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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“patient device” in claim 5
“a device external to the implantable pressure sensor” in claims 12 and 15
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Paragraph [0041] defines a “patient device” as an external device comprising “a processor 20, communication circuitry 21 for (wirelessly) communicating with the implantable pressure sensor 1, communication circuitry 22 for establishing a (wireless) communication connection with the telemedical monitoring service center 3, and a sensing device 23 for sensing and atmospheric pressure outside of the patient”. Paragraph [0039] defines a device external to the implantable pressure sensor as the patient device and therefore also defines it ad a device comprising “a processor 20, communication circuitry 21 for (wirelessly) communicating with the implantable pressure sensor 1, communication circuitry 22 for establishing a (wireless) communication connection with the telemedical monitoring service center 3, and a sensing device 23 for sensing and atmospheric pressure outside of the patient”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-15 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 indicating a current state of awareness of a patient based on the comparison of acquired data. 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 step of correcting said processing data based on the fitted curve to compensate for a drift effect in said measured data obtained using the implantable pressure sensor sets forth a judicial exception. This step describes a mathematical calculation. Thus, the claim is drawn to a Mathematical Concept, which is 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. The correction of the data 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 corrected data, 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. Claim 1 also recites the steps of deriving, from said processing data , a multiplicity of fit values; and determining, using said fit values, a fitted curve, which are also drawn to a mathematical concept. Besides the Abstract Ideas, the claim recites additional step of a obtaining processing data, based on measured data indicative of a measured pressure obtained using the implantable pressure sensor. Obtaining data from an implantable pressure sensor is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the obtaining 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 and comparing 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.
Regarding claim 15, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited implantable pressure sensor is a generic sensor configured to perform pre-solutional data gathering activity, the external device is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. Claims 2-14 comprise Mathematical Concepts and data collection. Claim 14 is drawn to insignificant post solutional activity, The calculating 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 § 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(s) 1-6, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1).
In regards to claim 1 Stone teaches a method for correcting a drift effect in measured data obtained using an implantable pressure sensor ([0153] implantable pressure sensor), the method comprising:
obtaining processing data, based on measured data indicative of a measured pressure obtained using the implantable pressure sensor ([0143] “Drift of the MEMS pressure sensors is then characterized by testing the second test MEMS pressure sensor under specified, pre-determined conditions. In certain embodiments, pressure induced drift is characterized by testing the second MEMS pressure sensor under specified time(s) at various pressures. The pressure induced drift characterization is then recorded in a suitable recording medium, e.g., electronic flash memory”);
determining a fitted curve ([0145] “fitted data coefficients of mathematical drift functions, The drift characterizations may then accompany all sensors manufactured from the tested material lot or batch, permitting the information to be used in third party applications to compensate for sensor drift”);
and correcting said processing data based on the fitted curve to compensate for a drift effect in said measured data obtained using the implantable pressure sensor ([0145]”The drift characterizations may then accompany all sensors manufactured from the tested material lot or batch, permitting the information to be used in third party applications to compensate for sensor drift”);.
Stone fails to teach deriving, from said processing data, a multiplicity of fit values from which the fitted curve is derived. Rooke teaches filtering data before curve fitting ([0072] “A curve fitting is next performed on the filtered or smoothed sample”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to include a step of filtering the data before fitting the curve. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing a more accurate data set free of noise to perform fitting on.
In regards to claim 2 modified Stone teaches the method according to claim 1, wherein said step of obtaining processing data includes:
obtaining measured data from the implantable pressure sensor (Stone [0162] first MEMS sensor detects data) ;
obtaining a reference value (Stone [0162] atmospheric pressure is reference value);
and deriving the processing data based on the measured data and the reference value (Stone [0163] In certain embodiments, the gauge pressure is determined by subtracting the absolute pressure measured by the first MEMS sensor, i.e. pressure proximate a pressure sensor, e.g., sensor 10 and/or sensor 100, from the absolute atmospheric pressure measured by the second MEMS sensor 78).
In regards to claim 3 modified Stone teaches the method according to claim 2, wherein the processing data are derived by forming a difference between said measured data and the reference value (Stone [0163] In certain embodiments, the gauge pressure is determined by subtracting the absolute pressure measured by the first MEMS sensor, i.e. pressure proximate a pressure sensor, e.g., sensor 10 and/or sensor 100, from the absolute atmospheric pressure measured by the second MEMS sensor 78).
In regards to claim 4 modified Stone teaches the method according to claim 2 wherein said reference value is indicative of the atmospheric pressure (Stone [0163] In certain embodiments, the gauge pressure is determined by subtracting the absolute pressure measured by the first MEMS sensor, i.e. pressure proximate a pressure sensor, e.g., sensor 10 and/or sensor 100, from the absolute atmospheric pressure measured by the second MEMS sensor 78).
In regards to claim 5 modified Stone teaches the method according to claim 2 wherein said reference value is measured by a patient device operable outside of a patient and being in communication connection with said implantable pressure sensor (Stone [0161] “In certain embodiments, the pressure compensation system includes a pressure sensing system, which is in communication (and cooperates) with the reader processing means 72. In the noted embodiments, the pressure sensing system similarly includes at least two MEMS pressure sensors; at least a first MEMS pressure sensor 30 disposed in the sensor housing 12, and at least a second (external) MEMS pressure sensor 78 disposed in or associated with the reader 70”).
In regards to claim 6 modified Stone teaches the method according to claim 1 wherein said step of deriving a multiplicity of fit values includes: deriving said fit values by filtering the processing data (Rooke [0072] “A curve fitting is next performed on the filtered or smoothed sample”).
In regards to claim 12 modified Stone teaches the method according to claim 1 wherein said steps of deriving a multiplicity of fit values (F1=F5), determining a fitted curve (F) and correcting said processing data (D) are carried out in a device external to the implantable pressure sensor (1) ([0122] processing means are external to the implanted pressure sensor. Fig 7 sensor is 44, external processors are 47a and 47b).
In regards to claim 15 modified Stone teaches the system for obtaining data indicative of a pressure in a patient, comprising:
an implantable pressure sensor configured to obtain measured data indicative of a measured pressure ([0153] implantable pressure sensor);
and a device external to the implantable pressure sensor, the device being configured to obtain processing data based on the measured data obtained using the implantable pressure sensor ([0143] “Drift of the MEMS pressure sensors is then characterized by testing the second test MEMS pressure sensor under specified, pre-determined conditions. In certain embodiments, pressure induced drift is characterized by testing the second MEMS pressure sensor under specified time(s) at various pressures. The pressure induced drift characterization is then recorded in a suitable recording medium, e.g., electronic flash memory”);
to determine, a fitted curve ([0145] “fitted data coefficients of mathematical drift functions, The drift characterizations may then accompany all sensors manufactured from the tested material lot or batch, permitting the information to be used in third party applications to compensate for sensor drift”);
and to correct said processing data based on the fitted curve to compensate for a drift effect in said measured data obtained using the implantable pressure sensor ([0145] ”The drift characterizations may then accompany all sensors manufactured from the tested material lot or batch, permitting the information to be used in third party applications to compensate for sensor drift”).
Stone fails to teach deriving, from said processing data, a multiplicity of fit values from which the fitted curve is derived. Rooke teaches filtering data before curve fitting ([0072] “A curve fitting is next performed on the filtered or smoothed sample”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Stone to include a step of filtering the data before fitting the curve. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing a more accurate data set free of noise to perform fitting on.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1) as applied to claim 1 further in view of Papanicolau (US 20170254889 A1).
In regards to claim 7 modified Stone teaches the method according to claim 1. Modified Stone fails to teach a method wherein said step of deriving a multiplicity of fit values includes: deriving each of said fit values by computing an average of a predefined multiplicity of samples of said processing data. Papanicolau teaches deriving fit values by computing an average of a predefined multiplicity of samples of processing data ([0105] “This step may, for example, calculate a line of best fit through the normalized averaged spectral window data using a least squares approach, or indeed other regression types”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to include a step of averaging windows of the data like the method of Papanicolau before fitting the curve. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of smoothing the data signal before applying a fitted curve.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1) as applied to claim 1 further in view of Greenberg (US 20110214030 A1).
In regards to claim 8 modified Stone teaches the method according to claim 1. Modified Stone fails to teach a method wherein said step of determining a fitted curve (F) includes: fitting said multiplicity of fit values (F1-F5) to a parametric function. Greenberg teaches fitting data using linear regression to determine an offset drift estimate ([0069] “The linear regression produces an offset and drift estimate”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to use linear regression to determine the offset drift estimate like the method of Greenberg in order to correct sensor drift. Doing so would be a simple substitution of one known fit method for another to obtain the predictable result of determining how much sensor drift is present in the data.
In regards to claim 9 modified Stone teaches the method according to claim 8. Modified Stone fails to explicitly teach a method wherein said parametric function is mathematically expressed as:
f
t
=
a
-
b
*
e
-
c
*
t
, where f(t) is the parametric function, and a, b, and c are parameters determined by fitting said multiplicity of fit values to the parametric function. However, it would be obvious to a person of ordinary skill in the art to perform several types of regression fittings, including a parametric exponential regression fitting, in order to determine which fitting produces the best fit. Doing so would merely choosing from a finite number of identified, predictable solutions (linear regression, polynomial regression, exponential regression), with a reasonable expectation of success.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1) as applied to claim 1 further in view of Adithya (US 10667701 B1).
In regards to claim 10 modified Stone teaches the method according to claim 1. Modified Stone fails to teach a method wherein fit values are determined repeatedly anew during operation of the implantable pressure sensor. Adithya teaches determining pressure continuously using a fitted curve (Col 3 lines 14-19 “In addition, signal processing techniques can be used to determine continuous blood pressure from the signals. In some embodiments, the heart sounds and respiratory sounds are extracted using a wavelet-based source separation technique while the continuous blood pressure is determined using a regression model”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to continuously monitor pressure over time like the device of Adithya. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing continuous real time corrected pressure data which can allow for health issues to be detected as soon as they appear.
In regards to claim 11 modified Stone teaches the method according to claim 10, wherein said steps of determining a fitted curve and correcting said processing data are repeated at the availability of a new fit value (Adithya Col 3 lines 14-19 “In addition, signal processing techniques can be used to determine continuous blood pressure from the signals. In some embodiments, the heart sounds and respiratory sounds are extracted using a wavelet-based source separation technique while the continuous blood pressure is determined using a regression model”).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1) as applied to claim 1 further in view of Fischer (US 20210361219 A1).
In regards to claim 13 modified Stone teaches the method according to claim 1. Modified Stone fails to teach a method wherein said step of correcting said processing data includes: forming a difference between correction the fitted curve and the processing data to obtain corrected processing data. Fischer teaches forming a difference between correction the fitted curve and the processing data to obtain corrected processing data ([0080] “the algorithm may calculate the least squares regression line through all points within a 5000-sample recording, and then subtract the line from the original signal”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to include forming a difference between the fitted curve and the processing data to obtain corrected processing data like the method of Fischer. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing continuous real time corrected pressure data which can allow for health issues to be detected as soon as they appear.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 20110160609 A1 - cited by applicant) in view of Rooke (US 20100292586 A1) as applied to claim 1 further in view of Randall (US 20230270389 A1).
In regards to claim 14 modified Stone teaches the method according to claim 1. Modified Stone fails to teach a method wherein an additional step of transmitting corrected processing data, obtained as a result of said step of correcting said processing data, to a telemedical monitoring service center external to the implantable pressure sensor. Randall teaches transmitting data to a telemedical monitoring service center ([0237] data is transmitted to Medaica Auscultation hub). t would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of Stone to include transmitting the corrected data to a telemedical monitoring service center external to the implantable pressure sensor like the method of Randall. Doing so would allow for health professionals to access a patient’s data remotely and allow for more accurate telemedicine visits (Randall [0004] “For telemedicine to be truly useful, the Patient must be able to collect and transmit a variety of data the healthcare professional needs to assess the Patient's health”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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