United States: USPTO To Accelerate Examination Of Cancer-Related Immunotherapy Treatment Methods

Last Updated: July 1 2016
Article by Michael S. Montgomery

The United States Patent and Trademark Office has announced a program to accelerate examination of patent applications having at least one claim to a method of treating a cancer with immunotherapy.

The pilot program calls for granting "special status" to the application upon a petition by the Applicant that meets the criteria set forth in this alert.1 The objective of this program, announced on June 29, 2016, is to complete examination of such patent applications within 12 months of granting special status. No fee is required for such a petition.

Criteria for Granting Special Status

The USPTO may grant special status provided that the following requirements are met.

The application must:

  • be a non-reissue, non-provisional utility application.
  • not contain more than three total independent claims and no more than 20 total claims.
  • include at least one claim to a method of treating a cancer using immunotherapy.
  • (If the USPTO decides the claims are directed to multiple inventions, e.g. an immunoconjugate and a method of treating cancer using an immunoconjugate, the Applicant must agree to make an election by telephone and without traverse to an invention directed to a method of treating cancer using immunotherapy.)
  • not have been granted any other special status (e.g. PPH, prioritized examination).
  • comply with the sequence requirements set forth in 37 C.F.R. §§ 1.821 through 1.825.
  • not be subject to a nonpublication request. Petitions must be submitted with a request for early publication.

Petition Timing

Except in a circumstance where the claimed immunotherapy is the subject of an active Investigational New Drug (IND) application that has entered phase II or phase III clinical trials, filed by the patent applicant or an "agent" of the applicant (including a licensee of the applicant), a petition must be filed prior to the first office action, including restriction requirements, or with a proper request for continued examination (RCE).

If the claimed immunotherapy is the subject of an active IND in phase II/III clinical trials, a petition may be filed any time prior to an appeal or a final rejection, unless there is an outstanding office action; i.e. the applicant can file a petition with a response, or a response prior to a petition. Note that in any circumstance, the applicant must have at least one method claim directed to treating a cancer using immunotherapy currently under examination, i.e. not withdrawn, otherwise the applicant is not eligible for granting special status.

The USPTO will decide a petition once an application has been docketed for examination. If the application does not contain at least one method claim directed to treating a cancer using immunotherapy, the petition will be dismissed outright. Otherwise, if the petition is deficient, e.g. there is an outstanding office action or the application fails to comply with sequence listing requirements, the USPTO will notify the applicant of the deficiency. The applicant will be given one opportunity to correct the deficiency, and must respond within 30 days, which is not extendable.

'Treating a Cancer Using Immunotherapy'

To be considered as having at least one claim directed to a method of treating a cancer using immunotherapy, the method must be directed to one 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."

The USPTO has provided the following examples: administration of cells, antibodies, proteins or nucleic acids that i. "invoke an active" or ii. "achieve a passive" immune response to destroy cancerous cells, including vaccines that work by activating the immune system to prevent or destroy cancer growth. The methods can be in vivo or ex vivo and may include adoptive immunotherapy, including those using autologous and/or heterologous cells or immortal cell lines. The USPTO has stated that the program will also consider claims that are drawn to co-administration of biological adjuvants (e.g. cytokines, interleukins) with conventional therapies for treating cancer, e.g. chemotherapy, radiation or surgery.

Noticeably absent from this list are any claims directed to diagnostic methods or methods of detection, which have fallen out of favor recently due to the stricter subject matter eligibility standards under Section 101.

Caveats and Other Considerations

The mailing of a final office action or a notice of appeal constitutes a "final disposition" for purposes of the pilot program, as does a notice of allowance. This means that an application will not retain its special status after the filing of an RCE. Likewise, if an applicant files for a petition for extension of time, the special status of the application will be terminated. Responses to non-final office actions that add more than three independent claims, or more than 20 claims total, will be deemed non-responsive, and applicants may be given 30 days, non-extendable, to submit a compliant response.

Applicants should therefore be prepared to amend the claim scope as necessary in response to the first office action (not counting a restriction requirement) in order to overcome the rejections and place the case in condition for allowance within the time provided by the patent office. Investment in researching prior art and an emphasis on clear and concise claim drafting prior to examination may take on a greater significance.

Footnote

1. https://www.gpo.gov/fdsys/pkg/FR-2016-06-29/pdf/2016-15533.pdf, 81 FR 42328

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Michael S. Montgomery
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