DETAILED ACTION
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 .
Applicant’s amendment, filed on 1/20/2026, is acknowledged.
Claims 1-8, 11, 12, 15-19, 21-27, and 41-50 are currently pending.
Claims 1 and 47-50 are independent claims.
Election/Restrictions
Applicant’s election of: i) the administration schedule of claim 17; ii) a full dose of 48 mg; iii) a priming dose of 0.16mg; iv) an intermediate dose of 0.8mg; v) relapsed/refractory CLL; and vi) a subject with r/r CLL after receiving two prior antineoplastic agents in the reply filed on 1/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2, 18, 22, 48, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 1, 3-8, 11, 12, 15-17, 19, 21, 23-27, 41-47, and 49 are under examination as reading on the elected species of method of treating CLL in a human comprising administration of epcoritamab or a biosimilar thereof.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/11/2023, 10/02/2023, and 1/20/2026 are compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner in their entireties.
Priority
Applicant’s claim for the benefit of a prior-filed U.S. Provisional Application No. 63/076,733 filed September 10, 2020, is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 21, 23-27, 41, 43-47, and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 21, 23-27, 41, 43-47, and 49 encompass a genus of biosimilars of epcoritamab in the treatment of CLL, which encompasses any and all biosimilars of epcoritamab of any structure that has the function of treating CLL.
However, there does not appear to be an adequate written description in the specification as-filed of the essential structural feature that provides the recited function of “treating CLL”. The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
The instant specification describes the structure of epcoritamab and using epcoritamab in a method of treating CLL in the claimed administration sequence (Fig 1 and 2, Examples 1 and 2). The specification additionally discloses that (pg. 15, lines 21-23): “[t]he term "biosimilar" ( e.g., of an approved reference product/biological drug) as used herein refers to a biologic product that is similar to the reference product based on data…”. The instant specification does not disclose any structure identifying characteristics to allow one with ordinary sill in the art to determine structure-function relationship between biosimilars to epcoritamab (which can be small molecules, antibodies, aptamers, etc.) and the function of “treating CLL”.
The level of skill and knowledge in the art is that there are no known biosimilars of epcoritamab that treat CLL, and no known correlation between any structural component and the ability to treat CLL. Thus, the disclosure does not allow one of skill in the art to visualize or recognize the structure of any biosimilar of epcoritamab required to practice the claimed method. Accordingly, one of ordinary skill in the art would conclude that the applicant would not have been in possession of the claimed method of using biosimilars of epcoritamab that treat CLLL because a biosimilar of epcoritamab possessing the desired activity required to practice the method is not adequately described and was not known in the art.
Possession is not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Sufficient description to show possession of such a genus may be achieved by means of a recitation of a representative number of biosimilar of epcoritamab. Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
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, 4, 11, 12, 15, 16, 41, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,435,154 (herein Pat ‘154). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘154 claims methods of treating B-NHL in a human (claim 1), including CLL (claim 4), comprising subcutaneous administration of 0.16mg of epcoritamab to the subject of day 1 (i.e., “a priming dose”), followed by a 0.8mg dose on week 8 (i.e., “an intermediate dose”) followed by a full dose (claim 1), wherein the full dose can be 48mg on days 15 and 22 (claim 2). This leads to full, 28 day administration cycle. Pat ‘154 claims that administration will continue until disease progression (claim 1). Thus, claims 1, 2, and 4 of Pat ‘154 anticipates instant claim 1.
Regarding claim 3, Pat ‘154 claims 48mg full doses (claim 2). Regarding claim 4, Pat ‘154 claims weekly administration (claim 2).
Regarding claims 11 and 12, Pat ‘154 claims a priming dose of 0.16mg (claim 1).
Regarding claims 15 and 16, Pat ‘154 claims an intermediate dose of 0.8mg (claim 1).
Regarding claim 41, the instant specification discloses that epcoritamab comprises the heavy and light chains recited in the claim (pg. 48, lines 10-19), and Pat ‘154 claims administration of epcoritamab (claim 1).
The invention encompassed by the reference patent anticipates the instantly claimed invention.
Claims 1, 3-8, 11, 12, 15-17, 19, 41-47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,435,154 (Pat ‘154, supra) in view of Lugtenburg et al. (Blood (2019) 134 (Supplement_1): 758).
The invention claimed by Pat ‘154 is discussed supra. Pat ‘154 does not claim multiple 28-day dosing cycles with different administration schedules of epcoritamab at the claimed dose values, such as weekly administration for 3 cycles, followed by biweekly administration for 6 cycles, followed by monthly administration (i.e., the limitations of instant claims 5-8, 17, 19, 43-47, and 49).
Lugtenburg et al., in the same field of endeavor, teaches dosing regimens of subcutaneous epcoritamab to treat B-cell non-Hodgkin lymphomas (Introduction). Lugtenburg teaches administration of epcoritamab in 28-day cycles until disease progression or unacceptable toxicity to treat patients with B-NHL (Methods): “…pts received SC GEN3013 flat dose in 28-day cycles (q1w: cycle 1-2; q2w: cycle 3-6; q4w thereafter) until disease progression or unacceptable toxicity)”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of treatment claimed by Pat ‘154 in view of Lugtenburg et al., to treat CLL via subcutaneous administration of epcoritamab using the first 28-day administration cycle claimed by Pat ‘154, followed by the subsequent administration cycles taught by Lugtenburg et al. with a reasonable expectation of success, as both references are teaching administration regimens of epcoritamab that can both be used with epcoritamab, or even combined. One would have been motivated to make this change for the purposes of treating CLL with this combined dosing regimen. Additionally, one with ordinary skill in the art would have arrived at this combined dosing regimen to treat CLL though routine experimentation, as all doses and intervals of administration of all epcoritamab recited in the instant claims are all result effective variables since they will affect the outcome of the therapy, how well said combination therapy functions to treat CLL. Therefore, they will all be identified by one of ordinary skill in this art using routine optimization. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Thus, all doses and intervals of administration of the instant claims will be identified by the practitioner using routine methods and so are obvious here. Further, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215,219 (CCPA 1980).
The combined dosing regimen of Pat ‘154 in view of Lugtenburg et al. would be as follow:
first 28-day cycle (claimed by Pat ‘154): 0.16mg priming dose day 1, 0.8mg intermediate dose day 8, 48mg full dose days 15 and 22
second and third 28-day cycle (taught by Lugtenburg et al., full dose claimed by Pat ‘154): 48mg on days 1, 8, 15 and 22
cycles 3-6 (taught by Lugtenburg et al., full dose claimed by Pat ‘154): 48mg on days 1 and 15
subsequent cycles (taught by Lugtenburg et al., full dose claimed by Pat ‘154): 48mg on day 1
This regimen meets the limitations of instant claims 5 and 6, as the full dose is administered weekly for 2.5 cycles followed by biweekly administration. Additionally, Though routine optimization (see supra), one with ordinary skill in the art would vary the biweekly administration cycle number to achieve optimal results, for example increasing it to 6 weeks instead of 4 before reducing administration of epcoritamab to monthly administration, which would lead a dosing regimens that meets the limitations of instant claims 7, 8, 17, 19, 43-47, and 49.
Therefore, the instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘154 in view of Lugtenburg et al., especially in absence to evidence to the contrary.
Claims 1, 3, 4, 11, 12, 15, 16, 21, 23-27, 41, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,435,154 (Pat ‘154, supra) in view of Maddocks et al. (JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218. PMID: 26182309).
The invention claimed by Pat ‘154 is discussed supra. Pat ‘154 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
Maddocks et al., in the same field of endeavor, evaluated CLL patients receiving ibrutinib BTK inhibitor monotherapy or ibrutinib in combination with ofatumumab (Results, Table 4). Maddocks et al. further teaches (pg. 5): “[o]f 31 patients who discontinued therapy due to disease progression, 13 progressed with CLL and 18 with Richter’s transformation…[p]atients with CLL progression tended to have rapid disease progression following discontinuation of ibrutinib…”
Maddocks et al., further teaches (pg. 6): “[a]fter progression, patients tended to require the initiation of therapy quickly in order to achieve disease control (Table 4). Of the 13 patients, 11 received further therapy, most within a few weeks of discontinuing ibrutinib…”
It would have been obvious to one with ordinary skill in the art to have modified the invention claimed by Pat ‘154 in view of Maddocks et al. to use the epcoritamab dosing regimen claimed by Pat ‘154 to treat CLL patients refractory to a combination of ibrutinib and ofatumumab with a reasonable expectation of success, as Pat ‘154 claims a CLL therapy that can be used on the patient population of Maddocks et al. One would have been motivated to make this change because Maddocks et al. teaches that CLL patients relapsing from dual antineoplastic therapy of ibrutinib and ofatumumab have rapid disease progression following discontinuation due to disease progression, and require initiation of a different therapy quickly in order to achieve disease control, motivating one to use a different therapy to treat the disease such as the therapy claimed by Pat ‘154.
Therefore, the instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘154 in view of Maddocks et al., especially in absence of evidence to the contrary.
Claims 1, 3-8, 11, 12, 15-17, 19, 41, 42, 47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,858,995 (herein Pat ‘995). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘995 claims a methods of treating chronic CLL in a human comprising subcutaneous administration of epcoritamab at a full dose of 12-60mg in 28 day cycles, wherein the first cycle has a priming dose of 0.16mg at day 1 and 0.8mg at day 8, followed by a full dose at days 15 and 55; cycles 2-3 is a full dose weekly; cycles 4-9 is a full dose biweekly; and cycle 10 and subsequent is a full dose monthly until CR, PR, stable disease, or progressive disease develops (claim 26), which are the limitations of instant claims 1, 4-8, 11, 12, 15-17, 41, 42, and 47.
Regarding claims 3, 19, and 49, Pat ‘995 claims the full dose of 48mg (claim 28).
The invention encompassed by the reference patent anticipates the instantly claimed invention.
Claims 1, 3-8, 11, 12, 15-17, 19, 21, 23-27, 41, 42, 47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,858,995 (Pat ‘995, supra) in view of Maddocks et al. (supra).
The invention claimed by Pat ‘995 is discussed supra. Pat ‘995 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘995 in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,548,952 (herein Pat ‘952) in view of Bacac et al. (Blood (2016) 128 (22): 1836. doi.org/10.1182/blood.V128.22.1836.1836). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat’ 952 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claim 1, 25), wherein the epcoritamab is administered at a priming dose of 0.16mg and an intermediate dose of 0.8mg (i.e., the limitations of instant claims 11, 12, 15, 16; Pat ‘952 claim 6), and a full dose of 48mg (i.e., the limitations of instant claim 3; Pat ‘952 claim 3). Pat ‘952 additionally claims weekly administration of epcoritamab starting with the priming dose, the intermediate dose, and then the full dose for three 28-day periods (i.e., the limitations of instant claims 4-6; Pat ‘952 claim 13), followed by biweekly administration for five cycles and then monthly administration afterwards (claim 15).
Pat ‘952 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
Bacac et al., in the same field of endeavor, teaches that the bispecific T-cell engager CD20-TCB demonstrated potent toxicity toward human CLL cells (Abstract): “CD20 TCB also demonstrated potent ex vivo activity in whole bone marrow aspirate samples of NHL and CLL patients (n=17)…”. Thus, Bacac et al. teaches that bispecific T-cell engagers directed to CD20 and CD3 have toxicity toward CLL tumors, motivating one to try these therapies to treat CLL in human patients.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the invention claimed by Pat ‘952 in view of Bacac et al. to use the method of Pat ‘952 to treat CLL with a reasonable expectation of success (i.e., the limitations of instant claim 1), as Bacac et al. teaches that C20/CD3 bispecific T-cell engagers have cytotoxicity against human CLL tumors. One would have been motivated to make this change for the purposes of using the claimed epcoritamab treatment method of Pat ‘952 to treat CLL.
Regarding instant claims 7, 8, 17, 19, 43-47, and 49, the invention claimed by Pat ‘952 differs from the instant claimed invention in that Pat ‘952 claims biweekly administration for 5 28-day cycles, while the instantly claimed invention claims 6 cycles. However, one with ordinary skill in the art would have arrived at this combined dosing regimen to treat CLL though routine experimentation, as all doses and intervals of administration of all epcoritamab recited in the instant claims are all result effective variables since they will affect the outcome of the therapy, how well said combination therapy functions to treat CLL. Therefore, they will all be identified by one of ordinary skill in this art using routine optimization. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Thus, all doses and intervals of administration of the instant claims will be identified by the practitioner using routine methods and so are obvious here. Further, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215,219 (CCPA 1980).
Therefore, the instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘952 in view of Bacac et al.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,548,952 (herein Pat ‘952) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by Pat ‘952 is discussed supra. Pat ‘952 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘952 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,845,805 (herein Pat ‘805) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘805 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claim 1, 29), wherein the epcoritamab is administered at a priming dose of 0.16mg and an intermediate dose of 0.8mg (i.e., the limitations of instant claims 11, 12, 15, 16; Pat ‘805 claims 32 AND 33), and a full dose of 48mg (i.e., the limitations of instant claim 3; Pat ‘805 claim 31). Pat ‘805 additionally claims weekly administration of epcoritamab starting with the priming dose, the intermediate dose, and then the full dose for three 28-day periods (i.e., the limitations of instant claims 4-6; Pat ‘952 claim 29), followed by triweekly administration for five cycles and then monthly administration afterwards (claim 24 and 25).
Pat ‘952 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘805 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,845,805 (Pat ‘805, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by Pat ‘805 in view of Bacac et al. is discussed supra. Pat ‘805 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘805 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,535,679 (herein Pat ‘679) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘679 claims methods of treating FL comprising subcutaneous administration of epcoritamab (claims 15 and 25) comprising administration of epcoritamab in 28-day cycles, wherein cycle 1 has a 0.16mg priming dose on day 1 and a 0.8mg intermediate dose on day 8, and a full 48mg dose on days 15 and 22, followed by weekly administration of the full dose for cycles 2-3, followed by 6 cycles of biweekly, followed by monthly administration of the full dose (i.e., the limitations of instant claims 3-8, 11, 12, 15-17, 19, 41, 42, 43-47, and 49; Pat ‘679 claim 11).
Pat ‘679 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘679 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,535,679 (Pat ‘679, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by Pat ‘679 is discussed supra. Pat ‘679 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘679 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,608,383 (herein Pat ‘383) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
Pat ‘383 claims methods of treating FL comprising subcutaneous administration of epcoritamab (claims 1 and 14) comprising administration of epcoritamab in 28-day cycles, wherein cycle 1 has a 0.16mg priming dose on day 1 and a 0.8mg intermediate dose on day 8, and a full 48mg dose on days 15 and 22, followed by weekly administration of the full dose for cycles 2-3, followed by 6 cycles of biweekly, followed by monthly administration of the full dose (i.e., the limitations of instant claims 3-8, 11, 12, 15-17, 19, 41, 42, 43-47, and 49; Pat ‘383 claim 15).
Pat ‘679 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘383 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,608,383 (Pat ‘383, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by Pat ‘383 is discussed supra. Pat ‘383 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘383 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claim 1, 3-8, 11, 12, 15, 16, 17, 19, 23, 42, 47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69, 70, 72-89, and 98-108 of copending Application No. 17/923,317 (herein App ‘317). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘317 claims methods of treating B-NHL (claim 69), including CLL (claim 72), comprising subcutaneous administration of epcoritamab at a dose of 0.16mg at day 1 (i.e., “priming dose”), followed by a 0.8mg dose at day 8 (i.e., “an intermediate dose”), followed by administration of 48mg at different intervals until progressive disease or unacceptable cytotoxicity (i.e., the limitations of instant claim 1, 3, 11, 12, 15, 16, and 42; App ‘317 claim 69).
App ‘317 further claims the following dosing regimen of epcoritamab, wherein the epcoritamab is administered in 28 day cycles (claim 98):
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Thus, App ‘317 claims the limitations of instant claims 4-8, 17, 19, 47, and 49.
Regarding claim 41, the instant specification discloses that epcoritamab comprises the heavy and light chains recited in the claim (pg. 48, lines 10-19), and Pat ‘154 claims administration of epcoritamab (claim 1).
Regarding claim 23, App ‘317 claims the method of treatment wherein the subject has received at least two prior antineoplastic therapies (claim 108).
The invention encompassed by the reference application anticipates the instant claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 3-8, 11, 12, 15, 16, 17, 19, 23-27, 42, 47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69, 70, 72-89, and 98-108 of copending Application No. 17/923,317 (App ‘317, supra) in view of Maddocks et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The invention claimed by App ‘317 is discussed supra. App ‘317 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject is refractory to two prior lines of antineoplastic therapy (claim 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The invention encompassed by App ‘317 in view of Maddocks et al. is a prima facie obvious variant of the instantly claimed invention for the same reasons discussed for Pat ‘154 supra. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, 29-36, 52, and 53 of copending Application No. 18/025,208 (herein App ‘208) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘208 claims methods of treating DLBCL comprising subcutaneous administration of epcoritamab (claims 1) comprising administration of epcoritamab in 28-day cycles, wherein cycle 1 has a 0.16mg priming dose on day 1 and a 0.8mg intermediate dose on day 8 (claim 25), and a full 48mg dose on days 15 and 22, followed by weekly administration of the full dose for cycles 2-3, followed by 6 cycles of biweekly, followed by monthly administration of the full dose (i.e., the limitations of instant claims 3-8, 11, 12, 15-17, 19, 41, 42, 43-47, and 49; App ‘208 claims 25).
App ‘208 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘208 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 12, 15, 17, 20, 22, 24, 25, 29-36, 52, and 53 of copending Application No. 18/025,208 (App ‘208, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘208 in view of Bacac et al. is discussed supra. App ‘208 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘208 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 20, 21, 23, 24, 26-29, 31, 32, 34, 35, 37-40, 47-53, and 67-70 of copending Application No. 18/025,206 (herein App ‘206) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘206 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claim 1), wherein the epcoritamab is administered at a priming dose of 0.16mg and an intermediate dose of 0.8mg (i.e., the limitations of instant claims 11, 12, 15, 16; App ‘206 claims 12-16), and a full dose of 48mg (i.e., the limitations of instant claim 3; App ‘206 claim 3). App ‘206 additionally claims weekly administration of epcoritamab starting with the priming dose, the intermediate dose, and then the full dose for three 28-day periods (i.e., the limitations of instant claims 4-6; App ‘206 claims 12-16), followed by biweekly administration for five cycles and then monthly administration afterwards (claims 7-9).
App ‘206 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘206 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 20, 21, 23, 24, 26-29, 31, 32, 34, 35, 37-40, 47-53, and 67-70 of copending Application No. 18/025,206 (herein App ‘206) in view of Bacac et al. (supra) as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App’ 206 in view of Bacac et al. is discussed supra. App ‘206 does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘206 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, 20, 22, 24, 25, 30-33, and 48 of copending Application No. 18/025,205 (herein App ‘205) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘205 claims methods of treating DLBCL comprising subcutaneous administration of epcoritamab comprising administration of epcoritamab in 28-day cycles (claim 1), wherein cycle 1 has a 0.16mg priming dose on day 1 (claims 10-12) and a 0.8mg intermediate dose on day 8 (claims 13-15), and a full 48mg dose on days 15 and 22 , followed by weekly administration of the full dose for cycles 2-3 (claims 4 and 5), followed by 6 cycles of biweekly (claim 6 and 7), followed by monthly administration of the full dose (claim 9), meeting the limitations of instant claims 3-8, 11, 12, 15-17, 19, 41, 42, 43-47, and 49.
App ‘205 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘205 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, 20, 22, 24, 25, 30-33, and 48 of copending Application No. 18/025,205 (App ‘205, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘205 in view of Bacac et al. is discussed supra. App ‘205 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘205 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33, 34-38, 45-50, and 64-67 of copending Application 18/025,203 (herein App ‘203) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘203 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claim 1), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1, followed by an intermediate dose of 0.8mg on day 8, followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles (i.e., the limitations of instant claims 3-6, 11, 12, 15, 16; App ‘203 claim 37). App ‘203 additionally claimed the regimen further comprising by triweekly administration for three cycles and then monthly administration afterwards (claim 36).
App ‘203 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘203 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33, 34-38, 45-50, and 64-67 of copending Application 18/025,203 (App ‘203, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘203 in view of Bacac et al. is discussed supra. App ‘203 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘203 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 12, 15, 18, 19, 22-25, 27, 28, 32-34, and 48-51 of copending Application No. 18/025,204 (herein App ‘204) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘204 claims methods of treating FL comprising administration of epcoritamab (claim 1) comprising administration of epcoritamab in 28-day cycles, wherein cycle 1 has a 0.16mg priming dose on day 1 (claims 1 and 12) and a 0.8mg intermediate dose on day 8 (claims 1 and 15), and a full 48mg dose on days 15 and 22 (claims 1 and 3), followed by weekly administration of the full dose for cycles 2-3, followed by 6 cycles of biweekly, followed by monthly administration of the full dose (i.e., the limitations of instant claims 3-8, 11, 12, 15-17, 19, 41, 42, 43-47, and 49; App ‘204 claim 1).
App ‘204 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘204 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 9, 12, 15, 18, 19, 22-25, 27, 28, 32-34, and 48-51 of copending Application No. 18/025,204 (App ‘204, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘204 in view of Bacac et al. is discussed supra. App ‘204 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘204 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50, and 64-67 of copending Application 18/500,799 (herein App ‘799) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘799 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claims 1, 64, 65), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1, followed by an intermediate dose of 0.8mg on day 8, followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles (i.e., the limitations of instant claims 3-6, 11, 12, 15, 16; App ‘203 claim 37). App ‘799 additionally claimed the regimen further comprising by triweekly administration for four cycles and then monthly administration afterwards (claim 37 and 38).
App ‘799 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘799 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50, and 64-67 of copending Application 18/500,799 (App ‘799, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘799 in view of Bacac et al. is discussed supra. App ‘799 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘799 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 11, 14, 16, 17, 20, 25, 26, 29-31, 33-35, 39-43, and 49 of copending Application No. 18/160,386 (herein App ‘386) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘386 claims methods of treating DLBCL comprising administration of epcoritamab (claim 1) comprising administration of epcoritamab in 28-day cycles, wherein cycle 1 has a 0.16mg priming dose on day 1 (claims 1 and 11) and a 0.8mg intermediate dose on day 8 (claims 1 and 14), and a full 48mg dose on days 15 and 22 (claims 1 and 3), followed by weekly administration of the full dose for cycles 2-3, followed by 2 cycles of biweekly, followed by monthly administration of the full dose (i.e., the limitations of instant claims 3, 4-6, 11, 12, 15, 16, 41, and 42; App ‘386 claim 1).
App ‘386 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘386 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 11, 14, 16, 17, 20, 25, 26, 29-31, 33, 3-35, 39-43, and 49 of copending Application No. 18/160,386 (App ‘386, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘386 in view of Bacac et al. is discussed supra. App ‘386 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘386 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 67, and 68 of copending Application 18/160,391 (herein App ‘391) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘391 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claim 1), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1 (claims 1 and 11), followed by an intermediate dose of 0.8mg on day 8 (claims 1 and 14), followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles (i.e., the limitations of instant claims 3-6, 11, 12, 15, 16; App ‘391 claims 1 and 67). App ‘391 additionally claimed the regimen further comprising by triweekly administration for three cycles (claim 67).
App ‘391 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘391 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 67, and 68 of copending Application 18/160,391 (App ‘391, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘391 in view of Bacac et al. is discussed supra. App ‘391 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘391 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, 33-36, 38, 41, 46, and 66 of copending Application 18/833,267 (herein App ‘267) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘267 claims methods of treating DLBCL in a human comprising administration of epcoritamab (claims 1 and 66), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1 (claims 9-11), followed by an intermediate dose of 0.8mg on day 8 (claims 12-14), followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles (i.e., the limitations of instant claims 3-6, 11, 12, 15, 16; App ‘267 claims 1 and 38). App ‘267 additionally claimed the regimen further comprising by triweekly administration for three cycles (claim 38)
App ‘267 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘267 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, 33-36, 38, 41, 46, and 66 of copending Application 18/833,267 (App ‘267, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘267 in view of Bacac et al. is discussed supra. App ‘267 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘267 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-28, 30, 34, 35, 41, 68-70, 74, 78-80, and 82 of copending Application 18/500,673 (herein App ‘673) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘673 claims methods of treating Richter’s Syndrome in a human comprising subcutaneous administration of epcoritamab (claims 1, 20, and 82), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1 (claims 1, 12, and 17), followed by an intermediate dose of 0.8mg on day 8 (claims 1, 14, and 17), followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles (claims 17 and 18), followed by biweekly administration of the full dose for 6 cycles (claim 17), followed by monthly administration (i.e., the limitations of instant claims 3-8, 11, 12, 15, 16, 17, 19, 42-47, and 49; App ‘671 claim 17 and 18).
App ‘673 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘673 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-28, 30, 34, 35, 41, 68-70, 74, 78-80, and 82 of copending Application 18/500,673 (App ‘673, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘673 in view of Bacac et al. is discussed supra. App ‘673 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘673 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-20 of copending Application 18/664,772 (herein App ‘772) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘772 claims methods of treating CD20 expressing B-cell cancers in a human comprising subcutaneous administration of epcoritamab (claims 1 and 5), wherein the epcoritamab is administered at a priming dose of 0.16mg on day 1, followed by an intermediate dose of 0.8mg on day 8 (claim 1), followed by the equivalent of administration of a 48mg full dose weekly for 3 28-week cycles and further followed by biweekly administration of the full dose for 6 cycles, then followed by monthly administration (i.e., the limitations of instant claims 3-8, 11, 12, 15, 16, 17, 19, 42-47, and 49; App ‘772 claim 6).
App ‘772 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘772 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-20 of copending Application 18/664,772 (App ‘772, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘772 in view of Bacac et al. is discussed supra. App ‘772 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘772 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9, 11, 12, 20, 21, 29, 33, 39, 44, 46, 48, 49, 54, 60-63, 67, 72, 73, and 83 of copending Application 18/855,842 (herein App ‘842) in view of Bacac et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
App ‘842 claims methods of treating a B-NHL in a human comprising subcutaneous administration of epcoritamab (claim 1), wherein the epcoritamab is administered at a dose of 48mg weekly (claims 1, 39 and 44), followed by biweekly administration at least 6 times (i.e., “6 cycles of 28 days”; App ‘842 claim 46), followed by monthly administration (claim 48). App ‘842 further claims the dosing regimen preceded by priming dose of 0.16mg on day 1 (claim 49), followed by an intermediate dose of 0.8mg on day 8 (i.e., the limitations of instant claims 3-8, 11, 12, 15, 16, 17, 19, 42-47, and 49; App ‘842 claim 54).
App ‘842 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘842 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9, 11, 12, 20, 21, 29, 33, 39, 44, 46, 48, 49, 54, 60-63, 67, 72, 73, and 83 of copending Application 18/855,842 (App ‘842, supra) in view of Bacac et al., as applied to claims 1, 3-8, 11, 12, 15, 16, 17, 19, 41-47, and 49 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘842 in view of Bacac et al. is discussed supra. App ‘842 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘842 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 1, 3-5, 11, 12, 15, 16, 41, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, 24, 28-31, 40, and 66 of copending Application 18/833,261 (herein App ‘261) in view of Bacac et al. (supra).
App ‘261 claims methods of treating DLBCL comprising administration of epcoritamab subcutaneously at a dose of 48mg (claims 1 and 3), wherein the dosing regimen comprises first a 0.16mg priming dose (claims 10-11), followed by a 0.8mg intermediate dose (claims 13 and 14), followed by weekly administration of the full 48mg dose to complete three cycles (claims 4 and 5), followed by monthly administration (claim 6), which are the limitations of instant claims 3-5, 11, 12, 15, 16, 41, and 42.
App ‘261 does not claim methods of treating CLL with the claimed epcoritamab dosing regimen (i.e., the limitations of instant claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘261 in view of Bacac et al. for the same reasons discussed for Pat ‘952 supra. This is a provisional double patenting rejection.
Claims 5-8, 17, 19, 43-47, and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, 24, 28-31, 40, and 66 of copending Application 18/833,261 (App ‘261, supra) in view of Bacac et al., as applied to claims 1, 3-5, 11, 12, 15, 16, 41, and 42 above, and further in view of Lugtenburg et al. (supra).
The invention claimed by App ‘261 in view of Bacac et al. is discussed supra. App ‘261 in view of Bacac et al. does not claim multiple 28-day dosing cycles with different administration schedules of epcoritamab at the claimed dose values, such as weekly administration for 3 cycles, followed by biweekly administration for 6 cycles, followed by monthly administration (i.e., the limitations of instant claims 5-8, 17, 19, 43-47, and 49).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘261 in view of Bacac et al., and further in view of Lugtenburg et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Claims 21 and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, 24, 28-31, 40, and 66 of copending Application 18/833,261 (App ‘261, supra) in view of Bacac et al., as applied to claims 1, 3-5, 11, 12, 15, 16, 41, and 42 above, and further in view of Maddocks et al. (supra).
The invention claimed by App ‘261 in view of Bacac et al. is discussed supra. App ‘261 in view of Bacac et al. does not claim treating r/r CLL with the claimed epcoritamab dosing regimen (claim 21), or wherein the subject has two prior lines of antineoplastic therapy (claim 23 and 27), or wherein one of the prior therapies is BTK inhibition (claims 24-26).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by App ‘261 in view of Bacac et al., and further in view of Maddocks et al. for the same reasons discussed for Pat ‘154 supra. This is a provisional double patenting rejection.
Conclusion
No claim is allowed.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641