DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-16 are pending and examined on the merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 1-3, 7, 11, 12, and 15-17 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by the abstract of DeAngelo et al (Blood, 2004, Vol. 104, No. 11, abstract no. 441, reference of the IDS submitted 04/07/2023).
The abstract of deAngelo et al discloses a method of treating patients with AML, comprising the administration of pretransplant autologous vaccine primed lymphocytes reinfused into the patients with an autologous stem cell graft (lines 3-5 of the paragraph headed “Methods”), which meets the limitation of a plurality of autologous immune cells (lymphocytes) and a plurality of autologous hematopoietic stem cells (autologous stem cell graft) in claim 1. The abstract discloses that for 28 patients a leukapheresis fraction was used to harvest leukemia stem cells (lines 1-2 of the paragraph headed “Results”) which meets the limitation of “purified” tumor cells in claims 1, 11 and 12 since the leukapheresis fraction purifies AML cells in the blood from red blood cells. Obtaining the leukapheresis fraction also meets the limitation of claim 7 because the leukapheresis separates the leukemic cells from whole blood which, in the case of the AML patients, is a suspension comprising primary tumor cells. The abstract discloses that the pre-transplant vaccine comprised the irradiated autologous leukemia cells mixed with GM-CSF gene modified K562 cells which meets the limitation of claim 15 requiring that the tumor cells are irradiated, and the limitations of claims 3 and 16 requiring that tumor cells are formulated with an adjuvant and that the adjuvant is GM-CSF because the modified K562 cells secrete GM-CSF (lines 1-2 of the abstract under “Background”).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 5, 7, 11, 12, and 15-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the abstract of DeAngelo et al (Blood, 2004, Vol. 104, No. 11, abstract no. 441) in view of Kato et al (Bone Marrow Transplantation, 2001, Vol. 28, pp. 587-595, reference of the IDS submitted 04/07/2023).
The abstract of DeAngelo et al teaches the limitations of claims 1-3, 7, 11, 12, and 15-17 for the reasons set forth above. The abstract does not teach that the ASCT (hematopoietic cells) further comprise CD34+ cells as required in claim 5.
Kato et al teach that a CD34+ population in bone marrow can provide durable donor-derived long-term host hematopoietic reconstitution (page 587, second column, lines 1-7). Kato et al teach that CD34+ recognized as a stem and progenitor cell marker is widely used in clinical autologous stem cell transplantation (page 587, second column, lines 7-11).
It would have been prima facie obvious at the time the invention was made to use CD34+ stem cell transplant for the ASCT of the abstract of DeAngelo et al. One of skill in the art would have been motivated to do so by the teachings of Kato et al that the CD34+ fraction of bone marrow provides long-term host hematopoietic reconstitution. One of skill in the art would understand that the induction and consolidation chemotherapy taught by the abstract of DeAngelo results in the killing of hematopoietic cells in the subject and necessitates the administration of a stem cell transplant to reconstitute the immune system of the subject.
Claims 1-3, 7, 8, 11, 12, and 15-17are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the abstract of DeAngelo et al (Blood, 2004, Vol. 104, No. 11, abstract no. 441) in view of Quesenberry (WO2005/003321, reference of the IDS submitted 04/07/2023) and Gelfand et al (WO2006/109300, reference of the IDS submitted 04/07/2023).
The abstract of DeAngelo et al teaches the limitations of claims 1-3, 7, 11, 12, and 15-17 for the reasons set forth above. The abstract does not teach that the ASCT and vaccine primed lymphocytes are formulated for intravenous administration, required in claim 8.
Quesenberry teaches that in general, methods for bone marrow/stem cell transplants after myeloablation with irradiation or chemotherapy involve intravenous infusion after the specific ablative therapy (page 9, lines 17-19).
Gelfand et al teach that donor cells obtained by apheresis to produce a fraction of PBMC, such as for a donor lymphocyte infusion, are usually injected intravenously or intrathecally (page 32, second full paragraph).
It would have been prima facie obvious at the time the invention was made to formulate the vaccine primed lymphocytes mixed with the ASCT graft for intravenous administration. One of skill in the art would have been motivated to do so because the abstract teaches that the vaccine primed lymphocytes were mixed with the ASCT, Quesenberry teaches the general practice of intravenous infusion of bone marrow/stem cell transplants, and Gelfand et al teach that donor lymphocytes are usually administered by intravenous or intrathecal injection.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No.11,468,301. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘301 anticipate the instant claims.
Claim 1 of ‘301 anticipates instant claims 1 and 4. Claims 2 and 3 of ‘301 anticipate claims 2 and 3, respectively. Claims 4 and 5 of ‘301 anticipate instant claims 5 and 6. Respectively. Claims 6-8 of ‘301 anticipate instant claims 6-8, respectively. Claims 9-11 of ‘301 anticipate instant claims 9-11. Claims 12-16 of ‘301 anticipate instant claims 12-16, respectively.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No.10,286,049. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of ‘049. Claim 1 of ‘049 teaches a therapeutic composition comprising a plurality of immune cells and a plurality of hematopoietic cells purified from a patient vaccinated with an effective dose of purified tumor cells, wherein the purified tumor cells used for vaccination of the patient are the same type of tumor cells in the patient. Claim 2 of ‘049 teaches that the patient is vaccinated with an effective doses of purified tumor cells obtained from the patient.
It would have been prima facie obvious at the time prior to the effective filing date to treat cancer in a recipient by the method comprising administration of the therapeutic cell composition of claim 1. One of skill in the art would have been motivated to do so in order to treat cancer with the therapeutic composition. One of skill in the art would understand that the plurality of immune cells and hematopoietic cells purified from the patient vaccinate with the purified tumor cells are autologous immune cells and autologous hematopoietic cells and thus the recipient of claim 2 of ‘049 is the patient who is also the donor, thus rendering obvious claims 1 and 2.
Claims 2-16 of ‘049 teach the limitations of instant claims 2-16.
Claims 1-3, 6-10, 15, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No.8,506,954. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims.
Claim 1 of ‘954 discloses a method for treating cancer comprising vaccinating a subject with cancer by administering a purified solid tumor cells that have been irradiated, and formulating in combination with adjuvant; collecting immune and hematopoietic cells from the vaccinated subject; and injecting the collected cells combined with adjuvant back to the subject after myeloablative total body irradiation, which anticipates instant claims 1-3, 6, 10 and 15 because the plurality of immune cells and plurality of hematopoietic cells are autologous, being obtained from the patient and administered back into the patient. Claims 2 and 3 of ‘954 anticipate instant claims 8 and 9. Claims 4 and 5 anticipate instant claims 3 and 16. Claim 12 drawn to primary tumor cells anticipates instant claims 7.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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