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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4-30-26 has been entered.
The prior rejection of claim 130 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, enablement, has been withdrawn in view of applicant’s claim amendments.
Claims 83, 110-128 and 130 are pending and under examination.
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 83, 113 and 114 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.
Neither the instant specification nor the knowledge in the art recognize “anaplastic large-cell lymphoma” as a form of “mature B cell neoplasm.” Instead, this rare form of non-Hodgkin lymphoma was known to be a T cell lymphoma comprising TCR gene rearrangements (see, e.g., Feldman et al., Modern Pathology (2010) 23, 593–602, cited herewith, at Abstract; page 595-99 bridging paragraph; p 600, left col., last full paragraph). Thus, as of applicant’s earliest filing date the ordinarily skilled artisan would not have understood how “anaplastic large-cell lymphoma” could be understood to be a “mature B cell neoplasm.”
Note that claims 83 and 113 are rejected along with claim 114 because, by virtue of the principal of claim differentiation, base claims 83 and 113 necessarily encompass the various embodiments of dependent claim 114 in their breadth.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 83, 113 and 114 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification does not recognize “anaplastic large-cell lymphoma” as a form of “mature B cell neoplasm;” rather, the instant specification identifies “anaplastic large-cell lymphoma” (ALCL) as one of a group of diseases “treatable with the bispecific antibodies of the invention.” (see page 86-87 bridging paragraph and page 90, 3rd full paragraph).
However, as described above, this rare form of non-Hodgkin lymphoma was known to be a T cell lymphoma comprising TCR gene rearrangements (see, e.g., Feldman et al., Modern Pathology (2010) 23, 593–602, cited herewith, at Abstract; page 595-99 bridging paragraph; p 600, left col., last full paragraph). Thus, the instant specification does not describe treatment of a “mature B cell neoplasm” which is an “anaplastic large-cell lymphoma.”
Note that claims 83 and 113 are rejected along with claim 114 because, by virtue of the principal of claim differentiation, base claims 83 and 113 necessarily encompass the various embodiments of dependent claim 114 in their breadth.\
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 83, 110, 112-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12435154 (cited on an IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
For example, at col. 2, 1st full paragraph the ‘154 instructs that the epcoritamab antibody is disclosed in WO201611057, from which the instant application is the US National stage entry. Moreover, reference claims 9, 18 and 26 are drawn to treat a relapsed or refractory B-NHL which selected from various species of B-NHL including follicular lymphoma (FL) by subcutaneously administering a dose of 0.16 mg of epcoritamab to the subject on day one (1) of treatment and subcutaneously administering a dose of 0.8 mg of epcoritamab to the subject on day eight (8) of treatment, wherein the subject does not experience cytokine release syndrome (CRS) or experiences manageable cytokine release syndrome of grade 1 or grade 2, and wherein after day eight (8) of treatment epcoritamab is subcutaneously administered in intervals to the subject until progressive disease develops or unacceptable toxicity occurs.
Thus, claims 83, 110, 112-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12435154.
Claim 111 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12435154 for the reasons set forth above, and further in view of Martelli et al. (Critical Reviews in Oncology/Hematology 87 (2013) 146–171)( made of record 9-11-24). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
The anticipatory subject matter of reference claims 1-29 of U.S. Patent No. 11548952 is described above; however, the reference claims do not explicitly set forth a method of treating a B-cell non-Hodgkin lymphoma (B-NHL) wherein the B-NHL is a metastatic cancer.
However, as taught by Martelli, the B-NHL which is Diffuse large B-cell lymphoma (DLBCL)
is positive for CD20 (see section 2.3.4. at page 152); moreover, as set forth in Table 1 and further described in Section 2.3, a variety of DLBCL subtypes manifest predominately extranodal locations, i.e., these cancers have a metastatic phenotype, and this sort of dissemination outside the mediastinum commonly occurs in the case of disease relapse (see Section 2.3.1). That said, as additionally taught by Martelli at page 161, right col., first full paragraph, DLBCL patients with relapsed/refractory disease have been successfully treated with a combination therapy employing an anti-CD20 antibody (rituximab).
Given the teachings of Martelli, it would have been obvious to the ordinarily skilled artisan, and the ordinarily skilled artisan would have been motivated to treat, e.g., a metastatic manifestation of DLBCL, such as primary mediastinal (thymic) large B-cell lymphoma (PMBL), with the antibody of the instant claims.
In view of the reference teachings it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 130 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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