DETAILED ACTION
This Office Action is in response to the Amendment filed 17 December 2025. Claim(s) 1-3, 5-12, 21-31 are currently pending. The Examiner acknowledges cancelled claims 4, 13-20 and amended claims 1, 8, 12 and 21.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 17 December 2025 has been entered.
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 .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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.
Claim(s) 1, 2, 6-10 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonner et al. (US 2016/0015968A1, “Bonner”).
Regarding claim 1, Bonner discloses a system including a lead anchor pushing tool (500; [0028]; Fig. 5) with a body having an outer diameter capable of fitting within an incision and abut a biological tissue of a patient (Fig. 5). A bore (535; Fig. 5) at a distal end of the body has a first diameter. A bore (520; Fig. 5) at a proximal end of the body has a second diameter that changes from the first diameter and is coaxial with the first bore. The second diameter is smaller than the first diameter (Fig. 5).
Regarding claim 2, Bonner discloses that the second diameter is capable of providing a pushing surface sufficient for pushing the lead anchor (Fig. 5; [0028]).
Regarding claim 6, Bonner discloses that the anchor pushing tool includes a handle at the distal end of the body, wherein a handle is a portion of the distal end by which an element is held. Thus the handle of the anchor pushing tool is located at the distal end portion of the body in which a user is capable of grabbing, grasping or holding (Fig. 5, see marked up figure below).
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Regarding claims 7-9, 21, 26-28, Bonner a lead anchor delivery tube (see annotated figure below) having a body with an outer diameter and an inner diameter capable of receiving an electrical lead (1210;Fig. 5B). The inner diameter of the lead anchor delivery tube is capable of receiving a lead connector. It is noted that the lead connector is not positively recited.
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Regarding claims 10 and 29, Bonner discloses that the lead anchor delivery tube includes a handle at the distal end of the body, wherein a handle is a portion of the distal end by which an element is held. Thus, the handle of the lead anchor delivery tube is located at the proximal end of the lead anchor delivery tube in which a user is capable of grabbing, grasping or holding (Fig. 5, see annotated figure above).
Regarding claim 22, Bonner discloses that the second diameter is capable of providing a pushing surface sufficient for pushing the lead anchor (Fig. 5; [0028]).
Regarding claim 25, Bonner discloses that the anchor pushing tool includes a handle at the distal end of the body, wherein a handle is a portion of the distal end by which an element is held. Thus the handle of the anchor pushing tool is located at the distal end portion of the body in which a user is capable of grabbing, grasping or holding (Fig. 5, see marked up figure below).
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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.
Claim(s) 3, 5, 23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonner.
Regarding claim 3 and 23, as seen in Bonner (Fig. 5), the first and second diameters of the lead anchor pushing tool are disclosed to be result effective variables in that changing the diameters such that the second diameter is 2mm smaller than the first diameter affects the capability of a lead anchor abutting a proximal portion of the first bore at the distal end of the body which facilitates the ability to push the lead anchor from within the bore. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Bonner to have diameters in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bonner by making the second diameter 2mm smaller than the first diameter as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5 and 24, as seen in Bonner (Fig. 5), the outer diameter of the lead anchor pushing tool is disclosed to be result effective variable in that changing the outer diameter such that the outer diameter does not fit between patient ribs affects the capability of a lead anchor pushing tool of facilitating pushing a lead anchor from within the first bore. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Bonner to have an outer diameter that does not fit between patient ribs in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bonner by making the outer diameter unable to fit between patient ribs as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 12 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonner in view of Juravic et al. (US 2010/0010538A1, “Juravic”).
Regarding claims 12 and 31, Bonner does not disclose a lead anchor delivery tube including hypotubing. In the same field of endeavor, anchor delivery tubes, Juravic teaches a delivery tube (82) coupled to an anchor (10; Fig. 8). The delivery tube may be formed of a hypotube [0064]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the delivery tube of Bonner of hypotube, as taught by Juravic, as this modification involves the simple substitution of one material for another for the predictable result of providing means to deliver an anchor into tissue.
Allowable Subject Matter
Claim(s) 11 and 30 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Perryman et al. (US 2020/0222670A1) discloses a lead anchoring device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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