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 .
Claims Status
Claims 1-22 are pending and under examination.
Priority
The instant application claims priority to provisional application 63/389,041. Priority is given with the earliest effective filing date of 07/14/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see paragraph [0049] of the instant specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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, 5-8, 12-13, and 18 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.
Claims 1, 5-8, 12-13, and 18 recite “about”. Applicant has provided an
explicit definition for “about” meaning “an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined” [see paragraph 0040 of the specification]. However, the metes and bounds for “about” are dependent on the interpretation of others for determining what is an “acceptable” error range. Given a single value, one person of ordinary skill in the art could determine that the value is acceptably in the error range. However, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.” Therefore, these claims are indefinite. The Examiner recommends amending the claims to remove the “about” to overcome the rejections.
Claim 9 recites the limitation “wherein the method further comprises one or more chemotherapeutic agents comprising platinum.” The claim does not recite any method steps and therefore is unclear how the method further comprises one or more chemotherapeutic agents.
Claim 10, which depends from claim 9, also does not set forth any method steps and therefore is indefinite for the same reasons set forth above.
Note: The Examiner recommends amending claim 9 to recite “wherein the method further comprises administering one or more chemotherapeutic agents comprising platinum” to overcome the rejection.
Claim 13 recites the limitation “carboplatin AUC 5”. Applicant does not provide an explicit definition for this term and so, it is unclear if “carboplatin AUC 5” is referring to carboplatin administered to achieve area under the curve (AUC) 5, such as is recited in instant claim 12, or if it is referring to something else. Therefore, the scope of this claim is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1, from which claims 5-7 depend, recites that the antibody is administered once per a 21 day cycle. Claims 5-7 require multiple administrations per a 21 day cycle, and therefore, do not further limit the single administration set forth in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-3, 8-10, 14-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04077463, 2021 (instant PTO-892) in view of FDA, 2021 (instant PTO-892).
Note: Applicant defines the claimed bispecific antibody, comprising the sequences as set forth in instant claims 1, 15, and 17, as amivantamab or JNJ-61186372 [see paragraph 79 of the instant specification]. Therefore, the bispecific antibody taught by NCT04077463 and FDA, amivantamab, is the same as the claimed bispecific antibody. Further, Applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the Lazertinib as taught by NCT04077463 is the same as the claimed Formula I.
Regarding claims 1-3, 9-10, 14-18, and 21-22, NCT04077463 teaches administering oral Lazertinib in combination with intravenous amivantamab, carboplatin, and pemetrexed on a 21 day cycle [page 14, Arms and Interventions] to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer) [pages 12-13, Brief Description; Page 20, Inclusion Criteria].
However, NCT04077463 does not specifically teach that the amivantamab is administered at a dose of about 1400-2100 mg.
FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the amivantamab of NCT04077463 at a dose of 1400 mg as taught by FDA. One would have been motivated to administered the amivantamab at a dose of 1400 mg because it is a known dose of amivantamab in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Regarding claim 8, as set forth above, FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1]. FDA further teaches that RYBREVANT can be administered at various dosages every week and then every two weeks thereafter [page 6, Table 5] and teaches administering amivantamab over a dosage range from 350 to 1750 mg [page 14, 12.3 Pharmacokinetics].
The art demonstrates that the amount of amivantamab administered and how often is a result effective variable. Through routine optimization, one of ordinary skill in the art would arrive at the specific doses and dosing schedule as claimed. See MPEP 2144.05(II). Absent evidence to the contrary, given the explicit teachings in FDA, it would have been obvious to manipulate these variables as set forth in the claims.
Further regarding claims 14, 16, and 18, since NCT04077463 and FDA teach a bispecific antibody (i.e. amivantamab) that has the same structure of the claimed bispecific antibody, then the amivantamab necessarily comprises a first domain that binds EGFR and a second domain that binds c-Met, as claimed in instant claim 14, is an IgG1 isotype, as claimed in instant claim 16, and has a biantennary glycan structure with a fucose content of between about 1% to about 15%, as claimed in instant claim 18.
Claims 1-4, 8-10, 14-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04077463, 2021 (instant PTO-892) in view of FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Dhillon, 2021 (instant PTO-892).
The teachings of NCT04077463 and FDA are above.
However, NCT04077463 and FDA do not specifically teach that the Lazertinib (3rd generation EGFR TKI) is administered at a dose of 240 mg daily.
Regarding claim 4, Dhillon teaches that the recommended dosage of Lazertinib is 240 mg once daily taken orally [page 1107, right column second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the Lazertinib of NCT04077463 at a dose of 240 mg daily, as taught by Dhillon. One would have been motivated to have administered the Lazertinib at a dose of 240 mg daily because Dhillon teaches that this is the recommended dosage of Lazertinib. There would be a reasonable expectation of success in administering the Lazertinib at a dose of 240 mg daily because this is a known parameter in the art.
Claims 1-3, 8-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04077463, 2021 (instant PTO-892) in view of FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Tamiya et al., 2013 (instant PTO-892).
The teachings of NCT04077463 and FDA are above.
However, NCT04077463 and FDA do not specifically teach that the pemetrexed is administered at a dose of 500 mg/m2, that the carboplatin is administered to achieve AUC 5, each administered on day 1 of a 21 day cycle for four cycles.
Regarding claims 11-13, Tamiya teaches that the patients with NSCLC were administered 500 mg/m2 pemetrexed and area under the concentration-time curve (AUC 5) carboplatin intravenously, which were the recommended doses for the combination therapy, each administered on day 1 of a 21-day cycle for a maximum of four cycles [see Abstract; page 981, right column, third paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the pemetrexed and carboplatin of NCT04077463 at a dose of 500 mg/m2 pemetrexed and AUC 5 carboplatin on day 1 of a 21 day cycle for 4 cycles, as taught by Tamiya. One would have been motivated to have administered the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 each on day 1 of a 21 day cycle for 4 cycles because Tamiya teaches that these are the recommended doses and dosing regimens for the pemetrexed and carboplatin to treat NSCLC. There would be a reasonable expectation of success in administering the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 on day 1 of a 21 day cycle for 4 cycles because these are known parameters in the art.
Claims 1-3, 8-10, and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04077463, 2021 (instant PTO-892) in view of FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of WO2018194356 (09/24/2024 IDS).
Note: To reiterate, applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the mesylate salt of Formula I of Oh is Lazertinib mesylate as claimed in instant claims 19 and 20.
The teachings of NCT04077463 and FDA are above.
However, NCT04077463 and FDA do not specifically teach that the compound of formula (I) is Lazertinib mesylate represented by formula (II).
Regarding claims 19 and 20, Oh teaches a mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, as represented by Formula (I) (i.e. Lazertinib mesylate) [paragraph 14].
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Oh further teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base [paragraph 49].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lazertinib of NCT04077463 to be Lazertinib mesylate, as taught by Oh. One would have been motivated to have modified the Lazertinib of NCT04077463 to be the lazertinib mesylate of Oh because Oh teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base.
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, 8-10, 14-18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,593,164, claims 1-22 of U.S. Patent No. 9,580,508, claims 1-8 of U.S Patent No. 9,695,242, claims 1-44 of U.S. Patent No. 11,879,013, claims 1-23 of U.S. Patent No. 12,448,455, and claims 1-19 of U.S. Patent No. 12,528,869 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892).
Note: Applicant defines the claimed bispecific antibody, comprising the sequences as set forth in instant claims 1, 15, and 17, as amivantamab or JNJ-61186372 [see paragraph 79 of the instant specification]. Therefore, the bispecific antibody taught by NCT04077463, and FDA, amivantamab, is the same as the claimed bispecific antibody. Further, SEQ ID NOs: 17-20 (claimed in instant claim 17) comprises SEQ ID NOs: 13-16 (claimed in instant claim 15) and SEQ ID NOs: 1-12 (claimed in instant claim 1) of the instant application. Sequence alignments for instant SEQ ID NOs: 17-20 aligned to each of the patent documents’ claimed SEQ ID NOs: for the HC1, LC1, HC2, and LC2 were completed with 100% sequence identity for each. See attached document for alignments. Therefore, the bispecific antibody taught by U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869 are also the same as the claimed bispecific antibody.
Further, Applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the Lazertinib as taught by NCT04077463 is the same as the claimed Formula I.
Regarding claims 1-3, 9-10, 14-18, and 21-22, although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of U.S. Patent No. 9,593,164, claims 1-22 of U.S. Patent No. 9,580,508, claims 1-8 of U.S. Patent No. 9,695,242, claims 1-44 of U.S. Patent No. 11,879,013, claims 1-23 of U.S. Patent No. 12,448,455, and claims 1-19 of U.S. Patent No. 12,528,869 each are drawn to an identical anti-EGFR/c-Met bispecific antibody (i.e. amivantamab) that is used in the claimed method, and wherein a method of treating cancer comprising administering the bispecific antibody is disclosed in the specification and/or claims of each. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office's use of disclosed utilities of compositions when applying double patenting rejections to method claims.
However, U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869 do not specifically teach that the bispecific antibody (amivantamab) is administered at a dose of about 1400-2100 mg once per a 21 day cycle of that the bispecific antibody is administered in combination with a 3rd generation EGFR TKI of formula I (Lazertinib) and the chemotherapeutic agents of pemetrexed and carboplatin.
NCT04077463 teaches administering oral Lazertinib in combination with intravenous amivantamab, carboplatin, and pemetrexed on a 21 day cycle [page 14, Arms and Interventions] to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer) [pages 12-13, Brief Description; Page 20, Inclusion Criteria].
FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the bispecific antibody (i.e. amivantamab) as taught by each of U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, and NCT04077463 at a dose of 1400 mg, as taught by FDA, once per 21 day cycle, as taught by NCT04077463. One would have been motivated to administered the amivantamab at a dose of 1400 mg once per 21 day cycle because this is a known dose and dosing regimen of amivantamab in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.” It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the bispecific antibody (i.e. amivantamab) as taught by each of U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869 in combination with Lazertinib, carboplatin, and pemetrexed to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer), as taught by NCT04077463. One would have been motivated to have combined the bispecific antibody with the Lazertinib, carboplatin, and pemetrexed to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer) with a reasonable expectation of success because NCT04077463 teaches treating this patient population with the specific combination treatment. It is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Regarding claim 8, as set forth above, FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1]. FDA further teaches that RYBREVANT can be administered at various dosages every week and then every two weeks thereafter [page 6, Table 5] and teaches administering amivantamab over a dosage range from 350 to 1750 mg [page 14, 12.3 Pharmacokinetics].
The art demonstrates that the amount of amivantamab administered and how often is a result effective variable. Through routine optimization, one of ordinary skill in the art would arrive at the specific doses and dosing schedule as claimed. See MPEP 2144.05(II). Absent evidence to the contrary, given the explicit teachings in FDA, it would have been obvious to manipulate these variables as set forth in the claims.
Further regarding claims 14, 16, and 18, since the U.S. Patent Nos. listed above, NCT04077463, and FDA each teach a bispecific antibody (i.e. amivantamab) that has the same structure of the claimed bispecific antibody, and thus, the bispecific antibody/amivantamab necessarily comprises a first domain that binds EGFR and a second domain that binds c-Met, as claimed in instant claim 14, is an IgG1 isotype, as claimed in instant claim 16, and has a biantennary glycan structure with a fucose content of between about 1% to about 15%, as claimed in instant claim 18.
Claims 1-4, 8-10, 14-18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,593,164, claims 1-22 of U.S. Patent No. 9,580,508, claims 1-8 of U.S. Patent No. 9,695,242, claims 1-44 of U.S. Patent No. 11,879,013, claims 1-23 of U.S. Patent No. 12,448,455, and claims 1-19 of U.S. Patent No. 12,528,869 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Dhillon, 2021 (instant PTO-892).
The teachings of U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA are above.
However, U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA do not specifically teach that the Lazertinib (3rd generation EGFR TKI) is administered at a dose of 240 mg daily.
Regarding claim 4, Dhillon teaches that the recommended dosage of Lazertinib is 240 mg once daily taken orally [page 1107, right column second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the Lazertinib of NCT04077463 at a dose of 240 mg daily, as taught by Dhillon. One would have been motivated to have administered the Lazertinib at a dose of 240 mg daily because Dhillon teaches that this is the recommended dosage of Lazertinib. There would be a reasonable expectation of success in administering the Lazertinib at a dose of 240 mg daily because this is a known parameter in the art.
Claims 1-3, 8-18, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,593,164, claims 1-22 of U.S. Patent No. 9,580,508, claims 1-8 of U.S. Patent No. 9,695,242, claims 1-44 of U.S. Patent No. 11,879,013, claims 1-23 of U.S. Patent No. 12,448,455, and claims 1-19 of U.S. Patent No. 12,528,869 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Tamiya et al., 2013 (instant PTO-892).
The teachings of U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA are above.
However, U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA do not specifically teach that the pemetrexed is administered at a dose of 500 mg/m2, that the carboplatin is administered to achieve AUC 5, each administered on day 1 of a 21 day cycle for four cycles.
Regarding claims 11-13, Tamiya teaches that the patients with NSCLC were administered 500 mg/m2 pemetrexed and area under the concentration-time curve (AUC 5) carboplatin intravenously, which were the recommended doses for the combination therapy, each administered on day 1 of a 21-day cycle for a maximum of four cycles [see Abstract; page 981, right column, third paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the pemetrexed and carboplatin of NCT04077463 at a dose of 500 mg/m2 pemetrexed and AUC 5 carboplatin on day 1 of a 21 day cycle for 4 cycles, as taught by Tamiya. One would have been motivated to have administered the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 each on day 1 of a 21 day cycle for 4 cycles because Tamiya teaches that these are the recommended doses and dosing regimens for the pemetrexed and carboplatin to treat NSCLC. There would be a reasonable expectation of success in administering the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 on day 1 of a 21 day cycle for 4 cycles because these are known parameters in the art.
Claims 1-3, 8-10, and 14-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,593,164, claims 1-22 of U.S. Patent No. 9,580,508, claims 1-8 of U.S. Patent No. 9,695,242, claims 1-44 of U.S. Patent No. 11,879,013, claims 1-23 of U.S. Patent No. 12,448,455, and claims 1-19 of U.S. Patent No. 12,528,869 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of WO2018194356 (09/24/2024 IDS).
Note: To reiterate, applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the mesylate salt of Formula I of Oh is Lazertinib mesylate as claimed in instant claims 19 and 20.
The teachings of U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA are above.
However, U.S. Patent No. 9,593,164, U.S. Patent No. 9,580,508, U.S. Patent No. 9,695,242, U.S. Patent No. 11,879,013, U.S. Patent No. 12,448,455, and U.S. Patent No. 12,528,869, NCT04077463, and FDA do not specifically teach that the compound of formula (I) is Lazertinib mesylate represented by formula (II).
Regarding claims 19 and 20, Oh teaches a mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, as represented by Formula (I) (i.e. Lazertinib mesylate) [paragraph 14].
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Oh further teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base [paragraph 49].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lazertinib of NCT04077463 to be Lazertinib mesylate, as taught by Oh. One would have been motivated to have modified the Lazertinib of NCT04077463 to be the lazertinib mesylate of Oh because Oh teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base.
Claims 1-3, 8-10, 14-18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 18/201,516, claims 1-72 of copending Application No. 18/216,026, and claims 1-26 of copending Application No. 19/389,439 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892).
Note: Applicant defines the claimed bispecific antibody, comprising the sequences as set forth in instant claims 1, 15, and 17, as amivantamab or JNJ-61186372 [see paragraph 79 of the instant specification]. Therefore, the bispecific antibody taught by NCT04077463, and FDA, amivantamab, is the same as the claimed bispecific antibody. Further, SEQ ID NOs: 17-20 (claimed in instant claim 17) comprises SEQ ID NOs: 13-16 (claimed in instant claim 15) and SEQ ID NOs: 1-12 (claimed in instant claim 1) of the instant application. Sequence alignments for instant SEQ ID NOs: 17-20 aligned to each of the patent documents’ claimed SEQ ID NOs: for the HC1, LC1, HC2, and LC2 were completed with 100% sequence identity for each. See attached document for alignments. Therefore, the bispecific antibody taught by copending Application No. 18/201,516, copending Application No. 18/216,026, and copending Application No. 19/389,439 is also the same as the claimed bispecific antibody.
Further, Applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the Lazertinib as taught by NCT04077463 is the same as the claimed Formula I.
Regarding claims 1-3, 9-10, 14-18, and 21-22, although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-54 of copending Application No. 18/201,516, claims 1-72 of copending Application No. 18/216,026, and claims 1-26 of copending Application No. 19/389,439 each are drawn to an identical anti-EGFR/c-Met bispecific antibody (i.e. amivantamab) that is used in the claimed method, and wherein a method of treating cancer comprising administering the bispecific antibody is disclosed in the specification and/or claims of each. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office's use of disclosed utilities of compositions when applying double patenting rejections to method claims.
However, copending Application No. 18/201,516, copending Application No. 18/216,026, and copending Application No. 19/389,439 do not specifically teach that the bispecific antibody (amivantamab) is administered at a dose of about 1400-2100 mg once per a 21 day cycle of that the bispecific antibody is administered in combination with a 3rd generation EGFR TKI of formula I (Lazertinib) and the chemotherapeutic agents of pemetrexed and carboplatin.
NCT04077463 teaches administering oral Lazertinib in combination with intravenous amivantamab, carboplatin, and pemetrexed on a 21 day cycle [page 14, Arms and Interventions] to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer) [pages 12-13, Brief Description; Page 20, Inclusion Criteria].
FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the bispecific antibody (i.e. amivantamab) as taught by each of copending Application No. 18/201,516, copending Application No. 18/216,026, and copending Application No. 19/389,439, and NCT04077463 at a dose of 1400 mg, as taught by FDA, once per 21 day cycle, as taught by NCT04077463. One would have been motivated to administered the amivantamab at a dose of 1400 mg once per 21 day cycle because this is a known dose and dosing regimen of amivantamab in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F). Further, MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.” It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the bispecific antibody (i.e. amivantamab) as taught by each of copending Application No. 18/201,516, copending Application No. 18/216,026, and copending Application No. 19/389,439 in combination with Lazertinib, carboplatin, and pemetrexed to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer), as taught by NCT04077463. One would have been motivated to have combined the bispecific antibody with the Lazertinib, carboplatin, and pemetrexed to treat patients with non-small cell lung cancer (NSCLC) with EGFR mutated (EGFR-expressing cancer) with a reasonable expectation of success because NCT04077463 teaches treating this patient population with the specific combination treatment. It is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Regarding claim 8, as set forth above, FDA teaches that RYBREVANT (amivantamab-vmjw) dosage is based on body weight with 1050 mg as the recommended dose for subjects weighing less than 80 kg and 1400 mg for subject weighing more than 80 kg [page 2, Table 1]. FDA further teaches that RYBREVANT can be administered at various dosages every week and then every two weeks thereafter [page 6, Table 5] and teaches administering amivantamab over a dosage range from 350 to 1750 mg [page 14, 12.3 Pharmacokinetics]. Further, claims 8-9 and 44-45 of 18/216,026 teaches that the antibody is administered at a dose of between 350 mg to about 3400 mg, and claims 13-14 and 49-50 teach that the antibody is administered at a dose of 1750 mg and 2100 mg.
The art demonstrates that the amount of amivantamab administered and how often is a result effective variable. Through routine optimization, one of ordinary skill in the art would arrive at the specific doses and dosing schedule as claimed. See MPEP 2144.05(II). Absent evidence to the contrary, given the explicit teachings in FDA, it would have been obvious to manipulate these variables as set forth in the claims.
Further regarding claims 14, 16, and 18, since the U.S. Patent Nos. listed above, NCT04077463, and FDA each teach a bispecific antibody (i.e. amivantamab) that has the same structure of the claimed bispecific antibody, and thus, the bispecific antibody/amivantamab necessarily comprises a first domain that binds EGFR and a second domain that binds c-Met, as claimed in instant claim 14, is an IgG1 isotype, as claimed in instant claim 16, and has a biantennary glycan structure with a fucose content of between about 1% to about 15%, as claimed in instant claim 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 8-10, 14-18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 18/201,516, claims 1-72 of copending Application No. 18/216,026, and claims 1-26 of copending Application No. 19/389,439 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Dhillon, 2021 (instant PTO-892).
The teachings of copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA are above.
However, copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA do not specifically teach that the Lazertinib (3rd generation EGFR TKI) is administered at a dose of 240 mg daily.
Regarding claim 4, Dhillon teaches that the recommended dosage of Lazertinib is 240 mg once daily taken orally [page 1107, right column second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the Lazertinib of NCT04077463 at a dose of 240 mg daily, as taught by Dhillon. One would have been motivated to have administered the Lazertinib at a dose of 240 mg daily because Dhillon teaches that this is the recommended dosage of Lazertinib. There would be a reasonable expectation of success in administering the Lazertinib at a dose of 240 mg daily because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 8-18, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 18/201,516, claims 1-72 of copending Application No. 18/216,026, and claims 1-26 of copending Application No. 19/389,439 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of Tamiya et al., 2013 (instant PTO-892).
The teachings of copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA are above.
However, copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA do not specifically teach that the pemetrexed is administered at a dose of 500 mg/m2, that the carboplatin is administered to achieve AUC 5, each administered on day 1 of a 21 day cycle for four cycles.
Regarding claims 11-13, Tamiya teaches that the patients with NSCLC were administered 500 mg/m2 pemetrexed and area under the concentration-time curve (AUC 5) carboplatin intravenously, which were the recommended doses for the combination therapy, each administered on day 1 of a 21-day cycle for a maximum of four cycles [see Abstract; page 981, right column, third paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the pemetrexed and carboplatin of NCT04077463 at a dose of 500 mg/m2 pemetrexed and AUC 5 carboplatin on day 1 of a 21 day cycle for 4 cycles, as taught by Tamiya. One would have been motivated to have administered the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 each on day 1 of a 21 day cycle for 4 cycles because Tamiya teaches that these are the recommended doses and dosing regimens for the pemetrexed and carboplatin to treat NSCLC. There would be a reasonable expectation of success in administering the pemetrexed at a dose of 500 mg/m2 and the carboplatin administered to achieve AUC 5 on day 1 of a 21 day cycle for 4 cycles because these are known parameters in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 8-10, and 14-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 18/201,516, claims 1-72 of copending Application No. 18/216,026, and claims 1-26 of copending Application No. 19/389,439 in view of NCT04077463, 2021 (instant PTO-892) and FDA, 2021 (instant PTO-892), as applied to claims 1-3, 8-10, 14-18, and 21-22 above, and further in view of WO2018194356 (09/24/2024 IDS).
Note: To reiterate, applicant defines Lazertinib as a 3rd generation EGFR tyrosine kinase inhibitor (TKI), the chemical name of the Lazertinib free base represented by Formula I is N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, referred to as Lazertinib [see paragraph 107 of the instant specification]. Therefore, the mesylate salt of Formula I of Oh is Lazertinib mesylate as claimed in instant claims 19 and 20.
The teachings of copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA are above.
However, copending Application No. 18/201,516, copending Application No. 18/216,026, copending Application No. 19/389,439, NCT04077463, and FDA do not specifically teach that the compound of formula (I) is Lazertinib mesylate represented by formula (II).
Regarding claims 19 and 20, Oh teaches a mesylate salt of N-(5-(4-(4-((dimethylamino)methyl)-3-phenyl-1H-pyrazol-1-yl)pyrimidine-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamide, as represented by Formula (I) (i.e. Lazertinib mesylate) [paragraph 14].
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Oh further teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base [paragraph 49].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lazertinib of NCT04077463 to be Lazertinib mesylate, as taught by Oh. One would have been motivated to have modified the Lazertinib of NCT04077463 to be the lazertinib mesylate of Oh because Oh teaches that the mesylate salt has excellent stability, solubility, and bioavailability as compared to the compound in the form of a free base.
This is a provisional nonstatutory double patenting rejection.
Examiner’s Note on Double Patenting
Efforts were made to discover any pending application or grated US patent that
claimed patentably indistinct subject matter. However, it is also noted that the number of
patent applications filed on this or related subject matter is significant. Applicant is in the
best position to identify any other pending applications or US patents that are a)
directed to the instant claimed bispecific antibody and b) discloses treatment of cancer. Assistance in identifying such documents is appreciated.
Conclusion
No claims are allowed.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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