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 the following:
Species A: anti-IGSF8 L2-01 antibody comprising HCDRs1-3, LCDRs1-3, VH, and VL set forth in Seq ID Nos: 643, 644, 646, 652, 653, 655, 703, and 707, respectively,
Species B: an anti-PD-1 antibody, specifically cemiplimab, and
Species C: melanoma
in the reply filed on 5 January 2026 is acknowledged.
Status of the Claims
Claims 1-144 were originally filed 9 February 2023. The preliminary amendment filed 19 September 2023 has been entered. Claims 1-2, 5-6, 8-10, 12-22, 25, and 28-29 are currently pending and under consideration.
Priority
The instant application claims priority to PCT/CN2020/108129 filed 10 August 2020. The PCT/CN2020/108129 does not recite or contemplate the instantly elected anti-IGSF8 L2-01 antibody comprising HCDRs1-3 as Seq ID Nos: 643, 644, 646, LCDRs1-3 as Seq ID Nos: 652, 653, and 655, VH as Seq ID No: 703, and a VL as Seq ID No: 707 (see instant specification pg. 180, bottom; see PCT/CN2020/108129 specification pg. 127, table 1).
Therefore, the priority date for the instant claims 1-2, 5-6, 8-10, 12-22, 25, and 28-29 is that of PCT/CN2021/111469 filed 9 August 2021.
Claim Objections
Claims 1, 6, 9, 18, 19, and 29 are objected to because of the following informalities:
Claim 1 recites, “An isolated or recombinant monoclonal antibody or an antigen binding fragment thereof” in lines 1-2 and should recite, “An isolated [[or]] recombinant monoclonal antibody or an antigen binding fragment thereof”.
Claim 6 recites, “a single chain Fv or scFv” in lines 3-4 and should recite, “a single chain Fv (scFv)”.
Claim 6 recites “an Fcab” in the last line and should recite, “a[[n]] Fcab”.
Claim 9 recites “an deficient Fc” in line 2 and should recite, “a[[n]] deficient Fc”.
Claim 18 and 19 recite “administrating” in lines 2 and should recite, “administering”.
Claim 29 recites a myriad of products which are all capitalized and should be lower case.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 18, 20-22, and 29 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 a method of treating cancer in a subject in need thereof, does not reasonably provide enablement for a method of modulating an immune response in a subject in need thereof. 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.
As a preliminary matter please note the following:
MPEP § 2111 instructs:
“The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the ‘broadest reasonable interpretation’ standard:
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The Patent and Trademark Office (‘PTO’) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must ‘conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.’ 37 CFR 1.75(d)(1).”
Likewise, MPEP § 2164.08 instructs:
“All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled. Accordingly, the first analytical step requires that the examiner determine exactly what subject matter is encompassed by the claims.”
(emphasis added).
Claim 18 recites the following (emphasis added)
“A method of modulating an immune response in a subject in need thereof, the method comprising administrating a therapeutically effective amount of the anti-IGSF8 monoclonal antibody or antigen-binding fragment thereof of claim 1 to the subject”
The specification defines “therapeutically effective amount” as an amount of a drug effective to treat a disease or disorder in a subject (see specification pg. 31, 1st para). The specification defines cancer as referring to a group of cells that exhibit abnormally high levels of proliferation and growth, including benign, premalignant, or malignant (see specification pg. 26, 3rd full para). While the specification is predominantly drawn to methods of treating cancer there are recitations of also treating an “infectious disease” but no specific infectious or other disease is set forth (e.g., see specification pg. 55, 1st full para).
The specification discloses IGSF8 has been “speculated to regulate the roles of CD9 and CD81 in certain cellular functions, including cell migration and viral infection” and “as a potential tumor suppressor” and is “likely required for KAI1/CD82-mediated suppression of cancer cell migration” (see specification pg. 1, 3rd para). Applicant also discloses there remains a need to identify NK cell-suppressing, non-HLA ligands that may have been hijacked by cancer cells to evade NK cell-mediated killing in the tumor microenvironment, and reagent that can block suppression of NK cells” (see specification pg. 2, last full para).
IGSF8 is a novel cancer treatment target and is highly expressed in multiple cancer types specifically melanoma, cervical cancer, NSCLC, and colorectal cancer (see specification pg. 17, 2nd para). IGSF8 binds to primary NK cells through its D1 domain through the KIR family receptor KIR3DL2 (see specification pg. 18, 1st full para). Up regulation of IGSF8 allows tumors to evade NK cell-mediated immune surveillance of cancer by binding to KIR receptors on NK cells (see specification pg. 18, 2nd para).
Considering the guidance set forth above, the utility of the claimed method for modulating an immune response in a subject in need thereof of the instant claims would be understood by the skilled artisan to lie in treating cancer and infectious disease. By contrast the skilled artisan knowledgeable of the prior art and the teaching of the instant specification would not be interested in “modulating the immune response in a subject in need thereof” in any given subject, e.g., a subject with any disease, merely for the sake of doing so.
Applicant has demonstrated particular anti-IGSF8 antibodies with increased affinity and decreased Fc activity have better in vivo anti-tumor efficacy than those with reduced affinity and normal IgG1 or IgG4 activity (see specification pg. 195, Table 4, pg. 197, Table G, pg. 205, example 30). It is noted the instantly claimed antibodies do not bind mouse IGSF8 (see specification pgs. 202-203, table 5). Applicant has not provided an example of the instantly claimed antibodies decreasing immune activity as encompassed by modulate, nor modulation of alternative immune cells (e.g., dendritic cells, B-cells), nor in the context of any other disease or disorder as encompassed by the instant claim language.
In the absence of such information the skilled artisan would not know how to use the instantly claimed anti-IGSF8 antibodies with any Fc region in a method of modulating an immune response (e.g., decreasing) to a subject with any disease or disorder.
Claim 25 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 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.
Claim 25 is drawn to wherein the cancer is “a cancer infiltrated with immune cells expressing a receptor to IGSF8” (see last two lines).
The specification teaches, “little is known about the biological function of IGSF8” (see specification pg. 1, 3rd para). Applicant’s disclosure is drawn primarily to the interaction of IGSF8 and KIR3DL2 (see specification pg. 18, last para, pgs. 166-169, example 17). The state of the art teaches ligands/receptors of IGSF8 remain unknown (see Bautista et al. (2026) Next-generation immune checkpoints and tumor microenvironment modulation in cancer immunotherapy. Journal of Immunology Research. 7864229, 20 pages, in particular pg. 4 Table 1).
Therefore, a person of ordinary skill in the art would reasonably conclude that the disclosure identifies only KIR3DL2/1 as ligand/receptors of IGSF8 while the state of the art (2026) does not disclose any known ligand/receptors of IGSF8. Given the targets of IGSF8 have not been fully elucidated a person of ordinary skill cannot determine the cancers encompassed in the language “a cancer infiltrated with the immune cells expressing a receptor to IGSF8”. Thus, the claimed subject matter is not supported by any adequate written description and therefore, applicant was not in possession of the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 1, 2, 5, 6, 9-10, 12-22. 25, 28, and 29 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 1 recites the limitation "said monoclonal antibody" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggest amending to recite “said recombinant monoclonal antibody”.
Claims 1, 2, and 5 recite “any one antibody of Table G” (e.g., see claim 1 last line, claim 5 last line), which comprises sequences for the HCDRs1-3, LCDRs1-3, VH, and VL of ten antibodies (see specification pgs. 197 (bottom)-202 (top)). Pursuant to MPEP §2173.05(s) claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). It is noted Table G recites both antibody CDRS and VH/VL sequences; therefore it is unclear if the claim is drawn to the VH/VL sequences with CDRs from any known numbering scheme or alternatively the CDR sequences set forth in the table.
Claim 1 is drawn to “consists essentially of”. Pursuant to MPEP § 2111.03 (III) consists essentially of limits the scope of the claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristics” of the claimed invention. The claims are drawn to a IGSF8 antibodies with specific CDRs. It is unclear which particular residues and/or novel characteristics are in the scope of consists essentially of.
Claim 2 is drawn to a VL CDR comprising “GVS (SEQ ID NO: 653) HTS (SEQ ID NO: 654)”. It is unclear if the claimed antibody requires both sequences or alternatively only one of the recited sequences.
Claim 6 is drawn to wherein the antibody of claim 1 has a Fd, V-NAR domain, an IgNar, an intrabody, a single-domain antibody, or an Fcab structure. Claim 1 is drawn to antibodies or antigen binding fragments thereof that necessarily comprise a VH and VL. Therefore, it is unclear how the antibody can have the Fd, V-NAR domain, an IgNar, an intrabody, a single-domain antibody, or an Fcab structure when these structures necessarily comprise a heavy chain variable region only.
In addition claim 6 is drawn to “humanized” antibodies. The specification defines a “humanized antibody” as an antibody in which at least one amino acid in a framework region of a non-human variable region has been replaced with the corresponding amino acid from a human variable region (see specification pg. 24, 4th para). Given the claimed antibodies were initially engineered from a computer algorithm using the human B cell repertoire it is unclear how the instantly claimed antibody can be humanized. The specification’s definition of “humanized” implies the starting material (i.e., antibody) is “non-human”.
Claim 9 is drawn several recitations of parentheticals. For example, IgG1-L234A/L235A (IgG1-LALA)”. It is unclear if what is recited in the paratheses is a limitation, an alternative name for IgG1-L234A/L235A, or an example. Examiner recommends amending the claim to remove the parentheticals.
Claims 12, 13, 16, 17, and 25 recite the limitation "antigen binding portion/fragment thereof" throughout. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending claims to recite, “antigen binding
Claim 13 is drawn to “a polynucleotide encoding a monoclonal antibody of claim 1, a heavy chain or light chain thereof”. However, the monoclonal antibody of claim 1 requires both a heavy and light chain variable region; therefore, it is unclear how the polynucleotide encoding either a heavy or light chain antibody can encode the monoclonal antibody of claim 1 which necessarily requires both a heavy and light chain variable region. To address this indefiniteness Examiner suggests amending claim 13 to recite, “A polynucleotide encoding a monoclonal antibody of claim 1
Claim 14 is drawn to “stringent conditions”. The specification does not provide a limiting definition for stringent and therefore what conditions are considered within or outside “stringent” is unclear.
Similarly, claim 16 is drawn to expressing either the heavy or light chain thereof of the monoclonal antibody of claim 1. However, the monoclonal antibody of claim 1 requires both a heavy and light chain variable region; therefore, it is unclear how the host cell comprising the polynucleotide encoding either a heavy or light chain antibody can encode the monoclonal antibody of claim 1 which necessarily requires both a heavy and light chain variable region. To address this indefiniteness Examiner suggests amending claim 13 to recite, “A host cell comprising the polynucleotide claim 13 for expressing the encoded monoclonal antibody
Similarly, claim 17 is drawn to culturing either the heavy or light chain thereof of the monoclonal antibody of claim 1. However, the monoclonal antibody of claim 1 requires both a heavy and light chain variable region; therefore, it is unclear how the culture can comprise a host cell capable of expressing either a heavy or light chain of the monoclonal antibody of claim 1 can encode the monoclonal antibody of claim 1 which necessarily requires both a heavy and light chain variable region. To address this indefiniteness Examiner suggests amending claim 16 to recite, “capable of expressing said monoclonal antibody
Claims 13, 16, and 17 recites the limitation "the heavy or light chain thereof" throughout. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the host cell" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites, “optionally recovering/isolating/purifying the expressed” in line 7. It is unclear if the method optionally requires 1 additional step or 3 additional steps. For example, is the method drawn to optionally requiring either recovering, isolating, or purifying, or alternatively is the method drawn to optionally requiring recovering, isolating, and purifying the expressed monoclonal antibody.
Claim 25 is drawn several recitations of parentheticals. For example, “melanoma (including skin cutaneous melanoma”. It is unclear if what is recited in the paratheses is a limitation, an alternative name, or an example. Examiner recommends amending the claim to remove the parentheticals.
In addition claim 25, the phrase "for example" (i.e., ““(e.g., non-small cell lung cancer”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 29 it is unclear if lines 7-8 are a duplicate of lines 5-6 or if there is some other differences meant to be recited here. Second, the phrase "such as" (e.g., see lines 5, 7, 9, 12-15) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 29 depends from claim 20 which is drawn to administering “a second therapeutic agent comprising an immunotherapy, an immunocheckpoint inhibitor” (see claim 20 lines 2-3) while claim 29 is drawn to wherein the immunotherapy comprises certain products but also wherein said second therapeutic agent comprises the same products (e.g., cemiplimab).
Claim 29 is drawn to wherein the second therapeutic agent is various products identified using alpha numeric, e.g., 3F8, 8H9, BCD-100, FBTA05, IMAB363, NEOD001, OMS721, PRO 140, SA237. It is unclear what these are, for example, are these particular clone names for an antibody or a commercially available product.
Claim 29 is drawn several recitations of parentheticals. For example, “(IMAB362, Claudiximab)”. It is unclear if what is recited in the paratheses is a limitation, an alternative name for a product, or an example. Examiner recommends amending the claim to remove the parentheticals.
Claim 29 is drawn to a second therapeutic comprising an antibody or an antigen-binding fragment chosen from a long list. However, it is unclear if the second therapeutic is limited to comprising the antibody or antigen binding fragment from a particular product or any portion of the product. For example, can the second therapeutic be vedotin (i.e., drug) alone from azintuxizumab vedotin, or alternatively, the second therapeutic is the whole thing azintuxizumab vedotin (i.e., ADC), or alternatively is the second therapeutic limited to the antigen binding domain azintuxizumab with any drug conjugated.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-17, and 29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 and 17 is drawn to “a polynucleotide encoding a monoclonal antibody of claim 1, a heavy chain or light chain thereof”. However, the monoclonal antibody of claim 1 requires both a heavy and light chain variable region; therefore, a polynucleotide encoding a monoclonal antibody of claim 1 necessarily requires both a heavy and light chain region. Thus, claim 13 expands the scope of claim 1.
Claim 14 is drawn to a polynucleotide that hybridizes under stringent conditions with the polynucleotide of claim 13, or with a complement of the polynucleotide of claim 13 wherein the poly nucleotide has to encode the antibody. However, claim 14 is broader because it encompasses structure that hybridize and therefore may have reduced sequence identity (e.g., 90%) and would therefore not necessarily encode the antibody. Claim 14 broadens the scope of claim 13 by encompassing a genus of variants and could include CDR variants/non-binding antibodies.
Claim 16 is drawn to a host cell comprising the polynucleotide of claim 13 for expressing the encoded monoclonal antibody, heavy or light chain thereof. However, the monoclonal antibody of claim 13 which depends from claim 1 requires both a heavy and light chain variable region; therefore, a host cell comprising the polynucleotide encoding the antibody of claim 1 necessarily requires both a heavy and light chain variable region. Thus, claim 16 expands the polynucleotide encoding the monoclonal antibody of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Cancelled.
A monoclonal antibody or an antigen-binding fragment thereof specific for IGSF8, wherein said monoclonal antibody or antigen binding fragment thereof comprises a heavy chain variable region (VH) comprising a VH CDR1, VH CDR2, VH CDR3, and a light chain variable region (VL) comprising a VL CDR1, VL CDR2, and VL CDR3 comprising the following amino acid sequences:
VH CDR1 comprises SEQ ID NO: 643;
VH CDR2 comprises SEQ ID NO: 644;
VH CDR3 comprises SEQ ID NO: 646;
VL CDR1 comprises SEQ ID NO:652
VL CDR2 comprises SEQ ID NO: 653; and
VL CDR3 comprises SEQ ID NO: 655.
5. The monoclonal antibody or an antigen-binding fragment thereof of claim 2, wherein the VH and VL sequences comprise SEQ ID Nos: 703 and 707, respectively.
6. The monoclonal antibody or antigen-binding fragment thereof of claim 2, which is a human-mouse chimeric antibody, a human antibody, a CDR-grafted antibody, a resurfaced antibody, a Fab, Fab', a F(ab')2, a single chain Fv (scFv), a disulfide linked Fv, an IgGACH2, a minibody, an F(ab')3, a tetrabody, a triabody, a diabody, a DVD-Ig, a mAb2, a (scFv)2 or a scFv-Fc.
8. The monoclonal antibody or antigen-binding fragment thereof of claim 2, comprising a heavy chain constant region, wherein
(a) the heavy chain constant region is wild-type human IgG1, human IgG2, human IgG3, human IgG4; or
(b) the heavy chain constant region has an Fc domain deficient in antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and/or antibody-dependent cellular phagocytosis (ADCP).
9. The monoclonal antibody or antigen-binding fragment thereof of claim 8, wherein the heavy chain constant region with an deficient Fc domain is selected from a group consisting of IgGl-L234A/L235A, IgGl-L234A/L235A/P329G, IgG1-N297A/Q/G, IgG1-L235A/G237A/E318A, IgG1-G236R/L328R, IgG1-S298G/T299A, IgG1- L234F/L235E/P331S, IgG1-L234F/L235E/D265A, IgG4-L234A/L235A, IgG4-S228P/L235E, IgG1-E233P/L234V/L235A/G236del/S267K, IgG2-H268Q/V309L/A30S/P331S and IgG2-V234A/G237A/P238S/H268A/V309L/A330S/P331S.
10. The monoclonal antibody or antigen-binding fragment thereof of claim 2, wherein said monoclonal antibody or antigen-binding fragment thereof binds IGSF8 with a Kd of less than about 25 nM, 20 nM, 15 nM, 10 nM, 5 nM, 2 nM, or 1 nM.
12. The antibody or monoclonal antibody of claim 2, wherein the antibody or antigen-binding fragment thereof inhibits IGSF8 binding to KIR3DL1/2.
13. A polynucleotide encoding the monoclonal antibody or antigen binding fragment thereof of claim 2.
14. cancelled.
15. A vector comprising the polynucleotide of claim 13.
16. A host cell comprising the polynucleotide of claim 13 for expressing the encoded monoclonal antibody or antigen binding fragment thereof.
17. A method of producing the monoclonal antibody or antigen binding fragment thereof, the method comprising:
(i) culturing the host cell of claim 16 under a condition suitable to express said monoclonal antibody or antigen binding fragment thereof; and, optionally
(ii) recovering the monoclonal antibody or antigen binding fragment thereof.
18. cancelled.
19. A method of treating a cancer in a subject in need thereof, the method comprising administering a therapeutically effective amount of the anti-IGSF8 monoclonal antibody or antigen-binding fragment thereof of claim 2.
20. The method of claim 19, further comprising administering to the subject an effective amount of a second therapeutic agent comprising an immunotherapy, an immune checkpoint inhibitor, a cancer vaccine, a chimeric antigen receptor, a chemotherapeutic agent, a radiation therapy, an anti-angiogenesis agent, a growth inhibitory agent, an immune-oncology agent, an anti-neoplastic composition, a surgery, or a combination thereof.
21. The method of claim 19, wherein the anti-IGSF8 monoclonal antibody or antigen-binding fragment thereof is conjugated to a cytotoxic agent.
22. The method of claim 21, wherein the cytotoxic agent is selected from the group consisting of a chemotherapeutic agent, a biologic agent, a toxin, and a radioactive isotope.
25. The method of claim 19, wherein the cancer is melanoma, cervical cancer, lung cancer, colorectal cancer, lymphoma, leukemia, BLCA tumor, breast cancer, head and neck carcinoma, head-neck squamous cell carcinoma, PRAD, THCA, or UCEC, thyroid cancer, unitary tract cancer, uterine cancer, esophagus cancer, liver cancer, ganglia cancer, renal cancer, pancreatic cancer, pancreatic ductal carcinoma, ovarian cancer, prostate cancer, gliomas, glioblastoma, neuroblastoma, thymoma, and B-CLL.
28. The method of claim 19, wherein the monoclonal antibody or antigen-binding fragment thereof stimulates T cells, NK cell activation and/or increases infiltration into the tumor microenvironment.
29. cancelled.
Conclusion
No claim allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644