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Patent Application 17128926 - METHOD APPARATUS AND SYSTEM FOR DETERMINING A - Rejection

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Patent Application 17128926 - METHOD APPARATUS AND SYSTEM FOR DETERMINING A

Title: METHOD, APPARATUS, AND SYSTEM FOR DETERMINING A VALUE OF ONE OR MORE PARAMETERS OF A RESPIRATORY EFFORT OF A SUBJECT

Application Information

  • Invention Title: METHOD, APPARATUS, AND SYSTEM FOR DETERMINING A VALUE OF ONE OR MORE PARAMETERS OF A RESPIRATORY EFFORT OF A SUBJECT
  • Application Number: 17128926
  • Submission Date: 2025-05-16T00:00:00.000Z
  • Effective Filing Date: 2020-12-21T00:00:00.000Z
  • Filing Date: 2020-12-21T00:00:00.000Z
  • National Class: 600
  • National Sub-Class: 301000
  • Examiner Employee Number: 81321
  • Art Unit: 3796
  • Tech Center: 3700

Rejection Summary

  • 102 Rejections: 1
  • 103 Rejections: 2

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on February 24, 2025 has been entered. By this amendment, claims 1-4, 6, 12-17, 19, and 20 are amended, claims 21-25 are added, and claims 1-25 are now pending in the application.
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 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) an abstract idea set forth as a series of steps, or functions done by a processor, of obtaining signals and determining the value of one or more parameters using a model. This judicial exception is not integrated into a practical application because either the abstract idea is not performed on any particular structure, or the generically recited computer elements, such as the sensors and processor of claim 19 do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements merely modify the abstract idea with specific measures (i.e. thoracic respiratory inductive plethysmograph in claim 2) rather that providing additional elements.
The claims are directed to an abstract idea and/or the end result of the system and method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer receiving data and fitting the data to a model. The claims are directed to an abstract idea, i.e. implementing the idea of receiving and fitting data to a model, such as may be done by a mental process, critical thinking, and/or paper and pencil, with additional generic computer elements recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well-understood, routine and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims is a system and method having sensors, at least one processor, and a hardware storage device, wherein the processor is configured to receive data and apply a model. The claims do not impose any limits on how the data is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how model is fitted, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The sensors, processor, and hardware storage device are recited so generically that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(1) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(1). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’! v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP,LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
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, 10, 11, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoskuldsson et al. in the publication (US 2015/0126879 A1).
Regarding claims 1, 19, and 20, Hoskuldsson discloses a computer-implemented method, system, and hardware storage device of determining a value of one or more parameters of a respiratory effort of a subject (Abstract recites: the invention is for a method of measuring respiratory effort of a subject, where a thorax effort signal and an abdomen effort signal are obtained), the method comprising: 
obtaining a thoracic signal (T), the thoracic signal (T) being an indicator of a thoracic component of the respiratory effort (¶:[0007] recites: thorax effort signal being an indicator of a thoracic component of the respiratory effort); 
obtaining an abdomen signal (A), the abdomen signal (A) being an indicator of an abdominal component of the respiratory effort (¶:[0007] further recites: an abdomen effort signal is obtained, the abdomen effort signal is an indicator of an abdominal component of the respiratory effort);
determining, without directly measuring, on one or more processors of a computing system, the value of the one or more parameters of the respiratory effort by using constraints and/or relationships of components of a model of a respiratory system of the subject (¶:[0025-0031] recites equations are derived for calculating the respiratory effort using a relationship of the two components thoracic and abdominal constraints of respiratory effort, those equations represent a model which is used for estimation of respiratory effort as recited), those derived equations are same as the equations used in the current specification in (¶:[0063-0066]) for estimating respiratory effort; and
fitting the components of the model of the respiratory system of the subject with data from the obtained thoracic signal (T) and data from the obtained abdomen signal (A) the model describes respiratory movements based on the thorax effort signal T and the abdomen effort signal A as recited in (¶:[0034]), where the one or more parameters include one or a combination of: an airway resistance Rr of the subject (claim 14, “evaluating flow resistance”).
Regarding claim 2, Hoskuldsson discloses a computer-implemented method of determining a value of one or more parameters of a respiratory effort of a subject (Abstract recites: the invention is for a method of measuring respiratory effort of a subject, where a thorax effort signal and an abdomen effort signal are obtained), the method comprising: 
obtaining a thoracic signal (T), the thoracic signal (T) being an indicator of a thoracic component of the respiratory effort (¶:[0007] recites: thorax effort signal being an indicator of a thoracic component of the respiratory effort); 
obtaining an abdomen signal (A), the abdomen signal (A) being an indicator of an abdominal component of the respiratory effort (¶:[0007] further recites: an abdomen effort signal is obtained, the abdomen effort signal is an indicator of an abdominal component of the respiratory effort);
determining, without directly measuring, on one or more processors of a computing system, the value of the one or more parameters of the respiratory effort by using constraints and/or relationships of components of a model of a respiratory system of the subject (¶:[0025-0031] recites equations are derived for calculating the respiratory effort using a relationship of the two components thoracic and abdominal constraints of respiratory effort, those equations represent a model which is used for estimation of respiratory effort as recited), those derived equations are same as the equations used in the current specification in (¶:[0063-0066]) for estimating respiratory effort; and
fitting the components of the model of the respiratory system of the subject with data from the obtained thoracic signal (T) and data from the obtained abdomen signal (A) the model describes respiratory movements based on the thorax effort signal T and the abdomen effort signal A as recited in (¶:[0034]), 
wherein the thoracic signal (T) is a thoracic respiratory inductive plethysmograph (RIP) signal; and the abdomen signal (A) being an abdomen respiratory inductive plethysmograph (RIP) signal (Respiratory Inductive Plethysmography (RIP) is a method to measure respiratory related areal changes, the RIP belts contain a conductor which forms a conductive loop when put on a subject, that loop creates an inductance that is directly proportional to the absolute cross sectional area of the body part which it encircles, when such belts are placed around the abdomen and thorax, the cross sectional area is modulated with the respiratory movements and therefore inductance of the belts changes and the measured value of the belt inductance is directly proportional with the respiratory movements, Hoskuldsson also recites a mathematical model for deriving respiratory volume from thoracic and abdominal RIP value,  as recited in (¶:[0017] & [0023]). It is respectfully submitted that the use of the model of Hoskuldsson would necessarily result in “wherein each of the determined one or more parameters of the respiratory effort is different than each of the thoracic component of the respiratory effort, the abdominal component of the respiratory effort, a weighted thoracic component of the respiratory effort, a weighted abdominal component of the respiratory effort, a paradox component of the respiratory effort, and a respiratory movement”, as the output of the model will differ from the inputs of the model.
Regarding claim 10 Hoskuldsson discloses the method of claim 1, wherein the thoracic signal (T) and abdomen signal (A) are obtained by a Respiratory Inductive Plethysmograph (RIP) system (¶:[0017] recites RIP technique is used for measuring respiratory related changes),
including a first stretchable belt including a first conductor formed therein, the first stretchable belt being configured to obtain the thoracic signal (T) from a thoracic region of the subject, and a second stretchable belt including a second conductor formed therein, the second stretchable belt being configured to obtain the abdomen signal (A) from an abdomen of the subject (Fig.1a shows two stretchable belt worn by the person under test, belt-31at thoracic region and the other belt-32 at the abdominal region of the body, and ¶:[0017] recites the belt 31 & 32 have conductors 34 and 35 respectively), and a processing unit configured to obtain the thoracic signal (T) as a first inductive signal from the first conductor and the processing unit is configured to obtain the abdomen signal (A) as a second inductive signal from the second conductor (¶:[0017] recites the conductors 34 & 35 are connected to a processor-38 through leads and it measures the inductance value to respiratory effort from thoracic and abdominal area of the person) and (¶:[0018] recites: stretch signals from thoracic and abdominal area sensed by the RIP belts are transmitted to a processor for analyzing).
Regarding claim 11 Hoskuldsson discloses the method of claim 1, wherein the determining of the value of the one or more parameters of the respiratory effort includes determining any one or more of intercostal muscle drive force FTm, a diaphragm drive force FAm, a thorax counterforce FTb, an abdomen counterforce FAb based on a Respiratory Inductive Plethysmograph (RIP) system Hoskuldsson further discloses the RIP system captures respiratory movements caused by intercostal muscle and diaphragm, while the sensor measures the starching of belts the resulting signal is a quantitative measure of different muscle drive force, as explained in (¶:[0015]); the Respiratory Inductive Plethysmograph (RIP) system including a first stretchable belt including a first conductor formed therein, the first stretchable belt being configured to obtain the thoracic signal (T) from a thoracic region of the subject, and a second stretchable belt including a second conductor formed therein, the second stretchable belt being configured to obtain the abdomen signal (A) from an abdomen of the subject (Fig.1a shows two stretchable belt worn by the person under test, belt-31 at thoracic region and the other belt-32 at the abdominal region of the body, and ¶:[0017] recites the belt 31 & 32 have conductors 34 and 35 respectively), and a processing unit configured to obtain the thoracic signal (T) as a first inductive signal from the first conductor and the processing unit is configured to obtain the abdomen signal (A) as a second inductive signal from the second conductor (¶:[0017] recites the conductors 34 & 35 are connected to a processor-38 through leads and it measures the inductance value to respiratory effort from thoracic and abdominal area of the person).
Regarding claim 18 Hoskuldsson discloses determining, without directly measuring, a weighted sum of the thoracic signal (T) and the abdomen signal (A) that correctly represents the respiratory volume by the relative contribution of the thoracic signal and the abdomen signal to two or more harmonics of the weighted sum are also disclosed by Hoskuldsson in (Claim-16 where he recites: measuring respiratory effort comprises first and second weight factors to create a weighted sum of signals based on the thorax effort signal and the abdomen effort signal).
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of the publication (US 2008/0072912 A1) by Scott.
Regarding claim-4 Hoskuldsson discloses the limitations of claim-3, Hoskuldsson does not clearly disclose the one or more parameters includes at least the thoracic negative pressure force FTp.
However Scott discloses an appliance used in a method for treating sleep apnea (Abstract), Scott further recites (¶:[0003] measurement of airflow and respiratory effort are central to the understanding of respiratory dynamics of sleep) and teaches in (¶:[0004] a intra-thoracic air pressure is reduced for about 10cm down in water scale relative to ambient atmospheric pressure, that intra-thoracic pressure causes air to flow into the lungs), the 10cm reduction in air pressure in thorax compared to atmospheric pressure is considered as the negative thoracic pressure force which helps in inhalation. It would have been obvious at to one of ordinary skill in the art before the effective filing date of the claimed invention to know a negative pressure gradient in thorax creates a force which causes air to flow into the lungs to equilibrate the pressure with atmospheric pressure as taught by Scott (¶:[0004]).
Regarding claim-5 Hoskuldsson in view of Scott disclose all the limitations of claim-4, Scott discloses the thoracic negative pressure force FTp is based on an additional force caused by an intrathoracic pressure Pit across a thoracic area (At), such that FTp = Pit * At as explained in (¶:[0013]) the intra-thoracic pressure changes based on the change in volume or area of thorax.
Claims 6 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of the publication (US 2009/0159082 A1) by Eger.
Regarding claims 6 and 7 Hoskuldsson discloses the limitations of claim-3, Hoskuldsson does not clearly disclose the one or more parameters includes at least the abdomen negative pressure force FAp, wherein the abdomen negative pressure force FAp is based on an additional force caused by an intrathoracic pressure Pit across an Abdomen area (Aa), such that FAp = Pit * Aa
However Eger discloses method of automatically controlling a respiration system for proportional assisted ventilation where the airway pressure, the volume flow as well as the patient's lung mechanical parameters are measured. Eger discloses in (¶:[0012] measuring negative airway pressure of abdominal region) and demonstrated a mathematical relationship between negative abdominal pressure and intrathoracic pressure. It would have been obvious at to one of ordinary skill in the art before the effective filing date of the claimed invention to modify to know a negative airway pressure is created by forcing abdominal muscle during inspiration and to come up with a mathematical relationship between the negative airway pressure and intrathoracic pressure as taught by Eger (¶:[0012]). 
Regarding claim-8 Hoskuldsson in view of Eger discloses all the limitations of claim-7, Eger further discloses low airway resistance Rr of the subject results in low thoracic negative pressure force Ffp (¶:[0012] recites negative pressure in thoracic and or abdominal corresponds to low airway resistance force).
Regarding claim-9 Hoskuldsson in view of Eger discloses all the limitations of claim-7. For the limitation low airway resistance Rr indicates that an upper airway resistance is low Eger discloses lower value of airway resistance due to a negative pressure or resistance in the upper airway, as explained in (¶:[0014-0015]).
Response to Arguments
Applicant's arguments filed February 24, 2025 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 USC 101 as being directed to an abstract idea without adding significantly more, the Applicant argues that the second part of the Alice/Mayo test is referred to as a search for an inventive concept and that the claims are directed to an inventive concept and therefore the claims as a whole amount to significantly more than the judicial exception. Essentially, the Applicant is arguing that because Applicant alleges that the claims are allowable over the prior art, then such claims necessarily are directed to an inventive concept. Step 2B, while it is referred to as a search for an inventive concept, it is also directed to whether the claim as a whole is directed to “significantly more” than the judicial exception. Applicant’s argument is essentially that the judicial exception itself is the inventive concept, not that the claim as a whole is significantly more than the judicial exception. In the instant case, the claims are rejected as being directed to the mental process category of abstract ideas because the claim can be practically performed in the human mind or with pen and paper. Applicant has failed to show how the claim is directed to “significantly more” than this judicial exception because Applicant’s arguments are directed to the abstract idea itself being an inventive concept. For at least the reasons given above, the rejection stands.
Regarding the rejection of the claims under 35 USC 102(a)(1) as being unpatentable over Hoskuldsson, the Applicant argues that the model of Hoskuldsson is not analogous to “a model of a respiratory system of the subject”, but fails to provide support or further explanation for such an assertion. The Applicant fails to point out what differences Applicant feels exist between the two models. The Applicant further argues that Hoskuldsson fails to disclose the newly-added elements of claim 1 which were taken from previous claim 3, arguing that the previous citations for claim 3 do not satisfy the limitations. While this is found persuasive, the examiner respectfully submits that claim 14 of Hoskuldsson describes the airway resistance. As such, the rejection stands as set out above. Regarding claim 2, the Applicant argues that the model of Hoskuldsson expressly describes the parameters of claim 2. The Examiner respectfully submits that the model of Hoskuldsson describes the parameters of claim 2 as inputs and, the claimed “one or more parameters of the respiratory effort” are outputs. As such, the Examiner’s logic stands. 
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986.  The examiner can normally be reached on Monday through Friday from 8 am until 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on 571-272-4949.  The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system.  Status information for published applications may be obtained from either Private PAIR or Public PAIR.  Status information for unpublished applications is available through Private PAIR only.  For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.




/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796                                                                                                                                                                                                        


    
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
    


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