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 February 27, 2026. As directed by the amendment: claims 1, 4-6, 9-10, 15-17 and 19 have been amended, claim 3 has been cancelled, and claims 20-21 have been added. Thus, claims 1-2 and 4-21 are presently pending in this application. Applicant’s amendments are sufficient to overcome the §112(b) rejections of the previous action, with the exception of claims 9 and 19, see below.
Response to Arguments
Applicant's arguments filed February 27, 2026 have been fully considered but they are not persuasive.
On page 6 of the Remarks, Applicant argues that the device of Horzewski does not read on newly amended claim 1 because it does not teach accommodating two tools simultaneously. In response, Examiner notes that newly amended claim 1 does not recite “simultaneously”, so that the recited two tools may accommodated at different times.
On page 8 of the Remarks, Applicant argues claim 10, specifically the modification to Gregory with the guidewire of Jacobsen. To the best of Examiner’s understanding, Applicant is arguing the Jacobsen guidewire would have been used at step 42 in Fig. 4 of Gregory with a guide catheter, and not in subsequent steps with catheter 10 of Gregory. In response, Examiner points to Gregory c 5 ln 40-45 that teaches guidewire 28 is advanced through lumen 20 (of catheter 10) to protrude approximately 3 centimeters beyond the distal end of catheter 10 (step 44) and the catheter (10) is then inserted into the guiding catheter and advanced through the tortuous path into the cerebral arteries or other vessels to the clot (step 46). Thus, there is only one guidewire used in the process of Gregory, and it is used with catheter 10 to advance catheter 10 through the tortuous path into the cerebral arteries or other vessels to the clot. The modification to the method of Gregory is to the guidewire of Gregory, see below.
Claim Objections
Claims 5 and 15 are objected to because of the following informalities: insert “a” between “than non-tapering”. Appropriate correction is required.
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 20-21 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.
Claim 20 recites “…the catheter is a steerable robotic catheter.”. The written description P0044 teaches catheter 10, shown in Fig. 3, has a steerable device with a distal bending section, and is called a Snake Robotic Catheter. If the recited claim limitation is intended to further limit the catheter with some structure rather than to merely label it, then the written description lacks support teaching only that the catheter 10 has a steerable distal section, and that the catheter is labeled a Snake Robotic Catheter.
Claim 21 recites “…wherein inserting the catheter into a subject to a desired target also comprises robotically steering the catheter.”. P0018 of the written description teaches the method, which does not include robotically steering the catheter. Instead, the catheter is merely labeled a Snake Robotic Catheter.
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.
Claims 1-2, 4-9 and 20 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 1 line 3 recites that the proximal section has “…an inner diameter…”, and line 7 that recites the proximal section inner diameter “….is tapered…”. It is not clear how a diameter can be tapered. For purposes of examination, the proximal section is interpreted to have an inner diameter and wherein the transition has a tapered lumen. Claims 2, 4-9 and 20 are rejected at least because they depend from claim 1.
Claim 9 lines 2-3 recite “…providing more pushability of the catheter…”. It is not clear what this is relative to. For purposes of examination, this is interpreted as “…thereby providing more pushability of the catheter relative to a proximal section having the same stiffness as the bending section…”. Claim 19 is similarly rejected and interpreted.
Claim 20 recites “…the catheter is a steerable robotic catheter.”. It is not clear whether or not this further limits the claim with any structure, or is merely a recitation of the type of catheter because the written description refers to catheter 10 as a Snake Robotic Catheter. For purposes of examination, this is interpreted as “…wherein the catheter is configured to be steered by a robot.”.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4-7, 9 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horzewski et al. (Horzewski) US 2002/0032459 A1.
Regarding claim 1, Horzewski discloses a multi-section catheter (guiding catheter, P0042 as shown in Figs. 1A-1D) comprising: a bendable section (shaft sections 5 and 6 P0043, that are flexible P0045 and P0051) having an outer diameter (outer diameter shown in Fig. 1B taken at A-A of Fig. 1A); and a proximal section (shaft section 7 and transition, P0043), having an outer diameter (outer diameter shown in Fig. 1D taken at B-B of Fig. 1C) and an inner diameter (inner diameter shown in Fig. 1D taken at B-B of Fig. 1C) attached to the bendable section (Fig. 1C), wherein the proximal section includes a transition (transition, see annotated Fig. 1C below) from the bendable section to the proximal section (see annotated Fig. 1C below), wherein the inner diameter of the proximal section is tapered (see annotated Fig. 1C below) and is further configured to accommodate at least two tools (Figs. 2A-F, wherein the Figs. 2A-C show use of a guidewire P0051, and wherein Figs. 2D-F show use of an ultrasonic delivery catheter ball-tipped laser catheter, P0051).
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Regarding claim 2, Horzewski discloses the catheter of Claim 1, wherein the outer diameter of the bendable section is less than the outer diameter of the proximal section (Fig. 1C).
Regarding claim 4, Horzewski discloses the catheter of Claim 1, where the at least two tools are selected from the group comprising of a camera, needle, probe and other medical devices (other medical devices include the guidewire and ultrasonic delivery catheter ball-tipped laser catheter of claim 3).
Regarding claim 5, Horzewski discloses the catheter of Claim 1, wherein the catheter can perform endoscopic-type procedures, but will be able to navigate to more distal anatomy, and achieve a smaller bend radii due to a smaller bending section profile than a non-tapering catheter (the guiding catheter of claim 1 is fully capable of performing endoscopic-type procedures, but will be able to navigate to more distal anatomy, and achieve a smaller bend radii due to a smaller bending section profile than a non-tapering catheter because it has the claimed structure and is for use in medical applications, and see P0041).
Regarding claim 6, Horzewski discloses the catheter of claim 1, wherein a tapered inner diameter of the proximal section provides an increase of fluid flow rates in the catheter as compared to a non-tapering catheter (the tapered inner diameter of the proximal section is fully capable of increasing fluid flow rates in the catheter as comparison to a non-tapering catheter, due to the relative increased diameter of the tapered inner diameter of the proximal section).
Regarding claim 7, Horzewski discloses the catheter of Claim 1, further comprising a braided tube (wire braid tubular element 28, P0045) abutting the bending section (28 is adjacent or lying near to the sections 5 and 6, and see office action appendix definitions of abut and adjacent from dictionary.com).
Regarding claim 9, Horzewski discloses the catheter of claim 1, wherein the proximal section is stiffer than the bending section, concentrating a bending at the bending section and providing more pushability of the catheter (P0045).
Regarding claim 20, Horzewski discloses the catheter of claim 1, wherein the catheter is a steerable robotic catheter (the catheter is fully capable of being steered by a robot because it has the claimed structure).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Horzewski in view of Shimada et al. (Shimada) US 2013/0172851 A1.
Regarding claim 8, Horzewski discloses the catheter of Claim 7.
Horzewski does not teach wherein the braided tube is progressive.
However, Shimada teaches a catheter wherein the braided tube is progressive (Fig. 3C, P0074).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the pics per inch (PPI) of the braid of Horzewski to be progressive as taught by Shimada for the purpose of maximizing torque transmission proximally and decreasing stiffness distally, Shimada P0074.
Claims 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory et al. (Gregory) US 6,290,668 B1 in view of Jacobsen et al. (Jacobsen) US 2006/0146172 A1.
Regarding claim 10, Gregory discloses a method for using a multi-section catheter (remove a blood clot in the brain, c 5 ln 34-35) comprising: providing a multi-section catheter (catheter 10, shown in Figs. 1-2) having: a bendable section (distal shaft 12, c 4 ln 27, flexible c 2 ln 58); and a proximal section (proximal shaft 14, c 4 ln 27-28) attached to the bendable section (Fig. 1), wherein the proximal section includes a transition (tapered transition region 18, c 4 ln 29) from the bendable section to the proximal section which is tapered (Figs. 1-2), inserting the catheter into a subject to a desired target (clot, c 5 ln 34-46); flowing fluid (contrast fluid, c 5 ln 65) through the catheter to the target.
Gregory does not teach inserting the catheter into the subject to the desired target using a camera.
However, Jacobsen teaches a miniaturized utility device having integrated optical capabilities wherein the guidewire 6 P0049 and shown in Fig. 2 includes a camera 14.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Gregory with the guidewire 6 of Jacobsen for the purpose of navigating to the desired target, Jacobsen P0004 and P0006-0007.
Regarding claim 11, Gregory in view of Jacobsen teaches the method of Claim 10, wherein an outer diameter of the bendable section is less than an outer diameter of the proximal section (Gregory, Figs. 1-2).
Regarding claim 12, Gregory in view of Jacobsen teaches the method of Claim 10, wherein the camera is retracted to the proximal section before flowing fluid through the catheter to the target (Gregory, once the catheter is in position adjacent the clot, guidewire is retracted fully into lumen 22, c 5 ln 56-57).
Regarding claim 13, Gregory in view of Jacobsen teaches the method of Claim 10, wherein an inner diameter of the proximal section is configured to accommodate at least two tools (Gregory, Fig. 2, guidewire 28 and light guide 30, c 5 ln 56-57).
Regarding claim 14, Gregory in view of Jacobsen teaches the method of Claim 13, where the at least two tools are selected from the group comprising of a camera (modified method with guidewire camera of Jacobsen), needle, probe and other medical devices (Gregory, light guide 30).
Regarding claim 15, Gregory in view of Jacobsen teaches the method of Claim 10, wherein the catheter can perform endoscopic-type procedures, but will be able to navigate to more distal anatomy, and achieve a smaller bend radii due to a smaller bending section profile than non-tapering catheter (the catheter of claim 10 is fully capable of performing endoscopic-type procedures, but will be able to navigate to more distal anatomy, and achieve a smaller bend radii due to a smaller bending section profile than non-tapering catheter, because it has the claimed structure and is for use in medical applications, and see P0041).
Regarding claim 16, Gregory in view of Jacobsen teaches the method of claim 10, wherein a tapered inner diameter of the proximal section provides an increase of fluid flow rates in the catheter as compared to a non-tapering catheter (the tapered inner diameter of the proximal section is fully capable of increasing fluid flow rates in comparison as compared to a non-tapering catheter, due to the relative increased diameter of the tapered inner diameter of the proximal section).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory in view of Jacobsen in view of Horzewski.
Regarding claim 17, Gregory in view of Jacobsen teaches the method of Claim 10.
Gregory in view of Jacobsen does not teach wherein the catheter further comprises a braided tube abutting the bending section.
Horzewski teaches a catheter further comprising a braided tube (wire braid tubular element 28, P0045) abutting the bending section (28 is adjacent or lying near to the sections 5 and 6, and see dictionary.com definitions of abut and adjacent).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter 10 of Gregory with a braided tube as taught by Horzewski for the purpose of enhancing the rigidity of the proximal section, Horzewski P0045.
Regarding claim 19, Gregory in view of Jacobsen teaches the method of claim 10.
Gregory in view of Jacobsen teaches that the distal shaft is flexible (c 2 ln 58), but does not explicitly teach wherein the proximal section is stiffer than the bending section, concentrating the bending at the bending section and providing more pushability of the catheter.
However, Horzewski teaches a catheter wherein the proximal section is stiffer than the bending section, concentrating the bending at the bending section and providing more pushability of the catheter, Horzewski P0045.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Gregory to have a relatively stiffer proximal section as taught by Horzewski for the purpose of enhanced pushability and guidewire trackability, Horzewski P0045.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gregory in view of Jacobsen in view of Horzewski in view of Shimada.
Regarding claim 18, Gregory in view of Jacobsen in view of Horzewski teaches the method of Claim 17.
Gregory in view of Jacobsen in view of Horzewski does not teach wherein the braided tube is progressive.
However, Shimada teaches a catheter wherein the braided tube is progressive (Fig. 3C, P0074).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the pics per inch (PPI) of the braid of Horzewski to be progressive as taught by Shimada for the purpose of maximizing torque transmission proximally and decreasing stiffness distally, Shimada P0074.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gregory in view of Jacobsen as applied to claim 10 above, and further in view of Doisneau et al. (Doisneau) US 2020/0253670.
Regarding claim 21, Gregory in view of Jacobsen teaches the method of Claim 10.
Gregory in view of Jacobsen does not teach wherein inserting the catheter into a subject to a desired target also comprises robotically steering the catheter.
However, Doisneau teaches robotically controlled clot manipulation and removal wherein inserting the catheter into a subject to a desired target also comprises robotically steering the catheter, P0149.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to robotically steer the catheter of Gregory as taught by Doisneau for the purpose of enabling telemanipulation, Doisneau P0149, also known as operation at a distance which distances the operator from potentially hazardous materials/conditions used for patient imaging.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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