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 .
DETAILED ACTION
1. The Amendment filed January 16, 2026 in response to the Office Action of October 16, 2025 is acknowledged and has been entered. Claims 20-26 have been cancelled. Claims 1-3, 5-7, 27- 29, 32, and 34 have been amended. New claims 36-38 have been added.
2. Claims 1-19 and 27-38 are currently being examined.
Rejections Maintained/Modified
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.
3. Claim(s) 1-19, 27-30 and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0017285 A1 (Laquerre et al. Jan. 21, 2021), “Laquerre” in view of WO 2021/245238 (Frendéus et al. Dec. 09, 2021), “Frendéus” and in view of Canadian Agency for Drugs and Technologies in Health (1000 mg versus 600/650 mg Acetaminophen for Pain or Fever: A Review of the Clinical Efficacy, 17 June 2016), “Canadian”.
Laquerre teaches a method of treating a subject having an EGFR or c-Met expressing cancer, comprising administering to the subject a combination therapy, wherein the combination therapy comprises a therapeutically effective amount of an isolated bispecific anti-epidermal growth factor receptor (EGFR)/hepatocyte growth factor receptor (c-Met) antibody and a therapeutically effective amount of a compound of formula (I)/Lazertinib. See abstract and ¶¶ 0006-0007.
Laquerre teaches treating cancer with JNJ-61186372/amivantamab in combination with Lazertinib or Osimertinib. See ¶¶ 0008-0013, 0063, 0065, 00172, Example 2, Figs. 1-6 and claims 1-5.
Laquerre teaches additionally treating with methotrexate. ¶ 0180.
JNJ-61186372/amivantamab comprises SEQ ID NOs: 1-20. See ¶ 0065 and Appendix.
Laquerre teaches that the EGFR/c-Met antibody is an IgG1 isotype. See ¶¶ 0097 and 0352 and claim 4
Laquerre teaches doses of the EGFR/c-Met antibody of about 1.050 mg, about 1,400 mg, or about 1,600 mg,. See ¶¶ 0143-0146, 0156-0165, and 0168-0171.
Laquerre teaches the bispecific anti-EGFR/c-Met antibody is administered once a week or once in two weeks. See ¶¶ 0147-0148.
Laquerre teaches administering the EGFR/c-Met antibody weekly for four weeks and once in two weeks thereafter. See ¶¶ 0156-0171.
Laquerre teaches administering JNJ-61186372/amivantamab as a monotherapy. See ¶¶ 0008-0013, and Examples 1-3.
Laquerre teaches infusion related reactions is one of the more common toxicities associated with JNJ-61186372/amivantamab. See ¶ 0245.
Laquerre does not specifically teach using dexamethasone or acetaminophen for reducing occurrence or severity of infusion-related reactions (IRRs) in a subject.
Frendéus teaches a method that maintains the therapeutic effectiveness of an antibody, whilst reducing and/or preventing IRRs associated with its administration. Frendéus teaches administering several separate doses of the antibody, including an initial sub-maximal therapeutic dose of the antibody, and performing that antibody administration after a corticosteroid has been given to the subject. The inventors' approach therefore provides an improved regimen for administering such antibodies, as it does so in a way that reduces and/or prevents tolerability issues in the subject. See p. 4-last paragraph.
Frendéus teaches the corticosteroid is dexamethasone. Frendéus teaches the dexamethasone is administered at a dose from 0.5 mg to 20 mg, about 4-12 mg, or about 20 mg. See p. 37-2nd to 4th paragraph.
Frendéus teaches intravenous and oral administration of the corticosteroid, dexamethasone. See p. 52-3rd to 7th paragraph.
Frendéus teaches the corticosteroid, dexamethasone is administered 10-48 hours prior to the administration of the antibody. See p. 57-2nd and 3rd paragraph, p. 66-4th paragraph and p. 69-4th paragraph.
Frendéus teaches repeat administrations of the corticosteroid or two administrations of the corticosteroid. See p. 36-entire page and p. 66-3rd and 4th paragraphs.
Frendéus teaches additionally treating with antihistamines, antipyretics/acetaminophen, and/or corticosteroids. See p. 2-4th paragraph, p. 3-3rd paragraph, p71-2nd paragraph and p. 98-3rd paragraph.
Frendéus teaches that dexamethasone relieved IRRs induced by antibody treatment. See p. 80- 3rd paragraph, p. 93-3rd paragraph and Fig. 11.
Canadian teaches acetaminophen usually comes in two forms: regular strength (300/325 mg pills) and extra strength (500 mg pills). The nonprescription acetaminophen label instructs adults or children ≥12 years old to take single doses of 650 mg (2x325mg) every 4 to 6 hours, or 1000 mg (2x500mg) every 6 hours while symptoms last (the maximum recommended daily dose is 4 grams). See p. 1-2nd paragraph.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Laquerre, Frendéus, and Canadian and administer oral dexamethasone 2 days prior to administering JNJ-61186372/amivantamab , and further administer antipyretics/acetaminophen and antihistamines to reduce occurrence or severity of IRRs because Frendéus teaches a method of alleviating an infusion reaction to antibody by treatment with dexamethasone, antipyretics/acetaminophen and antihistamines, Frendéus teaches the corticosteroid, dexamethasone is administered 10-48 hours prior to the administration of the antibody and Frendéus teaches oral administration. One would have been motivated to treat patients administered the bispecific anti-EGFR/c-Met antibody of Laquerre with dexamethasone 2 days prior to administering JNJ-61186372/amivantamab and further administer antipyretics/acetaminophen and antihistamines because Laquerre teaches infusion related reactions is one of the more common toxicities associated with JNJ-61186372/amivantamab, Frendéus teaches that dexamethasone relieved IRRs induced by antibody treatment and antipyretics/acetaminophen and antihistamines are routinely used in the art to treat IRRs and Frendéus teaches the corticosteroid, dexamethasone is orally administered 10-48 hours prior to the administration of the antibody .
Additionally, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to modify the dose and/or timing of treatment with the bispecific anti-EGFR/c-Met antibody, dexamethasone, antipyretics/acetaminophen and/or antihistamines because Laquerre teaches a therapeutically effective amount may vary depending on factors such as the disease state, age, sex, and weight of the individual, and the ability of a therapeutic or a combination of therapeutics to elicit a desired response in the individual and Canadian teaches that the standard doses of acetaminophen are 650 mg and 1000 mg . Thus, one would have been motivated modify the dose and/or timing of treatment with the bispecific anti-EGFR/c-Met antibody, JNJ-61186372/amivantamab, dexamethasone, antipyretics/acetaminophen and/or antihistamines to optimize the treatment for the specific needs of a patient.
4. Claim(s) 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0017285 A1 (Laquerre et al. Jan. 21, 2021), “Laquerre” in view of WO 2021/245238 (Frendéus et al. Dec. 09, 2021), “Frendéus” and in view of Canadian Agency for Drugs and Technologies in Health (1000 mg versus 600/650 mg Acetaminophen for Pain or Fever: A Review of the Clinical Efficacy, 17 June 2016), “Canadian” as applied to claims 1-19, 27-30 and 33-38 above, and further in view of Moore et al. (Clinical Lymphoma Myeloma And Leukemia Vol. 20, Issue 10, October 2020, IDS), “Moore”.
Laquerre and Frendéus teach as set forth above.
Laquerre and Frendéus do not teach using diphenhydramine for reducing occurrence or severity of infusion-related reactions (IRRs) in a subject.
Moore teaches that montelukast treatment as a premedication reduced IRRs in response to treatment with the anti-CD38 antibody daratumumab. See abstract.
Moore teaches that the patients were pretreated with montelukast, acetaminophen, diphenhydramine (25 or 50 mg), and dexamethasone (20 or 40 mg) as a pre-medications to reduce IRRs in response to treatment with the anti-CD38 antibody daratumumab.. See abstract, p. e779-left col.,-2nd paragraph and Table 1.
Moore teaches that the administration of montelukast prior to the first daratumumab infusion led to a statistically significant reduction in the incidence of IRRs when given in addition to standard pre-daratumumab acetaminophen, corticosteroid/dexamethasone, and diphenhydramine. See paragraph bridging e779-e780.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Laquerre, Frendéus and More and administer dexamethasone, acetaminophen, diphenhydramine and montelukast, to reduce occurrence or severity of IRRs because Moore teach alleviating an infusion reaction to antibody by treatment with dexamethasone, acetaminophen, diphenhydramine and montelukast. One would have been motivated to treat patients administered the bispecific anti-EGFR/c-Met antibody of Laquerre with dexamethasone, acetaminophen, diphenhydramine and montelukast because Laquerre teaches infusion related reactions is one of the more common toxicities associated with JNJ-61186372/amivantamab, Frendéus teaches a method of alleviating an infusion reaction to antibody by treatment with dexamethasone, antipyretics/acetaminophen and antihistamines and Moore teaches that dexamethasone, acetaminophen, diphenhydramine and montelukast can reduce IRRs in response antibody treatments.
Response to Arguments
5. Applicant argues that the Office states that Laquerre does not teach using dexamethasone for reducing occurrence or severity of an IRR in a subject. (Action at page 8). Joseph, Albert, and Canadian do not cure the deficiencies of Laquerre, nor are they alleged to. While the Office relies upon Frendeus, Streit, and Moore for purported disclosure of dexamethasone, the Office has not established, for example, that these references, alone or in combination with any other cited reference, teach or suggest administering oral dexamethasone to the subject 2 days prior to administration of an anti- EGFR/c-Met antibody to reduce occurrence or severity of an IRR, as claimed. There is no reason to believe that one of ordinary skill in the art would have arrived at the claimed methods from the disclosures of the cited references, alone or in combination.
6. Applicant's arguments have been considered, but have not been found persuasive with respect to Laquerre in view of Frendéus and in view of Canadian and/or in further view of Moore. As previously set forth and above, Frendéus teaches intravenous and oral administration of the corticosteroid, dexamethasone for reducing and/or preventing IRRs associated with its administration. See p. 52-3rd to 7th paragraph. Also, Frendéus teaches the corticosteroid, dexamethasone is administered 10-48 hours prior to the administration of the antibody. See p. 57-2nd and 3rd paragraph, p. 66-4th paragraph and p. 69-4th paragraph. Thus, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Laquerre, Frendéus, and Canadian and administer oral dexamethasone 2 days prior to administering JNJ-61186372/amivantamab to reduce occurrence or severity of IRRs. One would have been motivated modify the dose and/or timing of treatment with the bispecific anti-EGFR/c-Met antibody, JNJ-61186372/amivantamab, dexamethasone, antipyretics/acetaminophen and/or antihistamines to optimize the treatment for the specific needs of a patient. Thus the rejections are maintained is maintained for the reason previously set forth and above.
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.
7. Claims 1-19 and 27-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-67 of co-pending Application No. 18/613,945 (published as US 2024/0368310 A1) in view of US 2021/0017285 A1 (Laquerre et al. Jan. 21, 2021), “Laquerre”, in view of WO 2021/245238 (Frendéus et al. Dec. 09, 2021), “Frendéus”, in view of Moore et al. (Clinical Lymphoma Myeloma And Leukemia Vol. 20, Issue 10, October 2020, IDS), “Moore” and in view of WO 2020/240434 A1 (Streit M., Dec. 03, 2020), “Streit”.
The ‘945 claims are drawn to:
32. A method of reducing an adverse reaction associated with the use of amivantamab to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in a subject, the method comprising: to a subject who is receiving a therapeutically effective amount of an intravenous amivantamab infusion to treat the locally advanced or metastatic NSCLC and who experiences a grade 1 or grade 2 infusion-related adverse reaction: interrupting the intravenous amivantamab infusion, monitoring the subject until the grade 1 or grade 2 infusion-related adverse reaction resolves, resuming the intravenous amivantamab infusion at 50% of the infusion rate at which the grade 1 or grade 2 infusion-related adverse reaction occurred, and, if there are no additional adverse reactions after 30 minutes, increasing the infusion rate; who experiences a grade 3 infusion-related adverse reaction: interrupting the intravenous amivantamab infusion, monitoring the subject until the grade 3 infusion-related adverse reaction resolves, resuming the intravenous amivantamab infusion at 50% of the infusion rate at which the grade 3 infusion-related adverse reaction occurred, and, if there are no additional adverse reactions after 30 minutes, increasing the infusion rate; or who experiences a grade 4 infusion-related adverse reaction: permanently discontinuing administration of the amivantamab.
37. The method of claim 32, wherein the therapeutically effective amount of amivantamab comprises 1050 mg of the amivantamab for subjects who weigh less than 80 kg, or 1400 mg of the amivantamab for subjects who weight greater than or equal to 80 kg.
38. The method of claim 32, further comprising administering premedications comprising an antihistamine and an antipyretic.
39. The method of claim 38, wherein the antihistamine comprises diphenhydramine and the antipyretic comprises acetaminophen.
40. The method of claim 38, further comprising administering glucocorticoid as a premedication.
41. The method of claim 40, wherein the glucocorticoid comprises dexamethasone or methylprednisolone.
42. The method of claim 38, further comprising administering a corticosteroid.
43. The method of claim 42, comprising, further administering a corticosteroid to the subject having the grade 1, grade 2, or grade 3 infusion-related reactions, prior to administration of an intravenous amivantamab infusion.
47. The method of claim 44, wherein the therapeutically effective amount of amivantamab comprises 1050 mg of the amivantamab for subjects who weigh less than 80 kg, or 1400 mg of the amivantamab for subjects who weight greater than or equal to 80 kg.
48. A method of reducing an adverse reaction associated with the use of amivantamab to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in a subject, the method comprising: to a subject who is receiving a therapeutically effective amount of an intravenous amivantamab infusion to treat the locally advanced or metastatic NSCLC and who experiences a grade 2 dermatologic adverse reaction: initiating supportive care management, and, if the grade 2 dermatologic adverse reaction does not improve after two weeks, administering a reduced dose of the amivantamab to the subject; who experiences a grade 3 dermatologic adverse reaction: withholding the amivantamab and initiating supportive care management and resuming administration of the amivantamab at a reduced dose if the grade 3 dermatologic adverse reaction becomes a grade 2 or lower dermatologic adverse reaction, or permanently discontinuing the amivantamab if no improvement in the grade 3 dermatologic adverse reaction occurs within 2 weeks; or who experiences a grade 4 dermatologic adverse reaction or severe bullous, blistering, or exfoliating skin: permanently discontinuing administration of the amivantamab.
52. The method of claim 48, wherein the therapeutically effective amount of amivantamab comprises 1050 mg of the amivantamab for subjects who weigh less than 80 kg, or 1400 mg of the amivantamab for subjects who weigh greater than or equal to 80 kg.
53. The method of claim 52, wherein the reduced dose comprises 700 mg or 350 mg for subjects having a body weight of less than 80 kg, or 1050 mg or 700 mg for subjects having a body weight of greater than or equal to 80 kg.
54. The method of claim 48, further comprising administering premedications comprising an antihistamine and an antipyretic.
55. The method of claim 54, wherein the antihistamine comprises diphenhydramine and the antipyretic comprises acetaminophen.
56. The method of claim 54, further comprising administering glucocorticoid as a premedication.
57. The method of claim 56, wherein the glucocorticoid comprises dexamethasone or methylprednisolone.
58. A method of reducing an adverse reaction associated with the use of amivantamab to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in a subject, the method comprising: to a subject who is receiving a therapeutically effective amount of an intravenous amivantamab infusion to treat the locally advanced or metastatic NSCLC and who experiences at least one other grade 3 adverse reaction: withholding amivantamab until the at least one other grade 3 adverse reaction reduces to grade 1 or baseline and resuming the amivantamab at the same dose if the subject recovers from the grade 3 adverse reaction within 1 week; resuming the amivantamab at a reduced dose if the subject recovers from the grade 3 adverse reaction after 1 week but within 4 weeks; or permanently discontinuing the amivantamab if the subject does not recover from the grade 3 adverse reaction within 4 weeks; or who experiences at least one other grade 4 adverse reaction: withholding amivantamab until the at least one other grade 4 adverse reaction reduces to grade 1 or baseline and resuming the amivantamab at a reduced dose if the subject recovers from the grade 4 adverse reaction within 4 weeks; or permanently discontinuing the amivantamab if the subject does not recover from the grade 4 adverse reaction within 4 weeks.
62. The method of claim 58, wherein the therapeutically effective amount of amivantamab comprises 1050 mg of the amivantamab for subjects who weigh less than 80 kg, or 1400 mg of the amivantamab for subjects who weight greater than or equal to 80 kg.
63. The method of claim 62, wherein the reduced dose comprises 700 mg or 350 mg for subjects having a body weight of less than 80 kg, or 1050 mg or 700 mg for subjects having a body weight of greater than or equal to 80 kg.
64. The method of claim 58, further comprising administering premedications comprising an antihistamine and an antipyretic.
65. The method of claim 64, wherein the antihistamine comprises diphenhydramine and the antipyretic comprises acetaminophen.
66. The method of claim 64, further comprising administering glucocorticoid as a premedication.
67. The method of claim 66, wherein the glucocorticoid comprises dexamethasone or methylprednisolone.
The ‘945 claims do not teach administering oral dexamethasone 2 days prior to administering amivantamab, treating with lazertinib or Osimertinib or the various dosing and treatment regimens claimed.
Laquerre, Frendéus and More teach as set forth above.
Streit teaches administering to a subject an effective amount of at least one of the antihistamine cetirizine and montelukast in combination with an anti-CD40 antibody, to thereby reduce infusion-related reactions (IRRS) or reaction of pruritus, preferably cetirizine and montelukast are administered no earlier than 3 days before and no later than 3 days after the administration of the anti-CD40 antibody. See claim 7 and p. 30-lines 1-7.
Streit teaches supportive therapy, such as pre-infusion and post-infusion supportive therapy can be used for the treatment of advanced solid tumors in addition to the administration of an anti-CD40 antibody. Streit teaches examples of the medications for supportive therapy include, but are not limited to, corticosteroid, antihistamine, antipyretic, H2-antagonist, and antiemetic. Streit teaches examples of suitable corticosteroids include dexamethasone and methylprednisolone. Streit teaches dexamethasone can be administered at 20 mg and methylprednisolone at 80 mg. Streit teaches antihistamines include diphenhydramine and cetirizine. Cetirizine can be administered at 10 mg. . Streit teaches suitable antipyretics include acetaminophen. Acetaminophen can be administered at doses of 650-1000 mg. See p. 18-line 15 to p. 19-line 6.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘945 claims, Laquerre, Frendéus More and Streit and administer oral dexamethasone 2 days prior to administering JNJ-61186372/amivantamab acetaminophen and/or diphenhydramine to reduce occurrence to reduce occurrence or severity of IRRs because Frendéus, More, and Streit teach a method of alleviating an infusion reaction to antibody by treatment with oral dexamethasone, acetaminophen and/or diphenhydramine 2 days prior to administering a therapeutic antibody. One would have been motivated to treat patients administered amivantamab with oral dexamethasone, acetaminophen and diphenhydramine because Laquerre teaches infusion related reactions is one of the more common toxicities associated with JNJ-61186372/amivantamab and Frendéus, More and Streit teach that dexamethasone, acetaminophen and diphenhydramine can reduce IRRs in response antibody treatments.
Additionally, It would have been prima facie obvious to additionally treat with Lazertinib or Osimertinib because Laquerre teaches treating cancer with JNJ-61186372/amivantamab in combination with Lazertinib or Osimertinib.
Also it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to modify the dose and/or timing of treatment with amivantamab, Lazertinib, Osimertinib, dexamethasone, acetaminophen and/or diphenhydramine because Laquerre teaches a therapeutically effective amount may vary depending on factors such as the disease state, age, sex, and weight of the individual, and the ability of a therapeutic or a combination of therapeutics to elicit a desired response in the individual and Frendéus, More and Streit teach various doses of the medications that can be used. Thus, one would have been motivated modify the dose and/or timing of treatment with amivantamab, dexamethasone, acetaminophen and/or diphenhydramine to optimize the treatment for the needs of a patient.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
8. Applicant argues that solely to advance prosecution, claim 1 is amended as described above and claims 20-26 are canceled. There is no reason to believe that one of ordinary skill in the art would have arrived at the claimed methods from the claims of the reference application or disclosures of the cited references, alone or in combination. Favorable reconsideration is requested.
9. Applicant's arguments have been considered, but have not been found persuasive. As previously set forth and above, the ‘945 claims teach administering dexamethasone, diphenhydramine and acetaminophen as premeditations prior to administering amivantamab. Also, as previously set forth and above, Frendéus teaches intravenous and oral administration of the corticosteroid, dexamethasone for reducing and/or preventing IRRs associated with its administration. See p. 52-3rd to 7th paragraph. Also, Frendéus teaches the corticosteroid, dexamethasone is administered 10-48 hours prior to the administration of the antibody. See p. 57-2nd and 3rd paragraph, p. 66-4th paragraph and p. 69-4th paragraph. Thus, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘945 claims Laquerre, Frendéus, More, and Streit and administer oral dexamethasone 2 days prior to administering amivantamab to reduce occurrence or severity of IRRs. One would have been motivated modify the dose and/or timing of treatment with the bispecific anti-EGFR/c-Met antibody, JNJ-61186372/amivantamab, dexamethasone, antipyretics/acetaminophen and/or antihistamines to optimize the treatment for the specific needs of a patient. Thus the rejections are maintained is maintained for the reason previously set forth and above.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claims 36-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 36-38 recite the limitation "the IV dexamethasone" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
11. All other objections and rejections recited in the Office Action of October 16, 2025 are withdrawn in view of Applicant’s amendments and arguments.
12. No claims allowed.
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
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/Peter J Reddig/
Primary Examiner, Art Unit 1642