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 1-12 and 14-21 are pending in the instant application.
Domestic Benefit
Acknowledgement is made for Applicant’s claim for domestic benefit based on U.S. Provisional Application Nos. 63/287,716, 63/306,399, and 63/397,322, filed on December 19th, 2021, February 3rd, 2022, and August 11th, 2022, respectively. Claims 1-12 and 14-21 are fully supported by U.S. Provisional Application No. 63/287,716, and will be evaluated with an effective filing date of December 19th, 2021.
Information Disclosure Statement
The Information Disclosure Statement filed on June 7th, 2024 has been fully considered by the examiner, except where marked with a strikethrough.
Specification
The disclosure is objected to because of the following informalities:
At Page 489, Compound 39 is presented as
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, with a double bond between S and O erroneously omitted.
At Page 493, Compound 47 is presented as
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, with a double bond between S and O erroneously omitted.
At Page 494, Compound 50 is presented as
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, with a double bond between S and O erroneously omitted.
At Page 496, Compound 53 is presented as
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, with a double bond between S and O erroneously omitted.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Claim Objections
Claims 9 and 20-21 are objected to because of the following informalities:
Rule 1.141(a) states:
Two or more independent and distinct inventions may not be claimed in one national application, except that more than one species of an invention, not to exceed a reasonable number, may be specifically claimed in different claims in one national application, provided the application also includes an allowable claim generic to all the claimed species and all the claims to species in excess of one are written in dependent form (§ 1.75) or otherwise include all the limitations of the generic claim.
Claims 9 and 20-21 claim a large number of species of the generic claim, but in independent format. Multiple inventions may not be claimed in a single application unless they are species claims which are dependent upon the larger, generic claim. In the past, the Office has held a “reasonable number” to be five (5) species. The present claim contains well over this number of species. One could envision forty pages of species compounds in a single claim which is not dependent upon any genus claim. This would cause undue burden to the Office in examining such a large claim. Therefore, it is recommended that Claims 9 and 20-21 either be dependent from a larger, genus claim, or, that claims 9 and 20-21 incorporate all of the limitations of the genus claim. Applicants are invited to contact the examiner if further clarification is needed. No new matter is permitted.
Additionally, some of the structures shown in Claim 9 appear to be missing bonds. For example, compound 50 is presented as
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, with a double bond between S and O omitted, and compound 73 is presented as
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, with a double bond between S and O and a single bond between S and N omitted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-8, 10-12, and 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a compound of Formula (I) or pharmaceutically acceptable salt, stereoisomer, solvate, or tautomer thereof in which W is -CN or W and ring B together with the atoms to which they are attached and any intervening atoms form a 5-10 membered heterocycle, R1 is C1-3 alkyl or C1-3 alkoxy optionally substituted with halogens, R2 is halogen, C1-3 alkyl, or C1-6 alkoxy, R3 is hydrogen or L4, L5 is (CH2)1-4, Ring B is 5-7 membered heterocycle, 6 membered heteroaryl, R6 is H, C1-3 alkyl, -C(O)R7, -NHC(O)R7, S(O)sR11, -NHS(O)2NR9R10, heterocyclyl, or C1-3 alkanediyl aryl, R7 is R8, R8 is C1-3 alkyl, C2-3 alkenyl, R9 and R10 are H, and R11 is C1-3 alkyl, or C3 cycloalkyl, does not reasonably provide enablement for a compound of Formula (I) or prodrug thereof in which these variables are otherwise defined. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and 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 a compound of the Formula (I):
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Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to any compound of the above formula, allowing for myriad combinations of the variables as defined, for example at instant Claim 1. Additionally, the claim is drawn to any prodrug of a compound of Formula (I). A person having ordinary skill in the art would readily recognize a multitude of functionalization at multiple points within molecules that read on Formula (I) that could be modified to generate a compound that would function as a prodrug of a compound of Formula (I).
State of the prior art and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
The compound core depicted with specific substituents represents a narrow subgenus for which applicant has provided sufficient guidance to make and use; however, the disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working examples of any compound of Formula (I) in which W, R1, R2, L, R3, L4, L5, ring B, R6, R7, R8, R9, R10, and R11 were not defined as noted above in the instant application. With respect to prodrugs, sufficient disclosure has not been provided such that a person having ordinary skill in the art would readily ascertain which prodrugs are intended to be encompassed by the instant invention, nor would they readily understand the benefit of making particular prodrugs of compounds of Formula (I).
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples of the description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.1(p).
MPEP § 2164.01(a) states, “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. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for making these compounds.
Claims 15-16 and 18-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating leukemia, does not reasonably provide enablement for a method for the treatment or prevention of any disease or disorder associated with the interaction of menin and MLL. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and 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 a method for the prevention or treatment of any disease or disorder associated with the interaction of menin and MLL comprising administration of a compound of Formula (I) as recited at instant Claim 1.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to the prevention or treatment of any disease or disorder associated with the interaction of menin and MLL. This includes a myriad of diseases and disorders, both known presently, and those that are yet to be discovered, but are later classified as being associated with the interaction of menin and MLL. Can the Applicant simply “reach through” and obtain patent protection for the prevention and/or treatment of diseases or disorders yet to be discovered, or diseases and disorders that are presently known, but later are classified within the instantly claimed scope?
State of the prior art and predictability in the art:
No compound has ever been found to treat cancers of all types generally. Since this assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits. The existence of such a “silver bullet” is contrary to our present understanding of oncology. The state of the art is not indicative of any pharmaceutical agents that are useful in the treatment of cancer generally. At Page 1004, Cecil Textbook of Medicine states that “each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study”. Different types of cancers affect different organs and have different methods of growth and harm to the body. Also see In re Buting, 163 USPQ 689 (CCPA 1969), wherein ‘evidence involving a single compound and two types of cancer, was held insufficient to establish the utility of the claims directed to disparate types of cancers’. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally.
A similar statement appears at In re Application of Hozumi et. al., 226 USPQ 353: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way”. There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers.
The attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from a bewildering variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body’s cell growth regulatory mechanisms, but also such external factors such as viruses (an estimated at least 20% are of viral origin e.g. Human papillomavirus, EBV, Hepatitis B and C, HHV-8, HTLV-1 and other retroviruses, and quite possibly Merkel cell polyomavirus, and there is some evidence that CMV is a causative agent in glioblastoma), exposure to chemicals such as tobacco tars, excess alcohol consumption (which causes hepatic cirrhosis, an important cause of HCC), ionizing radiation, and unknown environmental factors.
Similarly, In re Novak, 134 USPQ 335, 337-338 says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case for a compound that treats all types of cancer. Likewise, In re Cartright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if Applicant’s assertion that cancer in general could be treated with these compounds were plausible -- which it is not --, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.
Recently, Wu et. al. (“Small-molecule inhibitors, immune checkpoint inhibitors, and more: FDA- approved novel therapeutic drugs for solid tumors from 1991 to 2021; Journal of Hematology & Oncology, 15, 143, 2022; hereinafter referred to as Wu), at the Abstract, discloses that between 1991 and 2021 there have been 228 new cancer drugs approved by the U.S. Food and Drug Administration of which 120 of these are drawn to the treatment of solid tumors alone. At Page 5, Table 1 Wu teaches that there are 21 different approved drugs for treating lung cancers, some of which have cellular targets. At Page 10, Table 2, Wu teaches breast cancer has 22 different drugs that have varied cellular targets and are indicated for different types of breast cancer. At Page 17, Table 4, Wu teaches there are 17 different drugs available to treat different forms of gastrointestinal cancers. At Page 38, Figure 12, Wu summarizes the protein structure of some cellular targets and the binding site of their respective drugs. Taken together, Wu teaches that no single therapeutic has ever been identified as a treatment for all forms of cancer; and closer examination of Figure 12 provides a logical explanation. As highlighted in Figure 12, molecular protein targets implicated in different cancers (e.g. EGFR for lung cancer in Table 1, VEGFR2 for gastric cancer in Table 4) have different three-dimensional protein structures, different active sites, and therefore require different drugs with the right shape and chemical groups in order to bind the target active site and have an effect in treating cancer. In other words, there is no one size fits all approach to treating cancer simply for the reason that no single molecule will have the shape and chemical functional groups necessary to bind and modulate all modular targets of cancer, all of which have varied shapes. It is commonly known in the pharmaceutical arts that shape dictates function wherein drugs which have a shape complimentary to the protein target will bind and have an effect (this is often referred to simplistically as a “Lock and Key” model). Given the varied shape of protein targets in cancer (e.g. EGFR and VEGFR2), it is pure fantasy to speculate that a single drug with a single three dimensional shape will bind all protein targets implicated in cancer therapy and have an effect in treating all forms of the disease. As such, at present the “silver bullet” drug therapy to treat all forms of cancer is elusive and such a therapy is not recognized in the art where the reality is that different forms of cancer require different drug therapies.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
With respect to the utility of the instantly claimed compounds, several examples are disclosed beginning at Page 576 of the instant application.
Beginning at Page 577 of the instant specification, assays are sufficiently described disclosing the activity of the instantly claimed compounds against the HEK293 (embryonic kidney cells), MV4-11 (leukemia cell line), and MOLM-13 (AML cell line) cell lines.
These examples are sufficiently enabling for the treatment of leukemia. These limited examples, however, are insufficient to provide enablement for the treatment or prevention of any disease associated with the interaction of menin and MLL.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would need to identify and/or develop metrics to evaluate the efficacy of compounds in treating diseases or conditions beyond leukemia.
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 invention without undue experimentation.
The specification fails to provide enough support for the broadly claimed method of treating or preventing any disease or disorder associated with the interaction of menin and MLL.
Genentech Inc. V. Novo Nordisk A/S (CAFC) USPW2d 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 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 having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of the instantly claimed method of treating or preventing any disease or disorder associated with the interaction of menin and MLL.
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 18-19 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.
Claim 18 recites the limitation "wherein the subject is a mammal" and Claim 19 recites the limitation “wherein the subject is a human.” There is insufficient antecedent basis for this limitation in the claim, as these claims depend from Claims 12 and 14, which do not recite a limitation of a subject.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 10-12, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Claremon et. al. (US 2019/0010167 A1; cited on Applicant’s Information Disclosure Statement filed June 7th, 2024; hereinafter referred to as Claremon).
At Page 58, Claremon teaches the following pair of enantiomers as Example 86:
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These compounds read on a compound of Formula (I) as recited at instant Claim 1 when the variables are recited as follows:
X1 is N.
X1, X2, X3, X4, and X5 are each N.
W is -CN.
p is 1, and R1 is C2-alkyl, substituted with three halogen atoms, wherein each halogen is fluoro.
r is 1, and R2 is C1-alkyl.
L is (CR52)q, wherein R5 is H and q is 1.
R3 is hydrogen.
R4 is hydrogen.
One m is 1, and the other is 2.
One n is 1, and the other is 2.
Regarding Claim 3, this compound reads on a compound of Formula (I-C) when the variables are defined as above.
Regarding Claim 4, this compound reads on a compound of Formula I-I when the variables are defined as above.
Additionally, at Page 62, Claremon teaches the following compound as Example 90:
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This compound read on a compound of Formula (I) as recited at instant Claim 1 when the variables are defined as follows:
X1 and X6 are each N.
X2, X3, X4, and X5 are each N.
W is -CN.
p is 1, and R1 is C2-alkyl, substituted with three halogen atoms, wherein each halogen is fluoro.
r is 1, and R2 is C1-alkyl.
L is (CR52)q, wherein R5 is H and q is 1.
R3 is hydrogen.
R4 is hydrogen.
One m is 1, and the other is 2.
One n is 1, and the other is 2.
Regarding Claim 3, this compound reads on a compound of Formula (I-C) when the variables are defined as above.
Regarding Claim 4, this compound reads on a compound of Formula I-I when the variables are defined as above.
Regarding Claim 10, at Claim 42, Claremon teaches a pharmaceutical composition comprising the aforementioned compound.
Regarding Claim 11, at Page 16, Paragraph 0162, Claremon teaches administering a compound, inclusive of Example 90, as taught above, with an additional anti-cancer agent.
Regarding Claims 12 and 14, beginning at Page 73, Paragraph 0580, Claremon teaches both in vitro and cellular assays for evaluating the inhibition of the interaction of menin and MLL in a cell. At Page 74, Table 1, Claremon teaches the compound taught as Example 90, above, is an inhibitor of the interaction of menin and MLL.
Regarding Claims 15-19, Claremon teaches at Claims 44-48 a method of treating cancer in a patient by administering the above compound, wherein the cancer is leukemia, and at Claim 48 recites the leukemia is MLL, AML, and mixed lineage leukemia. At Page 11, Paragraph 0134, Claremon states, “Typically, the subject or patient is a human in need of treatment.”
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 9-12 and 14-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/334,801 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and instant claims are drawn to an overlapping group of compounds and methods of use thereof.
Claim 1 of the reference application is drawn to a compound selected from:
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Instant Claim 9 recites as compound 82 the following:
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This compound is the racemic mixture of compounds 101 and 102, above, in the reference application.
Further, at instant Claim 9, the same compounds 101 and 102 as recited above are instantly claimed:
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In other words, instant Claim 9 and reference Claim 1 are both drawn to compounds 101 and 102. Therefore, the instantly claimed pharmaceutical composition at Claims 10-11 read on the pharmaceutical composition claimed at reference claims 2-3.
Instantly, these compounds read on a compound of Formula (I) as recited at instant Claim 1. Therefore, the instant method claims 12 and 14-19 read on the reference method claims 4-10, as they are both drawn to administering compound 101 and 102, above, in a method of inhibiting the interaction of menin and MLL in a cell or a method for the treatment or prevention of a disease or disorder associated with the interaction of menin and MLL.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-12, and 14-19 are rejected.
Claims 20-21 are objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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