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 .
Priority
Claims 2, 5-9, 11-14, and 18-21 are deemed to have an effective filing date of November 9, 2018. Claims 3-4, 10, and 15-17 are deemed to have an effective filing date of October 31, 2019 as the provisional application does not provide support for compressed into direct contact the conductor coil/coupling tube and compressing the conductive tubing to constrain motion of the connection portion of the conductor coil.
Claim Interpretation
Claims 1, 11, and 18 are product-by-process claims, which are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113). The Examiner also notes that the instant specification indicates that the electrode can be formed from a non-tubular conductive sheet, and thus, the conductive tube is not critical to the claimed invention (e.g., paragraphs [0074] and [0069] of the originally filed specification).
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 2-21 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.
In claims 2, 11, and 18, “a conductive tube” (line 3 of each claim) is inferentially included and it is unclear if the applicant is positively reciting or functionally reciting the element. If the element is being functionally recited, it is suggested to use functional terms such as “adapted to be” or “for”. If the element is being positively recited, it is suggested to first state the system includes the element before it is used in a connection in the claim. The Examiner has interpreted this element as a functional element in a product-by-process claim.
Claim 11, line 7, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 3-10, 12-17, and 19-21 are rejected because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-3, 5-6, 8, 10, 11-12, 13-15, 17, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2012/0110844 to Johnson et al. (hereinafter referred to as “Johnson”).
Referring to claim 2, Johnson discloses a component for a medical device (e.g., paragraph [0002]: invention is directed to systems for securing electrode leads (a medical component)), the component comprising: at least one conductor coil including a connection portion (e.g., paragraph [0015]: lead 20 can be a coil as shown in Fig. 1 – where the connection portion of the coil is under the connector 40); and an electrode formed from a conductive tube, wherein the conductive tube is compressed at least partially around the connection portion of the at least one conductor coil to at least partially surround and couple to the connection portion (e.g., paragraphs [0014]-[0017]: electrode assembly 10 is formed from a conductive tube 40 made from bio-compatible metals which is compressed via forces F in Fig. 2B at least partially around the connection portion of the coil), the electrode including: a flattened portion including a substantially flat surface configured to contact and stimulate tissue (e.g., Fig. 2B and paragraph [0021]: contact 30 has a face 36 through which electrical energy is delivered to and/or from the patient); and at least one protrusion extending from the flattened portion of the electrode (e.g., paragraph [0014]: electrode assembly 10 includes a lead/coil 20, a contact 30 configured to deliver/receive electrical signals to/from the lead 20, and a connector 40 – where the connector 40 is a protrusion as shown in Fig. 1), wherein the connection portion of the conductor coil is disposed within the protrusion of the electrode (e.g., Fig. 1 – the connection portion of coil 20 is within/under the connector).
Regarding claim 11, Johnson discloses a component for a medical device (e.g., paragraph [0002]: invention is directed to systems for securing electrode leads (a medical component)), the component comprising: at least one conductor coil including a connection portion (e.g., paragraph [0015]: lead 20 can be a coil as shown in Fig. 1 – where the connection portion of the coil is under the connector 40); and an electrode formed from a conductive tube, wherein the conductive tube includes an inner surface facing inwardly toward an axis of the conductive tube and an outer surface facing outwardly away from the axis of the conductive tube, the connection portion of the at least one conductor coil being coupled to a first portion of the inner surface, wherein the electrode includes the conductive tube collapsed such that at least the first portion of the inner surface and the connection portion of the at least one conductor coil contacts at least a second portion of the inner surface to substantially sandwich the connection portion of the at least one conductor coil between the first portion of the inner surface and the second portion of the inner surface (e.g., paragraphs [0014]-[0017]: electrode assembly 10 is formed from a conductive tube 40 made from bio-compatible metals which is compressed via forces F in Fig. 2B at least partially around the connection portion of the coil to substantially sandwich the connection portion of the coil between a first and second portion of the connector inner surface), the electrode including: a flattened portion including a substantially flat surface configured to contact and stimulate tissue (e.g., Fig. 2B and paragraph [0021]: contact 30 has a face 36 through which electrical energy is delivered to and/or from the patient); and at least one protrusion extending outwardly from the flattened portion of the electrode (e.g., paragraph [0014]: electrode assembly 10 includes a lead/coil 20, a contact 30 configured to deliver/receive electrical signals to/from the lead 20, and a connector 40 – where the connector 40 is a protrusion as shown in Fig. 1), wherein the connection portion of the at least one conductor coil is disposed within the at least one protrusion of the electrode (e.g., Fig. 1 – the connection portion of coil 20 is within/under the connector).
Referring to claim 18, Johnson discloses a component for a medical device (e.g., paragraph [0002]: invention is directed to systems for securing electrode leads (a medical component) via a crimped tube arrangement), the component comprising: at least one conductor coil including a connection portion (e.g., paragraph [0015]: lead 20 can be a coil as shown in Fig. 1 – where the connection portion of the coil is under the connector 40); and an electrode formed from a conductive tube, wherein the conductive tube is compressed at least partially around the connection portion of the at least one conductor coil to at least partially surround and couple to the connection portion (e.g., paragraphs [0014]-[0017]: electrode assembly 10 is formed from a conductive tube 40 made from bio-compatible metals which is compressed via forces F in Fig. 2B at least partially around the connection portion of the coil), the electrode including: a stimulation portion configured to contact and stimulate tissue (e.g., Fig. 2B and paragraph [0021]: contact 30 has a face 36 through which electrical energy is delivered to and/or from the patient); and at least one protrusion extending from the stimulation portion of the electrode (e.g., paragraph [0014]: electrode assembly 10 includes a lead/coil 20, a contact 30 configured to deliver/receive electrical signals to/from the lead 20, and a connector 40 – where the connector 40 is a protrusion as shown in Fig. 1), wherein the connection portion of the at least one conductor coil is disposed within the at least one protrusion of the electrode (e.g., Fig. 1 – the connection portion of coil 20 is within/under the connector).
With respect to claims 3 and 15, Johnson discloses the component of claims 2 and 11, wherein the conductive tube is compressed into direct contact with the at least one conductor coil (e.g., paragraph [0017]: the inner wall 45 [of connector 40/42] has a diameter greater than the outer diameter of the lead 20 and an external force is applied to the connector to crimp or otherwise press the inner wall against the outer surface of the lead).
As to claim 5, Johnson discloses the component of claim 2, wherein the connection portion is welded to the electrode (e.g., paragraph [0021]: the contact interface 44 of the connector 40 is welded to the contact 30 of the electrode assembly 10 where the connection portion is welded to the electrode via the connector 44).
With respect to claims 6, 13, and 20, Johnson discloses the component of claims
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2, 11, and 18, wherein the flattened portion and the at least one protrusion substantially form a T-shape (see annotated Fig. 2B of Johnson when the electrode assembly is welded).
As to claim 8, Johnson discloses the component of claim 2, wherein the medical device includes an elongate lead, wherein the electrode is disposed within the lead with at least an electrode surface being exposed to an exterior of the lead (e.g., paragraph [0025] and Fig. 5 shows a lead with electrodes/contacts disposed within the lead with an electrode surface exposed).
With respect to claims 10 and 17, Johnson discloses the component of claims 2 and 11, wherein the conductive tube is compressed at least partially around the connection portion of the at least one conductor coil to constrain motion of the connection portion of the at least one conductor coil relative to the conductive tube (e.g., paragraph [0004]: background paragraph discusses need for an electrode/lead connection that is both flexible and secure with respect to the connection being resilient w/r/t movement; and [0014]: connector 40 secures the lead 20 to the contact/electrode 30 in a secure, robust manner and prevents deforming or collapsing during surgical implantation and/or operation).
As to claim 12, Johnson discloses the component of claim 11, wherein, with the first portion of the inner surface of the conductive tube contacted to the connection portion of the at least one conductor coil, the second portion of the inner surface is disposed between the first portion of the inner surface and the flattened portion of the electrode (see annotated Fig. 2B of Johnson above).
With respect to claim 19, Johnson discloses the component of claim 18, wherein the stimulation portion includes a substantially flat surface (e.g., Fig. 2B and paragraph [0021]: contact 30 has a face 36 through which electrical energy is delivered to and/or from the patient).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of US Patent No. 4,314,095 to Moore et al. (hereinafter referred to as “Moore”).
Johnson discloses the component of claim 2, but does not expressly disclose a coupling tube, wherein the conductive tube is compressed into direct contact with the coupling tube, the at least one conductor coil being at least partially disposed within the coupling tube. However, Moore, in a related art: device and method for making electrical devices with electrodes resistance to fractures caused by flexing (e.g., column 1, lines 6-25 and 55-59; and column 2, lines 38-42: implanted medical devices must have extreme resistance to fractures caused by flexing and the present inventio is directed to electrical connectors between a highly flexible wire and an implantable metal electrode), teaches a coupling tube or flared tubing 70 which is slipped over a flexible wire 52 and is inserted into the channel 20 of the clip/connector 10 after the wire mesh 48 has been inserted therein so that when forming a compression joint, the maximum stress is placed on the sleeve [of tubing 70] and not on the delicate wire and where portions of the sleeve will corrode before the wire (e.g., column 4, lines 17-31 of Moore). Accordingly, one of ordinary skill in the art would have recognized the benefits of a coupling tube that is in direct contact with the clip/connector where the wire/coil is at least partially disposed within the coupling tube in view of the teachings of Moore. Consequently, one of ordinary skill in the art would have modified the component of Johnson to have a coupling tube in order to prevent corrosion of the coil and/or to avoid direct compression to the coil in view of the teachings of Moore that such was a well-known engineering expedient in the medical arts for electrical connections.
Claims 7, 14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of US Patent No. 6,421,569 to Treaba et al. (hereinafter referred to as “Treaba”).
Johnson discloses the component of claims 2, 11, and 18, but does not expressly disclose that the flattened portion and the at least one protrusion substantially form a U-shape. While Johnson discloses that its contact/electrode assemblies secure leads to contacts/electrodes to apply electrical signals or fields to a patient for cortical electrical stimulation, Johnson also discloses that its assemblies can be used in other applications (e.g., paragraph [0012]). The Abstract of Johnson also notes that the contact/electrode can have a tubular shape. Treaba, in a related art: cochlear implant electrode array, teaches an electrode/contact 32 having a tubular shape can have a U-shape as shown in Figs. 2b and 2c. Thus, one of ordinary skill in the art would have recognized the benefits of electrode having a U-shape in certain medical applications in view of the teachings of Treaba. Consequently, one of ordinary skill in the art would have modified the component of Johnson so that its electrode assembly (protrusion and contact) substantially form a U-shape in view of the teachings of Treaba that such was a well-known shape for medical applications, and because the combination would have yielded a predictable result of coil to electrode/contact with a U-shape.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of US Patent Application Publication No. 2020/0046964 to Rotman et al. (hereinafter referred to as “Rotman”).
Johnson discloses the component of claim 2, but does not expressly disclose that the medical device includes an elongate catheter, wherein the electrode is disposed within the catheter with at least an electrode surface being exposed to an exterior of the catheter. However, Rotman, in a related art: multi-electrode catheters, teaches a medical device, such as a mapping-catheter that may be introduced into the heart of a patient where electrodes fitted at the distal-end of the catheter acquire electro-physiological signals from the patient’s heart (e.g., Fig. 1 and paragraphs [0017] and [0025] of Rotman: catheter 29 performs electro-anatomical mapping of a heart of a patient using electrodes 22 at the distal end of the catheter 29), and catheter 29 is electrically connected to apparatus 50 via a connector 45 at a handle 32 of the catheter and electrodes 22 are connected by a wire within catheter 29 as shown in Fig. 2 (e.g., Fig. 2 and paragraph [0030] of Rotman) .
Accordingly, one of ordinary skill in the art would have recognized the benefits of a catheter with an elongated lead where in the electrode is disposed within the catheter with at least an electrode surface being exposed to an exterior of the catheter in view of the teachings of Rotman. Consequently, one of ordinary skill in the art would have modified the component of Johnson to be used with a catheter medical device in view of the teachings of Rotman that a catheter was a well-known expedient for inserting electrodes to an area of interest in a patient for diagnosis and treatment of a heart, and because the combination would have yielded a predictable result.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-6, 8-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, and 12-15 of U.S. Patent No. 12,144,632 (hereinafter referred to as the ‘632 patent) in view of Johnson.
Instant claims 2 and 6 are encompassed by and conflicts with claim 1 of the ‘632 patent, except that the ‘632 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 2. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 2 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘632 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Instant claims 3-4 are encompassed by and conflict with claims 6-7, respectively, of the ‘632 patent, as modified by Johnson.
Instant claim 5 is encompassed by and conflicts with claim 3 of the ‘632 patent, as modified by Johnson.
Instant claims 8-9 are encompassed by and conflict with claims 4-5, respectively, of the ‘632 patent, as modified by Johnson.
Instant claim 10 is encompassed by and conflicts with claim 8 of the ‘632 patent, as modified by Johnson.
Instant claims 11-13 are encompassed by and conflicts with claim 9 of the ‘632 patent, except that the ‘632 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 11. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 11 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘632 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Instant claim 15 is encompassed by and conflicts with claim 12 of the ‘632 patent, as modified by Johnson.
Instant claim 16 is encompassed by and conflicts with claim 13 of the ‘632 patent, as modified by Johnson.
Instant claim 17 is encompassed by and conflicts with claim 14 of the ‘632 patent, as modified by Johnson.
Instant claims 18 and 19-20 are encompassed by and conflict with claim 1 of the ‘632 patent, except that the ‘632 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 18. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 18 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘632 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Claims 7, 14, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 15 of U.S. Patent No. 12,144,632 in view of Johnson and Treaba.
Instant claims 7, 14, and 21 are encompassed by and conflicts with claims 1, 9, and 15, respectively, of the ‘632 patent as modified by Johnson, except that the ‘632 patent does not expressly claim that the flattened portion and protrusion substantially form a U-shape. However, as discussed above w/r/t the rejection of claims 7, 14, and 21 under 35 USC 103, Treaba teaches that a U-shaped contact/electrode was known to those skilled in the medical arts. Consequently, one of ordinary skill in the art would have modified the component of the ‘632 patent so that its electrode assembly (protrusion and contact) substantially form a U-shape in view of the teachings of Treaba that such was a well-known shape for medical applications, and because the combination would have yielded a predictable result of coil to electrode/contact with a U-shape.
Claims 2-6, 8-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 11, 15-17, and 20 of U.S. Patent No. 11,241,184 (hereinafter referred to as the ‘184 patent) in view of Johnson.
Instant claims 2 and 6 are encompassed by and conflicts with claim 1 of the ‘184 patent, except that the ‘184 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 2. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 2 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘184 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Instant claims 3-4 are encompassed by and conflict with claims 6-7, respectively, of the ‘184 patent, as modified by Johnson.
Instant claim 5 is encompassed by and conflicts with claim 3 of the ‘184 patent, as modified by Johnson.
Instant claims 8-9 are encompassed by and conflict with claims 4-5, respectively, of the ‘184 patent, as modified by Johnson.
Instant claim 10 is encompassed by and conflicts with claim 8 of the ‘184 patent, as modified by Johnson.
Instant claims 11-13 are encompassed by and conflicts with claim 11 of the ‘184 patent, except that the ‘184 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 11. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 11 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘184 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Instant claim 15 is encompassed by and conflicts with claim 16 of the ‘184 patent, as modified by Johnson.
Instant claim 16 is encompassed by and conflicts with claim 17 of the ‘184 patent, as modified by Johnson.
Instant claim 17 is encompassed by and conflicts with claim 20 of the ‘184 patent, as modified by Johnson.
Instant claims 18 and 19-20 are encompassed by and conflict with claim 1 of the ‘184 patent, except that the ‘184 patent refers to a conductor wire instead of a conductor coil as now recited in instant claim 18. However, Johnson teaches a component for a medical device having a conductor coil being connected to an electrode as discussed above with respect to the rejection of claim 18 under 35 USC 102(a)(1). Accordingly, one of ordinary skill in the art would have recognized that a conductor coil, as well as a conductor wire, can be used transmit electrical signals to an electrode in view of the teachings of Johnson. Consequently, one of ordinary skill in the art would have modified the conductor wire of the ‘184 patent to be a conductor coil as both elements transmit electrical signals to an electrode, and because the combination would have yielded a predictable result.
Claims 7, 14, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11,241,184 in view of Johnson and Treaba.
Instant claims 7, 14, and 21 are encompassed by and conflicts with claims 1, 11 and 1, respectively, of the ‘184 patent as modified by Johnson, except that the ‘184 patent does not expressly claim that the flattened portion and protrusion substantially form a U-shape. However, as discussed above w/r/t the rejection of claims 7, 14, and 21 under 35 USC 103, Treaba teaches that a U-shaped contact/electrode was known to those skilled in the medical arts. Consequently, one of ordinary skill in the art would have modified the component of the ‘184 patent so that its electrode assembly (protrusion and contact) substantially form a U-shape in view of the teachings of Treaba that such was a well-known shape for medical applications, and because the combination would have yielded a predictable result of coil to electrode/contact with a U-shape.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent No. 8,792,996 to Sethna et al. is directed to an implantable medical lead and method of making the same where an electrical conductor 100 is position relative to a crimp slug 105 that is adjacent to an electrical component 80, such as an electrode or sensor as shown in Figs. 1, 2C-2D (e.g., column 4, line 59 – column 5, line 16).
US Patent No. 8,280,528 to Kuzma is directed to an implantable cochlear lead where the positively recited structural element of the product-by-process claims are shown in Figs. 3A, 3D and 8 and Kuzma discloses that the conductor wires can be straight, zigzag or coiled, but zigzag and coiled are better with preventing fractures than straight wires (e.g., column 5, lines 3-8).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792
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