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 Arguments
Applicant's arguments filed October 8, 2025 have been fully considered but they are not persuasive in view of the rejection set forth below addressing the amendments to the claims.
In response to applicant’s argument that spring 606 is separate from the plunger 604 and therefore cannot provide support for a resiliently biased material of the plunger 604, according to the interpretation below, the off-set portion comprises a portion of the anchor body that includes both the plunger and the spring (604, 606) and therefore the off-set portion comprises a resiliently biased material of the spring. Therefore, applicant’s arguments are not persuasive.
Applicant’s arguments with respect to claim 22 are also not persuasive in view of the rejection set forth below addressing the newly added claims.
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.
(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.
Claims 2, 3, 6, 8, 10-16, 20-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grigsby et al (US 20140155973).
Regarding claim 2, Grigsby et al (hereafter Grigsby) teaches anchor for securing an elongate device to body tissue, the anchor comprising: an anchor body (600) configured to receive the elongate device and form a tortuous path (figure 19) for engaging the elongate device to resist movement of the elongate device with respect to the anchor body, and wherein the anchor body comprises: a base (602); an off-set portion (604, 606) extending from the base, wherein the off-set portion comprises a resiliently biased material (606) to cause the off-set portion to move away from the base (portion 604 of off-set portion moves away from surface of base); and at least one tissue engagement element (620) configured to assist in attaching the anchor body to the body tissue (paragraph 0053, locking rod assists in advancing the anchor along the lead to a desired placement position, which encompasses ‘assist in attaching the anchor body to the body tissue’).
Regarding claim 3, Grigsby teaches all of the limitations set forth in claim 2, wherein the elongate device comprises a lead (100, it is noted the elongate device is not positively recited).
Regarding claim 6, Grigsby teaches all of the limitations set forth in claim 4, wherein the tortuous path is constructed and arranged to avoid damaging the elongate device (atraumatic resistance, paragraph 0008).
Regarding claim 8, Grigsby teaches all of the limitations set forth in claim 2, wherein the base comprises a first lumen (610) therethrough and the off-set portion comprises a second lumen therethrough (614), wherein the anchor body is configured to transition between an aligned state in which the first and second lumens are aligned (figure 18) and a misaligned state in which the first and second lumens are misaligned (figure 19), and wherein the tortuous path is formed when the anchor body is in the misaligned state (figure 19).
Regarding claim 10, Grigsby teaches all of the limitations set forth in claim 2, wherein the anchor body further comprises one or more of an elastic material or a shape-memory material (spring, 606).
Regarding claim 11, Grigsby teaches all of the limitations set forth in claim 8, wherein the first lumen and the second lumen are constructed and arranged to receive the elongate device when the first lumen and the second lumen are in the aligned state (figure 18).
Regarding claim 12, Grigsby teaches all of the limitations set forth in claim 11, wherein first lumen and the second lumen are configured to transition to the aligned state via a movement of the at least one off-set portion, such that the elongate device can be advanced through the first lumen and the second lumen (figure 18, figure 0053).
Regarding claim 13, Grigsby teaches all of the limitations set forth in claim 12, wherein the first lumen and the second lumen are configured to transition to the misaligned state via a movement of the at least one off-set portion, such that a position of the elongate device is maintained (paragraph 0054, figure 19).
Regarding claim 14, Grigsby teaches all of the limitations set forth in claim 8, wherein the anchor body is configured such that the first lumen and the second lumen are resiliently biased in the misaligned state (relaxed configuration, figure 17).
Regarding claim 15, Grigsby teaches all of the limitations set forth in claim 8, wherein the off-set portion extends upward from the base in an arch shape (See image below).
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Regarding claim 16, Grigsby teaches all of the limitations set forth in claim 8, wherein the at least one off-set portion comprises a first off-set portion (604) comprising the second lumen (614), and a second off-set portion (see image below) comprising a third lumen (616), and wherein in the misaligned state the third lumen (616) is misaligned with the first lumen (614, 616 and 614 are not aligned).
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Regarding claim 20, Grigsby teaches all of the limitations set forth in claim 2, wherein the anchor body further comprises one or both of one or more grooves and/or holes (610) configured to receive a suture to attach the anchor to the body tissue (the limitation “configured to receive a suture to attach the anchor to the body tissue” is a functional limitation which is not given full patentable weight. As long as the prior art meets the structural requirements, holes in which a suture can pass through, and is capable of performing the recited functions, putting a suture through the hole where the lead goes to attach the anchor body to body tissue, the prior art meets the limitations).
Regarding claims 2 and 21, according to another embodiment, Grigsby teaches an anchor for securing an elongate device to body tissue, the anchor comprising: an anchor body (800) configured to receive the elongate device and form a tortuous path (between mating surfaces 806a, 806b) for engaging the elongate device to resist movement of the elongate device with respect to the anchor body, and wherein the anchor body comprises: a base (802b); an off-set portion (804, 802a, 808) extending from the base, wherein the off-set portion comprises a resiliently biased material (flexible implantable material, paragraph 0058) to cause the off-set portion to move away from the base; and at least one tissue engagement element (802a) configured to assist in attaching the anchor body to the body tissue (paragraph 0060, positioning the anchor along the lead and fixedly attaching it thereto helps attach the anchor body to the tissue), wherein the at least one tissue engagement element comprises at least one tissue grabbing jaw (802a).
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Regarding claim 22, Grigsby teaches an anchor for securing an elongate device to body tissue, the anchor comprising: an anchor body (600) configured to receive the elongate device (100) and form a tortuous path (figure 19, paragraph 0054) for engaging the elongate device to resist movement of the elongate device with respect to the anchor body, wherein the anchor body comprises: a base (602); and an off-set portion(604, 606) extending from the base in an arch-shape (604, figure 19, see image above with respect to claim 15), wherein the off-set portion is biased out of alignment with a longitudinal axis of the anchor body (figure 19, paragraph 0053-0054).
Regarding claim 23, Grigsby teaches all of the limitations set forth in claim 22, wherein the base comprises a first lumen (610) therethrough and the off-set portion comprises a second lumen (614) therethrough, wherein the anchor body is configured to transition between an aligned state in which the first and second lumens are aligned (figure 18) and a misaligned state in which the first and second lumens are misaligned (figure 19), and wherein the tortuous path is formed when the anchor body is in the misaligned state (figure 19, paragraph 0054).
Regarding claim 24, Grigsby teaches all of the limitations set forth in claim 23, wherein the first lumen and the second lumen are configured to receive the elongate device when the first lumen and the second lumen are in the aligned state (figure 18, paragraph 0053).
Regarding claim 25, Grigsby teaches all of the limitations set forth in claim 24, wherein the first lumen and the second lumen are configured to transition to the aligned state via a movement of the off-set portion, such that the elongate device can be advanced through the first lumen and the second lumen (paragraph 0053, figure 18).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Grigsby et al (US 20140155973) as applied to claim 16 above.
Regarding claims 18 and 19, Grigsby teaches all of the limitations set forth in claim 8, but does not specifically teach in this embodiment that the first lumen and/or the second lumen comprise a surface modification configured to increase a retention force of the anchor body with the elongate device. However, Grigsby teaches it was known in the art at the time of the invention for the tortuous path to include surface characteristics such as a textured surface, a surface with a high coefficient of friction, and/or a surface with a gripping feature (paragraph 0060) to increase the friction holding the lead. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to further make the first lumen of the embodiment shown in figures 17-19 comprise a surface modification such as a textured surface, a surface with a high coefficient of friction, and/or a surface with a gripping feature, as taught in the embodiment in figures 24A-24Bof Grigsby, in order to increase the friction holding the lead and increase a retention force of the anchor body with the elongate device.
Claims 2, 8, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Grigsby et al (US 20140155973) and further in view of Siegel (US 20060036273).
Regarding claims 2, 8, 16, and 17, according to another embodiment, Grigsby teaches an anchor for securing an elongate device to body tissue, the anchor comprising: an anchor body (900) configured to receive the elongate device and form a tortuous path for engaging the elongate device to resist movement of the elongate device with respect to the anchor body (figures 25-26B), and wherein the anchor body comprises: a base (902b); an off-set portion (902a, 902c) extending from the base; and at least one tissue engagement element (906) configured to assist in attaching the anchor body to the body tissue (paragraph 0065, locking rod assists in advancing the anchor along the lead to a desired placement position, which encompasses ‘assist in attaching the anchor body to the body tissue’), wherein the base comprises a first lumen (902b) therethrough and the off-set portion comprises a second lumen (910a) therethrough, wherein the anchor body is configured to transition between an aligned state (figure 26B) in which the first and second lumens are aligned and a misaligned state (Figure 26A) in which the first and second lumens are misaligned, and wherein the tortuous path is formed when the anchor body is in the misaligned state (path in figure 26A is tortuous), wherein the off-set portion comprises a first off-set portion (902a) comprising the second lumen (910a), wherein the anchor body further comprises and a second off-set portion (902c) comprising a third lumen (910c), and wherein in the misaligned state the third lumen is misaligned with the first lumen (figure 26a), wherein in the aligned state the third lumen is aligned with the first lumen (paragraph 0056, figure 26B). Grisby further discloses that the off-set portion is connected to one another on one edge by a hinge (paragraph 0064, but does not specifically disclose wherein the off-set portion comprises a resiliently biased material to cause the off-set portion to move away from the base. Siegal teaches it was known in the art at the time of the invention for pivotal interconnection regions (70, figure 10C) comprising parallel effective hinge axes comprise a resiliently biased material to allow freedom of pivotal movement between the elements (paragraph 0090, 0091). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the hinge between the off-set and base portions of the device of Grisby to comprise a resiliently biased material to cause the off-set portion to move away from the base, as taught as known by Siegal, 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. In re Leshin, 125 USPQ 416.
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771