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 .
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. This application is a 371 of PCT/US2021/038005 filed June 18, 2021, which claims the benefit of US Provisional Application No. 63/041,493 filed June 19, 2020. All claims have been given an effective filing date of June 19, 2020.
Claim Status
Claim listing filed on January 2, 2024 is pending. Claims 21-28 are canceled. Claims 7, 9, 12, and 15 are amended. Claims 1-20 are examined upon their merits.
Information Disclosure Statement
The information disclosure statements filed on 12/19/2022, 02/10/2023, and 02/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because “IL-12for” lacks a space and should recite “IL-12 for.” 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 Objections
Claims 2, 7, 9-10, 12, 14, and 17 are objected to because of the following informalities:
Claim 2 recites “treated with systemic administration of the at least one dose of the checkpoint inhibitor wherein the checkpoint inhibitor.” The last four words appear to by a typographical error as the phrase is not finished before the end of the sentence. Appropriate correction recites “treated with systemic administration of the at least one dose of the checkpoint inhibitor.”
Claim 7 recites “the method of any one of claim 1” wherein “the method of claim 1” is correct.
Claim 9 recites “the method of any one of claim 1” wherein “the method of claim 1” is correct.
Claim 10 recites “and/or the least one additional dose” wherein “and/or at least one additional dose” is correct.
Claim 10 recites “anti -PD- 1” in line 3 wherein “anti-PD-1” without the unnecessary spaces is correct and used elsewhere in the claims.
Claim 12 recites “the method of any one of claim 1” wherein “the method of claim 1” is correct.
Claim 12 recites “ER negative breast cancer triple negative breast cancer” wherein “ER negative breast cancer, triple negative breast cancer” is correct with a comma separating “ER negative breast cancer” and “triple negative breast cancer” as these are two distinct cancer types as defined in specification paragraph [164].
Claim 14 requires a colon after comprises to recite “tumor sample comprises:”
Claim 17 requires a colon after comprises to recite “tumor sample comprises:”
Appropriate correction is required.
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.
Claims 1-20 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.
Claims 1, 12-13, and 16 are indefinite because they recite the abbreviations “CXCR3,” “CXCL9,” “CD3 half-BiTE,” and “ER” without defining the abbreviations in the claims. For the purpose of compact prosecution, “CXCR3” is interpreted as C-X-C motif chemokine receptor 3, “CXCL9” is interpreted as C-X-C motif chemokine ligand 9, “CD3 half-BiTE” is interpreted as cluster of differentiation 3 half-bispecific T-cell engager (structure further defined in specification paragraph [17]), and “ER” is interpreted as estrogen receptor.
Claim 1 recites the limitation "the tumor sample" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is interpreted as “in a tumor sample obtained from the subject.”
Claims 1, 13, and 16 recite a “predetermined control” which is not defined in the specification such that one of ordinary skill would understand what is claimed. Specification paragraphs [114]-[115] list non-limiting examples of what the predetermined control could be by reciting “in some embodiments.” Because comparing CXCR3 expression to the predetermined control dictates treatment administration in the claimed method, it is of utmost important that one of ordinary skill understands the metes and bounds of “predetermined control.”
Claim 8 recites wherein the predetermined control comprises “a tumor sample obtained from the subject prior to step (a).” Claim 8 depends from Claim 7 which recites a step (a), and Claim 7 depends from Claim 1 which recites a step (a). It is unclear what step (a) is being referenced. Even if Claim 8 was understood to reference step (a) of Claim 1, the phrase is still unclear because step (a) of Claim 1 is directed to measuring CXCR3 expression in a tumor sample from a pre-treated subject. As claimed, the predetermined control could be obtained from a pre-treated subject immediately before measuring the CXCR3 expression as recited in step (a) of Claim 1. There is no requirement that the predetermined control be obtained from the subject prior to treatment. Further, Claim 8 (b) recites a standard derived from a population of known responders and/or known non-responders to checkpoint inhibitor therapy. It is unclear what is encompassed by a “standard derived from.” Further, specification paragraph [115] defines that the level of CXCR3 expression in a population of known responders and/or known-non-responders may be calculated as or expressed as an average or mean of the levels of CXCR3 expression as measured in the known responders and/or known non-responders. If experimentation and calculation are required for one of ordinary skill to understand what is encompassed by “a standard derived from a population of known responders and/or known non-responders”, then one of ordinary skill would not understand the metes and bounds of the claim from the claim language. Claims 15 and 19 are also rejected for indefiniteness for defining wherein the predetermined control comprises a standard derived from a population of known responders and/or known non-responders to checkpoint inhibitor therapy.
Claim 19 recites wherein the predetermined control comprises a tumor sample obtained from the subject prior to administration of the at least one dose of the checkpoint inhibitor. However, Claim 19 depends from Claim 16, and Claim 16 only defines administering a checkpoint inhibitor after comparing CXCR3 expression to the predetermined control. With this circular reasoning, the predetermined control could be the same as the tumor sample defined in Claim 16 (a). There is no requirement that the predetermined control be obtained from the subject prior to treatment. Claim 19 (a) is unclear.
Claim 16 recites a product, specifically a nucleic acid encoding CXCL9 and/or CD3 half-BiTE. The intended use of the product (for use in a method of treating cancer) does not structurally change the nucleic acid. MPEP § 2111.02.II states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” Therefore, the use in a method of treating cancer is not considered a claim limitation, and Claim 16 is interpreted as directed to a nucleic acid encoding CXCL9 and/or CD3 half-BiTE. Because Claim 16 is directed to a product and not a method, the preambles of Claims 17-20 are indefinite. The preambles of Claims 17-20 recite “the nucleic acid for use in the method of claim 16.” However, Claim 16 is not directed to a method. Appropriate correction could recite “the nucleic acid of claim 16.”
Claim 16 recites the limitation "the subject" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is interpreted as “a tumor sample obtained from a subject.”
Note, “increased” as recited in Claims 1 and 16 is not specifically defined in the specification and is interpreted with the broadest reasonable interpretation to include any increase in expression, even a non-significant change.
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.
Claims 1-12 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 ameliorating cancers known in the art to respond to immune checkpoint inhibitors, does not reasonably provide enablement for the full scope of treating any type of cancer, which the disclosure defines as encompassing prevention (Claim 1). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex, encompassing the treatment of any type of cancer (Claim 1). The specification defines “treatment” as a medicament for inhibition or reduction of proliferation of cancer cells, destruction of cancer cells, prevention of proliferation of cancer cells, prevention of initiation of malignant cells, arrest or reversal of the progression of transformed premalignant cells to malignant disease, or amelioration of the disease (paragraph [104], emphasis added). It is interpreted that this definition of treatment includes both therapeutic treatment of established cancers and prophylactic treatment to prevent the onset of cancers.
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. MD Anderson Cancer Center 2020 teaches that immune checkpoint inhibitors are a standard treatment for melanoma, small cell lung cancer, non-small cell lung cancer, bladder cancer, kidney cancer, stomach cancer, liver cancer, head and neck cancers, and lymphoma (paragraph 3). However, certain cancers including pancreatic cancer, prostate cancer, and glioblastoma have been especially resistant to checkpoint inhibitors (paragraph 4). Additionally, the World Health Organization 2025 teaches that only 30-50% of cancer cases are preventable, and prevention primarily comprises risk management such as avoiding tobacco, alcohol, obesity, and carcinogens (“Preventing Cancer”) instead of therapeutic intervention.
The state of the art shows a continued lack of predictability even after the effective filing date of the instant invention in treating and preventing any type of cancer by administering checkpoint inhibitor therapy, and there is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability.
Chow et al. Immunity 2019 teaches a method of treating cancer patients identified by CXCR3 biomarkers with a combination of CXCL9 and checkpoint inhibitors (abstract and discussion last paragraph). However, the only cancer types evaluated by Chow comprise colon adenocarcinoma, melanoma, and breast cancer (paragraph spanning pages 1504-1505, page 1500 paragraphs 1-2, and paragraph spanning pages e3-e4). Chow teaches no examples of preventing cancer by administering prophylactic treatments or treating cancer types known to be resistant to immune checkpoint inhibitors such as pancreatic cancer, prostate cancer, and glioblastoma.
Level of skill in the art:
The level of skill would be high encompassing oncology, immunology, in vivo experimentation, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches therapeutically treating in vitro models and in vivo mouse models of colon cancer (Examples 7 and 18-21), melanoma (Examples 10-11 and 13-14), and breast cancer (Examples 13 and 22). There are no working examples that teach preventing cancer.
While the working examples show anti-tumor effects across three cancer types, a person having ordinary skill in the art would still have to make a substantial inventive contribution in order to treat and prevent any type of cancer, since there is no guidance within the disclosure as filed pertaining to this embodiment. No evidence is provided that the instantly claimed method of treatment is effective in the cancer types known to be resistant to checkpoint inhibitors (pancreatic cancer, prostate cancer, and glioblastoma).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Given that the nature of the claims is in vivo treatment and prevention, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of treatment and prevention in a representative number of cancer types in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of success.
The instant specification does not enable the invention to treat and prevent any type of cancer (Claim 1).
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 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Specifically, the instant claims encompass both natural phenomena and abstract ideas.
Claims 13-15 are directed to a method of identifying a subject with cancer at risk of not responding to checkpoint inhibitor therapy comprising measuring a level of CXCR3 in a tumor sample and comparing the level to a predetermined control to indicate whether the subject is at risk of not responding to therapy. The claims comprise the abstract ideas of “identifying” and “comparing” CXCR3 levels. MPEP § 2106.04(a)(2).III.A teaches that claims directed to “identifying” and “comparing” (such as comparing BRCA sequences) recite mental processes that can practically be performed in the human mind. These teachings read on the instant claims that comprise determining whether a level of CXCR3 is less than or more than a predetermined control. The claims also comprise the observation of a law of nature without significantly more. MPEP § 2106.04(b) teaches that the courts identified a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk as an example of a law of nature or natural phenomena, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). The case law applies to the instant method which identifies a correlation between the level of CXCR3 in a sample and risk of non-response to treatment.
Claims 16-20 are directed to a nucleic acid encoding CXCL9 (see claim interpretation in 112(b) above). Fukuda et al. Cancer Sci. Jan 2020 teaches that CXCL9 is a member of the ELR-motif negative-CXC chemokine family and is endogenously produced by macrophages, endothelial cells, hepatocytes and tumors (abstract and introduction paragraph 3). Further, NCBI Gene ID: 4283 (updated 2026) teaches that human CXCL9 is located on chromosome 4 (genomic context section). These teachings demonstrate that nucleic acid encoding CXCL9 is a product of nature as it occurs endogenously within the human body.
Therefore, claims 13-20, while directed to a process or composition of matter (Step 1 – YES), do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. The rationale for this determination is explained below:
a) The current invention is essentially directed to a method of observing a natural law/natural phenomenon (i.e. a correlation of CXCR3 expression and treatment response) and comprises the abstract/mental concepts of “comparing” CXCR3 levels and “identifying” at-risk subjects. The claims are further directed to a naturally occurring nucleic acid encoding CXCL9 (Step 2A, Prong One - YES).
b) These judicial exceptions are not integrated into a practical application because the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. For example, the method Claims 13-15 do not comprise administering a treatment (MPEP § 2106.04(d)(2)). The intended use of Claims 16-20 does not alter the structure of the naturally occurring nucleic acid (MPEP § 2111.02.II) (Step 2A, Prong Two - NO).
c) Nothing significantly more than the judicial exceptions is recited within the claims. The courts have defined that simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to a judicial exception is not “significantly more” (MPEP § 2106.05.I.A). The courts have recognized determining the level of a biomarker in blood by any means, amplifying and sequencing nucleic acid sequences, detecting DNA or enzymes in a sample, and using polymerase chain reaction to amplify and detect DNA as routine activities in the life sciences when claimed at a high level of generality (MPEP § 2106.05(d).II) (Step 2B - NO).
In Mayo Collaborative Services it was held that:
"Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. [emphasis added].
The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply observe and restate a law of nature while adding the words "apply it." As set forth in the decision,
"[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself," further, "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. [emphasis added]"
The discovery of a naturally occurring correlation between CXCR3 expression and checkpoint inhibitor response is merely the observation of a law of nature in subjects with cancer. For these reasons, Claims 13-20 are rejected under section 101 as being directed to non-statutory subject matter.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al. Immunity 2019 in view of Twitty WO 2020/112987 (published June 4, 2020 and not a prior art exception due to a different inventive entity) as evidenced by Tokunaga et al. Cancer Treat. Rev. 2018.
In regard to Claims 1-3, 8, 10, 12-13, 15, Chow teaches that the CXCR3 chemokine system is a biomarker for sensitivity to PD-1 blockade and that augmenting the intratumoral function of this chemokine system could improve clinical outcomes (abstract). In Cxcr3-/- mice, the response to anti-PD-1 antibody treatment was significantly diminished compared with those in WT mice (results paragraph 1 and Fig. 1B+C) which shows that the presence of CXCR3 is crucial to anti-PD-1 antibody sensitivity. Chow analyzed CXCL9 expression in samples from melanoma patients before and after treatment with PD-1 blockade therapy and observed that the levels of CXCL9 (a CXCR3 ligand) correlated significantly with treatment response (page 1508 paragraph 1). Specifically, levels of CXCL9 increased after anti-PD-1 antibody treatment in responders and did not increase in non-responders (Fig. 7A) which shows that the CXCR3 ligand CXCL9 can be an early biomarker for response to immune checkpoint inhibition (page 1508 paragraph 1). Further, Chow teaches that therapeutically upregulating CXCL9 in non-responders by administering epigenetic modulators promotes responsiveness to anti-PD-1 therapy (paragraph spanning pages 1505 to 1508). Therefore, administering CXCL9 in non-responders can rescue sensitivity to immune checkpoint inhibition (page 1510, paragraph 1). Note, it is understood in the art that mechanistically CXCR3 upregulation and CXCL9 upregulation are correlated as both the receptor (CXCR3) and ligand (CXCL9) are a part of the same chemokine system and both are induced by IFN-γ (as evidenced by Tokunaga abstract, page 41, and page 45). Therefore, it is obvious from the teachings of Chow to measure CXCR3 expression after checkpoint inhibitor therapy wherein an increase in CXCR3 expression relative to pre-treatment levels of CXCR3 indicates response to checkpoint inhibitor therapy and no increase in CXCR3 expression relative to pre-treatment levels of CXCR3 indicates poor response wherein CXCL9 should be administered in combination with the checkpoint inhibitor to promote sensitivity. The cancer types evaluated by Chow comprise colon adenocarcinoma, melanoma, and breast cancer (paragraph spanning pages 1504-1505, page 1500 paragraphs 1-2, and paragraph spanning pages e3-e4).
In regard to Claims 7 and 14, Chow teaches measuring CXCR3-expressing CD8+ T cell populations within MC38 murine colon adenocarcinoma tumors (paragraph spanning pages 1502 to 1504). Chow also teaches measuring RNA and protein levels of the CXCR3 ligands CXCL9 and CXCL10 in tumors (page 1504 paragraph 1). Given the known mechanistic connection between CXCR3 and CXCL9 as evidenced by Tokunaga above, it would be obvious to one of ordinary skill to measure RNA and protein levels of CXCR3 in a tumor in addition to or instead of levels of CXCL9 (a CXCR3 ligand).
Chow fails to teach wherein the subject has been previously treated with an immunostimulatory cytokine administered by intratumoral electroporation of a nucleic acid encoding the cytokine (Claim 4); wherein the cytokine is IL-12 (Claim 5); wherein the nucleic acid encoding IL-12 comprises a first nucleic acid sequence and a second nucleic acid sequence encoding the IL-12 p35 and p40 subunits respectively and separated by a 2A translation modification element (Claims 6 and 11); intratumoral electroporation of one or more nucleic acids encoding CXCL9 or CD3 half-BiTE (Claim 9); or a nucleic acid encoding CXCL9 or CD3 half-BiTE (Claims 16-20).
However, Twitty teaches a method of treating cancer by administering an expression cassette by intratumoral electroporation (paragraph [0011]) wherein the expression cassette can encode CXCL9, CXCL9 plus IL-12, CD3 half-BiTE, or CD3 half-BiTE plus IL- 12 (paragraph [007]). Note, an “expression cassette” refers to an RNA or DNA coding sequence or segment of RNA or DNA that codes for an expression product such as a protein (paragraph [0058]). Specifically, the encoded IL-12 can comprise a nucleic acid encoding the IL-12 p35 subunit and a nucleic acid encoding the IL-12 p40 subunit separated by an IRES or 2A element (paragraph [008]). The method of treating cancer can further comprise administering an immune checkpoint inhibitor in combination with the expression cassette (paragraphs [0012]-[0013]). Intratumoral electroporation of IL12 and CXCL9 is a synergistic combination that expands antigen-specific T cells and controls tumor growth (paragraphs [00218]-[00223]). Similarly, intratumoral electroporation of CXCL9 and CD3 half-BiTE effectively treats melanoma and breast cancer tumors in mouse models (paragraphs [00236]-00237]). The triple combination of intratumoral electroporation of CXCL9, IL12, and CD3 half-BiTE significantly decreased melanoma tumors in mouse models as compared to IL12 treatment alone (paragraph [00238]). Overall, Twitty teaches how administering nucleic acid encoding CXCL9 plus IL-12 or CD3 half-BiTE plus IL- 12 promotes anti-tumor T-cell responses and can be combined with immune checkpoint inhibitor therapy.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to adapt the method of treating cancer taught by Chow to comprise administering the expression cassettes taught by Twitty. Specifically, Chow teaches identifying patients who will likely not respond to immune checkpoint inhibitor therapy and administering CXCL9 in addition to the immune checkpoint inhibitor to sensitize these non-responders to the therapy. Twitty teaches expression cassettes comprising CXCL9 that can be administered to treat cancer in combination with immune checkpoint inhibitors. Twitty further teaches that it is favorable to combine CXCL9 with IL-12 and/or CD3 half-BiTE to promote anti-tumor T-cell responses in a synergistic manner. It would be obvious to one of ordinary skill to administer the expression cassettes of Twitty to the patients identified by the method of Chow because (1) Chow teaches that CXCL9 can resensitize non-responders to checkpoint inhibition therapy, (2) Twitty teaches synergistic combinations that enhance the function of CXCL9, (3) expression cassettes that promote T-cell responses would mechanistically support immune checkpoint inhibitors that are known to “release the brakes” on the immune system and allow T cells to recognize and attack tumor cells, and (4) combination therapy treatment is standard in oncology treatment. In combination, each therapy performs the same function as it does separately, and the results of the combination are predictable. The motivation to combine the references is to better identify cancer patients who would benefit from CXCL9 supplementation (Twitty) by measuring expression of the known CXCR3 biomarker (Chow).
Conclusion
No claim is allowed.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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