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 .
Remark
The response and amendment was filed on 12/17/2025. Claims 2-4 and 12 were canceled. Claims 1, 5-7 and 9-11 are pending and considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 5-7, 9 and 11 are still rejected under 35 U.S.C. 102((a) (1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2015031166A1 to Jesse D. Bloom and further in view of the Martin et al. (Virology 1998, Vol. 241 pages 101-111) for claim 10.
In the instant case, Applicants argued that the claimed invention is directed to mutations are presented at position 98, 153 and 183 referenced to SEQID NO: 7, whereas the ground of the rejected is based on only one position that matches to one of the mutation cited in the rejected claims.
Applicants’ argument has been respectfully considered; however, it is not found persuasive because what Applicants argued is not what is cited in the claims. The claimed subject matter is still read on one residue mutation at position 98, 153 and 183. Therefore,
The novelty is the amino acid residues at positions 98, 153 and 183 are all mutated, rather than one or two mutation Because Jesse D. Bloom teaches in several places regarding to make a mutation on sialic-acid receptor binding site as it was described in the previous office action: Example 1, CONSTRUCTION OF INFLUENZA NA RECEPTOR BINDING MUTANT A hemagglutinin (HA) gene from influenza A/Hong Kong/2/1968 (H3N2) strain was mutated to eliminate its sialic-acid receptor binding activity. In the H3 numbering scheme, these mutations included Y98F, H183F, L194A.
While Jesse D. Bloom does not explicitly teach the mutation at the position 153 as cited in claim 10, Martin et al. also teach that mutation of 153 from W to A can prevent cell surface expression of HA (See Abstract, Fig. 1 and Table 1-2).
Therefore, or obviously , it would have been obviously for any person with an ordinary skill in the art to be motivated to make the similar change described by Bloom using the HA set forth with SEQ ID NO: 121 as a reference sequence aligned with the claimed SEQ ID NO: 7 to produce the same biological mutant at the same sialic-acid receptor binding sites with a reasonable expectation of success because Bloom et al. also taught by that the mutation at the position of Y98F, H183F, L194A can eliminate the its sialic-acid receptor binding activity for the HA as well as take the successful conclusion of the mutation at 153 from W to A (W153A) to produce a HA mutant peptide antigen that absence of the sialic-acid receptor binding activity with a reasonable expectation of success. To this context, the rejection is maintained.
Claim Rejections - 35 USC § 112
The rejection of Claim 8 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, has been removed because of the persuasive argument.
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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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671