As tipped off by Dennis Crouch’s Patently Obvious blog, the U.S. Government Department of Health & Human Services (HHS) has requested an inter-partes reexamination of U.S. Pat. No. 6,653,104 for an anti-cancer antibody assigned to Immunomedics, Inc.

See the OG Notice here.

The ‘104 patent claims:

1. A cytotoxic reagent comprising an antibody and a moiety having ribonucleolytic activity derived from a non-human ribonuclease, wherein said antibody and said moiety are linked through recombinant production.

2. A cytotoxic reagent comprising an internalizing antibody and a moiety having ribonucleolytic activity, wherein said internalizing antibody is directed against a lineage-dependent antigen or against an antigen associated with cancer cells, and wherein said internalizing antibody and said moiety are linked through recombinant production.

92. A cytotoxic reagent comprising an antibody and a moiety having ribonucleolytic activity derived from a non-human ribonuclease, wherein said antibody is human or humanized.

93. A cytotoxic reagent comprising an internalizing antibody and a moiety having ribonucieolytic activity, wherein said internalizing antibody is directed against a lineage-dependent antigen or against an antigen associated with cancer cells, and wherein said internalizing antibody is human or humanized.

It’s a peculiar act for a governmental agency to request an inter partes reexamination. These proceedings are intended to reduce expensive patent litigation in U.S. district courts by giving third-party requesters, in addition to the existing ex parte reexamination in title 35, the option of inter partes reexamination proceedings in the USPTO.

35 USC 312 establishes an inter partes reexamination procedure which third-party requesters can use at their option. Third parties who request inter partes reexamination are allowed to submit one written comment each time the patent owner files a response to the USPTO. In addition, such third-party requesters can appeal to the USPTO Board of Patent Appeals and Interferences from an examiner’s determination that the reexamined patent is valid, but may not appeal to the Court of Appeals for the Federal Circuit.

To prevent harassment, anyone who requests inter partes reexamination must identify the real party in interest and third-party requesters who participate in an inter partes reexamination proceeding are estopped from raising in a subsequent court action or inter partes reexamination any issue of patent validity that they raised or could have raised during such inter partes reexamination.

Keep in mind that an inter partes reexamination cannot be commenced unless the USPTO makes a determination that a ‘substantial new question’ of patentability is raised and this determination cannot be appealed. Grounds for inter partes reexamination are limited to earlier patents and printed publications.

Update:

Dennis Crouch has added a copy of the Request for Re-Exam here.

Interestingly, the HHS attacks the ‘104 patent based on U.S. Pat. No. 5,840,840, to Rybak et al. This patent was cited in the parent case, was submitted on the IDS by the applicants and the Examiner initialed this reference on the IDS form indicating the Examiner considered the reference. Apparently, the HHS now is contending the Examiner DID NOT consider it since it is not mentioned explicitly in the Non-Final Office Action or Notice of Allowability.

This brings up the question: If you have a piece of art that is close that you need to get considered, should you prompt the Examiner by mentioning it in a Response?

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