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 July 3, 2025, is a reissue of U.S. Patent 8,940,744 (hereafter the '744 patent), which issued from U.S. application Serial No. 14/464,602 (the ‘602 application) with claims 1-30 on January 27, 2015.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
The Consent of Assignee filed 07/03/2025 is defective because it does not state the assignee’s name in the box that states: “The assignee(s) owning an undivided interest in said original patent is/are and the assignee(s) consent to the accompanying application for reissue.”
A proper Consent of the Assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
Certificate of Correction (CofC)
As noted in MPEP 1411.01, “[t]he applicant should include any changes, additions, or deletions that were made by a certificate of correction to the original patent grant in the reissue application without underlining or bracketing. This includes changes made by a certification of correction dated before the filing of the reissue application or dated during the pendency of the reissue application. The examiner should make certain that all certificate of correction changes in the patent have been properly incorporated into the reissue application.”
The CofC issued August 16, 2016 made changes to the claims. However, the changes made to the claims were not included in the reissue amendment filed 07/03/2025. Accordingly, Applicant should incorporate the CofC changes in the claims without underlining and bracketing.
Additionally, the CofC issued August 16, 2016 has made a change to the title page, but the change has not been presented in the reissue application without underlying and bracketing. For example, Applicant’s next amendment should recite: On the title page, below the abstract replace “33 Claims, 3 Drawing Sheets” with --36 Claims, 3 Drawing Sheets--.
Non-Compliant Amendment
The amendments to the specification and claims filed 07/03/2025 are improper. The amendments do not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendments have been entered and considered, a supplemental paper correctly amending the reissue application 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 issue is as follows:
Specification
The amendment to the specification uses strikethrough rather than single bracketing to delete subject matter.
Claims
The amendment to claim 22 uses double bracketing rather than single bracketing to delete subject matter.
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, 10-13, 19-23, 28, 29 and 31-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,456,403 (the ‘403 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4 and 16 of the ‘403 patent teach a pharmaceutically acceptable salt, e.g., a sulfonic acid or carboxylic acid salt, of at least one compound selected from the (E) isomer, (Z) isomer, and a mixture of (E) and (Z) isomer of 2-[(3R)-3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]-pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile. The pharmaceutical composition in claim 16 of the ‘403 patent further includes a pharmaceutically acceptable excipient. Accordingly, claims 1, 4 and 16 of the ‘403 patent anticipate instant claims 1, 10-13, 19-21, 31, 33, 35 and 37.
The claims of the ‘403 patent differ from the instant claims 22, 23, 28, 29, 39 and 41, in not teaching the use of the compound or pharmaceutical composition to treat the Markush group of diseases here claimed.
However, the ‘403 patent specification teaches that a contemplated utility for the compound and composition is to treat diseases such as arthritis, psoriatic arthritis, lupus, uveitis, myasthenia gravis, Sjogren's syndrome, Sjogren's dry eye, non-Sjogren's dry eye disease, psoriasis, asthma, etc. (See col. 9, lines 4-57).
It would have been obvious to one of ordinary skill in the art to have used the compound or pharmaceutical composition in the ‘403 patent claims to treat a disease such as arthritis, psoriatic arthritis, lupus, uveitis, myasthenia gravis, Sjogren's syndrome, Sjogren's dry eye, non-Sjogren's dry eye disease, psoriasis, asthma, etc., because such is a contemplated utility for the compound and composition, as taught by the ‘403 patent specification. See MPEP 804.II.B.1.
Instant claims 43-46 require that the disease to be treated is “warm autoimmune hemolytic anemia.” However, the ‘403 patent specification further teaches that a contemplated utility for the compound and composition is to treat autoimmune hemolytic anemia (see, e.g., col. 9, lines 26-27 and col. 11, lines 27-29).
It would have been obvious to one of ordinary skill in the art to have used the compound or pharmaceutical composition in the ‘403 patent claims to treat autoimmune hemolytic anemia, e.g., warm autoimmune hemolytic anemia, because such is a contemplated utility for the compound and composition, as taught by the ‘403 patent specification. See MPEP 804.II.B.1.
With respect to claims 32, 34, 36, 38, 40, 42, 44 and 46, which require the (E) and/or (Z) isomer of the compound, not its salt, the use of the compound in the ‘403 patent claims in free base form would have been obvious as free base and salt are known alternative forms for pharmaceutical compounds. In fact, the ‘403 patent specification teaches that the compound can be in free base or salt form (see, e.g., Abstract and ¶ bridging cols. 2-3).
Claims 1, 10-13, 19-23, 28, 29 and 31-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,092,569 (the ‘569 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘569 patent sets forth the treatment of cutaneous lupus or lupus nephritis by administering to a mammal a pharmaceutical composition comprising: at least one compound selected from the (E) isomer, (Z) isomer, and a mixture of (E) and (Z) isomers of 2-[(3R)-3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile; and/or at least one pharmaceutically acceptable salt of any of the foregoing compounds; and at least one pharmaceutically acceptable carrier or excipient. Accordingly, the claims of the ‘569 patent anticipate instant claims 1, 10-13, 19-23, 28, 29 and 31-42.
Instant claims 43-46 require that the disease to be treated is “warm autoimmune hemolytic anemia.” This disease is not recited in the claims of the ‘569 patent as a disease to be treated. However, the ‘569 patent specification further teaches that a contemplated utility for the compound and composition is to treat autoimmune hemolytic anemia (see, e.g., col. 9, lines 26-27 and col. 11, lines 27-29).
It would have been obvious to one of ordinary skill in the art to have used the compound or pharmaceutical composition in the ‘569 patent claims to treat autoimmune hemolytic anemia, e.g., warm autoimmune hemolytic anemia, because such is a contemplated utility for the compound and composition, as taught by the ‘569 patent specification. See MPEP 804.II.B.1.
Claims 1, 10-13, 19-23, 28, 29 and 31-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,828,307 (the ‘307 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘307 patent sets forth administering to a mammal a pharmaceutical composition comprising a compound selected from the (E) isomer, (Z) isomer, and a mixture of (E) and (Z) isomer of 2-[(3R)-3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile; or a pharmaceutically acceptable salt of any of the foregoing compounds. Claim 3 of the ‘307 patent further sets forth that the pharmaceutical composition includes a pharmaceutically acceptable excipient. Accordingly, the claims of the ‘307 patent anticipate instant claims 1, 10-13, 19, 20 and 31-37.
With respect to instant claims 21 and 38, claim 1 of the ‘307 patent does not require that the pharmaceutical composition further contains a pharmaceutical excipient when a mixture of the (E) and (Z) isomers is present. However, it would have been obvious to one of ordinary skill in the art to have further included a pharmaceutically acceptable excipient in the pharmaceutical composition of claim 1 of the ‘307 patent because a pharmaceutically acceptable excipient is a conventional ingredient of a pharmaceutical composition.
Instant claims 22, 23, 28, 29 and 39-46 require particular diseases to be treated that are not recited in claims 1-4 of the ‘307 patent. However, the ‘307 patent specification further teaches that a contemplated utility for the compound and composition is to treat the instantly claimed diseases (see, e.g., col. 9, lines 4-33 and col. 11, lines 26-28).
It would have been obvious to one of ordinary skill in the art to have used the compound or pharmaceutical composition in the ‘307 patent claims to treat the diseases here claimed because such is a contemplated utility for the compound and composition, as taught by the ‘307 patent specification. See MPEP 804.II.B.1.
Claims 1, 10-13, 19-23, 28, 29 and 31-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,369,613 (the ‘613 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘613 patent sets forth the treatment of lupus nephritis by administering to a mammal a pharmaceutical composition comprising: a compound selected from (E) isomer, (Z) isomer, and a mixture of (E) and (Z) isomer of 2-[(3R)-3-[4-amino-3-(2-fluoro-4-phenoxy-phenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine-1-carbonyl]-4-methyl-4-[4-(oxetan-3-yl)piperazin-1-yl]pent-2-enenitrile; or a pharmaceutically acceptable salt thereof. Accordingly, the claims of the ‘569 patent anticipate instant claims 1, 10-13, 19, 20, 22, 23, 28, 29 and 31-37, 39-41.
With respect to instant claims 21, 38 and 42, claim 1 of the ‘613 patent does not require that the pharmaceutical composition further contains a pharmaceutical excipient when a mixture of the (E) and (Z) isomers is present. However, it would have been obvious to one of ordinary skill in the art to have further included a pharmaceutically acceptable excipient in the pharmaceutical composition of claim 1 of the ‘613 patent because a pharmaceutically acceptable excipient is a conventional ingredient of a pharmaceutical composition.
Instant claims 43-46 require that the disease to be treated is “warm autoimmune hemolytic anemia.” This disease is not recited in the claims of the ‘613 patent as a disease to be treated. However, the ‘613 patent specification further teaches that a contemplated utility for the compound and composition is to treat autoimmune hemolytic anemia (see, e.g., col. 9, lines 26-27 and col. 11, lines 27-29).
It would have been obvious to one of ordinary skill in the art to have used the pharmaceutical composition in the ‘613 patent claims to treat autoimmune hemolytic anemia, e.g., warm autoimmune hemolytic anemia, because such is a contemplated utility for the compound and composition, as taught by the ‘569 patent specification. See MPEP 804.II.B.1.
Allowable Subject Matter
Claims 2-9, 14-18 and 24-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No additional prior art that teaches or renders obvious the compound and method in claims 2-9, 14-18 and 24-27 has been made of record in the instant reissue application. Accordingly, claims 2-9, 14-18 and 24-27 are patentable for the same reasons as in the ‘744 patent file.
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. 8,940,744 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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