CTNF 18/900,512 CTNF 101584 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 (IDS) submitted on 01/07/2025 is being considered by the examiner. Drawings 06-22-06 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: element 114 in specification page 4, paragraph [0064] . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 07-29 AIA The disclosure is objected to because of the following informalities: Page 2, paragraph [0004] reads “shell ha a” should read “shell has a”. Page 12, paragraph [0069] reads “distal region 122” should read “distal region 116” . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 1, 5, 7, 13, 16-18, and 20 are objected to because of the following informalities: Claim 1, line 3 reads “having proximal end” should read “having a proximal end”. Claim 1, line 5 reads “the lead body” should read “the tubular lead body”. Claim 1, line 6 reads “the lead” should read “the implantable lead”. Claim 1, line 14 reads “the inner preform” should read “the tubular inner preform”. Claim 1, lines 15-16 read “the shell” should read “the outer shell”. Claim 1, lines 19-20 read “the inner preform” should read “the tubular inner preform”. Claim 1, line 24 reads “the shell” should read “the outer shell”. Claim 1, line 25 reads “the lead body” should read “the tubular lead body”. Claim 5, line 1 reads “the inner preform” should read “the tubular inner preform”. Claim 7, line 3 reads “the inner preform” should read “the tubular inner preform”. Claim 13, line 7 reads “the inner preform” should read “the tubular inner preform”. Claim 13, line 8 reads “the shell” should read “the outer shell”. Claim 13, line 12 reads “the inner preform” should read “the tubular inner preform”. Claim 13, lines 13-14 reads “coupler; a” should read “couples; and a”. Claim 13, line 16 reads “the shell” should read “the outer shell”. Claim 13, line 17 reads “the lead body” should read “the tubular lead body”. Claim 15, line 1 reads “the inner preform” should read “the tubular inner preform”. Claim 16, lines 3-4 reads “the inner preform” should read “the tubular inner preform”. Claim 17 line 2 reads “the inner preform” should read “the tubular inner preform”. Claim 18 line 3 reads “having proximal end” should read “having a proximal end”. Claim 18 line 5 reads “the lead body” should read “the tubular lead body”. Claim 18 lines 11-12 read “the shell” should read “the outer shell”. Claim 18 lines 15-16 read “the inner preform” should read “the tubular inner preform”. Claim 18 line 20 reads “the shell” should read “the outer shell”. Claim 18 line 21 reads “the lead body” should read “the tubular lead body”. Claim 20 line 1 reads “claim 19” should read “claim 18”. Claim 20 line 2 reads “the lead body” should read “the tubular lead body” . Appropriate correction is required. 07-05-05 Applicant is advised that should claim 1 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1, 6, 13, and 16 are 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. 07-34-03 AIA The term “ partially ” in claim s 1, 6, 13 and 16 is a relative term which renders the claim indefinite. The term “ partially ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not disclose the measurement value of partially . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-2, 4, 6-10, 12-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (US 20150297884 A1), hereinafter Jang, and in view of Casavant et al. (US 20030083727 A1), hereinafter Casavant, and in further view of Guenther (US 20090203258 A1), hereinafter Guenther . Regarding claim 1, Jang teaches an implantable lead (Fig. 1, element 100, para. 0056 (implantable medical electrical lead)) for use with an implantable medical device (IMD) (para. 0058 (defibrillator, pacemaker)), the implantable lead comprising: a tubular lead body (para. 0056 (lead has a proximal end and a distal end)) having proximal end (Fig. 1, element 102) and a distal end (Fig. 1, element 104) opposite the proximal end; a proximal connector at the proximal end of the lead body (Fig. 2, element 112) configured for mechanically and electrically coupling the lead to the IMD (para. 0058 (connector pin may be adapted at one end for plugging into a socket of an electrical stimulation device)); a distal assembly (para. 0057 (lead includes a system of parts or pieces)) extending from the distal end of the lead body, the distal assembly comprising: an outer shell having a proximal portion and a distal portion (Fig. 10A, element 152, para. 0092 (proximal end of the outer sheath)); a tubular inner preform (Fig. 6A, element 114, para. 0077 (proximal seal)) disposed at least partially within the outer shell and comprising a proximal end (Fig. 6A, element 191, para. 0077 (proximal annular tip)), a distal end opposite the proximal end (Fig. 6A, element 198, para. 0077 (flush portion)), a longitudinal slot extending from the distal end toward the proximal end (Fig. 6A, element 150, para. 0078 (bore extending from the proximal end toward to the distal end), and a circumferential slot (Fig. 6A, element 195, para. 0077 (relatively deep channels)); a coupler (Fig. 5A, element 116, para. 0070 (connector insulator)) comprising, a proximal portion having a proximal end (Fig. 5A, element 184, para. 0070 (proximal extension) and a channel extending distally from the proximal end (Fig. 5A, element 118, para. 0074 (connector insulator may include center bore)) a distal portion opposite the proximal portion (Fig. 5A, element 186, para. 0070 (distal extension), and an intermediate portion (Fig. 5A, element 182, para. 0070 (central body)) between the proximal and distal portions, wherein the inner preform is mechanically coupled to the proximal portion of the coupler (para. 0070 (connector insulator may be configured for supporting a portion of the proximal seal), 0073 ([connector insulator] proximal extension may extend underneath the proximal seal)); and a helical electrode (Fig. 1, element 108 (para. 0056 (helical electrode)) having a distal portion extending distally from the distal portion of the shell (para. 0098 (distal tip of the helical anchor electrode protrudes beyond the soft tip plug in the distal end of the tip housing)); and a first electrical conductor (Fig. 2, element 120) extending through the lead body and mechanically and electrically coupled to the coupler within the channel (para. 0075 (conducted end of the connector pin may be pressed through the bore of the connector insulator)). Jang does not teach a coupler made of an electrically conductive material disposed within the shell, a circumferential slot extending partially around a circumference of the inner preform, and a helical electrode having a proximal portion disposed about the distal portion of the coupler. Casavant teaches a coupler made of an electrically conductive material disposed within the shell (para. 0029 (drive shaft may be formed of any biocompatible conductive material)) and comprising, and a helical electrode (Fig. 2, element 110, para. 0014 (fixation helix functioning as an electrode)) having a proximal portion (Fig. 2, element 162) disposed about the distal portion of the coupler (Fig. 2), and a distal portion (Fig. 2, element 160) extending distally from the distal portion of the shell (para. 0029 (fixation helix is coupled to drive shaft)); Casavant does not teach a circumferential slot extending partially around a circumference. Guenther teaches a circumferential slot extending partially around a circumference (Fig. 5, element 12a; peripheral groves) of the inner preform (Fig. 5, element 10; supporting element). Jang, Guenther, and Casavant are all considered to be analogous to the claimed invention because they are in the same field of coupling an implantable line to an electrical implant. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the combination of teachings and provide an electrically conductive coupler, helical electrode arrangement, and partial circumferential slot structure. Jang teaches a coupler and helical electrode structure while Casavant teaches the conductive material of the coupler, and arrangement of the helical electrode. Incorporating Casavant’s teaching would improve mechanical coupling between lead components while maintaining electrical connectivity and flexibility within the distal assembly. Therefore, it would have predictably enhanced assembly stability of the inner preform, as well as preserving the structural integrity. Jang teaches circumferential slots around the entire circumference of the tubing preform, while Guenther teachings partial circumferential slots. Incorporating Guenther’s teaching would provide circumferential slots which may preserve a structural integrity of tubing member. Regarding claim 2, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1. Jang teaches wherein the distal portion of the outer shell is a distal preform (Fig. 9A, element 140, para. 0092 (boot seal may be configured for encompassing and sealing… outer sheath)) configured to mechanically couple to the intermediate portion of the coupler (para. 0096 (like the proximal seal the radially projecting ribs of the boot seal), Fig. 5A, element 182, para. 0070 (central body), 0070 (connector insulator may be configured for supporting a portion of the proximal seal)). Regarding claim 4 , Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1. Jang does not teach wherein one or both of the proximal and distal portions of the outer shell are formed by an overmolding process. Casavant teaches wherein one or both of the proximal and distal portions of the outer shell are formed by an overmolding process (Fig. 1, element 116; sleeve head, para. 0028 (sleeve head may be fabricated of polyurethane)). It would have been obvious to have obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Casavant and provide an outer shell formed by an overmolding process. Doing so would improve sealing and secure attachment of the distal assembly components. Regarding claim 6, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1, Jang teaches wherein the coupler includes a radial rib extending partially around a circumference of the proximal portion (para. (outer surface of the proximal extension may be formed as a plurality of alternating flat annular ribs)) that is configured to be received within the circumferential slot of the inner preform to couple the inner preform to the proximal end of the coupler (para. 0073 (proximal seal is positioned on the proximal extension)). Regarding claim 7, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1, Jang teaches a ring electrode (Fig. 15A, element 103; ring electrode), wherein the ring electrode includes an inner projection extending radially inward (para. 0108 (ring electrode may define a lumen of two different bore sizes)) and received within the longitudinal slot of the inner preform (Fig. 6A, element 150, para. 0078 (bore extending from the proximal end toward to the distal end)). Regarding claim 8, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1, Jang teaches wherein the distal end of the tubular inner preform includes a beveled edge (Fig. 6b, para. 0077 (flush portion may be substantially cylindrical with an outer diameter substantially matching the outer diameter of the of the central body of the connect insulator being flushed therewith)) Regarding claim 9, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1. Jang teaches a drug or therapeutic (Fig. 10B, element 107, para. 0102 (steroid capsule)). Jang does not explicitly disclose an outer shell including a drug or therapeutic. Casavant teaches wherein the outer shell includes a collar impregnated with a drug or therapeutic (para. 0028 (sleeve head may be couples to a monolithic controlled release device impregnated with a glucocorticosteroid or another steroid)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Casavant and provide the drug or therapeutic within the outer shell. Jang teaches a steroid capsule within the helical electrode as opposed to the outer shell. Therefore, by implementing the steroid within the outer shell, taught by Casavant, would have allowed the drug to be released easier as opposed to being within the device itself. Regarding claim 10, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1. Jang teaches wherein the proximal portion of the coupler has a first diameter, the intermediate portion of the coupler has a second diameter, and the distal portion of the coupler has a third diameter (para. 0073 (proximal extension of the connecter insulator… a diameter smaller than that of the central body), 0070 (central body may have an outer diameter. The distal extension may include an outer diameter smaller than that of the central body)). Regarding claim 12, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 10. Jang teaches wherein the second diameter is larger than the first and third diameter (para. 0073 (proximal extension of the connecter insulator… a diameter smaller than that of the central body), 0070 (central body may have an outer diameter. The distal extension may include an outer diameter smaller than that of the central body)). Regarding claim 13, Jang teaches a distal assembly (para. 0057 (lead includes a system of parts or pieces)) for an implantable lead (Fig. 1, element 100), the distal assembly comprising: an outer shell having a proximal portion and a distal portion (Fig. 10A, element 152, para. 0092 (proximal end of the outer sheath)); a tubular inner preform (Fig. 6A, element 114, para. 0077 (proximal seal)) disposed at least partially within the outer shell and comprising a proximal end, a distal end opposite the proximal end (Fig. 6A, element 191, para. 0077 (proximal annular tip), Fig. 6A, element 198, para. 0077 (flush portion)), a longitudinal slot extending from the distal end toward the proximal end, and a circumferential slot extending around a circumference of the inner preform (Fig. 6A, element 150, para. 0078 (bore extending from the proximal end toward to the distal end), Fig. 6A, element 195, para. 0077 (relatively deep channels)); a coupler (Fig. 5A, element 116, para. 0070 (connector insulator)) disposed within the shell and comprising a proximal portion having a proximal end and a channel extending distally from the proximal end (Fig. 5A, element 184, para. 0070 (proximal extension), Fig. 5A, element 118, para. 0074 (connector insulator may include center bore)), a distal portion opposite the proximal portion, and an intermediate portion between the proximal and distal portions (Fig. 5A, element 186, para. 0070 (distal extension), Fig. 5A, element 182, para. 0070 (central body)), wherein the inner preform is mechanically coupled to the proximal portion of the coupler (para. 0070 (connector insulator may be configured for supporting a portion of the proximal seal), 0073 ([connector insulator] proximal extension may extend underneath the proximal seal)); a helical electrode having a distal portion extending distally from the distal portion of the shell (Fig. 1, element 108 (para. 0056 (helical electrode), 0098 (distal tip of the helical anchor electrode protrudes beyond the soft tip plug in the distal end of the tip housing)); and a ring electrode (Fig. 15A, element 103; ring electrode) disposed at a junction between the distal end of the lead body and the proximal portion of the outer shell (para. 0120 (curbs bonds the outer sheath to the proximal end of the ring electrode)). Jang does not teach a coupler made of an electrically conductive material disposed within the shell, a circumferential slot extending partially around a circumference of the inner preform, and a helical electrode having a proximal portion disposed about the distal portion of the coupler, and a ring electrode disposed at a junction in the distal end of the lead body. Casavant teaches a helical electrode (Fig. 2, element 110, para. 0014 (fixation helix functioning as an electrode)) having a proximal portion (Fig. 2, element 162) disposed about the distal portion of the coupler (Fig. 2), and a distal portion (Fig. 2, element 160) extending distally from the distal portion of the shell (para. 0029 (fixation helix is coupled to drive shaft)); a ring electrode (Fig. 2, element 146; ring electrode) disposed at a junction between the distal end of the lead body (Fig. 2, element 156; distal end) and the proximal portion of the outer shell, wherein one or both of the proximal and distal portions of the outer shell (Fig. 2, element 116) are formed by an overmolding process (para. 0028 (sleeve head may be fabricated of polyurethane)). Casavant does not teach a circumferential slot extending partially around a circumference. Guenther teaches a circumferential slot extending partially around a circumference (Fig. 5, element 12a; peripheral groves) of the inner preform (Fig. 5, element 10; supporting element). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the combination of teachings and provide an electrically conductive coupler, a partial circumferential slot structure, a helical electrode and ring electrode arrangement. Jang teaches a coupler and helical electrode structure while Casavant teaches the conductive material of the coupler, and arrangement of the helical electrode and ring electrode. Incorporating Casavant’s teaching would improve mechanical coupling between lead components while maintaining electrical connectivity and flexibility within the distal assembly. Additionally, the arrangement of the ring electrode improves electrical connectivity within the distal lead assembly. Therefore, it would have predictably enhanced assembly stability of the inner preform, as well as preserving the structural integrity. Jang teaches circumferential slots around the entire circumference of the tubing preform, while Guenther teachings partial circumferential slots. Incorporating Guenther’s teaching would provide circumferential slots which may preserve a structural integrity of tubing member. Regarding claim 16, Jang (in view of Casavant and in further view of Guenther) teaches the distal assembly of claim 13. Jang teaches wherein the coupler includes a radial rib extending partially around a circumference of the proximal portion (para. (outer surface of the proximal extension may be formed as a plurality of alternating flat annular ribs)) that is configured to be received within the circumferential slot of the inner preform to couple the inner preform to the proximal end of the coupler (para. 0073 (proximal seal is positioned on the proximal extension)). Regarding claim 17, Jang (in view of Casavant and in further view of Guenther) teaches the distal assembly of claim 13. Jang teaches a ring electrode (Fig. 15A, element 103; ring electrode), wherein the ring electrode includes an inner projection extending radially inward (para. 0108 (ring electrode may define a lumen of two different bore sizes)) and received within the longitudinal slot of the inner preform (Fig. 6A, element 150, para. 0078 (bore extending from the proximal end toward to the distal end)) . 07-21-aia AIA Claim s 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (in view of Casavant and in further view of Guenther) and Guo et al. (US 20200406025 A1), hereinafter Guo . Regarding claim 3, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 2. Jang teaches the distal preform (Fig. 9A, element 140) and the intermediate portion of the coupler (Fig. 5A, element 182, para. 0070 (central body)) includes a radial flange (Fig. 5B, element 127; inner shoulder surface). Jang does not teach the distal prefrom includes an inner recess extending circumferentially around an inner surface thereof that is received in the inner recess in a snap-fit arrangement. Guo teaches the distal preform (Fig. 5C, element 114, para. 0050 (outer layer…polyurethane)) includes an inner recess extending circumferentially around an inner surface thereof (Fig. 5C, element 115), and the intermediate portion of the coupler (Fig. 5A, element 102) includes a radial flange (Fig. 5C, element 111) that is received in the inner recess in a snap-fit arrangement (para. 0051 (outer layer is extruded with inner recesses that correspond in shape to the ribs on liner)). Jang, Guenther, Casavant, and Guo, are all considered to be analogous to the claimed invention because they are in the same field of connecting a line to an electrical implant. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Guo and incorporate the snap-fit recess and radial flange arrangement. Doing so would provide improved retention of the coupler and outer shell components, reducing possible separation between the components. Regarding claim 14, Jang (in view of Casavant and in further view of Guenther) teaches the distal assembly of claim 13. Jang teaches the intermediate portion of the coupler (Fig. 5A, element 182, para. 0070 (central body)) includes a radial flange (Fig. 5B, element 127; inner shoulder surface). Jang does not teach wherein the distal portion of the outer shell includes an inner recess extending circumferentially around an inner surface thereof, and the radial flange is received in the inner recess in a snap-fit arrangement. Guo teaches wherein the distal portion of the outer shell (Fig. 5C, element 114, para. 0050 (outer layer…polyurethane)) includes an inner recess extending circumferentially around an inner surface thereof (Fig. 5C, element 115), and the intermediate portion of the coupler (Fig. 5A, element 102) includes a radial flange (Fig. 5C, element 111) that is received in the inner recess in a snap-fit arrangement (para. 0051 (outer layer is extruded with inner recesses that correspond in shape to the ribs on liner)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Guo and incorporate the snap-fit recess and radial flange arrangement. Doing so would provide improved retention of the coupler and outer shell components, reducing possible separation between the components . 07-21-aia AIA Claim s 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (in view of Casavant and in further view of Guenther) and Van der Vennet et al. (EP4306812A1), hereinafter Van . Regarding claim 5, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 1, Jang does not teach wherein the circumferential slot of the inner preform includes a first end and a second end opposite the first end, wherein the longitudinal slot is located between the first end and the second end. Van teaches wherein the circumferential slot of the inner preform includes a first end and a second end opposite the first end (Fig. 1, element 106; circumferential slit) wherein the longitudinal slot is located between the first end and the second end (Fig. 2, element 206; longitudinal groove). Jang and Van are considered to be analogous to the claimed invention because Van teaches circumferential and longitudinal slot arrangements formed in tubular structures, for desired mechanical characteristics such as connecting modules. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Van and provide a longitudinal slot that is between the ends of the circumferential slot. Although Jang teaches a longitudinal slot, the circumferential slot is around the entire circumference of the connector insulator. Therefore, by combining Van’s teachings of a partial circumferential slot, allows for the longitudinal slot to be between the two ends. Doing so modifies the mechanical properties of the connector insulator to connect with the proximal seal. Regarding claim 15, Jang (in view of Casavant and in further view of Guenther) teaches the distal assembly of claim 13. Jang does not teach wherein the circumferential slot of the inner preform includes a first end and a second end opposite the first end, wherein the longitudinal slot is located between the first end and the second end. Van teaches wherein the circumferential slot of the inner preform includes a first end and a second end opposite the first end (Fig. 1, element 106; circumferential slit) wherein the longitudinal slot is located between the first end and the second end (Fig. 2, element 206; longitudinal groove). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Van and provide a longitudinal slot that is between the ends of the circumferential slot. Although Jang teaches a longitudinal slot, the circumferential slot is around the entire circumference of the connector insulator. Therefore, by combining Van’s teachings of a partial circumferential slot, allows for the longitudinal slot to be between the two ends. Doing so modifies the mechanical properties of the connector insulator to connect with the proximal seal . 07-21-aia AIA Claim s 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (in view of Casavant) . Regarding claim 18, Jang teaches an implantable lead (Fig. 1, element 100, para. 0056 (implantable medical electrical lead)) configured to be coupled to an implantable medical device (IMD) (para. 0003 (proximal end of the lead may be coupled to a defibrillator or a pacemaker)), the implantable lead comprising: a tubular lead body having proximal end and a distal end opposite the proximal end (para. 0056 (lead has a proximal end and a distal end), Fig. 1, element 102, Fig. 1, element 104)); a distal assembly extending from the distal end of the lead body (para. 0057 (lead includes a system of parts or pieces)), the distal assembly comprising: an outer shell having a proximal portion and a distal portion (Fig. 10A, element 152, para. 0092 (proximal end of the outer sheath)); a tubular inner preform disposed at least partially within the outer shell and comprising a proximal end and a distal end opposite the proximal end (Fig. 6A, element 114, para. 0077 (proximal seal) ,Fig. 6A, element 191, para. 0077 (proximal annular tip), Fig. 6A, element 198, para. 0077 (flush portion)); a coupler (Fig. 5A, element 116, para. 0070 (connector insulator)) made of an electrically conductive material disposed within the shell and comprising a proximal portion having a proximal end and a channel extending distally from the proximal end (Fig. 5A, element 184, para. 0070 (proximal extension), Fig. 5A, element 118, para. 0074 (connector insulator may include center bore)), a distal portion opposite the proximal portion, and an intermediate portion between the proximal and distal portions (Fig. 5A, element 186, para. 0070 (distal extension), Fig. 5A, element 182, para. 0070 (central body)), wherein the inner preform is disposed about and mechanically coupled to the proximal portion of the coupler (para. 0070 (connector insulator may be configured for supporting a portion of the proximal seal), 0073 ([connector insulator] proximal extension may extend underneath the proximal seal)); and a helical electrode (Fig. 1, element 108 (para. 0056 (helical electrode)) having a distal portion extending distally from the distal portion of the shell (para. 0098 (distal tip of the helical anchor electrode protrudes beyond the soft tip plug in the distal end of the tip housing)); and a first electrical conductor extending through the lead body and mechanically and electrically coupled to the coupler within the channel (Fig. 2, element 120, para. 0075 (conducted end of the connector pin may be pressed through the bore of the connector insulator)). Jang does not teach a coupler made of an electrically conductive material and a helical electrode having a proximal portion. Casavant teaches a coupler made of an electrically conductive material disposed within the shell (para. 0029 (drive shaft may be formed of any biocompatible conductive material)) and comprising, and a helical electrode (Fig. 2, element 110, para. 0014 (fixation helix functioning as an electrode)) having a proximal portion (Fig. 2, element 162) disposed about the distal portion of the coupler (Fig. 2), and a distal portion (Fig. 2, element 160) extending distally from the distal portion of the shell (para. 0029 (fixation helix is coupled to drive shaft)); It would have been obvious to have obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Casavant and provide a coupler made of a conductive material and a proximal portion of a helical electrode. Jang teaches a coupler and helical electrode structure while Casavant teaches the conductive material of the coupler, and arrangement of the helical electrode. Incorporating Casavant’s teaching would improve mechanical coupling between lead components while maintaining electrical connectivity and flexibility within the distal assembly. Therefore, it would have predictably enhanced assembly stability of the inner preform, as well as preserving the structural integrity. Regarding claim 19, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 18. Jang does not teach wherein one of the proximal portion and the distal portion of the outer shell are formed by an overmolding process. Casavant teaches wherein one of the proximal portion and the distal portion of the outer shell are formed by an overmolding process (Fig. 1, element 116; sleeve head, para. 0028 (sleeve head may be fabricated of polyurethane)). It would have been obvious to have obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Casavant and provide an outer shell formed by an overmolding process. Doing so would improve sealing and secure attachment of the distal assembly components. Regarding claim 20, Jang (in view of Casavant and in further view of Guenther) teaches the implantable lead of claim 19. Jang teaches wherein the distal assembly further comprises a ring electrode (Fig. 15A, element 103; ring electrode) disposed at a junction between the distal end of the lead body and the proximal portion of the outer shell (para. 0120 (curbs bonds the outer sheath to the proximal end of the ring electrode)). Jang does not teach a ring electrode disposed at the distal end of the lead body. Casavant teaches a ring electrode (Fig. 2, element 146; ring electrode) disposed at a junction between the distal end of the lead body (Fig. 2, element 156; distal end) and the proximal portion of the outer shell (Fig. 2, element 116, para. 0028 (sleeve head may be fabricated of polyurethane)). It would have been obvious to have obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jang to incorporate the teachings of Casavant and provide ring electrode with a junction between the distal end of the lead body and the proximal portion of the outer shell. Doing so would provide electrode stability of the assembly for reliable electrical performances . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 11, the primary reason for indication of allowable subject matter is that the prior art fails to teach wherein the first diameter is larger than the second and third diameter. The closest prior art Jang, provides the first, second, and third diameter. However, Jang does not explicitly disclose that the first diameter is larger than the second and third diameter . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Mitusina et al. (US 2011022069 A1) and Seifert et al. (US 20170312494 A1) are additional examples of an inner tubular member composed with partial circumferential slots. Victorine et al. (US 20110218603 A1), Sethna et al. (US 8792996 B2), and Eckerdal et al. (US 20100137957 A1) are additional examples of a distal end including a ring electrode . Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 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, Niketa Patel can be reached at (571) 272-4156. 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. /EILEEN ROBLES/Examiner, Art Unit 3792 /NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/900,512 Page 2 Art Unit: 3792 Application/Control Number: 18/900,512 Page 3 Art Unit: 3792 Application/Control Number: 18/900,512 Page 4 Art Unit: 3792 Application/Control Number: 18/900,512 Page 5 Art Unit: 3792 Application/Control Number: 18/900,512 Page 6 Art Unit: 3792 Application/Control Number: 18/900,512 Page 7 Art Unit: 3792 Application/Control Number: 18/900,512 Page 8 Art Unit: 3792 Application/Control Number: 18/900,512 Page 9 Art Unit: 3792 Application/Control Number: 18/900,512 Page 10 Art Unit: 3792 Application/Control Number: 18/900,512 Page 11 Art Unit: 3792 Application/Control Number: 18/900,512 Page 12 Art Unit: 3792 Application/Control Number: 18/900,512 Page 13 Art Unit: 3792 Application/Control Number: 18/900,512 Page 14 Art Unit: 3792 Application/Control Number: 18/900,512 Page 15 Art Unit: 3792 Application/Control Number: 18/900,512 Page 16 Art Unit: 3792 Application/Control Number: 18/900,512 Page 17 Art Unit: 3792 Application/Control Number: 18/900,512 Page 18 Art Unit: 3792 Application/Control Number: 18/900,512 Page 19 Art Unit: 3792 Application/Control Number: 18/900,512 Page 20 Art Unit: 3792 Application/Control Number: 18/900,512 Page 21 Art Unit: 3792 Application/Control Number: 18/900,512 Page 22 Art Unit: 3792 Application/Control Number: 18/900,512 Page 23 Art Unit: 3792 Application/Control Number: 18/900,512 Page 24 Art Unit: 3792 Application/Control Number: 18/900,512 Page 25 Art Unit: 3792
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