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 .
Status of the Claims
The amendments filed 8/04/2026 have been entered.
Election/Restrictions
Newly submitted claim 59 directed to a species that is independent or distinct from the species originally elected for the following reasons: claim 59 is drawn to a compound of Formula (X) wherein U is NH, whereas in Applicant’s elected species, U is S.
Accordingly, claim 59 is withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and MPEP § 821.03.
Response to Arguments
Applicant’s elected species
PNG
media_image1.png
244
386
media_image1.png
Greyscale
reads on currently pending claims 1-5, 11-12, 15-17, 19-21, 50-52 and 55-58.
As discussed in the previous Action mailed on 8/27/2025, the elected species has been searched and is deemed to be free of the prior art and non-obvious. The closest prior art compound is considered to be CAS 339174-55-9 (entered into STN on 6/01/2001; of record) as follows
PNG
media_image2.png
176
298
media_image2.png
Greyscale
, a tautomer of
PNG
media_image3.png
206
324
media_image3.png
Greyscale
, which differs from Applicant’s elected compound species in that V is =O (or -OH) as opposed to -NH2, L is -CH2- as opposed to -CH(CH2CH3)-, and R4 is not substituted with -OC1 alkyl and -Cl.
Considering that CAS 339174-55-9 merely discloses the compound and the compound is not further identified as having any associated activity, there would have been no obvious reason to consider modifying CAS 339174-55-9 to arrive at the Applicant’s instantly elected compound species.
Accordingly, in the Action mailed on 8/27/2025, the search was 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 was
PNG
media_image3.png
206
324
media_image3.png
Greyscale
and claims 1-3, 6, 8-11, 16-17 and 19, based thereon, were rejected.
Additionally, claims 1-12, 15-17, 19-20 and 52 were rejected on the grounds of containing an “improper Markush grouping” in that Action.
In Applicant’s response filed 11/21/2025, Applicant amended the claims to exclude the above prior art compound and overcome the rejection of claims based thereon and to overcome the rejection of claims on the grounds of containing an “improper Markush grouping”
Accordingly, in the Action mailed on 12/17/2025, the search was again 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 was
PNG
media_image4.png
232
348
media_image4.png
Greyscale
and claims 1-3, 11-12, 16-17 and 19-20 were rejected.
In Applicant’s response filed 3/16/2026, Applicant amended the claims to exclude the above prior art compound and overcome the rejection of claims based thereon.
Accordingly, in the Action mailed on 5/05/2026, the search was again 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 was
PNG
media_image5.png
216
422
media_image5.png
Greyscale
and claims 1-3, 11-12, 16-17, 19-20 and 52 were rejected.
In Applicant’s response filed 8/04/2026, Applicant amended the claims to exclude the above prior art compound and overcome the rejection of claims based thereon.
Accordingly, in the instant Action, the search has again 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_image6.png
182
310
media_image6.png
Greyscale
wherein, in Formula (X), L is alkylene; U is S; V is NR2R3 wherein R2 and R3 are H; W is N; X is NR6 wherein R6 is H; Y1 is N; Y2 is N; R1 is H; and R4 is
PNG
media_image7.png
66
94
media_image7.png
Greyscale
– which reads on claims 1, 11-12, 17 and 52. A rejection to those claims follows.
Since the search has not been expanded beyond the single additional species identified above, claims 2-6, 15-16, 19-21, 50-51 and 55-58, which are directed to the elected species but which do not include the single additional species, are objected to as indicated below, and have 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, 11-12, 17 and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McMurry et al (US 6,096,724).
Claim 1 is drawn to a compound of Formula (X) which embraces the following compound species:
PNG
media_image6.png
182
310
media_image6.png
Greyscale
wherein L is alkylene; U is S; V is NR2R3 wherein R2 and R3 are H; W is N; X is NR6 wherein R6 is H; Y1 is N; Y2 is N; R1 is H; and R4 is
PNG
media_image7.png
66
94
media_image7.png
Greyscale
– which reads on claims 1, 11-12, 17 and 52.
McMurry et al teach the instantly claimed compound (Columns 27-28, Table 1A, B 4228).
Accordingly, claims 1, 11-12 and 17 are anticipated.
Claim 52 is drawn to a pharmaceutical composition comprising an effective amount of a compound of claim 1 and one or more pharmaceutically acceptable excipients.
McMurry et al teach synthesis of B 4228 using methanol as a solvent for crystallization (Columns 27-28, Table 1A, B 4228).
The solution comprising compound 10 and ethanol as a solvent entails a pharmaceutical composition as claimed.
Accordingly, claim 52 is also anticipated.
Claim Objections
Claims 2-6, 15-16, 19-21, 50-51 and 55-58, are objected to as depending from a rejected base claim. Since the search has not been expanded beyond the single additional species identified above, claims 2-6, 15-16, 19-21, 50-51 and 55-58, which are directed to the elected species but which do not include the single additional species have not been further examined.
Conclusion
The new ground of rejection presented in this Office action is necessitated by Applicant’s amendments to the claims. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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.
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