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 January 3, 2024 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 1-18 are currently pending and subject to examination.
Claim Objection- Improper Multiple Dependent Claims
Claims 4-18 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 4-18 have not been further treated on the merits.
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.”
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.
Claim(s) 1-3 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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image2.png
148
302
media_image2.png
Greyscale
(Specification, p. 50, example 8).
Duplessis 2 teaches largely similar mutant EGFR inhibitors
PNG
media_image3.png
171
237
media_image3.png
Greyscale
, wherein A is
PNG
media_image4.png
97
137
media_image4.png
Greyscale
(Duplessis 2, Specification, p. 8, lines 20-30). For example, Duplessis 2 teaches the compound:
PNG
media_image5.png
168
204
media_image5.png
Greyscale
(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:
PNG
media_image6.png
70
48
media_image6.png
Greyscale
(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:
PNG
media_image7.png
182
170
media_image7.png
Greyscale
(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 2 is directed towards the compound of claim 1, wherein A is -CH-. As shown above, one of ordinary skill in the art would have a reasonable expectation of success to have an EGFR inhibitor of formula (I) wherein A is CH because both Duplessis and Duplessis 2 teach EGFR inhibitors wherein A is CH.
Therefore, claim 2 was prima facie obvious at the time of filng.
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:
PNG
media_image8.png
165
199
media_image8.png
Greyscale
(Duplessis 2, Specification, p. 40, example 53).
Therefore, claim 3 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Note: A declaration providing (1) an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure and (2) a reasonable explanation of the presence of additional authors is required to exempt Duplessis 2 as prior art under the 35 U.S.C. § 102(b)(1)(A) exception.
Nonstatutory 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 1-3 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
PNG
media_image9.png
152
298
media_image9.png
Greyscale
(‘091 patent, claim 17). Claim 1 is directed towards a compound of formula (I):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image2.png
148
302
media_image2.png
Greyscale
(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.
Claims 2-3 read on the compound example 8 and are rejected on the same grounds.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image10.png
154
303
media_image10.png
Greyscale
(Specification, p. 34, example 1).
The ‘613 patent claims a compound of formula (I):
PNG
media_image11.png
194
425
media_image11.png
Greyscale
(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:
PNG
media_image6.png
70
48
media_image6.png
Greyscale
(Duplessis, Specification, p. 6) wherein R2 is halogen, halogen-C1-6 alkyl or C1-6 alkyl (Duplessis, Specification, p. 6-7).
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18/255,085.
Although the claims at issue are not identical, they are not patentably distinct because both Applications are directed towards compounds of the formula (I),
PNG
media_image12.png
183
399
media_image12.png
Greyscale
except that the instant claims allow A to be N or CH, R3 is only alkyl and there are more variable substituents for R4. As such, the claims largely cover the same compounds.
Instant claim 1 recites:
PNG
media_image13.png
694
642
media_image13.png
Greyscale
Copending claim 1 recites:
PNG
media_image14.png
402
633
media_image14.png
Greyscale
(Application No. 18/255,085, claim 1).
As such, the instant claims are anticipated by 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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of 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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1).
For example,
PNG
media_image15.png
223
255
media_image15.png
Greyscale
(Specification, p. 56, example 11).
Copending Application No. 17/620,242 claims 1-2 claim a largely similar compound:
PNG
media_image16.png
261
302
media_image16.png
Greyscale
.
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:
PNG
media_image6.png
70
48
media_image6.png
Greyscale
(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 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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image10.png
154
303
media_image10.png
Greyscale
(Specification, p. 34, example 1).
The copending Application No. 19/221,423 claims a compound of formula (I):
PNG
media_image11.png
194
425
media_image11.png
Greyscale
(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:
PNG
media_image6.png
70
48
media_image6.png
Greyscale
(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 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”).
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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image2.png
148
302
media_image2.png
Greyscale
(Specification, p. 50, example 8).
Claims 1-2 of copending Application No. 17/620,240 are directed towards the compound
PNG
media_image17.png
321
607
media_image17.png
Greyscale
(name recited in claims 1-2, structure shown on p. 18 of the specification.
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 halogen 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:
PNG
media_image6.png
70
48
media_image6.png
Greyscale
(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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/255,076 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):
PNG
media_image1.png
183
399
media_image1.png
Greyscale
(claim 1). For example,
PNG
media_image18.png
196
264
media_image18.png
Greyscale
(Specification, p. 46, example 6).
Copending claim 1 is directed towards compounds of formula (I):
PNG
media_image19.png
162
298
media_image19.png
Greyscale
(claim 1), for example,
PNG
media_image20.png
157
390
media_image20.png
Greyscale
(copending Application No. 18/255,076, Specification, p. 25, example 1).
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:
PNG
media_image21.png
379
489
media_image21.png
Greyscale
Duplessis, Specification, p. 22.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
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.
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, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 86-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629