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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 13-15, 17, 18, and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “of the at least one temperature difference” in line 25 lacks proper antecedent basis. For examination purposes, the phrase is being interpreted as “of the at least one temperature difference course”. Further regarding claim 1, the phrase “the at least two subsequent indicator dilution curves of the detected temperature difference course” lacks proper antecedent basis. The claim previously recites that a temperature difference course is detected with at least two subsequent indicator dilution curves, not that the at least two subsequent indicator dilution curves are of the detected temperature difference course.
Regarding claim 2, it is unclear what is meant by “the detected temperature difference course includes the at least three subsequent indicator dilution curves”. What does it mean for a temperature difference course to include a dilution curve?
Regarding claim 6, it is unclear what an “outcome of the mammal body” would be. As best understood, the limitation is referring to an outcome of performing a method on the mammal body. Further regarding claim 6, two of the three options within the claim comprise overlapping subject matter, wherein one option is narrower than the other. “Utilizing at least one of the cardiovascular parameters to improve a treatment and/or outcome of the mammal body” and “utilizing at least one of the cardiovascular parameters to optimize pacemakers and improve results of minimal-invasive cardiac procedures of the mammal body” are a broad and narrow version, respectively, of using at least one of the cardiovascular parameters to improve a treatment and/or outcome of the mammal body. When the method comprises both of these steps, the claim includes both a broad and narrower limitation, which renders the claim indefinite.
Regarding claim 9, it is unclear what a “difference in time between successive indicator dilution curves” is. How is a “difference in time” (i.e., a time difference) determined between two curves?
Regarding claim 10, as with claim 9, it is unclear how a difference in time between dilution curves would be determined.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 1-11, 13-15, 17, 18, and 20-23 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 6 follows.
Regarding claim 1, the claim recites a series of steps or acts, including performing a measurement action, determining at least one cardiovascular parameter based on obtained cardiovascular information, recording a temperature difference course, measuring temperature difference values, recording the temperature difference course at least with two subsequent indicator dilution curves, and determining the at least one cardiovascular parameter by interpreting at least two subsequent indicator dilution curves. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining at least one cardiovascular parameter by interpreting at least two subsequent indicator dilution curves sets forth a judicial exception. This step describes 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.
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 1 fails to recite any application of the determined at least one cardiovascular parameter. The determination of the at least one cardiovascular parameter value 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 determination, nor does the method use a particular machine to perform the Abstract Idea. It is noted that while the claim recites performing the aforementioned steps with “at least one processor” (a computer), 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.
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 steps of performing a measurement action, recording a temperature difference course, determining temperature difference values, and recording the temperature difference course at least with two subsequent indicator dilution curves. The performing, recording, measuring, and additional recording steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps 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 the additional steps from well-understood, routine, and conventional data gathering 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 measuring and recording 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)).
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 claim 1 as they generally recite method steps pertaining to data gathering using generic sensors, or mentally interpreting temperature difference course information to determine specific cardiovascular parameters. The performing, determining, and recording steps recited in claim 1 maintain a high level of generality even when considered in combination with the dependent claims.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
None of the prior art discloses or suggests, either alone or in combination, a thermodilution method wherein a measurement period is set so as to cover at least two times an expected blood circulation time through the entirety of a mammal body, in combination with the other claimed steps.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered.
Regarding the rejections of the claims under 35 U.S.C. 112(b), while the amendments to the claims have overcome some of the previous rejections, as noted in paragraph 3 above, some rejections remain, and the amendments have warranted new indefiniteness rejections.
Regarding the rejection of claims 6-10 under 35 U.S.C. 101, Applicant’s arguments are not persuasive. When the method comprises “determining the at least one cardiovascular parameter during a surgical event of the mammal body”, the claim does not recite an application of the method.
Regarding the rejections of the claims in view of the previously cited prior art, the incorporation of the subject matter of previously examined claim 16 into claim 1 has overcome the prior art rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lisogurski et al.’959 (US Pub No. 2013/0137959 – previously cited), as discussed in paragraph 7 of the last Non-Final Rejection, is the closest prior art applicable to the claims.
‘T Hooft et al.’757 (US Pub No. 2014/0194757 – previously cited) teaches that a Fiber Bragg Grating sensor can be used to analyze photonic signals for the purpose of providing a temperature measurement (see ABSTRACT, and sections [0017], [0043-0044], [0047]).
Minor et al.’876 (US Pub No. 2020/0196876 – previously cited) teaches performing a thermodilution measurement method by placing an object or a substance having a substance temperature below the temperature of the body (a bolus of cold air) in the mouth of a mammal body (section [0141]).
Orr et al.’866 (US Pub No. 2002/0174866 – previously cited) teaches that methods comprising using thermodilution measurements to determine cardiac output typically include a sensor of a measurement device that is kept at a position inside a mammal body throughout a measurement period (section [0005]), and that it is also known in the art to use a sensor that is positioned outside of the blood stream in a portion of the esophagus that is in proximity to the wall of the left atrium (section [0006]).
Hubbard’181 (USPN 5,595,181 – previously cited) teaches using a set of thermodilution curves obtained over time to determine cardiovascular information.
Eggers et al.’155 (USPN 5,928,155 – previously cited) teaches a thermodilution-based cardiac output determination method.
Konno et al.’618 (USPN 4,858,618 – previously cited) teaches a method for obtaining cardiovascular information that uses thermodilution curves.
Huber et al.’836 (WO 2020/083836 – previously cited (US translation as seen in US Pub No. 2022/0079453)) teaches a method for obtaining cardiovascular information that uses thermodilution curves.
Goldau’477 (WO 98/32477 – previously cited) teaches a method for obtaining cardiovascular information that uses thermodilution curves.
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.
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/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791
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