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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 6, 9, and 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5, 6, 9, and 12-15, the phrase "preferably" and “including” (claim 12) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention or meant to be a further limitation. See MPEP § 2173.05(d). The claims are treated as the broadest limitation.
Claim 15 provides for the use of a vector, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is
intending to encompass. A claim is indefinite where it merely recites a use without any active,
positive steps delimiting how this use is actually practiced.
Claim 15 is not treated beyond the 112/101 issues.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki , 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner ,
255F.Supp. 131, 49 USPQ 475 (D.D.C. 1966).
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 1-15 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.
The claims require a virus comprising a functional mutation that functions to increase immunogenicity in comparison with the same vector without said functional mutation.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991).
In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention.
The specification only shows one deletion that has the required function.
No other examples are shown nor is any direction given for any of the vast potential insertions, deletions and or substitutions of the CBP.
The specification does not disclose all types of insertions, deletions and or substitutions of the CBP that have the claimed functions. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
Thus, the specification does not provide an adequate written description of the genus of insertions, deletions and or substitutions of the CBP that is required to practice the claimed invention. Applicants have not described the genus sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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) 1-4, 6-8, and 13-14 are rejected under 35 U.S.C. 102a1 as being anticipated by Fleming et al. (Frontiers in Microbiology Vol 8, year 2017) as evidenced by Martins et al. (Veterinarian Microbiology vol 257, year 2021).
For claim 1, Fleming et al. teach a parapoxvirus with a functional deletion of the chemokine binding protein (CBP) (abstract page 3 right column, CBP-knockout). For claim 2, because it has the same structure it will have the same function. For claims 3 and 4, the CBP deletion may be advantageous for recombinant vaccine development (page 15, right column top) and is an orf virus (abstract).
For claim 6 the CBP deletion is ORF 112. This is evidenced by Martins et al. that teaches CBP is ORF112 (abstract). For claims 13 and 14, the CBP knockout was administered to sheep and infected cells (abstract). For claims 7-8, the vector is modified to express a transgene with a promoter that that controls expression (insert beta-gal into the CBP region and delete CBP sequence, page 3, right column middle).
Thus, Fleming 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) 5 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al. (Frontiers in Microbiology Vol 8, year 2017) as evidenced by Martins et al. (Veterinarian Microbiology vol 257, year 2021) as applied to claims 1-4, 6-8, and 13-14 above, and further in view of Hanns-Joachim et al. (VIRUSES, vol. 11, no. 2, 30 January 2019 (2019-01-30), page 127pp).
Fleming et al. is discussed above.
Fleming et al. does not teach strain D1701, specific promoters,
For claims 9, Hanns-Joachim et al. teach that D1701 is a strain of ORF virus and can be used to deliver vaccine antigens from two insertion sites (abstract). For claims 10-11, Hanns-Joachim et al. teach specific early promoters including eP1 and eP2 (SEQ ID# 1 and 2) (sequence in Table 1) and that they can be used to drive expression (abstract and page 21 top). For claim 12, it would be obvious to use a viral antigen in in the vector because there are many viral antigens that have been used in vaccines.
One of ordinary skill in the art before the effective time of filing would have the expectation of success using the CBP deletion of Fleming et al. because both are ORF virus.
One of ordinary skill in the art before the effective time of filing would have the expectation of success using the BCP region to insert a transgene because Fleming et al. already expressed a transgene (page 3) and taught the vector could be used as a recombinant vaccine and that the CBP deletion can be advantageous for recombinant vaccine even though attenuated still induces an antibody response (end of discussion).
Thus, it would have been prima facie obvious before the effective filing date to use the mutations of Fleming et al. in the viral strain of Hanns-Joachim et al. with the expectation of success as they are both ORF virus and been able to choose the promoter based on the teaching of Hanns-Joachim et al.
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-Fri.
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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