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 1, 3-15 and 19-24 are pending in the instant invention. According to the Amendments to the Claims, filed July 3, 2025, claims 1 and 3-15 were amended, claims 2 and 16-18 were cancelled and claims 19-24 were added.
Status of Priority
This invention is a Continuation (CON) of US Application No. 17/586,726, filed January 27, 2022 and now US 11,820,777, which is a Continuation (CON) of abandoned US Application No. 17/344,233, filed June 10, 2021, which is a Continuation (CON) of US Application No. 16/863,033, filed April 30, 2020 and now US 11,059,829, which is a Continuation (CON) of US Application No. 16/177,927, filed November 1, 2018 and now US 10,640,509, which is a Continuation (CON) of US Application No. 15/707,508, filed September 18, 2017 and now US 10,167,291, which is a Continuation (CON) of US Application No. 15/200,875, filed July 1, 2016 and now US 9,796,721, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 62/271,708, filed December 28, 2015; and b) 62/188,468, filed July 2, 2015.
Status of Restrictions / Election of Species
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The forthcoming second Office action and prosecution on the merits includes (1) claims 1 and 3-15, drawn to a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, shown to the right; and (2) claims 19-24, drawn to a method for inhibiting Bruton’s tyrosine kinase activity in a human, wherein the method comprises administering... a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, shown to the right above, respectively.
Similarly, the inventor or joint inventor should further note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in the Non-Final Rejection, mailed on January 7, 2025.
Moreover, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed July 3, 2025.
Thus, a second Office action and prosecution on the merits of claims 1, 3-15 and 19-24 is contained within.
Status of Claim Rejections - Obviousness-type Double Patenting
The inventor’s or joint inventor’s arguments, on page 8 of the Remarks, filed July 3, 2025, with respect to claims 16-18, have been fully considered, but will not be discussed further, since according to the Amendments to the Claims, filed July 3, 2025, claims 16-18 have been cancelled by the inventor or joint inventor.
The inventor’s or joint inventor’s arguments, on page 8 of the Remarks, filed July 3, 2025, with respect to claims 1-15, have been fully considered, but are not persuasive. Consequently, the rejection of claims 1-15, made in the Non-Final Rejection, mailed on January 7, 2025, is hereby maintained for the reasons of record.
The inventor or joint inventor respectfully requests that the instant rejection under Obviousness-type Double Patenting be held in abeyance until such time that allowable subject matter is found by the Examiner to be present in the pending claims.
In response to the inventor’s or joint inventor’s request for the instant rejection under Obviousness-type Double Patenting to be held in abeyance until such time that allowable subject matter is found by the Examiner to be present in the pending claims, the Examiner respectfully denies said request and in accordance with MPEP § 804.I.A, will hereby maintain the obviousness-type double patenting rejection until there are no longer any conflicting claims between the instant invention and US 9,796,721, US 10,167,291, and US 10,640,509, respectively.
The inventor or joint inventor should note that in order to be entitled to reconsideration or further examination, the inventor or joint inventor or patent owner must reply to every ground of rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. See MPEP § 714.02.
Moreover, the inventor or joint inventor should further note that if the reply is with respect to an invention, a request may be made that only an objection and/or a requirement as to form not necessary to further consideration of the claims, not a rejection of the claims, be held in abeyance until allowable subject matter is indicated. See MPEP § 714.02.
As a result of the Amendments to the Claims, filed July 3, 2025, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on January 7, 2025, is amended below, in the section entitled New Claim Rejections - Obviousness-type Double Patenting, to omit cancelled claims 16-18 and encompass new claims 19-24, respectively.
New Claim Objections
Claim 1 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 at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide of the following formula:
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,
wherein the crystal form is Form I; and
wherein Form I is characterized by a transmission X-ray powder diffraction pattern comprising peak angles (º2q) at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by a transmission X-ray powder diffraction pattern comprising one or more additional peak angles (º2q) selected from the group consisting of 10.9º ± 0.2 º2q, 12.7º ± 0.2 º2q, 13.4º ± 0.2 º2q, 14.3º ± 0.2 º2q, 14.9º ± 0.2 º2q, and 18.2º ± 0.2 º2q.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by a transmission X-ray powder diffraction pattern comprising one or more additional peak angles (º2q) selected from the group consisting of 11.3º ± 0.2 º2q, 15.1º ± 0.2 º2q, 16.1º ± 0.2 º2q, 17.3º ± 0.2 º2q, 19.2º ± 0.2 º2q, 19.4º ± 0.2 º2q, 19.8º ± 0.2 º2q, 20.7º ± 0.2 º2q, 21.1º ± 0.2 º2q, 21.4º ± 0.2 º2q, 21.6º ± 0.2 º2q, 21.9º ± 0.2 º2q, 22.6º ± 0.2 º2q, 23.3º ± 0.2 º2q, 23.6º ± 0.2 º2q, 24.9º ± 0.2 º2q, 25.2º ± 0.2 º2q, 25.4º ± 0.2 º2q, 25.7º ± 0.2 º2q, 26.1º ± 0.2 º2q, 26.4º ± 0.2 º2q, 26.8º ± 0.2 º2q, 26.9º ± 0.2 º2q, 27.7º ± 0.2 º2q, 28.6º ± 0.2 º2q, 29.1º ± 0.2 º2q, 29.4º ± 0.2 º2q, 30.1º ± 0.2 º2q, 30.5º ± 0.2 º2q, 31.7º ± 0.2 º2q, 31.9º ± 0.2 º2q, 32.2º ± 0.2 º2q, 32.6º ± 0.2 º2q, 33.1º ± 0.2 º2q, 33.4º ± 0.2 º2q, 34.5º ± 0.2 º2q, 35.9º ± 0.2 º2q, 36.1º ± 0.2 º2q, 36.8º ± 0.2 º2q, 37.4º ± 0.2 º2q, 38.1º ± 0.2 º2q, 38.9º ± 0.2 º2q, and 39.5º ± 0.2 º2q.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by a transmission X-ray powder diffraction pattern corresponding to the representative X-ray powder diffraction pattern shown in Figure 2.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by a Raman spectrum comprising one or more peaks (cm-1) selected from the group consisting of 1620 cm-1 ± 4 cm-1, 1609 cm-1 ± 4 cm-1, 1547 cm-1 ± 4 cm-1, 1514 cm-1 ± 4 cm-1, and 1495 cm-1 ± 4 cm-1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 6, wherein the crystal form is further characterized by a Raman spectrum comprising one or more additional peaks (cm-1) selected from the group consisting of 1680 cm-1 ± 4 cm-1, 1574 cm-1 ± 4 cm-1, 1454 cm-1 ± 4 cm-1, 1433 cm-1 ± 4 cm-1, 1351 cm-1 ± 4 cm-1, 1312 cm-1 ± 4 cm-1, 1255 cm-1 ± 4 cm-1, 1232 cm-1 ± 4 cm-1, 1187 cm-1 ± 4 cm-1, 1046 cm-1 ± 4 cm-1, 995 cm-1 ± 4 cm-1, 706 cm-1 ± 4 cm-1, 406 cm-1 ± 4 cm-1, and 280 cm-1 ± 4 cm-1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by a Raman spectrum corresponding to the representative Raman spectrum shown in Figure 4.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by an infrared (IR) spectrum comprising one or more peaks (cm-1) selected from the group consisting of 1621 cm-1 ± 4 cm-1, 1608 cm-1 ± 4 cm-1, 1403 cm-1 ± 4 cm-1, 1303 cm-1 ± 4 cm-1, and 764 cm-1 ± 4 cm-1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 9, wherein the crystal form is further characterized by an infrared (IR) spectrum comprising one or more additional peaks (cm-1) selected from the group consisting of 3367 cm-1 ± 4 cm-1, 3089 cm-1 ± 4 cm-1, 2246 cm-1 ± 4 cm-1, 1682 cm-1 ± 4 cm-1, 1574 cm-1 ± 4 cm-1, 1514 cm-1 ± 4 cm-1, 1504 cm-1 ± 4 cm-1, 1454 cm-1 ± 4 cm-1, 1428 cm-1 ± 4 cm-1, 1345 cm-1 ± 4 cm-1, 1248 cm-1 ± 4 cm-1, 1194 cm-1 ± 4 cm-1, 1177 cm-1 ± 4 cm-1, 1149 cm-1 ± 4 cm-1, 1109 cm-1 ± 4 cm-1, 1049 cm-1 ± 4 cm-1, 1023 cm-1 ± 4 cm-1, 1003 cm-1 ± 4 cm-1, 947 cm-1 ± 4 cm-1, 900 cm-1 ± 4 cm-1, 858 cm-1 ± 4 cm-1, 842 cm-1 ± 4 cm-1, 816 cm-1 ± 4 cm-1, 734 cm-1 ± 4 cm-1, 729 cm-1 ± 4 cm-1, 701 cm-1 ± 4 cm-1, 689 cm-1 ± 4 cm-1, 665 cm-1 ± 4 cm-1, 623 cm-1 ± 4 cm-1, and 612 cm-1 ± 4 cm-1.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 1, wherein the crystal form is further characterized by an infrared (IR) spectrum corresponding to the representative infrared (IR) spectrum shown in Figure 5 or Figure 6.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 13, wherein the extragranular acidulant is selected from the group consisting of alginic acid, a salt of alginic acid, ascorbic acid, Carbopol 971P, fumaric acid, isoascorbic acid, Protacid AR 1112, Protacid F 120 NM, succinic acid, racemic tartaric acid, D-tartaric acid, and L-tartaric acid, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition of Claim 13, wherein:
(a) the extragranular acidulant is selected from the group consisting of alginic acid, a sodium salt of alginic acid, and a potassium salt of alginic acid; and
(b) the alginic acid, sodium salt of alginic acid, or potassium salt of alginic acid is at a concentration in the range of 5% to 33% by weight.
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 19, wherein the human is suffering from a hyperproliferative disease selected from the group consisting of chronic lymphocytic leukemia, mantle cell lymphoma, small lymphocytic lymphoma, and Waldenström’s macroglobulinemia.
Appropriate correction is required. See MPEP § 2173.02.
New Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claim 3 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 3 recites the limitation, The pharma-ceutical composition of Claim 2,…, in line 1 of the claim. There is insufficient antecedent basis, in claim 2, for this limitation, with respect to the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base. According to the Amendments to the Claims, filed July 3, 2025, claim 2 is not recited, with respect to the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base.
The examiner suggests amending the claim, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 12 recites the limitation, The pharma-ceutical composition of Claim 2,…, in line 1 of the claim. There is insufficient antecedent basis, in claim 2, for this limitation, with respect to the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base. According to the Amendments to the Claims, filed July 3, 2025, claim 2 is not recited, with respect to the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base.
The examiner suggests cancelling the claim, to overcome this rejection.
New Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(d) REFERENCE IN DEPENDENT FORMS. Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 12 is rejected under 35 U.S.C. § 112(d) because the recitation of a physicochemical property for a pharmaceutical composition must result in a further structural limitation in the pharmaceutical composition, in order to be further limiting. In the instant dependent claim, the pharmaceutical composition comprising at least one pharma-ceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, as recited in claim 2, is further characterized by the absence of water in the crystal structure. Consequently, since the physicochemical property of the pharmaceutical composition comprising at least one pharma-ceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, as recited in claim 2, whereby the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a-]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base is further characterized by the absence of water in the crystal structure, fails to result in a further structural limitation to the pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide free base, as recited in claim 2, and/or fails to include all the limitations of the pharma-ceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, as recited in claim 2, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
New 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. 9,796,721
Consequently, claims 1, 3-15 and 19-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US Patent No. 9,796,721. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 9,796,721 recites a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide characterized by a reflection X-ray powder diffraction pattern comprising peaks at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, respectively, which provides overlapping subject matter with respect to the instantly recited pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, wherein the crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base is characterized by a transmission X-ray powder diffraction pattern comprising peak angles (º2q) at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, 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] 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 [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. 10,167,291
Claims 1, 3-15 and 19-24 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of US Patent No. 10,167,291. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 10,167,291 recites a solid pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and 95-105 mg of a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide characterized by a reflection X-ray powder diffraction pattern comprising peaks at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, respectively, which provides overlapping subject matter with respect to the instantly recited pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, wherein the crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base is characterized by a transmission X-ray powder diffraction pattern comprising peak angles (º2q) at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, 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)}.
Moreover, 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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349 F.3d 1373, 68 USPQ2d 1865, (Fed. Cir. 2003)}.
US Patent No. 10,640,509
Claims 1, 3-15 and 19-24 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 10,640,509. Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claim 1 recites a pharmaceutical composition comprising at least one pharma-ceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base, wherein the crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide free base is characterized by a transmission X-ray powder diffraction pattern comprising peak angles (º2q) at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, respectively, which is administered within the method for treating diffuse large B-cell lymphoma in a human, comprising administering… a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide characterized by a reflection X-ray powder diffraction pattern comprising peaks at 6.4º ± 0.2 º2q, 8.6º ± 0.2 º2q, 10.5º ± 0.2 º2q, 11.6º ± 0.2 º2q, and 15.7º ± 0.2 º2q, respectively, as recited in claim 1 in US 10,640,509.
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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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
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed July 3, 2025, necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The inventor or joint inventor is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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