DETAILED ACTION
The following is a Final Office Action on the merits.
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 .
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 11/18/2025.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6 & 23-24 is/are rejected under 35 U.S.C. 103 as unpatentable over Sterrett et al. (2017/0112405, previously cited) in view of Askin, III et al. (2015/0264816, previously cited), Helgeson et al. (2016/0346038, previously cited) and Starksen (2009/0209950, previously cited).
Concerning claim 1, as illustrated in at least Figs. 19A-D & 23A-F, Sterrett et al. disclose a catheter (catheter 101; [0079]), comprising:
a shaft for insertion into an organ of a patient (catheter shaft 107; [0082]);
an expandable distal-end assembly, which is coupled to the shaft and comprises multiple splines (flexible tip portion 500 couples to shaft 107 and comprises arms 504, 506, 508, 510; [0180]), wherein at least one of the multiple splines comprises a flexible substrate having an outer surface comprising a planar surface, the flexible substrate configured to conform to tissue of the organ (arms 504, 506, 508, 510 comprise flexible mounting portion 516/understructure 610, coated with top and bottom dielectric layers 612-1, 612-2 having planar outer surfaces and first and second overcoat dielectric layers 640-1, 640-2 that protect and/or prevent tissue contact of one or more electrically conductive traces 636-1, 636-2 and one or more electrically conductive pads 638; [0180], [206]); and
a first electrical interconnection (electrically conductive traces 518, contact pads 520 and electrodes 502 form an electrical interconnection/ one or more electrically conductive traces 636-1, 636-2, one or more electrically conductive pads 638, electrodes 644; [0181], [0193], [0206]) having: (i) a first section, which is formed within the flexible substrate and is configured to conduct ablation signals (electrically conductive traces 518 are disposed along mounting portion 516/ electrically conductive traces 636-1, 636-2 are disposed between dielectric layers 612-1, 612-2 and first and second overcoat dielectric layers 640-1, 640-2; [0181-0182], [0206]), and (ii) a second section thicker than the first section, the second section comprising a cross-section which protrudes from the outer surface of the flexible substrate and is configured to apply the ablation signals to the tissue (electrodes 502 are overlayed on pads 520 over outer surface of mounting portion 516 and electrically connect to traces 518 to convey ablation energy to tissue, where electrodes 502 have a thickness more than that of the electrically conductive traces 518 / electrodes 644 are overlayed on exposed area 642 that forms a via that extends through overcoat dielectric layers 640-1, 640-2 to conductive pads 638, thus forming a thicker second section, particularly in the via area, that connect to electrically conductive traces 636-1, 636-2; [0181-0182], [0193], [0206]); and
a second electrical interconnection (electrically conductive traces 518, contact pads 520 and electrodes 502 form an electrical interconnection/ one or more electrically conductive traces 636-1, 636-2, one or more electrically conductive pads 638, electrodes 644; [0181], [0193], [0206]) having: (i) a first section, which is formed within the flexible substrate and is configured to conduct ablation signals (electrically conductive traces 518 are disposed along mounting portion 516/ electrically conductive traces 636-1, 636-2 are disposed between dielectric layers 612-1, 612-2 and first and second overcoat dielectric layers 640-1, 640-2; [0181-0182], [0206]), and (ii) a second section thicker than the first section, the second section comprising a rectangular cross-section which protrudes from an outer surface of the flexible substrate (electrodes 502 are overlayed on pads 520 over outer surface of mounting portion 516 and electrically connect to traces 518 to convey ablation energy to tissue, where electrodes 502 have a thickness more than that of the electrically conductive traces 518 / electrodes 644 are overlayed on exposed area 642 that forms a via that extends through overcoat dielectric layers 640-1, 640-2 to conductive pads 638, thus forming a thicker second section, particularly in the via area, that connect to electrically conductive traces 636-1, 636-2; [0181-0182], [0193], [0206]).
The Examiner notes that Figs. 4A-D also illustrate an embodiment with a thicker second section and discussed in Pars. [0107].
PNG
media_image1.png
635
1463
media_image1.png
Greyscale
Sterrett et al. fail to disclose the second sections being integral with the first sections of the first and second electrical interconnections. However, Askin, III et al. disclose a flexible electrical interconnection (100/300a/300b) formed from either different electrically conductive layers (Fig. 2B) or a single electrically-conductive layer thus integrally forming the first and second sections of an entirety of the electrically-conductive layer that forms a single electrical trace at the same time (Fig. 3A) ([0033-0035], [0038]; Fig. 1-3). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Sterrett et al. such that the second sections are integral with the first sections of the first and second electrical interconnections since Askin, III et al. teach a single electrically conductive layer and multiple electrically conductive layers forming an electrical interconnection to be equivalents in the art and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). See also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Further, Applicant places no criticality of the second sections being integral with the first sections of the first and second electrical interconnections since Applicant discloses: “In some embodiments, conductor 77 and layer 82 are formed in one common process step, and layer 80 is formed over layer 82 using a different process step. In other embodiments, both conductor 77 and electrode 88 are made at the same time by forming an electrical trace having a thickness 76, and subsequently, thinning conductor 77 to thickness 74 and producing layer 70 over conductor 77.” (Pg. 13-14, ll. 23-2)
Sterrett et al. in view of Askin, III et al. fail to disclose the second section of the first electrical interconnection comprising a curvilinear or ovoid cross-section. However, Helgeson et al. disclose a catheter (10) having an electrical interconnection having a second section (20’’) that comprises a curvilinear or ovoid cross-section that protrudes from an outer surface of a substrate (84) thereby providing an atraumatic transition from the substrate outer surface to the electrode. Further, Starksen discloses a catheter comprising first and second electrical interconnections having sections that may be recessed, raised or flush with a substrate surface and may have a cross-sectional configuration that is circular, elliptical, square, rectangular, triangular, polygonal, or any other shape ([0132]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sterrett et al. in view of Askin, III et al. such that the second section of the first electrical interconnection comprises a curvilinear or ovoid cross-section in order to provide the benefit of atraumatic electrodes as taught by Helgeson et al. ([0046-0048]; Fig. 2 & 8) and, it would have been obvious to one of ordinary skill in the art to modify the invention of Sterrett et al. in view of Helgeson et al. such that the catheter comprises the first and second electrical interconnections with both a rectangular and curvilinear/ovoid cross-sectional configuration since Starksen teaches the equivalency of various cross-sectional configurations that can be raised with respect to a substrate surface. Further, Applicant provides no criticality in the originally filed disclosure as to having both cross-sectional configurations and merely states: “In the present example, a first conductor 77 configured to conduct the ablation signals to a rectangular electrode 88, and a second longer conductor 77 configured to conduct the ablation signals to a round electrode 88, which is positioned closer to apex 89 relative to rectangular electrode 88. In other embodiments, all electrodes 88 of distal-end assembly 40 have the same shape. Moreover, each spline 55 may have any suitable number of electrodes 88 (e.g., between one and fifty) formed along the spline.” (Pg. 10-11, ll. 20-2). (The Examiner notes that Applicant only provides criticality for the curvilinear/ovoid cross-section: “As compared to the rectilinear (FIG. 2A) or square cross-section, the curvilinear or ovoid cross sections (electrode 88′ in FIG. 2B) can be utilized to reduce stress concentrations on the electrodes 88′ during the expansion or collapse of the spines 66.”).
Concerning claim 2, Sterrett et al. further disclose a top portion (502) of the second section (502, 520) if the first electrical interconnection can have a thickness of 0.1-1000 microns and that a bottom portion (520) of the second section (502, 520) and the first section (518) can have a thickness of approximately 7 microns, although the thickness of the material used (e.g., copper) can be greater or less than 7 microns ([0193], [0205]). Thus, Sterrett et al. disclose a second section having a thickness of 7.1-1007 microns (0.0071 – 1.007 mm). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Sterrett et al. in view of in view of Askin, III et al., Helgeson et al. and Starksen such that the second section has a thickness of 0.1 mm as Applicant appears to have placed no criticality on the claimed range (see pp. 12 of originally filed disclosure) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 3, Sterrett et al. disclose the flexible substrate (516/610, 612, 640) comprises a flexible printed circuit board (FPCB) and wherein the first electrical interconnection comprises an electrical trace (636) made from gold ([0180], [0182], [0186], [0206]).
Concerning claim 4, Sterrett et al. disclose the FPCB comprises at least an electrically insulating layer (640) formed over the first section (518/636) and configured to electrically insulate between the first section (518/636) of the first electrical interconnection and tissue ([0182], [0206]; Fig. 23A-F).
Concerning claim 5, Sterrett et al. disclose the second section (502, 520/638, 642, 644) of the first electrical interconnection has at least a surface (520/644), which is not covered by the electrically insulating layer (640) and is configured to apply the ablation signals to the tissue ([0180], [0206]; Fig. 4C, 19A-D, 23A-F).
Concerning claim 6, as discussed above, Sterrett et al. disclose the second section (502, 520) can have a thickness of 7.1-1007 microns and the first section (518) can have a thickness of 7 microns. Sterrett et al. fail to specifically disclose the second section of the first electrical interconnection is approximately 20 or 100 times thicker than the first section. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Sterrett et al. in view of in view of Askin, III et al., Helgeson et al. and Starksen such that the second section is approximately 20 or 100 times thicker than the first section as Applicant appears to have placed no criticality on the claimed range (“electrode…has a thickness 76 that is typically larger than thickness 74, e.g., from about 100 m to about 1 mm, or any other suitable thickness”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 23, the modified invention of Sterrett in view of in view of Askin, III et al., Helgeson et al. and Starksen further discloses the curvilinear or ovoid cross section (20””) of the second electrical interconnection protrudes from the outer surface of the substrate (84) orthogonally relative to a plane formed by the outer surface of the flexible substrate (84) (Helgeson: Fig. 8, Starksen: [0132]).
Concerning claim 24, Sterrett in view of in view of Askin, III et al., Helgeson et al. and Starksen fail to disclose the second section of the second electrical interconnection comprising the rectangular cross section is disposed proximal to the second section of the first electrical interconnection comprising the curvilinear or ovoid cross-section. However, it would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sterrett in view of Helgeson et al. and Starksen such that the second section of the second electrical interconnection comprising the rectangular cross section is disposed proximal to the second section of the first electrical interconnection comprising the curvilinear or ovoid cross-section since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, Applicant provides no criticality as to the locations of the different cross-sectional configurations and merely discloses: “In some embodiments, one spline 55 may comprise two or more electrical interconnections. In the present example, a first conductor 77 configured to conduct the ablation signals to a rectangular electrode 88, and a second longer conductor 77 configured to conduct the ablation signals to a round electrode 88, which is positioned closer to apex 89 relative to rectangular electrode 88. In other embodiments, all electrodes 88 of distal-end assembly 40 have the same shape. Moreover, each spline 55 may have any suitable number of electrodes 88 (e.g., between one and fifty) formed along the spline.” (Pg. 10-11, ll. 20-2)
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as unpatentable over Sterrett et al. (2017/0112405, previously cited) in view of Askin, III et al. (2015/0264816, previously cited), Helgeson et al. (2016/0346038, previously cited) and Starksen (2009/0209950, previously cited), as applied to claim 1, in further view of Sutermeister et al. (2019/0350649, previously cited) and Basu et al. (2018/0184982, previously cited).
Concerning claim 25, Sterrett et al. in view of in view of Askin, III et al., Helgeson et al. and Starksen fail to disclose the expandable distal-end assembly comprises an expandable basket catheter, wherein the multiple splines extend between a ring coupled to the shaft and an apex. However, Sutermeister et al. disclose a catheter (10) comprising either a planar end-effector assembly (301) or a basket end-effector assembly (201), the basket end-effector assembly (201) comprising an expandable basket catheter (201), wherein the multiple splines (210) coupled to the shaft (205) and an apex (215). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sterrett et al. in view of in view of Askin, III et al., Helgeson et al. and Starksen such that the expandable distal-end assembly comprises an expandable basket catheter, wherein the multiple splines extend between a shaft and an apex since Sutermeister et al. teach planar and basket catheter assemblies to be equivalents in the art for purposes of facilitating customizable ablation therapies as taught by Sutermeister et al. ([0030]; Fig. 1-2A & 3A). Sterrett et al. in view of in view of Askin, III et al., Helgeson et al., Starksen, and Sutermeister et al. fail to disclose the multiple splines extending between a ring coupled to the shaft and the apex, wherein the shaft extends distally from the ring, and wherein the catheter further comprises a bump stop coupled to the apex to abut a distal end of the shaft and prevent the distal-end assembly from flattening. However, Basu et al. disclose a catheter (10) comprising an expandable distal-end catheter (16), wherein multiple splines (18) extend between a ring coupled to a shaft (12) and an apex, wherein the shaft (12) extends distally from the ring, and the catheter (10) further comprises a bump stop coupled to the apex to abut a distal end of the shaft (12) and prevent the distal-end assembly (16) from flattening.
At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sterrett et al. in view of in view of Askin, III et al., Helgeson et al., Starksen, and Sutermeister et al. such that the multiple splines extend between a ring coupled to the shaft and the apex, wherein the shaft extends distally from the ring, and wherein the catheter further comprises a bump stop coupled to the apex to abut a distal end of the shaft and prevent the distal-end assembly from flattening in order to provide the benefit of controlling bowing of the spines to change the shape of the basket as taught by Basu et al. ([0052]; Fig. 1)
Claim(s) 8-12, 16-19, 21 & 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (2009/0171274, previously cited) in view of Askin, III et al. (2015/0264816, previously cited), Sleefe et al. (6,369,588, previously cited), Sterrett et al. (2017/0112405, previously cited), Helgeson et al. (2016/0346038, previously cited) and Starksen (2009/0209950, previously cited).
Concerning claims 8 & 21, as illustrated in at least Figs. 2A-B, 3A-4D, 6A-B & 9A-B, Harlev et al. disclose a method for producing a catheter (construction methodology of catheter 10 and distal array segment 36; [0065]), the method comprising:
producing, in a flexible substrate having an outer surface comprising a planar surface, two or more electrical interconnections interconnection (traces/metallization layers 88, 90, 54 on flexible printed circuit (FPC) 60 having a planar top overcoat/outer surface connect to electrodes 54; [0065], [0074]), at least one of the two or more electrical interconnections are made by:
i) forming electrically-conductive layers having first and second sections (electrode 54 and metallization layer 88 are formed on core insulating layer 86, where area without electrode 54 is taken to be the first section and area with electrode 54 is taken to be the second section; [0074]),
iii) covering the first section of the electrically-conductive layers with an electrically insulating layer (top overcoat 92 serves to insulate portions of the top metal layer 88 from external contact; [0074]),
the second section of a first electrical interconnection of the two or more electrical interconnections comprising a cross section, and the second section of a second electrical interconnection of the two or more electrical interconnections comprising a rectangular cross section (areas with electrodes 54 comprise rectangular cross-sections; Fig. 6B);
cutting one or more stripes of the flexible substrate for producing one or more splines of the catheter (splines 50 are separated from each other using slits 108 that are thin gaps that are cut in FPC using one or many cutting techniques where the slits are cut using a laser so as to position slit location precisely; [0072]) such that the first electrical interconnection and the second electrical interconnection are provided on a same spline (areas with electrode 54 are provided on the same splines; Fig. 6A-B); and
assembling the one or more splines to a distal-end assembly of the catheter (bonding band 70 and termination band/section 106 are fixed by encapsulation and anchoring or bonding to the tip electrode 53/153 and distal end of catheter shaft; [0067-0068], [0071], [0074-0076], [0104]).
Harlev et al. fail to disclose forming the electrically-conductive layers as a single electrically-conductive layer and thus forming the first and second sections of an entirety of the electrically-conductive layer that forms a single electrical trace at the same time. However, Askin, III et al. disclose a method for producing flexible electrical interconnections (100/300a/300b) formed from either different electrically conductive layers (Fig. 2B) or a single electrically-conductive layer thus forming the first and second sections of an entirety of the electrically-conductive layer that forms a single electrical trace at the same time (Fig. 3A) ([0033-0035], [0038]; Fig. 1-3). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Harlev et al. and form the electrically-conductive layers as a single electrically-conductive layer and thus form the first and second sections of an entirety of the electrically-conductive layer that forms a single electrical trace at the same time since Askin, III et al. teach a single electrically conductive layer and multiple electrically conductive layers forming an electrical interconnection to be equivalents in the art and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). See also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Harlev in view of Askin, III et al. fail to disclose then thinning the first section of the single electrically-conductive layer forming the single electrical trace to a second thickness. However, Sleefe et al. disclose producing one or more electrical interconnections by thinning a trace section of an electrically-conductive layer to a thickness. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Askin, III et al. to further comprise thinning the first section of the single electrically-conductive layer forming the single electrical trace to a second thickness in order to provide the benefit of reducing parasitic impedances in the trace as taught by Sleefe et al. (Col. 7, ll. 5-11)
While Harlev et al. teaches the equivalence of in-contact mapping and non-contact mapping for mapping of the heart ([0005]), Harlev et al. in view of Askin, III et al. and Sleefe et al. fail to disclose a second section having a first thickness protruding from an outer surface of the flexible substrate. However, Sterrett et al. disclose a method of manufacturing a catheter comprising producing two or more electrical interconnections (518, 520, 502 / 636, 638, 642, 644) in a flexible substrate (516/610, 612, 640), the electrical interconnections (518, 520, 502 / 636, 638, 642, 644) comprising a second section (502, 520 / 638, 642, 644) thicker than and protruding from a first section (518 / 636), the second section comprising a rectangular cross section protruding from the outer surface of the flexible substrate (516/610, 612, 640). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Askin, III et al. and Sleefe et al. such that the second section protrudes from the first section, the second section comprising a rectangular cross section protruding from the outer surface of the flexible substrate in order to provide the benefit of more easily contacting tissue as taught by Sterrett et al. ([0193]; Fig. 4C & 23A-F)
Harlev et al. in view of Askin, III et al., Sleefe et al. and Sterrett et al. fail to disclose the second section of the first electrical interconnection comprising a curvilinear or ovoid cross-section. However, Helgeson et al. disclose a catheter (10) having an electrical interconnection having a second section (20’’) that comprises a curvilinear or ovoid cross-section that protrudes from an outer surface of a substrate (84) thereby providing an atraumatic transition from the substrate outer surface to the electrode. Further, Starksen discloses a catheter comprising first and second electrical interconnections having sections that may be recessed, raised or flush with a substrate surface and may have a cross-sectional configuration that is circular, elliptical, square, rectangular, triangular, polygonal, or any other shape ([0132]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Askin, III et al., Sleefe et al. and Sterrett et al. such that the second section of the first electrical interconnection comprises a curvilinear or ovoid cross-section in order to provide the benefit of atraumatic electrodes as taught by Helgeson et al. ([0046-0048]; Fig. 2 & 8) and, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Askin, III et al., Sleefe et al., Sterrett et al. and Helgeson et al. such that the catheter comprises the first and second electrical interconnections with both a rectangular and curvilinear/ovoid cross-sectional configuration since Starksen teaches the equivalency of various cross-sectional configurations that can be raised with respect to a substrate surface and Applicant provides no criticality in the originally filed disclosure as to having both cross-sectional configurations. (The Examiner notes that Applicant only provides criticality for the curvilinear/ovoid cross-section: “As compared to the rectilinear (FIG. 2A) or square cross-section, the curvilinear or ovoid cross sections (electrode 88′ in FIG. 2B) can be utilized to reduce stress concentrations on the electrodes 88′ during the expansion or collapse of the spines 66.”).
Concerning claim 9, Harlev et al. disclose assembling the one or more splines (50) comprises coupling (i) a proximal end of the spline (60) to a proximal element (106) of the distal-end assembly (36), and (ii) a distal end of the spline (60) to a distal element (53/153) of the distal-end assembly (36), wherein the proximal element (106) and the distal element (53) are movable relative to one another for expanding and collapsing the distal-end assembly (36) ([0057-0058]; Fig. 3A-B & 15)
Claim 10 is rejected upon the same rationale as provided for claim 2.
Concerning claim 11, Harlev et al. disclose producing the electrical interconnection (88, 54) comprising producing electrical traces (88) from a biocompatible layer of gold ([0074]).
Concerning claim 12, Harlev et al. disclose the biocompatible layer comprising gold ([0074]).
Concerning claim 16, Harlev et al. disclose the electrically-conductive layer (88, 90, 54) comprises gold ([0078]). The modified invention of claim 8 fails to disclose the first thickness being larger than 0.1 mm. However, Sterrett et al. further disclose a top portion (502) of the second section (502, 520) can have a thickness of 0.1-1000 microns and that a bottom portion (520) of the second section (502, 520) and the first section (518) can have a thickness of approximately 7 microns, although the thickness of the material used (e.g., copper) can be greater or less than 7 microns ([0193], [0205]). Thus, Sterrett et al. disclose a second section having a thickness of 7.1-1007 microns (0.0071 – 1.007 mm). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the modified invention of claim 8 such that the first thickness is larger than 0.1 mm as Applicant appears to have placed no criticality on the claimed range (see pp. 12 of originally filed disclosure) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 17, Harlev et al. disclose the electrically-conductive layer (88, 90, 54) comprises gold ([0078]). The modified invention of claim 8 fails to disclose the second thickness is smaller than 0.1 mm after thinning. However, Sterrett et al. further disclose a top portion (502) of the second section (502, 520) can have a thickness of 0.1-1000 microns and that a bottom portion (520) of the second section (502, 520) and the first section (518) can have a thickness of approximately 7 microns, although the thickness of the material used (e.g., copper) can be greater or less than 7 microns ([0193], [0205]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the modified invention of claim 8 such that the second thickness is smaller than 0.1 mm after thinning as Applicant appears to have placed no criticality on the claimed range (see pp. 12 of originally filed disclosure) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 18, Harlev et al. disclose coupling the distal-end assembly (36) to a shaft (31) of the catheter (10) ([0067]).
Concerning claim 19, the modified invention of claim 8 fails to disclose the second section to be approximately 20 to 100 times thicker than the first section. However, as discussed above, Sterrett et al. disclose the second section (502, 520) can have a thickness of 7.1-1007 microns and the first section (518) can have a thickness of 7 microns. Sterrett et al. fail to specifically disclose the second section is approximately 20 or 100 times thicker than the first section. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the modified invention of claim 8 such that the second section is approximately 20 or 100 times thicker than the first section as Applicant appears to have placed no criticality on the claimed range (“electrode…has a thickness 76 that is typically larger than thickness 74, e.g., from about 100 m to about 1 mm, or any other suitable thickness”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 26 is rejected upon the same rationale as applied to claim 24.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Applicant’s arguments regarding Sterrett failing to disclose the second sections being integral with the first sections in the newly amended limitation of claim 1 (Pg. 7) are considered moot in view of the new grounds of rejection above citing Askin, III et al. teaching the equivalence of separately or integrally formed first and second sections of an electrical interconnection and Applicant providing no criticality for the integral formation (see Pg. 13-14, ll. 23-2).
In response to Applicant's arguments against the references individually (Helgeson fails to disclose the first and second sections being integral, Pg. 8), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Askin, III et al. is cited for this teaching.
In response to Applicant's argument that “one of ordinary skill in the art would not have been motivated to modify a planar flexible tip portion of Sterrett with the ring electrode of Helgeson” and specifically since Helgeson discloses the electrodes are “annular ring electrodes” that “would not be applicable to the planar tip portion” of Sterrett (Pgs. 8-9), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Helgeson teaches using an electrode (20) having a curvilinear/ovoid-cross section protruding from a substrate (84) where the electrode ends (72, 74) that connect to the substrate (84) are rounded which provides an atraumatic transition from the substrate outer surface to the electrode ([0042], [0046]; Fig. 8). The Examiner notes that the modification is not providing for the bodily incorporation of the ring electrodes of Helgeson, but rather for the teachings of an atraumatic transition between edges of the electrode and the substrate.
In response to Applicant's arguments against the references individually (Starksen fails to disclose the first and second sections being integral, Pg. 9), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)., In this case, Askin, III et al. is cited for this teaching.
In response to Applicant’s arguments that because Starksen “does not disclose nor depict a reference through a ‘cross-sectional configuration of the electrode’ is taken and thus does not disclose the claimed curvilinear or ovoid cross section that protrudes from the outer surface of the substrate (Pg. 9-10), the Examiner respectfully disagrees. Starksen clearly teaches: “The electrodes may be recessed, raised or flush with the catheter surface. The electrodes may have any of a variety of shapes, including but not limited to band or ring-shaped electrodes, coil electrodes, point electrodes, or a combination thereof. The cross-sectional configuration of the electrode may be circular, elliptical, square, rectangular, triangular, polygonal, or any other shape.” ([0132]) Thus, the portion of the conductive material forming the electrode is clearly disclosed as having various cross-sectional shapes. The Examiner notes the claim also fails to specifically state the respective direction of the cross-sectional configuration (e.g., taken along the longitudinal axis, or taken parallel to the longitudinal axis, etc.).
In response to Applicant's arguments against the references individually (Sutermeister and Basu fail to teach the first and second sections being integral, Pg. 10-11), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)., In this case, Askin, III et al. is cited for this teaching.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (no other cited references to teach the claim, Pg. 11), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the Examiner notes that Applicant places no criticality as to the location of the shapes of the electrodes (see rejection of claim 24 above).
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “forming the first and second sections of an entirety of the electrically-conductive layer that forms a single electrical trace at the same time”, Pg. 12-13) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In particular, Applicant further argues with respect to “304b-c”, which refer to Figs. 3B-C; however, the Examiner notes that Fig. 3A is noted as teaching the use of a single/integral material forming both the trace (304a) and the electrode (302a).
In response to Applicant’s arguments that Sleefe fails to disclose thinning only the first section (Pg. 13), the Examiner respectfully disagrees. Sleefe discusses conductive traces (23, 25-n) leading to electrodes (22, 24-n) with respect to Fig. 4 (Col. 5, ll. 11-37), and thus, the thinning discussed in Col. 7, ll. 5-11 is described with respect to traces, not electrodes.
In response to Applicant’s arguments that it would not have been obvious to modify the invention of Harlev in view of Askin, III in view of the teachings of Sleefe to thin only the first section, or the traces (Pg. 13-14), the Examiner respectfully disagrees. The modified invention of Harlev in view of Askin, III disclose an integrally formed protruding electrode and trace. Sleefe teaches thinning traces to reduce parasitic impedances, thus one of ordinary skill in the art would look to Sleefe to reduce the trace thickness by thinning to also reduce the parasitic impedance. Further, one of ordinary skill in the art would also recognize that to achieve an exposed electrode and associated conductive trace powering the electrode covered by an insulating layer, the trace layer either has to be reduced in thickness or more material needs to be deposited on a trace layer to create the electrode, and thus choosing form a finite number of identified, predictable solutions with a reasonable expectation of success.
In response to Applicant's arguments against the references individually (Sterrett, Staksen, and Helgeson all fail to disclose thinning only the first section, Pg. 14), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)., In this case, Sleefe is cited for this teaching.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794