October 24, 2016

BioPharma Patents Quick Tips & News – October 2016

By Leanne M. Rakers, Principal; Gregory S. DeLassus, Associate

October 2016 BioPharma Newsletter — Halloween Edition

U.S. patent eligibility can be scary!


Tips to avoid the Grim Reaper (a.k.a. the Examiner or a Judge) killing your claims: 

  1. The CellzDirect patentee was helped by the careful description of the ways in which the claimed invention improved upon prior art techniques, so be sure to give copious details about how your invention improves upon the prior art.
  2. Judge Lourie suggested in his Ariosa dissent that a Jepson claim (e., a claim to an improvement over the prior art, where the preamble recites the prior art, followed by the transition “wherein the improvement consists in…”) might have been patentable, even if Ariosa’s actual claims were invalid. Your basic U.S. filing fee entitles you to three independent claims, so consider using one of them for a Jepson claim.
  3. Judge Dyk’s Ariosa concurrence suggested that claims limited to embodiments that Ariosa had reduced to actual practice before filing might have been patentable. Therefore, be sure to include dependent claims that are limited to embodiments that have been successfully tested and described in the application.
  4. The May 2016 guidelines from the USPTO show that subtle differences in claim form can make the difference between a claim that is a trick and one that is a treat. You need the ability in prosecution to change a method of “diagnosing” into a method of “detecting,” or even a method of “making.” Therefore, be sure to include lots of alternative phrasings in your pre-filed application, so that you will have written description support for later amendments.
  5. The May 2016 guidelines also suggest that a claim to a natural product (e.g. werewolf hair) is not eligible, but a claim to a pharmaceutical composition comprising werewolf hair and a carrier selected from alcohol, toad oil, and bat gall might be eligible. Therefore, consider adding lists of specific excipients to claims to get past a subject-matter eligibility rejection.
  6. In CellzDirect, the patentee claimed a method, but the end-product of the claimed method was a physical substance (frozen liver cells). In Ariosa the patentee claimed a method, but the end-product of the method was information (diagnosis of a trisomy condition). Try, therefore, to make your method claims focus on a physical outcome, rather than an information Instead of a claim to a method of diagnosing vampire bites using antibodies against VAMP-1 antigen in the wound, recite a method of making a VAMP-1/antibody complex, the method comprising applying anti-VAMP-1 antibodies to wounds on a human neck.

Bonus tip: This strategy works even better if it is limited to a new anti-VAMP-1 antibody disclosed for the first time in the patent application.

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