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 with traverse of Group I (claims 31-52 and 73-82) in the reply filed on 04/28/2026 is acknowledged. The traversal is on the ground that the restriction requirement is based on the claimed structures, which overlap among the three groups, and all of these ACC structures were searched, examined, and granted in parent patent U.S. Pat. No. 11,667,687. This is found persuasive and the restriction requirement is withdrawn. Claims 31-82 are pending and are examined.
Claim Interpretation
The claims 78, 79 81 and 82 are interpreted as method of treatment of a disease.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 78 and 81 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
“[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). See also MPEP 2163.04.
The claims are interpretated as method of treatment of 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, human 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 B 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 B 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.
In the instant case, Applicant treated mouse xenografts of ovarian cancer cell, breast cancer cells, head and neck cancer cells and melanoma cells with some of the activatable cytokine constructs (ACC)s claimed. It is abundantly clear the four cancer cell cancers treated do not represent a representative amount of species for the vast genus of cancer. A skilled artisan would inexorably conclude that Applicant does not have methods of treatment for the vast genus of cancer but only for four types of cancer.
Claims 78, 79, 81 and 82 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are interpreted as drawn to methods of treatment of cancer, in particular melanoma.
Any method of treatment comprises the composition to be administered, a range dosage per kg or m2, a treatment regimen and metrics for determining if the goal of the treatment has been achieved. The specification does not address these parameters.
As indicated supra Applicant used particular (ACC)s to treat mouse xenografts of ovarian cancer cell, breast cancer cells, head and neck cancer cells and melanoma cells. First of all, Applicant treated a small number of cancer types and not the genus of cancer. Second, each treatment method needs to be painstakingly tested for the parameters mentioned above and this testing implies a vast amount of experimentation with uncertain results. This amount of experimentation is considered undue.
Applicant is invited to detail the treatment method parameters and, if supplemental data regarding treatment of other types of cancer are submitted they would be critically examined.
Conclusion
Claims 31-77 and 80 are allowed. Claims 78, 79, 81 and 82 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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