DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 07 January 2025 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US 2015/0157391 A1) in view of Mihalik (US 2015/0216580 A1).
Regarding claim 1, Ben-Ezra teaches a method for deploying a medical device (the medical device 100 is configured to be deployed within the patient’s body [abstract, 0093, 0294, 0277, FIG. 42]), the method comprising:
inserting the medical device into a cavity of a body ([0093]), wherein the medical device includes:
a sheath (the medical device 100 comprises a sheath 4208 [0138, 0335, FIG. 42, FIG. 42E, FIG. 42G]);
an end cap (the medical device 100 comprises an end cap 4207 [0294, 0309, 0362, FIG. 42E, FIG. 43B]);
a hollow core extending from the sheath to the end cap (figure 42E illustrates the hollow core or telescopic shaft 4250 extending between the end cap 4207 and the sheath 4208 [0301, FIG. 42E]);
a plurality of thin film elements, wherein the plurality of thin film elements includes a plurality of mapping electrodes (the plurality of thin conductive printed elements may include the electrodes 132 [0150, 0191, 0215, 0334]. Specifically, the electrodes 132 include mapping features [0094, 0191, 0334]); and
a travel limiter disposed along the hollow core (the hollow core or telescopic shaft 4250 is coupled to the stopper components 4205 [0295-0296, FIG. 42E]);
providing tension on a pull cable to retract the end cap towards a distal end of the sheath and retract the hollow core within the sheath (the pull wires 330 extends through the sheath 4208 and further along the telescopic shaft 4250 to connect with the end cap 4207 [0296-0297, 0301-0303]. Specifically, this allows the end cap 4207 to be retracted to cover the outer edges of the sheath 4208 [0297, 0301, 0325-0326, FIG. 42E]. As a result, the balloon 110 and the telescopic shaft 4250 are retracted back into the sheath 4208 [0296-0297, 0301, 0325, 0337, FIG. 42E]);
expanding the plurality of thin film elements to a second configuration (the plurality of thin conductive printed elements consists of the electrodes 132 which can transition into an expanded or elongated configuration [0150, 0215, 0334]).
Ben-Ezra teaches an alternate embodiment consisting of the plurality of thin film elements being disposed in a first configuration around the hollow core (the plurality of thin conductive printed elements may include the electrodes 132 that are configured to rotate around the hollow core or shaft 120 while the balloon 110 is being expanded [0215, 0334]). Therefore, it would have been obvious to a person having ordinary skill in the art to combine each of the corresponding embodiments to arrive at an overall device similar to the one claimed. Specifically, combining each of the embodiments will result in the plurality of thin film elements being disposed in a first configuration around the hollow core. The advantage of such modification will provide electrodes around the hollow core to provide electrical mapping of the bladder ([0024, 0094, 0215, 0334]).
Ben-Ezra does not explicitly teach the travel limiter being disposed between the plurality of thin film elements and the hollow core.
However, the Examiner respectfully submits that Ben-Ezra teaches the travel limiter disposed along the hollow core (see the explanation above) and the hollow core being surrounded by the thin film elements (see the explanation above). Thus, configuring the travel limiter to be disposed between the hollow core and the thin film elements would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Ben-Ezra does not explicitly teach anchoring the travel limiter to the distal end of the sheath.
The prior art by Mihalik is analogous to Ben-Ezra, as they both teach a balloon catheter comprising a mapping electrode ([abstract]).
Mihalik teaches anchoring the travel limiter to the distal end of the sheath (the stopper 64 may be retained within the sheath 16 by a gentle pull force exerted on the wires 66 [0040]. Specifically, the sheath 16 includes a protrusion or ridge 108 that prevents the stopper 64 from retracting too far within the sheath [0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Ben-Ezra’s travel limiter to anchored to the distal end of the sheath, as taught by Mihalik. The advantage of such modification will provide a protrusion or ridge within the sheath that prevents the stopper from being retracted too far within the sheath (see paragraphs [0040, 0046] by Mihalik).
Regarding claim 2, Ben-Ezra in view of Mihalik suggests the method of claim 1. Ben-Ezra and Mihalik teach wherein in the first configuration: each thin film element of the plurality of thin film elements extends from the distal end of the sheath to the end cap in a straight line parallel to a central axis of the hollow core; and each thin film element of the plurality of thin film elements is attached to the end cap.
The Examiner respectfully submits that Ben-Ezra teaches the use of a plurality of thin film elements (the plurality of printed elements or layers may include the electrodes 132 [0191, 0215, 0332, 0334]), a sheath (sheath 4208 [0318, 0335, FIG. 42, FIG. 42E, FIG. 42G]), an end cap (end cap 4207 [0294, 0309, 0362, FIG. 42, FIG. 42E, FIG. 43B]), and a hollow core (figure 42E illustrates the hollow core or telescopic shaft 4250 extending between the end cap 4207 and the sheath 4208 [0215, 0301, FIG. 42E]). Thus, configuring each of the thin film elements to extend from a distal end of the sheath onto the end cap in a straight line parallel to a central axis of the hollow core would be a matter of changing the size and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 3, Ben-Ezra in view of Mihalik suggests the method of claim 2. Ben-Ezra and Mihalik do not explicitly teach wherein, in the second configuration, each of the plurality of thin film elements take on a bell-shaped curve.
The Examiner respectfully submits that Ben-Ezra teaches the use of a plurality of thin film elements that expand into a second configuration (the plurality of thin conductive printed elements consists of the electrodes 132 which can transition into an expanded configuration [0191, 0215, 0334]). Thus, configuring the thin film elements to take on a bell-shaped curve while in the second configuration would be a matter of changing the shape of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 4, Ben-Ezra in view of Mihalik suggests the method of claim 1. Ben-Ezra does not explicitly teach wherein in the first configuration: each thin film element of the plurality of thin film elements extends from the distal end of the sheath to the end cap in a helix around the hollow core; and each thin film element of the plurality of thin film elements is attached to the end cap.
The Examiner respectfully submits that Ben-Ezra teaches the use of a plurality of thin film elements (the plurality of printed elements or layers may include the electrodes 132 [0191, 0215, 0334]), a sheath (sheath 4208 [0318, 0335, FIG. 42, FIG. 42E, FIG. 42G]), an end cap (end cap 4207 [0294, 0309, 0362, FIG. 42, FIG. 42E, FIG. 43B]), and a hollow core (figure 42E illustrates the hollow core or telescopic shaft 4250 extending between the end cap 4207 and the sheath 4208 [0215, 0301, FIG. 42E]). Thus, configuring each of the thin film elements to extend from a distal end of the sheath of the sheath onto the end cap in a helix around the hollow core would be a matter of changing the size, shape, and rearranging the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 5, Ben-Ezra in view of Mihalik suggests the method of claim 4. Ben-Ezra teaches wherein, in the second configuration, each of the plurality of thin film elements take on a coil shape including end portions and a center having a central portion (the Examiner respectfully submits that a previous modification was made in claim 1 to combine Ben-Ezra’s embodiments to arrive at an overall device consisting of the thin film elements (e.g., the plurality of printed elements including electrodes 132) rotating around the hollow core or shaft of the device [0215, 0334]. Specifically, the thin film elements (e.g., the plurality of printed elements including electrodes 132) are configured to rotate in a spiral (e.g., coil) around the hollow core or shaft [0215, 0334]. The Examiner respectfully submits that it is inherent that the spiral configuration of the thin film elements (e.g., the plurality of printed elements including electrodes 132) would include opposite end portions and a center portion that is between the opposite end portions [0215, 0334]).
Ben-Ezra and Mihalik do not explicitly teach wherein the end portions have a smaller radius than a radius of the central portion.
The Examiner respectfully submits as Ben-Ezra teaches the coil shape having the end portions and the central portion (see the explanation above), configuring the end portions to have a smaller radius than a radius of the central portion would be a matter of changing the size of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
5. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. in view of Sterrett et al. (US 2017/0112405 A1).
Regarding claim 6, Ben-Ezra teaches a medical device (the medical device 100 is configured to be deployed within the patient’s body [abstract, 0093, 0294, 0277, FIG. 42]) comprising:
a sheath (the medical device 100 comprises a sheath 4208 [0138, 0335, FIG. 42, FIG. 42E, FIG. 42G]);
a balloon disposed over at least a portion of the sheath (the balloon 110 is configured to retract over the interior surface of the sheath 4208 [0335]); and
a flexible framework comprising an expandable region and a non-expandable region (the flexible framework may consist of struts 330 having lines or segments (e.g., strut segments 330S) of increased bending flexibility [0177, 0200, 0293, 0334, FIG. 30B, FIG. 42, FIG. 42E, FIG. 42G]. Furthermore, the struts 330 may also include a portion (e.g., origin) that is composed of a non-expandable or non-elastic material 370 [0177, 0198]), wherein:
the expandable region comprises a plurality of longitudinal extending arms (the struts 330 comprises lines or segments (e.g., strut segments 330S) of increased bending flexibility [0177, 0200, 0293, 0334, FIG. 30B, FIG. 42, FIG. 42E, FIG. 42G]. Specifically, each of the segments 330S of the struts 330 extends longitudinally [FIG. 32, FIGS. 34A-34B, FIG. 42]), each arm of the plurality of longitudinal extending arms comprises one or more conductive wires, and one or more electrodes electrically connected to the one or more conductive wires (the electrodes 132 are disposed on the segments 330S of the struts 330 [0200, 0221]. Furthermore, the wiring 380 is routed through the entirety of the struts 330 to connect with the electrodes 132 [0221-0222]), the expandable region is formed on an inflatable portion of the balloon (the segments 330S of the struts 330 are formed over the balloon 110 [0174, 0199-0201, 0211]), the non-expandable region comprises the one or more conductive wires (the wiring 380 is routed through the entirety of the struts 330 to connect with the electrodes 132 [0198, 0221-0222]. As stated previously, above the origin or center point of the struts 330 includes a non-elastic material 370 [0198]), and the non-expandable region is formed on the sheath (figure 42G illustrates the non-expanded portion of the struts 330 being formed along the inner surface of the sheath 4208 and the expanded portion of the struts 330 surrounding the balloon 110 [FIG. 42G]); and
a cable comprising a plurality of wires (the medical device 100 comprises a plurality of electrical wires 380 which can extend through the proximal end and distal end of the medical device 100 [0221]).
Ben-Ezra does not explicitly teach wherein each arm of the plurality of longitudinal extending arms comprises one or more layers of dielectric material;
wherein the conductive wires on the expandable region and non-expandable regions of the flexible framework are in the form of conductive traces;
wherein the non-expandable region of the flexible framework comprises one or more layers of dielectric material, and one or more contacts electrically connected to the one or more conductive traces; and
wherein the plurality of wires of the cable are electrically connected to the one or more contacts.
The prior art by Sterrett is analogous to Ben-Ezra, as they both teach a catheter comprising a framework that is coupled to one or more mapping electrodes ([abstract, 0207]).
Sterrett teaches wherein each arm of the plurality of longitudinal extending arms comprises one or more layers of dielectric material (a dielectric coating may be coated on the flexible framework 660 which comprises the longitudinal extending arms 668, 670, 672, and 674 [abstract, 0207-0208, FIG. 24A]);
wherein the conductive wires on the expandable region and non-expandable regions of the flexible framework are in the form of conductive traces (the traces 664 are configured to extend along the expandable region (e.g., longitudinal extending arms 668, 670, 672, and 674) of the flexible framework 660 [0207, FIG. 24A]. Furthermore, the traces 664 are configured to extend along the non-expandable portion 696 of the flexible framework 660 to connect with the contact pads 684-1 and 684-2 [0207, 0209]); and
wherein the non-expandable region of the flexible framework comprises one or more layers of dielectric material (a dielectric coating may be coated on the flexible framework 660 which comprises a non-expanded portion 696 [0208-0209, FIG. 24A]), and one or more contacts electrically connected to the one or more conductive traces (the traces 664 are configured to extend along the non-expandable portion 696 of the flexible framework 660 to connect with the contact pads 684-1 and 684-2 [0207, 0209]).
Sterrett teaches an alternate embodiment wherein the plurality of wires of the cable are electrically connected to the one or more contacts (the plurality of wires 746 are connected to each of the contact pads [0213, FIG. FIG. 26]. Meanwhile, the traces 750 are routed from the contact pads and are electrically coupled to the electrodes 748 [0213, FIG. 26]). Therefore, it would have been obvious to a person having ordinary skill in the art to combine Sterrett’s embodiments to arrive at an overall device similar to the one claimed. Specifically, combining each of the embodiments will result in the plurality of wires of the cable being electrically connected to the one or more contacts ([0207, 0209, 0213]). This modification is beneficial, as the electrical connection density is increased by connecting the wires, contacts, traces, and the electrodes (see paragraphs [0144, 0146, 0207, 0209, 0213] by Sterrett).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Ben-Ezra’s flexible framework to include a dielectric material on the expandable region (e.g., longitudinal extending arms) and the non-expandable region, as taught by Sterrett. The advantage of such modification will allow the expandable region (e.g., arms 668, 670, 672, and 674) and the non-expandable region (e.g., region 696) of the flexible framework (e.g., flexible framework 660) to have dielectric material which insulates the conductive traces (see paragraphs [0207-0209] by Sterrett). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the Ben-Ezra’s electrodes on the expandable region (e.g., longitudinally extending arms) to be coupled to one or more conductive traces that extend to non-expandable region to connect with one or more contacts, and the contacts being further connected to wires, as further taught by Sterrett. This modification is beneficial, as the electrical connection density is increased by connecting the wires, contacts, traces, and the electrodes (see paragraphs [0144, 0146, 0207, 0209, 0213] by Sterrett).
Regarding claim 7, Ben-Ezra teaches wherein the cable is integrated into the sheath or runs through a lumen or channel of the sheath (as stated previously in claim 6, the medical device 100 comprises a plurality of electrical wires 380 which can extend through the proximal end and distal end of the medical device 100 to connect with the electrodes 132 on the struts 330 [0221, FIG. 42]. Based on figure 42, the wires 380 will extend from the proximal end and through the distal end (e.g., sheath 4208) of the medical device 100 to form a connection with the electrodes 132 on the struts 330 ([0221, 0321, FIG. 42]. The Examiner further submits that figure 42D illustrates the sheath 4208 containing additional wires that are coalesced or wounded into a conductor’s cable 4224 [0321, FIG. 42D]).
Regarding claim 8, Ben-Ezra in view of Sterrett suggests the medical device of claim 6. Sterrett teaches wherein the one or more layers of the dielectric material of the expandable region comprises parylene (a dielectric coating (e.g., parylene) may be coated on the flexible framework 660 which comprises the expandable region (e.g., longitudinal extending arms 668, 670, 672, and 674) [abstract, 0089, 0207-0208, FIG. 24A]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the dielectric material of the expandable region suggested by Ben-Ezra in view of Sterrett to include parylene, as further taught by Sterrett. The advantage of such modification will allow the expandable region (e.g., arms 668, 670, 672, and 674) of the flexible framework (e.g., flexible framework 660) to have a dielectric material (e.g., parylene) which insulates the conductive traces (see paragraphs [0089, 0207-0209] by Sterrett).
Regarding claim 9, Ben-Ezra in view of Sterrett suggests the medical device of claim 6. Sterrett teaches wherein the one or more layers of dielectric material of the non-expandable region comprises a polymer of imide monomers (a dielectric coating (e.g., polyimide) may be coated on the flexible framework 660 which comprises a non-expanded portion 696 [0089, 0208-0209, FIG. 24A]. The Examiner respectfully submits that polyimide is known to be a polymer of imide monomers [0089]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the dielectric material of the non-expandable region suggested by Ben-Ezra in view of Sterrett to include a polymer of imide monomers, as further taught by Sterrett. The advantage of such modification will allow the non-expandable region (e.g., region 696) of the flexible framework (e.g., flexible framework 660) to have dielectric material (e.g., polyimide) which insulates the conductive traces (see paragraphs [0089, 0208-0209] by Sterrett).
Double Patenting
6, The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 11, and 14-15 of U.S. Patent No. 12,226,141 B2 in view of Ben-Ezra et al.
Regarding claim 1, U.S. Patent No. 12,226,141 B2 teaches a method for deploying a medical device ([claim 7]), the method comprising: inserting the medical device into a cavity of a body (the medical device comprises a guidewire that is inserted through the sheath [claim 7, claim 11]. The Examiner respectfully submits that a guidewire is known to be used to help guide a device to a target site [claim 11]), wherein the medical device includes: a sheath ([claim 7, claim 11]); an end cap ([claim 7, claim 11]);
a hollow core extending from the sheath to the end cap ([claim 7]);
a plurality of thin film elements disposed in a first configuration around the hollow core ([claim 7]), wherein the plurality of thin film elements includes a plurality of mapping electrodes ([claim 7]); and
a travel limiter disposed between the plurality of thin film elements and the hollow core ([claim 7]);
providing tension on a pull cable to retract the end cap towards a distal end of the sheath and retract the hollow core within the sheath ([claim 7]);
anchoring the travel limiter to the distal end of the sheath ([claim 7]); and
U.S. Patent No. 12,226,141 B2 does not explicitly teach expanding the plurality of thin film elements to a second configuration.
The prior art by Ben-Ezra is analogous to U.S. Patent No. 12,226,141 B2, as they both teach thin film elements including mapping electrodes (Ben-Ezra teaches wherein the plurality of thin conductive printed elements consists of the electrodes 132 which can transition into an expanded or elongated configuration [0150, 0191, 0215, 0334]).
Ben-Ezra teaches expanding the plurality of thin film elements to a second configuration (the plurality of thin conductive printed elements consists of the electrodes 132 which can transition into an expanded or elongated configuration [0150, 0191, 0215, 0334]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify U.S. Patent No. 12,226,141 B2’s thin film elements to be expanded into a second configuration, as taught by Ben-Ezra. The advantage of such modification will allow the electrodes of the thin film elements to be flexed or elongated while maintaining electrical continuity (see paragraphs [0150, 0215, 0334] by Ben-Ezra).
Regarding claim 2, U.S. Patent No. 12,226,141 B2 teaches wherein in the first configuration: each thin film element of the plurality of thin film elements extends from the distal end of the sheath to the end cap in a straight line parallel to a central axis of the hollow core ([claim 14]); and
each thin film element of the plurality of thin film elements is attached to the end cap ([claim 14]).
Regarding claim 3, U.S. Patent No. 12,226,141 B2 in view of Ben-Ezra suggests the method of claim 2. U.S. Patent No. 12,226,141 B2 and Ben-Ezra do not explicitly teach wherein, in the second configuration, each of the plurality of thin film elements take on a bell-shaped curve.
The Examiner respectfully submits that Ben-Ezra teaches the plurality of thin film elements expanding into the second configuration (the plurality of thin conductive printed elements consists of the electrodes 132 which can transition into an expanded configuration [0191, 0215, 0334]). Thus, configuring the thin film elements to take on a bell-shaped curve while in the second configuration would be a matter of changing the shape of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 4, U.S. Patent No. 12,226,141 B2 teaches wherein in the first configuration: each thin film element of the plurality of thin film elements extends from the distal end of the sheath to the end cap in a helix around the hollow core ([claim 15]); and
each thin film element of the plurality of thin film elements is attached to the end cap ([claim 15]).
Regarding claim 5, U.S. Patent No. 12,226,141 B2 in view of Ben-Ezra suggests the method of claim 4. Ben-Ezra teaches wherein, in the second configuration, each of the plurality of thin film elements take on a coil shape including end portions and a center having a central portion (the Examiner respectfully submits that a previous modification was made in claim 1 to combine Ben-Ezra’s embodiments to arrive at an overall device consisting of the thin film elements (e.g., the plurality of printed elements including electrodes 132) rotating around the hollow core or shaft of the device [0215, 0334]. Specifically, the thin film elements (e.g., the plurality of printed elements including electrodes 132) are configured to rotate in a spiral (e.g., coil) around the hollow core or shaft [0215, 0334]. The Examiner respectfully submits that it is inherent that the spiral configuration of the thin film elements (e.g., the plurality of printed elements including electrodes 132) would include opposite end portions and a center portion that is between the opposite end portions [0215, 0334]).
U.S. Patent No. 12,226,141 B2 and Ben-Ezra do not explicitly teach wherein the end portions have a smaller radius than a radius of the central portion.
The Examiner respectfully submits as Ben-Ezra teaches the coil shape having the end portions and the central portion (see the explanation above), configuring the end portions to have a smaller radius than a radius of the central portion would be a matter of changing the size of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights