1. PATENT REFORM University of Rochester KATHRYN DOYLE, Ph.D., J.D. RIVERSIDE LAW, LLP

2. COMPONENTS AND DATES FOR IMPLEMENTATION First Inventor to File Novelty Non-obviousness Inventor Oath or Declaration Fees – 15% Surcharge Electronic Filing Incentive Fee Setting Authority Best Mode Derivation Proceedings Prior Use Defense Inter partes transition threshold March 16, 2013 (filed on/after) September 26, 2012 (filed before/on/after) September 26, 2011 (fees on/after) November 15, 2011 (filed on/after) As rulemaking is completed September 16, 2011 (proceedings on/after) March 16, 2013 (filed on/after) September 16, 2011 (issued on/after) September 16, 2011 (filed on/after)

3. COMPONENTS AND DATES FOR IMPLEMENTATION Post-Grant Review Inter partes Review Prioritized Examination Genetic Testing Report Human Organism Prohibition Third party art submission Supplemental Examination Virtual and False Marking Advice of Counsel Joinder of Parties September 16, 2012 (priority on/after) September 16, 2012 (issued before/on/after) September 26, 2011 (filed on/after) June 16, 2012 September 16, 2011 (filed before/on/after) September 16, 2012 (filed before/on/after) September 16, 2012 (issued before/on/after) September 16, 2011 (proceedings on/after) September 16, 2012 (proceedings on/after) September 16, 2011 (proceedings on/after)

4. FIRST INVENTOR TO FILE Filed on/after March 16, 2013 FIRST TO FILE WINS THE PRIZE NOT AS SIMPLE AS IT LOOKS

5. FIRST INVENTOR TO FILE Effective Filing Date is: Actual Filing Date Earliest Priority Date to which the application is entitled for each claim

6. Depends on the Effective Filing Date (EFD) of each individual pending CLAIM If the Effective Filing Date is BEFORE March 16, 2013, the Pre-AIA law applies If the Effective Filing Date is ON/AFTER March 16, 2013, the new AIA-law applies WHICH LAW APPLIES?

7. CONDITIONS FOR PATENTABILITY NOVELTY 35 U.S.C. § 102(a) Cannot get a patent if the invention was patented, described in a publication, in public use, on sale, or otherwise available to the public before the effective filing date -or- another inventor filed first

8. NOVELTY 35 U.S.C. § 102(a) Prior art is anything, anywhere that can be found with reasonable diligence that is available before the Effective Filing Date What does “otherwise available to the public” mean?

9. AVAILABLE TO THE PUBLIC “Whether an invention has been made available to the public is the same inquiry that is undertaken under existing law to determine whether a document has become publicly accessible… A document is publicly accessible if it has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.” 157 Cong. Rec. S1335, 1370 (daily ed. Mar. 8, 2011)(statement of Sen. Jon Kyl, quoting Cordis Corp. v. Boston Scientific Corp., 561 F.3 1319, 1333 (Fed Cir 2009)

10. NOVELTY - EXCEPTIONS A disclosure was made one year or less before the effective filing date, and -the disclosure was made by the inventor, joint inventor, or by someone who obtained the invention directly or indirectly from the inventor or joint inventor -or- -the subject matter was disclosed by the inventor or joint inventor or by someone who obtained the invention directly or indirectly from the inventor or joint inventor prior to the disclosure.

11. Patents and patent applications are not prior art if: The subject matter disclosed in them was obtained from the inventor, The inventor had disclosed the invention prior to the Effective Filing Date of the prior art patent or patent application, The two are commonly owned, or were under an obligation to be assigned to a common owner, not later than the effective filing date. NOVELTY - EXCEPTIONS

12. The public disclosure of an invention by the inventor essentially saves that inventor’s place in line for the subject matter disclosed, provided the inventor files his application within one year of the disclosure and provided he files what he disclosed. If he files more than what he disclosed, he may lose the grace period If another person files an application after the disclosure above, and the inventor of the disclosure files his application within one year, the inventor is given first to file status, but within the above limits. Put another way, prior publication by an inventor may, BUT ONLY UNDER LIMITED CIRCUMSTANCES, preserve for one year that inventor's priority for filing a patent application. NOVELTY - EXCEPTIONS

13. “(c) AGREEMENTS.—Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(C) if— “(1) the subject matter disclosed was developed and the claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention; “(2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and “(3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. NOVELTY - EXCEPTIONS

14. JOINT RESEARCH AGREEMENT 35 U.S.C. §100(h) The term ‘joint research agreement’ means a written contract, grant, or cooperative agreement entered into by 2 or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

15. NOVELTY Inventor publicly discloses March 15 2012 X Inventor files application March 15, 2013 claiming X Old Pre-AIA Law Applies

16. NOVELTY Inventor publicly discloses April 2012 X Inventor files application April 2013 claiming X, Y and XY Grace period only applies to X New AIA law applies to X, Y, and XY

17. NOVELTY Inventor A publicly discloses April 2013 X Inventor A files application April 2014 claiming X, Y and XY B will get Y, and will only get X’ if nonobvious over X Inventor B files application October 2014 claiming X’, Y Inventor B publicly discloses October 2013 X’, Y A will get X, and XY, but only if nonobvious over X’ and Y

18. DIFFERENT EFFECTIVE FILING DATES Provisional application filed April 2012 discloses X Non-provisional filed April 2013 discloses X, Y and XY Old pre-AIA law applies to X New AIA law applies to Y and XY

19. APPLICATION OF EFFECTIVE FILING DATE Whether an application is treated under the new AIA law (FITF) or the pre-AIA law (FTI) is based on the Effective Filing Date of the application But, The New AIA laws apply to any application that contains, or contained at any time, claims to an invention with an effective filing date after March 16, 2013 And, once you cross over into new AIA law status, you can never go back

20. CONDITIONS FOR PATENTABILITY OBVIOUSNESS The criteria for obviousness remain essentially the same except that the holding in KSR has been incorporated into the Statute.

21. NON-OBVIOUSNESS § 103. Conditions for patentability; non-obvious subject matter ‘‘A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.’’

22. HARSH REALITY If a prior publication only discloses some “portion” of the later filed invention, For example, mouse data are disclosed in a manuscript, but the claims in the eventually filed application are to human therapy, The Effective Filing Date for claims to human therapy will likely be the date of filing, the grace period will not apply as to the publication of the mouse data, and the invention to the human therapy may be held obvious over the mouse disclosure All provisional applications should now include a broader disclosure and claims so that the invention is more clearly defined

23. HARSH REALITY Best to NOT rely on the grace period After March 16, 2013, if you need to rely on the grace period, you may be required to file a declaration to establish that you are entitled to it. “Specifically, the inventor or joint inventor must establish the date and content of their earlier public disclosure. If the earlier disclosure was a printed publication, the affidavit or declaration must be accompanied by a copy of the printed publication.” “ If the earlier disclosure was not a printed publication, the affidavit or declaration must describe the earlier disclosure with sufficient detail and particularity to determine that the earlier disclosure is a public disclosure of the subject matter.”

24. RECOMMENDATIONS To maximize protection now Any provisionals filed ON/AFTER March 16, 2012, should try to convert BEFORE March 16, 2013 If any Inventor has published patentable subject matter between March 16, 2012 and now, should try to file a provisional covering the subject matter of the publication BEFORE March 16, 2013 If have invention disclosure now, file before March 16, 2013

25. RECOMENDATIONS Do not rely on grace period For transitional applications, keep a claim chart that tracks claims falling under old and new law File complete provisionals going forward to establish a solid Effective Filing Date for all of the claims All provisional applications should now include a broader disclosure and claims so that an Effective Filing Date for the claims is established as early as possible

26. INVENTOR OATH OR DECLARATION Filed before/on/after September 26, 2012 The normal oath or declaration is largely unchanged But, it is now easier to step into the shoes of the inventor, should the inventor be unable or unwilling to execute the oath Assignee can be a non-inventor applicant, provided the inventor was or is under an obligation to assign the invention

27. INVENTOR OATH OR DECLARATION Only one inventor needs to be named at the time of filing Need to name all in the oath or declaration that must be filed by the time the issue fee is paid But, if you do not name all inventors by the time the examiner is examining – run the risk of having art cited that may not apply, i.e., if the art is the inventor’s own work

28. BEST MODE Proceedings on/after September 16, 2012 The inventor must disclose the best mode at the time of filing the application. But, failure to disclose the best mode will no longer be grounds to invalidate the issued patent. So, it is a patentability issue, and not clear if any Examiner will ever be able to tell if the best mode was not satisfied. Can be challenged during post-grant review?

29. PRIORITIZED EXAMINATION Filed on/after September 16, 2011 Set up for technologies that are important to the national economy and national competitiveness. Applications filed with a Request for Prioritized Examination are targeted to reach final disposition within twelve months of filing. A Request for Prioritized Examination may be submitted with any original utility or plant application filed on or after September 26, 2011. The Request must be filed with the new application along with a Request fee of $4800 ($2400 for small entities, $1200 for micro entities).

30. PRIORITIZED EXAMINATION New applications and continuations and divisionals, continuations of PCT, and RCE’s qualify. Reissue and reexam and design applications are excluded. If regular application pending and no office action has issued, can convert to “prioritized examination status” Prioritized Examination no longer requires a pre-examination search and does not require an accelerated examination support document. The law limits the number of applications filed with a Request for Prioritized Examination to 10,000 applications during any fiscal year.

31. PRIORITIZED EXAMINATION Application must be filed with Executed Oath or Declaration Specification and formal drawings Electronic submission of sequence listing, large tables or computer listings Completed Application Data Sheet No more than 30 total claims and 4 independent claims No multiple dependent claims all applicable fees In your best interest to include the Information Disclosure Statement at the time of filing

32. PRIORITIZED EXAMINATION USPTO to reach final disposition within twelve months Notice of Allowance Final Office Action If Applicant requests an extension of time, or if files a non- compliant amendment, application will revert to regular status

33. PRIORITIZED EXAMINATION Why do this? Commercially viable compound – issued patent in US, use Prosecution Highway to get granted claims in foreign countries Allow you to establish patentability of subject matter for investment, partnering purposes Allow you to more quickly enforce claims against an infringer Get quick read on patentability – if not patentable, file petition for non-publication and maintain technology and trade secret

34. THIRD PARTY ART SUBMISSION Filed before/on/after September 16, 2012 Any third party may submit for consideration and inclusion in the record of a patent application, any patent, published patent application, or other printed publication of potential relevance to the examination of the application, if such submission is made in writing before the earlier of— (A)the date a notice of allowance; or (B)the later of— (i) 6 months after the date on which the application for patent is first published, or (ii) the date of the first rejection of any claim by the examiner. Effective Date: Any app filed before, on, or after 16 September 2012

35. THIRD PARTY ART SUBMISSION The submission must include: A statement that sets forth a concise description of the asserted relevance of each submitted document - can be a narrative description, or a claim chart a fee, a statement by the person making such submission affirming that the submission was made in compliance with this section.

36. THIRD PARTY ART SUBMISSION Concise Statement must include: A separate page for each document submitted Lay out the facts that explain how the document is potentially relevant to the examination A narrative or a claim chart format is acceptable – claim chart likely preferable Must be more than a simple statement that it is relevant Be specific as to page numbers, paragraphs, etc. Cannot propose rejections, leave out language like anticipation, obviousness, references to 35 U.S.C. sections

37. THIRD PARTY ART SUBMISSION If filed anonymously, must be filed by a registered attorney or agent Otherwise, must name the party making the filing No need to serve the Patent Owner

38. DERIVATION PROCEEDINGS Filed on/after March 16, 2013 An applicant for patent may petition to institute a derivation proceeding to determine whether an inventor named in an earlier filed application derived the claimed invention from an inventor of petitioner’s application, and, without authorization, the earlier application claiming the invention was filed. A petition to institute Derivation Proceedings may be filed within one year of the publication of a claim to an invention that is the same or substantially the same as the earlier applicant’s claim. The Director decides if the standard for instituting Derivation Proceedings has been met. The decision is not appealable.

39. SUPPLEMENTAL EXAMINATION Issued before/on/after September 16, 2012 A patent owner may request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent. If a substantial new question of patentability is found, the Director shall order reexamination of the patent. A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent, if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. If the Director becomes aware, during the course of a supplemental examination proceeding, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination, then in addition to any other actions the Director is authorized to take, including the cancellation of any claims found to be invalid, the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate.

40. SUPPLEMENTAL EXAMINATION Only available to the Patent Owner and all co-owners must participate Does not apply to exclusive licensee No limit to the number of requests that can be filed Patent Office to render decision within three months of filing if an ex parte reexamination will commence If Patent Office determines the submission raises a “substantial new question of patentability” an ex parte reexamination of the patent will commence Different from traditional ex parte reexamination Patent Owner cannot file a statement No amendments to claims until first office action Documents other than publications can be submitted, e.g., public use, sale

41. SUPPLEMENTAL EXAMINATION The Request Must: Establish ownership and therefore the right to file the Supplemental Examination Identify the patent and each claim for that is to be reviewed Provide a list of the information items (written Items but not limited to patents and publications); Provide a separate, detailed explanation of relevance and how to apply each item to each identified claim –a separate explanation of each item as applied to each claim limitation of each claim at issue –cite the relevant sections of the Item with reference to the relevant claim limitation Identify any other post-issuance proceedings

42. POST-GRANT REVIEW Priority on or after September 16, 2012 A third party to challenge the validity of a patent. Must be filed within nine months from the date the patent is granted. Third party must be named, cannot be anonymous. A petition is filed by the third party. The patent owner has an opportunity to respond. The petition is decided by the Director. The Director’s decision is not appealable. The threshold is that it is “more likely than not” that at least one of the challenged claims of the patent is unpatentable. Or, the petition may be granted if it raises a “novel or unsettled legal question that is important to other patents or patent applications.”

43. POST-GRANT REVIEW The final decision is appealable to the Federal Circuit. The proceedings will bar the petitioner from raising the same invalidity arguments in a subsequent civil action. Third parties are forced to choose between challenging validity in post-grant review proceedings or in court.

44. INTER PARTES REVIEW Issued before/on/after September 16, 2012 Third party challenge to the validity of a patent. Patent can only be challenged on prior art grounds using patents or printed publications. Cannot be filed until after nine months from the issuance of a patent -or- after a post-grant review is terminated, if one was instituted. Patent owner can file a preliminary response. “Reasonable likelihood that petitioner would prevail with respect to at least one claim.” Director decides. The decision is not appealable.

45. KATHRYN DOYLE, Ph.D., J.D. RIVERSIDE LAW 300 Four Falls Corporate Center, Suite 710 300 Conshohocken State Road West Conshohocken, PA 19428 215-268-3888 www.riversidelaw.com www.riversidelaw.com