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 Objections
Claims 1, 19, and 20 are objected to because of the following informalities:
Claim 1, line 5, “a local sensor, (…) patient’s body or a user-selected” should read “a local sensor, (…) patient’s body, or a user-selected”
Claim 19, line 1, “the system” should read “the pneumatic vest system”
Claim 20, line 1, “the system” should read “the pneumatic vest system”
Appropriate correction is required.
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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 limitations are:
Regarding “a restriction element configured to secure the device body to at least a portion of a patient’s back and/or upper abdominal and minimize pressure variations throughout the patient’s breathing cycle” in claim 8-9, 11-20.
Uses the term “element” which is a generic placeholder for means
The functional language that modified the “element” is that it configured for restriction to secure the device body to at least a portion of a patient’s back and/or upper abdominal and minimize pressure variations throughout the patient’s breathing cycle.
“element” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked. The examiner notes that claim 10 incorporates sufficient structure and therefore does not invoke 112(f).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is 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 claim 20, the phrase "for example" 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).
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.
Claims 8, 9, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huster (US 20180228687).
Regarding claim 8, Huster discloses
a pneumatic vest system (figs. 1, 12-23, and 29-34; inflatable vests 550, 552, 554 with system 300; [0111], [0115]-[0117], [0186]-[0196] and [0211]) comprising:
a device body comprising a plurality of independently controllable inflatable bladders (figs. 1, 29-34; vest 554 contains multiple bladders 600’, 600”, which define inflatable chambers, that are independently controlled; [0194]);
a restriction element configured to secure the device body to at least a portion of a patient's back and/or upper abdomen and minimize pressure variations throughout the patient's breathing cycle (see figs. 37 and 39; back straps 652 with couplers 653 aids with fitting the garment on the patient and may extend around the patient's waist from one side of the bottom region of the vest to the other to prevent or reduce the movement of the bottom region of the vest away from the patient during HFCWO therapy; similarly shoulder straps 640 prevents the upper region of the vest from expanding away from the patient; therefore enhancing concentration the oscillatory forces imparted on the patient; [0208]-[0209] and [0211]); and
a controller operatively coupled to the plurality of independently controllable inflatable bladders (fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the upper and lower region/chambers of the vest 554; [0194]-[0196]),
the controller being configured to regulate an amount of pressure applied to at least a portion of the patient's back and/or upper abdomen (see fig. 31; bladders 600’, 600” are positioned on the patient’s upper abdomen) by controlling inflation and deflation of each of the plurality of independently controllable inflatable bladders (fig. 31; the controller 616 commands the operation of air pulse modules 612, 614 which may regulate the pressure such as the baseline pressure and/or amplitude of the oscillating pressure of the four bladders 600’, 600”; [0194]-[0196]; therefore the therefore, that specific bladders 600′, 600″ of vest 554 can be inflated (and deflated as the pressure is oscillating) according to different pressure and frequency settings).
Regarding claim 9, Huster further discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8,
wherein the controller is configured to control inflation and deflation of each of the plurality of independently controllable inflatable bladders (fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]) based at least in part on oxygenation data indicative of a detected oxygen level in the patient's body (figs. 12-23; system 300 which comprises the air pulse generator, further comprises an assessment system including a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where data from the assessment system is used to adjust the frequency and intensity of the HFCWO therapy; [0006]) or a user- selected target oxygen level.
Regarding claim 17, Huster further discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8, further comprising:
a graphical user interface in electronic communication with the controller (figs. 12-23; system 300 comprises a user interface/display 330 which is electrically connected to the controller; [0117] and [0124]) that is configured to receive user inputs and facilitate monitoring of the patient (figs. 12-23; display is configured to monitor various data on the screen and allows the caregiver to control the operation of the pulse generator, such as user input for entry of different operating parameter of air modules 612,614, and other operations of the respiratory system; [0117], [0194]-[0196], and [0211]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Biondo (US 20020104535) in view of Huster (US 20180228687).
Regarding claim 1, Biondo discloses
a method for improving oxygenation, being either a synergistic mode with proning or a replacement therapy (figs. 7, 11, 18, and 26-33; a method for improving oxygenation through cycling and proning using a pneumatic vest and a ventilator system; [0112] and [0127]), the method comprising:
receiving, by a controller operatively coupled to a wearable pneumatic vest (figs. 26-33; controller 307 controls switching valve 312 which inflates bladders 294-300 of vest 280; [0124]-[0129]),
regulating, by the controller, a pressure applied to at least a portion of the patient's back and/or upper abdomen by the wearable pneumatic vest (figs. 26-33; the controller 307 regulates which bladders 294-300 receive pressure/are inflated based on periodic cycles; [0124]-[0129]; see fig. 29, bladders 294 and 296 are placed on the front portion 282 and bladders 298 and 300 are placed on the rear portion 284 of vest 280; [0124]-[0129]).
Biondo does not disclose a control input from a local sensor, another device in communication with the controller indicative of a detected oxygen level in a patient's body or a user-selected target oxygen level received via manual input or by adjusting pneumatic vest settings; determining, by the controller, a plurality of operating parameters for the wearable pneumatic vest based at least in part on the detected oxygen level or the user-selected target oxygen level; and regulating, by the controller, an amount of pressure applied to at least a portion of the patient's back and/or upper abdomen by the wearable pneumatic vest based at least in part on the plurality of operating parameters.
Huster discloses an analogous wearable vest with inflatable bladders comprising
a control input from a local sensor, another device in communication with the controller indicative of a detected oxygen level in a patient's body (figs. 12-23 and 31; assessment system comprises a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where controller 616 commands the operation of air pulse modules 612, 614 [0194]-[0196] (HFCWO) and the data is used to adjust the frequency and intensity of the HFCWO therapy; [0006]) or a user-selected target oxygen level received via manual input or by adjusting pneumatic vest settings;
determining, by the controller, a plurality of operating parameters for the wearable pneumatic vest (fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]) based at least in part on the detected oxygen level (figs. 12-23; system 300 which comprises the air pulse generator, further comprises an assessment system including a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where data from the assessment system is used to adjust the frequency and intensity of the HFCWO therapy; [0006]) or the user-selected target oxygen level; and
regulating, by the controller, an amount of pressure applied to at least a portion of the patient's back and/or upper abdomen (see fig. 31; bladders 600’, 600” are positioned on the patient’s upper abdomen) by the wearable pneumatic vest (fig. 31; the controller 616 commands the operation of air pulse modules 612, 614 which may regulate the pressure such as the baseline pressure and/or amplitude of the oscillating pressure of the four bladders 600’, 600”; [0194]-[0196]; therefore the therefore, that specific bladders 600′, 600″ of vest 554 can be inflated (and deflated as the pressure is oscillating) according to different pressure and frequency settings) based at least in part on the plurality of operating parameters (figs. 12-23; system 300 which comprises the air pulse generator, further comprises an assessment system including a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where data from the assessment system is used to adjust the frequency and intensity of the HFCWO therapy; [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and pump system of Biondo with the pulse oximeter, controller, and air pulse generator of Huster such that the bladders may be operable independently according to different operating parameters such that the intensity and frequency imparted on the patient by bladders may be unique and different than the intensity and frequency of oscillatory forces imparted on the patient by the other bladders (Huster: [0194]-[0196]).
Regarding claim 3, the modified method of Biondo further discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control) of any of claim 1,
wherein the wearable pneumatic vest comprises a plurality of inflatable bladders (Biondo: see fig. 29, bladders 294 and 296 are placed on the front portion 282 and bladders 298 and 300 are placed on the rear portion 284 of vest 280; Huster: figs. 1, 29-34; vest 554 contains multiple bladders 600’, 600”, which define inflatable chambers, that are independently controlled; [0194]).
Claims 2, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Biondo (US 20020104535) in view of Huster (US 20180228687) and further in view of Garrison (US 20050126578).
Regarding claim 2, the modified method of Biondo discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control) of claim 1, further comprising:
receiving, by the controller, oxygenation data (Huster: a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]), wherein the plurality of operating parameters are determined based at least in part on the oxygenation data (Huster: figs. 12-23; where data from the assessment system (which uses the pulse oximeter) is used to adjust the frequency and intensity of the HFCWO therapy; [0006]).
Garrison discloses an analogous pressure garment used in combination with a ventilator (abstract) where the system further comprises
receiving, by the controller, oxygenation data obtained via at least one other device (figs. 1-2; the PLC 60 receives oxygenation data using transcutaneous oxygen and carbon dioxide sensors and arterial blood gas sensors 43; [0041], [0043]-[0047]), wherein the plurality of operating parameters are determined based at least in part on the oxygenation data (figs. 1-2; the PLC 60 adjusts the cuff pressure and tidal volume, respiratory rate, and inspired oxygen concentration; [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and controller of Huster with the PLC and sensors as disclosed in Garrison to adjust the inspired oxygen concentration delivered to the patient in order to achieve desired arterial pH, blood gas concentrations, and meet clinician-selected parameters (Garrison: [0010], [0012] and [0047]) while also facilitating improved inspiratory-expiratory functionality and oxygen supply via blood flow through pressure sequence for the cuffs (Garrison: [0042]-[0048]).
Regarding claim 4, the modified method of Biondo further discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control; Garrison: sensors and PLC for facilitating improved oxygen supply) of claim 2,
wherein the plurality of operating parameters comprises a duty cycle for each of a plurality of inflatable bladders (Biondo: figs. 12-23; where the bladders 294a, 296a, 298a, and 300a are inflated during periodic cycle; [0127]; Garrison: PLC 60 controls pressure cuffs using a pressure sequencing and data; [0041]-[0047]).
Regarding claim 5, the modified method of Biondo discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control; Garrison: sensors and PLC for facilitating improved oxygen supply) of claim 4,
wherein determining the plurality of operating parameters comprises:
identifying, by the controller and based at least in part on the oxygenation data (Garrison: figs. 1-2; the PLC 60 receives oxygenation data using transcutaneous oxygen and carbon dioxide sensors and arterial blood gas sensors 43; [0041], [0043]-[0047]), the detected oxygen level (Huster: figs. 12-23 and 31; assessment system comprises a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where controller 616 commands the operation of air pulse modules 612, 614 [0194]-[0196] (HFCWO) and the data is used to adjust the frequency and intensity of the HFCWO therapy; [0006]), or the user-selected target oxygen level, a target location of the patient's back and/or upper abdomen (Biondo: figs. 26-33; the controller 307 regulates which bladders 294-300 receive pressure/are inflated based on periodic cycles such that air is forced downwardly into the lower portion of the lungs [0124]-[0129]) and Garrison: adjusts cuff pressure and pressure sequence of the external garment and ventilation based on received data from the PLC 60 to externally compress the lungs to assist the patient with expiratory functionality and improves the flow of oxygen-enriched blood; [0045]) and a corresponding pressure value (Huster: figs. 12-23; where data from the assessment system (which uses the pulse oximeter) is used to adjust the frequency and intensity (pressure) of the HFCWO therapy; [0006], [0116], [0126], and [0194]-[0196]);
selecting, by the controller, at least one of the plurality of inflatable bladders associated with the target location (Biondo: figs. 26-33; the controller 307 regulates which bladders 294-300 receive pressure/are inflated based on periodic cycles such that air is forced downwardly into the lower portion of the lungs [0124]-[0129]; Garrison: figs. 1, 2, and 7; selecting an abdominal cuff and then a thoracic cuff to externally compress the lungs to assist the patient with expiratory functionality; [0045]); and
causing, by the controller, at least one of the plurality of inflatable bladders to inflate or deflate to reach the corresponding pressure value (Huster: figs. 12-23; where data from the assessment system (which uses the pulse oximeter) is used to adjust the frequency and intensity (pressure) of the HFCWO therapy and where the controller 616 commands the operation of air pulse modules 612, 614 which may regulate the pressure such as the baseline pressure and/or amplitude of the oscillating pressure of the four bladders 600’, 600”; [0006], [0116], [0126], and [0194]-[0196]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Biondo (US 20020104535) in view of Huster (US 20180228687) and further in view of Brans (US 20220331200).
Regarding claim 6, the modified method of Biondo discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control) of claim 1, further comprising:
While the modified method of Biondo discloses using pulse oximeter data to adjust the intensity of the pressure of the bladders (Huster: [0006], [0116], [0126]), it does not explicitly disclose receiving, by the controller, sensor data for the patient; adjusting, by the controller, the plurality of operating parameters based at least in part on the sensor data; and modifying, by the controller, the amount of pressure applied to at least a portion of the patient's back and/or upper abdomen by the wearable pneumatic vest based at least in part on the adjusted operating parameters.
Brans discloses an analogous wearable pneumatic vest (figs. 1-3b; vest bod 110a with an air flow generator 102a; [0029]) comprising
receiving, by the controller, sensor data for the patient (see figs. 1-4; each of the compartments 303a comprises one or more pressure sensors 107 that is located between each compartment and the patient 203; [0031], [0034], [0041]; where the computer 400 with the controller 440 sends and received data from the devices; [0054]-[0059], and claim 2);
modifying, by the controller, the amount of pressure applied to at least a portion of the patient's back and/or upper abdomen by the wearable pneumatic vest (figs. 1-3b; pneumatic vest may utilize an air generator to control or adjust the inflation/deflation based on the one or more pressure sensor 107 which provide an indication of inflation level of each of the compartments; [0028], [0034], [0041]-[0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the bladders of the modified method of Biondo to have one or more pressure sensors between the compartment and the patient as disclosed in Brans in order to detect areas of proper or improper fit during therapy (e.g., body shape, body position, posture, etc.) and independently adjust the inflation/deflation of each of the compartments based on whether the sensor data meets the desired thresholds, acceptable ranges, or baseline values. (Brans: [0042], [0045], [0046]).
It directly follows that the resultant controller and bladders of Biondo combined with the one or more pressure sensors of Brans would meet the claimed structural limitations since:
adjusting, by the controller, the plurality of operating parameters (Huster: fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]) based at least in part on the sensor data (Brans: adjust the inflation/deflation based on the indication of inflation level of each of the compartments; [0028], [0034], [0041]-[0046]) and
modifying, by the controller, the amount of pressure applied to at least a portion of the patient's back and/or upper abdomen by the wearable pneumatic vest based at least in part on the adjusted operating parameters (Brans: figs. 1-3b; pneumatic vest may utilize an air generator to control or adjust the inflation/deflation based on the one or more pressure sensor 107 which provide an indication of inflation level of each of the compartments; [0028], [0034], [0041]-[0046]; Huster: fig. 31; commands the operation of air pulse modules 612, 614 which may regulate the pressure such as the baseline pressure and/or amplitude of the oscillating pressure of the four bladders 600’, 600”; [0194]-[0196]).
Regarding claim 7, the modified method of Biondo further discloses
the method (Biondo: method for improving oxygenation; Huster: pulse oximeter and air pulse generators for independent control; Brans: array of pressure sensors for further control) of claim 6,
wherein the sensor data comprises at least one of an internal pressure value for each of a plurality of inflatable bladders, vibration data, audio data, or an applied amount of pressure (Brans: figs. 1-4b; one or more pressure sensors 107 measures pressure between each of the inflatable compartments and the patient 203; therefore, it is measuring the localized mechanical transcutaneous pressure applied to the patient at each of the compartments; [0031], [0034], [0041]-[0046]) to at least a portion of the patient's back and/or upper abdomen (Biondo: see fig. 29, bladders 294 and 296 are placed on the front portion 282 and bladders 298 and 300 are placed on the rear portion 284 of vest 280; [0124]-[0129]).
Claim 10 is ejected under 35 U.S.C. 103 as being unpatentable over Huster (US 20180228687) in view of a second embodiment of Huster (US 20180228687).
Regarding claim 10, Huster discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8,
wherein the restriction element comprises one or more straps attached to an anterior surface of the device body (see figs. 37 and 39; back straps 652 and shoulder straps 640 are attached to the outside surface of the vest body; [0208]-[0209] and [0211]).
Huster does not explicitly disclose wherein the restriction element comprises one or more removable straps.
A second embodiment of Huster discloses straps 529 to tighten the garment 508 in place relative to the patient [0184]-[0185],
wherein the restriction element comprises one or more removable straps (fig. 28; buckles or other releasable fasteners may couple straps 529 to layers 509 of garment 508; [0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps and vest of Huster with the releasable fasteners or buckles of the second embodiment of Huster to provide adjustability to the amount that the straps extend away from layers 509 so that patients of different sizes may be accommodated (Huster: [0184]).
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Huster (US 20180228687) in view of Brans (US 20220331200).
Regarding claim 11, Huster discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8, further comprising:
Huster does not disclose at least one sensor array located on a posterior portion of the wearable pneumatic vest.
Brans discloses an analogous wearable pneumatic vest (figs. 1-3b; vest bod 110a with an air flow generator 102a; [0029]) comprising
at least one sensor array located on a posterior portion of the wearable pneumatic vest (see figs. 1-3b; each of the compartments 303a comprises one or more pressure sensors 107 that is located between each compartment and the patient 203; [0031], [0034], [0041]; each compartment being provided with one or more sensors creates a sensor array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the bladders of Huster to have one or more pressure sensors between the compartment and the patient as disclosed in Brans in order to detect areas of proper or improper fit during therapy (e.g., body shape, body position, posture, etc.) and independently adjust the inflation/deflation of each of the compartments based on whether the sensor data meets the desired thresholds, acceptable ranges, or baseline values. (Brans: [0042], [0045], [0046]).
Regarding claim 13, the modified device of Huster further discloses
the pneumatic vest system (Huster: inflatable vests with system 300; Brans: array of pressure sensors for independent control) of claim 11,
wherein the at least one sensor array is configured to monitor at least one of a localized transcutaneous pressure value (Brans: figs. 1-4b; one or more pressure sensors 107 measures pressure between each of the inflatable compartments and the patient 203; therefore, it is measuring the localized mechanical transcutaneous pressure applied to the patient at each of the compartments, in other words, the pressure sensors interfaced between each of the compartments and the patient measures the force between the two as the compartment inflates/presses the pressure sensor against the patient; [0031], [0034], [0041]-[0046]), cardiovascular pressure values, and an esophageal pressure value.
Regarding claim 13, the modified device of Huster further discloses
the pneumatic vest system (Huster: inflatable vests with system 300; Brans: array of pressure sensors for independent control) of claim 12,
wherein the at least one sensor array comprises at least one of a pressure sensor (Brans: see figs. 1-3b; each of the compartments 303a comprises one or more pressure sensors 107 that is located between each compartment and the patient 203; [0031], [0034], [0041]; each compartment being provided with one or more sensors creates a sensor array), a vibration sensor, and an audio sensor.
Regarding claim 15, the modified device of Huster further discloses
the pneumatic vest system (Huster: inflatable vests with system 300; Brans: array of pressure sensors for independent control) of claim 11,
wherein the controller is further configured to control inflation and deflation of each of the plurality of independently controllable inflatable bladders (Huster: fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]) based at least in part on sensor data obtained from the at least one sensor array (Brans: figs. 1-3b; pneumatic vest may utilize an air generator to control or adjust the inflation/deflation based on the one or more pressure sensor 107 which provide an indication of inflation level of each of the compartments; [0028], [0034], [0041]-[0046]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huster (US 20180228687) in view of Receveur (US 8845562).
Regarding claim 14, Huster discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8,
Huster does not disclose wherein each of the plurality of independently controllable inflatable bladders is operatively coupled to a respective pressure sensor via a pneumatic connector, and wherein each respective pressure sensor is configured to monitor an internal pressure value for one of the plurality of independently controllable inflatable bladders.
Receveur discloses a pressurized mattress containing individual inflatable cells, a compression sleeve with multiple zones, and a pneumatic vest device (figs. 1-6)
wherein each of the plurality of independently controllable inflatable bladders is operatively coupled to a respective pressure sensor via a pneumatic connector (fig. 1; the gas bladders 26 have a plurality of sensors S1 to measure pressure through sense lines that are pneumatically coupled to the gas bladders 26; col. 3, lines 21-27), and
wherein each respective pressure sensor is configured to monitor an internal pressure value for one of the plurality of independently controllable inflatable bladders (see fig. 1; each of the bladders 26 comprises its own individual sensor S1 to measure pressure through the sense line that is coupled to the bladder 26; such as a first bladder at a first pressure, a second bladder at a second pressure, and a third bladder at third pressure; col. 1, lines 31-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladders of the vest of Huster with the plurality of sensors coupled to the bladders as disclosed in Receveur to measure the fluid pressure within the gas bladders and be able to adjust and maintain each bladder at a respective pressure (Receveur: col. 1, lines 31-41, col. 3, lines 21-27, co1. 6, lines 53-67 and col. 7, lines 1-46).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Huster (US 20180228687) in view of Stec (US 20220031494).
Regarding claim 16, Huster comprises
the pneumatic vest system (inflatable vests with system 300) of claim 9,
wherein the controller comprises that is configured to drive an internal pressure of each of the plurality of independently controllable inflatable bladders to a specified internal pressure (fig. 31; controller 616 commands the operation of air pulse modules 612, 614 regulate the pressure such as the baseline pressure and/or amplitude of the oscillating pressure of the four bladders 600’, 600” and are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]) based at least in part on the oxygenation data or the user selected target oxygen level (figs. 12-23; system 300 which comprises the air pulse generator, further comprises an assessment system including a pulse oximeter to measure the patient’s blood oxygenation; [0116], [0126]; where data from the assessment system is used to adjust the frequency and intensity of the HFCWO therapy; [0006]).
Huster does not explicitly disclose wherein the controller comprises a Proportional-Integral-Derivative (PID) controller that is configured to drive an internal pressure to a specified internal pressure.
Stec discloses a pneumatic compression bandage which includes a cuff with a chamber to be filled with pressurized fluid and comprises a control and pumping unit 6 (abstract)
wherein the controller comprises a Proportional-Integral-Derivative (PID) (fig. 1 the controller is a PID controller: one of 4 known controller types (P,PI,PD,PID); [0033]) and the controller that is configured to drive an internal pressure to a specified internal pressure (fig. 1; where the controller controls the pump to increase pressure until the pressure value is higher than or equal to the preset one is reached or control the pressure within the cuff when the pressure if too high or too low; [0033] and [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the controller of Huster to be a PID controller as disclosed in Stec to yield the predictable results of having a rarer and shorter activation of the pump and the valve->smaller battery use, being able to more effectively and more accurately reach and maintenance the preset pressure value and, consequently, compression force (Stec: [0031]-[0032]).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Huster (US 20180228687) in view of Garrison (US 20050126578).
Regarding claim 18, Huster discloses
the pneumatic vest system (inflatable vests with system 300) of claim 8, further comprising:
While Huster discloses a respiratory therapy system being interfaced with system 300 ([0116] and [0125]), it does not disclose a ventilator configured for delivering varying concentrations of oxygen to the patient's lungs , the controller having an interface to communicate with the ventilator.
Garrison discloses an external pressure system for assisting respiratory functions where
a ventilator configured for delivering varying concentrations of oxygen to the patient's lungs (fig. 1-10; a coordinated positive pressure inspiratory ventilator 90 allows control of aerosolized pharmaceuticals for control of airway resistance and automatic control of respiratory rate, tidal volume, and inspired oxygen concentration; [0010], [0012] and [0047]), the controller having an interface to communicate with the ventilator (see fig. 2; ventilator 90 is interfaced/communicates with PLC 60 to adjust adjusts tidal volume, respiratory rate, and inspired oxygen concentration; [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and controller of Huster with the ventilator, PLC, and sensors as disclosed in Garrison to adjust the inspired oxygen concentration delivered to the patient in order to achieve desired arterial pH, blood gas concentrations, and meet clinician-selected parameters (Garrison: [0010], [0012] and [0047]) while also facilitating improved oxygen supply via blood flow through pressure sequence for the cuffs (Garrison: [0042]-[0048]).
Regarding claim 19, the modified device of Huster further discloses
the system (Huster: inflatable vests with system 300; Garrison: PLC interfaced with ventilator for varying oxygen concentration and sensors) of claim 18,
wherein the controller is in operable communication with at least one of
a pulse oximeter (Huster: figs. 12-23; system 300 which comprises the air pulse generator, further comprises an assessment system including a pulse oximeter; [0116], [0126]]), a blood oxygen monitor (Garrison: PLC 60 monitors transcutaneous, intraarterial oxygen, oxygen saturation, and cardiovascular vital signs through using transcutaneous oxygen sensors, arterial blood gas sensors 43, and EKG leads; [0044], [0047],[0048], and [0050]), and ventilation equipment (Garrison: ventilator 60; [0047]; Huster: respiration therapy system may further comprises a spirometer for lung assessment; [0133]) to facilitate measurement of at least one of
lung mechanics (Huster: fig. 19; spirometer 370 is configured to measure the lung volume (the volume of air inhaled and exhaled), the flow rate (the displacement volume per unit of time) and the lung elasticity of the patient; [0133]), impact on cardiovascular function, and intra-abdominal pressure (Huster: pulse oximeter measure the patient’s blood oxygenation; [0116], [0126]; pulse oximeters also measure pulse rate; Garrison: set of sensors attached to the subject monitor cardiovascular vital signs; [0044], [0047],[0048], [0050] and claim 3).
Regarding claim 20, the modified device of Huster further discloses
the system (Huster: inflatable vests with system 300; Garrison: PLC interfaced with ventilator for varying oxygen concentration and sensors) of claim 19,
wherein the controller is configured to regulate the pressure applied by the pneumatic vest (Huster: fig. 31; controller 616 commands the operation of air pulse modules 612, 614 which are used to independently inflate/deflate the bladders 600’, 600” of the vest 554; [0194]-[0196]; Garrison: fig. 2; PLC 60 controls the pressure cuffs via supply lines 31A-31B; [0046] and sequences the cuffs to compress the lungs to assist expiratory functionality; [0045]) based at least in part on one or more ventilator operating parameters (the external pressure garment is used in combination with a positive pressure ventilator such that complete respiratory control--both expiratory and inspiratory functions--of the patient can be achieved; [0047], the PLC 60 adjusts tidal volume, respiratory rate, and inspired oxygen concentration and further adjusts cuff pressure while monitoring expiratory pressure and flow rate; [0047]) (e.g., a ventilator mode, a pressure, a rate, a tidal volume, a peak flow, a positive end-expiratory pressure, a fractional concentration of oxygen, and an inspiratory time).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ashkenazi (US 20230226293) discloses a pneumatic vest which includes multiple sensor to help control inflation/deflation of the chambers including a sensor selected from a group consisting of a pressure sensor, a microphone, a volumeter, an impedance sensor, an imaging system, a strain gauge, sensors for lung auscultation, and a combination thereof.
Gattinoni (US 6461315) – An apparatus for improving distribution of gas in the lungs of a patient receiving respiratory treatment from a ventilator using a vest with selectively pressurized compartments
Pan (US 20180000651) – A compression therapy device with a plurality of inflatable chambers and an array of sensors which includes at least one pressure sensor
Barak (US 20050159690) – A compression sleeve with a plurality of cuff cells hat are connected to a pressure sensors array that measures pressure at the end of each pressure line connecting to the cells such that the sleeve can be independently inflated by the pump unit and can vary according to desired treatments
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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