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
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 08/06/2026 has been entered. Claims 1-5 are pending and currently under consideration. Claims 29-43 are added. Claims 17-43 are pending. Claims 17-20, 22, and 25-43 are currently under consideration. Claims 21 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Withdrawn Objections and/or Rejections
The rejection of claims 17-20, 22, and 25-28 under 35 U.S.C. 112(b) is withdrawn in view of amended claims.
The rejection of claim 18 under 35 U.S.C. 112(b) is withdrawn in view of amended claim.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 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.
(ii). Claims 17-20, 22, and 25-28 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention. The basis for the rejection is set forth in the office action mailed on 04/06/2026. New claims 29-43 are also rejected on the same basis.
Applicant argues that the SEQ ID NO: 2 versus SEQ ID NO:3 has 99.17 % overall sequence identity; SEQ ID NO: 1 versus SEQ ID NO: 2 has 94.74 % overall sequence identity; and SEQ 1 versus SEQ 3 has 94.74 % overall sequence identity. Applicant argues that because all three sequences between themselves have at least 90 %
sequence identity, it follows that all species recited in present claim 17 are fully defined by their sequences. Applicant argues that a person of skill can envision that Applicant was in possession of the full genus as claimed in claim 17.
Applicant’s argument has been fully considered but is not deemed to be persuasive. For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses an E4 orf4-encoded protein comprising the amino acid sequence of SEQ ID NO: 1, 2, or 3 (see, e.g., page 3). SEQ ID NO: 1 shares 94.74 % overall sequence identity with SEQ ID NO: 2 or SEQ ID NO:3, whereas SEQ ID NO: 2 shares 99.17 % overall sequence identity with ID NO:3. The specification does not disclose any other homologues or variants of the amino acid sequences of SEQ ID NO: 1, 2, or 3. Moreover, the specification discloses the adenovirus of SEQ ID NO: 4 (Ad5/11 p53, SEQ ID NO: 4), which comprises the amino acid sequence of SEQ ID NO: 1 and an inactivated E4 orf3 (Figures 1, 6-7). Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what the E4 orf4-encoded protein variants or homologues might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of E4 orf4-encoded proteins comprising an amino acid sequence with at least 90% overall sequence identity to SEQ ID NO: 1, 2, or 3. Thus, the rejection is maintained.
Claim Objections
Claims 22, 23, 37, and 38 are objected to because they recite “a sequence of nucleotides No. 380...625 of SEQ ID NO: 4”, “a sequence of nucleotides No. 321..963 of SEQ ID NO: 6”, “a sequence of nucleotides No. 6539..7144 of SEQ ID NO: 6”. It is suggesting to amend to “a sequence of nucleotides No. 380 to 625 of SEQ ID NO: 4”, “a sequence of nucleotides No. 321 to 963 of SEQ ID NO: 6”, “a sequence of nucleotides No. 6539 to 7144 of SEQ ID NO: 6”.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 August 17, 2026
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