DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1-4, 7, 9, 14, 17, 20 is/are amended and claim(s) 16 is/are canceled. Claims 1-15 and 17-20 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 3 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, added limitations such as “an impermeable barrier having a leading portion and a trailing portion spaced from the leading portion along the central axis, the impermeable barrier configured to transition between a retracted configuration, where the leading portion and the trailing portion of the impermeable barrier are collapsed toward the central axis, and an expanded configuration, where the leading portion is adjacent to the central axis and the trailing portion is expanded outwardly and radially away from the central axis” overcome the previous rejection as written. However, a new grounds of rejection is provided over Arnott.
Claim Objections
Claim 20 is objected to because of the following informalities:
In claim 20: “wherein impermeable barrier” should read “wherein the impermeable barrier”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 2, the claim states “the elongated catheter that is configured to aid on conforming the elongated configurable catheter”, which is indefinite as it is unclear as to how the elongated catheter is configured in conforming itself. For examination purposes, the limitation will be seen as “wherein the one or more actuators are coupled to the elongated configurable catheter configured to aid in conforming the elongated configurable catheter”.
Claim 7 recites the limitation "the respective first and second lumens" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as wherein the intermediate sections of the first strut and the second strut exit a lumen.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 9-12, 15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnott (US 20040087971 A1).
Regarding claim 1, Arnott discloses a surgical system, comprising:
an elongated configurable catheter (32) that extends along a central axis (Paragraph 0077 states “Containment collar 32 is preferably made from Teflon tubing….can be made from other flexible biocompatible materials”. Since the tubing is flexible, collar 32 is seen as a configurable catheter.) (Figure 5-6; Paragraph 0059; 0065; 0079);
a main shaft (distal portion of 32) having a terminal end (Figure 1; Paragraph 0059);
a first strut (26) positioned and slidable relative to the elongated configurable catheter (Figure 2; Paragraph 0078);
a second strut positioned and slidable relative to the elongated configurable catheter (Figure 2; Paragraph 0078);
an impermeable barrier (12) coupled at the main shaft (Figure 1D; Paragraph 0083) (Paragraph 0083 states that sack 12 may be formed of a nonporous material which occludes flow in the vessels, thus is seen as an impermeable barrier) and having a leading portion (distal tip of 12) and a trailing portion (proximal end of 12) spaced from the leading portion along the central axis (Figure 5-6), the impermeable barrier configured to transition between a retracted configuration (Figure 1A; 5), where the leading portion and the trailing portion of the impermeable barrier are collapsed toward the central axis (Figure 1A; 5; Paragraph 0028; 0059), and an expanded configuration (Figure 1D; 6), where the leading portion is adjacent to the central axis and the trailing portion is expanded outwardly and radially away from the central axis (Figure 1D; 5; Paragraph 0028; 0059); and
one or more actuators (4, 34) coupled to the first and second struts and configured to cause the impermeable barrier to transition between the retracted configuration and the expanded configuration (Paragraph 0064; 0073).
Regarding claim 3, Arnott discloses wherein the elongated configurable catheter further includes a configurable section (body of 32), the configurable section being configured to selectively conform into a curved configuration (the body if 32 is flexible thus is configured to selectively conform into a curved configuration) (Paragraph 0077).
Regarding claim 4, Arnott further discloses wherein the impermeable barrier is configured to transition between the retracted configuration and the expanded configuration such that the first strut and the second strut are spaced outwardly away from the main shaft (Figure 2, 6).
Regarding claim 5, Arnott further discloses wherein the first strut and the second strut each have an intermediate section (middle sections of 26) and a terminal end (distal ends of 26) (Figure 2).
Regarding claim 6, Arnott further discloses wherein the elongated configurable catheter includes a distal tapered tip (20) that is coupled to terminal ends of the first strut, the second strut, and the main shaft (Figure 5; Paragraph 0063; 0084) (the struts and main shaft are coupled to the apex 20 via the sack 12).
Regarding claim 9, Arnott further discloses wherein advancement of the first strut and the second strut in a distal direction causes the intermediate sections of the first strut and the second strut to expand outwardly in order to maintain the impermeable barrier in the expanded configuration, wherein the intermediate sections of the first strut and the second strut are configured to transition into a configuration that is spaced outwardly away from the main shaft (Figure 5-6).
Regarding claim 10, Arnott further discloses wherein the first strut and the second strut are movable relative to each other and the main shaft (Figure 5-6) (both of arms 26 move outwards relative to each other and slide within the shaft).
Regarding claim 11, Arnott further discloses wherein the main shaft includes a guidewire lumen (36, 37) (Figure 1; Paragraph 0065).
Regarding claim 12, Arnott further discloses wherein the main shaft is conformable and able to be selectively fixed in a curved configuration (the main shaft is flexible as containment collar 32 is made of a flexible material thus is conformable and fully capable of being selectively fixed in a curved configuration) (Figure 4; Paragraph 0079).
Regarding claim 15, Arnott further discloses a handle (38) disposed on a proximal end of the elongated configurable catheter (Figure 1A-C; Paragraph 0070; 0090).
Regarding claim 20, Arnott further discloses wherein the impermeable barrier is divided into one leaflet between the first strut, the second strut, and the main shaft (the body of 12 is seen as a leaflet) (Figure 6).
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.
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.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnott.
As best understood in view of the 112(b) issues above, regarding claim 7, Arnott further discloses wherein the intermediate sections of the first strut and the second strut exit the respective first and second lumens at a preset angle relative to each other, a preset shape, and a preset range of distances controllable via the one or more actuators (Figure 2, 6; Paragraph 0079) (As manufactured, due to the shape memory material of the struts, the device of Arnott would be fully capable of having the intermediate sections of the first strut and the second strut exit the respective first and second lumens at a preset angle relative to each other, a preset shape, and a preset range of distances controllable via an actuator, preset to manufacturing requirements.).
Arnott fails to explicitly disclose wherein the preset angle of the first strut and the second strut is between 90 degrees and 180 degrees.
There is no evidence of record that establishes changing the preset angle of Arnott to be between 90 degrees and 180 degrees would result in a difference in function of Arnott’s device. Further, a person having ordinary skill in the art, being faced with modifying the preset angle of Arnott, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may” be within the claimed range and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the preset angle of Arnott to have between 90 degrees and 180 degrees] as an obvious matter of design choice within the skill of the art.
Regarding claim 8, Arnott discloses the system of claim 7 but does not explicitly disclose wherein the preset angle of the first strut and the second strut is about 120 degrees.
There is no evidence of record that establishes changing the preset angle of Arnott to [desired claim] would result in a difference in function of Arnott’s device. Further, a person having ordinary skill in the art, being faced with modifying the preset angle of Arnott would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle “may” be within the claimed range, and offering other acceptable ranges (e.g., between approximately 90 degrees to 180 degrees, (Paragraph 0034) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the present angle of Arnott wherein the preset angle of the first strut and the second strut is about 120 degrees as an obvious matter of design choice within the skill of the art.
Claim(s) 2, 13, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnott, as applied to claim 1 and 3 above, and further in view of Purcell et al. (US 20230047943 A1) (previously of record).
As best understood in view of the 112(b) issues above, regarding claim 2, Arnott discloses the surgical system according to claim 1, but fails to explicitly disclose wherein the one or more actuators are coupled to the elongated configurable catheter configured to aid in conforming the elongated configurable catheter.
However, Purcell is directed to an expandable medical device and teaches a pull-wire controlled sheath (604), wherein the one or more actuators (pull wire) coupled to the elongated configurable catheter (604) and configured to aid in conforming the elongated configurable catheter (Figure 6A-B; Paragraph 0097).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Arnott to include wherein the one or more actuators are coupled to the elongated configurable catheter configured to aid in conforming the elongated configurable catheter, as taught by Purcell, as both references and the claimed invention are directed to expandable 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 Arnott with the teachings of Purcell by incorporating wherein the one or more actuators are coupled to the elongated configurable catheter configured to aid in conforming the elongated configurable catheter, in order to easily steer the sheath (Purcell Paragraph 0097).
Regarding claim 13, Arnott discloses the surgical system according to claim 3, but fails to further disclose one or more pull rods or wires coupled to the main shaft and configured to aid in curving the main shaft.
However, Purcell is directed to an expandable medical device and teaches a pull-wire controlled sheath (604), which comprises one or more pull rods (pull wire) coupled to the main shaft (604) and configured to aid in curving the main shaft (Figure 6A-B; Paragraph 0097).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Arnott to include one or more pull rods coupled to the main shaft and configured to aid in curving the main shaft, as taught by Purcell, as both references and the claimed invention are directed to expandable 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 Arnott with the teachings of Purcell by incorporating one or more pull rods or wires coupled to the main shaft and configured to aid in curving the main shaft in order to create bending areas, in order to easily steer the sheath (Purcell Paragraph 0097).
Regarding claim 17-18, Arnott discloses the surgical system according to claim 3, but fails to further disclose wherein the one or more actuators are configured to cause the configurable section to selectively change and one or more push-pull rods or wires coupled to the configurable section of the elongated configurable catheter, wherein activation of the one or more push-pull rods or wires causes the configurable section to curve into and out of a curved configuration.
However, Purcell is directed to an expandable medical device and teaches a pull-wire controlled sheath (604), wherein the one or more actuators (pull wire) are configured to cause the configurable section to selectively change (Paragraph 0097), which comprises one or more pull rods (pull wire) coupled to the catheter (604) and configured to aid in curving the configurable section of the elongated configurable catheter (Figure 6A-B; Paragraph 0097). When combined with the catheter of Arnott, the modification would result in one or more push-pull rods coupled to the configurable section of the elongated configurable catheter, wherein activation of the one or more push-pull rods causes the configurable section to curve into and out of a curved configuration.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arnott with the teachings of Purcell by incorporating wherein the one or more actuators are configured to cause the configurable section to selectively change and one or more pull rods or wires in order to create bending areas, in order to easily steer the sheath (Purcell Paragraph 0097).
Regarding claim 19, Arnott as modified by Purcell teaches the surgical system according to claim 17, but Arnott fails to disclose one or more push-pull rods or wires coupled to a distal tip of the elongated configurable catheter, wherein activation of the one or more push-pull rods or wires causes the configurable section to curve into and out of a curved configuration.
However, Purcell teaches a pull-wire controlled sheath (604), which comprises one or more pull rods (pull wire) coupled to the elongated configurable catheter (604) and configured to aid in curving the main shaft (Figure 6A-B; Paragraph 0078). When combined with the catheter of Arnott, the modification would result in one or more push-pull rods coupled to a distal tip of the elongated configurable catheter, wherein activation of the one or more push-pull rods causes the configurable section to curve into and out of a curved configuration.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Arnott with the teachings of Purcell by incorporating one or more pull rods or wires in order to create bending areas, in order to easily steer the sheath (Purcell Paragraph 0097).
The modification fails to explicitly disclose one or more push-pull rods or wires coupled to a distal tip of the elongated configurable catheter. However, there are a number of choices available to a person of ordinary skill in the art for locations to couple a pull wire to a catheter. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnott, as applied to claim 3 above, and further in view of Eidenschink (US 20140257362 A1) (previously of record).
Regarding claim 14, Arnott discloses the surgical system according to claim 3, but fails to explicitly disclose wherein a coupling location of the first strut and the second strut to the main shaft controls orientation of the first strut and the second strut.
However, Eidenschink teaches wherein coupling location of the first strut (30) and the second strut (40) to the main shaft (50) controls orientation of the first strut and the second strut (Paragraph 0030) (Pull-wires 30 and 45 are positioned at least partially within the main shaft, thus are coupled to the main shaft. As the pull-wires move relative to the shaft, their location is adjusted, further controlling the orientation of the wires).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Arnott such that a coupling location of the first strut and the second strut to the main shaft controls orientation of the first strut and the second strut, as taught by Eidenschink, as both references and the claimed invention are directed to vascular 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 Arnott with the teachings of Eidenschink by incorporating a coupling location of the first strut and the second strut to the main shaft controls orientation of the first strut and the second strut in order to manipulate Arnott’s sack and allow for opening and closing as desired (Eidenschink Paragraph 0030).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771