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 .
Response to Arguments
Applicant’s argument on Page 7 regarding the objections to Claims 3, 7, 9, 12, and 15 has been fully considered and are withdrawn in view of the amendments.
Applicant’s argument on Page 7 regarding the rejection of Claim 7 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claim 7 under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
Applicant’s argument on Pages 7-10 regarding the rejection of Claims 1 and 12 under 35 U.S.C. 103 over Hong in view of Lisiecki has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Pages 9-10 relies on the supposed deficiencies with respect to the rejection of parent Claims 1 and 12. Applicant’s argument is moot for the same reasons detailed above.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: power device in Claim 7.
The disclosure merely cites: the power device (disclosed in the specification as external power supply) provides power to the wearable device ([0020]) or may be wired to power supply 50 and may be an alternating current electrical outlet ([0017]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ragauskas et al. (US 20100331684) in view of Lisiecki et al. (US 20120197118).
Regarding Claim 1, Ragauskas teaches an apparatus for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “A method and apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), comprising: a wearable device configured for temporary placement on an exterior of a patient's closed eyelid, (Figs. 4A-4C and [0032] “The head frame 22 of the apparatus is mountable to the head of a person so that an eye engaging inflatable device 28 can apply a slight pressure against the eyelid 23”), the wearable device including
a) a flexible strip that is conformable to a curvature of the exterior of the patient's closed eyelid (Fig. 1A and [0032] “inner flexible membrane 32”);
b) an ultrasonic transducer array fixed on a side of the flexible strip that faces the patient's closed eyelid, (Fig. 1A-1C and [0049] “Whichever type of transducer, it is helpful that the transducer's central axis, or "bore site", 44, is first aligned to the optical canal and directed to view the IOA 46 and internal carotid artery (ICA) 41 (FIG. 1A). This alignment is accomplished by positioning an ultrasonic transducer on the eyelid”), the ultrasonic transducer array arranged to focus on an eyeball area of the patient at an optic nerve (Figs. 1A-1C “optic nerve canal 42”); and
c) hydrogel that covers the ultrasonic transducer array on the flexible strip ([0059] “Head frame with ultrasonic transducer is placed on patient and acoustic contact between ultrasonic transducer and eyelid is established with coupling gel or acoustically similar material.”).
However, Ragauskas does not explicitly teach a waterproof strip; at least two ultrasonic transducer arrays separated by a distance on the flexible waterproof strip; and an adhesive that adheres the flexible waterproof strip to the patient's closed eyelid.
In an analogous ultrasonic monitoring of physiological parameters field of endeavor, Lisiecki teaches an apparatus comprising: a wearable device configured for temporary placement on an exterior of a patient, ([0037] “ultrasonic monitoring device 10 positioned on skin 40”), the wearable device including
a) a flexible waterproof strip (Fig. 3 and [0033] “The substrate 16 is made of a semi-rigid, flexible material such as Polyvinyl Chloride (PVC), polycarbonate, a medical plastic, or other type of semi-rigid flexible material.”);
b) at least two ultrasonic transducer arrays separated by a distance on the flexible strip ([0032] “The ultrasonic monitoring device 10 is an electronic path that may be worn by a patient over various areas of the patient’s body to use ultrasonic technology to evaluate anatomical structures below the patient’s skin to determine the physiological status of the patient” and Fig. 3, where there are five rows and three columns of ultrasonic transducer elements to make up the array 28 of ultrasonic transducer elements); and
c) an adhesive that adheres the flexible waterproof strip to the patient's closed eyelid ([0036] “The adhesive, conformable, gel layer 22 is flexible and ultrasonically conductive, and may comprise a polymer, or another type of adherent, flexible, ultrasonically conductive material for flexibly and adherently conforming to a mammal's skin.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Ragauskas with the flexible waterproof strip of Lisiecki because if desired, the strip may be inflated to efficiently make contact with the region of interest on the patient (in such case, an eyelid). Furthermore, it would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Ragauskas with the at least two ultrasonic transducer arrays on the strip of Lisiecki because the modification improves image resolution and signal-to-noise ratios. Moreover, it would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Ragauskas with the adhesive of Lisiecki because the modification ensures securement to the object with comfortability of the patient in mind.
Regarding Claim 2, the modified apparatus of Hong teaches all limitations of Claim 1, as discussed above. Furthermore, Lisiecki teaches a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid, wherein the waterproof conformable, elastic membrane has the adhesive on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid (Fig. 3 and [0036] “The adhesive, conformable, gel layer 22 is flexible and ultrasonically conductive, and may comprise a polymer, or another type of adherent, flexible, ultrasonically conductive material for flexibly and adherently conforming to a mammal's skin.” Where it is understood by one of ordinary skill in the art that polymers are waterproof, conformable, and elastic.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki because a waterproof, conformable, elastic membrane ensures there is proper conduction between the ultrasound transducers and the patient’s skin (eyelid).
Regarding Claim 3, the modified apparatus of Ragauskas teaches all limitations of Claim 1, as discussed above. Furthermore, Ragauskas teaches a transceiver located external to the wearable device, the transceiver being in at least one of wired and wireless electrical communication with the at least two ultrasound transducer arrays on the flexible waterproof strip (Fig. 2 and [0038] “The orbital Doppler velocity meter 1 consists of: […] receiver 1.3,” the at least two ultrasound transducer arrays and waterproof strip taught by the modified apparatus as discussed above.).
Regarding Claim 6, the modified apparatus of Ragauskas teaches all limitations of Claim 1, as discussed above. Furthermore, Lisiecki teaches a power supply disposed on the flexible waterproof strip and in electrical communication with the at least two ultrasonic transducer arrays (Fig. 3 and Claim 1 “power source coupled to at least one of the plurality of ultrasonic transducer elements”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki by a power supply because the modification allows the device to be portable and self-sustainable, and may also vary in size.
Regarding Claim 7, the modified apparatus of Ragauskas teaches all limitations of Claim 6, as discussed above. Furthermore, Lisiecki teaches wherein the power supply is at least one of a single-use battery, a rechargeable battery, ([0039] “The power source 46 comprises a battery for powering the electronic system 14. The battery may comprise a flat battery, a rechargeable battery, or another type of battery.”), and a power device that receives power via a wire or wirelessly from a source external to the wearable device (A battery is a power device that receives power externally via a wire (during manufacturing) or wirelessly (during charging) from a source external to the wearable device.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki by including a power supply of a single-use battery or a rechargeable battery because the modification allows for consistent, repetitive use of mobile monitoring of the patient, and with modern battery technology, may not need a replacement for many weeks.
Regarding Claim 8, the modified apparatus of Ragauskas teaches all limitations of Claim 3, as discussed above. Furthermore, Lisiecki teaches wherein the transceiver, ([0041] “The microprocessor 48, in conjunction with the computer readable memory medium 54, saves, analyzes, and processes the data generated by the array 28 of ultrasonic transducer elements” and [0044] “the microprocessor 48 stores the determined physiological parameters 62 of the internal structure 41 of the mammal 42 in the computer readable memory medium 54, and either displays the determined physiological parameters 62 on the display 21 located on the first housing 12 of the ultrasonic monitoring device 10, or wirelessly transmits the physiological parameters 62, using the wireless connectivity communication device 52, to a remote device 66,” where remote device 66 is interpreted as the transceiver, and is in communication with the ultrasound transducers via microprocessor 48.), is a portable, hand-held device ([0045] “The remote device 66 may comprise […] a hand-held device,” where it is understood a hand-held device is portable.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki by including a hand-held portable transceiver because this allows the device to observe the patient freely, without obstruction or limitations to location and operator.
Regarding Claim 10, the modified apparatus of Ragauskas teaches all limitations of Claim 1, as discussed above. Furthermore, Lisiecki teaches wherein the wearable device includes at least one flexible circuit board disposed on the flexible waterproof strip, ([0033] “The first housing surface 12 attaches to the substrate 16, through screws or other attachment mechanisms, to house the electronic system 14 within a first cavity (hidden from view) of the first housing surface 12 between the first housing surface 12 and the substrate 16” and Fig. 3, where the FCBP 30 is disposed on substrate 16 by way of sensor system 18), and connected to the at least two ultrasound transducer arrays ([0034] “flexible printed circuit board 30 which bridges connectivity between the array 28 of ultrasonic transducer elements and the electronic system 14.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki by including an flexible circuit board because the modification provides the advantages of flexible circuit boards, which include durability, minimal connections, and design flexibility, all of which are advantageous in the manufacturing of an apparatus to monitor a patient.
Regarding Claim 11, the modified apparatus of Ragauskas teaches all limitations of Claim 10, as discussed above. Furthermore, Lisiecki teaches wherein the at least one flexible circuit board includes a transceiver for data communication and transfer, data processing circuitry, and memory to store ultrasonic image data ([0041] “The microprocessor 48, in conjunction with the computer readable memory medium 54, saves, analyzes, and processes the data generated by the array 28 of ultrasonic transducer elements” and [0044] “the microprocessor 48 stores the determined physiological parameters 62 of the internal structure 41 of the mammal 42 in the computer readable memory medium 54, and […] wirelessly transmits the physiological parameters 62, using the wireless connectivity communication device 52, to a remote device 66”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki by including a transceiver because it offers cost-effectiveness, reduces complexity, and promotes a compact design, which is preferable when manufacturing an apparatus to monitor the patient, specifically on the eye.
Regarding Claim 12, Ragauskas teaches an apparatus for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “A method and apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), comprising:
a) a wearable device configured for temporary placement on an exterior of a patient's closed eyelid, (Figs. 4A-4C and [0032] “The head frame 22 of the apparatus is mountable to the head of a person so that an eye engaging inflatable device 28 can apply a slight pressure against the eyelid 23”), the wearable device including
i) a flexible strip that is conformable to a curvature of the exterior of the patient's closed eyelid (Fig. 1A and [0032] “inner flexible membrane 32”);
ii) an ultrasonic transducer arrays fixed on a side of the flexible strip that faces the patient's closed eyelid, (Fig. 1A-1C and [0049] “Whichever type of transducer, it is helpful that the transducer's central axis, or "bore site", 44, is first aligned to the optical canal and directed to view the IOA 46 and internal carotid artery (ICA) 41 (FIG. 1A). This alignment is accomplished by positioning an ultrasonic transducer on the eyelid”), the ultrasonic transducer array arranged to focus on an eyeball area of the patient at an optic nerve (Figs. 1A-1C “optic nerve canal 42”); and
iii) hydrogel that covers each of the at least two ultrasonic transducer arrays on the flexible strip ([0059] “Head frame with ultrasonic transducer is placed on patient and acoustic contact between ultrasonic transducer and eyelid is established with coupling gel or acoustically similar material.”); and
b) a transceiver located external to the wearable device, the transceiver being in at least one of wired and wireless electrical communication with the at least two ultrasound transducer arrays on the flexible strip (Fig. 2 and [0038] “The orbital Doppler velocity meter 1 consists of: […] receiver 1.3”).
However, Ragauskas does not explicitly teach a waterproof strip; at least two ultrasonic transducer arrays separated by a distance on the flexible waterproof strip; an adhesive that adheres the flexible waterproof strip to the patient's closed eyelid; and a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid, wherein the waterproof, conformable, elastic membrane has the adhesive on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid.
In an analogous ultrasonic monitoring of physiological parameters field of endeavor, Lisiecki teaches an apparatus comprising:
a) a wearable device configured for temporary placement on an exterior of a patient, ([0037] “ultrasonic monitoring device 10 positioned on skin 40”), the wearable device including
i) a flexible waterproof strip (Fig. 3 and [0033] “The substrate 16 is made of a semi-rigid, flexible material such as Polyvinyl Chloride (PVC), polycarbonate, a medical plastic, or other type of semi-rigid flexible material.”);
ii) at least two ultrasonic transducer arrays separated by a distance on the flexible waterproof strip ([0032] “The ultrasonic monitoring device 10 is an electronic path that may be worn by a patient over various areas of the patient’s body to use ultrasonic technology to evaluate anatomical structures below the patient’s skin to determine the physiological status of the patient” and Fig. 3, where there are five rows and three columns of ultrasonic transducer elements to make up the array 28 of ultrasonic transducer elements);
iii) an adhesive that adheres the flexible waterproof strip to the patient's closed eyelid ([0036] “The adhesive, conformable, gel layer 22 is flexible and ultrasonically conductive, and may comprise a polymer, or another type of adherent, flexible, ultrasonically conductive material for flexibly and adherently conforming to a mammal's skin.”); and
b) a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid, wherein the waterproof, conformable, elastic membrane has the adhesive on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid (Fig. 3 and [0036] “The adhesive, conformable, gel layer 22 is flexible and ultrasonically conductive, and may comprise a polymer, or another type of adherent, flexible, ultrasonically conductive material for flexibly and adherently conforming to a mammal's skin.” Where it is understood by one of ordinary skill in the art that polymers are waterproof, conformable, and elastic.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki because a waterproof, conformable, elastic membrane ensures there is proper conduction between the ultrasound transducers and the patient’s skin (eyelid).
Claims 4-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ragauskas et al. (US 20100331684) in view of Lisiecki et al. (US 20120197118), as applied to Claim 3 above, further in view of Quirk et al. (US 8672851).
Regarding Claim 4, the modified apparatus Ragauskas teaches all limitations of Claim 3, as discussed above. However, the modified apparatus of Ragauskas does not explicitly teach wherein the transceiver includes a data processor that determines an Optical Nerve Sheath Diameter (ONSD) of the patient from ultrasound images received from the at least two ultrasound transducer arrays.
In an analogous ocular ultrasound based assessment field of endeavor, Quirk teaches an apparatus for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), wherein the transceiver includes a data processor that determines an Optical Nerve Sheath Diameter (ONSD) of the patient from ultrasound images received from the at least two ultrasound transducer arrays (Fig. 9A, Column 22 Lines 10-13 “the controller 606 can execute one or more machine-executable instruction sets that permit the autonomous identification and measurement of the optic nerve sheath diameter,” and Column 27 Lines 16-20 “one or more image processing algorithms executed by the controller 606 can identify a number of points 904a-904b on the optic nerve sheath (collectively "optic nerve sheath diameter points 904")”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the data processor of Quirk because the diameter provides insight to the ICP, as taught by Quirk in Column 2 Lines 23-26.
Regarding Claim 5, the modified apparatus of Ragauskas teaches all limitations of Claim 4, as discussed above. Furthermore, Quirk teaches wherein the transceiver includes a visual display that displays the ONSD (Column 27 Lines 26-29 “The controller 606 can generate one or more signals to display a numeric value corresponding to the optic nerve sheath diameter 906 (e.g., 5.25 mm) on the display 108.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk by a visual display that displays the ONSD because the modification allows for the wearer or clinician to easily observe the ONSD, which can provide an indication of whether a subject is suffering from an elevated ICP, and is done without the use of ionizing radiation or an invasive procedure, as taught by Quirk in Column 27 Lines 29-34.
Regarding Claim 9, the modified apparatus of Ragauskas teaches all limitations of Claim 4, as discussed above. Furthermore, Quirk teaches wherein the ONSD is measured at a point 3mm behind an eyeball of the patient (Column 20 Lines 31-36 “Thus, the target area investigated using the ultrasonic transducer 202 is relatively small; located an axial distance 506 of from about 23 millimeters to 33 millimeters from the face of the ultrasonic transducer assembly 202 and having a radius of coverage 508 of about 3 to 6 millimeters.” Where the average globe depth (front to back measurement of the eyeball is 24 millimeters, as disclosed by Quirk in Column 20 Lines 29-30, thus a point 3mm behind the eyeball falls within the disclosed range of the ultrasonic transducer 202.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk by the measuring point because the distance provides optimal imaging and resolution of the ONSD, as well as avoids imaging artifacts at such a distance.
Claims 13-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ragauskas et al. (US 20100331684) in view of Lisiecki et al. (US 20120197118) and Quirk et al. (US 8672851).
Regarding Claim 13, Ragauskas teaches a method for monitoring Intracranial Pressure (ICP), comprising: providing the apparatus of claim 1 and temporarily attaching it to the patient's closed eyelid (as discussed above).
However, Ragauskas does not explicitly teach obtaining ultrasonic images of the patient's optic nerve to produce an image of an optical nerve sheath of the patient; and electronically measuring a diameter of the optical nerve sheath.
In an analogous ocular ultrasound based assessment field of endeavor, Quirk teaches a method for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “A method and apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), comprising:
a) obtaining ultrasonic images of the patient's optic nerve to produce an image of an optical nerve sheath of the patient (Column 9 Lines 38-42 “an acoustic image and data relevant to the optical nerve sheath diameter or globe depth of a subject may be obtained by placing the optical three-dimensional ultrasound based assessment device 100 on the exterior surface of the subject's eyelid.”); and
b) electronically measuring a diameter of the optical nerve sheath (Fig. 9A, Column 22 Lines 10-13 “the controller 606 can execute one or more machine-executable instruction sets that permit the autonomous identification and measurement of the optic nerve sheath diameter,” and Column 27 Lines 16-20 “one or more image processing algorithms executed by the controller 606 can identify a number of points 904a-904b on the optic nerve sheath (collectively "optic nerve sheath diameter points 904")”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk by a visual display that displays the ONSD because the modification allows for the wearer or clinician to easily observe the ONSD, which can provide an indication of whether a subject is suffering from an elevated ICP, and is done without the use of ionizing radiation or an invasive procedure, as taught by Quirk in Column 27 Lines 29-34.
Regarding Claim 14, the modified method of Ragauskas teaches all limitations of Claim 13, as discussed above. Furthermore, Quirk teaches visually displaying the diameter on a screen of a mobile transceiver (Column 9 Lines 31-33 “a display 108 may be optionally positioned on a back end 110 of the housing” and Column 27 Lines 26-29 “The controller 606 can generate one or more signals to display a numeric value corresponding to the optic nerve sheath diameter 906 (e.g., 5.25 mm) on the display 108.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk by a visual display that displays the ONSD because the modification allows for the wearer or clinician to easily observe the ONSD, which can provide an indication of whether a subject is suffering from an elevated ICP, and is done without the use of ionizing radiation or an invasive procedure, as taught by Quirk in Column 27 Lines 29-34.
Regarding Claim 15, the modified method of Ragauskas teaches all limitations of Claim 13, as discussed above. Furthermore, Quirk teaches wherein the diameter is measured at a point 3mm behind the eyeball are of the patient (Column 20 Lines 31-36 “Thus, the target area investigated using the ultrasonic transducer 202 is relatively small; located an axial distance 506 of from about 23 millimeters to 33 millimeters from the face of the ultrasonic transducer assembly 202 and having a radius of coverage 508 of about 3 to 6 millimeters.” Where the average globe depth (front to back measurement of the eyeball is 24 millimeters, as disclosed by Quirk in Column 20 Lines 29-30, thus a point 3mm behind the eyeball falls within the disclosed range of the ultrasonic transducer 202.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk by the measuring point because the distance provides optimal imaging and resolution of the ONSD, as well as avoids imaging artifacts at such a distance.
Regarding Claim 16, the modified method of Hong teaches all limitations of Claim 13, as discussed above. Furthermore, Quirk teaches wherein the ultrasonic images are obtained intermittently (Column 20 Lines 54-59 “a pulse-echo system in which the transducer (e.g., a piezoelectric element) 602 is alternately placed in an active mode where energy is emitted for a first period of time followed by a passive mode where reflected energy returned from the subject is received for a second period of time.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk because the modification ensures safety of the patient, limiting heating of the device and the tissue being imaged.
Regarding Claim 18, the modified method of Ragauskas teaches all limitations of Claim 13, as discussed above. Furthermore, Ragauskas teaches wherein the ultrasonic images are three-dimensional images obtained via triangulation (Fig. 1C).
Regarding Claim 19, the modified method of Ragauskas teaches all limitations of Claim 13, as discussed above. Furthermore, Lisiecki teaches wherein the step of providing and temporarily attaching includes temporarily attaching using an adhesive ([0036] “The adhesive, conformable, gel layer 22 is flexible and ultrasonically conductive, and may comprise a polymer, or another type of adherent, flexible, ultrasonically conductive material for flexibly and adherently conforming to a mammal's skin.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Lisiecki because the modification offers comfortability for the patient, is relatively cheap to manufacture, and is compatible with the patient’s eye, with minimal possibility of damage to the eye structure or function.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ragauskas et al. (US 20100331684) in view of Lisiecki et al. (US 20120197118) and Quirk et al. (US 8672851), as applied to Claim 13 above, further in view of Sumaily (US 10856841)
Regarding Claim 17, the modified method of Ragauskas teaches all limitations of Claim 13, as discussed above. However, the modified method of Ragauskas does not explicitly teach wherein the ultrasonic images are obtained continuously.
In an analogous ultrasonic imaging field of endeavor, Sumaily teaches a method wherein the ultrasonic images are obtained continuously (Column 3 Lines 28-30 “a real-time image of the tissue being imaged by the ultrasonic transducer 40.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Sumaily with continuous ultrasonic images because the probe allows the surgeon to visualize anatomical structures, such as the optic nerve, which enables accurate surgical planning and procedures, when required by the diameter of the optic nerve sheath.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ragauskas et al. (US 20100331684) in view of Lisiecki et al. (US 20120197118) and Quirk et al. (US 8672851).
Regarding Claim 20, Ragauskas teaches an apparatus for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “A method and apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), comprising:
a) a wearable device configured for temporary placement on an exterior of a patient's closed eyelid, (Figs. 4A-4C and [0032] “The head frame 22 of the apparatus is mountable to the head of a person so that an eye engaging inflatable device 28 can apply a slight pressure against the eyelid 23”), the wearable device including
i) a flexible strip that is conformable to a curvature of the exterior of the patient's closed eyelid (Fig. 1A and [0032] “inner flexible membrane 32”);
ii) an ultrasonic transducer array fixed on a side of the flexible strip that faces the patient's closed eyelid, (Fig. 1A-1C and [0049] “Whichever type of transducer, it is helpful that the transducer's central axis, or "bore site", 44, is first aligned to the optical canal and directed to view the IOA 46 and internal carotid artery (ICA) 41 (FIG. 1A). This alignment is accomplished by positioning an ultrasonic transducer on the eyelid”), the ultrasonic transducer array arranged to focus on an eyeball area of the patient at an optic nerve (Figs. 1A-1C “optic nerve canal 42”).
However, Ragauskas does not explicitly teach a waterproof strip; the ultrasonic transducer array fixed on a side of the flexible waterproof strip that faces the patient’s closed eyelid, the at least two ultrasonic transducer arrays separated by a distance on the flexible strip; a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid with a first adhesive side, wherein the waterproof, conformable, elastic membrane has a second adhesive side on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid, and wherein the elastic membrane is configured to keep the patient's eyelid closed; and hydrogel that covers each of the at least two ultrasonic transducer arrays on the flexible strip, wherein the hydrogel is contained in place on the ultrasound transducers by the elastic membrane.
In an analogous ultrasonic monitoring of physiological parameters field of endeavor, Lisiecki teaches an apparatus comprising: a wearable device configured for temporary placement on an exterior of a patient, ([0037] “ultrasonic monitoring device 10 positioned on skin 40”), the wearable device including
a) a flexible waterproof strip (Fig. 3 and [0033] “The substrate 16 is made of a semi-rigid, flexible material such as Polyvinyl Chloride (PVC), polycarbonate, a medical plastic, or other type of semi-rigid flexible material.”); and
b) at least two ultrasonic transducer arrays separated by a distance on the flexible waterproof strip ([0032] “The ultrasonic monitoring device 10 is an electronic path that may be worn by a patient over various areas of the patient’s body to use ultrasonic technology to evaluate anatomical structures below the patient’s skin to determine the physiological status of the patient” and Fig. 3, where there are five rows and three columns of ultrasonic transducer elements to make up the array 28 of ultrasonic transducer elements).
However, Ragauskas modified by Lisiecki does not explicitly teach a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid with a first adhesive side, wherein the waterproof, conformable, elastic membrane has a second adhesive side on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid, and wherein the elastic membrane is configured to keep the patient's eyelid closed; and hydrogel that covers each of the at least two ultrasonic transducer arrays on the flexible strip, wherein the hydrogel is contained in place on the ultrasound transducers by the elastic membrane.
In an analogous ocular ultrasound based assessment field of endeavor, Quirk teaches an apparatus for monitoring Intracranial Pressure (ICP) of a patient, (Abstract “apparatus for obtaining the absolute value of intracranial pressure in a non-invasive manner”), comprising:
a) a waterproof, conformable, elastic membrane attached to the side of the flexible waterproof strip that faces the patient's closed eyelid with a first adhesive side, (Column 9 Lines 66-67 and Column 10 Lines 1-10 “The flexible membrane 104 provides a continuous, fluidly impermeable, resilient covering extending across some or all of the exposed portions of the ultrasonic transducer assembly. The one or more relief contours 120 may include, but are not limited to any number of folds, pleats, ridges, shoulders, diaphragms, or similar continuous or discontinuous features capable of facilitating the three-dimensional movement or displacement of the flexible membrane 104 in response to movement of the ultrasonic transducer assembly proximate at least a portion of an inside facing surface of the flexible membrane 104.”), wherein the waterproof, conformable, elastic membrane has a second adhesive side on an eyelid-facing side to thereby adhere the flexible waterproof strip to the patient's closed eyelid, and wherein the elastic membrane is configured to keep the patient's eyelid closed (Column X Lines X “The gel filled flexible membrane 104 is then placed into contact with the outer surface of the subject's eyelid 922.”); and
b) hydrogel that covers each of the at least two ultrasonic transducer arrays on the flexible strip, wherein the hydrogel is contained in place on the ultrasound transducers by the elastic membrane (Column 27 Lines 44-48 “the cavity 230 formed in the flexible membrane 104 is at least partially filled with an acoustic coupling gel 920. The gel filled flexible membrane 104 is then placed into contact with the outer surface of the subject's eyelid 922.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Quirk because the hydrogel and elastic membrane may improve the quality of the acoustic image data by the ultrasonic transducer. Additionally, the modification tends to minimize discomfort of the subject.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davidsen is cited for teaching a wearable device configured for temporary placement on an exterior of a patient, (Fig. 7 and [0003]), the wearable device including a flexible waterproof strip ([0035]); at least two ultrasonic transducer arrays separated by a distance on the flexible waterproof strip (Fig. 2B, [0024]-[0025], and [0032]); and an adhesive that adheres the flexible waterproof strip to the patient's closed eyelid ([0032]-[0033]).
Maltz is cited for teaching an apparatus for monitoring Intracranial Pressure (ICP) of a patient, ([0002]), comprising: a wearable device configured for temporary placement on an exterior of a patient's closed eyelid, ([0077], [0081], and [0091]).
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795