DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-12 are pending.
Priority
This application is filed 01/12/2024 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
Four references from IDS(s) received on 01/16/2024, 12/09/2024, 04/02/2025, and 03/03/2026 have been considered unless marked with a strikethrough. Several foreign patents are marked with a strikethrough because of the lack of the English translations.
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard consistent with the specification (See MPEP 2111).
With respect to claim 8, the phase “EGFR or HER2 mutations” is interpreted as “EGFR and/or HER2 mutations” as applying inclusive logic.
With respect to claim 12, the claim recites that “the anticancer effect is enhanced by administration of the pharmaceutical composition in combination with an anticancer agent.” The phase “administration of the pharmaceutical composition in combination with an anticancer agent” is a broad and undefined phase, and the claim/specification do not clearly specify the nature or scope of the “an anticancer agent” with which the agent is combined. Therefore, the meaning and boundaries of limitation “administration of the pharmaceutical composition in combination with an anticancer agent” is interpreted to encompass administration of the claimed pharmaceutical composition together with any substances that have any anticancer activities. Moreover, the phase “the anticancer effect is enhanced“ is interpreted to mean “enhancing the anticancer effect relative to administration of the claimed composition alone”
Claim Objections
Claims 6 and 8 are objected to because of the following informalities:
In the claim 6, as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In the claim 8, “EGFR (epidermal growth factor receptor)” should be “epidermal growth factor receptor (EGFR)” or “EGFR” only. The term should be first then the abbreviation, or use abbreviation only because the term was defined earlier.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, Written Description
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 7-12 are 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed.
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
With respect to claims 7-12, the claims recite methods of preventing or treating cancer by administering compositions according to claim 1, wherein the compounds are defined in part of their ability to inhibit EGFR and/or HER2 mutations across a range of cancers and mutations. These claims rely on functional limitations to define the compounds. However, the specification does not demonstrate that substantially all compounds within the claimed structural genus possess the recited biological activity, and does not establish a correlation between structure and function. The current specification does include experimental data relating to inhibition of wild type EGFR, EGFR mutants, EGFR Ex20 insertion mutant enzyme, Ba/F3 EGFR mutant cell lines, Ba/F3 EGFR Ex20 insertion mutant cell growth, and HER mutation (pages 41 -49). These experimental data do not establish that substantially all compounds falling within the full structural scope of Formula 1 possess the recited biological activity, nor does it identify any structure/function correlation. In addition, these assays and cell lines help researchers identify effective drugs, such as TKIs (tyrosine kinase inhibitors), that can kill cancer cells harboring these mutations, not a preventing cancer.
Kerru et al. (A review on recent advances in nitrogen-containing molecules and their biological applications, Molecules, 25(8), 1909, pub’d 4/20/2020) discloses heterocyclic systems often demonstrate superior biological activity relative to simple alkyl substituents, often due to low toxicity, less adverse effects, high bioavailability, lower drug resistance, good biocompatibility with diverse pharmacological effects (conclusion section), and Zhang et al. (Targeting cancer with small molecule kinase inhibitors, Nat Rev Cancer., 9(1), 28–39, pub’d 01/2019) describes that kinase inhibitor activity is highly dependent on precise structural fractures (abstract section). Moreover, Zhang further explains that kinase targets of the second and third classes can be highly context dependent of the survival, proliferation and/or tumorigenesis of cancer cells and much more difficult to investigate (kinases in cancer section).
As can be seen from the study by Zhang, kinase targets including EGFR/HER2 are not universal cancer drivers. Their relevance is cancer type dependent and often heterogeneous (kinases in cancer section). In view of unpredictability from a relationship between a structure and function, and context dependency, taught by Kerru and Zhang, one of ordinary skill in the art would not reasonably expect that all compounds within the claimed genus would exhibit the claimed inhibitory activity in the full range of recited EGFR and/or HER2 mutations, cancer/disease indications and combination with an anticancer agent from the claims 9-12. As absent such information of a relationship between a structure and function, and context dependency, the specification fails to delineate the boundaries of the claimed invention in a manner that demonstrates possession.
As evidenced by Kerru and Zhang, claimed inhibitors response and sensitization mechanisms are highly unpredictable, varying across tumor types, therapeutic classes, and treatment contexts. In view of such unpredictability and the lack of any disclosed structure function or mechanism based correlation, a person of ordinary skill in the art would not recognize that the inventors had possession of which compounds of formula (I), cancer types, and combinations of anticancer agents would achieve the claimed inhibition effect at the time of filing. Furthermore, EGFR/HER2 inhibitors fundamentally function by blocking the activity of EGFR/HER2 proteins, which promote cell division and, when mutated, drive cancer, thereby serving as effective therapeutic agents for controlling established cancers harboring such mutations. In light of the aforementioned unpredictability, the absence of disclosed structure-function or mechanism-based correlations, and the lack of such correlations specifically pertaining to cancer cells, mutations, and normal cells, a person skilled in the art would not have been able to discern, at the time of filing, which specific compounds of Formula (I), cancer types, and combinations of anticancer agents the inventors could utilize to achieve the effects of claimed preventing cancer.
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), 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 2161.01).
Accordingly, in view of the breadth of the claimed combinations, the lack of representative examples (i.e., enzyme based assays and Ba/F3 based cellular assays in selected mutant contexts), and the unpredictability of the art as discussed above, the specification does not reasonably convey to those skilled in the art that the inventors are in possession of the full scope of claimed combination therapies at the time of filing.
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.
The rejections under this section are made when the scope of the claimed subject matter is not clear. (See MPEP 2173)
Claims 1-4, and 7-12 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. See MPEP § 2173.05(d).
Regarding claims 1-4, and 7-12, the term “may be” in the claims 1-3 renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed as “uncertain possibility or optional”), thereby rendering the scope of the claim(s) unascertainable. Dependent claims 4, 7-12 are also rejected because they do not resolve this issue.
Regarding claims 9, the term “etc” renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by “and other things”), thereby rendering the scope of the claim(s) unascertainable.
Accordingly, claims 1-4, and 7-12 are rendered indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following rejection under 35 USC 103 is based on the scope of the claims that is supported by the specification, including the scope supported by the disclosed enzyme based assays, and Ba/F3 based cellular assays in selected EGFR and/or HER2 mutant contexts, as discussed above.
Claim(s) 1-5, 7, 8, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (WO 2019/190259 A1, pub’d 10/03/2019), in view of Bunker et al. (WO 2017/205459 A1, pub’d 01/15/2019).
With respect to independent claim 1, the claim recites that sulfonamide derivatives having inhibitory effect on epidermal growth factor receptor mutation (EGFR) represented by formula 1, a stereoisomer thereof, a solvate thereof, a hydrate thereof, or a pharmaceutically acceptable salt thereof, defined by a Markush group of formula 1.
Jang discloses sulfonamide derivatives represented by the following chemical formula 1, including stereoisomers, solvates, and pharmaceutically acceptable salts thereof, for use in the prevention or treatment of cancers associated with EGFR mutation (abstract). Jang teaches a broad Markush genus encompassing multiple substituent variations, including heterocyclic moieties such as monocyclic and bicyclic heterocyclyl groups (claims 1-3). Jang further teaches the specific indole compound (claim 6) that is the similar as the indoline compound in example 2 (instant specification table 1), as shown below.
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(Formula 1 of Instant claim) (Example 2 in Instant application) (Jang’s compound)
Jang fail to teach exemplify indoline that is in the formula 1 of instant claim.
Bunker disclose nitrogen containing bicyclic heterocyclic compounds useful for the treatment of cancer, including compounds that inhibit EGFR activity (claims 50 and 65). Bunker further teaches bicyclic heterocyclic scaffolds, including indole and indoline, as suitable structural motifs in anticancer agents and identifies such scaffolds as part of compounds exhibiting EGFR inhibitory activity (claims 1 and 60, and paragraphs [0134]-[0135]).
It would have been obvious to a PHOSITA at the time of the invention to combine selected indoline as the bicyclic heterocyclyl substituent within the genus disclosed by Jang in view of Bunker. Jang provides a defined set of substituent options that includes bicyclic heterocyclyl groups, and Bunker teaches Infoline as a known bicyclic heterocyclic scaffold used in compounds having EGFR inhibitory activity. For example, Jang teaches compounds having activity against EGFR mutated cancers, and Bunker teaches that compounds incorporating indoline scaffolds exhibit EGFR inhibitory activity in anticancer applications. In corporation of an indoline moiety into the compounds of Jang would have been expected to yield compounds maintaining or enhancing EGFR inhibitory activity while utilizing a known bicyclic heterocyclic scaffold associated with such activity. This substitution represents the predictable selection of a known species from a disclosed genus based on its recognized utility in the same field of use. Accordingly, the combination of Jang and Bunker would have predictably resulted in compounds having EGFR inhibitory activity.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B) and (E) in the independent claim 1, it would have been prima facie obvious to substitute indoline for the closely related indole type bicyclic heterocyclic substituents disclosed by Jang, as Bunker teaches indoline as a bicyclic heterocyclic scaffold showing EGFR inhibitory activity, and the difference between indole and indoline is only the saturation of a carbon-carbon double bond. Because Jang discloses a finite number of identified bicyclic heterocyclic substituents, and Bunker teaches indoles as a suitable option in the same field of use, such substitution would have been a predictable variation yielding predictable results in EGFR inhibition. (see MPEP 2141)
With respect to claims 2-4, the claims recite the specific limitations of substituents within formula 1.
Jang teaches a defined set of substituent classes for each variable position with the Markush structures, including bicyclic heterocyclyl groups suitable for use in compounds having activity against EGFR mutated cancers (abstract, and claims 1-3). As discussed above with respect to independent claims 1, Bunker teaches indoline as a bicyclic heterocyclic scaffold commonly used in compounds showing EGFR inhibitory activity and in anticancer agents targeting EGFR. Accordingly, these claims would have been obvious for the same reasons set forth above with respect to independent claim 1.
With respect to claim 5, the claim recites the specific compounds comprising numerous species within the claimed genus. As discussed above with respect to independent claim 1, these compounds result from applying the same scaffold modification to Jang’s compounds and differ only in variations of indoline as a bicyclic heterocyclic scaffold substituents within the claimed scope.
Jang and Bunker teach structurally analogous compounds with similar core scaffolds and substituent variations, demonstrating that such modifications represent predictable variations within the level of ordinary skill in the art (claims 1-3). Representative compounds derived from Jang’s disclosed structures with Bunker’s scaffold teachings would result in compounds falling within the scope of the claimed species. For example, the compound <2> of instant claim 5, namely 5-chloro-N2-(2-methoxy-4-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)phenyl)-N4- (1-(methylsulfonyl)indolin-7-yl)pyrimidine-2,4-diamine would have been obvious over Jang’s compound, namely 5-Chloro-N - (2-methoxy-4-(4-(4-methylpiperazine-1-yl)piperidine-1-yl)phenyl)- N - (1-(methylsulfonyl)-1H-indole-7-yl)pyrimidine-2,4-diamine in claim 6. Accordingly, because the claimed compounds share a common core structure and differ by predictable substituent variations, claim 5 would have been obvious over Jang in view of for the same reasons set forth above with respect to independent claim 1.
With respect to claim 7, the claim recites that a pharmaceutical composition for preventing or treating cancer, containing the compound represented by formula 1, stereoisomer thereof, solvate thereof, hydrate thereof, or pharmaceutically acceptable salt thereof.
Jang teaches compounds having activity against EGFR mutated cancers, and Bunker teaches that compounds incorporating indoline scaffolds exhibit EGFR inhibitory activity in anticancer applications. Jang further teaches a pharmaceutical composition comprising compounds represented by formula (I), including a solvate, a stereoisomer or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, for preventing or treating cancer associated with an EGFR mutation (claims 1 and 7, and paragraph [111]).
With respect to claim 8, the claim recites that the compound represented by formula 1, stereoisomer thereof, solvate thereof, hydrate thereof, or pharmaceutically acceptable salt thereof inhibits EGFR or HER2 mutations.
Jang teaches that the disclosed compositions are effective against EGFR mutations, including activation mutations and resistance mutations such as del19 and L858R (claims 9-11).
With respect to claim 10, the claim recites that a list of a cancer types for preventing or treating using the pharmaceutical composition.
Jang teaches that the treatment of cancers associated with EGFR mutations, including lung cancer, liver cancer, colon cancer etc., which overlap with cancers recited in the claim 10 (claim 12).
With respect to claim 12, the claim recites that the anticancer effect is enhanced by administration of the pharmaceutical composition in combination with an anticancer agent.
Jang teaches that the anticancer effect is enhanced by administration of the pharmaceutical composition in combination with an anticancer agent (paragraph [107]).
Claim(s) 1, 7, 8, 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (WO 2019/190259 A1, pub’d 10/03/2019), in view of Bunker et al. (WO 2017/205459 A1, pub’d 01/15/2019), and in further view of Koga et. al. (Activity and mechanism of acquired resistance to tarloxotinib in HER2 mutant lung cancer: an in vitro study, Transl. Lung Cancer Res., 10(8), 3659-3670, pub'd 06/25/2021).
The combination teaches from Jang and Bunker as disclosed above and at least those teachings are incorporated by reference herein.
The combination fails to teach the HER2 mutation is at least one selected from the group consisting of HER2 A775_G776insYVMA, HER2 G776_delinsVC, etc.
With respect to claim 9, the claims recite that “the EGFR mutation is at least one selected from the group consisting of EGFR dell9,EGFR T790M, EGFR C797S, EGFR L858R, EGFR Ex20 insertion mutations, EGFR A763_Y764insFHEA, EGFR V769_D770insASV and EGFR D770_N771insSVD, etc.; and the HER2 mutation is at least one selected from the group consisting of HER2 A775_G776insYVMA, HER2 G776_delinsVC, etc.”, and the compound inhibits EGFR and HER2 mutations.
As discussed above, Jang teaches the disclosed compositions are effective against EGFR mutations, including activating and resistance mutations such as EGFR dell9,EGFR T790M, EGFR C797S, which correspond to the EGFR mutation limitations recited in claim 9.
Koga teaches that HER2 exon 20 insertion mutations, including A775_G776insYVMA, are recognized therapeutic targets and that small molecule kinase inhibitors are developed to target such mutations (introduction and Establishment of Ba/F3 cells with HER2 mutations section). It is well established in the art that EGFR and HER2 mutations, including exon 20 insertions and resistance mutations, are part of the same therapeutic target space for kinase inhibitor developments (introduction). The instant specification itself acknowledges that HER2 belongs to the same ErbB receptor tyrosine kinase family as EGFR and exhibits high structural similarity to EGFR (instant specification paragraphs [0017]-[0018]). Therefore, Koga provides express support for the additionally recited HER2 mutation limitation of claim 9.
It would have been obvious to a PHOSITA at the time of the invention to select known EGFR and HER2 mutant inhibitors from the finite number of identified bicyclic heterocyclyl substituents disclosed by Jang and Bunker to try the additionally recited HER2 mutation target of claim 9, taught by Koga, because Koga teaches that such HER2 mutations are known clinically relevant targets within the same EGFR/HER2 directed kinase inhibitor field.
Applying KSR example rationale (E) in the claim 9, it would have been prima facie obvious to try the finite number of EGFR/HER2 mutant invitros disclosed by Jang and Bunker to reflect identification of known clinically relevant mutations, predictable solutions, with a reasonable expectation of success. (see MPEP 2141)
With respect to claim 11, the claim recites that the compound inhibits EGFR and HER2 mutations.
The combination teaches from Jang, Bunker and Koga about the compound inhibits EGFR and HER2 mutations as disclosed above, the claim would have been obvious for the same reasons set forth above with respect to the claim 9.
Art of Record but not Applied
Carbain et al. (Trifluoroacetic Acid in 2,2,2-Trifluoroethanol Facilitates SNAr Reactions of
Heterocycles with Arylamines, Chem. Eur. J., 20, 2311 – 2317, pub’d 01/23/2014) demonstrates the Trifluoroacetic acid-2,2,2-trifluoroethanol(TFA-TFE) is as an effective combination for achieving SNAr reactions between chloro-substituted heteroaromatic compounds (i.e., 2,8-dimethyl-9-methylpurine) and amine (i.e., 4-bromoaniline) as nucleophiles under acidic conditions. (abstract, table 1 and scheme 1). However, has distinct solvents/acid system for a method to substitute a chloro-pyrimidine with an aromatic amine and lacks enough of the same embodiments to qualify as 103 prior art.
Conclusion
Claims 1-5, and 7-12 are rejected.
Claims 6, and 8 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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