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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 23 April 2026. As directed by the amendment: Claims 1 and 2 have been amended, Claim 3 has been cancelled, and Claim 15 has been added. Thus, Claims 1, 2, and 4-15 are presently pending in this application.
The amendments to the Specification (Title) have been reviewed and accepted by the Examiner.
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, 2, and 4-15 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.
Regarding Claim 1, the claim has been amended to recite “wherein the depression structure has a first inner surface, a second inner surface, and an opening, both of the first inner surface and the second inner surface have convex, and a maximum width of the contacting portion is greater than the minimum width of the opening.” However, this limitation is unclear and appears to be missing words. Firstly, “the minimum width” lacks antecedent basis in the claim. Secondly, “both of the first inner surface and the second inner surface have convex” appears to be missing words, and furthermore, it is unclear as to how the surfaces are convex (i.e., with respect to which direction).
For purposes of examination, the Examiner is interpreting this limitation as “wherein the depression structure has a first inner surface, a second inner surface, and an opening, wherein both of the first inner surface and the second inner surface have convex shapes with respect to a longitudinal axis, and a maximum width of the contacting portion is greater than a minimum width of the opening.”
Claims 2 and 4-15 are rejected for depending on Claim 1. Appropriate correction or clarification is required.
Regarding Claim 15, the claim recites “wherein when the rotating member is fixed at a close position, the contacting portion with the maximum width passes through the minimum width of the opening.” However, this limitation is unclear, and appears to be missing words. Furthermore, it is unclear as to what is intended by the limitation “fixed at a close position”, and how a static position (i.e. a fixed or closed position) can also have elements “passing through” one another (i.e., an active step). Therefore, these limitations are indefinite. As best understood by the Examiner, this limitation will be interpreted as “wherein the anchor is configured such that while the rotating member is rotating to a closed position to compress the lead, the contacting portion passes through the minimum width of the opening.” Appropriate correction or clarification is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lubenow et al. (US Publication No. 2008/0196939, previously cited) in view of Jones et al. (US Patent No. 8,140,172, previously cited as pertinent prior art).
Regarding Claims 1 and 2, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, comprising:
a protecting member (body 22, 23, 23a, Figs. 1-3; see annotated Figs. 2-3 below), having an accommodating slot (recess 60 and connected channel 24, Figs. 1-3, see annotated Figs. 2-3 below), a first through hole (24a, Figs. 1-3), and a second through hole (24b, Figs. 1-3), wherein the accommodating slot is disposed between the first through hole and the second through hole (see annotated Figs. 2-3 below; Paragraph 0035, 0050), and the accommodating slot (recess 60 and connected channel 24, Figs. 1-3, see annotated Figs. 2-3 below) is in communication with the first through hole and the second through hole (see annotated Figs. 2-3 below; Paragraph 0035, 0039, 0050);
a fixed member (inner perimeter section/walls of recess 60 and channel 24 which accommodate the rotating member/arm 52, pivot structures 54/58, and latch structures 70/72; see annotated Figs. 2-3 below), disposed in the accommodating slot (recess 60 and connected channel 24, Figs. 1-3, see annotated Figs. 2-3 below) and having a depression structure (inner walls of channel 24, recess 60, and connected latch depression structure 68/74; see annotated Figs. 2-3 below; Paragraph 0045-0050);
and a rotating member (arm 52/66, Figs. 1-3, see annotated Figs. 2-3 below; Paragraph 0039, 0045, 0047, 0050), comprising a contacting portion (protrusions 84 with surface 82, Figs. 1-3, 11; Paragraph 0050-0051) and pivotally connected to the fixed member (inner perimeter section/walls of recess 60 and channel 24 which accommodate the rotating member/arm 52, pivot structures 54/58, and latch structures 70/72; see annotated Figs. 2-3 below),
wherein when the lead (lead 30, Figs. 1-3) passes through the first through hole, the depression structure, and the second through hole (Paragraph 0035, 0050; see annotated Figs. 2-3 below), the rotating member (arm 52/66, Figs. 1-3, see annotated Figs. 2-3 below; Paragraph 0039, 0045, 0047, 0050) is enabled to rotate relative to the fixed member (Paragraph 0045, 0047, 0049; see annotated Figs. 2-3 below) to let the contacting portion (protrusions 84 with surface 82, Figs. 1-3, 11; Paragraph 0050-0051) be accommodated in the depression structure and compress the lead (Paragraph 0050-0051; “the arm 52 applies a force to the lead cable 30 sufficient to retain the lead cable 30 in position, yet insufficient to damage the lead cable 30”, Paragraph 0051).
Lubenow et al. further discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the depression structure (inner walls of channel 24, recess 60, and connected latch depression structure 68/74; see annotated Figs. 2-3 below; Paragraph 0045-0050) has a first inner surface, a second inner surface (opposite the first inner surface as indicated by the arrow within the depression structure), and an opening (see annotated Fig. 10 below), the first inner surface faces the second inner surface (see annotated Fig. 10 below), and a width of the opening is less than a maximum distance between the first inner surface and the second inner surface (see annotated Fig. 10 below), and wherein a maximum width of the contacting portion is greater than the width of the opening (see annotated Fig. 10 below).
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However, Lubenow et al. does not explicitly disclose wherein the depression structure has a first inner surface, a second inner surface, and an opening, such that both of the first inner surface and the second inner surface have convex, and a maximum width of the contacting portion is greater than the minimum width of the opening.
Jones et al. teaches an anchor for a lead (Abstract; Col. 2, Lines 9-40) comprising a protecting member including a fixed member with a depression structure (see annotated Figs. 3a and 3b below) which receives a rotating member locking structure (Figs. 1a-b, 2-3; Abstract; Col. 2, Lines 9-40; Col. 4, Line 65-Col. 5, Line 50), wherein the depression structure has a first inner surface, a second inner surface, and an opening (see annotated Figs. 3a and 3b below), such that both of the first inner surface and the second inner surface have convex (convex shapes, see annotated Figs. 3a and 3b below), and a maximum width of the contacting portion is greater than the minimum width of the opening (see annotated Figs. 3a and 3b below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first inner surface and the second inner surface be convex, and to configure a maximum width of the contacting portion to be greater than the minimum width of the opening, as taught by Jones et al., in the lead anchor taught by Lubenow et al., in order to enable the lead to be securely “locked” in the anchor (see Jones et al., Col. 4, Line 65 – Col. 5, Line 45), and since such a modification would have involved a mere change in the form or shape of a component (e.g. the shape of the first and second surfaces, and the shape of the opening/contacting portion). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claim 4, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the depression structure (inner walls of channel 24, recess 60, and connected latch depression structure 68/74; see annotated Figs. 2-3 above; Paragraph 0045-0050) has a bottom surface (bottom surface of walls of channel 24/recess 60/connected latch depression structure 68/74; see annotated Figs. 2-3 above; Paragraph 0045-0050) and when the rotating member (arm 52/66, Figs. 1-3, see annotated Figs. 2-3 above; Paragraph 0039, 0045, 0047, 0050) is at a closed angle (closed in Fig. 3), a distance between the contacting portion (protrusions 84, Figs. 1-3, 11; Paragraph 0050-0051) and the bottom surface is less than a diameter of the lead (bottom of contacting protrusions 84 are at the bottom of lead anchor when pivot arm is closed, therefore a small/minimal distance between bottom surface of depression structure [therefore substantially less than lead width], see Figs. 2-3 and 10 above).
Regarding Claim 5, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the fixed member has a base, a first lateral wall, and a second lateral wall (see annotated Fig. 10 below, with a base, a first lateral wall, and a second lateral wall), the first lateral wall and the second lateral wall are adjacent to the base (see annotated Fig. 10 below), and the depression structure is formed between the first lateral wall and the second lateral wall (see annotated Fig. 10 below).
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Lubenow et al. further discloses, “The pin, arm, and body may likewise be made of any appropriate material, including polymeric materials, metallic material, such as titanium, or the like. Further, the components may be formed of one material and coated with a second, as, for example, when the body comprises a base formed of a first, relatively hard material, with an overcoat formed of a second, relatively soft material, such as urethane or silicone. In this way, the anchoring assembly 20 may allow for some degree of stress-form flexion to be absorbed.” (Lubenow et al., Paragraph 0044). However, Lubenow et al. does not explicitly disclose wherein the first lateral wall and the second lateral wall are elastic.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first lateral wall and the second lateral wall from elastic materials, since Lubenow et al. does disclose components made from “polymeric materials” and “relatively soft material, such as urethane or silicone”, in order for “some degree of stress-form flexion to be absorbed” (Lubenow et al., Paragraph 0044), which may reduce pain/pressure of the lead, and to prevent breakage, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding Claim 6, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the fixed member further has a pivot portion (pivot section structures including bore 56/protrusion 62, see annotated Fig. 10 above), the pivot portion is connected to the base (all structures are connected, see annotated Fig. 10 above), and a hinge (hinge pin 54, 64, see annotated Fig. 10 above; Paragraph 0039-0044) is pivotally connected to the pivot portion and the rotating member (see annotated Fig. 10 above; Paragraph 0039-0044), wherein a gap is formed between the pivot portion and the first lateral wall, and an additional gap is formed between the pivot portion and the second lateral wall (gaps between pivot elements and lateral walls, see Fig. 10 annotated above, see also gaps in Fig. 3).
Regarding Claim 7, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the fixed member comprises an abutting portion (any portion adjacent to the first later wall may be considered ‘abutting portion’, e.g. intersecting walls/surfaces, see Figs. 2-3 and 10 annotated above), adjacent to the first lateral wall (see annotated Fig. 10 above) and having an abutting surface (any portion adjacent to the first later wall may be considered ‘abutting portion’ with surfaces, e.g. intersecting walls/surfaces, see Figs. 2-3 and 10 annotated above), wherein an angle is formed between the first lateral wall and the abutting surface (any connection angle would be considered “an angle”, including an angle of 0 degrees – 180 degrees).
Regarding Claim 8, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, including the protecting member (body 22, 23, 23a, Figs. 1-3; see annotated Figs. 2-3, 10 above) and the abutting surface (any portion adjacent to the first later wall may be considered ‘abutting portion’ with surfaces, e.g. intersecting walls/surfaces, see Figs. 2-3 and 10 annotated above). However, Lubenow et al. doesn’t explicitly disclose wherein the protecting member and the abutting surface are separable.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the protecting member and the abutting surface to be separable, such as for ease in manufacturing or installing the lead anchor, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 9, Lubenow et al. further discloses, “ A typical lead cable 30 preferably has a circular outer diameter OD of about 1.35 mm (0.053 inch); although, it will be appreciated that the lead anchor 20 of the present invention may be sized to accommodate lead cables or tubes having diameters that are either smaller or larger than this” (Paragraph 0037) and that the lead transverses the first and second through holes in that “the lead cable 30 may be inserted into the inlet 24a, through the channel 24, and out of the outlet 24b” (Paragraph 0050). However, Lubenow et al. does not explicitly disclose wherein a diameter of the first through hole is greater than a diameter of the lead, and a diameter of the second through hole is greater than the diameter of the lead.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first and second through holes to be greater in diameter than that of the lead, in order to allow for the lead to easily/smoothly transverse the through holes, since such a modification would have involved a mere change in the size of a component (e.g. configuring the lead to be smaller, or the through holes to be larger). A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding Claim 10, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the protecting member (body 22, 23, 23a, Figs. 1-3; see annotated Figs. 2-3 above) has an outer surface (e.g. top surface 23a, Figs. 1-3), and when the rotating member is at a closed angle (see closed arm 52/66, Figs. 1, 3; Paragraph 0039, 0045, 0047, 0050), the rotating member does not protrude from the outer surface (see Figs. 1 and 3 with closed arm 52/66, which is flush with top surface 23a).
Regarding Claim 11, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the protecting member (body 22, 23, 23a, Figs. 1-3; see annotated Figs. 2-3 above) has an outer surface (outer surfaces 23, e.g. top surface 23a; Fig. 1-3), and a plurality of notches (suture bores/wells, 90, 92, 94, 96; see Figs. 1-3) parallel to each other are formed on the outer surface (Paragraph 0052-0053).
Regarding Claim 12, Lubenow et al. further discloses that any of the components of the lead anchor structure may comprise hard/soft materials in that, “The pin, arm, and body may likewise be made of any appropriate material, including polymeric materials, metallic material, such as titanium, or the like. Further, the components may be formed of one material and coated with a second, as, for example, when the body comprises a base formed of a first, relatively hard material, with an overcoat formed of a second, relatively soft material, such as urethane or silicone. In this way, the anchoring assembly 20 may allow for some degree of stress-form flexion to be absorbed, which may potentially produce less pain upon palpation or pressure” (Paragraph 0044). However, Lubenow et al. does not explicitly disclose wherein a hardness of the protecting member is less than a hardness of the fixed member.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the materials of any of the lead structures disclosed by Lubenow et al. to be harder/softer than other elements, in order for “some degree of stress-form flexion to be absorbed” (Lubenow et al., Paragraph 0044), which may reduce pain/pressure of the lead, and to prevent breakage, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding Claim 13, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein the anchor further comprises a hinge (hinge structure 54, 64, 56, 62, Figs. 3, 10; Paragraph 0039-0044), pivotally connected to the fixed member and the rotating member (see Figs. 2-3, 10 annotated above; Paragraph 0039-0044).
Regarding Claim 14, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein when the rotating member is in an opened angle relative to the fixed member (rotating member in open position, see Fig. 2 annotated above), at least a portion of the contacting portion (protrusions 84 with surface 82, Figs. 1-3, 11; Paragraph 0050-0051) is disposed outside the depression structure (see Fig. 2 annotated above), wherein when the rotating member rotates from the opened angle to a closed angle (rotating member in closed position, see Fig. 3 annotated above), the contacting portion is accommodated in the depression structure (see Fig. 3 annotated above).
Regarding Claim 15, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein when the rotating member is fixed at a close position, the contacting portion with the maximum width passes through the minimum width of the opening (limitation unclear, see 35 U.S.C. 112(b) rejection above. As best interpreted by the Examiner, while the rotating member is rotating to a closed position to compress the lead, the contacting portion passes through a minimum width of the opening; see Figs. 2, 3, and 10 annotated above in which the contacting portion passes through the opening).
Response to Arguments
The amendments to the Specification (Title) have been reviewed and accepted by the Examiner, therefore the previous Objections to the Specification as made in the Non-Final Rejection Office Action mailed 02 February 2026 have been withdrawn.
The previous Claim Objections have been withdrawn due to the Applicant’s amendments to Claim 1 correcting the previous issues. However, new 35 U.S.C. 112(b) rejections have been made above due to the amendments to Claim 1 and new Claim 15.
The Applicant's arguments with respect to the previous 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections of Claims 1-14 as filed in the Amendment/Response filed 23 April 2026 have been fully considered by the Examiner. The Applicant argues (Pages 8-11 of Remarks) that the previously cited Lubenow et al. reference fails to disclose all of the claimed elements of Claim 1 as amended, particularly the newly recited limitation “wherein the depression structure has a first inner surface, a second inner surface, and an opening, both of the first inner surface and the second inner surface have convex, and a maximum width of the contacting portion is greater than the minimum width of the opening”.
In response to the Applicant’s arguments (Page 9 of Remarks) that Lubenow et al. fails to disclose a “second inner surface”, the Examiner disagrees with this argument. Lubenow et al. discloses that the depression structure (inner walls of channel 24, recess 60, and connected latch depression structure 68/74; see annotated Figs. 2-3 above; Paragraph 0045-0050) has a first inner surface, a second inner surface (opposite the first inner surface as indicated by the arrow within the depression structure), and an opening (see annotated Fig. 10 below), the first inner surface faces the second inner surface (see annotated Fig. 10 below). Thus the “second inner surface” is the inside surface opposite the first inner surface, as indicated by the arrows.
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Furthermore, new 35 U.S.C. 103 rejections have been made above with respect to Claims 1, 2, and 4-15 with the addition of the Jones et al. reference. As described above, the Examiner agrees that Lubenow et al. does not explicitly disclose wherein the depression structure has a first inner surface, a second inner surface, and an opening, such that both of the first inner surface and the second inner surface have convex, and a maximum width of the contacting portion is greater than the minimum width of the opening.
Jones et al. teaches an anchor for a lead (Abstract; Col. 2, Lines 9-40) comprising a protecting member including a fixed member with a depression structure (see annotated Figs. 3a and 3b below) which receives a rotating member locking structure (Figs. 1a-b, 2-3; Abstract; Col. 2, Lines 9-40; Col. 4, Line 65-Col. 5, Line 50), wherein the depression structure has a first inner surface, a second inner surface, and an opening (see annotated Figs. 3a and 3b below), such that both of the first inner surface and the second inner surface have convex (convex shapes, see annotated Figs. 3a and 3b below), and a maximum width of the contacting portion is greater than the minimum width of the opening (see annotated Figs. 3a and 3b below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first inner surface and the second inner surface be convex, and to configure a maximum width of the contacting portion to be greater than the minimum width of the opening, as taught by Jones et al., in the lead anchor taught by Jones et al., in order to enable the lead to be securely “locked” in the anchor (see Jones et al., Col. 4, Line 65 – Col. 5, Line 45), and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, with respect to new Claim 15, the limitations of this claim are unclear and therefore indefinite. As best interpreted by the Examiner, Lubenow et al. discloses an anchor (20, Fig. 1-3; Paragraph 0035; Abstract) for a lead, further wherein when the rotating member is fixed at a close position, the contacting portion with the maximum width passes through the minimum width of the opening (while the rotating member is rotating to a closed position to compress the lead, the contacting portion passes through a minimum width of the opening; see Figs. 2, 3, and 10 annotated above).
No additional specific arguments were made with respect to the previous 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejections of dependent Claims 2 and 4-14. Therefore, Claims 1, 2, and 4-15 are rejected as described above.
Conclusion
The Applicant's amendments 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 PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 10:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
