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 claims the benefit of U.S Provisional Patent Application No. 63/124,665 filed December 11, 2020; U.S. Provisional Patent Application No. 63/214,718 filed June 24, 2021; U.S. Provisional Patent Application No. 63/253,012 filed October 6, 2021; and U.S. Provisional Patent Application No. 63/277,561 filed November 9, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct. 10, 2024 and Sept. 26, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-3, 7, 14, 24, 38, and 60 are currently pending and subject to examination.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
“A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claims 1, 3, 7, 14 and 60 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fu et al. (WO2020061103A1, published March 26, 2020) (of record, IDS filed Sept. 26, 2023, cite no. 3).
Claim 1 is directed towards a method of treating a subject having cancer comprising administering to the subject a therapeutically effective amount of a compound of Formula I:
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in combination with an EGFR inhibitor.
Fu teaches a method of treating a subject having cancer comprising administering to the subject a therapeutically effective amount of a compound of Formula I and an EGFR inhibitor:
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Fu, Specification, p. 35;
Where the subject in need is suffering from or at risk of suffering from cancer, the subject can be treated with a compound of this disclosure in any combination with one or more other anti-cancer agents including but not limited to:
…
Epidermal growth factor receptor (EGFR) inhibitors: Gefitnib (sold under the tradename Iressa®), N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3"S")-tetrahydro-3- furanyl]oxy]-6- quinazolinyl]-4(dimethylamino)-2-butenamide, sold under the tradename Tovok® by Boehringer Ingelheim), cetuximab (sold under the tradename Erbitux® by Bristol-Myers Squibb), panitumumab (sold under the tradename Vectibix® by Amgen).
Fu, Specification, p. 101-102;
In general, the compounds of this disclosure will be administered in a therapeutically effective amount by any of the accepted modes of administration for agents that serve similar utilities.
Fu, Specification, p. 97.
Therefore, claim 1 is anticipated.
Claim 3 is directed towards the method of claim 1, wherein the cancer comprises an EGFR mutation selected from EGFR gene copy gain, EGFR gene amplification, chromosome 7 polysomy, EGFR L858R, EGFR exon 19 deletion, EGFR exon 19 insertion, EGFR L861Q, EGFR G719C, EGFR G719S, EGFR G719A, EGFR V765A, EGFR T783A, EGFR exon 20 insertion, EGFR splice variant, EGFR A289D, EGFR A289T, EGFR A289V, EGFR G598A, EGFR G598V, EGFR T790M, and EGFR C797S.
Fu teaches the treatment of patients with EGFR mutations, including EGFR gene amplification:
The present disclosure provides certain fused tricyclic ring derivatives that are Src Homology-2 phosphatase (SHP2) inhibitors and are therefore useful for the treatment of diseases treatable by inhibition of SHP2.
Fu, Specification, p. 1;
Knock-down of SHP2 significantly inhibited cell growth of lung cancer cell lines with SHP2 mutation or EML4/ALK translocations as well as EGFR amplified breast cancers and esophageal cancers. SHP2 is also activated downstream of oncogenes in gastric carcinoma, anaplastic large -cell lymphoma and glioblastoma.
Fu, Specification, p. 93 (emphasis added);
SHP2 acts as a positive regulator in receptor tyrosine kinase (RTK) signaling. Cancers containing RTK alterations (EGFR amp , Her2 amp , FGFR amp , Met 31 " 15 , translocated/activated RTK, i.e. ALK, BCR/ABL) include Esophageal, Breast, Lung, Colon, Gastric, Glioma, Head and Neck cancers.
Esophageal cancer (or oesophageal cancer) is a malignancy of the esophagus. There are various subtypes, primarily squamous cell cancer (<50%) and adenocarcinoma. There is a high rate of RTK expression in esophageal adenocarcinoma and squamous cell cancer. A SHP2 inhibitor of the invention can, therefore, be employed for innovative treatment strategies.
Breast cancer is a major type of cancer and a leading cause of death in women, where patients develop resistance to current drugs. There are four major subtypes of breast cancers including luminal A, luminal B, Her2 like, and triple negative/Basal-like. Triple negative breast cancer (TNBC) is an aggressive breast cancer lacking specific targeted therapy.
Epidermal growth factor receptor I (EGFR) has emerged as a promising target in TNBC. Inhibition of Her2 as well as EGFR via SHP2 may be a promising therapy in breast cancer.
Lung Cancer - NSCLC is currently a major cause of cancer-related mortality, accounting for about 85% of lung cancers ( predominantly adenocarcinomas and squamous cell carcinomas). Although cytotoxic chemotherapy remains an important part of treatment, targeted therapies based on genetic alterations such as EGFR and ALK in the tumor are more likely to benefit from a targeted therapy.
Colon Cancer - Approximately 30% to 50% of colorectal tumors are known to have a mutated (abnormal) KRAS, and BRAF mutations occur in 10 to 15% of colorectal cancers. For a subset of patients whose colorectal tumors have been demonstrated to over express EGFR, these patients exhibit a favorable clinical response to anti-EGFR therapy.
Fu, Specification, p. 94-95 (emphasis added).
Therefore, claim 3 is anticipated.
Claim 7 is directed towards the method of claim 1, wherein the EGFR inhibitor is selected from osimertinib, dacomitinib, lazertinib, nazartinib, neratinib, mobocertinib, afatinib, erlotinib, gefitinib, lapatinib, lifirafenib, amivantamab, cetuximab, panitumumab, necitumumab, mirzotamab clezutoclax, nimotuzumab, and vandetanib.
As shown in the rejection of claim 1, Fu teaches the EGFR inhibitors: “Gefitnib (sold under the tradename Iressa®), N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3"S")-tetrahydro-3- furanyl]oxy]-6- quinazolinyl]-4(dimethylamino)-2-butenamide, sold under the tradename Tovok® by Boehringer Ingelheim), cetuximab (sold under the tradename Erbitux® by Bristol-Myers Squibb), panitumumab (sold under the tradename Vectibix® by Amgen)” (Fu, Specification, p. 102) Tovok has the active ingredient afatinib.
Fu also teaches neratinib (id., p. 103, line 2) and erlotinib (id., line 14).
Therefore, claim 7 is anticipated.
Claim 14 is directed towards the method of claim 1, wherein the method comprises administering a third MAPK pathway inhibitor.
Fu teaches that the compound of Formula I can be administered in combination with a MAPK inhibitor and an EGFR inhibitor:
Where the subject in need is suffering from or at risk of suffering from cancer, the subject can be treated with a compound of this disclosure in any combination with one or more other anti-cancer agents including but not limited to:
MAP kinase pathway (RAS/RAF/MEK/ERK) inhibitors including but not limited to: Vemurafanib (PLX4032), Dabrafenib, Encorafenib (LGX818), TQ-B3233, XL-518 (Cas No. 1029872- 29-4, available from ACC Corp); trametinib, selumetinib (AZD6244), TQ-B3234, PD184352, PD325901, TAK-733, pimasertinib, binimetinib, refametinib, cobimetinib (GDC- 0973), AZD8330, BVD-523, LTT462, Ulixertinib, AMG510, ARS853, and any RAS inhibitors disclosed in patents WO2016049565, W020l6l64675,W020l6l68540, WO2017015562, WO2017058728, WO2017058768, WO2017058792, W020l7058805,W02017058807, W02017058902, WO2017058915, W02017070256, WO2017087528, W02017100546, WO2017172979, W02017201161, WO2018064510, WO2018068017, WO2018119183.
Fu, Specification, p. 101.
Therefore, claim 14 is anticipated.
Claim 60 is directed towards the method of claim 1, wherein the cancer is selected from head and neck cancer, lung cancer, stomach cancer, liver cancer, colon cancer, colorectal cancer, kidney cancer, breast cancer, pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC), juvenile myelomonocytic leukemia, neuroblastoma, melanoma, and acute myeloid leukemia.
As shown in the rejection of claim 3, Fu teaches the treatment of Esophageal, Breast, Lung, Colon, Gastric, Glioma, Head and Neck cancers (Fu, Specification, p. 94, lines 25-26).
Therefore, claim 60 is anticipated.
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, 7, 14, 24, 38 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (WO2020061103A1, published March 26, 2020), as applied to claims 1, 3, 7, 14 and 60 above.
The rejection of claims 1, 3, 7, 14 and 60 above as anticipated by Fu is incorporated herein by reference. As such, these claims were prima facie obvious at the time of filing.
Claim 24 is directed towards a kit comprising a compound of Formula I and an EGFR inhibitor.
Fu teaches that the compound of formula I can be administered in combination with an EGFR inhibitor as shown in the rejection of claim 1. While Fu does not specifically teach a kit comprising the compound of formula I and an EGFR inhibitor, one of ordinary skill in the art would have a reasonable expectation to make a kit comprising a compound of formula I and an EGFR inhibitor because it is commonly known in the art that compounds are contained in packaging and could be packaged together.
For example, Fu teaches kits (formulations presented in unit-dose or multi-dose containers to be mixed with sterile liquid carrier):
The formulations may be presented in unit-dose or multi-dose containers, for example sealed ampoules and vials, and may be stored in powder form or in a freeze dried (lyophilized) condition requiring only the addition of the sterile liquid carrier, for example, saline or sterile pyrogen-free water, immediately prior to use. Extemporaneous injection solutions and suspensions may be prepared from sterile powders, granules and tablets of the kind previously described.
Fu, Specification, p. 98.
Therefore, claim 24 was prima facie obvious at the time of filing.
Claim 38 is directed towards the method of claim 1, wherein the compound of Formula I, or pharmaceutically acceptable salt thereof, is administered at a dose selected from between about 20 mg to 400 mg per day, about 20 mg and about 260 mg per day, about 20 mg and about 60 mg per day, about 40 mg per day or about 60 mg per day, about 10 mg and about 100 mg twice per day, and about 20 mg and about 80 mg.
One of ordinary skill in the art would have a reasonable expectation of success to administer the compound of Formula I at the above dose because Fu teaches that a suitable dosage level may be about 0.1 to about 50 mg/kg per day and that for oral administration, the compositions can be provided in the form of tablets containing about 1, 5, 10, 15, 20, 25, 50, 75, 100, 150, 200, 250, 300, 400, 500, 600, 750, 800, 900, and 1000 milligrams of the active ingredient (Fu, Specification, p. 97). As these ranges overlap the claimed range, a prima facie case of obviousness exists (MPEP § 2144.05).
Therefore, claim 38 was prima facie obvious at the time of filing.
Claim(s) 1-3, 7, 14, 24, 38 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (WO2020061103A1, published March 26, 2020), as applied to claims 1, 3, 7, 14 and 60 above, and further in view of Chen et al. (Oncogene, volume 25, pages 1205–1215 (2006)).
The rejection of claim 1, 3, 7, 14 and 60 above is incorporated herein by reference.
Claim 2 is directed towards the method of claim 1, wherein the EGFR in the subject is expressed constitutively.
As shown in the rejection of claim 3, Fu teaches the treatment of non-small cell lung cancer (NSCLC), wherein the cancer has an EGFR mutation which confers sensitivity to targeted therapy (Fu, Specification, p. 95, lines 5-9).
While Fu does not specifically teach that the EGFR mutation is constitutively expressed EGFR, one of ordinary skill in the art would have a reasonable expectation of success to treat a cancer with constitutively expressed EGFR with a combination of the compound of Formula I and an EGFR inhibitor because it is commonly known in the art that cancer that have constitutively expressed EGFR are sensitive to targeted therapies with EGFR inhibitors.
For example, Chen teaches that clinical resposnsiveness to the EGFR inhibitor gefitinib is associated with EGFR alterations such as constitutively active EGFR:
The majority of EGFR mutants are more sensitive to gefitinib than wild-type EGFR, because lower concentrations of gefitinib were needed to suppress Tyr phosphorylation of the EGFR mutants (Figure 1). Interestingly, the constitutively active EGFRvIII mutant was also hypersensitive to gefitinib when compared to wild-type EGFR (Figure 1). This result indicates that a mutation in the kinase domain of EGFR is not essential for acquiring hypersensitivity to gefitinib.
Chen, col. 2, p. 1206;
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Chen, Fig. 1, p. 1207.
Therefore, claim 2 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.
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.
Claim(s) 1, 3, 7, 14, 24, 38 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 9, 10, 19, 21, 24, and 66 of copending Application No. 18/572,412 (reference application) in view of Fu et al. (WO2020061103A1, published March 26, 2020),. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of copending Application No. 18/572,412 are directed towards a method of treating cancer with the compound of Formula I and combination of MAPK pathway inhibitors.
For example, claim 1 of the instant application is directed towards a method of treating cancer comprising administering the compound of Formula I and an EGFR inhibitor. Claim 14 is directed towards administering a third MAPK pathway inhibitor. Claim 1 of the copending application is directed towards a method of treating cancer, comprising administering the compound of Formula I with a CDK4/6 inhibitor. Claim 19 of the copending application is directed towards the method of claim 1, wherein the method comprising administering a third MAPK pathway inhibitor, including an EGFR inhibitor. As such, these claims are anticipated by the claims of the copending application.
Given the teachings of Fu shown above in the 102 and 103 rejections, incorporated herein by reference, the patient populations of the instant application and the specific EGFR inhibitors are obvious over the claims of the copending application in view of Fu. The instant claims and the copending claims also recite the same doses of the compound of Formula I and overlapping types of cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1, 3, 7, 14, 24, 38 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 12-14, 20, 32, and 47 of copending Application No. 18/256,091 (reference application) in view of Fu et al. (WO2020061103A1, published March 26, 2020),. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of copending Application No. 18/256,091 are directed towards a method of treating cancer with the compound of Formula I and a combination of MAPK pathway inhibitors.
For example, claim 1 of the instant application is directed towards a method of treating cancer comprising administering the compound of Formula I and an EGFR inhibitor. Claim 14 is directed towards administering a third MAPK pathway inhibitor. Claim 1 of the copending application is directed towards a method of treating cancer, comprising administering the compound of Formula I with a KRAS inhibitor. Claim 12 of the copending application is directed towards the method of claim 1, wherein the method comprising administering a third MAPK pathway inhibitor. Fu teaches that MAPK pathway inhibitors useful in combination with the compound of formula I include EGFR inhibitors and RAS inhibitors, as shown by the teachings of Fu above, incorporated herein by reference. As such, the instant claims are obvious over the claims of the copending application.
Given the teachings of Fu shown above in the 102 and 103 rejections, incorporated herein by reference, the patient populations of the instant application and the specific EGFR inhibitors are obvious over the claims of the copending application in view of Fu. The instant claims and the copending claims also recite the same doses of the compound of Formula I and overlapping types of cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1, 3, 7, 14, 24, 38 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 60-70, 75-78, and 84-88 of copending Application No. 18/256,090 (reference application) in view of Fu et al. (WO2020061103A1, published March 26, 2020),. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of copending Application No. 18/256,090 are directed towards a method of treating cancer with the compound of Formula I and a combination of MAPK pathway inhibitors.
For example, claim 1 of the instant application is directed towards a method of treating cancer comprising administering the compound of Formula I and an EGFR inhibitor. Claim 14 is directed towards administering a third MAPK pathway inhibitor. Claim 60 of the copending application is directed towards a method of treating cancer, comprising administering the compound of Formula I with a MEK inhibitor. Claim 75 of the copending application is directed towards the method of claim 1, wherein the method comprising administering a third MAPK pathway inhibitor. Fu teaches that MAPK pathway inhibitors useful in combination with the compound of formula I include EGFR inhibitors and MEK inhibitors, as shown by the teachings of Fu above, incorporated herein by reference. As such, the instant claims are obvious over the claims of the copending application.
Given the teachings of Fu shown above in the 102 and 103 rejections, incorporated herein by reference, the patient populations of the instant application and the specific EGFR inhibitors are obvious over the claims of the copending application in view of Fu. The instant claims and the copending claims also recite the same doses of the compound of Formula I and overlapping types of cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1, 3, 7, 14, 24, 38 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 39, 41. 42. 45, 57-63, 65, 85-90, 94-95, 127, and 134 of copending Application No. 18/572,404 (reference application) in view of Fu et al. (WO2020061103A1, published March 26, 2020),. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of copending Application No. 18/572,404 are directed towards a method of treating cancer with the compound of Formula I and a combination of MAPK pathway inhibitors.
For example, claim 1 of the instant application is directed towards a method of treating cancer comprising administering the compound of Formula I and an EGFR inhibitor. Claim 14 is directed towards administering a third MAPK pathway inhibitor. Claim 3 of the copending application is directed towards a method of treating cancer, comprising administering the compound of Formula I (compound 2) in combination with the compound 1, and cetuximab, an EGFR inhibitor as in the instant claims. As such, these claims are anticipated by the claims of the copending application.
Given the teachings of Fu shown above in the 102 and 103 rejections, incorporated herein by reference, the patient populations of the instant application and the specific EGFR inhibitors are obvious over the claims of the copending application in view of Fu. The instant claims and the copending claims also recite the same doses of the compound of Formula I and overlapping types of cancer. Claim 65 of the copending application specifically recites EGFR mutant cancer as in claim 3 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is found to be allowable.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629