DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 22, 2025 has been entered.
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, 3, 5-7, 10-11, 14-18, 20-21, and 23-31 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 11 have been amended to recite the limitation: “…wherein the hollow distal tip lumen of the hollow distal tip region has a maximum cross-sectional area that is less than half the cross-sectional area of the internal lumen of the catheter body.” The description as originally filed does not have support for the limitation as no statement regarding the distal tip cross-sectional area relative to the internal lumen is set forth. The drawings depict a distal tip lumen which might be less than half of the cross-sectional area of the internal lumen, however, no statement as to the scale of the drawings is made and one cannot reasonably limit the distal tip diameter without disclosure of the dimension and how it compares to that of the internal lumen. The same reasoning applies to new claim 31 which requires an axial length of the hollow distal tip lumen to be greater than or equal to an axial length of the distal opening. The disclosure fails to support this statement and provides no remarks as to the relative length of the distal tip lumen compared to the distal opening. For these reasons the claims are considered to represent subject matter not supported by the originally filed disclosure. Claims 3, 5-7, 10-11, 14-18, 20-21, and 23-30 are rejected due to their dependence from claims 1 and 11.
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.
Claim(s) 1, 3, 5-7, 11, 14-15, 17-18, 20, 23-28, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 5,766,194).
Regarding claim 1, Smith discloses a clot removal device (17; Col. 4, line 66-Col. 5, line 4; Figures 1 and 21), comprising: a catheter body (11) comprising a proximal portion (12), a distal portion (16), and an internal lumen (18) therebetween having a cross-sectional area (seen in Figure 4 and which is analogous to other embodiments in terms of lumen and tip structure), wherein the distal portion comprises at least one a distal opening (17) that is configured to provide fluid communication with the internal lumen (Col. 5, lines 9-20) and an external surface of the catheter body (Figure 1); and wherein the internal lumen is configured to be in fluid communication with an aspiration source (suction pump 13); and a hollow distal tip (terminal portion of 16, Figure 3) region located distal to the distal opening and having a closed distal tip (16, Figures 4 and 21 depict that the tip extends beyond the side opening forming the hollow closed distal tip at a location distal to the opening) and a hollow distal tip lumen (portion of lumen 18 extending into tip 16 as depicted in Figures 4 and 21) in fluid communication with the internal lumen (18), wherein the hollow distal tip lumen has a maximum cross-sectional area that is less than the cross-sectional area of the internal lumen (it can be seen in Figure 21, that the diameter of the tip is smaller in cross-section than the primary fluid lumen portion within as it is tapered to the terminal distal tip surface). Smith fails to explicitly disclose that the cross-sectional area of the hollow distal tip region is less than half the cross-sectional area of the internal lumen of the catheter body.
However, Smith discloses (Col. 5, lines 10-11) that the distal tip can be any desired shape without deviating from the intent of the disclosed device. The tapered embodiment of Figure 21 teaches that it is known to form the hollow tip lumen with a smaller diameter than the internal lumen as claimed. There is no evidence of record that establishes that changing the cross-sectional area of the tip portion to be half that of the internal lumen would result in a difference in function of the Smith device. Furthermore, one of ordinary skill in the art at the time of filing, being faced with modifying the distal tip section of Smith, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed cross-sectional area. Finally, applicant has not disclosed that the claimed relative difference in cross-sectional area solves any stated problem or places any criticality on the dimension such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to form the hollow distal tip lumen having a cross-section less than half that of the internal lumen as an obvious matter of design choice within the skill of the art.
Regarding claims 3 and 14, Smith further teach the aspiration source (pump element 13 of Smith) in fluid communication with the internal lumen, where in a cyclic aspiration configuration, the aspiration source repeatedly alternates between a first aspiration force and a second aspiration force lower than the first aspiration force (the suction pump is fully capable of being run at two speeds to apply first and second aspiration forces as claimed; the claim sets forth a functional recitation of intended use of the aspiration catheter and the prior art is considered fully capable of being used in the claimed manner; there is no controller or processor structure claimed which limits the manner in which the device performs the claimed function).
Regarding claim 5, Smith further discloses wherein the at least one distal opening is positioned at an angle relative to the longitudinal axis of the catheter body in a range of 15 degrees to 315 degrees (the opening is orthogonal or 90 degrees to the longitudinal axis as depicted in Figure 21).
Regarding claims 6 and 18, Smith further discloses wherein the at least one distal opening (36) comprises the shape of an oval (Figure 21; Col. 5, lines 12-13).
Regarding claim 7, Quinn further discloses wherein the hollow distal tip region comprises a shape of a cone (Figure 21, the distal tip is conical as it tapers to the closed tip section).
Regarding claim 11, Smith discloses (Figures 1 and 21) a clot removal catheter system, comprising: a catheter body (11) comprising a proximal portion (adjacent element 12, Figure 1), a distal portion (comprising tip 16), and an internal lumen (18) therebetween having a cross-sectional area (depicted in Figure 4), wherein the distal portion comprises a distal opening (17) that is configured to provide fluid communication between the internal lumen (Figure 21; it’s a lumen and is designed to provide a fluid path from a fluid source) and an external surface of the catheter body (adjacent the outlet 17), wherein the distal opening has a distal-most point, a proximal-most point, and a distal opening axis that passes therebetween (forming the oval-shaped opening depicted in Figures 1 and 21), wherein the distal opening axis is angled (it’s orthogonal to the longitudinal axis of the catheter and is therefore at an angle of 90 degrees relative to the longitudinal axis of the catheter) to a central longitudinal axis of the internal lumen of the catheter body (it is orthogonal), and wherein the internal lumen is in fluid communication with an aspiration source (suction pump 13); and a hollow distal tip region (portion of lumen extending beyond opening 17 into tip section 16) located distal to at least a portion of the distal opening (Figures 1 and 21) and having a closed distal tip (Figures 1 and 21) and a hollow distal tip lumen in fluid communication with the internal lumen of the catheter body (the lumen through 18 is fluidly connected through to the tip portion), wherein the hollow distal tip lumen of the hollow distal tip region has a maximum cross-sectional area that is less than the cross-sectional area of the internal lumen of the catheter (it can be seen in Figure 21 that the distal tip is tapered in a conical manner to the terminal tip portion thereby reducing the cross-sectional area at the tip section). Smith fails to explicitly state that the cross-sectional area is less than half the cross-sectional area of the internal lumen of the catheter body.
However, Smith discloses (Col. 5, lines 10-11) that the distal tip can be any desired shape without deviating from the intent of the disclosed device. The tapered embodiment of Figure 21 teaches that it is known to form the hollow tip lumen with a smaller diameter than the internal lumen as claimed. There is no evidence of record that establishes that changing the cross-sectional area of the tip portion to be half that of the internal lumen would result in a difference in function of the Smith device. Furthermore, one of ordinary skill in the art at the time of filing, being faced with modifying the distal tip section of Smith, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed cross-sectional area. Finally, applicant has not disclosed that the claimed relative difference in cross-sectional area solves any stated problem or places any criticality on the dimension such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to form the hollow distal tip lumen having a cross-section less than half that of the internal lumen as an obvious matter of design choice within the skill of the art.
Regarding claim 15, Smith further discloses wherein the distal opening of the catheter body is proximal to the hollow distal tip lumen (Figure 3, the opening is proximal to the lumen portion within the tip).
Regarding claim 17, Smith further discloses (e.g., Figure 21) a plurality of distal openings (17, 22) at different longitudinal positions from each other, wherein the plurality of distal openings comprises the distal opening (one of the openings is considered as the distal opening), wherein the plurality of distal openings are in fluid communication with the internal lumen and the external surface of the catheter body (Figure 21).
Regarding claim 20, Smith further discloses wherein the distal portion of the catheter body further comprises a tapered intermediate portion (beginning portion of the tapered conical tip section) connecting the hollow distal tip region to the distal opening of the catheter body (any portion of the tapered section may be considered an intermediate section between the side opening 17 and the hollow distal tip terminal section).
Regarding claim 23, Smith further discloses wherein the hollow distal tip region comprises a wall that surrounds a perimeter of the hollow distal tip lumen at a longitudinal axis of the hollow distal tip region (e.g., the distal tip comprises a wall-thickness having inner and outer boundaries which is considered to meet the claim limitation of “a wall” as it encloses the distal tip section lumen).
Regarding claim 24, Smith further discloses (Figure 21) wherein the plurality of distal openings (e.g., 22) are distal to the distal opening (they are formed closer to the tip than opening 17).
Regarding claim 25, Smith discloses, as set forth above, the ability of the combined device to be used to aspirate tissue (e.g., clot material). The claim sets forth a method of use of the device, however, the structure of the claimed device is known from the prior art as set forth above for claim 3. For this reason, the prior art device is considered fully capable of being used in the manner set forth in claim 25. No additional structure has been added which might prevent the prior art device from functioning in such a manner and as such the claim is considered to be anticipated by the prior art.
Regarding claim 26, Smith discloses a clot removal device, comprising: a catheter body (11) having proximal portion (adjacent element 12, Figure 1), a distal portion (16), and an internal lumen 18) therebetween having a cross-sectional area (Figure 4), wherein the distal portion comprises at least one distal opening (17) that is configured to be in fluid communication with an aspiration source (via suction pump 13), wherein the at least one distal opening is configured to provide fluid communication with the internal lumen (Figure 4) and an external surface of the catheter body (Figures 1 and 21, the opening is adjacent the catheter body); and a distal tip (terminal portion of end 16) means for capturing at least a portion of an aspirated clot from the internal lumen of the catheter body (Col. 5, lines 9-16), wherein the distal tip means is located distal to the distal opening (Figure 21, the tip is distal to opening 17 as claimed) at the distal portion of the catheter body and has a closed distal tip (Figures 1 and 21) and a hollow distal tip lumen in fluid communication with the internal lumen (portion of lumen 18 downstream of opening 17), wherein the hollow distal tip lumen has a maximum cross-sectional area that is less than the cross-sectional area of the internal lumen (it can be seen in Figure 21 that the tapered tip section comprises a smaller cross-sectional area than at the opening 17), wherein the distal tip means comprises a second distal opening (22) proximal to the closed distal tip (openings 22 are between opening 17 and the closed tip) and an interior cavity therebetween (Figure 21, there is a portion of the lumen between the openings and the closed tip section), wherein at least a portion of the at least one distal opening of the catheter body is proximal to the second distal opening of the distal tip means (opening 17 is part of the “at least one distal openings” and is proximal to openings 22 as claimed). Smith fails to explicitly disclose that the cross-sectional are of the tip section is less than half that of the cross-sectional area of the internal lumen.
However, Smith discloses (Col. 5, lines 10-11) that the distal tip can be any desired shape without deviating from the intent of the disclosed device. The tapered embodiment of Figure 21 teaches that it is known to form the hollow tip lumen with a smaller diameter than the internal lumen as claimed. There is no evidence of record that establishes that changing the cross-sectional area of the tip portion to be half that of the internal lumen would result in a difference in function of the Smith device. Furthermore, one of ordinary skill in the art at the time of filing, being faced with modifying the distal tip section of Smith, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed cross-sectional area. Finally, applicant has not disclosed that the claimed relative difference in cross-sectional area solves any stated problem or places any criticality on the dimension such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to form the hollow distal tip lumen having a cross-section less than half that of the internal lumen as an obvious matter of design choice within the skill of the art.
Regarding claim 27, Smith further discloses an angled transition area distal to the external surface of the hollow distal tip region and proximal to the distal opening, the angled transition area comprising an angled surface relative to a central longitudinal axis of the catheter body (it can be seen in Figure 21 of Smith that the distal end of the device is tapered to the terminal distal end and therefore comprises an angled transition area along the distal section which may be considered to comprise a portion proximal to the external surface of the hollow distal tip region as claimed and distal to the distal opening as the claim language is being interpreted; the transition area is claimed to transition from the tip section proximally toward the distal opening 17).
Regarding claim 28, Smith further discloses wherein the central longitudinal axis intersects with the distal opening (the opening is formed in the sidewall and therefore intersects lumen 18 orthogonally; the claim does not require the central axis to pass through the distal opening at some angle and therefore, the prior art teaches a central axis of the opening intersecting the longitudinal axis of the lumen which is considered to meet the claim limitation as currently set forth; fluid cannot pass through the lumen without exiting the opening).
Regarding claim 31, Smith further discloses wherein the closed distal tip is at a distal-most point of the clot removal device (Figures 1 and 21) and the hollow distal tip lumen comprises a length (portion of lumen 18 distal to opening 17). Smith fails to explicitly disclose the axial length of the distal tip portion relative to an axial length of the distal opening.
However, Smith discloses (Col. 5, lines 10-11) that the distal tip can be any desired shape without deviating from the intent of the disclosed device. The tapered embodiment of Figure 21 teaches that it is known to form the hollow tip lumen with a length. There is no evidence of record that establishes that changing the length of the tip lumen portion to be greater than or equal to an axial length of the distal opening would result in a difference in function of the Smith device. Furthermore, one of ordinary skill in the art at the time of filing, being faced with modifying the distal tip section of Smith, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the relative lengths. Finally, applicant has not disclosed that the claimed relative difference in tip lumen length relative to the distal opening length solves any stated problem or places any criticality on the dimension such that it produces an unexpected result. In fact, the disclosure fails to even address the relative dimensions which teaches away from any potential criticality provided by such features at the time of filing. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to form the hollow distal tip lumen having a length greater than or equal to a length of the distal opening as an obvious matter of design choice within the skill of the art.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Mogi et al. (US 2018/0338770).
Regarding claim 10, Smith teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the use of a radiopaque marker along an edge of the distal opening.
Mogi et al. (henceforth Mogi) teaches a catheter device comprising a radiopaque marker positioned on a distal end thereof (paragraph [0163] discloses the positioning of a radiopaque marker near opening 130).
Therefore, 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 clot removal device disclosed by Smith so that a radiopaque marker positioned along an edge of the first distal opening as taught by Mogi to improve the visibility of the catheter under fluoroscopy (see paragraph [0163] “Alternatively or in combination with such bands or markers, certain portions of the catheter 110 can comprise a radiopaque material to improve the visibility of such portions under fluoroscopy”).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Yagi (US 2015/0306347).
Regarding claim 21, Smith teach the claimed invention substantially as set forth above for claim 11, but fail to explicitly disclose a spiral shape, a helical shape, or a conical helical shape for the hollow distal tip region.
Yagi teaches (Figure 6), a catheter distal tip section (50) comprising a spiral shape (e.g., formed as slit 52; the claim does not require the tip body to be formed as a spiral or the like).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal tip section of Smith to comprise the spiral slit of Yagi so as to provide for a distal tip section which is sufficiently flexible to reduce the risk of perforating a blood vessel during use as taught by Yagi (paragraph [0030]).
Claim(s) 16, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Gregersen et al. (US 2009/0112153).
Regarding claim 16, Smith discloses the claimed invention substantially as set forth above for claim 11, but fails to explicitly disclose a recessed area of the catheter body having a lower surface angled radially inwardly in a distal direction to direct a clot into the internal lumen of the catheter body, wherein the opening is formed in the lower surface of the recessed area.
Gregersen et al. (henceforth Gregersen) teaches (Figure 3A) a catheter device comprising a distal opening (44) formed as a recessed area of the catheter body (it’s a skived opening cut into the shaft and is therefore a depression; ¶¶ [0046]-[0047]). Having a lower surface angled radially inwardly in a distal direction (the cut is angled in both directions include radially inwardly toward the proximal end) to direct a clot into the internal lumen of the catheter body via the distal opening (as the opening is cut and angled it may aid clot material in being drawn into the opening if used during aspiration), wherein the distal opening is formed in the lower surface of the recessed area (Figure 3A, the opening is formed at the bottom of the recess as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the side opening of the catheter of Smith to be formed as a skived opening in the shaft wall so as to allow for the control of fluid flow or material flow during an aspiration procedure as taught by Gregersen (e.g., ¶ [0047] discloses the openings can be formed at various angles to vary the fluid flow, which would include both infusion and aspiration, through the opening).
Regarding claim 29, Smith further fails to explicitly disclose the longitudinal depression extending from the distal opening along an exterior surface of the distal tip region. However, the skived opening of Gregersen may be considered to comprise such a longitudinal depression as the skive forms a recessed area extending around the opening which would include a portion of the shaft extending distally toward the terminal tip section as claimed.
Regarding claim 30, Smith further discloses a set of distal tip openings (17 and 22) configured to provide fluid communication between an external surface of the hollow distal tip region and the hollow distal tip lumen (Figure 21; openings 22 allow for fluid flow from the inner lumen through the hollow tip section and out the catheter tip as claimed).
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783