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 June 23, 2025, is a reissue continuation of U.S. application Serial No. 18/159,328, filed January 25, 2023, now U.S. Patent RE50,497, which is a reissue continuation of U.S. application Serial No. 17/013,342, filed September 4, 2020, now U.S. Patent RE49,445, which is a reissue continuation of U.S. application Serial No. 16/164,681, filed October 18, 2018 now U.S. Patent RE48,285, which is a reissue of U.S. Patent 9,469,613 (hereafter the '613 patent), which issued from U.S. application Serial No. 14/736,690 (the ‘690 application, filed June 11, 2015) with claims 1-23 on October 18, 2016.
Reissue Continuation
It is acknowledged that the specification of the instant reissue application has been amended so as to recite a cross reference to the prior reissue applications for the ‘613 patent, i.e., Serial Nos. 18/159,328, 17/013,342 and 16/146,681. However, the specifications in Serial Nos. 18/159,328, 17/013,342 and 16/146,681 have not been amended so as to recite a cross reference to the instant application. 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). See MPEP also 1451.I. Since Serial Nos. 18/159,328, 17/013,342 and 16/146,681 have issued as reissue patents, it is requested that the amendments to their specifications be taken care of by Applicant by Certificate of Correction.
For example, each Certificate of Correction for 18/159,950 may state: “Notice: More than one reissue application has been filed for the reissue of Patent No. 9,469,613. The reissue applications are application number 19/245,507, 18/159,328 (now RE50,497), 17/013,342 (now RE49,445), and 16/164,681 (now RE48,285).”
Reissue Declaration and 35 USC 251
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The error statement in the reissue declaration is as follows:
The patentee claimed less than the patentee had the rights to claim in the U.S. Pat. No. 9,469,613 (the "613 patent"). As filed on June 11, 2015, application serial no. 14/736,690, from which the '613 patent issued (the "792 application") included claims that were drawn to the composition of various salt forms and polymorphs of N-(Cyanomethyl)-4-(2-(4-Morpholinophenylamino)Pyrimidin-4-yL) benzamide. The Preliminary Amendment filed concurrently with this reissue application is broadening, in that it adds new claims 24-46 directed to a method of treatment to maintain or elevate hemoglobin levels in a subject experiencing anemia or hemoglobin decline that is described in the specification of the '613 patent.
This error statement is defective because the instant reissue application is a broadening reissue application, but the above error statement fails to identify an issued claim that is being broadened and fails to identify a single word, phrase, or expression in the issued claim, and how it renders the original patent wholly or partly inoperative or invalid. See MPEP 1414.II(B). Claims 24-26 identified in the error statement are new claims, not original claims.
Applicant is required to provide a new reissue declaration with an acceptable error statement. An example of an acceptable error statement is as follows:
This is a broadening reissue application and claim 23 is to be broadened. Claim 23 is unduly narrow because it is limited to a method treating a disease associated with Janus Kinase (JAK). New claims 24-46 are added and are directed to a method treatment to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline.
Claims 24-46 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 27-31, 33-35 and 37-39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 27-31 depend from claim 26, which requires that the compound in crystalline form is N-(cyanomethyl)-4-(2-(4-morpholinoohenylamino)pyrimidin-4-yl)benzamide dihydrochloride monohydrate, Form II. The cell unit parameters in claim 27, the X-ray powder diffraction (XRPD) pattern of claim 28 which is substantially as set forth in Fig. 5, the XRPD peaks in claim 29, the differential scanning calorimetry (DSC) pattern of claim 30 which is substantially as set forth in Fig. 8, and the dynamic vapor sorption (DVS) pattern of claim 31 which is substantially as set forth in Fig. 14, are inherent characteristics of said crystalline Form II. In particular, see Table 1, Example 1 and Table 2 of the ‘613 patent specification. Accordingly, claims 27-31 do not further limit the crystalline form compound in claim 26.
Claims 33-35 depend from claim 32, which requires that the compound in crystalline form is N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrirnidin-4-yl)benzarnide monohydrochloride anhydrous, Form I. The XRPD pattern of claim 33 which is substantially as set forth in Fig. 6, the XRPD peaks in claim 34, and the DSC pattern of claim 35 which is substantially as set forth in Fig. 9, are inherent characteristics of said crystalline Form I. In particular, see Table 1 and Example 1 of the ‘613 patent specification. Accordingly, claims 33-35 do not further limit the crystalline form compound in claim 32.
Claims 37-39 depend from claim 36, which requires that the compound in crystalline form is N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide monohydrochloride anhydrous, Form III. The XRPD pattern of claim 37 which is substantially as set forth in Fig. 7, the XRPD peaks in claim 38, and the DSC pattern of claim 39 which is substantially as set forth in Fig. 10, are inherent characteristics of said crystalline Form III. In particular, see Table 1 and Example 1 of the ‘613 patent specification. Accordingly, claims 37-39 do not further limit the crystalline form compound in claim 36.
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 24-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. RE48,285 (hereinafter the ‘285 patent).
With respect to instant claims 24-39 and 45, claims 1-16 of the ‘285 patent are directed to Form I, Form II or Form III of N-(cyanomethyl)-4-(2-4-morpholinophenylaminolpyrimidin-4-yl)benzamide dihydrochloride monohydrate. Claim 19 of the ‘285 patent further teaches Form II in a pharmaceutical composition in an amount equivalent to 50 mg, 100 mg, 150 mg or 200 mg of free base.
Claims 1-16 and 19 of the ‘285 patent differ from instant claims 24-29 and 45 in not teaching use of the compound to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline.
However, the ‘285 patent specification teaches that a contemplated utility for the compound is to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline (see col. 22, lines 31-52).
It would have been obvious to one of ordinary skill in the art to have used the compound and pharmaceutical composition in claims 1-16 and 19 of the ‘285 patent to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline because such is a contemplated utility of the compound/composition, as taught by the ‘285 patent specification. See MPEP 804.II.B.1.
Instant claims 40-44 and 46 further require particular subjects with particular hemoglobin levels, the subject has undergone or is undergoing chemotherapy or radiation therapy, the subject has a particular disease, or administration of the compound once per day.
While claims 1-16 and 19 of the ‘285 patent do not teach such requirements, the requirements would have been obvious to one of ordinary skill in the art as a matter of routine optimization so as to determine which particular subjects experiencing anemia or hemoglobin decline need maintenance or elevation of hemoglobin levels, and the frequency of dosing the compound.
Claims 24-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-62 of U.S. Patent No. RE49,445 (hereinafter the ‘445 patent) in view of U.S. Patent 6,376,531 to Bell (hereinafter “Bell”).
With respect to instant claims 24-39, 45 and 46, claims 27-53 of the ‘445 patent are directed to Form I, Form II or Form III of N-(cyanomethyl)-4-(2-4-morpholinophenylaminolpyrimidin-4-yl)benzamide dihydrochloride monohydrate and a pharmaceutical composition containing the compound, wherein one or more hydrogen atoms attached to carbon atoms of the compound are replaced by deuterium. Claims 45, 47 and 49 of the ‘445 patent further teach that the compound is present in the pharmaceutical composition in an amount equivalent to 50 mg, 100 mg, 150 mg or 200 mg of free base. Claims 51-53 of the ‘445 patent also teach a single oral dose.
Claims 27-53 of the ‘445 patent differ from instant claims 24-29, 45 and 46 in not teaching use of the compound to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline.
However, the ‘445 patent specification teaches that a contemplated utility for the compound is to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline (see col. 22, lines 31-52).
It would have been obvious to one of ordinary skill in the art to have used the compound and pharmaceutical composition in claims 27-53 of the ‘445 patent to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline because such is a contemplated utility of the compound/composition, as taught by the ‘285 patent specification. See MPEP 804.II.B.1.
As noted above, one or more hydrogen atoms attached to carbon atoms of the compound in claims 27-53 of the ‘445 patent are replaced by deuterium. The compounds of the instant claims do require any deuterium. Nonetheless, Bell teaches the following at col. 6, lines 3-20 (emphasis added):
Deuterium, or heavy hydrogen, is a stable, non-radioactive isotope of hydrogen and has an atomic weight of 2.0144. It is represented by the symbol D or 2H and usually exists in the diatomic state. In nature it is a colorless and odorless gas. It is well known in the art that in the natural world hydrogen actually represents a mixture of the isotopes 1H (hydrogen), D (2H or deuterium), and T (3H or tritium). Thus, all chemical compounds comprising a hydrogen (or protium) atom or proton are always present as a mixture of deuterated and non-deuterated compounds with the portion of deuterium amounting to about 0.015 mole-percent. Therefore, in the present invention, the therapeutic compound consists of a mixture wherein the percentage of the deuterated compound over the non-deuterated compound is increased in the mixture to an amount greater than 0.015 mole-percent. In a preferred embodiment of the present invention, the percent deuterium is at least 10 mole-percent and can be as much as 100 mole-percent.
Thus, it would have been obvious to one of ordinary skill in the art to have utilized the compound in claims 27-53 of the ‘445 patent as a mixture of deuterated and non-deuterated compounds with the portion of deuterium amounting to about 0.015 mole-percent because all chemical compounds comprising a hydrogen (or protium) atom or proton are always present as such a mixture, as taught by Bell.
Instant claims 40-44 further require particular subjects with particular hemoglobin levels, the subject has undergone or is undergoing chemotherapy or radiation therapy, or the subject has a particular disease.
While claims 27-53 of the ‘445 patent do not teach such requirements, the requirements would have been obvious to one of ordinary skill in the art as a matter of routine optimization so as to determine which particular subjects experiencing anemia or hemoglobin decline need maintenance or elevation of hemoglobin levels.
Claims 24-31 and 40-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-47 of U.S. Patent No. RE50,497 (hereinafter the ‘497 patent).
With respect to instant claims 24-31 and 45, claims 24-32 of the ‘497 patent are directed to a pharmaceutical composition containing a combination of Form II of N-(cyanomethyl)-4-(2-4-morpholinophenylaminolpyrimidin-4-yl)benzamide dihydrochloride monohydrate and said Form II wherein one or more hydrogen atoms attached to carbon atoms of the compound are replaced by deuterium. Claim 32 of the ‘497 patent further teach that the Form II compounds are present in the pharmaceutical composition in an amount equivalent to 100 mg, 150 mg or 200 mg of free base.
Claims 24-32 of the ‘497 patent differ from instant claims 24-29 and 45 in not teaching use of the pharmaceutical composition to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline.
However, the ‘497 patent specification teaches that a contemplated utility for the Form II compound is to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline (see col. 22, lines 31-52).
It would have been obvious to one of ordinary skill in the art to have used the pharmaceutical composition in claims 24-32 of the ‘497 patent to maintain or elevate hemoglobin levels in a subject experiencing anemia or a hemoglobin decline because such is a contemplated utility of the Form II compound in the pharmaceutical composition, as taught by the ‘497 patent specification. See MPEP 804.II.B.1.
Instant claims 40-44 and 46 further require particular subjects with particular hemoglobin levels, the subject has undergone or is undergoing chemotherapy or radiation therapy, the subject has a particular disease, or administration of the compound once per day.
While claims 24-32 of the ‘497 patent do not teach such requirements, the requirements would have been obvious to one of ordinary skill in the art as a matter of routine optimization so as to determine which particular subjects experiencing anemia or hemoglobin decline need maintenance or elevation of hemoglobin levels, and the frequency of the dosing of the compound.
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. 9,469,613 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 Reexamination Specialist
Central Reexamination Unit 3991
Conferee:
/JOSEPH R KOSACK/ /Patricia L Engle/Patent Reexamination Specialist SPRS, CRU 3991
Central Reexamination Unit 3991
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