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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17, in the reply filed on January 5, 2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 5, 2026.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/14/2023 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the 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 1-17 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.
Claim 1 recites the limitation "the contact connector" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the contact connector" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
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 1-7 and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al. (U.S. 2013/0116754), herein Sharma. Regarding claim 1, Sharma discloses a system for making an electrical connection to a lead contact 202a-h of a medical device lead 200 or lead extension (see Figure 2), the system comprising a connector contact assembly including: a connector block 502/702 configured to receive and retain a conductive spring 504 within an interior of the connector block to form the contact connector (“contact assembly 302 having a ring-shaped or annular housing 502, a contact 504”, paragraph [0030], “FIG. 7 is an isometric view of a contact assembly 700 having a housing 702”, paragraph [0035] and Figures 5, 7, and 8), wherein a combination of the connector block and the spring are configured to receive a proximal end of the medical lead or a proximal end of the lead extension when the proximal end is inserted through the combination (“As described above, the contact assemblies 302 of FIGS. 3 and 4 can be configured to engage the conductors 202 of the conductor assembly 200 (FIG. 2)”, paragraph [0030], and “When a conductor 202 (FIG. 2) is inserted into the contact assembly 700”, paraqgraph [0036]); the connector block having an open center portion 508/706, and further having a first end, an opposing second end, a longitudinal length extending between the first end and the second end, an outer surface, and an inner surface forming a perimeter of the open center portion of the connector block (see Figures 5 and 7), the connector block further including a first flange at the first end and a second flange at the second end, wherein the first and second flanges extend inward from the inner surface of the connector block (“contact assembly 700 having a housing 702 with inwardly protruding rims 704 (identified individually as a first protruding rim 704a and a second protruding rim 704b) configured in accordance with a further embodiment of the present technology. The protruding rims 704 extend toward the center of an opening 706 in the housing 702 and can contain, capture or hold the contact 504 within the housing”, paragraph [0035]); and the spring 504 being formed from a material with shape-memory (“The contact 504 can be fabricated (e.g., by casting, stamping or other suitable processes) from a variety of metals or metal alloys. For example, in some embodiments, the contact 504 includes MP35N, stainless steel, titanium and/or a platinum/iridium alloy such as 80/20 or 90/10 Pt/Ir.”, paragraph [0033]), the spring being configured to be compressed for insertion through one of the first flange or the second flange, and to at least partially expand into an expanded state such that the spring is retained between the first flange and the second flange within the open center portion of the connector block (“The spring 524may be compressed, due to the shape memory of the material and the gap 538 which closes under compression, and then positioned with the cavity or open center portion 525 of the connector block 523. Assembling the connector contact assembly may include applying a compressive force to the spring 524 to reduce a spring size to a compressed size, inserting the spring 524 having the compressed size through an opening in one of the flanges 531, 532 so that the spring is with the interior of the connector block, and removing the compressive force, allowing the spring 524 to expand from the compressed shape to at least a partially expanded shape larger than the opening such that the spring 524 is retained within the interior of the connector block 523.”, paragraph [0035]), the spring having a biasing structure configured to physically contact the lead contact when the proximal end is inserted into a final position within the connector contact assembly (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly.”, paragraph [0036]). It is respectfully submitted that contact 504 of Sharma is considered to be “formed from a material with shape-memory” because it is described as being compressed during insertion and expanding after insertion (“The contact 504 can be compressed, making the diameter 610 at the rings 604 smaller than a diameter 802 of the opening 706 at the protruding rims 704. In this manner, the contact 504 can be inserted into the housing 702 from either above or below. For example, while compressed, the contact 504 can be pushed into the opening 706 from above until both rings 604 are past the protruding rim 704a. The contact 504 subsequently expands”, paragraph [0035]), which follows the same definition of shape memory material as described at paragraph [0061] of Applicant’s specification (“The spring 524may be compressed, due to the shape memory of the material and the gap 538 which closes under compression, and then positioned with the cavity or open center portion 525 of the connector block 523. Assembling the connector contact assembly may include applying a compressive force to the spring 524 to reduce a spring size to a compressed size, inserting the spring 524 having the compressed size through an opening in one of the flanges 531, 532 so that the spring is with the interior of the connector block, and removing the compressive force, allowing the spring 524 to expand from the compressed shape to at least a partially expanded shape larger than the opening such that the spring 524 is retained within the interior of the connector block 523.”). Furthermore, the material of the spring of Sharma, MP35N, is the same material as the spring of Applicant’s invention, as described in paragraph [0059]).
Regarding claim 2, Sharma discloses that both the connector block and the spring are conductive and in contact with each other (“The contact 504 can be fabricated (e.g., by casting, stamping or other suitable processes) from a variety of metals or metal alloys. For example, in some embodiments, the contact 504 includes MP35N, stainless steel, titanium and/or a platinum/iridium alloy such as 80/20 or 90/10 Pt/Ir. Similarly, the housing 502 can also be constructed of metals or metal alloys, including MP35N, stainless steel and/or titanium.”, paragraph [0033]), and a conductive member 404 extends from an exterior of the connector block to provide an electrical connection to the spring retained within the open center portion of the connector block (see Figure 4 and “a plurality of contact assemblies 302 that are operably coupled to conducting wires 404”, paragraph [0029]).
Regarding claim 3, Sharma discloses that the spring is not affixed to the connector block (the embodiment in Figures 7 and 8 is decribed as having the contact 504 contained in the housing via expansion and is not described as being affixed), and the combination of the connector block and the spring are configured to allow movement of the spring, when the spring is in the expanded state between the first flange and the second flange, within the open center portion of the connector block (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly. Flexing the leaf spring portions 602 causes the contact 504 to exert pressure against the protruding rims 704.”, paragraph [0036], is considered to be a description of the movement of the spring).
Regarding claim 4, Sharma discloses that when the spring is retained within the open center portion of the connector block, the connector block has a connector block center axis and the spring has a spring center axis generally parallel to the connector block, and the movement moves an offset of the spring center axis with respect to the connector block axis to accommodate the lead (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly. Flexing the leaf spring portions 602 causes the contact 504 to exert pressure against the protruding rims 704.”, paragraph [0036]).
Regarding claim 5, Sharma discloses that the spring includes a first end and an opposing second end; and a first rim at the first end and a second rim at the second end, wherein each of the first and second rims have rim ends and a gap separating the rim ends, wherein the biasing structure includes a plurality of biasing members 602 configured to physically contact that lead contact, each of the plurality of biasing members extending between the first rim and the second rim and including a bend to provide a biasing force against the lead contact, and wherein the biasing forces corresponding to the plurality of biasing members align the spring center axis with a center axis of the proximal portion of the lead or the lead extension (see annotated Figures 6A and 6B below).
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Regarding claim 6, Sharma discloses that each of the plurality of biasing members are perpendicularly attached to the first rim and to the second rim (see annotated figures above).
Regarding claim 7, Sharma discloses that the first and second rims are arc-shaped (see annotated figures above).
Regarding claim 12, Sharma discloses that both the connector block and the spring are made from a same conductive material (“The contact 504 can be fabricated (e.g., by casting, stamping or other suitable processes) from a variety of metals or metal alloys. For example, in some embodiments, the contact 504 includes MP35N, stainless steel, titanium and/or a platinum/iridium alloy such as 80/20 or 90/10 Pt/Ir. Similarly, the housing 502 can also be constructed of metals or metal alloys, including MP35N, stainless steel and/or titanium.”, paragraph [0033]), and a conductive member 404 extends from an exterior of the connector block to provide an electrical connection to the spring retained within the open center portion of the connector block (see Figure 4 and “a plurality of contact assemblies 302 that are operably coupled to conducting wires 404”, paragraph [0029]).
Regarding claim 13, Sharma discloses that the biasing structure comprises at least one bend that extends into the open center portion of the contact housing and narrows an inner diameter of the open center portion (“The leaf spring portions 602 extend from the first ring portion 604a to the second ring portion 604b and bow inwardly or have an inward offset toward the center of the contact 504. The ring portions 604 and the plurality of leaf spring portions 602 define, at least in part, an opening 608, and the arcuate shapes of the bowed leaf spring portions 602 provide an axially varying diameter for the opening 608.”, paragraph [0031]).
Regarding claim 14, Sharma discloses that the connector block has a cylindrical shape, where both the outer surface and the inner surfaces are curved surfaces (see Figures 5 and 7).
Regarding claim 15, Sharma discloses that the connector-contact assembly is one of a plurality of similar connector-contact assemblies (see Figures 3 and 4), and the system further includes: an elongated connector housing 300/101 having a first end and an opposing second end (see Figures 3 and 4); a connector lumen 312/412a/412b defined in the connector housing (see Figures 3 ane 4), the connector lumen configured and arranged to receive the proximal end of the lead or the lead extension (“The patient implantable element 300 can be configured to receive the conductor assembly 200 (FIG. 2) of the lead 111 (FIG. 1).”, paragraph [0028] and “The receiving elements 400 provide for multiple lead extensions 102 or multiple signal delivery devices 110 (e.g., leads 111) to be connected to the implantable pulse generator 101.”, paragraph [0029]); and the plurality of similar connector-contact assemblies (see Figures 3 and 4).
Regarding claim 16, Sharma discloses that when the spring is retained within the interior of the connector block, the connector block has a connector block center axis and the spring has a spring center axis generally parallel to the connector block, and the movement moves an offset of the spring center axis with respect to the connector block axis to accommodate the lead (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly. Flexing the leaf spring portions 602 causes the contact 504 to exert pressure against the protruding rims 704.”, paragraph [0036]); at least two connector blocks within the plurality of connector-contact assemblies have connector block axes misaligned with respect to each other (receiving elements 400a and 400b each include a plurality of connector contact assemblies 302 and because receiving elements 400a and 400b have axes misaligned with respect to each other, their respective connector contact assemblies likewise have axes misaligned with respect to each other); and the combination of the connector block and the spring for each of the plurality of plurality of connector-contact assemblies are configured to allow movement of the spring in the expanded state within the open center portion of the connector block when the spring is retained between the first flange and the second flange such that a spring axis align with a center axis of the proximal end of the lead or the lead extension (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly. Flexing the leaf spring portions 602 causes the contact 504 to exert pressure against the protruding rims 704.”, paragraph [0036]).
Regarding claim 17, Sharma discloses a medical device, comprising: a control module 101 configured to be electrically connected to a lead 200 (“For example, the conductor assembly 200 can be integral with any of the signal delivery devices 110 described above, e.g., the leads 111.”, paragraph [0024]), the lead including: a lead body with a proximal portion, a distal portion, and a longitudinal length (see Figure 2), a plurality of electrodes disposed along the distal portion of the lead body (“the lead or leads 111 can include one or more electrodes or electrical contacts that direct electrical signals into the patient's tissue”, paragraph [0018]), a plurality of terminals 202a-h disposed along the proximal portion of the lead body (see Figure 2), and a plurality of lead conductors 204a-h electrically coupling the plurality of electrodes to the plurality of terminals (“In such an embodiment, the wires 204 electrically connect individual conductors 202 to corresponding electrodes carried by the lead 111.”, paragraph [0024]); the control module including: a housing (see Figure 4); an electronic subassembly disposed in the housing; an elongated connector housing having a first end and an opposing second end (header portion of device 101 shown in Figure 4); a connector lumen 412a/b defined in the connector housing, the connector lumen configured and arranged to receive the proximal end of the lead or the lead extension (“The first receiving element 400a further includes a first receiving cavity 412a, and a first receiving block 406a having a first opening 408a, each of which functions in a manner generally similar to those described above with reference to FIGS. 2 and 3. Similar to the first receiving element 400a, the second receiving element 400b includes a second receiving cavity 412b and a second receiving block 406b having a second opening 408b.”, paragraph [0029]); and a plurality of similar connector-contact assemblies 302, each of the plurality including: a connector block 502/702 configured to receive and retain a conductive spring 504 within an interior of the connector block to form the contact connector (“contact assembly 302 having a ring-shaped or annular housing 502, a contact 504”, paragraph [0030], “FIG. 7 is an isometric view of a contact assembly 700 having a housing 702”, paragraph [0035] and Figures 5, 7, and 8), wherein a combination of the connector block and the spring are configured to receive a proximal end of the medical lead or a proximal end of the lead extension when the proximal end is inserted through the combination (“As described above, the contact assemblies 302 of FIGS. 3 and 4 can be configured to engage the conductors 202 of the conductor assembly 200 (FIG. 2)”, paragraph [0030], and “When a conductor 202 (FIG. 2) is inserted into the contact assembly 700”, paraqgraph [0036]); the connector block having an open center portion 508/706, and further having a first end, an opposing second end, a longitudinal length extending between the first end and the second end, an outer surface, and an inner surface forming a perimeter of the open center portion of the connector block (see Figures 5 and 7), the connector block further including a first flange at the first end and a second flange at the second end, wherein the first and second flanges extend inward from the inner surface of the connector block (“contact assembly 700 having a housing 702 with inwardly protruding rims 704 (identified individually as a first protruding rim 704a and a second protruding rim 704b) configured in accordance with a further embodiment of the present technology. The protruding rims 704 extend toward the center of an opening 706 in the housing 702 and can contain, capture or hold the contact 504 within the housing”, paragraph [0035]); and the spring 504 being formed from a material with shape-memory (“The contact 504 can be fabricated (e.g., by casting, stamping or other suitable processes) from a variety of metals or metal alloys. For example, in some embodiments, the contact 504 includes MP35N, stainless steel, titanium and/or a platinum/iridium alloy such as 80/20 or 90/10 Pt/Ir.”, paragraph [0033]), the spring being configured to be compressed for insertion through one of the first flange or the second flange, and to at least partially expand into an expanded state such that the spring is retained between the first flange and the second flange within the open center portion of the connector block (“The spring 524may be compressed, due to the shape memory of the material and the gap 538 which closes under compression, and then positioned with the cavity or open center portion 525 of the connector block 523. Assembling the connector contact assembly may include applying a compressive force to the spring 524 to reduce a spring size to a compressed size, inserting the spring 524 having the compressed size through an opening in one of the flanges 531, 532 so that the spring is with the interior of the connector block, and removing the compressive force, allowing the spring 524 to expand from the compressed shape to at least a partially expanded shape larger than the opening such that the spring 524 is retained within the interior of the connector block 523.”, paragraph [0035]), the spring having a biasing structure configured to physically contact the lead contact when the proximal end is inserted into a final position within the connector contact assembly (“When a conductor 202 (FIG. 2) is inserted into the contact assembly 700, the leaf spring portions 602 flex outwardly.”, paragraph [0036]). It is respectfully submitted that contact 504 of Sharma is considered to be “formed from a material with shape-memory” because it is described as being compressed during insertion and expanding after insertion (“The contact 504 can be compressed, making the diameter 610 at the rings 604 smaller than a diameter 802 of the opening 706 at the protruding rims 704. In this manner, the contact 504 can be inserted into the housing 702 from either above or below. For example, while compressed, the contact 504 can be pushed into the opening 706 from above until both rings 604 are past the protruding rim 704a. The contact 504 subsequently expands”, paragraph [0035]), which follows the same definition of shape memory material as described at paragraph [0061] of Applicant’s specification (“The spring 524may be compressed, due to the shape memory of the material and the gap 538 which closes under compression, and then positioned with the cavity or open center portion 525 of the connector block 523. Assembling the connector contact assembly may include applying a compressive force to the spring 524 to reduce a spring size to a compressed size, inserting the spring 524 having the compressed size through an opening in one of the flanges 531, 532 so that the spring is with the interior of the connector block, and removing the compressive force, allowing the spring 524 to expand from the compressed shape to at least a partially expanded shape larger than the opening such that the spring 524 is retained within the interior of the connector block 523.”). Furthermore, the material of the spring of Sharma, MP35N, is the same material as the spring of Applicant’s invention, as described in paragraph [0059]).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (U.S. 2013/0116754, cited above). Sharma discloses the invention substantially as claimed, including showing in Figures 6A and 6B illustrations of each of the first and second rims having an angle of rotation that appears greater than 240, 270, and 315 degrees or between 320 to 340 degrees, and the gap having an angle of rotation of less than 120, 90, and 45 degrees or between 20 and 40 degrees, but Sharma fails to describe these angles of rotation, merely showing the spring devices including the gap. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sharma such that each of the first and second rims has an angle of rotation greater than 240, 270, and 315 degrees and between 320 and 340 degrees and the gap has an angle of rotation less than 120, 90, and 45 degrees and between 20 and 40 degrees, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796