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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/6/2026 has been entered.
Response to Amendment
Claims 1, 4-7, 9, 12-19, 21-23. 25-34 have been amended and claims 10-11 are canceled. Claims 35-45 are added. Claims 2-3, 8, 20, and 24 were previously canceled. Claims 1, 4-7, 9, 12-19, and 21-23 and 25-45 are now pending examination.
Response to Arguments
Applicant’s arguments, filed 3/6/2026, with respect to the rejection(s) of claim(s) 1 and 31 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the amendments to the claims, specifically “wherein the electronic drive circuit is adapted to generate said electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner for fracturing the blood clot for ingestion of the clot or the portion thereof through the opening” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Claim Objections
Claims 29 and 34 are objected to because of the following informalities:
Regarding claim 29, the limitation “wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being having a predetermined slew rate” should read “wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform [[being]] having a predetermined slew rate”.
Claim 34 recites “wherein the electrical signals comprise a sequence of electrical pulses” which should read “wherein the electrical signal comprises a sequence of electrical pulses”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 9, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krogh et al (US 20090082723 A1) in view of Wallace et al. (US 20170303948 A1) (previously of record) and Hendriks et al. (US 20180102717 A1) (previously of record).
Regarding claim 1, Krogh discloses a catheter system, comprising:
an electronic drive circuit (100) (Paragraph 0209);
an aspiration catheter (70) (Figure 20A-B; Paragraph 0188) comprising:
a proximal end (proximal end of 70);
(ii) a distal end (distal end of 70) having a tip (13) that comprises an electroactive polymer actuator (31) which is configured for vibrational motion in response to an electrical signal applied thereto (Figure 14A; Paragraph 0176; 0191),
(iii) a shaft (body of 70), comprising a catheter material, extending between the proximal end and the distal end (Figure 20A-B; Paragraph 0195; 0210),
the shaft including wiring for carrying the electrical signal between the proximal end and the distal end (Paragraph 0199; 0209) and
wherein the shaft has an annular recessed portion (groove) in the catheter material extending about an entire circumference of the distal end wherein the electroactive polymer actuator is mounted to the annular recessed portion (Figure 14A, D; Paragraph 0177), with the electroactive polymer actuator comprising two or more layers (multilayer actuator) of electroactive polymer (EAP) films wrapped around onto the annular recessed portion of the catheter material (Figure 14A, D; Paragraph 0017; 0177),
wherein said aspiration catheter has an opening (distal opening of 70) at said distal end for ingestion of a blood clot or a portion thereof and wherein said shaft has a lumen (lumen of 70) for communicating pressure to said opening for ingestion of the blood clot or a portion thereof ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.);
wherein the EAP films are electrically connected to said electronic drive circuit via said wiring (Paragraph 0209) and wherein the EAP films expand and contract in a circumferential direction of the catheter in response to the application of the electrical signal causing a strain response in the circumferential direction (Paragraph 0031);
wherein the electronic drive circuit is adapted to generate said electrical signal to repeatedly expand and contract the EAP films in the circumferential direction for ingestion of the clot or the portion thereof through the opening (the EAP is placed circumferentially around the shaft, thus would expand and contract in the circumferential direction and would be fully capable of ingestion of the clot or the portion thereof through the opening) (Paragraph 0194; 0210).
Krogh fails to explicitly disclose (b) a braid or coil within which the wiring is provided, wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including at least one selected from the group consisting of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE), and wherein the electronic drive circuit is adapted to generate said electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner for fracturing the blood clot for ingestion of the clot or the portion thereof through the opening.
However, Wallace is directed to a thrombectomy catheter and teaches wherein the shaft (144) includes a braid or coil (Wallace Paragraph 0013).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Hegde such that the shaft includes a braid or coil as taught by Wallace, in which the wiring would be provided as a result of such modification, as the references and the claimed invention are directed to thrombectomy catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde with the teachings of Wallace by incorporating a shaft including a braid or coil in which the wiring would be provided in order provide flexibility and support to the catheter (Wallace Paragraph 0013).
Furthermore, Hendriks et al. is directed to an electroactive polymer catheter and teach for wherein at least one of the EAP films (30) of the electroactive polymer actuator comprises a material including one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) (Paragraph 0158-0159).
It would have been obvious to one having ordinary skill in the art at the time the invention was made one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), and chlorotrifluoroethylene (CTFE), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde and Wallace with the teachings of Hendriks by incorporating the electroactive polymer actuator comprises a material which includes one or more of: P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) in order to improve electrorestriction in the electroactive polymer layer (Hendriks Paragraph 0159).
Additionally, Hendriks teaches wherein the electronic drive circuit (34) is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films (30) in the circumferential direction in a vibrating manner (Paragraph 0090-92).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh with the teachings of Hendriks by incorporating the electronic drive circuit is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner in order to control the movement of the EAP at a constant rate. Further, Krogh mentions electrical signals but is silent to a particular waveform, thus the modification would simply exemplify the signals of Krogh rather than fully changing them.
Regarding claim 9, Wallace further teaches wherein the braid or coil is formed out of poly-tetrafluroethylene (PTFE) (Paragraph 0013).
Regarding claim 21, Hendriks further teaches wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being sinusoidal (Figure 4; Paragraph 0090).
Regarding claim 37, Krogh further discloses wherein the EAP films expand and contract volumetrically in response to the application of the electrical signal causing the strain response in the circumferential direction to expand and contract the electroactive polymer actuator circumferentially (the EAP films are located circumferentially around the shaft thus would be caused to expand and contract circumferentially when provided with the electrical signal) (Figure 14A; Paragraph 0031; 0125).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and further in view of Bauer et al. (NPL titled “Recent Advances in highly Electrostrictive P(VDF-TrFE-CFE) Terpolymers”) (previously of record).
Regarding claim 4, Krogh as modified by Hegde Wallace, and Hendriks discloses the catheter of claim 1, but fails to further disclose, teach, or suggest wherein the electroactive polymer actuator exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron.
However, Bauer et al. teach P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% when the electrical signals provide an electric field of 20-200 volts per micron (abstract). (P(VDF-TrFE-CFE) is used to form the electroactive polymer actuator.)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron as this is an inherent property of the material. Thus, the device of Krogh as modified by Wallace, and Hendriks to have an electroactive polymer actuator wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including P(VDF-TrFE-CTFE) would exhibit such a property.
Claim 5 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks, as applied to claim 1 above, and further in view of Cotter et al (US 20170304655 A1) (previously of record).
Regarding claim 5, Krogh as modified by Wallace, and Hendriks discloses the catheter of claim 1, but fails to further disclose, teach, or suggest wherein the electronic drive circuit is adapted to generate the waveform to expand and contract the electroactive polymer at a frequency that is tuned to a resonant frequency of the tip.
However, Cotter is directed to a vibrating surgical tool and teaches wherein the electronic drive circuit is adapted to generate the waveform (ultrasonic wave) at a frequency that is tuned to a resonant frequency of the tip (Paragraph 0008; 0079). As a result of the modification, the electronic drive circuit of Krogh as modified by Hendriks would be adapted to generate the waveform to expand and contract the electroactive polymer at a frequency that is tuned to a resonant frequency of the tip
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, and Hendriks such that the vibrational motion has a frequency that is tuned to a resonant frequency of the tip, as taught by Cotter, as the references and the claimed invention are directed to vibrating surgical tools. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde Wallace, and Hendriks with the teachings of Cotter by incorporating the vibrational motion has a frequency that is tuned to a resonant frequency of the tip in order to optimize energy utilization (Cotter Paragraph 0008).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and further in view of Van De Molengraaf et al. (US 20190214545 A1).
Regarding claim 6, Krogh as modified by Wallace and Hendriks teaches the catheter system of Claim 1 but fails to explicitly disclose wherein the electrical signal has an amplitude between 50 volts and 250 volts.
However, Van De Molengraaf is directed to an electroactive polymer actuator device and teaches wherein the electrical signal (60) has an amplitude between 0 and 200 volts, and preferably 100 volts, which is within the claimed range of between 50 volts and 250 volts (Paragraph 0082).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace and Hendriks such that the electrical signal has an amplitude between 50 volts and 250 volts, as taught by Van De Molengraaf, as both references and the claimed invention are directed to electroactive polymer devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace and Hendriks with the teachings of Van De Molengraaf by incorporating wherein the electrical signal has an amplitude between 50 volts and 250 volts in order to prevent curve shifting between actuation cycles by using an optimized drive scheme (Van De Molengraaf Paragraph 0083-84). Further, Hendriks states “the higher the amplitude of the AC signal, the lower will be the friction as the vibrations are larger” (Paragraph 0096), thus the modification would be obvious to reduce friction.
Regarding claim 7, Krogh as modified by Wallace and Hendriks and Van De Molengraaf teaches the catheter system of Claim 6, and Hendriks further teaches wherein the electrical signal has a DC offset (Paragraph 0099).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace and Hendriks with the teachings of Hendriks by incorporating wherein the electrical signal has a DC offset so that there will result a vibration around an almost non-actuated state, i.e. the device will vibrate between the non-actuated state and a small amplitude actuated state (Hendriks Paragraph 0099).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks, as applied to claim 1 above, and further in view of Zelka (US 20190015260 A1) (previously of record).
Regarding claim 12, Krogh as modified by Wallace, and Hendriks discloses the catheter of claim 1, and Krogh further discloses the electroactive polymer layers being the EAP films (Paragraph 0179) but fails to further disclose, teach, or suggest the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode.
However, Zelka is directed to an electroactive polymer actuator device and teaches the electroactive polymer actuator (61) comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode (Paragraph 0115).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, and Hendriks such that the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode, as taught by Zelka, as the references and the claimed invention are directed to electroactive polymers. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, and Hendriks, with the teachings of Zelka by incorporating the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode in order to improve strength or durability of the actuator (Examiner note: as indicated in applicant’s own specification (Page 5, lines 34-37), it is clear that the layering of electrodes with the electroactive polymer layers is what forms the “capacitors” and via the nature of the layering in both Hendriks et al. and as modified by Zelka, this would meet the “plurality of capacitors” limitation) (Zelka Paragraph 0067).
Regarding claim 13, Krogh as modified by Wallace, Hendriks and Zelka, discloses the catheter system of claim 12, but fail to explicitly disclose wherein each electroactive polymer layer is between 2.0 - 20.0 µm thick.
However, Hendriks et al. teaches wherein the electroactive polymer layer is between 2.0 - 20.0 µm thick (Hendriks Paragraph 0128).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Zelka with the teachings of Hendriks by incorporating the electroactive polymer layer is between 2.0 - 20.0 µm thick in order to serve as a support structure (Hendriks Paragraph 0128).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks and Zelka, as applied to claim 12 above, and further in view of Harrison (US 20060057377 A1) (previously of record).
Regarding claim 14, the claimed phrase “the electroactive polymer layer is formed by dip-coating in a solution of the electroactive polymer dissolved in a polar solvent” is being treated as a product by process limitation; that is, the phrase will be examined as “the electroactive polymer layer is formed in a solution of the electroactive polymer dissolved in a polar solvent”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Krogh as modified by Wallace, Hendriks and Zelka teaches the catheter of claim 12, but fails to teach wherein the electroactive polymer layer is formed in a solution of the electroactive polymer dissolved in a polar solvent.
However, Harrison is directed to electroactive polymers and teaches the electroactive polymer layer is formed in a solution of the electroactive polymer dissolved in a polar solvent (Paragraph 0010).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks and Zelka, such that the electroactive polymer layer is formed in a solution of the electroactive polymer dissolved in a polar solvent, as taught by Harrison, as the references and the claimed invention are directed to electroactive polymers. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Zelka, with the teachings of Harrison by incorporating the electroactive polymer layer is formed in a solution of the electroactive polymer dissolved in a polar solvent in order to enhance the polymer with high tensile strength and modulus, high electrical conductivity, and high thermal conductivity (Harrison Paragraph 0009).
Regarding claim 15, Harrison further teaches the polar solvent comprises diethylformamide (DMF) (Paragraph 0010).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and Zelka, as applied to claim 12 above, and further in view of Yang (US 20170231520 A1) (previously of record).
Regarding claim 16, the claimed phrase “each of the first and second electrodes comprises a material formed by sputtering, dip-coating, pad printing or spray coating using a conductive electric ink” is being treated as a product by process limitation; that is, the phrase is examined as “each of the first and second electrodes comprises a material using a conductive electric ink”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Krogh as modified by Wallace, Hendriks and Zelka teach the catheter system of claim 12 but fail to further teach wherein each of the first and second electrodes comprises a material using a conductive electric ink.
However, Yang is directed to electrically conductive medical device and teaches each of the first and second electrodes (14) comprises a material using a conductive electric ink (Paragraph 0029).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks and Zelka, such that each of the first and second electrodes comprises a material using a conductive electric ink, as taught by Yang, as the references and the claimed invention are directed to electrical medical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Zelka, with the teachings of Yang by incorporating each of the first and second electrodes comprises a material using a conductive electric ink in order to simplify the manufacturing process by removing the need for soldering and lowering manufacturing costs (Yang Paragraph 0013).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks and Zelka, as applied to claim 12 above, and further in view of Nguyen (US 20190388112 A1) (previously of record).
Regarding claim 17, Krogh as modified by Wallace, Hendriks and Zelka teach the catheter system of claim 12 but fail to further teach wherein the first and second electrodes are braided to form space-apart coaxially placed coils.
However, Nguyen is directed to a thrombectomy device and teaches the first and second electrodes (204) are braided to form space-apart coaxially placed coils (Paragraph 0277).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks and Zelka, such that the first and second electrodes are braided to form space-apart coaxially placed coils, as taught by Nygren, as the references and the claimed invention are directed to devices to remove thromboses from the body. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Zelka, with the teachings of Nguyen by incorporating wherein the first and second electrodes are braided to form space-apart coaxially placed coils in order to facilitate conduction of electrical activity (Nguyen Paragraph 0277).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks and Zelka, in view of Nguyen, as applied to claim 17 above, and further in view of Schaer (US 20030083613 A1) (previously of record).
Regarding claim 18, Krogh as modified by Wallace, Hendriks, Zelka and Nguyen teach the catheter system of claim 17 but fail to further teach each coil is formed out of fine wire that has a 12.7-25.4 µm diameter.
However, Schaer is directed to a catheter device and teaches each coil is formed out of fine wire that has a 12.7-25.4 µm diameter.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks, Zelka, and Nguyen such that each coil is formed out of fine wire that has a 12.7-25.4 µm diameter, as taught by Schaer, as both references and the claimed invention are directed to electric devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks, Zelka, and Nguyen with the teachings of Schaer by incorporating that each coil is formed out of fine wire that has a 12.7-25.4 µm diameter in order to be sized to fit within the tubular porous membrane (Schaer Paragraph 0115).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks and Zelka, as applied to claim 12 above, in view of Beetel et al. (US 20120101413 A1) (previously of record).
Regarding claim 19, Krogh as modified by Wallace, Hendriks and Zelka teaches the catheter system of claim 12 but fail to further teach wherein each of the first and second electrodes comprise conductive wires in a Tri-Axe braid pattern.
However, Beetel is directed to an electric catheter and teaches wherein each of the first (116) and second (24) electrodes comprise conductive wires in a Tri-Axe braid pattern (1422) (Figure 14; Paragraph 0107; in accordance with applicant’s disclosure of ‘Tri-Axe braid pattern’).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks and Zelka, such that each of the first and second electrodes comprise conductive wires in a Tri-Axe braid pattern, as taught by Beetel, as the references and the claimed invention are directed to electrical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Zelka, with the teachings of Beetel by incorporating each of the first and second electrodes comprise conductive wires in a Tri-Axe braid pattern in order to facilitate the stable contact of the electrodes with the artery (Beetel Paragraph 0107).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and further in view of Yang et al. (US 20190336727 A1).
Regarding claim 22, Krogh as modified by Wallace and Hendriks teaches the catheter system of Claim 1 but fails to explicitly disclose wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being a square waveform.
However, Yang is directed to a catheter and teaches electrical signal waveforms, and specifically that a square waveform is an equivalent alternative to a sinusoidal waveform (Paragraph 0139).
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks, as applied to claim 22 above, and further in view of Pelssers (WO 2020120524 A1) (previously of record).
Regarding claim 23, Krogh as modified by Wallace, and Hendriks discloses the catheter system of claim 22 but fail to further disclose, teach, or suggest the EAP films of the electroactive polymer actuator are rolled into a compact form.
However, Pelssers teaches the EAP films (80) of the electroactive polymer actuator are rolled into a compact form (Figure 8; Page 12, lines 11-14).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, and Hendriks such that the EAP films of the electroactive polymer actuator are rolled into a compact form, as taught by Pelssers, as the references and the claimed invention are directed to electroactive actuator devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, and Hendriks with the teachings of Pelssers by incorporating the EAP films of the electroactive polymer actuator are rolled into a compact form since the mobile positive ions will migrate to the outer electrode and thereby the ionic EAP located close to the outer electrode will increase in density and will increase the stiffness (Pelssers Page 12, lines 17-19).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and Pelssers, as applied to claim 23 above, and further in view of Zelka.
Regarding claim 25, Krogh as modified by Wallace, Hendriks and Pelssers teaches the catheter system of claim 23 but fail to further teach wherein each layer of the EAP films is coated on one side by a conductive material.
However, Zelka teaches wherein each layer of EAP films is coated on one side by a conductive material (Paragraph 0041).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks and Pelssers, such that each layer of EAP material is coated on one side by a conductive material, as taught by Zelka, as the references and the claimed invention are directed to EAP devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks and Pelssers, with the teachings of Zelka by incorporating each layer of EAP material is coated on one side by a conductive material in order to improve conduction to the EAP.
Regarding claim 26, Zelka further teaches wherein the conductive material comprises a metal (Paragraph 0043).
Claim 27 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks, Pelssers, and Zelka, as applied to claim 25 above, and further in view of Johnson (EP 3420894 A1) (References correspond with attached Espacenet document) (previously of record).
Regarding claim 27, Krogh as modified by Wallace, and Hendriks, Pelssers and Zelka, teaches the catheter system of claim 25 but fail to further teach wherein the electroactive polymer actuator is provided a parallel-plate capacitor configuration, with electrodes being provided by the conductive coatings.
However, Johnson is directed to an electroactive actuator device and teaches the electroactive polymer actuator is provided a parallel-plate capacitor configuration, with electrodes being provided by the conductive coatings (Paragraph 0039).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, Hendriks, Pelssers, and Zelka such that the electroactive polymer actuator is provided a parallel-plate capacitor configuration, with electrodes being provided by the conductive coatings, as taught by Johnson, as the references and the claimed invention are directed to electroactive actuators. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, Hendriks, Pelssers, and Zelka with the teachings of Johnson by incorporating the electroactive polymer actuator is provided a parallel-plate capacitor configuration, with electrodes being provided by the conductive coatings in order to enhance performance of the electroactive polymer.
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks, Pelssers, Zelka, and Johnson as applied to claim 27 above, and further in view of Yang et al. (US 20190336727 A1).
Regarding claim 28, the combination of Krogh, Wallace, Hendriks, Pelssers, Zelka, and Johnson teaches the catheter system of claim 27, and Pelssers et al. further disclose wherein the electroactive polymer actuator provides a vibrational response when actuated by an electrical signal of a frequency between 20.0-500.0 Hz (Pelssers Page 2, lines 1-5), but fails to explicitly disclose the electronic drive circuit is adapted to generate said electrical signals with the driving waveform having a frequency between 20 and 500 Hz.
However, Yang is directed to a catheter and teaches wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency less than 500 Hz, which encompasses the claimed range of between 20 Hz and 500 Hz (Paragraph 0152).
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 drive electronic circuit of Krogh as modified by Hendriks such that the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, and Hendriks and further in view of Wham et al. (US 20050004564 A1).
Regarding claim 29, Krogh as modified by Wallace and Hendriks teaches the catheter system of claim 1 but fails to explicitly disclose wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being having a predetermined slew rate.
However, Wham is directed to an electrosurgical device and teaches wherein the electronic drive circuit (316) is adapted to generate said electrical signal with the driving waveform being having a predetermined slew rate (target slew rate) (Paragraph 0265-266).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace and Hendriks such that wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being having a predetermined slew rate, as taught by Wham, as both references and the claimed invention are directed to electrosurgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace and Hendriks with the teachings of Wham by incorporating wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform being having a predetermined slew rate in order to maintain control of the system (Wham Paragraph 0266).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks, and Wham as applied to claim 29 above and further in view of Van De Molengraaf et al. (US 20190214545 A1).
Regarding claim 30, Krogh as modified by Wallace and Hendriks and Wham teaches the catheter system of claim 29, but fails to explicitly disclose wherein the waveform has a peak-to-peak amplitude between 50.0-250.0 volts.
Krogh as modified by Wallace and Hendriks teaches the catheter system of Claim 1 but fails to explicitly disclose wherein the waveform has a peak-to-peak amplitude between 50 volts and 250 volts.
However, Van De Molengraaf is directed to an electroactive polymer actuator device and teaches wherein the electrical signal (60) has an amplitude between 0 and 200 volts, and preferably 100 volts, which is within the claimed range of between 50 volts and 250 volts (Paragraph 0082).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace and Hendriks and Wham such that the electrical signal has an amplitude between 50 volts and 250 volts, as taught by Ref 2, as both references and the claimed invention are directed to electroactive polymer devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace and Hendriks and Wham with the teachings of Van De Molengraaf by incorporating wherein the electrical signal has an amplitude between 50 volts and 250 volts in order to prevent curve shifting between actuation cycles by using an optimized drive scheme (Van De Molengraaf Paragraph 0083-84). Further, Hendriks states “the higher the amplitude of the AC signal, the lower will be the friction as the vibrations are larger” (Paragraph 0096), thus the modification would be obvious to reduce friction.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh in view of Hendriks and Chou et al. (US 20150366508 A1) (previously of record).
Regarding claim 31, Krogh discloses a catheter system (10), comprising:
an electronic drive circuit (100) (Paragraph 0209);
an aspiration catheter (70) (Figure 20A-B; Paragraph 0188) comprising:
a proximal end (proximal end of 70);
(ii) a distal end (distal end of 70) having a tip (13) that comprises an electroactive polymer actuator (31) which is configured for vibrational motion in response to an electrical signal applied thereto (Figure 14A; Paragraph 0176; 0191; 0209),
a shaft (main shaft of 70), comprising a catheter material, extending between the proximal end and the distal end (Figure 20a-b; Paragraph 0195; 0210),
the shaft including wiring (electrical leads) for carrying the electrical signal between the proximal end and the distal end (Paragraph 0199).
wherein shaft has an annular recessed portion (groove) in the catheter material extending about an entire circumference of the distal end, wherein the electroactive polymer actuator is mounted to the annular recessed portion (Figure 20a-b; Paragraph 0195), with the electroactive polymer actuator comprising two or more layers of electroactive polymer (EAP) films (multilayer actuator) (Paragraph 0017) wrapped onto the annular recessed portion of the catheter material (Figure 20a-b; Paragraph 0195-96) (the EAP material parts are within and fully enclosed in the groove, thus are “wrapped around the recess portion of the catheter material”);
wherein said aspiration catheter has an opening (distal opening of 70) at said distal end for ingestion of a blood clot or a portion thereof and wherein said shaft has a lumen (lumen of 70) for communicating pressure to said opening for ingestion of the blood clot or a portion thereof; ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.);
wherein the EAP films are electrically connected to said electronic drive circuit via said wiring (Paragraph 0209) and wherein the EAP films expand and contract in a circumferential direction of the catheter in response to the application of the electrical signal causing a strain response in the circumferential direction (Paragraph 0031);
wherein the electronic drive circuit is adapted to generate said electrical signal to repeatedly expand and contract the EAP films in the circumferential direction for ingestion of the clot or the portion thereof through the opening (the EAP is placed circumferentially around the shaft, thus would expand and contract in the circumferential direction and would be fully capable of ingestion of the clot or the portion thereof through the opening) (Paragraph 0194; 0210).
Krogh fails to explicitly disclose wherein the electroactive polymer actuator is formed as a cylindrical structure with a hollow core; wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) and insulated wiring and wherein the electronic drive circuit is adapted to generate said electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner for fracturing the blood clot for ingestion of the clot or the portion thereof through the opening.
Further, Hendriks et al. is directed to an electroactive polymer catheter and teach for wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) (Paragraph 0158-0159).
It would have been obvious to one having ordinary skill in the art at the time the invention was made one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), and chlorotrifluoroethylene (CTFE), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde with the teachings of Hendriks by incorporating the electroactive polymer actuator comprises a material which includes one or more of: P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) in order to improve electrorestriction in the electroactive polymer layer (Hendriks Paragraph 0159).
Additionally, Hendriks teaches wherein the electronic drive circuit (34) is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films (30) in the circumferential direction in a vibrating manner (Paragraph 0090-92).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh with the teachings of Hendriks by incorporating the electronic drive circuit is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner in order to control the movement of the EAP at a constant rate. Further, Krogh mentions electrical signals but is silent to a particular waveform, thus the modification would simply exemplify the signals of Krogh rather than fully changing them.
Furthermore, Chou is directed to an electric catheter and discloses a catheter incorporating insulated wiring (115) (Paragraph 0080).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Hegde and Hendriks such that the wiring is insulated, as taught by Chou, as both references and the claimed invention are directed to catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde and Hendriks with the teachings of Chou by incorporating insulated wiring in order to protect the patient from electrical current or prevent electrical charge from affecting the catheter prematurely.
Regarding claim 38, Krogh further discloses wherein the EAP films expand and contract volumetrically in response to the application of the electrical signal causing the strain response in the circumferential direction to expand and contract the electroactive polymer actuator circumferentially (the EAP films are located circumferentially around the shaft thus would be caused to expand and contract circumferentially when provided with the electrical signal) (Figure 14A; Paragraph 0031; 0125).
Claim 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Wallace, Hendriks, and Cotter as applied to claim 5 above, and further in view of Yang et al. (US 20190336727 A1).
Regarding claim 32-33, Krogh as modified by Wallace, Hendriks, and Cotter teaches the catheter system of claim 5 and Hendriks further discloses the vibration signal can comprise a vibration signal frequency which is chosen to be: <1 MHz, <100 kHz, <10 kHz, or <1 kHz (Paragraph 0018) but fails to explicitly disclose wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz.
However, Yang is directed to a catheter and teaches wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency less than 500 Hz, which encompasses the claimed range of between 20 Hz and 200 Hz (Paragraph 0152).
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 drive electronic circuit of Krogh as modified by Hendriks such that the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art.
Regarding claim 34, Hendriks further teaches wherein the electrical signals comprise a sequence of electrical pulses (Paragraph 0017).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh in view of Hegde, Hendriks and Wallace and further in view of Hegde et al. (US 20040230090 A1) (previously of record).
Regarding claim 35, Krogh as modified by Wallace, Hendriks teaches the catheter system of claim 1, but fails to explicitly disclose wherein the electroactive polymer actuator is formed as a cylindrical structure with a hollow core received on the annular recessed portion.
However, Hegde is directed to an EAP and teaches wherein the electroactive polymer actuator (300) is formed as a cylindrical structure with a hollow core (space where 308 is able to pass through) (Figure 9A-C; Paragraph 0149); wherein the electroactive polymer actuator comprises two or more layers of electroactive polymer (EAP) films (302, 304, 306) (Paragraph 0149), and when modified to be placed in the recesses of Krogh, would result in the cylindrical structure being received on the annular recessed portion.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh such that the electroactive polymer actuator is formed as a cylindrical structure with a hollow core, as taught by Hegde, as both references and the claimed invention are directed to EAP devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh with the teachings of Hegde by incorporating wherein the electroactive polymer actuator is formed as a cylindrical structure with a hollow core in order to increase stroke of the EAP (Paragraph 0148).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh in view of Hendriks and Chou et al. in view of Hegde.
Regarding claim 3, Krogh as modified by Hendriks and Chou teaches The catheter system of claim 31, but fails to explicitly disclose wherein the electroactive polymer actuator is formed as a cylindrical structure with a hollow core received on the annular recessed portion.
However, Hegde is directed to an EAP and teaches wherein the electroactive polymer actuator (300) is formed as a cylindrical structure with a hollow core (space where 308 is able to pass through) (Figure 9A-C; Paragraph 0149); wherein the electroactive polymer actuator comprises two or more layers of electroactive polymer (EAP) films (302, 304, 306) (Paragraph 0149), and when modified to be placed in the recesses of Krogh, would result in the cylindrical structure being received on the annular recessed portion.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh such that the electroactive polymer actuator is formed as a cylindrical structure with a hollow core, as taught by Hegde, as both references and the claimed invention are directed to EAP devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh with the teachings of Hegde by incorporating wherein the electroactive polymer actuator is formed as a cylindrical structure with a hollow core in order to increase stroke of the EAP ( Paragraph 0148).
Claim 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Hendriks and Chou as applied to claim 31 above, and further in view of Yang et al. (US 20190336727 A1).
Regarding claim 40-41, Krogh as modified by Hendriks, and Chou teaches the catheter system of claim 5 and Hendriks further discloses the vibration signal can comprise a vibration signal frequency which is chosen to be: <1 MHz, <100 kHz, <10 kHz, or <1 kHz (Paragraph 0018) but fails to explicitly disclose wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz.
However, Yang is directed to a catheter and teaches wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency less than 500 Hz, which encompasses the claimed range of between 20 Hz and 200 Hz (Paragraph 0152).
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 drive electronic circuit of Krogh as modified by Hendriks such that the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art.
Claims 42 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Hendriks and Chou, as applied to claim 31 above, and further in view of Zelka (US 20190015260 A1) (previously of record).
Regarding claim 42, Krogh as modified by Hendriks and Chou discloses the catheter of claim 1, and Krogh further discloses the electroactive polymer layers being the EAP films (Paragraph 0179) but fails to further disclose, teach, or suggest the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode.
However, Zelka is directed to an electroactive polymer actuator device and teaches the electroactive polymer actuator (61) comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode (Paragraph 0115).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Hendriks and Chou such that the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode, as taught by Zelka, as the references and the claimed invention are directed to electroactive polymers. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hendriks and Chou, with the teachings of Zelka by incorporating the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode in order to improve strength or durability of the actuator (Examiner note: as indicated in applicant’s own specification (Page 5, lines 34-37), it is clear that the layering of electrodes with the electroactive polymer layers is what forms the “capacitors” and via the nature of the layering in both Hendriks et al. and as modified by Zelka, this would meet the “plurality of capacitors” limitation) (Zelka Paragraph 0067).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Hendriks and chou as applied to claim 31 above and further in view of Bauer et al. (NPL titled “Recent Advances in highly Electrostrictive P(VDF-TrFE-CFE) Terpolymers”) (previously of record).
Regarding claim 39, Krogh as modified by Hendriks and Chou discloses the catheter of claim 31, but fails to further disclose, teach, or suggest wherein the electroactive polymer actuator exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron.
However, Bauer et al. teach P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% when the electrical signals provide an electric field of 20-200 volts per micron (abstract). (P(VDF-TrFE-CFE) is used to form the electroactive polymer actuator.)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron as this is an inherent property of the material. Thus, the device of Krogh as modified by Hendriks and Chou to have an electroactive polymer actuator wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including P(VDF-TrFE-CTFE) would exhibit such a property.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh in view of Hendriks and Yang.
Regarding claim 43, Krogh discloses a catheter system (10), comprising:
an aspiration catheter (70) (Figure 20A-B; Paragraph 0188) comprising:
a proximal end (proximal end of 70);
(ii) a distal end (distal end of 70) having a tip (13) that comprises an electroactive polymer actuator (31) which is configured for vibrational motion in response to an electrical signal applied thereto (Figure 14A; Paragraph 0176; 0191); and
(iii) a shaft (body of 70), comprising a catheter material, extending between the proximal end and the distal end (Figure 20A-B; Paragraph 0195; 0210), the shaft including wiring for carrying the electrical signal between the proximal end and the distal end (Paragraph 0199; 0209) and wherein the shaft has an annular recessed portion (groove) in the catheter material extending about an entire circumference of the distal end wherein the electroactive polymer actuator is mounted to the annular recessed portion (Figure 14A, D; Paragraph 0177), with the electroactive polymer actuator comprising two or more layers (multilayer actuator) of electroactive polymer (EAP) films wrapped around onto the annular recessed portion of the catheter material (Figure 14A, D; Paragraph 0017; 0177),
wherein said aspiration catheter has an opening (distal opening of 70) at said distal end for ingestion of a blood clot or a portion thereof and wherein said shaft has a lumen (lumen of 70) for communicating pressure to said opening for ingestion of the blood clot or a portion thereof ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.);
an electronic drive circuit (100) electrically connected to said wiring that generates said electrical signal wherein the EAP films expand and contract in a circumferential direction of the catheter in response to the application of the electrical signal at said frequency causing a strain response in the circumferential direction for fracturing the blood clot for ingestion of the clot or the portion thereof through the opening (the EAP is placed circumferentially around the shaft, thus would expand and contract in the circumferential direction and would be fully capable of ingestion of the clot or the portion thereof through the opening) (Paragraph 0194; 0209-0210).
Krogh fails to explicitly disclose wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including at least one selected from the group consisting of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1-chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) and a driving waveform at a frequency between 20.0-500.0 Hz for application to the EAP films via said wiring in a vibrating manner.
However, Hendriks et al. is directed to an electroactive polymer catheter and teach for wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), chlorotrifluoroethylene (CTFE), P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) (Paragraph 0158-0159).
It would have been obvious to one having ordinary skill in the art at the time the invention was made one or more of vinylidene fluoride (VDF), trifluoroethylene (TrFE), 1,1- chlorofluoroethylene (CFE), and chlorotrifluoroethylene (CTFE), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Hegde with the teachings of Hendriks by incorporating the electroactive polymer actuator comprises a material which includes one or more of: P(VDF-TrFE-CTFE) and P(VDF-TrFE-CFE) in order to improve electrorestriction in the electroactive polymer layer (Hendriks Paragraph 0159).
Additionally, Hendriks teaches wherein the electronic drive circuit (34) is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films (30) in the circumferential direction in a vibrating manner (Paragraph 0090-92).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh with the teachings of Hendriks by incorporating the electronic drive circuit is adapted to generate an electrical signal as a driving waveform to repeatedly expand and contract the EAP films in the circumferential direction in a vibrating manner in order to control the movement of the EAP at a constant rate. Further, Krogh mentions electrical signals but is silent to a particular waveform, thus the modification would simply exemplify the signals of Krogh rather than fully changing them.
Further, Yang is directed to a catheter and teaches wherein the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency less than 500 Hz, which encompasses the claimed range of between 20 Hz and 200 Hz (Paragraph 0152).
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 drive electronic circuit of Krogh as modified by Hendriks such that the electronic drive circuit is adapted to generate said electrical signal with the driving waveform having a frequency between 20 Hz and 500 Hz, or between 20 Hz and 200 Hz since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Hendriks and Yang as applied to claim 31 above and further in view of Bauer et al. (NPL titled “Recent Advances in highly Electrostrictive P(VDF-TrFE-CFE) Terpolymers”) (previously of record).
Regarding claim 39, Krogh as modified by Hendriks and Yang discloses the catheter of claim 43, but fails to further disclose, teach, or suggest wherein the electroactive polymer actuator exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron.
However, Bauer et al. teach P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% when the electrical signals provide an electric field of 20-200 volts per micron (abstract). (P(VDF-TrFE-CFE) is used to form the electroactive polymer actuator.)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention that P(VDF-TrFE-CFE) exhibits an electrostrictive strain that is greater than 3% in the circumferential direction in response to the electrical signal providing an electric field of 20-200 volts per micron as this is an inherent property of the material. Thus, the device of Krogh as modified by Hendriks and Yang to have an electroactive polymer actuator wherein at least one of the EAP films of the electroactive polymer actuator comprises a material including P(VDF-TrFE-CTFE) would exhibit such a property.
Claims 45 is rejected under 35 U.S.C. 103 as being unpatentable over Krogh as modified by Hendriks and Yang, as applied to claim 43 above, and further in view of Zelka (US 20190015260 A1) (previously of record).
Regarding claim 45, Krogh as modified by Hendriks and Yang discloses the catheter system of claim 43, and Krogh further discloses the electroactive polymer layers being the EAP films (Paragraph 0179) but fails to further disclose, teach, or suggest the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode.
However, Zelka is directed to an electroactive polymer actuator device and teaches the electroactive polymer actuator (61) comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode (Paragraph 0115).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Krogh as modified by Wallace, and Hendriks such that the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode, as taught by Zelka, as the references and the claimed invention are directed to electroactive polymers. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krogh as modified by Wallace, and Hendriks, with the teachings of Zelka by incorporating the electroactive polymer actuator comprises a plurality of capacitors each including an electroactive polymer layer provided between a first electrode and a second electrode in order to improve strength or durability of the actuator (Examiner note: as indicated in applicant’s own specification (Page 5, lines 34-37), it is clear that the layering of electrodes with the electroactive polymer layers is what forms the “capacitors” and via the nature of the layering in both Hendriks et al. and as modified by Zelka, this would meet the “plurality of capacitors” limitation) (Zelka Paragraph 0067).
Conclusion
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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