DETAILED ACTION
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 the Claims
Claims 1-29 are pending in this application.
Claim Interpretation
For the purposes of applying art, the divalent groups -NR8-, -NR8C(O)-, -OC(O)NR8-, and -C(O)NR8-, will be interpreted as connecting to the tricyclic core and to R5 in any direction. See 112(b).
Claim Rejections - 35 USC § 112
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 1-20, and 22-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-11, 13, 15-20, and 29 are indefinite because they state that Y (a divalent group) can be alkyl, wherein one of the -CH2- (methylenes) can be replaced with N(R8)2, OC(O)N(R8)2, or C(O)N(R8)2 – these groups don’t allow for divalent substitution, since the nitrogens have 2 R8 substituents in every case, and therefore would have to be positively charged to accommodate the at least 1 required R5 group (since n = 1, 2, or 3). These groups will be interpreted as -NR8-, -NR8C(O)-, -OC(O)NR8-, and -C(O)NR8-.
Claims 10, 12, 14, and 22-28 are rejected for depending upon the limitations of claim 1.
Claim 29 is indefinite because there are different sets of definitions for Y and R5 (see below for Y, for example):
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And wherein,
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The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claim 12 is rejected for failing to further limit claim 1, from which it depends. Claim 1 speaks to wherein Y is alkyl, and a -CH2- is replaced with
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, while claim 12 extends this limitation to include any nitrogen-containing heterocycle.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 12 and 29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ali et al. (WO 2014/101120 A1) (“Ali”).
Claim 12 is broader than claim 1, from which it depends – see 112(d), therefore, as it pertains to the limitations that fall outside the scope of claim 1, this rejection applies:
Regarding claims 12 and 29, Ali discloses the compound below (page 42) which anticipates the instant claims when R1-2, 4 are H and R3 is OMe; Y is a straight alkyl wherein a -CH2- has been replaced with a nitrogen containing heterocycle; and R5 is alkyl (isopropyl).
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Claims 1-7, 9-12, 14-15, 17, 19, and 29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zheng et al. (US 2018/0193314 A1 – Pub Date: Jul. 12, 2018) (“Zheng”).
Regarding claims 1-7, 9-11, Zheng discloses the compounds below as A2A inhibitors (abstract; pages 33 and 38), which anticipate the instant compounds when instant R1-4 are H, or -OMe; Y is alkyl wherein a -CH2- has been replaced by: -C(O)NH- (in Ex. 80), -C(O)NH- and -NHC(O)- (in compound 1), and -C(O)NH- and -NHC(O)O- (in compound 2) (corresponding to one or more of -NR8-, -NR8C(O)-, -OC(O)NR8-, and -C(O)NR8-; see 112(b)). These compounds correspond to instant R5 being phenyl (aryl) substituted with F and Br (Ex. 80); quinoline (heterocycle) (compound 1); and t-butyl (alkyl) (compound 2).
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(Ex. 80)
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(1)
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(2)
Regarding claims 12 and 29, Zheng discloses the compound 93 below (page 36), wherein a -CH2- in Y has been replaced with a nitrogen containing heterocycle.
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(Ex. 93)
Regarding claim 14, Zheng discloses the compound 67 below (page 30), anticipating Y being
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and R5 being -OH.
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(Ex. 67)
Regarding claim 15, Zheng discloses the compounds 80 and 93 above wherein R5 is phenyl.
Regarding claims 17 and 19, Zheng discloses the compound 1 above wherein R5 is
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.
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.
Claims 1-8, 12-14, 16, 18-22, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (WO 2014/101120 A1) (“Ali”); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
Regarding claims 1-8, 12-14, 18-21, and 29, Ali discloses their compounds of Formula GII below as A2A inhibitors [0014]. Ali’s compounds render the instant claims obvious when: RGaa, Gba, Gca are H, C1-6 alkyl, alkoxy, F, Cl, etc.; GGf (corresponding to instant Y) can be -CH2-, ethyl, or -C(O)CH2; and RGe (corresponding to instant R5) can be polycyclic aryl/ heteroaryl.
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Ali specifically discloses the compounds below (pages 41-42 and 46), which read on the instant compounds when instant Y is alkyl, wherein a -CH2- has been replaced with
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and R5 is alkyl (ethyl, isopropyl, or cyclopropyl).
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(Ex. 13)
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(Ex. 8)
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(Ex. 40)
Ali also discloses the compound 120 below (page 67) which reads on the instant compounds when Y is alkyl, wherein a -CH2- is replaced with -NR8-, wherein R8 can be H or alkyl; and R5 can be
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or
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(Ex. 120)
Ali also discloses the compound 9 below (page 38), which reads on the instant compounds when R5 is -SO2-alkyl.
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While Ali doesn’t specifically teach their compounds wherein the group corresponding to instant Y has a carbonyl next to the nitrogen bound to the alkyl chain in Ex. 8, 13, or 40; or a F on the phenyl in Ex. 120; or an -NH- group in place of a -CH2- in the alkyl chain corresponding to Y in 9; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell discloses introduction of a carbonyl next to the cyclic amine in compound 233 to make 235, results in a new H-bond acceptor, which significantly impacts the polarity and potentially potency of a compound (page 2554, col. 2, top half). Thus, Meanwell suggests that introduction of a carbonyl moiety in a cyclic amine is a known and common transformation in the context of bioisosteric modifications of drugs and lead compounds. Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2- and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1). Furthermore, Meanwell teaches that cyclopropyl has been examined as an isostere of alkyl groups based on their size similarity and improved metabolic stability (page 2539, col. 2, section 3.2.13).
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Therefore, regarding claims 1-8, 12-14, 16, 18-21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Ali’s disclosed formula GII and compounds 8 and 13 above, in view of Meanwell; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by Ali, in view of Meanwell’s teaching that introduction of a carbonyl to make a lactam from a cyclic amine, impacts the H-bond accepting properties and polarity of a compound, which may be beneficial in the context of lead and drug optimization. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, by introducing a carbonyl by the cyclic amine moiety of Ali’s heterocycles to arrive at the claimed invention.
Further regarding instant claim 21, the compound below, for example, is particularly obvious in light of the disclosures above:
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Regarding the F in the position corresponding to instant R1, Ali teaches their RGca group can be F, and Meanwell also teaches that H and F are bioisosteres. Therefore, the compound is obvious in view of Ali’s disclosure and in view of Ali’s preferred embodiments 8 and 13 in view of Meanwell.
Applicant is advised that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Further regarding claims 8 and 13-14, Ali discloses compound 120, which reads on the instant compounds when Y is alkyl, wherein a -CH2- is replaced with N (or
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). Although Ali’s compound shows the nitrogen as being incorporated in the cyclic group corresponding to instant R5, Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Further regarding claim 13, wherein Y is a branched alkyl group, Applicant is advised that H vs. Me is considered an obvious modification in the absence of superior, unexpected results. Note In re Wood 199 USPQ 137; In re Lohr 187 USPQ 548 and In re Bowers 149 USPQ 573. Note also In re Fauque 121 USPQ 425 in which differences were 2H’s vs 2 methyl groups. Also see MPEP 2144.09. Thus, Ali’s compounds, wherein the group corresponding to instant Y is a straight ethylene chain, read on the instant compounds when one of the H is replaced by a Me to produce a branched alkyl chain.
Further regarding claim 16, Ali discloses the compound 40 above, corresponding to instant R5 being cyclopropyl. While the heterocycle in the alkyl chain corresponding to instant
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in Y differs in the arrangement of the nitrogens and the presence of the carbonyl, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Further regarding claim 20, Ali discloses their compound 9 above, and Meanwell further teaches that cyclopropyl has been examined as an isostere of alkyl groups based on their size similarity and improved metabolic stability (page 2539, col. 2, section 3.2.13).
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Ali’s disclosed compounds in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Ali in view of Meanwell. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding claim 22, Ali discloses pharmaceutical compositions comprising their compounds and acceptable excipients (reading on carrier) ([0085] and [0102]).
Claims 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (WO 2014/101120 A1) (“Ali”); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”); as applied to claims 1-8, 12-14, 16, 18-22, and 29; further in view of Sek et al. (Int. J. Mol. Sci. 2018, 19, 3837, 23 pages) (“Sek”).
The teachings of Ali and Meanwell are disclosed above and incorporated herein.
Ali teaches their compounds are A2A- receptor agonists (abstract).
While Ali in view of Meanwell does not teach: (i) treatment of cancers, like head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma (claims 23-24); (ii) or administration with another agent, like a PD-1 antagonist, such as pembrolizumab (claims 25-28); the teachings of Sek are relied upon for these disclosures.
Sek teaches that therapeutic agents have been developed to target downstream adenosine receptors (A1R, A2AR, A2BR, A3R) to enhance anti-tumor immune responses (abstract) and that the A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), and in several breast and melanoma cell lines (page 5, last para.). Sek specifically teaches that inhibition of A2AR in combination with anti-PD-1, has been shown to elicit enhanced anti-tumor T cell responses (page 9, para. 1, 13-20). Sek also teaches pembrolizumab as a PD-1 inhibitor being administered in combination with an A2A inhibitor for treating solid cancers (table 1, page 10, 3rd from last row).
Therefore, regarding claims 23-28, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Ali’s A2A receptor inhibitors alone or in combination with a known PD-1 inhibitor, such as pembrolizumab, in view of Sek. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Ali in view of Meanwell’s disclose their compounds and pharmaceutical compositions thereof as A2AR inhibitors. Further because Sek teaches A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma; that targeting adenosine receptors enhances anti-tumor immune responses; and that inhibition of A2AR in combination with anti-PD-1, such as pembrolizumab, has been shown to elicit enhanced anti-tumor T cell responses.
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Furthermore, with respect to a mixture of the two claimed reagents, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Claims 1-8, 13, 15, 17, 19, 21-22, and 29 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (US 2018/0193314 A1 – Pub Date: Jul. 12, 2018) (“Zheng”); as applied to claims 1-7, 9-12, 14-15, 17, 19, and 29; in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
The teachings of Zheng are disclosed in the 102-section above and incorporated herein.
Regarding claims 1-8, 13, 15, 17, 19, 21, and 29, Zheng discloses their compounds 11 and 17 (pages 20-21), which read on the instant compounds when Y is alkyl, wherein a -CH2- may be -NH-. Thus, Zheng’s compounds are embraced by the instant claims.
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(Ex. 11)
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(Ex 17)
While Ali doesn’t specifically teach their compounds wherein the group corresponding to instant Y wherein a -CH2- in the alkyl chain is replaced with -NH- in Ex. 11 or 17; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2- and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1).
Therefore, regarding claims 1-8, 13, 15, 17, 19, 21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Zheng’s disclosed compounds 11 and 17 above, in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by Zheng, in view of Meanwell’s teaching that -CH2- and -NH2- are bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, by replacing a -CH2- in the group corresponding to instant Y in Zheng’s compounds with a -NH- to arrive at the claimed invention.
Further regarding claim 21, the compound below, for example, is particularly obvious in view of Zheng’s disclosure:
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Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Regarding claim 22, Zheng discloses pharmaceutical compositions comprising their compounds and a pharmaceutical excipient (Zheng’s claim 7).
Claims 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (US 2018/0193314 A1 – Pub Date: Jul. 12, 2018) (“Zheng”); as applied to claims 1-7, 9-12, 14-15, 17, 19, and 29; and alternatively in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”); as applied to claims 1-8, 13, 15, 17, 19, 21-22, and 29; further in view of Sek et al. (Int. J. Mol. Sci. 2018, 19, 3837, 23 pages) (“Sek”).
The teachings of Zheng and Meanwell are disclosed above and incorporated herein.
Zheng teaches their compounds are A2A- receptor agonists (abstract).
While Zheng in view of Meanwell does not teach: (i) treatment of cancers, like head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma (claims 23-24); (ii) or administration with another agent, like a PD-1 antagonist, such as pembrolizumab (claims 25-28); the teachings of Sek are relied upon for these disclosures.
Sek teaches that therapeutic agents have been developed to target downstream adenosine receptors (A1R, A2AR, A2BR, A3R) to enhance anti-tumor immune responses (abstract) and that the A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), and in several breast and melanoma cell lines (page 5, last para.). Sek specifically teaches that inhibition of A2AR in combination with anti-PD-1, has been shown to elicit enhanced anti-tumor T cell responses (page 9, para. 1, 13-20). Sek also teaches pembrolizumab as a PD-1 inhibitor being administered in combination with an A2A inhibitor for treating solid cancers (table 1, page 10, 3rd from last row).
Therefore, regarding claims 23-28, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Zheng’s A2A receptor inhibitors alone or in combination with a known PD-1 inhibitor, such as pembrolizumab, in view of Sek. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Zheng in view of Meanwell’s disclose their compounds and pharmaceutical compositions thereof as A2AR inhibitors. Further because Sek teaches A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma; that targeting adenosine receptors enhances anti-tumor immune responses; and that inhibition of A2AR in combination with anti-PD-1, such as pembrolizumab, has been shown to elicit enhanced anti-tumor T cell responses.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Furthermore, Applicant is reminded that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
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 1-8, 12-14, 16, 18-19, 21-22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,011,615 B2 (US ‘615); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
Regarding instant claims 1-8, 12-14, 16, 18-19, 21, and 29, US ‘615 claims the compounds of Formula GI below, rendering the instant compounds when RGa1 is -OH, -CN, halogen, C1-8 alkyl, or O(C1-4 alkyl); RG5 and RG6 are independently -H, or C1-10 alky optionally substituted with one or more F atoms, (reading on instant Y being straight or branched alkyl wherein a -CH2 – group has been replaced by
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when GI is
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, etc.) (US ‘615’s claims 1-10) (corresponding to instant R5 being alkyl, CF3, or cyclopropyl).
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(Formula GI), wherein RG3 is
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Regarding claim 22, US ‘615 claims a pharmaceutical composition comprising their compounds and an acceptable carrier (US ‘615’s claim 13).
While US ‘615 doesn’t specifically teach their compounds wherein the group corresponding to instant Y has a carbonyl next to the nitrogen bound to the alkyl chain; or an -NH- group in place of a -CH2- in the alkyl chain corresponding to Y in 9; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell discloses introduction of a carbonyl next to the cyclic amine in compound 233 to make 235, results in a new H-bond acceptor, which significantly impacts the polarity and potentially potency of a compound (page 2554, col. 2, top half). Thus, Meanwell suggests that introduction of a carbonyl moiety in a cyclic amine is a known and common transformation in the context of bioisosteric modifications of drugs and lead compounds. Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2- and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1).
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Therefore, regarding claims 1-8, 12-14, 16, 18-19, 21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘615’s disclosed formula, in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by US ‘615, in view of Meanwell’s teaching that introduction of a carbonyl to make a lactam from a cyclic amine, impacts the H-bond accepting properties and polarity of a compound, which may be beneficial in the context of lead and drug optimization; further because Meanwell teaches -NH- and -CH2 as divalent bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the instant claims.
Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Claims 23-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,011,615 B2 (US ‘615); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”); as applied to claims 1-8, 12-14, 16, 18-19, 21-22, and 29; further in view of Sek et al. (Int. J. Mol. Sci. 2018, 19, 3837, 23 pages) (“Sek”).
The teachings of US ‘615 and Meanwell are disclosed above and incorporated herein.
US ‘615 teaches their compounds are A2A- receptor agonists (abstract).
While US ‘615 in view of Meanwell does not teach: (i) treatment of cancers, like head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma (claims 23-24); (ii) or administration with another agent, like a PD-1 antagonist, such as pembrolizumab (claims 25-28); the teachings of Sek are relied upon for these disclosures.
Sek teaches that therapeutic agents have been developed to target downstream adenosine receptors (A1R, A2AR, A2BR, A3R) to enhance anti-tumor immune responses (abstract) and that the A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), and in several breast and melanoma cell lines (page 5, last para.). Sek specifically teaches that inhibition of A2AR in combination with anti-PD-1, has been shown to elicit enhanced anti-tumor T cell responses (page 9, para. 1, 13-20). Sek also teaches pembrolizumab as a PD-1 inhibitor being administered in combination with an A2A inhibitor for treating solid cancers (table 1, page 10, 3rd from last row).
Therefore, regarding claims 23-28, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘615’s A2A receptor inhibitors alone or in combination with a known PD-1 inhibitor, such as pembrolizumab, in view of Sek. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘615 in view of Meanwell’s disclose their compounds and pharmaceutical compositions thereof as A2AR inhibitors. Further because Sek teaches A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma; that targeting adenosine receptors enhances anti-tumor immune responses; and that inhibition of A2AR in combination with anti-PD-1, such as pembrolizumab, has been shown to elicit enhanced anti-tumor T cell responses.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Furthermore, Applicant is reminded that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
Claims 1-8, 12-19, 21-22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,688,082 B2 (US ‘082); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
Regarding claims 1-8, 12-19, 21, and 29, US ‘082 claims the compounds of Formula I below (US ‘082), which render the instant compounds obvious when: Z is -CH-2-R3, wherein R3 is aryl, heteroaryl, halogen, etc. (US ‘082’s claim 1) – reading on instant Y being alkyl and R5 being aryl, heteroaryl, halogen, cycloalkyl, etc.
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Regarding instant claim 22, US ‘082 claims a pharmaceutical composition comprising their compounds and an excipient (US ‘082’s claim 17).
While US ‘082 doesn’t specifically teach their compounds wherein Z (corresponding to instant Y-R5 wherein Y is alkyl with a -CH2- replaced by -NH-; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2- and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1).
Therefore, regarding claims 1-8, 12-19, 21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘082’s disclosed compounds of Formula I above, in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by US ‘082, in view of Meanwell’s teaching that -CH2- and -NH2- are bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, by replacing a -CH2- in the group corresponding to instant Y in US ‘082’s compounds with a -NH- to arrive at the claimed invention.
Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Claims 23-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,688,082 B2 (US ‘082); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”); as applied to claims 1-8, 12-19, 21, and 29; further in view of Sek et al. (Int. J. Mol. Sci. 2018, 19, 3837, 23 pages) (“Sek”).
The teachings of US ‘082 and Meanwell are disclosed above and incorporated herein.
US ‘082 teaches their compounds are A2A- receptor agonists (abstract).
While US ‘082 in view of Meanwell does not teach: (i) treatment of cancers, like head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma (claims 23-24); (ii) or administration with another agent, like a PD-1 antagonist, such as pembrolizumab (claims 25-28); the teachings of Sek are relied upon for these disclosures.
Sek teaches that therapeutic agents have been developed to target downstream adenosine receptors (A1R, A2AR, A2BR, A3R) to enhance anti-tumor immune responses (abstract) and that the A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), and in several breast and melanoma cell lines (page 5, last para.). Sek specifically teaches that inhibition of A2AR in combination with anti-PD-1, has been shown to elicit enhanced anti-tumor T cell responses (page 9, para. 1, 13-20). Sek also teaches pembrolizumab as a PD-1 inhibitor being administered in combination with an A2A inhibitor for treating solid cancers (table 1, page 10, 3rd from last row).
Therefore, regarding claims 23-28, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘082’s A2A receptor inhibitors alone or in combination with a known PD-1 inhibitor, such as pembrolizumab, in view of Sek. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘082 in view of Meanwell’s disclose their compounds and pharmaceutical compositions thereof as A2AR inhibitors. Further because Sek teaches A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma; that targeting adenosine receptors enhances anti-tumor immune responses; and that inhibition of A2AR in combination with anti-PD-1, such as pembrolizumab, has been shown to elicit enhanced anti-tumor T cell responses.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Furthermore, Applicant is reminded that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
Claims 1-8, 12-19, 21-22, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,498,923 B2 (US ‘923); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
Regarding claims 1-8, 12-19, 21, and 29, US ‘923 claims the compounds of Formula I below, for example, compound 1 (US ‘923’s claims 1-2), which render the instant compounds obvious when: Z is -CH-2-phenyl, wherein phenyl is optionally substituted with halogen, alkyl, heterocycles, etc.– reading on instant Y being alkyl and R5 being aryl.
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(1)
Regarding instant claim 22, US ‘923 claims a pharmaceutical composition comprising their compounds and an excipient (US ‘923’s claim 3).
While US ‘923 doesn’t specifically teach their compounds wherein Z (corresponding to instant Y-R5 wherein Y is alkyl with a -CH2- replaced by -NH-; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2- and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1).
Therefore, regarding claims 1-8, 12-19, 21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘923’s disclosed compounds of Formula I above, in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by US ‘923, in view of Meanwell’s teaching that -CH2- and -NH2- are bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, by replacing a -CH2- in the group corresponding to instant Y in US ‘923’s compounds with a -NH- to arrive at the claimed invention.
Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Claims 23-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,498,923 B2 (US ‘923); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”); as applied to claims 1-8, 12-19, 21, and 29; further in view of Sek et al. (Int. J. Mol. Sci. 2018, 19, 3837, 23 pages) (“Sek”).
The teachings of US ‘923 and Meanwell are disclosed above and incorporated herein.
US ‘923 teaches their compounds are A2A- receptor agonists (abstract).
While US ‘923 in view of Meanwell does not teach: (i) treatment of cancers, like head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma (claims 23-24); (ii) or administration with another agent, like a PD-1 antagonist, such as pembrolizumab (claims 25-28); the teachings of Sek are relied upon for these disclosures.
Sek teaches that therapeutic agents have been developed to target downstream adenosine receptors (A1R, A2AR, A2BR, A3R) to enhance anti-tumor immune responses (abstract) and that the A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), and in several breast and melanoma cell lines (page 5, last para.). Sek specifically teaches that inhibition of A2AR in combination with anti-PD-1, has been shown to elicit enhanced anti-tumor T cell responses (page 9, para. 1, 13-20). Sek also teaches pembrolizumab as a PD-1 inhibitor being administered in combination with an A2A inhibitor for treating solid cancers (table 1, page 10, 3rd from last row).
Therefore, regarding claims 23-28, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘923’s A2A receptor inhibitors alone or in combination with a known PD-1 inhibitor, such as pembrolizumab, in view of Sek. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘923 in view of Meanwell’s disclose their compounds and pharmaceutical compositions thereof as A2AR inhibitors. Further because Sek teaches A2AR is overexpressed in some cancers, such as head and neck squamous cell carcinoma (HNSCC), breast cancer, and melanoma; that targeting adenosine receptors enhances anti-tumor immune responses; and that inhibition of A2AR in combination with anti-PD-1, such as pembrolizumab, has been shown to elicit enhanced anti-tumor T cell responses.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Furthermore, Applicant is reminded that the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
Claims 1-8, 12-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 and 16-22 of copending Application No. 18/015,364 (Copending ‘364); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”)
Regarding instant claims 1-8, 12-21, and 29, Copending ‘364 claims the compounds of Formula I below and pharmaceutical compositions thereof, which read on the instant compounds when Y C1-5 alkyl, wherein a -CH2- is substituted for -O-, -S-, or -SO2- and R5 is halogen, aryl, alkyl, etc.(reading on instant Y being straight or branched alkyl wherein a -CH2 – group has been replaced by -NH-).
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Regarding instant claims 22-28, Copending ‘364 claims a method of treating cancer (Copending ‘364 claims 17-19) comprising administration of their compounds of Formula I. Copending ‘364 also speaks to coadministration of an additional therapeutic agent that is a PD-1 antagonist, such as pembrolizumab (Copending ‘364 claims 20-22).
Applicant is reminded, similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
While Copending ‘364 doesn’t specifically teach their compounds wherein Z (corresponding to instant Y-R5 wherein Y is alkyl with a -CH2- replaced by -NH-; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell also teaches H and F are classical monovalent bioisosteres and that -CH2-, -O-, -S-, and -NH- are classical divalent bioisosteres (Table 1, page 2530, col. 1).
Therefore, regarding claims 1-8, 12-19, 21, and 29, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Copending ‘364’s disclosed compounds of Formula I above, in view of Meanwell. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of A2A inhibitor compounds disclosed by Copending ‘364, in view of Meanwell’s teaching that -CH2- and -NH2- are bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, by replacing a -O-, -S-, or -CH2- in the group corresponding to instant Y in Copending ‘364’s compounds with a -NH- to arrive at the claimed invention.
Applicant is reminded that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Furthermore, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Specification
Applicant’s comment is acknowledged. Indeed, the Examiner did not allege that the disclosure was deficient in the appropriate use of trade names. However, while the Examiner has made every attempt to check the Specification for trade mark compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding trade mark use compliance. No objection has been made to the specification.
Claim Objections
Previously presented claim objections are withdrawn in light of new rejections, which were not necessitated by amendments to the claims. Therefore, this action is non-final.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see pages 31, filed 12/02/2025, with respect to 35 USC § 112(b) rejections have been fully considered and are persuasive. The 35 USC § 112(b) rejection of the claims has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of applicant’s amendments and new claims added.
Double Patenting
Applicant’s arguments, see pages 32-37, filed 12/02/2025, with respect to obviousness type double patenting rejections over U.S. Patent No. 9,676,780 B2 (US ‘780); 9,708,347 B2 (US ‘347); 12,263,171 B2 (US ‘171); 11,312,719 (US ‘719); and Copending App. No. 18/836,154 (Copending ‘154) have been fully considered and are persuasive. The obviousness type double patenting rejections over U.S. Patent No. 9,676,780 B2 (US ‘780); 9,708,347 B2 (US ‘347); 12,263,171 B2 (US ‘171); 11,312,719 (US ‘719); and Copending App. No. 18/836,154 (Copending ‘154) have been withdrawn.
However, as it pertains to U.S. Patent No. 10,011,615 B2 (US ‘615); 10,688,082 B2 (US ‘082); 11,498,923 B2 (US ‘923); and copending Application No. 18/015,364 (Copending ‘364); applicant’s arguments are not persuasive for the reasons outlined in this office action.
In light of new rejections not presented in the non-final filed 07/02/2025, and not necessitated by amendment, this action is non-final.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627