DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 10 March 2026 has been entered. Claim(s) 1, 10, 19-20, 27 and 33 is/are currently amended. Claim(s) 2, 4, 6-7, 11-15, 18, 24-26 and 29 has/have been canceled. Claim(s) 1, 3, 5, 8-10, 16-17, 19-23, 27-28 and 30-35 is/are pending.
Rejections Withdrawn
Rejections of claim(s) under 35 U.S.C. 101, 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph), 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) and/or 35 U.S.C. 112(d) (pre-AIA 35 U.S.C. 112, fourth paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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 pre-AIA 35 U.S.C. 112, 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(s) 33-35 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 33 and claims dependent thereon, the limitation "wherein the values of the first and second weight factors (kT and kA) are selected by performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during differing levels of obstructed breathing" is indefinite. It is unclear if "during differing levels of obstructed breathing" is intended to limit when the values of the weight factors are selected, or if the limitation is intended to indicate data obtained during differing levels of obstructed breathing is used in combination to select first and second weight factors.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 33-35 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 33 and claims dependent thereon, the limitation "wherein the values of the first and second weight factors (kT and kA) are selected by performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during differing levels of obstructed breathing" is indefinite, as discussed above. Further, if it is Applicant's intention that data must be acquired during each of plurality of differing levels of obstructed breathing in order to select the values, Applicant does not appear to disclose an algorithm commensurate in scope with this intention. At best, Applicant discloses a model may "successfully describe respiratory movements of thorax and abdomen for differing levels of obstruction, given that the coefficients, kA and kVT are known" (¶ [0039]), but does not describe, or disclose an algorithm for, selecting weight factor values "performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during differing levels of obstructed breathing."
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.
Claim(s) 33-35 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 33-35 recite the steps of weighting a thorax effort signal by a first weight factor and weighting an abdomen effort signal by a second weight factor to produce a volume-proportional signal; and selecting the weight factor(s) to minimize/reduce non-volume contributing components in the volume-proportional signal during various levels of breathing obstruction. These steps, as drafted, are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. But for the generic computer structure/processor language, the steps encompass a relatively straight-forward mathematical procedure(s) capable of being practically performed manually and/or mentally including solving a linear equation(s) given input values and selecting coefficients/weight factors that provide an optimal result. If a claim limitation, under its BRI, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. In particular, the claim only recites the additional elements for/steps of receiving or gathering the data (i.e., effort signals) necessary to perform the abstract idea, and a generic computer component (processor) for implementing the abstract idea. The processor is recited at a high-level of generality (i.e., as a generic processor performing generic computer functions of performing calculations), such that it amounts no more than mere instructions to apply the exception using a generic computer component. The elements for/steps of receiving the effort signals amount to necessary data gathering comparable to steps/elements that have been found to be insignificant extra-solution activity, such as performing clinical tests on individuals to obtain input for an equation. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, the elements for/steps of receiving or gathering the effort signals are recited at a high level of generality and encompass well-understood, routine and/or conventional activity/elements. For example, the courts have identified receiving and/or retrieving data as a well‐understood, routine, and conventional function. See MPEP 2106.05(d). Furthermore, the application as filed appears to acknowledge the claimed sensors (e.g., respiratory effort belts) and various methods of calibrating said sensors are well-known and/or conventional (e.g., ¶ [0005]). Accordingly, the above-noted claims are not patent eligible.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,834,109 A (previously cited, Watson).
Regarding claims 33-35, Watson discloses/suggests a computer-implemented method of measuring respiratory effort of a subject, the method comprising:
obtaining a thorax effort signal (T), the thorax effort signal (T) being an indicator of a thoracic component of the respiratory effort (Fig. 1, elastic tube 16 comprising conductor 12 extending about the rib cage for measuring RC signal shown in Fig. 3), the thorax effort signal (T) including a volume contributing thoracic component (VST) representing a volume contributing component of respiratory effort, and a thoracic paradox component (PT) representing a non-volume contributing thoracic component of respiratory effort (understood to be inherent based on the application as filed, e.g., ¶¶ [0036]-[0037], etc.);
obtaining an abdomen effort signal (A), the abdomen effort signal (A) being an indicator of an abdominal component of the respiratory effort (Fig. 1, elastic tube 18 comprising conductor 14 extending about the abdomen for measuring AB signal of Fig. 3), the abdomen effort signal (A) including a volume contributing abdominal component (VSA) representing a volume-contributing component of the respiratory effort, and an abdomen paradox component (PA) representing a non-volume contributing abdominal component of the respiratory effort, wherein the non-volume-contributing abdominal component (PA) is negatively proportional to the non-volume-contributing thoracic component (PT) (understood to be inherent based on the application as filed, e.g., ¶¶ [0036]-[0037], etc.); and
performing a calibration of the thorax effort signal (T) and the abdomen effort signal (A), which includes:
weighting the thorax effort signal (T) by a first weight factor (kT) and weighting the abdomen effort signal (A) by a second weight factor (kA) to obtain a volume- proportional signal (VSw), the volume proportional signal (VSw) being proportional to the actual respiratory volume of the respiratory effort (col. 5, Equation E, where RC is weighted by a proportionality factor and AB is weighted by a value of 1); and
selecting values for the weight factors (kT and kA) that minimize or reduce the non-volume-contributing thoracic component (PT) and the non-volume-contributing abdominal component (PA) in the resulting volume-proportional signal (VSw) (col. 7, lines 13-37; col. 8, line 38 - col. 9, line 5, calculating proportionality constant Z for solution of Equation E; col. 5, lines 28-30, where the proportionality constant/factor Z defines the correct relative contributions of the rib cage (RC) and abdomen (AB) to tidal volume (V)),
wherein the values of the first and second weight factors (kT and kA) are selected by performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during non-obstructed breathing (e.g., col. 6, lines 4-33; col. 7, lines 13-37; etc.),
wherein the step of performing the calibration of the thorax effort signal (T) and the abdomen effort signal (A) is performed based on the obtained thorax effort signal (T) and the abdomen effort signal (A) without requiring an additional respiratory signal or reference signal (throughout document, wherein the method for calibrating is non-invasive, i.e., does not require a spirometer or other device measuring respiration volume at the mouth, as described in, e.g., col. 3, lines 33-36).
Watson does not expressly disclose the values of the first and second weight factors (kT and kA) are selected by performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during obstructed breathing including partially obstructed breathing and differing levels of obstructed breathing. However, the only requirement disclosed by Watson for breathing during the baseline period is that the breathing is "substantially steady state." Watson does not appear to require breathing during the baseline period to be non-obstructed, or any particular state of obstruction. Additionally, Watson discloses the values may be continuously monitored, repeatedly recalculated, and/or the calibration routine rerun (e.g., col. 8, lines 23-37), and further discloses the baseline constant tidal volume assumption underlying the calibration routine can be satisfied by removing outlying effort signal data (col. 7, lines 13-37). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Watson to comprise performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during abnormal breathing of the subject, including partially obstructed breathing and differing levels of obstructed breathing in order to enable updating the values as needed, particularly if said the obstructed breathing is steady and/or the assumptions underlying the calibration routine can be satisfied (Watson, col. 8, lines 23-37; col. 7, lines 13-37).
Alternatively/Additionally, as discussed with respect to claim 1, Watson further discloses an alternate/additional calibration technique (isovolume calibration technique), which Applicant further acknowledges is "conventional" (e.g., ¶ [0055]), in which the weight factor values (i.e., proportionality factor Z) may be selected based on data acquired during obstructed breathing (col. 5, lines 28-47, the subject breathes against a closed airway; Equations F-G; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Watson with performing one or more calculations on data from the abdomen effort signal (A) and the thorax effort signal (T) during differing levels of obstructed breathing of the subject in order to facilitate alternatively select said values when obstructed breathing is practical (Watson, col. 5, line 62 - col. 6, line 3); facilitate providing an value selection that can be updated as needed (Watson, col. 8, lines 23-37); facilitate selecting the values by multiple techniques that can be used in combination; etc.
Allowable Subject Matter
Claims 1, 3, 5, 8-10, 14-17, 19-23 and 25-32 are allowed for at least the reasons discussed in the prior Office action(s) (e.g., mailed 18 November 2024, pgs. 15-16).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant does not appear to provide any arguments specific to the rejections of claim 33 (and/or claims dependent thereon). To the extent Applicant's arguments regarding the rejection of claim 1 under 35 U.S.C. 101 are applicable to the claim 33, the examiner respectfully disagrees with said arguments. In particular, Applicant contends the method "is expressly integrated into a particular machine, and as such is not directed to an abstract idea, and if directed to a judicial exception, such judicial exception is integrated into a practical application" (Remarks, pg. 21); and is "directed to an inventive concept and therefore that the claims as a whole amount to significantly more than the judicial exception that the Office Action asserts" (Remarks, pg. 22). Applicant further contends the rejection fails to consider the method as a whole, contending because features of the pending claims are allegedly not disclosed or suggested by the prior art of record, the claims include features that are not conventional, well-understood, and routine (Remarks, pg. 23).
The examiner respectfully disagrees. As noted in MPEP 2106.05(b), "It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine." The preamble indicating the method is "computer-implemented," is, at best, an additional element of the claim requiring the use of a computer as a tool to implement an otherwise abstract idea.
Additionally, specific algorithms disclosed by Applicant as not requiring another reference signal, or any particular breathing state and/or maneuver (e.g., the weight factor value selection methods of claim 1) have not been rejected as ineligible under 35 U.S.C. 101. To the extent the scope of the pending claims is understood by the examiner in light of their indefiniteness discussed above, the examiner respectfully disagrees that the claimed invention is commensurate in scope with Applicant's alleged inventive concept. Specifically, the pending claims appear to encompass use of the known Qualitative Diagnostic Calibration (QDC) and iso-volume calibration techniques, as disclosed by Watson and acknowledged by Applicant as being known and/or conventional (e.g., ¶ [0033], ¶ [0055], etc.) during levels of obstructed and/or non-obstructed breathing. Accordingly, it is unclear what, if any, practical application and/or inventive concept is encompassed by the limitations of pending claims 33-35.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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