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
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(s) 1, 2, 5-10, and 15-19 are rejected under 35 U.S.C. 102a1 as being anticipated by Buchholz et al. (WO2001004335 from IDS).
For claims 1, 2, 5-10, Buchholz et al. teach a non-human Mononegavirales vector (Claim 1 and Fig 1b, rBRSV/A2) that has a Human RSV F insert (Claim 1 and Fig 1b, rBRSV/A2). For claims 15-16, the vector is used in a method with pharmaceutical carrier and administered intranasally (claim 48 and Example II, human individuals page 84 lines 7-9). For claim 17, the vector is made (see Examples and Figure 1B). For claim 18, Example II has the vector and it is inherently in a container. For claim 19, inducing an immune response is taught (page 85, lines 11-18).
Thus, Buchholz et al. anticipate 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.
Claim(s) 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Buchholz et al. (WO2001004335 from IDS) as applied to claims 1, 2, 5-10, and 15-19 above, and further in view of Brock et al. (JVI 2012, vol 86, no 10, pages 5829-5843, from IDS).
Buchholz et al. is discussed above.
Buchholz et al. does not teach MPV (murine pneumovirus) as a vector.
Brock et al. suggest using MPV as a vaccine vector, “PVM might be useful as a vaccine vector for human immunization via the respiratory tract, since it replicates at low levels and is highly immunogenic” (using the name PVM for MPV). (page 5842 col 1, last para of discussion).
One of ordinary skill in the art at the effective time of filing would be able to choose vectors for the RSV antigens to and be motivated to choose MPV since it replicates to low levels and is highly immunogenic. One of ordinary skill in the art at the effective time of filing would have the expectation of success knowing that PVM highly immunogenic and that it is similar to HRSV but there is not a strong existing immune response from humans (page 5842 col 1).
Thus, it would be prima facie obvious at the effective time of filing to use another vaccine vector to administer HRSV antigens by using the vector of Brock et al. in the constructs of Buchholz et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US12071632B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to the same viral vectors and RSV inserts.
Claims 1-4 to mononegavirales vectors are taught by claim 1 of the patent drawn to a MPV.
Claims 5-11 drawn to RSV as the expressed protein as covered in patent claims 2-6.
Claims 12-14 drawn to sequences of vectors are covered in claims 7-9 drawn to the same sequences.
Claims 15-16, drawn to formulation with carrier and for intranasal administration is covered by claims 10-11 of the patent.
Claim 17 drawn to a method of making the vector, is covered by claim 12 of the patent.
Claim 18 drawn to a kit is covered by claim 13 of the patent.
For claim 19, drawn to a method of inducing an immune response is covered by patent claim 14.
Thus, claims 1-19 are anticipated by the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon, Tues, Thurs, Fri..
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1648
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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