DETAILED ACTION
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 .1
Status of the Claims
Claims 1 and 37-52 are pending in the application and under examination.
The claims are directed to a method of treating autoimmune hemolytic anemia and/or pemphigus in a patient, comprising administering to said patient a therapeutically effective amount of a compound which is of 4-{3-[1-(4-amino-3-methyl-1Hpyrazolo[3, 4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl}pyrrolidin-
2-one (Examples 345-348 of the application as filed) as the compound of Formula (I), and -{3-[1-(4-amino-3-methyl-1Hpyrazolo[3, 4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl}pyrrolidin-2-one.
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Claims 1 and 37-52 are directed to said compound, (R) and (S) isomers and/or pharmaceutically acceptable salt of the above compound and its isomers.
As noted in the prosecution of the parent application, now abandoned, the claimed compound has been identified as the following:
1. CAS Registry Number 1625633-60-4
4-[3-[1-(4-amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]- 2-Pyrrolidinone
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193
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2. CAS Registry Number 1995889-48-9
4-[3-[(1S)-1-(4-amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]- 2-Pyrrolidinone, hydrochloride (1:1), (4R)-
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3. CAS Registry Number 1426698-90-9
(4S)-4-[3-[(1R)-1-(4-Amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]-2-pyrrolidinone
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4. CAS Registry Number 1426698-89-6
(4S)-4-[3-[(1S)-1-(4-Amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]-2-pyrrolidinone
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5. CAS Registry Number 1426698-88-5
(4R)-4-[3-[(1S)-1-(4-Amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]-2-pyrrolidinone
Parsaclisib
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6. CAS Registry Number 1426698-87-4
(4R)-4-[3-[(1R)-1-(4-Amino-3-methyl-1H-pyrazolo[3,4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl]-2-pyrrolidinone
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The earliest art compound CAS Reg. No. 1625633-60-4 can be found in is Li et al. US Publication 20130059835 (see SciFinder searches), cited in the obviousness rejection of the non-final office action of the parent application 15/910,708 but eventually overcome.
The second compound of claim 1, 5-{3-[1-( 4-amino-3-methyl-1H-pyrazolo[3, 4-d]pyrimidin-1-yl)ethyl]-5-chloro-2-ethoxy-6-fluorophenyl }-1,3-oxazolidin-2-one (CAS Registry Number: 1625633-63-7)
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is represented by various stereoisomers:
CAS Registry Number: 1426698-98-7 (5R) (1S)
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CAS Registry Number: 1426699-00-4 (5S) (1S)
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CAS Registry Number: 1426698-99-8 (5S) (1R)
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CAS Registry Number: 1426698-97-6 (5R) (1R)
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Non-Statutory Double Patenting Rejections
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 obviousness-type 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 1 and 37-52 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-50 of US Patent 9932341 (cited on Applicant’s IDS), in view of Terry J. Hamblin Autoimmune Complications of Chronic Lymphocytic Leukemia, Seminars in Oncology, Volume 33, Issue 2, 2006, Pp. 230-239. Hamblin is cited on the PTO-892 form.
The contents and disclosure of claims 1 and 37-52 are discussed above and hereby incorporated herein.
The current application is a CON of 17/364,551 issued as US PAT 12152033; 17/364,551 is a CON of 15/910,708 03/02/2018 now abandoned. 15/910,708 is a CON of 14/193,481 02/28/2014, issued as the current reference patent, US PAT 9932341.
The currently claimed species of autoimmune hemolytic anemia was neither claimed nor restricted out in the prior application. Accordingly, the basis for this double patenting rejection is proper.
US Patent 9932341 generally claims the identical species of PI3K inhibitor as currently claimed
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for the treatment of various types of cancer, such as Chronic lymphocytic leukemia (CLL), see claim 1.
While the reference 341 patent discloses the claimed compound administered to a subject in need for the treatment of CLL, it does not necessarily recite the treatment of autoimmune hemolytic anemia (AHA) or pemphigus as claimed.
However, it would be routine to do so per Hamblin. Hamblin teaches that autoimmune complications are common in chronic lymphocytic leukemia (CLL), including the most common manifestation such as autoimmune hemolytic anemia (AHA). See abstract. Additionally, autoimmune blistering skin disease has long been reported in association with CLL, where Anhalt has recognized such skin blistering of paraneoplastic pemphigus. See page 222, column 2.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent to treat CLL would have found it prima facie obvious to AHA and pemphigus as noted by Hamblin.
Claims 1 and 37-52 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-4, 31, 32 and 34-37 of US 11084822 B2, cited on the PTO-892 form.
The contents and disclosure of claims 1 and 37-52 are discussed above and hereby incorporated herein. The currently claimed species of autoimmune hemolytic anemia was neither claimed nor restricted out in the prior application. Accordingly, the basis for this double patenting rejection is proper.
Reference 822 patent claim 1 discloses method of inhibiting an activity of a PI3Kδ kinase, comprising contacting the kinase with a salt which is crystalline (R)-4-(3-((S)-1-(4-amino-3-methyl-1H-pyrazolo [3,4-d]pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one hydrochloric acid salt, wherein the crystalline (R)-4-(3-((S)-1-(4-amino-3-methyl-1H-pyrazolo [3, 4-d]pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one hydrochloric acid salt has at least four XRPD peaks, in terms of 2-theta, selected from about 11.3°, about 16.4°, about 21.0°, about 23.0°, about 28.1°, about 31.2°, and about 32.8°.
Claims 3, 4 and 32 disclose treatment of autoimmune hemolytic anemia.
Claim 31 discloses pemphigus as claimed.
Claims 1 and 37-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14-18 of US 20250129079
in view of Terry J. Hamblin Autoimmune Complications of Chronic Lymphocytic Leukemia, Seminars in Oncology, Volume 33, Issue 2, 2006, Pp. 230-239. Hamblin and US 20250129079 are cited on the PTO-892 form.
The contents and disclosure of claims 1 and 37-52 are discussed above and hereby incorporated herein.
The currently claimed species of autoimmune hemolytic anemia was neither claimed nor restricted out in the prior application. Accordingly, the basis for this double patenting rejection is proper.
The reference publication discloses a salt of the claimed compound, a pharmaceutical composition, a method of inhibiting PI3K kinase (δ); and treating a PI3K kinase associated disease, see claims 1 and 14-18. Note that the specification of the reference application defines PI3K kinase associated diseases include chronic lymphocytic leukemia (CLL). See paragraph 190. While there is a general prohibition against use of the specification in a double patenting rejection, exceptions recognized are using the specification as a dictionary for claim terminology; and relying upon portions of the disclosure which provide support for the claims in the potentially conflicting patent or application to determine the proper scope of a claim. See: MPEP 804(II)(B)(2)(a)
While the reference publication discloses a salt of the claimed compound, pharmaceutical compositions and methods of treating PI3K associated diseases defined as CLL, it does not necessarily recite the treatment of autoimmune hemolytic anemia (AHA) or pemphigus as claimed.
However, it would be routine to do so per Hamblin. Hamblin teaches that autoimmune complications are common in chronic lymphocytic leukemia (CLL), including the most common manifestation such as autoimmune hemolytic anemia (AHA). See abstract. Additionally, autoimmune blistering skin disease has long been reported in association with CLL, where Anhalt has recognized such skin blistering of paraneoplastic pemphigus. See page 222, column 2.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent to treat PI3K modulated diseases would have found it prima facie obvious to AHA and pemphigus as noted by Hamblin.
This is a provisional nonstatutory double patenting rejection.
Conclusion and Correspondence
In summary, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a CON of 17/364,551 06/30/2021 PAT 12152033
17/364,551 is a CON of 15/910,708 03/02/2018 ABN
15/910,708 is a CON of 14/193,481 02/28/2014 PAT 9932341
14/193,481 has PRO 61/771,480 03/01/2013
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