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 1-18 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 “a local spot of a temperature that deviates a deviation amount from the temperature of the mammal body has been created” renders the claim indefinite. For this examination, the phrase is being interpreted as “a local spot having a temperature that deviates a deviation amount from the temperature of the mammal body has been created”. Furthermore, it is unclear what the “measurement action” is that is being performed. The claim later recites recording a temperature difference course and measuring temperature difference values. What is the “measurement action” that is being performed? For this examination, any of the recording steps or measuring step in claim 1 is being considered the performed measurement action. The “recording” step in claim 1 also renders the claim indefinite. It is unclear what two temperature values are used to determine a “temperature difference” course. It is unclear what “an overall trend of temperature difference values representing temperature difference to a baseline temperature through time in relation to the respective ide of the heart” means in the context of the recording limitation. Clarification is requested. For this examination, the recording step is being interpreted such that temperature measurements over time are recorded. Regarding the “measuring” step, it is unclear how a difference value would be “measured”; a difference value is calculated, not measured. Finally, clarification is requested as to whether the temperature difference course is recorded twice (once without the at least two subsequent indicator dilution curves, and once with the at least two subsequent indicator dilution curves).
Regarding claim 6, it is unclear if the “a temperature difference course” recited in the claim is referring to the recorded “temperature difference course” recited in claim 1. Clarification is requested.
Regarding claim 9, it is unclear what a “time difference” between dilution curves is. How is a time difference between two curves determined? Furthermore, is the “a temperature difference course” the same as or different than the “time difference course” recited in claim 1? Clarification is requested.
Regarding claim 10, as with claim 9, it is unclear how a time difference between dilution curves would be determined. Furthermore, the phrases “the one temperature difference course” and “the other temperature difference course” lack proper antecedent basis.
Regarding claim 12, the phrase “a moment at which a local spot of a temperature that deviates the deviation amount” renders the claim indefinite. Is this moment the same as or different than the moment recited in claim 1? For this examination, the phrase is being interpreted as “the moment at which the local spot of a temperature that deviates the deviation amount”. The same indefiniteness issue and interpretation also apply to claims 13-15.
Regarding claim 14, the phrase “the mouth” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “the mouth of the mammal body”.
Regarding claim 15, the phrase “the lungs” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “the lungs of the mammal body”.
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 6-10 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 6, the claim recites a series of steps or acts, including performing a measurement action, recording a temperature difference course, measuring temperature difference values, recording the temperature difference course at least with two subsequent indicator dilution curves, and determining at least one cardiovascular parameter by interpreting a temperature difference course. 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 a temperature difference course in relation to at least one side of the heart 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 6 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.
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, measuring 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 6 as they generally recite method steps pertaining to mentally interpreting temperature difference course information to determine specific cardiovascular parameters. The performing, recording, measuring, recording, and determining steps recited in claim 6 maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 6-13, 17, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lisogurski et al.’959 (US Pub No. 2013/0137959).
Regarding claim 1, Lisogurski et al.’959 discloses a method for obtaining cardiovascular information from a mammal body (see ABSTRACT, and section [0003]), the method comprising: performing a measurement action during a measurement period including a period following a moment at which a local spot of a temperature that deviates a deviation amount from the temperature of the mammal body has been created in the blood vascular system of the mammal body (sections [0060-0069], [0081]); recording, for the duration of the measurement period and in relation to at least one side of the heart, a temperature difference course in relation to the local spot in the blood vascular system of the mammal body, which temperature difference course is an overall trend of temperature difference values representing temperature difference to a baseline temperature through time in relation to the respective side of the heart (sections [0064], [0067-0069], [0077]); measuring the temperature difference values at at least one measuring position in proximity to, on, or in the mammal body by means of a measurement device including at least one sensor that is configured to enable recordation of the temperature difference course with at least two subsequent indicator dilution curves resulting from at least two subsequent times that the local spot passes at the at least one measuring position (sections [0064], [0067-0069], [0077], [0081]); and recording the temperature difference course at least with the at least two subsequent indicator dilution curves (sections [0064], [0067-0069], [0076-0077], [0081]).
Regarding claim 2, the at least one sensor of the measurement device is configured to enable recordation of the temperature difference course with at least three subsequent indicator dilution curves resulting from at least three subsequent times that the local spot passes at the at least one measuring position (sections [0069-0074], [0076], [0081]); and the temperature difference course is recorded at least with the at least three subsequent indicator dilution curves (section [0081]).
Regarding claim 6, at least one cardiovascular parameter is determined by interpreting a temperature difference course in relation to at least one side of the heart (sections [0003], [0060-0062], [0069], [0081-0082]).
Regarding claim 7, the at least one cardiovascular parameter is cardiac output (sections [0003], [0060-0062], [[0069], [0081-0082]).
Regarding claims 8-10, as the chosen cardiovascular parameter of claim 7 is cardiac output, limitations regarding unchosen cardiovascular parameters need not be taught by the cited prior art. For the subject matter in claims 8-10 to be given patentable weight, each claim must first positively recite that the chosen cardiovascular parameter of claim 7 is the ejection fraction (for claim 8), the circulating thermal volume (for claim 9), and the pulmonary thermal volume (for claim 10).
Further regarding claim 10, as Figure 6 of Lisogurski et al.’959 shows sensor systems on both sides of the heart, the method comprises recording temperature difference courses in relation to both sides of the heart.
Regarding claim 11, the moment at which a local spot of a temperature that deviates the deviation amount from the temperature of the mammal body has been created in the blood vascular system of the mammal is a cold intake moment at which a local cold spot has been created in the blood vascular system of the mammal body (section [0062]).
Regarding claim 12, the measurement period includes a period directly following a moment at which a local spot of a temperature that deviates the deviation amount from the temperature of the mammal body has been crated in the blood vascular system of the mammal body (sections [0060], [0062], [0065]).
Regarding claim 13, the measurement period includes a period directly following a moment at which a local spot of a temperature that deviates the deviation amount from the temperature of the mammal body has been created in the blood vascular system of the mammal body by injecting the mammal body intravenously with a volume of a substance having a substance temperature below the temperature of the body (sections [0062-0065]).
Regarding claim 17, as shown in Figure 6 and disclosed in sections [0017] and [0065], the at least one sensor of the measurement device is kept at a position outside of the mammal body throughout the measurement period.
Regarding claim 18, as shown in Figure 6 and disclosed in sections [0017] and [0065], the at least one sensor of the measurement device is kept at a position in proximity to or on the skin of the mammal body throughout the measurement period.
Regarding claim 21, as shown in Figure 6 and disclosed in sections [0017] and [0065], the at least one sensor of the measurement device is kept at a position outside of the bloodstream.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lisogurski et al.’959, as applied to claim 1.
Regarding claim 3, Lisogurski et al.’959 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for explicitly disclosing that the at least one sensor of the measurement device is configured to detect the temperature difference values with a precision of at least 0.0001 K and a dynamic range of at least 105. However, it would have been an obvious design choice to a person of ordinary skill in the art to have modified the at least one sensor of Lisogurski et al.’959 to be configured to detect the temperature difference values with a precision of at least 0.0001 K and a dynamic range of at least 105 because Applicant has not disclosed that the feature provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the claimed at least one sensor because both provide the same or similar predictable results, e.g., providing temperature measurements.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine the optimal precision and dynamic range of the at least one sensor of Lisogurski et al.’959.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lisogurski et al.’959, as applied to claim 4, in view of ‘T Hooft et al.’757 (US Pub No. 2014/0194757 – cited by Applicant).
Lisogurski et al.’959 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the at least one sensor being a photonic sensor, the photonic sensor being a Fiber Bragg Grating sensor. ‘T Hooft et al.’757 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]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the at least one sensor of Lisogurski et al.’959 to include a photonic Fiber Bragg Grating sensor, as ‘T Hooft et al.’757 teaches that a photonic Fiber Bragg Grating sensor can be used to determine temperature values within a mammal body. The modification to Lisogurski et al.’959 would merely be combining prior art elements according to known methods to yield predictable results.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lisogurski et al.’959, as applied to claim 12, in view of Minor et al.’876 (US Pub No. 2020/0196876).
Regarding claim 14, Lisogurski et al.’959 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the method comprising placing a object or a substance having a substance temperature below the temperature of the body in the mouth. Minor et al.’876 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]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Lisogurski et al.’959 to include placing a cold air bolus in the mouth of the mammal body, as it would merely be substituting one known method (placing a cold bolus in a mouth) for another (injecting a bolus of cold injectate) to obtain predictable results.
Regarding claim 15, section [0141] of Minor et al.’876 teaches that the bolus of cold air is placed in the mouth and inhaled into the lungs.
Claims 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lisogurski et al.’959, as applied to claims 1 and 12, in view of Orr et al.’866 (US Pub No. 2002/0174866).
Regarding claim 20, Lisogurski et al.’959 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the at least one sensor being kept at a position inside the mammal body throughout the measurement period. Orr et al.’866 teaches that methods comprising using thermodilution measurements to determine cardiac output typically include a sensor of a measurement deice that is kept at a position inside a mammal body throughout a measurement period (section [0005]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have substituted a sensor kept at a position inside the mammal body for one of the sensors positioned outside of the mammal body as it would merely be the simple substitution of one known method (thermodilution temperature measurements using a conventionally used invasive temperature sensor) for another (the non-invasive temperature sensors of Lisogurski et al.’959) to obtain predictable results. It is further noted that Applicant admits on page 2 of the filed specification that it is well known to use sensors of a measurement device kept at a position inside the mammal body throughout a measurement period to determine cardiac output.
Regarding claim 22, section [0006] of Orr et al.’866 teaches 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. It would have been obvious to one of ordinary skill in the art to have modified the method of Lisogurski et al.’959 to include placing at least one sensor in a portion of the esophagus that is in proximity to the wall of the left atrium as it is known in the art to use a sensor in the claimed location.
Regarding claim 23, both the sensor of section [0005] of Orr et al.’866 and of section [0006] of Orr et al.’866 is mounted on or in a probe.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections against claim 16:
None of the prior art discloses or suggests, either alone or in combination, a method for obtaining cardiovascular information 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hubbard’181 (USPN 5,595,181) teaches using a set of thermodilution curves obtained over time to determine cardiovascular information. Eggers et al.’155 (USPN 5,928,155) teaches a thermodilution-based cardiac output determination method. Konno et al.’618 (USPN 4,858,618 – cited by Applicant) teaches a method for obtaining cardiovascular information that uses thermodilution curves. Huber et al.’836 (WO 2020/083836 – 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) teaches a method for obtaining cardiovascular information that uses thermodilution curves.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791