Detailed Action
This is the final office action for US application number 18/856,570. Claims are evaluated as filed on August 7, 2026.
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 August 7, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Nino, Germain, and Patel teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that 119 is shown in Fig. 2A as designating an abrupt flare of tube 118 which is consistent with paragraph 91’s disclosure that the diameter of tube 118 may decrease abruptly and then continues with a constant diameter (Remarks p. 13-14), Examiner notes that 119 in Fig. 2A points at tube 118 which is shown using what appear to be straight lines indicating the outer wall of the tube and does not show the argued abrupt change. Examiner has provided a copy of the relevant portion of Fig. 2A below that has been enlarged to the maximum ability of office software, but appears to show no indication of an abrupt diameter change as argued at 119.
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Applicant’s arguments with respect to Real 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.
With regards to Applicant’s argument that the mapping of Nino’s gear wheel to elements conflates two structurally and functionally distinct components as sleeve 50 with its forward end 54/55 is the mount that connects 100 and is where the alleged latch/catch resides as disclosed in ¶s 36, 40, but nut 30 is a separate component that translates along the threaded neck 20 and thus does not read on limitations of claim 80 that provide that the gear wheel is mechanically coupled to the threaded proximal portion and able to translate along the threaded portion and comprises the annular flange, etc. as sleeve 50 does not translate along a threaded portion and nut 30 does not carry detent elements (Remarks p. 16-17), Examiner notes as an initial matter that it is not simply alleged that the sleeve is mounted on 100 and that is where the latch/catch resides but that paragraph 36 explicitly discloses that “sliding sheath sleeve whereby the threaded internal section slides on top of a cannula mount. Additionally, the mounting may be a latch and catch (not shown) to accomplish a positive lock.” and paragraph 37 provides that “On the cannula mount is a threaded section (not shown) by which the threaded forward end of the sheath sleeve may be positively attached. As previously noted, a slide on fixation is also within the scope of this disclosure as is latch and catch fitting. In some instances the hollow sheath 40 and the sheath sleeve may be combined into a unitary part which both holds the memory aim and blade in a compressed state and has a mount to connect with the cannula. Such a unitary part is within the scope of this disclosure”. It has not been asserted that nut 30 has detent elements and such an argument is therefore moot. Applicant’s assertion that sleeve 50 does not translate along a threaded portion is incorrect and does not appear to be based upon the disclosure of Nino. As detailed in the rejection below and on page 4 of the non-final office action dated May 12, 2026, threaded mount 100 is expressly disclosed to be threaded to gear wheel portion 50/54 in ¶s 36, 37, and 40. That is, paragraph 36 discloses that “At the forward end 54 of the sheath sleeve is a mounting guide which mates with a cannula mount and which may be threaded 55….. The threading 55 is one form of a temporary mount.”, paragraph 37 discloses that “the threaded forward end 54 of the may be fitted into a cannula mount 100. On the cannula mount is a threaded section (not shown) by which the threaded forward end of the sheath sleeve may be positively attached.”, and paragraph 40 discloses that “The cannula mount is a temporary or reversible mount which may be a friction fit, a slide fit, a threaded fit or a latch and catch”.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 101, the specification appears to lack proper antecedent basis for “at least one of a tactile click and an audible click” in lines 3-4 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 as well as “successive clicks at regular intervals” in line 4 that is in addition to the “continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback” of claim 80 lines 30-32 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument” in lines 4-6 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 101. That is, there does not appear to be a disclosure of clicks that are in addition to the feedback nor does there appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, the specification fails to provide proper antecedent basis for “at least one of a tactile click and an audible click” in lines 3-4 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 as well as “successive clicks at regular intervals” in line 4 that is in addition to the “continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback” of claim 80 lines 30-32 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument” in lines 4-6 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37.
As to claim 102, the specification appears to lack proper antecedent basis for “each engagement between a respective one of the plurality of detent elements and the one or more detents corresponds to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” in lines 2-4 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 102 depends. That is, there does not appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, the specification fails to provide proper antecedent basis for “each engagement between a respective one of the plurality of detent elements and the one or more detents corresponds to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” in lines 2-4 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37.
As to claim 108, the specification appears to lack proper antecedent basis for “the threaded proximal portion comprises a multi-start thread” of lines 1-2. That is, the most similar disclosure appears to be limited to “The threads may comprise triple threads” of ¶95. Thus, the specification fails to provide proper antecedent basis for “the threaded proximal portion comprises a multi-start thread” of lines 1-2.
As to claim 108, the specification appears to lack proper antecedent basis for “a plurality of successive feedback events, each comprising at least one of tactile feedback and audible feedback, and advances the access instrument by a predetermined axial increment.” of lines 3-6 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 108 depends. That is, there does not appear to be a disclosure of feedback events comprising at least one of tactile feedback and audible feedback that are in addition to the feedback nor does there appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, the specification fails to provide proper antecedent basis for “a plurality of successive feedback events, each comprising at least one of tactile feedback and audible feedback, and advances the access instrument by a predetermined axial increment.” of lines 3-6 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “119” has been used to designate both an abrupt flare in ¶91 and a portion of tube 118 in Fig. 2a.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the subject matter of claims 101, 102, and 108 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 101, 102, and 108 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 101, “at least one of a tactile click and an audible click” in lines 3-4 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 as well as “successive clicks at regular intervals” in line 4 that is in addition to the “continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback” of claim 80 lines 30-32 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument” in lines 4-6 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 101 depends appears to be new matter. That is, there does not appear to be a disclosure of clicks that are in addition to the feedback nor does there appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, “at least one of a tactile click and an audible click” in lines 3-4 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 as well as “successive clicks at regular intervals” in line 4 that is in addition to the “continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback” of claim 80 lines 30-32 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument” in lines 4-6 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 constitutes new matter.
As to claim 102, “each engagement between a respective one of the plurality of detent elements and the one or more detents corresponds to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” in lines 2-4 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 102 depends appears to be new matter. That is, there does not appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, “each engagement between a respective one of the plurality of detent elements and the one or more detents corresponds to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” in lines 2-4 that is in addition to the “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 constitutes new matter.
As to claim 108, “the threaded proximal portion comprises a multi-start thread” of lines 1-2 appears to be new matter. That is, the most similar disclosure appears to be limited to “The threads may comprise triple threads” of ¶95. Thus, “the threaded proximal portion comprises a multi-start thread” of lines 1-2 constitutes new matter.
As to claim 108, “a plurality of successive feedback events, each comprising at least one of tactile feedback and audible feedback, and advances the access instrument by a predetermined axial increment.” of lines 3-6 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 from which claim 108 depends appears to be new matter. That is, there does not appear to be a disclosure of feedback events comprising at least one of tactile feedback and audible feedback that are in addition to the feedback nor does there appear to be a disclosure of multiple predetermined increments of advancement as claimed. Thus, “a plurality of successive feedback events, each comprising at least one of tactile feedback and audible feedback, and advances the access instrument by a predetermined axial increment.” of lines 3-6 that is in addition to the “at least one of tactile feedback and audible feedback” of claim 80 line 26 and “each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion” of claim 80 lines 33-37 constitutes new matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 100 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Germain (US 2010/0082033).
As to claim 100, Germain discloses a similar bone access system (Figs. 1-7C) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 7A-7C), the system comprising: an introducer cannula (120, 140) comprising a proximal handle (140) and a distal elongate tube (120) extending from the proximal handle (Fig. 4, ¶37); wherein the proximal handle of the introducer cannula comprises a central opening (shown holding 142, 122, and 170 in Fig. 4, Fig. 4) in its upper surface (Fig. 4), wherein the central opening comprises one or more detents (145) projecting radially inward from an inner surface of the central opening (Fig. 4), and wherein the distal elongate tube of the introducer cannula comprises a lumen (shown holding 122 and 170 in Fig. 4, Fig. 4) accessible via the central opening (Fig. 4); and an access instrument (122, 142) capable of being inserted through the central opening and along the lumen of the introducer cannula (Fig. 4) until a distal end portion of the access instrument extends beyond an open distal tip of the introducer cannula (Figs. 6A-7C), wherein the access instrument comprises a gear wheel (outer portion of the lower region of 142 as shown in Fig. 4, Figs. 1 and 4) mechanically coupled to a threaded proximal portion of the access instrument (150, Fig. 4, ¶39) and capable of being translated proximally and distally along the threaded proximal portion via rotation of the gear wheel (Fig. 4, ¶39), wherein the gear wheel comprises an annular flange (as shown below 146 in Fig. 4, Figs. 1 and 4) comprising a plurality of detent elements (146s, Figs. 1 and 4, ¶37) spaced around a circumference of a lower surface of the annular flange (Figs. 1 and 4) capable of mechanically engaging with the one or more detents within the central opening of the proximal handle of the introducer cannula (Figs. 1 and 4, ¶37); wherein engagement of the gear wheel with the introducer cannula defines a longitudinal position of the access instrument within the introducer cannula (Figs. 4-7C, ¶39); and wherein continued rotation of the gear wheel produces successive feedback comprising at least one of tactile feedback and audible feedback via interaction of the plurality of detent elements with the one or more detents (due to the shown structure ratcheting as disclosed in ¶37, Figs. 1 and 4, ¶37, as evidenced by Murphy et al. (US 2021/0153893 protrusion 1016/1004 and recess 1014, Fig. 10, ¶79 discloses that such provides an audible “snap” or click to be heard or felt as 1016 moves in contact with surface 1012 and eventually rests in 1014), each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument (Figs. 1 and 4, ¶37).
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 of this title, 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) 80-85, 100, and 103-107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nino et al. (US 2014/0257302, hereinafter “Nino”) in view of Germain (US 2010/0082033).
As to claims 80-85 and 103-106, Nino discloses a bone access system (Figs. 1-11, ¶45) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 8-11, ¶45), the system comprising: an introducer cannula (101, Figs. 5-11) comprising a proximal handle (102) and a distal elongate tube (103) extending from the proximal handle (Fig. 5, ¶38); wherein the proximal handle of the introducer cannula comprises a central opening (shown holding 50 in Fig. 5, Fig. 5) in its upper surface (right facing surfaces of 102 as shown in Fig. 5, Fig. 5-7B), the central opening comprising an inner surface (Figs. 5-7B), and wherein the distal elongate tube of the introducer cannula comprises a lumen (hollow passage of 103 holding 10 in Figs. 5-11, Figs. 5-11, ¶39) accessible via the central opening of the proximal handle of the introducer cannula (Figs. 5-11, ¶39), the central opening further comprising a threaded mount (100, ¶s 36, 37, and 40) with a latch/catch (¶s 36 and 37 disclose that the cannula mount is threaded and additionally has an unshown a “latch and catch” to accomplish a positive lock); and an access instrument (5) capable of being inserted through the central opening and along the lumen of the introducer cannula (Figs. 5-11, ¶42) until a distal end portion of the access instrument (11, 12, Figs. 3, 7A, 7B, and 9-11) extends beyond an open distal tip of the introducer cannula (104, Figs. 7A, 7B, and 9-11, ¶s 40, 42, 43, 45, and 46), wherein the access instrument comprises an elongate shaft (10, 20) having a threaded proximal portion (20) and a generally smooth distal portion (10) and a gear wheel (50, 40, 30) mechanically coupled to the threaded proximal portion (Figs. 4-7B, ¶s 33, 42, and 43) and capable of being translated proximally and distally along the threaded proximal portion via rotation of the gear wheel (Figs. 4-7B, ¶s 33, 42, and 43), wherein the gear wheel comprises an annular flange (54 of portion 50, 40), and wherein the annular flange comprises a latch/catch (¶s 36 and 37 disclose that annular flange is threaded at 55 to mate with the threaded cannula mount that additionally has an unshown a “latch and catch” to accomplish a positive lock, i.e. with the annular flange) around a lower surface of the annular flange (to engage the cannula, Figs. 5-7B, ¶s 36 and 37) capable of mechanically engaging with the cannula latch/catch within the central opening of the proximal handle of the introducer cannula (Figs. 5-7B, ¶s 36 and 37) so as to provide feedback (visible feedback, Figs. 5-7B) to an operator upon engagement of the access instrument with the introducer cannula (Figs. 5-7B) so as to provide controlled advancement of the access instrument with respect to the introducer cannula (via threads of 25, 30, 50, and 100, Figs. 5-7B, ¶s 33, 36, 37, 40, and 42). As to claim 84, Nino discloses that engagement between the latch/catch of the cannula and the latch/catch of the flange of the gear wheel results in an increase in an amount of torque required to disengage the cannula from the flange of the gear wheel (due to the latch/catch, ¶36 discloses that the latch/catch is to provide a positive lock). As to claim 104, Nino discloses that the increase in the amount of torque required to disengage is sufficient to resist inadvertent movement of the access instrument relative to the introducer cannula during insertion or withdrawal of a further tool through the access instrument (¶36 discloses that the latch/catch is to provide a positive lock).
Nino is silent to details of the disclosed latch/catch with the threaded cannula mount, i.e. the central opening of the proximal handle of the introducer cannula comprises one or more detents projecting radially inward from the inner surface of the central opening and the annular flange comprises a plurality of detent elements spaced around a circumference of the lower surface of the annular flange adapted to mechanically engage with the one or more detents within the central opening of the proximal handle of the introducer cannula so as to provide at least one of tactile feedback and audible feedback to an operator upon engagement of the plurality of detent elements of the access instrument with the one or more detents of the introducer cannula, wherein continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback via interaction of the plurality of detent elements with the one or more detents, each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion. As to claim 81, Nino is silent to the plurality of detent elements of the annular flange comprises notches or recesses. As to claim 82, Nino is silent to the one or more detents comprises protrusions formed along the inner surface of the central opening. As to claim 83, Nino is silent to the one or more detents and the plurality of detent elements produce an audible click upon at least one of engagement and disengagement. As to claim 84, Nino is silent to engagement between the one or more detents and a respective one of the plurality of detent elements results in an increase in an amount of torque required to disengage the one or more detents from the respective one of the plurality of detent elements. As to claim 85, Nino is silent to the plurality of detent elements are uniformly spaced around a circumference of the annular flange of the gear wheel of the access instrument. As to claim 103, Nino is silent to the gear wheel is rotatable freely relative to the introducer cannula until the plurality of detent elements come into an engagement range of the one or more detents. As to claim 105, Nino is silent to each of the plurality of detent elements comprises a shape selected from the group consisting of a triangular shape, a sawtooth shape, and a sinusoidal shape. As to claim 106, Nino is silent to the central opening comprises an abutment member extending radially inward from the inner surface of the central opening and providing an upper surface against which the lower surface of the annular flange is adapted to abut upon advancement of the access instrument, and wherein the one or more detents extend from the abutment member.
Germain teaches a similar bone access system (Figs. 1-7C) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 7A-7C), the system comprising: an introducer cannula (120, 140) comprising a proximal handle (140) and a distal elongate tube (120) extending from the proximal handle (Fig. 4, ¶37); wherein the proximal handle of the introducer cannula comprises a central opening (shown holding 142, 122, and 170 in Fig. 4, Fig. 4) in its upper surface (Fig. 4), wherein the central opening of the proximal handle of the introducer cannula comprises one or more detents (145) projecting radially inward from an inner surface of the central opening (Fig. 4), and wherein the distal elongate tube of the introducer cannula comprises a lumen (shown holding 122 and 170 in Fig. 4, Fig. 4) accessible via the central opening of the proximal handle of the introducer cannula (Fig. 4); and an access instrument (122, 142) capable of being inserted through the central opening and along the lumen of the introducer cannula (Fig. 4) until a distal end portion of the access instrument extends beyond an open distal tip of the introducer cannula (Figs. 6A-7C), wherein the access instrument comprises an elongate shaft (lower portion of 142 as shown in Fig. 4, 122, Fig. 4) having a threaded proximal portion (150, Fig. 4, ¶39) and a gear wheel (outer portion of the lower region of 142 as shown in Fig. 4, Figs. 1 and 4) mechanically coupled to the threaded proximal portion (Fig. 4) and capable of being translated proximally and distally along the threaded proximal portion via rotation of the gear wheel (Fig. 4, ¶39),wherein the gear wheel comprises an annular flange (as shown below 146 in Fig. 4, Figs. 1 and 4), and wherein the annular flange comprises a plurality of detent elements (146s, Figs. 1 and 4, ¶37) spaced around a circumference of a lower surface of the annular flange (Figs. 1 and 4) capable of mechanically engaging with the one or more detents within the central opening of the proximal handle of the introducer cannula (Figs. 1 and 4, ¶37) so as to provide at least one of tactile feedback and audible feedback to an operator upon engagement of the plurality of detent elements of the access instrument with the one or more detents of the introducer cannula (¶37) so as to provide controlled advancement of the access instrument with respect to the introducer cannula (Figs. 1 and 4, ¶37), wherein continued rotation of the gear wheel provides further feedback comprising at least one of tactile feedback and audible feedback via interaction of the plurality of detent elements with the one or more detents (Figs. 1 and 4), each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument along the threaded proximal portion (Figs. 1 and 4, ¶37). As to claim 81, Germain teaches that the plurality of detent elements of the annular flange comprises notches or recesses (Fig. 1). As to claim 82, Germain teaches that the one or more detents comprises protrusions formed along the inner surface of the central opening (Figs. 1 and 4). As to claim 83, Germain teaches that the one or more detents and the plurality of detent elements produce an audible click upon at least one of engagement and disengagement (due to the shown structure ratcheting as disclosed in ¶37, Figs. 1 and 4, as evidenced by Murphy et al. (US 2021/0153893 protrusion 1016/1004 and recess 1014, Fig. 10, ¶79 discloses that such provides an audible “snap” or click to be heard or felt as 1016 moves in contact with surface 1012 and eventually rests in 1014)). As to claim 84, Germain teaches engagement between the one or more detents and a respective one of the plurality of detent elements results in an increase in an amount of torque required to disengage the one or more detents from the respective one of the plurality of detent elements (due to the shown structure ratcheting as disclosed in ¶37, Figs. 1 and 4). As to claim 85, Germain teaches that the plurality of detent elements are uniformly spaced around a circumference of the annular flange of the gear wheel of the access instrument (Fig. 1, ¶37 discloses that such causes locking at a certain degree of rotation). As to claim 103, Germain teaches that the gear wheel is rotatable freely relative to the introducer cannula until the plurality of detent elements come into an engagement range of the one or more detents (Fig. 4, i.e. during insertion of 142 into 140 and prior to engagement with 145). As to claim 104, Germain teaches that the increase in the amount of torque required to disengage is sufficient to resist inadvertent movement of the access instrument relative to the introducer cannula during insertion or withdrawal of a further tool through the access instrument (due to the shown structure ratcheting as disclosed in ¶37, Figs. 1 and 4, ¶37 discloses that such provides a temporary lock in a certain degree of rotation). As to claim 105, Germain teaches that each of the plurality of detent elements comprises a shape selected from the group consisting of a sawtooth shape and a sinusoidal shape (when viewed from above the view of Figs. 1 and 4, Figs. 1 and 4). As to claim 106, Germain teaches that the central opening comprises an abutment member (lower, upward facing surface of the opening as shown in Fig. 4, Fig. 4) extending radially inward from the inner surface of the central opening (Fig. 4) and providing an upper surface against which the lower surface of the annular flange is adapted to abut upon advancement of the access instrument (Fig. 4), and wherein the one or more detents extend from the abutment member (Fig. 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the unshown latch/catch of the cannula mount and the latch/catch of the annular flange of the gear wheel as disclosed by Nino comprise circumferentially spaced and oriented detent recesses and detent protrusions as taught by Germain in order to use a known structure (Germain Figs. 1 and 4, ¶37) to provide a tactile indication and temporary locking in a certain degree of rotation (Germain Figs. 1 and 4, ¶37), where the engagement and disengagement permits ratcheting (rotation and locking) portions (Germain Figs. 1 and 4, ¶37).
As to claim 107, the combination of Nino and Germain discloses the invention of claim 80 as well as the one or more detents (145) being one or more flex tabs (¶37) and the plurality of detent elements/notches being positioned substantially 180 degrees apart (Fig. 4).
The combination of Nino and Germain is silent to the one or more detents comprises two detents positioned substantially 180 degrees apart around the inner surface of the central opening.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to construct the assembly of the combination of Nino and Germain where the one or more detents comprises two detents positioned substantially 180 degrees apart around the inner surface of the central opening, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to provide the disclosed more detents (Germain ¶37) at a positioning able to engage one of the plurality of detent elements/notches (Germain Fig. 4), to predictably provide a larger tactile indication and temporary locking in a certain degree of rotation (Germain Figs. 1 and 4, ¶37), where the engagement and disengagement permits ratcheting (rotation and locking) portions (Germain Figs. 1 and 4, ¶37).
As to claim 100, Nino discloses a bone access system (Figs. 1-11, ¶45) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 8-11, ¶45), the system comprising: an introducer cannula (101, Figs. 5-11) comprising a proximal handle (102) and a distal elongate tube (103) extending from the proximal handle (Fig. 5, ¶38), wherein the proximal handle of the introducer cannula comprises a central opening (shown holding 50 in Fig. 5, Fig. 5) in its upper surface (right facing surfaces of 102 as shown in Fig. 5, Fig. 5-7B), wherein the central opening comprises an inner surface (Figs. 5-7B), and wherein the distal elongate tube of the introducer cannula comprises a lumen (hollow passage of 103 holding 10 in Figs. 5-11, Figs. 5-11, ¶39) accessible via the central opening (Figs. 5-11, ¶39), wherein the central opening further comprises a threaded mount (100, ¶s 36, 37, and 40) with a latch/catch (¶s 36 and 37 disclose that the cannula mount is threaded and additionally has an unshown a “latch and catch” to accomplish a positive lock); and an access instrument (5) capable of being inserted through the central opening and along the lumen of the introducer cannula (Figs. 5-11, ¶42) until a distal end portion of the access instrument (11, 12, Figs. 3, 7A, 7B, and 9-11) extends beyond an open distal tip of the introducer cannula (104, Figs. 7A, 7B, and 9-11, ¶s 40, 42, 43, 45, and 46), wherein the access instrument comprises a gear wheel (50, 40, 30) mechanically coupled to a threaded proximal portion of the access instrument (20, Figs. 4-7B, ¶s 33, 42, and 43) and capable of being translated proximally and distally along the threaded proximal portion via rotation of the gear wheel (Figs. 4-7B, ¶s 33, 42, and 43), wherein the gear wheel comprises an annular flange (54 of portion 50, 40), and wherein the annular flange comprises a latch/catch (¶s 36 and 37 disclose that annular flange is threaded at 55 to mate with the threaded cannula mount that additionally has an unshown a “latch and catch” to accomplish a positive lock, i.e. with the annular flange) around a lower surface of the annular flange (to engage the cannula, Figs. 5-7B, ¶s 36 and 37) capable of mechanically engaging with the cannula latch/catch within the central opening of the proximal handle of the introducer cannula (Figs. 5-7B, ¶s 36 and 37); wherein engagement of the gear wheel with the introducer cannula defines a longitudinal position of the access instrument within the introducer cannula (Figs. 3-5, ¶s 37 and 40) so as to provide feedback (visible feedback, Figs. 5-7B) to an operator upon engagement of the access instrument with the introducer cannula (Figs. 5-7B) so as to provide controlled advancement of the access instrument with respect to the introducer cannula (via threads of 25, 30, 50, and 100, Figs. 5-7B, ¶s 33, 36, 37, 40, and 42).
Nino is silent to details of the disclosed latch/catch with the threaded cannula mount, i.e. the central opening comprises one or more detents projecting radially inward from the inner surface of the central opening, and the annular flange comprising a plurality of detent elements spaced around a circumference of a lower surface of the annular flange adapted to mechanically engage with the one or more detents within the central opening of the proximal handle of the introducer cannula; and wherein continued rotation of the gear wheel produces successive feedback comprising at least one of tactile feedback and audible feedback via interaction of the plurality of detent elements with the one or more detents, each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument.
Germain teaches a similar bone access system (Figs. 1-7C) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 7A-7C), the system comprising: an introducer cannula (120, 140) comprising a proximal handle (140) and a distal elongate tube (120) extending from the proximal handle (Fig. 4, ¶37); wherein the proximal handle of the introducer cannula comprises a central opening (shown holding 142, 122, and 170 in Fig. 4, Fig. 4) in its upper surface (Fig. 4), wherein the central opening comprises one or more detents (145) projecting radially inward from an inner surface of the central opening (Fig. 4), and wherein the distal elongate tube of the introducer cannula comprises a lumen (shown holding 122 and 170 in Fig. 4, Fig. 4) accessible via the central opening (Fig. 4); and an access instrument (122, 142) capable of being inserted through the central opening and along the lumen of the introducer cannula (Fig. 4) until a distal end portion of the access instrument extends beyond an open distal tip of the introducer cannula (Figs. 6A-7C), wherein the access instrument comprises a gear wheel (outer portion of the lower region of 142 as shown in Fig. 4, Figs. 1 and 4) mechanically coupled to a threaded proximal portion of the access instrument (150, Fig. 4, ¶39) and capable of being translated proximally and distally along the threaded proximal portion via rotation of the gear wheel (Fig. 4, ¶39), wherein the gear wheel comprises an annular flange (as shown below 146 in Fig. 4, Figs. 1 and 4) comprising a plurality of detent elements (146s, Figs. 1 and 4, ¶37) spaced around a circumference of a lower surface of the annular flange (Figs. 1 and 4) capable of mechanically engaging with the one or more detents within the central opening of the proximal handle of the introducer cannula (Figs. 1 and 4, ¶37); wherein engagement of the gear wheel with the introducer cannula defines a longitudinal position of the access instrument within the introducer cannula (Figs. 4-7C, ¶39); and wherein continued rotation of the gear wheel produces successive feedback comprising at least one of tactile feedback and audible feedback via interaction of the plurality of detent elements with the one or more detents (due to the shown structure ratcheting as disclosed in ¶37, Figs. 1 and 4, ¶37, as evidenced by Murphy et al. (US 2021/0153893 protrusion 1016/1004 and recess 1014, Fig. 10, ¶79 discloses that such provides an audible “snap” or click to be heard or felt as 1016 moves in contact with surface 1012 and eventually rests in 1014), each successive engagement between a respective one of the plurality of detent elements and the one or more detents corresponding to a predetermined increment of axial translation of the access instrument (Figs. 1 and 4, ¶37).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the unshown latch/catch of the cannula mount and the latch/catch of the annular flange of the gear wheel as disclosed by Nino comprise circumferentially spaced and oriented detent recesses and detent protrusions as taught by Germain in order to use a known structure (Germain Figs. 1 and 4, ¶37) to provide a tactile indication and temporary locking in a certain degree of rotation (Germain Figs. 1 and 4, ¶37), where the engagement and disengagement permits ratcheting (rotation and locking) portions (Germain Figs. 1 and 4, ¶37).
Claim(s) 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nino and Germain in view of Patel et al. (US 2015/0297246, hereinafter “Patel”).
As to claim 86, the combination of Nino and Germain discloses the invention of claim 80 but is silent to the proximal handle of the introducer cannula comprises a curved insertion slot.
Patel teaches a similar bone access system (Figs. 20-26) capable of facilitating percutaneous access to a target treatment location within bone (Figs. 20-26, ¶182), the system comprising: an introducer cannula (410) comprising a proximal handle (412) and a distal elongate tube (414) extending from the proximal handle (Fig. 22); wherein the proximal handle of the introducer cannula comprises a central opening (418/420) in its upper surface (Figs. 22 and 23, ¶182), wherein the central opening of the proximal handle of the introducer cannula comprises one or more detents (426s, Figs. 22 and 23, ¶184) projecting from an inner surface of the central opening (Figs. 22 and 23, ¶184), and wherein the distal elongate tube of the introducer cannula comprises a lumen (418, Fig. 22) accessible via the central opening of the proximal handle of the introducer cannula (Figs. 22 and 23, ¶182); and an access instrument (450) capable of being inserted through the central opening and along the lumen of the introducer cannula (¶183) until a distal end portion of the access instrument extends beyond an open distal tip of the introducer cannula (¶183), wherein the access instrument comprises an elongate shaft (454) and a plurality of detent elements (458s, Fig. 20, ¶184); wherein the proximal handle of the introducer cannula comprises a curved insertion slot (422, Figs. 22-24C).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the proximal handle of the introducer cannula as disclosed by the combination of Nino and Germain by adding a curved insertion slot as taught by Patel in order to aid in insertion of a curved instrument tip without having to pre-straighten the instrument tip (¶189).
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 extension fee 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 date of this final action.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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