Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
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. This application, filed December 18, 2024, is a reissue of U.S. Patent 8,309,707 (hereinafter the ‘707 patent), which issued from U.S. application Serial No. 12/584,625 (the ‘625 application) with claims 1-3 on November 13, 2012.
Inter Partes Review (IPR)
IPR 2023-00875 for the ‘707 patent concluded with issuance of a certificate cancelling claims 1-2 on February 18, 2025. As per MPEP 1410, Applicant must provide a copy of the IPR certificate. Currently, a copy of the IPR certificate is not present in the reissue file.
Additionally, since issued claims 1 and 2 were cancelled by the IPR certificate, they must be presented in the reissue application with strikethrough. As noted in MPEP 1453.VI(B), “[a] claim canceled by the certificate must be deleted by a direction to strike through the claim, i.e., the canceled claim(s) should be lined through, and not surrounded by brackets.” Applicant may present reissue claims 1 and 2 as new claims, e.g., new claims 9 and 10. In particular, reissue claims 1 and 2, as presented in the amendment filed 12/18/2024, are examined in the instant Office action, but must be presented as new claims since claims 1 and 2 no longer exist in the ‘707 patent.
Note that when presenting issued claim 1 and 2 with strikethrough, the text of claims 1 and 2 must match the text of issued claims 1 and 2. Currently, in claim 2, the eleventh line on p. 4 of the amendment recites the phrase: “or, B is a modified nucleoside base radical selected from the group consisting of”. However, issued claim 2, at col. 36 lines 1-2, recites “or B is selected from the group of modified nucleoside base radicals selected from the group consisting of”.
Sequence Listing
The present reissue application has a sequence listing.
During the prosecution of the application that became the ‘214 patent, Applicant filed the requirements for a patent application containing DNA sequence disclosure. However, the required sequence information is not present in the instant reissue application pursuant to 37 CFR §§1.804 and 1.821-1.839. As such, applicant must resubmit all required documents and statements directed to the sequence as well as the computer readable format (CRF) in this reissue application to have a compliant sequence for this reissue application that is processed by SCORE and STIC at the USPTO. See MPEP §§1410, 2412 and 2422.03.
Non-Compliant Amendment
The claim amendment filed 12/18/2024 is improper. The amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, a compliant amendment is required with Applicant’s next response. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and (2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
Amended claim 3 has added the term “Formula (1)” at line 3 of the claim without underling. Note that “Formula (1)” is not present in issued claim 3 at col. 36, line 21.
Amended claim 3 has changed the term “N,N” to “N.N” at each of the fifth line from the bottom on p. 5 of the amendment and the fourth line from the top on p. 6 of the amendment, without using underlining and bracketing. The term should be restored as “N,N”.
Amended claim 3 has added a comma immediately after the term “isoproylphenoxyacetylguaninyl)-“ at the last line on p. 5 of the amendment. The comma is not present in issued claim 3 and thus, must be underlined.
Claim Objections
Claims 1-3 are objected to because of the following informalities: In claim 1 at the last line on p. 2, in claim 2 at the thirteenth line on p. 4, and in claim 3 at the fifth line on p. 6, there should be a space after the comma in the term “cytosinyl)-,1”. Appropriate correction is required.
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 1-5 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.
In each of claims 1-3, the selection for B includes the following radicals: “-9-(N6-benzoyladeninyl)-“ and “-(5-fluoro-uracil)-“. These radicals are indicated as being divalent since they have leading and ending bonds. However, B in Formulas (1) and (2) in claims 1-3 is shown as being monovalent, not divalent. Accordingly, claims 1-3 are indefinite in view of the recitation of divalent radicals “-9-(N6-benzoyladeninyl)-“ and “-(5-fluoro-uracil)-“ for B, i.e., it is unclear what else constitutes B.
Likewise, in claims 4 and 5, the radical “-9-(N6-benzoyladeninyl)-“ for B is divalent. However, B in structure 16 is shown as being monovalent, not divalent. Accordingly, claim 5 is indefinite in view of the recitation of divalent radical “-9-(N6-benzoyladeninyl)-“ for B.
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, 2 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 8,933,214 (the ‘214 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1 and 2, claim 1 of the ‘214 patent sets forth a process that utilizes compounds having the following Formulas 1 and 2:
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146
256
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102
218
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,
wherein R1, R2, R3, X1, W, R4 and B in the above Formula 1 are the same as R1, R2, R3, Z, W and R4, respectively, in instant Formula 1; and M, Z, B and R in the above Formula 2 are the same as M, Z, B and R4, respectively, in instant Formula 2.
Formula 1 in claim 1 of the ‘214 patent reads on Formula 1 in instant claim 1 when Y is selected as an oxygen atom out of an oxygen atom and a sulfur atom.
Formula 2 in claim 1 of the ‘214 patent reads on Formula 2 in instant claim 2 when W is selected as an oxygen diradical out of an oxygen diradical, a N-H diradical and a fluorine radical.
Accordingly, claim 1 of the ‘214 patent anticipates instant claims 1 and 2.
With respect to instant claims 4-8, Formula 1 in claim 1 of the ‘214 patent is generic to the phosphoramidite compounds of structure 16 here claimed. However, the instantly claimed compounds are disclosed in the ‘214 patent specification at col. 15, lines 3-30.
Since the instantly claimed compounds are taught within the disclosure of the ‘214 patent, it would have been obvious for a person of ordinary skill in the art to select the instantly claimed compounds to practice the method in claim 1 of the ‘214 patent. One of ordinary skill in the art would understand that the instantly claimed compounds are within the scope of the generic compound of Formula I present in claim 1 of the ‘214 patent. Accordingly, claims 4-8 are rendered obvious by the claim 1 of the ‘214 patent.
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 proceed-ing in which Patent No. 8,309,707 is or was involved. These proceedings would include interferences, reissues, reexaminations, 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 mate-rial to patentability of the claims under consideration in this reissue appli-cation. 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 ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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 on 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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Signed:
/ALAN D DIAMOND/Patent Reexam Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexam Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 X in Formula 2 in claim 1 of the ‘214 patent is a typo and should be “Z” since Z is defined in claim 1 of the ‘214 patent at col. 38, lines 16-18. There is no X defined in claim 1 of the ‘214 patent. Also, in Formula 2 presented in the ‘214 patent specification, “Z”, not “X”, is present (see col. 13, lines 45-53).
Prosecution Insights