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
• [phone]
• irem.yucel_at_uspto.gov

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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

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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?

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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

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TerminologyDefined by Function

• Cells must fulfill two criteria to be considered
  Stem Cells
• must self-renew and
• must differentiate

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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)

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Demystifying the Examination of Stem Cell-Related
Inventions

• Embryonic Transgenic Animals
• Fetal Therapeutic Methods
• Adult

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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)

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35 U.S.C. 101

• Is there a specific, substantial, and credible
  utility asserted?
• Is the claimed invention directed to statutory
  subject matter?

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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."

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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?

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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.

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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

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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

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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.

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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

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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

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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

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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.

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35 USC 102/103

• Are the claimed cells novel and non-obvious?

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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

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Demystifying the Examination of Stem Cell-Related
Inventions

• Thank You