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
The rejections pursuant to 35 U.S.C. 112(a) are withdrawn in light of amendments.
Response to Arguments
Applicant's arguments filed on 11/04/2025 have been fully considered.
Applicant’s arguments, see Remarks, under “Rejections under 35 U.S.C. 102” and “Rejections under 35 U.S.C. 103”, on pages 6-10, filed on 11/04/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art references that rejects the amendments made.
Claim Objections
Claim 12 is objected to because of the following grammatical informalities:
Claim 12, line 19, recites “outer jacket (223)”, should read, “outer jacket” for purposes of consistency with the other claims.
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.
Claim 12 is 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 12, line 17, the statement “wherein the third”, renders the claim indefinite because it is an unfinished limitation. For purposes of examination, the examiner interprets “wherein the third” as “wherein the third durometer value is less than the first durometer value, and greater than the second durometer value” similar to the amendments made in claim 1.
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.
Claims 1 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Borovsky et al. (US 20050228290 A1, herein, Borovsky) in view of Hewitt et al. (US 20040153049 A1, herein, Hewitt) and further in view of Euteneuer et al. (US 20050137501 A1, herein, Euteneuer).
Regarding claim 1, Borovsky discloses an apparatus, comprising:
a transducer assembly (10 – Fig.1);
a bending neck (22 – Fig.12) connected to a proximal end of the transducer assembly (Fig.12); and an insertion tube (12 – Fig.12) disposed in tandem with the bending neck and comprising a distal end (16 – Fig.12) connected to a proximal end of the bending neck, and a proximal end (14 – Fig.12) for manipulation of the transducer assembly (14- Fig.12, Para [0074], lines 1-2), the insertion tube having a first durometer value at a first section, and a second durometer value at a second section, wherein the first durometer value is greater than the second durometer value (Para [0022], lines 1-9),
the insertion tube further comprising a middle section disposed between the first section and the second section of the insertion tube, wherein the insertion tube has a third durometer value in the middle section, and the third durometer value is less than the first durometer value, and greater than the second durometer value (Para [0022], lines 1-9).
However, Borovsky fails to explicitly disclose wherein the insertion tube comprises a first braid at its first section the first braid having a first durometer value, and a second braid at its second section, the second braid having a second durometer value, wherein the first durometer value is greater than the second durometer value,
the apparatus further comprising a third braid disposed in the middle section and having a third durometer value, wherein the third durometer value is less than the first durometer value, and greater than the second durometer value,
wherein the insertion tube further comprises an outer jacket disposed around first and second braids, and
wherein the insertion tube further comprises an inner jacket around which the first and second braids are disposed.
Hewitt teaches an insertion tube (400 – Fig.4) comprises a first braid at its first section (see annotated figure below) the first braid having a first durometer value, and a second braid at its second section (see annotated figure below), the second braid having a second durometer value, wherein the first durometer value is greater than the second durometer value (Para [0043]). Even though Hewitt doesn’t explicitly describe a first and second braid and sections, one skilled in the art could interpret that the differences in braid angles and flexibility along the catheter would be considered different braids and sections and even though Hewitt doesn’t explicitly describe a durometer value for the different braids, one skilled in the art could interpret that a more flexible or softer section of the catheter would have a lower durometer since durometer relates to the measurement of hardness.
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Hewitt teaches an apparatus with a third braid disposed in the middle section and having a third durometer value (see annotated figure 6 above), wherein the third durometer value is less than the first durometer value, and greater than the second durometer value (Para [0043]). Even though Hewitt doesn’t explicitly describe a first, second, and third braid and sections, one skilled in the art could interpret that the differences in braid angles and flexibility along the catheter would be considered different braids and sections and even though Hewitt doesn’t explicitly describe a durometer value for the different braids, one skilled in the art could interpret that a more flexible or softer section of the catheter would have a lower durometer since durometer relates to the measurement of hardness.
Hewitt teaches an apparatus wherein an insertion tube further comprises an outer jacket (30 – Fig.4) disposed around first and second braids (Fig.4).
Hewitt teaches an apparatus wherein an insertion tube further comprises an inner jacket (10 – Fig.9) around which the first and second braids are disposed.
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to include braids with different durometer values as taught by Hewitt to provide a desired strength or flexibility or even a varying flexibility along the catheter length (Hewitt, Para [0043]), to modify the apparatus disclosed by Borovsky to include a third braid as taught by Hewitt to provide a desired strength or flexibility or even a varying flexibility along the catheter length (Hewitt, Para [0043]), to modify the apparatus disclosed by Borovsky to comprise an outer jacket as taught by Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]), to modify the apparatus disclosed by Borovsky to comprise an inner jacket as taught by Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]).
Although Borovsky in view of Hewitt disclose a modified apparatus as set forth above, Borovsky, as modified, does not explicitly disclose wherein the inner jacket comprises a monocoil and wherein one or more of a pitch and a thickness of the monocoil varies along a length of the inner jacket to thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end.
Euteneuer teaches an inner shaft (214 – Fig.6) comprising a monocoil (224 – Fig.6) and wherein one or more of a pitch (“pitch of the coil can be varied along the length device” – Para [0042]) and a thickness (“the thickness of coil may be varied along the longitudinal axis of the device” – Para [0042]) of the monocoil varies along a length of the inner jacket, the limitation “thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end” is interpreted to be a functional limitation (the catheter system of Euteneuer is capable of performing these functions since the system comprises all the elements provided above, which can vary the stiffness of the inner shaft from the insertion tube proximal end to the insertion tube distal end).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the inner jacket disclosed by modified, Borovsky to comprise a monocoil, wherein one or more of a pitch and a thickness of the monocoil varies along a length of the inner jacket to thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end as taught by Euteneuer so that inner jacket has a generally stiff proximal portion and a generally flexible distal tip (Euteneuer, Para [0024], Para [0042]) which allows for the device to navigate the tortuous anatomy more easily, reducing the risk of trauma to tissue.
Regarding claim 12, Borovsky discloses an apparatus, comprising:
a transducer assembly (10 – Fig.1);
a bending neck (22 – Fig.12) connected to a proximal end of the transducer assembly (Fig.12); and an insertion tube (12 – Fig.12) disposed in tandem with the bending neck and comprising a distal end (16 – Fig.12) connected to a proximal end of the bending neck, and a proximal end (14 – Fig.12) for manipulation of the transducer assembly (14- Fig.12, Para [0074], lines 1-2), the insertion tube having a first durometer value at a first section, and a second durometer value at a second section, wherein the first durometer value is greater than the second durometer value (Para [0022], lines 1-9),
the insertion tube further comprising a middle section disposed between the first section and the second section of the insertion tube, wherein the insertion tube has a third durometer value in the middle section, and the third durometer value is less than the first durometer value, and greater than the second durometer value (Para [0022], lines 1-9).
However, Borovsky fails to explicitly disclose wherein the insertion tube comprises a first braid at its first section the first braid having a first durometer value, and a second braid at its second section, the second braid having a second durometer value, wherein the first durometer value is greater than the second durometer value,
the apparatus further comprising a third braid disposed in the middle section and having a third durometer value, wherein the third durometer value is less than the first durometer value, and greater than the second durometer value,
wherein the insertion tube comprises a jacket disposed around first, second and third braids,
wherein the jacket is an outer jacket, and the insertion tube further comprises an inner jacket around which the first, second and third braids are disposed.
Hewitt teaches an insertion tube (400 – Fig.4) comprises a first braid at its first section (see annotated figure below) the first braid having a first durometer value, and a second braid at its second section (see annotated figure below), the second braid having a second durometer value, wherein the first durometer value is greater than the second durometer value (Para [0043]). Even though Hewitt doesn’t explicitly describe a first and second braid and sections, one skilled in the art could interpret that the differences in braid angles and flexibility along the catheter would be considered different braids and sections and even though Hewitt doesn’t explicitly describe a durometer value for the different braids, one skilled in the art could interpret that a more flexible or softer section of the catheter would have a lower durometer since durometer relates to the measurement of hardness.
Hewitt teaches an apparatus with a third braid disposed in the middle section and having a third durometer value (see annotated figure 6 below), wherein the third durometer value is less than the first durometer value, and greater than the second durometer value (Para [0043]). Even though Hewitt doesn’t explicitly describe a first, second, and third braid and sections, one skilled in the art could interpret that the differences in braid angles and flexibility along the catheter would be considered different braids and sections and even though Hewitt doesn’t explicitly describe a durometer value for the different braids, one skilled in the art could interpret that a more flexible or softer section of the catheter would have a lower durometer since durometer relates to the measurement of hardness.
Hewitt teaches an apparatus wherein an insertion tube comprises a jacket disposed around first, second and third braids (30 – Fig.4).
Hewitt teaches an apparatus wherein a jacket is an outer jacket (30 – Fig.4), and an insertion tube further comprises an inner jacket (10 – Fig.9A) around which the first, second and third braids are disposed (Fig.4).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to include braids with different durometer values as taught by Hewitt to provide a desired strength or flexibility or even a varying flexibility along the catheter length (Hewitt, Para [0043]), to modify the apparatus disclosed by Borovsky to include a third braid as taught by Hewitt to provide a desired strength or flexibility or even a varying flexibility along the catheter length (Hewitt, Para [0043]), to modify the apparatus disclosed by Borovsky to comprise a jacket disposed around braids as taught by Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]), to modify the apparatus disclosed by Borovsky to comprise an inner and outer jacket as taught by Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]).
Although Borovsky in view of Hewitt discloses a modified apparatus as set forth above, Borovsky, as modified, does not explicitly disclose wherein the inner jacket comprises a monocoil, and
wherein one or more of a pitch and a thickness of the monocoil varies along a length of the inner jacket to thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end.
Euteneuer teaches an inner shaft (214 – Fig.6) comprising a monocoil (224 – Fig.6) and wherein one or more of a pitch (“pitch of the coil can be varied along the length device” – Para [0042]) and a thickness (“the thickness of coil may be varied along the longitudinal axis of the device” – Para [0042]) of the monocoil varies along a length of the inner jacket, the limitation “thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end” is interpreted to be a functional limitation (the catheter system of Euteneuer is capable of performing these functions since the system comprises all the elements provided above, which can vary the stiffness of the inner shaft from the insertion tube proximal end to the insertion tube distal end).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the inner jacket disclosed by modified, Borovsky to comprise a monocoil, wherein one or more of a pitch and a thickness of the monocoil varies along a length of the inner jacket to thereby vary a stiffness of the inner jacket from the insertion tube proximal end to the insertion tube distal end as taught by Euteneuer so that inner jacket has a generally stiff proximal portion and a generally flexible distal tip (Euteneuer, Para [0024], Para [0042]) which allows for the device to navigate the tortuous anatomy more easily, reducing the risk of trauma to tissue.
Regarding claim 13, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the first braid has a first braid angle and a second braid angle that is greater than the first braid angle.
Hewitt teaches an apparatus wherein a first braid has a first braid angle and a second braid angle that is greater than the first braid angle (See annotated Fig.6 above).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise different braid angles as taught by Hewitt since having a lower pic rate at the proximal end provides increased strength and a higher pic rate at the distal end to provide increased kink resistance and flexibility (Hewitt, Para [0039]).
Regarding claim 14, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the first braid comprises a first plurality of wires, the second braid comprises a second plurality of wires, and the first plurality of wires has a greater durometer value than the second plurality of wires.
Hewitt teaches an apparatus wherein the first braid comprises a first plurality of wires, the second braid comprises a second plurality of wires (“One or more wires can be used”, Para [0042]), and the first plurality of wires has a greater durometer value than the second plurality of wires (Para [0043], See annotated Fig.6 above).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise braids with a plurality of wires as taught by Hewitt so flexibility can be further achieved (Hewitt, Para [0043]).
Regarding claim 15, Borovsky discloses an apparatus, comprising:
a transducer assembly (10 – Fig.1);
a bending neck (22 – Fig.12) connected to a proximal end of the transducer assembly (Fig.12); and an insertion tube (12 – Fig.12) disposed in tandem with the bending neck and having a distal end (16 – Fig.12) connected to a proximal end of the bending neck, and a proximal end (14 – Fig.12) for manipulation of the transducer assembly (14- Fig.12, Para [0074], line 1-2), the insertion tube having a durometer value that decreases along its length between the proximal end of the insertion tube and distal end of the insertion tube (Para [0022], lines 1-9).
However, Borovsky fails to explicitly disclose wherein the insertion tube comprises a jacket having a durometer value that decreases along its length between the proximal end of the insertion tube and distal end of the insertion tube.
Hewitt teaches an apparatus wherein an insertion tube (400 – Fig.4) comprises a jacket (30 – Fig.7) having a durometer value that decreases along its length between the proximal end of the insertion tube and distal end of the insertion tube (“proximal durometers are higher than the more distal durometers.” - Para [0047]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise jacket with varying durometer values as taught Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]).
Although Borovsky in view of Hewitt discloses a modified apparatus as set forth above, Borovsky, as modified, does not explicitly disclose wherein the jacket comprises a monocoil having one or more of a pitch and a thickness of the monocoil which varies along a length of the jacket to thereby vary a stiffness of the jacket from the insertion tube proximal end to the insertion tube distal end.
Euteneuer teaches an shaft (214 – Fig.6) comprising a monocoil (224 – Fig.6) having one or more of a pitch (“pitch of the coil can be varied along the length device” – Para [0042]) and a thickness (“the thickness of coil may be varied along the longitudinal axis of the device” – Para [0042]) of the monocoil which varies along a length of the jacket, the limitation “thereby vary a stiffness of the jacket from the insertion tube proximal end to the insertion tube distal end” is interpreted to be a functional limitation (the catheter system of Euteneuer is capable of performing these functions since the system comprises all the elements provided above, which can vary the stiffness of the shaft from the insertion tube proximal end to the insertion tube distal end).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the jacket disclosed by modified, Borovsky to comprise a monocoil having one or more of a pitch and a thickness of the monocoil which varies along a length of the jacket to thereby vary a stiffness of the jacket from the insertion tube proximal end to the insertion tube distal end as taught by Euteneuer so that jacket has a generally stiff proximal portion and a generally flexible distal tip (Euteneuer, Para [0024], Para [0042]) which allows for the device to navigate the tortuous anatomy more easily, reducing the risk of trauma to tissue.
Regarding claim 16, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the jacket has a durometer value that decreases along its length between the proximal end of the insertion tube and distal end of the insertion tube.
Hewitt teaches an apparatus wherein a jacket (30 – Fig.7) has a durometer value that decreases along its length between the proximal end of the insertion tube and distal end of the insertion tube (“proximal durometers are higher than the more distal durometers.” - Para [0047]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise jacket with varying durometer values as taught Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]).
Regarding claim 17, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the insertion tube comprises a braid having a decreasing durometer value along its length between the proximal end of the insertion tube and the distal end of the insertion tube.
Hewitt teaches an apparatus wherein the insertion tube comprises a braid (20 – Fig.6) having a decreasing durometer value along its length between the proximal end of the insertion tube and the distal end of the insertion tube (Para [0043]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise a braid with varying durometer values as taught by Hewitt so flexibility can be further achieved (Hewitt, Para [0043]).
Regarding claim 18, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein a braid angle of the braid decreases along its length between the proximal end of the insertion tube and the distal end of the insertion tube.
Hewitt teaches an apparatus wherein a braid angle of a braid decreases along its length between the proximal end of an insertion tube and the distal end of the insertion tube (Fig.6).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise varying braid angles since having a lower pic rate at the proximal end provides increased strength and a higher pic rate at the distal end provides increased kink resistance and flexibility (Hewitt, Para [0039]).
Regarding claim 19, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the braid comprises a plurality of wires, and a durometer value of the plurality of wires decreases between the proximal end and the distal end of the insertion tube.
Hewitt teaches an apparatus wherein the braid comprises a plurality of wires (“One or more wires can be used”, Para [0042]), and a durometer value of the plurality of wires decreases between the proximal end and the distal end of the insertion tube (Para [0043], lines 7-15).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise a braid with a plurality of wires with varying durometer values as taught by Hewitt so flexibility can be further achieved (Hewitt, Para [0043]).
Regarding claim 20, Borovsky discloses the apparatus set forth above but Borovsky does not expressly disclose wherein the jacket further comprises an outer jacket, and the insertion tube further comprises an inner jacket around which the braid is disposed.
Hewitt teaches an apparatus wherein the jacket further comprises an outer jacket (30 – Fig.9A), and the insertion tube further comprises an inner jacket (10 – Fig.9A) around which the braid is disposed (Fig.9).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the apparatus disclosed by Borovsky to comprise an outer and inner jacket as taught by Hewitt to provide varying flexibility along a length of the catheter (Hewitt, Para [0029]).
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.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783