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 .
Election/Restrictions
Applicant’s election of Group II, claims 14-16, 18, 20, 22, 23, 26, 28, 29, and 39-41, and species (A) peripheral T-cell lymphoma-not otherwise specified for T cell lymphoma type, (B) peripheral T cell lymphoma-not otherwise specified as one PTCL, (C) anaplastic lymphoma kinase negative (ALK-) as sALCL, and (D) one type of PTCL as CD30-expressing PTCL in the reply filed on July 9, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-6, 8, 10-11, 13, 21, 24, 32-34, 36-37, 44, 46, 48, 57, 61, 63-65, 69, and 79 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 14-16, 18, 20, 22, 23, 26, 28, 29, and 39-41 are under consideration in this office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit to U.S. Provisional Application No. 62/580,261, filed November 1, 2017.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 23, 2024 and February 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement (pg 50). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (once on pg 16, four times on pg 17, once on pg 49). 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
Applicant is advised that should claim 20 be found allowable, claim 39 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
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 14-16, 18, 20, 22, 23, 26, 28, 29, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Fanale et al, published October 1, 2014 (see IDS from 2/23/2024, NPL 17) in view of Renwick, et al, published 2009 (see IDS from 2/23/2024, NPL 38) and FDA, Adcetris, HIGHLIGHTS OF PRESCRIBING INFORMATION (see IDS from 2/23/2024, NPL 19).
Fanale et al teaches a method of successfully treating T cell lymphoma with the combination of the anti-CD30 antibody drug conjugate brentuximab vedotin (1.8 mg/kg) and standard-dose CHP for six cycles (1x/3wks)(Abstract), as in claims 14, 20, 26, 28-29, 39-40. Fanale reports neutropenia as the most commonly observed serious adverse event resulting from the treatment (Abstract; pg 3140-3141). Fanale et al teaches that the study population comprises treatment-naïve patients, as in instant claim 18.
Fanale differs from the presently claimed methods, because it fails to teach administration of a granulopoiesis stimulating factor in addition to combination therapy. However, as taught by Renwick, primary prophylaxis with granulocyte-colony stimulating factor (G-CSF) was already well known to reduce the incidence of neutropenia occurring during chemotherapy (abstract), as in the GCSF of claims 22-23. For example, Renwick describes neutropenia as a toxicity of chemotherapy that is mitigated through stimulation of neutrophil production by G-CSF and human recombinant forms of the protein (Abstract). Renwick asserts that clinical trials and meta-analyses establish that primary prophylaxis with G-CSF beginning in the first cycle of chemotherapy reduces the incidence of neutropenia (Id.) with as little as 5 mg/kg/d (pg 179-180), as in instant claims 15-16, 24, and 41. Furthermore, the 2014 FDA prescribing information for brentuximab vedotin recommends G-CSF prophylaxis to mitigate potential incidence of neutropenia, indicated as the most common adverse reaction. (pg 1, Warnings and Precautions, Adverse Reactions; pg 4, 2.2 Dose Modification).
Fanale recognizes neutropenia as a common serious adverse event in treating T cell lymphoma with brentuximab vedotin and CHP. It would have been obvious to the oriday artisan to administer G-CSF prophylaxis in order to mitigate the incidence of neutropenia associated with brentuximab vedotin and CHP, based on the recognition that G-CSF reduces the incidence of neutropenia, as indicated by Renwick and the FDA. Optimization of variables such as the administration time claims 15, 16, and 24 represents well understood, routine, and conventional practice in treating cancer, and this type of optimization is obvious absent evidence demonstrating unexpected results.
Claims 14-16, 18, 20, 22, 23, 26, 28, 29, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Fanale et al in view of Renwick and FDA, as applied to claims 14-16, 18, 20, 22, 23, 26, 28, 29, 39, and 41, above, and further in view of U.S. Clinical Trial NCT01777152, update published September 28, 2016 (see instant PTO-892).
The teachings of Fanale et al in view of Renwick and FDA are discussed above; these references do not teach the dose regimen for cyclophosphamide, doxorubicin, and prednisone of instant claim 40
Clinical Trial NCT01777152, the subject of Fanale, indicates administration of cyclophosphamide at 750 mg/m2, doxorubicin at 50 mg/m2, and prednisone at 100 mg on days 1 to 5 of a 21 day cycle. (p. 11-12, “Arms and Interventions”).
Given that Fanale et al in view of Renwick et al and FDA teach a method for treating patients with mature T cell lymphoma comprising administration of anti-CD30 antibody drug conjugate in combination with CHP and a granulopoiesis stimulating factor, and further given that NCT ‘152 teaches the doses and dose intervals claimed, it would have been obvious to one of ordinary skill in the art to apply the doses and dose intervals of NCT ‘152 in the method of Fanale et al in view of Renwick and FDA to achieve predictable results. Such amount to combining prior art elements according to known methods to achieve predictable outcomes, see MPEP 2143.I(C).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
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