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 .
DETAILED ACTION
Status of 18/249,209
Claims 1-3, 13-16, 19-29, 31, and 204-210 are currently pending.
Priority
Instant application 18/249,209, filed 4/14/2023, claims priority as follows:
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The provisional application contains support for the instant claims, and thus, claims 1-3, 13-16, 19-29, 31, and 204-210 are granted the effective filing date of 10/16/2020.
Information Disclosure Statement
All references from the IDS submitted on 1/17/2025 have been considered unless marked with a strikethrough. The references struck through on the IDS at hand were pixelated and illegible, and thus not able to be considered.
Election/Restriction
Applicant’s election of breast cancer as the single disclosed species of cancer to treat, compound 101:
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as the single disclosed species of Formula (I), a 14 day treatment cycle, once or twice daily for the first 7 days of the cycle at a dose of 1-30 mg/day and withheld for the subsequent 7 days of the cycle as the single disclosed species of dosing regimen, a CDK4/6 inhibitor as the single disclosed inhibitor as to which the cancer is resistant or has become refractory, and a taxane as the single disclosed species of second anti-cancer agent, with traverse, in the reply filed 11/20/2025 is acknowledged. The Examiner notes compound 101 is a compound of Formula (I):
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When R1 is methyl, R2 is methyl, R3 is 6,6-dimethylpiperidin-3-yl, and R4 is CF3.
The traversal is on the grounds that the pending claims have been amended to treating a human patient with compounds of Formula (I), and thus, the prior art does not teach the inventive concept. This argument is not found persuasive because the claim set examined for the election of species requirement was the amended claim set submitted 4/14/2023, which recited treatment of a patient. A patient is defined in the instant disclosure on page 46, lines 10-18, and includes research animals such as rodents and transgenic mice. Thus, the art applied in the election of species requirement of 9/23/2025 is valid. The amendments to the claims to recite a human patient were submitted on 11/20/2025, in response to the election of species requirement. The requirement is still deemed proper and is therefore made FINAL.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. Additionally, during the search, additional prior art was identified where the second anti-cancer agent of the method is fulvestrant, which is a selective estrogen receptor degrader (SERD). The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-3, 13-16, 19-20, 25-29, 31, 204-206, 208, and 210 read on the elected and expanded species. Claims 21-24, 207, and 209 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Interpretation
Claim 1 recites compounds of Formula (I), which when R1 is methyl, R2 is methyl, R3 is 6,6-dimethylpiperidin-3-yl, and R4 is CF3, maps to the elected species, which is also known in the present disclosure as compound 101. During the search, the elected species was also found to be known in the art as SY-5609. Thus, the elected species is currently being interpreted as synonymous with the terminology of “compound 101” and “SY-5609”.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 206 and 208 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 206 and 208 recite the limitation, “paclitaxel (protein bound), in reference to a taxane as a second anti-cancer agent. The phrase within the parentheses is indefinite because it is exemplary language and it is not clear if the contents of the parentheses are required, or just examples of what is required. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 13-16, 19-20, 25-29, 31, 204-206, and 208 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, "To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims are drawn to a method of treating a human patient who has a cancer that is characterized by the presence of a solid tumor and associated with overexpression and/or aberrant activity of CDK7, the method comprising administering a pharmaceutical composition comprising a therapeutically effective amount of Formula (I). Specifically, claim 1 is drawn to where the cancer is characterized by the presence of a solid tumor and, “associated with overexpression and/or aberrant activity of CDK7”. Applicant has not described the claimed genus of cancers that are associated with overexpression and/or aberrant activity of CDK7 in a manner that would indicate they were in possession of the full scope of the genus, or even to describe what this genus is comprised of.
The genus of cancers associated with overexpression and/or aberrant activity of CDK7 is not fully defined in the instant disclosure. Though the instant specification does state that two events or entities are “associated” with one another of one or more features of the first are correlated with a feature of a second (page 14, lines 2-4), the “associated” term is not defined with respect to the genus of cancers encompassed by the instant claims. Applicants fail to describe the full scope of cancers associated with overexpression and/or aberrant activity of CDK7 and thus, it is unclear where the possession of the association lie. Though cancer is known in the art, the description is not adequate to allow one skilled in the art to ascertain that Applicant is in possession of the knowledge of the entire scope of the genus.
A review of the prior art at the time of filing identifies Patel (Patel, H. et. al. Clin. Cancer. Res. 2016, 22(23); 5929-5938). Patel teaches that generally, CDK7 expression is elevated in breast cancer compared with normal breast tissue (abstract). However, Patel also teaches that CDK7 is not elevated in all breast tumors when compared with adjacent normal breast tissue in examples 3, 7, 15, and 16 (Supp Fig. 1A):
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Though Patel discloses breast cancers where CDK7 is elevated, it also discloses breast cancers where CDK7 expression is not elevated and thus, Applicant has not demonstrated the possession of the knowledge of which cancers would or would not have this function. Stated differently, there is no structure/function correlation between what cancers would be able to be treated with CDK7 inhibitors.
In addition to the lack of structure/function relationship established, there is also an insufficient representative number of examples. As described in MPEP § 2163, for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. The instant specification provides examples of cancers “associated with overexpression and/or aberrant activity of CDK7” in the form of specific cell lines of breast cancer, small cell lung cancer, ovarian cancer, pancreatic ductal adenocarcinoma, colorectal cancer in examples 9-13, indicating that the instant disclosure does not provide descriptive support for the genus of the claims. Applicant has not described the claimed genus of treating a cancer “associated with overexpression and/or aberrant activity of CDK7” in a manner that would indicate they were in possession of the knowledge of the full scope of the genus, or even to describe what the genus is comprised of.
Methods of inhibiting CDK7 are, in general, known to the person of ordinary skill; however, methods of treating cancers associated with overexpression and/or aberrant activity of CDK7 embraced by the instant claims are beyond the skill of the artisan, particularly when the term, “associated with” is merely partially described. As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the methods.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Dependent claims 2-3, 13-16, 19-20, 25-29, 31, 204-206, and 208 do not resolve these issues, since these claims do not further limit or provide further definition of the cancers associated with the overexpression and/or aberrant activity of CDK7. Accordingly, claims 2-3, 13-16, 19-20, 25-29, 31, 204-206, and 208 are also rejected.
Claim Rejections - 35 USC § 112(a)- Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13-16, 19-20, 25-29, 31, 204-206 and 210 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant specification, while being enabled for CDK7 inhibition, inhibition of triple negative breast cancer cell lines, inhibition of tumor growth in breast, ovarian, lung, and colorectal PDX models, and treatment of breast, colorectal, lung, ovarian, or pancreatic cancer in human patients, does not reasonably provide enablement for treating all other cancers. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples, and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the Invention
The invention is drawn to methods of treating a human patient with compounds of Formula (I), where the compounds disclosed inhibit CDK7.
Breadth of the Claims
The claims are broadly directed to the use of compounds of Formula (I) for the treatment of all cancers in human patients. The definition of cancers is disclosed on page 16, lines 8-22:
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and provides some examples of cancers claimed to be treated in the methods of the instant claims.
Level of Ordinary Skill in the Art
The artisans using Applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical arts, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
For example, different types of cancers affect different organs and have different methods of growth and/or harm to the body, and different vulnerabilities. The skill thus depends on the cancers. There are some cancers where the skill level is high and there are multiple successful therapeutic treatments. The mechanism of action in these situations, however, is not necessarily the same as is alleged for these compounds.
State of the Prior Art and Predictability in the Art
At the time of filing, there were multiple compounds targeting CDK7 in development, and a variety of scaffolds are present in literature (Sava, G. P. et. al. Cancer and Metastasis Reviews, 2020, 39, 805-823). However, none have been shown to have a broad spectrum of treatment of all cancers, and a large number have poor selectivity, resulting in numerous side effects that resulted in failure in clinical cancer treatment. Further, there are different types of treatments available for cancer, including surgery, chemotherapy, hormonal therapy, biological therapy, and radiation. Not every treatment option is effective for every patient, and for some patients, combinations of the above treatment options are necessary to manage their symptoms. Therefore, the ability to treat all cancers by CDK7 inhibition unpredictable, much less the ability to anticipate which patients are at risk for cancer.
For example, Sava was identified as close prior art at the time of filing, and discloses four CDK7 inhibitors in Phase I/II clinical trials capable of treating breast cancer, prostate cancer, ovarian cancer, bladder cancer, epithelial cancer, and soft tissue sarcoma (abstract, clinical trials). In addition, Sava discloses that gastric cancer, ovarian cancer, oral squamous cell carcinoma, hepatocellular carcinoma, and glioblastoma have connections between CDK7 and reduced survival (page 809, Section 3.1). No other evidence of treating all cancers by CDK7 inhibition was provided.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous cancers claimed herein. That a single compound or class of compounds can be used to treat all cancers embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all of the cancers by administering the instant claimed compounds.
Amount of Direction Provided and Working Examples The only direction or guidance present in the instant disclosure is the listing of cancers in claims 2 and 3 Applicant alleges are treatable by the compounds of the instant claims, the activity of certain compounds of Formula (I) in CDK7 inhibition, inhibition of triple negative breast cancer cell lines, inhibition of tumor growth in breast, ovarian, lung, and colorectal PDX models, and treatment of breast, colorectal, lung, ovarian, or pancreatic cancer in human patients. The specification does not show any examples where compounds of the claims were used to treat the full scope of cancer as set forth in claims, but merely demonstrates that certain compounds inhibit CDK7, inhibit triple negative breast cancer cell lines, inhibit tumor growth in breast, ovarian, lung, and colorectal PDX models, and treat breast, colorectal, lung, ovarian, or pancreatic cancer in human patients. (See MPEP § 2164.02 (“Compliance with enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed… Lack of a working example, however is a factor to be considered, especially in a case involving an unpredictable and undeveloped art”.)
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what cancers out of all cancers would be benefited (treated, prevented, or cured) and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment of the claimed cancers.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the pharmaceutical compositions for the full scope of the claimed intended uses.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The specification fails to provide enough support of the broad use of the methods of administering compounds of the claims in the treatment of all cancers as a result necessitation one of skill to perform an exhaustive search for which cancers can be treated by what compounds of the invention to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-3, 13-16, 19-20, 25-29, 31, 204-206, 208, and 210 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03134638 (https://clinicaltrials.gov/study/NCT03134638?cond=Breast%20Cancer&term=CDK7&rank=2&tab=history&a=9#version-content-panel, V9, published 2019-09-12, accessed 3/10/2026, herein after “NCT03134638”) and further in view of Diab (Diab, S. Yu, M. and Wang, S. J. Med. Chem. 2020, 63, 7458-7474). This rejection applies to the expanded species where the second anti-cancer agent is fulvestrant, a selective estrogen receptor degrader (SERD). See below for the rejection of the elected species, where the second anti-cancer agent is a taxane.
Determining the scope and contents of the prior art
The reference NCT03134638 teaches methods of treating human patients with advanced solid tumors with CDK7 inhibitor SY-1365 (title). Specifically, NCT03134638 teaches the treatment of cohort 5, which is approximately 12 patients with HR+ metastatic breast cancer post CDK4/6+ hormonal therapy treatment with SY-1365 and fulvestrant (page 6). The drug SY-1365 was administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4-week cycle, which phrased differently, is where SY-1365 is withheld for the subsequent 7 days of the cycle after drug administration, and fulvestrant, a second anti-cancer agent, is administered at a dose of 500 mg every 2 weeks (pages 9-10). Further, cohort 5 consists of postmenopausal women with HR+, HER2- or TNBC who have failed prior treatment with a CDK4/6 inhibitor, which indicates resistance to a previously administered anti-cancer agent (page 13).
The reference Diab teaches the compound SY-5609, also known as the instant elected species of Formula (I), as a potent, orally bioavailable CDK7 inhibitor (page 7467). Diab further teaches the treatment of breast cancer cell lines and PDX models with SY-5609.
Ascertaining the differences between the prior art and the claims at issue
NCT03134638 fails to teach the method of treatment with the compound SY-5609, also known as the elected species of instant Formula (I).
Diab fails to teach a method of treating a human patient with breast cancer.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating cancers by CDK7 inhibition. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of treating cancers by CDK7 inhibition and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one having ordinary skill in the art to substitute the CDK7 inhibitor of clinical trial NCT03134638 with the elected species, also known as CDK7 inhibitor SY-5609, because both compounds have the same target. Thus, the substitution of the CDK7 inhibitor of NCT03134638 for the instant elected species would be expected to have similar properties, and a skilled artisan would have been motivated before the effective filing date to make such a substitution to identify additional methods of treating breast cancer. A skilled artisan would have reasonably expected success in view of the teachings of Diab and NCT03134638.
With respect to the dosage limitations of claims 1, 2, 204, and 210, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the dosage amounts, frequencies, and durations recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the dosage amounts, frequencies, and durations to provide optimal cancer treatment. The dosage amounts, frequencies, and durations are result effective parameters that will affect the outcome of the final treatment. The amount of a compound of Formula (I) in method of treatment is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the duration of administration of the compound. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the dosage amounts, frequencies, and durations, disclosed by NCT03134638 above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal limitations to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the dosage limitations and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claims 31, 205, and 208 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03134638 (https://clinicaltrials.gov/study/NCT03134638?cond=Breast%20Cancer&term=CDK7&rank=2&tab=history&a=9#version-content-panel, V9, published 2019-09-12, accessed 3/10/2026, herein after “NCT03134638”), in view of Diab (Diab, S. Yu, M. and Wang, S. J. Med. Chem. 2020, 63, 7458-7474) and in further view of Syros Pharmaceuticals, Inc. (WO 2018/231859 A1, herein after “Syros”). This rejection applies to the elected species where the second anti-cancer agent is a taxane.
Determining the scope and contents of the prior art
The references NCT03134638 and Diab teach as disclose above, and at least those teachings are incorporated herein. Further, the reference Syros teaches methods of treating cancer with CDK7 inhibitors, and specifically identifies administration of the combination of a CDK7 inhibitor and a taxane (page 10, para [27]).
Ascertaining the differences between the prior art and the claims at issue
NCT03134638 fails to teach the method of treatment with the compound SY-5609, also known as the elected species of instant Formula (I).
Diab fails to teach a method of treating a human patient with breast cancer.
Syros fails to teach a method of treating a human patient with the instant elected species.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of treating cancers by CDK7 inhibition. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of treating cancers by CDK7 inhibition and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious to one having ordinary skill in the art to substitute the second anti-cancer agent, the SERD fulvestrant, of NCT03134638 with a taxane because both SERDs and taxanes are known in the art to treat breast cancer in combination with CDK7 inhibitors. Thus, the substitution of fulvestrant of NCT03134638 for a taxane would be expected to have similar properties, and a skilled artisan would have been motivated before the effective filing date to make such a substitution to identify additional methods of treating breast cancer. A skilled artisan would have reasonably expected success in view of the teachings of NCT03134638, Diab, and Syros.
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.
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Claims 1-3, 19-20, 26-29, and 210 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,738,067 B2 (herein after the “‘067 Patent”) in view of Clinical Trial NCT03134638 (https://clinicaltrials.gov/study/NCT03134638?cond=Breast%20Cancer&term=CDK7&rank=2&tab=history&a=9#version-content-panel, V9, published 2019-09-12, accessed 3/10/2026, herein after “NCT03134638”) and Diab (Diab, S. Yu, M. and Wang, S. J. Med. Chem. 2020, 63, 7458-7474).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘067 Patent teach the instant elected species of Formula (I), also known as SY-5609. The utility disclosed in the specification provides further support for a nonstatutory double patenting rejection. See MPEP § 804(I)(B)(1) and Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). Though the ‘067 Patent fails to recite the dosage limitations of the instant claims, the references NCT03134638 and Diab teach the deficiencies of the ‘067 Patent as disclosed above to arrive at the instant claims.
Claims 1-3, 19-20, 26-29, and 210 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-11, 13, and 20 of U.S. Patent No. 12,240,869 B2 (herein after the “‘869 Patent”) in view of Clinical Trial NCT03134638 (https://clinicaltrials.gov/study/NCT03134638?cond=Breast%20Cancer&term=CDK7&rank=2&tab=history&a=9#version-content-panel, V9, published 2019-09-12, accessed 3/10/2026, herein after “NCT03134638”) and Diab (Diab, S. Yu, M. and Wang, S. J. Med. Chem. 2020, 63, 7458-7474).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘869 Patent teach compounds of Formula (I), which is identical to instant Formula (I) including the variables for R1, R2, R3, and R4. The utility disclosed in the specification provides further support for a nonstatutory double patenting rejection. See MPEP § 804(I)(B)(1) and Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). Though the ‘869 Patent fails to recite the dosage limitations of the instant claims, the references NCT03134638 and Diab teach the deficiencies of the ‘869 Patent as disclosed above to arrive at the instant claims.
Claims 1-3, 19-20, 26-29, and 210 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/037,690 (reference application, herein after the “’690 Application”) in view of Clinical Trial NCT03134638 (https://clinicaltrials.gov/study/NCT03134638?cond=Breast%20Cancer&term=CDK7&rank=2&tab=history&a=9#version-content-panel, V9, published 2019-09-12, accessed 3/10/2026, herein after “NCT03134638”) and Diab (Diab, S. Yu, M. and Wang, S. J. Med. Chem. 2020, 63, 7458-7474).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the ‘690 Application teaches a method of treating or preventing a disease in a subject in need thereof, comprising administering a pharmaceutical composition comprising a compound of Formula (I) where the disease is a proliferative disease. The Formula (I) of the ‘690 Application is identical to the Formula (I) of the instant claims, including the variables for R1, R2, R3, and R4. Though the ‘690 Application fails to recite the dosage limitations of the instant claims, the references NCT03134638 and Diab teach the deficiencies of the ‘690 Application as disclosed above to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-3, 13-16, 19-20, 25-29, 31, 204-206, 208, and 210 are rejected. Claims 21-24, 207, and 209 are withdrawn.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621