RESTRICTION PRACTICE

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RESTRICTION PRACTICE

• POLYNUCLEOTIDES
• POLYPEPTIDES
• AND FRAGMENTS
• Christopher Low
• TC1600 /AU 1653 [phone]
• christopher.low_at_uspto.gov

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Official Gazette, 1192 O.G. 68 (Nov 19, 1996)

• Nucleotide sequences encoding different proteins
  are structurally distinct chemical compounds and
  are unrelated to one another. These sequences
  are thus deemed to normally constitute
  independent and distinct inventions within the
  meaning of 35 U.S.C. 121.
• The PTO Will Permit Applicants to Claim Up to
  Ten Independent and Distinct Nucleotide Sequences
  In One National Application
• By statute, "if two or more independent and
  distinct inventions are claimed in one
  application, the Commissioner may require the
  application to be restricted to one of the
  inventions." 35 U.S.C. 121.
• Absent evidence to the contrary, each such
  nucleotide is presumed to represent an
  independent and distinct invention, subject to a
  restriction requirement pursuant to 35 U.S.C.
  121 and 37 CFR 1.141.
• In some exceptional cases, the complex nature of
  the claimed material may necessitate that the
  reasonable number of sequences to be selected be
  less than 10.
• In other cases, applicants may petition
  pursuant to 37 CFR 1.181 for examination of
  additional nucleotide sequences by providing
  evidence that the different nucleotide sequences
  do not cover independent and distinct inventions.

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Key Drivers For Change

• More CPU processing horsepower necessary
• Exponential growth in size of the databases
  e.g., GenBank - doubles in about 14 months
• 1996 2000
• No. Nucleotides 651,972,984 11,101,066,288
• No. Sequences 1,021,211
  10,106,023
• Increased complexity of the searches
• Increased number searches/sequences searched
• 1999 2001 (est)
• 7010/52797 9476/47122
• Time constraints only so many hours allotted to
  examination of one application

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Brief Background

• Practice is consistent
• Large number of claims sometimes presented in
  response to a restriction
• Multiple restrictions in one application

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GOAL

• Consistent examination
• Consistent treatment of claims
• Consistent restriction practice

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Factors To Consider

• Sequences patentably indistinct one from the
  other examined in a single application
• Claim(s) drawn generically to nucleotide
  sequences encoding a single protein generally
  considered to define a single invention

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Search

• SEQUENCE SEARCH
• Outline a search strategy to achieve more
  efficient sequence searches
• Search claimed/elected/selected sequence using
  full length and/or oligomer algorithms and where
  necessary, indistinct fragments
• TEXT SEARCH
• Pertinent patent and nonpatent literature using
  keywords and review as appropriate
• Utilize a multiple database searching strategy
  where and when possible

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Sample Claims - nucleotides

• An isolated polynucleotide encoding protein with
  amino acid sequence of SEQ ID NO2.
• The isolated polynucleotide of claim 1 wherein
  the sequence of bases is selected from the group
  consisting of SEQ ID NO1, 3, 5, 7, 8, 9 and 11.

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Sample Claims - polypeptides

• An isolated protein with amino acid sequence of
  SEQ ID NO2.
• The isolated polypeptide of claim 1 wherein one
  or more residues at positions selected from the
  group consisting of 11, 33, 59, 73, 81, 99 and
  1001 have been conservatively substituted with an
  amino acid not normally found at that position in
  SEQ ID NO2.

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Summary

• Our search will result in more consistent
  examination
• Both the search and treatment of the claims will
  result in more consistent restriction practice

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Intentionally Blank