Doc Code: PET.IMMUNO Document Description: Petition for Cancer Immunotherapy Pilot PTO/SB/443 (06-16) CERTIFICATION AND PETITION TO MAKE SPECIAL UNDER THE CANCER IMMUNOTHERAPY PILOT PROGRAM Application Number (if known): First Named Inventor: Title: Filing Date: Practitioner Docket Number: PATENT APPLICANT HEREBY CERTIFIES THE FOLLOWING AND PETITIONS TO PARTICIPATE IN THE CANCER IMMUNOTHERAPY PILOT PROGRAM ("PILOT PROGRAM") FOR THE ABOVE-IDENTIFIED PATENT APPLICATION. See Instructions starting on page 3. 1. This certification and petition is being electronically filed using the USPTO electronic filing system (EFS-Web). 2. This patent application is a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371. 3. Special status under this Pilot Program is sought because this patent application contains a claim to a method of treating a cancer using immunotherapy that meets the eligibility requirements for the Pilot Program that were set forth in the Federal Register notice entitled "Cancer Immunotherapy Pilot Program." 4. Certification that patent applicant or patent applicant's agent has an active Investigational New Drug (IND) application at the U.S. Food and Drug Administration (FDA), currently in Phase II or Phase III of development (Note: this certification is only required if this patent application has received a first Office action or the request for continued examination (RCE) was not filed with this petition): By checking this box, patent applicant hereby certifies that the claimed method of treating a cancer using immunotherapy (i) meets the eligibility requirements for this Pilot Program, and (ii) is the subject of an active IND application at the FDA filed by patent applicant or their agent (e.g., patent applicant's assignee or licensee) that has entered phase II or phase III clinical trials. 5. Claim Limit and No Multiple Dependent Claims: a. This patent application contains, or is amended to contain, at least one claim but no more than three (3) independent claims and twenty (20) total claims. b. This patent application does not contain any multiple dependent claims. [Page 1 of 4] American LegalNet, Inc. www.FormsWorkFlow.com PTO/SB/443 (06-16) CERTIFICATION AND PETITION TO MAKE SPECIAL UNDER THE CANCER IMMUNOTHERAPY PILOT PROGRAM (continued) Application Number (if known): Filing Date: 6. Special status under any program has not been previously granted in this patent application. 7. Any previous nonpublication request for this patent application has been rescinded on or before the filing date of this form. 8. Publication status (check either box a or b below, but not both): a. This patent application is published. b. This patent application is unpublished. By checking this box, patent applicant hereby requests early publication under 37 CFR 1.219. 9. By filing this form, patent applicant agrees to make an election without traverse in a telephonic interview and elect an invention that is directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements for this Pilot Program if the Office determines that the claims are directed to multiple inventions. 10. By filing this form, patent applicant agrees to comply with the following requirements while this patent application is in special status under this Pilot Program: (a) the patent application will not contain more than three (3) independent claims, more than twenty (20) total claims, or any multiple dependent claims; and (b) the patent application will contain at least one claim to a method of treating a cancer using immunotherapy that meets the eligibility requirements for this Pilot Program. NOTE: This form must be signed in accordance with 37 CFR 1.33. Please see 37 CFR 1.4(d) for the signature requirements. Submit multiple forms if for more than one signature is required - see below.* Signature Name (Print/Typed) Date Registration Number *Total of ___ forms are submitted. [Page 2 of 4] American LegalNet, Inc. www.FormsWorkFlow.com Instructions for Certification and Petition to Make Special Under the Cancer Immunotherapy Pilot Program (Not to be Submitted to the USPTO) The following is a summary of the petition requirements for the Cancer Immunotherapy Pilot Program (for more information regarding these requirements and the Pilot Program guidelines, see the Federal Register Notice entitled "Cancer Immunotherapy Pilot Program" available on the USPTO web site at http://www.uspto.gov/patent/laws-and-regulations/patent-related-notices/patent-relatednotices-2016 ): 1. The petition to make special must be filed electronically using the USPTO electronic filing system, EFS-Web, and selecting the document description of "Petition for Cancer Immunotherapy Pilot" on the EFS-Web screen. Patent applicant should use form PTO/SB/443, which will be available as a Portable Document Format (PDF) fillable form in EFS-Web and on the USPTO Web site. 2. The patent application must be a non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371. 3. The petition to make special must include a statement that special status under the Pilot Program is sought because the patent application contains a claim to a method of treating a cancer using immunotherapy that meets the eligibility requirements for this Pilot Program that were set forth in the Federal Register notice entitled "Cancer Immunotherapy Pilot Program." 4. In general, the petition to make special must be filed (i) at least one day prior to the date that notice of a first Office action (which may be an Office action containing only a restriction requirement) appears in the Patent Application Information Retrieval (PAIR) system (patent applicant may check the status of the application using PAIR), or (ii) with a proper request for continued examination (RCE) in compliance with 37 CFR 1.114. For patent applicants whose claimed cancer immunotherapy both (i) meets the eligibility requirements for this Pilot Program, and (ii) is the subject of an active Investigational New Drug (IND) application at the U.S. Food and Drug Administration (FDA) that has entered phase II or phrase III clinical trials, the petition may be filed any time prior to an appeal or a final rejection if patent applicant certifies both (i) and (ii) in the petition