DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 127-132 are pending in the instant invention. According to the Claim Amendments, filed July 10, 2024, claims 1-126 were cancelled and claims 127-132 were added.
Status of Priority
This invention is a Continuation (CON) of US Application No. 18/228,602, filed July 31, 2023 and now US 12,116,371, which is a Continuation (CON) of US Application No. 18/094,929, filed January 9, 2023 and now US 12,077,544, which is a Divisional (DIV) of US Application No. 17/352,146, filed June 18, 2021 and now US 11,702,421, which is a Continuation (CON) of US Application No. 16/732,226, filed December 31, 2019 and now US 11,084,825, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 62/786,842, filed December 31, 2018.
Restrictions / Election of Species
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The forthcoming first Office action and prosecution on the merits includes (1) claims 127-129, drawn to (R)-4-((3-acrylamidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide, shown to the right above, and/or a pharmaceutical composition thereof; and (2) claims 130-132, drawn to a method for treating diabetes, wherein the method comprises administering… (R)-4-((3-acryl-amidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)-picolinamide, shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 127-132 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying a particular utility for (R)-4-((3-acrylamidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide.
The following title is suggested: (R)-4-((3-ACRYLAMIDOPIPERIDIN-1-YL)METHYL)-N-(4-(4-MORPHOLINO-7H-PYRROLO[2,3-d]PYRIMIDIN-6-YL)PHENYL)PICOLINAMIDE AS AN IRREVERSIBLE INHIBITOR OF MENIN-MLL INTERACTION.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of (R)-4-((3-acrylamidopiperidin-1-yl)-methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide into the abstract, to overcome this objection.
Claim Objections
Claim 127 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A compound, wherein the compound is:
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,
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 128 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 127, wherein the compound is:
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 129 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of the compound according to claim 127, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 130 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating diabetes in a patient, wherein the method comprises administering to the patient in need thereof a therapeutically effective amount of the compound according to claim 127, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
US Patent No. 11,084,825
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Consequently, at least claims 127-129 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 1-5, 8-13, 16, 19, and 23-26 of US Patent No. 11,084,825. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 11,084,825 recites substituted pyridines according to the formula (I), shown to the left, where Cy = -pyrrolo[2,3-d]pyrimidin-6-yl, wherein Q = N, and substituted with R7; R7 = -4- to 7-membered heterocycloalkyl having 1 nitrogen heteroatom and 1 oxygen heteroatom; X = -NR3a-, wherein R3a = -H; W = -C(O)-; Y’ = -a single bond-; A = N; m = 2; R1 = -CH2-Cy2-NHC(O)-CR6a=CR6bR6c, wherein Cy2 = -4- to 7-membered heterocycloalkylene having 1 nitrogen heteroatom-, R6a = -H, R6b = -H, and R6c = -H; R2 = -H; and each R4b = -H, respectively, which provides overlapping subject matter, with respect to the instantly recited (R)-4-((3-acrylamido-piperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide, shown to the right above, where Cy = -pyrrolo[2,3-d]pyrimidin-6-yl, wherein Q = N, and substituted at C-4, with R7; R7 = -morpholin-4-yl; X = -NR3a-, wherein R3a = -H; W = -C(O)-; Y’ = -a single bond-; A = N; m = 2; R1 = -CH2-Cy2-NHC(O)-CR6a=CR6bR6c, wherein Cy2 = -1,3-piperidinylene-, R6a = -H, R6b = -H, and R6c = -H; R2 = -H; and each R4b = -H, respectively.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that [A] pure optical isomer is not patentable over the racemic mixture unless it possesses properties not possessed by the racemic mixture. {See In re Anthony, 414 F.2d 1383, 162 USPQ 594, (CCPA 1969)}.
Moreover, the inventor or joint inventor should further note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
US Patent No. 11,702,421
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At least claims 127-129 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 1 and 3 of US Patent No. 11,702,421. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 11,702,421 recites (R)-4-((3-acrylamidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide, shown to the left, which provides overlapping subject matter, with respect to the instantly recited (R)-4-((3-acrylamidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo-[2,3-d]pyrimidin-6-yl)phenyl)picolinamide, shown to the left above.
The inventor or joint inventor should note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
US Patent No. 12,116,371
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Claims 127-132 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US Patent No. 12,116,371. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 12,116,371 recites substituted pyridines according to the formula (XVI), shown to the left above, which provides overlapping subject matter, with respect to the instantly recited (R)-4-((3-acrylamidopiperidin-1-yl)methyl)-N-(4-(4-morpholino-7H-pyrrolo[2,3-d]pyrimidin-6-yl)phenyl)picolinamide, shown to the right below.
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The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that [A] claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. {See Sun Pharmaceuticals Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001 (Fed. Cir. 2008); and Geneva
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Pharmaceuticals, Inc. v. GlaxoSmithKline PLC,
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349 F.3d 1373, 68 USPQ2d 1865, (Fed. Cir. 2003)}.
Moreover, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Furthermore, the inventor or joint inventor should also note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights