DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I in the reply filed on Jan. 20, 2026 is acknowledged. Claims 44-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jan. 20, 2026.
Claim Status
3. The amendment filed Jan 20, 2026 has been entered. Claims 44-55 have been withdrawn. Claims 36-43 are under consideration in this Office Action.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on April 23, 2023 and Feb. 9, 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
5. Claims 36-43 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 treatment of gliomas in a human, the method comprising administering a therapeutic amount of a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient, does not reasonably provide enablement for a method for the prevention and/or treatment of a condition selected from an immune-related disease and a cancer in a subject, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
The claims are drawn to a method for the prevention or treatment a condition selected from an immune-related disease and a cancer in a subject in need thereof, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient. Claim 39 wherein the immune-related disease is at least one selected from the group consisting of autoimmune disease, graft-versus-host disease, organ transplant rejection, asthma, atopy, and acute or chronic inflammatory disease. Claim 40 recites wherein the autoimmune disease is at least one selected from the group consisting of rheumatoid arthritis, systemic scleroderma, systemic lupus erythematosus, atopic dermatitis, psoriasis, alopecia areata, asthma, Crohn's disease, Behcet's disease, Sjogren's syndrome, Guillain-Barre syndrome, chronic thyroiditis, multiple sclerosis, multiple myositis, ankylosing spondylitis, fibroblast and nodular multiple arteritis. And claim 43 recites wherein the cancer is at least one selected from the group consisting of gastric cancer, liver cancer, glioblastoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, breast cancer, metastasis cancer, prostate cancer, pancreatic cancer, melanoma and lung cancer.
The claims are broad and inclusive of all types of cancer or neoplasia in humans generally. The claims are broad and inclusive of all types of a conditions selected from any type of immune-related disease in humans generally. The breadth of the claim exacerbates the complex nature of the subject matter to which the present claims are directed. The claims are extremely broad due to the vast number of possible cancer types and tumor cell growth mechanisms and immune-related diseases represented by the phrase “preventing or treating a condition selected from an immune-related disease and a cancer in a subject in need thereof cancer in a subject in need thereof.”
Cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. Here are some assorted categories:
A. CNS cancers cover a very diverse range of cancers in many categories and subcategories. There are an immense range of neuroepithelial tumors. Gliomas, the most common subtype of primary brain tumors, most of which are aggressive, highly invasive, and neurologically destructive tumors are considered to be among the deadliest of human cancers. These are any cancers which show evidence (histological, immunohistochemical, ultrastructural) of glial differentiation. These fall mostly into five categories. There are the astrocytic tumors (astrocytomas): pilocytic astrocytoma (including juvenile pilocytic astrocytoma, JPA, and pediatric optic nerve glioma) diffuse astrocytomas (including fibrillary astrocytomas, protoplasmic astrocytomas and gemistocytic astrocytomas), anaplastic astrocytomas (including adult optic nerve glioma), Glioblastoma multiforme (GBM), gliosarcoma and giant cell glioblastoma, and pleomorphic xanthoastrocytoma. Second, there are the oligodendroglial tumors (oligodendrogliomas): low grade oligodendroglioma and anaplastic oligodendroglioma. Third, there is oligoastrocytomas (“mixed glioma”), a type of tumor with both astrocytoma & oligodendroglioma features. The fourth type is the ependymomas, which are intracranial gliomas, including papillary ependymoma, myxopapillary ependymoma, tanycytic ependymoma, anaplastic ependymoma and subependymal giant-cell astrocytomas. A fifth type is the gangliogliomas (glioneuronal tumors or glioneurocytic tumors), which have both glial and neuronal components, and are extremely varied, based in part on what types of glial and what types of neuronal components are present. Another division is tumors of the meninges. There are also mesenchymal, non-meningothelial tumors. A third division is the tumors of cranial and spinal nerves. There is also Perineurioma (Intraneural and Soft tissue) and malignant peripheral nerve sheath tumor (MPNST). A fourth division are germ cell tumors. A fifth division are the tumors of the sellar Region, viz. pituitary adenoma, pituitary carcinoma, granular cell myoblastoma and craniopharyngiomas (adamantinomatous and papillary). Yet another division are local extensions from regional tumors, including paraganglioma, chodroma, chordoma, and chondrosarcoma. There are also Primitive Neuroectodermal Tumors (PNETs). There are Vascular brain Tumors and Meningeal Carcinomatosis. There are lymphoma and haemopoietic neoplasms. And there are many, many others, including Leukemia is any malignant neoplasm of the blood-forming tissues, Carcinomas of the Liver, and lung and pleural cancer are small cell. There are some soft tissue tumors including localized fibrous tumor. There are assorted bronchial adenomas. There are papillomas, malignant melanoma, Thyroid cancers, cancers of the skin cells,
eccrine carcinomas, colorectal cancers, Renal carcinomas, prostate cancers and many more types of cancer where each type of cancer breaks down in to infinites subtypes of cancers.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
While the state of the art is relatively high with regard to the treatment of specific cancer types, the state of the art with regard to preventing or treating any condition from any type of immune-related disease and any type of cancer broadly is underdeveloped. In particular, there is no known anticancer agent that is effective against all cancer cell types. The autoimmune disease treatment and cancer treatment art involves a very high level of unpredictability. While the state of the art is relatively high with regard to the prevention or treatment of specific immune diseases with specific agents and specific cancers with specific agents, it has long been underdeveloped with regard to the prevention or treatment of autoimmune diseases and cancers broadly. The lack of significant guidance from the present specification or prior art with regard to the actual prevention of treatment of all autoimmune diseases and all cancer cells in a mammal, including a human subject, with the claimed “agent” makes practicing the claimed invention unpredictable.
One cannot prevent any type of immune disease or cancer from forming in any type of subject or even in a human subject. While there is no guaranteed way to prevent autoimmune diseases, as they often result from complex interactions between genetics and environment, you can reduce your risk by managing chronic stress, eating a nutrient-dense anti-inflammatory diet, avoiding smoking, getting regular exercise, and reducing exposure to toxins. See https://my.clevelandclinic.org/health/diseases/21624-autoimmune-diseases, 2024. Systemic lupus erythematosus (SLE) cannot be currently prevented as its causes are not fully understood, but its flares and complications can be managed through lifestyle changes—such as avoiding sun exposure (using SPF >55), quitting smoking, managing stress, and maintaining a healthy diet. See Dai et al., (Sig Transduct Target Ther 10, 102 (2025).
With regard to cancer prevention, There is currently no FDA-approved vaccine to prevent (prophylactic) prostate cancer. The only FDA-approved vaccine, Sipuleucel-T (Provenge), is a therapeutic vaccine used to treat advanced, metastatic, hormone-resistant prostate cancer, not to prevent it. Lin et al., (Critical Reviews in Oncology/Hematology. Volume 208, April 2025, 104643). Sporn (Chemoprevention of Cancer, 2000, Carcinogenesis, Volume 21, Number 3, Pages 525-530) teaches the magnitude of mortality of cancers and that mortalities are in fact still rising and that new approaches to a variety of different cancer are critically needed. Sporn also teaches that “given the genotype and phenotype heterogeneity of advanced malignant lesions as they occur in individual patients, one wonders just exactly what are the specific molecular and cellular targets for the putative
cure.”
Furthermore, the art indicates the difficulties in going from in vitro to in vivo for drug development for treatment of cancers. Auerbach (Angiogenesis assays: Problems and pitfalls, 2000, Cancer and Metastasis Reviews, Volume 19, Pages 167-172) indicates that one of the major problems in angiogenesis research has been the difficulty of finding suitable methods for assessing the angiogenic response. Finally, at best, the state of the art shows that peptide vaccines could limit pancreatic cancer progression induce an immune response against cancer-causing cells in the lymph nodes. There is no teaching of prevention or treatment of any related conditions. At best, lymph node-targeting amphiphile vaccination induced persistent T cell responses targeting oncogenic driver KRAS mutations, alongside personalized, tumor antigen-specific T cells, which may correlate to clinical outcomes in pancreatic and colorectal cancer. Wainberg et al., (Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results. Nat Med 31, 3648–3653 (2025).
Happe et al., teach LRIG1 was less expressed in glioma compared to peritumoral tissue with additional decrease with ascending tumors grade. Further, secondary glioblastoma expressed more LRIG1 protein than primary. On mRNA level, the same was seen for LRIG2, were low grade glioma expressed significantly more LRIG2 than high grade glioma. And on protein level, secondary glioblastoma showed higher expression than primary. LRIG3 mRNA expression, in contrast, was significantly higher in grade II gliomas compared to surrounding control tissue, whereas chemotherapy did not significantly affect expression levels in glioblastoma. There was no treating of prevention or treatment. Oncotarget. 2025; 16: 793-807.
Thus the state of art clearly shows there is no prevention of any condition selected from an immune-related disease and a cancer in a subject in need thereof, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient. There is no single treatment which treats any or all conditions selected from an immune-related disease and cancers in any type of subject in need thereof. These teachings collectively demonstrate that the treatment of cancer is highly unpredictable, if even possible for many cancers.
(6) the amount of direction or guidance presented; (7) the presence or absence of working examples:
There is a lack of working examples in the specification for treating all types of cancer encompassed by the instant claims. Applicant has provided evidence of in vitro confirmation of the effector T cell inhibitory effect. However, Applicant has not provided any substantive evidence of treating or prevent any cancer or any conditions selected from any immune-related disease the claimed helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient. Because the
Immune diseases, conditions and cancers encompassed by the instant claims are so disparate and no single example can be representative of all the other encompassed immune diseases, conditions or cancers, a demonstration of treatment or prevention would not provide support for the breadth of the claims.
Additionally, the term "preventing" is generally understood in the art to encompass a total protection from disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. There are no examples directed to the palliative, preventative, or curative treatment of any cancers or immune diseases conditions. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the broadly claimed method in how to use the method to prevent or treat a condition selected from an immune-related disease and a cancer in a subject, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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.
6. Claims 36-43 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.
It is noted that the claims fails to recite an amount for the administered helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein being given to the subject. Therefore, it is suggested the claim recite administering a “therapeutically effective amount” or similar specification supported language. Clarification is required to overcome the rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
7. Claims 36 and 41-43 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Kim et al., (WO 2020080854 published April 23, 2020 priority to 2019-10-17).
The claims are drawn to a method for the prevention and/or treatment of a condition selected from an immune-related disease and a cancer in a subject, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient.
Kim et al., discovered Lrig-1 protein that is present specifically on the surface of regulatory T cells [para 20]. The Lrig-1 protein is a transmembrane protein consisting of 1091 amino acids present on the surface of regulatory T cells, and is composed of leucine-rich repeats (LRRs) and three immunoglobulin-like domains on the extracellular or lumen side, a cell transmembrane sequence, and a cytoplasmic tail portion. The LRIG gene family includes LRIG1, LRIG2, and LRIG3, and the amino acids therebetween are highly conserved. The LRIG1 gene is highly expressed in normal skin and can be expressed in basal and hair follicle cells to regulate proliferation of epithelial stem cells. Therefore, the LRIG1 gene plays an important role in maintaining homeostasis of the epidermis, and its absence may develop psoriasis or skin cancer [para 23]. The cell surface antigen of immune cells of Lrig1 (leucine-rich and immunoglobulin-like domains 1) [para 18]. The cell surface antigen of the present invention is a cell surface antigen of an activated immune cell that is comprised of the Lrig1 protein or the gene that encodes such protein [para 19]. The effector T cells of the present invention can be at least one of those selected from the group consisting of Th1, Th2, Th17 and Th22, but are not limited thereto [para 22]. In the cell therapy, the “cell therapy” herein refers to a living cell used in a treatment method that is directly injected into the patient wherein the contents related to immune cells and Lrig1 protein are administered [para 36-37].
Kim et al., provided a pharmaceutical composition for preventing or treating cancer, comprising, as an active ingredient, the binding molecule [para 127]. The binding molecule can suppress the function of immune cells, in particular, regulatory T immune cells (Treg cells), and thus effectively prevent, ameliorate, or treat cancer [para 128]. The cancer to be prevented, ameliorated, or treated in the present invention may be solid tumor formed of agglomerates caused by abnormal growth of cells in a solid organ, and may be, but is not limited to, gastric cancer, liver cancer, gliocytoma, ovarian cancer, colorectal cancer, head and neck cancer, bladder cancer, renal cell cancer, breast cancer, metastatic cancer, prostate cancer, pancreatic cancer, melanoma, lung cancer, or the like, depending on location of the solid organ, with melanoma being preferred. On the other hand, in the present invention, the “prevention” may include, without limitation, any act of blocking symptoms of a disease, or suppressing or delaying the symptoms, using the pharmaceutical composition of the present invention [para 129].
Therefore Kim et al., anticipate the rejected instant claims.
Claim Rejections - 35 USC § 102
8. Claims 36-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR20180116925 (published 2018-10-26).
The claims are drawn to a method for the prevention and/or treatment of a condition selected from an immune-related disease and a cancer in a subject, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient.
KR20180116925 describe information in cell therapy for cancer or autoimmune disease prevention or treatment, including the Lrig-1 + immune cells of the present invention relates to the Lrig-1 + immune cells, cancer, immune diseases, prevention and treatment are described in the pharmaceutical compositions. KR20180116925 describe a cancer therapeutic agent for preventing or treating cancer or immune disease comprising Lrig-1 + immune cells. In the present invention, the cell therapeutic agent refers to a living cell used for cell therapy in which live cells are directly injected into a patient. Thus teaching claim 36. For the purpose of the present invention, the cell therapy agent may be a cell expressing Lrig-1 protein on the surface of T cell, more preferably the regulatory T cell may be CD4 + T cell, but is not limited thereto. Th0, Th1, Th2, Th17 and iTreg, which are subset of T cells, were prepared to confirm that Lrig-1 protein was expressed only in regulatory T cells (Tregs) [See examples 1 and 5]. Thus teaching claims 38 and 41.
In the present invention, the cancer is preferably selected from breast cancer, biliary cancer, gallbladder cancer, pancreatic cancer, colon cancer, uterine cancer, esophageal cancer, stomach cancer, brain cancer, rectal cancer, lung cancer, bladder cancer, kidney cancer, ovarian cancer, prostate cancer, Leukemia, lymphoma, blood cancer, and liver cancer, but are not limited thereto. Thus teaching claim 43.
In the present invention, the above-mentioned immune diseases include Alopecia greata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune adison disease, autoimmune diseases of the adrenal glands, autoimmune hemolytic anemia, autoimmune hepatitis, Autoimmune thrombocytopenia, Behcet's disease, vesicular pemphigoid, cardiomyopathy, celiac spruedermatitis, chronic fatigue syndrome, chronic inflammatory dehydration polyneuropathy, Churg-Strauss syndrome, scarring pheochromocytoma. Thus teaching claims 37 and 39. The present invention relates to a method of treating a patient suffering from chronic thrombocytopenic purpura associated with chronic thrombocytopenic purpura such as CREST syndrome, cold agglutinin disease, Crohn's disease, dyspepsia, metachromatic hypothyroidism, fibromyalgia-fibrosis, glomerulonephritis, IgA neuritis, osteoarthritis, squamous cell carcinoma, lupus erythematosus, Meniere's disease, mixed connective tissue disease, multiple Myelodysplastic syndrome, rheumatoid polyposis, multiple myositis and dermatomyositis, primary hypergammaglobulinemia, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, multiple sclerosis, type I or immuno-mediated diabetes mellitus, myasthenia gravis, Primary dysplasia cirrhosis, psoriasis, psoriatic arthritis, Raynaud's phenomenon, lighter syndrome, rheumatoid arthritis, sarcoidosis, scleroderma, rigid human syndrome, systemic lupus erythematosus, lupus erythematosus, But is not limited to, any one selected from the group consisting of cell arteritis, ulcerative colitis, uveitis, vitiligo and Wegener's granulomatosis. Thus teaching claim 40.
Thus, KR20180116925 describe the instantly rejected claims.
Claim Rejections - 35 USC § 102
9. Claims 36-42 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Lee et al., (US20150239964 published Aug. 27, 2015; priority to 2012-01-20).
The claims are drawn to a method for the prevention and/or treatment of a condition selected from an immune-related disease and a cancer in a subject, the method comprising administering a helper T cell with an Lrig1 protein or a gene that encodes an Lrig1 protein to the subject as an active ingredient.
Lee et al., describe a novel use of regulatory T cell-specific surface protein Lrig-1, and more specifically to an immunosuppressive agent comprising siRNA which inhibits the expression of surface protein Lrig-1 [abstract]. Lee provides a composition for treating immune-related diseases comprising Lrig1 protein [para 10]. The immune-related diseases may be any one selected from the group consisting of autoimmune diseases, graft versus host diseases, organ transplant rejection, asthma, atopy, acute and chronic inflammatory diseases, cardiovascular diseases and cognitive disorders [para 18]. Thus teaching claim 39. Also, the immune-related disease may be atopic dermatitis, acute and chronic inflammatory diseases, cardiovascular diseases and cognitive disorders. Thus teaching claims 37 and 40. there is provided a composition for anti-cancer treatment comprising a cell membrane surface protein of Lrig1 protein or a protein including all or part of antibody specifically binding thereto [para 21]. Lee et al., teach a method for administering an effective amount of a Lrig1 protein, or a protein comprising a cell membrane surface protein of Lrig1 protein, or a composition including all or part of the antibody specifically binding thereto to a subject with the cancers [para 27]. Thus teaching claim 41. FIG. 1 shows a comparison of the expression levels of Lrig1 in non-contacted T cells, Th1, Th2, Th17. Thus teaching claims 38 and 42.
Thus Lee et al., disclose the limitations of the rejected claims.
Pertinent Art
10. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See WO2020190104 and KR20200112745. KR102306345, and 2020080853 all teach administering the LRIG1.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dan Kolker, can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645