DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 6-7, 9, and 15-17 are objected to because of the following informalities:
In claim 6, line 3, "an IV catheter” should read “and an intravenous (IV) catheter”.
In claim 7, “wherein the wherein” should read “wherein”.
In claim 9, line 3, the "along an exterior surface” should read –along an exterior surface--.
In claims 15 and 16, "An indwelling medical device” should read –The indwelling medical device --.
In claim 15, line 4, "system” should read –device--.
In claim 15, lines 2-3, "a proximal end opposite a direction of the body and a distal end in the direction of the body” should read, for example, –a distal end configured to be implanted in the subject's body and a proximal end opposite the distal end--.
In claim 17, the last para., the "X-potential” should read –Z-potential--.
Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-4 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4 of copending Application No. 17646753, with claim 1 corresponding to claim 1 of the copending Application; claim 2 corresponding to claim 2 of the copending Application; claim 3 corresponding to claim 3 of the copending Application, and claim 4 corresponding to claim 4 of the copending Application. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis (US20130006153), hereinafter Lewis.
Regarding claim 1, Lewis teaches a portable ultrasound system (10) comprising:
an energy generating module (20) operative to generate a driving signal (28) that can be transformed into ultrasonic energy, wherein said energy generating module comprises a power source (21), an oscillator (22), and a driver component (23) (“FIG. 1 is a schematic drawing of the portable ultrasound system of the present invention. As shown in FIG. 1, portable ultrasound system 10 includes energy generating module 20 and ultrasound transducer 30. Energy generating module 20 includes power source 21, oscillator 22, and driver component 23, so that energy generating module 20 is operative to generate a driving signal 28 that can be transformed into ultrasonic energy.” [0058]); and
an ultrasound transducer (30) comprising a piezoelectric component (60), said ultrasound transducer being operative to receive the driving signal from the energy generating module, to transform the driving signal into ultrasonic energy, and to control a direction of the ultrasonic energy emitted from the ultrasound transducer (“Ultrasound transducer 30 includes piezoelectric component 60 ... Ultrasound transducer 30 is operative to receive the driving signal 28 from energy generating module 20, to transform the driving signal into ultrasonic energy, and to control the direction of the ultrasonic energy emitted from ultrasound transducer 30.” [0058]. “As shown in FIGS. 5A-5D, ultrasound transducer 30 can be configured to control the direction of emitted ultrasonic energy 35 in various wave patterns, including diverging wave pattern 35a (FIG. 5A), scattering wave pattern 35b (FIG. 5B), focused wave pattern 35c (FIG. 5C), and parallel wave pattern 35d (FIG. 5D).” [0066]), wherein the oscillator and driver component are housed on or within the ultrasound transducer, and the power source is not housed on or within the ultrasound transducer (“Portable ultrasound system 10 can be assembled so that energy generating module 20 is at least partially housed on or within ultrasound transducer 30. In one embodiment of this assembly arrangement, oscillator 22 and driver component 23 are housed on or within ultrasound transducer 30, and power source 21 is housed in housing 40, with cable 51 operatively coupling power source 21 to oscillator 22/driver component 23 (housed on or within ultrasound transducer 30).” [0076]).
Regarding claim 2, Lewis teaches the portable ultrasound system according to claim 1, wherein the ultrasound energy from the transducer is emitted as pulsed, continuous, or both pulsed and continuous ultrasonic energy (“The portable ultrasound system of the present invention is operative to emit ultrasonic energy as pulsed, continuous, or both pulsed and continuous ultrasonic energy.” [0056]).
Regarding claim 3, Lewis teaches the portable ultrasound system according to claim 1, wherein the energy generating module comprises a voltage controller (24) operative to control power distribution from the power source to the oscillator and driver component (“As shown in FIG. 2B, in one embodiment, energy generating module 20 can further include voltage controller 24, which is operative to control power distribution (e.g., as an on/off power switch) from power source 21 to oscillator 22 and driver component 23. In a particular embodiment, voltage controller 24 can include on/off controller 24a coupled to transistor switch 24b.” [0061]).
Regarding claim 4, Lewis teaches the portable ultrasound system according to claim 3, wherein the voltage controller comprises an on/off controller (24a) coupled to a transistor switch (24b) (“voltage controller 24 can include on/off controller 24a coupled to transistor switch 24b.” [0061]; Figs. 3C-D).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis as applied to claim 1, and further in view of Jiao (WO2021232318), hereinafter Jiao.
Regarding claim 5, Lewis teaches the portable ultrasound system according to claim 1.
While teaching that the energy generating module and the ultrasound transducer are operatively connected (“Ultrasound transducer 30 is operative to receive the driving signal 28 from energy generating module 20, to transform the driving signal into ultrasonic energy, and to control the direction of the ultrasonic energy emitted from ultrasound transducer 30.” [0058]), Lewis does not teach that the driving signal is wirelessly communicated to the ultrasound transducer without a bus.
However, in the ultrasound devices for disinfection field of endeavor, Jiao discloses operating component of public equipment, which is analogous art. Jiao teaches the energy generating module (13) and the ultrasound transducer (12) are operatively connected and the driving signal is wirelessly communicated to the ultrasound transducer without a bus (“The ultrasonic transducer microcontroller 13 (hereinafter referred to as the microcontroller) is arranged on the button body 11 and connected to the piezoelectric wafer 12, and is configured to drive the piezoelectric wafer 12 to vibrate in the vibration state. The connection between the microcontroller and the transducer may be a wireless connection …, and the connection mode is not shown in the drawings.”; p. 6, l. 14-16).
Therefore, based on Jiao’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Lewis to have the energy generating module and the ultrasound transducer that are operatively connected and the driving signal is wirelessly communicated to the ultrasound transducer without a bus, as taught by Jiao, in order to facilitate operation of the ultrasound device (Jiao: Abstract).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as applied to claim 1, and further in view of Zumeris et al (US20070213645), hereinafter Zumeris.
Regarding claim 6, Lewis teaches the portable ultrasound system according to claim 1.
Lewis does not teach an assembly of an indwelling medical device and the portable ultrasound system according to claim 1, wherein the indwelling medical device is selected from a PEG tube an IV catheter and comprises the portable ultrasound transducer coupled to an exterior surface thereof.
However, in the surface acoustic wave treatments field of endeavor, Zumeris discloses a system and method for surface acoustic wave treatment of medical devices, which is analogous art. Zumeris teaches an assembly of an indwelling medical device (330) (“a central venous catheter system 330” [0126]) and the portable ultrasound system (204), wherein the indwelling medical device is selected from a PEG tube and an IV catheter (“Reference is now made to FIG. 17, which is an illustration of a central venous catheter system 330 inserted into a body 405 of a patient.” [0126]) and comprises the portable ultrasound transducer (204A, 204B) coupled to an exterior surface thereof (“As shown in FIG. 17, in one embodiment, two thin piezo-elements 204 are attached at separate locations on central venous catheter system 330. A first thin piezo element 204A is incorporated into a pad 331, and a second thin piezo element 204B is attached as a clip-on to an external portion of catheter system 330. The two piezo-elements 204 are in electrical communication with processor 300, which is located outside of the body 405. First piezo-element 204A is configured to provide an infection-free environment at the insertion site--adjacent to an internal location of catheter system 330, and to help heal the catheter insertion wound…Second piezo-element 204B creates SAW on internal and external surfaces of central venous catheter system 330 and possibly on the hub or connector of the system to inhibit biofilm formation in critical device construction areas." [0127]).
Therefore, based on Zumeris’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Lewis to have an assembly of an indwelling medical device and the portable ultrasound system according to claim 1, wherein the indwelling medical device is selected from a PEG tube an IV catheter and comprises the portable ultrasound transducer coupled to an exterior surface thereof, as taught by Zumeris, in order to prevent bacterial growth on the indwelling medical device (Zumeris: [0003]).
Regarding claim 7, Lewis modified by Zumeris teaches the assembly according to claim 6
Lewis does not teach that the ultrasound transducer comprises a plurality of ultrasound transducers configured to supply SAW in a plurality of directions.
.
However, in the surface acoustic wave treatments field of endeavor, Zumeris discloses a system and method for surface acoustic wave treatment of medical devices, which is analogous art. Zumeris teaches that the ultrasound transducer comprises a plurality of ultrasound transducers (204A, 204B) (“As shown in FIG. 17, in one embodiment, two thin piezo-elements 204 are attached at separate locations on central venous catheter system 330." [0127]) configured to supply SAW in a plurality of directions (“An electrical signal from processor 300 excites bi-directional vibrations in PZT plate element 210, as shown by arrows 211 and 212." [0101]; Fig. 15).
Therefore, based on Zumeris’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Lewis to have an assembly of an indwelling medical device and the portable ultrasound system according to claim 1, wherein the indwelling medical device is selected from a PEG tube an IV catheter and comprises the portable ultrasound transducer coupled to an exterior surface thereof, as taught by Zumeris, in order to prevent bacterial growth on the indwelling medical device (Zumeris: [0003]).
Claims 8-12 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zumeris et al (US20070213645), hereinafter Zumeris.
Regarding claim 8, Zumeris teaches a portable ultrasound device (500) comprising:
a power source (302);
an ultrasound driver (304-306); and
an ultrasound transducer (200) configured to receive and convert a driving signal from the ultrasound driver into low frequency (“KHz” [0058]) surface acoustic waves (“Upon receipt of an electrical signal from processor 300, actuator 200 is capable of generating high frequency mechanical vibrations, in a range from KHz to MHz.” [0058]; “actuator 200 a piezoelectric actuator, and works by converting electrical signals from processor 300 into mechanical energy, wherein the mechanical energy is transmitted to device 100 and creates SAW on surfaces thereof." [0065]; Fig. 2),
wherein the portable ultrasound device is comprised by an indwelling medical device (100) (550) (“2. SAW Applications for Indwelling Medical Devices Catheters” [0118]; “As shown in FIG. 21, implant 550, which may be any type of implant, is positioned within the body… as shown in FIG. 22, actuator 200 is incorporated within or onto implant 550” [0137]) and the surface acoustic waves generated by the ultrasound transducer are transmitted along a surface of the indwelling medical device (“Reference is now made to FIG. 1, which is a schematic illustration of a medical device 100 with an actuator 200 for producing surface acoustic waves, in accordance with embodiments of the present invention. Device 100 has an external surface 110, an internal surface 120 a first end 130 and a second end 135. An actuator 200 is attached to external surface 110.” [0058]; “Reference is now made to FIG. 3A, which is a schematic representation (not to scale) showing the propagation of a Rayleigh wave on an elastic surface. As shown in FIG. 3A, the physical motion of this "true-SAW" wave type is associated with mechanically time-dependent elliptical displacement of the surface structure. One component of the physical displacement is parallel to the SAW propagation axis X, and another component is normal to the surface along axis Y.” [0069]; Figs. 1-2, 3A).
Regarding claim 9, Zumeris teaches the portable ultrasound device according to claim 8, wherein the portable ultrasound device is coupled to an exterior surface of the indwelling medical device and transmits the surface acoustic waves along an exterior surface of the indwelling medical device in an elongated direction thereof (“An actuator 200 is attached to external surface 110.” [0058]; “Reference is now made to FIG. 3A, which is a schematic representation (not to scale) showing the propagation of a Rayleigh wave on an elastic surface. As shown in FIG. 3A, the physical motion of this "true-SAW" wave type is associated with mechanically time-dependent elliptical displacement of the surface structure. One component of the physical displacement is parallel to the SAW propagation axis X, and another component is normal to the surface along axis Y.” [0069]; “Reference is now made to FIG. 15, which is a schematic illustration of SAW generation on a device 100. The device 100 shown herein is a urinary catheter 101, but it should be readily apparent that the following description applies to many devices. Actuator 200 is comprised of a thin piezo-electric (PZT) plate element 210, which is attached to catheter 101. Processor 300 is a driver which provides periodic electrical pulses to PZT plate element 210, which results in mechanical vibrations in normal modes. PZT plate element 210 is attached to an external surface 110 of catheter 101, and is connected via a cable 320 to processor 300. An electrical signal from processor 300 excites bi-directional vibrations in PZT plate element 210, as shown by arrows 211 and 212. The sum of the bi-directional vibrations is a bending vibration mode, depicted by sinusoidal lines 219 having maximum points on each side, as depicted by points 213 and 214. Maximum points 213 and 214 generate mechanical vibrations on the device surface 110.” [0101]; Figs. 1-2, 3A, 6C, 15-16).
Regarding claim 10, Zumeris teaches the portable ultrasound device according to claim 8, wherein wherein the indwelling medical device is an intravenous (IV) catheter or a PEG tube (“Types of catheters include standard IV, peripherally inserted central catheters (PICC)/midline, central venous catheters (CVC), angiographic catheters, guide catheters, feeding tubes,” [0118]. “Reference is now made to FIG. 17, which is an illustration of a central venous catheter system 330 inserted into a body 405 of a patient.” [0126]. “First piezo-element 204A is configured to provide an infection-free environment at the insertion site--adjacent to an internal location of catheter system 330, and to help heal the catheter insertion wound…Second piezo-element 204B creates SAW on internal and external surfaces of central venous catheter system 330 and possibly on the hub or connector of the system to inhibit biofilm formation in critical device construction areas." [0127]).
Regarding claim 11, Zumeris teaches the portable ultrasound device according to claim 8, wherein the ultrasound transducer comprises a plurality of ultrasound transducers (200A and 200B) (204A, 204B) (Reference is now made to FIG. 11, which is an illustration of one method for achieving SAW, showing a summation of SAW from two actuators 200A and 200B placed at an angle .alpha. relative to one another on a surface of device 100. Thus, running type waves 122 excited and transmitted by each of actuators 200A and 200B (in directions indicated by arrows 211) interfere with each other, thus forming standing waves 123 on the surface of device 100.” [0096]. “As shown in FIG. 17, in one embodiment, two thin piezo-elements 204 are attached at separate locations on central venous catheter system 330." [0127]).
Regarding claim 12, Zumeris teaches the portable ultrasound device according to claim 8, comprising a thin plate piezo transducer (210) in direct contact with a surface of the indwelling medical device (101) (“Reference is now made to FIG. 15, which is a schematic illustration of SAW generation on a device 100. The device 100 shown herein is a urinary catheter 101, but it should be readily apparent that the following description applies to many devices. Actuator 200 is comprised of a thin piezo-electric (PZT) plate element 210, which is attached to catheter 101. Processor 300 is a driver which provides periodic electrical pulses to PZT plate element 210, which results in mechanical vibrations in normal modes. PZT plate element 210 is attached to an external surface 110 of catheter 101, and is connected via a cable 320 to processor 300. An electrical signal from processor 300 excites bi-directional vibrations in PZT plate element 210, as shown by arrows 211 and 212. The sum of the bi-directional vibrations is a bending vibration mode, depicted by sinusoidal lines 219 having maximum points on each side, as depicted by points 213 and 214. Maximum points 213 and 214 generate mechanical vibrations on the device surface 110.” [0101]; Figs. 1-2, 3A, 6C, 15-16), wherein the thin plate piezo transducer is configured to vibrate in bending vibration modes to create standing acoustic waves (“FIG. 14A is an illustration of creation of surface acoustic focused standing waves using a ring-shaped piezo-element;” [0028]; “The sum of the bi-directional vibrations” [0101]) upon activation by a processor (300) (“Processor 300 is a driver which provides periodic electrical pulses to PZT plate element 210, which results in mechanical vibrations in normal modes…The sum of the bi-directional vibrations is a bending vibration mode, depicted by sinusoidal lines 219 having maximum points on each side, as depicted by points 213 and 214. Maximum points 213 and 214 generate mechanical vibrations on the device surface 110.” [0101]; Figs. 1-2, 3A, 6C, 15-16).
Regarding claim 14, Zumeris teaches the portable ultrasound device according to claim 8, wherein the ultrasound transducer is implantable within a subject as part of an indwelling medical device (“As shown in FIG. 21, implant 550, which may be any type of implant, is positioned within the body… as shown in FIG. 22, actuator 200 is incorporated within or onto implant 550, and only processor 300 and optionally sensing device 232 are placed external to the body.” [0137]).
Regarding claim 15, Zumeris teaches an indwelling medical device (100) (550) for implantation in a subject's body (“2. SAW Applications for Indwelling Medical Devices Catheters” [0118]), the indwelling medical device having an elongated tube shape comprising a proximal end opposite a direction of the body (130) and a distal end (135) in the direction of the body (“Reference is now made to FIG. 1, which is a schematic illustration of a medical device 100 with an actuator 200 for producing surface acoustic waves, in accordance with embodiments of the present invention. Device 100 has an external surface 110, an internal surface 120 a first end 130 and a second end 135. An actuator 200 is attached to external surface 110.” [0058]; Figs. 1, 15, 17), and comprising the portable ultrasound system of claim 8 operatively coupled thereto, wherein the portable ultrasound transducer is configured within a surface of the indwelling medical device (“As shown in FIG. 21, implant 550, which may be any type of implant, is positioned within the body… as shown in FIG. 22, actuator 200 is incorporated within or onto implant 550” [0137]).
Regarding claim 16, Zumeris teaches an indwelling medical device (100) (550) (“2. SAW Applications for Indwelling Medical Devices Catheters” [0118]) comprising the portable ultrasound system of claim 8 operatively coupled thereto (An actuator 200 is attached to external surface 110.” [0058]; Figs. 1, 15, 17), wherein the ultrasound transducer comprises a piezoelectric element in direct contact with the surface of the indwelling medical device (“Actuator 200 is comprised of a thin piezo-electric (PZT) plate element 210, which is attached to catheter 101.” [0101]; Figs. 1-2, 3A, 6C, 15-16) and, upon receipt of the electrical signal, generates high frequency mechanical vibrations to create surface acoustic waves in the nanoscale range on an internal surface (120) and external surface (130) of the indwelling medical device (“Reference is now made to FIG. 1, which is a schematic illustration of a medical device 100 with an actuator 200 for producing surface acoustic waves, in accordance with embodiments of the present invention. Device 100 has an external surface 110, an internal surface 120 a first end 130 and a second end 135. An actuator 200 is attached to external surface 110…Upon receipt of an electrical signal from processor 300, actuator 200 is capable of generating high frequency mechanical vibrations, in a range from KHz to MHz. These high frequency mechanical vibrations create surface acoustic waves 121 (in the nanometer range) on internal surface 120 and external surface 110 of device 100. The frequency of generated mechanical oscillations in actuator 200 is directly related to the frequency produced by processor 300. Thus, for example, if oscillations are in the MHz range, the mechanical vibrations will also be in the MHz range, and similarly for other ranges. The energy source applied via processor 300 may have a periodical or non-periodical character, and may be electro-mechanical” [0058]).
Regarding claim 17, Zumeris teaches a method for inhibiting formation of bacterial biofilm (Abstract) associated with an implanted medical device (“The present invention is directed to methods for treating the surfaces of medical devices with surface acoustic waves. Specifically, the present invention can be used to treat biofilms that form on implantable medical devices by disrupting bacterial growth via surface acoustic waves (SAW) having frequencies on a nanoscale.” [0056]), comprising:
providing an indwelling medical device (100) (“2. SAW Applications for Indwelling Medical Devices Catheters” [0118]; Figs. 16-18), an ultrasound transducer (200) (204) (“actuator 200 is capable of generating high frequency mechanical vibrations, in a range from KHz to MHz.” [0058]; "ultrasound energy" [0064]; "electromagnetic ultrasound transducers" [0075]) positioned on the indwelling medical device (“Actuator 200 is comprised of a thin piezo-electric (PZT) plate element 210, which is attached to catheter 101.” [0101]; Figs. 1-2, 3A, 6C, 15-16), wherein the ultrasound transducer comprises a piezoelectric material in direct contact with a surface of the indwelling medical device (“Actuator 200 is comprised of a thin piezo-electric (PZT) plate element 210, which is attached to catheter 101” [0101]; Figs. 1-2, 3A, 6C, 15-16), and a processor (300) in electrical communication with the ultrasound transducer (“Reference is now made to FIG. 1, which is a schematic illustration of a medical device 100 with an actuator 200 for producing surface acoustic waves, in accordance with embodiments of the present invention. Device 100 has an external surface 110, an internal surface 120 a first end 130 and a second end 135. An actuator 200 is attached to external surface 110.” [0058]; “actuator 200 a piezoelectric actuator, and works by converting electrical signals from processor 300 into mechanical energy, wherein the mechanical energy is transmitted to device 100 and creates SAW on surfaces thereof.” [0065]; Fig. 2. “Processor 300 is a driver which provides periodic electrical pulses to PZT plate element 210, which results in mechanical vibrations in normal modes. PZT plate element 210 is attached to an external surface 110 of catheter 101, and is connected via a cable 320 to processor 300. An electrical signal from processor 300 excites bi-directional vibrations in PZT plate element 210, as shown by arrows 211 and 212. The sum of the bi-directional vibrations is a bending vibration mode, depicted by sinusoidal lines 219 having maximum points on each side, as depicted by points 213 and 214. Maximum points 213 and 214 generate mechanical vibrations on the device surface 110.” [0101]; “The two piezo-elements 204 are in electrical communication with processor 300, which is located outside of the body 405.” [0127]; Figs. 1-2, 3A, 6C, 15-18);
positioning at least a distal end of the indwelling medical device in a body of a subject (seen in Fig. 17);
activating the ultrasound transducer by powering the processor, wherein activating the ultrasound transducer produces elliptical motion of particles and generates surface acoustic waves along a surface (910) (“the SAW propagation axis X” [0069]) of the indwelling medical device (“Reference is now made to FIG. 3A, which is a schematic representation (not to scale) showing the propagation of a Rayleigh wave on an elastic surface. As shown in FIG. 3A, the physical motion of this "true-SAW" wave type is associated with mechanically time-dependent elliptical displacement of the surface structure. One component of the physical displacement is parallel to the SAW propagation axis X, and another component is normal to the surface along axis Y.” [0069]; “Reference is now made to FIG. 16, which is a schematic illustration of device 100 positioned next to a body tissue 400, and depicting SAW in motion and its effect at different depths within tissue 400. SAW are created in a first direction 910, and the physical motion of SAW is associated mechanically with a time-dependent elliptical displacement of surface material particles as shown by ellipses 506.” [0108]); and
controlling parameters of the ultrasound transducer via the processor such that a vibration amplitude of the bacteria is smaller than a Z-potential repulsive zone of the bacteria (“When the SAW-generated bacterial vibration amplitudes are smaller than the Z potential repulsive zone, an overall net repulsion occurs, preventing bacterial attachment, and being effective in: inhibiting particle attachment to the surfaces, inhibiting adhesion, growth and aggregation of cells into micro colonies process on the surfaces, maturation and dissemination of progeny cells for new colony formation.” [0063]. “When the surface acoustic wave-generated particle relative elliptical oscillation amplitudes are smaller than the potential repulsive zone, an overall net repulsion occurs. This may cause inhibition of particle attachment to the surfaces, inhibition of adhesion, growth and aggregation of cells into micro-colonies on the surfaces, and inhibition of maturation and dissemination of progeny cells for new colony formation.” [0105]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zumeris as applied to claim 8, and further in view of Zhang (CN 111588969), hereinafter Zhang.
Regarding claim 13, Zumeris teaches the portable ultrasound device according to claim 8 configured within a patch for an indwelling medical device (550) (“Actuator 200 and processor 300 are attached to the body (externally), and are configured to excite SAW through the body and onto the surface of implant 550. In some embodiments, sensing device 232 is also placed on the body at a different location. Both actuator 200 (with processor 300 incorporated therein) and sensing device 232 may be configured, for example, as patches.” [0137].
Zumeris does not teach that the patch is for adhesion of the indwelling medical device to a patient.
However, in the medical auxiliary appliance field of endeavor, Zhang discloses a daily fixing device of drainage indwelling tube, which is analogous art. Zhang teaches that the patch is for adhesion of the indwelling medical device to a patient (“The invention claims a daily fixing device of drainage indwelling pipe, comprising an auxiliary material patch, wherein the upper surface of the auxiliary material patch is fixedly adhered with a fixing block; the inner part of the fixing block is provided with a through hole; the through hole is provided with a retention tube; the inner part of the fixing block is provided with two symmetrical I-shaped cavities; the front and back two sides of the inner wall of the I-shaped cavity are rotatably connected with a rotating shaft through a bearing; the surface of the rotating shaft close to the middle part is fixedly connected with a gear. The invention realizes the simple and fast clamping and fixing of the indwelling tube by the matching of the structure; it avoids the indwelling tube falling off from the body caused by the action of the external force; it affects the treatment effect, at the same time, when the indwelling tube enters the patient body through the fixing block, it can sterilize the surface of the indwelling tube, avoids the remaining bacteria on the surface of the indwelling tube to affect the treatment effect, so that the treatment effect of the patient using the indwelling tube is better.” Abstract).
Therefore, based on Zhang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zumeris to have that the patch for adhesion of the indwelling medical device to a patient, as taught by Zhang, in order to facilitate operation of the indwelling medical device thereby improving the treatment effect (Zhang: Abstract).
Conclusion
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/ALEXEI BYKHOVSKI/
Examiner, Art Unit 3798
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