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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on Mar. 12th, 2026 has been entered.
Status of the Claims
Claims 1-2, 6-7, 10, 12-13, 15-17 and 21-23 are pending in this application. Claims 3-5, 8-9, 11, 14, 18-20, and 24 have been cancelled by applicant. Claims 1-2, 6-7, 10, 12-13, 15-17 and 21 are under examination herein. Claims 22-23 remain withdrawn from consideration.
Claim Interpretation
Claim 1 has been amended to say that the instant compounds of Formula I cannot be the compounds below:
N-(4-((6-amino- 5-chloropyrimidin-4-yl)oxy)-2-fluorophenyl)-1-(4-chlorophenyl)-2-oxo-1,2-dihydropyridine-3- carboxamide
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N-(4-((6-amino-5-fluoropyrimidin-4- vl)oxy)phenyl)-1-(4-fluorophenyl)-2-oxo-1,2-dihydropyridine-3-carboxamide
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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 1-2, 6-7, 10, 12-13, 15-17 and 21 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 is indefinite because the claim language below is unclear:
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What does Applicant mean by: “…but wherein one of said R4-7 is F, or…” – But wherein one of said R4-7 is F, then what? Some condition or limitation appears to be missing. Does Applicant intend to say that at least one of R4-7 has to be F? If so, then why say that “R4-7 are all H” at the beginning of the line? For the purposes of applying art, it will be assumed that Applicant simply intended: “R4-7 are independently selected from H and F”.
Claims 2, 6-7, 10, 12-13, 15-17 and 21 are rejected for depending upon the limitations of claim 1.
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 1-2, 6, 12-13, 15-17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Traoré et al. (Eur. J. Med. Chem. 70, 2013, 789-801 – From IDS – previously cited) (“Traoré”).
Regarding claims 1-2, 6, 12-13, 15-17, Traoré discloses the compound below, which reads on the instant compounds when R1 is H; R2 is amino; R3 is chloro (halo); R4 is F; R5-7 are all H; R8 is -OEt; R9-10 are H; and R11 is p-F-Ph (reading on R14 being F and R11 being phenyl-R14) – the compound below is also not one of the compounds in the proviso (see claim interpretation above) (Table 1, row 1).
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Traoré discloses this compound as a potent inhibitor of different kinases – see below, taken from Table 1.
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These results are comparable to the instantly disclosed activities for related compound 2 (see below, taken from Table 2 of the specification, page 36) – It is noted that the instant table shows “%Residual enzymatic activity at 1 µM”, while Traoré discloses “%inhibition at 0.5, 1, and 75 µM” – thus, for a direct comparison, only inhibitions at 1 µM from Traoré were considered.
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While Traoré does not specifically disclose the instant compound 2 (with a pyrimidine instead of a pyridine), Traoré dislcoses a study aimed at exploring the effects of the position of the amino group in BMS-777607 and specifically teaches replacement of the pyridine in BMS-777607 with pyrimidines substituted at 2 and 6 respectively (page 791, col. 1, and Scheme 3), and specifically teaches that substitution of the pyridine ring by a pyrimidine ring seems to increase the specificity towards the four proteins of the HGFR/TAM family (page 792, col. 1, para. 1). While these other compounds with pyrimidines instead of pyridine showed lower % inhibitions (see Table 1, compounds 13a, c-d, and 23), these compounds, also lacked the ethoxy moiety from the pyridinone ring, which might account for their reduced activity relative to BMS-777607.
Therefore, regarding claims 1-2, 6, 12-13, 15-17, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, in view of Traoré’s disclosure of their TAM inhibitors, including BMS-777607, and structure-activity-relationship studies. One of ordinary skill would have been motivated to prepare the claimed compounds because Traoré teaches BMS-777607 as a highly active inhibitor of Tyro3, Axl, Mer, and Met, and their disclosure that substitution of BMS-777607’s pyridine for a pyrimidine resulted in increased specificity towards the 4 proteins in the HGFR/TAM family. Therefore, one of ordinary skill would have been motivated to replace the pyridine in BMS-777607 with a pyrimidine to arrive at the instant invention, with a reasonable expectation of success.
Further regarding claim 17, the compound 2 below is particularly obvious in view of Traoré.
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Regarding claim 21, Traoré discloses their kinase assays were conducted in DMSO (section 4.2, page 800).
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Traoré et al. (Eur. J. Med. Chem. 70, 2013, 789-801 – From IDS – previously cited) (“Traoré”); as applied to claims 1-2, 6, 12-13, 15-17, and 21; in view of Morita et al. (Obtained From gousei.f.u-tokyo.ac.jp [Retrieved on September 11th, 2025] <URL: https://gousei.f.u-tokyo.ac.jp/seminar/index.html#2012> - Published May 2012 – previously cited) (“Morita”).
The teachings of Traoré are disclosed above and incorporated herein.
While Traoré doesn’t specifically teach their compounds wherein the groups corresponding to instant R6 is F or wherein instant R4 is H (as required by claims 7 and 10, respectively; the teachings of Morita are relied upon for these disclosures.
Morita teaches bioisosteres introduce structural changes that can be beneficial in the development of lead compounds by allowing modulation of size, shape, lipophilicity, and polarity of compounds, among other variables, which may result in improvements in potency, selectivity, toxicity, and metabolism (page 3, bottom section). Morita further discloses -H and -F as monovalent bioisosteres; and that -F and -Me are also monovalent bioisosteres.
Therefore, regarding instant claims 7 and 10, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to swap the H in the position corresponding to instant R6 for an F, and the F in the position corresponding to instant R4 for an H, in Traoré’s compound BMS-777607, in view of Morita, to arrive at the instant invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Traoré discloses their compound BMS-777607 above as a potent inhibitors of TAM kinases for the treatment of cancer (see page 789, col. 1), which is the same intended use as the instantly claimed invention; further because Morita teaches H for F replacements are obvious, given the fact that H and F are monovalent bioisosteres. One would have been further motivated, with a reasonable expectation of success, in view of Morita’s teachings that bioisosteres introduce structural changes that can be beneficial for improvements in potency, selectivity, toxicity, and metabolism of drugs.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been added.
Claim Rejections - 35 USC § 112(d)
Applicant’s arguments, see page 8, filed 03/12/2026, with respect to 35 USC § 112(d) rejections of the claims have been fully considered and are persuasive. The 35 USC § 112(d) rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 8-10, filed 03/12/2026, with respect to 35 USC § 103 rejections of claims 1-2, 4-13, 15-17, 21, and 24 over Traoré in view of Morita have been fully considered and are persuasive. The 35 USC § 103 rejections of these claims has been withdrawn. However, upon further consideration, and in view of claim amendments, a new ground of rejection is made in view of Traoré; and Traoré in view of Morita as set forth above.
Applicant argues the compounds encompassed by the claims show unexpectedly superior activity over compounds in Traoré, and that compounds 6 and 33 have been disclaimed, because they do not show the same level of improved activity.
This is not persuasive, because, as disclosed in the 103 rejections herein:
Traoré discloses the compound below, which reads on the instant compound 2 (Table 1, row 1).
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Traoré discloses this compound as a potent inhibitor of different kinases – see below, taken from Table 1.
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These results are comparable to the instantly disclosed activities for related compound 2 (see below, taken from Table 2 of the specification, page 36) – It is noted that the instant table shows “%Residual enzymatic activity at 1 µM”, while Traoré discloses “%inhibition at 0.5, 1, and 75 µM” – thus, for a direct comparison, only inhibitions at 1 µM from Traoré were considered.
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, in view of Traoré’s disclosure of their TAM inhibitors, including BMS-777607, and structure-activity-relationship studies. One of ordinary skill would have been motivated to prepare the claimed compounds because Traoré teaches BMS-777607 as a highly active inhibitor of Tyro3, Axl, Mer, and Met, and their disclosure that substitution of BMS-777607’s pyridine for a pyrimidine resulted in increased specificity towards the 4 proteins in the HGFR/TAM family. Therefore, one of ordinary skill would have been motivated to replace the pyridine in BMS-777607 with a pyrimidine to arrive at the instant invention, with a reasonable expectation of success.
Therefore, the results observed for compound 2 (which is encompassed by the claims) are not unexpected, and claims stand rejected over Traoré.
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
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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