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
This Office Action is a response to applicant’s arguments and amendment filed 10/23/2025. Claims 1-2, 6-7 and 14 are amended. Claims 1-20 are currently pending, with claims 3, 8, 16 and 18-20 withdrawn from consideration.
The objection of claims 2 and 6 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/23/2025, with respect to the rejection(s) of claim(s) 1-2, 5-6, 9-10 and 12 under 35 U.S.C. 102(a)(2) as being anticipated by Sirhan; claim 4 under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Cummings; claim 7 under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Don Michael; claim 11 under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Brady; claim 13 under 35 U.S.C. 103 as being unpatentable over Sirhan; and claims 14-15 and 17 under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Saadat, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Sirhan does not teach or disclose the circumferential radial crease as claimed, because bend 163 is not a circumferential radial crease, as it does not extend continuously around a circumference of the outer surface of the proximal end of the flared tip (Remarks, pgs. 6-7).
In response to applicant’s argument, it is respectfully submitted the arguments are narrower than the claim limitations. Applicant continues to argue bends 163 do not meet the claim limitation, however, the claim language now recites one circumferential radial crease extending continuously around a circumference of an outer surface of a proximal end of the flared tip. The claim language does not preclude multiple bends 163 from existing within the device, such that a singular bend 163 meets the claim limitation of one circumferential radial crease, because a singular bend 163 still extends around a portion of the circumference of tip 1. Further, a singular bend 163 does not include gaps or segments within itself as depicted in fig. 16 and therefore meets the limitation of extending continuously as claimed. It appears applicant is trying to distinguish over Sirhan by claiming only one radial crease 218 which extends completely around the circumference of the tip without including any segments or gaps, however, this is not supported in the instant specification. The instant spec. does not describe radial crease 218 extending completely around the tip. Fig. 3a of the instant spec. depicts a cross-section of crease 218, however, this does not illustrate crease 218 being continuous, such that a cross-section of crease 218 including segments could look similar to the crease 218 depicted in fig. 3a. Accordingly, as discussed below, the claim limitation is met, because a singular bend 163 of Sirhan meets the claimed limitation of extending continuously around a circumference of an outer surface of a proximal end of the flared tip.
Claim Objections
Claim 7 is objected to because of the following informalities:
In claim 7, lines 1-2, the phrase “wherein the one circumferential radial crease are configured” should read “wherein the one circumferential radial crease is configured”.
Appropriate correction is required.
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.
Claim(s) 1-2, 5-6, 9-10 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sirhan (US 2023/0149035 A1) (all references previously of record).
Regarding claim 1, Sirhan discloses (abstract; paras. [0618]-[0879]; figs. 1a-93c) a catheter (fig. 1a) for administering intravascular treatments (abstract), the catheter comprising:
a longitudinal axis (fig. 1a);
an elongate body (includes intermediate shaft 2 and proximal shaft 3, para. [0619]) comprising a distal end (distal end of shaft 2), a lumen (fluid-impermeable lumen, para. [0630]; fig. 3), an inner liner (34, para. [0632]), a reinforcing layer (35), and one or more outer polymeric jackets (36, fig. 3);
a polymeric flared tip (1, embodiment of distal expandable segment depicted in fig. 16, paras. [0620] and [0626]) connected to the distal end of the elongate body (fig. 1a), the flared tip comprising a collapsed delivery configuration (contracted state, para. [0620]), and an expanded deployed configuration (expanded state, fig. 1b), and a plurality of axial ribs (162, para. [0677]; fig. 16); and
one circumferential radial crease (a first bend 163, which extends along at least a portion of a circumference and is therefore considered to meet the claim limitation of a circumferential radial crease, para. [0677]) located distal of the distal end of the elongate body (figs. 1a-3 depict tip 1 distal of intermediate shaft 2) and within the flared tip (extends internal to membrane 14, figs. 1b and 16), the circumferential radial crease extending continuously around a circumference of an outer surface of a proximal end of the flared tip (first bend 163 considered to extend continuously around a circumference of a proximal end of tip 1, because bend 163 extends around tip 1, therefore extending around a circumference of tip 1, and further extends continuously because a single bend 163 extends continuously (i.e. a single bend 163 is not segmented) and surrounds the proximal end of tip 1; note this appears to be consistent with fig. 3a of the instant spec. depicting crease 218 distal of the proximalmost end of the flared tip).
Regarding claim 2, Sirhan discloses the catheter of claim 1. Sirhan further discloses wherein the plurality of axial ribs comprise internal ribs (struts 162 considered to be internal to membrane 14, para. [0619]; figs. 1a-b) extending radially inward from the inner surface of the flared tip (covered by membrane 14, considered to extend radially inward from inner surface of membrane 14, figs. 1a-b) and terminating at the proximal end of the flared tip (terminates at proximal end 161, para. [0677]).
Regarding claim 5, Sirhan discloses the catheter of claim 1. Sirhan further discloses wherein a ratio of an inner diameter of the elongate body to a maximum inner diameter of the flared tip in the expanded deployed configuration is in a range from approximately 0.55-0.90 (diameter of scaffold may be expanded to between 2 and 6mm and expands to a diameter ranging from 1.1 to 3 times the non-expandable segment, such that when the maximum diameter of the scaffold is 2mm and the scaffold expands to a diameter 1.1 times the non-expandable segment of the catheter, the diameter of the non-expandable segment is 1.82mm, and the ratio of the inner diameter of the non-expandable segment (1.82mm) to the diameter of the scaffold (2mm) is 0.9, para. [0675]).
Regarding claim 6, Sirhan discloses the catheter of claim 1. Sirhan further discloses wherein the reinforcing layer of the elongate body terminates axially at the proximal end of the flared tip (terminates in shaft 31, figs. 1a and 3, paras. [0630]-[0632]).
Regarding claim 9, Sirhan discloses the catheter of claim 1. Sirhan further discloses the flared tip further comprising a maximum inner diameter in the expanded deployed configuration larger than that of an outer sheath through which the catheter is delivered (depicted in fig. 28a, para. [0694]).
Regarding claim 10, Sirhan discloses the catheter of claim 1. Sirhan further discloses wherein each of the one or more polymeric jackets comprises at least one of Pebax (para. [0632]).
Regarding claim 12, Sirhan discloses the catheter of claim 1. Sirhan further discloses the flared tip further comprising a maximum inner diameter in a range between approximately 0.088 inches and approximately 0.098 inches in the expanded deployed configuration (configured to expand between 2 and 6mm, para. [0621]).
Claim Rejections - 35 USC § 103
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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Cummings (US 2023/0076384 A1).
Regarding claim 4, Sirhan discloses the catheter of claim 1.
However, Sirhan fails to explicitly disclose wherein at least a portion of the flared tip has a wall thickness greater than a wall thickness of at least a portion of the elongate body.
Cummings teaches (para. [0093]; figs. 28-29), in the same field of endeavor, a catheter including an elongate body (106) and a flared tip (includes 302 and 300), wherein at least a portion of the flared tip has a wall thickness greater than a wall thickness of at least a portion of the elongate body (wall thickness of 302 may be greater, para. [0093]), in place of alternative thicknesses of the elongate body and the flared tip (para. [0093]).
The substitution of one known element (thickness of the flared tip being greater than the elongate body) for another (alternative thicknesses of the flared tip and the elongate body) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the thicker flared tip as taught by Cummings, would have yielded predictable results, specifically, maintaining the internal lumen of the flared tip and the elongate body.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Don Michael (US 2001/0044634 A1).
Regarding claim 7, Sirhan discloses the catheter of claim 1.
However, Sirhan fails to disclose wherein the one circumferential radial crease are configured to facilitate folding of the flared tip from the expanded deployed configuration to the collapsed delivery configuration.
Don Michael teaches (paras. [0085]-[0088]; figs. 12-13), in the same field of endeavor, a catheter for administering intravascular treatments (abstract; fig. 12) comprising a flared tip (fig. 13), wherein one circumferential radial crease (strip 132, para. [0085]; fig. 13) are configured to facilitate folding of the flared tip from the expanded deployed configuration to the collapsed delivery configuration (para. [0087]), for the purpose of providing the appropriate geometry so that deformation upon shape setting and during expansion/contraction stays below acceptable limits, causes a proper folding up of the strips while the filter is forced back into the cylindrical shape after conical shape setting (para. [0087]).
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 bend of Sirhan to be configured to facilitate folding of the flared tip, in order to cause proper folding of the scaffold when forced back into the collapsed configuration by providing the appropriate geometry during expansion/contraction, based on the suggestions and teachings of Don Michael (para. [0087]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Brady (US 2016/0015402 A1).
Regarding claim 11, Sirhan discloses the catheter of claim 1.
However, Sirhan fails to disclose wherein a first wall thickness of at least a portion of the flared tip is different than a second wall thickness of a different portion of the flared tip.
Brady teaches (para. [0202]; fig. 24), in the same field of endeavor, a flared tip (3301, fig. 1), wherein a first wall thickness of at least a portion of the flared tip is different than a second wall thickness of a different portion of the flared tip (strut 3302 comprises thickened strut sections), for the purpose of providing enhanced radiopacity through the additional material volume and surface area provided (para. [0202]).
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 flared tip of Sirhan to include thickened strut sections, in order to provide enhanced radiopacity through the additional material volume and surface area provided, based on the teachings of Brady (para. [0202], para. [0632] of Sirhan).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan.
Regarding claim 13, Sirhan discloses the catheter of claim 1.
However, with respect to the cited embodiment, Sirhan fails to disclose wherein the flared tip tapers at the distal end to a final inner diameter less than a maximum inner diameter of the tip.
However, in a separate embodiment, Sirhan teaches (para. [0691]; fig. 25), in the same field of endeavor, a flared tip (250), wherein the flared tip tapers at the distal end to a final inner diameter less than a maximum inner diameter of the tip (inward-pointing tips 251), for the purpose of pointing the tips into the lumen, such that if the expanded scaffold is advanced in the lumen the tip of the scaffold will help guide it along the vessel (para. [0691]).
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 distal end of struts to be inward-pointing tips, in order to help guide the scaffold along the vessel via the reverse angle of the distal end, based on the teachings of the separate embodiment of Sirhan (para. [0691]).
Claim(s) 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Saadat (US 11376028 B1).
Regarding claim 14, Sirhan discloses (abstract; paras. [0618]-[0879]; figs. 1a-93c) a catheter (fig. 1a) for removing a clot from a target blood vessel (abstract), the catheter comprising:
a longitudinal axis (fig. 1a);
a substantially tubular elongate body (includes intermediate shaft 2 and proximal shaft 3, para. [0619]) comprising a distal end (distal end of shaft 2), a reinforcing layer (35, para. [0632]), and one or more polymer jackets (36, fig. 3);
a metallic support frame (1, embodiment of distal expandable segment depicted in fig. 16, paras. [0622] and [0626]) connected to the distal end of the elongate body (para. [0622]); and
a polymeric flared tip (includes 14, fig. 1a) encapsulating the metallic support frame (covers distal expandable segment, para. [0619]); and
one circumferential radial crease (a first bend 163, which extends along at least a portion of a circumference and is therefore considered to meet the claim limitation of a circumferential radial crease, para. [0677]) located distal of the distal end of the substantially tubular elongate body (figs. 1a-3 depict tip 1 distal of intermediate shaft 2) and within the flared tip (extends internal to membrane 14, figs. 1b and 16), the circumferential radial crease extending continuously around a circumference of an outer surface of a proximal end of the flared tip (first bend 163 considered to extend continuously around a circumference of a proximal end of tip 1, because bend 163 extends around tip 1, therefore extending around a circumference of tip 1, and further extends continuously because a single bend 163 extends continuously (i.e. a single bend 163 is not segmented) and surrounds the proximal end of tip 1; note this appears to be consistent with fig. 3a of the instant spec. depicting crease 218 distal of the proximalmost end of the flared tip),
wherein the flared tip comprises a collapsed delivery configuration (contracted state, para. [0620]), and an expanded deployed configuration (expanded state, fig. 1b).
However, Sirhan fails to disclose the flared tip comprising a plurality of axial ribs.
Saadat teaches, in the same field of endeavor, a catheter (fig. 2a) for removing a clot from a target blood vessel (abstract) comprising a metallic support frame (102, col. 15 lines 50-62 and col. 16 line 66-col. 17 line 39) and a polymeric flared tip (cover 104, col. 16 lines 12-39) encapsulating the metallic support frame (on an outer surface of the frame 102, col. 15 line 63-col. 16 line 11; fig. 2f), wherein the flared tip comprising a plurality of axial ribs (each segment of engagement wall 110 surrounding each orifice, since orifice may include multiple punctures, formed with cover 104, col. 15 line 63-col. 16 line 11 and col. 21 lines 4-11; figs. 2a-3), for the purpose of initially presenting a smaller aspiration area, reducing the unintended collateral aspiration of blood and helping to limit unnecessary blood loss during the procedure when aspirating obstructive material smaller than an inner cross-sectional dimension of the capture structure (col. 14 lines 38-54; figs. 2b-c).
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 flared tip of Sirhan to further include the engagement wall portions extending radially inward, in order to initially present a smaller aspiration area, reducing the unintended collateral aspiration of blood and helping to limit unnecessary blood loss during the procedure when aspirating obstructive material smaller than an inner cross-sectional dimension of the capture structure, based on the teachings of Saadat (col. 14 lines 38-54; figs. 2b-c and 5a).
Regarding claim 15, Sirhan (as modified) teaches the catheter of claim 14. Sirhan (as modified) further teaches wherein the plurality of axial ribs comprise internal ribs (each segment of engagement wall 110 considered to be internal due to extending inwardly, figs. 2b-c and 5a of Saadat) extending radially inward from the inner surface of the flared tip (depicted in figs. 2b-c and 5a of Saadat).
Regarding claim 17, Sirhan (as modified) teaches the catheter of claim 14. Sirhan further discloses wherein the metallic support frame comprises one or more support arms (162, para. [0677]) extending distally from the distal end of the elongate body (figs. 1a and 16).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771