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 response to the previous Office action, dated January 23, 2026, has been received. No claim amendments were submitted with this reply.
Claims 1-4, 6-7, 17-19, 21-22, 24-25, and 31-32 are pending in the application. Claims 6 and 19 remain withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 13, 2022.
Claims 1-4, 7, 17-18, 21-22, 24-25, and 31-32 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated July 25, 2025.
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.
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 1-4, 7, 17-18, 21-22, 24-25, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fanale (J Clin Oncol. 2014 Oct 1;32(28):3 137-43) in view of Fasenmade (WO2018089890A1).
Applicant argues that a person of ordinary skill in the art would not be motivated to choose the specifically claimed patient population based upon the teachings of Fanale, as Fanale does not teach a patient with stage III cancer, nor would such a person be motivated to choose the claimed therapy based upon those recited in Fanale, nor would such a person expect the results of the claimed method. Applicant further argues that Fasanmade describes possible treatment with BV+CHP but does not disclose any results or efficacy data, and that Fasanmede does not teach an adult with stage III non-Hodgkin's lymphoma. Applicant asserts that the study of the effects of antibody + CHP in the recited cancer population had not been done prior to the filing of the application, and the results would not have been obvious from the combination of Fanale and Fasanmade, i.e., it was not reasonably predictable that the treatment would have been better in Stage III PTCL disease compared to Stage I or II subjects with hard to treat, advanced stage PTCL using the claimed combination therapy in view of the cited art.
Applicant's arguments have been considered fully but are not found to be persuasive.
Applicant has traversed the primary and the secondary references pointing to the differences between the claims and the disclosure in each reference. Applicant is respectfully reminded that the rejection is under 35 U.S.C. 103 and that non-obviousness cannot be established by attacking the references individually when the rejection is based on the combination of the references. In re Keller, 642 F.2d 4B, 208 USPQ 871, 882 (CCPA 1981) and MPEP 2145(IV). This Applicant has not done, but rather argues the references individually and not their combination. One cannot show non-obviousness by attacking references individually where the rejections are based on a combination of references.
As stated previously, Fanale is explicit in teaching that "[b]rentuximab vedotin, administered sequentially with CHOP or in combination with CHP, had a manageable safety profile and exhibited substantial antitumor activity in newly diagnosed patients with CD30 PTCL." (abstract). Fanale also teaches administration of brentuximab vedotin in relapsed sALCL patients (page 3138, left column, second and third paragraphs).
Fanale at page 3142, right column, third paragraph states: "Combining brentuximab vedotin with CHP provided an encouraging signal of activity, a manageable safety profile, and no treatment-related mortality. These data raise the possibility that BV+CHP may provide improved outcomes over standard CHOP in patients with CD30+ PTCL, and an ongoing double-blind, randomized phase III study of BV+CHP versus CHOP will formally test this hypothesis."
Fanale also teaches that the patients ranged from 21-82 years old (i.e., adult), and may be diagnosed at stage III (Table 1).
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). MPEP 2143.02(II).
Fanale states at page 3142, right column, second paragraph: "Combination treatment with BV+CHP was studied to provide safety and activity estimates to support future development efforts. The 88% CR rate and 100% ORR exceeded what would typically be expected for multiagent treatment in the PCL front-line setting, despite the omission of vincristine. Notably, these results were achieved in patients of whom two thirds had advance-stage or intermediate-high risk disease". This is a clear and explicit indication that combinations of brentuximab vedotin and CHP would be beneficial in treating advanced stage (i.e., Stage III) peripheral T-cell lymphoma. Such a teaching suggests that combinations of combinations of brentuximab vedotin and CHP would reasonably be expected to be useful in treating advanced stage (i.e., Stage III) peripheral T-cell lymphoma, and would motivate the ordinary artisan to select such a treatment.
In response to Applicant's allegations of unexpected results, Fanale teaches an objective response rate of 85% (table 5), and a progression free survival a patient with stage III peripheral T cell lymphoma of 18.4 months (table 2). Applicant's specification at page 30 states an objective response rate of 83%. Given the similarity of the results between Applicant's experiments and the results of Fanale, Applicant's results cannot be said to be unexpected.
This rejection is therefore maintained.
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 1-4, 7, 11, 17-18, 21-22, 24-25, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over the listed claims of the following U.S. patents and patent applications below, in view of Fanale and Fasenmede.
Application/Patent Conflicting Claims
Application 17/762,867 1, 12-14, 19, 46-48
Application 18/449,591 1, 4-6, 8, 13-14, 20, 26, 28-29, 32-33, 39-40, 44, 46, 48, 54, 57
U.S. patent 11,795,229 1, 11, 13, 15-16, 18
U.S. Patent 10,912,813 1
U.S. Patent 10,940,178 1-3, 17-19, 21, 23, 25-26
U.S. Patent 11,559,558 1, 3-5, 8-9
Applicant argues that the above patent disclosures cited above do not disclose or suggest a combination therapy comprising brentuximab vedotin and CHP, and provide no more motivation or expectation of success than the disclosures of Fanale and Fasanmade. This is not persuasive, for reasons described supra.
The above rejections are therefore maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/PETER JOHANSEN/Examiner, Art Unit 1644