Restriction: Definition & Characteristics A tool used by the USPTO to limit the substantive examination of a patent application to a single invention

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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 Road Map Restriction Definition Types Linking Claim Rejoinder Restriction vs. Unity of Invention Double Patenting Statutory Non-Statutory Questions 1

2 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 ; ; ), 02), e.g., separate status in the art; separate classification; divergent field of search 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 2

3 Categories of Related Inventions Product and process of use; MPEP (h) Product and Process of making; MPEP (f) Process and apparatus for its practice; MPEP (e) Apparatus and product; MPEP (g) Combination and subcombination ; MPEP (a-c) Subcombinations useable together; MPEP (d) Intermediate and final product MPEP (b) Product, process of making, process of using MPEP (i) Linking Claims: Definition and Characteristics One or more claims inseparable from claims to two or more otherwise properly divisible i ibl 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 If deemed allowable, restriction must be withdrawn.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 3

4 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 i compound di is water. 4. A method of treating infertility using the pharmaceutical composition of claim 1. 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 Sua sponte rejoinder by the USPTO Process of making and using claims must be of the same scope as the product claims 4

5 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 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 priority date A divisional application cannot be subject to a DP rejection over its parent application/patent. 5

6 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 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 dd A terminal disclaimer does not overcome a DP rejection under 35 USC 101 6

7 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 Questions Thank you for your kind attention 7

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