Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-27 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 10/9/24 (2). The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 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 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 -37 of U.S. Patent No.9,023,880, Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
* » The claims of the instant application refers to treating FLT3 mutated proliferative disorders such as leukemia etc administering the compound crenolanib and the claims of the patent refers to inhibiting or reducing deregulated FITS tyrosine kinase activity in the same types of proliferative disorders and or treating as required by the patented claims administering crenolanib.
* * Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
* * Thus one of ordinary skill in the art would have been motivated to use the patented claims to treat FLT3 muted proliferative disorders and hematological diseases (i.e., leukemia etc) with a reasonable expectation of success because when the FLT3 is reduced or inhibited it treats the proliferative disorders and leukemia thus reducing the effect by the administration of the compound. Additionally the treatment overlaps in the patented claims and the instant application.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-43 of U.S. Patent No.9,101,624. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
* The claims of the instant application refers to treating FLT3 mutated proliferative disorder, leukemia administering the compound crenolanib and the claims of the patent refers treating hematological malignancy administering the same compound..
* • Both set of claims recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
* • Thus one of ordinary skill in the art would have been motivated to use the patented claims to treat FLT3 muted proliferative disorders and hematological diseases (i.e.,, leukemia etc) with a reasonable expectation of success because when the FLT3 is reduced or inhibited it treats the proliferative disorders and leukemia thus reducing the effect by the administration of the compound. Additionally the treatment overlaps in the patented claims and the instant application
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-43 of U.S. Patent No.9,393,240. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
* * The claims of the instant application refers to treating FLT3 mutated proliferative disorder, administering the compound crenolanib and the claims of the patent refers to treating FLT3 mutated hematological cancer administering to the patient a therapeutically effective amount of crenolanib. The proliferative disorder in the instant claims overlaps with that of the patented claims.
* » Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
* » Thus one of ordinary skill in the art would have been motivated to use the patented claims to treat FLT3 proliferative disorders as the diseases of proliferative disorders overlaps with the patented claims. Additionally the treatment overlaps in the patented claims and the instant application.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-25 of U.S. Patent Application No. 9480683. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows: The claims of the instant application refers to treating FLT3 proliferative disorder administering the compound crenolanib and the claims of the patent are directed to treating leukemia the same disease disorders recited In the Instant claims (see 2). Therefore one of ordinary skill in the art would have been motivated to use the instant claims in practicing the patented claims with a reasonable expectation of success.
Thus In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-24 of U.S. Patent Application No. 9889127. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows: The claims of the instant application refers to treating FLT3 proliferative disorder administering the compound crenolanib and the claims of the patent are directed to treating method of inhibiting or reducing mutant C-KIT tyrosine kinase activity or expression in a subject suffering from a proliferative disease administering the same drug.
Thus In view of the foregoing, the patented claims and the current application claims are
obvious variations.
Claims 1-22 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-37 of U.S. Patent
No. 9801869. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows: The claims of the instant application refers to treating FLT3 proliferative disorder administering the compound crenolanib and the claims of the patent are directed to treating leukemia the same disease disorders recited in the instant claims.
Thus In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-22 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-29 of US Patent 10,213,423.
The claims of the instant application and the patented claims overlap in scope. Using the same treatment for the same proliferative disorders. They both recite treating a FLT3 muted proliferative disorder such as leukemia, hematological (i.e, leukemia a hematological disease administering the same dosage amount (see claims 1-2 of the instant and patented claims).
Thus In view of the foregoing, the co-pending claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness" type double patenting as being unpatentable over claims 1-21 of US Patent application 11,078,541,
Both sets of claims refer to treating mutated FLT3 proliferative disorder wherein the disease disorders are the same. Therefore In view of the foregoing, the co-pending claims and the current application claims are obvious variations
The claims of the instant application and the patented claims overlap in scope. Using the same treatment for the same proliferative disorders.
Thus In view of the foregoing, the co-pending claims and the current application claims are obvious variations.
Claims 1-27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-22 of U.S. Patent No.11,458,131. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
* » The claims of the instant application refers to treating FLT3 mutated proliferative disorders such as leukemia etc administering the compound crenolanib and the claims of the patent refers to inhibiting or reducing deregulated FITS tyrosine kinase activity in the same types of proliferative disorders and or treating as required by the patented claims administering crenolanib. They differ only in the recitation of claims 22 reciting a method for treating a patient, obtaining a sample, determining if the patient has become resistant to prior tyrosine kinase inhibitors and the patented claims are the same and differs only in that it recites that the patient has leukemia.
* * Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
* * Thus one of ordinary skill in the art would have been motivated to use the patented claims to treat FLT3 muted proliferative disorders and hematological diseases (i.e., leukemia etc) with a reasonable expectation of success because when the FLT3 is reduced or inhibited it treats the proliferative disorders and leukemia thus reducing the effect by the administration of the compound. Additionally the treatment overlaps in the patented claims and the instant application.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of patented US 12/404,555 . Although the instant claims are not identical, they are not patentably distinct from each other because the present claims and the claims are both inclusive of methods for treating a human patient with leukemia, including AML, with Crenolanib, comprising: obtaining a biological sample from the human patient; performing a genotyping assay on the biological sample to determine that the human patient has both a mutated FLT3 or a constitutively active FLT3 mutant and one or more additional genetic abnormalities / mutations (i.e., a driver mutation in an epigenetic regulator protein that results in loss of function of the epigenetic regulator protein in the claims of ‘468), wherein the presence of both the mutated FLT3 and the one or more driver mutations indicates that the patient has a poor prognosis; and administering to the patient determined to have the poor prognosis a therapeutically effective amount of crenolanib or a pharmaceutically acceptable salt thereof, to treat the leukemia. The present claims and the claims of ‘468 further include the limitations that the amount of crenolanib that is administered is from about 50 to 500 mg per day, 100 to 450 mg per day, 200 to 400 mg per day, 300 to 500 mg per day, 350 to 500 mg per day, or 400 to 500 mg per day; or crenolanib is administered at least one of continuously, intermittently, systemically, or locally; or crenolanib is administered orally, intravenously, or intraperitoneally; the crenolanib or the pharmaceutically acceptable salt thereof is crenolanib besylate, crenolanib phosphate, crenolanib lactate, crenolanib hydrochloride, crenolanib citrate, crenolanib acetate, crenolanib toluenesulphonate, and crenolanib succinate; and the therapeutically effective amount of crenolanib or the pharmaceutically acceptable salt thereof is: administered up to three times or more a day for as long as the human patient is in need of treatment for the leukemia; or provided at least one of sequentially or concomitantly, with another pharmaceutical agent in a newly diagnosed leukemia human patient, to maintain remission of an existing human leukemia patient, or in a relapsed/refractory human leukemia patient; or provided as a single agent or in combination with another pharmaceutical agent in a patient with a newly diagnosed leukemia, to maintain remission, or in a relapsed/refractory human leukemia patient; or provided as a single agent or in combination with another pharmaceutical agent in a newly diagnosed human leukemia pediatric patient, to maintain remission, or in a relapsed/refractory human leukemia pediatric patient.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of 12534764. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘764 are both inclusive of methods for treating a human patient with leukemia, including AML, with Crenolanib, comprising: obtaining a biological sample from the human patient; performing a genotyping assay on the biological sample to determine that the human patient has both a mutated FLT3 or aconstitutively active FLT3 mutant and one or more additional genetic abnormalities / mutations (i.e., a driver mutation in a nuclear transport protein that results in a loss of localization of the nuclear transport protein in the claims of ‘250), wherein the presence of both the mutated FLTS and the one or more driver mutations indicates that the patient has a poor prognosis; and administering to the patient determined to have the poor prognosis a therapeutically effective amount of crenolanib or a pharmaceutically acceptable salt thereof, to treat the leukemia. The present claims and the claims of ‘250 further include the limitations that the amount of crenolanib that is administered is from about 50 to 500 mg per day, 100 to 450 mg per day, 200 to 400 mg per day, 300 to 500 mg per day, 350 to 500 mg per day, or 400 to 500 mg per day; or crenolanib is administered at least one of continuously, intermittently, systemically, or locally; or crenolanib is administered orally, intravenously, or intraperitoneally; the crenolanib or the pharmaceutically acceptable salt thereof is crenolanib besylate, crenolanib phosphate, crenolanib lactate, crenolanib hydrochloride, crenolanib citrate, crenolanib acetate, crenolanib toluenesulphonate, and crenolanib succinate; and the therapeutically effective amount of crenolanib or the pharmaceutically acceptable salt thereof is: administered up to three times or more a day for as long as the human patient is in need of treatment for the leukemia; or provided at least one of sequentially or concomitantly, with another pharmaceutical agent in a newly diagnosed leukemia in a human
In summary, it is noted that applicant has numerous issued patent and pending applications encompassing the same or similar subject matter of the instant application i.e., 11642340 (claims 1-25), 11471451. Applicant should review all subject matter considered the same or similar, and submit.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached on M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 06/18/2026
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