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 09/30/2025. As directed by the amendment: claim 40 has been amended, no claims have been cancelled, and now new claims have been added. Thus, claims 40-42, 44, 48, 52, 54, 56, and 58 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every 112(a) and 112(b) rejection set forth in the Non-Final Office Action mailed on 06/30/2025.
Response to Arguments
Applicant' s arguments, see “Remarks”, filed 09/30/2025, with respect to the rejection(s) of claim(s) 40 under 103 have been fully considered and are persuasive, specifically in regards to Salahieh not teaching or disclosing a cut comprising the three pluralities of elliptical slots. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claim 40 is objected to because of the following informalities:
Regarding claim 40, the phrase “ontigudinal axis” in line 10 should read “longitudinal axis” for proper grammar,
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 40-42, 44, 48, 52, 54, 56, and 58 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.
Regarding claim 40, the phrase “a ontigudinal axis” in line 10 renders the claim indefinite because it is unclear. It is unclear whether this is a different longitudinal axis or the aforementioned longitudinal axis in lines 2-3. Examiner is interpreting this as the same axis.
Regarding claims 41-42, 44, 48, 52, 54, 56, and 58, these claims are rejected due to their dependency upon a rejected claim.
Claim Rejections - 35 USC § 103
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.
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(s) 40-42 , 44, 48, 52, 54, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (U.S Patent Pub. No. 20110077498 A1) in view of Salahieh et al. (U.S Patent Pub. No. 20120277730 A1, “Salahieh”) in view of Seto et al. (U.S Patent Pub. No. 20140163321 A1, “Seto”).
Regarding claim 40, McDaniel discloses the limitations of (Claim 40) a catheter (10, see Fig. 1-2B, 3B, and 6A-7) comprising: a proximal catheter shaft (12); a distal deflectable section (14) having a proximal end (proximal end of 14) and a distal end (distal end of 14) defining a longitudinal axis therebetween (see Fig. 1 and para. 0024 – longitudinal axis is being interpreted as an axis running lengthwise through proximal and distal end of distal deflectable section 14, see annotated McDaniel drawing 1 below for axis), the proximal end (distal end of 14) being coupled to a distal end (distal end of 12) of the proximal catheter shaft (12) and having a plurality of electrodes (46, 48) disposed at the distal end (distal end of 14) of the distal deflectable section (14, see Fig. 1 and 6B-7 and para. 0024 and para. 0044– catheter 10 comprises a proximal catheter body 12, a deflectable intermediate section 14 that extends from the catheter body 12, and a tip section 18 comprising electrodes 46 and 48 disposed distally of the deflectable intermediate section 14), a catheter curve shape strut (52) comprising a proximal end (proximal end of 52) and a distal end (distal end of 52 (see Fig. 3B and para. 0030-0032), and a deflectable insert component (50) comprising the following: a longitudinally-extending body (body of 50) configured to facilitate planar deflection of the deflectable insert component (50, see Fig. 3B and para. 0010 and 0030), the longitudinally-extending body (body of 50) having inner surface (inner surface of 50 and 63) and an outer surface (outer surface of 50) and extending along a longitudinal axis (see annotated McDaniel drawing 1 below for inner surface and axis), the longitudinally- extending body (body of 50) comprising three longitudinally-extending lumens (see Fig. 3B and para. 0059 – inner layer 50 may provide a central lumen straddled by two diametrically opposed lumens of tubing 63 for puller wires 42, examiner notes the tubings 63 may be glued or the like within the central lumen of inner layer 50 such that examiner is interpreting the lumens of tubings 63 as lumens created within the inner layer 50), including a central lumen straddled by a pair of offset pull wire lumens (lumens of 63), wherein the longitudinally-extending body (body of 50) is configured to be inserted into the catheter curve shape strut (52, see Fig. 3B and para. 0031), wherein the pair of offset pull wire lumens (lumens of 63) are diametrically-opposed from each other (see Fig. 3B), wherein each of the pair of offset pull wire lumens (lumens of 63) inwardly displaces a section of the inner surface (inner surface of 50 and 63) of the longitudinally-extending body (body of 50, see annotated McDaniel drawing 1 below), wherein the deflectable insert component (50) is configured to extend along a length of the distal deflectable section (14) from the proximal end (proximal end of 14) of the distal deflectable section (14) to a distal end (distal end of 14) of the distal deflectable section (14, see para. 0030).
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However, McDaniel is silent to the limitations of (Claim 40) wherein the pair of offset pull wire lumens are oriented relative to a cut pattern comprising a first plurality of elliptical slots arranged along the longitudinal axis from the proximal end to the distal end of the catheter curve shape strut, a second plurality of elliptical slots arranged along a proximal portion of the catheter curve shape strut and staggered with the first plurality of elliptical slots, and a third plurality of elliptical slots arranged along a distal portion of the catheter curve shape strut and staggered with the first plurality of elliptical slots. Salahieh discloses a steerable delivery device to access a target location within the body. Salahieh teaches the limitation (Claim 40) a cut pattern of the catheter curve shape strut (922, see Fig. 40 and 42 and para. 0146 and 0148 – distal portion 914 of sheath 900 comprises an intermediate layer 922 with cutouts extending along its length).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the braided catheter curve shape strut taught by McDaniel with a slotted catheter curve shape strut as taught by Salahieh. The substitution would have been obvious because Salahieh teaches that a tubular structure with a cut pattern is a known equivalent or alternative to a braided pattern commonly used in catheters for providing controlled bending, and the substitution would have yielded predictable results (see para. 0148). Salahieh further provides motivation for using a cut pattern as it allows for controlled variation in the bending stiffness of the tubular member in difference planes (see para. 0148).
In combination, the braided layer 152 of McDaniel is being substituted with the slotted layer 922 of Salahieh which upon modification would thus cover the limitation of wherein the pair of offset pull wire lumens (lumens of 63) are oriented relative to the cut pattern of the now incorporated slotted layer 922 of Salahieh.
However, modified McDaniel fails to disclose (Claim 40) the cut pattern comprising a first plurality of elliptical slots arranged along the longitudinal axis from the proximal end to the distal end of the catheter curve shape strut, a second plurality of elliptical slots arranged along a proximal portion of the catheter curve shape strut and staggered with the first plurality of elliptical slots, and a third plurality of elliptical slots arranged along a distal portion of the catheter curve shape strut and staggered with the first plurality of elliptical slots.
Seto discloses a bendable endoscope (1) comprising a distal deflectable section (12) comprising a catheter curve shape strut (20, see Fig. 1-3), wherein Seto teaches (Claim 40) the cut pattern (30) comprising a first plurality of elliptical slots (30a) arranged along the longitudinal axis from the proximal end (proximal end of 20) to the distal end (distal end of 20) of the catheter curve shape strut (20, see Fig. 2-3 and para. 0054 – slots 30a are arranged lengthwise along the entire length of strut 20, slots 30a have a partial arc-like shape as seen in Fig. 2-3 which is interpreted as being elliptical in shape), a second plurality of elliptical slots (30b in 20b and 20c) arranged along a proximal portion (20b and 20c) of the catheter curve shape strut (20) and staggered with the first plurality of elliptical slots (30a, see Fig. 2-3 and para. 0055 and 0057-0058 - slots 30b have a partial arc-like shape as seen in Fig. 2-3 which is interpreted as being elliptical in shape, proximal portions 20ba and 20c comprises the second plurality of slots 30b which are staggered with first slots 30a), and a third plurality of elliptical slots (30b in 20a) arranged along a distal portion (20a) of the catheter curve shape strut (20) and staggered with the first plurality of elliptical slots (30a, see Fig. 2-3 and para. 0055 and 0057-0058 - slots 30b have a partial arc-like shape as seen in Fig. 2-3 which is interpreted as being elliptical in shape, distal portion 20a comprises the third plurality of slots 30b which are staggered with first slots 30a).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cut pattern of the slotted catheter curve shape strut taught by modified McDaniel with the cut pattern taught by Seto. This modification is motivated as Seto teaches a cut pattern that allows for improved advancing characteristics with the distal region able to bend the easiest with the smallest bending radius and the subsequent proximal portions having increase in bending radius (see para. 0008 and 0058)
Regarding claim 41, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 41) wherein the outer surface (outer surface of 50) of the longitudinally-extending body (body of 50) has a cylindrical configuration (see Fig. 3B).
Regarding claim 42, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 42) wherein the outer surface (outer surface of 50) of the longitudinally-extending body (body of 50) is circular in cross section (see Fig. 3B).
Regarding claim 44, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 44) wherein the inner surface (inner surface of 50 and 63) of the longitudinally-extending body (body of 50) circumscribes the central lumen (see Fig. 3B and annotated McDaniel drawing 1 above – the inner surface of inner layer 50 and the sections of the outer surface of tubings 63 circumscribe the central lumen such that the central lumen is restricted within the limits of the inner surface).
Regarding claim 48, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 48) wherein the pair of offset pull wire lumens (lumens of 63) comprises a first pull wire lumen and a second pull wire lumen (see Fig. 3B - the lumens of tubings 63 are being interpreted as a first and second lumen), wherein the first pull wire lumen and the second pull wire lumen straddle the central lumen (see Fig. 3B).
Regarding claim 52, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 52) wherein the pair of offset pull wire lumens (lumens of 63) extend parallel to the longitudinal axis and are located between the inner surface (inner surface of 50 and 63) and the outer surface (outer surface of 50) of the longitudinally-extending body (body of 50, see Fig. 3B and annotated McDaniel drawing 1 above – the lumens of tubings 63 extend parallel to the longitudinal axis and through the body of inner layer 50 between the inner and outer surface as illustrated in the McDaniel annotated drawing 1 above).
Regarding claim 54, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 54) wherein the longitudinally- extending body (body of 50) is formed from an extruded polymer (see para. 0030 – inner layer 50 is formed of an extrudable polymeric material).
Regarding claim 56, modified McDaniel discloses the catheter of claim 40, as discussed above. In modified McDaniel, McDaniel discloses (Claim 56) wherein the combined longitudinally-extending body (body of 50) and catheter curve shape strut (52) are configured to be inserted into an outer body (56) of the distal deflectable section (14) of the catheter (10, see Fig. 3B and para. 0030-0031 – deflectable intermediate section 14 of catheter 10 further comprises outer wall 56 where the braided mesh 52 and inner layer 50 are inserted within).
Claim(s) 58 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel in view of Salahieh in view of Seto as applied to claim 56 above, and further in view of Lee et al. (U.S Patent Pub. No. 20060095074 A1, “Lee”).
Regarding claim 58, modified McDaniel discloses the catheter of claim 56, as discussed above.
However, modified McDaniel fails to disclose (Claim 58) wherein the catheter curve shape strut comprises at least two alignment tabs for orienting the pair of offset pull wire lumens relative to the cut pattern in the catheter curve shape strut.
Lee discloses a slotted, flexible shaft for minimally invasive procedures. Lee teaches (Claim 58) wherein the catheter curve shape strut (20) further comprises at least two alignment tabs (116) for orienting the pair of offset pull wires (100a, 100b) relative to the cut pattern (112) in the catheter curve shape strut (20, see Fig. 21 and para. 0072-0073 – pull cables 100a and 100b are oriented relative to the slots 112 of flexible member 20 based upon the alignment of tab 116 to the proximal catheter shaft 14, there may be provided more than one tab 116 on flexible member 20).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slotted catheter curve shape strut taught by modified McDaniel to incorporate at least two alignment tabs as taught by Lee. Lee teaches that catheter curve shape strut must be sufficiently aligned with the proximal catheter shaft to thus orient the slots of the strut correctly relative to the pull cables (see para. 0072-0073). Examiner notes that the intermediate braided layer of McDaniel is being substituted with an intermediate slotted layer as taught by Salahieh and further modified to have the cut pattern taught by Seto. The now intermediate slotted layer of modified McDaniel is further incorporating the alignment tabs of Lee to thus correctly orient the catheter curve shape strut with the proximal catheter shaft and the pull wires as taught by Lee such that the lumens of the tubing 63 of modified McDaniel would be oriented relative to the cut pattern of the catheter curve shape strut.
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783