81_FR_44163 81 FR 44034 - Government-Owned Inventions; Availability for Licensing

81 FR 44034 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 129 (July 6, 2016)

Page Range44034-44034
FR Document2016-15890

The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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.

Federal Register, Volume 81 Issue 129 (Wednesday, July 6, 2016)
[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Page 44034]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15890]



[[Page 44034]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 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: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing, and copies 
of the U.S. patent applications listed below may be obtained by 
contacting: Attn. Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of Invention: Improved Fixative for Paraffin-Embedded Tissue 
Samples.

Description of Technology

    Tissues samples collected during medical procedures, such as 
biopsies, are used to diagnose a wide variety of diseases. Before 
diagnosis, patient samples are typically processed by fixation and 
paraffin embedding. This fixation/embedding process is used to preserve 
tissue morphology and histology for subsequent evaluation. 
Unfortunately, most fixative agents damage or destroy nucleic acids 
(RNA and DNA) and proteins, thereby potentially impairing diagnostic 
assessment of tissue.
    Researchers in the National Cancer Institute's Laboratory of 
Pathology have developed an improved tissue fixative solution that is 
formaldehyde-free. This fixative, BE70, significantly improves DNA, 
RNA, and protein biomolecule integrity in histological samples compared 
to traditional fixatives. Additionally, BE70 is compatible with current 
protocols and does not alter tissue processing. In vitro an in vivo 
data are available and the fixative has been tested on paraffin-
embedded samples.

Potential Commercial Applications

     Improves integrity of fixed tissue samples.
     Improves RNA/DNA quality in fixed tissue samples.
     Non-cross linking, improves protein quality.

Value Proposition

     There is substantial interest in new fixatives to replace 
neutral buffered formalin (a carcinogen) as primary fixative agent for 
surgical pathology.
     BE70 overcomes several limitations of other fixatives, 
including cost and disposal issues.
     Could be formulated as a concentrate, and marketed as an 
additive (to be added during dilution of ethanol).

Development Stage

    In vivo data: YES.

Inventor(s)

    Stephen M. Hewitt (NCI), Joon-Yong Chung (NCI), Candice D. Perry 
(Leidos Biomedical LLC).

Intellectual Property

    HHS Reference No. E-139-2015/0-US-01 US Provisional Patent 
Application 62/255,030 (HHS Reference No. E-139-2015/0-US-01) filed 
November 13, 2015, entitled ``Fixative and Methods of Use''.

Publications

    Perry C, Chung JY, et al. J Histochem Cytochem. 2016 May 24; E-pub 
[PMID: 27221702].

Contact Information

    Requests for copies of the patent application or inquiries about 
licensing, research collaborations, and co-development opportunities 
should be sent to John D. Hewes, Ph.D., email: [email protected].

    Dated: June 28, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-15890 Filed 7-5-16; 8:45 am]
BILLING CODE 4140-01-P



                                             44034                         Federal Register / Vol. 81, No. 129 / Wednesday, July 6, 2016 / Notices

                                             DEPARTMENT OF HEALTH AND                                 compared to traditional fixatives.                     DEPARTMENT OF HEALTH AND
                                             HUMAN SERVICES                                           Additionally, BE70 is compatible with                  HUMAN SERVICES
                                                                                                      current protocols and does not alter
                                             National Institutes of Health                            tissue processing. In vitro an in vivo                 National Institutes of Health
                                                                                                      data are available and the fixative has
                                             Government-Owned Inventions;                                                                                    National Institute on Aging; Notice of
                                                                                                      been tested on paraffin-embedded
                                             Availability for Licensing                                                                                      Closed Meeting
                                                                                                      samples.
                                             AGENCY:    National Institutes of Health,                                                                         Pursuant to section 10(d) of the
                                                                                                      Potential Commercial Applications                      Federal Advisory Committee Act, as
                                             HHS.
                                             ACTION:   Notice.                                           • Improves integrity of fixed tissue                amended (5 U.S.C. App.), notice is
                                                                                                      samples.                                               hereby given of the following meeting.
                                             SUMMARY:     The invention listed below is                                                                        The meeting will be closed to the
                                             owned by an agency of the U.S.                              • Improves RNA/DNA quality in                       public in accordance with the
                                             Government and is available for                          fixed tissue samples.                                  provisions set forth in sections
                                             licensing in the U.S. in accordance with                    • Non-cross linking, improves protein               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                             35 U.S.C. 209 and 37 CFR part 404 to                     quality.                                               as amended. The grant applications and
                                             achieve expeditious commercialization                                                                           the discussions could disclose
                                             of results of federally-funded research                  Value Proposition                                      confidential trade secrets or commercial
                                             and development. Foreign patent                                                                                 property such as patentable material,
                                                                                                         • There is substantial interest in new
                                             applications are filed on selected                                                                              and personal information concerning
                                                                                                      fixatives to replace neutral buffered
                                             inventions to extend market coverage                                                                            individuals associated with the grant
                                                                                                      formalin (a carcinogen) as primary
                                             for companies and may also be available                                                                         applications, the disclosure of which
                                                                                                      fixative agent for surgical pathology.
                                             for licensing.                                                                                                  would constitute a clearly unwarranted
                                             ADDRESSES: Invention Development and                        • BE70 overcomes several limitations                invasion of personal privacy.
                                             Marketing Unit, Technology Transfer                      of other fixatives, including cost and
                                                                                                                                                               Name of Committee: National Institute on
                                             Center, National Cancer Institute, 9609                  disposal issues.                                       Aging Special Emphasis Panel; Delirium
                                             Medical Center Drive, Mail Stop 9702,                       • Could be formulated as a                          Research Networks.
                                             Rockville, MD 20850–9702.                                concentrate, and marketed as an                          Date: July 29, 2016.
                                             FOR FURTHER INFORMATION CONTACT:                         additive (to be added during dilution of                 Time: 2:00 p.m. to 5:00 p.m.
                                                                                                                                                               Agenda: To review and evaluate grant
                                             Information on licensing, and copies of                  ethanol).                                              applications.
                                             the U.S. patent applications listed below                                                                         Place: National Institute on Aging,
                                             may be obtained by contacting: Attn.                     Development Stage
                                                                                                                                                             Gateway Building, Suite 2W200, 7201
                                             Invention Development and Marketing                           In vivo data: YES.                                Wisconsin Avenue, Bethesda, MD 20892,
                                             Unit, Technology Transfer Center,                                                                               (Telephone Conference Call).
                                             National Cancer Institute, 9609 Medical                  Inventor(s)                                              Contact Person: Isis S. Mikhail, DRPH, MD,
                                             Center Drive, Mail Stop 9702, Rockville,                                                                        MPH, National Institute on Aging, Gateway
                                             MD 20850–9702, Tel. 240–276–5515 or                        Stephen M. Hewitt (NCI), Joon-Yong                   Building, 7201 Wisconsin Avenue, Suite
                                                                                                      Chung (NCI), Candice D. Perry (Leidos                  2W200, Bethesda, MD 20892, 301–402–7704.
                                             email ncitechtransfer@mail.nih.gov. A
                                                                                                      Biomedical LLC).                                       mikhaili@mail.nih.gov.
                                             signed Confidential Disclosure
                                                                                                                                                             (Catalogue of Federal Domestic Assistance
                                             Agreement may be required to receive                     Intellectual Property                                  Program Nos. 93.866, Aging Research,
                                             copies of the patent applications.                                                                              National Institutes of Health, HHS)
                                             SUPPLEMENTARY INFORMATION:                                 HHS Reference No. E–139–2015/0–
                                                                                                      US–01 US Provisional Patent                              Dated: June 29, 2016.
                                             Technology description follows.
                                                Title of Invention: Improved Fixative                 Application 62/255,030 (HHS Reference                  Melanie J. Gray,
                                             for Paraffin-Embedded Tissue Samples.                    No. E–139–2015/0–US–01) filed                          Program Analyst, Office of Federal Advisory
                                                                                                      November 13, 2015, entitled ‘‘Fixative                 Committee Policy.
                                             Description of Technology                                                                                       [FR Doc. 2016–15882 Filed 7–5–16; 8:45 am]
                                                                                                      and Methods of Use’’.
                                                Tissues samples collected during                                                                             BILLING CODE 4140–01–P
                                             medical procedures, such as biopsies,                    Publications
                                             are used to diagnose a wide variety of
                                                                                                        Perry C, Chung JY, et al. J Histochem                DEPARTMENT OF HEALTH AND
                                             diseases. Before diagnosis, patient
                                             samples are typically processed by                       Cytochem. 2016 May 24; E-pub [PMID:                    HUMAN SERVICES
                                             fixation and paraffin embedding. This                    27221702].
                                             fixation/embedding process is used to                                                                           National Institutes of Health
                                                                                                      Contact Information
                                             preserve tissue morphology and
                                                                                                        Requests for copies of the patent                    National Institute on Drug Abuse;
                                             histology for subsequent evaluation.
                                                                                                      application or inquiries about licensing,              Notice of Closed Meeting
                                             Unfortunately, most fixative agents
                                             damage or destroy nucleic acids (RNA                     research collaborations, and co-                         Pursuant to section 10(d) of the
                                             and DNA) and proteins, thereby                           development opportunities should be                    Federal Advisory Committee Act, as
                                             potentially impairing diagnostic                         sent to John D. Hewes, Ph.D., email:                   amended (5 U.S.C. App), notice is
                                             assessment of tissue.                                    john.hewes@nih.gov.                                    hereby given of the following meeting.
ehiers on DSK5VPTVN1PROD with NOTICES




                                                Researchers in the National Cancer                      Dated: June 28, 2016.
                                                                                                                                                               The meeting will be closed to the
                                             Institute’s Laboratory of Pathology have                                                                        public in accordance with the
                                             developed an improved tissue fixative                    John D. Hewes,                                         provisions set forth in sections
                                             solution that is formaldehyde-free. This                 Technology Transfer Specialist, Technology             552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                             fixative, BE70, significantly improves                   Transfer Center, National Cancer Institute.            as amended. The grant applications and
                                             DNA, RNA, and protein biomolecule                        [FR Doc. 2016–15890 Filed 7–5–16; 8:45 am]             the discussions could disclose
                                             integrity in histological samples                        BILLING CODE 4140–01–P                                 confidential trade secrets or commercial


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Document Created: 2016-07-06 07:56:14
Document Modified: 2016-07-06 07:56:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactInformation on licensing, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
FR Citation81 FR 44034 

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