DETAILED ACTION
The following Office Action is in response to the Amendment filed on June 12, 2026. Claims 1-20 are currently pending.
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 .
Response to Arguments
Concerning the “§102 Rejections” section on pages 6-7 of the Applicant’s Response filed on June 12, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “§103 Rejections” section on pages 7-8 of the Applicant’s Response filed on June 12, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
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) 1-13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 2013/0204336, hereinafter Sharma) in view of Meyer et al. (US 2021/0330961, hereinafter Meyer).
Concerning claim 1, the Sharma et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figures 6A-E; 650) comprising: a solid anchor block (Figure 2A; 260) having a lumen (Figure 2B; 258) and at least one opening having a maximum opening diameter (Figure 2B; 266), wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 2B; 111) and wherein said at least one opening is connected with said lumen and has a longitudinal axis (Figure 2B; longitudinal axis defined by dotted line defining 266); an anchor body at least partially covering said solid anchor block (Figure 2A; 250); and a fixing element (Figure 2B; 264) having a fastening portion (Figure 2B; threaded body of 264) and a head portion (Figure 2B; head portion of 264), wherein said fastening portion is configured to be inserted along the axis into said opening to fix the portion of the neuromodulation lead ([¶ 0041]), wherein said head portion comprises an enlarged head portion (Figure 2B; flange of set screw 264).
Although the Sharma reference does not provide specific details with regards to the structure of the set screw which provides the clamping mechanism for the anchor system, it includes a head having a larger diameter than the threaded fastening portion. Additionally, the Meyer reference teaches a lead connection system, therein being in the same field of endeavor as the Sharma reference, wherein said lead connection system also includes a set screw (Figure 5; 46), wherein the Meyer reference teaches that said set screw may include a stop feature having a dimension in a radial direction with respect to a longitudinal axis which is greater than the maximum opening diameter of said at least one opening (Meyer; Figure 5; 50 | [¶ 0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the set screw of the Sharma reference include the stop feature of the Meyer reference to allow the set screw to only be advanced to a predetermined position and to further allow for an O-ring to be included around the set screw to provide a seal around the set screw to prevent tissue ingrowth into the set screw bore (Meyer; [¶ 0040]).
Concerning claim 2, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein Meyer reference further teaches at least one second stop feature (Figure 5; O-ring 49 may be interpreted as a second stop feature), wherein said at least one second stop feature is configured to limit translation of the fixing element against a direction of insertion (the friction of the o-ring may limit translation).
Concerning claim 3, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein Meyer reference further teaches the at least one first stop feature and the at least one second stop feature of the fixing element being offset longitudinally along the fixing element (Figure 5; 49, 50).
Concerning claim 4, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches a portion of the neuromodulation lead being at least partially arranged within a sleeve (Figure 2B; 263).
Concerning claim 5, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 4, wherein the sleeve is fixed within the solid anchor block and may be permanently fixed if the user decides to never remove it.
Concerning claim 6, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the solid anchor block comprising at least one cap (Figure 6B; 252, 254, 256) arranged at one end of said lumen and capable of securing a sleeve.
Concerning claims 7-9, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the solid anchor block comprising two eyelets, wherein the eyelets are arranged offset (Figure 6E; 657ab), wherein the eyelets protrude from the anchor body and penetrate the anchor body (Figure 6E; the eyelets extend away from the anchor body, therein protruding, and additionally comprise grooves that are recessed into the anchor body, therein penetrating the anchor body).
Concerning claim 10, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the solid anchor block comprising at least one projection (Figure 6E; eyelets 657ab may be interpreted as projections that are part of the anchor block), wherein suture material is capable of being positioned at least partially around the at least one projection when the lead anchor is sutured (suture material may be inserted through eyelets to suture the lead anchor).
Concerning claim 11, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the solid anchor block comprising a polymer material ([¶ 0052]).
Concerning claim 12, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the anchor body comprising a polymer material ([¶ 0038]).
Concerning claim 13, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Meyer reference further teaches the head portion of the fixing element comprising a tool mount (Meyer; Figure 5; hex key aperture of set screw 46).
Concerning claim 15, the Sharma et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figures 6A-E; 650) comprising: a solid anchor block (Figure 2A; 260) having a lumen (Figure 2B; 258) and at least one threaded opening (Figure 2B; 266), wherein said at least one threaded opening includes a threaded portion (Figure 2B; 266b), wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 2B; 111) and wherein said at least one threaded opening is connected with said lumen and has a longitudinal axis (Figure 2B; longitudinal axis defined by dotted line defining 266); an anchor body at least partially covering said anchor block (Figure 2A; 250); and a fixing element (Figure 2B; 264) having a fastening portion (Figure 2B; threaded body of 264) and a head portion (Figure 2B; head portion of 264), wherein said fastening portion is configured to be inserted along the axis into said at least one threaded opening to fix the portion of the neuromodulation lead ([¶ 0041]), wherein said head portion comprises an enlarged head portion (Figure 2B; flange of set screw 264).
Although the Sharma reference does not provide specific details with regards to the structure of the set screw or planar contact surface of the threaded opening which provides the clamping mechanism for the anchor system, it includes a head having a larger diameter than the threaded fastening portion. Additionally, the Meyer reference teaches a lead connection system, therein being in the same field of endeavor as the Sharma reference, wherein said lead connection system also includes a set screw (Figure 5; 46) and a threaded opening defining a planar contact surface (Figure 5; 48), wherein the Meyer reference teaches that said set screw may include a stop feature configured to contact the planar contact surface to thereby limit threaded insertion of said fastening portion along the longitudinal axis (Meyer; Figure 5; 50 | [¶ 0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the set screw of the Sharma reference include the stop feature of the Meyer reference to allow the set screw to only be advanced to a predetermined position and to further allow for an O-ring to be included around the set screw to provide a seal around the set screw to prevent tissue ingrowth into the set screw bore (Meyer; [¶ 0040]).
Concerning claim 16, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 15, wherein the Sharma reference further teaches an eyelet and a groove, wherein the eyelet defines at least a portion of the groove (Figure 2A; 259).
Concerning claims 17 and 18, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Sharma reference further teaches the solid anchor block comprising a row of two projections (Figure 2A; wall portions of eyelet 259 may be interpreted as projections arranged in a row that are part of the anchor block), wherein the row of two projections is configured to guide a suture between the two projections of the row of two projections (suture material may be inserted through eyelets to suture the lead anchor), wherein each projection of the row of two projections are positioned on opposing sides of the groove from one another.
Concerning claim 19, the Sharma et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figures 6A-E; 650) comprising: a solid anchor block (Figure 2A; 260) having a lumen (Figure 2B; 258) and at least one opening having a maximum opening diameter (Figure 2B; 266), wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 2B; 111) and wherein said at least one opening is connected with said lumen and has a longitudinal axis (Figure 2B; longitudinal axis defined by dotted line defining 266); an anchor body at least partially covering said anchor block (Figure 2A; 250); and a fixing element (Figure 2B; 264) having a fastening portion (Figure 2B; threaded body of 264) and a head portion (Figure 2B; head portion of 264), wherein said fastening portion is configured to be inserted along the axis into said opening to fix the portion of the neuromodulation lead ([¶ 0041]), wherein said head portion comprises an enlarged head portion (Figure 2B; flange of set screw 264).
Although the Sharma reference does not provide specific details with regards to the structure of the set screw which provides the clamping mechanism for the anchor system, it includes a head having a larger diameter than the threaded fastening portion. Additionally, the Meyer reference teaches a lead connection system, therein being in the same field of endeavor as the Sharma reference, wherein said lead connection system also includes a set screw (Figure 5; 46), wherein the Meyer reference teaches that said set screw may include a stop feature having a dimension in a radial direction with respect to a longitudinal axis which is greater than the maximum opening diameter of said at least one opening (Meyer; Figure 5; 50 | [¶ 0040]), and wherein a stop feature of said head portion extends beyond said solid anchor block (Figure 5; top of head portion of set screw 50.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the set screw of the Sharma reference include the stop feature of the Meyer reference to allow the set screw to only be advanced to a predetermined position and to further allow for an O-ring to be included around the set screw to provide a seal around the set screw to prevent tissue ingrowth into the set screw bore (Meyer; [¶ 0040]).
Concerning claim 20, the combination of the Sharma and Meyer references as discussed above teaches the lead anchor according to claim 1, wherein the Meyer reference further teaches the head portion being configured to contact each of the solid anchor block and the anchor body (Figure 5; 50).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 2013/0204336, hereinafter Sharma) in view of Meyer et al. (US 5,060,649, hereinafter Meyer) as applied to claims 1-13 and 15-20 above and further in view of Govea et al. (US 2015/0066121, hereinafter Govea).
Concerning claim 14, the combination of the Sharma and Meyer references as discussed above teaches a method of manufacturing the lead anchor according to claim 1, wherein the Sharma reference further teaches the method comprising the following steps: providing the anchor block with the at least one opening (Figure 6A; 660), inserting the fixing element with its fastening portion into the opening (Figure 6B; 662), and attaching an anchor body while leaving at least the head portion of the fixing element partially exposed (Figure 6A; 662), but does not specifically teach the attachment process being accomplished by overmolding.
However, the Govea reference teaches a method of manufacturing a lead anchor, wherein the method includes providing an anchor block (Figure 4B; 412), and overmolding the anchor block thereby creating the anchor body ([¶ 0060]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of manufacturing of the Sharma and Meyer combination include the step of overmolding the anchor block thereby creating the anchor body given the Govea reference teaches overmolding as a method of creating an anchor body and attaching it to an anchor block (Govea; [¶ 0060]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 9/11/2026
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