Source: https://www.patentdocs.org/patent_profile/page/3/
Timestamp: 2020-07-05 23:35:43
Document Index: 648526794

Matched Legal Cases: ['Application No. 10', 'Application No. 60', 'Application No. 60', 'Application No. 10', 'Application No. 09', 'Application No. 09', 'Application No. 60', 'Application No. 11', 'Application No. 60']

Patent Docs: Patent Profiles
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Patent Profile: Kylin Therapeutics Receives Patent Covering pRNA Technology
On Apr. 6, 2010, Kylin Therapeutics of West Lafayette, IN announced the issuance of U.S. Patent No. 7,655,787, which broadly covers a number of functionalities for Kylin's lead technology platform, "pRNA," or "packaging RNA." These functionalities include receptor binding, ribozyme activity, and RNA-interference. The main feature of pRNA is its ability to enhance RNA stability in cells by altering RNA folding and protecting it from exonuclease degradation. The '787 patent, which issued on February 2, 2010, is based on principal inventor Peixuan Guo's (below) original discovery of a virally-encoded 120-base RNA involved in bacteriophage DNA packaging.
The '787 patent issued from U.S. Application No. 10/373,612, filed February 24, 2003, and claims the benefit of U.S. Provisional Application No. 60/433,697, filed December 16, 2002. The patent is also a continuation-in-part of International Application No. PCT/US01/26333, filed August 23, 2001, which claims the benefit of U.S. Provisional Application No. 60/227,393, filed August 23, 2000.
The Examples provided in the patent specification include construction of pRNA chimeras and in vitro pRNA-ribozyme activity assays. The '787 patent contains 18 total claims covering pRNA chimeras, methods of making the pRNAs, and methods of delivery of DNA encoding the pRNAs. The five independent claims recite:
(b) a spacer region comprising a biologically active RNA, the spacer region covalently linked at its 5' and 3' ends to the pRNA region, wherein the biologically active RNA specifically binds a pre-identified substrate; wherein the pRNA region comprises:
(i) in the 5' to 3' direction beginning at the covalent linkage of the pRNA with the 3' end of the spacer region a first loop; a second loop; and a lower stem-loop structure comprising a bulge, a first stem section and a third loop;
(v) an opening defining 5' and 3' ends of the pRNA chimera.
(b) a spacer region comprising a biologically active RNA that specifically binds a pre-identified ligand or receptor, the spacer region covalently linked at its 5' and 3' ends to the pRNA region; wherein the pRNA region comprises:
(i) in the 5' and 3' direction beginning at the covalent linkage of the pRNA with the 3' end of the spacer region a first loop; a second loop; and a lower stem-loop structure comprising a bulge, a first stem section and a third loop;
(b) a spacer region comprising a biologically active RNA that comprises at least one of a specific binding activity and an enzymatic activity, the spacer region covalently linked at its 5' and 3' ends to the pRNA region; wherein the pRNA region comprises:
(b) a spacer region comprising a biologically active RNA that does not comprise the nucleotide sequence UAAUACGACUCACUAUA as set forth in SEQ ID NO:8, the spacer region covalently linked at its 5' and 3' ends to the pRNA region, wherein the biologically active RNA specifically binds a pre-identified substrate; wherein the pRNA region comprises:
(b) a spacer region comprising a biologically active RNA, the spacer region covalently linked at its 5' and 3' ends to the pRNA region, wherein the biologically active RNA binds a pre-identified substrate and comprises a polyribonucleotide selected from the group consisting of an RNA of at least 25-100, 46, 47, 63, 66, 94, 120, 168 and 188 nucleotides, wherein the pRNA region comprises:
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Patent Profile: Athersys Obtains U.S. and European Patents for Non-Embryonic Multipotent Stem Cells
On February 9th, Athersys, Inc. was issued U.S. Patent No. 7,659,118 covering multipotent adult stem cells (MASC), their isolation and expansion, and related pharmaceutical compositions. In a February 10, 2010 press release, the Cleveland-based company also announced the grant of European patent EP 1 218 489 B1, the counterpart to the '118 patent. Athersys adds these patents to an already robust patent portfolio covering its stem cell technology, which includes fourteen patents and more than 120 global patent applications.
Both the '118 and '489 patents cover the company's MultiStem technology, which is an investigational stem cell therapy that has demonstrated therapeutic potential to treat a range of problems, including heart attack, stroke, bone marrow transplant rejection, and inflammatory bowel disease. MultiStem has the ability to produce a range of factors and form multiple cell types. MultiStem promotes tissue repair and healing in multiple ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. Unlike traditional stem cell therapies that aim to replace damaged tissue, MultiStem produces factors that regulate the immune system, protect damaged or injured cells, and promote tissue repair and healing, giving the therapy a more drug-like effect. Thus, the company believes that MultiStem represents a unique "off-the-shelf" stem cell product.
The '118 patent describes the advantages of using cells from the developed individual rather than an embryo, specifically overcoming the problem of tissue incompatibility. The claimed MASC are negative for many common antigens, including CD44, CD45, and HLA class I and II. The MASC express transcription factors Oct3/4, REX-1, and ROX-1, express telomerase, and respond to the growth factor LIF. The patent describes the method of MASC isolation from human bone marrow, after which the MASC can be maintained in undifferentiated state or differentiated into several cell types, depending on desired use. The MASC are also suited for ex vivo genetic alteration prior to introduction or engraftment into a human patient. The MASC are described as efficient for a number of uses, including cancer treatment, tissue damage repair, induction of immune responses to fight infection, and cardiovascular therapy. The patent contains 11 examples, which describe the isolation, differentiation, development, characterization, and engraftment of the cells.
Both the U.S. and European patents claim the MASCs and pharmaceutical compositions, as well as methods for their production. The '489 patent contains 21 claims, additionally claiming the use of the MASC for agent screening applications. The '118 patent contains 12 claims; representative claims include:
1. A cell culture comprising isolated expanded human multipotent, non-embryonic, non-germ cells that can differentiate into at least one cell type of each of the endodermal, ectodermal, and mesodermal embryonic lineages and express telomerase, said cells having undergone at least 10-40 cell doublings in culture.
9. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and isolated expanded human multipotent, non-embryonic, non-germ cells that can differentiate into at least one cell type of each of the endodermal, ectodermal, and mesodermal embryonic lineages and express telomerase, said cells having undergone at least 10-40 cell doublings in culture, said cells obtained from the cell culture of claim 1 or 2.
10. A method for making a pharmaceutical composition comprising admixing a pharmaceutically acceptable carrier and isolated expanded human multipotent, non-embryonic, non-germ cells that can differentiate into at least one cell type of each of the endodermal, ectodermal, and mesodermal embryonic lineages and express telomerase, said cells having undergone at least 10-40 cell doublings in culture, said cells obtained from the cell culture of claim 1 or 2.
In a December 2009 press release, Athersys announced a strategic partnership with Pfizer under which the companies will jointly develop MultiStem for inflammatory bowel disease, and a partnership with Angiotech to develop MultiStem in acute myocardial infarction and other cardiovascular indications. Athersys is still seeking partners to develop MultiStem for stroke victims as well as leukemia patients who have rejected bone marrow treatments.
On February 16, 2010, Athersys, Inc. announced that it has completed patient enrollment for its phase I clinical trial which will test administration of Multistem to individuals following acute myocardial infarction.
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Patent Profile: NexBio Granted U.S. Patent for Flu Therapeutic
Last week, NexBio, Inc. announced the issuance of U.S. Patent No. 7,645,448, entitled "Class of Therapeutic Protein Based Molecules." The '448 patent, issued January 12, 2010, is the company's first issued U.S. patent. The patent covers NexBio's sialidase pharmaceutical compositions, including its lead compound DAS181 (Fludase®) and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions.
Fludase® (at left) is a recombinant fusion protein that inactivates sialic viral receptors on the cells of the human respiratory tract, thereby preventing all types of influenza (including H1N1) and other viruses from both infecting the human body and amplifying in already-infected individuals. Fludase® is currently undergoing a Phase II clinical trial for the treatment of community-acquired influenza. More information on the clinical trial can be found here.
Current antivirals target the virus particle and thus are limited by virus resistance. According to the patent, NexBio's technology is not limited by virus resistance because its compounds target the virus point of attachment and entry on cells, rather than the virus itself. The patent further discloses the use of these compounds to enhance gene delivery for gene therapy applications. Finally, the patent contains several examples of synthesizing sialidase proteins and corresponding functional assays.
The 21 allowed claims cover the peptides, pharmaceutical compositions, and methods of treating or preventing viral infection. Representative claims include:
1. An isolated polypeptide comprising an amino acid sequence that begins at any of the amino acids from amino acid 270 to amino acid 290 of the Actinomyces viscosus sialidase protein sequence (SEQ ID NO:12) and ends at any of the amino acids from amino acid 665 to amino acid 901 of the Actinomyces viscosus sialidase protein sequence (SEQ ID NO:12), wherein the isolated polypeptide does not comprise the sequence extending from amino acid 1 to amino acid 269 of SEQ ID NO:12 and wherein the isolated polypeptide has sialidase activity.
7. A pharmaceutical formulation comprising the isolated polypeptide of claim 1.
9. A method of treating or preventing viral infection by influenza, comprising:
applying a therapeutically effective amount of the formulation of claim 7 to epithelial cells of a subject.
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Patent Profile: Fate Therapeutics to Receive First U.S. Patent for Induced Pluripotent Stem Cell Technology
This week, Fate Therapeutics of San Diego, CA was issued a Notice of Allowance for U.S. Application No. 10/997,146 (U.S. Patent Application Publication No. 2008/0280362), titled "Methods for Reprogramming Somatic Cells." With a priority date of November 26, 2003, the application is believed to contain the earliest allowed claims in the United States for induced pluripotent stem cell technology. Upon issuance, the invention by Rudolf Jaenisch, M.D. (below left), founding member of the Whitehead Institute for Biomedical Research and scientific founder of Fate Therapeutics, will cover methods for generating pluripotent stem cells and compositions for identifying agents that enable the reprogramming of human somatic cells.
The application first describes the need for alternative methods of generating human pluripotent cells without using embryos, oocytes, or nuclear transfer technology and how reprogrammed somatic cells can enable autologous cell therapy, including the treatment of neurological diseases. The application describes novel methods of reprogramming somatic cells by introducing certain pluripotency genes, such as Oct4, Nanog, or Sox2. The application further covers compositions used in screening for agents to generate these pluripotent cells, including genes, classes of small molecules, or pluripotency proteins. The application's lone Example describes the generation of a transgenic mouse by integration of an inducible Oct-4 gene and the resulting enhanced stem cell populations.
After a series of amendments, including an examiner's amendment, twelve total claims were allowed, including three independent claims:
17. A primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, wherein the cell additionally comprises an exogenously introduced nucleic acid encoding a pluripotency protein and operably linked to at least one regulatory sequence, wherein the endogenous pluripotency gene is a gene that is expressed in a pluripotent embryonic stem cell, is required for the pluripotency of the embryonic stem cell, and is downregulated as the embryonic stem cell differentiates, and wherein the pluripotency protein is a protein expressed in a pluripotent embryonic stem cell, and is downregulated as the embryonic stem cell differentiates.
36. A primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, wherein the first endogenous pluripotency gene encodes Oct4 or Nanog, and wherein the cell additionally comprises an exogenously introduced nucleic acid encoding Oct4, Nanog, or Sox2 and operably linked to at least one regulatory sequence.
(i) a primary somatic cell comprising in its genome a first endogenous pluripotency gene operably linked to DNA encoding a first selectable marker in such a manner that expression of the first selectable marker substantially matches expression of the first endogenous pluripotency gene, and additionally comprising an exogenously introduced nucleic acid encoding Oct4, Nanog, or Sox2 and operably linked to at least one regulatory sequence; and
(ii) a candidate agent of interest with respect to its potential to reprogram a somatic cell, wherein the first endogenous pluripotency gene encodes Oct4 or Nanog.
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Patent Profile: OncoGenex Announces Issuance of Patent for Antisense Cancer Therapeutic
Last month, OncoGenex Pharmaceuticals, Inc. announced that the U.S. Patent and Trademark Office had issued U.S. Patent No. 7,569,551. The '551 patent is directed to a method of enhancing cancer cell chemo- or radiation-sensitivity using an antisense oligodeoxynucleotide targeted against the testosterone-repressed prostate message-2 (TRPM-2) gene. The inventors found that that administration of TRPM-2 antisense oligodeoxynucleotides can reduce the expression of TRPM-2, and as a result enhance the sensitivity of cancer cells to chemotherapeutic agents or radiotherapy either in vitro and in vivo. While the '551 patent is assigned to the University of British Columbia, Oncogenex notes that it has exclusively licensed the patent.
According to the biopharmaceutical company's announcement, the '551 patent encompasses methods for treating cancers that express the protein clusterin (the historical name for TRPM-2) using Oncogenex's lead cancer drug candidate, OGX-011 (also known as custirsen sodium), or any other clusterin antisense oligonucleotide, in combination with any chemotherapeutic agent or radiation therapy. Oncogenex President and CEO Scott Cormack stated that the '551 patent "expands [the company's] intellectual property estate for treating clusterin-expressing cancers using antisense therapy and provides us with a broad patent that applies well beyond prostate cancer."
The Onogenex release also notes that OGX-011 utilizes antisense technology licensed from Isis Pharmaceuticals, and that OncoGenex and Isis partnered in the discovery and initial development of OGX-011. Last year, OncoGenex and Isis amended their agreement involving OGX-011 to provide OncoGenex with sole rights to the molecule and sole responsibility for its development, subject to financial obligations to Isis. The company's website states that preliminary data in a Phase 2 clinical trial evaluating OGX-011 in combination with second-line chemotherapy in patients with hormone refractory prostate cancer has shown that retreatment with docetaxel in combination with OGX-011 may reverse docetaxel resistance and improve patient survival. OGX-011 is also being tested for use in the treatment of non-small cell lung cancer and breast cancer.
The '551 patent issued from U.S. Application No. 09/967,726, filed September 28, 2001, which is a continuation-in-part of U.S. Application No. 09/913,325, filed August 10, 2001, which is a national stage application of International Application No. PCT/US00/0487, filed February 25, 2000, and claims the benefit of U.S. Provisional Application No. 60/236,301, filed September 28, 2000. Independent claims 1 and 36 of the '551 patent recite:
1. A method for enhancing the chemo- or radiation sensitivity of cancer cells in an individual suffering from a cancer that expresses TRPM-2 in amounts different from normal tissue of the same type, comprising treating the individual with either chemotherapy or radiation therapy and administering to the individual a composition comprising an oligonucleotide targeted to TRPM-2 and effective to inhibit expression of TRPM-2 by cancer cells during at least a portion of the time that the chemotherapy or radiation therapy is active against cancer cells.
36. A method for treating a cancer which expresses TRPM-2 before or after treatment with a chemotherapy agent, comprising administering to an individual suffering from the cancer a chemotherapeutic agent which is at least partially effective against the cancer and a an oligonucleotide which is targeted to TRPM-2 and reduces the amount of TRPM-2 in cancer cell.
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Patent Profile: Cytori Receives Notice of Allowance for Use of Adipose-Derived Stem Cells in Bone Disorders
Recently, Cytori Therapeutics, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for claims directed to prosthetic devices seeded with adipose-derived stem cells. According to the press release, these claims are related to the use of Cytori's Celution® System for the treatment of bone diseases.
Although not specified in Cytori's recent press release, a quick review of the online databases at the USPTO indicates that on June 23, 2009, a Notice of Allowance was issued in U.S. Patent App. No. 10/885,293 (U.S. Patent App. Pub. No. 2005/0058632) in response to the applicants' filing of amended claims, which included the following:
1. A method of processing adipose tissue that comprises a population of cells comprising adipose-derived stem cells for reintroduction into a patient, comprising:
removing unprocessed adipose tissue that comprises a cell population comprising adipose-derived stem cells from said patient;
introducing the removed adipose tissue into a self-contained adipose-derived stem cell processing unit configured to maintain a closed system where said self contained adipose-derived stem cells processing unit comprises
a tissue collection chamber that is configured to receive unprocessed adipose tissue that is removed from said patient, wherein the tissue collection chamber is defined by a closed system;
a first filter that is disposed within said tissue collection chamber, wherein said first filter is configured to retain a first component of said unprocessed adipose tissue and pass a second component of said unprocessed adipose tissue, such that said first filter separates said first component from said second component, and wherein said first component comprises a cell population comprising adipose-derived stem cells and said second component comprises lipid, mature adipocytes, and saline;
a processing chamber, which is configured to receive said first component comprising said population of cells comprising adipose-derived stem cells from said tissue collection chamber, wherein said processing chamber is within said closed system;
a conduit configured to allow passage of said first component comprising said cell population comprising adipose-derived stem cells from said tissue collection chamber to said processing chamber while maintaining a closed system;
a cell concentrator disposed with said processing chamber, which is configured to facilitate the concentration of said first component comprising said cell population comprising adipose-derived stem cell so as to obtain a concentrated population of cells comprising adipose-derived stem cells, wherein said cell concentrator comprises a centrifuge or a filter; and
an outlet configured to allow the aseptic removal of said concentrated population of cells comprising adipose-derived stem cells;
processing said removed, unprocessed adipose tissue to obtain said concentrated population cell comprising adipose-derived stem cells; and
introducing said concentrated population of cells that comprises adipose-derived stem cells into a prosthetic device, wherein said prosthetic device comprises a cell carrier portion and a cell carrier containment portion, and wherein said concentrated population of cells comprising adipose-derived stem cells is introduced into said cell carrier portion of said prosthetic device.
3. The method of claim 1, wherein said patient has a bone related disorder.
Cytori and its proprietary system were profiled in 2006 by the San Diego Union Tribune. Also, as Patent Docs reported previously, Cytori is assembling a significant portfolio of patents and patent applications covering various uses of adipose-derived stem cells and methods for their isolation.
According to information available from Cytori's website, the Celution® System consists of a cell processing device, single use consumables and related instrumentation and reagents. The cell processing device "rapidly and reliably delivers a clinical grade, mixed population of non-cultured adipose derived stem and regenerative cells at the patient's beside." Cytori does not sell these cells as a pharmaceutical product, unlike other stem cell commercialization enterprises, but rather commercializes the cell processing device, related instruments, consumables, and other reagents.
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Patent Profile: Thrasos Therapeutics Announces Issuance of U.S. Patent No. 7,482,329
Thrasos Therapeutics, a Hopkinton, MA based biotechnology company, announced earlier this week the issuance of U.S. Patent No. 7,482,329 ("Single Domain TDF-Related Compounds and Analogs Thereof," issued January 27, 2009) directed to small molecules that selectively activate the key receptors of the bone morphogenetic protein (BMP) family. BMPs are part of the TGF-β superfamily of proteins, and are implicated, via the SMAD signaling pathway, in the reduction and control of inflammation and fibrosis and in the prevention of apoptosis in many different cells, tissues, and organs. BMPs are also implicated in the stimulation of the growth of cartilage and bone.
The claimed compounds selectively target key receptors of the BMP family of proteins to specifically activate the repair and regenerative effects of BMP, without stimulating bone growth, providing cell and tissue protection, repair and regenerative treatment without bone growth stimulation. The compounds in particular offer promise in the treatment of Acute Kidney Injury and Chronic Kidney Disease.
Claim 1 of the patent recites:
1. A compound comprising an amino acid sequence selected from the group consisting of
SEQ ID NO.45 (H)-CYFDDSSNVLCKKYRS-(OH)
SEQ ID NO.33 (H)-CYFDDSSNVLCKKYRS-(NH2)
SEQ ID NO.24 (H)-CYFDDSSNVICKRYRS-(OH)
SEQ ID NO.43 (H)-CYFDDSSOVLCKKYRS-(OH)
Patent Profile: Vermillion Announces Allowance of Ovarian Cancer Biomarker Application
Last week, Vermillion, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance for its application directed to diagnostic methods using hepcidin as a biomarker for ovarian cancer. The patent that eventually issues from the allowed application will be the Fremont, CA-based molecular diagnostics company's third U.S. patent.
A search of the USPTO Published Applications database and Public PAIR suggests that the Notice of Allowance described in Vermillion's press release was mailed for U.S. Application No. 11/373,833, which is entitled "Biomarker for Ovarian and Endometrial Cancer: Hepcidin," and which was published on March 8, 2007 as U.S. Patent Application Publication No. 2007/0054329. The Public PAIR record for this application indicates that the Notice of Allowance was mailed on November 17, 2008. Vermillion's patent is expected to issue sometime within the next four months.
According to the statement released by Vermillion, "the discovery of hepcidin as a biomarker for ovarian cancer . . . could ultimately lead to the development of an improved, next-generation assay that might provide physicians with additional, valuable information to diagnose ovarian cancer." Ovarian cancer leads to approximately 15,000 deaths each year in the United States, with approximately 20,000 new cases of ovarian cancer being diagnosed per year. The majority of new diagnoses are made in patients with late stage disease, where the cancer has spread beyond the ovary. The prognosis for these patients is, unfortunately, poor. However, when detected in stage 1, ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy.
The '833 application claims the benefit of U.S. Provisional Application No. 60/662,090, filed March 11, 2005. Allowed claim 1 of the '799 application, which includes amendments introduced by Examiner's Amendment, recites:
1. A method for qualifying ovarian cancer status in a subject comprising: (a) measuring the level of hepcidin in a biological sample from the subject being screened for ovarian cancer; and (b) correlating the measurement of an increased level of hepcidin in the biological sample from the subject as compared to the level of hepcidin in a biological sample from a healthy subject with the diagnosis of ovarian cancer.
The claim, as presented in Vermillion's last response, recited:
1. A method for qualifying ovarian cancer status in a subject comprising: (a) measuring one or more biomarkers in a biological sample from the subject, wherein at least one biomarker is hepcidin; and (b) correlating the measurement or measurements with an ovarian cancer status selected from ovarian cancer and a benign ovarian tumor, wherein an increase in level of hepcidin is indicative of ovarian cancer.
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