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 .
Claims 1-100 are cancelled. Therefore, claims 101-120 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a CON of 17/306,052 05/03/2021 PAT 12128045
17/306,052 is a CON of 16/810,160 03/05/2020 PAT 11026948
16/810,160 is a CON of 16/613,912 11/15/2019 ABN
16/613,912 is a 371 of PCT/IB2018/053428 05/16/2018
PCT/IB2018/053428 has PRO 62/513,627 06/01/201
FOREIGN APPLICATIONS
UNITED KINGDOM 1707864.3 05/16/2017
Information Disclosure Statement
Applicants’ Information Disclosure Statement, filed on September 23, 2024, has been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 101-120 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,026,948 B2
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claims are either anticipated by, or would have been obvious over, the reference claims.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to the same art specific subject matter.
The instant claims are directed at methods for treating cancer in a patient in need thereof comprising administering to the patient a compound of formula I,
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or a compound of Formula II,
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Wherein the cancer has the characteristic of being a type prone to being or becoming refractory or resistant to platinum drug-based therapy, t and the treatment is with a dose that achieves a blood concentration of about 0.5 µM or greater of the compound for at least 72 hours.
U.S. Patent No. 11,026,948 B2 is also directed to
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Both sets of claims use the same active ingredient to treat the same disorder. The instant claims are covered by the patented claims because there is overlap on the specific dosage and interval in administration. The difference between the instant and the patented claims is in scope only.
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in art is relatively high.
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness.” Takeda v. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). “The ‘reason or motivation’ need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship…to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.” Aventis v. Lupin, 84 USPQ2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). “Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties.” Id.
MPEP 804 states: “where the claims of an application are not the "same” as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.”
Although the conflicting claims are not identical, the Examiner finds that a person having ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to any patent granted to U.S. Patent No. 11,026,948 B2. The claimed methods are already covered by the claims of in U.S. Patent No. 11,026,948 B2. Accordingly, U.S. Patent No. 11,026,948 B2 renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 101-120 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,128,045 B2
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claims are either anticipated by, or would have been obvious over, the reference claims.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to the same art specific subject matter.
The instant claims are directed at methods for treating cancer in a patient in need thereof comprising administering to the patient a compound of formula I,
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135
327
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or a compound of Formula II,
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171
340
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,
wherein the cancer has the characteristic of being a type prone to being or becoming refractory or resistant to platinum drug-based therapy, t and the treatment is with a dose that achieves a blood concentration of about 0.5 µM or greater of the compound for at least 72 hours.
U.S. Patent No. 12,128,045 B2 is also directed to
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60
417
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245
705
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Both sets of claims use the same active ingredient to treat the same disorder. The instant claims are covered by the patented claims because there is overlap on the specific dosage and interval in administration. The difference between the instant and the patented claims is in scope only.
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in art is relatively high.
“Structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, create a prima facie case of obviousness.” Takeda v. Alphapharm, 83 USPQ2d 1169 (Fed. Cir. 2007) (quoting In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990). “The ‘reason or motivation’ need not be an explicit teaching that the claimed compound will have a particular utility; it is sufficient to show that the claimed and prior art compounds possess a ‘sufficiently close relationship…to create an expectation,’ in light of the totality of the prior art, that the new compound will have ‘similar properties’ to the old.” Aventis v. Lupin, 84 USPQ2d 1197 (Fed. Cir. 2007) (citing Dillion, 919 F.2d 692). “Once such prima facie case is established, it falls to the applicant or patentee to rebut it, for example with a showing that the claimed compound has unexpected properties.” Id.
MPEP 804 states: “where the claims of an application are not the "same” as those of the first patent, but the grant of a patent with the claims in the application would unjustly extend the rights granted by the first patent, a double patenting rejection under nonstatutory grounds is proper.”
Although the conflicting claims are not identical, the Examiner finds that a person having ordinary skill in the art would recognize that the claimed invention would unjustly extend the rights granted to any patent granted to U.S. Patent No. 12,128,045 B2. The claimed methods are already covered by the claims of in U.S. Patent No. 12,128,045 B2. Accordingly, U.S. Patent No. 12,128,045 B2, renders the instant claims obvious absent a showing of unpredictability or comparative evidence suggesting otherwise.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicants are 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, 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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/Kamal A Saeed/
Primary Examiner, Art Unit 1626
Prosecution Insights