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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/13/2025 has been entered.
Response to Arguments
Claims 4-6 and 14-16 are canceled. Claims 1, 7-8, 13 and 17 are amended. Claims 21-22 are new. Claims 1-3, 7-12 and 21-22 are pending in this action.
Claim Rejections - 35 USC § 102/103
Applicant’s arguments with respect to claim(s) 11/13/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, claim 1 cites the newly cited prior art as taught by Clark (US 20150073248 A1 – hereinafter Clark), which teaches a similar electrical stimulation lead (abstract – “Described is an implantable lead comprising a flexible body extending between a proximal end and a distal end and a distal assembly coupled to the distal end of the body”), and further teaches the lead body (figure 2, lead body 22; figure 2),
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And further discloses the amended features of claim 1, including an additional electrode in the form of an expandable helical electrode 24 as shown in figure 4, which is configured to engage tissue (paragraph 0032), and is able to extend from a first axial length and being elastically expandable to a second axial length (figure 3). New claims 21-22 are further rejected as a result under the combined invention including Clark.
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Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-12 in the reply filed on June 11, 2025 was acknowledged. Claims 13-20 were non-elected.
Information Disclosure Statement
The information disclosure statement(s) filed December 21, 2022 and April 20, 2023 has/have been considered by the Examiner.
Claim Interpretation
The term(s) “for”, “configured to”, “capable of” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 7-8 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camps (US 20030028232 A1 – hereinafter Camps) in view of Chu (US 20180177505 A1 – hereinafter Chu) [BOTH previously cited], and in further view of Clark (US 20150073248 A1 – hereinafter Clark) [NEW].
Re. claim 1, Camps discloses an electrical stimulation lead (abstract – “A medical electrical lead, a system for providing electrical stimulation or sensing using such a lead…”) comprising:
a lead body having a proximal end and a distal end (figure 1, lead 30 with a proximal IPG connector 38 and distal electrode 44);
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a connection interface coupled to the proximal end (figure 1, proximal IPG connector 38);
a tip electrode coupled to the distal end (figure 1, distal electrode 44),
the tip electrode in electrical communication with the connection interface (paragraph 0039 – “Electrode 44 is mechanically and electrically connected by an electrical conductor disposed within lead body 36 (not shown in the Figures). The electrical conductor, in turn, is attached to the distal end of IPG connector 38”);
and a suture line extending from the tip electrode (figure 1, suture line 33 extends from tip electrode 44),
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the suture line having a barbed structure configured to engage a tissue in which it is placed (figure 1, suture needle 32; paragraph 0029 – “Needle 32 is first inserted through the muscle and electrode 44 drawn therethrough by means of line 33”).
Camps teaches the suture line extending from the tip electrode, the suture line having a barbed structure configured to engage a tissue as stated above (Camps figure 1, suture needle 32), but does not explicitly teach the barbed structure comprising a plurality of barbs, each extending generally away from the direction that the suture line is inserted into the tissue to facilitate passage through tissue in one direction and to discourage passage in an opposite direction.
Chu teaches a similar barbed suture structure (Chu abstract – “A novel barbed suture comprises improved retaining strength or anchoring ability within the tissue in both directions of the suture”), and further teaches in figure 6, a suture line having a barbed structure (Chu figure 6, barbed suture line 31; paragraph 0130 – “In another embodiment of the present invention, a new unidirectional barbed suture 31…”),
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the barbed structure comprising a plurality of barbs (Chu figure 6, barbs 30; paragraph 0130 – “In another embodiment of the present invention, a new unidirectional barbed suture 31 comprises a suture thread 37 and a plurality of barbs 30…”),
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each extending generally away from the direction that the suture line is inserted into the tissue to facilitate passage through tissue in one direction and to discourage passage in an opposite direction (Chu figure 6, barbs 30 are shown to extend away from the insertion portion of the barbed suture 31).
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Camps and Chu both teach within the field of sutures, particularly with barbed structures. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Camps, specifically the barbed structure of Camps, to incorporate the plurality of barbs, as taught by Chu, since such modification would predictably result in providing the suture with enhanced retention strength on the same plane perpendicular to the central axis of the suture (Chu paragraph 0130).
The combined invention does not explicitly teach an additional electrode coupled to the lead body, wherein the additional electrode is in electrical communication with the connection interface,
wherein the additional electrode is a flexible helical electrode capable of engaging tissue, the flexible helical electrode disposed towards the distal end, the flexible helical electrode having a first axial length and being elastically expandable to a second axial length.
Clark teaches a similar electrical stimulation lead (abstract – “Described is an implantable lead comprising a flexible body extending between a proximal end and a distal end and a distal assembly coupled to the distal end of the body”), and further teaches the lead body (figure 2, lead body 22; figure 2),
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including an additional electrode coupled to the lead body (figure 2, helical electrode 24; paragraph 0038 – “…the fixation helix 24 is electrically active and thus can be used to sense the electrical activity of the heart 16 or to apply a stimulating pulse to the right ventricle 28”), wherein the additional electrode is in electrical communication with the connection interface (figure 2, helical electrode 24, which connects to the connector assembly 40; paragraph 0038 – “…the fixation helix 24 is electrically active and thus can be used to sense the electrical activity of the heart 16 or to apply a stimulating pulse…”; paragraph 0039 – “A connector assembly 40 is disposed at or near the proximal region 18 of the lead 14. The connector assembly 40 includes a connector 46 and a terminal pin 48. The connector 46 is configured to be coupled to the lead body 22 and is configured to mechanically and electrically couple the lead 14 to the header 13 on the pulse generator 12 (see FIG. 1)”).
Clark further teaches wherein the additional electrode is a flexible helical electrode capable of engaging tissue (paragraph 0032 – “The fixation helix 24 locates and/or secures the distal region 20 of the lead 14 within the heart 16”), the flexible helical electrode disposed towards the distal end (figure 3, helical electrode 24 is disposed on the distal portion 60), the flexible helical electrode having a first axial length and being elastically expandable to a second axial length (paragraph 0032 – “The distal region 20 includes an extendable/retractable fixation helix 24”; figure 3 shows the helical electrode 24 including a first axial length and expanded to a second axial length along the distal end).
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The combined invention and Clark both teach within the field of electrical stimulation leads as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lead of the combined invention, to incorporate the flexible helical electrode, as taught by Clark, since such modification would predictably result in providing stimulation pulses to a target tissue as well as fixating the lead to a target tissue.
Re. claim 2, the combined invention of Camps, Chu and Clark (hereinafter the combined invention) further teaches wherein the suture line is a biodegradable suture line comprises glycolide, dioxanone, trimethylene carbonate, glycolic acid, polymers thereof, copolymers thereof, or combinations thereof (Camps paragraph 0057 – “Additionally, it may be another feature of suture 33 of the present that suture 33 be formed or made of a material which is absorbable, resorbable, and/or biodegradable within the human body after lead 30 has been implanted…Examples of appropriate biodegradable, decomposable, absorbable and/or resorbable materials suitable for use in suture 33 of the present invention include, but are not limited to, polydioxanone (PDS II)…”).
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Re. claim 3, Camps of the combined invention further teaches in paragraph 0057 – “The rate at which suture 33 degrades or decomposes within the patient can be controlled by appropriately selecting the material and/or physical dimensions from which suture 33 is made”. However, Camps does not explicitly teach wherein the suture line is configured to degrade within five days to 180 days.
It is reminded however that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114 Apparatus and Article Claims — Functional Language.
Since Camps of the combined invention teaches structural elements of the biodegradable suture made of glycolide, dioxanone, trimethylene carbonate, glycolic acid, polymers thereof, copolymers thereof, or combinations thereof as claimed in claim 2 (Camps paragraph 0057 - “Examples of appropriate biodegradable, decomposable, absorbable and/or resorbable materials suitable for use in suture 33 of the present invention include, but are not limited to, polydioxanone (PDS II) …”), the suture line 33 structure of Camps meets the functional limitation of claim 3.
Re. claim 7, the combined invention further teaches wherein the flexible helical electrode comprises stainless steel, platinum and iridium alloys, nickel, nickel and cobalt alloys, titanium, cobalt, chromium, and molybdenum, or combinations thereof (Clark paragraph 0043 – “In some embodiments, the fixation helix 24 is made at least in part of an electrically conductive material such as ELGILOY.TM., MP35N.TM., tungsten, tantalum, iridium, platinum, titanium, palladium, stainless steel as well as alloys of any of these materials”).
Re. claim 8, the combined invention further teaches wherein the flexible helical electrode has a flare defined by a first diameter at a proximal end of the flexible helical electrode and a second diameter at a distal of the flexible helical electrode, wherein the second diameter is larger than the first diameter (Clark figure 3).
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Re. claim 21, the combined invention further teaches wherein the flexible helical electrode is configured to elastically expand from the first axial length to the second axial length when the flexible helical electrode is engaged with tissue and the lead body is pulled in a proximal direction (Clark figure 3 shows the helical electrode 24 including a first axial length and expanded to a second axial length along the distal end).
Re. claim 22, the combined invention further teaches wherein the flexible helical electrode extends over the tip electrode when expanded to the second axial length (Clark figure 3 shows the helical electrode 24 including a first axial length and expanded to a second axial length along the distal end and over the distal portion 60).
Claim(s) 9-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camps (US 20030028232 A1 – hereinafter Camps) in view of Chu (US 20180177505 A1 – hereinafter Chu) [previously cited] and Clark (US 20150073248 A1 – hereinafter Clark) [NEW], and in further view of Algee (US 6990378 B1 – hereinafter Algee) [previously cited].
Rel claim 9, the combined invention of Camps, Chu and Clark (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, but does not explicitly teach the lead further comprising one to six auxiliary electrodes, each coupled to the lead body and each in electrical communication with the connection interface.
Algee teaches a similar electrical stimulation lead comprising a lead 12 with a distal tip electrode 38 (figure 1, tip electrode 38), and further teaches one to six auxiliary electrodes (Algee figure 1 includes 2 additional ring electrodes 40, 42 in addition to tip electrode 38 and coil electrode 44),
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each coupled to the lead body and each in electrical communication with the connection interface (column 5, lines 11-14: “The ring and cardioverting/defibrillating electrodes 40, 42 and 44 shown in the example are electrically connected to the ring terminal contacts 26 28 on the connector assembly 22”).
Since the combined invention and Algee all teach within the field of electrical stimulation leads, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lead of the combined invention, to incorporate the additional electrode as taught by Algee since such modification would predictably result in, for example, the additional electrodes serving as both tissue-stimulating and tissue-sensing electrodes (Algee column 4, lines 59-60).
Re. claim 10, the combined invention of Camps, Chu, Clark and Algee (hereinafter the combined invention) further teaches wherein each of the auxiliary electrodes is a ring electrode or a flexible helical electrode (Algee figure 1 includes two additional ring electrodes 40, 42, in addition to tip electrode 38 and coil electrode 44).
Re. claim 12, the combined invention further teaches wherein the connection interface has a coaxial configuration (Camps figure 1 shows the proximal connector 38 with three coaxial rings).
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Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camps (US 20030028232 A1 – hereinafter Camps) in view of Chu (US 20180177505 A1 – hereinafter Chu) [previously cited], Clark (US 20150073248 A1 – hereinafter Clark) [NEW] and Algee (US 6990378 B1 – hereinafter Algee) [previously cited] and in further view of Holmstrom (US 5800468 A – hereinafter Holmstrom) [previously cited].
Re. claim 11, the combined invention of Camps, Chu, Clark and Algee (hereinafter the combined invention), specifically Camps of the combined invention teaches the stimulation lead comprising a tip electrode (figure 1, tip electrode 44);
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Algee of the combined invention also teaches the stimulation lead comprising a tip electrode (figure 1, tip electrode 38), and further teaches an additional electrode (figure 1, coil electrode 44) and auxiliary electrodes (figure 1, ring electrodes 40, 42) as stated above, all spaced apart (figure 1).
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The combined invention does not explicitly teach wherein the tip electrode, the additional electrode, and any auxiliary electrodes are each separated by an interelectrode distance, the interelectrode distance being 1 mm to 15 mm.
Holmstrom teaches a similar electrical stimulation lead (abstract – “A pacemaker system includes an electrode lead having a distal tip electrode for supplying stimulation pulses to cardiac tissue…”), where figure 1B-1C and figure 2 teaches a lead body 1 with tip electrode 2, and ring electrode 6 spaced along the lead (figure 1B-1C and figure 2);
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And further teaches it is known that inter-electrode distances between the electrodes can be arranged between 5-30 mm (Holmstrom column 2, lines 40-41: “…the distance between the electrodes may be 5-30 mm, preferably 10-20 mm.”). It is reminded that a prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", see MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. In the instant case, a prima facie case of obviousness exists since the inter-electrode distance range of 5-30 mm as taught by Holmstrom overlaps to the claimed inter-electrode distance of 1 mm to 15 mm.
Since the combined invention teaches the stimulation lead comprising a tip electrode, additional electrode, and auxiliary electrode spaced apart on a lead, and Holmstrom teaches a similar stimulation lead comprising a tip electrode and an additional/auxiliary electrode spaced apart, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inter-electrode distances of the combined invention to incorporate the electrode distances of 5-30 mm as taught by Holmstrom since such modification would predictably result in the lead/electrodes providing balanced stimulation over a desired target region of interest (Holmstrom column 2, lines 36-39: “According to another embodiment the electrodes are arranged at such a distance between each other that when the tip electrode is introduced into the apex of the ventricle, then the ring electrode will be also be positioned in the ventricle.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Harris (US-4103690-A) teaches an electrical stimulation lead (abstract) comprising a lead body having a proximal end and a distal end with a distal tip electrode 27 (figure 1) and a suture 31 extending from the tip electrode (figure 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796