RESTRICTION PRACTICE

1. RESTRICTION PRACTICE POLYNUCLEOTIDES POLYPEPTIDES AND FRAGMENTS Christopher Low TC1600 /AU 1653 (703) 308-2923 christopher.low@uspto.gov

2. 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, "[i]f 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”.

3. 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

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

5. GOAL • Consistent examination • Consistent treatment of claims • Consistent restriction practice

6. 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

7. 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

8. Sample Claims - nucleotides • An isolated polynucleotide encoding protein with amino acid sequence of SEQ ID NO:2. • The isolated polynucleotide of claim 1 wherein the sequence of bases is selected from the group consisting of SEQ ID NO:1, 3, 5, 7, 8, 9 and 11.

9. Sample Claims - polypeptides • An isolated protein with amino acid sequence of SEQ ID NO:2. • 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 NO:2.

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

11. Intentionally Blank