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.
Claim 5 recites the limitation "a histogram of values"; it is unclear whether this is the same histogram of values of claim 1 or not. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation " a distribution of the histogram"; it is unclear whether this is the same a distribution of the histogram of claim 7 or not. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation " a distribution of the histogram"; it is unclear whether this is the same a distribution of the histogram of claim 7 or claim 8 or not. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation " a distribution of the histogram"; it is unclear whether this is the same a distribution of the histogram of claim 10 or not. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "a histogram of values"; it is unclear whether this is the same histogram of values of claim 1 or not. There is insufficient antecedent basis for this limitation in the 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 1-18, 33, 39 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-16 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03. Claims 17-18, 33 and 39 recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03.
2A – Prong 1: The independent claims 1, 17 and 33 recite a judicial exception by reciting the limitations of “receiving a pressure signal; generating a histogram of values observed within a time window associated with the pressure signal; and determining the position of the heart pump based, at least in part, on a morphology of the histogram”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper and/or using mathematical calculations. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1, 17 and 33 recite the additional limitations of “at least one pressure sensor arranged on the heart pump []”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-16, 18 and 39 depend on claims 1, 17 and 33. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “differential pressure sensor”, “user interface”, etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 1-18, 33, 39 are directed to an abstract idea and are therefore rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-5, 14-18, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No 20180078159 granted to Edelman et al. (hereinafter “Edelman”) in view of US Pat Pub No 20030045772 to Reich et al. (hereinafter “Reich”).
Regarding claims 1, 17 and 33, Edelman discloses a method/system/controller of determining a position of a heart pump in a heart of a patient (para 0160 method of using the user interface [] to “verify the position of the intravascular heart pump”), the method comprising: receiving a pressure signal from at least one pressure sensor arranged on the heart pump (para 0160 “pressure signal waveform 2002 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 312)”); generating values observed within a time window associated with the pressure signal (fig. 20A); and determining the position of the heart pump based, at least in part, on a [the values] (para 0160 “pressure signal waveform 2002 can be used by a healthcare professional to properly place an intravascular heart pump (such as intravascular heart pump 100 in FIG. 1) in the heart. The pressure signal waveform 2002 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 2002 is an aortic or ventricular waveform”). but fails to explicitly disclose determining histogram.
Reich from a similar field of endeavor shows that it is known to determine a histogram of past pressure signal levels to determine the failure mode (para 0077). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Edelman with the known teachings of Reich to provide the predictable result of determining fault.
Regarding claims 2 and 18, Edelman as modified by Edelman renders obvious the method of claim 1 and system of claim 17, wherein the at least one pressure sensor comprises a differential pressure sensor (para 0065, 0084, 0095, 0107, 0161 “pressure difference between the inlet and outlet areas of the cannula resulting in a variable volume load on the rotor).
Regarding claim 3, Edelman as modified by Edelman renders obvious the method of claim 1, wherein a length of the time window is at least four seconds and less than ten seconds (fig. 20A, para 0160 “a waveform of a metric of cardiac function over time” – As written, neither the claim nor the specification provide any details regarding the criticality of the time windows. The claims as read under their broadest statement requires a time window that is arbitrarily drawn/identified. Here, Edelman discloses the waveform to be drawn and displayed on the user interface which a user can monitor to make the determinations based on any portions of the waveform, including time windows of various durations.)
Regarding claim 4. Edelman as modified by Edelman renders obvious the method of claim 3, wherein the length of the time window is at least five seconds and less than seven seconds (fig. 20A, para 0160 “a waveform of a metric of cardiac function over time” – As written, neither the claim nor the specification provide any details regarding the criticality of the time windows. The claims as read under their broadest statement requires a time window that is arbitrarily drawn/identified. Here, Edelman discloses the waveform to be drawn and displayed on the user interface which a user can monitor to make the determinations based on any portions of the waveform, including time windows of various durations.)
Regarding claim 5. (Original) Edelman as modified by Edelman renders obvious the method of claim 1, further comprising: filtering the pressure signal to generate a filtered pressure signal, wherein generating a histogram of values comprises generating a histogram of values observed within a time window of the filtered pressure signal (para 0170).
Regarding claim 14. (Original) Edelman as modified by Edelman renders obvious the method of claim 1, further comprising: outputting via a user interface, an indication of the position of the heart pump (para 0160 “The pressure signal waveform 2002 is used to verify the position of the intravascular heart pump by evaluating whether the waveform 2002 is an aortic or ventricular waveform. An aortic waveform indicates that the intravascular heart pump motor is in the aorta. A ventricular waveform indicates that the intravascular heart pump motor has been inserted into the ventricle which is the incorrect location.”).
Regarding claim 15. (Original) Edelman as modified by Edelman renders obvious the method of claim 1, further comprising: determining a pulsatility of the pressure signal, wherein generating a histogram of values is performed in response to the pulsatility of the pressure signal being above a first threshold pulsatility value and below a second threshold pulsatility value (Fig 20A; the claim does not provide any details regarding the first or second thresholds, under its broadest reasonable interpretation, any threshold would read over the claimed limitation. Here, a user viewing the data and making judgment would use arbitrary thresholds to make their determination).
Regarding claim 16. (Original) Edelman as modified by Edelman renders obvious the method of claim 1, wherein the heart pump is configured to provide right heart support for the patient, and determining the position of the heart pump based, at least in part, on a morphology of the histogram comprises determining whether an outlet of the heart pump is located in a pulmonary artery of the patient (para 0072, 0074, etc.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edelman as modified by Edelman as applied to claims above, and further in view of US Pat Pub No. 20190046709 to Sternby et al. (hereinafter “Sternby”).
Regarding claim 6. (Original) Edelman as modified by Edelman renders obvious the method of claim 5, but fails to disclose wherein filtering the pressure signal comprises filtering the pressure signal with a finite impulse response (FIR) filter.
Sternby, from a similar field of endeavor teaches generating the emulated pressure signal by using a FIR (finite impulse response) filter to suppress signal interferences (abstract, para 0020). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Edelman as modified by Reich with the teachings of Sternby to provide the predictable result of suppress signal interferences.
Claim(s) 7, 10-11 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edelman as modified by Edelman as applied to claims above, and further in view of 20090124910 to Eide.
Regarding claims 7 and 39. (Original) Edelman as modified by Edelman renders obvious the method of claim 1 and controller of claim 33, wherein determining the position of the heart pump based, at least in part, on a morphology of the histogram (see rejection of claim 1) comprises determining the position of the heart pump based, at least in part (see rejection of claim 1), but fails to disclose determining on a distribution of the histogram.
Elde, from a similar filed of endeavor teaches creating histogram after sampling pressure signal, on time sequence, to perform analysis (para 0488). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Edelman as modified by Reich with the teachings of Elde to provide the predictable result of performing analysis.
Regarding claim 10. (Original) Edelman as modified by Edelman renders obvious the method of claim 1, wherein determining the position of the heart pump based, at least in part (see rejection of claim 1), but fails to disclose [determining] distribution of the histogram further comprises determining whether the distribution is a normal distribution.
Elde, from a similar filed of endeavor teaches creating histogram after sampling pressure signal, on time sequence, to perform analysis (para 0488). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Edelman as modified by Reich with the teachings of Elde to provide the predictable result of performing analysis.
It is noted that determining whether the disturbing is normal is understood to be simple calculation performed by a user viewing the data.
Regarding claim 11. (Original) Edelman as modified by Edelman and Elde renders obvious the method of claim 10, wherein determining the position of the heart pump based, at least in part, on a distribution of the histogram further comprises: determining that the heart pump is positioned properly (para 0160 “An aortic waveform indicates that the intravascular heart pump motor is in the aorta.”) when the histogram has the normal distribution (see rejection of claim 10).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796