DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 7 , and 14 are objected to because of the following informalities:
Regarding claim 1, the phrase “a catheter hub, a proximal-end portion of the catheter tube disposed in the catheter hub“ in lines 11-12 should read “a catheter hub, wherein a proximal-end portion of the catheter tube is disposed in the catheter hub” for proper grammar,
Regarding claim 7, the phrase “, remaining piezoelectric transducers of the plurality of piezoelectric transducers capable of vibrations” in lines 5-6 should read “, wherein remaining piezoelectric transducers of the plurality of piezoelectric transducers are capable of vibrations” for proper grammar,
Regarding claim 14, the phrase “a method of catheter assembly” in line 1 should read “a method of using a catheter assembly” for proper grammar,
Regarding claim 14, the phrase “a catheter hub, a proximal-end portion of the catheter tube disposed in the catheter hub“ in lines 7-8 should read “a catheter hub, wherein a proximal-end portion of the catheter tube is disposed in the catheter hub” for proper grammar,
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1, 9, 12-14, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al. (U.S Patent Pub. No. 20140243789 A1, “Mehta”) in view of Ofek et al. (U.S Patent Pub. No. 20210378593 A1, “Ofek”).
Regarding claim 1, Mehta discloses the limitations of (Claim 1) a catheter assembly (see at least Fig. 1-2, see para. 0049), comprising:
a catheter (200 in Fig. 1-2) including:
a catheter tube (210 in Fig. 2-4) incorporating a plurality of piezoelectric transducers (231, 232 in Fig. 4) into a length of the catheter tube (210, see para. 0055), the plurality of piezoelectric transducers (231, 232) configured as a plurality of vibrators for vibrating and, thereby, inhibiting buildup of biomaterial on a luminal surface of the catheter tube (210), an abluminal surface of the catheter tube (210), or both the luminal and abluminal surfaces of the catheter tube (210) by way of vibrations along the length of the catheter tube (210) when the catheter tube (210) is placed in a vasculature (see para. 0048 and 0056-0057 – the plurality of piezoelectric elements 231 and 232 are configured to generate acoustic vibrations that reduce intralumenal fluid stagnation within tube 210 and prevent biofilm formation within the lumen of tube 210 [luminal] and along its exterior surface [abluminal]);
a catheter hub (100 in Fig. 1-2 and 7-8, see para. 0049), a proximal-end portion of the catheter tube (210) disposed in the catheter hub (100, see para. 0051 – the proximal end portion of catheter tube 210 is disposed within a connection port of the hub 100);
a controller (“control circuitry” of 170 in Fig. 8, see para. 0061 and 0077 – panel 170 comprises the control circuitry interpreted as the controller), the controller (“control circuitry” of 170 in para. 0061 and 0077) configured to control at least the plurality of piezoelectric transducers (231, 232, see para. 0061 and 0077 – examiner notes the controller is being interpreted as the combined structure of the activator said to have a control circuit for controlling the acoustic wave generation elements); and
an internal power source (“power source” of 170 in para. 0061 and 0077) configured to power the controller (“control circuitry” of 170 in para. 0061 and 0077) and the plurality of piezoelectric transducers (231, 232, see para. 0060-0061 and 0077).
However, Mehta fails to explicitly disclose that the control circuitry of the panel (170) interpreted as the controller includes (Claim 1) a processor and memory.
Ofek discloses a venous catheter assembly (10 in Fig. 1) comprising a sensor array (30 in Fig. 1) and a catheter hub (16 in Fig. 1), wherein the catheter hub (16) or other structures of the catheter may comprise a printed circuit board (36 in Fig. 1) including a microprocessor for governing sensor operation, a power source for powering the sensor array (30), and a non-volatile memory storage location (see para. 0037).
Since Mehta discloses a catheter assembly (see Fig. 1-2) having a catheter hub (100 in Fig. 1-2 and 7-8) with a panel (170 in Fig. 8) comprising control circuitry and a power source for controlling and powering a transducer array, and Ofek discloses a catheter assembly (10 in Fig. 1) having a catheter hub (16 in Fig. 1) with a printed circuit board (36) comprising a microprocessor, power source, and memory, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control circuit of panel (170) of Mehta to explicitly comprise a microprocessor and memory as taught by Ofek to provide explicit structures for governing sensor operation and enabled sensor data to be temporarily or permanently stored therein (see para. 0037).
Regarding claim 9, modified Mehta discloses the catheter assembly of claim 1, as discussed above. In modified Mehta, Mehta discloses (Claim 9) wherein the controller (“control circuitry” of 170 in para. 0061 and 0077) and the internal power source (“power source” of 170 in para. 0061 and 0077) are incorporated into a portion of the catheter hub (100 in Fig. 8, see para. 0077).
Regarding claim 12, modified Mehta discloses the catheter assembly of claim 1, as discussed above. In modified Mehta, Mehta discloses (Claim 12) wherein the buildup of biomaterial is an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, or a combination thereof (see para. 0057 – biomaterial is biofilm formation).
Regarding claim 13, modified Mehta discloses the catheter assembly of claim 1, as discussed above. In modified Mehta, Mehta discloses (Claim 13) wherein the catheter is a central venous catheter (“CVC”) or a peripherally inserted central catheter (“PICC”) (see para. 0049 and 0073-0074 – lumens 210 are the lumens for central venous catheters having the central venous catheter hub 100).
Regarding claim 14, Mehta discloses the limitations of (Claim 14) a method of catheter assembly (see Fig. 1-2 and 8-9 and para. 0073), comprising:
placing a catheter (200 in Fig. 1-2) of the catheter assembly in a vasculature of a patient (400 in Fig. 9, see para. 0074), the catheter (200) including:
catheter tube (210 in Fig. 2-4) incorporating a plurality of piezoelectric transducers (231, 232 in Fig. 4) into a length of the catheter tube (210, see para. 0055), the plurality of piezoelectric transducers (231, 232) configured as a plurality of vibrators (see para. 0048 and 0056-0057 – the plurality of piezoelectric elements 231 and 232 are configured to generate acoustic vibrations); and
a catheter hub (100 in Fig. 1-2 and 7-8, see para. 0049), a proximal-end portion of the catheter tube (210) disposed in the catheter hub (100, see para. 0051 – the proximal end portion of catheter tube 210 is disposed within a connection port of the hub 100); and
powering up the catheter assembly by way of an internal power source (“power source” of 170 in para. 0061, 0064, and 0077 – the catheter assembly is powered by when electrical communication is established with the power source of panel 170), the powering up of the catheter assembly activating a controller (“control circuitry” of 170 in para. 0061 and 0077) configured to control the plurality of piezoelectric transducers (231, 232, see para. 0061 and 0077 – upon electrical communication of the power source of panel 170 with the transducer array 230, the control circuitry of panel 170 is activated to control acoustic wave generation thereto), thereby vibrating and, thusly, inhibiting buildup of biomaterial on a luminal surface of the catheter tube (210), an abluminal surface of the catheter tube (210), or both the luminal and abluminal surfaces of the catheter tube (210) by way of vibrations along the length of the catheter tube (210, see para. 0048 and 0056-0057 – the plurality of piezoelectric elements 231 and 232 are configured to generate acoustic vibrations that reduce intralumenal fluid stagnation within tube 210 and prevent biofilm formation within the lumen of tube 210 [luminal] and along its exterior surface [abluminal]).
However, Mehta fails to explicitly disclose that the control circuitry of the panel (170) interpreted as the controller includes (Claim 14) a processor and memory.
Ofek discloses a venous catheter assembly (10 in Fig. 1) comprising a sensor array (30 in Fig. 1) and a catheter hub (16 in Fig. 1), wherein the catheter hub (16) or other structures of the catheter may comprise a printed circuit board (36 in Fig. 1) including a microprocessor for governing sensor operation, a power source for powering the sensor array (30), and a non-volatile memory storage location (see para. 0037).
Since Mehta discloses a catheter assembly (see Fig. 1-2) having a catheter hub (100 in Fig. 1-2 and 7-8) with a panel (170 in Fig. 8) comprising control circuitry and a power source for controlling and powering a transducer array, and Ofek discloses a catheter assembly (10 in Fig. 1) having a catheter hub (16 in Fig. 1) with a printed circuit board (36) comprising a microprocessor, power source, and memory, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control circuit of panel (170) of Mehta to explicitly comprise a microprocessor and memory as taught by Ofek to provide explicit structures for governing sensor operation and enabled sensor data to be temporarily or permanently stored therein (see para. 0037).
Regarding claim 20, modified Mehta discloses the method of claim 14, as discussed above. In modified Mehta, Mehta discloses (Claim 20) wherein the controller (“control circuitry” of 170 in para. 0061 and 0077) and the internal power source (“power source” of 170 in para. 0061 and 0077) are incorporated into a portion of the catheter hub (100 in Fig. 8, see para. 0077).
Regarding claim 21, modified Mehta discloses the method of claim 21, as discussed above. In modified Mehta, Mehta discloses (Claim 21) wherein the buildup of biomaterial is an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, or a combination thereof (see para. 0057 – biomaterial is biofilm formation).
Claim(s) 2, 4, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek as applied to claims 1 and 14, respectively, above, and further in view of Walinsky et al. (U.S Patent No. 5240004, “Walinsky”) as evidenced by Prakash et al. (U.S Patent Pub. No. 20220280984 A1, “Prakash”).
Regarding claim 2, modified Mehta discloses the catheter assembly of claim 1, as discussed above. In modified Mehta, Mehta discloses (Claim 2) the plurality of piezoelectric transducers (231, 232 in Fig. 4) and electrical leads (220 in Fig. 4) connecting the plurality of piezoelectric transducers (231, 232) to the controller (“control circuitry” of 170 in para. 0060-0061 and 0077 – wires 220 are interpreted as the electrical leads which connect the transducer array elements 231 and 232 to a metal ring in electrical communication with the control circuitry).
However, modified Mehta fails to disclose (Claim 2) wherein the plurality of piezoelectric transducers and electrical leads are flexible electronics fabricated on the luminal surface of the catheter tube, fabricated on the abluminal surface of the catheter tube, or disposed between the luminal and abluminal surfaces of the catheter tube.
Walinsky discloses an intravascular, ultrasonic imagining catheter (10 in Fig. 3) comprises a plurality of discrete driving electrodes (20 in Fig. 3) which may be polarized to be piezoelectrically active and disposed on a luminal surface of the catheter tube (see Col.5, lines 31-38 and Col.8, lines 1-10 – electrodes 20 are spot polarized to act as piezoelectric transducers). Walinsky teaches (Claim 2) the plurality of piezoelectric transducers (20 in Fig. 3) and electrical leads (14 in Fig. 3) are flexible electronics fabricated on the luminal surface of the catheter tube (10, see Col.8, lines 24-37 and Col.9, lines 53-60 – electrodes 20 and electrical connectors 14 are integrally formed metallic strips made of a metal that is sufficiently flexible).
Since Mehta discloses a plurality of piezoelectric transducers (231, 232) integrated into the wall of the catheter tube (210) and electrical leads (220) formed as wires coupled thereto, and Walinsky discloses a plurality of piezoelectric transducers (20) formed on a luminal surface of the catheter tube (10) and electrical leads (14) integrally formed therewith, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of piezoelectric transducers and electrical leads of modified Mehta to be flexible electronics fabricated on the luminal surface of the catheter tube as taught by Walinsky. Walinksy teaches that the transducers and connectors being integrally formed, flexible metallic layers on the luminal surface of the catheter does not require any separate connections need to be made between the transducers and connections and thus minimize the likelihood of breakage or discontinuity (see Col.8, lines 29-37), and the flexibility ensures that the catheter maintains its required flexibility for maneuvering vasculature to the target site (see Col.2, lines 58-66).
Examiner notes the catheter of Mehta would operate as intended upon incorporating the transducers and electrical leads as flexible electronics fabricated on the luminal surface of the catheter tube as taught by Walinsky and as evidenced by Prakash. Prakash discloses an ultrasonic device (100A in Fig. 1A) in the form of a flexible, tubular body (102 in Fig. 1A) which comprises a plurality of ultrasonic transducers (116 in Fig. 1A) that may provide agitation or vibration of the tubular body (102) to dislodge contaminants therefrom (see para. 0040 and 0044), wherein the transducers (116) may be disposed on the outside surface (114 in Fig. 1A), the inside surface (112 in Fig. 1A), or embedded within the flexible body (102, see para. 0040 and 0044).
Regarding claim 4, modified Mehta discloses the catheter assembly of claim 2, as discussed above.
In modified Mehta, while Walinsky discloses that the average electrode and/or connector described herein (as flexible electronics) has a thickness of about 800-1000 Angstroms (0.08-0.1 microns, see Col.9, lines 49-52), Walinsky fails to explicitly disclose (Claim 4) wherein a thickness of the flexible electronics ranges from about 1 μm to about 500 μm.
Walinsky discloses that the average electrode and/or connector has a thickness that needs to be optimized to make “any contribution to the stiffness of the resulting catheter negligible” (see Col.9, lines 49-52). Thus, the thickness of the flexible electronics of Walinsky are disclosed to be a result effective variable in that changing the thickness of said flexible electronics would alter the stiffness of the catheter which affects its flexibility and size. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the flexible electronics of Walinksy to have a thickness within the claimed range, as it involves adjusting the dimensions of a component of a catheter that Walinsky discloses as having different layers with thicknesses that may vary depending upon their size and the size of the vessel to be imaged (see Col.9, lines 35-37). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Walinsky by making the thickness of the flexible electronics from about 1 micron to about 500 microns as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it appears that applicant places no criticality on the range claimed, indicating simply that the thickness of the flexible electronics “can be at least about” a plurality of dimensions as noted in para. 0045 of the instant specification and specifically stating “no more than about 1 μm”.
Regarding claim 15, modified Mehta discloses the method of claim 14, as discussed above. In modified Mehta, Mehta discloses (Claim 15) the plurality of piezoelectric transducers (231, 232 in Fig. 4) and electrical leads (220 in Fig. 4) connecting the plurality of piezoelectric transducers (231, 232) to the controller (“control circuitry” of 170 in para. 0060-0061 and 0077 – wires 220 are interpreted as the electrical leads which connect the transducer array elements 231 and 232 to a metal ring in electrical communication with the control circuitry).
However, modified Mehta fails to disclose (Claim 15) wherein the plurality of piezoelectric transducers and electrical leads are flexible electronics fabricated on the luminal surface of the catheter tube, fabricated on the abluminal surface of the catheter tube, or disposed between the luminal and abluminal surfaces of the catheter tube.
Walinsky discloses an intravascular, ultrasonic imagining catheter (10 in Fig. 3) comprises a plurality of discrete driving electrodes (20 in Fig. 3) which may be polarized to be piezoelectrically active and disposed on a luminal surface of the catheter tube (see Col.5, lines 31-38 and Col.8, lines 1-10 – electrodes 20 are spot polarized to act as piezoelectric transducers). Walinsky teaches (Claim 15) the plurality of piezoelectric transducers (20 in Fig. 3) and electrical leads (14 in Fig. 3) are flexible electronics fabricated on the luminal surface of the catheter tube (10, see Col.8, lines 24-37 and Col.9, lines 53-60 – electrodes 20 and electrical connectors 14 are integrally formed metallic strips made of a metal that is sufficiently flexible).
Since Mehta discloses a plurality of piezoelectric transducers (231, 232) integrated into the wall of the catheter tube (210) and electrical leads (220) formed as wires coupled thereto, and Walinsky discloses a plurality of piezoelectric transducers (20) formed on a luminal surface of the catheter tube (10) and electrical leads (14) integrally formed therewith, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of piezoelectric transducers and electrical leads of modified Mehta to be flexible electronics fabricated on the luminal surface of the catheter tube as taught by Walinsky. Walinksy teaches that the transducers and connectors being integrally formed, flexible metallic layers on the luminal surface of the catheter does not require any separate connections need to be made between the transducers and connections and thus minimize the likelihood of breakage or discontinuity (see Col.8, lines 29-37), and the flexibility ensures that the catheter maintains its required flexibility for maneuvering vasculature to the target site (see Col.2, lines 58-66).
Examiner notes the catheter of Mehta would operate as intended upon incorporating the transducers and electrical leads as flexible electronics fabricated on the luminal surface of the catheter tube as taught by Walinsky and as evidenced by Prakash. Prakash discloses an ultrasonic device (100A in Fig. 1A) in the form of a flexible, tubular body (102 in Fig. 1A) which comprises a plurality of ultrasonic transducers (116 in Fig. 1A) that may provide agitation or vibration of the tubular body (102) to dislodge contaminants therefrom (see para. 0040 and 0044), wherein the transducers (116) may be disposed on the outside surface (114 in Fig. 1A), the inside surface (112 in Fig. 1A), or embedded within the flexible body (102, see para. 0040 and 0044).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek in view of Walinsky as applied to claim 2 above, and further in view of Hastings et al. (U.S Patent Pub. No. 20120059286 A1, “Hastings”).
Regarding claim 3, modified Mehta discloses the catheter assembly of claim 2, as discussed above.
While Mehta discloses that the internal power source may be a battery (see para. 0064), however modified Mehta fails to disclose (Claim 3) wherein the internal power source is a lithium-ion battery or a flexible battery.
Hastings discloses a self-powered ablation catheter (200 in Fig. 4) comprising a catheter tube (218 in Fig. 4) having an electrode arrangement (233 in Fig. 4) and a catheter hub (201 in Fig. 4) housing an internal power source (208 in Fig. 4), wherein Hastings teaches (Claim 3) wherein the internal power source (208) is a lithium-ion battery (see para. 0107).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the battery taught by modified Mehta to be a lithium-ion battery as taught by Hastings. Hastings provides that a lithium-ion battery is a standard rechargeable battery allowing it to be recharged and reused for the self-powered ablation catheter (see para. 0107).
Claim(s) 5-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek as applied to claims 1 and 14, respectively, above, and further in view of Tachibana et al. (W.O Patent Pub. No. 9848711 A1, “Tachibana”).
Regarding claim 5, modified Mehta discloses the catheter assembly of claim 1, as discussed above.
However, modified Mehta fails to disclose (Claim 5) wherein individual piezoelectric transducers of the plurality of piezoelectric transducers, individual groups of piezoelectric transducers of the plurality of piezoelectric transducers, or a combination of the individual piezoelectric transducers and the individual groups of piezoelectric transducers are individually electronically addressed.
Tachibana discloses an ultrasound catheter (10 in Fig. 1A-1B) comprises a plurality of ultrasound elements (12 in Fig. 1A-1B) which may be piezoelectric ceramic oscillators for delivering ultrasound energy to vasculature (p.5, lines 1-2 and p.6, lines 9-17), wherein Tachibana teaches (Claim 5) wherein individual piezoelectric transducers (12 in Fig. 2C) of the plurality of piezoelectric transducers (12 in Fig. 2C) are individually electronically addressed (see Fig. 2C and Col.7, lines 4-16 – each ultrasound element 12 has its own return wire 24 allowing each element 12 to be individually electronically addressed).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of transducers (231, 232) and electrical leads (220) of modified Mehta such that each transducer is individually electronically addressed as taught by Tachibana. Thus, each transducer (231, 232) of Mehta would be individually electronically addressed by its own return lead such that each transducer can be independently controlled and the catheter’s flexibility is maintained as taught by Tachibana (see Col.7, lines 4-16).
Regarding claim 6, modified Mehta discloses the catheter assembly of claim 5, as discussed above. In modified Mehta, Tachibana discloses (Claim 6) wherein the individual piezoelectric transducers (12 in Fig. 2C) being individually electronically addressed allows function of the transducers (12) along the length of the catheter tube (10) to be customized by location of the individual piezoelectric transducers (12, see Col.7, lines 4-16).
Thus, in modified Mehta, the individually electronically addressed piezoelectric transducers (231, 232) would thus allow the vibrations from the piezoelectric transducers (231, 232) to be customized in the same manner as taught by Tachibana.
Regarding claim 7, modified Mehta discloses the catheter assembly of claim 5, as discussed above. In modified Mehta, Tachibana discloses (Claim 7) wherein the individual piezoelectric transducers (12 in Fig. 2C) being individually electronically addressed allows a distal-end portion of the catheter tube to be excised for a desired placement length of the catheter tube (10), remaining piezoelectric transducers (12) of the plurality of piezoelectric transducers (12) capable of functioning along the placement length of the catheter tube (10) in accordance with being individually electronically addressed (see Col.7, lines 4-16 – each transducer 12 can be individually activated by closing a switch to complete a circuit between common wire 22 and respective return wire 24 thus indicating that if the distal most [right-hand side] transducer 12 in Fig. 2C was excised, the remaining transducers 12 would still be able to form closed circuits and function normally).
Thus, in modified Mehta, the individually electronically addressed piezoelectric transducers (231, 232) would thus allow the piezoelectric transducers (231, 232) remaining on the desired placement length after excision to be capable of producing the vibrations as taught by Tachibana.
Regarding claim 16, modified Mehta discloses the method of claim 14, as discussed above.
However, modified Mehta fails to disclose (Claim 6) wherein individual piezoelectric transducers of the plurality of piezoelectric transducers, individual groups of piezoelectric transducers of the plurality of piezoelectric transducers, or a combination of the individual piezoelectric transducers and the individual groups of piezoelectric transducers are individually electronically addressed.
Tachibana discloses an ultrasound catheter (10 in Fig. 1A-1B) comprises a plurality of ultrasound elements (12 in Fig. 1A-1B) which may be piezoelectric ceramic oscillators for delivering ultrasound energy to vasculature (p.5, lines 1-2 and p.6, lines 9-17), wherein Tachibana teaches (Claim 16) wherein individual piezoelectric transducers (12 in Fig. 2C) of the plurality of piezoelectric transducers (12 in Fig. 2C) are individually electronically addressed (see Fig. 2C and Col.7, lines 4-16 – each ultrasound element 12 has its own return wire 24 allowing each element 12 to be individually electronically addressed).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of transducers (231, 232) and electrical leads (220) of modified Mehta such that each transducer is individually electronically addressed as taught by Tachibana. Thus, each transducer (231, 232) of Mehta would be individually electronically addressed by its own return lead such that each transducer can be independently controlled and the catheter’s flexibility is maintained as taught by Tachibana (see Col.7, lines 4-16).
Regarding claim 17, modified Mehta discloses the method of claim 16, as discussed above. In modified Mehta, Tachibana discloses (Claim 17) wherein the individual piezoelectric transducers (12 in Fig. 2C) being individually electronically addressed allows function of the transducers (12) along the length of the catheter tube (10) to be customized by location of the individual piezoelectric transducers (12, see Col.7, lines 4-16).
Thus, in modified Mehta, the individually electronically addressed piezoelectric transducers (231, 232) would thus allow the vibrations from the piezoelectric transducers (231, 232) to be customized in the same manner as taught by Tachibana.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek in view of Tachibana as applied to claim 16 above, and further in view of Kassab et al. (U.S Patent Pub. No. 20150080762 A1, “Kassab”).
Regarding claim 18, modified Mehta discloses the method of claim 16, as discussed above. In modified Mehta, Tachibana discloses (Claim 18) wherein the individual piezoelectric transducers (12 in Fig. 2C) being individually electronically addressed allowing remaining piezoelectric transducers (12) of the plurality of piezoelectric transducers (12) capable of functioning along the placement length of the catheter tube (10) after the powering up the catheter assembly in accordance with being individually electronically addressed (see Col.7, lines 4-16 – each transducer 12 can be individually activated by closing a switch to complete a circuit between common wire 22 and respective return wire 24 thus indicating that if the distal most [right-hand side] transducer 12 in Fig. 2C was excised, the remaining transducers 12 would still be able to form closed circuits and function normally).
However, modified Mehta fails to disclose the method of (Claim 18) further comprising excising a distal-end portion of the catheter tube for a desired placement length of the catheter tube before placing of the catheter in the vasculature of a patient.
Kassab discloses a device (100 in Fig. 1) configured as a central venous catheter (CVC) or a peripherally inserted central catheter (PICC, see para. 0087), wherein Kassab teaches (Claim 18) further comprising excising a distal-end portion of the catheter tube (100) for a desired placement length of the catheter tube (100) before placing of the catheter in the vasculature of a patient (see para. 0122 – distal portion of device 100 may be cut down/trimmed before being delivered into the patient as desired or required for a particular patient).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of using the catheter assembly of modified Mehta to comprise excising a distal-end portion of the catheter tube for a desired placement length of the catheter tube before placing of the catheter in the vasculature of a patient as taught by Kassab. Kassab provides that cutting down or trimming a catheter before delivery into a patient allows said catheter’s length to be customized for a particular patient to meet their individual needs (see para. 0122).
Thus, in modified Mehta, the individually electronically addressed piezoelectric transducers (231, 232) would thus allow the piezoelectric transducers (231, 232) remaining on the desired placement length after excision to be capable of producing the vibrations as taught by Tachibana.
Claim(s) 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek as applied to claims 1 and 14, respectively, above, and further in view of Carmeli et al. (U.S Patent Pub. No. 20120302820 A1, “CarmelI”).
Regarding claim 8, modified Mehta discloses the catheter assembly of claim 1, as discussed above.
However, modified Mehta fails to disclose (Claim 8) wherein the plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and, thereby, monitoring environmental conditions of the catheter tube when the catheter tube is placed in the vasculature.
Carmeli discloses a vibrating guidewire (244 in Fig. 3A) for use in a vascular catheter assembly utilized for opening a passage through an occlusion (see para. 0031), wherein the vibrating guidewire (244) comprises an ultrasonic vibrating element (247 in Fig. 3A) which may be in the form of a piezoelectric transducer configured for inducing acoustic vibrations and/or for sensing and characterizing the substance/tissue that is in proximity to the distal end of the guidewire (244, see para. 0045 and 0160). Thus, Carmeli teaches (Claim 8) wherein the piezoelectric transducer (247) is further configured as a sensor for sensing and, thereby, monitoring environmental conditions of the guidewire (244) when the guidewire (244) is placed in the vasculature (see para. 0160).
Since Mehta discloses a catheter tube comprising a plurality of piezoelectric, ultrasonic transducers configured to produce acoustic vibrations for vibrating the catheter tube, and Carmeli discloses a guidewire comprising a piezoelectric, ultrasonic transducer configured to produce acoustic vibrations for vibrating the guidewire, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of piezoelectric transducers of modified Mehta to be further configured as a plurality of sensors for sensing and, thereby, monitoring environmental conditions of the catheter tube when the catheter tube is placed in the vasculature as taught by Carmeli. Carmeli provides that the piezoelectric, ultrasonic transducer is further configured to sense the tissue/substance being in contact with the guidewire which advantageously is used to provide an indication of position within vasculature (see para. 0032 and 0045).
Regarding claim 19, modified Mehta discloses the method of claim 14, as discussed above.
In modified Mehta, Mehta discloses the method limitations of (Claim 19) the placing of the catheter in the vasculature of the patient, the powering up of the catheter assembly, and the activating of the controller (“control circuitry” of 170 in para. 0061 and 0077 – upon electrical communication of the power source of panel 170 with the transducer array 230, the control circuitry of panel 170 is activated to control acoustic wave generation thereto and thus the catheter assembly is powered up).
However, modified Mehta fails to disclose (Claim 19) wherein the plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and, thereby, monitoring environmental conditions of the catheter tube.
Carmeli discloses a vibrating guidewire (244 in Fig. 3A) for use in a vascular catheter assembly utilized for opening a passage through an occlusion (see para. 0031), wherein the vibrating guidewire (244) comprises an ultrasonic vibrating element (247 in Fig. 3A) which may be in the form of a piezoelectric transducer configured for inducing acoustic vibrations and/or for sensing and characterizing the substance/tissue that is in proximity to the distal end of the guidewire (244, see para. 0045 and 0160). Thus, Carmeli teaches (Claim 19) wherein the piezoelectric transducer (247) is further configured as a sensor for sensing and, thereby, monitoring environmental conditions of the guidewire (244) when the guidewire (244) is placed in the vasculature (see para. 0160).
Since Mehta discloses a catheter tube comprising a plurality of piezoelectric, ultrasonic transducers configured to produce acoustic vibrations for vibrating the catheter tube, and Carmeli discloses a guidewire comprising a piezoelectric, ultrasonic transducer configured to produce acoustic vibrations for vibrating the guidewire, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of piezoelectric transducers of modified Mehta to be further configured as a plurality of sensors for sensing and, thereby, monitoring environmental conditions of the catheter tube when the catheter tube is placed in the vasculature as taught by Carmeli. Carmeli provides that the piezoelectric, ultrasonic transducer is further configured to sense the tissue/substance being in contact with the guidewire which advantageously is used to provide an indication of position within vasculature (see para. 0032 and 0045).
Thus, in modified Mehta, Mehta discloses the method of the plurality of piezoelectric transducers (231, 232) which are powered up upon activation of the control circuitry and ready for placement within the vasculature of the patient, and would further be configured as a plurality of sensors upon placement within the vasculature, powering up of the catheter assembly, and activating the control circuitry of Mehta as taught by Carmeli.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek as applied to claim 1 above, and further in view of Ta et al. (U.S Patent Pub. No. 20210205611 A1, “Ta”).
Regarding claim 10, modified Mehta discloses the catheter assembly of claim 1, as discussed above.
In modified Mehta, Mehta discloses a base plate (310 in Fig. 5-6 and 8) of a catheter securement device (300 in Fig. 5-6 and para. 0066).
In modified Mehta, Ofek further discloses the printed circuit board (36) comprising the controller and internal power source incorporated in the hub (16) or other suitable location (see para. 0037).
However, modified Mehta fails to disclose (claim 10) wherein the controller and the internal power source are incorporated into a base plate or top cover of a catheter securement device, the base plate or top cover of the catheter securement device including securement device-based electrical connectors for connecting to catheter-based electrical connectors for powering and controlling the plurality of piezoelectric transducers.
Ofek teaches a catheter securement device (50) including securement device-based electrical connectors (“posts” in para. 0040) for connecting to catheter-based electrical connectors (40 in Fig. 1) for powering and controlling the sensor array (30, see para. 0039-0040 – a securement device 50 may comprise posts configured to be electrically connected to contacts 40 on suturing wings 22 of the catheter 10 for providing power and control from the battery and PCB to the sensor array 30).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter securement device of modified Mehta to comprise securement device-based electrical connectors for connecting to catheter-based electrical connectors for powering and controlling the plurality of piezoelectric transducers as taught by Ofek according to known methods to yield predictable results. Both Mehta and Ofek disclose catheter securement devices, control circuitry, and a power source, and thus one of ordinary skill in the art would have recognized that incorporating respective electrical connectors into the catheter securement device for electrical communication with the plurality of piezoelectric transducers would have yielded results that were predictable.
Ta discloses a catheter assembly (100 in Fig. 2) comprising a catheter (140 in Fig. 2) and a catheter-securement device (110 in Fig. 2) having a top cover (218 in Fig. 2) for locking the suture wings (246 in Fig. 2) of the catheter (140) therein (see para. 0047 and 0050), wherein the catheter assembly (100) further comprises a power source in the form of a battery and a control circuit for modulating the power to the catheter (140, see para. 0053 and 0055). Ta teaches (Claim 10) the controller and the internal power source are incorporated into a top cover (281) of a catheter securement device (110, see para. 0053 and 0055).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller and the internal power source of modified Mehta to be incorporated into a top cover of the catheter securement device as taught by Ta according to known methods to yield predictable results. One of ordinary skill in the art could have modified the control panel (170) of Mehta disposed on the hub (100 in Fig. 8) to instead be disposed on a top cover of the catheter securement device (300 in Fig. 8) of Mehta as taught by Ta to yield predictable results. Said electrical connectors taught by Ofek would operate in the same manner by having said posts on the catheter securement device electrically connected to annular contacts within the catheter hub to provide the power and control modulations integrated on the catheter securement device to the catheter.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Ofek as applied to claim 1 above, and further in view of Zumeris et al. (U.S Patent Pub. No. 20070244423 A1, “Zumeris”).
Regarding claim 11, modified Mehta discloses the catheter assembly of claim 1, as discussed above. In modified Mehta, Mehta discloses the limitations of (Claim 11) wherein the controller (“control circuitry” in para. 0077) is configured to vibrate the plurality of piezoelectric transducers (231, 232) in a frequency range from about 30 Hz to about 15 MHz (see para. 0056-0057 and 0061 – the control circuitry which controls the activator vibrates the piezoelectric elements 231 and 232 in a frequency range of 300-700 kHz and 100-300 kHz which both fall within the claimed range).
However, Mehta fails to disclose (Claim 11) a frequency range from about 30 Hz to about 15 MHz with an amplitude range from about 1 nm to about 100 μm.
Zumeris discloses a urinary catheter (100 in Fig. 2) which may comprise a piezo-electric element (210 in Fig. 3) configured to vibrate and conduct acoustic waves on an external (110 in Fig. 3), internal (120 in Fig. 3), or end surface (130 in Fig. 3) of the catheter (100) to prevent the formation of biofilm on said catheter (100, see para. 0106-108). Zumeris teaches (Claim 11) wherein the controller (300 in Fig. 3) is configured to vibrate the piezoelectric transducer (210) in a frequency range from about 30 Hz to about 15 MHz with an amplitude range from about 1 nm to about 100 μm (see para. 0116).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller and plurality of piezoelectric transducers of modified Mehta to be configured to vibrate in a frequency range from about 30 Hz to about 15 MHz with an amplitude range from about 1 nm to about 100 μm as taught by Zumeris. Zumeris discloses the mechanical amplitudes of the surface acoustic waves and frequency ranges that are effective in inhibiting bacteria attachment to urinary catheter surfaces, inhibiting adhesion, growth, and aggregation of cells into micro-colonies process on urinary catheter surfaces, and preventing maturation and dissemination of progeny cells for new colony formation while ensures the acoustic waves do not irritate the tissue (see para. 0115-0116).
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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