DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of the invention of Group II (claims 2-17) in the reply filed on 12/12/2005 is acknowledged.
Claim 1 is withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention.
Claims 2-17 are presently under consideration.
3. Applicant's claim for domestic priority under 35 U.S.C. 119(e) and 35 U.S.C. 120 is acknowledged. Provisional applications USSN 62843190, 62855828, 62868262, 62931669, and 62944903, and non-provisional application USSN 16865369, upon which priority is claimed, fail to provide adequate support under 35 U.S.C. 112 for claims 2-17 of this application.
Specifically, priority applications fail to provide adequate support under 35 U.S.C. 112 for the limitations of administering a steroid when the patient experiences Grade 1 or 2 CRS, or Grade 1 neurologic toxicity. To the contrary, the specification of each of the priority applications listed above contains Table 1, which specifies that steroids are administered for Grade 3 CRS, or for Grade 2 CRS only if there is no improvement within 24 hours after starting tocilizumab, and Table 2, which specifies that steroids are administered for Grade 2 neurologic toxicity.
Consequently, claims 2-17 have been accorded the priority of the filing date of the instant application, i.e. 02/10/2023.
Should Applicant disagree with the Examiner’s determination, it is incumbent upon Applicant to provide a showing that specifically supports the above claim limitations.
4. As pointed out in section 3 above, this application claims subject matter not presented in priority application USSN 16865369. Since this application names an inventor or inventors named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to obtain the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120 and 37 CFR 1.78. Applicant is required to amend the first paragraph of the specification to reflect the correct status of this application as a continuation-in-part of the prior application.
5. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP §608.01(o). Correction of the following is required:
Applicant is requested to identify the written support for claims 2-4 and 17, particularly the claimed limitations of administering a steroid when the patient experiences Grade 1 or 2 CRS, or Grade 1 neurologic toxicity. Alternatively, Applicant is required to amend the specification to provide antecedent basis for the claimed subject matter.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 2-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Topp et al. (2019) alone, or as evidenced by Locke et al. (2019) and/or Neelapu et al. (2018)
Topp describes clinical trial (ZUMA-1) of axicabtagene ciloleucel in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Axicabtagene ciloleucel is an autologous anti-CD19 CAR T cell therapy. Patients (median age 63 years, range 36 – 73) received early steroid intervention starting at Grade 1 neurologic adverse events and at Grade 1 CRS when no improvement was observed after 3 days of supportive care, and most patients received tocilizumab. Topp concludes that early use of steroids may help in managing severe CRS and neurologic events by potentially reducing their incidence in patients treated with CAR T cell therapy without affecting response rates. Accordingly, Topp explicitly teaches all of the limitations of claims 2-5, 7, 11-12 and 14-17, thereby anticipating these claims.
Claim 6 lists the common symptoms of neurologic toxicity, i.e. the limitations of claim 6 are inherent in Topp’s teachings of neurologic adverse events. Furthermore, these symptoms were observed in ZUMA-1 trial, as evidenced by Locke (e.g. Table 1 at p. 38).
Claims 8-10 are included in the rejection, because intravenous administration of dexamethasone at about 10 mg, one to four times a day was a common regimen before the effective fling date of the claimed invention (see e.g. Neelapu Table 3 at p. 54), and as such would be at once envisaged by those skilled in the art.
Claim 13 is included, because anti-CD20 antibody treatment and anthracycline chemotherapy were common first-line treatments for BCL and ALL before the effective fling date of the claimed invention, and as such would be at once envisaged by those skilled in the art. Furthermore, Locke provides evidence that patients in ZUMA-1 trial had previously received an anti-CD20 monoclonal antibody containing-regimen and an anthracycline-containing chemotherapy (e.g. the Abstract).
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 2-3, 5, 7-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 17/774720, published as US 20220387492.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘720, which recite protocols for managing CRS in mantle cell lymphoma (claim 23) and B cell ALL (claim 26) patients treated with anti-CD19 CAR-T cells (claim 1).
The protocols call for administering tocilizumab in Grade 2 CRS, and if no improvement occurs within 24 hours, managing per Grade 3. Managing Grade 3 includes administering dexamethasone at 10 mg intravenously every 6 hours. Accordingly, USSN ‘720 claims recite administering a steroid when the patient experiences Grade 2 CRS, which is within the scope of instant claim 2.
Limitations of instant clams 12-13 are recited in USSN ‘720 claims 2-4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 2, 7-8, 11 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18/497745, published as US 20240058381.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘745, which recite a method of treating B-cell lymphoma by administering axicabtagene ciloleucel (claim 1), and administering dexamethasone if the patient experiences CRS Grade 2 symptoms which do not improve within 24 hours (claims 12-14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. The following US Patents and/or copending US applications share a coinventor and/or an assignee with the present application, and disclose and/or claim subject matter similar to that of the present claims, but do not contain patented or currently pending claims which would anticipate or make obvious the presently claimed invention:
US Patent No. 12357646
USSN 17/091039, published as US 20210161959
12. The following prior art is cited of record but not presently relied upon:
Hay K.A. (2018) British Journal of Haematology, 183, 364–374.
Le et al. (2018) The Oncologist 23: 943-947.
Liu et al. (2018) Journal of Hematology & Oncology 11:121, 1-7.
Shimabukuro-Vornhagen et al. (2018) Journal for ImmunoTherapy of Cancer 6:56, 1-14.
Wang et al. (2018) Biomarker Research 6:4, 1-10.
13. Conclusion: no claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644