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 specie represented by VEGFR inhibitor in the reply filed on 06/12/2026 is acknowledged. Upon further consideration, the election of species requirement is withdrawn and the claims will be examined for all species. Claims 1-16 are pending and are examined.
Claim Objections
Claim 9 is objected to because of the following informalities: the abbreviation DMXAA and CDN should be spelled out at their first encounter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 13, 14 and 16 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991) (emphasis added). See also MPEP 2163.04.
The claims are drawn to a method for preventing or treating cancer, comprising a step of administering, to a subject, a fusion protein dimer comprising a CD80 fragment and an IL-2 variant; and an anticancer agent, wherein the CD80 fragment is an extracellular domain of CD80 protein; the IL-2 variant comprises substitutions of R38A and F42A in the amino acid of SEQ ID NO: 10; and wherein the anticancer agent is selected form the group consisting of anti-PD-1antibody, anti-PD-L1 antibody, anti-TIGIT antibody, VEGFR inhibitor, EGFR inhibitor, PARP inhibitor, DNA methyltransferase inhibitor, TGF- β receptor inhibitor, CDK4/6 inhibitor, STING agonist, alkylating agent, a microtubule inhibitor, antimetabolite and topoisomerase inhibitor.
The claims raise two aspects treating cancer and preventing cancer.
With respect to treating cancer, cancer is the name given to a collection of related diseases characterized by cellular out of control division and spreading in the surrounding or distant tissues. Cancer can start almost anywhere in the human body, which is made up of trillions of cells. Normally, cells grow and divide to form new cells as the body needs them. When cells grow old or become damaged, they die, and new cells take their place. When cancer develops, however, this orderly process breaks down. As cells become more and more abnormal, old or damaged cells survive when they should die, and new cells form when they are not needed. These extra cells can divide without stopping and may form growths called tumors. Many cancers form solid tumors, which are masses of tissue. Cancers of the blood, such as leukemias, generally do not form solid tumors.
There are more than 100 types of cancer. Types of cancer are usually named for the organs or tissues where the cancers form. Cancers also may be described by the type of cell that formed them, such as an epithelial cell or a squamous cell. Some categories of cancers that begin in specific types of cells are:
• Carcinomas- they are the most common type of cancer. They are formed by
epithelial cells, which are the cells that cover the inside and outside surfaces of the body. There are many types of epithelial cells, which often have a column-like
shape when viewed under a microscope. Carcinomas that begin in different
epithelial cell types have specific names:
o Adenocarcinoma is a cancer that forms in epithelial cells that produce fluids or mucus. Tissues with this type of epithelial cell are sometimes called
glandular tissues. Most cancers of the breast, colon , and prostate are adenocarcinomas.
o Basal cell carcinoma is a cancer that begins in the lower or basal (base)
layer of the epidermis, which is a person's outer layer of skin.
o Squamous cell carcinoma is a cancer that forms in squamous cells, which are epithelial cells that lie just beneath the outer surface of the skin.
Squamous cells also line many other organs, including the stomach, intestines, lungs, bladder, and kidneys. Squamous cells look flat, like fish scales, when viewed under a microscope. Squamous cell carcinomas are sometimes called epidermoid carcinomas.
o Transitional cell carcinoma is a cancer that forms in a type of epithelial
tissue called transitional epithelium, or urothelium. This tissue, which is made up of many layers of epithelial cells that can get bigger and smaller, is found in the linings of the bladder, ureters, and part of the kidneys (renal pelvis), and a few other organs. Some cancers of the bladder, ureters, and kidneys are transitional cell carcinomas.
• Sarcomas- they are cancers that form in bone and soft tissues, including muscle, fat, blood vessels, lymph vessels, and fibrous tissue (such as tendons and ligaments). Osteosarcoma is the most common cancer of bone. The most common types of soft tissue sarcoma are leiomyosarcoma, Kaposi sarcoma, malignant fibrous histiocytoma, liposarcoma, and dermatofibrosarcoma protuberans.
• Leukemias- they are cancers that begin in the blood-forming tissue of the bone
marrow. These cancers do not form solid tumors. Instead, large numbers of
abnormal white blood cells (leukemia cells and leukemic blast cells) build up in the blood and bone marrow, crowding out normal blood cells. The low level of normal blood cells can make it harder for the body to get oxygen to its tissues, control bleeding, or fight infections. There are four common types of leukemia, which are grouped based on how quickly the disease gets worse (acute or chronic) and on the type of blood cell the cancer starts in (lymphoblastic or myeloid).
• Lymphomas- they are cancers that begins in lymphocytes (T cells or B cells).
These are disease-fighting white blood cells that are part of the immune system.
In lymphoma, abnormal lymphocytes build up in lymph nodes and lymph vessels,
as well as in other organs of the body. There are two main types of lymphoma:
o Hodgkin lymphoma - People with this disease have abnormal lymphocytes
that are called Reed-Sternberg cells. These cells usually form from 8 cells.
o Non-Hodgkin lymphoma - This is a large group of cancers that start in
lymphocytes. The cancers can grow quickly or slowly and can form from B
cells or T cells.
• Multiple myeloma is cancer that begins in plasma cells, another type of immune
cell. The abnormal plasma cells, called myeloma cells, build up in the bone marrow and form tumors in bones all through the body. Multiple myeloma is also called plasma cell myeloma and Kahler disease.
• Melanoma- is cancer that begins in cells that become melanocytes, which are
specialized cells that make melanin (the pigment that gives skin its color). Most
melanomas form on the skin, but melanomas can also form in other pigmented
tissues, such as the eye.
• Brain and Spinal Cord Tumors. There are different types of brain and spinal cord tumors. These tumors are named based on the type of cell in which they formed and where the tumor first formed in the central nervous system. For example, an astrocytic tumor begins in star-shaped brain cells called astrocytes, which help keep nerve cells healthy.
• Germ Cell Tumors- are a type of tumor that begins in the cells that give rise to
sperm or eggs.
• Neuroendocrine Tumors- they form from cells that release hormones into the blood in response to a signal from the nervous system. These tumors, which may make higher-than-normal amounts of hormones, can cause many different symptoms.
• Carcinoid Tumors- are a type of neuroendocrine tumor. They are slow-growing
tumors that are usually found in the gastrointestinal system (most often in the
rectum and small intestine). Carcinoid tumors may spread to the liver or other sites in the body, and they may secrete substances such as serotonin or prostaglandins, causing carcinoid syndrome.
An abbreviated list of cancer types is presented below:
A) Bone and muscle sarcomas:
■ Chondrosarcoma
■ Ewing's sarcoma
■ Malignant fibrous histiocytoma of bone/osteosarcoma
■ Osteosarcoma
■ Rhabdomyosarcoma
■ Heart cancer
B) Brain and nervous system:
■ Astrocytoma
■ Brainstem glioma
■ Pilocytic astrocytoma
■ Ependymoma
■ Primitive neuroectodermal tumor
■ Cerebellar astrocytoma
■ Cerebral astrocytoma
■ Glioma
• Medulloblastoma
■ Neuroblastoma
■ Oligodendroglioma
■ Pineal astrocytoma
■ Pituitary adenoma
■ Visual pathway and hypothalamic glioma
C) Breast:
■ Breast cancer
■ Invasive lobular carcinoma
■ Tubular carcinoma
■ Invasive cribriform carcinoma
■ Medullary carcinoma
■ Male breast cancer
■ Phyllodes tumor
■ Inflammatory Breast Cancer
D) Endocrine system:
■ Adrenocortical carcinoma
■ Islet cell carcinoma (endocrine pancreas)
■ Multiple endocrine neoplasia syndrome
■ Parathyroid cancer
■ Pheochromocytoma
■ Thyroid cancer
■ Merkel cell carcinoma
E) Eye:
■ Uveal melanoma
■ Retinoblastoma
F) Gastrointestinal
■ Anal cancer
■ Appendix cancer
■ cholangiocarcinoma
■ Carcinoid tumor, gastrointestinal
■ Colon cancer
■ Extrahepatic bile duct cancer
■ Gallbladder cancer
■ Gastric (stomach) cancer
■ Gastrointestinal carcinoid tumor
■ Gastrointestinal stromal tumor (GIST)
■ Hepatocellular cancer
■ Pancreatic cancer, islet cell
■ Rectal cancer
G) Genitourinary and gynecologic
■ Bladder cancer
■ Cervical cancer
■ Endometrial cancer
■ Extragonadal germ cell tumor
■ Ovarian cancer
■ Ovarian epithelial cancer (surface epithelial-stromal tumor)
■ Ovarian germ cell tumor
■ Penile cancer
■ Renal cell carcinoma
■ Renal pelvis and ureter, transitional cell cancer
■ Prostate cancer
■ Testicular cancer
■ Gestational trophoblastic tumor
■ Ureter and renal pelvis, transitional cell cancer
■ Urethral cancer
■ Uterine sarcoma
■ Vaginal cancer
■ Vulvar cancer
■Wilms tumor
F) Head and neck
■ Esophageal cancer
■ Head and neck cancer
■ Nasopharyngeal carcinoma
■ Oral cancer
■ Oropharyngeal cancer
■ Paranasal sinus and nasal cavity cancer
■ Pharyngeal cancer
■ Salivary gland cancer
■Hypopharyngeal cancer
G) Hematopoietic
■ Acute biphenotypic leukemia
■ Acute eosinophilic leukemia
■ Acute lymphoblastic leukemia
■ Acute myeloid leukemia
■ Acute myeloid dendritic cell leukemia
■ AIDS-related lymphoma
■ Anaplastic large cell lymphoma
■ Angioimmunoblastic T-cell lymphoma
■ B-cell prolymphocytic leukemia
■ Burkitt's lymphoma
■ Chronic lymphocytic leukemia
■ Chronic myelogenous leukemia
■ Cutaneous T-cell lymphoma
■ Diffuse large B-cell lymphoma
■ Follicular lymphoma
■ Hairy cell leukemia
■ Hepatosplenic T-cell lymphoma
■ Hodgkin's lymphoma
■ Hairy cell leukemia
■ lntravascular large 8-cell lymphoma
■ Large granular lymphocytic leukemia
■ Lymphoplasmacytic lymphoma
■ Lymphomatoid granulomatosis
■ Mantle cell lymphoma
■ Marginal zone 8-cell lymphoma
■ Mast cell leukemia
■ Mediastinal large 8 cell lymphoma
■ Multiple myeloma/plasma cell neoplasm
■ Myelodysplastic syndromes
■ Mucosa-associated lymphoid tissue lymphoma
■ Mycosis fungoides
■ Nodal marginal zone B cell lymphoma
■ Non-Hodgkin lymphoma
■ Precursor 8 lymphoblastic leukemia
■ Primary central nervous system lymphoma
■ Primary cutaneous follicular lymphoma
■ Primary cutaneous immunocytoma
■ Primary effusion lymphoma
■ Plasmablastic lymphoma
■ Sezary syndrome
■ Splenic marginal zone lymphoma
■ T-cell prolymphocytic leukemia
H) Skin
■ Basal cell carcinoma
■ Squamous cell carcinoma
■ Skin adnexal tumors (e.g. sebaceous carcinoma)
■ Melanoma
■ Merkel cell carcinoma
■ Sarcomas of primary cutaneous origin (e.g. dermatofibrosarcoma protuberans)
■ Lymphomas of primary cutaneous origin (e.g. mycosis fungoides)
I) Thoracic and respiratory
■ Bronchial adenomas/carcinoids
■ Small cell lung cancer
■ Mesothelioma
■ Non-small cell lung cancer
■ Pleuropulmonary blastoma
■ Laryngeal cancer
■ Thymoma and thymic carcinoma
J) HIV/ AIDS related
■ AIDS-related cancers
■ Kaposi sarcoma
K) Unsorted
■ Epithelioid hemangioendothelioma (EHE)
■ Desmoplastic small round cell tumor
■ Liposarcoma
(https://en.wikipedia.org/wiki/List_of_cancer_types- accessed 05/22/2020;
https://www.cancer.gov/about-cancer/understanding/what-is-cancer) .
This represents a short list of the diseases that are to be treated by the method of treatment claimed by the instant Application and is illustrative of the breadth of claims.
The specification provides guidance and examples of treating mouse xenografts of lung, colorectal, breast and renal cancer cell lines. It is obvious that these four types of cancer are not representative of cancer in general as claimed in the instant Application. Thus, it is submitted that Applicant was in possession of methods of treatment of the four types of cancers indicated supra but not the whole genus claimed.
With regard to the prevention aspect, there is no indication that any type of cancer was prevented. The phrase "preventing a disorder", given its broadest reasonable interpretation in light of the teachings in the specification, requires that absolutely no cell, nor tissue, or individual would present any symptom of a disorder after treatment with the compound of claim 1. There is no evidence, either in the specification or in the prior art, that any method to date can accomplish this goal. There is no support for the prevention of any disorder or disease, as is required by the claims, and neither can such support be obtained through reasonable extrapolation of the data or teachings in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,639,383. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims 1 and 2.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,875,601. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims 1-12.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed. Claims 15 is objected to and claims 1-14 and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
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