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 .
Priority
This Application is a 371 of PCT/EP2021/0833, filed Nov. 29, 2021, and claims foreign priority to EP20210868.4, filed Dec. 1, 2020 with the European Patent Office.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 28, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-7, 10, 13, 17 and 19-33 are pending. In the Remarks filed April 28, 2026, the Applicant has affirmed the election of the following species:
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Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 read on the elected species and are currently active and subject to examination. Claim 2, 22-26, 28-32 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections – Withdrawn
The provisional rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 17/620,240 in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is withdrawn.
The above rejection is withdrawn as moot because copending Application No. 17/620,240 was abandoned.
Claim Rejections – 35 USC § 103 – Previously Presented
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 rejection of claim(s) 1, 3-7, 10, 13, 17, 19-21, 27, and 33 under 35 U.S.C. 103 as being unpatentable over Duplessis et al. (WO2020002487A1, published January 2, 2020) (of record, IDS cite no. 15) (herein “Duplessis 2”) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
Response to Arguments
The Applicant argues that there is no overlap between the instant formula (I) and the formula I of Duplessis 2 (Remarks, p. 22-23). These arguments were fully considered but are not persuasive. The exemplified species falling within formula I of Duplessis 2 are substantially similar to the compounds falling within instant formula (I), demonstrating the substantial overlap between instant formula (I) and formula I of Duplessis 2. The following compounds were compared in the last office action, which differ only by the replacement of a C(O) vs. N in the core feature:
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(Duplessis 2, Specification, p. 39, example 51; cited on page 4 of the prior office action).
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(Specification, p. 50, example 8; cited on page 4 of the prior office action).
The Applicant argues that Duplessis 2 would not have provided any reason or motivation as to why a skilled artisan would make the modifications to the compounds of Duplessis 2 to arrive at the compounds of the instant invention, let alone a reasonable expectation of success (Remarks, p. 23). The Applicant argues that the Examiner provides no reason to select example 51 as a starting point (id.). The Applicant argues that the Examiner does not provide any evidence showing that oxo-isoindoline is a bioisostere of indazole (id., p. 24). These arguments were fully considered but are not persuasive. As stated in the MPEP:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
MPEP § 2144.09.I.
The prior office action shows that one of ordinary skill in the art would have reasonably expected the compounds of the instant invention to have similar properties to the compounds of Duplessis 2 due to their close structural relationship and identical utility. Contrary to Applicant’s assertion that the Examiner has not provided any evidence showing that oxo-isoindoline is a bioisostere of indazole, the prior office action shows that compounds with both oxo-isoindoline or indazole cores function as highly potent EGFR inhibitors. As shown in the prior office action, Duplessis teaches an EGFR inhibitor with the following structure, which is largely similar to the compounds of Duplessis 2 and the instant invention:
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(Duplessis, Specification, p. 20, example 10; prior office action p. 5).
The core feature of Duplessis 2 is bioisosteric to the core feature of Duplessis because both core features produce compounds with similar inhibitory activities at the EGFR receptor. All the compounds of Duplessis 2 are highly potent with IC50s in the single digit to double digit nanomolar range and represent natural starting points for development efforts (see Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 91 USPQ2d 1018 (Fed. Cir. 2009) (explaining that lead compound analysis does not require that the art only point to a single lead compound, only that a particular compound be a natural starting point for development efforts).
The Applicant argues that Duplessis does not cure the deficiencies because Duplessis teaches a phenyl substituent at the alpha position of the indazole core (Remarks, p. 24-25). These arguments were fully considered but are not persuasive. Duplessis 2 supplies the claimed alpha substituent. The pyrrolo[1,2-c]imidazolyl appears in every one of its 68 examples, including Example 51. Duplessis is cited for two teachings only: (1) the indazole core; and (2) the express definition of R2 as halogen, halogen-C1-6-alkyl, or C1-6-alkyl. It is not cited for the alpha position at all. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Reiterated Rejection
Claim(s) 1, 3-7, 10, 13, 17, 19-21, 27, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duplessis et al. (WO2020002487A1, published January 2, 2020) (of record, IDS cite no. 15) (herein “Duplessis 2”) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Claim 1 is directed towards a compound of formula (I):
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(claim 1). For example,
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(Specification, p. 50, example 8).
Duplessis 2 teaches largely similar mutant EGFR inhibitors
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, wherein A is
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(Duplessis 2, Specification, p. 8, lines 20-30). For example, Duplessis 2 teaches the compound:
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(Duplessis 2, Specification, p. 39, example 51).
Example 51 largely similar to compounds of formula (I) but differs from instant formula (I) in that the core is oxo-isoindoline instead of indazole and the oxo-isoindoline is modified with two halogens instead of CF2 and methyl, however, these compounds are so similar that one of ordinary skill in the art would reasonably expect them to have similar properties when viewed in the totality of the prior art because it is known that the oxo-isoindoline is a bioisostere of indazole and that methyl and halomethyl are bioisosteres of halogen.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7). A representative species is:
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(Duplessis, Specification, p. 20, example 10) which is also largely similar to the compounds of instant formula (I).
Therefore, claim 1 was prima facie obvious at the time of filing.
Claim 3 is directed towards a compound according to claim 1 or 2, wherein R1 and R2 are independently selected from fluoro and hydrogen.
One of ordinary skill in the art would have a reasonable expectation of success to have a compound of formula (I) wherein R1 and R2 are independently selected from fluoro and hydrogen because Duplessis 2 teaches compounds of formula (I) wherein R1 and R2 are independently selected from fluoro and hydrogen. For example:
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(Duplessis 2, Specification, p. 40, example 53).
Therefore, claim 3 was prima facie obvious at the time of filing.
Claim 4 is directed towards the compound of claim 1, wherein R3 is methyl. The rejection of claim 1 is incorporated herein by reference which discusses the selection of methyl for R3. Therefore, claim 4 was prima facie obvious at the time of filing.
Claims 5-7 read on the compound of claim 1, wherein R4 is morpholinyl. The rejection of claim 1 is incorporated herein by reference which shows that Duplessis 2 teaches the compound:
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(Duplessis 2, Specification, p. 39, example 51), wherein R4 is morpholinyl. As such, claims 5-7 were prima facie obvious at the time of filing.
Claim 10 is directed towards a process for the preparation of a compound of formula (I),
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(claim 10), comprising the following steps:
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Claim 10.
One of ordinary skill in the art would have a reasonable expectation of success to prepare a compound of formula (I) with this synthesis scheme because this scheme is generally known in the art for similar compounds.
For example, Duplessis and Duplessis 2 teach this synthesis scheme for related compounds:
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.
Duplessis, Specification, p. 16.
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Duplessis 2, Specification, p. 23.
Both Duplessis and Duplessis 2 teach the structural features of the compound of formula (I) as explained in the rejection of claim 1 above, incorporated herein by reference. These differences do not change the method of synthesis, as shown above, as both Duplessis and Duplessis 2 teach the same general synthesis scheme as in the instant claims.
Therefore, claim 10 was prima facie obvious at the time of filing.
Claim 13 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a therapeutically inert carrier. One of ordinary skill in the art would have a reasonable expectation of success to formulate a composition comprising the compound of claim 1 with a pharmaceutically inert carrier because Duplessis 2 teaches pharmaceutical compositions comprising similar compounds and a pharmaceutically inert carrier (Duplessis 2, Specification, p. 44, lines 9-11).
Therefore, claim 13 was prima facie obvious at the time of filing.
Claim 17 is directed towards a method for the treatment or prophylaxis of a cancer in a patient in need thereof comprising administering an effective amount of the compound of claim 1 to the patient. Claim 19 is directed towards the method of claim 17, wherein the cancer is non-small cell lung cancer (NSCLC).
One of ordinary skill in the art would have a reasonable expectation of success to treat cancer, in particular NSCLC with the compound of claim 1 because Duplessis 2 teaches administering similar compounds for the “the therapeutic and/or prophylactic treatment of cancer, in particular non-small-cell lung cancer.” (Duplessis 2, Specification, p. 212, lines 26-29).
Therefore, claims 17 and 19 were prima facie obvious at the time of filing.
Claims 20 and 21 are directed towards the compound
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. The rejection of claim 1 is incorporated herein by reference which addresses this compound.
Therefore, claims 20-21 were prima facie obvious at the time of filing.
Claims 27 and 33 are directed towards the compound:
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. Duplessis 2 teaches the compound:
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(Duplessis 2, Specification, p. 39, example 51).
Example 51 largely similar to the claimed compound but differs from instant formula (I) in that the core is oxo-isoindoline instead of indazole and the oxo-isoindoline is modified with two halogens instead of CF2 and methyl and that there is a phenyl linked to the core instead of pyridinyl, however, these compounds are so similar that one of ordinary skill in the art would reasonably expect them to have similar properties when viewed in the totality of the prior art because it is known that the oxo-isoindoline is a bioisostere of indazole, that methyl and halomethyl are bioisosteres of halogen, and that phenyl is a bioisostere of pyridinyl.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7). A representative species is:
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(Duplessis, Specification, p. 21, example 12) which is also largely similar to the claimed compound, and has pyridinyl instead of phenyl. This compound has similar activity to the same compound with the phenyl group:
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(Duplessis, Specification, p. 20, example 10).
Duplessis example 12 has an IC50 of 31 nM (Duplessis, Specification, p. 21, example 12), Duplessis 2 example 51 has an IC50 of 11 nM (Duplessis 2, Specification, p. 39, example 51), while the instantly claimed compound has an IC50 of 12 nM (Instant Specification, p. 112, example 21). Clearly the claimed compound has activity within the range known in the prior art and fails to present any unexpected properties to distinguish it from the prior art.
Given the teachings above, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory Double Patenting – Previously Presented
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.
The rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 12209091 B2 (herein the ‘091 patent) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
The rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US 12344613 B2 (herein the ‘613 patent) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
The rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,552,801 (previously copending Application No. 18/255,085) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
The rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,479,849 (previously copending Application No. 17/620,242) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
The provisional rejection of claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 19/221,423 in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
The provisional rejection of claims 1, 3-7, 10, 13, 17 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13, 16, 20, 22-23 of copending Application No. 18/255,083 in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”) is maintained.
Response to Arguments
The Applicant argues that the rejections are traversed on the same grounds as the 103 rejection (Remarks, p. 26). These arguments were fully considered but are not persuasive. To the extent that the non-statutory double patenting rejections rely on the same arguments given in the 103 rejections, the arguments above are incorporated herein by reference (e.g. for the rejection over the ‘091 patent). Nonetheless, most of the nonstatutory double patenting below do not rely on the same arguments given in the 103 rejection above, and the Applicant has failed to respond to these rejections. For example, the ‘613 patent, U.S. Patent No. 12,552,801 (previously copending Application No. 18/255,085), U.S. Patent No. 12,479,849 (previously copending Application No. 17/620,242), copending Application No. 19/221,423, and copending Application No. 18/255,083 all claim compounds with the same core feature as the instant invention and thus cannot be traversed using the same arguments that the Applicant presented in response to the 103 rejection.
Reiterated Rejection
Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 12209091 B2 (herein the ‘091 patent) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because the ‘091 patent is the U.S. version of the Duplessis 2 document cited in the 35 U.S.C. 103 rejection above, the rejection incorporated herein by reference, and one of ordinary skill in the art would have a reasonable expectation of success to modify the compounds claimed by the ‘091 patent with the teachings of Duplessis to arrive at the claimed EGFR inhibitors.
For example, the ‘091 patent claims the compound
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(‘091 patent, claim 17). Claim 1 is directed towards a compound of formula (I):
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(claim 1). For example,
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(Specification, p. 50, example 8).
These compounds are so similar that one of ordinary skill in the art would reasonably expect them to have similar properties when viewed in the totality of the prior art because it is known that the oxo-isoindoline is a bioisostere of indazole and that methyl and halomethyl are bioisosteres of halogen. For example, see the teachings of Duplessis cited in the 103 rejection above.
Regarding the elected compound,
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, the ‘091 patent claims the largely similar compound
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(‘091 patent, claim 17).
The compound from claim 17 of the ‘091 patent is largely similar to the claimed compound but differs in that the core is oxo-isoindoline instead of indazole and the oxo-isoindoline is modified with two halogens instead of CF2 and methyl and that there is a phenyl linked to the core instead of pyridinyl, however, these compounds are so similar that one of ordinary skill in the art would reasonably expect them to have similar properties when viewed in the totality of the prior art because it is known that the oxo-isoindoline is a bioisostere of indazole, that methyl and halomethyl are bioisosteres of halogen, and that phenyl is a bioisostere of pyridinyl.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7). A representative species is:
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(Duplessis, Specification, p. 21, example 12) which is also largely similar to the elected compound. This compound has similar activity to the same compound with the phenyl group:
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(Duplessis, Specification, p. 20, example 10).
The ‘091 patent also claims pharmaceutical compositions (‘091, claim 23) and methods of treating cancer and NSCLC (‘091, claims 19-22). Regarding the method of synthesis, given that the ‘091 patent claims similar compounds and Duplessis teaches the overall scheme for synthesizing such compounds, one of ordinary skill in the art would have a reasonable expectation of success to use the synthesis method as in claim 10.
Therefore, the instant claims are rejected on the grounds of non-statutory patenting as being obvious over the ‘091 patent in view of Duplessis.
Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. US 12344613 B2 (herein the ‘613 patent) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because the claimed compounds are so similar that one of ordinary skill in the art would expect them to have similar properties.
Claim 1 is directed towards a compound of formula (I):
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(claim 1). For example,
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(Specification, p. 34, example 1).
The ‘613 patent claims a compound:
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(’613, claims 1-2).
These compounds are so similar that one of ordinary skill in the art would expect them to have similar properties. The only difference lies in the substituents of the indazole, however, one of ordinary skill in the art would expect that the chlorine substituents would behave similarly to difluoromethyl and methyl because this is a commonly known biosiosteric replacement.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7).
Regarding the elected compound,
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, the ‘613 patent claims a similar compound:
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(’613, claims 1-2).
The compound from claim 1-2 of the ‘613 patent is largely similar to the claimed compound but indazole two halogens instead of CF2 and methyl and that there is a phenyl linked to the core instead of pyridinyl, however, these compounds are so similar that one of ordinary skill in the art would reasonably expect them to have similar properties when viewed in the totality of the prior art because it is known that methyl and halomethyl are bioisosteres of halogen, and that phenyl is a bioisostere of pyridinyl.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7). A representative species is:
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(Duplessis, Specification, p. 21, example 12) which has pyridinyl instead of phenyl and is also largely similar to the elected compound. This compound has similar activity to the same compound with the phenyl group:
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(Duplessis, Specification, p. 20, example 10).
The ‘613 patent also claims pharmaceutical compositions (‘613, claim 6) and methods of treating cancer and NSCLC (‘613, claims 4-5, 7-10). Regarding the method of synthesis, given that the ‘091 patent claims similar compounds and Duplessis teaches the overall scheme for synthesizing such compounds, one of ordinary skill in the art would have a reasonable expectation of success to use the synthesis method as in claim 10.
Given the similarity between the claims and the teachings of Duplessis, the invention as a whole was obvious over the claims of the ‘613 patent in view of Duplessis and is rejected on the ground of nonstatutory double patenting.
Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,552,801 (previously copending Application No. 18/255,085) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because both Applications are directed towards very similar compounds of the formula (I),
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(instant claim 1)
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(copending claim 1) except that the instant claims have CF2 instead of CF3, allow A to be N or CH, R3 is only alkyl and there are more variable substituents for R4.
Instant claim 1 recites:
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Copending claim 1 recites:
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(Application No. 18/255,085, claim 1).
CF3 is so similar to CF2 that one of ordinary skill in the art would expect these compounds to have similar properties (compounds differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties (MPEP 2144.09)).
Regarding the elected compound,
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, the copending application claims a similar compound:
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(Application No. 18/255,085, named in claim 20, structure from p. 32 of Specification).
The compound from copending application so similar to the claimed compound that one of ordinary skill in the art would expect similar properties. CF3 is so similar to CF2 that one of ordinary skill in the art would expect these compounds to have similar properties (compounds differing regularly by the successive addition of the same chemical group are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties (MPEP 2144.09)). Phenyl is so similar to pyridinyl that one of ordinary skill in the art would expect similar properties.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7). A representative species is:
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(Duplessis, Specification, p. 21, example 12) which has pyridinyl instead of phenyl and is also largely similar to the elected compound. This compound has similar activity to the same compound with the phenyl group:
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(Duplessis, Specification, p. 20, example 10).
The copending application also claims the method of synthesis (copending claim 10), a pharmaceutical composition comprising the compound and an inert carrier (copending claim 13) and a method of treating cancer/ NSCLC by administering a therapeutically effective amount of the compound (copending claims 17 and 19).
As such, the instant claims are obvious over the claims of Application No. 18/255,085 and are provisionally rejected on the grounds of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,479,849 (previously copending Application No. 17/620,242) in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because the claimed compounds are so similar that one of ordinary skill in the art would expect them to have similar properties.
Claim 1 is directed towards a compound of formula (I):
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(claim 1).
For example,
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(claim 27).
Copending Application No. 17/620,242 claims 1-2 claim a largely similar compound:
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.
These compounds are so similar that one of ordinary skill in the art would expect them to have similar properties. The only difference lies in the substituents of the indazole, however, one of ordinary skill in the art would expect that the chlorine substituents would behave similarly to difluoromethyl and methyl because this is a commonly known biosiosteric replacement.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7).
The copending application also claims pharmaceutical compositions (copending claims 4 and 13) and methods of treating cancer and NSCLC (copending claims 11-12 and 14-15). Regarding the method of synthesis, given that the ‘091 patent claims similar compounds and Duplessis teaches the overall scheme for synthesizing such compounds, one of ordinary skill in the art would have a reasonable expectation of success to use the synthesis method as in claim 10.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-7, 10, 13, 17, 19-21, 27, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 19/221,423 in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because the claimed compounds are so similar that one of ordinary skill in the art would expect them to have similar properties.
Claim 1 is directed towards a compound of formula (I):
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(claim 1). For example,
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(Specification, p. 34, example 1).
The copending Application No. 19/221,423 claims a compound of formula (I):
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(claims 1-2).
These compounds are so similar that one of ordinary skill in the art would expect them to have similar properties. The only difference lies in the substituents of the indazole, however, one of ordinary skill in the art would expect that the chlorine substituents would behave similarly to difluoromethyl and methyl because this is a commonly known biosiosteric replacement.
For example, Duplessis teaches mutant EGFR inhibitors of generic formula I:
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(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-7, 10, 13, 17 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13, 16, 20, 22-23 of copending Application No. 18/255,083 in view of Duplessis et al. (WO2018115218A1, published June 28, 2018) (of record, IDS cite no. 13) (herein “Duplessis”).
Although the claims at issue are not identical, they are not patentably distinct because the claimed compounds are so similar that one of ordinary skill in the art would expect them to have similar properties.
Claim 1 is directed towards a compound of formula (I):
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(claim 1). For example,
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(Claim 20).
Copending claim 1 is directed towards compounds of formula (I):
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(claim 1), for example,
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(copending Application No. 18/255,076, claim 23).
While the claimed compound and the copending claimed compound differ in that the phenyl in the claimed compound is replaced with alkynyl in the copending compound, these compounds are so similar that one of ordinary skill in the art would expect them to have similar properties because this is a commonly known bioisosteric replacement.
For example, Duplessis teaches that these compounds have similar properties as EGFR inhibitors:
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Duplessis, Specification, p. 22.
Claims 3-7 read on the claimed compound as in the rejection of claim 1 and are rejected on the same grounds as claim 1. The copending application also claims pharmaceutical compositions (copending claim 16) and methods of treating cancer and NSCLC (copending claims 20 and 22). Regarding the method of synthesis, given that copending application claims similar compounds and Duplessis teaches the overall scheme for synthesizing such compounds, one of ordinary skill in the art would have a reasonable expectation of success to use the synthesis method as in claim 10.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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