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 amendments, filed 1/16/2026, is acknowledged.
Claims 41, 46-48, 53-56, and 59-65 are currently pending.
Claims 54-56 stand withdrawn, and newly added claims 63-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and/or Species.
Claims 41, 46-48, 53, and 59-62 are currently under examination as reading on a method of treating a disorder comprising administration of the anti-CD19 ADC and a PI3K inhibitor (the invention of Group I in the Restriction Requirement mailed on 3/18/2025), and the Species of: an anti-CD19 ADC comprising SEQ ID NO: 2 and 8, the PI3K inhibitor idelalisib, and Non-Hodgkin’s Lymphoma.
In view of the amendments and remarks filed on 1/16/2026, the following objections and rejections remain.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Browser-executable code appears on the following pages: 15, 16, 17, 18, 19, 20, 22, 23, 25, 26, 27, 30, 31, 32, and 33.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 41, 46-48, 53, and 59-62 are objected to for the following reasons:
Claim 41 currently recites the anti-CD19 ADC clone ADCT-402. The instant specification discloses clone ADCT-402 as loncastuximab tesirine (pg. 13, lines 31-34). There are potential issues with reciting the clone name and not the generic name of the ADC clone, and dependent claims 46-48, 53, and 59-62 do not resolve this issue and are also objected to.
It is recommended to amend instant claim to recite “loncastuximab tesirine” in place of “ADCT-402” to resolve any potential hybridoma deposit issues without changing the claim scope.
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 41, 46-48, 53, and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treating NHL with the elected combination therapy of ADCT-402 and idelalisib, does not reasonably provide enablement for methods of treating any B-cell lymphoma or leukemia (claims 41, 46-48, 53), or any B-cell lymphoma (claim 59). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a new ground of rejection necessitated by Applicant’s amendments.
Breadth of claims and nature of invention:
Claims 41, 46-48, and 53 encompass methods of treating any B-cell lymphoma or leukemia with a combination of ADCT-402 and the elected species of idelalisib, and claim 59 encompasses methods of treating any B-cell lymphoma with ADCT-402 and idelalisib.
The specification discloses methods of treating tumor cells with the elected combination therapy (Examples 3 and 4).
Amount of direction and existence of working examples:
Examples of methods of treating cancer cells with a combination of ADCT-402 and idelalisib are disclosed in Example 3.
The instant specification discloses that a combination of ADCT-402 and idelalisib can successfully kill the following cell lines: OCI-LY3, TMD8, VAL, and WSU-DLCL2 (pg. 78-80). Cellosaurus entries CVCL_8800 (cellosaurus.org/CVCL_8800), CVCL_A442 (cellosaurus.org/CVCL_A442), CVCL_1819 (cellosaurus.org/CVCL_1819), and CVCL_1902 (cellosaurus.org/CVCL_1902) are all provided as evidentiary references demonstrating that all four of these cell lines are DLBCL cell lines (see “Disease” section for each cell line entry), which is a type of Non-Hodgkin’s Lymphoma.
The instant specification discloses that all of these cell lines were killed by the combination of ADCT-402 and idelalisib (Example 3 and pg. 77).
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Level of predictability, state of prior art, and quantity of experimentation needed:
Neither the prior or nor the instant disclosure provide sufficient guidance to allow one with ordinary skill in the art to use a method of treating any and all B-cell lymphomas or leukemias (claims 41, 46-48, and 53), or any and all B-cell lymphomas (claim 59), with a combination of ADCT-402 and idelalisib. The instant specification provides guidance to one of ordinary skill in the art to use a methods of treating Non-Hodgkin’s Lymphoma/DLBCL with the combination of ADCT-402 and idelalisib. Undue experimentation would be required by one with ordinary skill in the art to make and use methods of treating the claimed genera of cancers with the combination therapy of ADCT-402 and idelalisib.
Applicant’s arguments, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant amended claims have obviated the 112(a) enablement rejection, and the scope of instant claim 41 is fully enabled by the experimental results as disclosed in Examples 3 and 4. However, this has been found to be not persuasive for the reasons discussed supra.
The specification does not reasonably provide enablement to make and use the invention of instant claims 41, 46-48, 53, and 59 as they are currently written. The specification does enable one with ordinary skill to make and use the method of treating NHL or DLBCL with the elected combination therapy, as discussed supra.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 41, 46-48, 53, 59, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (JCO 34, TPS7580. 2016. doi 10.1200/JCO.2016.34.15_suppl.TPS7580, in Office Action mailed on 7/25/2025) in view of Gopal et al. (N Engl J Med. 2014 Mar 13;370(11): 1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22, in Office Action mailed on 7/25/2025) and Rickles et al. (Cancer Res (2014) 74 (19_Supplement): 4765. https://doi.org/10.1158/1538-7445.AM2014-4765, on IDS submitted 8/17/2022, in Office Action mailed on 7/25/2025), as evidenced by Tiberghien et al. (ACS Med Chem Lett. 2016 May 24;7(11):983- 987. doi: 10.1021/acsmedchemlett.6b00062, in Office Action mailed on 7/25/2025). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention of instant claims 41, 46-48, 53, 59, and 60 were an obvious variant of the combined teachings of Chung et al., Gopal et al., and Rickles et al., as evidenced by Tiberghien et al., for the same reasons discussed in the Office Action mailed on 7/25/2025.
Claims 59 and 60 are included because Chung et al. and Gopal et al. both teach methods of treating B-NHL.
Applicant’s arguments, filed on 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues (remarks pg. 7): “[a] As the Office acknowledged, Chung does not disclose a method of treatment comprising administering ADCT-402 and a PBK inhibitor. Similarly, there is no disclosure of ADCT-402 or any ADC in Gopal as Gopal only disclosed the anti-tumor activity of idelalisib in a phase 1 study.”
However, in response to applicant’s arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combination of references. See MPEP 2145.
Contrary to applicant’s arguments against the references individually, note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145 IV.
Applicant further argues (pg. 7): “[t]he Office relied solely on the disclosure of Rickles showing that an anti-CD19 ADC combined with a PBK inhibitor showed synergy to argue that a POSA would be motivated to combine the disclosure of Chung with Gopal to arrive at the claimed method. However, Rickles specifically disclosed SAR3419, an anti-CD19 ADC comprising a different anti-CD19 antibody from the claimed method that is attached to a different cytotoxic agent DM4, which is an inhibitor of microtubule polymerization. In contrast to the Office's allegation, a POSA would not have a reasonable expectation that the synergistic effect observed in Rickles would be generically applicable to anti-CD19 ADCs. The Office has provided no evidence to suggest that a POSA would have a reasonable expectation that the results shown with the ADC of Rickles - with a different anti-CD19 antibody and with a different payload having a completely different mechanism of action - would be applicable to the results achieved with the ADCT-402 ADC currently claimed. Therefore, the Office failed to provide any evidence or support from the cited references why a POSA would be motivated to combine the disclosure of Chung and Gopal to arrive at the claimed method with a reasonable expectation of success in observing the same level of synergy as Rickles.”
However, the reference of Rickles et al. was not the sole disclosure relied on to establish a prima facie case of obviousness. As stated in the Office Action mailed on 7/25/2025, It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Additionally, regarding the motivation to combine for synergy taught by Rickles et al., the Rickles et al. reference provides evidence to one with ordinary skill in the art that synergy between and anti-CD19 ADC and a PI3K inhibitor is possible in the treatment of cancer. Thus, one with ordinary skill in the art would be motivated to try other anti-CD19 ADC and PI3K inhibitor combinations in light of this observed synergy, such as the ADC taught by Chung et al. and the PI3K inhibitor taught by Gopal et al., both of which are already known to be used to treat B-NHL, in absence of evidence to the contrary.
Applicant additionally argues (remarks pg. 7 and 8): “[a]lthough the Office also argued that based on In re Kerkhoven, combining two compositions to form a third composition that is to be used for the same purpose flows logically based on the individual disclosure, Applicants also submit that it is well known in the art that it is unpredictable whether synergism can be observed when combining different classes of drugs. In fact, the Office essentially acknowledged this because the Office pointed to Example 4 of the instant application where the combination of ADCT-402 with either bortezomib or lenalidomide showed no effect. Accordingly, a POSA would understand that merely combining any anti-CD19 ADC with any secondary agent for the treatment of the same disorder will not result in synergy as argued by the Office based on the disclosure of Rickles.”
However, a prima facie obvious case to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose, as stated in MPEP 2144.06, does not require the expectation of synergy. The idea of combining them flows logically from their having been individually taught in prior art.
Applicant argues unexpected results for a combination of ADCT-402 and a PI3K inhibitor, as this combination successfully killed cancer cells (remarks pg. 8)
However, the killing of cancer cells by the combination of ADCT-402 and idelalisib is expected from the prior art, as Chung et al. and Gopal et al. each teach this expected result for ADCT-402 and idelalisib monotherapies, respectively. Since the monotherapies were successful in killing cancer cells, one with ordinary skill in the art would expect the combination to also kill cancer cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Kahl et al. (Blood 2017; 130 (Supplement 1): 187. doi: 10.1182/blood.V130.Suppl_1.187.187) in view of Clinical Trial NTC03576443 (version 2018/07/02, clinicaltrials.gov/study/ NCT03576443).
Kahl et al. teaches a method of treating r/r DLBCL comprising administration of the anti-CD19 ADC ADCT-402, or loncastuximab tesirine (Methods): “[p]ts receive 1-hour intravenous infusions of Lonca-T every 3 weeks…” (Conclusions): “…Lonca-T has demonstrated encouraging single-agent anti-tumor activity and manageable toxicity in pts with R/R B-cell lineage NHL…”
Kahl does not teach a combination therapy of idelalisib and ADCT-402 to treat r/r DLBCL.
NTC03576443, in the same field of endeavor, teaches administration of idelalisib to treat r/r DLBCL (Brief Title): “Trial of ldelalisib in Patients With Relapsed Diffuse Large 8-cell
Lymphoma”. Idelalisib was administered at 150mg to patients (Arms): “Idelalisib 150mg x 2 p o, until progression”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to combined the monotherapies to treat r/r DLBCL taught by Kahl et al. and NTC03576443 to make a combination therapy of ADCT-402 and idelalisib to treat r/r DLBCL (i.e., the limitations of instant claims 41 and 59-62. It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claims 46 and 47 are included because determining a sequence of therapeutic administration is considered routine experimentation by one with ordinary skill in the art in absence to evidence to the contrary. See MPEP § 2144.05(11).
Claim 48 is included because both Kahl et al. and NTC03576443 teach treatment of patients that have a B-cell lymphoma (DLBCL).
Claim 53 is included because both Kahl et al. and NTC03576443 teach treatment of humans.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,889,207 (herein Pat ‘207, in Office Action mailed 7/25/2025) in view of Watkins et al. (Expert Opinion on Investigational Drugs, 27 (7), 601-611. doi:10.1080/13543784.2018.1492549, in Office Action mailed 7/25/2025), Gopal et al. (N Engl J Med. 2014 Mar 13;370(11):1008- 18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22, in Office Action mailed on 7/25/2025, supra), and Rickles et al. (Cancer Res (2014) 74 (19_Supplement): 4765. https://doi.org/10.l 158/1538-7445.AM2014-4765, on IDS submitted 8/17/2022, in Office Action mailed on 7/25/2025, supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘207 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed in the Office Action mailed on 7/25/2025.
Regarding claims 59 and 60, both Watkins et al. and Gopal et al. teach methods of treating B-NHL.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’207 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,646,584 (herein Pat ‘584, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘584 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’584 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,121,590 (herein Pat ‘590, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘590 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’590 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,931,414 (herein Pat ‘414, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘414 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’414 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,938,192 (herein Pat ‘192, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘192 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’192 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,771,775 (herein Pat ‘775, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘775 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’775 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,318,211 (herein Pat ‘211, in Office Action mailed 7/25/2025) in view of Watkins et al. (supra), Gopal et al. (supra) and Rickles et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘211 in view of Watkins et al., Gopal et al., and Rickles et al. for the same reasons discussed for Pat ‘207 supra.
Applicant’s remarks, filed 1/16/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that there is no prima facie case of obviousness established for the same reasons discussed for the 35 U.S.C. 103 rejection supra. However, for the reasons discussed supra, this has been found to be not convincing.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ’211 in view of Watkins et al., Gopal et al., and Rickles et al., especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,889,207 (Pat ‘207, supra) in view of Watkins et al. (supra), Kahl et al. (Blood 2017; 130 (Supplement 1): 187. doi: 10.1182/blood.V130.Suppl_1.187.187, supra) in view of Clinical Trial NTC03576443 (version 2018/07/02, clinicaltrials.gov/study/ NCT03576443, supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘207 claims ADCs comprising the following formula (claims 2 and 17):
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This drug formula is identical to the structure of instant claim 43. Pat ‘207 claims these conjugates comprising anti-CD19 antibodies (claim 5(47)).
Pat ‘207 does not claim methods of treating a disorder or NHL comprising the anti-CD19 ADC ADCT-402 and a PI3K inhibitor such as idelalisib.
Watkins et al., in the same field of endeavor, teaches anti-CD19 ADCs are used in methods of treating B-NHL in humans (Section 3). Multiple ADCs are under investigation with promising results (Section 3), including SAR3419, ADCT-402 (i.e., the ADC claimed by Pat ‘207 comprising the claimed conjugate and the RB4v1.2 antibody, which reads on the limitations of instant claims 41-45), SGN-CD19A, and SGN CD19B, establishing different anti-CD19 ADCs as art-recognized equivalents for the purposes of treating B-NHL.
Kahl et al., in the same field of endeavor, teaches a method of treating r/r DLBCL comprising administration of the anti-CD19 ADC ADCT-402, or loncastuximab tesirine (Methods): “[p]ts receive 1-hour intravenous infusions of Lonca-T every 3 weeks…” (Conclusions): “…Lonca-T has demonstrated encouraging single-agent anti-tumor activity and manageable toxicity in pts with R/R B-cell lineage NHL…”
Neither Pat ‘207, Watkins et al., nor Kahl et al. does not teach a combination therapy of idelalisib and ADCT-402 to treat r/r DLBCL.
NTC03576443, in the same field of endeavor, teaches administration of idelalisib to treat r/r DLBCL (Brief Title): “Trial of ldelalisib in Patients With Relapsed Diffuse Large 8-cell
Lymphoma”. Idelalisib was administered at 150mg to patients (Arms): “Idelalisib 150mg x 2 p o, until progression”.
It would have been obvious to modify the anti-CD19 ADC claimed by Pat ‘207 to comprise the RB4v1.2 antibody conjugated to the claimed payload structure (yielding ADCT-402), and to use the anti-CD19 ADC in a method to treat B-NHL in view of Watkins et al., as the reference teaches anti-CD19 ADCs such as ADCT-402 are being used in such treatments, providing motivation to one with ordinary skill. Additionally, it would have been obvious to use this ADC in a method of treating r/r DLBCL, as Kahl et al. teaches such a method. Furthermore, it would have been obvious to combine this ADCT-402 monotherapy to treat r/r DLBCL with the idelalisib monotherapy for r/r DLBCL taught by NTC03576443 to make a combination therapy for r/r DLBCL comprising administration of both ADCT-402 and idelalisib (i.e., the limitations of instant claims 41 and 59-62).
It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claims 46 and 47 are included because determining a sequence of therapeutic administration is considered routine experimentation by one with ordinary skill in the art in absence to evidence to the contrary. See MPEP § 2144.05(11).
Claim 48 is included because both Kahl et al. and NTC03576443 teach treatment of patients that have a B-cell lymphoma (DLBCL).
Claim 53 is included because both Kahl et al. and NTC03576443 teach treatment of humans.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘207 in view of Watkins et al., Kahl et al., and NTC03576443, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,646,584 (Pat ‘584, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘584 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,121,590 (Pat ‘590, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘590 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,931,414 (Pat ‘414, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘414 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,938,192 (Pat ‘192, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘192 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,771,775 (Pat ‘775, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘775 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,318,211 (Pat ‘211, supra) in view of Watkins et al. (supra), Kahl et al. (supra) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘211 in view of Watkins et al., Kahl et al., and NTC03576443 for the same reasons discussed for Pat ‘207 supra, especially in absence of evidence to the contrary.
Claims 41, 46-48, 53, and 59-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50, 53, 57-60, 62, and 64-66 of copending Application No. 17/819,185 (herein App '185, in Office Action mailed 7/25/2025) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
App ‘185 claims methods of treating DLBCL (claim 50) comprising administration of ADCx19 (i.e., the ADC of instant claim 41; App ‘185 claim 53). App ‘185 additionally claims methods of treating r/r DLBCL (claim 57).
App ‘185 does not teach combination therapies for treating r/r DLBCL comprising administration of ADCx19 and idelalisib (i.e., the limitations of instant claim 41).
NTC03576443, in the same field of endeavor, teaches administration of idelalisib to treat r/r DLBCL (Brief Title): “Trial of ldelalisib in Patients With Relapsed Diffuse Large 8-cell
Lymphoma”. Idelalisib was administered at 150mg to patients (Arms): “Idelalisib 150mg x 2 p o, until progression”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to combined the monotherapies to treat r/r DLBCL claimed by App ‘185 and taught by NTC03576443 to make a combination therapy of ADCTx19 and idelalisib to treat r/r DLBCL (i.e., the limitations of instant claims 41 and 59-62. It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claims 46 and 47 are included because determining a sequence of therapeutic administration is considered routine experimentation by one with ordinary skill in the art in absence to evidence to the contrary. See MPEP § 2144.05(11).
Claim 48 is included because both App ‘185 and NTC03576443 teach treatment of patients that have a B-cell lymphoma (DLBCL).
Claim 53 is included because NTC03576443 teach treatment of humans with r/r DLBCL.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘185 in view of NTC03576443 especially in absence of evidence to the contrary. This is a provisional double patenting rejection.
Claims 41, 46-48, 53, and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24, and 27-36 of copending Application No. 17/271,108 (herein App '108, in Office Action mailed 7/25/2025) in view of Clinical Trial NTC03576443 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
App ‘108 claims methods of treating cancer comprising administration of the anti-CD19 ADC encompassed by instant claim 41 (claim 21), including human patients (claim 29), and including treating DLBCL (claim 33).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘108 in view of NTC03576443 for the same reasons discussed for App ‘185 supra, especially in absence of evidence to the contrary. This is a provisional double patenting rejection.
Claims 62 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24, and 27-36 of copending Application No. 17/271,108 (herein App '108, in Office Action mailed 7/25/2025) in view of Clinical Trial NTC03576443 (supra), as applied to claims 41, 46-48, 53, and 59-61, and further in view of Kahl et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by instant claims 41, 46-48, 53, and 59-61 is a prima facie obvious variant of the invention claimed by App ‘108 in view of NTC03576443. The combined reference do not teach a combination therapy to treat r/r DLBCL.
Kahl et al., in the same field of endeavor, teaches that ADCT-402 can be used to treat r/r DLBCL (entire document).
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 combined teachings of App ‘108 and NTC03576443 further in view of Kahl et al. to treat r/r DLBCL, as NTC03576443 teaches that idelalisib can be used to treat r/r DLBCL, and Kahl et al. teaches that ADCT-402 can be used to treat r/r DLBCL, and thus one with ordinary skill in the art would appreciate that the combination therapy of App ‘108 and NTC03576443 can be used to treat r/r DLBCL in view of Kahl et al.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘185 in view of NTC03576443 especially in absence of evidence to the contrary. This is a provisional double patenting rejection.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641