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 April 15, 2024, is a reissue of U.S. Patent 11,542,275 (hereafter the '275 patent), which issued from U.S. application Serial No. 18/635,580 (the ‘580 application) with claims 1-19 on January 3, 2023.
Issues Resolved
As per the petition decision mailed 07/07/2026, the domestic benefit data has been updated in accordance with the corrected Application Data Sheet of 04/28/2016.
The Consent of Assignee filed 04/28/2026 is accepted.
The reissue declaration filed 04/28/2026 is also accepted. Accordingly, the rejection of claims 1-24 under 35 USC 251 as being based on a defective reissue declaration is moot.
Non-Compliant Amendment
The amendment to the claims filed 04/28/2026 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 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 issues are as follows:
At line 1 in each of claims 4-10, the phrase “The compound of [ claim1] claim 1” should read “The compound of claim 1”. This is so because, as noted above, all amendments in reissue are made relative to the patent to be reissued, not relative to a previously submitted amendment in the reissue application. Also, the status identifier for claims 4-10 should be “original” since they are unamended relative to issued claims 4-10, which recite the phase “The compound of claim 1”.
Likewise, the bracketed underline in claims 8 and 9 should be left out of the respective claims since there is no underline in issued claims 8 and 9. Claims 8 and 9 are original, unamended claims and thus, must not contain underlining or bracketing.
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 1-3, 5, 6 and 10-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,365,205 (the ‘205 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 1-3, 10-12 and 15-17, claims 10-12 of the ‘205 patent are pertinent and are reproduced below along with claim 1 from which they are dependent:
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Claims 10-12 of the ‘205 patent differ from the instant claims in that, for example, claims 10-12 set forth that “A” in formula (IB) can be “aryl”, but do not teach that the aryl is biphenyl.
However, the ‘205 patent specification defines the term “aryl” as follows (col. 72, lines 8-20, emphasis added):
As used herein, the term “aryl” is optionally substituted monocyclic, bicyclic or polycyclic aromatic hydrocarbon ring system of about 6 to 14 carbon atoms. Examples of a C6-C14 aryl group include, but are not limited to phenyl, naphthyl, biphenyl, anthryl, fluorenyl, indanyl, biphenylenyl and acenaphthyl. Aryl group can be optionally substituted with one or more substituents selected from alkyl, halogen, hydroxyl, carboxylic acid, alkoxycarbonyl, formyl, acyl, thiocarbonyl, thioester, thioacetate, thioformate, alkoxyl, oxo, phosphoryl, a phosphate, phosphonate, phosphinate, amino, amido, amidine, imine, cyano, nitro, azido, sulfhydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido and sulfonyl group.
Accordingly, it would have been obvious to one of ordinary skill in the art to have selected biphenyl for the aryl of “A” in the compound of formula (IB) in claims 10-12 of the ‘205 patent so as to fully practice the scope of claims 10-12 as the ‘205 patent specifies that aryl for “A” can be biphenyl.
With respect to instant claims 5, 6, 13, 14 and 18, claims 10-12 of the ‘205 patent differ from the instant claims in that claims 10-12 set forth that “A” in formula (IB) can be “heteroaryl”, but do not teach that the heteroaryl is, for example, bipyridinyl as per instant claims 5 and 14, bipyrazinyl as per instant claim 6, tripyridinyl as per instant claim 13, or, for example, pyrazinyl-pyridyl as per compound 37 in instant claim 18.
However, the ‘205 patent specification defines the term “heteroaryl” as follows (col. 71, line 39 through col. 72, line 7, emphasis added):
As used herein, the term “heteroaryl” refers to an aromatic heterocyclic ring system containing 5 to 20 ring atoms, suitably 5 to 10 ring atoms, which may be a single ring (monocyclic) or multiple rings (bicyclic, tricyclic or polycyclic) fused together or linked covalently. Preferably, “heteroaryl” is a 5- to 6-membered ring. The rings may contain from 1 to 4 heteroatoms selected from N, O and S, wherein the N or S atom is optionally oxidized or the N atom is optionally quarternized. Any suitable ring position of the heteroaryl moiety may be covalently linked to the defined chemical structure.
Examples of heteroaryl include, but are not limited to: furanyl, thienyl, pyrrolyl, pyrazolyl, imidazolyl, oxazolyl, cinnolinyl, isoxazolyl, thiazolyl, isothiazolyl, 1H-tetrazolyl, oxadiazolyl, triazolyl, pyridyl, pyrimidinyl, pyrazinyl, pyridazinyl, benzoxazolyl, benzisoxazolyl, benzothiazolyl, benzofuranyl, benzothienyl, benzotriazinyl, benzimidazolyl, indolyl, isoindolyl, indazolyl, quinolinyl, isoquinolinyl, quinazolinyl, quinoxalinyl, purinyl, pteridinyl, α-carboline, indolizinyl, benzoisothiazolyl, benzoxazolyl, pyrrolopyridyl, pyrazolopyrimidyl, furopyridinyl, benzothiadiazolyl, benzooxadiazolyl, benzotriazolyl, benzotriadiazolyl and the like. Preferably “heteroaryl” refers to 5- to 6-membered ring selected from the group consisting of furanyl, thienyl, pyrrolyl, pyrazolyl, imidazolyl, oxazolyl, cinnolinyl, isoxazolyl, thiazolyl, isothiazolyl, 1H-tetrazolyl, oxadiazolyl, triazolyl, pyridyl, pyrimidinyl, pyrazinyl and pyridazinyl. More preferably, pyrazolyl, pyridyl, oxazolyl, furanyl or benzimidazolyl. All heteroaryls are optionally substituted by one or more groups selected from alkyl, halogen, hydroxyl, carboxylic acid, alkoxycarbonyl, formyl, acyl, thiocarbonyl, thioester, thioacetate, thioformate, alkoxyl, oxo, phosphoryl, a phosphate, phosphonate, phosphinate, amino, amido, amidine, imine, cyano, nitro, azido, sulfhydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido and sulfonyl group.
Accordingly, it would have been obvious to one of ordinary skill in the art to have selected bipyridinyl, bipyrazinyl, tripyridinyl or pyrazinyl-pyridyl for the heteroaryl of “A” in the compound of formula (IB) in claims 10-12 of the ‘205 patent so as to fully practice the scope of claims 10-12 as the ‘205 patent specifies that heteroaryl for “A” can be a bicyclic or polycyclic heteroaryl, e.g., bipyridinyl, bipyrazinyl, tripyridinyl or pyrazinyl-pyridyl.
With respect to the pharmaceutical composition and treatment method in instant claims 19-24, the ‘205 patent teaches that the compound of formula (IB) in claims 10-12 of the ‘205 patent has the same utility as the instant compound, i.e., treatment of diseases mediated by PRMT5, in particular the same diseases as here claimed (see Abstract, col. 1, lines 15-20, and col. 67, line 32 through col. 68, line 41).
It would have been obvious to one of ordinary skill in the art to have administered the compound of formula (IB) in claims 10-12 of the ‘205 patent in a pharmaceutical composition further containing a conventional pharmaceutically acceptable carrier or excipient because the ‘205 patent specification contemplates the utility of the compound for treatment of diseases mediated by PRMT5, in particular the same diseases as here claimed.
Response to Arguments
Applicant's arguments filed April 28, 2026 have been fully considered but they are not persuasive.
Applicant argues that the instant reissue claims are patentably distinct from those of the ‘205 patent (Remarks, pp. 20-21). In particular, Applicant argues the following on p. 21 of the Remarks:
The Examiner's position is that because the specification of the '205 patent provides a broad generic disclosure of possible "aryl" and "heteroaryl" groups, which includes "biphenyl" as one of many examples, the selection of this specific group is obvious. This reasoning is an example of impermissible hindsight. The '205 patent discloses a vast and extensive list of potential substituents for the claimed genus. There is no teaching or suggestion within the '205 patent that would have directed one of ordinary skill in the art to specifically select a "biphenyl" group over the multitude of other enumerated options.
The Applicant respectfully submits that none of the exemplified or claimed compounds of the present invention contains a biphenyl moiety. Biphenyl is a distinct two-ring, non-fused system that is not present in the instant compounds. The Examiner's assumption that the present compounds would have been derived by "selecting biphenyl" from the '205 definition is therefore technically incorrect.
On pp. 22-23 of the Remarks, Applicant further provides a comparison chart of the instantly claimed compounds and that of the ‘205 patent claims and argues the following:
In contrast, the instant claimed compounds in reissue patent have:
a) a mandatory ring system having (X₁, X₂ & X₃), wherein this feature is absent in the '205 compounds;
b) the ring having X1, X₂ & X₃ is always directly linked to the ring A with a
covalent bond, which feature is not present in any of the exemplified compounds of '205 patent;
c) none of the compounds of '205 patent has either a biphenyl ring or a bicyclic heteroaryl ring linked through a covalent bond, as present in the currently claimed compounds.
These arguments are unpersuasive since the instant reissue claims are not patentably distinct from those of the ‘205 patent. Claims 10-12 of the ‘205 patent state that “A is aryl, heteroaryl, cycloalkyl of heterocycloalkyl.” The ‘205 patent specification defines the term “aryl” as follows (col. 72, lines 8-20, emphasis added):
As used herein, the term “aryl” is optionally substituted monocyclic, bicyclic or polycyclic aromatic hydrocarbon ring system of about 6 to 14 carbon atoms. Examples of a C6-C14 aryl group include, but are not limited to phenyl, naphthyl, biphenyl, anthryl, fluorenyl, indanyl, biphenylenyl and acenaphthyl. Aryl group can be optionally substituted with one or more substituents selected from alkyl, halogen, hydroxyl, carboxylic acid, alkoxycarbonyl, formyl, acyl, thiocarbonyl, thioester, thioacetate, thioformate, alkoxyl, oxo, phosphoryl, a phosphate, phosphonate, phosphinate, amino, amido, amidine, imine, cyano, nitro, azido, sulfhydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido and sulfonyl group.
There are eight examples of “aryl” given in the above paragraph, i.e., phenyl, naphthyl, biphenyl, anthryl, fluorenyl, indanyl, biphenylenyl and acenaphthyl. Thus, selection of biphenyl for the ‘205’s claimed aryl group for A would have been obvious when practicing the full scope of the ‘205 patent claims. With selection of biphenyl for the ‘205 patent’s claimed A, one of the phenyl groups of the biphenyl is the instant
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where each of X1, X2 and X3 is CH, and the other phenyl group of the biphenyl is the instant A., which can be aryl. Note, the two phenyl groups in biphenyl are directly linked to each other since biphenyl has the structure:
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.
Thus, selection of biphenyl for the ‘205’s claimed aryl group A results in a compound having the instant
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directly attached to the instant A with a covalent bond, as here claimed.
Furthermore, the fact that none of the compounds exemplified in the ‘275 patent specification has a biphenyl group is of no consequence. Instant claim 1 encompasses the use of biphenyl since, as noted above, each of the instant X1, X2 and X3 can be CH, and the instant A can be “aryl”, which the ‘275 patent specification teaches can be phenyl (see col. 33, line 49-53). As such, the instantly claimed compound can have a biphenyl group.
Applicant provides arguments with respect to the instant A being heteroaryl, which as noted above in the rejection, is pertinent to instant claims 5, 6, 13, 14 and 18. In particular, Applicant argues the following on p. 21 of the Remarks:
Similarly, the rejection of claims directed to specific heteroaryl compounds (e.g., bipyridinyl, bipyrazinyl) is flawed. The '205 patent provides a wide-ranging definition of "heteroaryl" that encompasses numerous bicyclic and polycyclic structures. There is nothing in the '205 patent that would have provided a person of ordinary skill with a reason to select the specific linked bipyridinyl or bipyrazinyl structures of the present invention. The path to this selection only becomes clear with the benefit of hindsight, which is an improper basis for an obviousness rejection.
This argument is unpersuasive. As set forth in the rejection, the ‘205 patent defines “heteroaryl” as an aromatic heterocyclic ring system containing 5 to 20 ring atoms, suitably 5 to 10 ring atoms, which may be a single ring (monocyclic) or multiple rings (bicyclic, tricyclic or polycyclic) fused together or linked covalently, with specific examples of heteroaryl being pyridyl and pyrazinyl (see col. 71, line 39 through col. 72, line 7). Thus, it would have been obvious to one of ordinary skill in the art to have selected bipyridinyl, bipyrazinyl, tripyridinyl or pyrazinyl-pyridyl for the heteroaryl of “A” in the compound of formula (IB) in claims 10-12 of the ‘205 patent so as to fully practice the scope of claims 10-12 as the ‘205 patent specifies that heteroaryl for “A” can be a bicyclic or polycyclic heteroaryl, e.g., bipyridinyl, bipyrazinyl, tripyridinyl or pyrazinyl-pyridyl.
Applicant argues the following on p. 23 of the Remarks:
The present invention expressly limits the identity and arrangement of the aromatic system to achieve defined, superior, and reproducible biological behaviour. Also, in the pharmaceutical sciences, even a small change in the structure of a molecule may have dramatic and unpredictable effects on the activity of a molecule. More specifically, any change in the structure of a compound can affect the manner in which the compound interacts with the target site and alter its biological activity.
This argument is unpersuasive because nothing unexpected with respect to the ‘205 patent and commensurate in scope with the instant claims, which include the presence in the compound of said biphenyl, bipyridinyl, bipyrazinyl, tripyridinyl or pyrazinyl-pyridyl, has been demonstrated. In fact, the ‘205 patent (e.g., col. 1, lines 15-20) and the ‘275 patent (e.g., col. 1, lines 22-27) teach use of their compounds for the treatment of PRMT5 dependent conditions and disorders.
Allowable Subject Matter
Claims 4 and 7-9 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.
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. 11,542,275 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.
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.
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
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