Detailed Action
This is the first office action on the merits for US application number 18/856,570.
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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, the product of claims 80-86, the reply filed on April 13, 2026 is acknowledged.
Applicant’s election without traverse of Species 1), of Figs. 5A-5C, in the reply filed on April 13, 2026 is acknowledged.
Accordingly, claims 87-99 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 13, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 218 on Fig. 1.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “216” has been used to designate both a handle of stylet 114 in ¶90 and a handle of cannula 212 in Fig. 1 and ¶86. Examiner suggests amending paragraph 90 to represent handle 126 of stylet 114 consistent with at least paragraph 85 and Fig. 1.
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 in ¶91 and a portion of tube 118 in Fig. 2a.
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 § 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nino et al. (US 2014/0257302, hereinafter “Nino”) in view of Real et al. (US 2017/0311981, hereinafter “Real”).
As to claims 80-85, 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 teaches 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).
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 tactile and/or audible feedback to the operator upon engagement of the plurality of detent elements of the access instrument with the one or more detents of the introducer cannula. 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 engagement and/or 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.
Real teaches a similar bone access system (Figs. 1-23, abstract) adapted to facilitate percutaneous access to a target treatment location within bone (Figs. 19 and 20), the system comprising: an introducer cannula (3, 6) comprising a proximal handle (6) and a distal elongate tube (3) extending from the proximal handle (Fig. 18); wherein the proximal handle of the introducer cannula comprises a central region (within the perimeter of 50 as shown in Fig. 9, Fig. 9) in its upper surface (as defined, Figs. 4a-4c, 11, and 13), wherein the central region of the proximal handle of the introducer cannula comprises one or more detents (42s, Fig. 9) projecting radially inward from an inner surface of the central opening (relative to the outer periphery of 50, Figs. 9 and 10), and wherein the distal elongate tube of the introducer cannula comprises a lumen (for passage of 1, Figs. 3C and 11-15) accessible via the central opening of the proximal handle of the introducer cannula (Figs. 11-15 and 18); and an access instrument (1, 5) capable of being inserted through the central opening and along the lumen of the introducer cannula (Figs. 13-20) until a distal end portion of the access instrument extends beyond an open distal tip of the introducer cannula (Figs. 13-20), wherein the access instrument comprises an elongate shaft (1, Figs. 3A-3C, 5, 11, and 18) having a proximal portion (10) and a generally smooth distal portion (Figs. 3A and 3B) and a gear wheel (5) mechanically coupled to the proximal portion (Figs. 5 and 18), wherein the gear wheel comprises an annular flange (lower portion of 5 as shown in Fig. 5 including 41s and 40, Figs. 5-7 and 16-18), and wherein the annular flange comprises a plurality of detent elements (41s) spaced around a circumference of a lower surface of the annular flange (Figs. 5-7 and 16-18) capable of mechanically engaging with the one or more detents within the central opening of the proximal handle of the introducer cannula (Figs. 16-18, ¶104 discloses that handle (5 and 7) rotate and the detents engage for effective torque transmission) so as to provide tactile and/or 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 (due to the shown structure, Figs. 5-7, 9, 10, and 16-18) so as to provide controlled advancement of the access instrument with respect to the introducer cannula (due to threads shown on luer/mount 55 in Fig. 9 and the rotation of ¶104). As to claim 81, Real teaches that the plurality of detent elements of the annular flange comprises notches or recesses (Figs. 7 and 16-18). As to claim 82, Real teaches that the one or more detents comprises protrusions formed along the inner surface of the central opening (Figs. 9 and 16-18). As to claim 83, Real teaches that the one or more detents and the plurality of detent elements produce an audible click upon engagement and/or disengagement (due to the shown structure and the rotation of ¶104, Figs. 7, 9, and 16-18, 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, Real 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, Figs. 7, 9, and 16-18). As to claim 85, Real 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 (Figs. 7 and 16-18).
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 Real in order to use a known structure (Real Figs. 5-7, 9, 10, and 16-18, ¶104) to accomplish a positive lock (Nino ¶36).
Claim(s) 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nino and Real in view of Patel et al. (US 2015/0297246, hereinafter “Patel”).
As to claim 86, the combination of Nino and Real 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 Real 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892, Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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