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 .
Status of Claims
Claims 29-48 are pending and are under examination in this office action. Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 1/13/26 and 10/22/24 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 §§ 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 29-48 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 18 of U.S. Patent No. 9,566,280. 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 refer to a method of treating cancer in a subject, the method comprising administering to the subject an effective amount of an androgen antagonist in combination with an effective amount of a polo-like kinase (Plk) inhibitor, wherein the androgen antagonist has the formula:
PNG
media_image1.png
158
214
media_image1.png
Greyscale
and the patented claims directed to a method of treating a patient with cancer comprising administering to the patient an effective amount of abiraterone or abiraterone acetate in combination with an effective amount of a polo-like kinase inhibitor (PLK), wherein the abiraterone or abiraterone acetate and the polo-like kinase inhibitor are administered simultaneous or wherein the abiraterone or abiraterone acetate is administered to the patient 1, 2, 3,4, 5,6, 8, 10, 12, 18, or 24 hours, 1,2,3, 4,5, 6, or 7 days, 1, 2, 3, or 4 weeks, prior to administration of the polo-like kinase inhibitor to the patient.
The difference in the instant claims and the patented claims is that, the instant claims recites a specific PLK inhibitor nonetheless when the specification of the patented claims is used as a dictionary it does teach the specific formula (see col. 14, lines 15+ for instant claims 29-34, 37 with the same chemical compound. and claims 2 and as recited by claim 33 the antiandrogen and antagonist is abiterone same as the that of the patented claims. When the patented specification is used as a dictionary, it defines NMS-1286937 as a PLK inhibitor (see col. 25, lines 60+) and patented claim 4 (same compound). Therefore it would have been obvious to one of ordinary skill in the art instant claimin treating cancer with the administration of additional active agent in the treatment of prostate cancer, breast cancer and pancreatic cancer to practice the invention with a reasonable expectation of success combining the PLK with antiandrogen or androgen antagonist abiraterone.
The compositions recited in the claims are anticipatory of each other or obvious as they ovelapp in scope.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
Claims 29-48 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 15 of U.S. Patent No. 10,155,006 and (10772898, claims 1-21). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the patent are directed to a method of treating cancer in a subject having cancer cells, comprising administering to the subject an effective amount of an antiandrogen or androgen antagonist in combination with an effective amount of a polo-like kinase (Plk) inhibitor, wherein the antiandrogen or androgen antagonist and the Plk inhibitor are administered to the subject simultaneously, or wherein the antiandrogen or androgen antagonist is administered to the subject prior to the time of administration of the Plk inhibitor to the subject, and wherein administration of the combination the antiandrogen or androgen antagonist and the Plk inhibitor reduces cancer cell proliferation or cancer cell viability in the subject and the claims of instant are to a claims of the instant refer to a method of treating cancer in a subject, the method comprising administering to the subject an effective amount of an androgen antagonist in combination with an effective amount of a polo-like kinase (Plk) inhibitor, wherein the androgen antagonist has the formula:
PNG
media_image1.png
158
214
media_image1.png
Greyscale
inhibitor to the subject, and wherein administration of the combination the antiandrogen or androgen antagonist and the PLK inhibitor reduces cancer cell proliferation or cancer cell viability in the subject.
One of ordinary skill in the art would have been motivated to use the patented claims to practice the instant claim invention with a reasonable expectation of success when the specification of the patented claims are used as a dictionary. (see supra).
Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 29-48 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 32 of U.S. Patent Application No. 12115171. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the patent are to a method of treating cancer, comprising administering NMS-1286937 (Onvansertib) and an antiandrogen or androgen antagonist to a subject, wherein the cancer is a solid tumor cancer and the claims of the instant are to a the claims of the instant claims recites to a to a method of treating cancer in a subject, the method comprising administering to the subject an effective amount of an androgen antagonist in combination with an effective amount of a polo-like kinase (Plk) inhibitor, wherein the androgen antagonist has the formula:
PNG
media_image1.png
158
214
media_image1.png
Greyscale
inhibitor to the subject, and wherein administration of the combination the antiandrogen or androgen antagonist and the PLK inhibitor reduces cancer cell proliferation or cancer cell viability in the subject. Both the instant and the patented claims do teach
Because both sets of claims recites the open term “comprising” which allows other actives to be present in the composition for treating cancer.
Thus one of ordinary skill in the art would have been motivated to practice the instant claimed invention by substituting the second compound for treating cancer.
As to the copending application claims 29-48, these claims refer to a method of treating wherein one of ordinary skill in the art would have substituted the patent NMS-1286937 with the claimed instant compounds to treat cancer with a reasonable expectation of success because the compounds are from the same class and one of ordinary skill in the art would.
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
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.
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, Robert A. Wax can be reached on 571-272-0623. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 06/4/23
Prosecution Insights