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 .
Specification
Applicant should update the first paragraph of the specification to provide the correct status of application number 17/557125 (i.e., patented).
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.
Claim 22 is 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 claim is directed to the method of claim 14, where the measles vaccine comprises an adjuvant having the ability to increase surface expression of CD46 or upregulate IFI44L. While many different types of adjuvants are known in the art, applicant has not identified an adjuvant that has the ability to increase surface expression of CD46 or upregulate IFI44L.
The court clearly states in Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision adjuvants that have the ability to increase surface expression of CD46 or upregulate IFI44L. The specification has not described any adjuvant that that has the ability to increase surface expression of CD46 or upregulate IFI44L. Accordingly, the full breadth of the claim does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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 14-15 and 19-21 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 14 is directed to, inter alia, a method of treating a human in need of a therapy comprising a measles virus based vector. After one of the recited alleles is detected, step (b) requires administering, inter alia, a therapy comprising a non-measles virus based vector to said human. It is not clear how administering a non-measles virus based vector is able to treat a human in need of a therapy comprising a measles virus based vector, as recited in the preamble of claim 14. This affects claims depending from claim 14 as well.
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 12-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11225691.
The instant claims are directed to a method for treating a human in need of a therapy comprising a measles virus-based vector, wherein said method comprises:
(a) detecting the presence of an allele selected from the group consisting of the major allele T of CD46 rs2724374, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44Lrs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A ofLOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rsl 1118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, and the minor allele C of CD46 rsl1806810 in a sample obtained from said human, and
(b) administering said therapy to said human.
The patented claims are directed to a method for treating a human having cancer, wherein said method comprises:
(a) detecting the presence of the major allele T of CD46 rs2724374, the major allele A of CD46 rs2724384, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44L rs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A of LOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rs11118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, or the minor allele C of CD46 rs11806810 in a sample obtained from said human, and
(b) administering a measles virus-based oncolytic treatment to said human.
The human having cancer of the patented claims is also a subject in need of a measles virus-based treatment as recited in the instant claims, and the virus-based oncolytic treatment of the patented claims is also a measles virus-based treatment as recited in the instant claims.
Patented claim 1 teaches instant claims 12 and 16.
Patented claim 2 teaches instant claim 13.
Patented claim 3 teaches instant claims 14 and 19.
Patented claim 4 teaches instant claim 15.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 12-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10683554.
The instant claims are directed to a method for treating a human in need of a therapy comprising a measles virus-based vector, wherein said method comprises:
(a) detecting the presence of an allele selected from the group consisting of the major allele T of CD46 rs2724374, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44Lrs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A ofLOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rsl 1118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, and the minor allele C of CD46 rsl1806810 in a sample obtained from said human, and
(b) administering said therapy to said human.
The patented claims are directed to a method for providing a human with a measles virus vaccination, wherein said method comprises:
(a) detecting the presence of the major allele T of CD46 rs2724374, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44L rs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A of LOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rs11118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, or the minor allele C of CD46 rs11806810 in a sample obtained from said human, and
(b) administering a measles virus vaccine to said human.
Patented claim 1 teaches instant claims 12, 14, 16 and 19.
Patented claim 2 teaches instant claims 13 and 15.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12054785.
The instant claims are directed to a method for treating a human in need of a therapy comprising a measles virus-based vector, wherein said method comprises:
(a) detecting the presence of an allele selected from the group consisting of the major allele T of CD46 rs2724374, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44Lrs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A ofLOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rsl 1118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, and the minor allele C of CD46 rsl1806810 in a sample obtained from said human, and
(b) administering said therapy to said human.
The patented claims are directed to a method for treating a human in need of a measles virus-based treatment, wherein said method comprises:
(a) detecting the presence of an allele selected from the group consisting of: the major allele T of CD46 rs2724374, the major allele A of IFI44L rs273259, the major allele T of IFI44L rs1333973, the major allele C of CD46 rs4844619, the major allele C of CD46 rs2466572, the major allele T of CD46 rs2724360, the major allele G of CD46 rs6657476, the major allele A of CD46 rs4844390, the major allele A of IFI44L rs4650590, the major allele G of IFI44L rs6693207, the major allele A of IFI44Lrs273255, the major allele G of IFI44L rs273261, the major allele A of IFI44L rs273256, the major allele A of IFI44L rs273244, the major allele T of LOC101929385 rs11118612, the major allele C of LOC101929385 rs4844392, the major allele A of LOC101929385 rs66532523, the major allele G of LOC101929385 rs4844620, the major allele G of intergenic rs2761437, the major allele T of intergenic rs2796265, the major allele G of intergenic rs2761434, the major allele T of intergenic rs56075814, the major allele T of intergenic rs6669384, the major allele T of intergenic rs55935450, the major allele C of intergenic rs11118668, the major allele T of intergenic rs1318653, the major allele T of intergenic rs61821293, the major allele G of intergenic rs273238, the major allele A of intergenic rs12026737, and the minor allele C of CD46 rs11806810 in a sample obtained from said human, and
(b) administering said measles virus-based treatment to said human.
Patented claims 1-11 teach instant claims 12-22, respectively.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claim is allowed.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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