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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/03/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/03/2026. As directed by the amendment: claims 13 have been amended and claims 15-88 have been cancelled. Thus, claims 1-14 and 89-106 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 10-13, filed 04/03/2026, with respect to the rejection of claims 1 and 93 under 35 U.S.C. 103 as being unpatentable over Lashinski et al (US 20200305887 A1), herein referenced to as “Lashinski” in view of Wang et al (US 20220022885 A1), herein referenced to as “Wang” have been fully considered but they are not persuasive.
The applicant argues that the prior art of record fails to teach or render obvious “a catheter configured to deploy the implant and defining a longitudinal axis… wherein each of the first dial and the second dial are configured to rotate about the longitudinal axis”. Specifically, they argue that the analysis of the Office action uses impressible hindsight.
The applicant argues that the embodiments of Lashinski in [0264] show that the implant can be fastened to a rupture of ostium to cause occlusion.
They argue that the examiner’s motivation to combine Wang with Lashinski of “allows the occluder to fasten and be closely attached to a rupture or ostium where the implant is deployed (see [0186])”, is improper hindsight reasoning because the prior art reference already solves this.
The examiner respectfully disagrees, as the embodiments of Lashinski relied upon does not describe the two portions of the occluder both being to used to fasten in a “close attachment” as described in Wang. As previously stated in the advisory action mailed 03/23/2026, the advantage here is minimizing the distance between both of the two structures of the occluder and the rupture, which is an explicit benefit that is not taught within Lashinski. This additionally lends benefits noted in [0012] "Therefore, when in cooperation with a pushing device, such a structure designed for the occluder of the present application can achieve high-efficiency, stable and reliable fastening, thereby improving the service life and occlusion performance of the occluder, reducing the risk of postoperative complications, which is particularly applicable for the occlusion treatment of rupture of aortic dissection."
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant additionally argues that “it is unclear how a change in the Lashinski catheter would allow the Lashinski implant to be implanted faster or closer to an occlusion” and “How could a catheter allow the Lashinski implant to be even closer to a rupture than what is already disclosed in Lashinski?”. The examiner notes that there was no mention of “faster” in the advisory action.
In response to applicant's argument that “it is unclear how a change in the Lashinski catheter would allow the Lashinski implant to be implanted faster or closer to an occlusion” and “How could a catheter allow the Lashinski implant to be even closer to a rupture than what is already disclosed in Lashinski?”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As such the USC 103 rejection will be maintained.
Applicant's arguments, see pages 13-15, filed 04/03/2026, with respect to the rejection of claim 13 under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wong and von Oepen et al (US 20210244916 A1), herein referenced to as “von Oepen” have been fully considered but they are not persuasive.
The applicant amended claim 13 to further recite “such that the catheter thereby contacts the slide”. The applicant argues that this is not taught by von Oepen.
The examiner respectfully disagrees. The catheter 82 of von Oepen contacts the slide 170 indirectly, hence the catheter contacts the slide. Essentially 82 contacts 132 which contacts 170, thus 82 contacts 170.
As such the USC 103 rejection will be maintained.
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) 1-7, 93, 95-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski et al (US 20200305887 A1), herein referenced to as “Lashinski” in view of Wang et al (US 20220022885 A1), herein referenced to as “Wang”.
Claim 1
Lashinski discloses: A system 140 (see Fig. 9I, [0288]) for treating a left atrial appendage (see [0288], occluding an LAA), comprising: an implant 142 (see Fig. 9I configured to be at least partially positioned within the left atrial appendage (see [0288], LAA); and a catheter 152 (see Fig. 9I, [0289]) configured to deploy (see [0289]) the implant 142 and defining a longitudinal axis (see Fig. 9I, the longitudinal axis of 152 which is shared with the outer sheath and the inner catheter member), the catheter 152 comprising: an outer sheath 152 (see Fig. 9I, [0289]); an inner catheter member 155 (see Fig. 9I, [0293], can rotate 148 which is part of the implant 142) configured to rotate the implant 142 when a distal end portion 165 (see Fig. 9I, [0294]) of the inner catheter member 155 is engaged with the implant 143.
Lashinski (Fig. 9I) does not explicitly disclose: the outer sheath coupled with a first connector; a first dial coupled with the outer sheath; a second dial coupled with the inner catheter member; wherein: the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction; and the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction.
However, a variant embodiment (see Figs. 150A-150C and 151B) of Lashinski teaches a system for treating a left atrial appendage (see Figs. 150A-150C and 151B) with an implant 2520 (see Figs. 150A-150C and 151B, [0455]) and an outer sheath the sheath (see annotated Fig. 151B below, [0457]). Lashinski (Figs. 150A-150C and 151B) further teaches: the outer sheath the sheath coupled with a first connector (see annotated Fig. 151B below, [0457]); a first dial actuator nut (see annotated Fig. 151B below, [0457], the nut is a dial as it turns like a dial to actuate) coupled with the outer sheath the sheath, wherein: the first dial actuator nut is configured to axially move the first connector (see annotated Fig. 151B below, [0457], the connector which is coupled to the outer sheath will be pulled back over a handle screw gear (screw)) and the outer sheath the sheath in a first axial direction (see [0457], withdrawal) from an initial axial position to a second axial position (see [0457], withdrawal from a first position to further back to a second position) when the first dial actuator nut is rotated in a first direction (see [0457], rotation of the actuator nut), wherein the first dial actuator nut (see annotated Fig. 151B below, [0457], the nut is a dial as it turns like a dial to actuate) is configured to rotate about the longitudinal axis (see Fig. 151B, this about the longitudinal axis of the catheter).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of variant embodiment (Figs. 150A-150C and 151B) and teach a system for treating a left atrial appendage with the outer sheath coupled with a first connector; a first dial coupled with the outer sheath; wherein: the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction. Motivation for such can be found in Lashinski as this allows for accurate positioning of the implant via controlled withdrawal of the sheath (see [0457]).
Lashinski does not explicitly teach: a second dial coupled with the inner catheter member; wherein: the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction, wherein the second dial is configured to rotate about the longitudinal axis.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and an implant 10 + 11 + 15 (see Figs. 1 and 53-59). Wang further teaches: a second dial 67 (see Figs. 1 and 54-55, [0086]) coupled with the inner catheter member 684 (see Fig. 1, [0086]); wherein: the second dial 67 is configured to rotate the inner catheter member 684 and the implant 15 in a first rotational direction (see Figs. 54-56, [0086], 67 causes 684 to rotate which causes 112 to screw to 689, and 112 causes 15 to rotate and advance as well) from an initial position (Fig. 54) to a second rotational position (see Fig. 56) when the second dial 67 is rotated in a first direction (see [0086]), wherein the second dial 67 is configured to rotate about the longitudinal axis (see Fig. 1, 67 rotates about the longitudinal axis of the catheter 42 + 68).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a system for treating a left atrial appendage with a second dial coupled with the inner catheter member; wherein: the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction. Motivation for such can be found in Wang as this allows the occluder to fasten and be closely attached to a rupture or ostium where the implant is deployed (see [0186]) and therefore, when in cooperation with a pushing device, such a structure designed for the occluder of the present application can achieve high-efficiency, stable and reliable fastening, thereby improving the service life and occlusion performance of the occluder, reducing the risk of postoperative complications, which is particularly applicable for the occlusion treatment of rupture of aortic dissection (see [0012], specifically, fastening bi-directionally instead of just from one direction allows for more stable and reliable fastening).
Claim 2
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. Lashinski further discloses: wherein the system 140 is configured to cause a rotating portion 144 (see Figs. 9I and 9A-9C, [0289]) of the implant 142 to move from a first state (see Fig. 9A, [0289]) to a second, expanded state (see Fig. 9C, [0289]) and to move an outside surface outside surface of 144 (see Fig. 9C) of the rotating portion 144 of the implant against an inner wall surface inner wall of the LAA (see Figs. 9A-9C) of the left atrial appendage LAA (see Figs. 9A-9C).
Claim 3
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. Lashinski further discloses: comprising a second inner catheter member 157 (see Fig. 9I, [0295]) and a locking portion 150 (see Fig. 9I, [0289]) of the implant 142.
Lashinski does not explicitly disclose: a third dial coupled with the second inner catheter member.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with a second dial 67 (see Fig. 1, [0086]) coupled with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and a second inner catheter member 682 (see Fig. 1, [0086], 684 is around 682, hence 682 is within 684). Wang further teaches: a third dial 66 (see Fig. 1, [0086]) coupled with the second inner catheter member 682 (see Figs. 1, 3, and 4-7, [0086]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a third dial coupled with the second inner catheter member. Motivation for such can be found in Wang as this allows for detachable connection to the implant (see [0087]).
The language, " wherein the third dial is configured to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Wang meets the structural limitations of the claim, and is capable of using the third dial which is connected to the second inner catheter member (Lashinski modified with Wang) and to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction (see [0295] of Lashinski, the implant and 157 the second inner catheter member can be rotated/twisted, and can be used to advance the locking portion 150 to the rotation portion 144, see Figs. 9D-9E).
Claim 4
The combination of Lashinski and Wang teaches: the system of claim 3, see 103 rejection above. Lashinski further discloses: wherein the locking portion 150 comprises one or more arms one or more arms of 150 (see Fig. 9I, [0267], multiple arms) extending away from a body portion tubular body portion of 150 that extends to the one or more arms (see Fig. 9I) of the implant 142 and configured to penetrate into the tissue of the left atrial appendage LAA (see Fig. 9E, the one or more arms penetrating into O, [0297]) that has constricted and gathered inwardly (see Figs. 9C-9E) around an outside surface the outside surface of 142 of a portion a central portion of 142 between 144 and 150 of the implant 142.
Claim 5
The combination of Lashinski and Wang teaches: the system of claim 4, see 103 rejection above. Lashinski further discloses: wherein the locking portion 150 (see Fig. 9I) comprises one or more arms one or more arms of 150 (see Fig. 9I, [0267], multiple arms) extending away from a body portion tubular body portion of 150 that extends to the one or more arms (see Fig. 9I) of the locking portion 150, the locking portion 150 being configured to move at least from a first state (see Fig. 9C) in which the one or more arms are collapsed (see Fig. 9C, the one or more arms of 150 are collapsed) and a second state (see Fig. 9D, the one or more arms are expanded and are spaced further apart from the main body tube than in the first state as shown in Fig. 9C) in which the one or more arms one or more arms of 150 are expanded such that an end portion the ends of the one or more arms of 150 (see Figs. 9C-9D and 9I) of each of the one or more arms one or more arms of 150 are spaced further apart from the body portion of the locking portion 150 when the locking portion 150 is in the second state (see Fig. 9D) than when the locking portion 150 is in the first state (see Fig. 9C).
Claim 6
The combination of Lashinski and Wang teaches: the system of claim 5, see 103 rejection above. Lashinski further discloses: wherein the one or more arms the one or more arms of 150 of the locking portion 150 are configured to extend (see Fig. 9D, the one or more arms of 150 extend towards 144) toward the rotating portion 144 of the implant 142 when the locking portion 150 is in the second state (see Fig. 9D).
Claim 7
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. Lashinski (see Fig. 151B) further teaches: further comprising a stop element (see annotated Fig. 151B below) configured to limit a range of movement of the first connector (see annotated Fig. 151B below) relative to the first dial (see annotated Fig. 151B below) so as to limit a range of movement of the outer sheath (see annotated Fig. 151B below) relative to the implant the implant.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to further incorporate the teachings of a variant embodiment of Lashinski (see Fig. 151B) and teach a system for treating a left atrial appendage with a stop element configured to limit a range of movement of the first connector relative to the first dial so as to limit a range of movement of the outer sheath relative to the implant. Motivation for such can be found in Lashinski as this can allow the user to carefully and precisely control the motion at which the sheath is withdrawn and allow for accurate positioning based on the control from the user (see [0457]).
Claim 93
Lashinski discloses: A system 140 (see Fig. 9I, [0288]) for treating an anatomical structure (see [0288], occluding an LAA), comprising: an implant 142 (see Fig. 9I configured to be at least partially positioned within the anatomical structure (see [0288], LAA); and a catheter 152 (see Fig. 9I, [0289]) configured to deploy (see [0289]) the implant 142 and defining a longitudinal axis (see Fig. 9I, the longitudinal axis of 152 which is shared with the outer sheath and the inner catheter member), the catheter 152 comprising: an outer sheath 152 (see Fig. 9I, [0289]); an inner catheter member 155 (see Fig. 9I, [0293], can rotate 148 which is part of the implant 142) configured to rotate the implant 142 when a distal end portion 165 (see Fig. 9I, [0294]) of the inner catheter member 155 is engaged with the implant 143.
Lashinski (Fig. 9I) does not explicitly disclose: the outer sheath coupled with a first connector; an actuator coupled with the outer sheath; a second dial coupled with the inner catheter member; each of a center of the actuator and a center of the second dial are centered about the longitudinal axis; the actuator is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the actuator is rotated in a first direction; and the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction.
However, a variant embodiment (see Figs. 150A-150C and 151B) of Lashinski teaches a system for treating a left atrial appendage (see Figs. 150A-150C and 151B) with an implant 2520 (see Figs. 150A-150C and 151B, [0455]) and an outer sheath the sheath (see annotated Fig. 151B below, [0457]). Lashinski (Figs. 150A-150C and 151B) further teaches: the outer sheath the sheath coupled with a first connector (see annotated Fig. 151B below, [0457]); an actuator the actuator nut (see annotated Fig. 151B below, [0457], the nut is a dial as it turns like a dial to actuate) coupled with the outer sheath the sheath, a center the center of the actuator nut (see annotated Fig. 151B below) of the actuator is centered about the longitudinal axis (the actuator nut is centered about the longitudinal axis of the outer sheath/catheter) the actuator the actuator nut is configured to axially move the first connector (see annotated Fig. 151B below, [0457], the connector which is coupled to the outer sheath will be pulled back over a handle screw gear (screw)) and the outer sheath the sheath in a first axial direction (see [0457], withdrawal) from an initial axial position to a second axial position (see [0457], withdrawal from a first position to further back to a second position) when the actuator the actuator nut is rotated in a first direction (see [0457], rotation of the actuator nut).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of variant embodiment (Figs. 150A-150C and 151B) and teach a system for treating an anatomical structure with the outer sheath coupled with a first connector; an actuator coupled with the outer sheath; the center of the actuator is centered about the longitudinal axis; the actuator is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the actuator is rotated in a first direction. Motivation for such can be found in Lashinski as this allows for accurate positioning of the implant via controlled withdrawal of the sheath (see [0457]).
Lashinski does not explicitly teach: a second dial coupled with the inner catheter member; a center of the second dial is centered about the longitudinal axis; the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and an implant 10 + 11 + 15 (see Figs. 1 and 53-59). Wang further teaches: a second dial 67 (see Figs. 1 and 54-55, [0086]) coupled with the inner catheter member 684 (see Fig. 1, [0086]); a center of the second dial 67 is centered about the longitudinal axis (the longitudinal axis of 42 + 68, see Fig. 1) the second dial 67 is configured to rotate the inner catheter member 684 and the implant 15 in a first rotational direction (see Figs. 54-56, [0086], 67 causes 684 to rotate which causes 112 to screw to 689, and 112 causes 15 to rotate and advance as well) from an initial position (Fig. 54) to a second rotational position (see Fig. 56) when the second dial 67 is rotated in a first direction (see [0086]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a system for treating an anatomical structure with a second dial coupled with the inner catheter member; a center of the second dial is centered about the longitudinal axis; the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction. Motivation for such can be found in Wang as this allows the occluder to fasten and be closely attached to a rupture or ostium where the implant is deployed (see [0186]) and therefore, when in cooperation with a pushing device, such a structure designed for the occluder of the present application can achieve high-efficiency, stable and reliable fastening, thereby improving the service life and occlusion performance of the occluder, reducing the risk of postoperative complications, which is particularly applicable for the occlusion treatment of rupture of aortic dissection (see [0012], specifically, fastening bi-directionally instead of just from one direction allows for more stable and reliable fastening).
Claim 95
The combination of Lashinski and Wang teaches: the system of claim 93, see 103 rejection above. Lashinski further discloses: wherein the system 140 is configured to cause a rotating portion 144 (see Figs. 9I and 9A-9C, [0289]) of the implant 142 to move from a first state (see Fig. 9A, [0289]) to a second, expanded state (see Fig. 9C, [0289]) and to move an outside surface outside surface of 144 (see Fig. 9C) of the rotating portion 144 of the implant against an inner wall surface inner wall of the LAA (see Figs. 9A-9C) of the left atrial appendage LAA (see Figs. 9A-9C).
Claim 96
The combination of Lashinski and Wang teaches: the system of claim 93, see 103 rejection above. Lashinski further discloses: comprising a second inner catheter member 157 (see Fig. 9I, [0295]) and a locking portion 150 (see Fig. 9I, [0289]) of the implant 142.
Lashinski does not explicitly disclose: a third dial coupled with the second inner catheter member.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with a second dial 67 (see Fig. 1, [0086]) coupled with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and a second inner catheter member 682 (see Fig. 1, [0086], 684 is around 682, hence 682 is within 684). Wang further teaches: a third dial 66 (see Fig. 1, [0086]) coupled with the second inner catheter member 682 (see Figs. 1, 3, and 4-7, [0086]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a third dial coupled with the second inner catheter member. Motivation for such can be found in Wang as this allows for detachable connection to the implant (see [0087]).
The language, " wherein the third dial is configured to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Wang meets the structural limitations of the claim, and is capable of using the third dial which is connected to the second inner catheter member (Lashinski modified with Wang) and to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction (see [0295] of Lashinski, the implant and 157 the second inner catheter member can be rotated/twisted, and can be used to advance the locking portion 150 to the rotation portion 144, see Figs. 9D-9E).
Claim 97
The combination of Lashinski and Wang teaches: the system of claim 96, see 103 rejection above. Lashinski further discloses: wherein the locking portion 150 comprises one or more arms one or more arms of 150 (see Fig. 9I, [0267], multiple arms) extending away from a body portion tubular body portion of 150 that extends to the one or more arms (see Fig. 9I) of the implant 142 and configured to engage tissue adjacent to the anatomical structure LAA (see Fig. 9E, the one or more arms penetrating into O, [0297]) that has constricted and gathered inwardly (see Figs. 9C-9E) around an outside surface the outside surface of 142 of a portion a central portion of 142 between 144 and 150 of the implant 142.
Claim 98
The combination of Lashinski and Wang teaches: the system of claim 97, see 103 rejection above. Lashinski further discloses: wherein the locking portion 150 (see Fig. 9I) comprises one or more arms one or more arms of 150 (see Fig. 9I, [0267], multiple arms) extending away from a body portion tubular body portion of 150 that extends to the one or more arms (see Fig. 9I) of the locking portion 150, the locking portion 150 being configured to move at least from a first state (see Fig. 9C) in which the one or more arms are collapsed (see Fig. 9C, the one or more arms of 150 are collapsed) and a second state (see Fig. 9D, the one or more arms are expanded and are spaced further apart from the main body tube than in the first state as shown in Fig. 9C) in which the one or more arms one or more arms of 150 are expanded such that an end portion the ends of the one or more arms of 150 (see Figs. 9C-9D and 9I) of each of the one or more arms one or more arms of 150 are spaced further apart from the body portion of the locking portion 150 when the locking portion 150 is in the second state (see Fig. 9D) than when the locking portion 150 is in the first state (see Fig. 9C).
Claim 99
The combination of Lashinski and Wang teaches: the system of claim 98, see 103 rejection above. Lashinski further discloses: wherein the one or more arms the one or more arms of 150 of the locking portion 150 are configured to extend (see Fig. 9D, the one or more arms of 150 extend towards 144) toward the rotating portion 144 of the implant 142 when the locking portion 150 is in the second state (see Fig. 9D).
Claim 100
The combination of Lashinski and Wang teaches: the system of claim 93, see 103 rejection above. Lashinski (see Fig. 151B) further teaches: further comprising a stop element (see annotated Fig. 151B below) configured to limit a range of movement of the first connector (see annotated Fig. 151B below) relative to the first dial (see annotated Fig. 151B below) so as to limit a range of movement of the outer sheath (see annotated Fig. 151B below) relative to the implant the implant.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to further incorporate the teachings of a variant embodiment of Lashinski (see Fig. 151B) and teach a system for treating a left atrial appendage with a stop element configured to limit a range of movement of the first connector relative to the first dial so as to limit a range of movement of the outer sheath relative to the implant. Motivation for such can be found in Lashinski as this can allow the user to carefully and precisely control the motion at which the sheath is withdrawn and allow for accurate positioning based on the control from the user (see [0457]).
Claim 101
The combination of Lashinski and Wang teaches: the system of claim 93, see 103 rejection above. Lashinski (see Fig. 151B) further teaches: wherein the actuator the actuator nut (see annotated Fig. 151B below claim 93) comprise a first dial ([0457], the nut is a dial as it turns like a dial to actuate).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wang as applied to claim 1 above, and further in view of Miles et al (US 20120316584 A1), herein referenced to as “Miles”.
Claim 8
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. Lashinski further discloses: comprising a third inner catheter member 153 (see Fig. 9I, [0289]).
The combination of Lashinski and Wang does not explicitly disclose: and a fourth dial coupled with the third inner catheter member, wherein the fourth dial is configured to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction.
However, Miles in a similar field of invention teaches a system for treating a left atrial appendage 10 (see Figs. 1-4D) with a first actuator 30 (see Fig. 2, [0136], 30 controls 16) coupled to the outer sheath 16 (see Fig. 3B), an inner catheter member 80 (see Fig. 3B), a second dial 26 coupled to the inner catheter member 80, a second inner catheter member 82 (see Fig. 3B), and a third inner catheter member 86 (see Fig. 3B). Miles further teaches: a fourth dial 28 (see Fig. 1B, [0136], meets the definition of a dial per Oxford Languages online dictionary “a plate or disk on a radio, stove, mashing machine, or other piece of equipment that is tuned to select a wavelength or setting” in this case this a disk that can select a setting in this case, changing from a delivery configuration to implant the device)) coupled with the third inner catheter member 86 (see [0136], 24 controls movement of the anchor system 44, which is coupled to 86, see Fig. 3B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Miles and teach a system for treating a left atrial appendage with a fourth dial coupled with the third inner catheter member. Motivation for such can be found in Miles as this allows control of the device to deploy and or capture the medical device/implant (see [0134]) from outside of the body and allow for independent control of the various parts of the implant (see [0135]).
The language, " wherein the fourth dial is configured to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Miles meets the structural limitations of the claim, and is capable of using the fourth dial which is connected to the third inner catheter member (Lashinski modified with Miles) and to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction (see [0294] of Lashinski, the implant and 165 which is the distal end of 153 the third inner catheter member can be rotated/twisted, and can be used to withdraw the delivery device from the implant 142).
Claim(s) 9-10 and 102-103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wang as applied to claim 1 and claim 93 above, and further in view of Miles and Hammer et al (US 20100280605 A1), herein referenced to as “Hammer”.
Claim 9
The combination of Lashinski and Miles teaches: the system of claim 1, see 103 rejection above. Lashinski further discloses: comprising a second inner catheter member 157 (see Fig. 9I, [0295]), a locking portion 150 (see Fig. 9I, [0289]) of the implant 142, and a third inner catheter member 153 (see Fig. 9I, [0289])
Lashinski does not explicitly disclose: a third dial coupled with the second inner catheter member and a fourth dial coupled with the third inner catheter member, and a linking element comprising a sleeve.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with a second dial 67 (see Fig. 1, [0086]) coupled with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and a second inner catheter member 682 (see Fig. 1, [0086], 684 is around 682, hence 682 is within 684). Wang further teaches: a third dial 66 (see Fig. 1, [0086]) coupled with the second inner catheter member 682 (see Figs. 1, 3, and 4-7, [0086]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a third dial coupled with the second inner catheter member. Motivation for such can be found in Wang as this allows for detachable connection to the implant (see [0087]).
The language, " wherein the third dial is configured to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Wang meets the structural limitations of the claim, and is capable of using the third dial which is connected to the second inner catheter member (Lashinski modified with Wang) and to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction (see [0295] of Lashinski, the implant and 157 the second inner catheter member can be rotated/twisted, and can be used to advance the locking portion 150 to the rotation portion 144, see Figs. 9D-9E).
The combination of Lashinski and Wang does not explicitly teach: a fourth dial coupled with the third inner catheter member, and a linking element comprising a sleeve.
However, Miles in a similar field of invention teaches a system for treating a left atrial appendage 10 (see Figs. 1-4D) with a first actuator 30 (see Fig. 2, [0136], 30 controls 16) coupled to the outer sheath 16 (see Fig. 3B), an inner catheter member 80 (see Fig. 3B), a second dial 26 coupled to the inner catheter member 80, and a second inner catheter member 82 (see Fig. 3B). Miles further teaches: a fourth dial 28 (see Fig. 1B, [0136], meets the definition of a dial per Oxford Languages online dictionary “a plate or disk on a radio, stove, mashing machine, or other piece of equipment that is tuned to select a wavelength or setting” in this case this a disk that can select a setting in this case, changing from a delivery configuration to implant the device)) coupled with the third inner catheter member 86 (see [0136], 24 controls movement of the anchor system 44, which is coupled to 86, see Fig. 3B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Miles and teach a system for treating a left atrial appendage with a fourth dial coupled with the third inner catheter member. Motivation for such can be found in Miles as this allows control of the device to deploy and or capture the medical device/implant (see [0134]) from outside of the body and allow for independent control of the various parts of the implant (see [0135]).
The language, " wherein the fourth dial is configured to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Miles meets the structural limitations of the claim, and is capable of using the fourth dial which is connected to the third inner catheter member (Lashinski modified with Miles) and to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction (see [0294] of Lashinski, the implant and 165 which is the distal end of 153 the third inner catheter member can be rotated/twisted, and can be used to withdraw the delivery device from the implant 142).
The combination of Lashinski, Wang, and Miles does not explicitly teach: and a linking element comprising a sleeve configured to selectively key the third dial with the fourth dial so that fourth dial cannot be independently rotated relative to the third dial when the linking element is engaged with the fourth dial and the third dial.
However, Hammer in a similar field of invention teaches a system 400 (see Figs. 9A-10D) for implanting an annuloplasty ring in the heart with a third dial 430 (see Figs. 9A-10D) and a fourth dial 432 (see Figs. 9A-10D). Hammer further teaches: and a linking element 462 + 410 (see Figs. 9A-10D, [0240], 410 is a sleeve that is a tubular element surrounds the knobs that includes element 462) comprising a sleeve 410 (see Figs. 9A-10D, [0240]) configured to selectively key the third dial 430 with the fourth dial 432 (see Fig. 9A, 430 and 432 engaged together) so that fourth dial 432 cannot be independently rotated (see [0244], rotation of 434 rotates both 430 and 432) relative to the third dial 430 when the linking element 462 + 410 is engaged with the fourth dial 432 and the third dial 430.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lashinski and Miles to incorporate the teachings of Hammer and teach a system for treating a left atrial appendage with a linking element comprising a sleeve configured to selectively key the third dial with the fourth dial so that fourth dial cannot be independently rotated relative to the third dial when the linking element is engaged with the fourth dial and the third dial. Motivation for such can be found in Hammer as this selectively allows the to rotate the knobs independently or with the same actuation by allowing coupling or decoupling of the dials (see [0244] and [0256]-[0257]) allowing for controlling two tubes at the same time or independently from one another.
Claim 10
The combination of Lashinski, Wang, Miles, and Hammer teaches: the system of claim 9, see 103 rejection above. Hammer further teaches: further comprising a removable locking element 464 (see Figs. 9A-10D, [0252]) configured to selectively prevent the linking element 462 + 410 from becoming disengaged from the third dial 430 and the fourth dial 432.
Lashinski in a variant embodiment (see [0453]) teaches a system (see [0453]) for treating a left atrial appendage with an implant (see [0453], implant) and a handle with controls for the implant (see [0453]) and a removable locking element (see [0453], suture material released by the user at a device handle). Lashinski further teaches: wherein the locking element comprises a suture (see [0453], suture material released by the user at a device handle).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the linking element of the combination of Lashinski and Hammer to incorporate the teachings of a variant embodiment of Lashinski (see [0453]) and teach a system for treating a left atrial appendage with the locking element comprises a suture. Motivation for such can be found in Lashinski as this allows a suture that can serve as a restraint both proximally and distally for the device, a distal continuation of the suture at the implant and a proximal one at the handle, and the suture can be removed as the last step of detaching the implant from the catheter (see [0453]).
Claim 102
The combination of Lashinski and Miles teaches: the system of claim 93, see 103 rejection above. Lashinski further discloses: comprising a second inner catheter member 157 (see Fig. 9I, [0295]), a locking portion 150 (see Fig. 9I, [0289]) of the implant 142, and a third inner catheter member 153 (see Fig. 9I, [0289])
Lashinski does not explicitly disclose: a third dial coupled with the second inner catheter member and a fourth dial coupled with the third inner catheter member, and a linking element comprising a sleeve.
However, Wang in a similar field of invention teaches a system for treating a left atrial appendage (see Fig. 1, [0002]) with a catheter 42 + 68 (see Fig. 1) with a second dial 67 (see Fig. 1, [0086]) coupled with an inner catheter member 684 (see Fig. 1, 3, 4-7, and 53-59) and a second inner catheter member 682 (see Fig. 1, [0086], 684 is around 682, hence 682 is within 684). Wang further teaches: a third dial 66 (see Fig. 1, [0086]) coupled with the second inner catheter member 682 (see Figs. 1, 3, and 4-7, [0086]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wang and teach a third dial coupled with the second inner catheter member. Motivation for such can be found in Wang as this allows for detachable connection to the implant (see [0087]).
The language, " wherein the third dial is configured to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Wang meets the structural limitations of the claim, and is capable of using the third dial which is connected to the second inner catheter member (Lashinski modified with Wang) and to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction (see [0295] of Lashinski, the implant and 157 the second inner catheter member can be rotated/twisted, and can be used to advance the locking portion 150 to the rotation portion 144, see Figs. 9D-9E).
The combination of Lashinski and Wang does not explicitly teach: a fourth dial coupled with the third inner catheter member, and a linking element comprising a sleeve.
However, Miles in a similar field of invention teaches a system for treating a left atrial appendage 10 (see Figs. 1-4D) with a first actuator 30 (see Fig. 2, [0136], 30 controls 16) coupled to the outer sheath 16 (see Fig. 3B), an inner catheter member 80 (see Fig. 3B), a second dial 26 coupled to the inner catheter member 80, and a second inner catheter member 82 (see Fig. 3B). Miles further teaches: a fourth dial 28 (see Fig. 1B, [0136], meets the definition of a dial per Oxford Languages online dictionary “a plate or disk on a radio, stove, mashing machine, or other piece of equipment that is tuned to select a wavelength or setting” in this case this a disk that can select a setting in this case, changing from a delivery configuration to implant the device)) coupled with the third inner catheter member 86 (see [0136], 24 controls movement of the anchor system 44, which is coupled to 86, see Fig. 3B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Miles and teach a system for treating a left atrial appendage with a fourth dial coupled with the third inner catheter member. Motivation for such can be found in Miles as this allows control of the device to deploy and or capture the medical device/implant (see [0134]) from outside of the body and allow for independent control of the various parts of the implant (see [0135]).
The language, " wherein the fourth dial is configured to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Miles meets the structural limitations of the claim, and is capable of using the fourth dial which is connected to the third inner catheter member (Lashinski modified with Miles) and to rotate the third inner catheter member and unthread the third inner catheter member from the implant to release the implant from the catheter at least when the fourth dial is rotated in a first direction (see [0294] of Lashinski, the implant and 165 which is the distal end of 153 the third inner catheter member can be rotated/twisted, and can be used to withdraw the delivery device from the implant 142).
The combination of Lashinski, Wang, and Miles does not explicitly teach: and a linking element comprising a sleeve configured to selectively key the third dial with the fourth dial so that fourth dial cannot be independently rotated relative to the third dial when the linking element is engaged with the fourth dial and the third dial.
However, Hammer in a similar field of invention teaches a system 400 (see Figs. 9A-10D) for implanting an annuloplasty ring in the heart with a third dial 430 (see Figs. 9A-10D) and a fourth dial 432 (see Figs. 9A-10D). Hammer further teaches: and a linking element 462 + 410 (see Figs. 9A-10D, [0240], 410 is a sleeve that is a tubular element surrounds the knobs that includes element 462) comprising a sleeve 410 (see Figs. 9A-10D, [0240]) configured to selectively key the third dial 430 with the fourth dial 432 (see Fig. 9A, 430 and 432 engaged together) so that fourth dial 432 cannot be independently rotated (see [0244], rotation of 434 rotates both 430 and 432) relative to the third dial 430 when the linking element 462 + 410 is engaged with the fourth dial 432 and the third dial 430.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Lashinski and Miles to incorporate the teachings of Hammer and teach a system for treating a left atrial appendage with a linking element comprising a sleeve configured to selectively key the third dial with the fourth dial so that fourth dial cannot be independently rotated relative to the third dial when the linking element is engaged with the fourth dial and the third dial. Motivation for such can be found in Hammer as this selectively allows the to rotate the knobs independently or with the same actuation by allowing coupling or decoupling of the dials (see [0244] and [0256]-[0257]) allowing for controlling two tubes at the same time or independently from one another.
Claim 103
The combination of Lashinski, Wang, Miles, and Hammer teaches: the system of claim 102, see 103 rejection above. Hammer further teaches: further comprising a removable locking element 464 (see Figs. 9A-10D, [0252]) configured to selectively prevent the linking element 462 + 410 from becoming disengaged from the third dial 430 and the fourth dial 432.
Lashinski in a variant embodiment (see [0453]) teaches a system (see [0453]) for treating a left atrial appendage with an implant (see [0453], implant) and a handle with controls for the implant (see [0453]) and a removable locking element (see [0453], suture material released by the user at a device handle). Lashinski further teaches: wherein the locking element comprises a suture (see [0453], suture material released by the user at a device handle).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the linking element of the combination of Lashinski and Hammer to incorporate the teachings of a variant embodiment of Lashinski (see [0453]) and teach a system for treating a left atrial appendage with the locking element comprises a suture. Motivation for such can be found in Lashinski as this allows a suture that can serve as a restraint both proximally and distally for the device, a distal continuation of the suture at the implant and a proximal one at the handle, and the suture can be removed as the last step of detaching the implant from the catheter (see [0453]).
Claim(s) 11-12 and 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wang as applied to claim 1 and claim 93 above, and further in view of Nishio (US 20190209205 A1), herein referenced to as “Nishio”.
Claim 11
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. The combination of Lashinski and Wang does not explicitly teach: wherein the other sheath comprises an inner layer and an outer layer positioned over the inner layer along at least a portion of a length of the inner layer such that a distal end portion of the inner layer having a plurality of openings therein is not covered by the outer layer.
However, Nishio in a similar field of invention teaches a medical system 10 (see Fig. 2) with a catheter 10 (see Fig. 2) with an outer sheath 70 (see Fig. 2) and an inner catheter 60 (see Fig. 2). Nishio further teaches: wherein the other sheath 70 (see 112b rejection above, interpreted as “outer sheath) comprises an inner layer inner layer including 70 and not 80 (see Fig. 2) and an outer layer 80 (see Fig. 2, [0036]) positioned over the inner layer inner layer including 70 and not 80 along at least a portion of a length the length of 70 that includes 80 (see Fig. 2) of the inner layer inner layer including 70 and not 80 such that a distal end portion distal end portion of 70 (see Fig. 2) of the inner layer inner layer including 70 and not 80 having a plurality of openings 75 (see Fig. 2, [0037]) therein is not covered by the outer layer 80 (see Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Lashinski to incorporate the teachings of Nishio and teach a system for treating a left atrial appendage with the outer sheath comprises an inner layer and an outer layer positioned over the inner layer along at least a portion of a length of the inner layer such that a distal end portion of the inner layer having a plurality of openings therein is not covered by the outer layer. Motivation for such can be found in Nishio as these plurality of openings can facilitate the bending of the outer sheath (see [0046]).
Claim 12
The combination of Lashinski, Wang, and Nishio teaches: the system of claim 11, see 103 rejection above. Nishio further teaches: wherein the plurality of openings 75 comprise a plurality of angled slits 75 (see Fig. 2, [0046], the slits are angled in a pattern) formed in the inner layer portion of 70 that does not include 80 of the outer sheath 70, wherein the plurality of angled slits 75 are configured to increase a flexibility (see [0046], the bendable direction is determined by shape of the pattern of 75) of the outer sheath 70 and to permit a passage of a contrast media through the angled slits.
The language, " to permit a passage of a contrast media through the angled slits," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Lashinski and Nishio meets the structural limitations of the claim, and is capable of the slits permitting a passage of a contrast media through the angled slits as the slits can reduce suction force, hence fluid can enter and exit out the slits (see [0050]).
Claim 104
The combination of Lashinski and Wang teaches: the system of claim 93, see 103 rejection above. The combination of Lashinski and Wang does not explicitly teach: wherein the other sheath comprises an inner layer and an outer layer positioned over the inner layer along at least a portion of a length of the inner layer such that a distal end portion of the inner layer having a plurality of openings therein is not covered by the outer layer.
However, Nishio in a similar field of invention teaches a medical system 10 (see Fig. 2) with a catheter 10 (see Fig. 2) with an outer sheath 70 (see Fig. 2) and an inner catheter 60 (see Fig. 2). Nishio further teaches: wherein the other sheath 70 (see 112b rejection above, interpreted as “outer sheath) comprises an inner layer inner layer including 70 and not 80 (see Fig. 2) and an outer layer 80 (see Fig. 2, [0036]) positioned over the inner layer inner layer including 70 and not 80 along at least a portion of a length the length of 70 that includes 80 (see Fig. 2) of the inner layer inner layer including 70 and not 80 such that a distal end portion distal end portion of 70 (see Fig. 2) of the inner layer inner layer including 70 and not 80 having a plurality of openings 75 (see Fig. 2, [0037]) therein is not covered by the outer layer 80 (see Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Lashinski to incorporate the teachings of Nishio and teach a system for treating a left atrial appendage with the outer sheath comprises an inner layer and an outer layer positioned over the inner layer along at least a portion of a length of the inner layer such that a distal end portion of the inner layer having a plurality of openings therein is not covered by the outer layer. Motivation for such can be found in Nishio as these plurality of openings can facilitate the bending of the outer sheath (see [0046]).
Claim 105
The combination of Lashinski, Wang, and Nishio teaches: the system of claim 11, see 103 rejection above. Nishio further teaches: wherein the plurality of openings 75 comprise a plurality of slits 75 (see Fig. 2, [0046], the slits are angled in a pattern) formed in the inner layer portion of 70 that does not include 80 of the outer sheath 70, wherein the plurality of slits 75 are configured to increase a flexibility (see [0046], the bendable direction is determined by shape of the pattern of 75) of the outer sheath 70 and to permit a passage of a contrast media through the angled slits.
The language, " to permit a passage of a contrast media through the angled slits," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Lashinski and Nishio meets the structural limitations of the claim, and is capable of the slits permitting a passage of a contrast media through the angled slits as the slits can reduce suction force, hence fluid can enter and exit out the slits (see [0050]).
Claim(s) 91 and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wang as applied to claim 1 and 93 above, and further in view of Wong et al (US 20200345483 A1), herein referenced to as “Wong”.
Claim 91
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. The combination of Lashinski and Wang does not explicitly teach: further comprising a steering device having a knob or dial configured to steer a steerable sheath.
However, Wong in a similar field of invention teaches a system of treating the heart (see Figs. 1-8) with an outer sheath 672 (see Fig. 81). Wong further teaches: further comprising a steering device 680 (see Figs. 6A-6D, [0054]) having a knob knob of 684 (see Figs. 6A-6D, [0054]) or dial knob/dial of 684 (see Figs. 6A-6D, [0054]) configured to steer a steerable sheath second elongated catheter shaft may be steered (see Figs. 1-8, [0054]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski and Wang to incorporate the teachings of Wong and teach a system for treating a left atrial appendage with a steering device having a knob or dial configured to steer a steerable sheath. Motivation for such can be found in Wong as this allows navigating the implant within the left atrium toward a desired direction to the desired location within the body (see [0054]-[0055]).
Claim 94
The combination of Lashinski and Wang teaches: the system of claim 1, see 103 rejection above. The combination of Lashinski and Wang does not explicitly teach: further comprising a support stand for supporting the catheter and at least a guide catheter.
However, Wong in a similar field of invention teaches a system of treating the heart (see Figs. 1-8) with an outer sheath 672 (see Fig. 81). Wong further teaches: and a support stand 600 (see Figs. 6A-6C, [0045]) for supporting the catheter 672 and at least a guide catheter third elongated catheter shaft (see Figs. 6A-6D, [053]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wong and teach a system for treating an anatomical structure with a support stand for supporting the catheter and at least a guide catheter. Motivation for such can be found in Wong as this can serve as a stable base to maintain the relative positions of the components of the system a procedure (see [0047]).
Claim(s) 13-14, 89, and 92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wong and von Oepen et al (US 20210244916 A1), herein referenced to as “von Oepen”.
Claim 13
Lashinski discloses: A system 140 (see Fig. 9I, [0288]) for treating a left atrial appendage (see [0288], occluding an LAA), comprising: an implant 142 (see Fig. 9I configured to be at least partially positioned within the left atrial appendage (see [0288], LAA); a catheter 152 (see Fig. 9I, [0289]) configured to deploy (see [0289]) the implant 142, the catheter 152 comprising: an outer sheath 152 (see Fig. 9I, [0289]); an inner catheter member 155 (see Fig. 9I, [0293], can rotate 148 which is part of the implant 142) configured to rotate the implant 142 when a distal end portion 165 (see Fig. 9I, [0294]) of the inner catheter member 155 is engaged with the implant 143.
Lashinski does not explicitly disclose: and a support stand for supporting the catheter and at least a guide catheter, wherein the support stand includes a slide; wherein: the catheter is configured to axially slide against the slide; the support stand is configured to be positioned on a support surface, such as a bed or table, or on a patient.
However, Wong in a similar field of invention teaches a system of treating the heart (see Figs. 1-8) with an outer sheath 672 (see Fig. 81). Wong further teaches: and a support stand 600 (see Figs. 6A-6C, [0045]) for supporting the catheter 672 and at least a guide catheter third elongated catheter shaft (see Figs. 6A-6D, [053]); wherein: the support stand 600 is configured to be positioned on a support surface (see [0047], procedure table, surgical tool table), such as a bed or table, or on a patient (will not be examined due to being an optional claim limitation).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wong and teach a system for treating a left atrial appendage with a support stand for supporting the catheter and at least a guide catheter; wherein: the support stand is configured to be positioned on a support surface, such as a bed or table, or on a patient. Motivation for such can be found in Wong as this can serve as a stable base to maintain the relative positions of the components of the system a procedure (see [0047]).
The combination of Lashinski and Wong does not explicitly teach: wherein the support stand includes a slide; the catheter is configured to axially slide against the slide such that the catheter thereby contacts the slide.
However, von Oepen in a similar field of invention teaches a system for treating the heart (see Figs. 4A-6B) with a catheter 82 (see Figs. 4A-6B) and a support stand 160 (see Figs. 4A-6B). von Oepen further teaches: wherein the support stand 160 includes a slide 170 (see Figs. 4A-6B, [0053]); the catheter 82 is configured to axially slide (see Figs. 4A-4B, 82 can slide independently axially against 170) against the slide 170 such that the catheter 82 thereby contacts the slide 170 (82 contacts the slide 170 indirectly, hence the catheter contacts the slide, 82 contacts 132 which contacts 170, thus 82 contacts 170).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski and Wong to incorporate the teachings of von Oepen and teach a system for treating a left atrial appendage with the support stand includes a slide; the catheter is configured to axially slide against the slide such that the catheter thereby contacts the slide. Motivation for such can be found in von Oepen as this allows for larger quicker adjustments and finer more controlled adjustments of an outer sheath (see [0051]).
Claim 14
The combination of Lashinski, Wong, and von Oepen teaches: the system of claim 13, see 103 rejection above. Wong further teaches: wherein the catheter 672 has a locking element 616 and one or more flanges of the delivery system handle (see Fig. 6C, [0050], fastener, flanges) configured to selectively secure the catheter 672 in a desired position along the slot the slot of 614 when the locking element 616 is engaged (see [0050], 616 holds 674 and therefore 672 in place in relation to the slot of 614).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wong and teach a system for treating a left atrial appendage with the support stand for supporting the catheter comprises a slot therein that is configured to receive a projection of the catheter, and wherein the catheter has a locking element configured to selectively secure the catheter in a desired position along the slot when the locking element is engaged. Motivation for such can be found in Wong as this prevents linear or rotational translation of the handle with respect to the support stand (see [0050]).
Von Oepen further teaches: wherein the slide 170 includes a slot the slot of 170 that supports the projection of 132 that is configured to receive a projection 132 (see Figs. 4A-6B, [0035], 132 projects distally from 82, hence is a projection of 82) of the catheter 82.
Claim 89
The combination of Lashinski, Wong, and von Oepen teaches: the system of claim 13, see 103 rejection above.
Lashinski (Fig. 9I) does not explicitly disclose: the outer sheath coupled with a first connector; a first dial coupled with the outer sheath; a second dial coupled with the inner catheter member; wherein: the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction.
However, a variant embodiment (see Figs. 150A-150C and 151B) of Lashinski teaches a system for treating a left atrial appendage (see Figs. 150A-150C and 151B) with an implant 2520 (see Figs. 150A-150C and 151B, [0455]) and an outer sheath the sheath (see annotated Fig. 151B below, [0457]). Lashinski (Figs. 150A-150C and 151B) further teaches: the outer sheath the sheath coupled with a first connector (see annotated Fig. 151B below, [0457]); a first dial actuator nut (see annotated Fig. 151B below, [0457], the nut is a dial as it turns like a dial to actuate) coupled with the outer sheath the sheath, wherein: the first dial actuator nut is configured to axially move the first connector (see annotated Fig. 151B below, [0457], the connector which is coupled to the outer sheath will be pulled back over a handle screw gear (screw)) and the outer sheath the sheath in a first axial direction (see [0457], withdrawal) from an initial axial position to a second axial position (see [0457], withdrawal from a first position to further back to a second position) when the first dial actuator nut is rotated in a first direction (see [0457], rotation of the actuator nut).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of variant embodiment (Figs. 150A-150C and 151B) and teach a system for treating a left atrial appendage with the outer sheath coupled with a first connector; a first dial coupled with the outer sheath; wherein: the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction. Motivation for such can be found in Lashinski as this allows for accurate positioning of the implant via controlled withdrawal of the sheath (see [0457]).
Claim 92
The combination of Lashinski, Wong, and von Oepen teaches: the system of claim 13, see 103 rejection above. Wong further teaches: further comprising a steering device 680 (see Figs. 6A-6D, [0054]) having a knob knob of 684 (see Figs. 6A-6D, [0054]) or dial knob/dial of 684 (see Figs. 6A-6D, [0054]) configured to steer a steerable sheath second elongated catheter shaft may be steered (see Figs. 1-8, [0054]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Wong and teach a system for treating a left atrial appendage with a steering device having a knob or dial configured to steer a steerable sheath. Motivation for such can be found in Wong as this allows navigating the implant within the left atrium toward a desired direction to the desired location within the body (see [0054]-[0055]).
Claim(s) 90 and 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski in view of Wong and von Oepen as applied to claim 13 above, and further in view of Miles.
Claim 90
The combination of Lashinski, Wong, and von Oepen teaches: the system of claim 13, see 103 rejection above.
The combination of Lashinski, Wong, and von Oepen does not explicitly teach: wherein the catheter further comprises a second dial coupled with the inner catheter member; wherein: the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction.
However, Miles in a similar field of invention teaches a system for treating a left atrial appendage 10 (see Figs. 1-4D) with a first actuator 30 (see Fig. 2, [0136], 30 controls 16) coupled to the outer sheath 16 (see Fig. 3B) and an inner catheter member 80 (see Fig. 3B). Miles further teaches: a second dial 26 (see Fig. 2, [0136], meets the definition of a dial per Oxford Languages online dictionary “a plate or disk on a radio, stove, mashing machine, or other piece of equipment that is tuned to select a wavelength or setting” in this case this a disk that can select a setting in this case, changing from a delivery configuration to implant the device) coupled with the inner catheter member 80 (see [0136], 26 controls movement of the anchor system 44, which is coupled to 80, see Fig. 3B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Miles and teach a system for treating a left atrial appendage with a second dial coupled with the inner catheter member. Motivation for such can be found in Miles as this allows control of the device to deploy and or capture the medical device/implant (see [0134]) from outside of the body and allow for independent control of the various parts of the implant (see [0135]).
The language, "the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Miles meets the structural limitations of the claim, and is capable of using the second dial which is connected to the inner catheter member (Lashinski modified with Miles) and to rotate the inner catheter member and the implant in a first rotation direction from an initial position to a second rotational position when the second dial is rotated in a first direction (see [0293] and [0297] of Lashinski, the implant and 155 the inner catheter member can be rotated/twisted).
Claim 106
The combination of Lashinski, Wong, and von Oepen teaches: the system of claim 13, see 103 rejection above. Lashinski further discloses: comprising a second inner catheter member 157 (see Fig. 9I, [0295]) and a locking portion 150 (see Fig. 9I, [0289]) of the implant 142.
Lashinski does not explicitly disclose: a third dial coupled with the second inner catheter member.
However, Miles in a similar field of invention teaches a system for treating a left atrial appendage 10 (see Figs. 1-4D) with a first actuator 30 (see Fig. 2, [0136], 30 controls 16) coupled to the outer sheath 16 (see Fig. 3B), an inner catheter member 80 (see Fig. 3B), a second dial 26 coupled to the inner catheter member 80, and a second inner catheter member 82 (see Fig. 3B). Miles further teaches: a third dial 22 (see Fig. 1B, [0136], meets the definition of a dial per Oxford Languages online dictionary “a plate or disk on a radio, stove, mashing machine, or other piece of equipment that is tuned to select a wavelength or setting” in this case this a disk that can select a setting in this case, changing from a delivery configuration to implant the device)) coupled with the second inner catheter member 82 (see [0136], 24 controls movement of the occluder system 42, which is coupled to 82, see Fig. 3B).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to incorporate the teachings of Miles and teach a system for treating a left atrial appendage with a third dial coupled with the second inner catheter member. Motivation for such can be found in Miles as this allows control of the device to deploy and or capture the medical device/implant (see [0134]) from outside of the body and allow for independent control of the various parts of the implant (see [0135]).
The language, " wherein the third dial is configured to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Lashinski and Miles meets the structural limitations of the claim, and is capable of using the third dial which is connected to the second inner catheter member (Lashinski modified with Miles) and to rotate the second inner catheter member and to move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction (see [0295] of Lashinski, the implant and 157 the second inner catheter member can be rotated/twisted, and can be used to advance the locking portion 150 to the rotation portion 144, see Figs. 9D-9E).
Conclusion
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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