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On May 5, 2016, the USPTO released an update to its examiner guidance on patent subject matter eligibility. The update includes a new set of <a href="http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf">life science examples</a>, a <a href="http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf">memorandum to the patent examining corps</a> with instructions on formulating subject matter eligibility rejections and responding to applicants’ replies, an <a href="http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex_index.pdf">index of eligibility examples</a>, and an <a href="http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-sme_crt_dec_0.pdf">appendix of subject matter eligibility court decisions</a>. All related documents can be viewed on the <a href="http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility-0">Subject Matter Eligibility page of the USPTO website</a>.

In this article, I will briefly outline the new aspects of the examiner guidance, particularly as it relates to the abstract idea exception. The new examples are designed to help patent applicants and patent examiners resolve subject matter eligibility issues in the life science areas, including vaccines and diagnostics. The specific examples will be reviewed in a separate article.

By way of background, in July 2015, the USPTO issued an update to the patent subject matter eligibility guidance to assist examiners in evaluating claims under 35 U.S.C. § 101, in view of the U.S. Supreme Court’s decisions in Alice Corp., Myriad, and Mayo. This new update was prepared in view of public comments and feedback from the patent examining corps. The intent of the guidance (and subsequent examiner training[1]) is “to promote greater consistency throughout the patent examining corps in evaluating whether the claimed subject matter is eligible for patenting, more thorough Office Actions, and greater assurance that applicant responses are thoughtfully considered by the examiner in determining whether to maintain a subject matter eligibility rejection.”[2]

The memorandum seeks to improve the quality and consistency of subject matter eligibility determinations and rejections by explaining that a reasoned rationale must be provided in the Office Action. Moreover, the memorandum reinforces the careful consideration examiners must give to all of an applicant’s arguments and evidence rebutting the subject matter eligibility rejection, and either withdraw the rejection when the response is persuasive or provide a rebuttal when the rejection is maintained.

In Section II, titled Formulating a § 101 Rejection, the memorandum says that a subject matter eligibility rejection under Step 2 should
<ol>
	<li>identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception;</li>
	<li>identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and</li>
	<li>explain the reason(s) that the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception.</li>
</ol>
(Memorandum p. 2, emphasis original.)

In respect to points 1 and 2 above, the memorandum stresses the importance of the examiner (a) tying the specific claim language to an alleged abstract idea, and (b) explaining to the applicant why this abstract idea corresponds to a concept that the courts have identified as an abstract idea:

A subject matter eligibility rejection should point to the specific claim limitation(s) that recites (i.e., sets forth or describes) the judicial exception. The rejection must identify the specific claim limitations and explain why those claim limitations set forth a judicial exception (e.g., an abstract idea). Where the claim describes, but does not expressly set forth, the judicial exception, the rejection must also explain what subject matter those limitations describe, and why the described subject matter is a judicial exception.

When the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it corresponds to a concept that the courts have identified as an abstract idea. … Citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea is a best practice that will advance prosecution.

(Memorandum at pp. 2-3.) The memorandum also states that examiners “should not go beyond those concepts that are similar to what the courts have identified as abstract ideas.” (Memorandum at 3, emphasis supplied.)

In respect to point 3, the memorandum says that examiners “should keep in mind that the courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic (DDR).” (Memorandum at 4, emphasis supplied.) I interpret this as saying that the recitation of a new function should be sufficient to confer patent eligibility for a software-related invention.

In Section III, titled Evaluating Applicant’s Response, the memorandum includes the following statements, which could be helpful to applicants:
<ul>
	<li>If applicant challenges the identification of an abstract idea that was based on a court case and the challenge is not persuasive, an appropriate response would be an explanation as to why the abstract idea identified in the claim is similar to the concept in the cited case. If the original rejection did not identify a Supreme Court or Federal Circuit decision in which a similar abstract idea was found and applicant challenges identification of the abstract idea, the examiner would need to point to a case in which a similar abstract idea was identified and explain why the abstract idea recited in the claim corresponds to the abstract idea identified in the case to maintain the rejection.</li>
	<li>If applicant responds to an examiner’s assertion that something is well-known, routine, conventional activity with a specific argument or evidence that the additional elements in a claim are not well-understood, routine, conventional activities previously engaged in by those in the relevant art, the examiner should reevaluate whether it is readily apparent that the additional elements are in actuality well-known, routine, conventional activities to those who work in the relevant field. It is especially necessary for the examiner to fully reevaluate his or her position when such additional elements are not discussed in the specification as being known generic functions/components/activities or not treated by the courts as well-understood, routine, conventional activities. If the rejection is to be maintained, the examiner should consider whether rebuttal evidence should be provided to further support the rejection and clarify the record for appeal.</li>
</ul>
(Memorandum at 6, emphasis supplied.)

In conclusion, in my opinion, the new guidance is potentially a positive development for inventors and those in favor of a strong patent system. However, this potential won’t be realized unless the examining corps follows the instructions. Applicants and practitioners should do their part by reminding examiners of the following points:
<ul>
	<li>In making an abstract idea rejection, it is the examiner’s responsibility to tie specific claim language to the asserted abstract idea.</li>
	<li>The examiner must explain why this abstract idea corresponds to a concept that the courts have identified as an abstract idea.</li>
	<li>The examiner should not go beyond those concepts that are similar to what the courts have identified as abstract ideas.</li>
	<li>Computer-implemented processes are patent-eligible in cases where generic computer components are used in combination to perform functions that are new and not “merely generic.”</li>
	<li>If the applicant rebuts an abstract idea rejection through argument or evidence that elements in the claim are not well-understood, routine, or conventional, the examiner should provide rebuttal evidence to support the rejection and clarify the record for appeal.</li>
</ul>
[1] According to the USPTO, it will be providing training on the new guidance in interactive workshops where examiners will receive hands-on experience evaluating eligibility and have the opportunity to facilitate discussions with subject matter experts. The life science training will follow the same format as the abstract idea workshops given this past year, using worksheets to analyze the eligibility of claims from select life science examples.

[2] See <a href="http://www.uspto.gov/blog/director/entry/update_to_examiner_guidance_on">Director’s Forum: A Blog from USPTO’s Leadership</a>.

USPTO Releases Next Iteration of Examiner Guidance on Patent Subject Matter Eligibility