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 .
Election/Restrictions
Election was made without traverse in the reply filed on 12/19/25.
Applicant elected Group II and “RSV deltaNS2/delta1313/I1314L virus" for prime administration and "B/HPIV3 DS-Cav1/B3TMCT virus" for boost administration. Claims 22-24 and 48-64 are under consideration.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 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.
Claims 22, 24 and 48-64 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 22 contains the negative limition wherein both the prime and the boost administration are not RSV 276.
The courts have found that any negative limitation or exclusionary proviso must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. See Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984)
Support for the negative limitation or the concept of it are not seen by the examiner.
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.
Claim(s) 22-24 and 48-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karron, et al. (The Journal of Infectious Diseases, Volume 222, Issue 1, Pages 82–91 (2019)) and Liang et al. (J Virology 2016, https://doi.org/10.1128/jvi.01196-16).
For claims 22 and 23, Karron et al. teach using RSV/ΔNS2/Δ1313/I1314L (abstract) and suggest using a prime boost with a PIV vectored vaccine virus and reference a prior study (page 90, col 1, top), for claim 24, the name of the clone and the structure described and referenced is the same so it has the same sequence, and for claims 48, 51-60, the section RESULTS page 85 teaches those human children with the ages, doses and serological status as recited, and for claim 49, the virus is administered intranasally (abstract).
Karron et al. do not teach specific PIV/RSV chimeric virus.
For claims 22-23, Liang et al. teach B/HPIV3 DS-Cav1/B3TMCT, a PIV3 vectored RSV F, with improvements that resulted in an attenuated virus that produced a high-quality immune response and improved version of this well-tolerated RSV/HPIV3 vaccine candidate, with potently improved immunogenicity, which can be returned to clinical trials (abstract) and for claim 24, the name of the clone and the structure described and referenced (Figure 1) is the same so it has the same sequence.
For claims 61-64, the immune responses obtained flow from the virus used and result in those immune responses.
One of ordinary skill in the art before the effective time of filing would be motivated to use a prime boost strategy with two viruses as suggested by Karron et al. and have the expectation of success knowing that both viruses have been used in young children and or have been improved to be a better vaccine candidate.
Thus, it would have been prima facie obvious before the effective filing date to modify the vaccine of Karron et al. with the vectored RSV F of Liang et al. as suggested by Karron et al.
Claim(s) 22-24 and 48-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al. (20170189520) and Liang et al. (J Virology 2016, https://doi.org/10.1128/jvi.01196-16).
For claims 22 and 23, Collins et al. teach RSV/ΔNS2/Δ1313/I1314L (claim 20) and that the virus contain mutations that make them more stable, attenuated and attractive vaccine candidates(abstract), for claim 24, the name of the clone and the structure described and referenced (the patent issued claim 20 has the genetic description) is the same so it has the same sequence, and for claims 22-23, 48, 51-3, and 56-60, Collins et al. teach human children with the ages, doses and prime boost vaccination, and for claim 49, the virus is administered intranasally. For claims 54-55, one of ordinary skill in the art before the effective filing date would know that almost all children get RSV by the age of two, and thus the younger populations with have both seropositive and seronegative subjects.
For claims 61-64, the immune responses obtained flow from the virus used and result in those immune responses.
Collins et al. do not teach specific PIV/RSV chimeric virus.
For claims 22-23, Liang et al. teach B/HPIV3 DS-Cav1/B3TMCT, a PIV3 vectored RSV F, with improvements that resulted in an attenuated virus that produced a high-quality immune response and improved version of this well-tolerated RSV/HPIV3 vaccine candidate, with potently improved immunogenicity, which can be returned to clinical trials (abstract) and for claim 24, the name of the clone and the structure described and referenced (Figure 1) is the same so it has the same sequence.
One of ordinary skill in the art before the effective time of filing would be motivated to use a prime boost strategy with two viruses and choose art known vaccine candidates and have the expectation of success knowing that both viruses have been improved to be a better vaccine candidate.
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly
support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the
CCPA held that a particular parameter must first be recognized as a result-effective variable,
i.e., a variable which achieves a recognized result, before the determination of the optimum or
workable ranges of said variable might be characterized as routine experimentation, because
"obvious to try" is not a valid rationale for an obviousness finding. However, in KSR
International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held
that "obvious to try" was a valid rationale for an obviousness finding, for example, when there
is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at
421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude,
in error, that a patent claim cannot be proved obvious merely by showing that the combination
of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable solutions, a person of ordinary
skill has good reason to pursue the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of innovation but of ordinary skill and
common sense. In that instance the fact that a combination was obvious to try might show that
it was obvious under §103.").
Thus, after KSR, the presence of a known result-effective variable would be one, but not
the only, motivation for a person of ordinary skill in the art to experiment to reach another
workable product or process.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not
inventive to discover the optimum or workable ranges by routine experimentation." In re Aller,
220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, it would have been prima facie obvious before the effective filing date to modify the vaccine of Collins et al. with the vectored RSV F of Liang et al. to arrive at the prime boost vaccine as claimed.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671