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  If deemed allowable, restriction must be withdrawn.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 1. A pharmaceutical composition comprising an inorganic or an organic compound. 2. The pharmaceutical composition of claim 1 wherein the organic compound is an estrogen. 3. The pharmaceutical composition of claim 1 wherein the inorganic compound is water. 4. 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