DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Currently, claims 1 and 4-20 are pending and under consideration in the instant application. Claims 11-20 are newly added. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 101
Claims 1 and 4-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method of diagnosing stroke using gene expression analysis to identify signatures diagnostic of stroke, distinguishing cardioembolic stroke from large artery atherosclerosis stroke, and atrial fibrillation “relative” to cardioembolic stroke. However this recitation is a natural correlation between expression levels of genes and stroke as well as stroke types. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites multiple elements directed to abstract ideas. “Diagnosing”, “normalizing”, “indicates”, etc encompass conclusions and determination which can occur entirely within the mind, as well as mathematical relationships and calculations. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of using gene expression signatures, including applying a trained two way random forest classifier, however this does not integrate the JE into a practical application because it directed to data gathering to establish the correlation and does not add a meaningful limitation to the method. The elements directed to diagnostic output merely recite steps that are directed to the natural correlation. Generating a stroke decision support report does not practically apply the JE’s because it is merely an intended use of the claimed invention and is not a positive limitation because it does not require that any actual treatment be used by or on a patient. Additionally, the elements in the report, including “stroke treatment”, “triage”, “interventional”, and “secondary prevention modality” are generally recited such that have no more than an nominal relationship to the recited JE’s. (see MPEP 2106.04(d)(2) for analysis of of Step 2A prong two). The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it.” CLS BankInt’l, 134 S.Ct. at 2358; Prometheus, 132 S. Cl, at 1294.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the steps of obtaining a sample, isolating RNA from the sample, and generating a report are directed to insignificant extra solution activity. The steps directed to determining expression (including with, for example, PCR) and normalizing expression are not only directed to data gathering, but are recited at a high level of generality. The generally recited steps and elements do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. Furthermore, the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity. The elements directed to a two way random forest classifier architecture are also generally recited and directed to well understood, routine and conventional activity. (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. The generally recited elements, even in combination, consist of using well understood, routine and conventional activity. The claims generally recited steps and elements are simply directed to gathering and analyzing gene expression data, using generic mathematical relationships, and ending in a step of producing a report of the analysis. These steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Response to Arguments
The response traverses the rejection and asserts that the claims have been amended such that it does not end with an observation of a natural correlation as the report identifies clinically actionable outcomes for stroke occurrence. The response asserts that the claim therefore applies the measured RNA expression information in a specific acute care diagnostic and treatment process. This argument has been thoroughly reviewed but was not found persuasive because generating a stroke decision support report does not practically apply the JE’s because it is merely an intended use of the claimed invention and is not a positive limitation because it does not require that any actual treatment be used by or on a patient. Additionally, the elements in the report, including “stroke treatment”, “triage”, “interventional”, and “secondary prevention modality” are generally recited such that they have no more than an nominal relationship to the recited JE’s. (see MPEP 2106.04(d)(2) for analysis of of Step 2A prong two). The response also asserts that the claimed classifier based workflow is more than routine data gathering, but rather directed to using predefined markers to generate three different diagnostic outcomes. This argument has been thoroughly reviewed but was not found persuasive because the information provided by the classifier is directed to a natural correlation. The generally recited and routine and conventional classifier analyzes the expression levels of genes and identifies signatures that are diagnostic of a particular stroke outcome. For these reasons and the reasons made of record above, the rejection is maintained.
Claim Rejections - 35 USC § 112
112(a)
Claims 1 and 4-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The claims have been amended extensively. Additionally, new claims 11-20 have been added.
As set forth in the MPEP at 2163IB:
While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.
At 2163IIA, the MPEP states:
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims.
Furthermore, at 2163.04I(B), the MPEP states:
A simple statement such as "Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘____’ in the application as filed." may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported.
See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 [subsection] (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection.").
The amendment makes a general statement that the claims are supported in the entire specification and example 1, as well as providing a general synopsis of the teachings of the specification. However it does not state where these individual limitations are supported, either explicitly, inherently, or implicitly. In response to this rejection, applicant should delete subject matter that is not supported in the disclosure as originally filed, or provide an explanation as to which particular paragraphs from the specification provide express, inherent, or implied support for the newly added claim limitations. If the support is not expressly recited, applicant should provide an explanation as to which paragraphs provide implied or inherent support along with an explanation as to the logic used to conclude that the specification supports the newly added claim limitations.
112(b)
Claims 1 and 4-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is unclear in the recitation of “atrial fibrillation relative to cardioembolic stroke not due to atrial fibrillation and large artery atherosclerosis stroke”. It is not clear if this recitation refers to atrial fibrillation caused by cardioembolic stroke or atrial fibrillation that is concurrent with cardioembolic stroke. It is not clear what type of atrial fibrillation is intended to be encompassed by the claim or what the relationship is between cardioembolic stroke or large artery atherosclerosis stroke and the atrial fibrillation being detected.
The response asserts that the claims have been amended to remove ambiguity, however this is not found persuasive because it is not clear what type of atrial fibrillation is detected.
112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-9, 11, and 16-18 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The dependent claims in question appear to simply recite what is already required by the independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/ Primary Examiner, Art Unit 1682
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