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 March 10, 2023, is a reissue continuation of U.S. application Serial No. 17/002,115 (hereinafter the parent ‘115 reissue application) filed August 25, 2020, now RE 49,575, which is a reissue of U.S. Patent 10,059,707 (hereafter the '707 patent), which issued from U.S. application Serial No. 15/329,043 (the ‘043 application) with claims 1-24 on August 28, 2018.
Claims Under Reissue
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification. In re Reuter, 651 F.2d 751, USPQ 249 (CCPA 1981) (claims given "their broadest reasonable interpretation consistent with specification"). This reissue application contains claims 25-36 directed to a compound of formula (I) in crystalline form of polymorph I. Claims 25 and 32 are independent and representative.
25. A compound of the formula (I) in crystalline form of polymorph I
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produced by a process of obtaining a compound of formula (I) present in one or more polymorphs or as a solvate in an inert solvent, stirring at a temperature of 20°C - 120°C, and isolating the compound of the formula (I) in crystalline polymorph I, wherein the x-ray diffractogram of the compound of the formula (I) in crystalline polymorph I exhibits peak maxima of the 2 theta angle at 8.5, 14.1, and 19.0.
32. A compound of the formula (I) in crystalline form of polymorph I
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prepared by a process comprising obtaining the compound of formula XIII
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separating the compound of formula XIII by chiral separation to obtain the compound of formula I, dissolving the compound of formula I in an inert solvent, stirring at a temperature of 20 °C - 120 °C and isolating the compound of the formula (I) in crystalline form of polymorph I, wherein the x-ray diffractogram of the compound of the formula (I) in crystalline form of polymorph I exhibits peak maxima of the 2 theta angle at 8.5, 14.1, and 19.0.
Issues Resolved
The Reissue Declaration and Consent of Assignee filed 11/10/2025 are accepted. Accordingly, the rejection of claims 25-36 under 35 USC 251 as being based on a defective reissue declaration, and the objection to the instant application under 37 CFR 1.172(a) as lacking the written consent of all assignees, are moot.
The Terminal Disclaimer filed 11/10/2025 is accepted. Accordingly, the non-statutory double patenting rejection over the claims of co-pending Application No. 18/514,674 has been overcome.
Statement Under 37 CFR 3.73(c)
The Statement Under 37 CFR 3.73(c) filed 11/10/2025 is improper since it does not list the patent number (10,059,707) and issue date (Aug. 28, 2018) at the top of the form. Nonetheless, the prior Statement Under 37 CFR 3.73(c) filed 03/10/2023 is proper for the reissue application. A new Statement Under 37 CFR 3.73(c) is not required.
Claim Rejections - 35 USC § 251
Claims 25-36 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.II.
During prosecution of the ‘043 application which became the ‘707 patent, a Restriction Requirement (hereinafter “Restriction”) was made 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 using a compound of claim 1.
Group IV, claim 10-24, drawn to a process of preparing a compound of formula I.
On p. 3 of the Restriction, the reasons for insisting on restriction were provided:
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, let alone a compound of formula I in crystalline form of polymorph l, as per non-elected Group I.
As set forth in MPEP 1412.01(I) (emphasis added):
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 25-36 are directed to a compound of formula I in crystalline form of polymorph I. Reissue claims 25 and 32, and claim 1 of the Restriction, are produced below in the following charts:
Reissue Claim 25
Claim 1 of the Restriction
A compound of the formula (I) in crystalline form of polymorph I
Compound of formula (I) in crystalline form of polymorph I
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produced by a process of obtaining a compound of formula (I) present in one or more polymorphs or as a solvate in an inert solvent, stirring at a temperature of 20°C - 120°C, and isolating the compound of the formula (I) in crystalline polymorph I;
wherein the x-ray diffractogram of the compound of the formula (I) in crystalline polymorph I exhibits peak maxima of the 2 theta angle at 8.5, 14.1, and 19.0.
characterized in that the x-ray diffractogram of the compound exhibits peak maxima of the 2 theta angle at 8.5, 14.1, 17.2, 19.0, 20.5, 25.6, 26.5.
Reissue Claim 32
Claim 1 of the Restriction
A compound of the formula (I) in crystalline form of polymorph I
Compound of formula (I) in crystalline form of polymorph I
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prepared by a process comprising obtaining the compound of formula XIII
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separating the compound of formula XIII by chiral separation to obtain the compound of formula I, dissolving the compound of formula I in an inert solvent, stirring at a temperature of 20° C - 120° C and isolating the compound of the formula (1) in crystalline form of polymorph I;
wherein the x-ray diffractogram of the compound of the formula (I) in crystalline polymorph I exhibits peak maxima of the 2 theta angle at 8.5, 14.1, and 19.0.
characterized in that the x-ray diffractogram of the compound exhibits peak maxima of the 2 theta angle at 8.5, 14.1, 17.2, 19.0, 20.5, 25.6, 26.5.
Despite reissue claims 25 and 32 having product-by-process steps, they are substantially identical to claim 1 of the Restriction since claims 1, 25 and 32 are directed to a compound of formula I in crystalline form of polymorph I, and the three peak maxima recited in reissue claims 25 and 32 are also recited in claim 1 of the Restriction.
Reissue claims 25-36, directed to a compound of the formula (I) in crystalline form of polymorph I, would have been grouped with the compound of formula I in crystalline form of polymorph l of non-elected Group I, and thus would not have been examined with the elected method claims. Furthermore, Applicant did not file a continuing application directed to the non-elected compound of formula I in crystalline form of polymorph l.
As stated above, a restriction requirement was made in the ‘043 application, Applicant permitted the elected method of making claims to issue in the ‘707 patent without filing a continuing application to pursue claims directed to the compound of formula (I) in crystalline form of polymorph I as in claim 1 of the Restriction or as in reissue claims 25-36. The reissue applicant’s failure to timely file a continuing application to the compound of formula (I) in crystalline form of polymorph I 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.
Claims 25-36 are rejected under 35 U.S.C. 251 as being broadened in a reissue application filed outside the two year statutory period.
As noted above, the present reissue application, filed March 10, 2023, is a reissue continuation of the parent ‘115 reissue application filed August 25, 2020, which is a reissue of the '707 patent, which issued on August 28, 2018.
The parent ‘115 reissue application did not unequivocally indicate an intent to broaden. Rather, the error statement in the reissue declaration filed 08/25/2020 stated the following (emphasis added):
Formulas (XI) and (XII) are incorrect in some instances in the specification and in claims 3-5 and 7-15. In this reissue application, the specification and claims 3-5 and 7-15 are amended so Formulas (XI) and (XII) are correct wherever they appear. Applicant believes correcting these errors does not broaden the claims; however, in an abundance of caution, Applicant defers to the USPTO for this determination.
Likewise, the Remarks filed 08/25/2020 noted that the correction of formulas (XI) and (XII) is a correction of obvious errors (p. 89).
The Office Action mailed 04/11/2022 (p. 2) agreed there was no broadening and stated the following (emphasis added):
It is agreed with as argued in the Remarks filed 08/25/2020 and the reissue declaration filed 08/25/2020 that correction of chemical formulas (XI) and (XII) in the specification and claims is a matter of correcting an obvious error, not one of broadening. Formulas (XI) and (XII) were known in the art as evidenced by the known process scheme discussed at col. 2, line 6 through col. 4, line 41 of the ‘707 patent specification.
Instant reissue claims 25-36, which were presented for the first time on 03/10/2023 in the present reissue application, were filed more than two years after issuance of the ‘707 patent on August 28, 2018.
Reissue claims 25-36, which are product-by-process claims directed to the compound of formula (I) in crystalline form of polymorph I, are broader than issued claims 1-24, which are directed to various methods. Reissue claims 25-36, which are product-by-process claims directed to the compound of formula (I) in crystalline form of polymorph I, are broader than issued claims 1-24, which are directed to various methods. See MPEP 1412.03.III, which notes that a new category of invention added in reissue is generally considered as broadening of the invention.
A claim is broader in scope than the original claims if it contains within its scope any conceivable product or process which would not have infringed the original patent. A claim is broadened if it is broader in any one respect even though it may be narrower in other respects.
Response to Arguments
Applicant's arguments filed November 10, 2025 have been fully considered but they are not persuasive.
Arguments with respect to the rejection of claims 25-36 under 35 USC 251 for lack of any defect in the original patent and lack of any error in obtaining the original patent:
Applicant argues the following on p. 56 of the Remarks:
Nowhere does the ‘707 patent examiner address product-by-process claims. The law on reissue does not provide for the Patent Office to later redetermine what would have happened if the reissue claims had been considered in the prosecution of the original patent and its requirement for restriction. The Patent Office is bound to follow the terms of its own prior examination. That prior examination was of claims to a compound without elements of the process by which it was produced. Because the instant claims are not the same as the claims present in the ‘707 patent’s prosecution when the restriction requirement issued, the claims are not now barred under section 251 as lacking a defect that is correctable by reissue.
Applicant’s arguments are unpersuasive. The Orita1 doctrine precludes reissue applicants from obtaining the same or substantially identical claims to those of non-elected groups identified in an examiner’s restriction requirement when such claims could not have been prosecuted in the application from which they were restricted. As set forth above in the rejection, though reissue claims 25 and 32 have product-by-process steps, they are substantially identical to claim 1 of the Restriction Requirement. In particular, claim 1 of non-elected Group I and reissue claims 25 and 32 are directed to a compound of formula I in crystalline form of polymorph I, and the three peak maxima recited in reissue claims 25 and 32 are also recited in claim 1 of the Restriction Requirement. Accordingly, the Orita doctrine bars Applicant from obtaining claims 25-36 in a reissue application.
Applicant argues that the Restriction Requirement was never finalized (Remarks, p. 56). In particular, Applicant argues (pp. 57-58 of the Remarks) that they presented all new claims after the Restriction Requirement, and in response, the Office stated the following:
Newly submitted claims 25-45 [sic, 25-48] are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Original claims 1-25 were drawn to specific crystalline forms of a compound of polymorph | 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.
Applicant further cites an unpublished Federal Circuit decision, i.e., In re Swartzel, and argues that the Orita doctrine has been narrowly construed to require a clear restriction requirement (Remarks, p. 57). Applicant argues that in Swartzel, claims that had been refused entry in the original prosecution were allowed to be part of the reissue application even though the USPTO argued that the refusal was “tantamount” to a restriction requirement (Remarks, p. 57). Applicant argues that the restriction requirement in the ‘043 application was never made final, and thus, the “divisional doctrine” in Orita does not apply (Remarks, p. 58).
Applicant’s arguments are unpersuasive. The fact pattern in Swartzel is distinguished from the instant case. In Swartzel, the Examiner denied entry of an amendment that canceled all process claims and added product-by-process claims in their place. Swartzel and his attorney admitted that they did not understand how the PTO interprets product-by-process claims, and that on appeal he was informed by the examiner that the PTO treats product-by-process claims as product claims without regard to process limitations. Swartzel did not believe that a divisional application could be filed because of his erroneous factual belief that others had created the product first. Declaratory evidence was also provided establishing that Swartzel and his representative misunderstood the scope of the product by process claims. The Federal Circuit ruled that “Swartzel cannot be said to have intentionally forfeited claims covering the liquid whole egg product. He did not understand that to be the scope of the unentered claims when he forfeited them.”
In the instant case, there was a restriction requirement rather than an action by the Office “tantamount” to a restriction requirement, and there is no evidence that Applicant misunderstood how the claims of the restricted groups would be interpreted.
As noted above in response to the restriction requirement, Applicant elected Group IV directed to the process of preparing a compound of formula (I), and filed an amendment that cancelled all claims, i.e., claims 1-24, and presented new claims 25-48 directed to processes for preparing compounds. In the Remarks (filed 09/07/2017) accompanying Applicant’s election, Applicant stated (p. 25):
Nevertheless, to be responsive [to the Restriction Requirement], 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)).
In a subsequent Office action mailed 10/19/2017, the Office held Applicant’s response to the Restriction Requirement to be non-responsive. The Office action noted that “[t]he newly submitted claims [25-48] are drawn to a process of preparing the compound generally; not limited to the polymorphic form.” (See p. 2). Nonetheless, unlike Swartzel, the Office entered claims 25-48, which subsequently issued as process claims 1-24 of the ‘707 patent without any further amendment.
There was no need for the Office to make the restriction requirement “final” since Applicant acquiesced to the restriction requirement by cancelling all claims to the non-elected groups, including the claims directed to the compound of formula I in crystalline form of polymorph l of non-elected Group I. In the Remarks accompanying the election, Applicant “respectfully disagree[d]” with the Restriction Requirement but did not provide any reasons why the Restriction Requirement was in error. By acquiescing to the Restriction Requirement and failing to file divisional applications on the subject matter of non-elected claims, Applicant foreclosed (because that was not error) their right to claim that subject matter.
Furthermore, to the extent Applicant has any concerns with the propriety of the Restriction Requirement (e.g., due to said finality), as noted in the In re Watkinson, 900 F.2d 230, 14 U.S.P.Q.2d 1407 (Fed. Cir. 1990) (emphasis added), “we reject Watkinson's argument and hold that the failure to file a divisional application, regardless of the propriety of the underlying restriction requirement, is not an error correctable by reissue under 35 U.S.C. § 251.”
Accordingly, the rejection of claims 25-36 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 is maintained.
Arguments with respect to the rejection of claims 25-36 under 35 USC 251 as being broadened in a reissue application outside the two year statutory period:
Applicant argues the following on p. 58 of the Remarks:
The ‘115 reissue application included a declaration where the box for identifying a broadening reissue by a claim to be broadened and by checking the box was completed - Applicant identified claims to be broadened and checked the box. The public was on notice that a timely filed broadening reissue existed.
Again, the Office tries to ignore what is of record and instead rewrite the record.
The Federal Circuit in In re Staats, 671 F.3d 1350 (2012) interpreted the two-year time limit of section 251 as merely requiring application within two years and identification of the application as broadening; no relationship between the original correction and subsequent broad claims was required. In the instant case, the Office now decides that the original error was not broadening and so, in this manner, attempts to revoke what is on the record. The Office does not have the authority to do this.
Applicant’s arguments are unpersuasive. The sole reissue declaration filed 08/25/2020 in parent reissue application 17/002,115 does not have a box to be checked indicating that the application is a broadening reissue.
As noted above in the rejection, the error statement in said reissue declaration filed 08/25/2020 stated that (emphasis added) “Applicant believes correcting these errors does not broaden the claims; however, in an abundance of caution, Applicant defers to the USPTO for this determination.” Likewise, Applicant’s accompanying Remarks filed 08/25/2020 stated that they are correcting obvious errors (see p. 89).
Contrary to Applicant’s argument, the Office is not attempting to “revoke what is of record.” Rather, the Office action mailed 04/11/2022 (p. 2) in parent reissue application 17/002,115 agreed with Applicant that what was being correcting was an obvious error and there was no broadening. Since Applicant did not unequivocally indicate an intent to broaden in parent reissue application 17/002,115 within two years of the ‘707 patent issue date of Aug. 28, 2018, Applicant cannot now broaden the ‘707 patent claims in the instant reissue application outside of two years. See MPEP 1412.03.IV.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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. 10,059,707 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.
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
1 In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977).
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