Download Brief Introduction of Patent Prosecution Issues in Biotech Field

CCPIT PATENT AND TRADEMARK LAW OFFICE
Brief Introduction of Patent Prosecution Issues
in Biotech Field
For FB Rice China Trade Delegation
October 23, 2012
2012/10/29
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Content
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Patenting of plants, plant parts and cells
Patenting of nucleic acids/proteins
Patenting of inventions involving human embryonic stem cells
Disclosure of sources of genetic resources
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Plants
Problems
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Plant varieties are not patentable under Article 25.1(4) of Chinese
Patent Law.
“Plant varieties” includes plants, plant individuals and propagating
materials such as seeds (Examination Guidelines).
“Plant varieties” includes transgenic plants (Examination
Guidelines).
Recently, some examiners try to interpret “plant varieties” to cover
“plant cells” and “plant parts” which may regenerate a whole plant.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of plants
Suggestions
1. Try plant cells/parts, by arguing they are not varieties because
 plant cells/parts are not “plant varieties” under UPOV convention
(specific, uniform and stable);
 plant cells/parts alone cannot maintain life by photosynthesis; and
 plant cells/parts are not traditional “propagating materials”:
regeneration involves human intervention.
Example:
Claim 12. A transfected or transformed cell, tissue or organ from a plant
comprising a nucleic acid molecule of claim 1.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Plants
Suggestions
2.
Try plant cells/parts disclaiming plant varieties/propagating
materials.
Example:
 Rejection: Plant cells not patentable.
 Response:
Claim 1. A wheat plant cell comprising at least one XXX nucleic acid
selected from … ,
wherein said wheat plant cell is not a plant variety.
 Rejection withdrawn.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Plants
Suggestions
3. Try method claims:
Non-biological processes for production of plants are patentable.
 Method for producing a plant having some trait/characteristic by
genetic engineering or traditional breeding.
 Method for producing a plant having some trait by sexual or asexual
reproduction.
 Method for growing a plant having some trait.
 Method for producing plant seeds comprising (1) growing plant(s)
having some trait and (2) collect the seeds of the plant.
 Method for producing transgenic plant cells/parts having some trait
by genetic engineering.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Plants
Suggestions
4. Try use claims.
 Use of a gene/construct/vector for producing a plant having some
characteristic (or plant cells/parts, or progeny).
 Use of a plant cell/part for producing a plant having some
characteristic (and a progeny thereof).
 Use of a plant having some characteristic or obtainable by above
methods for producing a plant having some characteristic (and a
progeny thereof).
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Nucleic Acids/Proteins
Problems
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Homology: lack of support
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Similar language: Identity, Hybridization, or Substitutions, additions
and/or deletions
“Comprising”/“having”: lack of support
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of nucleic acids/proteins
Homology
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Suggestions when responding to support rejections
 Any example of variants with experimental data? If yes, traverse
and add functional limitation. Preferably two examples.
 Gist of invention (technical problem)? If not relevant, traverse.
 Amount of direction provided in the specification.
 Try other formats:
 allelic variants,
 variants with conservative substitutions,
 variants with (conservative) substitutions of 1-10 amino acid
residues.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of nucleic acids/proteins
Homology
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Suggestions when responding to support rejections
Example:
 Rejections: “identity” lack support.
 Granted claim 1. An isolated toxin that is active against XXX
insects, wherein said toxin comprises an amino acid sequence
that has at least 93% sequence identity with SEQ ID NO: 2 and
wherein the C-terminus of said toxin comprises amino acids
579-787 of SEQ ID NO: 2
 Arguments:
Examples: native XXX toxin, corn-optimized XXX toxin, hybrid
toxin;
Teachings in the specification: active region.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of nucleic acids/proteins
“Comprising”/“having”
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Problem -- Typical scenario
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Claim: A nucleic acid (polypeptide) comprising a nucleotide
(amino acid) sequence as set forth in SEQ ID NO:1.
Rejection: “comprising” lacks support because additional
nucleotides (amino acids) added to any of the terminals of SEQ
ID NO:1 will change the activity of the nucleic acid (polypeptide)
with unpredictable results and verification/screening needs
overburden.
Question: “comprising” vs “consisting of” ?
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of nucleic acids/proteins
“Comprising”/“having”
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Suggestions
 Any example of additional sequence(s) with experimental data? If
yes, traverse and add functional limitation.
Examples: the construct, expression cassette, vector, fusion protein
such as comprising purification tag, targeting peptide, or leader
peptide.
 Add
“construct/expression
cassette/recombinant
nucleic
acid/chimeric gene” claims like “a construct comprising a sequence
of SEQ ID NO:1”:
 Add “fusion protein” claims.
 Add “cell/tissue/part” claims like “a cell comprising a sequence of
SEQ ID NO:1”.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of nucleic acids/proteins
“Comprising”/“having”
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Suggestions (continued)
 Change to “consisting of” but indicate possible additional
sequences, like
 “An isolated protein consisting of SEQ ID NO:1 and optional
sequence of 1-10 amino acid residues at N- and/or Cterminals”.
 Optional sequence may be regulatory sequence, or tag for
purification or expression or targeting.
 Add sequence variant claims such as using “identity” or
“hybridize” or “additions, deletions and/or substitutions”.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Invention Involving Human
Embryonic Stem (hES) cells
Problems:
 Usual rejections: the application contains the use of human
embryos for industrial or commercial purposes and thus is not
patentable, because
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hES cells recited in the claims may be obtained from human
embryos, and/or
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the description discloses that hES cells may be obtained from
human embryos.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Invention Involving Human
Embryonic Stem (hES) cells
Provisions:
 Article 5.1 of the Patent Law: No patent right shall be granted for
any invention that is contrary to social morality.
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Guidelines: the following is contrary to social morality:
 Use of human embryos for industrial or commercial purposes;
 hES cells and a preparation method thereof;
 Human body, including a germ cell (ovum and sperm),
oosperm, and embryo
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Patenting of Invention Involving Human
Embryonic Stem (hES) cells
Patent Re-examination Decisions:
 Inventions using commercially available hES cell lines and
without using human embryos do not belong to use of human
embryos for industrial or commercial purposes;
 A part of an application contains certain content that is contrary
to social morality and the rest part of the application is not, the
part contrary to social morality shall be deleted from both the
claims and description in order to comply with Article 5.1.
Suggestions:
 Limit claims to commercially available hES cell lines;
 Add claims which do not involve hES cells, such as cultural
medium or composition useful for differentiating hES cells;
 Delete use of human embryos for industrial or commercial
purposes from the description.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
General suggestions on patent prosecution
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Drafting new application: considering Chinese practice
 Patentable subject matters: allowable claims
 Different types of claims: obtain broad protection
 More examples: cover the whole scope of the claims
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Voluntary amendments
 Do not miss the opportunities:
- when entering into Chinese national phase
- When requesting substantive examination
- within three months upon receipt of notification of entering
into substantive examination procedure
 Add new claims: independent and dependent claims
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Genetic Resources (GR)-Related Requirements
under the New Chinese Patent Law
I. The acquisition and use of GR shall not violate
PRC laws or administrative regulations
Article 5.2: no patent right shall be granted for an inventioncreation where acquisition or use of the genetic resources, on
which the development of the invention-creation relies, is not
consistent with the provisions of the laws or administrative
regulations.
Interpretation: Acquisition/use of GR must be beforehand approved by
relevant administrative departments and licensed by relevant right
holder in accordance with the laws and administrative regulations of
China.
Fail to meet the requirement: Ground for rejection and Ground for
invalidation
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Genetic Resources (GR)-Related Requirements
under the New Chinese Patent Law
II. Disclosure of the Source of GR:
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Article 26.5: where an invention-creation is developed relying on
genetic resources, the applicant shall indicate, in the application
documents, the direct and original source of such genetic
resources; where the applicant fails to indicate the original
source, he or it shall state the reasons thereof.
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Fail to meet the requirements
 A ground for rejecting an application.
 Not ground for invalidating a patent.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Genetic Resources (GR)-Related Requirements
under the New Chinese Patent Law
II. Disclosure of the Source of GR:
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Time of disclosure of the information
 Not recommend to disclose at the time of filing new application, may
wait upon request of examiner
 Upon request of the examiner: Registration Form for disclosing
Source of Genetic Resources: Fill the specific information of the
direct and original source of GR.
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CCPIT PATENT AND TRADEMARK LAW OFFICE
Thank You
Contact us:
CCPIT Patent and Trademark Law Office
10/F, Ocean Plaza
158 Fuxingmennei Street
Beijing 100031 China
Tel: +86-10-66412345
Fax:+86-10-66415678
Email: [email protected]
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