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 .
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 November 20, 2023, is a reissue continuation of Ser. No. 17/087,659, filed November 3, 2020, which is a reissue of U.S. Patent 10,399,977 (hereafter the '977 patent), which issued from U.S. application Serial No. 16/114,198 (the ‘198 application) with claims 1-24 on September 3, 2019.
Certificate of Correction
There are multiple reissue applications for the ‘977 patent including the current reissue application and serial No. 17/087,659, now RE49,659. 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). It is acknowledged that the first sentence of the instant specifications recites a cross reference to the other reissue application. However, since 17/087,659 has issued as a reissue patent, it is requested that Applicant file a Certificate of Correction in the reissue patent to provide a cross reference to all the reissue applications of the ‘977 patent. See, e.g., MPEP 1451.I.
Non-Compliant Amendment
The amendment to the claims filed 11/20/2023 does not comply with 37 CFR 1.173 which sets for the manner of making amendments in reissue applications. While the improper amendment has 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:
The chemical structure in each of claims 25-27 is not underlined. Since claims 25-27 are new claims, they must be underlined in their entireties.
Defective Reissue Declaration and Claim Rejection - 35 USC § 251
The reissue oath/declaration filed with this application is defective for the following reasons. See 37 CFR 1.175 and MPEP § 1414.
The error set forth in the each of the reissue declarations filed 11/20/2025 is as follows:
1. Formulas (XI) and (XII) are incorrect in some instances in the specification.
2. Claims 1-5 are defective for claiming less than patentee had the right to claim in the patent. Claims 1-5 claim processes for preparing intermediates useful in the production of a compound of formula (I). Claims 1-5 are defective for not claiming the compound of formula (I) in crystalline polymorph I form, medicaments comprising crystalline polymorph I, and methods of prophylaxis and/or treatment of diseases by administering crystalline polymorph I.
Error No. 1 has already been corrected with the same specification amendment in parent reissue 17/087,659. As such, the error cannot support the instant reissue application.
Additionally, error No. 2, i.e., not claiming the compound of formula (I) in crystalline polymorph I form, medicaments comprising crystalline polymorph I, and methods of prophylaxis and/or treatment of diseases by administering crystalline polymorph I, is not an error correctable by reissue. See the rejection below of claims 25-34 under 35 U.S.C. 251 for lack of any defect in the original patent and lack of any error in obtaining the original patent.
Accordingly, since the errors stated in the reissue declaration cannot support a reissue of the ‘977 patent, the reissue declaration is defective.
Claims 25-34 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(s) in the reissue declaration is set forth in the discussion above in this Office action.
Claims 25-34 are rejected under 35 U.S.C. 251 for lack of any defect in the original patent and lack of any error in obtaining the original patent. See MPEP 1412.01(I).
The ‘977 patent issued from application Serial No. 16/114,198 (the ‘198 application), which is a continuation of application Serial No. 15/329,043 (the ‘043 application), which issued as U.S. patent 10,059,707 (the ‘707 patent).
During prosecution of the ‘043 application, the Examiner made a Restriction Requirement (hereinafter “Restriction”) on 07/07/2017 with respect to claims 1-24 based on the following four groups:
“Group I, claims 1-3, 6 and 7, drawn to a compound of formula I in crystalline form of polymorph l.
Group Il, claim 4, drawn to a process of preparing a compound of formula (I) in crystalline form of polymorph I.
Group Ill, claim 9, drawn to a method of [treatment of cardiovascular disorders] using a compound of claim 1.
Group IV, claim 10-24, drawn to a process of preparing a compound of formula (I).”
On p. 4 of the Restriction, the Examiner provided the reason for insisting on restriction: “In the instant application, the related technical feature of Groups I-IV is the compound of formula I. The related technical feature is known in the art and, therefore, does not constitute a special technical feature. See references cited in the International Search Report submitted January 25, 2017.”
On 09/07/2017, Applicant elected Group IV directed to the process of preparing a compound of formula (I), and filed an amendment that cancelled claims 1-24 and presented new claims 25-48. In the Remarks filed 09/07/2017 accompanying the election and amendment, Applicant stated the following:
Applicant respectfully disagrees [with the restriction requirement]. Nevertheless, to be responsive, Applicant elects Group IV, directed to a process of preparing a compound of formula (I). After entry of this amendment, at least claims 25-44 are within the elected restriction group. Claims 45-48 are dependent from claims within Group IV and further recite steps to form a compound of formula (I) in crystalline form of polymorph (I). It is urged that these claims be considered together with the claims in Group IV (which are directed to preparing a compound of formula (l)). Consideration of both sets of claims would not be burdensome on the Patent Office. Claims 45-48 depend from claims within the elected restriction group and, like the elected claims, also recite processes of preparation. Also, the subject matter of claims 45-48 is sufficiently close to the subject matter of the claims from which they depend to make examination of all the claims reasonable.
In an Office Action mailed 10/19/2017, the Examiner considered Applicant’s response filed 09/07/2017 to the Restriction to be non-responsive but nonetheless proceeded with prosecution and stated the following: “Original claims 1-25 [sic, 1-24] were drawn to specific crystalline forms of a compound of polymorph I and methods of preparing the specific polymorphic forms. The newly submitted claims are drawn to a method of preparing the compound generally; not limited by the polymorphic form. Accordingly, Applicant’s response to the July 7, 2017, Restriction Requirement is considered nonresponsive. Nonetheless, in order to advance prosecution claims 25-45 [sic, 25-48] have been examined below.” (See p. 2 of the Office Action).
Claims 25-48 subsequently issued as claims 1-24 of the ‘707 patent without any further amendment. None of claims 1-24 in the ‘707 patent are directed to a compound as per non-elected Group I, a medicament comprising the compound, a method for treatment of cardiovascular disorders as per non-elected Group III, or any other method of treatment.
The ‘198 application was subsequently filed on 08/27/2018 as a continuation of the ‘043 application with the same twenty-four claims that were restricted into four groups in the Restriction in the ‘043 application. Prior to an Office action, Applicant, on 09/14/2018, cancelled claims 1-24 and presented claims 25-48, which correspond with and are very similar to the method of preparing in claims 1-24 that issued in the ‘707 patent. Claims 25-48 of the ‘198 application subsequently issued as claims 1-24 of the ‘977 patent. Like the ‘707 patent, none of claims 1-24 in the ‘977 patent are directed to a compound as per non-elected Group I, a medicament comprising the compound, a method for treatment of cardiovascular disorders as per non-elected Group III, or any other method of treatment.
As set forth in MPEP 1412.01(I):
Where a restriction (or an election of species) requirement was made in an application and applicant permitted the elected invention to issue as a patent without filing a continuing application on the non-elected invention(s) or on non-claimed subject matter distinct from the elected invention, the non-elected invention(s) and non-claimed, distinct subject matter cannot be recovered by filing a reissue application. A reissue applicant’s failure to timely file a continuing application is not considered to be error causing a patent granted on the elected claims to be partially inoperative by reason of claiming less than the applicant had a right to claim. Accordingly, this is not correctable by reissue of the original patent under 35 U.S.C. 251. See In re Watkinson, 900 F.2d 230, 14 USPQ2d 1407 (Fed. Cir. 1990); In re Weiler, 790 F.2d 1576, 229 USPQ 673 (Fed. Cir. 1986); In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977); see also In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978). In this situation, the reissue claims should be rejected under 35 U.S.C. 251 for lack of any defect in the original patent and lack of any error in obtaining the original patent. Compare with In re Doyle, 293 F.3d 1355, 63 USPQ2d 1161 (Fed. Cir. 2002) where the court permitted the patentee to file a reissue application to present a so-called linking claim, a claim broad enough to read on or link the invention elected (and patented) together with the invention not elected. The non-elected invention(s) were inadvertently not filed as a divisional application.
Reissue claims 25-34 are directed to a compound of formula (I) in crystalline form of polymorph (I) (claims 25-27), a medicament comprising the compound (claim 28), a method for prophylaxis and/or treatment of cardiovascular disorders (claims 29. 31 and 32), and a method for prophylaxis and/or treatment of heart failure (claims 30, 33 and 34). The compound claims, i.e., reissue claims 25-27, are the independent reissue claims and are identical to compound claims 1-3 in Group I of the Restriction. Like the compound of formula I in crystalline form of polymorph l of non-elected Group I and the method of treatment of cardiovascular disorders in non-elected Group III, the subject matter of reissue claims 25-34 would not have been examined with the elected subject matter of Group IV, and thus, claims 29-34 cannot be obtained through reissue.
As stated above, a restriction requirement was made in the ‘043 application, Applicant permitted the elected method of making claims to issue in each of the ‘707 and ‘977 patents without filing a continuing application on non-elected invention(s), or on non-claimed patentably distinct subject matter, such as the compound and composition in reissue claims 25-28 and the method of using the compound as in reissue claims 29-34. The reissue applicant’s failure to timely file a continuing application to present reissue claims 25-34 is thus not a defect in the original patent or an error in obtaining the original patent. Accordingly, such is not correctable by reissue of the original patent under 35 U.S.C. 251. Thus, claims 25-34 are not further treated on the merits.
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. 10,399,977 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 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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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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