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 Objections
Claims 3, 4, and 5 are objected to because of the following informalities: The claims recite the acronym GMCSF without having made clear the full meaning of the term in its first use. Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 6-11 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.
Claim 6 states “wherein the vaccine comprises or more vectors,” which does not specify an initial quantity of vectors, and as such, the scope of the claim cannot be determined with reasonable certainty.
Therefore, claims 6-11 are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112a
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 1-20 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.
It should be noted that instant claim 6 states “wherein the vaccine comprises or more vectors” and this is interpreted for examination purposes as “comprises one or more vectors” which corresponds to the language of other claims. Appropriate correction is required.
Independent claims 1, 12, 13, 14, and 20 recite a vaccine comprising “one or more peptides having the sequence according to SEQ ID NOs: 1-34 and/or a nucleic acid capable of expressing the one or more peptides”. The specification, however, only describes a single peptide vaccine comprising a pool of the 20 specific peptides found in Table 2, and two plasmid constructs, NTC9382R-LS-rCOMP-TT-VACCS I and II, comprising specific nucleic acid groupings that, in total, do not encode all of SEQ ID NOs 1-34. There is no evidence in the specification to support that the inventors had possession of all possible combinations of one or more peptides and/or nucleic acid embodiments. All other claims are also rejected as they explicitly or implicitly require this composition.
Therefore, claims 1-20 are rejected under 35 U.S.C. 112(a) for lack of written description.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, and 12-15 are rejected under 35 U.S.C. 102a1 as being anticipated by Johnston et al., WO2018223093A1.
Independent claim 1 is drawn to a vaccine comprising one or more sequences according to SEQ ID NOs 1-34 and/or a nucleic acid capable of expressing the one or more of the peptides. Independent claims 12 and 13 are drawn to methods of eliciting an immune response and treating cancer. Independent claim 14 is drawn to the composition of claim 1.
Johnston et al. teaches a canine cancer vaccine comprising a pharmaceutically acceptable carrier and one or more peptides, or alternatively, nucleic acids encoding said peptides, selected from Johnston et al.’s SEQ ID NOs 1-6554, in which Johnston’s SEQ ID NOs 2844, 2847, 2849, 2923, 2934, 2955, 6322, 6524-6527, 6531-6533, 6536, 6539-6549, and 6551 correspond to SEQ ID NOs 1-33 of the instant application (instant claims 1 and 14). The vaccine may further comprise the adjuvant GM-CSF (instant claims 2 and 3), and the vaccine’s peptide coding sequences can be introduced into bacteria or a virus as a vector (instant claims 6 and 15). Of note, Johnston et al. does not enumerate the sequence for GM-CSF. Johnston et al. further teaches use of said vaccine to both elicit an immune response and treat cancer (claims 12 and 13).
Therefore, claims 1-3, 6, and 12-15 are rejected under 35 U.S.C. 102a1 as anticipated by Johnston et al.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of Nash et al.
Johnston et al.’s teachings are discussed above. Johnston et al. fails to teach the specific claimed amino acid sequence for canine GM-CSF or the specific vector NTC9382R-MCS-GMCSF.
Nash et al. teaches the same GM-CSF sequence as the instant application, and notes an increased immune response in canines (claim 4). One of ordinary skill in the art would be motivated to combine these teachings to enhance immune responses in dogs, with a reasonable expectation of success. Further, selection of a particular expression vector for GM-CSF, such as NTC9382R-MCS-GMCSF (instant claim 5), represents a routine design choice in molecular biology.
Accordingly, claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of Nash et al.
Claims 7, 10, 11, 16, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of Braun et al.
Johnston et al.’s teachings are discussed above. Johnston et al. do not disclose a vaccine with two vectors, the specific NTC9382R-LS-rCOMP-TT-VACCS I and II vectors, or said vaccine further comprising an additional peptide component comprising isolated peptides.
Braun et al. teach that co-administration of multiple plasmid DNA constructs encoding different antigenic proteins results in immune responses to the individual antigenic components without substantial interference by the other components, showing the compatibility of multiple plasmids expressing different antigens in a single vaccine. One of ordinary skill in the art would be aware of the payload capacities of plasmids and thus would be motivated to combine the sequences of Johnston et al. with the teachings of Braun et al. to distribute the large number of peptides across multiple vectors and therefore improve antigen expression and increase immune responses (instant claims 7 and 16). The selection of particular peptides to include in each vector and the selection of particular expression vectors, such as NTC9382R-LS-rCOMP-TT-VACCS I or NTC9382R-LS-rCOMP-TT-VACCS II, represent routine optimization and design choices in the art (instant claims 10 and 19).
Furthermore, regarding claim 11, although Johnston et al. do not disclose an additional peptide component to the two-vector vaccine described above, page 10 paragraph 1 of Johnston at al.’s specification notes a prime-boost paradigm comprising two rounds of genetic immunization with a gene gun and an additional peptide boost. As claim 11 only requires that an additional peptide component be present, this prime-boost paradigm described by Johnston et al. corresponds to a vaccine further comprising a peptide component comprising isolated peptides. It would have been obvious to one of ordinary skill in the art to combine these teachings and utilize the two-vector vaccine described above with a peptide boost model similar to that described by Johnston et al., as prime-boost strategies were well established in the art to enhance immunogenicity and breadth of immune responses.
Accordingly, claims 7, 10, 11, 16, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of Braun et al.
Claims 8, 9, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of van Rosmalen et al.
Johnston et al.’s teachings are discussed above. Johnston et al. do not disclose a linker.
van Rosmalen et al. teaches that flexible glycine-serine linkers are used in multidomain proteins to allow intrinsic flexibility between domains and that the linker flexibility can be tuned by the composition and length of the glycine and serine residues. Although van Rosmalen et al. do not specifically teach SEQ ID NO 36 of the instant application, it provides technical motivation, showing that GS repeat linkers are known elements with predictable properties. Given this, a person of ordinary skill in the art would have been motivated to combine these teachings and use a flexible GS linker (instant claims 8 and 17), such as the linker described in instant SEQ ID NO 36 (instant claims 9 and 18), to improve protein folding, with a reasonable expectation of success.
Accordingly, claims 8, 9, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al., in view of van Rosmalen et al.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al.
Johnston et al.’s teachings are discussed above. Johnston et al. do not disclose the vaccine as part of a kit.
However, assembling the vaccine into a kit with instructions constitutes a routine and predictable step for pharmaceutical products to facilitate distribution and proper administration (instant claim 20).
Accordingly, claim 20 is rejected under 35 U.S.C. 103.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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/T.D.J./ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675