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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application is CON of 17679439 02/24/2022 ABN, which is a CON of 17364047 06/30/2021 PAT 11292765, which claims benefit of the provisional applications 63/109,095 with a filing date 11/03/2020, and 63/045,901 with a filing date 06/30/2020.
2. Claims 21-53 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 46 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 46, line 1, recites the limitation “crystalline form” without X-ray diffraction pattern data, is ambiguous and indefinite. It is noted that a fully X-ray diffraction pattern data is the fingerprint characteristics of crystalline form compound. Incorporation of an X-ray diffraction pattern data into claim 46 would obviate the rejection.
Double Patenting
4. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 21, 25, 27, 33, 42, 45 and 49 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1-2, 15 and 21 of Bryson’s US11,292,765. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a compound/composition, wherein the compound is represented
by Formulae (I), (II), (III), or (IV), or is a pharmaceutically acceptable salt or zwitterion thereof:
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596
896
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, and methods of use for treating
diseases, see claims 21, 25, 27 and 33. A process of making compounds of formulae
(I) and (III) is claimed in claim 42.
Applicants claim a hydrochloride salt of the following formula:
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238
400
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, and methods of use for treating disease, see claims 45 and 49.
Bryson’s‘765 claims a compound/composition of Formula (I) (II), (III) or (IV) or a pharmaceutically acceptable salt or zwitterion thereof:
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486
456
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480
500
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, see claim 1 in column 28.
A specific compound of the formula , i.e.,
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274
438
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is claimed in claim 2, see column 29.
A processes of making compounds of formulae (I), (II), (IIII0 and (IV), and methods of use for treating disease is claims 15 and 21 in column 32.
The difference between instant claims and Bryson’s ‘765 is that the instant claim is embraced within the scope of Bryson’s ‘765.
One having ordinary skill in the art would find the claims 21, 25, 27, 33, 42, 45 and 49 prima facie obvious because one would be motivated to employ the compound/composition and methods of use of Bryson’s ‘765 to obtain instant invention.
The motivation to make the claimed compound/composition and methods of use derived from the known compound/composition and methods of use of Bryson’s ‘765 would possess similar activity to that which is claimed in the reference.
Claim Objections
5. Claims 22-24,26,28-32,34-41,43-44,47-48 and 50-53 are objected to as being dependent on rejected claims 21, 33 and 45.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
September 21, 2026
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