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 .
Notice of Amendment
In response to the amendment filed on 5/28/2026, amended claims 34 and 44, cancelled claims 1-33, and new claims 45-49 are acknowledged. Claims 34-49 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 34-35, 37-43, and 45-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swann (US Publication No. 2013/0150752 A1) (cited by Applicant), further in view of Allee et al. (US Patent No. 7,850,651 B2) (cited by Applicant).
Regarding claim 34, Swann discloses a method of aspirating bone marrow, the method comprising:
placing a needle assembly (20) into bone of a patient, the needle assembly comprising a cannula (32) attached to a handle (33) and a stylet (28) assembled into the cannula through a connector (82) at the handle (see Figures 6-7), the cannula having at least one side aperture (70) (see [0023] – “The needle 32 has opposing lateral holes 70 spaced from the point 68”), the cannula passing through a mechanism that is attached to and distal to the handle (see Figures 2 and 4-7 and [0023] – “The needle 32 extends from the threaded section 56 and has a penetrating end 66 partially defining the penetrating end 22 of the embodiment 20 (see FIG. 1)” and [0029] – “In FIGS. 6-7, the needle 32 is shown as a separate element of the embodiment 20, but may be integrally formed with the sleeve 30”), the mechanism including a threaded tube (34) and a lead screw (54) receivable in the threaded tube, a distal end (90) of the threaded tube being free (see Figures 1-7);
removing the stylet after the needle assembly is placed into the bone (see [0034] – “After penetration of the penetrating end 22 to the desired depth, the cap 26 and stylet 28 may be removed”); and
aspirating bone marrow through the at least one side aperture (see [0034] – “A syringe may then be inserted into the female fluid fitting 82 formed in the distal end 30 of the sleeve, and bone marrow aspirated through the needle 32. The lateral holes 70 through the sidewall of the needle 32 aids with aspiration”).
It is noted Swann does not specifically teach retrieving the cannula from the bone by rotating the lead screw relative to the threaded tube. However, Allee et al. teaches retrieving the cannula from the bone by rotating the lead screw relative to the threaded tube (see col. 6, lines 6-33 – “To aspirate additional bone marrow, the inner aspiration needle 14 is threaded further into the threaded collar 16 a predetermined number of degrees, such as about 90.degree., so that the inner aspiration needle 14 protrudes from the outer needle 12 to a second length L2 (FIG. 7B), which is greater than the first length L1. Rotating the inner aspiration needle 14 in this manner, while keeping the outer needle 12 stationary, advances the tip 32 of the needle 30 deeper into the bone and rotates the tip 32 such that the ports 34 are perpendicular to their previous position. Thus, the outer needle 12 serves as a guide for the inner aspiration needle 14 to direct the inner aspiration needle 14 to the bone. This process is performed as many times as needed to obtain a desired amount of bone marrow. Withdrawing bone marrow using the assembly 10 provides numerous advantages. For example, rotating the inner aspiration needle 14 so that its position in the bone changes permits withdrawal of bone marrow from different areas of the bone to prevent the aspirated marrow from possibly being diluted with peripheral blood. As an alternative to advancing the inner aspiration needle 14 into the bone as additional bone marrow is withdrawn, bone marrow aspiration can begin with the threaded portion 28 of the inner aspiration needle 14 in full threaded engagement with the threaded collar 16. As additional bone marrow is aspirated, the inner aspiration needle 14 can be rotated, for example counterclockwise at 90.degree., to withdraw the inner aspiration needle 14 out from within the outer needle 12”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Swann to include retrieving the cannula from the bone by rotating the lead screw relative to the threaded tube, as disclosed in Allee et al., so as to permit withdrawal of bone marrow from different areas of the bone to prevent the aspirated marrow from possibly being diluted with peripheral blood (see Allee et al.: col. 6, lines 20-25).
Regarding claim 35, Swann teaches the stylet extends through the cannula and past the at least one side aperture (see Figure 2 and [0023] – “The angle of the penetrating end 66 relative to the longitudinal axis corresponds to the angle of the penetrating end 29 of the stylet 28”).
Regarding claim 37, Swann teaches rotating the lead screw relative to the threaded tube includes turning the threaded tube (see [0031] – “The depth guard 34 is threaded onto the threaded section 54 of the sleeve 30 to control the depth of the needle 32 into the patient. The depth limit is set by adjusting the depth guard 34 to the desired position on the threaded section 54 according to the distance markings 59 on the planar surface 74, causing the distance D.sub.1 to correspond to the markings. Ridges 73 (shown in FIG. 2) provide a convenient gripping surface for rotating the depth gauge 34 with respect to the threaded section 56”).
Regarding claim 38, Swann teaches adjusting a length of the cannula that extends beyond a distal end of the threaded tube by advancing the lead screw into the threaded tube or reversing the lead screw out of the threaded tube (see [0031] – “The depth guard 34 is threaded onto the threaded section 54 of the sleeve 30 to control the depth of the needle 32 into the patient. The depth limit is set by adjusting the depth guard 34 to the desired position on the threaded section 54 according to the distance markings 59 on the planar surface 74, causing the distance D.sub.1 to correspond to the markings. Ridges 73 (shown in FIG. 2) provide a convenient gripping surface for rotating the depth gauge 34 with respect to the threaded section 56”).
Regarding claim 39, Swann teaches the length of the cannula that extends beyond the distal end of the threaded tube is adjustable between about 1 inch and about 8 inches (see [0031] – “The intended depth range for the needle 32 is from ten millimeters to thirty millimeters”).
Regarding claim 40, Swann teaches the lead screw is hollow and the cannula extends through the hollow lead screw (see Figures 2 and 4-7 and [0023] – “The needle 32 extends from the threaded section 56 and has a penetrating end 66 partially defining the penetrating end 22 of the embodiment 20 (see FIG. 1)” and [0029] – “In FIGS. 6-7, the needle 32 is shown as a separate element of the embodiment 20, but may be integrally formed with the sleeve 30”).
Regarding claim 41, Swann teaches the at least one side aperture includes plural side apertures arranged along a length of the cannula near a distal end of the cannula (see [0023] – “The needle 32 has opposing lateral holes 70 spaced from the point 68”).
Regarding claim 42, Allee et al. teaches the bone marrow is aspirated during retrieval of the cannula from the bone (see col. 6, lines 26-33 – “As an alternative to advancing the inner aspiration needle 14 into the bone as additional bone marrow is withdrawn, bone marrow aspiration can begin with the threaded portion 28 of the inner aspiration needle 14 in full threaded engagement with the threaded collar 16. As additional bone marrow is aspirated, the inner aspiration needle 14 can be rotated, for example counterclockwise at 90.degree., to withdraw the inner aspiration needle 14 out from within the outer needle 12”).
Regarding claim 43, Swann teaches the at least one side aperture is near a distal end of the cannula, the distal end of the cannula being closed (see [0023] – “The penetrating end 66 is angled relative to the longitudinal axis of the needle 32 and terminates in a sharp point 68. The angle of the penetrating end 66 relative to the longitudinal axis corresponds to the angle of the penetrating end 29 of the stylet 28. The needle 32 has opposing lateral holes 70 spaced from the point 68”).
Regarding claim 45, Swann teaches the connector is a Luer connector (see [0028] – “Referring to FIGS. 6-7, the cap 26 contains a tapered fluid fitting 76, such as a male Luer fitting, that extends from the distal endwall 40 into the interior space of the cap 26. The annular proximal endwall 44 contacts the distal surface of the proximal annular section 62 of the sleeve 30. The free end of the fluid fitting 76 extends into a female fluid fitting 82 formed in the sleeve 30”).
Regarding claim 46, Swann teaches the distal end of the threaded tube is not coupled to another handle (see Figures 1-7).
Regarding claim 47, Swann teaches the distal end of the threaded tube is free of a connector to couple to another handle or another cannula (see Figures 1-5).
Regarding claim 48, Swann teaches the needle assembly is placed into the bone without being guided by another cannula (see [0033] – “After the desired depth is selected and the locking nut 36 moved proximal to the depth gauge 34, the penetrating end 22 may then be inserted into the targeted vertebra (or other desired subject matter). The stylet 28 provides structural rigidity for the needle 32 during insertion. Insertion is limited to the distance D.sub.1 between the sharp point 68 of the penetrating end 22 and the proximal surface 90 of the depth gauge 34”).
Regarding claim 49, Swann teaches the cannula passes through the mechanism without passing through another cannula (see Figures 2 and 4-7 and [0023] – “The needle 32 extends from the threaded section 56 and has a penetrating end 66 partially defining the penetrating end 22 of the embodiment 20 (see FIG. 1)” and [0029] – “In FIGS. 6-7, the needle 32 is shown as a separate element of the embodiment 20, but may be integrally formed with the sleeve 30”).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swann and of Allee et al., further in view of Chu et al. (US Publication No. 2011/0071430 A1) (previously cited).
Regarding claim 36, it is noted Swann does not specifically teach the lead screw is attached to the handle, and wherein rotating the threaded lead screw relative to the threaded tube includes turning the handle. However, Chu et al. teaches the lead screw (220) is attached to the handle (230), and wherein rotating the threaded lead screw relative to the threaded tube (311) includes turning the handle (see Figures 3 and 5-6 and [0029] – “When the handle (230) of the acquiring element (200) is rotated by a force, the acquiring element (200) is moved in the through hole (311) and the trocar (320) relative to the fixation element (300)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Swann and Allee et al. to include the lead screw is attached to the handle, and wherein rotating the threaded lead screw relative to the threaded tube includes turning the handle, as disclosed in Chu et al., so as to tightly attach the lead screw to the threaded tube via the structure of the threads and accurately position the needle assembly into a target area by convenient calculation with a fixed distance (see Chu et al.: [0045]).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swann and of Allee et al., further in view of Miller (US Publication No. 2007/0016100 A1) (cited by Applicant).
Regarding claim 44, it is noted Swann does not specifically teach the cannula is a first cannula and the distal end of the first cannula is closed by inserting a second cannula coaxially through the first cannula after the stylet is removed, a distal end of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture of the first cannula. However, Miller teaches the cannula is a first cannula (80) and the distal end of the first cannula is closed by inserting a second cannula (62e) coaxially through the first cannula after the stylet is removed, a distal end (64) of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture (88a, 88b, 88c) of the first cannula (see Figures 8A-C and [0090] – “Various techniques and procedures may be satisfactorily used to selectively align sampling port 68 with respective sampling ports 88a, 88b and 88c. When sampling port 68 of inner penetrator 62a is respectively aligned with sampling port 88a, 88b or 88c of outer penetrator 80e, respective portions of bone marrow may be suctioned from adjacent target areas”; see also [0087], [0089], and [0092]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Swann and Allee et al. to include the cannula is a first cannula and the distal end of the first cannula is closed by inserting a second cannula coaxially through the first cannula after the stylet is removed, a distal end of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture of the first cannula, as disclosed in Miller, so as to allow sampling from multiple target areas while at the same time installing or inserting the device into only a single penetration site (see Miller: [0087]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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