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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/10/2023 have been considered by the examiner.
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 18 and 20 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 18 is rejected because it depends on claim 16, a canceled base claim. MPEP 608.01 (v) set forth that if the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. As such, claim 18 is rejected for being indefinite because the claim is not complete.
Claim 20 is rejected for same reason because it depends on claim 18.
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 1, 3-7, 9-15, 17, 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,604,549. Although the claims at issue are not identical, they are not patentably distinct from each other because the adenoviral genome claimed in claim 1 of ‘549 patent comprises same polynucleotide that having albumin binding moiety inserted in the coding region of hypervariable region 1 (HVR1) as claimed in claim 1 of present application. Claim 8 of ‘549 patent recites the genome further comprises tissue specific or tumor specific promoter. Therefore, the claimed adenovirus of present claim 1 is anticipated by claim 8 of ‘549 patent.
Regarding claims 3 and 4, claims 3 and 4 of ‘549 recites same limitation that albumin-binding moiety is from streptococcal protein G, Peptostreptococcus magnus protein (PAB), a sequence comprising SEQ ID NO: 9 and functional variant thereof.
Regarding claim 5, claim 5 of the ‘549 recites the same limitation that albumin binding moiety is inserted at D150 of the hexon protein.
Regarding claim 6 and 7, claims 6 and 7 of ‘549 patent recites same limitation that albumin binding moiety is connected to the hexon protein by a linker sequence comprise SEQ ID NO: 2.
Regarding claim 9, claim 9 of the ‘549 patent recites same limitation that the adenovirus is an oncolytic virus.
Regarding claim 10, claim 10 of ‘549 patent recites same limitation that the adenovirus further comprises mutations in one or more genes including E1a, E1b, E4 and VA-RNAs.
Regarding claim 11-13, claims 11-13 of ‘549 patent recite same limitation that adenovirus comprises more modifications to increase adenovirus infectivity and/or target the adenovirus to a receptor present in a tumor cel, which includes insertion of RGD into H1 loop of fiber protein, and substitution of a region of fiber gene from one serotype with another serotype.
Regarding claim 14 and 15, claim 14 and 15 of ‘549 patent recites same limitation that adenovirus comprises polynucleotides encoding genes for gene therapy or vaccination for cancer.
Regarding claim 17, claim 17 of ‘549 patent recites same limitation of a pharmaceutical composition that comprises the adenovirus of claim 1.
Regarding claim 21, claim 2 of ‘549 patent recites adenovirus is from serotype 5, which anticipates present claim 21.
Regarding claim 22, it is well known in the art the recited promoter are tissue specific and tumor specific promoter.
Claims 1, 3-7, 9-15, 17, 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,578,104. Although the claims at issue are not identical, they are not patentably distinct from each other because the adenoviral genome claimed in claim 1 of ‘104 patent comprises same polynucleotide that having albumin binding moiety inserted in the coding region of hypervariable region 1 (HVR1) as claimed in claim 1 of present application. Claim 7 of ‘104 patent recites the genome further comprises tissue specific or tumor specific promoter. Therefore, the claimed adenovirus of present claim 1 is anticipated by claim 7 of ‘104 patent.
Regarding claims 3 and 4, claims 2 and 3 of ‘104 recites same limitation that albumin-binding moiety is from streptococcal protein G, Peptostreptococcus magnus protein (PAB), a sequence comprising SEQ ID NO: 9 and functional variant thereof.
Regarding claim 5, claim 4 of the ‘104 recites the same limitation that albumin binding moiety is inserted at D150 of the hexon protein.
Regarding claim 6 and 7, claims 5 and 6 of ‘104 patent recites same limitation that albumin binding moiety is connected to the hexon protein by a linker sequence comprise SEQ ID NO: 2.
Regarding claim 9, claim 1 of the ‘104 patent recites same limitation that the adenovirus is an oncolytic virus.
Regarding claim 10, claim 8 of ‘104 patent recites same limitation that the adenovirus further comprises mutations in one or more genes including E1a, E1b, E4 and VA-RNAs.
Regarding claim 11-13, claims 9-11 of ‘104 patent recite same limitation that adenovirus comprises more modifications to increase adenovirus infectivity and/or target the adenovirus to a receptor present in a tumor cel, which includes insertion of RGD into H1 loop of fiber protein, and substitution of a region of fiber gene from one serotype with another serotype.
Regarding claim 14 and 15, claim 12 and 13 of ‘104 patent recites same limitation that adenovirus comprises polynucleotides encoding genes for gene therapy or vaccination for cancer.
Regarding claim 17, claim 14 of ‘104 patent recites same limitation of a pharmaceutical composition that comprises the adenovirus of claim 1.
Regarding claim 21, claim 1 of ‘549 patent recites adenovirus is from serotype 5, which anticipates present claim 21.
Regarding claim 22, it is well known in the art the recited promoter are tissue specific and tumor specific promoter.
Prior art:
The closest prior art is Kovesdi et al (WO2007/050128), which teaches adenoviral genome may comprises insertion of tissue specific and tumor specific promoter, mutation of one or more genes of E1a, E1b, E4 and VA-RNAs, and insertion of an albumin binding protein into capsid protein. However, Kovesdi does not teach or suggest the location of albumin binding protein should be in HVR1 of hexon protein coding region.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/Primary Examiner, Art Unit 1637
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