Airing the USPTO's Naturally Occurring Dirty Laundry — the Subject Matter Eligibility Stain

21 August 2014 PharmaPatents Blog

It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” While many of the rejections based on this Guidance are expected, some rejections leave even the most jaded practitioners scratching their heads. Do these rejections reflect the official USPTO position, or are individual examiners misapplying the Guidance?

Unfortunately, it will take many months and many more dollars to find out, and many would-be patent holders may be discouraged from pursuing important technologies due to this unprecedented uncertainty surrounding what types of inventions can be patented in the United States.

Doing Laundry is a Natural Process

Good news for any who have tried to get a stain out a favorite shirt—it’s a natural process that should take care of itself, at least as far as the USPTO is concerned! Yes, claims directed to methods of treating laundry with specific polypeptides having a specific enzymatic activity have been rejected under the new patent eligibility guidance.

The examiner’s rationale goes something like this:

  • The claims “encompass” products (the polypeptides) that appear to be naturally occurring.
  • Factor (c) of the Guidance is not met because the “treating” step “does not impact the judicial exception, because “there is no change to the structure of the polypeptide.”
  • Factor (h) is “not informative” because “while the claims are limited to the use [of the polypeptide] in a method that treats laundry … the claimed method is recited at a very high level of generality.”
  • Claims reciting that the treating composition has a specific pH fare no better, because the recited pH range encompasses a pH of 7 which is the pH of water. (???)
  • Claims reciting that the method is carried out at a specific temperature fare no better, because the recited temperature range encompasses ambient room temperature. (???)
  • Claims reciting that the treating composition also includes other enzymes fare no better because the other enzymes “are also naturally occurring.”

The rejection concludes:

The claims are not patent eligible, because the claims do not recite something significantly different than the judicial exception, since general instructions are provided, no machine or transformation is recited in the claim that integrates the judicial exception, [and the] claims simply recit[e] “treat” via soaking, rinsing or washing which is routine in the art or purely conventional and very general.

Treating a Disease is a Natural Process

Good news for any who suffer from a disease or condition—treatment of that disease is a natural process that should take care of itself, at least as far as the USPTO is concerned! Yes, claims directed to methods of treating a specific disease with a specific protein have been rejected under the new patent eligibility guidance because the protein is naturally occurring.

The examiner’s rationale goes something like this:

  • The claims recite methods using a “natural product” and so must be analyzed under the Guidance.
  • Factor (b) of the Guidance is not satisfied because the administering step “is merely routine and does not limit the claim scope in a meaningful way.”
  • Factor (c) is not satisfied because the protein “is not manipulated in a significant way.”

Administering a protein that is found naturally in the body is insignificant.

  • Factor (d) is not satisfied because “the administration step is nothing more than the general use or application of the [naturally occurring] protein.”
  • Factor (e) is not satisfied “because there is no machine or transformation recited in the claims.”
  • Factor (f) is not satisfied because the step of administering the protein “does not add a feature that is more than well-understood, purely conventional, and routine.”

Getting Out of the Spin Cycle

Could these applicants tip the scale in their favor by amending the claims to include a wherein” clause that recites a transformation (cleaner laundry, amelioration of the disease)? Or would the examiners still find that the other factors outweighed patent eligibility?

The MPEP instructs examiners that “Breadth is not indefiniteness.” While the Supreme Court’s concerns about preemption might preclude a similar blanket statement regarding patent eligibility, when the claims already are directed to a specific method of using a “natural product,” shouldn’t that be enough?

Examples like these reinforce my belief that the Guidance went too far by instructing examiners to scrutinize method claims under the multi-factored framework of the Guidance simply because they recite the use or manipulation of a “natural product.”  As the USPTO considers the public comments submitted on the Guidance, it also should review the rejections that examiners have been making based on the Guidance, and issue revised Guidance that brings USPTO practice back in line with Supreme Court precedent that mandates a cautious approach to creating new categories of exceptions to patent subject matter eligibility.

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