In a Patent Alert email distributed to stakeholders last month, the U.S. Patent and Trademark Office announced the replacement of four legacy search tools -- the Public-Examiner's Automated Search Tool (PubEAST), Public-Web-based Examiner's Search Tool (PubWEST), Patent Full-Text and Image Database (PatFT), and Patent Application Full-Text and Image Database (AppFT) -- with the Office's new Patent Public Search (PPUBS) tool.  That replacement took effect on September 30.

The Office noted that PPUBS provides for more convenient, remote, and robust full-text searching of all U.S. patents and U.S. patent application publications.  Additional information about PPUBS, including FAQs, training resources, and other information to assist stakeholders in transitioning to the new tool, can be found on the Patent Public Search webpage.

The Office also noted that existing links to U.S. patents and U.S. patent application publications in PatFT and AppFT have been terminated following the retirement of those services (which unfortunately has broken a lot of links on Patent Docs).  The Office also noted that stakeholders using PPUBS can directly access U.S. patents and U.S. patent application publications and can set up links for direct document access to such patents and published applications on a webpage or document (a step-by-step guide to performing these functions can be found here:  Patent Public Search-Setting up external searches PDF).

USPTO Extends After Final Consideration Pilot 2.0

In a Patent Alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced that the After Final Consideration Pilot (AFCP) 2.0 has been extended to September 30, 2023.  The Office indicated that the AFCP 2.0 is part of the USPTO's ongoing effort towards compact prosecution and increased collaboration between examiners and stakeholders.

The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program"), modified in May 2013 (see "USPTO News Briefs"), and extended several times since then, provides examiners with a limited amount of non-production time -- three hours for utility and reissue applications -- to consider responses filed following a final rejection.  The requirements for participating in the AFCP 2.0 are as follows:

(1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434);

(2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect;

(3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the Office, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant);

(4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and

(5) the required papers must be filed via the EFS-Web.

Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.

USPTO Extends Cancer Immunotherapy Pilot Program

In a notice published in the Federal Register (87 Fed. Reg. 58772) last week, the U.S. Patent and Trademark Office announced that it has extended the Cancer Immunotherapy Pilot Program, which allows patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination.  The pilot program, which was implemented in June of 2016 and has been extended four times previously, is being extended to January 31, 2023 (see "USPTO Implements Pilot Program to Support President's National Cancer Moonshot").

The notice indicates that the requirements of the pilot program have not been modified.  Under the pilot program, applications containing at least one claim reciting a method of treating a cancer using immunotherapy will be advanced out of turn for examination if the applicant files a grantable petition to make special, with the goal of completing examination of the application within twelve months of special status being granted.

In order to participate in the pilot program, an applicant must satisfy the following requirements:

(1) File a petition to make special under 37 C.F.R. § 1.102(d) in a non-reissue, nonprovisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered national stage under 35 U.S.C. § 371.  The petition must be filed 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 on PAIR, or with a Request for Continued Examination (RCE).  For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a petition to make special may be accepted any time prior to appeal or final rejection.  The Office recommends that applicants use form PTO/SB/443 for filing the petition, as the form contains check boxes that will allow the applicant to comply with several certification requirements under the new pilot program.

(2) The application cannot contain more than three independent claims, more than twenty total claims, or any multiple dependent claims.  For applications not meeting this requirement, an applicant must file a preliminary amendment to cancel the excess claims or multiple dependent claims at the time the petition to make special is filed.

(3) The application must include at least one claim to a method of treating a cancer using immunotherapy.  The notice explains that such claim must "encompass[] a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells."

(4) If restriction is required, the applicant must agree to make an election without traverse in a telephonic interview, and elect an invention directed to a method of treating a cancer using immunotherapy.  The applicant will be given two working days to respond to an examiner's request for an election, and in the event that the applicant fails to respond within that period, the examiner will treat the first group of claims directed to a method of treating a cancer using immunotherapy as being constructively elected without traverse.

(5) The application cannot have been previously granted special status.

(6) The petition to make special must be filed electronically via the EFS-Web (and the document description "Petition for Cancer Immunotherapy Pilot" must be selected for the petition).

(7) If the application has not been published, the applicant must file a request for early publication in compliance with 37 C.F.R § 1.219 with the petition to make special (or a rescission of a nonpublication request if one was filed).

For the purposes of the pilot program, the Office has waived the fee for a petition to make special under 37 C.F.R. § 1.102(d).

USPTO Unveils USPTO-FDA Collaboration Initiatives Webpage

In a Patent Alert email distributed to stakeholders last week, the U.S. Patent and Trademark Office announced the unveiling of a new webpage for collaboration efforts between the USPTO and the U.S. Food and Drug Administration (FDA).  The Office noted that the USPTO-FDA Collaboration Initiatives webpage contains the latest USPTO news, blog articles, reports, and USPTO engagements with the FDA and the public.  On the new webpage, the Office states that:

The USPTO is focused on ensuring our patent system incentivizes and protects the investments essential for bringing life-saving and life-altering drugs and biologics to market.  At the same time, the USPTO is focused on ensuring our system, as a whole, is not used to improperly delay getting more affordable generic drugs and biosimilars into the hands of Americans who need them.