Detailed Action
This is the final office action for US application number 18/027,814. Claims are evaluated as filed on November 18, 2025.
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 with respect to claims 1, 2, and 7-12 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
Applicant's arguments filed November 18, 2025 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 Vanleeuwen teaches all the newly-amended limitations and is 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 claim 29 has been amended to recite features of dependent claim 3 which was identified as reciting allowable subject matter (Remarks p. 8), Examiner disagrees. Examiner agrees that claim 3 was identified as reciting allowable subject matter; however, claim 3 depends from claim 1 and includes the spacer lock comprising a lock actuator configured to receive input from a user so that a lock mechanism is capable of releasably engaging the shaft of the treatment device to selectively permit movement of the treatment device within the sheath device. Current claim 29 does not recite a lock mechanism or a lock actuator or the functional abilities of these features recited in claim 3 nor does claim 29 recite the legs capable of being positioned in abutment with the cannula hub or a slot sized to be able to receive the sheath hub as recited in claim 1. Thus, current claim 29 has not been amended to recite allowable features of claim 3 as argued. Instead, claim 29 has been amended to recite features of claims 7, 10, 11, 31, and 32, all of which were previously rejected in view of Vanleeuwen. Accordingly, current claim 29 has been appropriately rejected in view of Vanleeuwen as detailed below.
Claim Objections
Claim(s) 3, 7, and 13 is/are objected to because of the following informalities:
Claim 3 lines 6-7 “so as to cause the lock mechanism to releasably engage the shaft of the treatment device and selectively permit movement of the treatment device relative to the sheath device.”.
Claim 7 lines 2-3 should read “grip surfaces oriented radially outwardly from a proximal end of the legs and sized to”.
Claim 13 lines “configured to receive an input from a user to selectively permit movement of the shaft of the treatment device relative to the access cannula or the sheath device so as to facilitate unsheathing of the working end of the treatment device.”.
Appropriate correction is required.
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) 1, 2, and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan-Malecki et al. (US 2013/0072941, hereinafter “Tan-Malecki”).
As to claim 1, Tan-Malecki discloses a system (Figs. 4-6 and 10) capable of augmenting a vertebral body (abstract), the system comprising: an access cannula (1, Figs. 6 and 10, i.e. as labeled on Fig. 3) comprising a cannula hub (7, 77s, Fig. 6, ¶37, i.e. as labeled on Fig. 3), and a cannula shaft (6, Fig. 6, ¶37, i.e. as labeled on Fig. 3) extending from the cannula hub with the cannula shaft comprising a distal end (Fig. 6) capable of being positioned within the vertebral body (Fig. 6) and defining a lumen (Fig. 6 shows 17 inserted therein, Fig. 6, ¶s 51, 83, and 91 for insertion of other devices therein) along a longitudinal axis (vertical as shown in Fig. 6, Fig. 6); an introducer device (“stylet” with cap 99 of ¶66, Fig. 6, ¶66, i.e. as labeled on Fig. 1) comprising a shaft (“distal shaft” of “stylet” of ¶66, Fig. 6, ¶66) comprising a distal portion (¶66) capable of being curved when deployed beyond the distal end of the cannula shaft (¶66, e.g. for a flexible device); a sheath device (15/44, 17, 21, Fig. 6, ¶s 43-45, i.e. as labeled on Fig. 1) comprising a sheath hub (21, Fig. 6, ¶s 43-45, i.e. as labeled on Fig. 1) and a sheath (17, Fig. 6, ¶s 43-45, i.e. as labeled on Fig. 1) extending from the sheath hub (Fig. 6), wherein the shaft of the introducer device is removably disposed within the sheath of the sheath device (Fig. 6, ¶66); and a spacer lock (9/43, Figs. 4-6, ¶s 40-42 and 71, i.e. as labeled on Fig. 1) capable of facilitating proximal movement of the sheath relative to the access cannula (Fig. 6, ¶72), the spacer lock comprising legs (73s, Fig. 5, ¶72) capable of being positioned in abutment with the cannula hub (Fig. 6, ¶72), and defining at least one slot (Fig. 6), wherein the sheath hub comprises at least one wing (left side of 21, right side of 21 as shown in in Fig. 6, Fig. 6) capable of sliding disposed through the at least one slot (if one chooses to assembly the spacer lock accordingly) and capable of being engaged by a finger of a user (Fig. 6).
As to claim 2, Tan-Malecki discloses that the spacer lock is capable of resting upon the access cannula under influence of gravity without an additional coupling mechanism (Fig. 6).
As to claim 7, Tan-Malecki discloses that the spacer lock further comprises a spacer hub (63) defining an aperture (“throughhole” of ¶72, shown in Fig. 6 with 44 passing therethrough, Figs. 4-6), and grip surfaces (71) oriented radially outwardly from a proximal end of the legs (Figs. 4-6) and sized to be engaged by a thumb of a hand (Figs. 4-6, ¶72) capable of facilitating movement of a treatment device with a syringe-style input (if one chooses to insert such therein, Figs. 4-6).
As to claim 8, Tan-Malecki discloses that the grip surfaces are coplanar with one another (along a plane extending through 71s, Fig. 5).
As to claim 9, Tan-Malecki discloses that the aperture is disposed on an axis centered between the legs (Figs. 4-6).
Claim(s) 29-31 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vanleeuwen et al. (US 2010/0036381, hereinafter “Vanleeuwen”).
As to claim 29, Vanleeuwen discloses a system (Figs. 1-26C) capable of augmenting a vertebral body (Figs. 25-26C), the system comprising: an access cannula (160, 110, Figs. 1-7) comprising a cannula hub (110, Fig. 5-7), and a cannula shaft (160, Fig. 4) extending from the cannula hub (Figs. 3 and 5) with the cannula shaft comprising a distal end (164) capable of being positioned within the vertebral body (Figs. 26A-26C) and defining a lumen (158, Fig. 4, ¶47) along a longitudinal axis (Fig. 4, ¶47); an introducer device (230, Fig. 3 and 20) comprising a shaft (236, 234, Figs. 3 and 20) comprising a distal portion (234, 232) capable of being curved when deployed beyond the distal end of the cannula shaft (¶89 discloses 232 is flexible material that can bend off axis to extend into tip bore 214; where 214 is labeled in Fig. 14); a sheath device (200, Figs. 8-17) comprising a sheath hub (240, Figs. 8, 9, and 17), and a sheath (206, 204, Fig. 8) extending from the sheath hub (Fig. 8), wherein the shaft of the introducer device is removably disposed within the sheath of the sheath device (Figs. 3, 16, and 17); a spacer lock (140) comprising a spacer hub (142, ¶77) defining an aperture (138 to 150, Fig. 18), legs (left and right portions of 146 as shown in Fig. 16, left and right portions of 148 and shown in Fig. 16, 235, Figs. 16 and 18, ¶77) extending from the spacer hub (Figs. 16-19, ¶77), and grip surfaces (286, outer surfaces between 286s as shown in Fig. 19, Fig. 19) oriented radially outwardly from a proximal end of the legs (Figs. 16-19, ¶77) and sized to be engaged by a thumb of a hand (Figs. 1 and 19) capable of facilitating movement of the sheath (Figs. 16 and 17) with a syringe-style input (40, 42, 44, Fig. 1, ¶60); and a treatment device (44, 40, 42, Fig. 1) comprising a shaft (40, proximal and central portion of 42) and a working end (“distal end” of 42 as disclosed in ¶60, ¶60; where ¶60 discloses that the distal end of 42 would have a fitting that allows 42 to connect to 240), wherein the shaft of the treatment device is capable of sliding disposed within the aperture (for connection to 240, ¶60), and wherein the spacer lock is capable of facilitating unsheathing of the working end of the treatment device through proximal movement of the sheath with the syringe-style input (Figs. 16 and 17, ¶45; to inject cement, Figs. 1, 25, and 26C, ¶117).
As to claim 30, Vanleeuwen discloses that the grip surfaces are coplanar with one another (along a plane extending through 140, Fig. 19).
As to claim 31, Vanleeuwen discloses that the aperture is disposed on an axis centered between the legs (Figs. 16 and 18).
As to claim 33, Vanleeuwen discloses that the treatment device is one of a cavity-forming device (Figs. 1, 25, and 26C, ¶117).
Allowable Subject Matter
Claims 3-6 and 12-15 are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights