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 – 20 were pending. No claims have been amended, canceled, or newly added. Claims 1 – 20 are currently pending and are the subject of this Office Action.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 02/09/2025 and 05/05/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 103
Claims 1 – 13 and 18 – 20 were rejected under 35 U.S.C. 103 as being unpatentable over LOIBNER (WO 2015/075194 A1, published 05/28/2015; see PTO-892: Notice of References Cited of 08/08/2025).
After further consideration, this rejection is withdrawn.
Claims 14 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over LOIBNER as applied to claims 1 – 13 and 18 – 20 above, and further in view of BAKER (Baker DL, et al. Outcome after reduced chemotherapy for intermediate-risk neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1313-23; see PTO-892 of 08/08/2025).
After further consideration, this rejection is withdrawn.
Double Patenting
Claims 1 – 20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of U.S. Patent No. 10,294,305 in view of LOIBNER, BAKER, and PEARSON.
After further consideration, this rejection is withdrawn.
Claims 1 – 20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 19 of U.S. Patent No. 9,777,068 in view of LOIBNER, BAKER, and PEARSON.
After further consideration, this rejection is withdrawn.
Claims 1 – 20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 16 of U.S. Patent No. 9,840,566 in view of LOIBNER, BAKER, and PEARSON.
After further consideration, this rejection is withdrawn.
Claims 1 – 20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,995,147 in view of LOIBNER, BAKER, and PEARSON.
After further consideration, this rejection is withdrawn.
NEW REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3, 5 – 7, 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over FURMAN (Furman WL, et al. A Phase II Trial of Hu14.18K322A in Combination with Induction Chemotherapy in Children with Newly Diagnosed High-Risk Neuroblastoma. Clin Cancer Res. 2019 Nov 1;25(21):6320-6328; see PTO-892: Notice of References Cited submitted with this Office Action).
The present application is directed to a method of treating a newly diagnosed neuroblastoma in a patient by administering chimeric anti- GD2 antibody dinutuximab beta to the patient in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2.
According to the present specification, dinutuximab beta is also referred to as ch14.18/CHO or APN311 and that a humanized version of ch14.18 is known as hu14.18K322A (p. 3 lines 5 – 7 and p. 2, lines 32 – 33).
FURMAN is directed an evaluation on whether combining a humanized antidisialoganglioside (anti-GD2) mAb (hu14.18K322A) with induction chemotherapy improves early responses and outcomes in children with newly diagnosed high-risk neuroblastoma. See FURMAN at Abstract: Purpose. FURMAN teaches that adding hu14.18K322A to induction chemotherapy produced early partial response (PR) or better in most patients, reduced tumor volumes, improved Curie scores (CSs) at the end of induction, and yielded an encouraging 2-year event-free survival (EFS). See FURMAN at Abstract: Conclusions.
FURMAN teaches that a chimeric anti-GD2 antibody (dinutuximab) in combination with granulocyte–macrophage colony-stimulating factor (GM-CSF), IL2, and isotretinoin administered at the end of therapy, in the context of MRD, significantly improves 2-year event-free survival (EFS; 66% vs. 46%; P = 0.01). See FURMAN at Introduction, first paragraph. Thus, although FURMAN uses the humanized version of dinutuximab, it would have been obvious to use dinutuximab because FURMAN teaches that dinutuximab also significantly improves EFS.
FURMAN teaches that four daily doses of hu14.18K322A (days 2–5) were added to each course of induction chemotherapy and that the hu14.18K322A dosage was fixed at 40 mg/m2 per dose. See FURMAN at Treatment, p. 6321, right column). Thus, because FURMAN teaches a cumulative dose of 160 mg/m2, FURMAN teaches the claimed cumulative dose of up to 500 mg/m2 of present claim 1, and because FURMAN teaches a dosage was fixed at 40 mg/m2 per dose, FURMAN teaches the limitations of claim 3.
As discussed above, FURMAN also teaches the claimed dose of up to 100 mg/m2 per cycle during one or more cycles of induction chemotherapy of present claim 2; the dose per cycle of 20 mg/m2 to 100 mg/m2 during one or more cycles of induction chemotherapy of present claim 5; the dose of up to 100 mg/m2 per cycle during one or more cycles of induction chemotherapy of present claim 6; and the cumulative dose of up to 500 mg/m2 of present claim 7; treatment density of at least 1 mg/m2/day of present claim 9; a cumulative dose of up to 500 mg/m2 of present claim 12.
Thus, at the effective filing date of the present application, it would have been obvious to arrive to the claimed method of present claim 1 with the teachings of FURMAN because FURMAN renders the methods of claims 1 – 3, 5 – 7, 9 and 12 obvious.
Response to Arguments
On p. 2 of the reply of 02/09/2026, Applicant argues that “the Office has focused on a statement on page 12 of Loibner, which reads: ‘The patient may have previously been treated or may be simultaneously treated with one or more other therapies, such as e.g. surgery, chemotherapy, radiation...’(emphasis added). Consequently, the Office asserts that Loibner suggests the simultaneous administration of a chimeric anti-GF2 antibody, such as dinutuximab beta, with induction chemotherapy. We respectfully disagree. The teaching in Loibner about former or simultaneous treatment is general. First, it relates to two alternative options: (1) that the patient has received previous treatment, such that the anti-GD2 antibody is not a first-line therapy, and (2) that some form of other treatment may be given ‘simultaneously’ with another therapy without actually defining any particular new regimen. Second, the sentence simply indicates that these two options relate to ‘one or more other therapies.’ What follows is then merely a general list of possible other therapies, but is not concretely tied to one or both of the specific options earlier in the sentence.”
On p. 3, second paragraph, of the reply, Applicant further argues that “Loibner does not explicitly disclose induction chemotherapy. In a broad reasonable interpretation, the term ‘chemotherapy’ is itself very broad and does not relate to any specific type or schedule of chemotherapy. In particular, Loibner does not explicitly disclose induction chemotherapy. In a broad reasonable interpretation, the term ‘chemotherapy’ encompasses various treatment phases, for example, consolidation and rescue therapy. Hence, the reference in Loibner to chemotherapy alone does not provide an unambiguous suggestion of induction chemotherapy, as required by the present claims. Without such a suggestion, a person of ordinary skill in the art would rely only on what was already known or common in the art. Notably, the Office has not identified any prior disclosure of a combination of anti-GD2 immunotherapy with induction chemotherapy, and so a skilled person would not have been taught or suggested to do so by the general statement in Loibner. Moreover, Loibner does not identify or suggest any particular chemotherapeutic agents or combination thereof that may be effective in conjunction with an anti-GD2 antibody.”
Applicant’s argument has been considered and thus FURMAN has been applied to present claims 1 – 3, 5 – 7, 9, and 12. As discussed above, FURMAN teaches that induction chemotherapy was coadministered with hu14.18K322A, the humanized version of dinutuximab; teaches that dinutuximab has had a similar success in the treatment of neuroblastoma; and teaches the dosing regimens of present claims 1 – 3, 5 – 7, 9 and 12.
On p. 4, second paragraph, of the reply, Applicant argues that “[i]t is not a question of whether prior art treatment regimens for neuroblastoma included some form of induction chemotherapy, but rather, whether there would have been any motivation to combine anti-GD2 immunotherapy ‘during’ the induction phase of chemotherapy.” However, FURMAN teaches the combination as discussed above.
Claims 4, 8, 10 – 11, 13 and 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over FURMAN as applied to claims 1 – 3, 5 – 7, 9 and 12 above, and further in view of LOIBNER (WO 2015/075194 A1, published 05/28/2015; see PTO-892: Notice of References Cited of 08/08/2025).
The teachings of FURMAN are presented above and are incorporated here. Although FURMAN teaches the method of present claims 1 and 2 (from which claims 4 or 10 or 11 depend from), FURMAN does not expressly teach the dosages recited in claims 4, 8, 10 – 11, 13 and 17.
LOIBNER is directed to preparations and methods for treating a GD2 positive cancer by administering a preparation comprising a chimeric or humanized anti-GD2 antibody to a patient. See abstract. LOIBNER teaches a method of treating neuroblastoma (see LOIBNER at claims 1 and 19 – 20) using the anti-GD2 antibody 14.18 antibody or ch14.18/CHO (see LOIBNER at claim 6), which is the same antibody of the present application, and also discloses that another version of the 14.18 anti-GD2 antibody is hu14.18K322A (see LOIBNER at p. 3, third paragraph). LOIBNER further teaches that the patient may have previously been treated or may be simultaneously treated with one or more other therapies, such as e.g. surgery, chemotherapy (see p. 12, last sentence of second to last paragraph).
Regarding claim 4, LOIBNER teaches that the anti-GD2 antibody may be administered in a dose of 10, 20, 25, 50, 60, 65, 68, 70, 75, 80, 100, 120, 150, 200, 210, 250, or 300 mg/m2/cycle or any range in between these doses (see p. 16, second paragraph) and that a treatment cycle may be repeated, either identically or in an amended form, e.g. with a different dose or schedule (see p. 11, second paragraph). Thus, it would have been obvious that a dose per cycle that varies by up to 20 mg/m2 between different cycles as recited in present claim 4.
Regarding claims 8 and 10 – 11 and 18 – 20, LOIBNER discloses that anti-GD2 antibody may be administered in daily antibody doses of 1 to 30 mg/m2, 1 to 35 mg/m2, 1 to 50 mg/m2, or 1 to 60 mg/m2, e.g. 1, 2, 3, 4, 5, 6, 7, 7.5, 8, 9, 10, 12, 13, 14, 15, 16, 17, 17.5, 18, 19, 20, 25, 30, 32, 35, 40, 45, 50, or 60 mg/m2 or any range in between these doses (see p. 15, last paragraph). Thus, LOIBNER renders the doses of the present claims obvious – specifically, a dose of up to 100 mg/m2 per cycle during one or more cycles of induction chemotherapy as recited in present claim 6, the treatment density of up to 5 mg/m2/day as recited in present claim 8 (or claim 10 or claim 11) or the doses of present claims 18 – 20. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Regarding claim 13, LOIBNER teaches that an anti-GD2 antibody is administered as continuous intravenous infusion for 24 hours per day for 4, 5, 10, 14, 15 or 21 consecutive days or any range in between these periods, in daily doses as specified above (e.g. 7, 10, 15, 17.5, 20, or 25 mg/m2/day), e.g. 15, 17.5, 20, or 25 mg/m2/day for 4 days, 20 mg/m2/day for 5 days, 10 mg/m2/day for 10 days, 15 mg/m2/day for 10 days, 7 mg/m2/day for 14 days, 15 mg/m2/day for 14 days, 10 mg/m2/day for 15 days, 7 mg/m2/day for 21 days, or 10 mg/m2/day for 21 days or any range in between these doses. See LOIBNER at p. 19, first paragraph.
Regarding claims 19 and 20, in addition to the doses disclosed by LOIBNER discussed above, LOIBNER also teaches that an anti-GD2 antibody may also be administered for 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, or more consecutive days (see p. 18, third paragraph), and anti-GD2 antibody is administered to the patient as a continuous intravenous infusion for one or more days (see abstract, p.1-1st paragraph, and paragraph bridging pp. 16-17) , rendering “wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient on consecutive days of a cycle until all of the dose per cycle of the chimeric anti-GD2 antibody dinutuximab beta has been administered” of present claims 19 and 20 obvious.
Claim 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over FURMAN as applied to claims 1 – 3, 5 – 7, 9 and 12 above, and further in view of BAKER (Baker DL, et al. Outcome after reduced chemotherapy for intermediate-risk neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1313-23; see PTO-892).
The teachings of FURMAN are presented above and are incorporated here. Although FURMAN teaches the method of present claim 1 (from which claims 14 and 16 depend from, directly and indirectly, respectively) and further FURMAN teaches that the induction chemotherapy agents were cyclophosphamide, topotecan, cisplatin, etoposide, doxorubicin, and vincristine, FURMAN does not expressly teach the chemotherapy steps as recited in present claim 14 (from which claim 16 depends).
BAKER is directed to prospective, phase 3, nonrandomized trial to determine whether a 3-year estimated overall survival of more than 90% could be maintained with reductions in the duration of therapy and drug doses, using a tumor biology-based therapy assignment, where the patients had newly diagnosed, intermediate-risk neuroblastoma. See Abstract: Methods. BAKER discloses four to six cycles of cisplatin, etoposide, and vindesine, alternating with doxorubicin, ifosfamide, vincristine, and dacarbazine every 3 weeks. See Table 3, second to last sentence of the caption.
Thus, because FURMAN renders the method of claim 1 obvious and BAKER discloses the induction therapy of claim 14, it would have been obvious to modify FURMAN’s method with BAKER’s chemotherapy. There would have been a reasonable expectation of success given that anti- GD2 antibody dinutuximab beta and cisplatin, etoposide, and vindesine, alternating with doxorubicin, ifosfamide, vincristine, and dacarbazine have been known to treat neuroblastoma as evidenced by the applied prior art.
Regarding claim 16, FURMAN teaches that four daily doses of hu14.18K322A (days 2–5) were added to each course of induction chemotherapy and that the hu14.18K322A dosage was fixed at 40 mg/m2 per dose. See FURMAN at Treatment, p. 6321, right column), which is a cumulative dose of 160 mg/m2.
It would have been prima facie obvious to a person of ordinary skill in the art to arrive at the claimed invention from the disclosures of FURMAN and BAKER at the effective filing date of the present application. The artisan would have been motivated to use the methods of claims 14 and 16 because FURMAN teaches adding an anti-GD2 antibody to induction chemotherapy yielded an encouraging 2-year event-free survival (EFS) and BAKER teaches the claimed chemotherapy had a very high rate of survival among neuroblastoma patients. Thus, the artisan would have a reasonable expectation of success with the teachings of FURMAN and BAKER.
Response to Arguments
On p. 4, third paragraph, of the reply of 02/09/2026, Applicant argues that “Baker relates to the treatment of localized neuroblastoma, for which immunotherapy is not typically used; rather, Baker focuses on resection and chemotherapy as treatments. Conversely, whilst the immunotherapy method of Loibner relates to GD2-positive cancer in general, including the treatment of neuroblastoma, it does not suggest treatment of a localized neuroblastoma. Therefore, for at least there reasons, there was no motivation to combine Loibner and Baker to arrive at the presently claimed methods.”
Applicant’s argument is not persuasive because BAKER does not appear to limit its disclosure to “localized” neuroblastoma. Nonetheless, because FURMAN renders a method of claim 1 obvious as discussed above and BAKER teaches the administration of the induction chemotherapy of claim 14 obvious as discussed above, it would have been obvious to combine the teachings of FURMAN and BAKER with a reasonable expectation of success.
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over FURMAN as applied to claims 1 – 3, 5 – 7, 9 and 12 above, and further in view of PEARSON (Pearson, Andrew DJ et al. “High-Dose Rapid and Standard Induction Chemotherapy for Patients Aged over 1 Year with Stage 4 Neuroblastoma: A Randomised Trial.” The lancet oncology 9.3 (2008): 247–256; see PTO-892 of 08/08/2025).
The teachings of FURMAN are presented above and are incorporated here. Although FURMAN teaches the method of present claim 1 (from which claims 15 and 17 depend from, directly and indirectly, respectively), FURMAN does not expressly teach the chemotherapy steps as recited in present claims 15 and 17.
PEARSON is directed to an intensive chemotherapy protocol that had a 10-day interval between treatments would improve event-free survival (EFS) in patients aged 1 year or over with high-risk neuroblastoma, where patients were randomly assigned to rapid treatment (cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C], known as COJEC) or standard treatment (vincristine [O], cisplatin [P], etoposide [E], and cyclophosphamide [C], ie, OPEC, alternated with vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C], ie, OJEC). See Summary: Background and Summary: Methods.
The regimen of present claim 15 seems to be alternating OJE and OCE with OP in between. Although this differs slightly from PEARSON’s alternating OJEC and OPEC, it would have been obvious to come to a method of present claim 15 by routine optimization. There would have been reasonable expectation of success given that the five chemotherapy drugs have been known to successfully treat neuroblastoma while administered in alternating sets similar to those of present claim 15, as evidenced by PEARSON.
Regarding claim 17, FURMAN teaches that four daily doses of hu14.18K322A (days 2–5) were added to each course of induction chemotherapy and that the hu14.18K322A dosage was fixed at 40 mg/m2 per dose. See FURMAN at Treatment, p. 6321, right column), which is within the range of a cumulative dose of 120 to 260 mg/m2.
It would have been prima facie obvious to a person of ordinary skill in the art to arrive at the claimed invention from the disclosures of FURMAN and PEARSON at the effective filing date of the present application. The artisan would have been motivated to use the methods of claims 15 and 17 because FURMAN teaches adding an anti-GD2 antibody to induction chemotherapy yielded an encouraging 2-year event-free survival (EFS) and PEARSON teaches the claimed chemotherapy and that it improved event-free survival (EFS) in patients aged 1 year or over with high-risk neuroblastoma (see PEARSON at Summary). Thus, the artisan would have a reasonable expectation of success with the combined teachings of FURMAN and PEARSON.
Response to Arguments
On p. 4, under “Loibner and Pearson” – p. 5, second paragraph, Applicant argues that “[f]irst, the teachings of Loibner do not form the basis for obviousness when combined with Pearson, because Claim 1 is not obvious in view of Loibner alone (as discussed above). Moreover, Pearson does not cure the deficiencies of Loibner because Pearson provides no suggestion to combine an anti-GD2 immunotherapy with induction chemotherapy.”
However, claim 1 is rendered obvious over FURMAN as discussed above and PEARSON teaches the chemotherapy of claims 15 and 17 as discussed above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 21 of U.S. Patent No. 10,294,305 in view of FURMAN, LOIBNER, BAKER, and PEARSON.
Patented claim 1 recites a method of treating neuroblastoma in a human patient comprising administering ch14.18 antibody in at least one treatment cycle, the at least one treatment cycle comprising at least one treatment period and optionally one or more days of no administration of the ch14.18 antibody to the patient between repeated treatment periods, wherein the treatment period is one or more consecutive days when the ch14.18 antibody is administered to the patient, the ch14.18 antibody being administered in a dose of or between 10 to 20 mg/m2/day by intravenous infusion over 10 to 24 hours per day to the patient without administering IL-2 within the same one or more treatment cycles, wherein the ch14.18 antibody comprises a heavy chain and a light chain, the heavy chain having an amino acid sequence comprising SEQ ID NO:4 and the light chain having an amino acid sequence comprising SEQ ID NO:3, and wherein a neuroblastoma is treated in the patient.
The main difference between the present claims and the patented claims is the administering in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2. However, FURMAN, LOIBNER, BAKER, and PEARSON disclose this difference. The teachings of FURMAN, LOIBNER, BAKER, and PEARSON, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 103 above.
Because the patented claims recite method of treating neuroblastoma in a human patient comprising administering ch14.18 antibody and FURMAN, LOIBNER, BAKER, and PEARSON teach that the anti-GD2 antibody may be administered in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2, it would have been obvious to one having ordinary skill in the art to modify the method of the patented claims with the chemotherapy and cumulative dose of FURMAN, LOIBNER, BAKER, and PEARSON. There would have been a reasonable expectation of success given that a chimeric anti- GD2 antibody dinutuximab beta and chemotherapy have been known to successfully treat neuroblastoma as evidenced by the applied prior art.
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 19 of U.S. Patent No. 9,777,068 in view of FURMAN, LOIBNER, BAKER, and PEARSON.
Patented claim 1 recites a method for treating a patient with a GD2 positive cancer in a manner such that a side effect of pain is substantially reduced in the patient during treatment comprising administering a preparation comprising a chimeric anti-GD2 antibody, wherein the chimeric anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0, to the patient as a continuous intravenous infusion over 24 hours per day, wherein the preparation is administered to the patient in a daily dose of 1 to 25 mg/m2 of the chimeric anti-GD2 antibody and in a dose of 50 to 150 mg/m2/cycle of the chimeric anti-GD2 antibody, and wherein a side effect of pain is substantially reduced compared to a non-continuous infusion schedule of the preparation comprising the chimeric anti-GD2 antibody.
The main difference between the present claims and the patented claims is the administering in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2. However, FURMAN,LOIBNER, BAKER, and PEARSON disclose this difference. The teachings of FURMAN, LOIBNER, BAKER, and PEARSON, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 103 above.
Because the patented claims recite a method for treating a patient with a GD2 positive cancer in a manner such that a side effect of pain is substantially reduced in the patient during treatment comprising administering a preparation comprising a chimeric anti-GD2 antibody, wherein the chimeric anti-GD2 antibody is ch14.18/CHO and FURMAN, LOIBNER, BAKER, and PEARSON teach that the anti-GD2 antibody may be administered in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2, it would have been obvious to one having ordinary skill in the art to modify the method of the patented claims with the chemotherapy and cumulative dose of FURMAN, LOIBNER, BAKER, and PEARSON. There would have been a reasonable expectation of success given that a chimeric anti- GD2 antibody dinutuximab beta and chemotherapy have been known to successfully treat neuroblastoma as evidenced by the applied prior art.
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 16 of U.S. Patent No. 9,840,566 in view of FURMAN, LOIBNER, BAKER, and PEARSON.
Patented claim 1 recites a method of treating a GD2 positive cancer in a patient comprising administering a preparation comprising a chimeric or humanized anti-GD2 antibody to the patient without concomitantly administering IL-2 within the same treatment cycle and/or within the same overall treatment period, wherein the anti-GD2 antibody is administered to the patient in a dose of 1 to 25 mg/m2/day and 50 to 150 mg/m2/cycle as a continuous infusion for 24 hours per day, and wherein a GD2 positive cancer is treated in the patient.
Patented claim 4 recites that the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0.
Patented claim 7 recites that the preparation is administered to the patient in a daily dose of 1 to 15 or 1 to 20 mg/m2; patented claim 8 recites that the preparation is administered to the patient in a daily dose of 7, 7.5, 8, 9, 10, 12, 13, 14, 15, 16, 17, 17.5, 18, 19, 20, or 25 mg/m2; patented claim 9 recites that the preparation is administered to the patient in a dose of 10 mg/m2/day for 10 consecutive days or in a dose of 15, 17.5, 20, or 25 mg/m2/day for 4 consecutive days.
Patented claim 13 recites that the GD2 positive cancer is neuroblastoma.
The main difference between the present claims and the patented claims is the administering in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2. However, FURMAN, LOIBNER, BAKER, and PEARSON disclose this difference. The teachings of FURMAN, LOIBNER, BAKER, and PEARSON, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 103 above.
Because the patented claims recite a method of treating a GD2 positive cancer in a patient comprising administering a preparation comprising a chimeric or humanized anti-GD2 antibody to the patient and FURMAN, LOIBNER, BAKER, and PEARSON teach that the anti-GD2 antibody may be administered in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2, it would have been obvious to one having ordinary skill in the art to modify the method of the patented claims with the chemotherapy and cumulative dose of FURMAN, LOIBNER, BAKER, and PEARSON. There would have been a reasonable expectation of success given that a chimeric anti- GD2 antibody dinutuximab beta and chemotherapy have been known to successfully treat neuroblastoma as evidenced by the applied prior art.
Claims 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,995,147 in view of FURMAN, LOIBNER, BAKER, and PEARSON.
Patented claim 1 recites a method of treating a high-risk neuroblastoma in a pediatric patient, the method comprising: administering to the patient a ch14.18/SP2/0 chimeric anti-GD2 antibody at a dose of 17.5 mg/m2/day as an intravenous infusion over 10 or more hours per day up to 20 hours per day over 4 consecutive days in a cycle having from 24 to 32 days, for at least 1 and up to 5 cycles.
The main difference between the present claims and the patented claim is the administering in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2. However, FURMAN, LOIBNER, BAKER, and PEARSON disclose this difference. The teachings of FURMAN, LOIBNER, BAKER, and PEARSON, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. 103 above.
Because the patented claim recites a method of treating a high-risk neuroblastoma in a pediatric patient, the method comprising: administering to the patient a ch14.18/SP2/0 chimeric anti-GD2 antibody and FURMAN, LOIBNER, BAKER, and PEARSON teach that the anti-GD2 antibody may be administered in combination with induction chemotherapy, wherein the chimeric anti-GD2 antibody dinutuximab beta is administered to the patient during the induction chemotherapy at a cumulative dose of up to 500 mg/m2, it would have been obvious to one having ordinary skill in the art to modify the method of the patented claim with the chemotherapy and cumulative dose of FURMAN, LOIBNER, BAKER, and PEARSON. There would have been a reasonable expectation of success given that a chimeric anti-GD2 antibody dinutuximab beta and chemotherapy have been known to successfully treat neuroblastoma as evidenced by the applied prior art.
Response to Arguments
On pages 5 – 6, of the reply of 02/09/2026, Applicant argues that the patented claims of the patents is the nonstatutory double patent rejections do not teach induction therapy with an anti-GD2 antibody, and as noted above, Loibner, Baker, and Pearson fail to cure these deficiencies in claim 1 of the patents. However, as discussed above, FURMAN teaches a method of administrating induction therapy with an anti-GD2 antibody of present claim 1; LOIBNER teaches additional dosing regimens claimed; and BAKER and PEARSON teach the claimed chemotherapy as discussed above. Thus, the double patenting rejections are maintained.
Conclusion
Claims 1 – 20 are rejected.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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