Government-Owned Inventions; Availability for Licensing, 47844-47845 [05-16138]

Download as PDF 47844 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Notices the conventional treatment with vasodilator medications and open heart surgery. The technology involves reapposing of mitral valve leaflets by percutaneous annuloplasty delivering circumferential tensioning devices. Under appropriate imaging guidance (such as fluoroscopic MRI) a circumferential device trajectory is navigated through anatomic (coronary sinus) and non-anatomic spaces to deliver a circumferential tensioning device. Provided are also designs of various catheters, systems that would be necessary to perform the repair of cardiac valves. Imaging methods, like fluoroscopic (real time MRI), could be used to assist the operator for placement and orientation purposes. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Variable Curve Catheter Robert J. Lederman, Parag Karmarkar (NHLBI). U.S. Provisional Patent Application 60/ 426,542 filed 15 Nov 2002 (HHS Reference No. E–035–2003/0–US–01); International Patent Application PCT/ US03/36210 filed 14 Nov 2003 (HHS Reference No. E–035–2003/0–PCT– 02). Licensing Contact: Michael Shmilovich; 301/435–5019; shmilovm@mail.nih.gov. The invention provides a deflectable tip guiding device, such as a catheter, that enables the operator to vary the radius of curvature of the tip of the catheter. This is a novel variation on the classic ‘‘fixed fulcrum,’’ tip deflectors used in minimally invasive procedures in open surgical treatments. The described device permits a more comprehensive ability to navigate complex geometric pathways in patient’s body and enables better access to target structures (e.g., to all endomyocardial walls from a transaortic approach). The guiding device can be made compatible with imaging methods like MRI. The described technology can be used as a platform for a variety of interventional devices for delivery of drugs, cells, energy, or sutures through complex trajectories of the body. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. VerDate jul<14>2003 13:17 Aug 12, 2005 Jkt 205001 Dated: August 5, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–16137 Filed 8–12–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, DHHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Benztropinamine Analogs as Dopamine Transport Inhibitors Amy H. Newman et al. (NIDA). U.S. Provisional Application No. 60/ 689,746 filed 10 Jun 2005 (HHS Reference No. E–089–2005/0–US–01). Licensing Contact: Marlene Shinn-Astor; 301–435–4426; shinnm@mail.nih.gov. Dopamine is a neurotransmitter that is directly involved in locomotor activity, motivation and reward, and cognition. The dopamine transporter is expressed on the plasma membrane of dopamine neurons and is responsible for clearing dopamine released into the extracellular space, thereby regulating neurotransmission. The dopamine transporter plays a significant role in neuropsychiatric diseases, such as Parkinson’s disease, drug abuse (especially cocaine addiction), Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD), PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 narcolepsy and a number of other CNS disorders. Therefore, the dopamine transporter is a target for research and potential therapeutics for the treatment of these indications. Benztropine and its analogs are an important class of dopamine transport inhibitors that are indicated for the treatment of cocaine abuse and ADHD. They bind with high affinity to the dopamine transporter and block dopamine uptake, but generally do not produce behavioral effects comparable to those produced by cocaine. In animal models of drug abuse, many benztropine analogs have been shown to (1) reduce cocaine-induced locomotor stimulation, (2) have long-lasting effects, and (3) lack a significant abuse liability. This suggests they may be useful medications for the treatment of human diseases where dopamine-related behavior is compromised, especially in situations in which an (partial) agonist treatment is indicated. However, some of the reported analogs have limited or poor solubility in aqueous systems or poor stability characteristics. To remedy this, the 3position benzhydrylether moiety of the benztropine analogs was replaced with the isosteric benzhydrylamine system in order to reduce hydrolysis of the less stable ether function, observed in the benztropine series, and further reduce lipophilicity to ultimately increase water solubility and bioavailability for improved therapeutic formulation and utility. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Inhibition of SMAD-Signaling Leads To Enhanced Insulin Production and Better Glucose Control: A Potential Therapy for Diabetes and Associated Complications Due to Hyperglycemia Sushil G. Rane et al. (NCI). U.S. Provisional Application No. 60/ 665,204 filed 25 Mar 2005 (HHS Reference No. E–235–2004/0–US–01). Licensing Contact: Marlene Shinn-Astor; 301–435–4426, shinnm@mail.nih.gov. TGFb and related proteins, activins and bone morphogenetic proteins (BMPs), are critical during pancreas development. Alterations in the TGFb pathway are observed in diseases of the pancreas, including diabetes and cancer, although the precise ramifications of altered TGFb functions are unclear. The DPC4 (deleted in pancreas cancer 4) locus that encodes the TGFb-signaling intermediate, SMAD 4, is mutated in 55–70% of pancreatic cancers and E:\FR\FM\15AUN1.SGM 15AUN1 Federal Register / Vol. 70, No. 156 / Monday, August 15, 2005 / Notices alterations in expression of the TGFb receptors I and II (TbRI and TbRII) are also observed during pancreatic cancer progression. These observations are consistent with an integral role of the TGFb pathway components in pancreas biology and disease progression. However, the molecular details and the target cell population of TGFb signals during pancreas development and disease are not known. SMAD proteins are downstream mediators of signals from TGFb 1,2,3 and activin, and SMAD proteins have been implicated as important factors in cellular proliferation, differentiation and migration. This invention identifies another important regulatory role for the TGFb-signaling pathway in insulin production. The inventors have shown that low levels of TGFb can suppress insulin production through the actions of the SMAD signaling proteins. Small molecule regulators of SMADdependent signaling may lead to better insulin production and allow better glucose regulation. Thus, controlled administration of TGFb signaling regulators may be useful in the treatment of diabetes, hyperglycemia and related complications. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Anti-Marinobufagenin Antibodies and Methods for Their Use Alexei Bagrov et al. (NIA). U.S. Provisional Application No. 60/ 694,733 filed 27 Jun 2005 (HHS Reference No. E–092–2004/0–US–01). Licensing Contact: Fatima Sayyid; 301– 435–4521; sayyidf@mail.nih.gov. Pre-eclampsia is associated with increased blood levels of marinobufagenin (MBG), a steroid that increases blood pressure by inhibiting a membrane enzyme, Na/K ATPase, in the vascular wall. Pre-eclampsia complicates up to 10% of pregnancies in the U.S. and is a significant factor in causing maternal and fetal mortality and morbidity worldwide. The present invention relates to compositions and methods for detecting the presence of MBG in a biological sample. It also relates to methods for the use of monoclonal antibodies or antigen binding fragments as prophylactic, therapeutic, and diagnostic agents for the detection, inhibition and treatment of hypertension. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. VerDate jul<14>2003 13:17 Aug 12, 2005 Jkt 205001 Dated: August 5, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–16138 Filed 8–12–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment; Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of a Teleconference Meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council to be held August 15, 2005. The meeting will include the review, discussion and evaluation of grant applications reviewed by Initial Review Groups. Therefore, the meeting will be closed to the public as determined by the SAMHSA Administrator, in accordance with Title 5 U.S.C. 552b(c)(6) and 5 U.S.C. App. 2, 10(d). Substantive program information and a roster of Council members may be obtained by accessing the SAMHSA Advisory Council Web site (https:// www.samhsa.gov) as soon as possible after the meeting, or by communicating with the contact whose name and telephone number are listed below. Committee Name: Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment National Advisory Council. Meeting Date: August 15, 2005. Place: 1 Choke Cherry Road, 5th Floor Conference Room, Rockville, MD 20857. Type: Closed: August 15, 2005–11 a.m.–12 p.m. Contact: Cynthia Graham, M.S., NAC Executive Secretary, SAMHSA/CSAT National Advisory Council, 1 Choke Cherry Road, Room 5–1036, Rockville, MD 20857. Telephone: (240) 276–1692. FAX: (240) 276– 1690. E-mail: cynthia.graham@samhsa.hhs.gov. This notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the Department and the review and funding cycle. Dated: August 10, 2005. Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health, Services Administration. [FR Doc. 05–16164 Filed 8–12–05; 8:45 am] BILLING CODE 4162–20–P PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 47845 DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Information Collection Renewal To Be Sent to the Office of Management and Budget (OMB) for Approval Under the Paperwork Reduction Act; OMB Control Number 1018–0119; Policy for Evaluating Conservation Efforts When Making Listing Decisions Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. AGENCY: SUMMARY: We (Fish and Wildlife Service, Service) plan to send OMB a request to renew approval for information collections associated with our Policy for Evaluation of Conservation Efforts When Making Listing Decisions (PECE). We use the information that we collect as part of the basis for identifying conservation efforts that can contribute to a decision to not list a species under the Endangered Species Act (ESA) or to list a species as threatened rather than endangered. DATES: You must submit comments on or before October 14, 2005. ADDRESSES: Send your comments on this information collection to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222–ARLSQ, 4401 North Fairfax Drive Arlington, Virginia 22203 (mail); hope_grey@fws.gov (e-mail); or (703) 358–2269 (fax). FOR FURTHER INFORMATION CONTACT: To request a copy of the information collection requirements or explanatory material, contact Hope Grey, Information Collection Clearance Officer, at the above addresses or by telephone at (703) 358–2482. For information related to the Policy for Evaluation of Conservation Efforts When Making Listing Decisions, please visit our Web site at https:// www.fws.gov/endangered/listing/pecefinal.pdf. The OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). We will ask OMB to renew approval of the collection of information for certain types of conservation agreements, conservation plans, and similar documents in relation to PECE (68 FR 15100, March 28, 2003). The current OMB control number for this SUPPLEMENTARY INFORMATION: E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 70, Number 156 (Monday, August 15, 2005)]
[Notices]
[Pages 47844-47845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16138]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Benztropinamine Analogs as Dopamine Transport Inhibitors

Amy H. Newman et al. (NIDA).
U.S. Provisional Application No. 60/689,746 filed 10 Jun 2005 (HHS 
Reference No. E-089-2005/0-US-01).
Licensing Contact: Marlene Shinn-Astor; 301-435-4426; 
shinnm@mail.nih.gov.

    Dopamine is a neurotransmitter that is directly involved in 
locomotor activity, motivation and reward, and cognition. The dopamine 
transporter is expressed on the plasma membrane of dopamine neurons and 
is responsible for clearing dopamine released into the extracellular 
space, thereby regulating neurotransmission. The dopamine transporter 
plays a significant role in neuropsychiatric diseases, such as 
Parkinson's disease, drug abuse (especially cocaine addiction), 
Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder 
(ADD/ADHD), narcolepsy and a number of other CNS disorders. Therefore, 
the dopamine transporter is a target for research and potential 
therapeutics for the treatment of these indications.
    Benztropine and its analogs are an important class of dopamine 
transport inhibitors that are indicated for the treatment of cocaine 
abuse and ADHD. They bind with high affinity to the dopamine 
transporter and block dopamine uptake, but generally do not produce 
behavioral effects comparable to those produced by cocaine. In animal 
models of drug abuse, many benztropine analogs have been shown to (1) 
reduce cocaine-induced locomotor stimulation, (2) have long-lasting 
effects, and (3) lack a significant abuse liability. This suggests they 
may be useful medications for the treatment of human diseases where 
dopamine-related behavior is compromised, especially in situations in 
which an (partial) agonist treatment is indicated.
    However, some of the reported analogs have limited or poor 
solubility in aqueous systems or poor stability characteristics. To 
remedy this, the 3-position benzhydrylether moiety of the benztropine 
analogs was replaced with the isosteric benzhydrylamine system in order 
to reduce hydrolysis of the less stable ether function, observed in the 
benztropine series, and further reduce lipophilicity to ultimately 
increase water solubility and bioavailability for improved therapeutic 
formulation and utility.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Inhibition of SMAD-Signaling Leads To Enhanced Insulin Production and 
Better Glucose Control: A Potential Therapy for Diabetes and Associated 
Complications Due to Hyperglycemia

Sushil G. Rane et al. (NCI).
U.S. Provisional Application No. 60/665,204 filed 25 Mar 2005 (HHS 
Reference No. E-235-2004/0-US-01).

Licensing Contact: Marlene Shinn-Astor; 301-435-4426, 
shinnm@mail.nih.gov.

    TGF[beta] and related proteins, activins and bone morphogenetic 
proteins (BMPs), are critical during pancreas development. Alterations 
in the TGF[beta] pathway are observed in diseases of the pancreas, 
including diabetes and cancer, although the precise ramifications of 
altered TGF[beta] functions are unclear. The DPC4 (deleted in pancreas 
cancer 4) locus that encodes the TGF[beta]-signaling intermediate, SMAD 
4, is mutated in 55-70% of pancreatic cancers and

[[Page 47845]]

alterations in expression of the TGF[beta] receptors I and II 
(T[beta]RI and T[beta]RII) are also observed during pancreatic cancer 
progression. These observations are consistent with an integral role of 
the TGF[beta] pathway components in pancreas biology and disease 
progression. However, the molecular details and the target cell 
population of TGF[beta] signals during pancreas development and disease 
are not known.
    SMAD proteins are downstream mediators of signals from TGF[beta] 
1,2,3 and activin, and SMAD proteins have been implicated as important 
factors in cellular proliferation, differentiation and migration. This 
invention identifies another important regulatory role for the 
TGF[beta]-signaling pathway in insulin production. The inventors have 
shown that low levels of TGF[beta] can suppress insulin production 
through the actions of the SMAD signaling proteins. Small molecule 
regulators of SMAD-dependent signaling may lead to better insulin 
production and allow better glucose regulation. Thus, controlled 
administration of TGF[beta] signaling regulators may be useful in the 
treatment of diabetes, hyperglycemia and related complications.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Anti-Marinobufagenin Antibodies and Methods for Their Use

Alexei Bagrov et al. (NIA).
U.S. Provisional Application No. 60/694,733 filed 27 Jun 2005 (HHS 
Reference No. E-092-2004/0-US-01).
Licensing Contact: Fatima Sayyid; 301-435-4521; sayyidf@mail.nih.gov.

    Pre-eclampsia is associated with increased blood levels of 
marinobufagenin (MBG), a steroid that increases blood pressure by 
inhibiting a membrane enzyme, Na/K ATPase, in the vascular wall. Pre-
eclampsia complicates up to 10% of pregnancies in the U.S. and is a 
significant factor in causing maternal and fetal mortality and 
morbidity worldwide.
    The present invention relates to compositions and methods for 
detecting the presence of MBG in a biological sample. It also relates 
to methods for the use of monoclonal antibodies or antigen binding 
fragments as prophylactic, therapeutic, and diagnostic agents for the 
detection, inhibition and treatment of hypertension.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: August 5, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-16138 Filed 8-12-05; 8:45 am]
BILLING CODE 4140-01-P

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