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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/2026 has been entered.
Drawings
Due to the cancellation of claim 24, the drawing objection set forth in the last Office Action is withdrawn.
Claim Objections
Claims 4 and 25 are objected to because of the following informalities: The second occurrence of the term “or” on line 9 of claim 4 and the only occurrence of the term “or” on line 2 of claim 25 should be replaced with the term “and” in order to be grammatically correct. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 has been incorrectly amended to change the antecedent basis of the longitudinal axis of the “tube” and not of the “deflectable tip catheter”; claim 9 should recite “[[the]] a center longitudinal axis of the tube” and “the longitudinal axis of the deflectable tip catheter”. Appropriate correction is required.
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 4, 6-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (PG PUB 2004/0044350) in view of McDermott et al. (PG PUB 2018/0021546) and Eaton et al. (US Pat 5,938,616).
Re claim 4, Martin discloses a deflectable tip catheter 10 (Fig 1) comprising: a first deflection region (the portion of shaft 11 forming curve 46 in Fig 2B,11B) operably deflectable into a first curve 46 (Fig 2B; “secondary curve”, Para 59,62) via a first control 26 (Fig 1; Para 59) that is rotatable (“thumbwheels”, Para 59); a second deflection region (the portion of shaft 11 forming curve 40 in Fig 2A,11B) operably deflectable into a second curve 40 (“primary curve”, Para 59,61) via a second control 22 (Fig 1; Para 59) that is rotatable (“thumbwheels”, Para 59); and a control element 80 (Fig 5; “pullwire”, Para 71) in a tube 106 (Fig 11A; “pullwire lumen liners 106 may […] encapsulate the pullwires 80”, Para 79), wherein the control element and the tube are in a lumen 82 (Fig 11A) in a wall (formed by articulating members 18 of shaft 11, Para 58) of a shaft 11 (Fig 1) of the deflectable tip catheter (Para 79). Martin discloses that the tube 106 “may be comprised of a braided polyimide or any suitable material to provide strength, flexibility, and protection of the pullwires 80” (Para 79) but does not disclose that disclose that the tube has cuts. Martin also discloses that the controls are rotatable, but not that they are rotatable along a longitudinal axis of the deflectable tip catheter such that rotation of one or both of the first and second controls causes angular displacement between the first and second controls that causes deflection of the deflectable tip catheter; Martin also does not disclose that the second control is proximal to the first control.
McDermott et al., however, teaches a deflectable tip catheter 10 (Fig 1) comprising a first region 12 (Fig 1) operably deflectable into a first curve (Para 29), a second deflection region 16 (Fig 1) operably deflectable into a second curve (Para 29), a shaft (“polymer material”, Para 25; “outer covering”, Para 34), a tube (“liner”, Para 25; “inner liner”, Para 34) comprised of a braided material (like tube 106 of Martin) and a tube 22 (Fig 2) having cuts (“cut metal tube”, Para 25,34) that is arranged over the tube braided tube (Para 25) for the purpose of giving additional support to the catheter (Para 25). Therefore, it would have been obvious to one of ordinary skill in the art to modify Martin to include a tube having cuts over its braided tube 106, as taught by McDermott, for the purpose of giving additional support to the catheter (Para 25). Since the tube having cuts would be placed over the braided tube 106, the tube having cuts would (like the braided tube 106) also be in lumen 82 of the wall of shaft 11. McDermott does not disclose that the controls are rotatable along a longitudinal axis of the deflectable tip catheter or that the second control is proximal to the first control.
Eaton, however, teaches, a deflection tip catheter (Fig 7) comprising a handle 206 (comparable to handle 20 or Martin) that includes a first control 208 (Fig 7) that is rotatable about a longitudinal axis of the catheter (Col 4, Lines 54-57) to deflect the catheter into a first curve (Col 5, Lines 7-11) and a second control 210 (Fig 7) that is rotatable about the longitudinal axis (Col 4, Lines 54-57) to deflect the catheter into a second curve (Col 5, Lines 7-11) and is proximal to the first control (as seen in Fig 7), wherein rotation of one or both of the first control and the second control causes angular displacement between the first control and the second control (Col 5, Lines 3-5 set forth that the rings 208,210 can be rotated independently; therefore, rotation of one would causes angular displacement between the two and rotation of both in any amount that is not exactly the same would also cause angular displacement between the two) that causes deflection of the deflectable tip catheter (Col 5, Lines 5-11); Eaton teaches that providing the rotatable controls such that they rotate about the longitudinal axis to cause angular displacement therebetween and such that the second control is proximal to the first control ensures that the controls are accessible around the complete circumference of the handle, easing operator use (Col 4, Lines 8-12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Martin to change the size of and rearrange the location of the controls 26 and 22 such that they are rotatable about the longitudinal axis to cause angular displacement therebetween and the second control is proximal to the first control, as taught by Eaton, for the purpose of ensuring that the controls are accessible around the complete circumference of the handle, easing operator use (Col 4, Lines 8-12). It is noted that this modification does not alter the operation of the controls, just their size and location.
Re claim 6, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that the tube is movable in the lumen (since the modification made in claim 4 would place McDermott’s cut tube in lumen 82, the cut tube would be within lumen 82 and would move with the lumen; therefore, it would be “movable in the lumen”; it is noted that the claim does not require the tube to be movable relative to the lumen).
Re claim 7, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that the tube is slidable in the lumen (since the modification made in claim 4 would place McDermott’s cut tube in lumen 82, the cut tube be within lumen 82 and would slide with the lumen; therefore, it would be “slidable in the lumen”; it is noted that the claim does not require the tube to slidable relative to the lumen).
Re claim 8, Martin discloses that a width of the lumen is less than a thickness of the wall of the shaft of the deflectable tip catheter (as seen in Fig 11A).
Re claim 9, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that a center longitudinal axis (which would be within lumen 82 in Fig 11A since it would surround braided tube 106, as set forth in the rejection of claim 4 above) of the tube is offset from the longitudinal axis (within lumen 16 in Fig 11A) of the deflectable tip catheter (as seen in Fig 11A).
Re claim 10, Martin discloses that a center longitudinal axis (which would be within lumen 82 in Fig 11A) of the control element is offset from the longitudinal axis of the deflectable tip catheter (as seen in Fig 11A).
Re claim 11, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that the tube is closer than the control element to the longitudinal axis (extending through lumen 16 in Fig 11A) of the deflectable tip catheter than the control element (since the modification made in claim 4 would place McDermott’s cut tube around the control element 8, the portion of the cut tube that is closest to lumen 16 would be closer to the center longitudinal axis than any portion of the control element).
Re claim 12, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that the control element is closer than a portion of the tube to an outer surface of the deflectable tip catheter than a portion of the tube (since the modification made in claim 4 would place McDermott’s cut tube around the control element 8, the control element would be closer to an outer surface of shaft 11 than the portion of the cut tube that is closest to lumen 16).
Re claim 13, Martin as modified to include the cut tube of McDermott in the rejection of claim 4 above discloses that the control element is closer than a portion of the tube to an outer surface of the first deflection region than a portion of the tube (since the modification made in claim 4 would place McDermott’s cut tube around the control element 8, the control element would be closer to an outer surface of shaft 11 than the portion of the cut tube that is closest to lumen 16).
Re claim 15, Martin discloses that the first deflection region is distal the second deflection region (as seen in Fig 2B; Para 61,62), wherein the first deflection region is independently deflectable relative to the second deflection region (Para 59), and wherein the second deflection region is independently deflectable relative to the first deflection region (Para 59).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (PG PUB 2004/0044350)/McDermott et al. (PG PUB 2018/0021546)/Eaton et al. (US Pat 5,938,616) in view of Kato et al. (PG PUB 2014/0243592).
Re claim 5, Martin as modified by McDermott in the rejection of claim 4 above sets forth that the control element would be in the cut tube, but does not explicitly state that it would be in a center of the cut tube. Kato, however, teaches a deflectable tip catheter 100 (Fig 1A) comprising a control element 150 (Fig 14A; formed as a wire, like Martin’s control element 80) so that it is only slightly smaller than the lumen 14 (Fig 14A) it resides in (as seen in Fig 14A) for the purpose of maintain the articulating members 10 (Fig 1C; like articulating members 18 of Martin) aligned and in close contact with each other (Para 51). Due to the similarity in size of the control element and the lumen, the control element is in a center of the lumen (as seen in Fig 14A). Therefore, it would have been obvious to include the control element so that it is only slightly smaller than the lumen it resides in – which is that of the braided tube 106 –, as taught by Kato, for the purpose of maintaining the articulating members aligned and in close contact with each other (Para 51). Since the cut tube surrounds the braided tube 106 in the modification of Martin by McDermott, the control element would also be in the centers of both the braided tube and the cut tube.
Re claim 14, Martin discloses that the deflectable tip catheter has a distal terminal end 15 (Fig 1,11B) formed by the distal-most articulating member 18 (as seen in Fig 11B) and that a distal terminal end 126 (Fig 11B) of the control element is located at the distal terminal end of the deflectable tip catheter (as seen in Fig 11B). Martin discloses that the lumen 82 reside within the articulating members 18, but Martin is silent as to whether the lumen ends proximal to the distal terminal end of the catheter or ends at the distal terminal end of the catheter. Therefore, Martin as modified by McDermott in the rejection of claim 4 above to include a cut tube within the lumen 82 fails to explicitly disclose that the control element is distal to a distal terminal end of the cut tube (so as to place the control element between the distal terminal end of the cut tube and the distal terminal end of the catheter). Kato, however, teaches a deflectable tip catheter 100 (Fig 1A) comprising shaft formed of articulating members 10 (Fig 1C; like articulating members 18 of Martin) having a lumen 14 (Fig 2A) extending therethrough and a control element 150 (Fig 1C; formed as a wire, like Martin’s control element 80) within the lumen (as seen in Fig 14A), wherein the catheter has a distal terminal end (defined by the distal-most protrusion 11, seen in Fig 1C, labeled in Fig 2B) and the lumen has a distal terminal end (to the left in Fig 2B) that is proximal to the distal terminal end of the catheter, and wherein the control element has a locking bead 151 (Fig 1C) formed at its distal terminal end that resides between the distal terminal end of the lumen and the distal terminal end of the catheter (as seen in Fig 1C) for the purpose of maintaining the articulating members aligned and in close contact with each other (Para 51). Therefore, it would have been obvious to modify Martin to include the articulating elements with a lumen having a distal terminal end that is proximal to a distal terminal end of the articulating elements and to include the control member with a locking bead at the distal terminal end of the control element, such that the control member is located between the distal terminal end of the lumen and the distal terminal end of the catheter, as taught by Kato, for the purpose of maintaining the articulating members aligned and in close contact with each other (Para 51). Since the cut tube resides within the lumen 82 in the modification of Martin by McDermott, the distal terminal end of the cut tube would correspond to the distal terminal end of the lumen, resulting in the control member being between the distal terminal end of the tube and the distal terminal end of the catheter.
Claims 4-7 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Greene et al. (US Pat 6,027,462) in view of Armand et al. (PG PUB 2013/0197306).
Re claim 4, Greene discloses a deflectable tip catheter 10+20 (Fig 2, with Fig 5 showing the internal features of the catheter 10+20; it is note that all reference characters cited below refer to Fig 2 and/or Fig 5 unless otherwise noted) comprising: a first deflection region (the distal-most portion of the deflectable tip catheter; labeled in annotated Fig A below) operably deflectable into a first curve (as seen in Fig 1 and annotated Fig A below) via a first control 14 that is rotatable along a longitudinal axis of the deflectable tip catheter (Col 5, Lines 7-9); a second deflection region (proximally adjacent to the distal-most portion of the deflectable tip catheter; labeled in annotated Fig A below) operably deflectable into a second curve (as seen in Fig 1 and annotated Fig A below) via a second control 200 (Fig 5) that is rotatable about the longitudinal axis of the deflectable tip catheter (Col 5, Lines 7-9; wherein control 200 is rotatable relative to control 14, just as control 14 is rotatable relative to control 200), wherein the second control is proximal to the first control (as seen in Fig 5); a control element 208 in a tube 16, wherein the control element and the tube are in a lumen (defined by the interior surface of the wall forming the shaft 24) of a wall (the wall forming the shaft 24) of a shaft 24 of the deflectable tip catheter (Col 3, Lines 12-13); and wherein rotation of one or both of the first control and the second control causes angular displacement between the first control and the second control (inherent in the fact that only one of the controls 14,200 rotates relative to the other), wherein the angular displacement causes deflection of the deflectable tip catheter (Col 2, Lines 57-59). Greene does not disclose that the tube has cuts.
Armand, however, teaches a deflectable stylet 100 (Fig 1A; like the deflectable stylet 16+208 of Greene) comprising a control element 104 (Fig 1A) in a tube 102 (Fig 1A) having cuts 114 (Fig 1A) that assist the stylet in bending (Para 41). Therefore, it would have been obvious to one of ordinary skill in the art to modify Greene to include the tube with cuts, as taught by Armand, for the purpose of assisting the deflectable stylet in bending (Para 41).
PNG
media_image1.png
197
512
media_image1.png
Greyscale
Re claim 5, Greene discloses that the control element is in a center of the tube (as seen in Fig 5).
Re claim 6, Greene discloses that the tube is movable in the lumen (Col 3, Lines 12-13 and 35-37).
Re claim 7, Greene discloses that the tube is slidable in the lumen (Col 3, Lines 12-13 and 35-37).
Re claim 25, Greene discloses that rotation of one or both of the first control and the second control causes longitudinal displacement between the first control and the second control, wherein the longitudinal displacement causes deflection of the deflectable tip catheter (Col 5, Lines 7-9).
Response to Arguments
Applicant’s arguments filed 1/29/2026 have been fully considered but are not persuasive.
Applicant argues that Eaton does not disclose “angular displacement between the first control and the second control” resulting in tip deflection as required by claim 1. Specifically, Applicant argues that “the rotation of the first ring 208 is the input to steer in one plane and the rotation of the second ring 210 is the input to steer in another” and, therefore, “while both of Eaton’s rings can be rotated, the deflection is a result of the absolute rotation of each individual ring about the same longitudinal axis, not the relative angular difference created between them”. This Examiner respectfully disagrees. The rotation of one ring will cause deflection in one plane, while the rotation of both rings will cause deflection in both planes (Col 5, Lines 3-5); both of these instances (deflection in one plane vs deflection in two planes) is “deflection of the deflectable tip catheter” as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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, Kevin Sirmons can be reached on (571)272-4965. 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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
