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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/29/2026 has been entered.
Response to Amendment
The amendment filed 05/29/2026 has been entered. Claim 1, 5-7, 16-23, 39-40, 42, 45-47 are pending in the application.
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 1 and 46 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. Claims 1 and claim 46 recites a version of the distal conical tapered region and the distal conical tapered region being flush with one another. While the specification provides support for the regions being “substantially flush” or having a dimensional transition that does not exceed 0.004” (see page 20, lines 6-15 of the instant specification), it does not provide any support for a fully flush transition.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “a gap between the distal conical tapered region and an outer diameter of the tapered distal tip region of the inner member is below 0.004"”. Claim 1 requires that the proximal portion of the tapered distal tip region is flush with the distal conical tapered region, thereby implying that there is no gap. Thus, it is unclear if the claims require a gap or not. For the sake of examination, claim 1 will be interpreted as reciting “substantially flush” instead of just “flush”.
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 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.
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.
Claims 1, 5, 7, 16, 18-20, 22, 23, 40, 42, 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405).
Regarding claim 1, An intravascular delivery system (150, Fig 2A) configured for controllable displacement along a guide wire in a blood vessel of interest (Para 0150, lines 5-12), comprising: an outer member (200, Fig 2A) comprising a distal sheath lumen (223, Fig 2A); and a proximal pusher (230, Fig 2A), wherein the proximal pusher is fused to a proximal end of the distal sheath lumen (Para 0130), further wherein the distal end of the distal sheath lumen comprises a distal conical tapered region that tapers down to a minimum diameter of the distal sheath lumen (Para 0099, lines 3-9), and a coupler (“correspondingly-shaped surface features”) at a proximal end of the distal sheath lumen (Para 0161); an inner member (300, Fig 2A) configured to be disposed through the distal sheath lumen (Para 0070, lines 19-21; Para 0125, lines 1-3), wherein the inner member comprises a tapered distal tip region (346, Fig 2A), the inner member further comprising a micro-catheter (Para 0145, lines 14-19), and a post (“detent”) extending proud of a middle section of the inner member, wherein the post is configured to releasably lock into the coupler to prevent forward movement of the inner member relative to the outer member (Para 0161) and so that a proximal portion of the tapered distal tip region is flush with the distal conical tapered region (Para 0148; the minimized lip between the two elements can be interpreted as nearly flush), wherein the inner member and the outer member may be moved together as an integral device by manipulating the proximal pusher (Para 0160-0161.)
Wilson is silent regarding the coupler being a snap-fit coupler; the distal taper region comprising a balloon member extending along the tapered distal tip of the inner member, wherein the balloon member is a pre-dilation balloon to pre-dilate a blockage within the blood vessel of interest.
Shaknovich teaches an inner member (7, Fig 1), wherein the inner member has a distal taper region comprising a balloon member (8, Fig 1) extending along the tapered distal tip of the inner member, wherein the balloon member is a pre-dilation balloon to pre-dilate a blockage within the blood vessel of interest (Col 5, lines 43-47).
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 inner member to comprise a pre-dilation balloon as taught by Shaknovich in order to have a relatively small uninflated diameter in order to reliably cross into the desired location in the vessel while also having a sufficiently large inflated diameter to create a channel adequate for passage of a stent-balloon assembly (Col 3, lines 15-20).
The modified invention of Wilson and Shaknovich disclose all of the elements of the invention as discussed above, however, is silent regarding the coupler being a snap-fit coupler.
Montano teaches an inner member (16, Fig 2) and an outer member (24, Fig 2), wherein the outer member comprises a snap-fit coupler (10, Fig 2) at a proximal end and the inner member comprises a post (22, Fig 2) extending proud, wherein the post is configured to releasable lock into the snap-fit coupler (Col 4, lines 1-11).
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 coupler and post discloses by Wilson to be a snap-fit coupler and post as taught by Montano in order to have an interconnection mechanism that is simple, easily detachable, and can maintain a firm connection (Col 3, lines 23-26).
Regarding claim 5, the modified invention of Wilson, Shaknovich, and Montano further discloses a diameter of said micro-catheter (346, Fig 2A -Wilson) does not exceed 1mm (Para 0145, lines 14-19 -Wilson; 0.031in = 0.79mm).
Regarding claim 7, the modified invention of Wilson, Shaknovich, and Montano further discloses the proximal pusher (230, Fig 4F -Wilson) comprises a flattened distal end region (Para 0128 -Wilson, lines 1-9; the solid wire can be oval or quarter circle shaped) fused to the proximal end of the distal sheath lumen thereof and secured to the outer member proximal end (Para 0127, lines 1-5; Also see Fig 2A -Wilson).
Regarding claim 16, the modified invention of Wilson, Shaknovich, and Montano disclose said micro-catheter (346, Fig 2A –Wilson) comprises a flexible material having differential flexibility along a length thereof, wherein the flexibility of the micro-catheter increases towards a distal end thereof (Para 0146, lines 6-8 -Wilson).
Regarding claim 18, the modified invention of Wilson, Shaknovich, and Montano further discloses a flat wire helical coil member (“wound ribbon”, Para 0117 -Wilson) forming at least a portion of the distal sheath lumen (222, Fig 2A -Wilson) (Para 0117 -Wilson).
Regarding claim 19, the modified invention of Wilson, Shaknovich, and Montano further discloses the proximal pusher (230, Fig 4F -Wilson) comprises a round solid wire flattened at the distal end thereof (Para 0128 -Wilson, lines 1-9; the solid wire can be oval or quarter circle shaped),
Regarding claim 20, the modified invention of Wilson, Shaknovich, and Montano further discloses the flat wire helical coil member comprises a shape memory alloy (Para 0117, lines 1-10 -Wilson; Nitinol is a shape-memory alloy).
Regarding claim 22, the modified invention of Wilson, Shaknovich, and Montano further discloses one or more radio-opaque markers (344a, Fig 2A -Wilson) attached to a distal end of the micro-catheter (Para 0121, lines 1-5; Para 0158, lines 11-16 -Wilson).
Regarding claim 23, the modified invention of Wilson, Shaknovich, and Montano discloses one or more radio-opaque markers (344a and 344b, Fig 2A -Wilson) attached to the tapered distal tip region (346, Fig 2A -Wilson) of the inner member in proximity to the balloon member (8, Fig 1 - Shaknovich) (As the balloon member is attached to the distal tip of inner member as taught by Shaknovich and the markers are on a distal tip of the inner member as taught by Wilson, the modified invention of Wilson and Shaknovich would teach that the markers on the distal tip are in proximity to the balloon member on the distal tip).
Regarding Claim 40, the modified invention of Wilson, Shaknovich, and Montano discloses the inner member (300, Fig 7A -Wilson) comprises a rapid exchange guidewire port (362, Fig 7B) proximal to the post (Para 0150; “the proximal opening 362 can be located near a region where the elongate body 360 is joined to the proximal portion 366”).
Regarding claim 42, the modified invention of Wilson, Shaknovich, and Montano discloses the balloon member (8, Fig 1 -Shaknovich) of the inner member comprises a smooth surface (See Fig 1 - Shaknovich; there are no surface features or drug crystals illustrated or discussed and thus is smooth at least compared to a balloon that contains surface features or drug crystals).
Regarding claim 45, the modified invention of Wilson, Shaknovich, and Montano discloses the balloon member is tapered (See Figs 1 and 2 of Shaknovich where the balloon is tapered at a distal end and proximal end of the balloon).
Regarding claim 46, the modified invention of Wilson, Shaknovich, and Montano discloses the distal conical tapered region is configured to be stretched to be flush against the distal conical tapered region of the inner member (Para 0148; the minimized lip between the two elements can be interpreted as flush).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405) and further in view of Meguro (US 2002/0087076).
Regarding claim 6, the modified invention of Wilson, Shaknovich, and Montano discloses said outer member, at the distal end thereof, is configured with a tapered outer tip (Para 0099, lines 3-8 -Wilson), however, is silent regarding wherein a gap between the distal conical tapered region and an outer diameter of the tapered distal tip region of the inner member is below 0.004".
Meguro teaches a tapered distal tip (5a, Fig 6) of said inner member (A, Fig 6) interfaces, at the outer surface thereof, with an inner surface of said tapered outer tip (6a, Fig 6) of said outer member (B, Fig 6), and wherein a gap between the outer diameter of the outer member and the outer diameter of the inner member is below 0.004" (Para 0059, “without a gap”).
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 inner member and outer member disclosed by Wilson, Shaknovich, Montano to have a dimensional transition below 0.004” as taught by Meguro in order to have an intravascular system that can mitigating pains felt by the patient (Para 0002; Para 0020-0021).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405) and further in view of Sutton (US 5704926).
Regarding claim 17, the modified invention of Wilson, Shaknovich, and Montano discloses the material of the micro-catheter increases in flexibility towards the distal end (Para 0146, lines 6-8 -Wilson), however, it is silent regarding the tapered delivery micro-catheter comprises a flat wire helical coil, and wherein a pitch of said flat wire helical coil changes along the length of said tapered delivery micro-catheter to increase the flexibility of the tapered delivery micro-catheter towards the distal end thereof.
Sutton teaches a catheter (10, Fig 2) that is formed of a flexible material having differentially flexibility along the length (Col 3, lines 28-51) and includes a flat wire helical coil (14, Fig 2) extending along said predetermined length of said catheter, and wherein the pitch of said flat wire helical coil changes along the length of said catheter to increase the flexibility of the catheter towards the distal end thereof (Col 3, lines 28-51)
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 micro-catheter disclosed by Wilson, Shaknovich, and Montano to include a flat wire helical coil of varying pitch in order to have a micro-catheter that has a good compression strength at the proximal end and has great trackability at the distal end (Col 3, lines 28-51).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405) and further in view of Stigall (US 2014/0058251).
Regarding claim 21, the modified invention of Wilson, Shaknovich, and Montano discloses the flat wire helical member can be made of a variety of different materials (Para 0117 -Wilson), however, it is silent regarding said flat wire helical coil comprises a radio-opaque material.
Stigall discloses a flat wire helical coil member (120, Fig 2) is formed of a radio-opaque material (Para 0034, lines 1-6).
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 flat wire helical coil member disclosed by Wilson, Shaknovich, and Montano with the radio-opaque flat wire helical coil taught by Stigall in order to have a micro-catheter where the user can visualize the progress of the catheter toward the target location (Para 0003, lines 1-3).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405) and further in view of Patterson (US 6,648,854).
Regarding claim 39, the modified invention of Wilson, Shaknovich, and Montano discloses the inner member comprises hub (375, Fig 7A), however, is silent regarding it being a balloon inflation hub.
Patterson teaches an analogous balloon catheter (10, Fig 1) comprising a balloon inflation hub (14, Fig 1).
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 hub disclosed by Wilson to be a ballon inflation hub in order to have a hub that can be connected to a fluid source such as a syringe for inflating and deflating balloon (Col 3, lines 34-37).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2018/0193042) in view of Shaknovich (US 5,807,398) and further in view of Montano (US 5,813,405) and further in view of Limon (US 6585747).
The modified invention of Wilson, Shaknovich, and Montano discloses the stent (Para 0091, lines 23-30 -Wilson) , wherein the stent is configured to be disposed at least partially within the sheath lumen of the outer member (the working device such as the stent is delivered through the outer member or catheter 200 as described in para 0094-0095 -Wilson), wherein the inner member and the stent are separate interventional devices (Para 0091, lines 23-30 -Wilson), however is silent regarding a stent catheter comprising a delivery balloon and a stent, wherein the stent catheter is configured to be disposed at least partially within the sheath lumen of the outer member subsequent to pre-dilatation, wherein, in a stent delivery mode of operation, the inner member is removed from the outer member and the stent catheter is configured to be advanced distally through the outer member, wherein the delivery balloon of the stent catheter is configured to be inflated to deploy the stent within the blood vessel of interest.
Limon teaches a stent catheter (12, Fig 1) comprising a delivery balloon (14, Fig 1) and a stent (26, Fig 1), wherein the stent catheter is configured to be disposed at least partially within the sheath lumen (“guide catheter”) of the outer member subsequent to pre-dilatation, wherein the inner member and the stent catheter are separate interventional devices , wherein, in a stent delivery mode of operation, the inner member is removed from the outer member and the stent catheter is configured to be advanced distally through the outer member, wherein the delivery balloon of the stent catheter is configured to be inflated to deploy the stent within the blood vessel of interest (Col 3, line 66- Col 4, line 5).
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 stent disclosed by Wilson, Shaknovich, and Montano to be a stent catheter comprising a delivery balloon and stent as taught by Limon in order to have a system that can reduce or prevent catching of the stent on objects as it moves through the vasculature and a system having a relatively low profile (Col 2, lines 12-19).
Response to Arguments
Applicant’s arguments filed 05/29/2025, on pages 8-10, regarding Wilson, Gianotti, and Alley failing to teach all of the elements of the amended claim have been fully considered but are moot in view of the current rejection that relies on Wilson, Shaknovich, and Montano to teach the new limitations. Specifically, Shaknovich is relied on to teach the pre-dilatation balloon as claimed and Montano is relied on to teach the snap-fit coupler.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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