DETAILED ACTION
The following Office Action is in response to the Request for Continued Examination filed on February 2, 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 2, 2026 has been entered.
Response to Amendment
Concerning the “Claim Objections” section on page 6 of the Applicant’s Response filed on January 5, 2026, the amendment to claim 1 to address the informality has obviated the necessity of the objection to the claim. Therefore, the objection is withdrawn.
Response to Arguments
Concerning the “§102 Rejections” section on pages 6-7 of the Applicant’s Response filed on January 5, 2026, the applicant’s arguments with regards to the rejection of claim 1 have been fully considered, but they are not persuasive. The applicant argues that the Nageri reference does not teach the limitation of “wherein said opening is connected to said lumen and has a longitudinal axis, wherein said longitudinal axis extends into said lumen”. However, the examiner asserts that the opening (Figure 4A; 418) is perpendicular to the lumen (Figure 4A; 412), wherein given an axis may extend an infinite distance, the longitudinal axis of the opening may extend into the lumen. Furthermore, the reference states that the fastener 446 may be a set screw ([¶ 0063]), wherein a set screw includes a head portion comprising at least one first stop feature having a dimension in a radial direction with respect to said axis which is greater than a diameter of said opening (i.e. Figures 4AB; dotted line of 426 | Figures 6-7; head of fastener 446 | Figure 8A; conical head as in 846). Therefore, the rejections of claim 1 and its dependent claims under 35 U.S.C. §102(a)(1) stand.
With regards to the rejection of claim 15, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Nageri reference does not teach the added limitation of “wherein said at least one threaded opening includes a threaded portion, wherein said threaded portion is positioned between said lumen and said contact structure”. However, the examiner asserts that the threaded opening includes a threaded portion (Figure 4B; distal portion of threaded lumen of 418), wherein said threaded portion is positioned between said lumen (Figure 4B; 412) and said contact surface (Figure 4A; portion of outer surface 410 surrounding opening 418), therein teaching the limitation. Therefore, the rejections of claim 15 and its dependent claims under 35 U.S.C. §102(a)(1) stand.
With regards to the rejection of claim 19, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Nageri reference does not teach the added limitation of “wherein the at least one stop feature of said head portion extends beyond said solid anchor block”. However, the examiner asserts that the head of the fastener (Figure 6 & 7AB; 446) may be defined as the stop feature, which extends beyond said solid anchor block (head of fastener sits above exterior wall of housing), and may further extend beyond said solid anchor block when turned away from the solid anchor block. Therefore, the rejections of claims 19 and 20 under 35 U.S.C. §102(a)(1) stand.
Concerning the “§103 Rejections” section on pages 7-8 of the Applicant’s Response filed on January 5, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the secondary references do not cure the deficiencies of the Nageri reference. However, as discussed above, the Nageri reference has not been found to be deficient in any teachings with regards to the independent claims. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
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.
Claim(s) 1-4, 6-13, and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nageri et al. (US 2015/0045865, hereinafter Nageri).
Concerning claim 1, the Nageri et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figure 6; 600) comprising: a solid anchor block (Figure 4A; 402) having a lumen (Figure 4A; 412) and at least one opening (Figure 4A; 418), wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 3B; 300) and wherein said opening is connected with said lumen and has a longitudinal axis (Figure 4B; 418), wherein said longitudinal axis extends into said lumen (Figure 4B; longitudinal axis of 418 intersects and extends into lumen 412); an anchor body at least partially covering said anchor block (Figure 6; 660); and a fixing element having a fastening portion and a head portion (Figure 6; 446, fastening portion = distal end, head portion = proximal end), wherein said fastening portion is configured to translate along the axis into said opening and towards the lumen to thereby fix the portion of the neuromodulation lead ([¶ 0063-0064]), wherein said head portion comprises at least a first stop feature having a dimension in a radial direction with respect to said axis which is greater than a diameter of said opening ([¶ 0063], fixing element may be a set screw, which includes a head with a diameter greater than an opening | Figure 4AB; dotted line of 446 defines head | also seen in Figures 6 & 7AB; 446).
Concerning claims 2 and 3, the Nageri reference teaches the lead anchor according to claim 1, wherein the head portion comprises at least one second stop feature, wherein said at least one second stop feature is configured to limit the translation of the fixed element against the direction of insertion (Figure 6; the top surface of head portion may be interpreted as the first stop feature and the bottom surface of head portion may be interpreted as the second stop feature), therein defining the at least one stop feature and the at least second stop feature of the fixing element being offset longitudinally along the fixing element.
Concerning claim 4, the Nageri reference teaches the lead anchor according to claim 1, wherein the portion of the neuromodulation lead is at least partially arranged within a sleeve (Figure 4A; 428).
Concerning claim 6, the Nageri reference teaches the lead anchor according to claim 1, wherein the anchor block comprises at least one cap arranged at one end of the lumen and configured to secure the sleeve (Figure 6; 662, 664).
Concerning claim 7-9, the Nageri reference teaches the lead anchor according to claim 1, wherein the anchor block comprises two eyelets, wherein the eyelets are arranged offset (Figure 7A; 770), wherein the eyelets protrude from the anchor body and penetrate the anchor body (Figure 7A; 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 Nageri reference teaches the lead anchor according to claim 1, wherein the anchor block comprises at least one projection (Figure 7A; eyelets 770 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 claims 11 and 12, the Nageri reference teaches the lead anchor according to claim 1, wherein the anchor body may comprise a polymer material ([¶ 0053]).
Concerning claim 13, the Nageri reference teaches the lead anchor according to claim 1, wherein the head portion of the fixing element comprises a tool mount (Figure 8A; 846).
Concerning claim 15, the Nageri et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figure 6; 600) comprising: a solid anchor block (Figure 4A; 402) having a lumen (Figure 4A; 412) and at least one threaded opening (Figure 4A; 418) defining a contact surface (Figure 4A; portion of outer surface 410 surrounding opening 418 = contact surface), wherein said at least one threaded opening includes a threaded portion (Figure 4B; distal portion of threaded opening 418 may be defined as threaded portion), wherein said threaded portion is positioned between said lumen and said contact surface, wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 3B; 300) and wherein said at least one threaded opening is connected with said lumen and has a longitudinal axis (Figure 4B; 418); an anchor body at least partially covering said anchor block (Figure 6; 660); and a fixing element having a fastening portion and a head portion (Figure 4B; 446, fastening portion = distal end, head portion = proximal end), wherein said fastening portion is configured to be threadably inserted along the axis into said threaded opening to thereby fix the portion of the neuromodulation lead ([¶ 0057]), wherein said head portion comprises at least one first stop configured to contact the contact surface to thereby limit threaded insertion of said fastening portion along the axis (Figure 6; bottom surface of head of 446).
Concerning claim 16, the Nageri reference teaches the lead anchor of claim 15, comprising an eyelet (Figure 7A; 770) and a groove (Figure 7A; 790), wherein the eyelet defines at least a portion of the groove.
Concerning claim 17, the Nageri reference teaches the lead anchor of claim 16, wherein the anchor block comprises a row of two projections (Figure 7A; 770), wherein the row of two projections is configured to guide a suture between the two projections of the row of two projections (Figure 7A; two sides of the eyelet may define a row of two projections, wherein a suture may be guided through said two sides of eyelet).
Concerning claim 18, the Nageri reference teaches the lead anchor of claim 17, wherein each projection of the row of two projections are positioned on opposing sides of the groove from one another (Figure 7A; 790).
Concerning claim 19, the Nageri et al. prior art reference teaches a lead anchor for a neuromodulation lead (Figure 6; 600) comprising: a solid anchor block (Figure 4A; 402) having a lumen (Figure 4A; 412) and at least one opening (Figure 4A; 418), wherein said lumen is configured to receive a portion of the neuromodulation lead (Figure 3B; 300) and wherein said opening is connected with said lumen and has a longitudinal axis (Figure 4B; 418); an anchor body at least partially covering said anchor block (Figure 6; 660); and a fixing element having a fastening portion and a head portion (Figure 4B; 446, fastening portion = distal end, head portion = proximal end), wherein said head portion comprises at least a first stop feature having a dimension in a radial direction with respect to said axis which is greater than a diameter of said opening ([¶ 0063], fixing element may be a set screw, which includes a head with a diameter greater than an opening | Figure 4AB; dotted line of 446 defines head | also seen in Figures 6 & 7AB; 446), wherein the at least one stop feature of said head portion extends beyond said solid anchor block (Figures 6 & 7AB; head of fastener 446 sits above exterior wall of housing and may further extend beyond said solid anchor block when turned away from the solid anchor block).
Concerning claim 20, the Nageri reference teaches the lead anchor of claim 19, wherein the head portion is configured to contact each of the solid anchor block and the anchor body (Figure 7AB; 446).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nageri et al. (US 2015/0045865, hereinafter Nageri) in view of Nguyen-Stella et al. (US 2010/0274336, hereinafter Nguyen-Stella).
Concerning claim 5, the Nageri reference teaches the lead anchor according to claim 4, but it silent as to whether the sleeve is permanently fixed within said lumen of said anchor block.
However, the Nguyen-Stella reference teaches a lead anchor similar to that of the Nageri reference, wherein the lead anchor includes a solid anchor block (Figure 6; 601) having a lumen wherein said lumen is configured to receive a portion of a neuromodulation lead (Figure 7; 640) and an anchor body at least partially covering said anchor block (Figure 6; 610), wherein the portion of the neuromodulation lead is at least partially arranged within a sleeve (Figure 7; 630), wherein the reference states that said sleeve may in an alternative embodiment be removable and placed around the lead before it is inserted into the lead anchor (Nguyen-Stella; [¶ 0056]), therein also teaching an alternative embodiment of the sleeve being permanently fixed within said lumen of said anchor block.
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 sleeve of the Nageri reference be permanently fixed within said lumen of said anchor block as a known alternative to having the sleeve be removable from said anchor block (Nguyen-Stella; [¶ 0056]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nageri et al. (US 2015/0045865, hereinafter Nageri) in view of Govea et al. (US 2015/0066121, hereinafter Govea).
Concerning claim 14, the Nageri reference teaches a method of manufacturing the lead anchor according to claim 1, wherein the method comprises the following steps: providing the anchor block with the at least one opening (Figure 4A; 410), inserting the fixing element with its fastening portion into the opening (Figure 4A; 446), and attaching an anchor body while leaving at least the head portion of the fixing element partially exposed (Figure 7A; 446), 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 Nageri reference 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
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 3/16/2026