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 .
Rejections Necessitated by Amendment
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 1-2, 4-6, and 8-16 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.
Applicant argues that guidance is given and a reference to compare to for the immunogenicity that a POSA can practice the claimed invention.
Applicant’s arguments have been fully considered and not found persuasive.
The ability to practice the invention is not the requirement for written description.
The ability of a POSA to determine the mutations is not sufficient to show possession of the genus of mutations. Applicant is reminded “[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.” (quoted from above).
Here, applicant has not shown enough mutants or provided a specific structure function relationship to show possession of the genus and be able to recognize the mutants without testing each one.
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.
Claims 1-2, 4-6, and 8-16 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) and Hanns-Joachim Rziha et al. (VIRUSES, vol. 11, no. 2, 30 January 2019 (2019-01-30), page 127pp).
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 (deletion of the CBP orf, page 3, col 2 middle). For claim 4, the CBP deletion may be advantageous for recombinant vaccine development (page 15, right column top) and is an orf virus (abstract).
For claims 1 and 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).
For claim 6 the CBP deletion is ORF 112. This is evidenced by Martins et al. that teaches CBP is ORF112 (abstract).
For claims 13-16, the CBP knockout was administered to sheep and infected cells (abstract).
Fleming et al. does not teach strain D1701, specific promoters or certain transgenes.
For claims 5, Rziha 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 claim 9, two transgenes can be expressed and can be used as vaccines to deliver antigens (abstract and part 5).
For claims 10-11, Rziha 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 to express viral antigen because both references show expression of transgenes and Rziha et al. suggests the use as vector to deliver vaccine antigens.
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 Rziha et al. with the expectation of success of expressing transgenes as they are both ORF virus and been able to choose the promoter based on the teaching of Hanns-Joachim et al.
Applicant argues that 103 rejected claims depend from claim 1 and asserts claim 1 is novel against the cited references (as argued in the 102 rejection). Applicant asserts that the examiner failed to provide reasons of how the POSA would arrive at the claimed invention. And the office acknowledged claim 1 as non-obvious. Thus, all the dependent claims are obvious.
Applicant’s arguments have been fully considered and not found persuasive.
Claim 1 was previously rejected under 102 anticipation and is now modified to be a 103 because of the amendment. One this topic, claim 1 was never stated by the office to be non-obvious because it was previously rejected as anticipated. As to the deficiency of not being able to arrive at the claimed invention, reasoning was provided and applicant does not point to any specific flaws.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 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 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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