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
Applicant’s election without traverse of invention I in the reply filed on 6/12/26 is acknowledged.
Claims 1-20 have been cancelled and claims 21-40 are newly presented. Claims 21-40 are examined on the merits.
Objections
Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. The specification is objected to because the amino acid sequence on page 23 of the specification does not contain a specific SEQ ID NO:.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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.
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 30-32 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.
This is a New Matter rejection.
The terms “polyprotein”, and “polyprotein comprises a plurality of antigens separated by protease cleavage sites” as recited in claims 30 and 31 are not supported by the original disclosure or claim as filed. Claim 32 is also rejected because it depends from claim 31, but does not remedy this deficiency.
Applicant’s amendment, filed 6/12/26, but they do not indicate where the specification supports these limitations. They do assert that no new matter has been added.
However, the specification as filed does not provide sufficient written description of the above-mentioned limitations. The specification does not provide sufficient support for a polyprotein or that the polyprotein comprises a plurality of antigens separated by protease cleavage sites.
Such limitations recited in the present claims, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. §112.
Applicant is required to cancel the new matter in the response to this Office Action. Alternatively, applicant is invited to provide sufficient written support for the “limitations” indicated above. See MPEP §714.02, §2163.05-06 and §2173.05(i).
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.
Claim 24 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 24 recites, “The method of claim 21, wherein the recombinant BAdV vector is administered at a dose that is at least 10-fold lower than a human adenoviral vector providing a comparable immune response.” However, it is unclear what the metes and bounds of “comparable immune response” are since more than one immune response type can be elicited.
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 21-29 39 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Custers et al. (USPGPub 2014/0073032) as evidenced by Hess et al. (Virology 238: 145-156 (1997).
Custers et al. teaches: bovine adenovirus 3 (BAdv3) [paragraph 38]; recombinant
adenoviral vectors with deletions, including the whole of E1 [paragraph 36]; as well as E1A, E1B and E3- deficient adenoviral vectors [paragraphs 36]. Custers et al. also teach using producer cells that express adenovirus genes that are missing from adenovirus vectors, thereby supporting replication of these adenovirus vectors. [see paragraphs 44, 54, 63 and 64] With the teachings that E1B can be deleted, such a virus would need support by the producer cell expressing a that deleted gene, therefore teaching claim 40. Custers et al. also teach administering to a subject, the adenovirus vectors in order to induce an immune response. Dosages can be between 10^7 to 10^12 viral particles. [see paragraphs 70-73] While Custers et al. do not teach the specific E1B genes of S and L, Hess et al. confirm that adenovirus E1B does possess these genes (see Table 2 of Hess et al.), therefore Custers et al. do teach this limitation, as evidenced by Hess et al. Furthermore, Custers et al. teach that adenoviruses which carry a gene of interest that encodes an antigen can be administered to elicit an immune response to this antigen. [see paragraph 3] Since the intent is to elicit an immune response, the gene of interest would function as a therapeutic nucleic acid. Examples of a gene of interest are heterologous viral antigens, such as flaviviruses (e.g., West Nile Virus, Hepatitis C Virus, Japanese Encephalitis Virus, Dengue Virus), ebola virus, Human Immunodeficiency Virus (HIV), and Marburg virus and influenza HA. [see paragraph 51] Custers et al. also teach that administration can occur intranasally, which would involve mucosal exposure to the adenovirus and resulting in IgA antibody responses. [see paragraph 71] In view of Custers et al. teaching the same active steps as applicant’s claimed method, the eliciting of a cell mediated immune response, such as a CD8+ T cell immune response including an increase in interferon gamma release compared to an undefined human adenoviral vector at a lower 10 fold or 30 fold lower dose and the induction of mucosal IgA would be inherent outcomes by Custers et al., see MPEP 2112.02.
Therefore, Custers et al. anticipate the instant 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.
Claims 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Custers et al. as evidenced by Hess et al. as applied to claims 21-29, 39 and 40 above, and further in view of Bett et al. (Journal of Virology, 1993, Vol 67, No. 10, pages 5911-5921).
Claims 33-34 require the heterologous gene of between at least 4kb to 5.5kb inserted into the BAdV vector.
The teachings of Custers et al., as evidenced by Hess et al. are summarized above. While Custers et al. teaches the insertion of heterologous genes, they do not teach the specific sizes of these insertions.
Bett et al. teach adenoviruses with E1 or E3 or both deletions, insertions of heterologous nucleic acid sequences of about 4.7 to 4.9 kb are possible [see introduction]
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Custers et al. in order to insert a heterologous sequence with at least 4 kb and up to 5.5 kb. One would have been motivated to do so, given the suggestion by Custers et al. that the adenovirus vectors taught are capable of accepting insertions of nucleic acid sequences that encode other viral glycoproteins and at multiple locations within the genome [see paragraph 50]. There would have been a reasonable expectation of success, given the knowledge that adenoviruses can accept the insertion of a heterologous nucleic acid sequence of 4.7 kb, as taught by Bett et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 §§ 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patcnts-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-29 and 33-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12220454. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is also drawn to a method of generating an immune response against a viral antigen encoded by a recombinant bovine adenovirus that lacks the E1A and E1B genes, is produced by a bovine host cell that expresses human adenovirus E1 and bovine adenovirus E1BL and the viral antigen can be an influenza HA protein. The method also elicits a cell mediated CD8+ Tcell response and IgA responses with a 30 fold less dose compared to human counterpart.
Claims 21-29 and 35-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-12, 14-17 of U.S. Patent No. 7025967 in view of Custers et al. as evidenced by Hess et al. and Bett et al. (supra).
U.S. Patent No. 7025967 recite a replication-defective recombinant bovine adenovirus (BAV) expression vector comprising a bovine adenovirus genome with a deletion of all or part of the E1 region; said expression vector further comprising an insertion, at the site of the deletion, of a non-BAV nucleotide sequence under the control of an effective promoter; further comprising a deletion of part or all of the E3 region; A replication-defective recombinant bovine adenovirus (BAV) comprising a bovine adenovirus subgroup 1 genome with a deletion of part or all of the E1 multiple gene coding region, said deletion being replaced by a heterologous nucleotide sequence coding for a polypeptide produced by a disease causing organism or an antigenic determinant produced by a disease causing organism, wherein said heterologous nucleotide sequence is in association with an effective promoter; further comprising a deletion of part or all of E3.
The teachings of Custers et al., Hess et al. and Bett et al. are summarized above.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Claims 21-29, 39 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 6001591 in view of Custers et al. as evidenced by Hess et al. and Bett et al. (supra).
Claims 1-6 of U.S. Patent No. 6001591 recite a live recombinant bovine adenovirus
(BAV) expression vector comprising a bovine adenovirus genome with a deletion of all or part of the E1 region; said expression vector further comprising an insertion, at the site of the
deletion, of a non-BAV nucleotide sequence under the control of an effective promoter; a live
recombinant bovine adenovirus (BAV) expression vector comprising a bovine adenovirus
genome with a deletion of all or part of the E3 region; said expression vector further comprising an insertion, at the site of the deletion, of a non-BAV nucleotide sequence under the control of an effective promoter; live recombinant bovine adenovirus (BAV) expression vector comprising a bovine adenovirus genome with deletions of all or part of the E1 region and all or part of the E3 region; said expression vector further comprising one or more insertions, at the site of at least one of the deletions, of one or more non-BAV nucleotide sequences, said non-BAV nucleotide sequences being under the control of one or more effective promoters.
The teachings of Custers et al., Hess et al. and Bett et al. are summarized above.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1648
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