DETAILED ACTION
Status of Claims
The amendment submitted November 2, 2025 has been entered.
Claims 11-23 are pending and under consideration.
Claims 1-10 were previously cancelled by Applicant.
Claim 23 is withdrawn as explained below in the Election/Restriction section.
Claims 11-22 are under consideration in the instant office action as explained below in the Election/Restriction section.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 11-22, drawn to a compound of formula 2 and pharmaceutical composition containing compounds of formulae 1 and 2 in the reply filed on November 2, 2025 is acknowledged.
The traversal is on the ground(s) that Applicant alleges that the Office has not shown that a serious search burden would be required to examine all of the claims. However, Applicant’s arguments are not found persuasive because the instant application is a 371 national stage application and is not filed under 35 U.S.C. 111(a); therefore, “unity of invention” analysis, not “independent and distinct” analysis is applied. Please refer to MPEP 1893.03 (d).
The examiner respectfully required restriction based on the lack of unity of invention as Applicant’s claims are directed towards more than one product and multiple methods of use.
The requirement is still deemed proper and is therefore made FINAL.
Claim 23 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 2, 2025.
Consequently, claims 1-22 are under consideration and the subject of this Office Action.
Priority
This application is a 371 National Phase Application of PCT/IB2021/053107 filed April 15, 2021 which claims the benefit of priority to Indian Patent Application No. IN202041016104, filed on April 14, 2020.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d), and the certified copy has been filed.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
One information disclosure statements (IDS) submitted on December 14, 2022 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The use of the terms “COMETRIQ,” and “CABOMETYX,” which are trade names or marks used in commerce, has been noted in this application.
The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Please see MPEP 608.01(v) for additional guidance.
Claim Rejections - 35 USC § 112(a)
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 11-22 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 claim(s) 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.
Vas-Cath Inc. v. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of claims 11-22 indicates that these claims are drawn towards the dimer of cabozantinib and pharmaceutical compositions containing cabozantinib and the dimer impurity.
However, Applicant has failed to provide any drawings or standard characterization data as is routine in the pharmaceutical and chemical arts to prove possession and existence of the claimed dimer such as NMR, HPLC or GCMS.
On page 3, paragraph 4, Applicant explains that “ The present application identifies challenges in developing pharmaceutical formulations comprising compound of Formula -1. Specifically, a compound of Formula -1 can degrade to form a compound having a dimer impurity (referred to herein as Formula -2). Reducing conversion of the drug substance into its dimer-containing degradation product is desirable, for example, to meet the required pharmaceutical specifications of the drug product. Thus, it has been determined in the present application that a pharmaceutical composition reduces generation of the dimer degradation product (i.e ., Formula -2).”
On page 5, last paragraph, Applicant describes HPLC conditions; however, no HPLC chromatograms are provided supporting the existence of the claimed dimer species.
In addition to no data confirming the existence of the dimer species, Applicant has also failed to include any working examples, additional experimental support for any of the pharmaceutical compositions claimed, or data suggesting differences between the pharmaceutical compositions with or without the dimer impurity.
To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing.
Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. See MPEP 2163, I
Consequently, the specification does not clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is claimed.
Therefore, claims 11-22 are rejected for lacking written description.
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 11-18, and 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Srinivasan et al. (USPN 11,261,160 B2).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 11 is directed towards the dimer of Cabozantinib (S)-malate.
On page 3, paragraph 4, Applicant explains that “ The present application identifies challenges in developing pharmaceutical formulations comprising compound of Formula -1. Specifically, a compound of Formula -1 can degrade to form a compound having a dimer impurity (referred to herein as Formula -2). Reducing conversion of the drug substance into its dimer-containing degradation product is desirable, for example, to meet the required pharmaceutical specifications of the drug product. Thus, it has been determined in the present application that a pharmaceutical composition reduces generation of the dimer degradation product (i.e ., Formula -2).”
Srinivasan teaches Cabozantinib (S)-malate and its polymorphs, and pharmaceutical compositions (Abstract, and column 1, lines 54-67; column 2, lines 9-52; claim 15 of Srinivasan); therefore, based on the inherent characteristic of Cabozantinib (S)-malate to degrade and form a dimer over time, the dimer must also be present.
As per MPEP 2112, I: “T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
As per MPEP 2112, II: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Applicant has failed to provide any characterization data for the dimer nor has Applicant provided any HPLC chromatograms confirming the existence of the dimer. Additionally, Applicant has failed to provide specific conditions and compositions as working examples or as details within the specification that promote or prevent dimer formation. Applicant has also failed to produce data indicating that compositions containing the dimer show different properties compared to compositions without the dimer impurity.
Therefore, it is reasonable to conclude that if the dimer exists, it is present as a minor impurity in all pharmaceutical compositions containing Cabozantinib (S)-malate and that the dimer does not have a substantial effect on the pharmacological properties of Cabozantinib (S)-malate and its compositions, absence any experimental data proving otherwise.
Claims 12-15 are directed towards pharmaceutical compositions “wherein the dimer impurity is less than about 2%,” “less than about 1%,” “less than about 0.5%,” and “less than about 0.1%.”
Using the broadest reasonable interpretation, the ranges claimed by Applicant are inclusive of 0% dimer, meaning the dimer does not need to exist within the pharmaceutical composition to meet the limitations of the claims.
Srinivasan teaches pharmaceutical compositions containing Cabozantinib (S)-malate that are 99.9% pure; therefore, Srinivasan meets the limitations of claims 12-15.
Srinivasan specifically teaches “The N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (S)-malate compound of formula-1a obtained according to the present invention is having purity greater than 99.9% by HPLC (column 18, lines 51-55).”
Claims 16-17 are directed towards pharmaceutical compositions containing Cabozantinib (S)-malate in crystalline form and more specifically crystalline form-S.
Srinivasan specifically teaches preparation of crystalline form-S as per Example 11 (column 23, lines 36-54), with a purity of 99.97% determined by HPLC, meeting the limitations of claims 16-17.
Claim 18 is directed pharmaceutical compositions containing Cabozantinib (S)-malate at least 98% pure “wherein the pharmaceutical composition is a tablet or capsule.”
As aforementioned, Srinivasan specifically teaches Cabozantinib (S)-malate which is 99.9% pure, and additionally teaches pharmaceutical compositions.
Srinivasan specifically teaches “As used herein, the term “pharmaceutical compositions” or “pharmaceutical formulations” include tablets, pills, powders, liquids, suspensions, emulsions, granules, capsules, suppositories, or injection preparations.”
Claim 22 is directed towards pharmaceutical compositions containing Cabozantinib (S)-malate at least 98% pure “wherein the pharmaceutical composition is obtained by direct compression, wet granulation, or dry granulation,” which is a product-by-process claim
As per MPEP 2113, I "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020)
Applicant has failed to demonstrate a notable difference for the pharmaceutical composition recited in claim 22. Consequently, it is reasonable to conclude that pharmaceutical composition recited in claim 22 is the same as claims 12, 18-19, absent evidence suggesting otherwise.
As per MPEP 2113, III "As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Therefore, claims 11-18 and 22 are rejected as being anticipated by Srinivasan
Claims 11-16, 18-20, and 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by St. Clair Brown et al. (USPN 8,877,776 B2).
Claim 11 is directed towards the dimer of Cabozantinib (S)-malate.
On page 3, paragraph 4, Applicant explains that “ The present application identifies challenges in developing pharmaceutical formulations comprising compound of Formula -1. Specifically compound of Formula -1 can degrade to form a compound having a dimer impurity (referred to herein as Formula -2). Reducing conversion of the drug substance into its dimer-containing degradation product is desirable, for example, to meet the required pharmaceutical specifications of the drug product. Thus, it has been determined in the present application that a pharmaceutical composition reduces generation of the dimer degradation product (i.e ., Formula -2).”
St. Clair Brown also teaches Cabozantinib (S)-malate and its polymorphs, and pharmaceutical compositions (Abstract);therefore, based on the inherent characteristic of Cabozantinib (S)-malate to degrade and form a dimer over time, the dimer must also be present.
As per MPEP 2112, I: “T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
As per MPEP 2112, II: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Applicant has failed to provide any characterization data for the dimer nor has Applicant provided any HPLC chromatograms confirming the existence of the dimer. Additionally, Applicant has failed to provide specific conditions and compositions as working examples or as details within the specification that promote or prevent dimer formation. Applicant has also failed to produce data indicating that compositions containing the dimer show different properties compared to compositions without the dimer impurity.
Therefore, it is reasonable to conclude that if the dimer exists, it is present as a minor impurity in all pharmaceutical compositions containing Cabozantinib (S)-malate and that the dimer does not have a substantial effect on the pharmacological properties of Cabozantinib (S)-malate and its compositions, absence any experimental data proving otherwise.
Claims 12-15 are directed towards pharmaceutical compositions “wherein the dimer impurity is less than about 2%,” “less than about 1%,” “less than about 0.5%,” and “less than about 0.1%.”
Using broadest reasonable interpretation, the ranges claimed by Applicant are inclusive of 0% dimer, meaning the dimer does not need to exist within the pharmaceutical composition to meet the limitations of the claims.
St. Clair Brown teaches pharmaceutical compositions containing Cabozantinib (S)-malate that are >90% pure; therefore, St. Clair Brown meets the limitations of claims 12-15.
St. Clair Brown specifically teaches “The malate salts of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, and particularly Compound (I), have a preferred combination of pharmaceutical properties for development. Under the conditions of 25°C./60% relative humidity (RH) and 40°C./60% RH, Compound (I) showed no change in assay, purity, moisture and dissolution. The DSC/TGA showed the Compound (I) to be stable up to 185°C. No solvent losses were observed. The uptake of water by the (L)-malate salt was reversible with a slight hysteresis. The amount of water taken up was calculated at about 0.60 wt % at 90% RH. The (L)-malate salt was synthesized with good yield and purity>90% and had sufficient solubility for use in a pharmaceutical composition (column 6, lines 56-67).”
St. Clair Brown also teaches “In another embodiment, the disclosure relates to a crystalline form of Compound (I), as described herein in any of the aspects and/or embodiments, is substantially pure N-1 form.
In another embodiment, the disclosure relates to a crystalline form of Compound (I), as described herein in any of the aspects and/or embodiments, is substantially pure N-2 form (column 8, lines 65-67 and column 9, lines 1-3).
St. Clair Brown also teaches that “As used herein, the term “substantially pure”means the crystalline form of Compound (I) referred to contains at least about 90 wt. % based on the weight of such crystalline form. The term “at least about 90 wt. %,”while not intending to limit the applicability of the doctrine of equivalents to the scope of the claims, includes, but is not limited to, for example, about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %, based on the weight of the crystalline form referred to. The remainder of the crystalline form of Compound (I) may comprise other Form(s) of Compound (I) and/or reaction impurities and/or processing impurities that arise, for example, when the crystalline form is prepared. The presence of reaction impurities and/or processing impurities may be determined by analytical techniques known in the art, such as, for example, chromatography, nuclear magnetic resonance spectroscopy, mass spectroscopy, and/or infrared spectroscopy (column 18, lines 18-36).”
St. Clair Brown also teaches that “Accordingly another aspect of this disclosure relates to a solid or dispersion pharmaceutical composition comprising at least one of a therapeutically effective amount of a crystalline form of Compound (I), Compound (II), Compound (III), or combinations thereof, and a pharmaceutically acceptable excipient (column 11, lines 36-41).”
Therefore, St. Clair Brown’s substantially pure crystalline forms are inclusive of >98% purity.
Claim 16 is directed towards pharmaceutical compositions containing Cabozantinib (S)-malate in crystalline form. As aforementioned, St. Clair Brown teaches pharmaceutical composition comprising crystalline forms of Cabozantinib (S)-malate
Claims 18-19 is directed pharmaceutical compositions containing Cabozantinib (S)-malate at least 98% pure “wherein the pharmaceutical composition is a tablet or capsule,” and “wherein the pharmaceutical composition is a coated tablet.”
St. Clair Brown specifically teaches “A pharmaceutical composition such as discussed above may be any pharmaceutical form which contains active Compound (I), Compound (II) and/or Compound (III), including the solid state forms thereof (hereinafter referred to as active compound(s). The pharmaceutical composition may be, for example, a tablet, capsule, liquid suspension, injectable, topical, or transdermal (column 14, lines 13-19),” and “solid dosage forms as described above can be prepared with coatings and shells, such as enteric coatings and others well known in the art (column 15, lines 52-55).”
Claim 20 is directed towards “A pharmaceutical composition comprising:
a) the compound of formula-1, in a total amount of up to 50% by weight based on the
total weight of the pharmaceutical composition,
wherein said pharmaceutical composition has less than about 2.0 % of dimer impurity of
formula-2 as measured by HPLC.”
St. Clair Brown specifically teaches “The pharmaceutical compositions generally contain about 1% to about 99% by weight of the active compound(s), or a crystalline form of the active compound(s), and 99% to 1% by weight of a suitable pharmaceutical excipient. In one example, the composition will be between about 5% and about 75% by weight of active compound, with the rest being suitable pharmaceutical excipients or other adjuvants, as discussed below,” which meets the limitation of claim 20. As aforementioned, Applicant has provided no working examples or details pertaining the pharmaceutical compositions claimed.
Claim 22 is directed towards pharmaceutical compositions containing Cabozantinib (S)-malate at least 98% pure “wherein the pharmaceutical composition is obtained by direct compression, wet granulation, or dry granulation,” which is a product-by-process claim
As per MPEP 2113, I "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020)
Applicant has failed to demonstrate a notable difference for the pharmaceutical composition recited in claim 22. Consequently, it is reasonable to conclude that pharmaceutical composition recited in claim 22 is the same as claims 12, 18-19, absent evidence suggesting otherwise.
As per MPEP 2113, III "As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Therefore, claims 11-16, 18-20 and 22 are rejected as being anticipated by St. Clair Brown.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11-22 are rejected under 35 U.S.C. 103 as being obvious over Srinivasan et al. (USPN 11,261,160 B2) in view of St. Clair Brown et al. (USPN 8,877,776 B2).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of Srinivasan and St. Clair Brown are applied as set forth above.
Srinivasan does not specifically teach the elements of claim 19 wherein the “wherein the pharmaceutical composition is a coated tablet.”
Srinivasan also does not specifically teach the pharmaceutical compositions recited in instant claims 20-21.
St. Clair Brown does not specifically teach the crystalline form-S as recited in instant claim 17.
St. Clair Brown also does not teach the specific ranges for the pharmaceutical composition as recited in claim 21.
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have combined the teachings of Srinivasan and St. Clair Brown to access the instantly claimed invention, and more specifically pharmaceutical compositions containing crystalline form-S because Srinivasan and St. Clair Brown both teach pharmaceutical compositions comprising Cabozantinib (S)-malate and its crystalline forms in purities >98% and because St. Clair Brown provides specific guidance formulating solid dosages forms, and more specifically coated tablets. Additionally, developing pharmaceutical formulations are a routine task well-known in the art.
Consequently, a person of ordinary skill in the art would arrive at the claimed pharmaceutical compositions through routine optimization as part of standard practices in developing solid dosage formulations of Cabozantinib (S)-malate as a highly predictable result with a reasonable expectation of success based on the beneficial teachings of Srinivasan and St. Clair Brown.
Therefore, Claims 11-22 are rejected as being obvious.
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 11-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, and 15 of U.S. Patent No. 11,261,160 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 11-22 are drawn towards identical compounds and pharmaceutical compositions as recited in ‘160.
Claims 1-4 of ‘160 are directed towards crystalline form-S, which inherently comprises the dimer as per instant claim 1.
Claim 15 of ‘160 is directed towards a pharmaceutical composition comprising crystalline form-S and a pharmaceutically acceptable carrier or diluent according to claim 1, which provides coverage for the scope of claims 2-22.
As per MPEP 2131.02, I: "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989)
The examiner additionally notes the use of the transitional word “comprising,” for both ‘160 and instant claims, which is open-ended and can include other unrecited elements. See MPEP 2111.03, I. for guidance.
Therefore, claims 11-22 are rejected on grounds of anticipation-type nonstatutory double patenting.
Conclusion
Claims 11-22 are under consideration and are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622