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 .
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 1-10 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.
Claim 1 is indefinite because it lacks proper antecedent basis for the term "the connecting
wire." The claim introduces "a pulling wire" but then refers to "the connecting wire" without first introducing "a connecting wire." It is unclear if "the connecting wire" is the same element as "a pulling wire" or a different element. To overcome this rejection, Applicant may amend the claim to clarify the relationship, for example, by stating "...wherein the pulling wire also serves as a connecting wire...".
Claim 3 is indefinite because it lacks proper antecedent basis for the term "two pulling wires." Claim 1, from which Claim 3 depends, only recites "a pulling wire" (singular). It is unclear whether the "two pulling wires" of Claim 3 include the single "pulling wire" of Claim 1 or are entirely new elements. This creates ambiguity as to the total number and identity of the pulling wires.
Claim 5 is indefinite because it lacks antecedent basis for the term "the centers." The claim does not introduce the concept of "centers" of the pulling wires.
Claim 6 is indefinite for multiple reasons:
it lacks proper antecedent basis for the term "pulling wires" (plural), as Claim 1 only
recites "a pulling wire" (singular); and
the term “lumen” is used without a preceding article (e.g., "a" or "the").
Claim 10 is indefinite for several reasons:
it improperly changes the claim category from an apparatus ("A steerable catheter") to
"A system for a steerable catheter." This makes the scope of the claim unclear.
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.
Claims 1, 3, 4, 5, 6, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tortonese (US2011/0106101A1) in view of Tung et al. (US 8,347,738B2; hereinafter “Tung”) and the publication Ruth et al., (“Shape Memory Alloy Wire for Force Sensing”; hereinafter “Ruth”).
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In relation to claim 1, Tortonese discloses a steerable catheter/stylet (400) comprising:
Tortonese discloses a steerable stylet/catheter (400) for inserting an electrode array into a cochlea [see figures 5A, 5B, 6B, and 7] comprising:
a polymer shaft with a bending portion;
Tortonese discloses a multi-lumen tube (510) made of silicone, fluoropolymers, polyurethane, or other materials (see paragraph [0046]) and a bending portion (195) (see figure 5A).
that comprises a pulling wire mechanically anchored at a distal part of the bending portion;
Pull wire (515) with wire anchor (516): "A wire anchor (516) is formed on one end of
the pull wire (515)” (see paragraph [0048] and Figure 6B).
where the shaft is provided with a central lumen; and
Central sensor lumen (511): "the multi-lumen tube (510) includes a central sensor
lumen (511)" (see paragraph [0045] and figures 6B and 7).
a force sensor at the distal part;
Sensor (700): "The sensor (700) is inserted into the sensor lumen (511)" (see paragraph [0053] and figure 7). Sensor lumen (511) extends to the distal end of the multi-lumen tube (510) (see figure 6B). A sensor (700) measures the extension of the electrode array (195) which is produced by the additional tension [force] applied to the dither wire (515-2) (see paragraph [0057]). It is important to note that in Tortonese, the sensor (700) is connected via separate gold wires (905) to a flex circuit (910): "one or more gold wires (905) connect to the sensor (900) and pass out of the sensor sleeve (902). The end of the gold wire (905) is attached to a contact pad on a flex circuit (910)" (see paragraph [0062]).
Tortonese does not disclose:
the pulling wire being the connecting wire to the force sensor, and
a connector that provides both mechanical anchoring AND electrical connection between the pulling wire and the force sensor.
However, Tung discloses a catheter with a shape memory alloy (SMA) sensor for detecting force and position. Tung explicitly discloses:
"The invention includes at least one force and/or position sensor with a material in a generally stable temperature and austenite state, where the sensor is incorporated proximal to the catheter first end and an electrical resistance across the sensor changes according to a displacement of the catheter first end, where a measure of a force and/or a position on the catheter first end is attained" (see Summary of the Invention, paragraph [0013]).
Tung further teaches:
"According to one embodiment of the invention, the sensor is formed from shape memory alloy (SMA)" (see paragraph [0017]).
In addition to Tung, Ruth teaches the principle of using an SMA wire for force sensing by measuring the change in its electrical resistance. Ruth describes using SMA wire as a force sensor based on resistance change:
“SMA wire along with a passive bias (antagonistic) element performs sensing as an actuated sensor, by the variation in its electrical resistance for a contact force, in a linear elastic manner” and “[t]he SMA-based sensor is able to provide an accurate static and dynamic force measurement. The variation in the electrical resistance of the SMA is a measure of the strain induced on the load cell for a contact force placed upon it” (see Ruth; Abstract).
Based on the above teachings, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the steerable stylet of Tortonese to use an SMA wire as the force sensor, as taught by Tung and Ruth.
Importantly, in the case at hand, a person of ordinary skill would have been motivated to simplify the design and reduce the number of components within the small diameter of the catheter. Using the pulling wire itself as the electrical connection to the SMA sensor would have been a logical and space-saving modification. This modification would have involved replacing Tortonese's sensor (700) and its separate gold wires (905) with a well-known SMA wire sensor. The substitution would have required using the existing pulling wire (515) [see figure 6B] to also carry the electrical signal, thus functioning as the "connecting wire." The wire anchor (516) of Tortonese would have been adapted to also serve as the electrical connection point, thus becoming the claimed "connector" that provides both mechanical anchoring and electrical connection.
In relation to claim 3, Tortonese discloses multiple pull wires: "[a] plurality of pull wires (515) and a sensor shaft (520) pass through the lumens in the multi-lumen tube (510)" (paragraph [0044]). Tortonese further discloses: "the multi-lumen tube (510) includes a central sensor lumen (511) which is surrounded by four equally spaced wire lumens (512)" (see paragraph [0045]). Moreover, Ruth teaches that SMA force sensing requires measuring resistance across the SMA wire, which inherently requires two electrical connections, one at each end of the SMA wire. Therefore, it would have been obvious to a person having ordinary skill in the art to use two of Tortonese's disclosed pulling wires (515) as the two electrical conductors connected to opposite ends of the SMA sensor, as this is the direct and obvious implementation of the force sensing principle taught by Ruth, which requires measuring resistance across the SMA wire.
In relation to claim 4, the analysis of the previous claims has demonstrated that SMA wires are well-known in the art. Additionally, in order for any SMA wire to be able to be introduced into a catheter lumen, the wire must have a shape that allows for the introduction of the wire into the lumen. Therefore, in view of this requirement/limitation, the particular shape of the wire would have been considered an obvious alternative in the design of the wire in order to facilitate introduction into the lumen of the catheter.
In relation to claim 5, the claim specifies a dimensional relationship between the connector spacing and the SMA wire length. This is a matter of design optimization to achieve a desired sensitivity and mechanical arrangement. Therefore, it would have been obvious to a person having ordinary skill in the art to optimize the distance between connectors relative to the SMA wire length to achieve the desired force sensing sensitivity and mechanical stability, as such dimensional optimization is within the ordinary skill of a catheter designer.
In relation to claim 6, Tortonese explicitly discloses this arrangement: "the multi-lumen tube (510) includes a central sensor lumen (511) which is surrounded by four equally spaced wire lumens (512)" (see paragraph [0045] and figures 6A and 7). The wire lumens (512) are located outside the center of the shaft, surrounding the central sensor lumen (511). Accordingly, in view of the demonstrated conventionality of this enhancement, its application in the invention would have been considered an obvious alternative in the design of the catheter.
In relation to claim 7, Tortonese's device is specifically designed as a catheter/stylet for inserting a cochlear implant electrode array: "This specification describes a steerable stylet that allows for automated insertion of the electrode array into the cochlea" (see paragraph [0024]). Accordingly, in view of the demonstrated conventionality of this enhancement, its application in the invention would have been considered an obvious alternative in the design of the catheter.
In relation to claim 9, Tortonese discloses multiple wire lumens capable of accommodating multiple sets of pulling wires: "the multi-lumen tube (510) includes a central sensor lumen (511) which is surrounded by four equally spaced wire lumens (512)" (see paragraph [0045]). Tortonese further discloses using multiple pull wires for multi-directional steering: "[i]n one embodiment, the wire to the left is called the inner pull wire (515-1) and the wire to the right is called the outer pull wire (515-3)" (see paragraph [0054]). Therefore, it would have been obvious to a person having ordinary skill in the art to provide at least two sets of pulling wires, each connected to a different SMA wire sensor, to enable multidirectional steering and force sensing in multiple directions. This is a straightforward
extension of the combined teachings of Tortonese (multiple pull wires for steering), Tung (SMA sensing),
and Ruth (SMA force measurement). Accordingly, in view of the demonstrated conventionality of this enhancement, its application in the invention would have been considered an obvious alternative in the design of the catheter.
In relation to claim 10, this claim describes a control scheme where sensed force (detected as resistance change in one SMA wire) triggers actuation (pulling) of another SMA wire. This is an obvious feedback control implementation for a steerable catheter. Tung teaches feedback control of catheters using SMA sensing: "[p]roviding position feedback from a catheter during minimally invasive therapy allows for closed-loop control of the catheter tip position under computer-aided guidance and enable force feedback to the physician" (Abstract). Accordingly, in view of the demonstrated conventionality of this enhancement, its application in the invention would have been considered an obvious alternative in the design of the catheter.
Claim 2 is are rejected under 35 U.S.C. 103 as being unpatentable over Tortonese (US2011/0106101A1) in view of Tung et al. (US 8,347,738B2; hereinafter “Tung”), the publication Ruth et al., (“Shape Memory Alloy Wire for Force Sensing”; hereinafter “Ruth”), as discussed above, and in further view of Honebrink (WO 2006/135774A1).
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In relation to claim 2, the combination of Tortonese, Tung, and Ruth does not disclose a connector with a radially extending protrusion. However, Honebrink discloses a push/pull wire anchor for a catheter with a skirt (800A) having a flared portion (802A) (see figure 8A). Honebrink states:
"the skirt 800A includes a flared portion 802A and a proximal portion 804. The flared portion 802A provides a wide and flat profile extending outside of the profile of the proximal portion 804 to facilitate grasping by the encapsulant 214" (Description of Figure 8A, starting on page 20, line 29).
This flared portion (802A) is a radially extending protrusion used to enhance mechanical anchoring of the push/pull wire within the catheter. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of the combined Tortonese/Tung/Ruth device with the flared portion (radially extending protrusion) of Honebrink to improve the mechanical anchoring of the pulling wire/connector within the catheter body. Honebrink teaches that such a flared portion "provides a wide and flat profile" (page 20, line 30) that facilitates grasping and anchoring, which is a well-known design goal for wire anchors in steerable catheters.
Claim 8 is are rejected under 35 U.S.C. 103 as being unpatentable over Tortonese (US2011/0106101A1) in view of Tung et al. (US 8,347,738B2; hereinafter “Tung”), the publication Ruth et al., (“Shape Memory Alloy Wire for Force Sensing”; hereinafter “Ruth”), as discussed above, and in further view of Evans (US 5,250,033A).
In relation to claim 8, the combination of Tortonese, Tung, and Ruth does not disclose a wall thickness region less than 200 μm characteristic of a peel-away or tear-away sheath. Evans discloses a peel-away introducer sheath with specific wall thickness dimensions. Evans states: "[t]ypically, the wall thickness of the tube sheath 12 will be in the range from about 0.03 mm to about 0.3 mm, usually being in the range from about 0.06 mm to about 0.15 mm" (see column 4, lines 16-19).
Converting to micrometers:
0.06 mm = 60 μm
0.15 mm = 150 μm
This range (60-150 μm) is well within the claimed "less than 200 μm." Evans further discloses that the sheath includes "a pair of thin or weakened axial grooves or lines 30, usually being diametrically opposed to each other" to facilitate the peel-away function (see column 3, lines 66-68). Based on the above comments, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the thin, peel-away wall construction of
Evans into the shaft of the combined Tortonese/Tung/Ruth device. A person of ordinary skill would have been motivated to do so to facilitate removal of the catheter sheath after placement of another device (such as a cochlear implant electrode), which is a well-known technique in the art for introducer sheaths.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783