DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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:
“an arrangement for filling the esophageal catheter with a measuring fluid” in claim 27.
“a device for determining at least one property characteristic … on the basis of the pressure detected in the esophageal catheter” in claim 27.
“a device for providing the esophageal catheter with at least one identifier” in claim 28.
“at least one controller configured to control and/or regulate a mass flow … introduced into … or withdrawn from the esophageal catheter” in claim 28.
“a leakage controller configured to control the characterization system such that it performs a method for detecting a leakage rate” in claim 28.
“a system volume controller configured to control the characterization system such that it performs a method for determining a system volume (Vsys)” in claim 28.
“a flow resistance controller configured to control the characterization system such that it performs a method for determining a flow resistance (RFlow)” in claim 28.
“a measurement range determination controller configured to control the characterization system such that it performs a method for determining an upper limit (Nmax) and a lower limit (Nmin)” in claim 28.
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.
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.
Specifically, the limitation “an arrangement for filling the esophageal catheter with a measuring fluid” in claim 27 is interpreted to include a pump and/or a valve, which is described in the specification as performing the claimed function (see specification, [0072] and [0186]), and equivalents thereof.
Specifically, the limitation “a device for determining at least one property characteristic … on the basis of the pressure detected in the esophageal catheter” in claim 27 is interpreted to include a hardware (combined/integrated controller component or integrated into a ventilation device) or a software controller (instructions executed on a processor, microprocessor, or microcontroller) executing the algorithms of Fig. 2-7, which is described in the specification as performing the claimed function (see specification, [0191-0193] and [00195-00260]), and equivalents thereof.
Specifically, the limitation “a device for providing the esophageal catheter with at least one identifier” in claim 28 is interpreted to include a display (displaying a machine-readable code, such as a barcode or QR code), a printer producing a sticker, a laser-marking apparatus, or an RFID/NFC writer, which is described in the specification as performing the claimed function (see specification, [0166-0168]), and equivalents thereof.
Specifically, the limitation “a leakage controller configured to control the characterization system such that it performs a method for detecting a leakage rate” in claim 28 is interpreted to include a hardware (combined/integrated controller component or integrated into a ventilation device) or a software controller (instructions executed on a processor, microprocessor, or microcontroller) executing the algorithms of Fig. 4, which is described in the specification as performing the claimed function (see specification, [0058-0069], [0191-0193], and [0211-0223]), and equivalents thereof.
Specifically, the limitation “a system volume controller configured to control the characterization system such that it performs a method for determining a system volume (Vsys)” in claim 28 is interpreted to include a hardware (combined/integrated controller component or integrated into a ventilation device) or a software controller (instructions executed on a processor, microprocessor, or microcontroller) executing the algorithms of Fig. 2, which is described in the specification as performing the claimed function (see specification, [0070-0088], [0191-0193], and [0195-0202]), and equivalents thereof.
Specifically, the limitation “a flow resistance controller configured to control the characterization system such that it performs a method for determining a flow resistance (RFlow)” in claim 28 is interpreted to include a hardware (combined/integrated controller component or integrated into a ventilation device) or a software controller (instructions executed on a processor, microprocessor, or microcontroller) executing the algorithms of Fig. 3, which is described in the specification as performing the claimed function (see specification, [0089-0097], [0191-0193], and [0203-0210]), and equivalents thereof.
Specifically, the limitation “a measurement range determination controller configured to control the characterization system such that it performs a method for determining an upper limit (Nmax) and a lower limit (Nmin)” in claim 28 is interpreted to include a hardware (combined/integrated controller component or integrated into a ventilation device) or a software controller (instructions executed on a processor, microprocessor, or microcontroller) executing the algorithms of Fig. 5, which is described in the specification as performing the claimed function (see specification, [0098-0152], [0191-0193], and [0224-0248]), and equivalents thereof.
Claim Rejections - 35 USC § 112
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.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the limitation “at least one controller configured to control and/or regulate a mass flow … introduced into … or withdrawn from the esophageal catheter” within claim 28 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In regards this limitation, the specification describes that “the controller can be designed to control and/or regulate the mass flow” and “with such a controller, the mass flow … can be reliably set to a predetermined value” ([0073]). However, this is aspirational, results-oriented language. No language is presented within the specification which describes any embodiment that achieves the claimed functions – there is no control diagram, no algorithm, no reference to any well-known control strategy, such as PID control. The written description thus fails to disclose adequate detail regarding how the disclosed controller is configured achieve a regulated mass flow, instead describing the pump/valve hardware from [0072] and presenting the bare assertion that the controller “can be designed to” control this hardware to achieve the claimed regulating function. Thus, the specification fails to provide evidence that the inventor had possession of the claimed controller configuration.
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.
Claims 1-4, 7, 9-10, 14-17, 20-21, 24-28, and 36-37 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.
Regarding claims 1, 7, 10, 14-17, 20-21, 24, 27, and 36-37, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2-4, 9, 25-26, and 28 are also rendered indefinite by virtue of being dependent upon one or more of these claims. In order to examine these claims and their dependents under broadest reasonable interpretation, the claims are interpreted in each case as not requiring the limitation(s) following the phrase. Appropriate clarification and/or correction is required.
Regarding claim 3, the limitation “at each of the measurement points resulting in this way” renders the claim indefinite, since it is unclear whether the phrase “in this way” refers to either of the methods for detecting the pressure prevailing in the esophageal catheter previously stated, or only one of the two. As such, the scope of the claim is rendered indefinite. In order to examine the claim under broadest reasonable interpretation, it is presented that the phrase “in this way” may refer to either of the methods. Appropriate clarification and/or correction is required. Claim 4 is also rendered indefinite due to its dependence upon claim 3. It should also be pointed out that each of these methods for detecting the pressure prevailing in the esophageal catheter imply that multiple measurement points exist as part of the method, however the claim would be clearer if such were stated more explicitly within the claim, for example, by defining “a plurality of measuring points” within the claim.
Regarding claim 4, the claim comprises three method steps which may be alternatively selected or used in combination (and/or), and the claim itself is dependent upon a claim (claim 3) in which two alternative methods are outlined (“a predetermined filling quantity … is set and the time course of the pressure is recorded” and “the filling quantity is changed between a start value and an end value of a measurement range for determining the characteristic property”). In order for such a claim to be definite, each possible combination of alternative method steps (each set of one method from claim 3 and one or more methods from claim 4) must be coherent, such that the method step(s) of claim 4 must, in all combinations, find antecedent basis in and further limit the scope of either alternative method of claim 3. Claim 4 fails to meet this condition, since the first method step of claim 4 (“wherein the start value used to determined…”) is relevant only to the second method of claim 3, therefore for an embodiment which exhibits the first method (in which a predetermined filling quantity is set) of claim 3, this limitation lacks antecedent basis and is meaningless (therefore not further limiting). Appropriate clarification/correction is required.
Regarding claim 4, the claim defines “a plurality of measurement values for the pressure in the esophageal catheter” in line 7, but later refers to a singular “the measurement value” in line 10, and describes this singular value as the subject of averaging and statistical variance operations. It is unclear how the singular “the measurement value” may be averaged or may be the subject of statistical variance operations. It is also unclear if this singular “the measurement value” refers to one of the “a plurality of measurement values for the pressure in the esophageal catheter” in line 7, or some other value, since the singular “the measurement value” lacks antecedent basis. For both reasons, the scope of the claim is unclear, and the claim is rendered indefinite. Appropriate clarification/correction is required. No reasonable interpretation of the claim can be made to allow for examination of the claim in view of the prior art, therefore no rejection over the prior art is presented. This should not, however, be taken as an indication of allowability of the claim.
Regarding claim 17, the claim recites the limitation "the start value and the end value" in line 3. There is insufficient antecedent basis for this limitation in the claim, since no “start value” or “end value” is defined within the claim or claim 1, upon which claim 17 depends. The meaning of these terms within claim 17 is thus unclear, thereby rendering the scope of the claim indefinite. Appropriate clarification and/or correction is required. For examination purposes, this limitation is understood in view of the specification as referring to a start value and an end value of a measurement range for determining the characteristic property, over which the filling quantity may be varied and the pressure of the catheter recorded, such as in the manner of claim 3.
Regarding claim 17, the terms “very small step size” in claim 17 and “arbitrarily short dwell times” are relative terms which render the claim indefinite. The terms “very small” and “short” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 28, the limitation “at least one controller configured to control and/or regulate a mass flow … introduced into … or withdrawn from the esophageal catheter” invokes 35 U.S.C. 112(f). In regards this limitation, the specification describes that “the controller can be designed to control and/or regulate the mass flow” and “with such a controller, the mass flow … can be reliably set to a predetermined value” ([0073]). However, the written description fails to disclose adequate detail (algorithm) regarding how the disclosed controller is configured to regulate mass flow (regulation to a setpoint requiring a closed-loop control strategy, necessitating feedback - a PID control algorithm, setpoint comparison, etc.), instead describing the pump/valve hardware from [0072] and presenting the bare assertion that the controller “can be designed to” control this hardware to achieve the claimed regulating function. This lack of sufficient structure (algorithm) distinguishing the controller configuration claimed has the effect of rendering the claim indefinite, since the specification gives no basis for determining which of the many possible control strategies which could perform the claimed control/regulation function the inventor actually possessed. Further, because adequate structure has not been identified in the specification for performing the claimed function, the “at least one controller configured to control and/or regulate a mass flow … introduced into … or withdrawn from the esophageal catheter” limitation is interpreted for the purpose of applying prior art as any known mechanical or electrical structure that can perform the control function as claimed.
Regarding claim 37, the claim defines the “an interface for connecting a characterization system” solely using functional language describing what an unclaimed external system (the “a characterization system according to claim 27”, this system being referenced solely within the functional language as an external system with which the interface is designed to interact) is capable of accomplishing via the feature. In particular, the limitation “wherein the interface is designed such that the characterization system is capable of determining at least one property characteristic of the esophageal catheter via the interface” renders the claim indefinite, since it introduces a circularity problem: to know whether a given interface falls inside or outside of the claim, one would not examine the interface itself, but rather would have to consider whether a hypothetical characterization system meeting claim 27’s description would be capable of determining a characteristic property through the interface. That is a test that depends on the capabilities of a separately claimed external apparatus, not on any ascertainable features of the interface being claimed. Further, the characterization system described in claim 27 is itself defined using predominantly functional, capabilities-based language (see Claim Interpretation above). Since the claim does not include any structural qualifiers whatsoever to limit the claimed interface and relies instead upon functional language referencing a system which is itself defined using functional language, it becomes easy to imagine that almost any physical opening or coupling may read upon the claimed configuration given a hypothetical characterization system which is sophisticated enough. These issues create significant uncertainty in regards to the scope of the claim, it being very difficult to determine if a given interface of an esophageal catheter does or does not meet the claimed limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 comprises a first limitation and a second limitation separated by an “and/or” conjunction and is dependent upon claims 1 and 14. However, the first limitation of claim 16 solely comprises the definition of a variable (NFull) which is not referenced within claims 1 or 14. As such, this limitation fails to further limit the subject matter of claims 1 and 14, being structurally and functionally immaterial to the method of claims 1 and 14. Because the invention (method) of claim 16 may be defined solely by the additional subject matter of the first limitation and without consideration of the remainder of the claim (by virtue of the “or” in “and/or”), claim 16 itself fails to further limit the subject matter of the claim upon which it depends in all potential variations. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 27, and 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Der Staay (WIPO Pub. No. 2019/234588 A1).
Regarding claim 1, Van Der Staay discloses a method for automated (initiated by the user, but automatically performed via a test algorithm – see [0016-0017]) ex vivo (in a test chamber/dummy) characterization of an esophageal catheter (tubular measuring probe line 15, 115) with balloon probe (inflatable balloon probe 117) for determining an esophageal pressure (see Fig. 2 and 4, [0003], [0006], [0012-0017], and [0104-0106]), comprising the following steps: filling the esophageal catheter with a measuring fluid (air) ex vivo (in a test chamber/dummy 135 – see installation, inflation, and holding maneuver of steps 51 and 52 of Fig. 2, [0038-0044], and [0096]); detecting a pressure prevailing in the esophageal catheter (step 54 – see Fig. 2, [0045-0047], and [0096], wherein a probe pressure readings Pes are detected continuously during the holding maneuver); determining at least one property (slope m and y-intercept b of the test curve, used to define a measuring probe volume index MVI) characteristic of the esophageal catheter on the basis of the detected pressure (step 60 – see [0052-0072], [0084], [0095-0103], wherein the resulting MVI is constructed based on the probe pressure readings Pes and is characteristic of the particular esophageal catheter tested); and storing at least the property characteristic of the esophageal catheter ([0022-0023], [0073-0083], [0095], and [0100-0101], wherein the resulting test curve and MVI is stored in the storage unit described in [0022-0023], enabling display to and reference use by the user).
Regarding claim 27, Van Der Staay discloses a characterization system (test unit 18/118) for automated ex vivo characterization of an esophageal catheter with balloon probe which can be inserted into the esophagus of a patient to be ventilated, for determining an esophageal pressure (see in re claim 1, and see [0014-0017]), wherein the characterization system comprises: an arrangement for filling the esophageal catheter with a measuring fluid before placing the esophageal catheter in an esophagus (see [0042] and [0096], wherein the balloon probe 117 is filled with air or oxygen while installed in the test chamber 137 in Steps 51-52, thereby inherently requiring a pump and/or a valve), a pressure sensor for detecting a pressure (probe pressure Pes) prevailing in the esophageal catheter (see [0095] and [0105]: here transducer 25/125 in connection with the probe connector 13/113 operates as a pressure sensor for detecting probe pressure Pes); a device (computing unit 19) for determining at least one property (MVI) characteristic of the esophageal catheter on the basis of the pressure (probe pressure Pes) detected in the esophageal catheter (see [0016] and [0095-0096]; wherein the MVI is constructed based on the probe pressure readings Pes and is characteristic of the particular esophageal catheter tested); a storage device (storage unit 21) for storing at least the property characteristic of the esophageal catheter (([0022-0023], [0073-0083], [0095], and [0100-0101], wherein the calculated test curve and MVI are stored in the storage unit described in [0022-0023], enabling display to and reference use by the user); and a controller for controlling the characterization system, which is configured such that the characterization system performs a method according to claim 1 (see in re claim 1, and see [0016] and [0095-0096], wherein the test unit 18/118, via the computing unit 19, executes the test algorithm and, in response to actuation of an input device 22/122, generates a control command causing a valve device 30/140 to trigger the hold maneuver, thus the test unit functions as a controller coordinating the steps of the method described in re claim 1).
Regarding claim 36, Van Der Staay discloses a ventilation device (medical apparatus 10/ventilator 110 – see Fig. 4, [0025], [0084], and [0104-0106]) comprising a characterization system for automated characterization of esophageal catheters with balloon probe, which can be inserted into the esophagus of a patient to be ventilated, for determining an esophageal pressure (probe pressure Pes), according to claim 27 (see in re claim 27, and see Fig. 2 and 4, [0003], [0006], [0012-0017], and [0104-0106]).
Regarding claim 37, Van Der Staay discloses an esophageal catheter with balloon probe for insertion into the esophagus of a patient to be ventilated for determining an esophageal pressure (probe pressure Pes) during mechanical ventilation by means of a ventilation device (see in re claims 1 and 36), comprising: a balloon probe (inflatable balloon probe 117) which can be inserted into the esophagus of a patient to be ventilated (see Fig. 2 and 4, [0003], [0006], [0012-0017], and [0104-0106]) and which can be acted upon by a measuring fluid (air or oxygen – see [0003], [0042], and [0096]), and an interface (probe connector 13/113, connectable to the test unit 18/118 via a probe line 15/115) for connecting a characterization system according to claim 27, wherein the interface is designed such that the characterization system is capable of determining at least one property characteristic of the esophageal catheter via the interface (see in re claim 27, and see Fig. 4, [0095-0100], and [0104-0105], wherein the test unit 18/118 receives probe pressure measurement values for the balloon probe via the probe connector 13/113 and probe line 15/115, thereby enabling it to determine the test curve and VMI).
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) 1-3, 7, 17, 20, 27, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Staay in view of Yang (NPL, “Optimal esophageal balloon volume for accurate estimation of pleural pressure at end-expiration and end-inspiration: an in vitro bench experiment”).
Regarding claim 1, Van Der Staay discloses a method for automated (initiated by the user, but automatically performed via a test algorithm – see [0016-0017]) ex vivo (in a test chamber/dummy) characterization of an esophageal catheter (tubular measuring probe line 15, 115) with balloon probe (inflatable balloon probe 117) for determining an esophageal pressure (see Fig. 2 and 4, [0003], [0006], [0012-0017], and [0104-0106]), comprising the following steps: filling the esophageal catheter with a measuring fluid (air) ex vivo (in a test chamber/dummy 135 – see installation, inflation, and holding maneuver of steps 51 and 52 of Fig. 2, [0038-0044], and [0096]); detecting a pressure prevailing in the esophageal catheter (step 54 – see Fig. 2, [0045-0047], and [0096], wherein a probe pressure readings Pes are detected continuously during the holding maneuver); determining at least one property (slope m and y-intercept b of the test curve, used to define a measuring probe volume index MVI) characteristic of the esophageal catheter on the basis of the detected pressure (step 60 – see [0052-0072], [0084], [0095-0103], wherein the resulting MVI is constructed based on the probe pressure readings Pes and is characteristic of the particular esophageal catheter tested); and storing at least the property characteristic of the esophageal catheter ([0022-0023], [0073-0083], [0095], and [0100-0101], wherein the resulting test curve and MVI is stored in the storage unit described in [0022-0023], enabling display to and reference use by the user).
However, insomuchas the limitation “determining at least one property characteristic of the esophageal catheter on the basis of the detected pressure” may be construed as requiring that the characteristic property be determined from the catheter’s own detected pressure signal, without reference to external pressure sensor signals, Yang discloses a method of testing a balloon probe of the same type as that of Van Der Staay (see Abstract and Background sections) and determining a characteristic property of the balloon probe in the form of VMIN and VMAX – the minimum and maximum inflating volumes defining an optimal balloon volume range corresponding to a linear segment of a sigmoid curve fitted to the balloon probe pressure plotted against balloon volume (see Fig. 1-2 with associated captions and pg. 3, ln 23 – pg. 6, ln 15). This determination is made without reference to any external pressure signal, and the resulting optimal balloon inflation volume range corresponds to the stated goal of Van Der Staay – to enable optimal adjustment of the filling volume of a measuring probe by identifying the optimal filling volume and constructing an index (VMI) to assist the user in interpreting the probe’s filling volume relative to the optimal (see [0012] and [0063] of Van Der Staay). In other words, Yang teaches an alternative method of characterizing the optimal filling volume of a balloon probe based upon measured balloon probe pressure vs. observed filling volume, as opposed to the method of Van Der Staay, which seeks to make the same characterization but based measured balloon probe pressure and a measured external pressure (PAW) (see [0096-0100]). Since Yang is closely related to Van Der Staay in terms of being within the same field of endeavor and seeking to solve the same problem – characterization of the optimal filling volume of a balloon probe – and since the method of Yang, if substituted for the characterization method of Van Der Staay, would simplify the system and method of Van Der Staay by eliminating its dependence upon external instrumentation (pressure sensor for measuring PAW) and achieve a predictable result (both Van Der Staay and Yang employing regression techniques applied to measured balloon pressure date to reach the same category of result – a characteristic parameter used to assess the probe’s fill state), it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method and system of Van Der Staay such that the method step of determining at least one property characteristic of the esophageal catheter on the basis of the detected pressure may comprise the optimal filling volume characterization method of Yang, wherein VMIN and VMAX – the minimum and maximum inflating volumes defining a characteristic optimal balloon volume/filling range – are determined corresponding to a linear segment of a sigmoid curve fitted to the detected balloon probe pressure plotted against balloon volume. Further, by adopting the characterization method of Yang, wherein directly interpretable reference points VMIN and VMAX are determined, as opposed to the abstract slope/intercept based MVI index of Van Der Staay, users are enabled to more quickly and easily assess the balloon probe’s fill state. It would then follow that the method step of storing the optimal balloon volume/filling range of the esophageal catheter may be done in the same manner described in [0022-0023] and [0095], and [0100-0101] of Van Der Staay.
Regarding claim 2, Yang further teaches that the characteristic property may be detected as a characteristic parameter associated with a particular pressure in the esophageal catheter (see Yang, Fig. 2 with associated captions, and “Balloon volume determination by sigmoid regression” section, wherein VMIN is defined as the balloon volume at a specific balloon pressure equal to c-d, and VMAX is defined as the balloon volume at a specific balloon pressure equal to c+d, thereby each is expressly associated with a particular pressure value). Because the characterization method of Yang is incorporated into the method and system of Van Der Staay in the above modification, the proposed combination of Van Der Staay as modified in view of Yang also exhibits the claimed feature.
Regarding claim 3, Yang further discloses that, for determining the at least one property characteristic of the esophageal catheter when detecting the pressure prevailing in the esophageal catheter, the filling quantity is changed between a start value (an initial “zero inflating volume” achieved by deflating the balloon under -10cmH2O of pressure) and an end value (the volume at which the balloon pressure exceeds +10cmH2O of pressure) of a measurement range for determining the characteristic property (see “Balloon volume manipulation at atmospheric pressure” section, wherein for this initial sequence of the characterization method, the filling quantity is change in a stepwise manner by progressively inflating the balloon in 0.5 ml increments, starting at the “zero inflating volume” and ceasing when balloon pressure exceeds +10cmH2O of pressure, and “Balloon volume manipulation under simulated passive ventilation”, pg. 4, ln 27 - pg. 5, ln 5, wherein the same procedure is followed in the second sequence of the characterization method in which measurements are taken at simulated end-expiratory and end-inspiratory conditions), and at each of the measurement points resulting in this way a respective pressure in the esophageal catheter detected by a pressure sensor is recorded and associated with the respective filling quantity (see “Balloon volume manipulation at atmospheric pressure” section, pg. 3, ln 33-36 and “Balloon volume manipulation under simulated passive ventilation”, pg. 4, ln 27 - pg. 5, ln 5), and wherein the characteristic property (VMIN and VMAX) for the esophageal catheter is determined on the basis of the recorded pressures and the respectively associated filling quantity (see Fig. 2a with associated captions, Equation 1, and “Balloon volume determination by sigmoid regression” section). Because the characterization method of Yang is incorporated into the method and system of Van Der Staay in the above modification, the proposed combination of Van Der Staay as modified in view of Yang also exhibits the claimed feature.
Regarding claim 7, Yang further discloses that the characteristic property comprises a filling quantity (maximum inflation volume VMAX) of the esophageal catheter corresponding to an upper limit of a linear range and a filling quantity (minimum inflation volume VMIN) of the esophageal catheter corresponding to a lower limit of a linear range (see Fig. 2 and “Balloon volume determination by sigmoid regression” section, wherein a linear region of minimal pressure change during progressive balloon inflation is observed spanning between the point of minimum inflation volume VMIN and the point of maximum inflation volume VMAX). Because the characterization method of Yang is incorporated into the method and system of Van Der Staay in the above modification, the proposed combination of Van Der Staay as modified in view of Yang also exhibits the claimed feature.
Regarding claim 17, Yang further discloses that the quantity (inflation volume) of measuring fluid in the esophageal catheter is changed stepwise (in 0.5 ml increments) between the start value and the end value and in each step a pair of measurement values is determined from the pressure in the esophageal catheter (Balloon pressure) and an associated change in the filling quantity (0.5 ml) in the esophageal catheter (see “Balloon volume manipulation at atmospheric pressure” section, pg. 3, ln 33-36 and “Balloon volume manipulation under simulated passive ventilation”, pg. 4, ln 27 - pg. 5, ln 5), wherein stepwise changing of the filling quantity comprises changes with arbitrary step sizes (Yang arbitrarily selects a 0.5 ml increase as the step size between each successive pair of measurements). Because the characterization method of Yang is incorporated into the method and system of Van Der Staay in the above modification, the proposed combination of Van Der Staay as modified in view of Yang also exhibits the claimed feature.
Regarding claim 20, Yang further discloses that at least two measurement cycles are performed in succession (Yang teaches performing, in succession on the same balloon catheter, a first measurement cycle in which the balloon pressure-volume relationship is determined at atmospheric pressure – see “Ballon volume manipulation at atmospheric pressure” section - and a second measurement cycle in which the ballon pressure-volume relationship is determined under simulated passive ventilation in the bench model – see “Balloon volume manipulation under simulated passive ventilation” section), each measurement cycle comprising filling the esophageal catheter with measuring fluid ex vivo (see in re claim 3) and detecting a pressure prevailing in the esophageal catheter (see in re claim 3). Because the characterization method of Yang is incorporated into the method and system of Van Der Staay in the above modification, the proposed combination of Van Der Staay as modified in view of Yang also exhibits the claimed feature.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Staay as modified by Yang according to claim 1, and in further view of Kremeier (U.S. Pat. Pub. No. 2023/0081811 A1).
Regarding claim 15, Yang teaches that the characteristic property comprises an upper limit (VMAX) and a lower limit (VMIN) of a linear range of the filling quantity (inflation volume) of the esophageal catheter in which the pressure (Ballon pressure) within the esophageal catheter changes substantially linearly with the filling quantity (see Fig. 2 and associated captions, and “Balloon volume determination by sigmoid regression” section, wherein a linear region of minimal pressure change during progressive balloon inflation is observed spanning between the point of minimum inflation volume VMIN and the point of maximum inflation volume VMAX). Yang further teaches that the method comprises in particular: setting a lower filling quantity (initial “zero inflating volume”) of the esophageal catheter (see in re claim 3); increasing the filling quantity (inflation volume) in the esophageal catheter in a stepwise manner while repeatedly determining the pressure (Balloon pressure) and an associated change in the filling quantity (0.5 ml increments of increased balloon volume) in the esophageal catheter with respect to a predetermined start value and with respect to a previous measurement point (see Fig. 2, and see in re claim 3), and determining, from the relationship thus determined between the pressure and the change in the filling quantity in the esophageal catheter, the upper limit (VMAX) and the lower limit (VMIN) of a linear range of the filling quantity of the esophageal catheter in which the pressure (Balloon pressure) within the esophageal catheter changes substantially linearly with the filling quantity (see Fig. 2 and associated captions, and “Balloon volume determination by sigmoid regression” section, wherein a linear region of minimal pressure change during progressive balloon inflation is observed spanning between the point of minimum inflation volume VMIN and the point of maximum inflation volume VMAX). Yang does not teach that the method comprises in particular: setting an upper filling quantity (maximum inflation volume) of the esophageal catheter; reducing the filling quantity (inflation volume) in the esophageal catheter stepwise while repeatedly determining the pressure (Balloon pressure) and an associated change in the filling quantity (incremental volume reduction) in the esophageal catheter with respect to a predetermined start value or with respect to a previous measurement point, the data collection process of Yang being oppositely sequenced – stepwise increase in filling quantity rather than stepwise decrease in filling quantity. However, it is well known within the art that a stepwise decrease in filling quantity may be equivalently chosen for such a data collection procedure. Kremeier, for example, exhibits a method of determining an optimal filling volume of a balloon probe similar to that of Yang and Van Der Staay, wherein the filling volume of the ballon probe may be incrementally changed and the balloon pressure continuously recorded and associated with the changes in filling volume (see Fig. 4, [0010], [0013-0018], [0021-0029] and [0107-0174]). Kremeier teaches that such a procedure may proceed via a stepwise increase starting from a minimum fill volume to a maximum fill volume, or alternatively and equivalently a stepwise decrease starting from a maximum fill volume to a minimum fill volume ([0021-0026]). Based on the teachings and example of Kremeier, it would thus have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Van Der Staay, incorporating the characterization method steps of Yang, such that the data collection process of Yang may be performed in the opposite but equivalent manner of setting an upper filling quantity (maximum inflation volume – the volume at which the balloon pressure exceeds +10cmH2O of pressure) of the esophageal catheter; reducing the filling quantity (inflation volume) in the esophageal catheter stepwise while repeatedly determining the pressure (Balloon pressure) and an associated change in the filling quantity (volume reduction in 0.5 ml increments) in the esophageal catheter with respect to a predetermined start value or with respect to a previous measurement point (as is done in Yang, Fig. 2), this sequencing being equivalent to the increasing increments of inflation volume taught in Yang, thus yielding predictable results, and there being only two alternatives to choose from – incremental increase or incremental decrease.
Claim(s) 25-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Staay in view of Monaghan.
Regarding claim 25, Van Der Staay discloses the method of claim 1, including determining a characteristic parameter (VMI) based on a detected probe pressure (Pes) and storing that parameter (see in re claim 1), and further discloses that a recognition device may be included within the system and may be used to identify a connected probe to activate manufacturer-specific presents ([0024]). Van Der Staay does not teach expressly teach providing the esophageal catheter with at least one identifier associated with the at least one characteristic parameter stored, however, per-unit identification/tagging of medical devices with test data is conventional in medical device manufacturing and calibration contexts within the art.
For example, Monaghan exhibits a system and method for managing medical devices (Fig. 2-3 and [0029-0033], wherein a medical device may be provided with a wireless communication device, in one embodiment an RFID tag (210 – see [0031]), which stores medical device assessment data including usage, diagnostic, and operational parameters specific to that device, together with a serial number identifying the specific unit ([0029-0030]), such that characteristic/operational parameters are stored together and associated with one another on the same indicator (RFID tag) affixed to the device. Monaghan further discloses that this RFID-based approach may be implemented using RFID, NFC, Bluetooth, or Wi-Fi technology ([0043]), and that it enables efficient device-specific tracking, service history, and inventory management ([0022-0023]).
Based on the teachings and example of Monaghan, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system and method of Van Der Staay by providing the esophageal catheter with at least one identifier associated with the characteristic parameter (MVI) determined and stored for that esophageal catheter, such as via an RFID tag storing characteristic parameters alongside a serial number as taught by Monaghan, in order to enable reliable tracking, retrieval, and management of the device-specific characterization data for that individual esophageal catheter with balloon probe, as suggested by Monaghan and consistent with Van Der Staay’s use of a recognition device to identify individual esophageal catheters.
Regarding claim 26, Van Der Staay as modified in view of Monaghan further exhibits that providing the esophageal catheter with an identifier may comprise attaching an RFID carrier or an NFC carrier to the esophageal catheter (see in re claim 25).
Regarding claim 28, Van Der Staay as modified in view of Monaghan further exhibits a device (RFID writer system 312) for providing the esophageal catheter with at least one identifier associated with the at least one characteristic property stored (see in re claim 25, and see Monaghan, [0031]).
Allowable Subject Matter
While no rejections over the prior art are presently presented for claims 9-10, 14, 16, 21, and 24, any indication of allowability regarding these claims is reserved until the respective rejections under 35 U.S.C. 112(b) are overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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, Chelsea Stinson can be reached on (571) 270-1744. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights