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Demystifying the Examination of Stem Cell-Related Inventions

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Demystifying the Examination of Stem Cell-Related Inventions Remy Yucel, Ph.D. Supervisory Patent Examiner Technology Center 1600 United States Patent & Trademark Office – PowerPoint PPT presentation

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Title: Demystifying the Examination of Stem Cell-Related Inventions


1
Demystifying the Examination of Stem Cell-Related
Inventions
  • Remy Yucel, Ph.D.
  • Supervisory Patent Examiner
  • Technology Center 1600
  • United States Patent Trademark Office
  • (571) 272-0781
  • irem.yucel_at_uspto.gov

2
Demystifying the Examination of Stem Cell-Related
Inventions
  • Examination of Stem Cell-related inventions is
    done under the same rules that apply generally to
    any application

3
Demystifying the Examination of Stem Cell-Related
Inventions
  • What kind of stem cell?
  • embryonic
  • fetal
  • adult
  • Does the specification contain a clear
    definition?
  • Does the definition correlate with the intended
    use as provided by the specification?

4
TerminologyDefined by Function
  • Totipotency-all cells in the placenta and
    embryo
  • Pluripotency-all cells in the embryo
  • Multipotency-a subset of cells in a given
    lineage/tissue

5
TerminologyDefined by Function
  • Cells must fulfill two criteria to be considered
    Stem Cells
  • must self-renew and
  • must differentiate

6
Types of Claims
  • Cells
  • Methods of making
  • Methods of using (for therapeutic purposes,
    including screening for therapeutics)
  • Methods of using (making of transgenic animals or
    cloning)

7
Demystifying the Examination of Stem Cell-Related
Inventions
  • Embryonic Transgenic Animals
  • Fetal Therapeutic Methods
  • Adult

8
Demystifying the Examination of Stem Cell-Related
Inventions
  • Claims are analyzed under 35 U.S.C.
  • 101
  • 112, first and second paragraphs
  • 102 and 103 (art rejections)

9
35 U.S.C. 101
  • Is there a specific, substantial, and credible
    utility asserted?
  • Is the claimed invention directed to statutory
    subject matter?

10
35 U.S.C. 112, first paragraph
  • "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."

11
35 U.S.C. 112, first paragraph
  • Is the full breadth of the claim adequately
    described?
  • Is the claimed subject matter enabled?
  • How to make?
  • How to use?

12
35 U.S.C. 112, first paragraph enablement
  • The test of enablement is whether one reasonably
    skilled in the art could make or use the
    invention from the disclosures in the patent
    coupled with information known in the art without
    undue experimentation.
  • United States v. Telectronics, Inc., 857 F.2d
    778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988)
  • A patent need not teach, and preferably omits,
    what is well known in the art.

13
Standard for Enablement
  • The standard for determining whether the
    specification meets the enablement requirement
  • Is the experimentation needed to practice the
    invention undue or unreasonable?
  • Supreme Court decision of Mineral Separation v.
    Hyde, 242 U.S. 261, 270 (1916)
  • M.P.E.P. 2164.01

14
Standard for Enablement
  • "In making the determination of enablement, the
    examiner shall consider the original disclosure
    and all evidence in the record, weighing evidence
    that supports enablement against evidence that
    the specification is not enabling.
  • Training materials for assessing enablement of
    chemical and biotech applications
    www.uspto.gov/web/offices/pac/dapp/1pecba.htm

15
In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed.
Cir. 1988)
  • The determination that "undue experimentation"
    would have been needed to make and use the
    claimed invention is not a single, simple factual
    determination.

16
Wands Factors
  • the nature of the invention
  • the state of the prior art
  • the predictability or lack thereof in the art
  • the amount of direction or guidance present
  • the presence or absence of working examples
  • the breadth of the claims
  • the relative skill of those in the art
  • the quantity of experimentation needed

17
Considerations for Treatment Methods using Stem
Cells
  • Reproducibility/predictability of obtaining
    appropriate stem cell population
  • Maintenance of the proper differentiated/de-differ
    entiated state in in-vivo environments
  • Ability to extrapolate from ex vivo to in vivo

18
Considerations for Treatment Methods using Stem
Cells
  • Targeting or migration of stem cells to
    appropriate sites in vivo
  • Viability in vivo
  • Challenges posed by genetic alteration of stem
    cells

19
References that Demonstrate Unpredictability
Regarding Germ Line Transmission (Transgenic
Animals)
  • Bradley et al., Modifying the Mouse Design and
    Desire. Bio/Technology, Vol. 10, pages 534-539,
    May 1992.
  • Babinet et al., Genome Engineering via Homologous
    Recombination in Mouse Embryonic Stem (ES) Cells
    an Amazingly Versatile Tool for the Study of
    Mammalian Biology. An Adad Bras Cienc., Vol. 73,
    No. 4, pages 577-580, 2001.
  • Moreadith et al., Gene Targeting in Embryonic
    Stem Cells The New Physiology and Metabolism.
    J. Mol. Med., Vol. 75, pages 208-216, 1997.

20
35 USC 102/103
  • Are the claimed cells novel and non-obvious?

21
Prior Art Issues to Consider
  • Characterization of the claimed cells
  • Distinction between the claimed cells and those
    of the prior art
  • Method of production
  • Screens using stem cells

22
Demystifying the Examination of Stem Cell-Related
Inventions
  • Thank You
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