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 .
Response to Amendment
Claims 1, 2, and 4-16 are currently pending. Claim 1 remains withdrawn. Claims 2 and 4-16 have been amended. Claims 5 and 15 have been amended to overcome the 35 U.S.C. 112(b) rejection set forth in the Non-Final Office Action mailed on 01 May 2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2 and 4-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 2 follows.
STEP 1
Regarding claim 2, the claim recites a series of structural elements, including a sequential gas delivery device. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
control a sequential gas delivery device to administer a deoxyhemoglobin signal to a subject, the deoxyhemoglobin signal comprising a step change in deoxyhemoglobin implemented by:
prospectively targeting a first partial pressure of oxygen in arterial blood (PaO2) in a subject using the sequential gas delivery device for a first duration of time; and
prospectively targeting a second PaO2 using the sequential gas delivery device for a second duration of time;
control a magnetic resonance imaging (MRI) system to measure a magnetic resonance signal in a voxel of the subject’s brain responsive to the deoxyhemoglobin signal; and
calculate a perfusion metric for the voxel based on the magnetic resonance signal;
wherein the perfusion metric is calculated based on a rate of change for the magnetic resonance signal and an integral of the rate of change
set forth a judicial exception. The calculating steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. The controlling, prospectively targeting, and administering steps also describe a concept of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claim is also drawn to Organizing Human Activity, which is also an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 2 recites calculating a perfusion metric for the voxel based on the magnetic resonance signal, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The calculating of the perfusion metric does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated perfusion metric, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional step of:
measuring a magnetic resonance signal in a voxel of the subject’s brain using magnetic resonance imaging (MRI) responsive to the deoxyhemoglobin signal; and
The measuring step is a well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the measuring step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
The device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited sequential gas delivery is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 4, 5, 9, and 13-15 merely provide more details to the first and second PaO2 and perfusion metric, which does not add anything significantly more. Claims 6-8, and 10-12 recite steps that add to the Abstract Idea. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Response to Arguments
Applicant argues that the steps in claim 2 are not directed to mental processes/organizing human activity. However, the controlling steps are organizing human activity as this could be an instruction to control the sequential gas delivery device and MRI system to perform the claimed steps. The prospectively targeting step could be an instruction to control the sequential gas delivery device to target the first and second PaO2. The calculating steps could be performed mentally or by hand as these are mere input of data to determine an output, or perfusion metric. Examiner suggests to amend claim 2 to include how the calculated perfusion metric transforms/improves the system to potentially overcome the 35 U.S.C. 101 rejection. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) rejections have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) and 103 rejections of claims 2 and 4-16 have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
