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 .
Election/Restrictions
Applicant's election with traverse of claims 1-18 in the reply filed on 26 May 2026 is acknowledged. The traversal is on the ground(s) that Group II (claims 19 and 20) contains only two additional claims that overall substantially with the claims of Group I (claims 1-18). This is not found persuasive because the current application is a national stage application submitted under 35 U.S.C. 371 and the unity of invention analysis is applicable. Section 1893.03(d) of the MPEP states:
“A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. For example, a corresponding technical feature is exemplified by a key defined by certain claimed structural characteristics which correspond to the claimed features of a lock to be used with the claimed key.”
Groups I and II share the technical feature of: receiving a plurality of non-driven impedance signals from a plurality of patch electrodes; defining a reference respiration signal using the plurality of non-driven impedance signals; for each non-driven impedance signal within a subset of the plurality of non-driven impedance signals: computing a polarity value for the non-driven impedance signal; and computing a scaling factor for the non-driven impedance signal; and computing a composite respiration signal from the subset of the plurality of non-driven impedance signals. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Hill et al. ‘810 (see Restriction Election Requirement filed 26 March 2026).
The requirement is still deemed proper and is therefore made FINAL.
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 and 7 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. Claims 2-6 and 8-18 are further rejected due to their dependency to claim 1.
Claim 1 recites “ a method of generating a respiration signal within an electroanatomical mapping system, comprising the electroanatomical mapping system:” in lines 1-2. It is unclear if there is one electroanatomical mapping system or two electroanatomical mapping system. Clarification is requested. For examination purposes, lines 1-2 is interpreted as: “a method of generating a respiration signal within an electroanatomical mapping system, comprising:”
Claim 7 recites the limitation “PRS-A signal” in line 3. It is unclear what the abbreviation “PRS-A” stands for. Clarification is requested.
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 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 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including receiving a plurality of non-driver impedance signals from a plurality of patch electrodes. Thus, the claim is directed to a process, 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
receiving a plurality of non-driven impedance signals from a plurality of patch electrodes;
defining a reference respiration signal using the plurality of non-driven impedance signals;
for each non-driven impedance signal within a subset of the plurality of non-driven impedance signals:
computing a polarity value for the non-driven impedance signal; and
computing a scaling factor for the non-driven impedance signal; and
computing a composite respiration signal from the subset of the plurality of non-driven impedance signals
set forth a judicial exception. These 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 computing steps also describe mathematical relationships, mathematical formulas or equations, mathematical calculations. Thus, the claim is also drawn to Mathematical Concepts, 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 1 recites computing a composite respiration signal from the subset of the plurality of non-driven impedance signals, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The computing of the composite respiration signal 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 computed composite respiration signal, 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: receiving a plurality of non-driven impedance signals from a plurality of patch electrodes. The receiving step is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the receiving 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 step does 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 the abstract independent claims. Claims 2-6, 14, 15, 17, and 18 recite steps that add to the Abstract Idea. Claims 2, 3, 5, 6, 14, 15, 17, and 18 recite steps that are mental processes and claims 2-5 and 14 recite steps that are mathematical concepts. Claims 7-13 and 16 how the polarity value of the composite respiration signal is defined, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
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 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, 3, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill et al. ‘810 (International Pub No. WO 2020/096810 – cited by Applicant).
Regarding claim 1, Hill et al. ‘810 teaches a method of generating a respiration signal within an electroanatomical mapping system, comprising the electroanatomical mapping system:
receiving a plurality of non-driven impedance signals from a plurality of patch electrodes ([0201]; “processing raw measurements”);
defining a reference respiration signal using the plurality of non-driven impedance signals ([0201]; “measure”);
for each non-driven impedance signal within a subset of the plurality of non-driven impedance signals ([0201]):
computing a polarity value for the non-driven impedance signal (Fig. 15
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𝜃S and [0171]-[0172]); and
computing a scaling factor for the non-driven impedance signal ([0201]; “bio impedance scaling”); and
computing a composite respiration signal from the subset of the plurality of non-driven impedance signals ([0201]; “virtual reference coordinate”).
Regarding claim 3, Hill et al. ‘810 teaches wherein computing the scaling factor for the non-driven impedance signal comprises normalizing the non-driver impedance signal ([0113]).
Regarding claim 6, Hill et al. ‘810 teaches defining a polarity value of the composite respiration signal ([0171]).
Regarding claim 7, Hill et al. ‘810 teaches wherein the polarity value of the composite respiration signal is defined such that a polarity of the composite respiration signal corresponds to a polarity of a PRS-A signal ([0119]).
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.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hill et al. ‘810 in view of Li ‘546 (CN Patent No. 11,255,546).
Regarding claim 2, Hill et al. ‘810 teaches all of the elements of the current invention as mentioned above except for wherein computing the polarity value for the non-driven impedance signal comprises:
computing a correlation coefficient between the non-driven impedance signal and the reference respiration signal; and
computing the polarity value based on a sign of the correlation coefficient.
Li ‘546 teaches the correlation parameter is correlation coefficient or Euclidean distance; reference breathing characteristic value sequence is based on a plurality of biological impedance signal of sample human body normal lung function; the control module is specifically further used for: judging whether the correlation coefficient is greater than the preset first threshold value; when the correlation coefficient is greater than the preset first threshold value, determining that the lung function of the detected human body is normal; or judging whether the Euclidean distance is less than the preset second threshold value; when the Euclidean distance is less than the preset second threshold value, determining that the lung function of the detected human body is normal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the computing of the polarity value of Hill et al. ‘810 to include computing a correlation coefficient between the non-driven impedance signal and the reference respiration signal; and computing the polarity value based on a sign of the correlation coefficient as Li ‘546 teaches that this will aid in determining that the lung function of the detect human body is normal.
Conclusion
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
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