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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 6 and 26 are 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 is recited to be dependent from claim 5. However, claim 5 has been previously canceled, rendering all limitations recited within claim 6 as lacking proper antecedent basis. For the purposes of examination, claim 6 is interpreted to depend from claim 1 until otherwise amended to provide proper antecedent basis for the recited limitations.
Claim 25 recites the limitation “the first elongate element”. There is no proper antecedent basis for this limitation as no “first elongate element” has been introduced or defined within claim 25. For the purposes of examination, “the first elongate element” is interpreted to as “the elongate element” which was introduced earlier in the claim, thereby providing proper antecedent basis for the limitation until otherwise amended.
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, 4, 9-12, 15, 19-20 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marchand (US 2017/0112513 A1).
Regarding claim 1, Marchand discloses:
A medical device for treating one of a thrombus and embolism (extraction device 202, see Fig. 7), comprising:
a first elongate element (intermediate shaft 140, see Figs. 7-8) having a first end (distal-most end of intermediate shaft 140 shown in Fig. 7) and a second end (proximal-most end of intermediate shaft 140 connected to handle 134, see Fig. 1), the first elongate element defining a lumen (lumen 804, see Fig. 8) and having a first diameter (see Figs. 7-8 showing a first diameter defined by the intermediate shaft 140);
a second elongate element (inner shaft 200, see Figs. 7-8), the second elongate element having a first end (distal-most end 218 of inner shaft 200, see Fig. 7) and a second end (proximal-most end of inner shaft 200 connected to plunger 154, see Fig. 3 and Para. [0098] and [0113] indicating the inner shaft directly couples to the plunger);
wherein the first end of the second elongate element is configured to extend beyond the first end of the first elongate element (see Figs. 7-10 showing the distal-most end 218 of the inner shaft 200 disposed distally beyond the intermediate shaft 140; inner shaft 200 is also slidably disposed within intermediate shaft 140 per Para. [0073] and may be moved relative thereto);
a frame (cylindrical portion 208, see Fig. 7) extending from the first end of the second elongate element (see Fig. 7), the frame having a second diameter when in a deployed configuration (see Fig. 7 showing wherein the cylindrical portion 208 defines a second diameter when expanded);
wherein the second diameter is greater than the first diameter of the first elongate element (see Fig. 7 showing the diameter of the cylindrical portion 208 being radially larger than the diameter of the intermediate shaft 140 when deployed); and
a plurality of lines (struts of coring element 206, see Figs. 4 and 7) coupled to the first elongate element (see Fig. 7 and Para. [0023] and [0096]) and the frame (see Figs. 7 and 11; see also Para. [0096]), the plurality of lines operable to be tensioned when the frame is in the deployed configuration (see Para. [0073] mentioning wherein the coring element can be compressed or expanded by relative movement of the intermediate shaft relative to the inner shaft which places tension on the coring elements to cause expansion or collapse), the plurality of lines operable to cut through at least one of an embolism or thrombus (see Para. [0007] mentioning wherein the coring element can be sharp to cut through thrombus).
Regarding claim 4, Marchand discloses the invention of claim 1, Marchand further discloses wherein the second elongate element is longitudinally moveable relative to the first elongate element (see Para. [0073]).
Regarding claim 9, Marchand discloses the invention of claim 1, Marchand further discloses wherein the frame defines an outer perimeter (radial outer perimeter of the cylindrical portion 208, see Fig. 7), wherein each line of the plurality of lines is coupled to the frame proximate the outer perimeter (see Fig. 11 showing the coupling of the struts of coring element 206 coupled to the proximal end of the cylindrical portion 208 proximate the radially-outer perimeter thereof).
Regarding claim 10, Marchand discloses the invention of claim 9, Marchand further discloses wherein the frame includes a plurality of radial struts extending from the second elongate element toward the outer perimeter of the frame (see Para. [0116]; see also Fig. 7 showing centrally-located proximal struts of the cylindrical portion extend distally outward towards the radially outer perimeter of the cylindrical portion).
Regarding claim 11, Marchand discloses the invention of claim 10, Marchand further discloses wherein each line of the plurality of lines is coupled to the frame at the plurality of radial struts (see Para. [0126]; see also Fig. 11 showing this connection between the struts of coring element 206 and struts of cylindrical portion 208).
Regarding claim 12, Marchand discloses the invention of claim 9, Marchand further discloses wherein the frame includes a plurality of peripheral struts extending between the plurality of radial struts proximate the outer perimeter of the frame (see Fig. 11 showing wherein proximal-most peripheral struts 1104 of the cylindrical portion extend between radial struts 1102 extending distally therefrom), wherein the plurality of lines are coupled to the frame at the plurality of peripheral struts between the plurality of radial struts (see Fig. 11).
Regarding claim 15, Marchand discloses the invention of claim 1, Marchand further discloses wherein the plurality of lines is coupled to an outer surface of the first elongate element (see Para. [0096] and Fig. 7 showing wherein struts of coring element 206 are coupled to the outer surface of the intermediate shaft through proximal end 210 which is directly coupled to the outer surface of the intermediate shaft).
Regarding claim 19, Marchand discloses the invention of claim 1, Marchand further discloses wherein the second elongate element is rotatable relative to the first elongate element (see Para. [0098]-[0100] mentioning wherein the plunger 154 (to which inner shaft 200 is connected per Para. [0090]) is rotatable relative to handle 134 (to which intermediate shaft 140 is connected per Para. [0087]) to selectively rotationally lock or unlock the inner shaft and intermediate shaft relative to one-another), wherein the plurality of lines are operable to be tensioned when the second elongate element is rotated (relative rotation between the inner shaft and intermediate shaft would impart tension onto the struts of coring element 206 since the proximal portion of the coring portion is secured to the intermediate shaft (see Para. [0096]) while the distal portion is secured to the cylindrical portion (see Fig. 11), which itself is secured to the distal end of the inner shaft (see Para. [0096])).
Regarding claim 20 (see 112(b) rejection above), Marchand discloses all of the limitations of the invention of claim 1, Marchand further discloses wherein the plurality of lines is coupled to an outer surface of the second elongate element (struts of coring element 206 are connected to the inner shaft indirectly via their connection to the cylindrical portion 208 (see Fig. 11) which is coupled to the distal end 218 of the inner shaft per Para. [0096]).
Regarding claim 25, Marchand discloses:
A medical device for treating at least one of a thrombus and embolism (extraction device 202, see Fig. 7), comprising:
an elongate element (intermediate shaft 140, see Figs. 7-8) having a first end (distal-most end of intermediate shaft 140 shown in Fig. 7) and a second end (proximal-most end of intermediate shaft 140 connected to handle 134, see Fig. 1), the first elongate element defining a lumen (lumen 804, see Fig. 8) and having a first diameter (see Figs. 7-8 showing a first diameter defined by the intermediate shaft 140), the first end including an opening to the lumen (see Figs. 7-8 showing an opening at the distal end of the intermediate shaft 140; Examiner notes that an opening must be present at both terminal ends of the intermediate shaft to allow inner shaft 200 to pass therethrough as shown in Figs. 7-8); and
a plurality of lines (struts of coring element 206, see Figs. 4 and 7) coupled to the first elongate element (see Fig. 7 and Para. [0023] and [0096]) such that the lines are extending across the opening (see Fig. 7 showing wherein the struts of coring element 206 extend distally over the distal end of the intermediate shaft 140, thus extending across the opening located at the distal end thereof), the plurality of lines operable to be tensioned when the elongate element is in a deployed configuration (see Para. [0073] mentioning wherein the coring element can be compressed or expanded by relative movement of the intermediate shaft relative to the inner shaft which places tension on the coring elements to cause expansion or collapse), the plurality of lines operable to cut through at least one of an embolism or thrombus (see Para. [0007] mentioning wherein the coring element can be sharp to cut through thrombus).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Merk (US 2016/0199080 A1).
Regarding claim 6 (see 112(b) rejection above), Marchand discloses all of the limitations of the invention of claim 1.
However, Marchand does not expressly disclose wherein the second elongate element includes at least one opening proximate the first end, the second elongate element is operable to be fluidically coupled to a fluid source including at least one of a contrast source, a saline source, and a therapeutic source.
In the same field of endeavor, namely thrombectomy devices comprising an expandable scaffold, Merk teaches a medical device for treating one of a thrombus and embolism (retrieval device 10, see Fig. 1) comprising a first elongate element (sheath 14, see Fig. 1) and a second elongate element (catheter 12, see Fig. 1); and an expandable frame (basket 16, see Fig. 1) connected to the second elongate element (see Fig. 1 and Para. [0019]); wherein the second elongate element comprises a plurality of openings connected to a lumen thereof (openings 18, see Fig. 1 and Para. [0019], [0022] and [0028]) configured to deliver a thrombolytic agent to the thrombus captured within the expandable frame (see Para. [0008], [0028] and [0032]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the inner shaft of Marchand to include a plurality of openings connected to a lumen thereof within the radial interior of the cylindrical portion as taught and suggested by Merk to, in this case, deliver a thrombolytic agent to a thrombus captured within the cylindrical portion (see Merk Para. [0008], [0028] and [0032]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Salahieh (US 2005/0137696 A1).
Regarding claim 8, Marchand discloses all of the limitations of the invention of claim 1.
However, Marchand does not expressly disclose wherein the frame includes a porous covering.
In the same field of endeavor, namely filter devices comprising an expandable frame, Salahieh teaches a medical device for treating one of a thrombus and embolism (see Figs. 6A-6C), comprising: an expandable frame (filter 520, see Figs. 6A-6B and Para. [0055]) configured to filter out and capture emboli (see Para. [0053] and [0055]); wherein the expandable frame may include a permeable/porous membrane along the exterior surface thereof to better assist filtering (see Para. [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the cylindrical portion of Marchand to include a permeable/porous membrane along an exterior surface thereof as taught and suggested by Salahieh to, in this case, better assist in filtering captured emboli from surrounding blood/fluids (see Salahieh Para. [0055]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Guo (US 2025/0114117 A1), considered prior art due to a foreign priority filing date of July 13, 2022.
Regarding claim 13, Marchand discloses all of the limitations of the invention of claim 1.
However, Marchand does not expressly disclose wherein each of the plurality of lines includes an ePTFE filament.
In the same field of endeavor, namely thrombectomy devices comprising an expandable scaffold, Guo teaches a medical device for treating one of a thrombus and embolism (see Figs. 1 and 15-16), comprising: a frame (filter mesh 205, see Fig. 15) and a plurality of lines (struts of skeleton 1601, see Fig. 15; see also Para. [0096]-[0097]); wherein the plurality of lines of the frame may be formed from expanded polytetrafluoroethylene (ePTFE) (see Para. [0097]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the cylindrical portion and coring portion to be made from ePTFE as disclosed by Guo since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Dong (US 2018/0228537 A1).
Regarding claim 14, Marchand discloses all of the limitations of the invention of claim 1.
However, Marchand does not expressly disclose wherein each line of the plurality of lines is a braided fiber.
In the same field of endeavor, namely expandable stent devices for treating vascular emboli, Dong teaches wherein an expandable stent (stent 110, see Fig. 1) may be made of wires, coils, braids, a sheet and/or other tubular bodies (see Para. [0038]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known stent formation method for another (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the stent coring element of Marchand from braided fibers, as opposed to wire material, as disclosed by Dong, since Dong provides an express disclosure of wherein the two stent formation methods may be used interchangeably while producing the same effective result (see Dong Para. [0038]). One of ordinary skill in the art would have expected the stent coring element of Marchand to function equally well with either a wire formation of braided formation, since Dong provides express disclosure within the same field of endeavor of the mutual effectiveness of both types of stents, used interchangeably with one-another.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Bruzzi (US 2017/0333076 A1).
Regarding claim 16, Marchand discloses all of the imitations of the invention of claim 1.
However, Marchand does not expressly disclose a secondary cutter coupled to the second elongate element proximate the first end of the first elongate element.
In the same field of endeavor, namely thrombectomy devices comprising an expandable scaffold, Bruzzi teaches a medical device for treating one of a thrombus and embolism (see Fig. 1) comprising a first elongate element (extractor tube 8, see Fig. 1) and a second elongate element (second control arm 9, see Fig. 1); an expandable frame (cage 3, see Fig. 1) coupled to the second elongate element (see Fig. 1); and a cutter coupled to the second elongate element positioned within the expandable frame, proximate the distal end of the first shaft member (helical member 7, see Fig. 1) configured to induce vibration within the frame, helping to dislodge thrombus from the walls of the vessel, thereby assisting in the removal of thrombus from the vessel (see Para. [0092]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Marchand to include a rotatable vibration cutter along the length of the inner shaft within the interior of the cylindrical portion as taught and suggested by Bruzzi to, in this case, allow a user to induce vibration along the cylindrical portion to further assist in dislodging thrombus from the walls of the vessel in contact with the cylindrical portion by imparting vibrational forces thereon (see Bruzzi Para. [0092]). In the resulting combined device, the rotatable helical member of Bruzzi, as incorporated into the device of Marchand, would constitute a “secondary cutter” used in conjunction with the sharp cutting edges of the struts of the coring element recited in Para. [0007] of Marchand.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand (US 2017/0112513 A1) in view of Morgan (US 2014/0018840 A1).
Regarding claim 17, Marchand discloses all of the limitations of the invention of claim 1.
However, Marchand does not expressly disclose an expandable member coupled to the first elongate element.
In the same field of endeavor, namely thrombectomy devices comprising an expandable scaffold, Morgan teaches a medical device for treating one of a thrombus and embolism (filter member 300, see Figs. 16A-16B) comprising a first elongate element (structure of catheter 322, see Fig. 16A) and a second elongate member (structure of catheter 314, see Fig. 16); an expandable frame (filter member 316, see Fig. 16A) coupled to the first elongate member (see Fig. 16A showing wherein the proximal end of filter member 316 couples to the exterior of the structure of catheter 314) and second elongate member (filter member 316 coupled to structure of catheter 322 indirectly through the structure of catheter 314, see Fig. 16A); and an expandable member (balloon 360, see Fig. 16B) coupled to the first elongate element (see Fig. 16B showing wherein the balloon 360 is coupled to the structure of catheter 322 indirectly through the structure of catheter 314); wherein the expandable member is configured to be inflated while within the interior of the expandable frame to break of thrombus captured therein (see Para. [0079]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Marchand to include an expandable balloon configured to be slidably inserted into the interior of the cylindrical portion 208 as taught and suggested by Morgan to, in this case, break of thrombus captured within the cylindrical portion when inflated (see Morgan Para. [0079]).
Regarding claim 18, the combination of Marchand and Morgan disclose the invention of claim 17, Marchand, as modified by Morgan, further discloses wherein the expandable member is positioned interior to the plurality of lines (see Morgan Figs. 16A-16B showing wherein the balloon 360, as incorporated into the device of Marchand, is positioned within the interior of the expandable frame structure) such that when the expandable member is expanded, the plurality of lines are tensioned (should a user cause sufficient inflation within the balloon 360 of Morgan, as incorporated into the device of Marchand, the balloon would contact the radially-inward walls of the coring element 206, imparting tension thereon due to the expansive force of the balloon).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2013/0041391 A1 to Spencer, US 2018/0271546 A1 to Uihlein, US 2023/0115101 A1 to Yang, US 2017/0245873 A1 to Diamant, US 2010/0016862 A1 to Hawkins, US 2016/0278805 A1 to Hatta, US 2024/0180568 A1 to Wang, US 2021/0128185 A1 to Nguyen, and US 7942892 B2 to D’Aquanni all disclose thrombectomy devices comprising a capture basket comprising a frame and plurality of ties connecting thereto. Additionally, US 10568654 B2 to Cartier, US 20240237998 A1 to Fulton, US 20220296291 A1 to Anderson and US 20200397452 A1 to Twomey all disclose expandable filter devices comprising an expandable frame and at least one aperture configured to deliver a therapeutic agent to a target captured thrombus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771 /Andrew Restaino/Primary Examiner, Art Unit 3771
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