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 .
Priority
The present application is the U.S. National Stage Application, pursuant to 35 U.S.C.371, of PCT International Application No.PCT/IB2021/05739 filed August 10, 2021 which claims priority to U.S. Provisional Application No. 63/065,160 filed on August 13, 2020.
Status of the Claims
Claims 1-15 and 21-25 are pending.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on February 10, 2023 (13 references), November 21, 2023 (3 references), October 31, 2023 and April 3, 2024 (1 reference) has been received entered into the present application, in compliance with the provisions of 37CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-9, 22, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al., WO 2019/207463 A1 (hereinafter ‘463), which claims priority to U.S. Provisional Applications, 62/663,096, 26 April 2018, 62/750,454 25 October 2018, and 62/826,609, 29 March 2019 1, in view of Sumanta Kumar Pal et. al., Identification of Mechanisms of Resistance to Treatment With Abiraterone Acetate or Enzalutamide in Patients with Castration-Resistant Prostate Cancer (CRPC), Cancer 2018;124:1216-24.
Claim 1 is of the instant application is directed to a method of treating cancer in a subject in need thereof comprising administering to the subject: (a) an amount of a compound of Formula (I) and (b) an antiandrogen wherein;
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(b) an amount of an antiandrogen; wherein the amounts in (a) and (b) together are effective in treating cancer.
Chen teaches the following compound:
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See page 264.
Although Chen teaches compounds within the instant claim and sets forth a method of treating cancer with the CDK4 inhibitors of Formula I (see instant claims 1, 2, 3, 6 and 7), the claims of the ‘463 do not set forth a combination method with an antiandrogen. And although it is an intermediate, the genus of actives is disclosed to include this compound (see pages 3-4). However, one of ordinary skill in the art would have a reasonable expectation of success in the addition of an antiandrogen to the method of treatment in combination with a CDK4 inhibitor because it is known in the art to use a combination approach for cancer with a CDK4 inhibitor and an anti-androgen. Both types of compounds have been used to successfully treat cancers, such as prostate cancer. For example, Sumanta Kumar Pal et. al., Identification of Mechanisms of Resistance to Treatment With
Abiraterone Acetate or Enzalutamide in Patients with Castration-Resistant Prostate Cancer (CRPC), Cancer 2018;124:1216-24, shows that CDK4 inhibitors have been used in conjunction with enzalutamide or abiraterone (both are antiandrogens) to treat prostate cancer.
“We also observed that CCND1 pathway signaling
was enriched in drug-resistant samples. We also made the important observation that CDK4/CDK6 inhibitors were effective at inhibiting the enzalutamide-resistant growth of LNCaP cells. The CCND1 pathway is commonly dysregulated in cancers 25 and has long been thought to contribute to prostate cancer progression.26.”
Sumanta Kumar Pal, page 1222, col. 1, paragraph 3. (emphasis added).
Sumanta Kumar Pal teaches the benefit of using CDK4 inhibitors to limit the growth of enzalutamide-resistant LNCaP cells. Some prostate cancers are resistant to the treatment with enzalutamide or abiraterone (antiandrogens) and require a change in therapy. Both CDK4 inhibitors an antiandrogen has been used in a combination to effect the growth of prostate cancer cells. The applicant is using a second well known therapeutic, an antiandrogen, in conjunction with an already known primary therapeutic that is a CDK inhibitor to treat prostate cancer.
Therefore, the instant claim is rejected.
Claim 2 and 22 of the instant application identifies the exact species of Formula (I) as:
1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-
benzimidazol-6-yl] pyrimidin-2-yl} amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof.
Claim 19 of ‘463 identifies 1,5-anhydro-3-({5-chloro-4-[4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 Hbenzimidazol-6-yl]pyrimidin-2-yl}amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof.
The species of the compound of Formula (I) in the instant claim and the species identified in claim 19 of ‘463.
Therefore, the instant claim is rejected because the compound of the instant claim is taught by ‘463.
Claim 3 further limits method of claim 1 to wherein the antiandrogen is selected from the group consisting of enzalutamide, N-desmethyl enzalutamide, darolutamide, apalutamide, and abiraterone, or a pharmaceutically acceptable salt or solvate thereof.
As shown in the rejection to claim 1 above, Sumanta Kumar Pal teach the use of both enzalutamide and abiraterone (both antiandrogens). Therefore, it would be obvious to one skilled in the art to select one of these commonly used antiandrogens to treat prostate cancer.
Claim 4 further limits claim 3, wherein the antiandrogen is enzalutamide or a pharmaceutically acceptable salt or solvate thereof.
Therefore, the instant claim is rejected on the same grounds of obviousness as claim 3 above.
Claim 5 further limits claim 1 and identifies the variety of cancers treated the cancer is selected from the group consisting of prostate cancer, breast cancer, lung cancer, liver cancer, kidney cancer, bladder cancer, ovarian cancer, peritoneal cancer, fallopian tube cancer, cervical cancer, uterine cancer, pancreatic cancer, stomach cancer, colorectal cancer, esophageal cancer, head and neck cancer, testicular cancer, adrenal cancer, skin cancer, brain cancer, sarcoma, and lymphoma.
As detailed above in the rejection to claim 1, Sumanta Kumar Pal teach the use of CDK4/CDK6 inhibitors and how they were effective at inhibiting the enzalutamide-resistant growth of LNCaP cells (a prostate cancer cell line).
Accordingly, the instant claim is rejected for the same obviousness reasons as claim 1.
Claims 6-8 and 23-25 further limit the claims to include the treatment of specific types or characteristics of prostate cancer (claims 6 and 23), metastatic prostate cancer (claims 7and 23), and non-metastatic prostate cancer (claims 8 and 24).
Although the instant claims are directed to several specific species of prostate cancer,
Sumanta Kumar Pal identify antiandrogen resistant cancer cell lines treated with a CDK inhibitor like the compound of Formula (I) (a CDK inhibitor) to treat prostate cancer. Combination therapies like the use of a CDK inhibitor in conjunction with an antiandrogen has been shown in the prior art. The distinction between the prostate cancers listed simply describes the patient condition and the stage of the disease progression; either the cancer spreads (metastatic) or it does not spread (non-metastatic).
Accordingly, the claims are rejected.
Claim 9 further limits the method of claim 6 wherein the prostate cancer is resistant to enzalutamide or abiraterone.
Sumanta Kumar Pal teaches that the use of CDK4/CDK6 inhibitors and how they were effective at inhibiting the enzalutamide-resistant growth of LNCaP cells (a prostate cancer cell line). The use of CDK inhibitors has been used to treat enzalutamide-resistant is known in the art.
Accordingly, the instant claim is rejected.
Claims 10-15 and 21, are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/207463 A1 in view of Hoda et.al., Androgen deprivation therapy with Leuprolide acetate for treatment of advanced prostate cancer, EXPERT OPINION ON PHARMACOTHERAPY, 2017 VOL. 18, NO. 1, 105–113.
Claim 10 further limits claim 1 further comprising administering to the subject: (c) an amount of an additional anticancer agent; wherein the amounts in (a), (b) and (c) together are effective in treating cancer.
Applicant purports to have invented a combination of therapies including a CKD inhibitor combined with an antiandrogen and a chemotherapeutic that together are effective in treating cancer. Hoda teaches that a combination of therapies is often used for prostate cancer. For example:
“This review discusses the pharmacological features of Leuprolide, a luteinizing hormone-releasing hormone (LHRH) agonists/analog and the most commonly used drug in ADT Although Leuprolide has been on the market for more than 30 years it is still the leading option for ADT and serves as a basis for most multimodal therapy concepts. The fact that with the onset of castration-resistance in late-stage metastatic disease, a prolongation of ADT in combination with a second line hormonal manipulation is recommended supports the importance of the compound for daily clinical practice.”
Hoda, abstract, page 105 (emphasis added).
Although the instant claim sets forth a method of treating cancer with a combination of a CDK inhibitors of Formula I, an antiandrogen and a chemotherapeutic. The use of the combination therapies is known in the art. One of ordinary skill in the art would have a reasonable expectation of success to use a combination approach for cancer with a CDK4 inhibitor an anti-androgen and a chemotherapy to treat prostate cancer.
Accordingly, the instant claim is rejected.
Claim 11 further limits claim 10 wherein the additional anti-cancer
agent is selected from the group consisting of an anti-tumor agent, an anti-angiogenesis
agent, a signal transduction inhibitor, an antiproliferative agent, and an androgen
deprivation therapy (ADT).
Hoda teaches the use of the drug Leuprolide, a luteinizing hormone-releasing hormone (LHRH) agonists/analog and the most commonly used drug in ADT. The use of ADT therapy is known in the art and has been used to treat prostate cancer for more than 30 years.
One of ordinary skill in the art would have a reasonable expectation of success to use a combination of approaches including ADT because it is the most common treatment for prostate cancer.
Accordingly, the instant claim is rejected.
Claim 12 further limits claim 11 wherein the additional anti-cancer agent is an ADT.
The instant claim is rejected for the same obviousness reasons as claim 11.
Claim 13 further limits 12 wherein the ADT is selected from the group consisting of a gonadotropin releasing hormone (GnRH) agonist and a gonadotropin releasing hormone (GnRH) antagonist.
As described in the rejection to claim 10, Hoda teaches Leuprolide, a luteinizing hormone-releasing hormone (LHRH) agonist.
Accordingly, the instant claim is rejected for the same obviousness reasons as claim 11.
Claim 14 further limits claim 12 wherein the ADT is selected from the
group consisting of leuprolide, buserelin, gonadorelin, goserelin, histrelin, nafarelin,
triptorelin, deslorelin, fertirelin, abarelix, cetrorelix, degarelix, ganirelix, ozarelix, elagolix,
relugolix and linzagolix, or a pharmaceutically acceptable salt thereof.
The use of leuprolide as an ADT is taught by Hoda as identified in the rejection to claim 10.
Accordingly, the instant claim is rejected for the same obviousness reasons as claim 11.
Claim 15 further limits claim 1 wherein the cancer is androgen dependent or androgen receptor (AR)-positive.
Hoda teaches the treatment of advanced prostate cancer includes treatments aimed at the AR binding pocket. For example:
“Instead, pharmacologic compounds able to lower androgen levels like LHRH analogs, LHRH antagonists, and 5-α-reductase inhibitors as well as antiandrogens targeting directly the AR binding pocket are currently used for the treatment of advanced disease”
Hoda, page 105, col. 2, (emphasis added).
The use of antiandrogens is known in the prior art. Antiandrogens target the AR binding pocket. One of ordinary skill in the art would have a reasonable expectation of success using an antiandrogen that targets the AR binding pocket as a part of prostate cancer therapy.
Accordingly, the instant claim is rejected.
Claim 21 further limits claim 1 wherein the subject is human.
Hoda teaches the use of Leuprolide to treat prostate cancer that has been on the market for more than 30 years it is still the leading option for ADT. Treating prostate cancer with a drug that has been on the market for 30 years is obviously used on humans.
Accordingly, the instant claim is rejected.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-15 and 21-25 are obvious variants of the claims in the ‘844 patent:
Claims 1-15 and 21-25 are unpatentable over claims 1-18, of U.S. Patent No. 10,766,884 B2 issued September 8, 2020 (hereinafter ‘884).
Claims 13-18 of ‘884 are directed to a compound of a genus of Formula (XI-A) including the limitations of the variables (claims 14-18) listed below to the genus of the compound identified in claim 13:
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The utility of the compound identified by the genus of (XI-A) is known to inhibit the activity of CD Ks, including CDK4 and/or CDK6, thereby effecting biological functions. ‘884 identifies the genus compound of (XI-A) is used in a method for the treatment of cancer as shown in claim 7:
7. A method for the treatment of cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound of claim 3, or a pharmaceutically acceptable salt thereof.
Claim 1 is of the instant application is directed to a method of treating cancer in a subject in need thereof comprising administering to the subject: (a) an amount of a compound of Formula (I) and (b) an antiandrogen wherein;
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(b) an amount of an antiandrogen; wherein the amounts in (a) and (b) together are effective in treating cancer.
Although the instant claims set forth a method of treating cancer with the CDK4 inhibitors of Formula I (see instant claims 1, 2, 3, 6 and 7), the claims of the ‘884 patent do not set forth a combination method with an antiandrogen. However, one of ordinary skill in the art would have a reasonable expectation of success in the addition of an antiandrogen to the method of treatment in combination with a CDK4 inhibitor because it is known in the art to use a combination approach for cancer with a CDK4 inhibitor and an anti-androgen. Both types of compounds have been used to successfully treat cancers, such as prostate cancer. For example, Sumanta Kumar Pal et. al., Identification of Mechanisms of Resistance to Treatment With
Abiraterone Acetate or Enzalutamide in Patients with Castration-Resistant Prostate Cancer (CRPC), Cancer 2018;124:1216-24, shows that CDK4 inhibitors have been used in conjunction with enzalutamide or abirateronee (both are antiandrogens) to treat prostate cancer.
“We also observed that CCND1 pathway signaling
was enriched in drug-resistant samples. We also made the important observation that CDK4/CDK6 inhibitors were effective at inhibiting the enzalutamide-resistant growth of LNCaP cells. The CCND1 pathway is commonly dysregulated in cancers 25 and has long been thought to contribute to prostate cancer progression.26.”
Sumanta Kumar Pal, page 1222, col. 1, paragraph 3. (emphasis added).
Sumanta Kumar Pal teaches the benefit of using CDK4 inhibitors to limit the growth of enzalutamide-resistant LNCaP cells. Some prostate cancers are resistant to the treatment with enzalutamide or abiraterone (antiandrogens) and require a change in therapy. Both CDK4 inhibitors an antiandrogen has been used in a combination to affect the growth of prostate cancer cells. The applicant is using a second well known therapeutic, an antiandrogen, in conjunction with an already known primary therapeutic that is a CDK inhibitor to treat prostate cancer.
Claim 3 of ‘884 identifies the species of the genus compound of Formula (XI) as:
1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-
benzimidazol-6-yl] pyrimidin-2-yl} amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically
acceptable salt thereof.
Claim 2 of the instant application identifies the exact species of Formula (I) as:
1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-
benzimidazol-6-yl] pyrimidin-2-yl} amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof.
Claim 3 of ‘884 and claim 2 of the instant claim are identical.
Claims 1-15 and 21-25 are obvious variants of the claims in the ‘494 patent:
Claims 1-15 and 21-25 are unpatentable over claims 1-21 of U.S. Patent No. 11,220,949 B2 issued January 11, 2022 (hereinafter ‘494).
Claim 7 of ‘494 identifies the compound used to treat a variety of cancers. For example:
7. A method for the treatment of cancer in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of 1,5-anhydro-3-({5- chloro-4-[4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2- yl)-1H-benzimidazol-6-y1]pyrimidin-2-yl}amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof, wherein the cancer is selected from the group consisting of breast cancer, ovarian cancer, bladder cancer, uterine cancer, prostate cancer, lung cancer, esophageal cancer, head and neck cancer, colorectal cancer, kidney cancer, liver cancer, pancreatic cancer, stomach cancer and thyroid cancer.
(emphasis added)
Claim 2 of the instant application identifies the exact species of Formula (I) as:
1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-
benzimidazol-6-yl] pyrimidin-2-yl} amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof.
Claim 7 of ‘494 and claim 2 of the instant claim are identical.
Claims 1-15 and 21-25 are obvious variants of the claims in the ‘232 patent:
Claims 1-15 and 21-25 are unpatentable over claims 1and 2 of U.S. Patent No. 123,378,232 B2 issued August 5, 2025 (hereinafter ‘232).
Claim 1 of ‘232 describes a compound, which is 1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-benzimidazol-6-yl ]pyrimidin-2-y 1 }amino )-2,3-dideoxy-D-threopentitol, wherein one or more hydrogen atoms are replaced by deuterium.
Claim 2 of the instant application identifies a method wherein the species of Formula (I) is 1,5-anhydro-3-( {5-chloro-4-[ 4-fluoro-2-(2-hydroxypropan-2-yl)-1-(propan-2-yl)-1 H-
benzimidazol-6-yl] pyrimidin-2-yl} amino)-2,3-dideoxy-D-threo-pentitol, or a pharmaceutically acceptable salt thereof.
Although the instant claim sets forth a method using the compound that is identical to ‘232, they do not require the compound to have one or more of the hydrogen atoms replaced by deuterium. However, one of ordinary skill in the art would have a reasonable expectation of success by deuterating the hydrogen of the compound because it is known in the art. For example, Pirali, et.al., Applications of Deuterium in Medicinal Chemistry, J. Med. Chem. 2019, 62, 5276−5297, teach that the deuteration of compounds are beneficial in drug design.
“Precision deuteration goes beyond the pure and simple amelioration of the pharmacokinetic parameters of a drug and might provide an opportunity when facing problems in terms of metabolism-mediated toxicity, drug interactions, and low bioactivation.”
(emphasis added).
‘232 does teaches the identical compound as the instant claim, but requires that one or more of the hydrogens to be deuterated, Pirali details the conditions related to motivation for deuteration; namely metabolism-mediated toxicity, drug interactions, and low bioactivation. The instant claim is directed to a method of treating cancer with the same compound and would be motivated to deuterate the hydrogen of the compound as in ‘232.
Conclusion
Claims 1-15 and 21-25 are rejected.
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 A U.S. patent document under 35 U.S.C. 102(a)(2) includes a U.S. patent, a published U.S. patent application, a published international application that designates the United States, and a published international design application that designates the United States. See 35 U.S.C. 374 and 390 which respectively provide that a published international application that designates the United States and a published international design application that designates the United States shall be deemed a publication under 35 U.S.C. 122(b).