1. BRIEFING YOUR APPEAL OF AN EXAMINER’S DECISION IN AN INTER PARTES REEXAMINATION Romulo H. Delmendo Administrative Patent Judge Board of Patent Appeals & Interferences United States Patent & Trademark Office

2. 8/17/20152 Outline of Discussion Today, we will discuss: –What should a brief do (from the Board’s perspective)? –How should a party prepare some of the important parts of the opening brief? –Some “do’s and don’ts” (from the Board’s perspective).

3. What should be the purpose of a brief? Provide an easy roadmap for us to follow, providing key landmarks (facts), that lead to your advocated position –Simplify, if complex; appeals in inter partes reexaminations are generally complex (appeal records often comprise 1000’s of pages of documents) –Will help the Board decide cases in a timely fashion 8/17/20153

4. A brief should: Demonstrate reversible error (or lack thereof) on the part of the examiner with –Accuracy (law and facts) –Conciseness –Completeness 8/17/20154

5. Issues Minimum - identify claims and rejections/decision favorable to patentability being appealed Address all rejections or decisions favorable to patentability (if a rejection or decision is not being contested or if rejections or decisions are argued together, say so) DO NOT include matters outside the Board’s jurisdiction in an inter partes reexamination appeal (SNQ in IP context, entry of amendments and/or evidence, inequitable conduct [Rules 906(c) & 933], etc.) 8/17/20155

6. Hypothetical Hypo Facts: – Claim 1. A bag for collection or storage of blood comprising polyvinyl chloride (PVC) plasticized with dioctyl phthalate (DOP). – Ref. A discloses a storage bag for blood comprising various polymers, one of which is PVC, and a plasticizer. – Ref. B discloses that DOP is a plasticizer for vinyl polymers. – The Examiner rejected claim 1 as obvious over the combined teachings of A and B, explaining that one of skill would have been led to use DOP, a known plasticizer for vinyl polymers, to make the plasticized bag of Ref. A. 8/17/20156

7. Additional Facts – Dr. Robertson, expert witness for the Patent Owner, states in his Rule 132 Declaration that a person of ordinary skill in the art would have expected that DOP is extractable from vinyl polymers, as evidenced by Ref. C, and would not have used it for blood applications. – As a result, Dr. Robertson testifies that a person of ordinary skill in the art would not have combined References A and B. – Dr. Robertson states that he tested the claimed bag, and, unexpectedly, DOP did not extract from the PVC. – Dr. Lebovitz, Vice President of Sales & Marketing for Patent Owner, testified that the sales of PVC bags with DOP generated $2 billion since its introduction, as compared to only $1 billion for previous PVC bags with a different plasticizer for an equivalent time period. 8/17/20157

8. Issue Statement Ex. 1 (Minimum) Whether the Examiner erred in rejecting claim 1 under Section 103 as obvious over References A & B? 8/17/20158

9. Issue Statement Ex. 2 (Better) Whether the Examiner, in rejecting claim 1 under Section 103 as obvious over References A & B, erred in failing to consider evidence that would have taught away from using DOP? Whether the Examiner, in rejecting claim 1 under obviousness, erred by failing to consider evidence of unexpected results and commercial success? 8/17/20159

10. Arguments – Ex. 1 (Probably Not Persuasive) Patent Owner submits that the Examiner failed to establish a prima facie case of obviousness because Refs. A & B do not teach or suggest the desirability of using DOP as a plasticizer in a blood bag. Therefore, the Board should confirm claim 1 as patentable. 8/17/201510

11. Arguments – Ex. 2 (More Persuasive) The Examiner made two errors. First, the Examiner overlooked evidence showing that a person of ordinary skill in the art would have been taught away from using DOP as a plasticizer in a blood bag. Dr. Robertson testified that one of skill reading Ref. C would have expected that DOP would have been unsuitable for use in a blood bag because it was known to be extractable (Robertson Decl., ¶¶ 1-5; Ref. C, col. 3, ll. 5-20). Second, the Examiner also erred in failing to consider and give proper weight to: (1) evidence of unexpected results (i.e., that DOP did not leach from PVC; Robertson Decl., ¶¶10- 12); and (2) evidence of commercial success that establishes a nexus between DOP and the increased sales (Lebovitz Decl., ¶¶1-10). These errors require reversal of the rejection. 8/17/201511

12. Evidence Relied Upon Should be gathered and submitted early in the prosecution Does it support the argument made? (If not, discuss with the client and supplement ASAP.) Identify when submitted and considered (hunting for documents in a voluminous record can be very frustrating and the Board will not normally do it) Unentered evidence will not be considered Trial documents are NOT automatically part of the reexamination record. Evidence appendix – comply with 37 C.F.R. § 41.67(a)(1)(ix). Use specific citations to the record (specific document and page, line numbers). 8/17/201512

13. Declaration Evidence – Unexpected Results – Over the closest prior art? – Reasonably commensurate in scope with claims? – Is there evidence in the record establishing that the results would not have been expected by one of ordinary skill in the art? 8/17/201513

14. Declaration Evidence – Commercial Success –Nexus between the asserted difference and the commercial success (mere sales figures may not be enough)? –Comparative sales figures of devices with and without claimed feature would be especially helpful, all other factors held relatively constant. 8/17/201514

15. Do’s Be courteous to the Examiner, opposing party, and Board personnel Consult and study the statutes and rules – e.g., appealable versus petitionable (e.g., entry of amendments/evidence, SNQ) Continually update copending civil litigation, including any (in)validity or unenforceability rulings Claim Construction – Specification and drawings have primacy over other sources (so discuss by reference to specification and drawings) MPF limitations – (1) define function; and (2) identify corresponding structures by specific reference to the patent (figures, column and line numbers). See In re Aoyama, ___ F.3d ___ (Fed. Cir. 2011). Support the arguments with facts in the record (specific citations required) Include only the best arguments (weak arguments dilute the strength of the best arguments) Address/explain potential weaknesses in your case 8/17/201515

16. Don’ts Don’t disperse arguments relating to the same or similar issue throughout the brief Don’t be longwinded or repetitive (goal is to make it easy for the judges to rule in your favor, not more difficult) Don’t incorporate by reference arguments made in other papers Delete mere attorney arguments (not supported by specific citations to facts and evidence timely presented/considered below) 8/17/201516

17. Recommended Reading Jerry D. Voight, “Arguing Before the Board of Patent Appeals and Interferences: Strategies for Success,” IP LITIGATOR (Sept./Oct. 2003). Hons. Michael Fleming, Sally Lane, Linda Horner, & John Jeffery, “Effective Appellate Advocacy in Ex Parte Appeals Before the Board of Patent Appeals and Interferences,” First Annual BPAI Conference (April 2010). 8/17/201517

18. Thank you. 8/17/201518