The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection. Upon further search and consideration, newly discovered prior art is made of record in the rejections below.
Claim Rejections - 35 USC § 112
Second Paragraph
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.
Claim 32 is 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 32 is rejected because “spacings … sized to enable growth of fibrotic tissue and prevent lead migration” is relative. The specification provides this same type of statement in paragraphs 77, 92 and 96 (paragraphs being indicated for the PGPUB 2024/0325735) without providing examples, ranges or specific spacing requirements that are sufficient “to enable” these result effective outcomes. Therefore, it is unclear what is considered properly spaced in these regards to deliver the claimed outcomes.
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.
Claims 1-2, 6-10, 21, 23-28 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Mar et al. (US Patent No. 5,439,485) in view of Belke et al. (DE 19758368 A1) and De Kock et al. (US Patent Pub. No. 2017/0319864).
Regarding claim 1, Mar discloses a flexible defibrillation electrode with an improved construction (see Title). Specifically, Mar teaches a shocking electrode (i.e., for defibrillation as indicated in the title) of a lead for an implantable medical device (IMD) (i.e., Mar teaches “an implantable defibrillator lead comprises a flexible core onto which is wound helically wound coils to form an electrode” – see Abstract)) the shocking electrode comprising:
A base structure (see the entire body of the elongate section shown in Figure 2, within which electrode coils 24 are embedded in an outer surface thereof)… with helical grooves along an outer surface of the base structure (note that Figure 2 appears to illustrate electrode coils 24 within outer surface of the base structure, which includes layers 22 and 28, which appear to illustrate grooves, however, note that Belke has been incorporated specifically for grooves below)…; and
A coiled conductor (see electrode 20 in Figure 1, provided with further detail as coils 24 in Figure 2) that … is configured to deliver high-voltage shocks for defibrillation therapy (see Abstract, which defines this as being an implantable defibrillator lead having an electrode), wherein the coiled conductor includes an electrically conductive element that is helically wrapped (see column 3, lines 63-66; “FIG. 2 shows a detail view of the distal connection of the lead 18 of FIG. 1. Electrode 20 is shown to be constructed of many (six) electrode coils 24 helically wound around a flexible tubular supporting core 22”) …, wherein the electrically conductive element is… (ii) a micro-coil that includes a coiled strand (see Figure 10, illustrating the device of Mar within the heart of a patient; see Figures 1-2 illustrating closer views of the same device, from which it is evident that the coils 24 are micro-sized and include coiled strands) … .
However, it is noted that Mar is deficient with respect to (1) true helical grooves within which the micro-coil resides in the base structure’s outer surface, since Mar teaches embedding of the micro-coil as shown in enhanced detail in Figures 4a,b, thereby also failing to teach that “the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure” and “the grooves along the outer surface of the base structure sized to accommodate the micro-coil in the grooves”; and (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
Belke discloses a defibrillation electrode arrangement, in which “The invention includes the finding that special Advantages in the manufacture of a helical electrode arrangement, in particular a defibrillation electrode, can be reached if the helix on a carrier in Fort Setting the supply line without mechanical connection and Contacting means for the DFT rope can be generated.” Specifically, Belke teaches a shocking electrode of a lead for an implantable medical device (IMD) (see lead in Figure 1 having electrode 3 thereon, note that on page 5 it states “Depending on the patient-specific conditions, either a separately implantable electrode or the metallic housing of the defibrillator is used as the counter electrode for the shock coil 3”, which means that shock coil 3 is implanted as well). Also Belke teaches a base structure (see numeral 6 in Figure 3) … with helical grooves along an outer surface of the base structure (see grooves within which DFT cables 13 reside within Figure 3, note that Figure 5 also shows these grooves and labels then as 29.6, “The groove provided in the tubular casing 29 in the area of the shock coil 23 is designated 29.6” – see page 5 of the Machine Translation in the paragraph beginning “The defibrillating electrode 23…”), the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure (see page 4 of the Machine Translation, “To form the helical coil 3 , the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6”). As shown in Figures 3 and 5, the grooves are along the outer surface of the base structure and are sized to accommodate the conductor in the grooves to form electrode 3 (see overall view of electrode 3 in Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to create a groove into the base structure itself, as taught by Belke, and to utilize this within the system and methods of Mar, because “in comparison to a conventional soldering or welding connection - because of the missing contact points lower technological effort producible. At the same time, the risk of breakage at a contact point between the supply line and the associated electrode is excluded” (see page 5 of the Machine Translation of Belke). The creation of the groove prevents the need for these soldering or welding connections (see page 4, where it states “To form the helical coil 3, the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6. The individual turns 3.1 of the shock electrode extend parallel to one another and are arranged in a positionally secure manner by a frictional connection with the tubular casing 6”). Additionally, this would eliminate the need for the elastomeric material 28 in Mar, which improves the trade-off of “The more metal exposed, the greater the electrode surface area for defibrillation, but the less material for providing mechanical stability” (see column 5, lines 6-8 of Mar) and additionally improves production of the device by eliminating the need for the joining material 47 and the use of the elastomeric material 28 (see column 5, lines 54-59).
However, Mar in combination with Belke is still deficient with respect to (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
De Kock teaches “A subcutaneous implantable cardioverter-defibrillator (S-ICD) comprising shocking electrodes” (see Abstract). As taught, “The shocking coil electrode 308 may have a generally flattened cross-sectional configuration… For example, referring to FIGS. 3B and 3C which illustrate an end view and a perspective view, respectively, of the illustrative coil electrode 308, the coil electrode 308 may have a cross-sectional shape that generally takes the form of an oval. The cross-sectional shape may have two curved ends and two parallel sides connecting the curved ends” (see paragraph 45). “The coil electrode 308 may have a larger surface area and/or shadow than a typical shocking coil electrode. It is contemplated that increasing the surface area and/or shadow of the shocking electrode 308 may allow the defibrillation threshold to be lowered” (see paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a flattened shape for a shocking/defibrillating electrode, as taught by De Kock, and to provide this shape in the system and methods of Mar, because “Some electrodes have a width or surface area that is larger than typical shocking electrodes. The increased surface area or shadow may reduce the defibrillation threshold” (see paragraph 4 of De Kock).
Regarding claim 2, it can be seen in Figure 2 of Mar that the coils 24 have micro-turns and macro-turns. That is, each coil is helically wound around the core 22 (i.e., macro-turns) and each coil itself has a plurality of small spirals making up the coil. By the combination with De Kock, it would be obvious to have an overall shape that has a generally flattened cross-sectional configuration for the core.
Regarding claim 6, it is re-iterated that the device of Mar as combined with Belke teaches a base structure with grooves within which the conductive element would reside, helically wrapping the base structure. Additionally, by the combination with De Kock, it would be obvious that this has an overall shape that has a generally flattened cross-sectional configuration.
Regarding claim 7, it can be seen in Figure 2 and Figure 4b of Mar in combination with Belke teaches, via Figures 3 and 5 of Belke, that the conductor would be embedded into the base structure’s outer surface via the grooves. It is also noted that Mar explicitly teaches “embedding” the micro-coil within the outer wall of the device.
Regarding claim 8, it can be seen in Figures 3 and 5 of Belke that the conductors are at least partially within the helical grooves of the outer surface of base structure 6.
Regarding claim 9, it is noted that Mar teaches that “This structure has elastomeric material 28, which also may be … insulative, partially encapsulating the electrode coils” (see column 4, lines 1-2). It is also noted that Belke teaches that element 6 (see Figure 3) is made of plastic (see 1st line on page 6) and/or a silicone material (see page 4, paragraph beginning “As shown in FIG. 2,…”), and it is noted that silicone and plastic are known to be electrically insulating.
Regarding claim 10, Mar teaches via Figure 4b that the coils 24 are embedded within the elastomeric material 28 such that they reside within grooves that allow the coils 24 to be partially embedded and partially exposed. Mar teaches that “One method of achieving this structure is to completely encapsulate the wrapped electrode coils, then abrade away the surface to partially expose the coils” (see column 4, lines 4-7), which clearly teaches to overmold the entire core 22 and coils 24, then removing some of the overmolded elastomeric material 28 away to expose a portion of the coils. Additionally, it is re-iterated that by the combination with De Kock, it would be obvious that this overall structure has an overall shape that has a generally flattened cross-sectional configuration.
Regarding claim 21, Mar teaches a shocking electrode (i.e., for defibrillation as indicated in the title) of a lead for an implantable medical device (IMD) (i.e., Mar teaches “an implantable defibrillator lead comprises a flexible core onto which is wound helically wound coils to form an electrode” – see Abstract)) the shocking electrode comprising:
An electrically insulative base structure (“This structure has elastomeric material 28, which also may be … insulative, partially encapsulating the electrode coils” - see column 4, lines 1-2)… and helical grooves along an outer surface of the electrically insulative base structure (note that Figure 2 appears to illustrate electrode coils 24 within outer surface of the base structure, which includes layers 22 and 28, which appear to illustrate grooves, however, note that Belke has been incorporated specifically for grooves below)…; and
A micro-coil helically wrapped around the electrically insulative base structure to define a coiled conductor (see Figure 10, illustrating the device of Mar within the heart of a patient; see Figures 1-2 illustrating closer views of the same device, from which it is evident that the coils 24 are micro-sized and include coiled strands that are helically wrapped around the base structure; also see electrode 20 in Figure 1; see column 3, lines 63-66)… and configured to deliver high-voltage shocks for defibrillation therapy (see Abstract, which defines this as being an implantable defibrillator lead having an electrode),
Wherein the micro-coil includes a coiled wire strand defining micro-turns along a length of the micro-coil (see column 4, lines 28-29, “each electrode coil 24 is made from a helically wound metal wire 26”),
Wherein the micro-coil defines macro-turns around the electrically insulative base structure… (it is noted that in Figure 2 of Mar the coils 24 have micro-turns and macro-turns. That is, each coil is helically wound around the core 22 (i.e., macro-turns) and each coil itself has a plurality of small spirals making up the coil (i.e., micro-turns)).
However, it is noted that Mar is deficient with respect to (1) true helical grooves within which the micro-coil resides in the base structure’s outer surface, since Mar teaches embedding of the micro-coil as shown in enhanced detail in Figures 4a,b, thereby also failing to teach that “the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure” and “the grooves along the outer surface of the base structure sized to accommodate the micro-coil in the grooves”; and (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
Belke discloses a defibrillation electrode arrangement, in which “The invention includes the finding that special Advantages in the manufacture of a helical electrode arrangement, in particular a defibrillation electrode, can be reached if the helix on a carrier in Fort Setting the supply line without mechanical connection and Contacting means for the DFT rope can be generated.” Specifically, Belke teaches a shocking electrode of a lead for an implantable medical device (IMD) (see lead in Figure 1 having electrode 3 thereon, note that on page 5 it states “Depending on the patient-specific conditions, either a separately implantable electrode or the metallic housing of the defibrillator is used as the counter electrode for the shock coil 3”, which means that shock coil 3 is implanted as well). Also Belke teaches a base structure (see numeral 6 in Figure 3) … with helical grooves along an outer surface of the base structure (see grooves within which DFT cables 13 reside within Figure 3, note that Figure 5 also shows these grooves and labels then as 29.6, “The groove provided in the tubular casing 29 in the area of the shock coil 23 is designated 29.6” – see page 5 of the Machine Translation in the paragraph beginning “The defibrillating electrode 23…”), the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure (see page 4 of the Machine Translation, “To form the helical coil 3 , the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6”). As shown in Figures 3 and 5, the grooves are along the outer surface of the base structure and are sized to accommodate the conductor in the grooves to form electrode 3 (see overall view of electrode 3 in Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to create a groove into the base structure itself, as taught by Belke, and to utilize this within the system and methods of Mar, because “in comparison to a conventional soldering or welding connection - because of the missing contact points lower technological effort producible. At the same time, the risk of breakage at a contact point between the supply line and the associated electrode is excluded” (see page 5 of the Machine Translation of Belke). The creation of the groove prevents the need for these soldering or welding connections (see page 4, where it states “To form the helical coil 3, the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6. The individual turns 3.1 of the shock electrode extend parallel to one another and are arranged in a positionally secure manner by a frictional connection with the tubular casing 6”). Additionally, this would eliminate the need for the elastomeric material 28 in Mar, which improves the trade-off of “The more metal exposed, the greater the electrode surface area for defibrillation, but the less material for providing mechanical stability” (see column 5, lines 6-8 of Mar) and additionally improves production of the device by eliminating the need for the joining material 47 and the use of the elastomeric material 28 (see column 5, lines 54-59).
However, Mar in combination with Belke is still deficient with respect to (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
De Kock teaches “A subcutaneous implantable cardioverter-defibrillator (S-ICD) comprising shocking electrodes” (see Abstract). As taught, “The shocking coil electrode 308 may have a generally flattened cross-sectional configuration… For example, referring to FIGS. 3B and 3C which illustrate an end view and a perspective view, respectively, of the illustrative coil electrode 308, the coil electrode 308 may have a cross-sectional shape that generally takes the form of an oval. The cross-sectional shape may have two curved ends and two parallel sides connecting the curved ends” (see paragraph 45). “The coil electrode 308 may have a larger surface area and/or shadow than a typical shocking coil electrode. It is contemplated that increasing the surface area and/or shadow of the shocking electrode 308 may allow the defibrillation threshold to be lowered” (see paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a flattened shape for a shocking/defibrillating electrode, as taught by De Kock, and to provide this shape in the system and methods of Mar, because “Some electrodes have a width or surface area that is larger than typical shocking electrodes. The increased surface area or shadow may reduce the defibrillation threshold” (see paragraph 4 of De Kock).
Regarding claims 23-24, it is noted that De Kock teaches a racetrack cross-sectional shape (see Figure 3B for a first cross-section, see Figure 3A illustrating a top-view cross section). Note that these shapes each have a major and minor dimension that are perpendicular to one another (similar to how this is true in Figure 2A of the instant application).
Regarding claim 25, it is noted that Belke teaches that “To form the helical coil 3 , the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6” (see page 4 of Belke).
Regarding claim 26, Mar teaches that “Conductor 30 extends through the lumen of core 22, making connection 34 at the distal end of electrode 20” (see column 5, lines 26-28 – emphasis added, see Figure 2).
Regarding claim 27, Mar teaches via Figure 4b that the coils 24 are embedded within the elastomeric material 28 such that they reside within grooves that allow the coils 24 to be partially embedded and partially exposed. Mar teaches that “One method of achieving this structure is to completely encapsulate the wrapped electrode coils, then abrade away the surface to partially expose the coils” (see column 4, lines 4-7), which clearly teaches to overmold the entire core 22 and coils 24, then removing some of the overmolded elastomeric material 28 away to expose a portion of the coils. Additionally, it is re-iterated that by the combination with De Kock, it would be obvious that this overall structure has an overall shape that has a generally flattened cross-sectional configuration.
Regarding claim 28, Mar teaches a lead for an implantable medical device (IMD), the lead comprising: a lead body (see Figure 1); and
A shocking electrode disposed along the lead body (see numeral 20) and configured to deliver high-voltage shocks for defibrillation therapy (see Abstract, which defines this as being an implantable defibrillator lead having an electrode), the shocking electrode comprising:
An.. based structure defining helical grooves along an outer surface of the… base structure, the helical grooves recessed into the outer surface and open radially outward at the outer surface (note that Figure 2 appears to illustrate electrode coils 24 within outer surface of the base structure, which includes layers 22 and 28, which appear to illustrate grooves, however, note that Belke has been incorporated specifically for grooves below); and
A micro-coil helically wrapped around the… base structure and received at least partially in the helical grooves to define a coiled conductor… (see Figure 10, illustrating the device of Mar within the heart of a patient; see Figures 1-2 illustrating closer views of the same device, from which it is evident that the coils 24 are micro-sized and include coiled strands that are helically wrapped around the base structure; also see electrode 20 in Figure 1; see column 3, lines 63-66).
However, it is noted that Mar is deficient with respect to (1) true helical grooves within which the micro-coil resides in the base structure’s outer surface, since Mar teaches embedding of the micro-coil as shown in enhanced detail in Figures 4a,b, thereby also failing to teach that “the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure” and “the grooves along the outer surface of the base structure sized to accommodate the micro-coil in the grooves”; and (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
Belke discloses a defibrillation electrode arrangement, in which “The invention includes the finding that special Advantages in the manufacture of a helical electrode arrangement, in particular a defibrillation electrode, can be reached if the helix on a carrier in Fort Setting the supply line without mechanical connection and Contacting means for the DFT rope can be generated.” Specifically, Belke teaches a shocking electrode of a lead for an implantable medical device (IMD) (see lead in Figure 1 having electrode 3 thereon, note that on page 5 it states “Depending on the patient-specific conditions, either a separately implantable electrode or the metallic housing of the defibrillator is used as the counter electrode for the shock coil 3”, which means that shock coil 3 is implanted as well). Also Belke teaches a base structure (see numeral 6 in Figure 3) … with helical grooves along an outer surface of the base structure (see grooves within which DFT cables 13 reside within Figure 3, note that Figure 5 also shows these grooves and labels then as 29.6, “The groove provided in the tubular casing 29 in the area of the shock coil 23 is designated 29.6” – see page 5 of the Machine Translation in the paragraph beginning “The defibrillating electrode 23…”), the helical grooves recessed into the outer surface of the base structure and open radially outward at the outer surface of the base structure (see page 4 of the Machine Translation, “To form the helical coil 3 , the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6”). As shown in Figures 3 and 5, the grooves are along the outer surface of the base structure and are sized to accommodate the conductor in the grooves to form electrode 3 (see overall view of electrode 3 in Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to create a groove into the base structure itself, as taught by Belke, and to utilize this within the system and methods of Mar, because “in comparison to a conventional soldering or welding connection - because of the missing contact points lower technological effort producible. At the same time, the risk of breakage at a contact point between the supply line and the associated electrode is excluded” (see page 5 of the Machine Translation of Belke). The creation of the groove prevents the need for these soldering or welding connections (see page 4, where it states “To form the helical coil 3, the distal end of the DFT cable 8 is led out of the lumen 6.2 through the tubular sleeve 6 and inserted into the helical groove 6.4 worked into the periphery of the tubular sleeve 6. The individual turns 3.1 of the shock electrode extend parallel to one another and are arranged in a positionally secure manner by a frictional connection with the tubular casing 6”). Additionally, this would eliminate the need for the elastomeric material 28 in Mar, which improves the trade-off of “The more metal exposed, the greater the electrode surface area for defibrillation, but the less material for providing mechanical stability” (see column 5, lines 6-8 of Mar) and additionally improves production of the device by eliminating the need for the joining material 47 and the use of the elastomeric material 28 (see column 5, lines 54-59).
However, Mar in combination with Belke is still deficient with respect to (2) “a coiled conductor that has an oblong cross-sectional shape” and “wherein the coiled conductor includes an electrically conducive element that is helically wrapped and defines the oblong cross-sectional shape”.
De Kock teaches “A subcutaneous implantable cardioverter-defibrillator (S-ICD) comprising shocking electrodes” (see Abstract). As taught, “The shocking coil electrode 308 may have a generally flattened cross-sectional configuration… For example, referring to FIGS. 3B and 3C which illustrate an end view and a perspective view, respectively, of the illustrative coil electrode 308, the coil electrode 308 may have a cross-sectional shape that generally takes the form of an oval. The cross-sectional shape may have two curved ends and two parallel sides connecting the curved ends” (see paragraph 45). “The coil electrode 308 may have a larger surface area and/or shadow than a typical shocking coil electrode. It is contemplated that increasing the surface area and/or shadow of the shocking electrode 308 may allow the defibrillation threshold to be lowered” (see paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a flattened shape for a shocking/defibrillating electrode, as taught by De Kock, and to provide this shape in the system and methods of Mar, because “Some electrodes have a width or surface area that is larger than typical shocking electrodes. The increased surface area or shadow may reduce the defibrillation threshold” (see paragraph 4 of De Kock).
Regarding claim 30, it is noted that Belke teaches that element 6 (see Figure 3) is made of plastic (see 1st line on page 6) and/or a silicone material (see page 4, paragraph beginning “As shown in FIG. 2,…”). It is additionally noted that Mar teaches that “a fourth alternative is to manufacture the core and elastomeric material portion simultaneously by putting uncured rubber onto a mandrel to form both portions” (see column 6, lines 10-13).
Regarding claim 31, Figure 3 of Belke illustrate that the grooves are sized to accommodate the conductor, which by combination with Mar would be the micro-coils, and maintain spacing between the macro-turns of the conductor.
Regarding claim 32, it is noted that Mar shows that there is spacing within the micro-turns of the micro-coil in Figure 2. Additionally, both Mar and Belke illustrate spacing within the macro-turns of their helically wound conductors. As such, this teaches “spacings… sized to enable growth of fibrotic tissue and prevent lead migration”, since there is spacing provided in all regards.
Regarding claim 33, Mar teaches via Figure 4b that the coils 24 are embedded within the elastomeric material 28 such that they reside within grooves that allow the coils 24 to be partially embedded and partially exposed. Mar teaches that “One method of achieving this structure is to completely encapsulate the wrapped electrode coils, then abrade away the surface to partially expose the coils” (see column 4, lines 4-7), which clearly teaches to overmold the entire core 22 and coils 24, then removing some of the overmolded elastomeric material 28 away to expose a portion of the coils. Additionally, it is re-iterated that by the combination with De Kock, it would be obvious that this overall structure has an overall shape that has a generally flattened cross-sectional configuration.
Claims 22 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Mar in view of Belke and De Kock as applied to claims 21 and 28 above, and further in view of Bardy et al. (US Patent Pub. No. 2006/0206181).
Mar in combination with Belke and De Kock is described above with respect to claims 21 and 28. It is noted that Mar teaches the defibrillation electrode may also sense, and Belke teaches additional electrodes 22, 24, 25 and 26 that are taught as “sensing and/or stimulation electrodes” (see claim 10 of Belke on page 7). However, in an effort to advance prosecution, Bardy teaches a lead electrode assembly for use with an implantable cardioverter-defibrillator (see Abstract). Bardy teaches that “Proximal to the coil electrode are two sense electrodes, a first sense electrode 25 is located proximally to the coil electrode and a second sense electrode 23 is located proximally to the first sense electrode. The sense electrodes are spaced far enough apart to be able to have good QRS detection” (see paragraph 115, see Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide two electrodes at both sides of a defibrillation electrode, as taught by Bardy, in order “to be able to have good QRS detection” (see paragraph 115 of Bardy).
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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/JAMES KISH/ Primary Examiner, Art Unit 3792
