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 without traverse of Group III (claims 20 and 21) in the reply filed on 6/12/2025 is acknowledged. In the restriction requirement dated 3/13/2025, the invention of group III is directed to a method of treating a disease characterized by chronic inflammation comprising administering a composition comprising a poxvirus and iPSC.
Applicant’s amended the claims in the response to the restriction requirement filed 6/12/2025 canceling the remaining pending claims and added new claims 59-74.
Claims 20-21 and new claims 59-62, 64-74 are pending and under consideration in this office action.
Claim Objections
Claims 64-74 are objected to because of the following informalities: In general these claims are objected to because they are misnumbered. The claim set is missing claim 63. It recites claim 62 and then claim 64, missing claim 63. Also the last two claims of the claim set are numbered claim 74. As such, Examiner will refer to the first claim 74 as claim 74a and the second claim 74 as 74b. The complete claim set will be referred to by Examiner as claims 20-21, 59-62, 64-74a and 74b from herein. Sequentially numbering the claims in the next response would be remedial Appropriate correction is required.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
(i) The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/854,817, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application for claims 61-62, 66-67, and 70-74a and 74b. These claims are recite elements of the method comprising the iPSC genetically modified to encoded a therapeutic molecule, particularly an antibody, further comprising a CAR-T cell, and/or further comprising a pancreatic beta cell. All of these limitations are not described by this application. As such, the are not granted the benefit of the effective filing date of this application.
(ii) The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/879,196, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application for claims 61-62, 66-67, and 71-73. These claims are recite elements of the method comprising the iPSC genetically modified to encoded a therapeutic molecule, particularly an antibody, and further comprising CAR-T cells All of these limitations are not described by this application. As such, these claims are not granted the benefit of the effective filing date of this application.
(iii)The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/911,640, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application for claims 72-74a and 74b. These claims are recite elements of the method further comprising a pancreatic beta cell. All of these limitations are not described by this application. As such, these claims are not granted the benefit of the effective filing date of this application.
Thus the effective filing dates for the claims are as follows:
Claims 20-21, 59-60, 64-65, 68-69 have an effective filing date of 5/30/2029;
Claims 61-62, 66-67, 71, and the pancreatic cell embodiments of claims 72-73 have and effective filing date of 7/26/2019;
Claims 70, 74a, and 74b, and the CAR-T cell embodiments of claims 72-73 have an effective filing date of 10/7/2019.
Claim Rejections - 35 USC § 112
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 61-74a and 74b 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.
Regarding claims 61-74a and 74b, each of the claims recites, “The composition of claim…”. These claims are dependent upon claim 20 directly or indirectly. However, claim 20 is “A method” not a composition. As such, it is not apparent if these claims are intended to be a composition product as recited or intended to be further limitations of claimed method of claim 20. As such, these claims are indefinite. For purposes of interpretation these claims are being interpreted as intending to further limit the method of the base claim and not a composition product.
Last claim 74b recites it is dependent upon itself. In other words, the claim express states, “74. The composition of claim 74”. Meaning the claim depends upon itself. A claim cannot depend upon itself. As such, it is not clear which claim, claim 74b is intended to depend upon. For purposes of interpretation, Examiner will interpret claim 74b as being dependent upon claim 74a.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(1) Claim(s) 20-21, 59-60, 64-65 is/are rejected under 35 U.S.C. 102(a)(1)102(a)(2) as being anticipated by Minev (US2017/0043010 A1 pub date: 2/16/2017 effectively filed 8/11/2015).
This rejection is a 102(a)(1) because the publication date is more than one year before the effective filing dates of the claims.
Also it is a 102(a)(2) rejection because the applied reference has a common inventor (Szalay) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 20-21, Minev discloses a method for treating a solid tumor or hematologic malignancy (i.e. a disease in a subject as recited in claim 20, more specifically a disease characterized by chronic inflammation as recited in claim 21) in a subject, comprising administering to the subject a smallpox vaccine concurrently with a stem cell. In some embodiments, the stem cell is an autologous stem cell. In some embodiments, the stem cell is selected from is selected from the group consisting of adult stem cells, embryonic stem cells, fetal stem cells, mesenchymal stem cells, neural stem cells, totipotent stem cells, pluripotent stem cells, multipotent stem cells, oligopotent stem cells, unipotent stem cells, adipose stromal cells, endothelial stem cells, induced pluripotent stem cells, bone marrow stem cells, cord blood stem cells, adult peripheral blood stem cells, myoblast stem cells, small juvenile stem cells, skin fibroblast stem cells, and combinations thereof. In some embodiments, the stem cell is an adipose stromal cell [0005]. As such, Minev expressly discloses the limitations of the claims.
Regarding claim 59, Minev does not expressly disclose that the iPSC are derived from ectoderm, endoderm or mesoderm cell types. However, these limitations are described the starting materially cell from which the iPSC is structural derived and do not further distinguish the structure of the iPSC. As such, Minev’s disclosure of iPSC as described above meets the limitations of this claim.
Regarding claim 60, in [0006] Minev discloses that the stem cell is autologous (i.e. derived from the subject to be treated with the composition as claimed). As such, Minev expressly discloses the limitations of the claim.
Regarding claim 64-65, Minev discloses in some embodiments, the smallpox vaccine is an attenuated New York City Board of Health (NYCBOH) strain of vaccinia virus. In some embodiments, the NYCBOH strain of vaccinia virus may be ATCC VR-118 or CJ-MVB-SPX. In some embodiments, the smallpox vaccine is selected from Dryvax, ACAM1000, ACAM2000, Lister, EM63, LIVP, Tian Tan, Copenhagen, Western Reserve, or Modified Vaccinia Ankara (MVA). Variola virus is the cause of smallpox. In contrast to variola virus, vaccinia virus, which has been used for smallpox vaccination, does not normally cause systemic disease in immune-competent individuals and it has therefore been used as a live vaccine to immunize against smallpox. Successful worldwide vaccination with Vaccinia virus culminated in the eradication of smallpox as a natural disease in the 1980s. Since then, vaccination has been discontinued for many years, except for people at higher risk of poxvirus infections (e.g., laboratory workers). Although the United States discontinued routine childhood immunization against smallpox in 1972, the use of smallpox vaccine is generally considered safe for pediatric use. In some embodiments, an attenuated strain derived from a pathogenic virus is used for the manufacturing of a live vaccine. Non-limiting examples of viral strains that have been used as a smallpox vaccine include but are not limited to the Lister (also known as Elstree), New York City Board of Health (“NYCBH strain”), Dairen, Ikeda, LC16M8, Western Reserve (WR), Copenhagen, Tashkent, Tian Tan, Wyeth, IHD-J, and IHD-W, Brighton, Ankara, MVA, Dairen I, LIPV, LC16MO, LIVP, WR 65-16, EM63, and Connaught strains. In some embodiments, the smallpox vaccine utilized in the methods disclosed herein is an attenuated New York City Board of Health (NYCBOH) strain of vaccinia virus. In some embodiments, the NYCBOH strain of vaccinia virus may be ATCC VR-118 or CJ-MVB-SPX. In some embodiments, the smallpox vaccine is non-attenuated. In some embodiments, the smallpox vaccine is selected from Dryvax, ACAM1000, ACAM2000, Lister, EM63, LIVP, Tian Tan, Copenhagen, Western Reserve, or Modified Vaccinia Ankara (MVA). In some embodiments, the smallpox vaccine is not deficient in any genes present in one or more of these strains. See [0006]; [0029]-[0032]. Thus expressly disclosing the limitation of the claims.
Thus, the prior art of Minev anticipates the claims because it expressly or inherently discloses the requisite limitations of the claims.
(2) Claim(s) 20-21, 59-60, 64-65 is/are rejected under 35 U.S.C. 102(a)(1)102(a)(2) as being anticipated by Szalay (US2018/032048 A1 effectively filed 8/11/2015; of record in the lack of unity).
The applied reference has a common inventor (Szalay) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 20-21, Szalay discloses a method for treating a solid tumor or hematologic malignancy (i.e. a disease in a subject as recited in claim 20, more specifically a disease characterized by chronic inflammation as recited in claim 21) in a subject, comprising administering to the subject a smallpox vaccine concurrently with a stem cell. In some embodiments, the stem cell is an autologous stem cell. In some embodiments, the stem cell is selected from is selected from the group consisting of adult stem cells, embryonic stem cells, fetal stem cells, mesenchymal stem cells, neural stem cells, totipotent stem cells, pluripotent stem cells, multipotent stem cells, oligopotent stem cells, unipotent stem cells, adipose stromal cells, endothelial stem cells, induced pluripotent stem cells, bone marrow stem cells, cord blood stem cells, adult peripheral blood stem cells, myoblast stem cells, small juvenile stem cells, skin fibroblast stem cells, and combinations thereof. In some embodiments, the stem cell is an adipose stromal cell [0005]. As such, Szalay expressly discloses the limitations of the claims.
Regarding claim 59, Szalay does not expressly disclose that the iPSC are derived from ectoderm, endoderm or mesoderm cell types. However, these limitations are described the starting materially cell from which the iPSC is structural derived and do not further distinguish the structure of the iPSC. As such, Szalay’s disclosure of iPSC as described above meets the limitations of this claim.
Regarding claim 60, in [0006] Szalay discloses that the stem cell is autologous (i.e. derived from the subject to be treated with the composition as claimed). As such, Szalay Minev expressly discloses the limitations of the claim.
Regarding claim 64-65, Szalay discloses in some embodiments, the smallpox vaccine is an attenuated New York City Board of Health (NYCBOH) strain of vaccinia virus. In some embodiments, the NYCBOH strain of vaccinia virus may be ATCC VR-118 or CJ-MVB-SPX. In some embodiments, the smallpox vaccine is selected from Dryvax, ACAM1000, ACAM2000, Lister, EM63, LIVP, Tian Tan, Copenhagen, Western Reserve, or Modified Vaccinia Ankara (MVA). Variola virus is the cause of smallpox. In contrast to variola virus, vaccinia virus, which has been used for smallpox vaccination, does not normally cause systemic disease in immune-competent individuals and it has therefore been used as a live vaccine to immunize against smallpox. Successful worldwide vaccination with Vaccinia virus culminated in the eradication of smallpox as a natural disease in the 1980s. Since then, vaccination has been discontinued for many years, except for people at higher risk of poxvirus infections (e.g., laboratory workers). Although the United States discontinued routine childhood immunization against smallpox in 1972, the use of smallpox vaccine is generally considered safe for pediatric use. In some embodiments, an attenuated strain derived from a pathogenic virus is used for the manufacturing of a live vaccine. Non-limiting examples of viral strains that have been used as a smallpox vaccine include but are not limited to the Lister (also known as Elstree), New York City Board of Health (“NYCBH strain”), Dairen, Ikeda, LC16M8, Western Reserve (WR), Copenhagen, Tashkent, Tian Tan, Wyeth, IHD-J, and IHD-W, Brighton, Ankara, MVA, Dairen I, LIPV, LC16MO, LIVP, WR 65-16, EM63, and Connaught strains. In some embodiments, the smallpox vaccine utilized in the methods disclosed herein is an attenuated New York City Board of Health (NYCBOH) strain of vaccinia virus. In some embodiments, the NYCBOH strain of vaccinia virus may be ATCC VR-118 or CJ-MVB-SPX. In some embodiments, the smallpox vaccine is non-attenuated. In some embodiments, the smallpox vaccine is selected from Dryvax, ACAM1000, ACAM2000, Lister, EM63, LIVP, Tian Tan, Copenhagen, Western Reserve, or Modified Vaccinia Ankara (MVA). In some embodiments, the smallpox vaccine is not deficient in any genes present in one or more of these strains. See [0006]; [0029]-[0032]. Thus expressly disclosing the limitation of the claims.
Thus, the prior art of Szalay anticipates the claims because it expressly or inherently discloses the requisite limitations of the claims.
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.
(1) Claim(s) 66 and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minev (US2017/0043010 A1 pub date: 2/16/2017 effectively filed 8/11/2015).
Regarding claim 66, Minev teach the claim as discussed above. Minev does not express teach that the iPSC cell comprising a recombinant polynucleotide encoding a therapeutic agent. However, Minev does teach in some embodiments, the carrier cell comprises heterologous nucleic acid. See [0008]. Minev teaches as used herein, “heterologous nucleic acid” refers to a nucleic acid, DNA or RNA, which has been introduced into a virus or a cell (or the cell's ancestor). Such heterologous nucleic acid may comprise the sequence and operable regulatory elements for genes. For example, the heterologous nucleic acid may comprise a selection marker gene, a suicide gene, or a gene expressing a useful protein product that is not expressed endogenously, or expressed endogenously at low levels [0027]. Minev further teaches recent studies have demonstrated extensive homing of stem cells to glioma tumors and the potential of gene loading into stem cells using viral vectors. These studies indicate that the stem cells are a promising candidate as a vehicle for delivery of the anti-cancer agent to the tumor sites [0043]. Accordingly, disclosed herein, in some embodiments, is the use of stem cells as a vehicle for in vivo delivery of smallpox vaccine to the cancer cells or tumor. In some embodiments, the smallpox vaccine is mixed with the vehicle stem cells to avoid the immune system from clearing the virus before the virus reaches the tumor. Thus, in some embodiments, disclosed herein is a method for treating a solid tumor or hematologic malignancy in a subject, comprising administering to the subject a smallpox vaccine concurrently with a stem cell [0044]. In some embodiments, the vehicle stem cells are modified. In some embodiments, the modified stem cell is transformed with a viral vector. In some embodiments, the modified stem cell is transformed with a lenti-virus or retrovirus. In some embodiments, the modified stem cell is transformed with the recombinant virus. In some embodiments, the modified stem cell is transiently transfected with an artificial chromosome, virus or plasmid DNA [0047].
As such, it would have been obvious to an artisan of ordinary skill before the time of effectively filling that Minev teaches using the stem cell in the claimed method as a vehicle for delivering anti-tumor agents. Minev teaches introducing a heterologous nucleic acid into the vehicle cell that encoding a suicide gene, which is an anti-tumor agent or a gene encoding a useful protein product, such as an anti-tumor agent. As such, one of ordinary skill would understand that Minev teaches the limitations of claim 66.
Regarding claim 68, Minev teaches in some embodiments, the smallpox vaccine does not comprise heterologous nucleic acid ([0028]). These teaching suggest that in the broader embodiments the claimed invention encompasses smallpox vaccines comprising heterologous nucleic acids and smallpox vaccines that do comprise heterologous nucleic acids. As discussed above described embodiments of heterologous nucleic acids include ones that encode suicide genes and useful protein products (i.e. anti-tumor agents and therapeutic agents as claimed). As such, it would have been obvious from the teachings of Minev to produce a variant method of Minev that using a smallpox virus comprising a suicide gene or useful protein product to predictably arrive at the limitations of claim 68.
(2) Claim(s) 67 and 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minev as applied to claims 20-21, 59-60, 64-66 and 68 above, and further in view of Lattime (US2003/0206886 pub date:11/6/2003).
Minev teaches the claims as discussed above. Minev does not teach that the therapeutic protein encoded by the recombinant polynucleotide is an antibody. However, long before the effective filing nucleic acid encoding neutralizing antibodies against cancer antigens and factors that promoter cancer growth were established and being used treat cancers and inhibit cancer growth. For example, Lattime teaches nucleic acids encoding neutralizing antibodies against immune suppressive factors for the immunotherapy of cancer and tumors (abstract). Lattime teaches neutralizing construct composed of both heavy and light chains of a monoclonal antibody capable of neutralizing immune suppressive factors is engineered. Gene delivery into the tumor environment leads to the expression and section of functional antibodies by the transfected cell, causing the neutralization and blocking of the immune suppressive factors present in the tumor environment, aiding in the efficacy of other anti-cancer treatments ([0031] of Lattime).
As such, it would have been obvious to an artisan of ordinary skill before the time of effective filing to transfect the iPSC of Minev with the neutralizing construct of Lattime to predictably arrive at the method of claim 67. Also it would have been obvious to an artisan of ordinary skill before the time of effective filing to incorporate the neutralizing construct of Lattime into the poxvirus of Minev to predictably arrive at the method of claim 69. An artisan would have a reasonable expectation of success because incorporating the neutralizing construct of Lattime into a viral vector and transfecting cells with such constructs was established for decades in the prior art, as demonstrated by Lattime. Further an artisan would have been motivated to incorporated the neutralizing construct of Lattime with the cancer/tumor treatment method of Minev because Minev teaches the intended use of additional anti-tumor therapies with their method and Lattime teaches that their neutralizing construct therapy aid in reducing immunosuppressive factors that inhibit immune responses against the tumor and allow for tumor growth. Thus Minev in view of Lattime render claims 67 and 69 obvious.
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.
(1) Claims 20-21, 59-60, 64-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9-12 of U.S. Patent No. 11,607,450. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claims disclose a species of the instant claims.
Regarding instant claims 20-21, patent claim 1 discloses a method of treating a solid tumor or a hematologic malignancy (i.e. a species of disease as claimed in instant claim 20 and a disease associated with chronic inflammation as recited in claim 21) in a subject, comprising administering to the subject a composition comprising a smallpox vaccine (i.e. another name for poxvirus as claimed) and a carrier cell, wherein the smallpox vaccine and the carrier cell were cultured together in vitro, wherein the carrier cell is a stem cell, which is selected from a group consisting of an adult stem cell, an embryonic stem cell, a fetal stem cell, a mesenchymal stem cell, a neural stem cell, a totipotent stem cell, a pluripotent stem cell, a multipotent stem cell, an oligopotent stem cell, a unipotent stem cell, an adipose stromal cell, an endothelial stem cell, an induced pluripotent stem cell, a myoblast stem cell, a small juvenile stem cell, a skin fibroblast stem cell, and combinations thereof.
Regarding claim 59, this claim dose not further limit the structure of the iPSC as such, patent claim 1 discloses a species of claim 59 as discussed above.
Regarding claim 60, patent claim 2 discloses wherein the stem cell is autologous to the subject (aka the stem cell is derived from a subject to be treated with the composition as claimed in claim 60).
Regarding claim 64-65, patent claim 9 discloses wherein the smallpox vaccine is a Wyeth strain, an attenuated Wyeth strain, a New York City Board of Health (NYCBOH) strain, or an attenuated NYCBOH strain. Patent claim 10 discloses wherein the strain is a NYCBOH strain that is designated as ATCC VR-118, or CJ-MVB-SPX. Patent claim 11 discloses wherein the smallpox vaccine is selected from among Dryvax, Lister, EM63, Tian Tan, Copenhagen, Western Reserve, and Modified Vaccinia Ankara (MVA) strains. Patent claim 12 discloses wherein the smallpox vaccine is an attenuated New York City Board of Health (NYCBOH) strain of vaccinia virus. Thus patent claims 9-12 discloses species of instant claims 64-65
(2) Claims 66-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,607,450 in further view of Lattime (US2003/0206886 pub date:11/6/2003).
Patent claim 1 teaches the claimed method as discussed above. Patent claim 1 does not teach does not teach that the therapeutic protein encoded by the recombinant polynucleotide is an antibody. However, long before the effective filing nucleic acid encoding neutralizing antibodies against cancer antigens and factors that promoter cancer growth were established and being used treat cancers and inhibit cancer growth. For example, Lattime teaches nucleic acids encoding neutralizing antibodies against immune suppressive factors for the immunotherapy of cancer and tumors (abstract). Lattime teaches neutralizing construct composed of both heavy and light chains of a monoclonal antibody capable of neutralizing immune suppressive factors is engineered. Gene delivery into the tumor environment leads to the expression and section of functional antibodies by the transfected cell, causing the neutralization and blocking of the immune suppressive factors present in the tumor environment, aiding in the efficacy of other anti-cancer treatments ([0031] of Lattime).
As such, it would have been obvious to an artisan of ordinary skill before the time of effective filing to transfect the iPSC of the patent claim with the neutralizing construct of Lattime to predictably arrive at the method of claims 66-67. Also it would have been obvious to an artisan of ordinary skill before the time of effective filing to incorporate the neutralizing construct of Lattime into the poxvirus of the patent claim to predictably arrive at the method of claims 68-69. An artisan would have a reasonable expectation of success because incorporating the neutralizing construct of Lattime into a viral vector and transfecting cells with such constructs was established for decades in the prior art, as demonstrated by Lattime. Further an artisan would have been motivated to incorporated the neutralizing construct of Lattime with the cancer/tumor treatment method of the patent claim because Lattime teaches that their neutralizing construct therapy aid in reducing immunosuppressive factors that inhibit immune responses against the tumor and allow for tumor growth. Thus the patent claim in view of Lattime render claims 66-69 obvious.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
Prosecution Insights