Sources tell us that the estimated publication date of the revised Myriad/Mayo Guidance in the Federal Register is the week of November 17, 2014 (previously was “promised” by the end of October). However, due to the importance of the Guidance, it is being reviewed by several layers of governmental organizations, making it uncertain whether even the revised date will be met.
Nevertheless, the source mentioned the following proposed changes in the version currently in review, which may be helpful to Applicants, assuming these changes are present in the final published version:
- A key difference is that the language in the prior guidance at step (2) of the flowchart (http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf) which currently reads “Does the claim recite or involve judicial exception(s)?” is going to be narrowed to read something like “Is the claim directed to judicial exception(s)?”
- This should provide the basis for an argument that the claim is patent-eligible, as it is directed to something other than a law of nature, and that it passes the test at this step.
- We expect that the Examples in the Guidance will clarify how to apply this argument.
- In addition, in particular for method claims, the “second level trap” of the methods reciting natural products may be explicitly rebuttable by noting that method claims are directed to steps, not the natural products in or of the steps.
- For composition claims directed to natural products, the guidance is going to be more explicit that functional differences, and not just structural ones, can be significantly different.
These changes should be helpful in mitigating some of the most difficult and troublesome of the types of rejections for lack of patent eligibility under 35 U.S.C. §101.
For applications in which there are pending Office Actions due with rejections for lack of patent eligibility, and for which it is not possible or desirable to wait for the new Guidance to be published, these arguments can be incorporated in rebuttal of the rejection with the expectation that, by the time the Examiner picks up the response for review, the new Guidance will have been published and in effect and will include these changes.