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 Amendment
The claims filed on April 10th, 2026 have been entered. Claims 1-13 and 21 are pending in the application. Claim 13 remains withdrawn from consideration for being drawn to an unelected species. The amendments to the claims overcome the previous claim objections and the previous 35 U.S.C. 112(b) rejection of claim 3.
Claim Objections
Claims 2 and 21 are objected to because of the following informalities:
Claim 2, Line 1 states “a first more distal hoop segment”, it is suggested to change this to “the first more distal hoop segment”.
Claim 2, Line 3 states “a second more proximal hoop segment of the plurality of distal hoop segments forming”, it is suggested to change this to “the second more proximal hoop segment of the plurality of distal hoop segments comprises”.
Claim 21, Lines 1- 2 state “a distalmost hoop”, it is suggested to change this to “a distal most hoop”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5 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 5, Lines 1-2 recites the limitation “one or more connecting spines connecting the distal hoop segments of the support frame with the elongate body”, it is unclear whether applicant is intending to further limit the axial spine, which is established within claim 1, or if applicant is intending to establish more spines in addition to the axial spine. For purposes of examination, this limitation is herein interpreted in the broadest reasonable interpretation as further limiting the axial spine, wherein the axial spine connects the distal hoop segments of the support frame with the elongate body.
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.
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.
The rejection of claims 1-8 and 10-11 under 35 U.S.C. 102(a)(1) over Nguyen et al. (WO 2021/016213) has been withdrawn in light of applicant’s amendments; specifically, Nguyen does not teach a first more distal hoop segment of the plurality of distal hoop segments defining a first plane forming a first folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, a second more proximal hoop segment of the plurality of distal hoop segments defining a second place comprising a second folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, and the first folded angle being less than the second folded angle, or wherein the first plane intersects the longitudinal axis at a first point distal to a second point where the second plane intersects the longitudinal axis.
The rejection of claims 9 and 12 under 35 U.S.C. 103 over Nguyen et al. (WO 2021/016213) has been withdrawn in light of applicant’s amendments; specifically, Nguyen does not teach a first more distal hoop segment of the plurality of distal hoop segments defining a first plane forming a first folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, a second more proximal hoop segment of the plurality of distal hoop segments defining a second place comprising a second folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, and the first folded angle being less than the second folded angle, or wherein the first plane intersects the longitudinal axis at a first point distal to a second point where the second plane intersects the longitudinal axis.
Claim(s) 1- 11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al. (US 11,376,028).
Regarding claims 1 and 9, Saadat (Saadat et al.) teaches a catheter (system 900)(abstract)(Figs. 9- 10B) comprising:
an elongate body (proximal member 906) comprising a longitudinal axis, an inner diameter, and a distal end (see annotated Fig. 9 below); and
a support frame (funnel scaffolding 901, funnel film 907) connected at the distal end of the elongate body comprising a collapsed delivery configuration, an expanded deployed configuration (see annotated Fig. 9 below)(Column 23, Line 61- Column 24, Line 10), and a framework of struts (funnel scaffolding 901) comprising a plurality of distal hoop segments (see annotated Fig. 10 below); and
an axial spine (guidewire lumen 902) extending through the elongate body and the support frame along the longitudinal axis (Column 23, Lines 61- 65), each of the plurality of distal hoop segments extending from the axial spine at distances from the elongate body (see annotated Fig. 10A below),
at least a portion of the distal hoop segments are configured to fold distally in the collapsed delivery configuration such that a collapsed inner diameter of the support frame is approximately equal to the inner diameter of the elongate body (see annotated Fig. 9 below),
a first more distal hoop segment of the plurality of distal hoop segments defining a first plane forming a first folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration (see annotated Fig. 9 below).
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Regarding a second more proximal hoop segment of the plurality of distal hoop segments defining a second place comprising a second folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, and the first folded angle being less than the second folded angle, although drawings are not to scale, it is obvious and well within the purview of one of ordinary skill in the art to make the device as shown in Fig. 9, therefore as the second hoop is smaller than the first hoop, then when in the collapsed configuration the second more proximal hoop segment of the plurality of distal hoop segments defines a second plane comprising a second folded angle that is greater than the first folded angle (see annotated Fig. 9 below).
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Saadat further teaches wherein the first plane intersects the longitudinal axis at a first point distal to a second point where the second plane intersects the longitudinal axis (see annotated Fig. 9 below).
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Regarding claim 2, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein the first more distal hoop segment of the plurality of distal hoop segments comprises a first diameter when the support frame is in the expanded deployed configuration and the second more proximal hoop segment of the plurality of distal hoop segments comprises a second diameter when the support frame is in the expanded deployed configuration, the first diameter being greater than the second diameter (see annotated Fig. 10A below)(see Fig. 10B)(Column 23, Line 61- Column 24, Line 10).
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Regarding claim 3, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein the distal hoop segments comprise a curvilinear profile in the collapsed delivery configuration (see annotated Fig. 9 below).
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Regarding claim 4, Saadat makes obvious the catheter as discussed above.
Saadat is silent to wherein the support frame further comprises a longitudinal length sized to be less than three times the inner diameter of the elongate body.
However, since Saadat teaches a catheter for use in the vasculature of the body that removes acute blockages from the vessel (abstract, Column 2, Lines 10- 17), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the longitudinal length of the support frame to be less than three times the inner diameter of the elongate body, as it has been held that 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 5, Saadat makes obvious the catheter as discussed above.
Saadat further teaches one or more connecting spines connecting the distal hoop segments of the support frame with the elongate body (see annotated Fig. 10A below).
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Regarding claim 6, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein the plurality of distal hoop segments is configured to fold so the support frame comprises a collapsed inner diameter in the collapsed delivery configuration approximately equal to the inner diameter of the elongate body (see annotated Fig. 9 below)(Column 23, Line 61- Column 24, Line 10).
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Regarding claims 7 and 8, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein the plurality of distal hoop segments comprise distally unconnected peaks which move distally when the support frame is folded to the collapsed delivery configuration and wherein the distally unconnected peaks are configured to move proximally when the support frame is in the expanded deployed configuration (see annotated Figs. 9 and 10A below)(Column 23, Line 61- Column 24, Line 10).
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Regarding claim 10, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein the plurality of distal hoop segments form a series of rings concentric with the longitudinal axis when the support frame is in the expanded deployed configuration (see annotated Fig. 10B below)(Column 23, Line 61- Column 24, Line 10).
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Regarding claim 11, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein at least a portion of each of the plurality of distal hoop segments form an acute angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration (see annotated Fig. 9 below)(Column 23, Line 61- Column 24, Line 10).
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Regarding claim 21, Saadat makes obvious the catheter as discussed above.
Saadat further teaches wherein a distal most hoop segment comprises a first radial size that is larger than a second radial size of a most proximal hoop segment (see annotated Fig. 10B below)(Column 23, Line 61- Column 24, Line 10).
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Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadat et al. (US 11,376,028) in view of Nguyen (WO 2021/016213).
Saadat does not teach wherein each hoop segment of the plurality of distal hoop segments comprises a non-planar cross section when the support frame is in the collapsed delivery configuration.
Nguyen teaches a support frame (Fig. 20) comprising a scaffold with struts (200) with bends (201) at the crown tip (Paragraph 0247) and therefore forming a non-planar cross section when the support frame is in the collapsed delivery configuration.
It would have been obvious to modify each hoop segment of the plurality of distal hoop segments as taught by Saadat to have a non-planar cross section as taught by Nguyen, since Nguyen teaches that the non-planar cross section allows for the scaffold “to better conform to the vessel in the expanded state for superior vacuum sealing” (Paragraph 0247).
Response to Arguments
Applicant’s arguments, see Pages 6- 7, filed April 10th, 2026, have been fully considered but are moot as the previous rejection were withdrawn in view of the amendments. It is noted that Nguyen is still relied upon for limitations not argued.
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 LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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