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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 10/30/2023. Claims 1-20 are currently pending and being examined.
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the wire” in lines 11 and 13. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the sensor wire”. Appropriate correction is required.
Claim 4 is objected to because of the following abnormalities: Claim 4 recites “wherein twisted pair” in line 1. Examiner suggests reciting “wherein the twisted pair”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the wire” in lines 10 and 12. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the sensor wire”. 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (USPAP 2010/0286626) in view of Ranum (USPAP 2019/0224447).
In reference to independent claim 1, Peterson discloses a catheter comprising:
an inner liner (46, fig 2) defining a first lumen (lumen of 46); an outer liner (38) formed over the inner liner (46); a metallic reinforcement structure (18) between the inner liner (46) and the outer liner (38, see fig 2);
a first sleeve (42) operably connected to the outer liner (38);
a core (14) in communication with the inner liner and having a second lumen of substantially the same diameter as the first lumen and a reduced diameter portion (at the space 26);
a pull wire (tensioning members) traversing the first sleeve (42) and anchored to the core (14) (para 0025 discloses “a steerable catheter 10 having one or more internal tensioning members coupling the proximal end portion [14] to one or more anchor points (rings and the like) as is known in the art”; in order to function the tensioning members must be on the distal side of at least the first set of fenestrations 20, meaning it would pass thru at least 42, fig 2); and
a sensor wire (71), having a first portion of the wire is formed in a plurality of windings wrapped around the reduced diameter portion of the core (12); and an outer sheath (36) exterior to the outer liner (38), the first sleeve (12), and the core (12), however
Peterson does not teach a second portion of the wire being formed as a twisted pair extending proximally along the outer liner
Ranum, a similar catheter, teaches a portion of the wire (71) being formed as a twisted pair extending proximally along the outer liner (para 0006 discloses “the twisted pair of the wire wraps about a proximal end portion of the catheter body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the twisted pair of wires as taught in Ranum in the catheter of Peterson “reduces or eliminates a signal from being generated by the wire 71 along the length of the braid 64 (i.e., utilizing the constructive interference to minimize the signal generated)” para 0058; Ranum. To be clear the modification is done by transforming the sensor wire of Peterson into the sensor wires of Ranum.
In reference to independent claim 8, Peterson discloses a catheter assembly comprising:
a catheter body (10, fig 2) formed of one or more polymeric materials (para 0035 discloses “as depicted in FIG. 2, the proximal end portion 14 of shaft 12 may be partially or substantially fully coated or covered (e.g., encapsulated) with a material 38. Material 38 may comprise a polymer” ), the catheter body defining a first lumen therethrough (lumen that contains 30 and 33, fig 2); a metallic reinforcement structure (18) in contact with the one or more polymeric materials (38 touches 18);
a core (12) distal of the metallic reinforcement structure (18) and the one or more polymeric materials (38); and a wire (sensor 71), however
Peterson does not teach a first portion of the wire is formed in a plurality of windings wrapped around the core and a second portion of the wire formed as a twisted pair extending proximally along the catheter body.
Ranum, a similar catheter, teaches a first portion of the wire (71) is formed in a plurality of windings wrapped around the core (para 0041 discloses “wire 71 includes leads 76a, 76b that are twisted together to form a twisted pair 80 that is coiled about the braid 64”, see fig 4) and a second portion of the wire formed as a twisted pair (80) extending proximally along the catheter body (para 0006 discloses “the twisted pair of the wire wraps about a proximal end portion of the catheter body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the twisted pair of wires as taught in Ranum in the catheter of Peterson “reduces or eliminates a signal from being generated by the wire 71 along the length of the braid 64 (i.e., utilizing the constructive interference to minimize the signal generated)” para 0058; Ranum. To be clear the modification is done by transforming the sensor wire of Peterson into the sensor wires of Ranum.
In reference to independent claim 19, Peterson discloses a catheter assembly comprising: a catheter body (10) formed of one or more polymeric materials (para 0035 discloses “as depicted in FIG. 2, the proximal end portion 14 of shaft 12 may be partially or substantially fully coated or covered (e.g., encapsulated) with a material 38. Material 38 may comprise a polymer” ), the catheter body (10) defining a first lumen (lumen that contains 30 and 33, fig 2); a metallic reinforcement structure (18) in contact with the one or more polymeric materials (38 touches 18);
a core (12) distal of the metallic reinforcement structure (18) and embedded in a wall of the catheter body (core 12 is in the wall of 10, see fig 2), the core (12) covered by at least one of the one or more polymeric materials (para 0035 discloses “Material 36 may comprise a low durometer polymer (e.g., durometer level of about 25-40 shore D) to allow for flexibility and bending.”), the core (12) extending partially around a diameter of the catheter body (12 extends around the catheter body 10); and a sensor wire (71), however
Peterson does not teach a first portion of the wire is formed in a plurality of windings wrapped around the core and a second portion of the wire formed as a twisted pair extending proximally along the catheter body.
Ranum, a similar catheter, teaches a first portion of the wire (71) is formed in a plurality of windings wrapped around the core (para 0041 discloses “wire 71 includes leads 76a, 76b that are twisted together to form a twisted pair 80 that is coiled about the braid 64”, see fig 4) and a second portion of the wire formed as a twisted pair (80) extending proximally along the catheter body (para 0006 discloses “the twisted pair of the wire wraps about a proximal end portion of the catheter body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the twisted pair of wires as taught in Ranum in the catheter of Peterson “reduces or eliminates a signal from being generated by the wire 71 along the length of the braid 64 (i.e., utilizing the constructive interference to minimize the signal generated)” para 0058; Ranum. To be clear the modification is done by transforming the sensor wire of Peterson into the sensor wires of Ranum.
In reference to dependent claim 3, Peterson in view of Ranum discloses the catheter of claim 1, Peterson discloses a catheter further comprising a plurality of fenestrations (20,34) formed in the outer liner and configured to allow the pull wire (tensioning cords in the cite below) to articulate a distal portion of the catheter (para 0010 discloses “a distal end portion and the deflection can be accomplished using adjustable tensioning cords or the like secured at various locations within the catheter”).
In reference to dependent claim 4, Peterson in view of Ranum discloses the catheter of claim 1, Ranum further discloses a catheter wherein twisted pair (80, fig 4) wraps around the outer liner (80 wraps around the internal side of 71) and is captured by the outer liner (71).
In reference to dependent claim 5, Peterson in view of Ranum discloses the catheter of claim1, Peterson further discloses a catheter wherein the core (14) includes a channel (channel of 14 that carries 30) for passage of the twisted pair (Peterson is silent to a twisted pair however, Ranum combined above, does disclose a twisted pair. The equivalent of the twisted pair in Peterson is the tracking coil 28 and its connection 30).
In reference to dependent claim 6, Peterson in view of Ranum discloses the catheter of claim 1, Peterson further discloses a catheter wherein the core (14) includes a cylinder (internal surface structure where the lumen in fig 2 narrows) formed on a proximal portion (left side of fig 2), the cylinder having an inner diameter substantially the same as the lumen in the inner liner (cylinder is substantially the same as the inner liner 46).
In reference to dependent claim 7, Peterson in view of Ranum discloses the catheter of claim 6, Peterson further discloses a catheter wherein the plurality of windings (Peterson is silent to windings, however Ranum, combined above, does disclose windings) are formed on the cylinder (connection 30 is inside the “cylinder” as interpreted above).
In reference to dependent claim 9, Peterson in view of Ranum discloses the catheter assembly of claim 8, Peterson further discloses a catheter wherein the core (12) includes a second lumen (portion of lumen formed by the narrowing inside 12) formed therein substantially the same diameter as the first lumen (the narrowing is “substantially” the same).
In reference to dependent claim 10, Peterson in view of Ranum discloses the catheter assembly of claim 8, Peterson further discloses a catheter wherein the core (12) includes a channel for passage of the twisted pair (channel thru the center that holds 30, the equivalent of the “twisted pair” in Peterson, Ranum, combined above, discloses a “twisted pair”).
In reference to dependent claim 11, Peterson in view of Ranum discloses the catheter assembly of claim 8, Peterson further discloses a catheter wherein the core (12) includes a reduced diameter portion (left side of lumen in fig 2) for receiving the wire (30) and forming the plurality of windings (Peterson is silent to a plurality of windings, however, Ranum combined above, does disclose a plurality of windings 76a and 76b, fig 4).
In reference to dependent claim 12, Peterson in view of Ranum discloses the catheter assembly of claim 8, Peterson further discloses a catheter further comprising a sleeve (42) formed in the catheter body (10).
In reference to dependent claim 13, Peterson in view of Ranum discloses the catheter assembly of claim 12, Peterson further discloses a catheter further comprising a pull wire (tensioning members) traversing the sleeve (42) and attached to the core (12 is attached to 14, see fig 2), wherein actuation of the pull wire articulates a distal portion of the catheter assembly (para 0025 discloses “a steerable catheter 10 having one or more internal tensioning members coupling the proximal end portion [14] to one or more anchor points (rings and the like) as is known in the art”; in order to function the tensioning members must be on the distal side of at least the first set of fenestrations 20, meaning it would pass thru at least 42, fig 2).
In reference to dependent claim 14, Peterson in view of Ranum discloses the catheter assembly of claim 13, Peterson further discloses a catheter further comprising a plurality of fenestrations (20, 34) formed in the catheter body (10) and configured to allow the pull wire to articulate a distal portion of the catheter (para 0010 discloses “a distal end portion and the deflection can be accomplished using adjustable tensioning cords or the like secured at various locations within the catheter”).
In reference to dependent claim 15, Peterson in view of Ranum discloses the catheter of claim 8, Peterson further discloses a catheter wherein the catheter body (10) includes an outer liner (38) and the twisted pair (Peterson is silent to a twisted pair, however Ranum, combined above discloses a twisted pair 80) is captured by the outer liner (28 and 30 in fig 2 are in the position of the twisted pair).
In reference to dependent claim 16, Peterson in view of Ranum discloses the catheter of claim 8, Peterson further discloses a catheter wherein the core (12) includes a channel (lumen that holds 30) formed for passage of the twisted pair (Peterson is silent to a twisted pair, however Ranum, combined above discloses a twisted pair 80).
In reference to dependent claim 17, Peterson in view of Ranum discloses the catheter of claim 8, Peterson further discloses a catheter wherein the catheter body (10) includes an inner liner (46) and the core includes a cylinder (internal surface structure where the lumen in fig 2 narrows) formed on a proximal portion (left side of fig 2), the cylinder having an inner diameter substantially the same as a diameter of a lumen in the inner liner (cylinder is substantially the same as the inner liner 46).
In reference to dependent claim 18, Peterson in view of Ranum discloses the catheter of claim 17, Peterson further discloses a catheter wherein the plurality of windings (Peterson is silent to windings, however Ranum, combined above, does disclose windings) are formed on the cylinder (connection 30 is inside the “cylinder” as interpreted above).
In reference to dependent claim 20, Peterson in view of Ranum discloses the catheter assembly of claim 19, Peterson further discloses a catheter further comprising a sleeve (42) operably connected to the catheter body (10) and embedded in the one or more polymeric materials (42 us embedded in 38 which it is next to, fig 2), wherein the twisted pair traverses the sleeve (30 traverses the sleeve 42).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson (USPAP 2010/0286626) in view of Ranum (USPAP 2019/0224447) in reference to claim 1 above, and further in view of Lundquist (USPN 5409453).
In reference to dependent claim 2, Peterson in view of Ranum discloses the catheter of claim 1, however
Peterson does not teach a second sleeve operably connected to the outer liner and within the outer sheath, wherein the twisted pair extends through the second sleeve.
Lundquist, a similar steerable catheter, teaches a second sleeve (28, fig 4) operably connected to the outer liner (34) and within the outer sheath (the outer layer of 34), wherein the sensor wires (62) extends through the second sleeve (62 extend through the center of 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the secondary sleeve as taught in Lundquist in the catheter of Peterson in view of Ranum “to provide a protective wall for the catheter” col 8, lines 52-53; Lundquist.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Costello (USPAP 2017/0079546) discloses a catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/ Examiner, Art Unit 3783