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
Claims filed on November 3rd, 2025 have been entered. Claims 1- 14 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of Species E in the reply filed on November 3rd, 2025 is acknowledged. Claims 13- 14 are withdrawn for being drawn to an unelected species.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claim 1, Line 6 states “segments folding distally”, it is suggested to change this to “segments fold distally”.
Claims 2- 12 are objected to for being dependent on or from objected claim 1.
Claim 2, Line 1 states “claim 1, a first more distal”, it is suggested to change this to “claim 1, wherein a first more distal”.
Claim 2, Line 2 states “comprising”, it is suggested to change this to “comprises”.
Claim 3, Line 1 states “claim 1, the struts of the distal hoop segments comprising”, it is suggested to change this to “claim 1, wherein the struts of the distal hoop segments comprise”.
Claim 4, Line 1 states “claim 1, the support frame further comprising”, it suggested to change this to “claim 1, wherein the support frame further comprises”.
Claim 6, Line 1 states “claim 1, the plurality of distal hoop segments folding so the”, it suggested to change this to “claim 1, wherein the plurality of distal hoop segments fold so that the”.
Claim 7, Line 1 states “claim 1, the plurality of distal hoop segments comprising”, it suggested to change this to “claim 1, wherein the plurality of distal hoop segments comprises”.
Claim 8, Line 1 states “claim 7, the distally unconnected peaks moving”, it is suggested to change this to “claim 7, wherein the distally unconnected peaks are move”.
Claim 9, Line 1 states “claim 1, a first”, it is suggested to change this to “claim 1, wherein a first”.
Claim 9, Line 2 states “forming”, it is suggested to change this to “forms”.
Claim 9, Line 4 states “forming”, it is suggested to change this to “forms”.
Claim 10, Line 1 states “claim 1, the plurality of distal hoop segments forming”, it suggested to change this to “claim 1, wherein the plurality of distal hoop segments form”.
Claim 11, Line 1 states “claim 1, at least”, it is suggested to change this to “claim 1, wherein at least”.
Claim 11, Line 2 states “forming”, it is suggested to change this to “forms”.
Claim 12 Line 1 states “claim 1, each”, it is suggested to change this to “claim 1, wherein each”.
Claim 12, Line 2 states “comprising”, it is suggested to change this to “comprises”.
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 3 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 3 recites the limitation "the struts of the distal hoop segments" in Line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear what struts are being referred to in this claim limitation, that of the framework of struts that comprises the distal hoop segments which would not be of the distal hoop segments but would be “the struts that form the distal hoop segments” as established in claim 1, or a new set of struts of which there is no antecedent basis. For purposes of examination, the framework of struts is interpreted as the struts within the claim.
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.
Claim(s) 1-8, and 10- 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (WO 2021/016213).
Regarding claim 1, Nguyen (Nguyen et al.) teaches a catheter (distal expandable segment 1, intermediate segment 2, proximal segment 3, self-expanding scaffold as shown in Figs. 20 and 21)(abstract, Paragraph 218)(Figs. 1A-1B, 20, and 21) comprising: an elongate body (2, 3) comprising a longitudinal axis, an inner diameter (Paragraph 0185), and a distal end (see annotated Fig. 1A below), and a support frame (distal expandable segment 1 and self-expanding scaffold as shown in Figs. 20 and 21)(Paragraph 218) connected at the distal end of the elongate body (Paragraph 0248) comprising a collapsed delivery configuration, an expanded deployed configuration (Paragraphs 0248- 250), and a framework of struts comprising a plurality of distal hoop segments (see annotated Fig. 21 below)(For purposes of examination, the embodiment of Nguyen used is shown within Fig. 21, but with another two sinusoidal rings attached to the proximal end of the scaffold, as taught in Paragraph 0252 by Nguyen.).
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Regarding wherein at least a portion of the distal hoop segments fold distally in the collapsed delivery configuration, as Nguyen teaches that the scaffold is self-expanding, compressible, and that the distal hoop segments are angled (Paragraphs 0237 and 0248)(see annotated Fig. 21 below), when the scaffold is pulled back into a sheath, the distal hoop segments would fold distally into a collapsed delivery configuration.
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Regarding that a collapsed inner diameter of the support frame is approximately equal to the inner diameter of the elongate body, when the scaffold is pulled into a sheath with a diameter that is equal to the elongate body (Paragraph 0237), then the portion of the distal hoop segments would be compressed into an internal diameter that is approximately equal to the inner diameter of the sheath.
Regarding claim 2, Nguyen teaches the catheter as discussed above.
Nguyen further teaches wherein a 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 (see annotated Fig. 21 below) and a second more proximal hoop segment (ring 212) of the plurality of distal hoop segments forming 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. 21 below)(Paragraph 0248).
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Regarding claim 3, Nguyen teaches the catheter as discussed above.
Nguyen further teaches wherein the struts of the distal hoop segments comprises a curvilinear profile in the collapsed delivery configuration (see annotated Fig. 21 below)(Paragraphs 0237 and 0248).
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Regarding claim 4, Nguyen teaches the catheter as discussed above.
Nguyen further teaches wherein the support frame further comprising a longitudinal length sized to be less than three times the inner diameter of the elongate body (Paragraphs 0051, 0081, and 0254).
Regarding claim 5, Nguyen teaches the catheter as discussed above.
Nguyen further teaches the catheter further comprising one or more connecting spines (240) connecting the distal hoop segments of the support frame with elongate body (The spines indirectly connect the distal hoop segments to the elongate body through the ring of the support frame.)(Paragraph 0248).
Regarding claim 6, Nguyen teaches the catheter as discussed above.
Regarding wherein the plurality of distal hoop segment fold so that the support frame comprises a collapsed inner diameter in the collapsed delivery configuration approximately equal to the inner diameter of the elongate body, as discussed above, when the scaffold is pulled into a sheath with a diameter that is equal to the elongate body (Paragraph 0237), then the distal hoop segments would be compressed into an internal diameter that is approximately equal to the inner diameter of the sheath.
Regarding claim 7, Nguyen teaches the catheter as discussed above.
Nguyen 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 (see annotated Fig. 21 below)(As Nguyen teaches that the scaffold is self-expanding, compressible, and that the distal hoop segments are angled (Paragraphs 0237 and 0248)(see annotated Fig. 21 below), when the scaffold is pulled back into a sheath, the unconnected peaks move distally.).
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Regarding claim 8, Nguyen teaches the catheter as discussed above.
Nguyen further teaches wherein the distally unconnected peaks move proximally when the support frame is in the deployed configuration (As Nguyen teaches that the scaffold is self-expanding and the distal hoop segments are angled (Paragraphs 0237 and 0248)(see annotated Fig. 21 below), when the scaffold is pushed out of a sheath, the distally unconnected peaks would move proximally to assume a deployed configuration.).
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Regarding claim 10, Nguyen teaches the catheter as discussed above.
Regarding 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, as discussed above, for purposes of examination, the embodiment of Nguyen used is shown within Fig. 21, but with another two sinusoidal rings attached to the proximal end of the scaffold, as taught in Paragraph 0252 by Nguyen, therefore the sinusoidal rings, and the plurality of distal hoop segments that make up the rings, would form a series of rings concentric with the longitudinal axis (see annotated Fig. 21 below).
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Regarding claim 11, Nguyen teaches the catheter as discussed above.
Regarding wherein at least a portion of each of the plurality of distal hoop segments forming an acute angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, as Nguyen teaches that the plurality of distal hoop segments are angled (see annotated Fig. 21 below), then when the plurality of distal hoop segments are collapsed within an outer sheath they would form an acute angle with respect to the longitudinal axis.
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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.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (WO 2021/016213).
Regarding claim 9, Nguyen teaches the catheter as discussed above.
Nguyen teaches a first more distal hoop segment of the plurality of distal hoop segments (see annotated Fig. 21 below) and a second more proximal hoop segment (ring 212) of the plurality of distal hoop segments.
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Regarding wherein the first more distal hoop segment of the plurality of distal hoop segments forms a first folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, as Nguyen teaches that the distal hoop segments are compressible, and that the distal hoop segments are angled with respect to the longitudinal axis, when compressed they would form a first folded angle (see annotated Fig. 21 below).
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Regarding wherein the second more proximal hoop segment of the plurality of distal hoop segments forms a second folded angle with respect to the longitudinal axis when the support frame is in the collapsed delivery configuration, when the scaffold is pulled into a sheath, the ring connected to the elongate body would form a folded angle of around 90 degrees in regards to the longitudinal axis.
Regarding wherein the first folded angle being less than the second folded angle, since the first more distal hoop segment would form an angle that is smaller compared to the folded angle of the ring, since it would be smaller than the around 90 degrees of the second folded angle, the first folded angle would be less than the second folded angle.
Regarding claim 12, Nguyen teaches the catheter as discussed above.
Nguyen does not teach in the current embodiment each hoop segment of the plurality of distal hoop segments comprising a non- planar cross section when the support frame is in the collapsed delivery configuration.
Nguyen teaches in another embodiment, 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 the first embodiment to have a non-planar cross section as taught by the second embodiment of 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).
Conclusion
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