DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not fully persuasive. Applicant argues that Koop does not teach or disclose the engaging member can anchor the distal extension and that the helical coil anchors are pacing electrodes useful for transmitting pacing pulses to a target. The examiner respectfully disagrees as Koop teaches pacing element (engaging member) 24b and Paragraphs [0066] and [0067] disclose engaging member is a helical anchor and is a biocompatible member/electrode. In addition, Paragraph [0097] discloses the distal extension 24 allows the leadless pacing device 20 to sense and/or pace and is biased to form a shape such as a helical coil.
Applicant argues Koop does not disclose the conductive lead wire is thinner and less stiff than the helical coil anchors. Regarding the less stiff argument the examiner notes that Kopp et al discloses Paragraph [0096] discloses lead 24 is a flexible and Paragraph [0096] discloses helical electrode is a biocompatible metal and Paragraph [0066] discloses the helical electrode 24b is used for anchoring and would therefore be stiffer than the lead wire which is flexible. However, Koop et al does not disclose that the conductive lead wire is thinner. Therefore, this argument is persuasive. The examiner notes that regarding claim 1 the Applicant’s arguments are persuasive and a new grounds of rejection has been added in view of Risi et al (US Publication 2016/0022990). However, claim 21 does not require the conductive lead wire to be thinner and in this instance the arguments are not persuasive.
Claim Rejections - 35 USC § 112
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.
Claims 4 and 24 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.
Claims 4 and 24 recites the limitation "the distal portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the first or second distal tip (from the independent claim) or if this is reciting the distal portion of claim 2 (or 22).
Claim Rejections - 35 USC § 102
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) 21-24, 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koop et al (US Publication 2020/0306530).
Referring to Claim 21, Koop et al teaches a biostimulator system, comprising: a transport system including a catheter having a distal catheter end (e.g. Paragraph [0064] delivery catheter and housing 22 and Figure 28 catheter 80); and a biostimulator coupled to the distal catheter end, wherein the biostimulator includes a housing having a longitudinal axis and containing an electronics compartment (e.g. Figure 2, Element 22 and Figure 3 illustrates the electronics compartment), a helix mount mounted on the housing (e.g. Figure 3, helix mount 81a); a helical fixation element coupled to the housing (e.g. Figures 2 and 3, helix 50 and Paragraph [0084]), wherein the helical fixation element includes an outer helix extending about the longitudinal axis to a first distal tip (e.g. tip 57), and a pacing element coupled to the housing, wherein the pacing element includes a helical electrode extending about the longitudinal axis to a second distal tip distal to the first distal tip (e.g. Figure 1, pacing element (engaging member) 24b and Paragraphs [0066] and [0067] disclose engaging member is a helical anchor and is a biocompatible member/electrode), wherein the pacing element includes a conductive lead wire electrically connected to the helical pacing electrode to transmit pacing pulses to a target tissue, wherein a pacing insulation covers an outer surface of the conductive lead wire, and wherein the conductive lead wire is less stiff than the helical pacing electrode (e.g. Figures 1 and 2, lead 24 connected to helical electrode 24b, insulation is necessarily there or electrodes 30-34 would short; Paragraph [0096] discloses lead 24 is a flexible and Paragraphs [0066] and [0096] discloses helical electrode is a biocompatible metal and used for engaging with tissue for anchoring, therefore the lead is less stiff than the helical electrode; abstract, Paragraphs [0004] and [0097] discloses distal extension 24 is inserted into the great cardiac vein 17 or other vessel to allow the leadless pacing device 20 to sense and/or pace).
Referring to Claim 22, Koop et al teaches the claimed invention, wherein a distal portion of the pacing element includes the helical pacing electrode (e.g. Figures 1 and 2, helical electrode 24b).
Referring to Claim 23, Koop et al teaches the claimed invention, wherein the pacing insulation includes an insulating sleeve (e.g. Figures 1 and 2 illustrate the sleeve around the conductive wires (72) within).
Referring to Claim 24, Koop et al teaches the claimed invention, wherein the conductive lead wire extends through the insulating sleeve to the distal portion (e.g. Figures 1 and 2 illustrate the sleeve around the conductive wires (72) and Paragraph [0099]).
Referring to Claim 27, Koop et al teaches the claimed invention, wherein the helical fixation element is electrically connected to the housing (e.g. Paragraph [0093] discloses 50 forms an electrode).
Referring to Claim 28, Koop et al teaches the claimed invention further comprising a header assembly mounted on the housing, wherein the header assembly includes an electrical feedthrough electrically connected to circuitry within the electronics compartment, and wherein the helical fixation element is electrically connected to the electrical feedthrough (e.g. Figures 2-3, Element 22b and Paragraph [0093]).
Referring to Claim 29, Koop et al teaches the claimed invention further comprising a therapeutic agent coupled to the pacing element (e.g. Paragraph [0136] discloses a drug to prevent fibrosis).
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) 1-4 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al (US Publication 2020/0306530) in view of Risi (US Publication 2016/0022990).
Referring to Claim 1, Koop et al teaches a biostimulator, comprising: a housing having a longitudinal axis and containing an electronics compartment (e.g. Figure 2, Element 22 and Figure 3 illustrates the electronics compartment), a helix mount mounted on the housing (e.g. Figure 3, helix mount 81a); a helical fixation element coupled to the housing (e.g. Figures 2 and 3, helix 50 and Paragraph [0084]), wherein the helical fixation element includes an outer helix extending about the longitudinal axis to a first distal tip (e.g. tip 57), and a pacing element coupled to the housing, wherein the pacing element includes a helical pacing electrode extending about the longitudinal axis to a second distal tip distal to the first distal tip (e.g. Figure 1, pacing element (engaging member) 24b and Paragraphs [0066] and [0067] disclose engaging member is a helical anchor and is a biocompatible member/electrode), wherein the pacing element includes a conductive lead wire electrically connected to the helical pacing electrode to transmit pacing pulses to a target tissue, wherein a pacing insulation covers an outer surface of the conductive lead wire, and wherein the conductive lead wire is less stiff than the helical pacing electrode (e.g. Figures 1 and 2, lead 24 connected to helical electrode 24b, insulation is necessarily there or electrodes 30-34 would short; Paragraph [0096] discloses lead 24 is a flexible and Paragraph [0096] discloses helical electrode is a biocompatible metal, therefore the lead is less stiff than the helical electrode and Paragraph [0066] discloses the helical electrode 24b is used for anchoring and would therefore be more stiff than the lead; abstract, Paragraphs [0004] and [0097] discloses distal extension 24 is inserted into the great cardiac vein 17 or other vessel to allow the leadless pacing device 20 to sense and/or pace). Koop et al does disclose in Paragraph [0066] the distal end 24 includes engaging members (e.g. helical coil). Koop et al also discloses in Paragraph [0089] helical coil is made of a diameter suitable for penetrating and engaging tissue. Figure 1 illustrates the middle of distal extension 24 bending within the great cardiac vein 17. However, Koop et al does not explicitly disclose the conductive lead wire is thinner than the helical pacing electrode,
Risi teaches that larger diameter wires are generally stiffer than smaller-diameter wires as set forth in Paragraphs [0008], [0031], and [0043] to adjust the stiffness based on the known technique by adjusting the diameter of the wire. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Koop et al, with larger diameter wires are generally stiffer than smaller-diameter wires as taught by Risi, since such a modification would provide the predictable results of adjusting the stiffness based on the known technique by adjusting the diameter of the wire.
Referring to Claim 2, Koop et al in view of Risi teaches the claimed invention, wherein a distal portion of the pacing element includes the helical pacing electrode (e.g. Figures 1 and 2, helical electrode 24b).
Referring to Claim 3, Koop et al in view of Risi teaches the claimed invention, wherein the pacing insulation includes an insulating sleeve (e.g. Figures 1 and 2 illustrate the sleeve around the conductive wires (72) within).
Referring to Claim 4, Koop et al in view of Risi teaches the claimed invention, wherein the conductive lead wire extends through the insulating sleeve to the distal portion (e.g. Figures 1 and 2 illustrate the sleeve around the conductive wires (72) and Paragraph [0099]).
Referring to Claim 8, Koop et al in view of Risi teaches the claimed invention, wherein the helical fixation element is electrically connected to the housing (e.g. Paragraph [0093] discloses 50 forms an electrode).
Referring to Claim 9, Koop et al in view of Risi teaches the claimed invention further comprising a header assembly mounted on the housing, wherein the header assembly includes an electrical feedthrough electrically connected to circuitry within the electronics compartment, and wherein the helical fixation element is electrically connected to the electrical feedthrough (e.g. Figures 2-3, Element 22b and Paragraph [0093]).
Referring to Claim 10, Koop et al in view of Risi teaches the claimed invention further comprising a therapeutic agent coupled to the pacing element (e.g. Paragraph [0136] discloses a drug to prevent fibrosis).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al (US Publication 2020/0306530) in view of Risi (US Publication 2016/0022990), as applied above, and further in view of Yang et al (US Publication 2019/0083800).
Referring to Claim 6, Koop et al in view of Risi teaches the claimed invention further comprising: an attachment feature mounted on a proximal housing end of the housing, wherein the helical fixation element and the pacing element are coupled to a distal housing end of the housing (e.g. Figures 1-3, proximal appendage 38); a proximal region of the helical fixation element is covered by the housing (e.g. Figure 3), the proximal region of the helical fixation element and wherein a distal region of the fixation element is not covered by the outer insulation (e.g. Paragraph [0093] and Figure 12). However, Koop et al does not explicitly disclose an outer insulation covering the attachment feature, the housing, and a proximal region of the fixation element.
Yang et al teaches that it is known to use the housing having a ring electrode where the remainder of the housing and proximal region are formed form a non-conductive material as set forth in Figure 1 and Paragraphs [0036] and [0071] to provide improved control of the electrical discharge and control over steering the electrical therapy by having electrodes separated by insulative material. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Koop et al, with an outer insulation covering the attachment feature, the housing, and a proximal region of the fixation element as taught by Yang et al, since such a modification would provide the predictable results of improved control of the electrical discharge and control over steering the electrical therapy by having electrodes separated by insulative material.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al (US Publication 2020/0306530) in view of Risi (US Publication 2016/0022990), as applied above, and further in view of Pender (US Publication 2021/0187305).
Referring to Claim 7, Koop et al in view of Risi teaches the claimed invention, except wherein the helical pacing electrode of the pacing element has a pacing impedance in a range of 450 to 650 ohms. Pender teaches that it is known to use pacing impedances of 450-550 ohms as set forth in Paragraph [0105] to provide reduced current drain to improve longevity of the device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Koop et al, with the distal portion of the pacing element has a pacing impedance in a range of 450 to 650 ohms as taught by Pender, since such a modification would provide the predictable results of reduced current drain to improve longevity of the device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al (US Publication 2020/0306530) in view of Yang et al (US Publication 2019/0083800).
Referring to Claim 25, Koop et al teaches the claimed invention further comprising: an attachment feature mounted on a proximal housing end of the housing, wherein the helical fixation element and the pacing element are coupled to a distal housing end of the housing (e.g. Figures 1-3, proximal appendage 38); a proximal region of the fixation element is covered by the housing (e.g. Figure 3), the proximal region of the helical fixation element and wherein a distal region of the helical fixation element is not covered by the outer insulation (e.g. Paragraph [0093] and Figure 12). However, Koop et al does not explicitly disclose an outer insulation covering the attachment feature, the housing, and a proximal region of the fixation element.
Yang et al teaches that it is known to use the housing having a ring electrode where the remainder of the housing and proximal region are formed form a non-conductive material as set forth in Figure 1 and Paragraphs [0036] and [0071] to provide improved control of the electrical discharge and control over steering the electrical therapy by having electrodes separated by insulative material. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Koop et al, with an outer insulation covering the attachment feature, the housing, and a proximal region of the fixation element as taught by Yang et al, since such a modification would provide the predictable results of improved control of the electrical discharge and control over steering the electrical therapy by having electrodes separated by insulative material.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al (US Publication 2020/0306530) in view of Pender (US Publication 2021/0187305).
Referring to Claim 26, Koop et al teaches the claimed invention, except wherein the helical pacing electrode of the pacing element has a pacing impedance in a range of 450 to 650 ohms.
Pender teaches that it is known to use pacing impedances of 450-550 ohms as set forth in Paragraph [0105] to provide reduced current drain to improve longevity of the device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Koop et al, with the distal portion of the pacing element has a pacing impedance in a range of 450 to 650 ohms as taught by Pender, since such a modification would provide the predictable results of reduced current drain to improve longevity of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Williams et al (US Patent 12,274,876) discloses a helical fixation element and a cable helix.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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