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 .
Election/Restrictions
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/05/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4,6-9, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat Pub No. 20100292768 to Sommer et al. (hereinafter “Sommer”).
Regarding claim 1. (Original) Sommer discloses a pacing device (para 0047, 0048 “lead 20”; of interest paras 0048-0051), comprising: an electrical conductor having a longitudinal axis (para 0047-0048 “lead body 21”; axis being drawn through the longitudinal axis of the lead body 21); and a tip electrode (para 0064, “helix tip 35”, figs 2, 7-8) electrically coupled to the electrical conductor (para 004-0051, “cable 28”, fig 2) and extending along a spiral axis about the longitudinal axis (figs 2, 7-8), wherein at a position along the spiral axis a surface of the tip electrode includes an insulative portion (para 0064, 0068, etc. “a layer or coating 42 or 142 of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen”, fig. 8) and a conductive portion (para 0064, 0068, etc., “uninsulated outer helical electrode 40”, fig. 8).
Regarding claim 2. (Original) Sommer discloses the pacing device of claim 1, wherein a cross-section of the tip electrode taken transverse to the spiral axis at the position includes a core wire having a perimeter, and wherein the insulative portion includes an insulative layer extending over an arc around the perimeter (para 0064, 0068, etc. “a layer or coating 42 or 142 of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen”, fig. 8).
Regarding claim 3. (Original) Sommer discloses the pacing device of claim 2, wherein the arc has an arc length that is less than a perimeter length of the perimeter (para 0064, 0068, etc. “a layer or coating 42 or 142 of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen”, figs. 7-8).
Regarding claim 4. (Original) Sommer discloses the pacing device of claim 3, wherein the arc length is at least half of the perimeter length (para 0064, 0068, etc. “a layer or coating 42 or 142 of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen”, figs. 7-8, 11).
Regarding claim 6. (Original) Sommer discloses the pacing device of claim 2 further comprising a surface modification extending over at least the conductive portion of the tip electrode (para 0016-0017, 0021, 0046, 0052, 0064, 0069, etc.).
Regarding claim 7. (Original) Sommer discloses the pacing device of claim 6, wherein the surface modification includes a low- polarization coating on the core wire (id, para 0068-0071, etc.).
Regarding claim 8. (Original) Sommer discloses the pacing device of claim 1, wherein the insulative portion includes an insulative strip spiraling about the longitudinal axis along the tip electrode (para 0016-0017, 0021, 0046, 0052, 0064, 0069, etc., fig 5-12).
Regarding claim 9. (Original) Sommer discloses the pacing device of claim 8, wherein the tip electrode includes an outer radial surface facing away from the longitudinal axis, and wherein at least a portion of the insulative strip extends along the outer radial surface (fig. 7, showing at least a portion of the insulative strip extends along the outer radial surface).
Regarding claim 13. (Original) Sommer discloses a biostimulator (para 0047, 0048 “lead 20”; of interest paras 0048-0051), comprising: a housing including an electronics compartment containing pacing circuitry (para 0047-0048, 0053 the outer housing containing the “lead body 21”, “IPG sensing and/or pacing pulse generating circuitry”); an electrical conductor electrically coupled to the pacing circuitry and having a longitudinal axis (para 0047-0048 “lead body 21”; axis being drawn through the longitudinal axis of the lead body 21); and a tip electrode (para 0064, “helix tip 35”, figs 2, 7-8) electrically coupled to the electrical conductor (para 004-0051, “cable 28”, fig 2) and extending along a spiral axis about the longitudinal axis (figs 2, 7-8), wherein a surface of the tip electrode includes an insulative portion (para 0064, 0068, etc. “a layer or coating 42 or 142 of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen”, fig. 8) and a conductive portion at a position along the spiral axis (para 0064, 0068, etc., “uninsulated outer helical electrode 40”, fig. 8).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sommer in view of US Pat No 7212870 to Helland.
Regarding claim 5. (Original) Sommer discloses the pacing device of claim 2, but fails to disclose wherein the tip electrode includes a transition zone between the insulative portion and the conductive portion over which a coating density of the insulative portion decreases along the perimeter in a direction of the conductive portion.
Helland, from a similar field of endeavor, teaches having an insulative portion and a conductive portion wherein the insulative portion is coated with a suitable insulative material [] and teaches that it is known to provide insulation/un-insulation areas as desired (Col. 2, lns 24-36, col 5, lns 38-55 and lns 56-64, figs 1, 2, 4, 4B, 6-9). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sommer with the known teachings of Helland to provide the predictable result of producing insulative/conductive regions as desired.
The difference is considered to be an aesthetic design change and therefore an obvious variation - In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Regarding claim 11. (Original) Sommer discloses the pacing device of claim 1, but fails to disclose wherein the tip electrode includes an inner radial surface facing toward the longitudinal axis, and wherein the conductive portion includes a conductive strip spiraling about the longitudinal axis along the inner radial surface.
Helland, from a similar field of endeavor, teaches having an insulative portion and a conductive portion wherein the insulative portion is coated with a suitable insulative material [] and teaches that it is known to provide insulation/un-insulation areas as desired such as in fig. 7 (Col. 2, lns 24-36, col 5, lns 38-55 and lns 56-64, figs 1, 2, 4, 4B, 6-9). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sommer with the known teachings of Helland to provide the predictable result of producing insulative/conductive regions as desired.
Note: the difference is considered to be an aesthetic design change and therefore an obvious variation - In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Regarding claim 12. (Original) Sommer as modified by Helland renders obvious the pacing device of claim 11, wherein the tip electrode includes a plurality of turns about the longitudinal axis (Sommer, figs 5-11), and wherein a spiral length of the conductive strip is less than one turn of the plurality of turns (Col. 2, lns 24-36, col 5, lns 38-55 and lns 56-64, figs 1, 2, 4, 4B, 6-9). The difference is considered to be an aesthetic design change - In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sommer in view of US Pat Pub No. 20200289835 to Eby et al. (hereinafter “Eby”).
Regarding claim 14. (Original) Sommer discloses the biostimulator of claim 13, Sommer discloses having a helical fixation element (para 0047) but fails to disclose further comprising an outer fixation element coupled to the housing radially outward of the tip electrode.
Eby, from a similar field of endeavor teaches having a fixation element extending helically about a same longitudinal axis to respective distal tips (para 0008, 0036, etc.) to engage a target tissue (para 0008). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sommer with the teachings of Eby to provide the predictable result of allowing the electrode to engage a target tissue.
See: In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) where the court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."; Here, it would be obvious to make the fixation element removable to engage a target tissue.
Regarding claim 15. (Original) Sommer as modified by Eby renders obvious the biostimulator of claim 14 further comprising a helix mount, wherein the electrical conductor includes an electrode cup within the helix mount, wherein the outer fixation element is mounted on the helix mount, and wherein a proximal portion of the tip electrode is mounted in the electrode cup (Eby, figs 1-5 para 0043-0046, 0064, 0068-0069).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sommer in view of US Pat No 4010758 A to Rockland et al. (hereinafter “Rockland”).
Regarding claim 10. (Original) Sommer discloses the pacing device of claim 8, but fails to disclose wherein a radial distance from a midline of the insulative strip to the longitudinal axis varies along the tip electrode.
Rockland, from a similar field of endeavor shows that it is known to provide a helical electrode having an insulating material covering most of the helical electrode, leaving exposed a portion thereof associated with the pointed tip 19 [] electrode 18 is of a helical configuration, whereby it is particularly adapted to be relatively inserted or screwed into body tissue (Col. 4, lns 14-44, figs 2A-C). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sommer with the teachings of Rockland to provide the predictable result of inserting the electrode into the body.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796