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 .
Status of the Claims
Claims 1 – 11, 17 – 18, 21 – 22, 30 – 32, 34 and 43 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Drawings
The drawings are objected to because FIGs. 1 – 3, 5, 7 – 9B include text and symbols that are illegible and must be modified so that they are clear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 6 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a natural product) without significantly more.
Claim 1 recites a composition comprising an oncolytic virus and an immune cell, wherein the immune cell is infected by the oncolytic virus. This judicial exception is not integrated into a practical application because the claim recites a naturally-occurring virus with a naturally occurring immune cell, which may occur together in nature. Furthermore, the claimed oncolytic virus can naturally infect the claimed immune cell. The claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 is evaluated using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106 (III).
Step 1: Is the claim to a process, machine, manufacture or composition of matter? Yes, the claim is drawn to a composition of matter (product) which is one of the four statutory categories.
Step 2A, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes, the claims are directed towards natural phenomenon (product of nature) of an oncolytic virus and an immune cell. According to the present specification, “[e]xamples of oncolytic viruses include, but are not limited to, adenoviruses, herpes viruses, measles viruses, coxsackie viruses, polioviruses, reoviruses, poxviruses, vaccinia viruses, Vesicular stomatitits virus, senecavirus, RIGVIR, semliki forrest virus, maraba virus and Newcastle disease viruses” (paragraph 0051 of the pre-grant publication), which are naturally-occurring viruses. The oncolytic virus is further limited to poxvirus on present claim 6.
According to the present specification, “[t]he term ‘lymphocytes’ as used herein refers to immune cells made in the bone marrow and found in the blood and in lymph tissue. Lymphocytes are a type of white blood cell. Other ‘immune cells’ include, but are not limited to, neutrophils, eosinophils, basophils, mast cells, monocytes, macrophages, dendritic cells, natural killer cells, and lymphocytes” (paragraph 0044 of the pre-grant publication), which are naturally-occurring cells.
Furthermore, an oncolytic viruses such as a poxvirus can naturally infect an immune cell. MCFADDEN (McFadden G. Poxvirus tropism. Nat Rev Microbiol. 2005 Mar;3(3):201-13; see PTO-892: Notice of References Cited) is a review that summarizes current understanding of poxvirus tropism and host range. See MCFADDEN at the abstract. MCFADDEN teaches that “Poxviruses that infect vertebrates are of the subfamily Chordopoxvirinae and share several biological features. All are large, brick-shaped DNA viruses, with genomes that range from 130–300 kb, and all replicate exclusively in the cytoplasm of infected cells.” See MCFADDEN at Cellular tropism: poxvirus replication, p. 203, right column. Thus, an oncolytic virus can infect an immune cell in nature.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claims recite two products of nature (an oncolytic virus and an immune cell) that can naturally occur together without any modifications to either the virus or the immune cell.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the judicial exception is recited without additional limitations amounting to significantly more than the exception.
Therefore, claims 1 – 6 and 10 do not amount to significantly more than the judicial exception that is claimed.
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 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.
Claims 1 – 11, 17 – 18, 21 – 22, 30 – 32, 34 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DRAGANOV (US 2019/0367880 A1, published 12/05/2019: see PTO-892: Notice of References Cited).
DRAGANOV is directed to a carrier cell, comprising an oncolytic virus, wherein: the virus can replicate in the cell; the cell can be administered to a human subject; the cell has been treated or modified or both to enhance the immunosuppressive properties or immunoprivileged properties of the cell for administration to a human subject. See DRAGANOV at claim 1. DRAGANOV’s claim 4 recites that The carrier cell of claim 1 that is selected from among a treated or modified stem cell, immune cell, and tumor cell. Thus, DRAGANOV anticipates claims 1 and 7.
Regarding claims 2 – 3, DRAGANOV teaches that the immune cell is selected from among granulocytes, mast cells, monocytes, dendritic cells, natural killer cells, lymphocytes, T-cell receptor (TCR) transgenic cells targeting tumor-specific antigens, and CAR-T cells targeting tumor-specific antigens. See DRAGANOV at claim 8.
Regarding claims 4 and 43, DRAGANOV teaches that co-cultures can include a patient's immune cells, such as PBMCs or whole blood, together with the cell-based delivery vehicle/carrier cells, including stem cells or tumor cells, and with or without the oncolytic virus to be tested, for example, vaccinia virus, herpes simplex virus and adenovirus, among others. See DRAGANOV at paragraph 0890. DRAGANOV further teaches that “vaccinia virus” or “VACV” or “VV” denotes a large, complex, enveloped virus belonging to the poxvirus family. See DRAGANOV at paragraph 0224. Thus, DRAGANOV teaches that immune cells are from the subject as recited in present claims 4 and 43, and DRAGANOV teaches the steps of the method of present claim 43.
Regarding claim 5, DRAGANOV teaches the cells can be autologous or allogeneic. See DRAGANOV at paragraphs 0010-0012. DRAGANOV teaches that cell carriers, including tumor cells and stem cells, including allogeneic stem and tumor cells. See DRAGANOV at paragraph 0019.
Regarding claim 6, DRAGANOV teaches that the oncolytic virus is a poxvirus. See DRAGANOV at claim 13.
Regarding claims 8 – 9, DRAGANOV teaches that the immune cell is a T-cell receptor (TCR) transgenic cells targeting tumor-specific antigens or CAR-T cells targeting tumor-specific antigens. See DRAGANOV at claim 8.
Regarding claim 10, although DRAGANOV does not expressly teach that the virus does not lyse the immune cell for at least 5 days after infection, DRAGANOV anticipates the composition of claim 1 that results in this property, and therefore DRAGANOV’s composition would inherently achieve the property “wherein the virus does not lyse the immune cell for at least 5 days after infection” as recited in claim 10. Alternatively, the recitation of “wherein the virus does not lyse the immune cell for at least 5 days after infection” in claim 10 is an intended use that does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and thus is not given weight for comparison of the claims with the prior art.
Regarding claim 11, 17 – 18, DRAGANOV teaches that the immune cell is a T-cell receptor (TCR) transgenic cells targeting tumor-specific antigens or CAR-T cells targeting tumor-specific antigens. See DRAGANOV at claim 8.
Regarding claim 21, DRAGANOV teaches that the oncolytic virus is a vaccina virus. See DRAGANOV at claim 14.
Regarding claim 22, DRAGANOV teaches that the vaccinia virus is selected from among a Lister strain, Western Reserve (WR) strain, Copenhagen (Cop) strain, Bern strain, Paris strain, Tashkent strain, Tian Tan strain, Wyeth strain (DRYVAX), IHD-J strain, IHD-W strain, Brighton strain, Ankara strain, CVA382 strain, Dairen I strain, LC16m8 strain, LC16M0 strain, modified vaccinia Ankara (MVA) strain, ACAM strain, WR 65-16 strain, Connaught strain, New York City Board of Health (NYCBH) strain, EM-63 strain, NYVAC strain, Lister strain LIVP, JX-594 strain, GL-ONC1 strain, a vvDD TK mutant strain with deletions in VGF and TK, ACAM2000, and ACAM1000. See DRAGANOV at claim 15.
Regarding claims 30 – 32, DRAGANOV teaches a pharmaceutical compositions containing any of the carrier cells provided herein in a pharmaceutically acceptable vehicle and that the pharmaceutical compositions are for use for treating cancer. See DRAGANOV at paragraph 0158.
Regarding claim 34, DRAGANOV teaches that the disclosed composition is administrated to a subject who has pancreatic cancer, lung cancer, ovarian cancer, breast cancer, cervical cancer, bladder cancer, prostate cancer, brain cancer, central nervous system cancer, adenocarcinomas, liver cancer, skin cancer, hematological cancers, biliary tract cancer, bone cancer, choriocarcinoma, colon and rectal cancers, connective tissue cancer, cancer of the digestive system, endometrial cancer, esophageal cancer, eye cancer, head and neck cancer, gastric cancer, intra-epithelial neoplasm, kidney cancer, larynx cancer, oral cavity cancer, retinoblastoma, rhabdomyosarcoma, cancer of the respiratory system, stomach cancer, testicular cancer, thyroid cancer, uterine cancer or urinary system cancers. See DRAGANOV at claims 57 and 62.
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 – 11, 17 – 18, 21 – 22, 30 – 32, 34 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 59 – 74 of copending Application No. 17/615,018 in view of DRAGANOV.
Copending claim 20 recites a method for treating a disease characterized by chronic inflammation in a subject, the method comprising administering to the subject a composition comprising a poxvirus and an induced pluripotent stem cell (iPSC).
The main difference between the present claims and the copending claims is that the present claims recites an immune cell (present claim 1) instead of an iPSC or that the composition comprises a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR (present claim 11) instead of an iPSC. However, DRAGANOV teaches this difference. The teachings of DRAGANOV, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. § 102 above.
Because the copending claims recite a composition comprising a poxvirus and an induced pluripotent stem cell (iPSC), and DRAGANOV teaches a composition comprising an oncolytic virus and immune cell or a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR, it would have been obvious to one having ordinary skill in the art to use the copending claims’ poxvirus in the composition of the present claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 11, 17 – 18, 21 – 22, 30 – 32, 34 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, 11, 16, 20 – 21, 26 – 29, 31, 45 – 46, 50 – 51 and 75 – 82 copending Application No. 17/615,661 in view of DRAGANOV.
Copending claim 1 recites a method for treating a disease in a subject in need thereof, the method comprising administering to the subject a poxvirus, wherein the disease is selected from a chronic inflammatory disease, a disease characterized by chronic inflammation, cytokine storm, or an infectious disease, and further wherein the disease is not a cancer, wherein the poxvirus is an attenuated virus, wherein a stem cell is administered with the poxvirus; wherein the stem cell or the poxvirus comprises a recombinant polynucleotide, wherein said recombinant polynucleotide encodes a therapeutic molecule.
The main difference between the present claims and the copending claims is that the present claims recites a composition comprising an immune cell (present claim 1) in addition to the poxvirus or a composition comprising a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR (present claim 11) in addition to the poxvirus. However, DRAGANOV teaches this difference. The teachings of DRAGANOV, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. § 102 above.
Because the copending claims recite a composition comprising a poxvirus, and DRAGANOV teaches that the composition further includes an immune cell or a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR, it would have been obvious to one having ordinary skill in the art to use the copending claims’ poxvirus in the composition of the present claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 11, 17 – 18, 21 – 22, 30 – 32, 34 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8, 15, 25, 42 – 44, 46 – 51 of copending Application No. 17/784,572 in view of DRAGANOV.
Copending claim 1 recites a method for regulating activity of a poxvirus viral polymerase in a cell infected with the poxvirus, the method comprising contacting the cell with a compound that reduces or prevents interaction of the viral polymerase with a glutamine tRNA (tRNAGlu), wherein the viral polymerase is a virus-encoded RNA polymerase.
Copending claim 7 recites that the cell is a stem cell, immune cell, or cancer cell.
The main difference between the present claims and the copending claims is that the present claims recites a composition with a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR (present claim 11) in addition to the poxvirus. However, DRAGANOV teaches this difference. The teachings of DRAGANOV, and how they relate to the claims, are set forth in the rejections under 35 U.S.C. § 102 above.
Because the copending claims recite a composition comprising a poxvirus, and DRAGANOV teaches a composition further includes a CAR-T cell or CAR-NK cell or a T-cell/NK-cell expressing an TCR, it would have been obvious to one having ordinary skill in the art to use the copending claims’ poxvirus in the composition of the present claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646
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