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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/09/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 01/09/2026. As directed by the amendment: claims 1, 13, and 19 have been amended, claims 3-6, 8-10, 14, 16-18, and 20 have been cancelled and claims 21-32 have been added. Thus, claims 1-2, 7, 11-13, 15, 19, and 21-32 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 8, filed 01/09/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see pages 8-12, filed 01/09/2026, with respect to the rejection(s) of claim(s) 1, 13, and 19 under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 20210236102 A1), herein referenced to as “Perszyk” in view of van der Burg et al (US 20050177182 A1), herein referenced to as “van der Burg” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite:
“the adjustable support comprising a member having a first end secured to the distal frame end and a second end, and a reversible suture lock comprising: a suture lock body defining a body lumen extending therethrough; a first element slidingly disposed within the body lumen, the first element including a first element lumen through which the member is free to extend a second element slidingly disposed within the body lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend: an engagement element adapted to releasably engage the first element, the engagement element including an engagement element lumen through which the member is free to extend: wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body”.
The examiner agrees that the amendments overcome the rejection of Perszyk and van der Burg.
However, the examiner does not agree with applicant’s assertions that the claim limitations that were cited to be taught by van der Burg do not teach the claim limitations.
The applicant argues that van der Burg does not teach a first element slidingly disposed within the body lumen, a second element slidingly disposed within the body lumen, an engagement element with engagement lumen, where all three elements work together to constrain the member between second element and the side wall of body lumen.
The applicant further argues that Van der Burg’s structure cannot meet this requirement because the core 312 extends throughout the entire catheter body, hence it is no discrete “body”.
The examiner respectfully disagrees.
Firstly, specifically “where all three elements work together to constrain the member between second element and the side wall of body lumen” is not claimed language in claim 1, hence is not considered as part of the prior art reading upon the claims.
Secondly, the claim does not require the second element slidingly disposed within the body lumen and engaged with the first element to be only a part of the implant. As the core 312 of van der Burg is still part of the implant as it mechanically interacts and couples with the implant in its implantation process.
The applicant argues that van der Burg teaches the opposite of the claimed structure “which requires that the member is constrained between the second element and a side wall of the body lumen, and constrained against movement relative to the suture lock body”. However, the examiner will point out, this language does not appear in the claims.
The applicant additionally argues that van der Burg teaches away from “to undergo a tug test during implantation” by citing that van der Burg teaches in [0182] “By decoupling the implant 304 from the axially moveable core 312 and other components coupled to the axially moveable core 312, the risk of accidently dislodging the implant form the left atrial appendage during testing is reduced.” This the examiner agrees is true, however, “decoupling” in this instance does not mean releasing the implant from the catheter, as explicitly stated in van der Burg in [0181], hence testing occurring during implantation. Again, while the axially moveable core may be decoupled, the implant is still not released from the implant allowing for testing to see how well the implant is held within the LAA 502 (see [0244]).
The applicant further argues against the combination of Rafiee and van der Burg, arguing that the first and second element of van der Burg cannot be combined with the suture lock body of Rafiee as the elements do not appear to be capable of being placed within Rafiee’s housing. They specifically argue that 320 of van der Burg is a part of the implant and extends proximally within the implant but the core 312 extends through the entire catheter body with specific functions that cannot be placed within Rafiee’s locking device housing.
The examiner respectfully disagrees. Rafiee has an element similar to van der Burg’s core 312, in the pusher pin (see Figs. 4 and 7 of Rafiee, see [0011], push rod/tube, which extends into the implant and to the delivery handle) the same as the core 312 of van der Burg, hence it would be possible for the core 312 to be placed within Rafiee’s locking device housing.
Furthermore, In response to applicant's argument that “the first and second element of van der Burg cannot be combined with the suture lock body of Rafiee as the elements do not appear to be capable of being placed within Rafiee’s housing”, 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).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case:
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 Perszyk to incorporate the teachings of van der Burg and teach an implantable medical device adapted to undergo a tug test during implantation. Motivation for such can be found in van der Burg as this confirms how well the implant is held within the LAA (see [0244]).
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 Perszyk to incorporate the teachings of Rafiee and have an implantable medical device wherein the adjustable support further comprises a reversible suture lock comprising: a suture lock body defining a lumen extending therethrough and an engagement element, the engagement element including an engagement element lumen through which the member is free to extend. Motivation for such can be found in Rafiee as this allows the proximal and distal portions of the implantable medical device to be adjustably connected, hence the distance between the two can be controlled, with a lock (see [0011]), the locking being adjustable to ensure proper positioning of the device (see [0018]).
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and have a reversible suture lock with a first element, the first element including a first element lumen through which the member is free to extend; a second element engaged with the first element, the second element including a second element lumen through which the member is free to extend; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body. Motivation for such can be found in van der Burg as this provides a quick-disconnect functionality for the implant by having axially slidable/movable elements (see [0194]).
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Perszyk in view of van der Burg and Rafiee.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the engagement element comprises a button operable to move the first element and the second element between the first position and the second position” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22, 26, and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed language “wherein the engagement element comprises a button operable to move the first element and the second element between the first position and the second position” does not have adequate support within the specification. Specifically, there is no mention of “a button operable to move the first element and the second element between the first position and the second position” within specification or the figures of the application.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-2, 7, 11-13, 15, 19, 21-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 20210236102 A1), herein referenced to as “Perszyk” in view of van der Burg et al (US 20050177182 A1), herein referenced to as “van der Burg” and Rafiee et al (US 20200383668 A1), herein referenced to as “Rafiee”.
Claim 1
Perszyk discloses: An implantable medical device (see Figs. 5A-5B, [0046]), comprising: an expandable frame 102 + 104 (see Figs. 5A-5B, [0046]) defining a body the body of the implant (see Figs. 5A-5B) of the implantable medical device (see Figs. 5A-5B), the expandable frame 102 + 104 moveable between a collapsed configuration (see [0007], reduced configuration for delivery, see also Fig. 5B) for delivery (see [0007]) and an expanded configuration (see [0007], expanded configuration) for deployment, the expandable frame 102 + 104 including a distal frame end 501 (see Fig. 5A, [0046]) and a proximal frame end 503 (see Fig. 5A, [0046]), the expandable frame 102 + 1-4 axially extendable beyond the expanded configuration in response to an applied axial force; and an adjustable support 505 (see Figs. 5A-5B, [0046]) extending between the distal frame end 501 and the proximal frame end 503, the adjustable support 505 adapted to limit how far the expandable frame 102 + 104 is able to extend axially (see [0046], 505 locks the position of 102 and 104, which would limit how far 102 + 104 is able to extend axially beyond its expanded configuration) beyond its expanded configuration, the adjustable support 505 comprising a member (see [0046], suture) having a first end first end of 505 secured to 501 (see Fig. 5A, [0046], 505 is looped through 501) secured to the distal frame end 501 and a second end second end of 505 (see [0046], the suture 505 is adjustable, hence releasably securable, until it has been tied off, in the locked state it is looped around 503 as well).
The language, "axially extendable beyond the expanded configuration in response to an applied axial force," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Perszyk meets the structural limitations of the claim, and is capable of being axially extendable beyond an expanded configured in response to an applied axial force, as the device is formed of nitinol and comprises two portions 102 + 104 that can be locked at a certain distance from one another, and pulling the distal portion of the device would elongate the overall device.
Perszyk does not explicitly disclose: the implantable medical device adapted to undergo a tug test during implantation; and a reversible suture lock comprising: a suture lock body defining a body lumen extending therethrough; a first element slidingly disposed within the body lumen, the first element including a first element lumen through which the member is free to extend a second element slidingly disposed within the body lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend: an engagement element adapted to releasably engage the first element, the engagement element including an engagement element lumen through which the member is free to extend: wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body; wherein the adjustable support is configured to resist movement in response to the implantable medical device undergoing the tug test during implantation.
However, However, van der Burg in a similar field of invention teaches an implantable medical device 304 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21) and an adjustable support 312 + 320 (see Fig. 21). Van der Burg further teaches: the implantable medical device 304 adapted to undergo a tug test testing the seal, stability testing (see [0181]-[0182] and [0243]-[0246], in [0244], deployment handle is alternatively retracted and advance, which is a tugging motion) during implantation (see [0181]-[0182] and [0243]-[0246]).
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 Perszyk to incorporate the teachings of van der Burg and teach an implantable medical device adapted to undergo a tug test during implantation. Motivation for such can be found in van der Burg as this confirms how well the implant is held within the LAA (see [0244]).
However, Rafiee in a similar field of invention teaches an implantable medical device (see Figs. 4 and 12) with an adjustable support limiting tether/hollow suture (see Figs. 4 and 12) and a member length limiting tether/hollow suture (see Figs. 4 and 12), and a pin locking device housing (see Fig. 4). Rafiee further teaches: wherein the adjustable support limiting tether/hollow suture (see Fig. 4) further comprises a reversible suture lock locking device/locking pin (see Fig. 4, [0052], [0013], and [0018], the lock can be released) comprising: a suture lock body locking device housing (see Fig. 4, [0052]) defining a lumen the lumen of the locking device housing (see Fig. 4) extending therethrough and an engagement element locking pin (see Fig. 4, [0052]), the engagement element locking pin including an engagement element lumen the lumen of the locking pin which the hollow suture extends through (see Fig. 4, [0052]) through which the member the hollow suture is free to extend.
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 Perszyk to incorporate the teachings of Rafiee and have an implantable medical device wherein the adjustable support further comprises a reversible suture lock comprising: a suture lock body defining a lumen extending therethrough and an engagement element, the engagement element including an engagement element lumen through which the member is free to extend. Motivation for such can be found in Rafiee as this allows the proximal and distal portions of the implantable medical device to be adjustably connected, hence the distance between the two can be controlled, with a lock (see [0011]), the locking being adjustable to ensure proper positioning of the device (see [0018]).
The combination of Perszyk and Rafiee does not explicitly teach: a first element slidingly disposed within the lumen, the first element including a first element lumen through which the member is free to extend; a second element slidingly disposed within the lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend; the engagement element is adapted to releasably engage the first element; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body.
However, van der Burg in a similar field of invention teaches an implantable medical device 300 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21), a suture lock 400 (see Fig. 28), and a member 442 (see Fig. 28). van der Burg further teaches: a first element 320 (see Fig. 28, [0194]), the first element 320 including a first element lumen the lumen of 320 through which the member 442 is free to extend (see Fig. 28, 442 goes through the lumen of 320); a second element 312 (see Fig. 28, [0194]) engaged with the first element 320 (see Fig. 28, [0194], 312 is engaged to 320), the second element 312 including a second element lumen the lumen of 312 (see Fig. 28) through which the member 442 is free to extend (see Fig. 28); wherein the first element 320 and the second element 312 are moveable (see [0194], axially moveable) between a first position (see Fig. 28) in which the member 442 is free to move relative to the suture lock body (see Fig. 28, 442 can leave through slot 440) and a second position (see Fig. 28, when 312 is pulled away from 440, 442 can no longer leave through 440, see [0195]) in which the member is constrained against movement relative to the suture lock body (see [0195]).
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and have a reversible suture lock with a first element, the first element including a first element lumen through which the member is free to extend; a second element engaged with the first element, the second element including a second element lumen through which the member is free to extend; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body. Motivation for such can be found in van der Burg as this provides a quick-disconnect functionality for the implant by having axially slidable/movable elements (see [0194]).
The combination of Perszyk, Rafiee, and van der Burg further teaches: the first element slidingly disposed within the lumen and the second element slidingly disposed within the lumen (as modified the first and second element of van der Burg, is within the lumen of the suture lock body of Rafiee, which as shown in Fig. 4 of Rafiee a pusher pin can also fit through, besides the suture) and the engagement element (as modified, the locking pin of Rafiee is able to engage other elements, due to having resilient arms that can releasably engagement the first element) is adapted to releasably engage the first element.
The language, " wherein the adjustable support is configured to resist movement in response to the implantable medical device undergoing the tug test during implantation," 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 Perszyk and van der Burg meets the structural limitations of the claim, and is capable of the adjustable support resisting movement in response to the implantable medical device undergoing the tug test during implantation, as when the adjustable support is axially locked it would resist further deformation when the device is pulled (see [0046] of Perszyk).
Claim 2
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Perszyk further discloses: wherein the adjustable support 505 comprises a first end first end of 505 secured to 501 (see Fig. 5A, [0046], 505 is looped through 501) secured to the distal frame end 501 and a second end second end of 505 (see [0046], the suture 505 is adjustable, hence releasably securable, until it has been tied off, in the locked state it is looped around 503 as well) releasably securable to the proximal frame end 503.
Claim 7
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 4, see 103 rejection above. Perszyk further discloses: wherein the member 505 comprises a suture (see [0046], 505 is a suture) that is wrapped over the distal frame end 501 (see Fig. 5A, [0046], 505 is wrapped over 501) and has a first free end and a second free end (see Fig. 5B, the free ends of 505, in the catheter, extending beyond 503, additionally the loop is closed by creating a slip knot which requires two free ends to form) that each extend proximally beyond the proximal frame end 503.
Claim 11
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Perszyk further discloses: comprising an LAAC (left atrial appendage closure) device (see [0025], the target location of the occlusion device includes the LAA) .
Claim 12
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Perszyk further discloses: wherein the expandable frame 102 + 104 is biased to the expanded configuration (see [0051], preset expanded configuration, see also [0046], nitinol shape formation).
Claim 13
Perszyk discloses: An implantable medical device (see Figs. 5A-5B, [0046]), comprising: an expandable frame 102 + 104 (see Figs. 5A-5B, [0046]) defining a body the body of the implant (see Figs. 5A-5B) of the implantable medical device (see Figs. 5A-5B), the expandable frame 102 + 104 moveable between a collapsed configuration (see [0007], reduced configuration for delivery, see also Fig. 5B) for delivery (see [0007]), an expanded configuration for deployment (see [0007], expanded configuration), and a distended configuration; the expandable frame 102 + 104 including a distal frame end 501 (see Fig. 5A, [0046]) and a proximal frame end 503 (see Fig. 5A, [0046]), a distance the distance between 501 + 503 (see Fig. 5A) between the distal frame end 501 and the proximal frame end 503 while within the expanded configuration (see Fig. 5A) defining an expanded configuration end distance the distance between 501 + 503 in Fig. 5A, a distance the distance between 501 + 503 between the distal frame end 501 and the proximal frame end 503 while in the distended configuration defining a distended configuration end distance; and a support member 505 (see Figs. 5A-5B, [0046]) extending between the distal frame end 501 and the proximal frame end 503, the support member 505 including a first end the first end of 505 secured to 501 (see Fig. 5A, [0046], 505 is looped through 501) secured to the distal frame end 501 and a second end second end of 505 (see [0046], the suture 505 is adjustable, hence releasably securable, until it has been tied off, in the locked state it is looped around 503 as well) releasably securable relative to the proximal frame end 503, the support member adapted to limit the distended configuration end distance relative to the expanded configuration end distance.
The language, " the implantable medical device moveable to a distended configuration, the distance while in the distended configuration defining a distended configuration apex distance, the adjustable support adapted to limit the distended configuration apex distance relative to the expanded configuration apex distance," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Perszyk meets the structural limitations of the claim, and is capable of being axially extendable beyond an expanded configured in response to an applied axial force to a distended configuration, as the device is formed of nitinol and comprises two portions 102 + 104 that can be locked at a certain distance from one another, and pulling the distal portion of the device would elongate the overall device. And in using 503 to lock the device, limits the distended configuration apex distance compared to the preset expanded configuration of the device.
Perszyk does not explicitly disclose: via a reversible suture lock, the reversible suture lock comprising: a suture lock body defining a body lumen extending therethrough; a first element slidingly disposed within the body lumen, the first element including a first element lumen through which the member is free to extend a second element slidingly disposed within the body lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend: an engagement element adapted to releasably engage the first element, the engagement element including an engagement element lumen through which the member is free to extend: wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body; wherein the support member is configured to resist distension of the expandable frame when the implantable medical device undergoes a tug test during an implantation process.
However, However, van der Burg in a similar field of invention teaches an implantable medical device 304 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21) and an adjustable support 312 + 320 (see Fig. 21). Van der Burg further teaches: the implantable medical device 304 adapted to undergo a tug test testing the seal, stability testing (see [0181]-[0182] and [0243]-[0246], in [0244], deployment handle is alternatively retracted and advance, which is a tugging motion) during implantation (see [0181]-[0182] and [0243]-[0246]).
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 Perszyk to incorporate the teachings of van der Burg and teach an implantable medical device adapted to undergo a tug test during implantation. Motivation for such can be found in van der Burg as this confirms how well the implant is held within the LAA (see [0244]).
However, Rafiee in a similar field of invention teaches an implantable medical device (see Figs. 4 and 12) with an adjustable support limiting tether/hollow suture (see Figs. 4 and 12) and a member length limiting tether/hollow suture (see Figs. 4 and 12), and a pin locking device housing (see Fig. 4). Rafiee further teaches: wherein the adjustable support limiting tether/hollow suture (see Fig. 4) further comprises a reversible suture lock locking device/locking pin (see Fig. 4, [0052], [0013], and [0018], the lock can be released) comprising: a suture lock body locking device housing (see Fig. 4, [0052]) defining a lumen the lumen of the locking device housing (see Fig. 4) extending therethrough and an engagement element locking pin (see Fig. 4, [0052]), the engagement element locking pin including an engagement element lumen the lumen of the locking pin which the hollow suture extends through (see Fig. 4, [0052]) through which the member the hollow suture is free to extend.
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 Perszyk to incorporate the teachings of Rafiee and have an implantable medical device wherein the adjustable support further comprises a reversible suture lock comprising: a suture lock body defining a lumen extending therethrough and an engagement element, the engagement element including an engagement element lumen through which the member is free to extend. Motivation for such can be found in Rafiee as this allows the proximal and distal portions of the implantable medical device to be adjustably connected, hence the distance between the two can be controlled, with a lock (see [0011]), the locking being adjustable to ensure proper positioning of the device (see [0018]).
The combination of Perszyk and Rafiee does not explicitly teach: a first element slidingly disposed within the lumen, the first element including a first element lumen through which the member is free to extend; a second element slidingly disposed within the lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend; the engagement element is adapted to releasably engage the first element; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body.
However, van der Burg in a similar field of invention teaches an implantable medical device 300 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21), a suture lock 400 (see Fig. 28), and a member 442 (see Fig. 28). van der Burg further teaches: a first element 320 (see Fig. 28, [0194]), the first element 320 including a first element lumen the lumen of 320 through which the member 442 is free to extend (see Fig. 28, 442 goes through the lumen of 320); a second element 312 (see Fig. 28, [0194]) engaged with the first element 320 (see Fig. 28, [0194], 312 is engaged to 320), the second element 312 including a second element lumen the lumen of 312 (see Fig. 28) through which the member 442 is free to extend (see Fig. 28); wherein the first element 320 and the second element 312 are moveable (see [0194], axially moveable) between a first position (see Fig. 28) in which the member 442 is free to move relative to the suture lock body (see Fig. 28, 442 can leave through slot 440) and a second position (see Fig. 28, when 312 is pulled away from 440, 442 can no longer leave through 440, see [0195]) in which the member is constrained against movement relative to the suture lock body (see [0195]).
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and have a reversible suture lock with a first element, the first element including a first element lumen through which the member is free to extend; a second element engaged with the first element, the second element including a second element lumen through which the member is free to extend; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body. Motivation for such can be found in van der Burg as this provides a quick-disconnect functionality for the implant by having axially slidable/movable elements (see [0194]).
The combination of Perszyk, Rafiee, and van der Burg further teaches: the first element slidingly disposed within the lumen and the second element slidingly disposed within the lumen (as modified the first and second element of van der Burg, is within the lumen of the suture lock body of Rafiee, which as shown in Fig. 4 of Rafiee a pusher pin can also fit through, besides the suture) and the engagement element (as modified, the locking pin of Rafiee is able to engage other elements, due to having resilient arms that can releasably engagement the first element) is adapted to releasably engage the first element.
The language, " wherein the support member is configured to resist distension of the expandable frame when the implantable medical device undergoes a tug test during an implantation process," 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 Perszyk and van der Burg meets the structural limitations of the claim, and is capable of resisting distension of the expandable frame when the implantable medical device undergoes a tug test during an implantation process, as when the adjustable support is axially locked it would resist further deformation when the device is pulled (see [0046] of Perszyk).
Claim 15
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 13, see 103 rejection above. Perszyk further discloses: wherein the support member comprises a suture (see [0046], 505 is a suture) that is wrapped over the distal frame end 501 (see Fig. 5A, [0046], 505 is wrapped over 501) and has a first free end and a second free end (see Fig. 5B, the free ends of 505, in the catheter, extending beyond 503, additionally the loop is closed by creating a slip knot which requires two free ends to form) that each extend proximally beyond the proximal frame end 503.
Claim 19
Perszyk discloses: An LAAC (left atrial appendage closure) device (see Figs. 5A-5B,[0025], the target location of the occlusion device includes the LAA, [0046]), comprising: an expandable frame 102 + 104 (see Figs. 5A-5B, [0046]) defining a body the body of the implant (see Figs. 5A-5B) of the implantable medical device (see Figs. 5A-5B), the expandable frame 102 + 104 moveable between a collapsed configuration (see [0007], reduced configuration for delivery, see also Fig. 5B) for delivery (see [0007]), an expanded configuration for deployment (see [0007], expanded configuration), and a distended configuration; the expandable frame 102 + 104 including a distal frame end 501 (see Fig. 5A, [0046], meets the interpretation of “a distal end”, see 112b rejection above) and a proximal frame end 503 (see Fig. 5A, [0046], meets the interpretation of “a proximal end”, see 112b rejection above), a distance the distance between 501 + 503 (see Fig. 5A) between the distal frame end 501 and the proximal frame end 503 while within the expanded configuration (see Fig. 5A) defining an expanded configuration end distance the distance between 501 + 503 in Fig. 5A, a distance the distance between 501 + 503 between the distal frame end 501 and the proximal frame end 503 while in the distended configuration defining a distended configuration end distance; and a support member 505 (see Figs. 5A-5B, [0046]) extending between the distal frame end 501 and the proximal frame end 503, the support member 505 including a first end the first end of 505 secured to 501 (see Fig. 5A, [0046], 505 is looped through 501) secured to the distal frame end 501 and a second end second end of 505 (see [0046], the suture 505 is adjustable, hence releasably securable, until it has been tied off, in the locked state it is looped around 503 as well) releasably securable relative to the proximal frame end 503, the adjustable support adapted to limit the distended configuration end distance relative to the expanded configuration end distance.
The language, " the implantable medical device moveable to a distended configuration, the distance while in the distended configuration defining a distended configuration apex distance, the adjustable support adapted to limit the distended configuration apex distance relative to the expanded configuration apex distance," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Perszyk meets the structural limitations of the claim, and is capable of being axially extendable beyond an expanded configured in response to an applied axial force to a distended configuration, as the device is formed of nitinol and comprises two portions 102 + 104 that can be locked at a certain distance from one another, and pulling the distal portion of the device would elongate the overall device. And in using 503 to lock the device, limits the distended configuration apex distance compared to the preset expanded configuration of the device.
Perszyk does not explicitly disclose: the adjustable supporting comprising a reversible suture lock, the reversible suture lock comprising: a suture lock body defining a body lumen extending therethrough; a first element slidingly disposed within the body lumen, the first element including a first element lumen through which the member is free to extend a second element slidingly disposed within the body lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend: an engagement element adapted to releasably engage the first element, the engagement element including an engagement element lumen through which the member is free to extend: wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body; the adjustable support adapted to resist movement in response to a tug test performed on the LAAC.
However, However, van der Burg in a similar field of invention teaches an implantable medical device 304 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21) and an adjustable support 312 + 320 (see Fig. 21). Van der Burg further teaches: the LAAC 304 adapted to undergo a tug test testing the seal, stability testing (see [0181]-[0182] and [0243]-[0246], in [0244], deployment handle is alternatively retracted and advance, which is a tugging motion) during implantation (see [0181]-[0182] and [0243]-[0246]).
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 Perszyk to incorporate the teachings of van der Burg and teach an implantable medical device adapted to undergo a tug test during implantation. Motivation for such can be found in van der Burg as this confirms how well the implant is held within the LAA (see [0244]).
However, Rafiee in a similar field of invention teaches an implantable medical device (see Figs. 4 and 12) with an adjustable support limiting tether/hollow suture (see Figs. 4 and 12) and a member length limiting tether/hollow suture (see Figs. 4 and 12), and a pin locking device housing (see Fig. 4). Rafiee further teaches: wherein the adjustable support limiting tether/hollow suture (see Fig. 4) further comprises a reversible suture lock locking device/locking pin (see Fig. 4, [0052], [0013], and [0018], the lock can be released) comprising: a suture lock body locking device housing (see Fig. 4, [0052]) defining a lumen the lumen of the locking device housing (see Fig. 4) extending therethrough and an engagement element locking pin (see Fig. 4, [0052]), the engagement element locking pin including an engagement element lumen the lumen of the locking pin which the hollow suture extends through (see Fig. 4, [0052]) through which the member the hollow suture is free to extend.
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 Perszyk to incorporate the teachings of Rafiee and have an implantable medical device wherein the adjustable support further comprises a reversible suture lock comprising: a suture lock body defining a lumen extending therethrough and an engagement element, the engagement element including an engagement element lumen through which the member is free to extend. Motivation for such can be found in Rafiee as this allows the proximal and distal portions of the implantable medical device to be adjustably connected, hence the distance between the two can be controlled, with a lock (see [0011]), the locking being adjustable to ensure proper positioning of the device (see [0018]).
The combination of Perszyk and Rafiee does not explicitly teach: a first element slidingly disposed within the lumen, the first element including a first element lumen through which the member is free to extend; a second element slidingly disposed within the lumen and engaged with the first element, the second element including a second element lumen through which the member is free to extend; the engagement element is adapted to releasably engage the first element; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body.
However, van der Burg in a similar field of invention teaches an implantable medical device 300 (see Figs. 21-21E and Fig. 28) with distal frame end 316 (see Fig. 21) and a proximal frame end 329 (see Fig. 21), a suture lock 400 (see Fig. 28), and a member 442 (see Fig. 28). van der Burg further teaches: a first element 320 (see Fig. 28, [0194]), the first element 320 including a first element lumen the lumen of 320 through which the member 442 is free to extend (see Fig. 28, 442 goes through the lumen of 320); a second element 312 (see Fig. 28, [0194]) engaged with the first element 320 (see Fig. 28, [0194], 312 is engaged to 320), the second element 312 including a second element lumen the lumen of 312 (see Fig. 28) through which the member 442 is free to extend (see Fig. 28); wherein the first element 320 and the second element 312 are moveable (see [0194], axially moveable) between a first position (see Fig. 28) in which the member 442 is free to move relative to the suture lock body (see Fig. 28, 442 can leave through slot 440) and a second position (see Fig. 28, when 312 is pulled away from 440, 442 can no longer leave through 440, see [0195]) in which the member is constrained against movement relative to the suture lock body (see [0195]).
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and have a reversible suture lock with a first element, the first element including a first element lumen through which the member is free to extend; a second element engaged with the first element, the second element including a second element lumen through which the member is free to extend; wherein the first element and the second element are moveable between a first position in which the member is free to move relative to the suture lock body and a second position in which the member is constrained against movement relative to the suture lock body. Motivation for such can be found in van der Burg as this provides a quick-disconnect functionality for the implant by having axially slidable/movable elements (see [0194]).
The combination of Perszyk, Rafiee, and van der Burg further teaches: the first element slidingly disposed within the lumen and the second element slidingly disposed within the lumen (as modified the first and second element of van der Burg, is within the lumen of the suture lock body of Rafiee, which as shown in Fig. 4 of Rafiee a pusher pin can also fit through, besides the suture) and the engagement element (as modified, the locking pin of Rafiee is able to engage other elements, due to having resilient arms that can releasably engagement the first element) is adapted to releasably engage the first element.
The language, " the adjustable support adapted to resist movement in response to a tug test performed on the LAAC," 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 Perszyk and van der Burg meets the structural limitations of the claim, and is capable of resisting movement in response to a tug test performed on the LAAC, as when the adjustable support is axially locked it would resist further deformation when the device is pulled (see [0046] of Perszyk).
Claim 21
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Rafiee further teaches: further comprising a hub coupling (see Fig. 9, [0020], which is a proximal end of the implant) secured to the proximal frame end proximal end of the system (see Fig. 9), wherein the reversible suture lock locking device is secured (see [0052], locking device is integrated with the proximal portion of the implant) to the hub coupling.
Claim 22
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Rafiee does not teach explicitly teach: wherein the engagement element comprises a button operable to move the first element and the second element between the first position and the second position.
However, van der Burg in a similar field of invention teaches an implantable medical device (Fig. 29) with an engagement element 439 (see Fig. 29), a first element 320 and a second element 312. van der Burg further teaches: wherein the engagement element 439 comprises a button (see [0199], release button, which can lock/unlock 439 in place, which controls the relative movements of 320 and 312) operable to move the first element and the second element between the first position and the second position.
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and teach an implantable medical device with the engagement element comprises a button operable to move the first element and the second element between the first position and the second position. Motivation for such can be found in van der Burg as this gives the engagement element (key) axial movement over a predetermined range, removing the need for manual control over distance for proper alignment and disengagement of the lock (see [0199]).
Claim 23
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above.
The language, " wherein the first element and the second element slide axially within the body lumen relative to the suture lock body when moving between the first position and the second position," 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 Perszyk, van der Burg, and Rafiee meets the structural limitations of the claim, and is capable of when the suture lock body is disengaged the tubes/catheters of the first and second elements can slide axially within the body lumen of the implant, as they are not otherwise fixedly secured to the suture lock body.
Claim 24
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 1, see 103 rejection above. Perszyk further discloses: wherein the member 505 comprises a suture (see [0046], suture) secured to a distal end cap 501 (see Fig. 5A, [0046]) at the distal frame end the distal frame end of 501, the suture 505 extending through the distal end cap 501 (see Fig. 5A), through the expandable frame 102 + 104.
The combination of Perszyk and Rafiee: through the reversible suture lock locking device (see Fig. 4, the hollow suture extending through the locking device housing).
Claim 25
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 13, see 103 rejection above. Rafiee further teaches: further comprising a hub coupling (see Fig. 9, [0020], which is a proximal end of the implant) secured to the proximal frame end proximal end of the system (see Fig. 9), wherein the reversible suture lock locking device is secured (see [0052], locking device is integrated with the proximal portion of the implant) to the hub coupling.
Claim 26
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 13, see 103 rejection above. Rafiee does not teach explicitly teach: wherein the engagement element comprises a button operable to move the first element and the second element between the first position and the second position.
However, van der Burg in a similar field of invention teaches an implantable medical device (Fig. 29) with an engagement element 439 (see Fig. 29), a first element 320 and a second element 312. van der Burg further teaches: wherein the engagement element 439 comprises a button (see [0199], release button, which can lock/unlock 439 in place, which controls the relative movements of 320 and 312) operable to move the first element and the second element between the first position and the second position.
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and teach an implantable medical device with the engagement element comprises a button operable to move the first element and the second element between the first position and the second position. Motivation for such can be found in van der Burg as this gives the engagement element (key) axial movement over a predetermined range, removing the need for manual control over distance for proper alignment and disengagement of the lock (see [0199]).
Claim 27
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 13, see 103 rejection above.
The language, " wherein the first element and the second element slide axially within the body lumen relative to the suture lock body when moving between the first position and the second position," 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 Perszyk, van der Burg, and Rafiee meets the structural limitations of the claim, and is capable of when the suture lock body is disengaged the tubes/catheters of the first and second elements can slide axially within the body lumen of the implant, as they are not otherwise fixedly secured to the suture lock body.
Claim 28
The combination of Perszyk, van der Burg, and Rafiee teaches: The implantable medical device of claim 13, see 103 rejection above. Perszyk further discloses: wherein the member 505 comprises a suture (see [0046], suture) secured to a distal end cap 501 (see Fig. 5A, [0046]) at the distal frame end the distal frame end of 501, the suture 505 extending through the distal end cap 501 (see Fig. 5A), through the expandable frame 102 + 104.
The combination of Perszyk and Rafiee: through the reversible suture lock locking device (see Fig. 4, the hollow suture extending through the locking device housing).
Claim 29
The combination of Perszyk, van der Burg, and Rafiee teaches: The LAAC device of claim 19, see 103 rejection above. Rafiee further teaches: further comprising a hub coupling (see Fig. 9, [0020], which is a proximal end of the implant) secured to the proximal frame end proximal end of the system (see Fig. 9), wherein the reversible suture lock locking device is secured (see [0052], locking device is integrated with the proximal portion of the implant) to the hub coupling.
Claim 30
The combination of Perszyk, van der Burg, and Rafiee teaches: The LAAC device of claim 19, see 103 rejection above. Rafiee does not teach explicitly teach: wherein the engagement element comprises a button operable to move the first element and the second element between the first position and the second position.
However, van der Burg in a similar field of invention teaches an implantable medical device (Fig. 29) with an engagement element 439 (see Fig. 29), a first element 320 and a second element 312. van der Burg further teaches: wherein the engagement element 439 comprises a button (see [0199], release button, which can lock/unlock 439 in place, which controls the relative movements of 320 and 312) operable to move the first element and the second element between the first position and the second position.
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 Perszyk and Rafiee to incorporate the teachings of van der Burg and teach an implantable medical device with the engagement element comprises a button operable to move the first element and the second element between the first position and the second position. Motivation for such can be found in van der Burg as this gives the engagement element (key) axial movement over a predetermined range, removing the need for manual control over distance for proper alignment and disengagement of the lock (see [0199]).
Claim 31
The combination of Perszyk, van der Burg, and Rafiee teaches: The LAAC device of claim 19, see 103 rejection above.
The language, " wherein the first element and the second element slide axially within the body lumen relative to the suture lock body when moving between the first position and the second position," 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 Perszyk, van der Burg, and Rafiee meets the structural limitations of the claim, and is capable of when the suture lock body is disengaged the tubes/catheters of the first and second elements can slide axially within the body lumen of the implant, as they are not otherwise fixedly secured to the suture lock body.
Claim 32
The combination of Perszyk, van der Burg, and Rafiee teaches: The LAAC device of claim 19, see 103 rejection above. Perszyk further discloses: wherein the member 505 comprises a suture (see [0046], suture) secured to a distal end cap 501 (see Fig. 5A, [0046]) at the distal frame end the distal frame end of 501, the suture 505 extending through the distal end cap 501 (see Fig. 5A), through the expandable frame 102 + 104.
The combination of Perszyk and Rafiee: through the reversible suture lock locking device (see Fig. 4, the hollow suture extending through the locking device housing).
Conclusion
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771