Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-10 and 13 are pending in the instant application.
Claims 1-10 and 13 are examined herein.
Priority
The instant application is a CON of U.S. Patent Application No. 18/148,672, filed on 30 December 2022, and claims benefit of priority to U.S. Provisional Application No. 31/389,393, filed on 04 October 2010, and the continuation of applications found below. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 04 October 2010.
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Information Disclosure Statement
No information disclosure statement (IDS) submitted by applicant.
Claim Interpretation
Claims 9 and 10 are directed to a composition; as such, the intended use (i.e. for treating cancer or for use in a pharmaceutical composition) does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2111.02.II:
[S]tatements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.
Claim Objections
Claim 6 is objected to because of the following informalities:
The ninth compound recited in claim 6 is missing an “e.” The compound is recited as “2-fluoro-N-{6-[2-methyl-4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamid,” it should read “2-fluoro-N-{6-[2-methyl-4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamide.”
The tenth compound recited in claim 6 contains an extra closed bracket at the end. The compound is recited as “N-{6-[4-(methylamino)phenoxy]pyridin-3-yl}-4-phenoxybenzamide],” it should read “N-{6-[4-(methylamino)phenoxy]pyridin-3-yl}-4-phenoxybenzamide.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 13 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of liver cancer fails to provide the required enablement for the treatment of all cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant claim is drawn to the method of treating cancer comprising administering a compound of formula (I). The specification fails to provide information that would allow the one skilled in the art to practice treating all cancer.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
the nature of the invention
the state of the prior art
the predictability of the art
the amount of direction or guidance provided
the presence or absence of working examples
the breadth of the claims
the quantity of experimentation necessary
the relative skill of those in the art
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention - is a method of treating cancer comprising administering a compound of formula (I).
The state of the prior art - the pharmacological art requires the screening of potential drug candidates in vitro and in vivo to determine if the drug candidates exhibit the desired pharmacological activities.
In order to treat a disease: one would need to precisely identify what the disease is, identify what biological target is connected with the disease, demonstrate that the drug candidate in some way modulates the normal processes of the biological target, and demonstrate that a patient benefited from such modification without detrimental side effects. Typically, this process includes in vitro laboratory screening, preclinical in vivo screening, and three phases of clinical trials. Once this arduous process has been successfully completed by a drug candidate, subsequent drug candidates will benefit from the established proof of concept. The subsequent drug candidates must demonstrate a substantial correlation between their biological activity and that of the known drug candidate.
In the instant case, the prior arts recognize that therapeutic agents have potential to exhibit antiproliferative effects against cancer cells. However, the art does not recognize one universal antitumor agent for the treatment of cancer. Even the broad-spectrum cancer therapies, such as doxorubicin, have a low limit of cancers they can treat. There are over 200 known cancers and doxorubicin is only known to treat under 20 (Johnson-Arbor et al. StatPearls.2026 https://www.ncbi.nlm.nih.gov/books/NBK459232/).
The predictability or unpredictability of the art – the law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in vivo animal model assays and a disclosed or a claimed method of use . . . if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for establishing the potential of new therapeutics.
Additionally, within pharmaceutics, the art of cancer therapeutics is well known to be unpredictable due to the differing etiologies and mechanisms of action for particular cancers. There are more than 200 known cancers; treatment applicable to one is unlikely to be applicable to another. Bianchi et al. (Current Opinion in Cell Biology. 2020; 63:135-143) attributes this unpredictability to tissue specificity, noting most cancer driver genes are mutated in a tissue-dependent manner, which affects therapeutic response (page 135). For example, BRAF inhibition is an effective therapy for BRAF-mutated melanomas, but not BRAF-mutated colon cancer (page 140); same mutation, different tumors, therefore different therapeutic outcomes. Therefore, from the well-established state of cancer arts, a skilled practitioner would not conclude all cancers could be treated, managed or improved with the same therapeutic agent.
The amount of direction or guidance presented – the instant specification does not provide and explanation of the biological activity of the compounds of instant formula (I). The specification briefly discusses the shortcomings of current carcinostatics, also known as antineoplastics, but does not discuss the mechanism of action by which the instant compounds inhibit the proliferation of cancer cells. The instant specification instead states, “…it is not known whether the compounds of the present application have antitumor action” (page 1, line 27). Therefore there is no direction or guidance provided that supports the use of the instant compounds to treat all cancer.
The amount of guidance or direction to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. MPEP § 2164.03 (quoting In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970)). As identified supra, the pharmaceutical art is recognized as unpredictable.
Thus, in order to support a claim for treating all cancer a vast amount of evidence is required because such a claim is not supported by the prior art or the instant specification.
The presence or absence of working examples - there are no working or prophetic examples in the specification that demonstrate that the instant compounds or compositions thereof may treat all cancer. The assays in the specification demonstrate that the instant compounds were tested for their antiproliferative activity against human hepatic cancer cells (page 36, line 14). No other cell lines were tested.
The breadth of the claims – is incommensurate in scope with the disclosure because a fair reading of the specification fails to support a finding that the compounds of instant formula (I) may treat all cancer in a patient.
The quantity of experimentation necessary – generally speaking, the amount of experimentation to transform a molecule into medicine is vast and the success thereof is low. Recent statistics indicate that the attrition rates during drug development remain high. Schafer et al. Drug Discovery Today 2008, 13 (21/22), 913-916. The article makes clear that there are many steps necessary to promote a new molecular entity toward its clinical use, any one of which is cumbersome.
For instance, Schafer et al. discloses: "proof of concept trials have failed when the decision to enter clinical development was based on preclinical experiments using the wrong compound, the wrong experimental model, or the wrong endpoint.” It can be gleaned from this article that a plethora of experimentation is needed to identify the lead compound (i.e. one among many in a Markush-type claim), to establish which preclinical tests are predictive of clinical success, and to establish which diseases are the best to target for each lead compound.
There is generally a vast amount of experimentation to take a drug from bench to the clinic. See e.g., Horig et al. Journal of Translational Medicine 2004, 2(44) (“Successful drug development requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patent acceptance.") The Examiner finds that one of ordinary skill in the art would agree with the statements in these articles; that is, the amount of experimentation required to enable a pharmaceutical drug is extensive.
The level of skill in the art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of the active workers in the field of pharmaceuticals and/or medicine, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in a field related to medicine and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
Therefore, claim 13 is rejected because the Examiner finds that the Wands factors suggest a conclusion that the skilled artisan would not be able to make and use the instant invention without undue experimentation, although the level of skill for an ordinary person in the art is high. That is, due to the breadth of the claims, the unpredictability of the art, the lack of guidance or direction from the disclosure, the lack of any working examples, and the amount of experimentation needed illustrate that a person having ordinary skill in the art would not be able to treat all cancer
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, and 6-7 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.
Claim 1 recites the limitation "said lower alkyl" in line 6. There is insufficient antecedent basis for this limitation in the claim as the previous mention of a lower alkyl group has been deleted.
Claims 6 and 7 recite five compounds where R2 is a linear alkoxy with 1 carbon atom. There is insufficient antecedent basis for this limitation in the claim. The compounds are the twelfth through sixteenth recited in each claim, namely; N-{6-[2-methoxy-4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamide, N-{6-[2-methoxy-4-(methylamino)phenoxy]pyridin-3-yl}-4-phenoxybenzamide, N-{6-[2-methoxy-4-(methylamino)phenoxy]pyridin-3-yl}biphenyl-4-carboxamide, 2-fluoro-N-{6-[2-methoxy-4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamide, and 2,3,4-trifluoro-N-{6-[2-methoxy-4-(methylamino)phenoxy]pyridin-3-yl}benzamide (pictured below).
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Claim Rejections - 35 USC § 112
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.
Claims 9 and 10 are 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 9 recites the intended use of a compound of claim 8, which does not alter the composition and therefore provide no further limit to claim 8.
Claim 10 recites the intended use of a compound of claim 1, which does not alter the composition and therefore provide no further limit to claim 1.
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.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8946437. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 10, the patent discloses a compound of formula (I) (pictured below), with the same substituents as the instant general formula except R1 cannot be chlorine (claim 1).
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Regarding claim 2, the patent discloses a compound where R2 is hydrogen (claim 2).
Regarding claim 3, the patent discloses a compound where R2 is a halogen (claim 3).
Regarding claim 4, the patent discloses a compound where R2 is a linear or branched alkyl group with 1 to 6 carbons (claim 4).
Regarding claim 5, the patent discloses a compound where R2 is a linear or branched alkoxy group with 1 to 6 carbons (claim 5).
Regarding claim 6, the patent discloses the same 20 compounds recited in the instant application (claim 6).
Regarding claim 7, the patent discloses the same 32 compounds recited in the instant application (claim 6).
Regarding claims 8 and 9, the patent discloses a pharmaceutical composition comprising a compound of formula(I) and an acceptable carrier (claim 8).
Claims 1-2, 4, 6-7, 10 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4 of U.S. Patent No.12220410. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are at least obvious over the reference claims.
Regarding claims 1-2, 4, and 10, the patent discloses a composition comprising a compound of formula (I) (pictured below), which overlaps with the instant formula (I) when R1 is a halogen or C1-6 alkyl, optionally substituted with one or more halogen atoms; R2 is a hydrogen atom or a C1-6 alkyl group; and m is an integer of 1 to 2, provided that when m is 2, R1 is the same or different (claim 1).
While the reference claim 1 also recites an antitumor agent, the requirement of a compound of general formula (I) still renders the compounds of the instant genus obvious.
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Regarding claims 6 and 7, the patent discloses N-{6-[2-methyl-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluromethyl)benzamide, 2-fluoro-N-{6-[2-methyl-4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamide, N-{6-[4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl) benzamide, and 2-fluoro-N-{6-[4-(methylamino)phenoxy]pyridin-3-yl}-4-(trifluoromethyl)benzamide (claim 2). These are the eighth, ninth, eighteenth and nineteenth compounds recited in both instant claims 6 and 7.
Regarding claim 13, the patent discloses a method of treating a tumor comprising administering a composition comprising a compound of reference general formula (I) (claim 4).
Claims 1-7, 10, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6 of co-pending Application No. 19/007,126 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are at least obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1-5 and 10, the reference application recites a composition comprising a compound of reference formula (I) (pictured below) with the same substituents as the instant general formula (I) (claim 1).
While the reference claim 1 also recites an antitumor agent, the requirement of a compound of general formula (I) still renders the compounds of the instant genus obvious.
Regarding claims 6 and 7, the reference application recites the same compounds recited in instant claim 6 and the first twenty recited in instant claim 7 (claim 4).
Regarding claim 13, the reference application recites a method of treating a tumor comprising administering a composition comprising a compound of reference general formula (I) (claim 6).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-10 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Matsuyama et al. (WO 2007/066784).
Regarding claims 1 and 10, Matsuyama discloses (claim 1) an antitumor agent comprising a compound of formula (I) (pictured below), which encompasses the genus of the instant formula (I) when the reference:
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R1 is -Z-R6; where Z is N(R8)-B-; R8 is H; B is CO; and R6 is optionally substituted phenyl
R2 is H
X1 is N
Y is -O-
A is
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; where R4 is –(T)l-N(R14)R15, where l is 0, R14 is H, and R15 is lower alkyl; and R3 is H, halogen, lower alkoxy or lower alkyl.
Matsuyama does not disclose a preferred embodiment of the instant formula (I).
Matsuyama does disclose example 922 or N-[6-(4-aminophenoxy)pyridin-3-yl]-3,4-dichlorobenzamide (pictured below). Compound 922 is a species of the instant formula except the aniline nitrogen is not substituted with a methyl group. This modification would be prima facie obvious to the skilled artisan as Matsuyama teaches the aniline nitrogen can be substituted, this substitution corresponds to R15 which can be lower alkyl. An example where R15 is methyl are seen in examples 799, 801, 804, and 806 (page 603, Table 109).
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Therefore as Matsuyama discloses the generic teaching of R15 being methyl and discloses preferred embodiments where this is the case, motivating the skilled artisan to produce other variants, it would be obvious to modify example 922 such that the aniline nitrogen is substituted once with a methyl group, arriving at a species of the instant genus.
Regarding claim 2, Matsuyama teaches R3, which corresponds to the instant R2, can be hydrogen (claim 1).
Regarding claim 3, Matsuyama teaches R3, which corresponds to the instant R2, can be halogen (claim 1).
Regarding claim 4, Matsuyama teaches R3, which corresponds to the instant R2, can be lower alkyl (claim 1). Matsuyama defines lower alkyl as linear or branched alkyl groups having 1 to 6 carbon atoms such as methyl, ethyl, propyl, isopropyl, 2,2-dimethylpropyl, 1-ethylpropyl, butyl, isobutyl, tert- butyl, isopentyl, pentyl, and hexyl groups (page 98, line 22).
Regarding claim 5, Matsuyama teaches R3, which corresponds to the instant R2, can be lower alkoxy (claim 1). Matsuyama defines lower alkoxy as linear or branched alkoxy groups having 1 to 6 carbon atoms such as methoxy, ethoxy, propoxy, isopropoxy, butoxy, tert-butoxyl, pentyloxy, and hexyloxy groups (page 98, line 18).
Regarding claims 6 and 7, the compounds disclosed are all species of the reference formula (I) (claim 1).
Regarding claims 8 and 9, Matsuyama teaches a pharmaceutical composition which contains a pharmaceutical carrier (page 425, line 5).
Regarding claim 13, Matsuyama teaches a method of treating a tumor comprising administering a compound of formula(I) or a salt thereof (claim 53). Matsuyama defines tumor to include cancer (page 428, line 16).
Conclusion
Claims 1-10 and 13 are rejected.
Claim 6 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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, Clinton 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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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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