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 .
Specification
The abstract of the disclosure is objected to because the inclusion of legal phraseology should be avoided [“said cuff” (line 2)]. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim(s) 15-16, 20, and 22-23 is/are objected to because of the following informalities:
Claim 15 should read “being equal to the first predefined pressure and/or the second predefined pressure or between the first predefined pressure and the second predefined pressure” [lines 4-5].
Claim 16 should read “to set [[as]] the third predefined pressure as the value of said optimal pressure” [lines 6-7].
Claim 20 should read “[[a]] the wearable blood monitoring device according to claim 13” [line 2].
Claim 22 should read “being equal to the first predefined pressure and/or the second predefined pressure or between the first predefined pressure and the second predefined pressure” [lines 4-5].
Claim 23 should read “setting [[as]] the third predefined pressure as the value of said optimal pressure” [lines 5-6].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 18-20 and those dependent therefrom is/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.
Claim 18 recites the limitation “the processing unit” [line 1], which is considered to lack antecedent basis, as claims 13 and 18 fail to previously define a processing unit, such that it is unclear whether claim 18 is meant to define a new element of a processing unit or refer to the control unit as performing the functions of the claimed processing unit; and wherein the recited limitation is further considered to render claim 18 indefinite, as it is not clear whether claim 18 is meant to be dependent from claim 16, which does define a processing unit to provide antecedent basis to the processing unit as recited in claim 18. For examination purposes, the Examiner has interpreted any interpretation as identified above to be applicable in light of any prior art applied under § 102 or § 103. Claim 19 is considered to recite similar subject matter to claim 18 that lacks antecedent basis and further renders claim 19 indefinite [“the processing unit” (line 2)], such that it is unclear whether claim 19 is meant to define a new element of a processing unit, or is meant to be dependent from any of claims 16 or 18 to provide antecedent basis for the processing unit. For examination purposes, the Examiner has interpreted any interpretation as identified with respect to claim 19 above to be applicable in light of any prior art applied under § 102 or § 103.
Claim 20 recites the limitation “a first predefined pressure to a second predefined pressure” [lines 4-5], which is considered indefinite, as claim 20 is dependent from claim 13, which previously defines “a first predefined pressure” [lines 11-12] and “a second predefined pressure” [line 12], such that it is unclear whether the first/second predefined pressures of claim 20 are meant to refer to the previously defined first/second predefined pressures of claim 13 or define new first/second predefined pressures. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any prior art applied under § 102 or § 103.
Claim 20 recites the limitation “acquiring at least one physiological signal” [line 6], which is considered indefinite, as claim 20 is dependent from claim 13, which previously defines “at least one physiological signal” [lines 12-13], such that it is unclear whether the at least one physiological signal of claim 20 is meant to refer to the previously defined at least one physiological signal of claim 13 or define a new at least one physiological signal. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any prior art applied under § 102 or § 103.
Claim 20 recites the limitation “a time window” [line 6], which is considered indefinite, as claim 20 is dependent from claim 13, which previously defines “a time window” [line 13], such that it is unclear whether the time window of claim 20 is meant to refer to the previously defined time window of claim 13 or define a new time window. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any prior art applied under § 102 or § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 13-24 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 1 [representing all independent claims] recite(s):
A wearable blood monitoring device configured to be worn around a limb of a subject, the device comprising:
a cuff configured, in use, to surround the limb of the subject, said cuff comprising an inflatable compartment and at least one first sensor configured to be in contact with the limb of the subject, said first sensor being configured to acquire a physiological signal from the limb;
a second sensor configured to acquire a pressure signal relating to a pressure inside the inflatable compartment;
a pumping unit configured to regulate the pressure inside the inflatable compartment; and
a control unit configured to inflate and/or deflate the inflatable compartment from a first predefined pressure to a second predefined pressure, and acquire at least one physiological signal from the first sensor in a time window while the inflatable compartment is inflated and/or deflated.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 1 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“acquire at least one physiological signal from the first sensor in a time window while the inflatable compartment is inflated and/or deflated” – may be performed by merely observing at least a limited amount of known or previously collected data, wherein the recitation of the control unit “being configured to” perform the acquisition “in a time window while the inflatable compartment is inflated and/or deflated” is not considered to positively recite any step of data gathering and is instead considered to merely further limit the type of data
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 1 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity identified above, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 18-19 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 18-19 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claim(s) 13 as individual whole(s) fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring, storing signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [controller, processor, each recited at a high level of generality and corresponding functions therein], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and corresponding functions, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 13 recites “a cuff configured, in use, to surround the limb of the subject, said cuff comprising an inflatable component”, wherein the control unit is configured to “inflate and/or deflate the inflatable compartment from a first predefined pressure to a second predefined pressure”, and “a pumping unit configured to regulate the pressure inside the inflatable compartment”; claims 14/21 recites “wherein the pressure in the inflatable compartment has a plurality of pressure values comprised between the first predefined pressure and the second predefined pressure”; claims 15/22 recites wherein the inflatable compartment may be at a “third predefined pressure… said third predefined pressure being configured to ensure optical contact between the first sensor and the limb of the subject, and being equal or comprised between the first predefined pressure and the second predefined pressure”; claim 17 recites wherein the inflatable compartment may “inflate and/or deflate… linearly in the time window”; claim 20 recites “inflating and/or deflating the inflatable compartment from a first predefined pressure to a second predefined pressure”. Such a cuff and pumping unit is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed pumping unit, and recites pumping unit at a high level of generality [For example, the pumping unit 11 may be a rolling air pump, a piezo electric pump, a resonant gas pump, a diaphragm/membrane gas pump, and the like. The pumping unit 11 may further comprise one or more active or passive valves (e.g., blowers) (Applicant’s Specification ¶0044)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of pressure cuffs. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Muehlsteff (US-20160100805-A1) [the pump 52 is for blowing air or other gas into the cuff 58 in order to inflate the cuff 58 and prevent blood flow in the limb around which the cuff 58 is placed (Muehlsteff ¶0090, Fig. 3)]
Schlottau (US-20140171780-A1) [FIG. 14 is alternate embodiment in which the sensor 12 includes an inflatable bladder 138 positioned within the cup 132. Inflation of the bladder 138 pushes the substrate 136 holding the emitter 16 and the detector 18 against the tissue. An inflation line 139 is accessible to an operator to connect to an external fluid source. Inflation of the bladder 138 may be accomplished via a syringe coupled to an inflation port or via a pumping mechanism that is controlled by the monitor 14 (Schlottau ¶0050)]
Borgos (US-20080071180-A1) [the occluding device 102 can be an adhesive bandage or a cuff (e.g., an elastic cuff or an inflatable cuff). In some implementations, the occluding device 102 can be an inflatable cuff 120 having an inflatable bladder 122. The bladder 122 can be pneumatically connected to a pump 124 via a hose 116. For example, a pneumatically inflatable cuff can be inflated (e.g., via a pump 124) and deflated (e.g., via a valve 126) to adjust the pressure applied to a portion of a subject's body 112 (Borgos ¶0038)]
Claim 13 recites “at least one first sensor configured to be in contact with the limb of the subject, said first sensor being configured to acquire a physiological signal from the limb”; claim 19 recites “wherein the at least one first sensor is an optical sensor”, wherein based on the broadest reasonable interpretation of the cuff and the at least one first sensor, the at least one first sensor is considered to be positioned about a casing [Applicant’s Specification ¶0046, Fig. 1]. Such a first sensor is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed first sensor, and recites the first sensor at a high level of generality [Said first sensor 12 is preferably an optical sensor such as a photoplethysmographic (PPG) sensor (Applicant’s Specification ¶0046)] . This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of monitoring physiological parameters. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Muehlsteff [the monitor 50 further comprises a physiological parameter sensor 64 that is for measuring a physiological parameter of the subject while the cuff 58 is being inflated (Muehlsteff ¶0091, Fig. 3); the sensor 64 can be integrated with the cuff 58 so the subject only has to place the cuff around their arm in order to start using the monitor 50 (Muehlsteff ¶0093)]
Schlottau [the sensor 12 may include optical components in the forms of emitters 16 and detectors 18. The emitter 16 and the detector 18 may be arranged in a reflectance or transmission-type configuration with respect to one another… Such sensors 12 may be used for pulse oximetry or regional saturation monitoring (e.g., INVOS.RTM. monitoring) (Schlottau ¶0034)]
Borgos [The inflatable cuff 120 can be adapted to be wrapped around the upper arm of a subject to allow the motion sensor 104 to detect movement due to arterial pulses from the brachial artery. The components of the motion sensor 104 can be packaged within a housing 200 located at the at the midpoint 134 of the cuff 120 (Borgos ¶0045)]
Claim 13 recites “a second sensor configured to acquire a pressure signal relating to a pressure inside the inflatable compartment”. Such a second sensor is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed second sensor, and recites the second sensor at a high level of generality [The device 1 further comprises a second sensor 13 configured to acquire a pressure signal relating to a pressure inside the inflatable compartment 101. The second sensor 13 may be laid onto the inflatable compartment 101. In some cases, the second sensor 13 is wired or wirelessly connected to a control unit 14 (which will be described later). In other examples, the second sensor 13 is located in a casing 15. Preferably, the second sensor 13 and the control unit 14 are located in the same casing 15 (Applicant’s Specification ¶0047)] . This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of pressure sensing In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Muehlsteff [A control unit 62 is connected to the pump 52 and the valve 56 to control the operation of those components, and is also connected to the pressure sensor 54 in order to receive the signal representing the pressure of the gas in the cuff 58 (the ‘pressure signal’) (Muehlsteff ¶0089, Fig. 3)]
Borgos [The cuff 120 can be wrapped around a subject's limb and the bladder 122 inflated to impart a pressure on the limb. The bladder 122 can be connected to a pump 124 by a hose 116. The bladder 122 can also be attached to a valve 126 which can control the deflation of the bladder 122. The pressure in the bladder 122 can be measured with a pressure transducer 128. The pressure transducer 128 can be located in the bladder, as shown, or can be pneumatically connected to the bladder 122 (e.g., via the hose 116) (Borgos ¶0045)]
Banet (US-20100160798-A1) [For the pressure-dependent measurement, a small pneumatic system attached to the cuff inflates the bladder to apply pressure to an underlying artery according to the pressure waveform. The cuff is typically located on the patient's upper arm, proximal to the brachial artery, and time-dependent pressure is measured by an internal pressure sensor, such as an in-line Wheatstone bridge or strain gauge, within the pneumatic system (Banet ¶0009)]
Examiner’s Note Regarding Additional Elements: The Examiner notes that the additional elements of the claimed cuff, pump unit, first sensor, and second sensor are considered to fail to integrate the judicial exception identified into a practical application at Step 2A Prong 2 or allow the claims as individual wholes to amount to significantly more at Step 2B, as each additional element is considered to be well-understood, routine, and conventional. Furthermore, regarding the subject matter of claims 15-16 and 22-23, the Examiner notes that a functionality/steps as defined by claims 16/23 to define the third predefined pressure is not considered to integrate the judicial exception identified into a practical application at Step 2A Prong 2 or allow the claims as individual wholes to amount to significantly more at Step 2B, as there is no positive recitation of applying the third predefined pressure to ensure optimal contact, and furthermore may be considered to be extra-solution activity of a necessary precursor for the mental analysis step of calculating a quality metric and determining whether the quality metric exceeds a predefined quality threshold. Additionally, no claim(s) are considered to recite subject matter that may considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 13 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 18/857,022, hereinafter De Begon De Larouziere De Montlosier, in view of Muehlsteff (US-20160100805-A1).
Conflicting claim 16, which is considered to incorporate the subject matter of conflicting claim 15 therein, is considered to anticipate almost each and every limitation of instant claim 13, except separately defining a second sensor, pumping unit, and control unit for performing the corresponding instantly claimed functions, as De Begon De Larouziere De Montlosier merely defines a pressure management unit for performing each instantly claimed function of the second sensor, pumping unit, and control unit.
Muehlsteff discloses a wearable blood monitoring device configured to be worn around a limb of a subject, the device comprising: a cuff configured, in use, to surround the limb of the subject, said cuff comprising an inflatable compartment [cuff 58 (Muehlsteff ¶0090, Fig. 3)] and at least one first sensor configured to be in contact with the limb of the subject, said first sensor being configured to acquire a physiological signal from the limb [Muehlsteff ¶¶0091, 0093, Fig. 3)]; a second sensor configured to acquire a pressure signal relating to a pressure inside the inflatable compartment [A control unit 62 is connected to the pump 52 and the valve 56 to control the operation of those components, and is also connected to the pressure sensor 54 in order to receive the signal representing the pressure of the gas in the cuff 58 (the ‘pressure signal’) (Muehlsteff ¶0089, Fig. 3)]; a pumping unit configured to regulate the pressure inside the inflatable compartment [pump 52 (Muehlsteff ¶¶0089-0090, Fig. 3)]; and a control unit configured to inflate and/or deflate the inflatable compartment from a first predefined pressure to a second predefined pressure, and acquire at least one physiological signal from the first sensor in a time window while the inflatable compartment is inflated and/or deflated [control unit 62 (Muehlsteff Fig. 3); A control unit 62 is connected to the pump 52 and the valve 56 to control the operation of those components (Muehlsteff ¶0089), wherein any level of inflation may read on the first predefined pressure and any additional level of inflation after inflating the cuff 58 may read on the second predefined pressure; there can be a wired connection between the sensor 64 and the control unit 62, whereas in other embodiments, the sensor 64 can communicate with the control unit 62 wirelessly (Muehlsteff ¶0093)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of De Begon De Larouziere De Montlosier to employ separate components of a second sensor, pumping unit, and control unit for performing the corresponding instantly claimed functions, as this modification would amount to mere simple substitution of known elements for another with similar expected results [control and regulate pressure within/level of inflation of the inflatable compartment] [MPEP § 2143(I)(B)].
Claim 13 of the Instant Application
Claim 16 of Conflicting Patent Application 18/857,022, hereinafter De Begon De Larouziere De Montlosier
A wearable blood monitoring device configured to be worn around a limb of a subject, the device comprising:
A wearable blood pressure monitoring device comprising: a cuff configured to be worn around a limb of a user [claim 15, lines 1-2]
a cuff configured, in use, to surround the limb of the subject, said cuff comprising an inflatable compartment and at least one first sensor configured to be in contact with the limb of the subject, said first sensor being configured to acquire a physiological signal from the limb;
a cuff configured to be worn around a limb of a user [claim 15, line 2]
an inflatable compartment located in the cuff and configured to be inflated or deflated [claim 15, line 4]
a casing connected to the cuff [claim 15, line 5]
wherein the casing housing a processing unit and at least one sensor configured to measure a physiological parameter of the user… the casing being attached to the cuff such that at least part of the bottom wall of the casing is flush with the bottom side of the cuff so as to be in contact with the limb of the user when the wearable blood pressure monitoring device is worn [claim 16, lines 1-3 and 4-7]
a second sensor configured to acquire a pressure signal relating to a pressure inside the inflatable compartment;
a pressure management unit configured to inflate or deflate the inflatable compartment and measure a pressure therein [claim 15, lines 5-6]
a pumping unit configured to regulate the pressure inside the inflatable compartment; and
a pressure management unit configured to inflate or deflate the inflatable compartment and measure a pressure therein [claim 15, lines 5-6]
a control unit configured to inflate and/or deflate the inflatable compartment from a first predefined pressure to a second predefined pressure, and acquire at least one physiological signal from the first sensor in a time window while the inflatable compartment is inflated and/or deflated.
a pressure management unit configured to inflate or deflate the inflatable compartment and measure a pressure therein [claim 15, lines 5-6]
[claim 16, lines 1-3 and 4-7, wherein the inflatable compartment is always considered to be in a state of either being inflated or deflated, such that the measured physiological parameter is considered to be acquired while the inflatable compartment is inflated and/or deflated]
This is a provisional nonstatutory double patenting rejection.
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.
Claim(s) 13-14, 19-21, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muehlsteff (US-20160100805-A1).
Regarding claim 13, Muehlsteff teaches
A wearable blood monitoring device configured to be worn around a limb of a subject, the device comprising:
a cuff configured, in use, to surround the limb of the subject, said cuff comprising an inflatable compartment [cuff 58 (Muehlsteff Fig. 3); the pump 52 is for blowing air or other gas into the cuff 58 in order to inflate the cuff 58 and prevent blood flow in the limb around which the cuff 58 is placed (Muehlsteff ¶0090, Fig. 3)] and at least one first sensor configured to be in contact with the limb of the subject, said first sensor being configured to acquire a physiological signal from the limb [the monitor 50 further comprises a physiological parameter sensor 64 that is for measuring a physiological parameter of the subject while the cuff 58 is being inflated (Muehlsteff ¶0091, Fig. 3); the sensor 64 can be integrated with the cuff 58 so the subject only has to place the cuff around their arm in order to start using the monitor 50 (Muehlsteff ¶0093)];
a second sensor configured to acquire a pressure signal relating to a pressure inside the inflatable compartment [A control unit 62 is connected to the pump 52 and the valve 56 to control the operation of those components, and is also connected to the pressure sensor 54 in order to receive the signal representing the pressure of the gas in the cuff 58 (the ‘pressure signal’) (Muehlsteff ¶0089, Fig. 3)];
a pumping unit configured to regulate the pressure inside the inflatable compartment [pump 52 (Muehlsteff ¶¶0089-0090, Fig. 3)]; and
a control unit configured to inflate and/or deflate the inflatable compartment from a first predefined pressure to a second predefined pressure, and acquire at least one physiological signal from the first sensor in a time window while the inflatable compartment is inflated and/or deflated [control unit 62 (Muehlsteff Fig. 3); A control unit 62 is connected to the pump 52 and the valve 56 to control the operation of those components (Muehlsteff ¶0089), wherein any level of inflation may read on the first predefined pressure and any additional level of inflation after inflating the cuff 58 may read on the second predefined pressure; there can be a wired connection between the sensor 64 and the control unit 62, whereas in other embodiments, the sensor 64 can communicate with the control unit 62 wirelessly (Muehlsteff ¶0093)].
Regarding claim 14, Muehlsteff teaches
The device according to claim 13, wherein the pressure in the inflatable compartment has a plurality of pressure values comprised between the first predefined pressure and the second predefined pressure, and at each value of pressure, the control unit is configured to acquire at least one measurement of said at least one physiological signal [Muehlsteff ¶0091; the extraction of the heart rate and adaptation of the filter can be a continuous process, in which case the method can return to step 123. If at step 135 a BP measurement is determined from the pressure signal, then the method passes to step 139 in which the inflation of the cuff 58 by the pump 52 is stopped, the cuff 58 is deflated and the BP measurement can be reported to the subject, other operator of the monitor 50 or a remote computer or base unit that collates and stores the BP measurement information for the subject (Muehlsteff ¶0118), wherein successively reiterating inflation of the cuff is considered to read on a plurality of pressure values between an arbitrary first predefined pressure and second predefined pressure as analyzed in claim 13 above].
Regarding claim 19, Muehlsteff teaches
The device according to claim 13, wherein the at least one first sensor is an optical sensor and the processing unit is further configured to compute at least one physiological parameter from the at least one physiological signal acquired from the at least one first sensor, said at least one physiological parameter being selected from the group consisting of: oxygen saturation, heart rate, blood pressure, respiratory rate, blood pressure trend, heart rate variability, and cardiac output [the sensor 64 is a sensor for measuring a heart parameter of the subject, and even more preferably the sensor 64 is a sensor for measuring the pulse rate, heart rate or beating of the heart of the subject. For example, the sensor 64 can be a pulse or heart beat sensor such as a photoplethysmography (PPG) sensor… the sensor 64 can comprise the appropriate sensing apparatus, e.g. light source and detector for a PPG sensor,… and the processing of the signals from those sensors to determine the pulse rate, heart rate or a signal representing the heart beats (so that arrhythmias can be identified) can be performed by the control unit 62 (Muehlsteff ¶0092)].
Regarding claim 20, Muehlsteff teaches
A method for blood monitoring of a subject, the method being implemented by a wearable blood monitoring device according to claim 13 and comprising the following steps:
inflating and/or deflating the inflatable compartment from a first predefined pressure to a second predefined pressure [Muehlsteff ¶¶0089-0090], and
acquiring at least one physiological signal in a time window while the inflatable compartment is inflated and/or deflated [Muehlsteff ¶0091].
Regarding claim 21, Muehlsteff teaches
The method according to claim 20, wherein the pressure in the inflatable compartment has a plurality of pressure values comprised between the first predefined pressure and the second predefined pressure, and at each value of pressure, the method further comprises acquiring at least one measurement of said at least one physiological signal [Muehlsteff ¶¶0091, 0118, wherein successively reiterating inflation of the cuff is considered to read on a plurality of pressure values between an arbitrary first predefined pressure and second predefined pressure as analyzed in claim 13 above].
Regarding claim 24, Muehlsteff teaches
The method according to claim 20, wherein the steps of the method are periodically repeated or user-initiated [one or more user interface components that allow a user (e.g. the subject or healthcare professional) to interact and control the monitor) (Muehlsteff ¶0094), wherein as the monitor 50 comprises control unit 62, which controls the pump 52 and valve 56 to inflate the cuff 58 (Muehlsteff ¶¶0089-0090), the steps of the method are considered to be user-initiated].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 15-16 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muehlsteff, as applied to claims 13 and 21 above, in view of Schlottau (US-20140171780-A1).
Regarding claim 16 [written in longhand format to include the subject matter of claim 15 therein], Muehlsteff teaches
The device according to claim 13, wherein the control unit is configured to acquire the at least one physiological signal at a third predefined pressure in the inflatable compartment; said third predefined pressure being equal or comprised between the first predefined pressure and the second predefined pressure [Muehlsteff ¶¶0091, 0118, wherein successively reiterating inflation of the cuff is considered to define at least a third predefined pressure that is equal to the first and/or second predefined pressures or between the first and second predefined pressures].
However, Muehlsteff fails to explicitly disclose the third predefined pressure being configured to ensure an optimal contact between the first sensor and the limb of the subject; the device further comprising a processing unit configured to: receive the acquired physiological signal; calculate a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, define an optimal pressure, and send instructions to the control unit to set as the third predefined pressure the value of said optimal pressure.
Schlottau discloses systems, devices, and methods for monitoring physiological parameters of a subject’s blood, wherein Schlottau discloses that the an expandable element that is configured to be expanded such that an applied pressure by the expandable element is configured to ensure an optimal contact between the a sensor and a limb of the subject [In accordance with the present techniques, the sensor 12 may be configured to provide optimal contact between a patient and the detector 18, and/or the emitter 16 (Schlottau ¶0039); The sensors 12 as provided herein may be capable of expanding against or applying pressure to the patient's tissue to hold the optical elements of the sensor 12 in place while physiological monitoring is conducted. Detection of small signals may involve pressure stability and/or dialing in pressure for highest signal. For that reason the sensors 12 may be used in conjunction with pre-determined or settable pressure (Schlottau ¶0040); FIG. 14 is alternate embodiment in which the sensor 12 includes an inflatable bladder 138 positioned within the cup 132. Inflation of the bladder 138 pushes the substrate 136 holding the emitter 16 and the detector 18 against the tissue. An inflation line 139 is accessible to an operator to connect to an external fluid source. Inflation of the bladder 138 may be accomplished via a syringe coupled to an inflation port or via a pumping mechanism that is controlled by the monitor 14. In particular embodiments, the bladder 138 is inflated or deflated in response to signal quality feedback from the monitor 14. In low signal quality cases, the inflation of the bladder 138 may be adjusted until the signal quality improves under the control of the monitor 14 (Schlottau ¶0050)], wherein Schlottau discloses a processor configured to: receive a physiological signal acquired by the sensor; calculate a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, define an optimal pressure [Schlottau ¶¶0040, 0050; The monitor 14 also includes a processor that may be used to execute code such as code for implementing the techniques discussed herein (Schlottau ¶0030)]. Schlottau further suggests the use of predefined pressures [Schlottau ¶0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ the third predefined pressure being configured to ensure an optimal contact between the first sensor and the limb of the subject; and further comprising a processing unit configured to: receive the acquired physiological signal; calculate a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, define an optimal pressure, and send instructions to the control unit to set as the third predefined pressure the value of said optimal pressure, so as to ensure contact between the first sensor and the limb of the subject to facilitate acquisition of the at least one physiological signal and improve signal quality, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply pressure to hold a sensor against a body part] [MPEP § 2143(I)(D)].
Regarding claim 23 [written in longhand format to include the subject matter of claim 22 therein], Muehlsteff teaches
The method according to claim 21, wherein the method further comprises acquiring the at least one physiological signal at a third predefined pressure in the inflatable compartment; said third predefined pressure being equal or comprised between the first predefined pressure and the second predefined pressure [Muehlsteff ¶¶0091, 0118, wherein successively reiterating inflation of the cuff is considered to define at least a third predefined pressure that is equal to the first and/or second predefined pressures or between the first and second predefined pressures].
However, Muehlsteff fails to explicitly disclose the third predefined pressure being configured to ensure an optimal contact between the first sensor and the limb of the subject; and wherein the method further comprises: receiving the acquired physiological signal; calculating a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, defining an optimal pressure, and setting as the third predefined pressure the value of said optimal pressure.
Schlottau discloses systems, devices, and methods for monitoring physiological parameters of a subject’s blood, wherein Schlottau discloses that the an expandable element that is configured to be expanded such that an applied pressure by the expandable element is configured to ensure an optimal contact between the a sensor and a limb of the subject [Schlottau ¶¶0039-0040, 0050], wherein Schlottau discloses steps to receive a physiological signal acquired by the sensor; calculate a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, define an optimal pressure [Schlottau ¶¶0030, 0040, 0050]. Schlottau further suggests the use of predefined pressures [Schlottau ¶0040].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Muehlsteff to employ the third predefined pressure being configured to ensure an optimal contact between the first sensor and the limb of the subject; and wherein the method further comprises: receiving the acquired physiological signal; calculating a quality metric of the acquired physiological signal; and whenever the quality metric of the acquired physiological signal exceeds a predefined quality threshold, defining an optimal pressure, and setting as the third predefined pressure the value of said optimal pressure, so as to ensure contact between the first sensor and the limb of the subject to facilitate acquisition of the at least one physiological signal and improve signal quality, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply pressure to hold a sensor against a body part] [MPEP § 2143(I)(D)].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muehlsteff, as applied to claim 13 above, in view of Banet (US-20100160798-A1).
Regarding claim 17, Muehlsteff teaches
The device according to claim 13.
However, Muehlsteff fails to explicitly disclose wherein the control unit is configured to inflate and/or deflate the inflatable compartment linearly in the time window.
Banet discloses systems, devices, and methods for monitoring physiological parameters of a subject’s blood using a pressure cuff and a physiological sensor, wherein Banet discloses a linear inflation rate time window, wherein physiological signals are acquired during the linear inflation rate time window [During the indexing measurement, a linear regression model is used to relate the pressure applied by the cuff to an `effective MAP` (referred to as MAP*(P) in FIG. 3A) representing a mean pressure in the patient's arm. MAP*(P) and the PTT value associated with it vary tremendously during an inflationary process. As shown in FIG. 3A, this results in a unique set of MAP*(P)/PTT paired data points which can be extracted for each heartbeat occurring as the applied pressure ramps from DIA to SYS. This means calibration can be performed with a single, inflation-based measurement that typically takes between 40-60 seconds. At a recommended inflation rate (approximately 3-10 mmHg/second, and most preferably about 5 mmHg/second) this typically yields between 5-15 data points. These are the data points analyzed with the linear regression model to determine the patient-specific slope. Blood pressure values (SYS.sub.INDEX, MAP.sub.INDEX, and DIA.sub.INDEX) and the ratios between them (R.sub.SYS=SYS.sub.INDEX/MAP.sub.INDEX; R.sub.DIA=DIA.sub.INDEX/MAP.sub.INDEX) determined during the inflation-based measurement are also used in this calculation, and then for subsequent pressure-free measurements (Banet ¶0065)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ wherein the control unit is configured to inflate and/or deflate the inflatable compartment linearly in the time window, as a linear inflation rate allows for collection of medically relevant physiological information, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [define a particular inflation rate of the inflatable compartment] [MPEP § 2143(I)(D)].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muehlsteff, as applied to claim 13 above, in view of Borgos (US-20080071180-A1).
Regarding claim 18, Muehlsteff teaches
The device according to claim 13, wherein the processing unit is further configured to receive the at least one physiological signal acquired from the at least one first sensor [Muehlsteff ¶0093].
However, Muehlsteff fails to explicitly disclose wherein the processing unit is further configured to compute at least one quality metric of the at least one physiological signal, said at least one quality metric being selected from the group consisting of: perfusion index, signal-to-noise ratio, motion, skewness, kurtosis, entropy, zero crossing rate, systolic wave detector, relative power, and combinations thereof.
Borgos discloses systems, devices, and methods for monitoring physiological parameters of a subject’s blood using a occluding device and a physiological sensor, wherein Borgos discloses computing a quality metric for a physiological signal, wherein the quality metric comprises zero crossing rate [the output from a plurality of optical detection regions 244 can each be AC coupled and fed into a zero-crossing detector. The electrical signals 420 corresponding to the different optical detection regions 244, as shown, for example, in FIG. 13, can be compared at the end of each arterial pulse or at the end of each blood pressure measurement cycle to determine which has the highest signal quality. The quality of an electrical signal 420 can also be determined by detecting a zero-crossing count for each signal. For example, the electrical signal 420 with the highest count may be considered to have the highest signal quality. The different zero-crossing counts for each of the different detectors (or a subset of different detectors) can also be averaged for each arterial pulse to produce a more reliable estimate of the pulse amplitude (Borgos ¶0083)]. Borgos further discloses applying a systolic wave detector to the physiological signal [the output unit 106 can include a systolic pressure waveform detector to determine a systolic pressure for a subject based upon a determined amplitude, magnitude and/or waveform and a pressure applied to the subject, which can be detected (e.g., a pressure detected in an inflatable cuff by a pressure sensor) (Borgos ¶0099)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ wherein the processing unit is further configured to compute at least one quality metric of the at least one physiological signal, said at least one quality metric being selected from the group consisting of: perfusion index, signal-to-noise ratio, motion, skewness, kurtosis, entropy, zero crossing rate, systolic wave detector, relative power, and combinations thereof, so as to assess signal quality of the physiological signal to determine reliability of additional analyses performed on the physiological signal, to allow for determination of systolic pressure of the subject, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [compute a quality metric of a measured signal to assess the quality of the measured signal] [MPEP § 2143(I)(D)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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