DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 3/13/2026 have been fully considered.
Regarding the amendments to the independent claims, Applicant’s arguments have been considered and are persuasive. Applicant argues that Pederson fails to teach the securement member including first and second separate visible markers positioned on either side of the release point. This arguments is convincing. Therefore, the prior rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made over Pederson in view of Bardsley et al (US 2021/0275337) as will be found below.
Regarding the rejection over Griffin, Applicant argues the Griffin teaches that the coupling coil 78 is electrolytically dissolved to decouple the occlusion member 75 from the delivery wire which is in direct contrast to Pederson in which the wire is meant to stay coupled to the securement member. This argument is not convincing. Griffin is relied upon to teach the means for securing the wire to the securement member. The electrolytic decoupling is a different process not relevant to the instant rejection. The rejection only relies upon the teaching of the means to connect a wire to a receiving member. Pederson teaches that the release wire and the securement member are fixed, but fails to disclose the means of doing so. Griffin is relied upon to teach that a wire that is received in another member can be securely fixed via a frictional fit.
Regarding the rejection of claims 9 and 12, Applicant argues that there is no rational reason for one of ordinary skill in the art to modify Pederson to achieve the claimed structure and the only such motivation is hindsight reasoning. This argument is not convincing. The rejection was based MPEP 2144.04(IV)(A), not hindsight reasoning. Additionally, the examiner noted that Applicant has not provided any criticality to these claims which Applicant did not provide evidence against.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 6-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson et al (US 2018/0133435) in view of Bardsley et al (US 2021/0275337).
Regarding claim 1, Pederson discloses a medical device system, comprising: a medical device 130; an elongate shaft 110 having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft (page 3, para. 0048); a release mechanism 170 moveable between a locked position in which the medical device is secured to the distal end of the elongate shaft (fig. 5) and an unlocked position in which the medical device is free to move relative to the distal end of the elongate shaft (fig. 6); a release wire 120 disposed within the lumen of the elongate shaft and extendable through the release mechanism (fig. 5; page 3, para. 0048); and a securement member 140 including a release point 150 formed within the securement member (fig. 6), the securement member including a proximal portion 142 extending proximally from the release point and a distal portion 144 extending distally from the release point (fig. 6); wherein the release point of the securement member is configured to allow a user to grasp the proximal portion of the securement member and the distal portion of the securement member on either side of the release point and to snap the securement member into two pieces at the release point in a single motion (page 4, para. 0051: the language “configured to allow” is interpreted to be an intended use limitation. The detachment point may be a perforation or frangible link which is capable of being snaped in a single motion).
Claim 1 differs form Pederson in calling for the securement member to include first and second separate visible markers positioned on either side of the release point such that the user can grasp the securement member at the first visible marker and the second visible marker to snap the securement member. Bardsley teaches a securement member having first and second separate visible markers 26 positioned on either side of the release point such that the user can grasp the securement member as the first and second markers and break the securement member at the release point between the two markers (fig. C; page 6, para. 0072). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the securement member of Pederson to include first and second visible markers on either side of the release point as taught by Pederson to provide the user with a readily discernable indication of where the break point is and thereby increase ease of use.
Regarding claim 2, Pederson discloses that the release wire extends through the securement member, with the release wire fixed relative to the proximal portion of the securement member such that once the securement member has been snapped at the release point, the proximal portion of the securement member is movable in a proximal direction in order to urge the release wire in a proximal direction (page 4, para. 0052; fig. 4).
Regarding claim 6, Pederson discloses that the release wire is free to move relative to the distal portion of the securement member (page 4, para. 0052; fig. 6).
Regarding claim 7, Pederson discloses that the release mechanism comprises: a first release mechanism portion 172 that is fixedly attached to the distal end of the elongate shaft; and a second release mechanism portion 174 that is fixedly attached to the medical device 130 (fig. 6; page 4, para. 0054).
Regarding claim 8, Pederson discloses that the securement member comprises a tubular structure made of a nickel-titanium alloy (page 6, para. 0063).
Claim 9 calls for the tubular structure to comprise an inner diameter (ID) that is in a range of 0.001 to 0.0049 inches; and an outer diameter (OD) that is in a range of 0.002 to 0.0050 inches. Pederson fails to disclose the diameter of the tubular structure. However, Applicant has not provided criticality to these dimensions. Pederson discloses the invention for a similar use as the claimed invention, and for use with a microcatheter as disclosed by the instant invention, and therefore, one of ordinary skill in the art would expect the device of Pederson and the claimed invention to be of similar sized. Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform different than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04(IV)(A)). Therefore, the claimed invention is not patentably distinct from the device of Pederson.
Regarding claim 10, Pederson discloses that the release point comprises a plurality of slots 150 extending circumferentially around the tubular structure at the release point (fig. 8A).
Regarding claim 11, Pederson discloses that the plurality of slots are radially aligned with one another, forming a plurality of beams extending circumferentially between adjacent slots (fig. 8A: beams of material between slots 150).
Claim 12 calls for the release point comprises a total of four radially aligned slots, with each of the slots having a length of 0.010 inches. Applicant has not provided any criticality to the number of slots nor the length of the slots. One or ordinary skill in the art would recognize that the device of Pederson and the claimed invention would work equally well with any number of slots sufficient to allow the member to break at the desired location upon application of a snapping force, and the slots having any size sufficient to achieve this. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the release point of Pederson to have four slots sized as claimed because doing so would have been a matter of obvious design choice.
Regarding claim 13, Pederson discloses that the proximal portion of the securement member is fixedly attached to the proximal end of the release wire and the distal portion of the securement member is fixedly attached to the proximal end of the elongate shaft (page 4, para. 0051).
Regarding claim 14, Pederson discloses that the proximal portion of the securement member is integrally formed with the distal portion of the securement member (page 3, para. 0050).
Regarding claim 15, Pederson discloses a medical device system, comprising: a medical device 130; an elongate shaft 110 having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft (page 3, para. 0048); a release mechanism 170 moveable between a locked position in which the medical device is secured to the distal end of the elongate shaft (fig. 5) and an unlocked position in which the medical device is free to move relative to the distal end of the elongate shaft (fig. 6); a release wire 120 disposed within the lumen of the elongate shaft and extendable through the release mechanism (fig. 5; page 3, para. 0048); and a tubular super-elastic nitinol securement member 140 including a release point 150 formed within the securement member (page 6, para. 0063; fig. 6), the tubular super-elastic nitinol securement member including a proximal portion 142 extending proximally from the release point and a distal portion 144 extending distally from the release point (fig. 6); the release point including circumferentially arranged slots formed in the tubular super elastic nitinol securement member (fig. 8A), the release point being configured to allow the user to grasp the proximal portion and the distal portion on om either side of the release point and to snap the member into two pieces at the release point in a single motion (page 4, para. 0051: the language “configured to allow” is interpreted to be an intended use limitation. The detachment point may be a perforation or frangible link which is capable of being snaped in a single motion).
Claim 15 differs from Pederson in calling for the securement member to include first and second separate visible markers positioned on either side of the release point such that the user can grasp the securement member at the first visible marker and the second visible marker to snap the securement member. Bardsley teaches a securement member having first and second separate visible markers 26 positioned on either side of the release point such that the user can grasp the securement member as the first and second markers and break the securement member at the release point between the two markers (fig. C; page 6, para. 0072). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the securement member of Pederson to include first and second visible markers on either side of the release point as taught by Pederson to provide the user with a readily discernable indication of where the break point is and thereby increase ease of use.
Claim 15 further calls for the release point to include a total of four slots. Pederson shown more than four slots in fig. 8A. However, Applicant has not provided any criticality to the number of slot. One or ordinary skill in the art would recognize that the device of Pederson and the claimed invention would work equally well with any number of slots sufficient to allow the member to break at the desired location upon application of a snapping force. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the release point of Pederson to have four slots as claimed because doing so would have been a matter of obvious design choice.
Claim 16 calls for the securement member to comprises: an inner diameter (ID) that is in a range of 0.001 to 0.0049 inches; and an outer diameter (OD) that is in a range of 0.002 to 0.0050 inches; and the release point comprises a plurality of slots extending radially around the tubular structure. Pederson fails to disclose the diameter of the tubular structure. However, Applicant has not provided criticality to these dimensions. Pederson discloses the invention for a similar use as the claimed invention, and for use with a microcatheter as disclosed by the instant invention, and therefore, one of ordinary skill in the art would expect the device of Pederson and the claimed invention to be of similar sized. Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform different than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04(IV)(A)). Therefore, the claimed invention is not patentably distinct from the device of Pederson.
Regarding claim 17, Pederson discloses a method of delivering a medical device 130 to a treatment site, comprising: inserting a microcatheter 190 into a patient's anatomy and guiding a distal end of the microcatheter to a location adjacent the treatment site (page 4, para. 0053); inserting a medical device disposed at a distal end of an elongate shaft into a proximal end of a lumen disposed within the microcatheter (page 4, para. 0053); wherein the medical device is releasably attached to the distal end of the elongate shaft by a pull wire 120 extending through a lumen within the elongate shaft (fig. 4), and wherein a securement 140 member extends proximally from the elongate shaft (fig. 4), the securement member being fixedly attached to the elongate shaft and the pull wire (fig. 4; page 4, para. 0052), the securement member including a release point 150; advancing the medical device through the microcatheter to the treatment site (page 4, para. 0053); grasping the securement member on either side of the release point and the securement member is snapped into two pieces at the release point with a single motion (page 4, para. 0055), with the pull wire fixedly secured to a proximal portion of the securement member (fig. 4); and translating the pull wire relative to the elongate shaft by moving the proximal portion of the securement member proximally, thereby releasing the medical device from the elongate shaft (page 4, para. 0054).
Claim 17 differs from Pederson in calling for the securement member to include first and second separate visible markers positioned on either side of the release point such that the user can grasp the securement member at the first visible marker and the second visible marker to snap the securement member. Bardsley teaches a securement member having first and second separate visible markers 26 positioned on either side of the release point such that the user can grasp the securement member as the first and second markers and break the securement member at the release point between the two markers (fig. C; page 6, para. 0072). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the securement member of Pederson to include first and second visible markers on either side of the release point as taught by Pederson to provide the user with a readily discernable indication of where the break point is and thereby increase ease of use.
Regarding claim 18, Pederson discloses that the proximal portion of the securement member is fixedly attached to the pull wire and the distal portion of the securement member is fixedly attached to the elongate shaft (page 4, para. 0051).
Regarding claim 19, Pederson discloses that a first portion of a release mechanism 172 is attached to the distal end of the elongate shaft and a second portion of the release mechanism 174 is attached to a proximal end of the medical device (page 4, para. 0054).
Regarding claim 20, Pederson discloses that the pull wire is slidably disposed within the distal portion of the securement member, the elongate shaft, the first portion of the release mechanism, and the second portion of the release mechanism (page 4, para. 0054).
Claim(s) 3-5 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson in view of Bardsley as applied to claim 1 above, and further in view of Griffin (US 2006/0282112).
Claim 3 differs from Pederson in calling for the release wire to form a frictional fit with the proximal portion of the securement member. Griffin teaches a medical device having a movable wire, wherein the wire is connected to an outer member via friction fit to ensure a secure connection between the wire and the outer member (page 3, para. 0028; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the release wire of Pederson to form a friction fit with the proximal portion of the securement member as taught by Griffin because Griffin teaches that friction fit is a secure means to attach a wire to an outer member that allows the two elements to be moved as a unit without decoupling. Additionally, this is a low cost means for attaching the elements to each other as it does not require additional materials.
Claim 4 differs from Pederson in calling for the proximal portion of the securement member to crimped down onto the release wire. Griffin teaches a medical device having a movable wire, wherein the wire is connected to an outer member by crimping the outer member onto the wire to ensure a secure connection between the wire and the outer member (page 3, para. 0028; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal portion of the release member to be crimped onto the wire as taught by Griffin because Griffin teaches that crimping is a secure means to attach a wire to an outer member that allows the two elements to be moved as a unit without decoupling. Additionally, this is a low cost means for attaching the elements to each other as it does not require additional materials.
Claim 5 differs from Pederson in calling for the release wire to welded, soldered or adhesively secured to the proximal portion of the securement member. Griffin teaches a medical device having a movable wire, wherein the wire is connected to an outer member by soldering or welding to ensure a secure connection between the wire and the outer member (page 3, para. 0028; fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal portion of the release member to be soldered or welded onto the wire as taught by Griffin because Griffin teaches that crimping is a secure means to attach a wire to an outer member that allows the two elements to be moved as a unit without decoupling. Additionally, this is attachment can withstand high temperatures such as those required for sterilization.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783