, and the content, safety and effectiveness of the live virus are verified. In the above step, the antiviral agent may be mixed with the virus to be propagated or may not be mixed. In the case of mixing an antiviral drug with a live virus, the antiviral drug may be mixed with the proliferated virus first and then purified, or the virus may be purified first and then mixed with the “proliferated virus” [sic].
(In the last sentence, it is presumed that the "neuraminidase inhibitor" is mixed instead of the "proliferated virus", since a purified virus would not then be mixed with a proliferated virus and mixing the proliferated virus with a neuraminidase inhibitor is consistent with the rest of Chen’s disclosure.)
While mixing the virus with the neuraminidase inhibitor in vitro is not discussed in Example 1, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). .). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123.
In the quoted excerpts under “Disclosure of Invention”, Chen teaches a neuraminidase inhibitor is mixed with the virus prior to or after virus purification, as required by the instant claims.
Applicant asserts that page 6 of the non-final rejection cites Example 1 of Chen as teaching a reduction in mortality from 70% to 30%, alleging that Chen combined the live virus with the neuraminidase inhibitor, which is not supported by Example 1.
Example 1 and applicant’s arguments have been fully considered, but are found unpersuasive. Example 1 of Chen clearly shows evidence of protective efficacy, i.e., reasonable expectation of success to the ordinary artisan, when the administered influenza and neuraminidase inhibitor are administered simultaneously.
Applicant correctly points out that RK-33 is not a neuraminidase inhibitor. It should also be pointed out that RK-33 is outside the scope of the instant claims because Chen identifies RK-33 as a nucleotide mimetic compound in the sixth paragraph under “Disclosure of Invention”.
Applicant argues Chen could not bind Tamiflu to a live virus in vitro because oseltamivir would not bind to a live virus as a prodrug. Applicant states oseltamivir has to be metabolized to its active form in vivo after oral ingestion and before the active form can bind to neuraminidase.
Applicant’s arguments have been fully considered. Instant claim 1, lines 4-5 recite:
“binding a live influenza virus with a viral neuraminidase inhibitor in vitro to form the active agent”
Claim 5 (depending from claim 1) recites: “wherein the neuraminidase inhibitor is… “oseltamivir carboxylate…”.
Therefore, the claims recite and require binding an influenza virus and oseltamivir carboxylate in vitro. Is applicant implying that this claimed embodiment is not enabled? Despite applicant’s implication, it is presumed that the ordinary artisan would know how to activate oseltamivir carboxylate in vitro, as taught by Chen in the seventh section under “Disclosure of the invention”, (underlining for convenience):
…And fifthly, the split-packaged live vaccine and the split-packaged antiviral drug are combined and packaged to form the live vaccine, a part of samples are randomly extracted, and the content, safety and effectiveness of the live virus are verified. In the above step, the antiviral agent may be mixed with the virus to be propagated or may not be mixed. In the case of mixing an antiviral drug with a live virus, the antiviral drug may be mixed with the proliferated virus first and then purified, or the virus may be purified first and then mixed with the “proliferated virus” [sic].
Applicant argues that Chen is only directed to adapted immunity in contrast to the instant invention, which induces trained and adaptive immunity.
Applicant’s arguments have been fully considered, but are found unpersuasive because Lanthier et al. teach potentiating mutation-agnostic innate and adaptive immune responses in subjects administered a live, attenuated influenza vaccine, generating an immune response following subsequent heterosubtypic influenza virus challenge. See the abstract, the paragraph above section 2; sections 3.2, 3.3; and the last three paragraphs on page 6. Therefore, the live, attenuated influenza vaccine of Lanthier et al. combined with a neuraminidase inhibitor, as taught by Chen, would have weakened the pathogenic capacity of the live virus vaccine in populations at high risk for complications from influenza, see pages 256-257 and Table 1 of Musana et al. and induced trained and adaptive immunity, as taught by Lanthier et al. and Chen.
Claims 8 and 14 remain rejected under 35 U.S.C. 103 as being unpatentable over Lanthier et al., Chen, and Musana et al. as applied to claims 1-7 and 9-11 above, and further in view of Music et al. (PLoS One. 2014; 9 (6): e100926) for reasons of record.
Applicant argues that Music et al. does not cure the deficiencies of Lanthier et al., Chen, and Musana et al. However, there are no deficiencies for Music et al. to cure and the rejection is maintained for reasons of record.
Conclusion
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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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