Nine strategies to overcome Section 101 rejections for personalized medicine and DNA-related subject matter

Over the past few months, Applicants have been receiving Section 101 rejections for non-patentable subject matter, especially where the subject matter involves personalized medicine and DNA-related compositions and methods. To successfully rebut these rejections, and in preparing newly filed disclosures and claims, there are some strategies that can be taken by the inventor and patent practitioner:

  1. Identify with specificity how the inventor has done enough to distinguish his claimed invention from the similar product in nature, making an inventive contribution.
  2. Identify a specific, substantial and credible utility recited in the disclosure.
  3. Identify with specificity a transformation in the claimed process steps. This recitation in the claim is the most important for meeting the test for patent subject matter eligibility under Section 101.
  4. Show how Applicant has claimed a process that applies a law of nature. The Supreme Court has held that processes applying laws of nature are patent-eligible if the patent claims do more than describe the natural law and incorporate routine steps already engaged in by the scientific community which, when viewed as a whole, add something significant beyond their individual parts. Thus, the critical question in determining patentability is “whether the claims do significantly more than simply describe natural biological relationships. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?” Point out how the claimed additional steps do not merely consist of well-understood, routine, conventional activity already engaged in by the scientific community. The claimed steps, when viewed as a whole, add significance beyond this sum of the parts taken separately.
  5. Identify how the claimed process application of the law of nature has meaningful limits in the execution of the claimed process steps. Show how this is a significant contribution to the art and applies natural law in a meaningful way to a specific articulated outcome.
  6. Show how the claimed process would not monopolize a natural force or scientific fact.
  7. Show how the law of nature is applied objectively, not subjectively.
  8. Show how Applicant has claimed more than a mere statement of a concept.
  9. Show how the claimed process is more that an abstract idea with conventional steps stated in broad generalities.

The interpretation of patentable subject matter is still evolving as the courts and the USPTO determine how to implement recent case law under Section 101. Anyone with inventions in this technology will want to keep abreast of the decisions every few months in order to be on top of the latest rulings and interpretations. As we watch how this issue unfolds, these approaches should put your application in the best position for being awarded a patent.