DETAILED ACTIONS
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 .
Claims Status
Claims 1-2, 4-6, 11-12, and 14-17 are pending and examined herein.
Claims 3, 7-10, 13, and 18-29 are canceled.
Priority
As detailed on the 11 June 2021 filing receipt, the application claims priority as early as 20 June 2018. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-2, 4-6, 11-12, and 14-17 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 recites “vaccinating at least one individual with the vaccine that includes the selected one or more amino acid sequences.” The specification discloses the “g-measure” for “(1) predicting epidemiology; (2) selecting component amino acids for the next flu vaccine based on effective mutations and EMPs; (3) evaluating a currently available flu vaccine strain based on comparing currently effective mutations to the vaccine strain” (pg. 8, paragraph [28]) and “antigen design” (pg. 10, paragraph [35]). The 17 January 2025 remarks points to the specification disclosing “preparing for a predicted increase in flu infections (including issuing public health advisories, producing additional medications used to treat flu patients, etc.); selecting flu strains (wild-type or genetically engineered sequences) to include in a flu vaccine; and/or assessing likely effectiveness of currently available flu vaccines” (pg. 14, paragraph [52]). These steps are all interpreted as being directed to design of a vaccine and evaluation of a vaccine design. Synthesis, generation, production, or administration of a vaccine based on the sequence(s) determined by the method is not disclosed in the specification. Therefore, the “vaccinating” step lacks written description support in the specification. Claims 2, 4-6, 11-12, and 14-17 are similarly rejected as they are dependent on claim 1.
Response to the 25 September 2025 Applicant Remarks
Applicant remarks assert that the inventors were in the possession of the idea of producing and administering a vaccine. Applicant notes the disclosure includes “production and distribution” of a vaccine in the background of the specification and that the prediction may be used for “aiding selection of viral strains for vaccine production” (pg. 1, paragraph [7]). Applicant asserts “the specification shows that the inventors had possession of the idea of including the predicted strain(s) in a vaccine that would be produced and distributed (including vaccinating individuals) in the same manner as existing vaccines (remarks: pg. 8, penultimate paragraph). This argument is not persuasive because while the background of vaccine production implies a vaccine will be produced and used on patients, the specific vaccine generated by the claimed steps is for “making predictions” including “aiding selection,” “providing real-time information,” and “forecasting virus activity” (remarks: pg. 8, penultimate paragraph). These are all interpreted as generation of data based on the claimed steps. Producing and/or administering a vaccine based on the claimed steps is not supported by the generation of predictions, aiding of selections, providing information, or forecasting activity. Therefore, the “vaccinating” step lacks written description support in the specification. Claims 2, 4-6, 11-12, and 14-17 are similarly rejected as they are dependent on claim 1.
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.
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/R.J.K./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685