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
As of the reply filed 12/11/2025, claims 1-20 are pending. Claims 16-20 have been withdrawn, and claim 1 has been amended.
Response to Arguments
Applicant's arguments filed 12/11/2025 with respect to the amended limitation have been fully considered but they are not persuasive.
Applicant argues that the amended claim 1 overcomes the Tzachar et al. reference because “Tzachar does not disclose or suggest any relative movement of the retainer with respect to the alleged housing 200 to manually slide the alleged retainer 510 in a proximal direction within the internal cavity of the housing to an undeployed position as recited in the claims” (see Remarks page 9), however the Examiner respectfully disagrees. The claim language as amended does not explicitly require any relative movement between the retainer and the housing, and only requires the retainer to be “manually slid in a proximal direction within the internal cavity of the housing to an undeployed position” (see last lines of claim 1). Since the retainer (510 in Fig. 12E) is configured to be slid proximally (see retraction of device 1 in Fig. 12E along with unlabeled 510 as shown in Fig. 12D) while remaining within the housing (200 in Fig. 3, see also 1 in Fig. 3, since Fig. 12E shows the dotted outline of the rest of the device 1 Fig. 12E also shows 510 being retracted along with housing 200), Tzachar et al. reads on the amended claim language.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tzachar et al. (PGPub US 2017/0181734 A1).
With respect to claim 1, Tzachar et al. discloses an intraosseous device (see Fig. 3, abstract) for accessing an intraosseous space (see MPEP 2112.01, the device is configured to access intraosseous space), the intraosseous access device (see Fig. 3) comprising:
a penetrator assembly (500 in Figs. 7a-b) having a sharp penetrating end (514, see also 603 in Fig. 9) operable to penetrate a bone and associated bone marrow (see Figs. 12a-e, PP [0053]: “the face 604 of cannula 600 is forcibly pushed to a limited depth within the bone by the face 515 at the end of the stylet 513”);
a housing (200) having an internal cavity (see opening through 200see also Figs. 5a-d) and an outer sleeve (201), the outer sleeve (210) defining a handle (300) operable to manually drive the penetrator assembly into the bone and associated bone marrow (300 is configured for grasping to drive the penetrator assembly downwards into bone);
a retainer (510 in Figs. 11c-d) having a distal retainer end and a proximal retainer end, the retainer (510) slidably coupled to the outer sleeve (201 in Figs. 5a-d, PP [0068]: “The unlocking of the hammer 510 causes the hammer to move forward until reaching the anvil, and topping at this position. The hammer movement causes the stylet 513 to penetrate the sternum bone”); and
a protective shield (distal end of 100 that sticks out in Fig. 3) having a distal end, a proximal shield end, and a longitudinal hollow passageway extending between the distal shield end and the proximal shield end (see Figs. 11c-d), the protective shield (distal end of 100 that sticks out) slidably coupled to the outer sleeve (201 in Figs. 5a-d, slidably coupled via snaps 201a-b, see Figs. 11c-d);
where the penetrator assembly (500) is operable to provide intraosseous access to the intraosseous space at a sternal insertion site by manually driving the penetrator assembly into the intraosseous space (see MPEP 2112.01, the user can manually drive the penetrator assembly by manipulating trigger 200 by hand) when the intraosseous access device is in a first mode of operation (see Figs. 14a-b, the assembly is configured to provide access at a sternal insertion site) in which the retainer (510) is locked in a deployed position (see Figs. 12a and 12d, PP [0058]: “Grasping elements 400a and 400b hold the probe unit 530, preventing any axial movement of the probe. In this situation, the proximal surface 537 of anvil 531 defines an axial movement limit for the hammer 510”, PP [0059]: “The hammer is axially pushed towards the sternum bone, until reaching its movement limit as defined in “step b” by the proximal surface 537 of anvil 531”, 510 is locked against 530 and extends slightly beyond 400 in a deployed position); and
where the penetrator assembly is operable to provide intraosseous access to the intraosseous space at a peripheral insertion site by manually driving the penetrator assembly into the intraosseous space (see MPEP 2112.01, the user can manually drive the penetrator assembly by manipulating trigger 200 by hand) when the intraosseous access device is in a second mode of operation (see Figs. 14a-b, the assembly is also configured to provide access at a peripheral insertion site) in which the retainer (510) is unlocked from the deployed position and manually slid in a proximal direction within the internal cavity of the housing (200 in Fig. 3, see also 1 in Fig. 12E) to an undeployed position (see Fig. 12E, the second mode of operation is when 510 is undeployed/manually slid in the proximal direction to disengage the device from the sternum, the device is still operable to provide intraosseous access at a peripheral insertion site, furthermore 510 is still within the device 1 and within the housing 200 in this mode of operation, see Figs. 3 and 12E).
Regarding claim 2, Tzachar et al. further discloses wherein the penetrator assembly (500 in Figs. 7a-b) further comprises an inner penetrator hub (511) having a distal end and a proximal end, an inner penetrator (513) extending from the distal end of the inner penetrator hub (511), an outer penetrator hub (602 in Fig. 9) having a distal end and a proximal end, and an outer penetrator (601) extending from the distal end of the outer penetrator hub (602), the outer penetrator (601) defining a longitudinal hollow bore (see Fig. 9) configured to slidably receive the inner penetrator (see Fig. 11d, 600 sits over 516).
Regarding claim 3, Tzachar et al. further discloses wherein the proximal end of the outer penetrator hub (602 in Fig. 9) is releasably engaged to the distal end of the inner penetrator hub (511, see Figs. 12a-e, 602 is releasably attached to 511).
Regarding claim 4, Tzachar et al. further discloses a housing core (100 in Fig. 3) fixedly disposed within the internal cavity of the housing (200), the housing core (100) including a distal core end coupled to the proximal end of the inner penetrator hub (511, the distal end of 100 is coupled to 511 via 12a-b, see Fig. 11c).
Regarding claim 5, Tzachar et al. further discloses wherein the inner penetrator (513 in Figs. 7a-b) comprises a rigid stylet (PP [0050]: “The end 514 of stylet 513 is of smaller diameter than the rest f the body of the stylet. The end of stylet 514 has a peripheral face 515 for engaging with a corresponding face 604 of cannula 600 (see FIG. 9), thereby pushing the cannula 600 to the bone”, stylet 513 is for pushing into bone therefore it is relatively rigid), and the outer penetrator (601) comprises a flexible cannula (PP [0053]: “The cannula comprises an elastic tube 601”).
Regarding claim 6, Tzachar et al. further discloses wherein the handle (300 in Fig. 3) includes an ergonomic grip (300 is curved and therefore ergonomic) suitable for grasping during the first and second modes of operation (since 300 is curved/ergonomic it is suitable for grasping).
Regarding claim 7, Tzachar et al. further discloses wherein the handle (300 in Fig. 3) is configured to allow manual force to be applied and at the same time permit rotation of the handle (300) to rotate the penetrator assembly (500 in Figs. 7a-b) during intraosseous insertion of the penetrator assembly during the first and second modes of operation (PP [0063]: “the user releases the first safety means, by rotating (for example, 90° rotation) the safety catch 300”) by manually pushing and twisting the handle (see Figs. 13c-g, the handle is pushed/pulled and rotated manually in order to move between the modes of operation).
Regarding claim 8, Tzachar et al. further discloses wherein the protective shield (distal end of 100 that sticks out in Figs. 11a-d) is configured to move between an extended position and a retracted position relative to the outer sleeve (201 in Figs. 5a-d) and the retainer (510) during the first mode of operation (PP [0047]: “the beveled snaps 203a and 203b, together with protrusions 105a and 105b and fingers 25a and 25b form a second safety mechanism of the device, in addition to safety catch 300 (which forms a first safety mechanism)”, see unmarked 100 in Fig. 13d versus 13g).
Regarding claim 9, Tzachar et al. further discloses wherein the protective shield (distal end of 100 that sticks out in Figs. 11a-d) is configured to provide sharps protection from the sharp penetrating end of the penetrator assembly (500, distal end of 100 covers the sharp ends of the probes, see Fig. 13c) when the protective shield (distal end of 100 that sticks out) is in the extended position during the first mode of operation (see Figs. 12a and 12d), and wherein the protective shield (distal end of 100 that sticks out) is configured to expose the sharp penetrating end of the penetrator assembly when the protective shield is in the retracted position to permit insertion of the penetrator assembly (500) into the bone and associated bone marrow during the first mode of operation (see Figs. 13f-g).
Regarding claim 10, Tzachar et al. further discloses a first biasing member (14 in Fig. 3, see also Figs. 11c-d) disposed between the retainer (510) and the protective shield (distal end of 100, 14 is radially between 510 and the distal end of 100), the first biasing member (14) configured to bias the protective shield (distal end of 100) toward the extended position during the first mode of operation (PP [0055]: “Main spring 14 is kept loaded by means of the balls 13a and 13b that lock and prevent any movement of the piston 511”, PP [0055]: “windows 204a and 204b of snaps 203a and 203b respectively accommodate the protrusions 105a and 105b, therefore coupling together the trigger 200 and barrel 100”, see Figs. 12a and 12d, 14 is between 510 and 530 in Fig. 12a, see Figs. 11c-d, and therefore biases the distal end of 100 toward the extended position, see Figs. 13a-g).
Regarding claim 11, Tzachar et al. further discloses a bone probe ring (521 in Figs. 7a-b) slidably coupled to the retainer (510), the bone probe ring (521) having a distal ring end and a proximal ring end; and a bone probe (530 and 522a-b) extending from the distal ring end of the bone probe ring (521), the bone probe (530 and 522a-b) including a bone probe tip (532a-c in Fig. 7b) operable to penetrate skin and subcutaneous tissue (probing needles 532a-c are operable to penetrate skin and tissue).
Regarding claim 12, Tzachar et al. further discloses wherein the bone probe ring (521 in Figs. 7a-b) is configured to move between a first position and a second position during the first mode of operation (see Figs. 12a versus 12d), where the bone probe ring (521) is closer to the distal retainer end of the retainer (510) when the bone probe ring (521) is in the first position than when the bone probe ring (521) is in the second position (first position in Fig. 12d versus second position in Fig. 12a).
Regarding claim 13, Tzachar et al. further discloses wherein the distal ring end of the bone probe ring (521 in Figs. 7a-b) includes an inwardly protruding nub (523a-b), the nub configured to engage a first detent (see unmarked detents on 510 in Figs. 7a-b which 522a-b fit into) on the retainer (510) to maintain the bone probe ring (521) in the first position during the first mode of operation, and the nub (523a-b) configured to engage a second detent (see unmarked detents on 510 in Figs. 7a-b which 522a-b fit into) on the retainer (510) to maintain the bone probe ring (521) in the second position (see Fig. 12d) during the first mode of operation (the detents maintain 521 radially in position in Fig. 12d).
Regarding claim 14, Tzachar et al. further discloses a second biasing member (15 in Fig. 3) disposed between the retainer (510 in Fig. Figs. 7a-b) and the bone probe ring (521, PP [0055]: “Secondary spring 15, in turn, is positioned loaded between face 525 of ring 521 and face 18 of rear cap 11”, see Figs. 11c-d), the second biasing member (15 in Fig. 3) configured to bias the bone probe ring (521 in Figs. 7a-b) toward the first position during the first mode of operation (PP [0068]: “Initially, balls 12a and 12b that previously locked the probe needles at the anvil 531 (this state is shown in FIG. 11c), come to within grooves 206a and 206b, thereby releasing the anvil 531. The secondary spring 15 pushes the probe unit 530 toward the bone”).
Regarding claim 15, Tzachar et al. further discloses wherein the outer sleeve (201 in Figs. 5a-d) further comprises a longitudinal track (206a-b in Figs. 5c-d) and a slider (balls 12a-b, see Fig. 11c) slidably coupled to the longitudinal track (206a-b in Figs. 5c-d), the slider (balls 12a-b, see Fig. 11c) operable to move the retainer (510 in Figs. 7a-b) and the protective shield (distal end of 100) between the deployed position and the undeployed position (see Figs. 12a/12d and 12e) relative to the outer sleeve (201) during the second mode of operation (PP [0068]: “as the user continues to squeeze the trigger, balls 13a and 13b come to within the grooves 206a and 206b respectively, thereby releasing the previously locked hammer 510. The unlocking of the hammer 510 causes the hammer to move forward until reaching the anvil, and topping at this position. The hammer movement causes the stylet 513 to penetrate the sternum bone”, 510 can be actuated in this way during the second mode of operation).
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771