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 .
Request for Continued Examination
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on January 28, 2026 is acknowledged. Claims 1, 3, 5-10 and 16-17 were canceled. Claims 11-15 and 18-20 are pending and under examination in this Office action.
Claim Rejections - 35 USC § 101
Rejection Claims 1, 3, 5-10 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is moot because Applicant canceled the claims.
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)(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.
Rejection of Claims 11-15 and 18-20 under 35 U.S.C. 102(a)(2) as being anticipated by Bakacs et al. (US Patent US 8,398,969) is moot because Applicant canceled the claims.
Rejection of Claims 11-15 and 18-20 under 35 U.S.C. 102(a)(2) as being anticipated by Bakacs et al. (US Patent US 8,398,969) is maintained in view of Applicant’s amendment.
Response to Applicant’s arguments
Applicant amended the claims to delete SEQ ID NO: 1 and SEQ ID NO: 2 and recite the 903/78 strain of the IBDV virus. Applicant argues that Bakacs et al. do not teach the method of treating a subject comprising administering a therapeutically effective dose of non-pathogenic 903/78 strain of the IBDV virus.
In response, it is the Examiner’s position that Present SEQ ID NO: 1 and SEQ ID NO: 2 are nucleic acids encoding segment A and segment B of 903/78 strain of the IBDV virus (see Bakacs et al. columns 4 and 5).
Columns 4 and 5 in Bakacs. The present invention relates to an attenuated clonal, viral replication inhibitory strain of Infectious Bursal Disease Virus (IBDV) comprising the RNA nucleotide sequence of the complete virus designated IBDV V903/78 as depicted in SEQ. ID. NO: 1 and 2 or a functionally equivalent tissue culture adapted derivative thereof, which can be grown in the HepG2 human liver cell line without causing detrimental effects to the cells.
Because, Bakacs et al. disclose IBDV virus comprising nucleic acid sequences having 100% identity with present SEQ ID NO: 1 and SEQ ID NO: 2 encoded within the IBDV V903/78 strain and the method of treating a subject having or suspected of having a disease caused by a Varicella zoster virus (VZV), the method comprising: administering a therapeutically effective dose of composition comprising a V903/78 strain of an Infectious Bursal Disease Virus (IBDV), and at least one pharmaceutically acceptable carrier or excipient, Bakacs anticipates the present claims.
Applicant’s amendment fails to overcome the present rejection for the reasons discussed above and thus the rejection is maintained.
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(l)(1) - 706.02(l)(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/patents-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.
Rejection of claims 11-15 and 18-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 8,398,969 is maintained.
Response to Applicant’s arguments
Applicant’s arguments have been fully considered but fail to persuade. Applicant argues that the present claims and the claims of the US Patent No. 8,398,969 are drawn to separate inventions. Applicant states that the pending claims are directed to a method of treating a subject having or suspected of having a disease caused by a Varicella zoster virus (VZV), the method comprising: administering to the subject a therapeutically effective dose of a composition comprising an Infectious Bursal Disease Virus (IBDV), wherein the IBDV is non-pathogenic attenuated strain 903/78, and pharmaceutically acceptable carrier or excipient. Applicant states that, in contrast, the claims of the '969 patent are completely silent as to any method of treatment, let alone a method of "[a] method of treating a subject having or suspected of having a disease caused by a Varicella zoster virus (VZV)," as recited in the currently pending claims. For at least these reasons, Applicant respectfully asserts that one of ordinary skill in the art would readily acknowledge that the pending claims of the present application and those of the '969 application are directed to patentably distinct subject matter. Therefore, Applicant respectfully requests that these double patenting rejections be withdrawn.
In response, the Examiner notes that the present Application is not a Divisional Application from the 12/475,127 now US Patent No. 8,398,969, thus there is no statutory protection from Double Patenting rejection in the present case. The presently claimed method is obvious over the product claimed in US Patent No. 8,398,969, thus the rejection is maintained.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648