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 .
Information Disclosure Statement
The information disclosure statement(s) filed 03/28/2024 has/have been considered by the Examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 120-130 and 132-149 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly cited reference as taught by Jaraczewski (US 5938694 A – hereinafter Jara) is relied upon to teach a similar shapable electrical stimulation catheter which includes proximal portion and a helical distal section, in which the longitudinal axis of the proximal portion and the central axis of the helix is coaxial as shown in the figure below.
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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.
Claim(s) 120-130 and 132-149 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westlund (US 20110077726 A1 – hereinafter Westlund, previously cited) in view of Jaraczewski (US 5938694 A – hereinafter Jara, NEW).
Re. claim 120, Westlund teaches an implantable medical electrical lead (abstract – “A medical electrical lead and methods of implanting medical electrical leads in lumens”; figure 1)
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comprising:
a lead body defining a longitudinal axis (figure 1, shown in arrow),
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the lead body having a proximal portion (figure 1, proximal portion 20),
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and a distal portion (distal bias portion 50),
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the proximal portion being generally straight (figure 1 shows the proximal portion 20 being generally straight),
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and the distal portion being formed with a helix, the helix having a central axis being defined through the helix (distal portion 50 shows a helical shape);
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and a plurality of electrodes arranged along the helix, each of the electrodes having a length parallel to a lead body portion on which each of the electrodes is disposed (figure 1, electrodes 40 shown to be disposed parallel to the lead body disposed on).
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Westlund teaches the lead comprising the proximal portion as stated above figure 1, proximal portion 20), and the central axis of the helix (figure 1 below),
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but does not expressly teach wherein a longitudinal axis of the proximal portion and the central axis of the helix are approximately coaxial.
Jara teaches a similar shapable electrical stimulation catheter comprising an electrode array (abstract – “An electrode array catheter, typically used for mapping, pacing and ablation, includes a flexible delivery sheath (36, 64) and an electrode assembly (2, 62) slidably mounted within the delivery sheath for movement between retracted and deployed positions”), further comprising a proximal portion (figure 1 below),
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And a flexible distal helix (figure 1, flexible electrode tip 24; column 5, lines 28-30: “In the embodiment of FIGS. 1-4, the tip 24 of the catheter is made so that it assumes a coiled conical shape as shown in FIGS. 1 and 2”; column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”) including electrodes 26 along the helical tip 24 (column 5, line 38: “Tip 24 includes fifteen electrodes 26 along its length”),
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And further teaches wherein a longitudinal axis of the proximal portion and the central axis of the helix are approximately coaxial (shown in figure 1 below).
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Both Westlund and Jara both teach within the field of shapable, therapeutic electrical stimulation systems/devices comprising proximal portions and distal helices with electrodes as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the helical lead configuration of Westlund, to try the coaxial longitudinal axis of the proximal portion and the central axis of the helix configuration as taught by Jara, since such modification would predictably result in, for example, ease of delivery to a target stimulation region of interest.
Re. claims 121-122, the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial longitudinal axis and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”).
The combined invention however does not expressly teach wherein the longitudinal axis diverges from the central axis by an angle a such that the longitudinal axis and the central axis are approximately coaxial, AND wherein a is less than 25 degrees.
However, it has been held that the configuration of the longitudinal and central axes, specifically the angle of the longitudinal axis diverging from the central axis, would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, and therefore the longitudinal axis of the lead body could be changed to an offset angle from the central axis of the helix. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s longitudinal axis of the proximal portion of the lead, to try offsetting the central axis of the helix by 25 degrees, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 123, the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial longitudinal axis and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”).
The combined invention however does not expressly teach wherein the longitudinal axis and the central axis are substantially parallel to one another and displaced from one another by less than a radius of a coil of the helix such that the longitudinal axis and the central axis are approximately coaxial.
However, it has been held that the configuration of the longitudinal and central axes, specifically the longitudinal axis and the central axis parallel to one another and displaced from one another by less than a radius of a coil of the helix such that the longitudinal axis and the central axis are approximately coaxial, would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, and therefore the longitudinal axis of the lead body could be changed to an offset parallel axis from the central axis of the helix such that the longitudinal axis and the central axis are approximately coaxial. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s longitudinal axis of the proximal portion of the lead, to try offsetting from the central axis of the helix and displacing from one another by less than a radius of a coil of the helix, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 124, the combined invention further teaches wherein the lead body further comprises a transition portion arranged between the proximal portion and the distal portion of the lead body (Jara figure 1 below).
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Re. claim 125, the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial longitudinal axis and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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The combined invention however does not expressly teach wherein the transition portion has a length along the central axis of about 20 mm.
However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, as per In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2114.04 Changes in Size/Proportion. In the instant case, the combined invention, specifically Jara figure 1, teaches the transition portion formed from the flexible tip 24 as stated in claim 124,
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Which could be pre-formed with a length of 20 mm along the central axes via the shapable lead body as taught by Westlund, and the flexible tip as taught by Jara, and would not perform differently from the claimed transition portion in facilitating implantation of the lead to a target tissue.
Since the combined invention teaches the transition portion as stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transition portion of the combined invention, to try incorporating the length of 20 mm to the transition portion, since such modification would still predictably result in facilitating accurate implantation of the lead to a target tissue.
Re. claim 126, the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial longitudinal axis and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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The combined invention however does not expressly teach wherein the transition portion comprises a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes.
However, it has been held that the configuration of the transition portion would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, while Jara teaches that the tip 24 including the transition can be pre-formed via its flexibility, and therefore the transition portion could be formed comprising a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s transition portion, to try a transition portion configuration with a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 127, Westlund of the combined invention further teaches wherein the helix comprises a plurality of coils (Westlund figure 1).
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Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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But the combined invention does not expressly teach wherein a radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix.
However, it has been held that the configuration of the transition portion would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, while Jara teaches that the tip 24 including the transition can be pre-formed via its flexibility, and therefore the transition portion could be formed comprising a radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s transition portion, to try a transition portion configuration with a radius of curvature not less than a radius of curvature of a smallest helix coil, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 128, the combined invention further teaches wherein the at least two coils of the helix are preformed to have one of a substantially constant diameter, an increasing diameter in a direction of a distal end of the lead body, OR a decreasing diameter in the direction of the distal end of the lead body (Westlund figure 1 shows the coils have substantially constant diameters).
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Re. claim 129, the combined invention further teaches wherein the helix comprises at least two coils (Westlund figure 1).
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Re. claim 130, the combined invention further teaches wherein the lead is one of a small lead having a helical diameter of about 14 to 18 mm, a medium lead having a helical diameter of about 19 to 23 mm, OR a large lead having a helical diameter of about 24 to 28 mm (Westlund paragraph 0024 – “An embodiment for this application may, for example, have a helix/coil diameter of 20 mm”).
Re. claim 132, the combined invention further teaches wherein the transition portion is connected to a first coil of a plurality of coils of the helix of the distal portion (Jara figure 1 shows the transition portion connected to a plurality of coils).
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Re. claims 133-134, Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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But the combined invention does not expressly teach wherein the transition portion has a radius of curvature of about 9 mm to 11 mm, AND wherein the transition portion has a length along the central axis of about 20 mm.
However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, as per In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2114.04 Changes in Size/Proportion. In the instant case, the combined invention, specifically Jara figure 1, teaches the transition portion formed from the flexible tip 24 as stated in claim 124,
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Which could be pre-formed with a radius of curvature of 9 mm to 11 mm and length of 20 mm along the central axes via the shapable lead body as taught by Westlund and the flexible tip as taught by Jara, and would not perform differently from the claimed transition portion in facilitating implantation of the lead to a target tissue.
Therefore, since the combined invention teaches the flexible transition portion as stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transition portion of the combined invention, to try incorporating the radius of curvature of 9 mm to 11 mm and length of 20 mm since such modification would still predictably result in facilitating accurate implantation of the lead to a target tissue.
Re. claim 135, the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial longitudinal axis and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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The combined invention however does not expressly teach wherein the transition portion comprises a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes.
However, it has been held that the configuration of the transition portion would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, while Jara teaches that the tip 24 including the transition can be pre-formed via its flexibility, and therefore the transition portion could be formed comprising a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s transition portion, to try a transition portion configuration with a proximal segment comprising a first curve in a first plane, a distal segment comprising a second curve in a second plane, and an intermediate segment disposed between the proximal segment and the distal segment and comprising a complex curve in multiple planes, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 136, Westlund of the combined invention further teaches wherein the helix comprises a plurality of coils (Westlund figure 1).
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Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”), and further teaches the transition portion as shown in figure 1.
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But the combined invention does not expressly teach wherein a radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix.
However, it has been held that the configuration of the transition portion would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, while Jara teaches that the tip 24 including the transition can be pre-formed via its flexibility, and therefore the transition portion could be formed comprising a radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s transition portion, to try a transition portion configuration with a radius of curvature not less than a radius of curvature of a smallest helix coil, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 137, the combined invention teaches electrodes arranged on the helical portion of the lead (Jara figure 1, tip electrode 10; Jara figure 2, electrodes 26) as well as the transition portion itself (Jara figure 1),
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but does not explicitly teach wherein at least one of the electrodes is arranged in the transition portion.
However, it has been held that limitations regarding the arrangement of essential working elements, specifically to the electrodes with respect to the lead, is held to be an obvious matter of design choice, as per in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Furthermore, shifting the arrangement of at least one of the electrodes to the transition portion would not modify operation of the device in stimulating a target region of tissue, as per in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), see MPEP 2114.04 Rearrangement of Parts. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the position of at least one electrode of the combined invention, to try placing an electrode on the transition portion since such modification would predictably result in stimulating a target region of tissue, while being further motivated by choice in design dictated by the limited available space.
Re. claim 138, the combined invention further teaches wherein the helix is pre-formed with at least a first coil and a second coil (Westlund figure 1 shows three different coils).
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Re. claim 139, the combined invention further teaches wherein the first coil includes at least two electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the first coil).
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Re. claim 140, the combined invention further teaches wherein the second coil includes at least two additional electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the second coil).
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Re. claim 141, the combined invention further teaches wherein the helix is pre-formed with at least a first coil, a second coil, and a third coil (Westlund figure 1 shows three coils).
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Re. claim 142, the combined invention further teaches wherein the first coil includes at least two electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the first coil).
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Re. claim 143, the combined invention further teaches wherein the second coil includes at least two additional electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the second coil).
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Re. claim 144, the combined invention teaches the first-third coils with electrodes (Westlund figure 1)
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But does not explicitly teach wherein the third coil is configured as a stabilization coil without including any electrodes.
However, it has been held that limitations regarding the arrangement of essential working elements, specifically to the electrodes with respect to the coils of the lead, is held to be an obvious matter of design choice, as per in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Furthermore, shifting the arrangement of at least one of the electrodes to the first and second coils to leave the third coil without electrodes would not modify operation of the device in facilitating implantation of the lead and stimulating a target region of tissue, as per in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), see MPEP 2114.04 Rearrangement of Parts. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the electrodes of the combined invention, to be placed on the first and second coils to leave the third coil without electrodes, since such modification would still predictably result in stimulating a target region of tissue, while being further motivated by choice in design dictated by the limited available space.
Re. claim 145, the combined invention teaches the first-third coils with electrodes (Westlund figure 1)
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But does not explicitly teach wherein the first coil is configured as a stabilization coil without including any electrodes.
However, it has been held that limitations regarding the arrangement of essential working elements, specifically to the electrodes with respect to the coils of the lead, is held to be an obvious matter of design choice, as per in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Furthermore, shifting the arrangement of at least one of the electrodes to the second and third coils to leave the first coil without electrodes would not modify operation of the device in facilitating implantation of the lead and stimulating a target region of tissue, as per in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), see MPEP 2114.04 Rearrangement of Parts. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of the combined invention, to be placed on the second and third coils to leave the first coil without electrodes, since such modification would still predictably result in stimulating a target region of tissue, while being further motivated by choice in design dictated by the limited available space.
Re. claim 146, the combined invention further teaches wherein the second coil includes at least two electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the second coil).
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Re. claim 147, the combined invention teaches the first-third coils with electrodes, specifically the third coil with a single electrode (Westlund figure 1)
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But does not explicitly teach wherein the third coil includes at least two additional electrodes of the plurality of electrodes.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, as per in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2114.04, Duplication of Parts. In the instant case, Westlund figure 1 shows the third coil which includes the electrode 40 as shown above, and duplicating the electrode on the third coil with a second/third electrode would not produce any new or unexpected result nor change operation of the device in stimulating a target tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the electrode of the third coil of the combined invention as shown above, to try duplicating the electrode with a second/third electrode on the third coil, since such modification would still predictably result in stimulating a target region of tissue.
Re. claim 148, the combined invention further teaches wherein the first coil includes at least two electrodes of the plurality of electrodes (Westlund figure 1 shows two electrodes 40 placed on the first coil).
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But does not explicitly teach wherein the third coil includes at least two additional electrodes of the plurality of electrodes.
However, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, as per in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2114.04, Duplication of Parts. In the instant case, Westlund figure 1 shows the third coil which includes the electrode 40 as shown above, and duplicating the electrode on the third coil with a second/third electrode would not produce any new or unexpected result nor change operation of the device in stimulating a target tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying at least electrode 50 of the third coil of the combined invention, to try duplicating the electrode with a second/third electrode on the third coil, since such modification would still predictably result in stimulating a target region of tissue.
The combined invention does not explicitly teach wherein the second coil is configured as a stabilization coil without including any electrodes.
However, it has been held that limitations regarding the arrangement of essential working elements, specifically to the electrodes with respect to the coils of the lead, is held to be an obvious matter of design choice, as per in re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Furthermore, shifting the arrangement of at least one of the electrodes to the second and third coils to leave the first coil without electrodes would not modify operation of the device in facilitating implantation of the lead and stimulating a target region of tissue, as per in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), see MPEP 2114.04 Rearrangement of Parts. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of the combined invention, to be placed on the second and third coils to leave the second coil without electrodes, since such modification would predictably result in stimulating a target region of tissue, while being further motivated by choice in design dictated by the limited available space.
Re. claim 149, the combined invention the combined invention of Westlund and Jara (hereinafter the combined invention) teaches the coaxial proximal portion and the helix central axis as stated above in claim 120.
Westlund of the combined invention further teaches the lead body 10 can be shapable to a pre-formed configuration (Westlund paragraph 0021 – “This bias region 50 may be formed by wrapping the lead around a spindle of other shape imparting structure and heat treating or otherwise shaping the lead body 10 in a way that the lead will be biased to return to this preformed shape. The lead body may be constructed from a shape memory polymer or metal or of any material suitable for the purpose. If constructed from a shape memory polymer, for example polyurethane, the thickness or diameter of the lead body or other parameters may be varied to adjust the degree of rigidity of the bias”).
Jara of the combined invention teaches that the catheter tip 24 is flexible (Jara column 5, lines 57-58: “To maintain the desired flexibility of tip 24…”).
The combined invention however does not expressly teach wherein the longitudinal axis of the proximal portion and the central axis of the helix are parallel and approximately coaxial such that in a presence of a rotation applied to the proximal portion, the distal portion rotates in a one-to-one manner with the proximal portion.
However, it has been held that the configuration of the proximal portion and central axis of the helix, specifically that the longitudinal axis of the proximal portion and the central axis of the helix are parallel and approximately coaxial such that in a presence of a rotation applied to the proximal portion, the distal portion rotates in a one-to-one manner with the proximal portion, would be considered an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular claimed configuration is significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Westlund teaches that the lead body 10 can be pre-formed into any configuration as stated above, and therefore the longitudinal axis of the lead body’s proximal portion could be changed to an offset parallel axis from the central axis of the helix such that the longitudinal axis and the central axis are approximately coaxial in a manner that would facilitate rotation of the distal portion in a one-to-one manner with the proximal portion. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the combined invention’s longitudinal axis of the proximal portion of the lead, to try offsetting from the central axis of the helix to be approximately coaxial such that in a presence of a rotation applied to the proximal portion, the distal portion rotates in a one-to-one manner with the proximal portion, since such modification would still predictably result in allowing ease of use during implantation to a target tissue region of interest.
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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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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