DETAILED ACTION
This Office Action is in response to the Amendment filed 2 June 2026. Claim(s) 1, 3, 5-12, 21, 23-31 are currently pending. The Examiner acknowledges cancelled claims 2, 4, 13-20, 22 and amended claims 1, 3, 6, 21, 23 and 25.
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 (e.g., ‘pushing tool’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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, 3, 5-12, 21, 23-31 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 lead anchor" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the lead anchor" in line 12. 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.
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). The second diameter is capable of providing a pushing surface sufficient for pushing the lead anchor (Fig. 5; [0028]). Figs. 5 of Bonner show a diameter near reference number (2535; Fig. 5B) that is less than the diameter of the distal end of the inner member (522). A user of Bonner is capable of pushing the lead anchor (1205) by way of pushing (530) toward the tissue, thus resulting in contacting the smaller bore’s pushing surface with the distal end (522) of the inner member having a larger diameter, and subsequently pushing the lead anchor.
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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 discloses the invention as discussed above in claim 1 and further discloses 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 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). Furthermore, it has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. It is further noted that independent claim 1 and independent claim 21 are not directed to a method but rather than a system and kit, respectively. The system of Bonner must only be capable of performing the claimed function even if it was not designed for that particular purpose. Bonner discloses that the device includes a distal-most portion having an outer diameter of approximately 0.8cm (8mm; [0026]) which is larger than an intercostal space between patient ribs which range from between 4mm to 15mm and is dependent on the patient which vary based on individual anatomy, age, and health conditions. Thus, the device of Bonner would be capable of not fitting between patient ribs having an intercostal space less than 8mm.
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 filed 2 June 2026 have been fully considered but they are not persuasive. With respect to independent claims 1 and 21, the Applicant contends, referencing Fig. 5B, that the pushing tool of Bonner does not push anything and is instead pulled backwards to expose device (1200). The Applicant contends that inner member (520) is used to push device (1200) rather than any part of tube (530). The Applicant contends that Bonner’s inner member (520) and distal end (522) do not have a diameter transition that forms a pushing surface. Figs. 5 of Bonner show a diameter near reference number (2535; Fig. 5B) that is less than the diameter of the distal end of the inner member (522). A user of Bonner is capable of pushing the lead anchor (1205) by way of pushing (530) toward the tissue, thus resulting in contacting the smaller bore’s pushing surface with the distal end (522) of the inner member having a larger diameter, and subsequently pushing the lead anchor.
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With respect to claim 5, the Applicant contends that Bonner does not disclose or suggest that the biological tissue is fascia or patient ribs and the outer diameter is sufficiently large to not fit between patient ribs since Bonner’s device is designed for delivery to or abutment with heart tissue rather than with fascia or patient ribs. Respectfully, it has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. It is further noted that independent claim 1 and independent claim 21 are not directed to a method but rather than a system and kit, respectively. The system of Bonner must only be capable of performing the claimed function even if it was not designed for that particular purpose. Bonner discloses that the device includes a distal-most portion having an outer diameter of approximately 0.8cm (8mm; [0026]) which is larger than an intercostal space between patient ribs which range from between 4mm to 15mm and is dependent on the patient which vary based on individual anatomy, age, and health conditions. Thus, the device of Bonner would be capable of not fitting between patient ribs having an intercostal space less than 8mm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schollmeyer et al. (US 5,036,854) discloses a lead insertion tool with first and second bores (Fig. 2) having different diameters which may be capable of providing a pushing surface.
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 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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