Well, it’s happening. Office Actions with new patent eligibility rejections based on the USPTO’s March 4, 2014 Guidance are being mailed out to patent practitioners across the nation. While some new rejections under §101 were expected, others have been more surprising. The most frustrating ones I have seen relate to pharmaceutical compositions, methods of making pharmaceutical compositions, and methods of treatment using pharmaceutical compositions.

Pharmaceutical Compositions

A pharmaceutical composition claim along these lines is rejected under 35 USC § 101 for allegedly being drawn to a product of nature:

A pharmaceutical composition comprising Protein A or a fragment thereof and X % by weight of Component Y.

True to the Pomelo Juice example, the Examiner made this rejection because Protein A is a “natural product” and Component Y could be a “natural product.”

The Examiner has found that the claimed composition is novel and non-obvious, but instead of issuing a Notice of Allowance, we have to go back to the drawing board with this new § 101 rejection.

Methods of Manufacture 

A method of manufacture claim along these lines is rejected under 35 USC § 101 for allegedly falling under the Guidance:

A method of making a pharmaceutical composition comprising Protein A and Component Y, comprising providing Protein A and Component Y [at specified relative amounts].

Extrapolating from the Guidance, the Examiner made this rejection because all of the claim language relates to the “natural products” and so there is nothing “in addition to the judicial exceptions” on which to base patent eligibility.

Methods of Treatment

A method of treatment claim along these lines is rejected under 35 USC § 101 for allegedly falling under the Guidance:

A method of treating Disease Z in a human, comprising administering to the human the composition according to claim 1.

Because the patent eligible therapeutic method claim in the Guidance (Example B, claim 3) recites a specific dosing regimen, the Examiner believes that broader therapeutic method claims that recite the administration of a “natural product” must be rejected under § 101.

What’s Next? 

On Friday, May 9, 2014, the USTPO is hosting a forum “to receive public feedback from organizations and individuals on the Guidance.” I will be one of about ten speakers who will be presenting alternative interpretations of the Supreme Court decisions cited in the Guidance, and alternative frameworks for evaluating claims for subject matter eligibility without eviscerating the patent system. In addition to listening to our views, I hope the USPTO will offer concrete suggestions for how applicants can respond to these new patent eligibility rejections, and what avenues of review offer the best chances for prompt reconsideration.

You can register to attend the forum in person or via webcast at the USPTO’s subject matter eligibility webpage.