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 .
Status of the Claims
Claims 1-65 were originally filed 27 January 2023 and the preliminary amendment filed 19 June 2023 has been entered. Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, and 67-68 are currently pending and under consideration.
Withdrawn Rejections
In view of Applicant amending claim 1 to remove the clause “or a biosimilar thereof” and to clarify which agents are administered the 35 USC 112(b) rejection over claim 1 is hereby withdrawn.
In view of Applicant canceling claims 63 and 64 the 35 USC 112(b) rejection over said claims is hereby withdrawn.
In view of Applicant providing a statement of an obligation of assignment to “Elliot” the 35 USC 103 rejection over Elliot and Tilly as evidence by Drug Bank is hereby withdrawn
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.
The following rejection is being amended from the non-final mailed 3 November 2025.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Hutchings (see Hutchings et al. as cited on the IDS received 02/03/2026 pg. 11 of 16, #31), Tilly (as cited on the PTO-892 mailed 11/03/2025), US Patent Publication 2018/0194841 A1 (Referred to herein as Smith), Clinical Trial: NCT03467373 (referred to herein as Hoffman, record from 06/17/2020), and Phillips (see Phillips et al. (2020) Mosunetuzumab, a Novel CD20/CD3 Bispecific Antibody, in Combination with CHOP Confers High Response Rates in Patients with Diffuse Large B-Cell Lymphoma. Blood (2020) 136 (Supplement 1): 37–38) as evidenced by Drug Bank (as cited on the PTO-892 mailed 11/03/2025).
It is noted Examiner cited an alternative Hutchings document (i.e., as cited on the IDS received 08/02/2023 pg. 6 of 9, #33) in the Non-Final mailed 3 November 2025. However, Applicant has correctly identified the intended document (i.e., as cited on the IDS received 02/03/2026 pg. 11 of 16, #31; specifically, Hutchings et al. (2021) Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase ½ study, Lancet, Vol. 398, pgs. 1157-1169). Applicant has provided a pertinent response using the intended Hutchings reference which will be addressed after the amended rejection below (see Response to Non-Final received 02/03/2026, referred to herein as Remarks, pg. 9, last section).
Instant claim 1 is drawn to a treating DLBCL using a combination of epcoritamab and pola-R-CHP. Specifically, the claim recites 21 day cycles; however, as a whole the claim is understood as administering epcoritamab weekly for 12 weeks (i.e., cycles 1-4, see claim 1(a)(i) and (ii)) wherein the first two doses are a priming and intermediate dose followed by full doses at 24 or 48 mg before reducing the frequency of doses to 1 every 21 days (see claim 1(a)(iii)). In claim 1 parts (b-f) the claimed agents comprise an art recognized therapy known as pola-R-CHP (see below).
Tilly discloses DLBCL is the most common form of lymphoma (see Tilly pg. 352, 1st col. 1st para). Combination treatment with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (i.e., R-CHOP) have yielded substantial improvements in patient outcomes; however, up to 40% of patients are refractory or relapse after an initial response (see Tilly pg. 352, 1st col. 1st para). In order to improve therapeutic outcomes several strategies involving intensifying chemotherapy or rituximab (e.g., modifying doses and timing), addition of maintenance therapy, second generation anti-CD20 antibodies, or incorporating novel agents have been conducted yet have not shown a meaningful improvement in outcomes (see Tilly pg. 352, 1st col. 1st para). Tilly discloses a modified R-CHOP combination wherein vincristine is removed and polatuzumab vedotin is substituted (i.e., pola-R-CHP) (see Tilly pg. 352, para spanning cols. 1-2). In particular, a pola-R-CHP protocol comprising eight 21-day cycles of intravenously administering on day 1 the following:
1.8 mg/kg of body weight polatuzumab vedotin,
375 mg/m2 rituximab,
750 mg/m2 cyclophosphamide,
50 mg/m2 doxorubicin, and
oral administration of prednisone at 100mg daily from 1-5 days of the first six cycles; and
during cycles 7 and 8 intravenous administration of 375 mg/m2 rituximab (i.e., pola-R-CHP) (see Tilly pg. 353, 1st col. 3rd para; see instant claims 1, 17, 25, 29, and 34).
It is noted instant claim 1 is drawn to a method comprising (i.e., open language), therefore the additional cycles disclosed in Tilly are within the scope of instant claims 1, 17, 25, 29, and 34. Tilly also discloses CNS prophylaxis with intrathecal chemotherapy was permitted and G-CSF was required during the first six cycles of treatment for primary prophylaxis against neutropenia (see Tilly pg. 353, 1st col. last para). Consolidative radiotherapy at initial bulky disease sites or extranodal was permitted (see Tilly pg. 353, 1st col. last para). Patients had CD20+ DLBCL, an Eastern Cooperative Oncology Group performance status score of 0-2, a baseline International Prognostic Index (IPI) score between 2-5, patients with MYC, BCL2, BCL6 or a combination of these, and had not received prior treatment for lymphoma (see Tilly pg. 352, 2nd col. last para, Figure 1; see instant claims 46, 47, and 49). Comparison of patients receiving pol-R-CHP or R-CHOP showed similar safety profiles and no significant difference in peripheral neuropathy (see Tilly pg. 357, 2nd col. 1st para, para spanning pgs. 357-358). Treatment with pola-R-CHP showed significant progression-free survival benefit over the commonly prescribed R-CHOP (see Tilly pg. 359, 1st col. last para). Specifically, a 27% decrease in risk of disease progression, relapse, or death than with R-CHOP and a progression free survival at 2 years of 76.7% compared to 70.2% in R-CHOP (see Tilly para spanning pgs. 359-360). Tilly teaches “remissions appeared to be more durable with pola-R-CHP than with R-CHOP” (see Tilly pg. 360. 2nd col. last para). A phase three clinical study using pola-R-CHP in combination with dose attenuated chemotherapy was ongoing (see Tilly pg. 361, 2nd col. 2nd para). This is specifically pertinent to instant claim 1(b-f).
Hutchings discloses a phase 1/2 study for treating CD20+ positive B-cell non-Hodgkin lymphoma (B-NHL) wherein 53 patients were administered ≤24mg or 48mg of epcoritamab (see Hutchings pg. 1161 figure 1). Specifically, in cycle 1 cohort 10a and 11a were administered a priming dose of .016mg on day 1, an intermediate dose of 0.8mg, and either a full dose of 24mg or 48mg on days 15 and 22 (i.e., in a 21 day cycle, day 22 in Hutchings corresponds to day 1 of the next cycle) (see Hutchings pg. 5 of Hutchings appendix, Table S3; see instant claims 1-3, 11, 14, 67, and 68) followed by full doses on days 1, 8, 15, and 22 during cycle 2 (see Hutchings pg. 1160, 1st col, 1st para). Subsequent cycles 3-6 administer a full dose on day 1 and 15 before stepping down to 1 dose every 28 days (see Hutchings pg. 1160, 1st col. 1st para). Subjects were treated in 28 day cycles until disease progression or unacceptable toxicity was observed (see Hutchings pg. 1160, 1st col. 1st para; see instant claim 7). Hutchings discloses B-NHL patients included among others those with transformed diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (see Hutchings pg. 1159, 2nd col. 4th para; see instant claims 48 and 50). Hutchings discloses there is an unmet medical need for novel therapeutics that are safe, effective, and convenient for patients (see Hutchings pg. 1167, 1st col. 3rd para). Furthermore,
“Epcoritamab was well tolerated and had a manageable safety profile, with no treatment related adverse events leading to discontinuation or death, no cases of neutropenic fever, and no grade 3 or higher CRS events.” (see Hutchings pg. 1167, 2nd col. 1st para).
“As a single agent, epcoritamab showed anti-tumor activity in heavily pretreated patients with B-cell non-Hodgkin lymphoma, including those with relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. Clinically relevant response rates were observed at doses of 48 mg (88% overall response rate, 38% complete response) and 48–60 mg (91% overall response rate, 55% complete response) in patients with relapsed or refractory diffuse large B-cell lymphoma” (see Hutchings pg. 1167, 2nd col. 2nd para).
Simply put, Hutchings teaches 9 weekly doses of epcoritamab (i.e., cycles 1-2 and the first dose of cycle 3) before stepping down the frequency of doses whereas the instant claims are drawn to 12 weekly doses (i.e., claim 1(a)(ii), specifically cycle 4) before stepping down the frequency of doses.
Smith discloses bispecific CD3xCD20 antibodies can be administered after a priming and intermediate dose weekly (see Smith pg. 21, 2nd col. para [0202]). Regarding effective dosage and schedules of administration Smith teaches these may be determined empirically,
“for example, a patient progress can be monitored by periodic assessment, and the dose adjusted accordingly” (see Smith pg. 24, 2nd col. para [0224]) and
“The frequency of administration may also be adjusted during the course of treatment by a physician depending on the needs of the individual patient following clinical examination” (see Smith pg. 27, 2nd col. para [0249]).
Furthermore, either the first or second dose can be administered once or twice a week for up to 10 or more weeks (see Smith pg. 27, 2nd para [0246]). In a preferred embodiment the secondary and/or tertiary dose is administered 1-26 weeks after the immediately preceding dose (see Smith pg. 27, 2nd col. para [0247-0248]). It is noted Smith teaches the tertiary dose can be different from the initial and secondary doses (see Smith pg. 27, 1st col. para [0244]).
Regarding Applicant’s arguments the ordinary artisan would not have combined the instantly claimed T cell engager (i.e., epcoritamab) with the instantly claimed chemotherapeutic agents (e.g. doxorubicin, cyclophosphamide), both Phillips and Hoffmann demonstrate this was combination was common practice. Specifically, Phillips demonstrates mosunetuzumab (i.e., bispecific CD20xCD3 antibody) in combination with CHOP (i.e., doxorubicin, cyclophosphamide, prednisone, and visicristine) what effective in treating DLBCL with a 96% response rate and 85.2% complete response rate (see Phillips pg. 3 Table 1). While Hoffman is a clinical trial of a glofitamab (i.e., an alternative bispecific CD20xCD3 antibody) in combination with CHOP or R-CHOP (see Hoffman pg. 1 brief title, pgs. 4-5 experimental part 1, right col).
Therefore, an ordinary artisan would have combined treating DLBCL with epcoritamab as taught by Hutchings with pola-R-CHP as taught by Tilly as these are both art recognized equivalents (i.e., DLBCL treatments) for the same purpose to yield predictable results. There is a reasonable expectation of success given both treatments are individually effective at treating DLBCL and both therapies were being pursued in combination with other standard of care agents (see Tilly pg. 361, 2nd col. 2nd para; see Hutchings pg. 1168, 1st col. last para). It is noted Hutchings discloses administering epcoritamab which has sequences identical to the instantly claimed Seq ID Nos: 24-27 as evidenced by Drug Bank (see instant claims 63, 64, and 66).
Alternatively, the ordinary artisan would combine treating DLBCL with epcoritamab as taught by Hutchings with pola-R-CHP as taught by Tilly as both Phillips and Hoffmann teaches combining CD3xCD20 bispecific antibodies with the R-CHOP/CHOP agents (e.g., doxorubicin, cyclophosphamide) (e.g., glofitamab, mosunetuzumab) was common practice and Tilly teaches pola-R-CHP is more effective than R-CHOP.
Regarding the instantly claimed 21 day cycle as compared to the 28 day cycle taught by Hutchings. Tilly teaches the pola-R-CHP agents are given in a 21 day cycle. Hutchings teaches epcoritamab administered safely and effectively at a weekly dose for 9 weeks. Taken together, the ordinary artisan would be motivated to adjust the 28 day cycle taught by Hutchings to mirror the administration of the additional agents (i.e., a 21 day cycle) for convenience. There is a reasonable expectation of success given longer cycles with weekly administration were safe and effective.
Regarding the 3 additional weekly doses instantly claimed (i.e., cycle 4) as compared to the 9 weekly doses taught by Hutchings; Smith discloses the frequency of doses can be easily adjusted to 10 or more weekly doses depending on patient outcomes and clinical examination. Increasing the number of doses is merely routine optimization to achieve a clinical outcome (i.e., treating DLBCL (see claim 1 preamble), alternatively, complete response (see claim 1 bottom, specifically “wherein” clause)). There is a reasonable expectation of success that increasing the 9 weekly doses taught by Hutchings to the claimed 12 doses given the success (i.e., both safety and efficacy) of the 9 weekly doses.
Regarding the step down to a dose administered on day 1 starting is cycle 5. First, Hutchings teaches in cycles 3-6 doses are administered on days 1 and 15 of the 28 day cycle. When mapped out using the instantly claimed 21 day cycles to match the pola-R-CHP protocol taught by Tilly a dose of epcoritamab is administered on day one of cycle 5. The administration of additional doses in the same cycle is within the scope of the instant claims given the method is drawn to open language (i.e., comprising). Alternatively, maintaining weekly doses for 10 or more weeks (e.g., 13 weeks) as taught by Smith would also be within the scope of the instant claims. In yet another view, it is well within the ordinary artisan’s ability to step down dosing in response to a patient’s needs and clinical outcomes (e.g., maintenance dose). There is a reasonable expectation of success given Hutchings discloses multiple administration frequencies (i.e., weekly/bimonthly/monthly) that were safe and effective. In addition, Smith discloses initial/secondary/tertiary doses can vary from one to the next depending on the needs of the patient as well as the frequency.
Thus, the instant claims are drawn to a combination of two art recognized treatments for DLBCL (i.e., epcoritamab and pola-R-CHP) wherein the length of the epcoritamab administration has been modified for convenience of aligning combination therapy and optimized (i.e., increasing the number of weekly doses) based on patient needs, both of which are well within the abilities of a practicing clinician.
Applicant's arguments filed 3 February 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant has argued the following:
neither reference teaches of suggests the combination of epcoritamab and pola-R-CHP (see Remarks pg. 10, end of 3rd para),
examiner used improper hindsight (see Remarks pg. 11, 1st full para), and
the instantly claimed protocol has unexpected results (see Remarks pg. 12, 2nd and 3rd para).
First, Hutchings is relied upon for disclosing treatment of DLBCL safely and effectively with epcoritamab while Tilly is relied upon for disclosing treatment of DLBCL safely and effectively with pola-R-CHP. The reason to combine is combining prior art elements according to known methods to yield predictable results (see MPEP § 2143(1)(A)). In addition, Hoffman and Phillips provide a second motivation for combining as alternative CD3xCD20 T cell engagers have been effective in combination with R-CHOP/CHOP. There is a reasonable expectation of success for the reasons set forth above.
Second, In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Third, Applicant argues the instantly claimed protocol has unexpected results (see Remarks pg. 12, 2nd and 3rd para). Specifically, all four DLCBL patients treated with the claimed 24mg epcoritamab and pola-R-CHP combination achieves 100% overall response rate and 3 (i.e., 75%) achieved a complete response and that these results could not have been predicted (see Remarks pg. 14, 2nd para; see specification pg. 80 lines 5-9). First, Applicant’s allegedly unexpected results are not commensurate in scope with the instant claims which are drawn to administering 24mg and 48mg epcoritamab (see MPEP § 712.02(d)). Second, evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). Third, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Applicant has not compared their findings with the closest prior art. Therefore, Applicant’s allegedly unexpected results cannot be relied upon to overcome the USC 103 rejection set forth above.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 67, and 68 is drawn to a “wherein” clause with clinical outcomes (i.e., complete response (CR), disease progression, or unacceptable toxicity)). The scope of the wherein clause is unclear. For example, are the clinical outcomes drawn to after cycle 5, or alternatively, for any stage of treatment (i.e., claim 1(a)(i-iii)). To put another way is a patient who experience unacceptable toxicity in cycle 3 within the scope of claims 1, 67 and 68) or is the claim limited to subject who receive a minimum of 5 cycles.
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, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7, 9-14, 33-36, 38, 41, 46, and 66 of copending Application No. 18/833267 (referred to herein as ‘267 application) as evidenced by Drug Bank (see Drug Bank Epcoritamab, accessed online 10/21/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 11, 12, 20, 29, 39,44, 46, 48, 49, 54, 60, 61, 67, 72, 83, 98, and 100 of copending Application No. 18/855842 (referred to herein as ‘842 application) in view of Tilly (see Tilly et al. (2022) Polatuzumab vedotin in previously untreated diffuse large B-Cell Lymphoma. N ENGL J MED 386;4, pgs. 351-363), Smith, Hoffman, and Phillips.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 9-11, 12-14, and 40 of copending Application No. 18/833261 (referred to herein as ‘261 application) in view of Tilly, Smith, Hoffman and Phillips as evidence by Drug Bank.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 11, 14, 29-31, 33, 40-43, 65, and 66 of copending Application No. 18/160386 (referred to herein as ‘386) in view of Tilly, Smith, Hoffman and Phillips.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 12, 15, 17, 20, 23, 26, 29, 47-50, and 64 of copending Application No. 18/500799 (referred to herein as ‘799 application) in view of Tilly, Smith, Hoffman and Phillips.
Claims 1, 3, 7, 11, 14, 17, 25, 29, 34, 46-50, 67, and 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 16 of copending Application No. 18/664772 (referred to herein as ‘772 application) in view of Tilly, Smith, Hoffman and Phillips as evidenced by Drug Bank.
Claims 1, 3, 7, 11, 14, 17, 25, 29, 34, 46-50, 67, and 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 16 of copending Application No. 18/664772 (referred to herein as ‘772 application) in view of Tilly, Smith, Hoffman and Phillips as evidenced by Drug Bank.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, 66, 67, and 68 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/664757 (referred to herein as ‘757 application) in view of Tilly, Smith, Hoffman and Phillips.
Therefore, an ordinary artisan would substitute the pharmaceutical composition claimed in the ‘757 applicant in a method of treating DLBCL as taught by Hutchings in combination with the pola-R-CHP taught by Tilly. The reason to do so would be to improve standard of care treatments of DLBCL as taught by both Tilly, Hutchings, Smith, Phillip and Hoffman (see above). Furthermore, both the ‘757 application and Hutchings are drawn to identical products (i.e., epcoritamab) and therefore there is a reasonable expectation of success the pharmaceutical composition claimed in the ‘757 application can be administered in the manner, amount, frequency, duration taught by Hutchings. Furthermore, combining the pola-R-CHP taught by Tilly with the epcoritamab therapy taught by Hutchings is a combination of two art recognized equivalents (i.e., DLBCL treatment) to yield predictable results (i.e., improved therapeutic outcomes over standard of care therapies).
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, 66, 67, and 68 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/635258 (referred to herein as ‘258 application) in view of Tilly, Smith, Hoffman and Phillips.
Therefore, an ordinary artisan would substitute the aqueous formulation claimed in the ‘258 application in a method of treating DLBCL as taught by Hutchings in combination with the pola-R-CHP taught by Tilly. The reason to do so would be to improve standard of care treatments of DLBCL as taught by both Tilly, Hutchings, Smith, Phillips, and Hoffman (see above). Furthermore, both the ‘258 application and Hutchings are drawn to identical products (i.e., epcoritamab) and therefore there is a reasonable expectation of success given aqueous formulation claimed in the ‘258 application can be administered in the manner, amount, frequency, duration taught by Hutchings and Smith. Furthermore, combining the pola-R-CHP taught by Tilly with the epcoritamab therapy taught by Hutchings is a combination of two art recognized equivalents (i.e., DLBCL treatment) to yield predictable results (i.e., improved therapeutic outcomes over standard of care therapies).
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, 66, 67, and 68 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/635258 (referred to herein as ‘258 application) in view of Tilly, Smith, Hoffman and Phillips.
The teachings of Tilly, Smith, Hoffman and Phillips are set forth above. Therefore for the reasons made of record and the teachings set forth above the non-statutory double patenting rejections set forth above are hereby maintained.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-28 of U.S. Patent No. 11,858,995 B2 (referred to herein as ‘995 patent) in view of Tilly.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 14, 16-18, 26, and 27 of U.S. Patent No. 11,548,952 B2 (referred to herein as ‘952 patent as seen on IDS received 08/02/2023 pg. 1 #3) in view of Tilly.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, 26, and 27 of U.S. Patent No. 11,535,679 B2 (referred to herein as ‘679 patent, as cited on the IDS received 08/02/2023 pg. 1 #4) in view of Tilly.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 8, 15-17, 24, and 29 of U.S. Patent No. 11,845,805 B2 (referred to herein as ‘805 patent) in view of Tilly.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6-9, and 13-18 of US Patent 11,608,383 B2 (referred to herein as ‘383 patent, as cited on the IDS received 08/02/2023 pg. 1, #2) in view of Tilly.
The above non-statutory double patenting rejections above are hereby maintained for the reasons made of record.
Claims 1-3, 7, 11, 14, 17, 25, 29, 34, 46-50, 63, 64, and 66-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following:
Claims 1-3, 12, 16, 17-19, 41, 42, 44, 46, and 47-49 of copending Application No. 18/025202 (referred to herein as ‘202 application),
Claims 1-3, 12, 15, 17, 20, 23, 29, 33, 34, 35-38, 47-50, 64, and 65 of copending Application 18/025203 (referred to herein as ‘203 application),
Claims 1-3, 7, 9, 12, 15, 18, 27, 28, 34, and 48-51 of copending Application 18/025204 (referred to herein as ‘204 application),
Claims 1-8, 10-15, 24, 25, 31-33, 47, and 48 of copending Application 18/025205 (referred to herein as ‘205 application), and
Claims 69, 70, 72, 73, 82, 98-100 of copending Application 17/923317 (referred to herein as ‘317 application),
in view of Tilly.
The above provisional nonstatutory double patenting rejections are hereby maintained for the reasons made of record.
Conclusion
No claim allowed.
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/H.A.P./
Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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