October 2016
CIPA Journal
By Rachael P. Dippold, Ph.D.; Erin M. Sommers, Ph.D.; Anthony C. Tridico, Ph.D.
The United States Patent and Trademark Office (USPTO) has recently introduced two new initiatives aimed toward expediting prosecution of certain cancer therapies and increasing the value of after final practice. This article provides details about these new programs aimed at streamlining patent prosecution.
In his final State of the Union Address earlier this year, President Obama announced the National Cancer Moonshot, a one billion dollar initiative with the goal of making ten years’ worth of advances in cancer research and treatment in the next five years.1In support of the National Cancer Moonshot, the USPTO recently initiated "Patents 4 Patients," also known as the Cancer Immunotherapy Pilot Program.2Under this pilot program, cancer immunotherapy applications are eligible for special status and examination out of turn with the goal of completing prosecution within 12 months of the grant of special status.3
According to the USPTO, it receives approximately 900 cancer immunotherapy-related applications annually.4The Cancer Immunotherapy Pilot Program is open to any applicant, including universities, early stage biotech companies, and large pharmaceutical companies.5There are also no eligibility restrictions based on where the technology was developed or the underlying research was performed or where the therapy may be manufactured.6
To qualify for the Cancer Immunotherapy Pilot Program, an application must contain at least one claim encompassing "a method of ameliorating, treating, or preventing a malignancy…" such that “the steps of the method assist or boost the immune system in eradicating cancerous cells."7Examples of qualifying immunotherapy technology provided by the USPTO include:
In most cases, in order to qualify for this program the application must either (i) not yet have been acted on (i.e., at least one day prior to an office action, including a restriction requirement) or (ii) have a proper request for continued examination. However, a petition for special status in this program may be filed at any time before a final office action or an appeal if the claimed cancer immunotherapy is the subject of an Investigational New Drug (IND) application fi led by the applicant or their agent (e.g., a licensee or assignee) at the U.S. Food and Drug Administration (FDA) that has entered phase II or phase III clinical trials.9If, in this latter scenario, there is an outstanding office action, the petition to make special must be accompanied by a response to the office action.10
The application must be a non-reissue utility application that has not already been granted special status in any other program (e.g., Patent Prosecution Highway, Track One, or Accelerated Examination).11The petition12to make special under this program must be electronically filed with the USPTO using EFS-Web by selecting the document description "Petition for Cancer Immunotherapy Pilot."13There is no fee to petition to make special under this program.14
If the application is not yet published, the petition must be accompanied by a request for early publication.15If a non-publication request was previously filed in the application, a rescission of the request must be filed no later than the petition to make special is filed.16
Participation in the pilot program requires the applicant, in the event of a restriction requirement, to make a telephonic election without traverse.17If the applicant does not make an election within two business days, the examiner will treat the first group of claims that meet the eligibility requirements (i.e., methods of treating cancer using an immunotherapy) as elected without traverse for examination.18
Applications that are accepted into the pilot program are not eligible to participate in the First Action Interview Pilot Program, but standard interview practice is available.
As with other special status programs, there are limits to the number of claims that the application may have. Specifically, for this pilot program the application may at no time have more than three independent claims and 20 claims in total.19Additionally, the application cannot contain any multiple dependent claims.20An amendment may be filed at the time of petition in order to make the application compliant with the claim requirements.21
The provisions for maintaining special status in the Cancer Immunotherapy Pilot Program are similar to those for Track One applications.22Like with the Track One procedures, taking of an extension of time by the applicant will terminate special status of the application.23Special status is also terminated when a final office action is issued or a notice of appeal or request for continued examination is filed.24
If the application does not meet all of the formal requirements for the pilot program, or if the application does not comply with the sequence listing requirements, the applicant will be given a one-time chance to correct the deficiencies.25If the deficiencies are not corrected within the shortened statutory one-month limit, the application will be examined under standard procedures rather than under special status.26One deficiency that cannot be remedied is the lack of at least one claim directed to treating a cancer using an immunotherapy. If the application does not contain at least one such claim at the time of fi ling the petition, the applicant will not be given an opportunity to correct the deficiency.27
In this program, special status extends after a notice of allowance is received in the application. However, failure to pay the issue fee within one month of receiving an allowance will terminate special status, as will the submission of a non-USPTO-required after-allowance amendment under 37 C.F.R. §1.312.28
Special status will not carry over to a new application. That is, if a continuation application is filed, a new petition must be filed in order to make the continuing application special.29
The USPTO began accepting petitions to make special under the Cancer Immunotherapy Pilot Program on 29 June 2016, and will continue to accept petitions until 29 June 2017. The USPTO may extend the pilot program in its current or a modified form.30
The USPTO recently announced the Post-Prosecution Pilot (P3) Program as an avenue to enhance post-final rejection patent practice. This program combines aspects of the existing After Final Consideration Pilot (AFCP) 2.0 program31and the Pre-Appeal Brief Conference Pilot Program32, and also incorporates new, requested features.33This program was developed in response to feedback gathered at public forums with the goal of reducing the number of appeals and requests for continued examination.34
Like the AFCP 2.0 program, P3 provides an opportunity for consideration of arguments and proposed amendments made in response to a final office action. And like the Pre-Appeal program, P3 provides a panel evaluation of applicant’s arguments prior to an appeal. As a new feature, P3 provides the applicant with the opportunity to provide oral arguments in front of a panel of examiners in support of arguments submitted in response to the final office action. Additionally, as another attractive new feature, the panel’s decision will be provided as a brief written summary.
P3 is available for original utility applications that have received a final rejection, as long as the request for participation is filed within two months from the mailing of the final rejection and prior to a notice of appeal.35However, a request to participate in P3 will not be granted if a proper request to participate in either the AFCP or Pre-Appeal program was previously filed in response to the same final rejection.36
Participation in P3 is free of charge. A request to participate in P3 must include a transmittal form, preferably the USPTO form specific to this program.37Like with the AFCP 2.0 program, P3 request must be accompanied by a response to the final office action under 37 C.F.R. §1.116.38However, unlike the AFCP 2.0 program, under the P3, the arguments in the response must be limited to no more than five pages.39Affidavits, or other evidence, filed with the response will count toward the five-page limit.40Additionally, arguments filed in multiple documents will be counted cumulatively toward the five-page limit.41However, the response may be formatted as single spaced, giving the applicant additional space with which to work.42
Also unlike the AFCP 2.0 program, a proposed non-broadening amendment to one or more claims is optional in P3.43Proposed amendments do not count toward the five-page argument limit.44
The request for P3 must also include a statement that the applicant is willing and available to participate in a conference with a panel of examiners.45The panel of examiners may include the examiner of record for the application, a supervisory patent examiner (SPE), and a primary examiner.46The SPE and primary examiner will preferably be the SPE of the examiner of record and signing primary examiner for the examiner of record.47If the examiner of record is unable to participate at the scheduled time, the conference will proceed without the examiner.48Another examiner may replace the examiner of record on the panel.49
If the request is found to be compliant, the USPTO will contact the applicant to schedule the conference.50If a date and time to hold the conference cannot be agreed upon within ten calendar days of the initial contact, or if the applicant declines to participate in the conference, the P3 request will be considered improper.51The applicant has the option of joining the conference in person, by telephone, or by a video conferencing tool set up by the USPTO (e.g., WebEx®).52
In the initial part of the conference, the applicant will have 20 minutes in which to present arguments.53The applicant may address appealable, not petitionable matters, and present arguments directed to the outstanding record or to the patentability of the proposed amendment, if one was included in the P3 request.54Notably, any presentation material used in the conference (e.g., PowerPoint®slides) will be placed in the file.55Entry of an affidavit, or other evidence used in the presentation, into the fi le is governed by the rules for after final amendments under 37 C.F.R. §1.116.56After the applicant’s presentation, he or she will be excused from the conference.57
Following the conference, the panel will provide their decision to the applicant in writing and will indicate one of the following: (a) the final rejection is upheld; (b) the application is allowable; or (c) prosecution is reopened.58If the final rejection is upheld, the notice of decision will summarize the reasons for maintaining any rejection.59The notice will also indicate whether any proposed amendment was entered or not entered, and if entered, which rejection(s) would be used to reject the amended claims.60A decision upholding the final rejection is not petitionable.61
The deadline for taking further action in the response to the final rejection expires on the later of (i) the mailing date of the notice of decision, or (ii) the date set forth in the final rejection.62However, the period for response set forth in the final office action cannot be extended past the six-month statutory period.63As such, in order to avoid abandonment, an RCE or notice of appeal should be filed within the statutory period set forth in the final office action.
If the panel decides the application is allowable, the notice of decision will be accompanied by a notice of allowance.64In the event that the rejections are withdrawn and prosecution is reopened, the notice of decision will be mailed with a new office action.65
After the P3 request is accepted, but before the mailing of the decision of the panel, certain applicant actions can terminate the P3 process: filing a notice of appeal; filing an RCE; filing an express abandonment under 37 C.F.R. §1.138; requesting the declaration of interference; or filing a petition requesting the institution of a derivation proceeding.66Additionally, the filing of a supplemental response to the final office action or further proposed amendments under 37 C.F.R. §1.116 after the initial response will terminate the P3 process.67
The USPTO began accepting requests for P3 on 11 July 2016, and will continue to accept requests until 12 January 2017, or until the USPTO meets a predetermined quota of accepted requests, whichever comes first.68The USPTO will only accept a total of 1,600 requests across all technology areas, and each technology center will only accept 200 compliant requests.69As such, P3 may remain available in one technology center after it closes in another. The USPTO provides an updated "Counter by Technology Center" that keeps tabs on the number of accepted P3 requests.70According to the USPTO, 69 P3 requests were accepted in the first three weeks of the program.71This is a potentially powerful tool to push an application toward allowance, but act quickly as P3 requests are going fast.
1https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot
2www.uspto.gov/about-us/national-cancer-moonshot
3Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
4-5www.uspto.gov/about-us/national-cancer-moonshot
6-8Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
9www.uspto.gov/patent/initiatives/patent-application-initiatives/patents-4-patients
10-11Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
12Certification and Petition to Make Special under the Cancer Immunotherapy Pilot Program, USPTO form PTO/SB/443, available at www.uspto.gov/sites/default/files/documents/sb0443.pdf
13-14Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
15Certification and Petition to Make Special under the Cancer Immunotherapy Pilot Program, USPTO form PTO/SB/443, available at www.uspto.gov/sites/default/files/documents/sb0443.pdf
16-18Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
19-20www.uspto.gov/patent/initiatives/patent-application-initiatives/patents-4-patients
21Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
22Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016) and Changes to Implement the Prioritized Examination Track (Track I), 76 Fed. Reg. 59050 (September 23, 2011)
23-30Cancer Immunotherapy Pilot Program, 81 Fed. Reg. 42328 (29 June 2016)
31www.uspto.gov/patent/initiatives/after-final-consideration-pilot-20
32www.uspto.gov/web/offices/com/sol/og/2005/week28/patbref.htm
33www.uspto.gov/patent/initiatives/post-prosecution-pilot
34Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
35-36www.uspto.gov/patent/initiatives/post-prosecution-pilot
37Certification and Request for Consideration under the Post-Prosecution Pilot Program (P3), USPTO form PTO/SB/444, available at www.uspto.gov/sites/default/files/documents/sb0444.pdf
38-44Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
45www.uspto.gov/patent/initiatives/post-prosecution-pilot
46-52Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
53www.uspto.gov/patent/initiatives/post-prosecution-pilot
54-55Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
56Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016), and see M.P.E.P §714.12.
57-58www.uspto.gov/patent/initiatives/post-prosecution-pilot
59-62Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
63Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016), and see 37 C.F.R. §1.136
64-65Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
66www.uspto.gov/patent/initiatives/post-prosecution-pilot
67-68Post-Prosecution Pilot Program, 81 Fed. Reg. 44845 (11 July 2016)
69-70www.uspto.gov/patent/initiatives/post-prosecution-pilot
71www.uspto.gov/patent/initiatives/post-prosecution-pilot, "Counter by Technology Center," updated as of 29 July 2016
Originally printed in CIPA Journal in October 2016. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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