DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/22/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 14-15 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of a single species in the reply filed on 6/22/2026 is also acknowledged.
The elected species read upon claims 1-2, 10, 13 and 21-22. Claims 3-8, 11-12 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
As indicated above, Applicant’s elected species:
PNG
media_image1.png
274
414
media_image1.png
Greyscale
reads upon claims 1-2, 10, 13 and 21-22.
The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice – a compound-by-compound search – to include a single additional species (M.P.E.P. § 803.02). That species is:
PNG
media_image2.png
282
482
media_image2.png
Greyscale
PNG
media_image3.png
134
140
media_image3.png
Greyscale
wherein R1 is halo; R2 is NR10R11 wherein R10 and R11 taken together with the atom to which they are bonded form a cycloheteroalkyl; R3 is H; R4 is NR13R14 wherein R13 and R14 are each independently heteroalkyl; R5 is H; R6 is halo; and X- is trifluoroacetate – which is not excluded by proviso and which reads on pending claims 1-2.
A rejection to those claims follows.
Since the search has not been expanded beyond the single additional species identified above, claim 10, which is directed to the elected species but which does not include the single additional species, is objected to as indicated below, and has not been further examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurt et al (WO 2012/135402).
Claim 1 is drawn to a compound of Formula (I) which embraces the following compound species:
PNG
media_image2.png
282
482
media_image2.png
Greyscale
PNG
media_image3.png
134
140
media_image3.png
Greyscale
wherein R1 is halo; R2 is NR10R11 wherein R10 and R11 taken together with the atom to which they are bonded form a cycloheteroalkyl; R3 is H; R4 is NR13R14 wherein R13 and R14 are each independently heteroalkyl; R5 is H; R6 is halo; and X- is trifluoroacetate – which is not excluded by proviso and which reads on pending claims 1-2.
Hurt et al teach the instantly claimed compound (Page 40, Example 24).
Accordingly, claims 1-2 are anticipated.
Claims 13 is drawn to a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
Hurt et al teach that “a composition comprising a compound described here, together with a pharmaceutically acceptable carrier or excipient” (Paragraph 0058).
Accordingly, claim 13 is also anticipated.
Claim Objections
Claim 10 is objected to as depending from a rejected base claim. Since the search has not been expanded beyond the single additional species identified above, claim 10, which is directed to the elected species but which do not include the single additional species, has not been further examined.
Allowable Subject Matter
Claims 21-22 are drawn to the following compound
PNG
media_image1.png
274
414
media_image1.png
Greyscale
or a pharmaceutically acceptable salt, solvate or hydrate thereof, as well as compositions thereof.
The closest prior art is Lu et al (Dyes and Pigments 89:44-48,2011) which teach the following compound and compositions thereof (Page 45, Column 1, Compound 1a):
PNG
media_image4.png
282
410
media_image4.png
Greyscale
which differs from the compound of claim 22 in lacking a third pyrrolidine substitution as indicated by arrow.
There would have been no obvious reason to modify Compound 1a taught by Lu et al to arrive at the instantly claimed compound with a reasonable expectation of success.
And since claims 21-22 contain written support and are enabled, the claims are ALLOWED.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8,809,317.
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 21 of the ‘317 Patent recites the compound
PNG
media_image2.png
282
482
media_image2.png
Greyscale
wherein it would have been obvious to formulate said compound as a salt and as a composition thereof.
Claims 1-2 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of U.S. Patent No. 8,828,986.
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 30 of the ‘986 Patent recites the compound
PNG
media_image5.png
212
404
media_image5.png
Greyscale
wherein it would have been obvious to formulate said compound as a salt and as a composition thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights