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 .
Claim Objections
Claim 22 is no longer objected to.
Applicant has indicated the intended interpretation of the claim(s) in the response dated 03/19/2026.
Response to Amendment
Applicant’s addition of Claims 31 and 32 is supported at least by Figure 4. It is noted that the term “notch” in the specification does not have an item number directly assigned to it.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 27 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landon (US20170367821A1).
Claim 27
Landon teaches a crimping device for an implant (¶0007 teaches a crimping device for a prosthetic valve, which is an implant.), the crimping device comprising (See annotated figure below for the structural limitations.): a body having an inner surface forming a funnel (¶0071) including a first end portion having a first diameter and a second end portion having a second diameter smaller than the first diameter, the funnel surrounding a cavity for receiving the implant (¶0073), the body including an opening at the second end portion and including a plurality of guide channels positioned proximate the opening (Proximate is a term of degree that is not defined by the claim or specification. The channels of Landon are interpreted as close/proximate to the opening.) that are formed between a plurality of protrusions (224), each of the guide channels configured to receive a strut of the implant (¶0080) and to space end couplers disposed at distal end portions of the struts from each other at the opening for coupling the implant to a delivery apparatus. (¶0080) wherein each guide channel comprises a notch extending from the inner surface of the body to an outer surface of the body. (Figure 14 shows the guide channels are made up of “notches” between the ribs (224) of the body (housing, 202). The notch extends from the inner surface (bottom of the cavity between ribs (224)) to “an outer surface” (either end of the ribs, the surface of the ribs facing the central axis, or the proximal or distal end surfaces of the body). Since the claim is not specific regarding the location of the outer surface in proximity to other portions of the device, it allows for a broader interpretation that potentially intended.)
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Examiner interpretation of Landon, Figure 14 for Claim 27
Claim 30
Landon teaches a system comprising: the crimping device of claim 27 (See rejection of Claim 27.); the implant (Figure 20, Item 300), wherein the implant is a prosthetic heart valve (¶0042 teaches the system is for a prosthetic heart valve.) including prosthetic valve leaflets (304) and a frame (302) including the end couplers (312, 314) for coupling with the delivery apparatus (¶0079 “The end portions 314 are configured to engage mating features of a delivery apparatus to form a releasable connection between the prosthetic valve and the delivery apparatus.”); and the delivery apparatus (400), where the delivery apparatus comprises: a coupler (410) having a plurality of receiving portions (412), each of the receiving portions configured to receive one of the end couplers of the frame (¶0082 “A valve-retaining member 410 can be connected to the distal end portion of the first shaft 404 and can include a plurality of circumferentially spaced slots 412 sized to receive the connecting arms 312 of the prosthetic valve 300.”), wherein the guide channels are spaced equally from each other (¶0072 teaches the ribs (224), which define the guide channels, are circumferentially spaced around the inner surface of the body. This is also taught by the structure of the pusher (204), as shown in Figure 17, having equally spaced fins (228) that interact with the analogous guide channels of the body.), and wherein the receiving portions are spaced equally relative to each other and have a same spacing as the guide channels (Landon teaches the guide channels are spaced equally as discussed above. ¶0080 further teaches that the ribs guide the anchors, and thereby the end portions (314), of the prosthetic such that it engages with the mating features of the delivery apparatus. The mating features of the delivery apparatus are the slots (412) of the valve retaining member (410) as described in ¶0082. ¶0082 describes the process as a pushing of the valve ends (312) out of the outlet (212) of the device (200) and into the slots (412), without detailing any rotation about the longitudinal axis. Therefore, the valve is moved down the longitudinal axis with portions within the guide channels, then pushed into the slots of the valve retaining member. The reference teaches the guide channels and slots are aligned.); and a capsule (402, 404) configured to receive the coupler (Figure 21) having the end couplers of the frame received within the receiving portions. (Figure 21 shows the capsule (402 or 404) receives the coupler (410). ¶0082-0083 teach the valve retaining member (410) is placed within the sheath (402) after the valve is connected.)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 16-17 and 19-24, 28-29 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Landon (US20170367821A1) in view of Abbate (US20140276408A1).
Claim 16
Landon teaches a crimping device for an implant (¶0007 teaches a crimping device for a prosthetic valve, which is an implant.), the crimping device comprising: a body having an inner surface forming a funnel extending from a wide end portion to a narrow end portion and surrounding a cavity for receiving the implant (See annotated Figure below.), the body including an opening (212) at the narrow end portion (Figure 14) wherein the body includes a plurality of slots (between instances of item 224) extending along the inner surface from the wide end portion to the narrow end portion of the body (Figure 14); and wherein the body surrounds a longitudinal axis (A) and includes a proximal portion and a distal portion, wherein the proximal portion extends from the wide end portion to the distal portion and the distal portion extends from the narrow end portion to the proximal portion (Figure 14), wherein the inner surface at the distal portion has a greater surface angle relative to the longitudinal axis than the inner surface at the proximal portion (Figure 14 shows the funnel segment (214) has a greater angle in relation to the longitudinal axis (A).),
Landon does not disclose a plurality of guide channels positioned proximate the opening and each extending radially outward from the opening, the plurality of guide channels configured to space end couplers of the implant from each other at the opening for coupling to a delivery apparatus for the implant; and wherein the plurality of guide channels are positioned on the inner surface at the distal portion and are disposed at the greater surface angle relative to the longitudinal axis.
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Examiner interpretation of Landon, Figure 14 for Claim 16
However, when applied to Landon, Abbate teaches a plurality of guide channels (518) positioned proximate the opening (Figure 5D shows the guide channels are used in all portions (506, 508, 510) of the axial path through the device housing (502), including near the opening (514).) and each extending radially outward from the opening (Figure 5D shows the channels (518) are located and extend outward from the opening (514). Additionally/alternatively, when combined with Landon, the guide channels are located on the analogous first (222) and second (216) sections in Landon and therefore meet the claimed orientation.), the plurality of guide channels configured to space end couplers of the implant from each other at the opening for coupling to a delivery apparatus for the implant (¶0059 teaches the legs of an implant are positioned within the channels during operation of the device.); and wherein the plurality of guide channels are positioned on the inner surface at the distal portion (Abbate teaches the guide channels (518) are located on first AND second sections of the device. When applying this teaching to Landon, the channels are located on the first (222) and second (216) portions of the device and therefore on the claimed distal portion.) and are disposed at the greater surface angle relative to the longitudinal axis. (When applying the guide channels on the second section technique/teaching from Abbate to the device of Landon, the guide channels will be located on Items 214/216 of Landon, which arrives at the claimed orientation.)
One of ordinary skill would have been motivated to apply the known continuous channel technique of Abbate to the crimping device of Landon in order to use a device that allows the legs of the implant to be guided/housed within the channels as it passes through the length of the device. (Abbate ¶0070 teaches having the channels in the second and third segments allows for maintaining of the alignment of the implant as it advanced.)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known continuous channel technique of Abbate to the crimping device of Landon because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Claim 17
Landon in view of Abbate teaches the crimping device of claim 16, wherein the plurality of guide channels are configured to space the end couplers of the implant equally from each other at the opening. (¶0072 of Landon teaches the ribs (224), which define the guide channels/slots, are circumferentially spaced around the inner surface of the body. This is also taught by the structure of the pusher (204), as shown in Figure 17, having equally spaced notches between the fins (228). The paragraph also discloses that the ribs prevent axial deformation of the valve during operation. Therefore, the structure of Landon is capable of performing the claimed intended use. When applying the guide channels on the second section from Abbate, this functionality will be maintained.)
Claim 19
Landon in view of Abbate teaches the crimping device of claim 16, wherein the plurality of guide channels are spaced equally from each other. (Landon ¶0072 teaches the ribs (224), which define the guide channels/slots, are circumferentially spaced around the inner surface of the body. This is also taught by the structure of the pusher (204), as shown in Figure 17, having equally spaced fins (228) that interact with the analogous guide channels of the body. When applying the guide channels on the second section from Abbate, this functionality will be maintained.))
Claim 20
Landon in view of Abbate teaches the crimping device of claim 16, wherein a plurality of protrusions (Abbate, Item 516) on the inner surface (Figure 5D) that are spaced from each other form the plurality of guide channels on the inner surface. (Figure 5D)
Claim 21
Landon in view of Abbate teaches the crimping device of claim 16, further comprising a threaded actuator (Landon, Item 206) and a pressing body (Landon, Item 204), the threaded actuator configured engage with threads on the body to move the pressing body to press the implant in a direction towards the opening. (See Landon Figure 15 and ¶0076)
Claim 22
Landon in view of Abbate teaches the crimping device of claim 21, wherein the pressing body includes a plurality of flanges (Landon Figure 17, Item 228), wherein the flanges of the pressing body are configured to slide within the slots as the pressing body presses the implant in the direction towards the opening in the narrow end portion of the body. (Landon ¶0074: “The fins 228 can be configured to be slidably disposed between the ribs 224 of the housing 202 such that as the pusher member 204 moves axially with respect to the housing 202, the fins 228 slide between the ribs 224.”)
Claim 23
Landon in view of Abbate teaches the crimping device of claim 22, wherein the pressing body (Landon, Item 204) comprises a pressing surface (Landon, Item 230) configured for contacting the implant (Landon, ¶0074 “The annular ledge 230 is configured to abut an adjacent end 232 of the prosthetic valve 250 when pushing the prosthetic valve through the housing 202.”), and wherein, when inserted within the body, the pressing surface and the flanges are perpendicular to a longitudinal axis of the body. (Landon, Figure 14 shows this feature.)
Claim 24
Landon in view of Abbate teaches a system comprising: the crimping device of claim 16 (See the rejection of Claim 16); and the implant (Landon Figure 20, Item 300), wherein the implant is a prosthetic heart valve (Landon ¶0042 teaches the system is for a prosthetic heart valve.) including a plurality of leaflets (Landon 304) and a frame (Landon 302) including the end couplers (Landon 312/314) for coupling the prosthetic heart valve with the delivery apparatus. (Landon ¶0079 “The end portions 314 are configured to engage mating features of a delivery apparatus to form a releasable connection between the prosthetic valve and the delivery apparatus.”)
Claim 28
Landon teaches a crimping device for an implant (¶0007 teaches a crimping device for a prosthetic valve, which is an implant.), the crimping device comprising (See annotated figure below for the structural limitations.): a body having an inner surface forming a funnel (¶0071) including a first end portion having a first diameter and a second end portion having a second diameter smaller than the first diameter, the funnel surrounding a cavity for receiving the implant (¶0073), the body including an opening at the second end portion; a pressing body (204) configured to press the implant distally towards the opening (See Figure 15 and ¶0076) and including flanges (228), wherein the body includes a plurality of slots extending along the inner surface from the first end portion to the second end portion (Figure 14 shows the body has slots between the ribs (224). See also ¶0074.) of the body, wherein the slots are configured for the flanges of the pressing body to slide therein as the pressing body presses the implant distally towards the opening. (¶0074: “The fins 228 can be configured to be slidably disposed between the ribs 224 of the housing 202 such that as the pusher member 204 moves axially with respect to the housing 202, the fins 228 slide between the ribs 224.”)
Landon does not explicitly disclose a plurality of guide channels positioned proximate the opening that are formed between a plurality of protrusions, each of the guide channels configured to receive a strut of the implant and to space end couplers disposed at distal end portions of the struts from each other at the opening for coupling the implant to a delivery apparatus, wherein each guide channel comprises a notch extending from the inner surface of the body to an outer surface of the body, and wherein each of the slots is aligned with one of the guide channels.
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Examiner interpretation of Landon, Figure 14 for Claim 28
However, Abbate teaches a conical valve crimper device (Figure 5D) with a plurality of guide channels (518) positioned proximate the opening (Figure 5D shows the guide channels are used in all portions (506, 508, 510) of the axial path through the device housing (502), including near the opening (514).) and are formed between a plurality of protrusions (516); the plurality of guide channels configured to receive a strut of the implant to space couplers disposed at distal end portions of the struts from each other at the opening for coupling to a delivery apparatus for the implant (¶0059 teaches the legs of an implant are positioned within the channels during operation of the device.); wherein each guide channel comprises a notch extending from the inner surface of the body to an outer surface of the body. (Figures 5A, 5B and 5D show the guide channels are made up of “notches” between the ribs (516) of the body. The notch extends from the inner surface (interior of the device) to an outer surface (the outer opening (514)) as shown in Figure 5D. When applied to Landon, the guide channels will be formed on the wall (216) and extend along said wall to the outlet (212). Since the claim is not specific regarding the location of the outer surface in proximity to other portions of the device, it allows for a broader interpretation that potentially intended.) and wherein each of the slots is aligned with one of the guide channels. (The analogous slots in Abbate are the guide channels in the first portion (506). ¶0053 teaches the channels (518) extend through each segment (506, 508, 510) of the device. This is a teaching of a continuous, thus aligned, set of channels/slots in the device.)
One of ordinary skill would have been motivated to apply the known continuous channel technique of Abbate to the crimping device of Landon in order to use a device that allows the legs of the implant to be guided/housed within the channels as it passes through the length of the device. (Abbate ¶0070 teaches having the channels in the second and third segments allows for maintaining of the alignment of the implant as it advanced.)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known continuous channel technique of Abbate to the crimping device of Landon because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Claim 29
Landon in view of Abbate teaches the crimping device of claim 28, further comprising a threaded actuator (Landon Item 206) configured engage with threads on the body to move the pressing body to press the implant in a direction towards the opening and slide the struts of the implant within the guide channels. (See Landon Figure 15 and ¶0076)
Claim 31
Landon in view of Abbate teaches the crimping device of claim 16, wherein the plurality of guide channels are circumferentially offset from the plurality of slots. (Abbate, ¶0055 teaches that the first segment (506) can have a differing number of ribs than the second (508). ¶0059 teaches the number of ribs in the first segment can be 2, 3, 4, 5, 6, 7 or more. ¶0063 teaches the number of ribs in the second segment can be 2, 3, 4, 5, 6, 7 or more. Figure 5B shows that the ribs are spaced around the longitudinal axis. Based on these teachings from Abbate, the second segment in the combined invention of Landon in view of Abbate will have a different number of ribs/channels that are spaced around the longitudinal axis. Since the number of channels differs, they will be offset circumferentially from one another.)
Claim 32
Landon in view of Abbate teaches the crimping device of claim 16, wherein each guide channel comprises a notch extending from the inner surface of the body to an outer surface of the body. (Figures 5A, 5B and 5D of Abbate show the guide channels are made up of “notches” between the ribs (516) of the body. The notch extends from the inner surface (interior of the device) to an outer surface (the outer opening (514)) as shown in Figure 5D. When applied to Landon, the guide channels will be formed on the wall (216) and extend along said wall to the outlet (212). Since the claim is not specific regarding the location of the outer surface in proximity to other portions of the device, it allows for a broader interpretation that potentially intended.)
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Landon in view of Abbate, as applied in Claim 24, further in view of Wu (US20210212808A1).
Claim 25
Landon in view of Abbate teaches the system of claim 24, further comprising the delivery apparatus (Landon Figure 21, Item 400), wherein the delivery apparatus comprises: a coupler (Landon 410) having a plurality of receiving portions (Landon 412), wherein each of the receiving portions is configured to receive one of the end couplers of the frame (Landon ¶0082 “A valve-retaining member 410 can be connected to the distal end portion of the first shaft 404 and can include a plurality of circumferentially spaced slots 412 sized to receive the connecting arms 312 of the prosthetic valve 300.”); and a capsule (Landon 402 or 404), wherein the capsule is configured to receive the coupler and the end couplers received within the receiving portions of the coupler. (Landon Figure 21 shows the capsule (402 or 404) receives the coupler (410).)
Landon in view of Abbate does not explicitly disclose a capsule including a plurality of bumps on an interior surface of the capsule.
However, Wu teaches a capsule including a plurality of bumps on an interior surface of the capsule. (Figures 4a-4c teach the use of a telescopic capsule that includes two segments (121a/b) that move in relation to one another. Figure 4b, specifically, shows a plurality of protrusions (bumps) on the inner wall of the capsule portion (121a).)
One of ordinary skill would have been motivated to apply the known telescopic capsule with the protrusion/rail technique of Wu to the capsule device of Landon in view of Abbate in order to use a device where “the space occupied by the capsule with a telescopic function in the embodiment of the present disclosure is greatly reduced compared with the space occupied by conventional capsules, thereby effectively avoiding the interference of the capsule to the inner tube during the withdrawal process, improving the accuracy and reliability of the positioning of the implant, and ensuring the stability of the release of the implant.” (See Wu, ¶0008)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known telescopic capsule with the protrusion/rail technique of Wu to the capsule device of Landon in view of Abbate because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is the delivery apparatus of Landon will use a telescopic capsule.
Claim 26
Landon in view of Abbate and Wu teaches the system of claim 25, wherein the guide channels of the body are spaced equally from each other (Landon, ¶0072 teaches the ribs (224), which define the guide channels, are circumferentially spaced around the inner surface of the body. This is also taught by the structure of the pusher (204), as shown in Figure 17, having equally spaced fins (228) that interact with the analogous guide channels of the body.); and wherein the receiving portions of the coupler are spaced equally relative to each other and have a same spacing as the guide channels. (Landon teaches the guide channels are spaced equally as discussed above. ¶0080 further teaches that the ribs guide the anchors, and thereby the end portions (314), of the prosthetic such that it engages with the mating features of the delivery apparatus. The mating features of the delivery apparatus are the slots (412) of the valve retaining member (410) as described in ¶0082. ¶0082 describes the process as a pushing of the valve ends (312) out of the outlet (212) of the device (200) and into the slots (412), without detailing any rotation about the longitudinal axis. Therefore, the valve is moved down the longitudinal axis with portions within the guide channels, then pushed into the slots of the valve retaining member. The reference teaches the guide channels and slots are aligned.)
Response to Arguments
Applicant’s arguments, see remarks, filed 03/19/2026, with respect to the rejection(s) of claim(s) 16 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made using Abbate as presented above.
Specifically, Landon does not disclose the guide channels and slots as presented in amended Claim 16.
Applicant's arguments filed 03/19/2026, with respect to the rejection of Claim 27 under 35 USC 102 have been fully considered but they are not persuasive. Applicant essentially argues that Landon does not teach Claim 27 as amended.
It is respectfully asserted that the rejection of Claim 27 above has been updated to suit applicant’s amendment. As a preliminary note, there is no item number assigned to “notch” in applicants specification, nor is the exact structure of the notch described. The standard definition found during research was generally a small cut shaped like a V. Since this is neither shown or described by applicant as being the claimed “notch”, a more broad interpretation is required. The interpretation used in the rejection(s) above for “notch” includes an indentation or opening between portions of a body. Landon, Figure 14 shows the body (202) includes inwardly protruding ribs (224). The area between the ribs is an indentation or opening that can be considered a notch as currently claimed. This “notch” extends from the inner surface (bottom surface of the “notch”) to “an” outer surface. This outer surface is not defined spatially in relation to anything else on the device, so it is interpreted as the outer surface of the notch.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the PTO-892 Notice of References Cited Form.
Document
Date
Description of Relevant Subject Matter
US20100292779A1
2010-05-12
Figure 9b teaches a funnel shaped device (10) that includes guide channels/slots (13) that comprise a notch (12) that extends from an inner to outer surface of the device. One of ordinary skill would have been motivated to combine the known notch of Straubinger to another crimping device in order to provide a structure that cooperates with other elements of the crimping system to allow for their alignment or cooperation during the process. See Straubinger ¶0133-0134.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael W Hotchkiss whose telephone number is (571)272-3854. The examiner can normally be reached Monday-Friday from 0800-1600.
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/MICHAEL W HOTCHKISS/Primary Examiner, Art Unit 3726
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