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 Arguments
Applicant's arguments filed on 06/26/2026 have been fully considered.
Applicant’s arguments, see Remarks, filed 06/26/2026, with respect to the rejection(s) of claim(s) 1-15 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 Therefore, the rejection has been withdrawn.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 reference in combination with previous art references.
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 1-4, 8, 10-14, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Guo (US Pub No. 20160317220 A1) in view of Ariola et al. (US Patent No. 5697906 A).
Regarding claim 1, Guo discloses a catheter comprising:
a catheter body (3 – Fig.2) extending from a proximal end of the catheter body (Shown at 20- Fig.1) to a distal end of the catheter body (Shown at 24 – Fig.2); and
a distal member (Shown between 24 and 22 in Fig.2, Fig.4A) comprising a proximal end part (Shown at 22 – Fig.2) connected to the distal end of the catheter body (21 – Fig.2, 10 – Fig.4A), wherein the distal member is a cylindrical shape extending from the proximal end part to a distal end part of the distal member(Fig.2, Fig.4A, Fig.6A), wherein the distal member comprises an axially intermediate part (111 – Fig.2) arranged between the proximal end part (22 – Fig.2) and the distal end part (24 – Fig.2)(Fig.2, “Between the shaft… and the deflectable segment… is a shaft transition region” - Para [0029]), wherein a Young's modulus of the proximal end part (22 – Fig.2) is greater (“polymer with an intermediate material rigidity” – para [0029]) than a Young's modulus of the axially intermediate part (111 – Fig.2)(“a softer polymer” – Para [0029]), and wherein the axially intermediate part defines a
bending portion of the distal member (111 - Fig.3) that is configured to bend when an external force in a bending direction is applied to the distal end part and the distal end of the catheter body is fixed (“a distal deflectable segment having anisotropic bending properties allows for improved catheter guidance and/or improved control for tissue access and tissue contact ” – [0025],Fig.3, Fig.4B).
However, Guo does not expressly disclose wherein the distal member comprises a continuous single unitary piece of material extending from the proximal end part to a distal end part of the distal member.
Ariola teaches a catheter (10 – Fig.1) wherein a distal member (38 – Fig.1) comprises a continuous single unitary piece of material (Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4) extending from a proximal end part (50 – Fig.4) to a distal end part of the distal member (39 – Fig.4).
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 distal member disclosed by Guo, to be a continuous single unitary piece of material extending from the proximal end part to a distal end part of the distal member as taught by Ariola as both references teach three different regions of flexibility in the distal member and furthermore, Ariola teaches that it a well-known technique to have three regions of flexibility in a single piece of material (Ariola, Col.3, lines 12-30).
Regarding claim 2, Guo, as modified, discloses the catheter set forth above, wherein the distal end part is formed in a tapered shape (24 – Fig.2).
Regarding claim 3, Guo, as modified, discloses the catheter set forth above, wherein the continuous single unitary piece of material of the distal member is formed from a thermoplastic resin (“Pebax” – Para [0037]).
Regarding claim 4, Guo discloses the catheter set forth above, wherein the distal member includes only at least one thermoplastic resin layer (14 – Fig.5, “Pebax” – Para [0037]).
Regarding claim 8, Guo, as modified, discloses the catheter set forth above, but Guo, as modified, does not expressly disclose wherein the proximal end part corresponds to a heat-transformed material section of the continuous single unitary piece of material.
Ariola teaches a catheter (10 – Fig.1), wherein a proximal end part (50 – Fig.4, Region C – Fig.4) corresponds to a heat-transformed material section (“the entire nitinol tube is initially submerged in the salt bath to achieve a desired austenite finish temperature for region C” – Col. 5, lines 36-38) of a continuous single unitary piece of material (38 - Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4).
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 proximal end part of the continuous single unitary piece of material disclosed by Guo, as modified, to correspond to a heat-transformed material section since Ariola teaches that a heat-transformation material section is a well known material to use heat to cause a physical change in material properties to vary the flexibility of a piece of material (Ariola, Col.3, lines 16-24).
Regarding claim 10, Guo discloses a catheter (3 – Fig.2) comprising:
a distal member (Shown between 24 and 22 in Fig.2) extending from a proximal end part of the distal member to a distal end part of the distal member, wherein the distal member is connected to a distal end of a catheter body (21 – Fig.2, 10 – Fig.4A), wherein:
the distal member comprises a bending portion (111 – Fig.2, 211 – Fig.4A) arranged between the proximal end part and the distal end part,
a Young's modulus of the bending portion is smaller (“a softer polymer” – Para [0029]) than a Young's modulus of the proximal end part (22 – Fig.2) (“polymer with an intermediate material rigidity” – para [0029]), and
the bending portion corresponds to a section of material that is configured to bend when an external force in a bending direction is applied to the distal end part and the distal end of (24 – Fig.2) the catheter body is fixed (“a distal deflectable segment having anisotropic bending properties allows for improved catheter guidance and/or improved control for tissue access and tissue contact ” – [0025],Fig.3, Fig.4B).
However, Guo, as modified, does not expressly disclose wherein the proximal end part, the distal end part, and the bending portion are formed in a continuous uninterrupted single unitary piece of material of the distal member.
Ariola teaches a catheter (10 – Fig.1) wherein a proximal end part (50, Region C – Fig.4), a distal end part (39, Region A – Fig.4), and a flexible portion (Shown at 38, Region B – Fig.4) are formed in a continuous uninterrupted single unitary piece of material of a distal member (38 – Fig.4)(Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4).
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 distal member disclosed by Guo, wherein the proximal end part, the distal end part, and the bending portion are formed in a continuous uninterrupted single unitary piece of material of the distal member as taught by Ariola as both references teach three different regions of flexibility in the distal member and furthermore, Ariola teaches that it a well-known technique to have three regions of flexibility in a single piece of material (Ariola, Col.3, lines 12-30).
Regarding claim 11, Guo discloses the catheter set forth above, wherein the Young's modulus of the bending portion (111 – Fig.2) is smaller (“a softer polymer” – Para [0029]) than a Young's modulus of the distal end part (22 – Fig.2)(“polymer with an intermediate material rigidity” – para [0029]).
Regarding claim 12, Guo discloses the catheter set forth above, wherein the distal member is connected to the distal end of the catheter body (21 – Fig.2) at the proximal end part (Fig.2).
Regarding claim 13, Guo, as modified, discloses the catheter as set forth above, wherein the proximal end part of the distal member, the bending portion, and the distal end part of the distal member are made from a single unitary piece of material seamless extending from the proximal end part to the distal end part (Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4).
Regarding claim 14, Guo, as modified, discloses the catheter as set forth above, wherein the proximal end part (22 – Fig.2) comprises a material section of the continuous uninterrupted single unitary piece of material (Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4).
Further, the limitation, “melted-and-cured material” is a product-by-process limitation, the Applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 21, Guo, as modified above, discloses the catheter set forth above, wherein the continuous uninterrupted single unitary piece of material comprises a cylindrical shape extending from the proximal end part to the distal end part (Fig.2, Fig.4A, Fig.6A).
Regarding claim 22, Guo, as modified above, discloses the catheter set forth above, wherein the distal end part is formed in a tapered shape (24 – Fig.2).
Regarding claim 23, Guo, as modified above, discloses the catheter set forth above, wherein the continuous uninterrupted single unitary piece of material of the distal member is formed from a thermoplastic resin (“Pebax” – Para [0037]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Ariola as applied to claim 1 above, and further in view of Chappel (US Pub No. 20110196315 A1).
Regarding claim 9, Guo, as modified, discloses the catheter set forth above, but Guo, as modified, does not expressly disclose wherein the distal end part corresponds to a heat-transformed material section of the continuous single unitary piece of material, and wherein a Young's modulus of the distal end part is greater than the Young's modulus of the axially intermediate part.
Ariola teaches a catheter (10 – Fig.1), wherein a proximal end part (39 – Fig.4, Region A – Fig.4) corresponds to a heat-transformed material section (“The extraction time is determined by the desired austenite finish temperature for region A” – Col. 5, lines 41-43) of a continuous single unitary piece of material (38 - Fig.4, “the inner tube is formed of nitinol” – Col. 5, lines 3-4).
Chappel teaches a distal end part (40 – Fig.3B) of a distal member (20 – Fig.3B) having a greater Young's modulus than a Young's modulus of a axially intermediate part (30 – Fig.3B)(“a flexible section with a pushability characteristic… and a stiff and radially rigid section at the distal end ” – Para [0026]).
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 distal end part of the continuous single unitary piece of material disclosed by Guo, as modified, to correspond to a heat-transformed material section since Ariola teaches that a heat-transformation material section is a well-known material to use heat to cause a physical change in material properties to vary the flexibility of a piece of material (Ariola, Col.3, lines 16-24).
It would also 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 distal end part of the continuous single unitary piece of material disclosed by Guo, as modified, to have a Young’s modulus greater than the Young's modulus of the axially intermediate part as taught by Chappel since Chappel teaches it minimizes the risk that the distal edge of the catheter tip will catch on the rough surface of the lumen wall of a curved vessel (Chappel, Para [0026]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Ariola as applied to claim 14 above, and further in view of Cragg et al. (US 20180015254 A1, herein, Cragg).
Regarding claim 15, Guo, as modified, discloses the catheter as set forth above, but Guo, as modified, does not expressly disclose wherein the Young's modulus of the proximal end part is equal to the Young's modulus of the distal end part.
Cragg teaches a catheter wherein the Young's modulus of the proximal end part (302 – Fig.6) is equal to the Young's modulus of the distal end part (“the distal portion can have a generally uniform stiffness profile along a length of the distal portion” – Para [0057]).
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 distal member disclosed by Guo, as modified, wherein the Young's modulus of the proximal end part is equal to the Young's modulus of the distal end part as taught by Cragg since fewer transition points between sections of varying stiffness, reduces the number of transition points that are prone to kinking (Cragg, Para [0057]).
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
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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