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 on 06/09/2026. As directed by the amendment: claims 1 and 7-9 have been amended, claim 6 has been cancelled, claim 22 has been added, and claims 9-21 remain withdrawn. Thus, claims 1-5 and 7-22 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 06/09/2026, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al (US 5226909 A), herein referenced to as “Evans” have been fully considered and are persuasive. The applicant amended claim 1 to include “an irrigation assembly, the irrigation assembly comprising a plurality of fluid delivery ports configured to dispense fluid into the body lumen”. The examiner agrees that Evans does not explicitly disclose the irrigation assembly comprising a plurality of fluid delivery ports. The USC 102(a)(1) rejection of claim 1 has been withdrawn.
Applicant's arguments, see pages 7-12, filed 06/09/2026, with respect to the rejection of claim 6 now incorporated into claim 1 under 35 U.S.C. 103 as being unpatentable over Evans in view of Bonnette et al (US 20150258258 A1), herein referenced to as “Bonnette” have been fully considered but they are not persuasive.
The applicant argues that it would not have been obvious for a person having ordinary skill in the art as this would fundamentally alter how the Evans catheter operates, such that introducing pressurized fluid into Evan’s body lumen, as required by Bonnette, would actively drive severed atheroma out of the lumen, defeating Evan’s state purpose of collecting that material.
The examiner respectfully disagrees, as the body lumen of Evan’s extends further beyond simply the area of the lumen where the blade lies, as the lumen further extends distally into the nose cone of the catheter of 160, see Fig. 2A. Hence, as with Bonnette where the irrigation assembly comprising of fluid delivery ports are configured to dispense fluid into a distal portion of the body lumen, this is advantageous to Evans as well as this prevents effluent from entering into the nose cone away from aspiration lumen and outside of the body where the debrided material is desired to be suctioned away to. Hence, modifying Evans as per the broadest reasonable interpretation of the claim language of “the irrigation assembly comprising of plurality of fluid delivery ports configured to dispense fluid into the body lumen” does not render Evans incapable, as there is no structural limitation in which the fluid delivery ports must be adjacent to the blade of Evans, but simply that is capable of dispensing fluid into the body lumen, which can include the distal part of the body lumen.
The applicant further cites that Bonnette is directed to a matter elimination catheter designed to prevent ingress and cites [0104] “This pressurized fluid establishes a pressure gradient that permits infusion fluid to exit while actively preventing effluent from entering the distal region through numerous pathways”.
However, this is a mischaracterization of the invention of Bonnette, as it does aspirate as well though 22 (see Fig. 13, [0071]), towards a more proximal portion of the device, hence having a more proximal and distal body lumen, akin to Evans, where the more proximal part of Evans lumen is desired to have aspiration, while the distal portion would not be desired to have material deposited.
Additionally, a variant embodiment of Evans (Figs. 1-2) which was relied upon in the previous rejection, taught the use of perfusion of liquids through the lumen 42 of the catheter body (see col. 4, lines 22-25, perfusion of fluids through 42). Hence, there is nothing in Evans that would suggest using irrigation would teach away or render Evans incapable of function with the use of irrigation.
Furthermore, applicant’s argument that one would not be motivated to combine Evans with Bonnette to include an irrigation assembly comprising a plurality of fluid delivery ports configured to dispense fluid into the body lumen seems to rely on assumption that structurally such as combination would result in the plurality of fluid delivery ports to be directly adjacent to helix member and the longitudinally-orientated blade and that would actively drive severed atheroma out of the lumen, which would put to question the enablement of applicant’s own device per elected Group 3, species B (Fig. 7B).
For the reasons above, the USC 103 rejections will be maintained.
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) 1 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al (US 5226909 A), herein referenced to as “Evans” in view of Bonnette et al (US 20150258258 A1), herein referenced to as “Bonnette”.
Claim 1
Evans discloses: A catheter 160 (see Figs. 2A and 2D, col. 6, lines 1-9) comprising: a cannula the cannula that forms 160 (see Figs. 2A and 2D, col. 6, lines 1-9) comprising a sidewall the side wall of 160 (see Fig. 2A) defining a cannula lumen the lumen of 160 which 168 extends through (see Fig. 2A); a distal portion 164 (see Figs. 2A and 2D, col. 6, lines 1-9)), disposed at a distal end distal end of 160 (see Fig. 1) of the cannula the cannula that forms 160, the distal portion 164 comprising a body the body of 164 (see Fig. 2A), said body 164 defining a body lumen the lumen of 164 that 166 gives access to (see 2A) and said body 164 further defining a lateral opening 166 (see Fig. 2A, col. 6, lines 1-9), extending through the body 164 and into the body lumen the lumen of 164 that 166 gives access to; a helix member 162 (see Fig. 1 and 2D, col. 6, lines 1-9) positioned at least partially within the cannula lumen the lumen of 160 and the body lumen the lumen of 164 and rotatable (see col. 6, lines 1-9, can axially translate and rotated) with respect to the sidewall the sidewall of 160; and a longitudinally-oriented blade 190 (see Fig. 2D, col. 6, lines 17-20), attached to said helix member 162, wherein at least a portion of the longitudinally-oriented blade 162 is intermittently exposed at the lateral opening 166 (see col. 6, lines 17-20, cuts as the blade rotated rather than as the blade is axially translated, see col. 6, lines 1-9).
Evans does not explicitly teach: the fluid delivery port is a plurality of fluid delivery ports.
However, Bonnette in a similar field of invention teaches a catheter 10 (see Figs. 15-17) with a body 60 (see Fig. 17) with a body lumen 42 + 60b (see Figs. 15-17). Bonnette further teaches: further comprising an irrigation assembly infusion fluid source (see [0012] and [0100]), the irrigation assembly infusion fluid source comprising a plurality of fluid delivery ports 78 (see Figs. 15-17, [0103]) configured to dispense fluid pressurized infusion fluid (see [0103]-[0104]) into the body lumen 42 + 60b (see Fig. 17, flow of fluid, [0104]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to incorporate the teachings of Bonnette and teach a catheter with a plurality of fluid delivery ports. Motivation for such can be found in Bonnette to allow continual filling of the lumen with saline and/or lubricant and provide a fluid barrier to prevent ingress of effluent where it is not desired (see [0103]-[0105]).
Claim 7
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. Bonnette further teaches: wherein the fluid pressurized infusion fluid (see [0103]) comprises saline (see [0103], saline) or thrombolytic agents (see [0058], anti-thrombosis medicaments).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to incorporate the teachings of Bonnette and teach a catheter with the fluid comprises saline or thrombolytic agents. Motivation for such can be found in Bonnette as this can assist in lubricating the drive to facilitate rotation without risk of fouling and assist in breaking up thrombi (see [0058]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Bonnette as applied to claim 1 above, and further in view of Costello et al (US 20150141869 A1), herein referenced to as “Costello”.
Claim 2
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. The combination of Evans and Bonnette does not explicitly teach: wherein the longitudinally-oriented blade is coupled to three or more loops of the helix member.
However, Costello in a similar field of invention teaches a catheter 100 (see Figs. 5A and 10A-10B) with a helix member 1142 (see Figs. 5A and 10A-10B) with a longitudinally-orientated blade 1146 + 1147 (see Figs. 10A-10B, [0069]). Costello further teaches: wherein the longitudinally-oriented blade 1146 + 1147 is coupled to three or more loops (see annotated Fig. 10B below) of the helix member 1142 (see Figs. 10A-10B).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to incorporate the teachings of Costello and teach a catheter with the longitudinally-oriented blade is coupled to three or more loops of the helix member. Motivation for such can be found in Costello by joining the loops of the helix member it can inhibit axial contraction and axial expansion of the helix member as it rotates/axially proceeds (see [0069]).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Bonnette as applied to claim 1 above, and further in view of Gruber et al (US 20080249553 A1), herein referenced to as “Gruber”.
Claim 3
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. The combination of Evans and Bonnette does not explicitly teach: wherein the body comprises one or more cutting edges disposed at the lateral opening.
However, Gruber in a similar field of invention teaches a catheter 304 (see Fig. 4d) with a body 304 (see Fig. 4d) and a lateral opening 310 (see Fig. 4d, [0129]). Gruber further teaches: wherein the body 304 comprises one or more cutting edges 310-2 (see Fig. 4d, [0129]) disposed at the lateral opening 310.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to incorporate the teachings of Gruber and teach a catheter with the body comprises one or more cutting edges disposed at the lateral opening. Motivation for such can be found in Gruber jagged ends can assist in grasping tissue to be resected (see [0129] and [0170]) and furthermore this optimizes high bite efficiency which is a factor of the open ratio of the resection window to the circumference of the tube (see [0128]).
Claim 4
The combination of Evans, Bonnette, and Gruber teaches: The catheter of claim 3, see 103 rejection above. Gruber further teaches: wherein the cutting edge 310-2 is configured to extend across a portion a portion of the 310 of the lateral opening 310 (see Fig. 4d, 310-2 extends proximally across the lateral opening).
Claim 5
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. The combination of Evans and Bonnette does not explicitly teach: wherein the body defines a distal end opening.
However, Gruber in a similar field of invention teaches a catheter 1151 (see Fig. 49) with a body 1153 (see Fig. 49). Gruber further teaches: wherein the body 1153 defines a distal end opening 1159 (see Fig. 49, [0200]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans to incorporate the teachings of Gruber and teach a catheter with the body defines a distal end opening. Motivation for such can be found in Gruber as this allows the device to be used to cut tissue with the lateral opening (window) or the distal end (see [0200]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Bonnette as applied to claim 1 above, and further in view of Golden et al (US 20130317529 A1), herein referenced to as “Golden”.
Claim 8
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. The combination of Evans and Bonnette does not explicitly teach: wherein the irrigation assembly is coupled to a circumferential periphery of the distal portion.
However, Golden in a similar field of invention teaches a catheter 450 (see Fig. 34) with a cannula 146 (see Fig. 34) with a distal portion 452 (see Fig. 34) that comprise a body 452 (see Fig. 34) and an irrigation assembly 472 (see Fig. 34). Golden further teaches: wherein the irrigation assembly 472 is coupled to a circumferential periphery (see annotated Fig. 34 below) of the distal portion 452 (see Fig. 34).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans and Bonnette to incorporate the teachings of Golden and teach a catheter with the irrigation assembly is coupled to a circumferential periphery of the distal portion. Motivation for such can be found in Golden as this allows for active rinsing of the cutting surfaces and for delivery of fluids into the chamber that serves as a carrier of the disrupted cells (see [0178]) and this also allows for separate manufacturing of the distal portion (cap) allowing for the different parts to use different materials (see [0177]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Bonnette as applied to claim 1 above, and further in view of Golden et al (US 20130317529 A1), herein referenced to as “Golden”.
Claim 22
The combination of Evans and Bonnette teaches: The catheter of claim 1, see 103 rejection above. The combination of Evans and Bonnette does not explicitly teach: wherein the fluid is pumped at a rate of 60 cc/min and/or is pressurized at 10,000 psi.
However, Demarais in a similar field of invention teaches a catheter 12 (see Fig. 1) with an irrigation assembly 13 (see Fig. 1, [0054]) configured to dispense fluid into the body lumen 17 (see Figs. 1-2, [0013] and [0054]-[0055]). Demarais further teaches: wherein the fluid is pumped at a rate of 60 cc/min (will not be examined here due to being an optional claim limitation) and/or is pressurized at 10,000 psi (see [0013], 10,000 psi).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evans and Bonnette to incorporate the teachings of Demarais and teach a catheter with the fluid is pressurized at 10,000 psi. Motivation for such can be found in Demarais as high pressure fluid infusion creates a Venturi effect to assist in breaking up clots and material (see [0006] and [0013])and be used to deliver thrombolytic and other therapeutic agents (see [0014]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jenkins et al (US 20140277043 A1) teaches a catheter with a screw-like/helix member (Fig. 37)
THIS ACTION IS MADE FINAL. 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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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