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 .
DETAILED ACTION
Claims 1-15 are currently pending and under prosecution.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites "…such as Bai1, MegF10, or MerTK" and "…such as an anti-CD47 or an anti-EGFR antibody…". A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
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 2, 3, 7-12, 14, and 15 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. This is a WRITTEN DESCRIPTION rejection.
The claims are drawn to a method of treatment comprising administering an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells.
Dependent claims 2 and 14 recite that the human iPSC-derived macrophages comprise a CAR expressed thereon. Dependent claim 12 recites that the method of claim 1 further comprises administering to the subject an effective amount of CAR T-cells, NK cells, or CAR-NK cells
Dependent clam 7 recites that the method further comprises administering to the subject an effective amount of an antibody specific for the cancer. Dependent claim 8 recites that the antibody is an anti-CD47 or an anti-EGFR antibody.
Dependent claim 11 recites that the method further comprises administering to the subject an effective amount of an immune-stimulating agent, a TLR agonist, or a checkpoint inhibitor.
Thus, the written description is directed towards the following:
The unknown structure of the chimeric antigen receptor
The broad genus of “an antibody specific for the cancer”
the broad genus of “immune-stimulating agent, a TLR agonist, or a “checkpoint inhibitor”
The instant specification discloses that human IPSC’s were used to generate human iPSC – CAR macrophages and that they were genetically engineered to express CARs against mesothelin tumor antigens. The instant specification discloses three examples of signaling domains capable of promoting phagocytosis that include MegF10, MerTK, and Bail1. The instant specification discloses that the macrophage-specific CAR molecule approach can be used to target any tumor antigen and can be used with any immunotherapy product, including CAR T-cells and CAR NK-cells. [see pgs 22 and 23 of the specification] No structure or support is demonstrated in the claims or the specification, and the claims encompass a very large genus of CAR molecules, that is not limited to a specific target or a specific structure.
Regarding anti-cancer antibodies, the instant specification discloses that human iPSC-derived macrophages with therapeutic antibodies (anti-CD47 and anti-EGFR antibodies) and disclosed that they improved phagocytic activity in intro in ovarian cancer xenograft. [pg 22, 0066] No other examples or structures of any other anti-cancer antibodies are disclosed in the specification. The instant specification does not disclose any examples of immune-stimulating agents, TLR agonists, or checkpoint inhibitors to be combined with the iPSC-derived macrophage cells.
State of the prior art
At the time of filing, antibody and/or CAR(s) antigen binding domain functionality was/were known to depend on the entire structure, particularly a full complement of six CDRs. With regards to anti-cancer antibodies, Chames et al (British J. Pharmacology, 2009, 157, 220-233) teaches that there are several challenges to development of therapeutic antibodies, including anti-cancer antibodies. Vaillant et al (Antibodies 2025, 14(2), 35) teaches the use of monoclonal antibodies in cancer therapy and teaches the vast use of antibodies and diversity of these antibodies. However, these antibodies face challenges including production, specialized administrations, etc Thus, the genus of anti-cancer antibodies is vast, and the specification does not disclose possession of the entire genus of anti-cancer antibodies.
With regards to chimeric antigen receptors, Zhang et al (Engineering CAR-T cells. Biomark Res. 2017 Jun 24;5:22) teaches that CAR-T cells generally comprise an extracellular antigen-binding domain comprising an scFv, a spacer, a transmembrane domain, and an intracytoplasmic domain (See Figure 1). Zhang teaches that although CAR-T cells have shown promising activity, there still remains challenges and high-quality CAR-T products need to be ensured through optimization protocols. The prior art does not teach however a CAR without the full structure or target that would allow the CAR to bind to a specific antigen.
With regards to a TLR agonists as the immune stimulating agent: Of note, the instant specification recites a TLR agonist as an example of an immune stimulating agent. [see paragraph 0083 of the published spec] Hennessy et al (Targeting Toll-like receptors: emerging therapeutics? Nat Rev Drug Discov 9, 293–307, 2010) teaches that there is a focus in identifying TLR antagonists and agonist. [pg 8-9] With regards to TLR agonists for treatment of cancer, Hennessy teaches that TLR ligands as therapies is still currently under investigation, and provides one only example imiquimod. [pg 9 “TLR agonists for cancer”]
With regards to any checkpoint inhibitor: de Miguel M et al (Clinical Challenges of immune checkpoint inhibitors. Cancer Cell 2020 Sep 14;38(3):326-333) teaches that there are many clinical challenges surrounding immune checkpoint inhibitors, including toxicity and efficacy. [whole document]
To provide adequate written description and evidence of possession of the claimed composition of an antibody genus, an immune-stimulating agent, a TLR agonist or a checkpoint inhibitor, the instant specification can structurally describe representative agents that functions as claimed, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.). A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product.
Although Applicants may argue that it is possible to screen for agents that function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future agents yet to be discovered that may function as claimed.
Given the lack of representative examples to support the full scope of the claimed agents, and lack of reasonable structure-function correlation, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of the claimed agents, including the anti-cancer antibody, the TLR agonist, or a checkpoint inhibitor, that is required to practice the claimed invention. Since the specification fails to adequately describe the product to which the claimed method uses, it also fails to adequately describe the method.
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 1-3, 6-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of cancer and fibrosis, does not reasonably provide enablement for treatment of every single cancer, autoimmune disorder, and senescent cells. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
BREADTH OF THE CLAIMS: Claim 1 is drawn to a method of treatment comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells. Dependent claim 4 recites treatment is for a cancer. Dependent claim 7 recites treatment is for fibrosis, autoimmune disorder, or senescent cells.
PRESENCE OR ABSENCE OF EXAMPLES: The example in the instant specification discloses the use of human iPSC-derived macrophages in ovarian cancer mouse models. The instant specification discloses that the macrophage-specific CAR molecule promotes macrophage phagocytosis of ovarian cells in vitro.
STATE OF THE ART: A search of the relevant art discloses that human iPSC-derived macrophage cells can be used for the treatment of cancers and fibrosis. Zhang et al (Pluripotent stem cell-derived CAR-macrophage cells with antigen-dependent anti-cancer cell functions. J Hematol Oncol 13, 153, 2020). teaches the use of CAR-iPSC derived macrophages for the treatment of cancer. Tadakoro et al (Human iPSC-liver organoid transplantation reduces fibrosis through immunomodulation. Sci Transl Med. 2024 Jul 24;16(757), Pounyanfard et al (Stem Cells, Volume 39, Issue 12, December 2021, Pages 1701–171) and Rasaei, et al. (Human pluripotent stem cell-derived macrophages and macrophage-derived exosomes: therapeutic potential in pulmonary fibrosis. Stem Cell Res Ther 13, 433, 2022) all teach the use of human iPSC-derived macrophages for the use in treatment of various types of fibrosis. However, the art does not teach that the human iPSC-derived macrophage cells can be used for every type of autoimmune disorder or senescent cells.
PREDICTABILITY: Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that administration of the claimed protein that will treat all of the claimed disorders, including autoimmune disorders or senescent cells. Additionally, every medical condition comprises a wide range of treatment modalities depending on the disease treated. For example, treatment of autoimmune disorders depends on various factors, including the type of disorder.
QUANTITY OF EXPERIMENTATION: Undue experimentation would be required to determine what human IPSC-derived macrophage cell could treat each specific condition as claimed. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed agents treat every single medical condition, and is not routine in the art as these diseases are unrelated and comprise various subgroups within each disease state. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
BREADTH OF THE CLAIMS: Claim 11 recites further comprising administering to the subject an effective amount of an immune-stimulating agent, a TLR agonist, or a checkpoint inhibitor.
PRESENCE OR ABSENCE OF EXAMPLES: The example in the instant specification discloses the combination of a human-iPSC derived macrophage cell with an anti-CD47 or an anti-EGFR antibody. The instant specification does not demonstrate any examples combining with an immune-stimulating agent, a TLR agonist, or a checkpoint inhibitor.
STATE OF THE ART: The art demonstrates the challenges of combining agents for treatment. Chames et al (British J. of Pharmacology, 2009, 157, 220-233) teach that there are several challenges to development therapeutic antibodies. These challenges include functional limitations such as inadequate pharmacokinetics, tissue accessibility and impaired interactions with the immune system (Abstract). Additionally, Chames teaches several limitations of therapeutic antibodies such as affinity between the antibody and its antigen, competition with patient’s IgG, and efficiency issues in triggering the immune response (pages 224-225). Furthermore, Hennessy et al (Targeting Toll-like receptors: emerging therapeutics?. Nat Rev Drug Discov 9, 293–307, 2010) teaches that there is a focus in identifying TLR antagonists and agonist to enhance the immune response and that the downside of activating TLRs is not clear at present and that overactivation of pathways could give rise to unwanted effects, including autoimmunity and tissue fibrosis. de Miguel M et al (Clinical Challenges of immune checkpoint inhibitors. Cancer Cell 2020 Sep 14;38(3):326-333) teaches that there are many clinical challenges surrounding immune checkpoint inhibitors, including toxicity and efficacy. [whole document]
QUANTITY OF EXPERIMENTATION: Undue experimentation would be required to determine which specific agent can be combined with what iPSC-derived macrophage cells to for treatment functions. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 3, 5 and 15 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.
Claim 5 recites the limitation "...wherein the cancer is ovarian". There is insufficient antecedent basis for this limitation in the claim.
Examiner’s suggestion: Amend claim 5 to depend on claim 4.
Claim 15 recites the limitation “…wherein the CAR is Bai1, MegF10 or MerTK.” There is insufficient antecedent basis for this limitation in the claim.
Examiner’s suggestion: Amend claim 15 to depend on claim 14.
Claims 3 and 15 recite the limitations “…wherein the CAR is Bai1, MegF10, or MerTK”. A Chimeric Antigen Receptor (CAR) is an engineered protein with multiple domains including an extracellular domain (which binds antigen), a transmembrane domain, an intracellular domain (or signaling domain). The instant specification discloses these molecules, Bai1, MegF10, or MerTK as signaling domains or targets of the CAR. [see at least pg 8, 0029; pg 22 paragraphs 0068] Thus, it is unclear what is being claimed by claims 3 and 15 and the claims are indefinite.
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.
Claim(s) 1, 4, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Senju et al (Application of iPS cell-derived macrophages to cancer therapy. Oncoimmunology. 2014 Jan 1;3(1):e27927)
Senju et al teaches a method of treating cancer comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells. Regarding claim 13, Senju teaches a pharmaceutically acceptable composition comprising human iPSC-derived macrophages. [Figure 1, pg 3, “Towards clinical application”]
Claim(s) 1, 2, 4, 5, 12, 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (Pluripotent stem cell-derived CAR-macrophage cells with antigen-dependent anti-cancer cell functions. J Hematol Oncol. 2020 Nov 11;13(1):153)
Zhang et al teaches a method of treating cancer comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells. [Abstract, pg 1, 2nd column] Regarding claim 2, Zhang teaches that the human iPSC-derived macrophages comprise a chimeric antigenic receptor. [abstract, pg 1, 2nd column] Regarding claims 13 and 14, Zhang teaches a pharmaceutically acceptable composition comprising human iPSC-derived macrophages, which comprise a CAR. [pg 1, Abstract] Regarding claims 4 and 5, Zhang teaches the treatment of ovarian cancer. [pg 3; col 1, last paragraph, col 2 2nd paragraph]
Claim(s) 1, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernareggi (Development of innate immune cells from human pluripotent stem cells. Exp Hematol. 2019 Mar;71:13-23).
Bernarreggia teaches a method of treatment comprising human pluripotent stem cells to derive therapeutic macrophages. [pg 5, last paragraph] Bernarreggia teaches that IPSC-derived macrophages have led to development of novel therapeutic targets for diseases that involve macrophages, such as liver fibrosis. Bernarreggia teaches that therapeutic application of murine iPSC-macrophages significantly diminished the amount of hepatic fibrosis. [pg 7, 2nd section]
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Pluripotent stem cell-derived CAR-macrophage cells with antigen-dependent anti-cancer cell functions. J Hematol Oncol. 2020 Nov 11;13(1):153), in view of Morrissey et al (Chimeric antigen receptors that trigger phagocytosis, eLife 2018;7:e36688), Crane et al (US20170087185 A1; Published 3/30/2017), and
Zhang et al teaches a method of treating cancer comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells. [Abstract, pg 1 2nd column, Regarding claim 2, Zhang teaches that the human iPSC-derived macrophages comprise a chimeric antigenic receptor. Regarding claims 13 and 14, Zhang teaches a pharmaceutically acceptable composition comprising human iPSC-derived macrophages, which comprise a CAR. [pg 1, Abstract] Regarding claims 4 and 5, Zhang teaches the treatment of ovarian cancer. [pg 3; col 1, last paragraph, col 2 2nd paragraph] Regarding claims 9 and 10, Zhang teaches that that the method further increases phagocytosis against ovarian cancer cells and reduced tumor burden [Figure 2]
However, Zhang does not teach: (1) that the CAR contains signaling domains such as Bail1, MegF10 or MerTK, [limitations of claim 3 and 15] (2) the method further comprises administering an effective amount of an antibody specific for cancer, such as an anti-CD47 antibody. [limitations of claim 7-8], and (3) combination with a checkpoint inhibitor.
Morrissey teaches macrophages are critical effectors of the innate immune system and harnessing macrophages to combat tumor growth is of longstanding interest. [pg 1, 2nd paragraph] Morrissey teaches the use of CARs to program macrophages for anti-cancer treatment. [pg 2, 2nd paragraph] Morrissey teaches identification of domains that promote phagocytosis, including Bail1, MerTK and MegF10. [pg 2, Results] Furthermore, Morrissey exemplifies a macrophage expressing CAR-p with MegF10 [pg 2, Results, Figure 1] Morrissey teaches that anti-CD47 antibodies regulate phagocytosis, reduce tumor burden. Morrissey teaches the addition of an anti-CD47 antibody in combination with the CAR-T cell that targets macrophages and teaches that this increased phagocytosis by 2.5-fold. Morrissey also teaches that CD47 inhibition is most effective when combined with a positive signal to promote target engulfment, which raises the possibility of combining CAR-P expression with CD47 inhibition for additive effects. [pg 6; pg 9, 1st paragraph, Figure supplement 3]
Crane teaches genetic engineering of macrophages for immunotherapy, including genetically modified immune cell, such as a chimeric antigen receptor (CAR). [Abstract, 0016] Crane teaches the use of the macrophages for the treatments. [0017] Crane teaches that this agent can be combined with other agents, such as CAR T-cell therapy, and checkpoint blockade inhibitors. [0101, 0108, 0124]
One of skilled in the art could have combined the teachings of Zhang, Morrissey and Crane because: (1) Zhang et al teaches a method of treating cancer comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells, wherein the human iPSC-derived macrophages comprise a chimeric antigenic receptor (2) Morrissey teaches the use and exemplifies of CARs to program macrophages for anti-cancer treatment, and (3) Crane teaches the use of teaches genetic engineering of macrophages for immunotherapy, including genetically modified immune cell, such as a chimeric antigen receptor (CAR). Thus, all the references teach the use of engineered macrophages for the treatment methods.
It is noted that claim(s) 3 and 15 require that the CAR contains Bai1, MegF10, or MerTK as signaling domains. This limitation would have been obvious to those of ordinary skill in the art because: (1) Zhang teaches a method of treating cancer comprising administering to a subject in need thereof an effective amount of a pharmaceutically acceptable composition comprising human iPSC-derived macrophage cells, wherein the human iPSC-derived macrophages comprise a chimeric antigenic receptor, (2) Zhang teaches that this method further increases phagocytosis and reduces tumor burden, and (3) Morrissey teaches the use of CARs to program macrophages for anti-cancer treatment, and teaches the use of domains Bail1, MerTK and MegF10, all in which further promote phagocytosis. Given the known methods as taught by Zhang, and given the known functions and use of Bai1, MegF10, or MerTK, one of skilled in the art could have pursued constructing the CAR of Zhang to comprise Bai1, MegF10, or MerTK, with a reasonable expectation of success.
It is noted that claim(s) 7 and 8 require that the method of treatment comprising administering iPSC-derived macrophage cells further comprises administering an anti-cancer antibody, such as anti-CD47 antibody, and claim 11 requires the method further comprising an immune checkpoint inhibitor. This limitation would have been obvious to those of ordinary skill in the art because: (1) Zhang teaches a method of treating cancer comprising administering human iPSC-derived macrophage cells, (2) Morrissey teaches the use of CARs to program macrophages for anti-cancer treatment, (3) Morrissey teaches the known role of anti-CD47 antibodies and that the combination with CAR-T cells that target macrophages increased phagocytosis further compared to alone, (4) Crane further teaches combination of genetically engineered macrophages with other anti-cancer antibodies, such as checkpoint blockade inhibitors. Thus, given the known method of treatment comprising administering iPSC-derived macrophage cells, given the known methods of combining this with other antibodies, such as anti-CD47 antibodies and immune checkpoint inhibitors, one of skilled in the art could have pursued combining the agents, with a reasonable expectation of success.
Conclusion
No claims are allowed.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
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