Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Claims and Application
US Patent 10,106,781 issued on 10/23/18 from application 14/443,299 with claims 1-44. US Patent 10,781,427 issued on 9/22/20 from application 16/159,336, which is a continuation of the ’299 application. The ’427 patent issued with claims 1-29.
On 9/22/22, applicants filed application 17/934,479 as a reissue of the ’427 patent. The ’479 application issued as RE50,753 on 1/20/26 with original claims 1-13, 15-20, and 22-28; amended claims 14, 21, and 29; and new claims 30-69.
On 8/27/25, applicants filed this application as a reissue of the ’427 patent and a continuation of the ’479 reissue application. This application contains original claims 1-29 from the ’427 patent and new claims 30-45. Claims 1-45 are pending.
Multiple Reissue Applications
This reissue application is the continuation of application 17/934,479. 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). Accordingly, the first sentence of each reissue specification must provide notice stating that more than one reissue application has been filed, and it must identify each of the reissue applications and their relationship within the family of reissue applications, and to the original patent. An example of the suggested language to be inserted is as follows:
Notice: More than one reissue application has been filed for the reissue of Patent No. 99,999,999. The reissue applications are application number 99/999,994 (the present application); and application number 99/999,995, which is a continuation reissue of Patent No. 99,999,999.
See MPEP 1451. In addition to amending the specification of this application, applicant should file a certificate of correction in the RE’753 patent to inform the public of the presence of both this application and the ’479 application.
Information Disclosure Statement
The information disclosure statement filed 4/6/26 fails to comply fully with 37 CFR 1.97 and 1.98, specifically 37 CFR 1.98(a)(2), because no copies of any foreign patents or non-patent publications have been supplied. See MPEP 1406 (requiring compliance with 37 CFR 1.98 in reissue applications and indicating that the examiner should line through references on a PTO/SB/08 form that are not accompanied by copies).
Nucleotide and/or Amino Acid Sequence Disclosures
This application is governed by ST.26 rules. Sequence listings submitted in either non-provisional applications filed under 35 U.S.C. 111(a) or provisional applications filed under 111(b) that have a filing date on or after 7/1/22, including reissue applications, must be in XML format and comply with WIPO Standard ST.26 and 37 CFR 1.831 through 1.835. See MPEP 1410, 2415.01.
Summary of Requirements for Patent Applications
Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because the “Sequence Listing XML,” as a separate part of the disclosure, is defective. Refer to document “Sequence Listing Report for Application No: 19312085” dated 8/28/25 regarding improper organism qualifier values.
Required response - Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above submitted in accordance with either item 1. or 2.; together with
o A statement that identifies the location of all additions, deletions or replacements of sequence information relative to the replaced “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
o A statement that indicates support for the replacement “Sequence Listing XML” in the application, as filed, as required by 37 CFR 1.835(b)(4); and
o A statement that the replacement “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(b)(5).
AND
• An amendment to the specification in compliance with 37 CFR 1.173, inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), along with a statement that the substitute specification contains no new matter.
Ownership by Assignees
Both statements under 37 CFR 3.73 filed on 8/27/25 are noncompliant because they each represent the other assignee as having both an unspecified percentage of ownership and an entire right, title, and interest. For example:
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Replacement statements under 37 CFR 3.73 that clearly establish the interest of each assignee are required.
Assignee’s Consent to Reissue
The 8/27/25 consent to reissue signed by Nichole Mercier is defective because it was neither signed by a person with apparent authority as defined in MPEP 325(V) nor signed by a person authorized to act on behalf of the assignee at the time of signing. MPEP 325(V) recognizes that persons with “apparent authority” to sign on behalf of an organization include officers of that organization, e.g., its chief executive officer, president, vice-president, secretary, or treasurer. Consenter Mercier is none of these, being designated only as “Assistant Vice Chancellor and Managing Director.” There is also nothing in the record to indicate that consenter Mercier was authorized to act on behalf of the assignee; compare the consent of David McCarthy, which identifies him as an “authorized signatory.”
This matter would be overcome by submission of a replacement consent of the assignee signed by either a person authorized to act on behalf of the assignee; an officer of the assignee; or a patent practitioner already appointed power of attorney at the time of signing.
Reissue Oath/Declaration
The reissue oath/declaration filed with this application is defective because it fails to identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414.
The reissue declaration filed with this application is a copy of the one submitted with the parent ’479 reissue application. 37 CFR 1.175(f)(2) instructs, “If all errors identified in the inventor’s oath or declaration from the earlier-filed reissue application are no longer being relied upon as the basis for reissue, the applicant must identify an error being relied upon as the basis for reissue.” The reissue application filed in this case does not identify any error that has not already been corrected in the RE’753 patent, and it is therefore noncompliant. See MPEP 1451(I)(B)(1)(a); (II)(B)(1).
Claim Rejections – 35 USC § 251
Claims 1-45 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect in the declaration is set forth in the discussion above in this Office action.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-29 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-29 of prior U.S. Patent No. 10,781,427. This is a statutory double patenting rejection.
Claims 1-13, 15-20, and 22-28 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-13, 15-20, and 22-28 of prior U.S. Patent No. RE50,753. This is a statutory double patenting rejection.
Double Patenting (Nonstatutory)
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 30 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 41, and 42 of U.S. Patent No. 10,106,781. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ’781 patent claims a recombinant adenovirus comprising a nucleotide sequence having 90% or greater sequence identity over the entire sequence of SEQ ID NO: 11 (which is identical to examined SEQ ID NO: 11). The ’781 patent’s adenovirus comprises a deletion in or of an E1 region such that the adenovirus is replication-defective. (Claim 1.) The ’781 patent claims that the virus may further comprise an antigenic gene product, specifically a viral protein. (Claims 5 and 6.) Regarding examined claim 35, the ’781 patent claims that the virus further comprises SEQ ID NO: 5 or SEQ ID NO: 8. (Claims 41 and 42.)
Claims 14, 21, 29, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 21, 29, and 58 of U.S. Patent No. RE50,753. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 14, 21, and 29 of RE’753 are species within the scope of examined claims 14, 21, and 29, respectively, and therefore anticipate them.
Regarding examined claim 40, RE’753 claims a method of producing a recombinant adenovirus comprising transfecting a cell with an isolated polynucleotide having a deletion in or of an E1 region as compared to sAd4310 and comprising a nucleotide sequence having at least 90% sequence identity over the entire sequence of SEQ ID NO: 11. (Claim 58.) The transfected cell also contains a rescue vector comprising an E1 region of sAd4310, which is narrower than examined claim 40’s requirement for a cell that is “engineered to rescue the E1 deletion.” The method of RE’753 claim 58 contains steps of culturing the cell in a suitable medium to permit replication of the isolated polynucleotide and harvesting the resulting adenovirus from the medium and/or cell. Claim 58 of RE’753 therefore anticipates examined claim 40, which is broader with respect to the nature of the E1-deletion rescue.
Conclusion
Claims 1-45 are rejected.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent Nos. 10,781,427 or RE50,753 are or were involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lora E Barnhart Driscoll, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/
Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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