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 response to the previous Office action, dated October 31, 2025, has been received. By way of this submission, Applicant has amended claims 1, 3-5, and 7, cancelled claims 6, 9, and 27-39, and introduced new claim 55.
Claims 1-5, 7-8, 10-26, and 40-55 are pending in the application. Claims 40-54 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed March 28, 2025.
Claims 1-5, 7-8, 10-26, and 55 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated July 2, 2025.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7, and 9-24 are rejected under 35 U.S.C. 103 as being unpatentable over Khurana (US20180110850A1) in view of Dormitzer (US20140044751A1).
Applicant argues that Dormitzer does not teach a virus-like particle containing a fusion peptide containing portions of two or more proteins, as the teachings of Dormitzer are not applicable to a virus-like particle. Applicant further argues that the combination of Khurana and Dormitzer provides no motivation or reasonable expectation of success in modifying the virus-like particle of Khurana with the transmembrane protein fused to the G protein of Dormitzer.
Applicant's arguments have been considered fully but are not found to be persuasive.
Dormitzer clearly teaches the use of virus-like particles for us as an anti-RSV immune composition (para. 0019 and claim 9). Dormitzer also teaches that the F protein, which comprises a stem/stalk region of a transmembrane protein, may be a component of a virus-like particle (para. 0042).
Khurana is explicit in teaching that combinations of RSV F protein and G protein are useful in an immunogenic composition (para. 0007). Khurana also incorporates by reference Lee (Vaccine. 2014 Oct 7;32(44):5866-74), which teaches that virus-like particles are useful for vaccination against RSV (para. 0144).
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
Applicant's argument that there is no reasonable expectation of success in combining the teachings of Khurana and Dormitzer is nothing more than an unsupported assertion. If there was no reasonable expectation of success, this statement must be supported by evidence. MPEP 2143.02(II). Arguments presented by applicant cannot take the place of evidence in the record. In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). MPEP 2145(I).
This rejection is therefore maintained.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over as Khurana and Dormitzer applied to claims 1, 16, 22, and 24 above, and further in view of Schmidt (J Immunol. 2019 Jun 1;202(11):3234-3245).
Applicant argues that the teachings of Schmidt do not remedy the above alleged deficiencies of Khurana and Dormitzer. This is not persuasive, for reasons described supra.
This rejection is therefore maintained.
Allowable Subject Matter
Claims 8 and 55 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hwang (Hum Vaccin Immunother. 2017 Jan 27;13(5):1031–1039) teaches a virus-like particle comprising the F and G proteins of RSV, fused to the transmembrane domain of Newcastle disease virus (NDV) (abstract).
No claim is allowed.
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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 4:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644