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 responsive to the amendment filed 12/04/2025. Claims 1 and 17 have been amended. Claims 1-4, 7-9, 12-17, and 19-20 are currently pending in the application
Response to Arguments
Applicant's arguments, see pg. 6, filed 12/04/2025, regarding the objection to claim 1 have been fully considered and are persuasive. The objection has been withdrawn.
Applicant's arguments, regarding the rejections of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues, see pg. 7-8, that it would not have been obvious to modify the device of Fleming to omit the intermediate layer at a distal end of the catheter since Fleming teaches the intermediate layer is necessary for providing rigidity and strength so that the liner can withstand torsional forces exerted on the inner liner by the outer layer and for protecting the guidewire from those effects.
The Examiner disagrees. It is the Examiner’s position that Fleming teaches the inner liner 14 prevents unwanted contact between the guidewire 26 and the rotating components of the catheter by isolating the guidewire 26 from the outer layer 12 and the tissue-removing element 20 (see Fleming [0026]). The inner liner 14 without the reinforcement layer at the distal end would still isolate the guidewire 26 and the rotating components of the device because the inner layer and outer layers would still provide a component intermediate the guidewire and rotating components of the device. The inner liner would therefore still function as intended with the modification. Further, one of ordinary skill in the art would have been motivated to make the modification since Spurchise teaches omitting the reinforcement layer at the distal end to increase flexibility which is desirable in catheters intended to be navigated through vasculature.
Applicant further argues that the features of the device of Spurchise are not relevant to the device of Fleming because Spurchise is directed to an aspiration catheter while Fleming is directed to a rotational atherectomy device and therefore, the operational requirements of the catheter of Spurchise are different from those of the catheter of Fleming.
It is the Examiner's position that both the devices of Fleming and Spurchise are catheters configured to navigate through blood vessels (see Fleming [0018] and Spurchise [0035]). Therefore, the features that enhance the navigability of the catheter of Spurchise are relevant to the catheter of Fleming.
Applicant makes similar arguments regarding the newly added limitations of claim 17 (see arguments pg. 9). Therefore, the Examiner’s arguments above with respect to claim 1 also apply to claim 17.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites “the distal end margin extends proximally from a distalmost end of the inner liner and terminates at a location proximal of a distal end of the tissue-removing element” which does not further limit the subject matter of claim 1 which has been amended to recite “the inner liner including a distal end margin extending from a distalmost end of the inner liner to a location proximal of a distal end of the tissue-removing element.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-4, 7-9, 12-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al. (US 2020/0078038) and further in view of Spurchise et al. (US 2009/0270800).
Regarding claims 1, 2, 3, 8, 9, and 12, Fleming discloses a tissue-removing catheter (10, see Fig. 1) for removing tissue in a body lumen, the tissue-removing catheter comprising: an elongate body (12) having an axis (LA) and proximal and distal end portions (16,18) spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen (the catheter is sized and shaped for insertion into a body lumen, see [0019]); a tissue-removing element (20) mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove tissue as the tissue-removing element is rotated by the elongate body within the body lumen (tissue removing element 20 is “is configured for rotation to remove tissue from a body lumen”, see [0020]); and an inner liner (14) received within the elongate body and defining a guidewire lumen (25, see Fig. 5), the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that torsional force is not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter (the inner liner 14 isolates guidewire 26, which is inside guidewire lumen 25, from any torsional force coming from the outer layer 12 and tissue removing element 20, see [0026]), the inner liner including a distal end margin configured to extend distally of the tissue-removing element (inner liner 14 includes a portion extending distally of the tissue removing element 20, see Fig. 2), the distal end margin having a construction different from a construction of a second portion of the inner liner which is positioned proximal of the distal end margin (the distal end margin includes marker 66 which causes the distal end margin to be fluoroscopically visible compared to other proximal portions of inner liner 14, see [0028]), wherein the inner liner (14, see Fig. 6) includes an inner layer (60), an outer layer (64), and an intermediate layer (60) disposed between the inner and outer layers (see [0027]), wherein the inner layer and the outer layer of the inner liner extend from a proximal end of the inner liner to a distalmost end of the inner liner (it is understood that the inner layer and outer layer of inner liner 14 would extend from a proximal end to a distalmost end of the liner absent some disclosure that these layers are omitted along some portion of the inner liner), and wherein the intermediate layer includes a metallic component (the intermediate braided layer 62 is made of stainless steel, see [0027]), wherein the tissue-removing catheter is free of a separate tip distal of the distal end of the inner liner (the portion of inner liner 14 extending distally from maker 66 can be considered the distal end of inner liner 14 and is free of a separate structure attached to it, see Fig. 2).
Fleming fails to teach the distal end margin has a fewer number of layers than the second portion of the inner liner and wherein distal end margin includes the inner layer and outer layer, the distal end margin being free of the intermediate layer, the distal end margin being free of metal, and wherein the distal end margin of the inner liner is more flexible than the remaining portion of the inner liner.
It is noted that inner liner 14 of Fleming is a multi-layer shaft and making the distal end of a shaft more flexible than the proximal portion is known in the art.
Spurchise, in the same field of art, teaches a multi-layer shaft (110, see Fig. 1A-1C) which has a more flexible distal end by omitting the intermediate layer of the shaft at the distal portion (see [0035]).
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 inner liner of Fleming to have a more flexible distal end by omitting the intermediate layer of the inner layer at the distal end, as taught by Spurchise, since doing so would have increased the flexibility of the inner liner which is known in the art to facilitate movement through tortuous vasculature and minimize tissue damage.
The combination of Fleming and Spurchise would result in the inner liner 14 of Fleming being free of the metallic intermediate braided layer 62 at the distal end. Therefore, the combination of Fleming and Spurchise teaches the distal end margin has a fewer number of layers than the second portion of the inner liner and wherein an entirety of the distal end margin includes the inner layer and outer layer, the entirety of the distal end margin being free of the intermediate layer, the distal end margin being free of metal, and wherein the distal end margin of the inner liner is more flexible than the remaining portion of the inner liner.
Fleming and Spurchise fail to expressly teach the distal end extending “from a distalmost end of the inner liner to a location proximal of a distal end of the tissue-removing element”.
However, it is the Examiner’s position that this limitation amounts to a recitation of the relative dimensions of the distal end margin.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Fleming and Spurchise to have a distal end margin extending “from a distalmost end of the inner liner and terminates at a location proximal of a distal end of the tissue-removing element” since 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 dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fleming and Spurchise would not operate differently with the claimed distal end margin dimensions and would function appropriately having the claimed distal end margin dimensions. Further, applicant places no criticality on the dimension claimed, indicating simply that the diameter “may extend from the distal end of the inner liner 14 to a location proximal to a distal end of the tissue-removing element 20” (Specification [0030]).
Regarding claim 4, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 2, wherein the guidewire lumen extends through the distalmost end of the inner liner (the guidewire lumen extends through the distalmost end of inner liner 14 since guidewire 26, which extends through the guidewire lumen 25, is shown extending past the distalmost end of inner liner 14, see Fig. 2).
Regarding claim 7, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 6. Fleming further discloses wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide (“inner liner 14 comprises an inner PTFE layer 60, an intermediate braided layer 62 comprised of stainless steel, and an outer layer 64 of polyimide”, see [0027]).
Regarding claim 13, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 1, wherein the second portion of the inner liner comprises an entirety of the inner liner extending proximally of the distal end margin of the inner liner (the designation of the distal end margin and the second portion is arbitrary and as discussed with reference to claim 1 there is a distal end margin of inner liner 14 including marker band 66 which has a different construction than the portion of inner liner 14 extending proximally of the marker band 66, see Fig. 2).
Regarding claim 14, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 1, further comprising a handle (40, see Fig. 1) mounted on to the proximal end portion of the elongate body (12) and operable to cause rotation of the elongate body (handle 40 includes an actuator 42 for selectively actuating a motor 43 to cause rotation of outer layer 12, see [0021]).
Regarding claim 15, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 14, further comprising a motor (43, see Fig. 1) in the handle (40) and operatively engaging the elongate body for driving rotation of the elongate body and the tissue-removing element mounted on the elongate body (“the motor 43 is configured to rotate the outer layer 12 and tissue removing element 20”, see [0021]).
Regarding claim 16, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 1, wherein the tissue-removing element comprises an abrasive burr (“tissue-removing element 20 comprises an abrasive burr”, see [0037]).
Regarding claims 17 and 19, Fleming discloses a tissue-removing catheter (10, see Fig. 1) for removing tissue in a body lumen, the tissue-removing catheter comprising: an elongate body (12) having an axis (LA) and proximal and distal end portions (16,18) spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen (the catheter is sized and shaped for insertion into a body lumen, see [0019]); a tissue-removing element (20) mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove tissue as the tissue-removing element is rotated by the elongate body within the body lumen (tissue removing element 20 is “is configured for rotation to remove tissue from a body lumen”, see [0020]); and an inner liner (14) disposed within the elongate body and defining a guidewire lumen (25, see Fig. 5), the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that torsional force is not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter (the inner liner 14 isolates guidewire 26, which is inside guidewire lumen 25, from any torsional force coming from the outer layer 12 and tissue removing element 20, see [0026]), the inner liner including a distal end margin extending distal of a distal end of the tissue-removing element, wherein the distal end margin of the inner liner extends to and includes a distalmost end of the inner liner (the portion of inner liner 14 extending distal of the tissue-removing element 20 and to the distalmost end of the inner liner 14 can be considered a distal end margin, see Fig. 2), wherein the distalmost end of the inner liner defines a distalmost end of the tissue-removing catheter (see Fig. 2). Further regarding claim 19, Fleming discloses the inner liner includes a metallic component (inner liner 14 includes a metallic component in the form of intermediate braided layer 62 which is made of stainless steel, see [0027]).
Fleming fails to teach the entirety of the distal end margin being more flexible than a second portion of the inner liner which is positioned proximal of the distal end margin and the distal end margin being free of metal. It is noted that inner liner 14 of Fleming is a multi-layer shaft and making the distal end of a shaft more flexible than the proximal portion is known in the art.
Spurchise, in the same field of art, teaches a multi-layer shaft (110, see Fig. 1A-1C) which has a more flexible distal end by omitting the intermediate layer of the shaft at the distal portion (see [0035]).
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 inner liner of Fleming to have a more flexible distal end by omitting the intermediate layer of the inner layer at the distal end, as taught by Spurchise, since doing so would have increased the flexibility of the inner liner which is known in the art to facilitate movement through tortuous vasculature.
The combination of Fleming and Spurchise would result in inner liner 14 of Fleming being free of the metallic intermediate braided layer 62 at the entirety of the distal end. Therefore, the combination of Fleming and Spurchise teaches “the distal end margin being free of metal” as claimed in claim 19.
Fleming and Spurchise fail to expressly teach the distal end extending “from a distalmost end of the inner liner to a location proximal of a distal end of the tissue-removing element”.
However, it is the Examiner’s position that this limitation amounts to a recitation of the relative dimensions of the distal end margin.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Fleming and Spurchise to have a distal end margin extending “from a distalmost end of the inner liner and terminates at a location proximal of a distal end of the tissue-removing element” since 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 dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fleming and Spurchise would not operate differently with the claimed distal end margin dimensions and would function appropriately having the claimed distal end margin dimensions. Further, applicant places no criticality on the dimension claimed, indicating simply that the diameter “may extend from the distal end of the inner liner 14 to a location proximal to a distal end of the tissue-removing element 20” (Specification [0030]).
Regarding claim 20, Fleming and Spurchise teach a tissue-removing catheter as set forth in claim 17, wherein the second portion of the inner liner comprises an entirety of the inner liner extending proximally of the distal end margin of the inner liner (Spurchise teaches the distal end of the inner liner being more flexible than the rest of the inner liner, which is understood to be a second portion extending proximally of the distal end margin).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Noone et al. (US 6,591,472) discloses a multi-layer catheter with a reinforcement layer omitted at the distal end of the catheter over a length “X” which can be adjusted depending on the desired flexibility and intended use of the catheter (see Fig. 13-14 and col. 13, line 59 – col. 14, line 11).
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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights