1. Restriction & Double Patenting Mojdeh Bahar, J.D., M.A., CLP Chief, Cancer Branch Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services

2. Road Map • Restriction • Definition • Types • Linking Claim • Rejoinder • Restriction vs. Unity of Invention • Double Patenting • Statutory • Non-Statutory • Questions

3. Restriction: Definition & Characteristics • A tool used by the USPTO to limit the substantive examination of a patent application to a single invention • Set forth in 35 USC 121 • It is discretionary • It can be set forth any time during prosecution • A proper restriction requirement establishes: • The existence of two or more independent or distinct inventions (See MPEP §802; §806), and a • serious burden on the examiner (See MPEP §803.02; §806.04; §808.01-02), e.g., separate status in the art; separate classification; divergent field of search

4. Example of Distinct Inventions The application contains claims to different inventions: • polypeptides • polynucleotides • antibodies • diagnostic kit • Applicant must elect an invention for examination • Election may be done with or without traverse. If the restriction is traversed, applicant can petition to Group Director. • Divisional Application may be filed covering non-elected invention

5. Categories of Related Inventions • Product and process of use; MPEP§806.05 (h) • Product and Process of making; MPEP§806.05 (f) • Process and apparatus for its practice; MPEP§806.05 (e) • Apparatus and product; MPEP§806.05 (g) • Combination and subcombination ; MPEP§806.05 (a-c) • Subcombinations useable together; MPEP§806.05 (d) • Intermediate and final product MPEP§806.04(b) • Product, process of making, process of using MPEP§806.05 (i)

6. Linking Claims: Definition and Characteristics • One or more claims inseparable from claims to two or more otherwise properly divisible invention; MPEP §809. • If deemed allowable, restriction must be withdrawn. • Upon withdrawal of the restriction, double patenting rejections may come in to play; protection of 35 USC 121 is no longer afforded

7. Example of a Linking Claim • A pharmaceutical composition comprising an inorganic or an organic compound. • The pharmaceutical composition of claim 1 wherein the organic compound is an estrogen. • The pharmaceutical composition of claim 1 wherein the inorganic compound is water. • A method of treating infertility using the pharmaceutical composition of claim 1.

8. Rejoinder • If the invention under examination is a product, once the product has been deemed allowable, the process of making and using the same must be allowed as well. • In re Ochiai; MPEP 821.04 • Sua sponte rejoinder by the USPTO • Process of making and using claims must be of the same scope as the product claims

9. Restriction vs. Unity of Invention • For 111 applications (applications filed under 35 USC 111) the standard is set forth in 35 USC 121; the standard is expressed as “independent”, “distinct”, “related” inventions • For 371 applications (applications filed under 35 USC 371), the standard is 35 USC 372 and 35 USC 121; the standard is expressed as “unity of invention”, “common technical feature”

10. Divisional Application and Non-Elected Subject matter • Independent or distinct invention carved out of a pending application claiming only subject matter disclosed in the earlier application, i.e., non-elected invention • Diagnostic kit • Antibodies • polynucleotides • Filed in response to a restriction requirement • The priority date is the original application’s priority date • A divisional application cannot be subject to a DP rejection over its parent application/patent.

11. Double Patenting: Purpose & Types • The purpose of DP rejections is to prevent unjustified extension of patent term • DP rejections are based on an issued patent or pending patent application with the same assignee • There are two types of Double patenting rejections: • Statutory Double Patenting under 35 USC §101 • Non-Statutory Double Patenting which is based on anticipation or obviousness analyses

12. Statutory Double Patenting : Characteristics and Cure • Identical subject matter is being claimed in the claims under examination and those of a commonly owned patent or patent application • The claims under examination and those in a commonly owned patent or patent application encompass the same embodiments • Claims subject to the DP rejection must be cancelled or amended • A terminal disclaimer does not overcome a DP rejection under 35 USC 101

13. Non-Statutory Double Patenting • It can be based on a anticipation or obviousness type analyses • It can be overcome by cancelling or amending the claim • It can also be overcome by a terminal disclaimer

14. Questions Thank you for your kind attention