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.
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) 120-148 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westlund (US 20110077726 A1 – hereinafter Westlund) in view of Bly (US 20080183259 A1 – hereinafter Bly).
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)
PNG
media_image1.png
296
360
media_image1.png
Greyscale
comprising:
a lead body defining a longitudinal axis (figure 1, shown in arrow),
PNG
media_image2.png
296
360
media_image2.png
Greyscale
the lead body having a proximal portion (figure 1, proximal portion 20),
PNG
media_image3.png
296
360
media_image3.png
Greyscale
and a distal portion (distal bias portion 50),
PNG
media_image4.png
296
360
media_image4.png
Greyscale
the proximal portion being generally straight (figure 1 shows the proximal portion 20 being generally straight),
PNG
media_image3.png
296
360
media_image3.png
Greyscale
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);
PNG
media_image4.png
296
360
media_image4.png
Greyscale
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).
PNG
media_image5.png
296
360
media_image5.png
Greyscale
Westlund does not explicitly teach wherein the longitudinal axis and the central axis are approximately coaxial.
Bly teaches a similar implantable medical electrical lead (abstract – “A medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described”), and further teaches in figure 6, a lead body 42 with a distal longitudinal axis that is approximately coaxial to the central axis of the biased helical portion 64.
PNG
media_image6.png
203
256
media_image6.png
Greyscale
Westlund and Bly teach within the field of implantable medical electrical leads with helical portions 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 proximal longitudinal portion of Westlund, to incorporate the approximately coaxial configuration with the central axis as taught by Bly, since such modification would predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 121, the combined invention of Westlund and Bly (hereinafter the combine invention) further teaches 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 (Bly figure 6 shows the approximately coaxial longitudinal and central axis offset by an angle).
PNG
media_image7.png
203
256
media_image7.png
Greyscale
Re. claim 122, the combined invention further teaches 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 as stated above in claim 121, but does not explicitly teach the angle a is less than 25 degrees.
However, it has been held that the configuration of the longitudinal and central axes would be considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Bly of the combined invention teaches in that the lead body is flexible (paragraph 0026 – “The lead body 42 is flexible…”), and therefore the longitudinal axis of the lead body can be changed to an offset angle from the central axis. 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 combined invention’s longitudinal axis of the proximal portion of the lead, to offset the central axis by 25 degrees, since such modification would predictably result in allowing ease of use during implantation to a target tissue region of interest.
PNG
media_image7.png
203
256
media_image7.png
Greyscale
Re. claim 123, the combined invention teaches the claimed invention as stated above in claim 120, but does not explicitly 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 would be considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, as per In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2114.04, Changes in Shape. Bly of the combined invention teaches in that the lead body is flexible (paragraph 0026 – “The lead body 42 is flexible…”), and therefore the longitudinal axis of the lead body 50 can be changed to an offset distance (shown in the dotted lines) that is less than a radius of a coil of the helix such that the longitudinal axis and the central axis (arrow) are approximately coaxial.
PNG
media_image8.png
198
318
media_image8.png
Greyscale
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 combined invention’s longitudinal axis of the proximal portion of the lead, to offset the central axis by a distance that is less than a radius of a coil of the helix such that the longitudinal axis and the central axis, since such modification would predictably result in allowing ease of use during implantation to a target tissue region of interest.
Re. claim 124, the combined invention teaches wherein the lead body further comprises a transition portion arranged between the proximal portion and the distal portion of the lead body (Bly figure 6),
PNG
media_image9.png
178
228
media_image9.png
Greyscale
the transition portion having a radius of curvature of about 9 mm to 11 mm (Bly paragraph 0031 – “…the effective outer diameter of the spiral 64 ranges from about 10 to about 35 mm”, indicating radii of 5 to 17 mm).
Re. claim 125, the combined invention teaches that the spiral 64 ranges of at least 40 mm (Bly paragraph 0031 – “More particularly, an overall length of the spiral 64 ranges from about 40 mm to about 80 mm”),
PNG
media_image10.png
178
228
media_image10.png
Greyscale
But does not explicitly teach that the transition portion has a length 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 was 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 Bly figure 6, teaches the spiral 64 to be at least 40 mm, and therefore the transition portion length would be less than 40 mm, 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 incorporate the length of 20 mm since such modification would predictably result in facilitating accurate implantation of the lead to a target tissue.
Re. claim 126, the combined invention further teaches 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 (Bly figure 6).
PNG
media_image11.png
178
228
media_image11.png
Greyscale
Re. claim 127, the combined invention further teaches wherein the helix comprises a plurality of coils (Bly figure 6),
PNG
media_image12.png
178
228
media_image12.png
Greyscale
and wherein the radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix (Bly figure 6 shows the coils are approximately constant diameters, which indicates the transition portion’s radius of curvature to also be constant to the coil diameters).
PNG
media_image13.png
178
228
media_image13.png
Greyscale
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).
PNG
media_image14.png
296
360
media_image14.png
Greyscale
Re. claim 129, the combined invention further teaches wherein the helix comprises at least two coils (Westlund figure 1).
PNG
media_image14.png
296
360
media_image14.png
Greyscale
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 131, 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 (Bly figure 6).
PNG
media_image11.png
178
228
media_image11.png
Greyscale
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 (Bly figure 6 shows the transition portion connected to the first helix).
PNG
media_image15.png
178
228
media_image15.png
Greyscale
Re. claim 133, the combined invention further teaches wherein the transition portion has a radius of curvature of about 9 mm to 11 mm (Bly paragraph 0031 – “…the effective outer diameter of the spiral 64 ranges from about 10 to about 35 mm”, indicating radii of 5 to 17 mm).
Re. claim 134, the combined invention teaches that the spiral 64 ranges of at least 40 mm (Bly paragraph 0031 – “More particularly, an overall length of the spiral 64 ranges from about 40 mm to about 80 mm”),
PNG
media_image10.png
178
228
media_image10.png
Greyscale
But does not explicitly teach that the transition portion has a length 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 was 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 Bly figure 6, teaches the spiral 64 to be at least 40 mm, and therefore the transition portion length would be less than 40 mm, 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 incorporate the length of 20 mm since such modification would predictably result in facilitating accurate implantation of the lead to a target tissue.
Re. claim 135, the combined invention teaches 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 (Bly figure 6).
PNG
media_image11.png
178
228
media_image11.png
Greyscale
Re. claim 136, the combined invention teaches wherein the helix comprises a plurality of coils and wherein the radius of curvature of the transition portion is not less than a radius of curvature of a smallest coil of the helix (Bly figure 6 shows the coils are approximately constant diameters, which indicates the transition portion’s radius of curvature to also be constant to the coil diameters).
PNG
media_image13.png
178
228
media_image13.png
Greyscale
Re. claim 137, the combined invention teaches electrodes arranged on the helical portion of the lead as well as the transition portion itself (Bly figure 6, electrodes 52 placed on the helical portion 64),
PNG
media_image13.png
178
228
media_image13.png
Greyscale
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 be placed 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 preformed with at least a first coil and a second coil (Westlund figure 1 shows three different coils).
PNG
media_image16.png
296
360
media_image16.png
Greyscale
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).
PNG
media_image17.png
296
360
media_image17.png
Greyscale
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).
PNG
media_image18.png
296
360
media_image18.png
Greyscale
Re. claim 141, the combined invention further teaches wherein the helix is preformed with at least a first coil, a second coil, and a third coil (Westlund figure 1 shows three coils).
PNG
media_image16.png
296
360
media_image16.png
Greyscale
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).
PNG
media_image17.png
296
360
media_image17.png
Greyscale
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).
PNG
media_image18.png
296
360
media_image18.png
Greyscale
Re. claim 144, the combined invention teaches the first-third coils with electrodes (Westlund figure 1)
PNG
media_image16.png
296
360
media_image16.png
Greyscale
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 modify 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 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)
PNG
media_image16.png
296
360
media_image16.png
Greyscale
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 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).
PNG
media_image18.png
296
360
media_image18.png
Greyscale
Re. claim 147, the combined invention teaches the first-third coils with electrodes, specifically the third coil with a single electrode (Westlund figure 1)
PNG
media_image19.png
296
360
media_image19.png
Greyscale
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 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 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 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).
PNG
media_image17.png
296
360
media_image17.png
Greyscale
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 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, 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 first and third coils to leave the second 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 first 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANH-KHOA N DINH/Examiner, Art Unit 3796