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 (571) 272-0781 [email protected] Demystifying the Examination of Stem Cell-Related Inventions.

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Demystifying the Examination of Stem Cell-Related Inventions

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Demystifying the examination of stem cell related inventions

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

[email protected]


Demystifying the examination of stem cell related inventions1

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


Demystifying the examination of stem cell related inventions2

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?


Terminology defined by function

Terminology:Defined 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


Terminology defined by function1

Terminology:Defined by Function

  • Cells must fulfill two criteria to be considered “Stem Cells:”

    • must self-renew and

    • must differentiate


Types of claims

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)


Demystifying the examination of stem cell related inventions3

Demystifying the Examination of Stem Cell-Related Inventions

EmbryonicTransgenic Animals

Fetal Therapeutic Methods

Adult


Demystifying the examination of stem cell related inventions4

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)


35 u s c 101

35 U.S.C. 101

  • Is there a specific, substantial, and credible utility asserted?

  • Is the claimed invention directed to statutory subject matter?


35 u s c 112 first paragraph

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."


35 u s c 112 first paragraph1

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?


35 u s c 112 first paragraph enablement

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.


Standard for enablement

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


Standard for enablement1

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


In re wands 858 f 2d 731 8 uspq2d 1400 fed cir 1988

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.


Wands factors

WandsFactors

  • 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


Considerations for treatment methods using stem cells

Considerations for Treatment Methods using Stem Cells

  • Reproducibility/predictability of obtaining appropriate stem cell population

  • Maintenance of the proper differentiated/de-differentiated state in in-vivo environments

  • Ability to extrapolate from ex vivo to in vivo


Considerations for treatment methods using stem cells1

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


References that demonstrate unpredictability regarding germ line transmission transgenic animals

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.


35 usc 102 103

35 USC 102/103

  • Are the claimed cells novel and non-obvious?


Prior art issues to consider

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


Demystifying the examination of stem cell related inventions5

Demystifying the Examination of Stem Cell-Related Inventions

Thank You


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