DETAILED ACTION
Response to Arguments
Applicant's arguments filed 7/28/2025 have been fully considered but they are not persuasive.
Arguments with respect to Claim 1 as rejected by US 2017/0340401 A1 to Miller et al. (pages 5-10)
The Applicant argues at pages 5-6 that the hub assembly 130a of Miller is simply a fitting disposed within the handle structure and does not extend from the handle. The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention because Claim 1 does not set forth where the fitting is disposed with respect to the handle structure (within/external) nor does the claims set forth that the hub assembly 130a extends from the handle. Claim 1 merely sets forth that the hollow shaft extends from a device body (not specifically a handle) and that the hollow shaft configured to impact a bone in an axial direction.
The Applicant argues at page 7 that the hub assembly 130a of Miller does not contact the bone or even extend into the subject, it is simply an opening in the handle. The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention because Claim 1 does not set forth where the hub assembly contacts the bone or extends into the subject. Claim 1 merely sets forth that the hub assembly is configured to impact a bone in an axial direction, without further defining how the hub assembly impacts bone in an axial direction. The hub assembly, especially as broadly claimed, impacts a bone in an axial direction, because the hub assembly transfers force from the handle while the device, including the penetrating needle, is advanced into the patient.
The Applicant argues at pages 7 and 8 that Miller does not disclose the hollow penetrating needle disposed within the hollow shaft, and further including a solid slider positioned within the hollow penetrating needle to provide structure support. The Examiner disagrees and respectfully submits that as interpreted by the Examiner, the hollow shaft is hub assembly 130a, the penetrating needle is biopsy needle 100c and the solid slider is trocar 120c. Miller anticipates placing a trocar 120c with the penetrating needle 100c (FIG. 4E), which would have been capable of providing structural support, and also anticipates placing the penetrating needle 100c within the hollow shaft 130a. Therefore, Miller discloses a hollow penetrating needle disposed within a hollow shaft, and further including a solid slider positioned within the hollow penetrating needle to provide structure support.
The Applicant argues at pages 7, 9 and 10 that Miller does not disclose a biasing element housing in the handle or a linear advancement mechanism, and more specifically, argues that Miller does not disclose a biasing element housing in the handle and coupled to a linear advancement mechanism, because the Examiner mistakenly believes that springs 274 are used for advancing needle sets. The Applicant argues that spring 274 is disposed outside of the handle/housing and is used for connecting the handle/housing mechanism to a drive mechanism. The Applicant argues that the purpose of spring 274 in Miller is to maintain first and second housing segments relative to each other. The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention because the claimed invention does not set what the purpose of both the biasing element and the linear advancement mechanism are for. More specifically, while the Applicant argues that the spring 274 is used for connecting first and second housings and not for advancing needle sets, the claims do not set forth what the biasing element is for, how it is housing in the handle/housing, and how it is coupled to a linear advancement mechanism. Miller discloses the limitation of “a biasing element, said biasing element housing in the handle” as the biasing element of Miller (coiled spring 274) is located within the housing of Miller (combination of housing 210 and hub 250a; Fig. 5A). Furthermore, the biasing element of Miller (coiled spring 274) is coupled to a linear advancement mechanism (end 224; [0224]) because all elements are in some way coupled to one another, as they are part of the same device.
Arguments with respect to Claim 1 as rejected by US 2005/0171504 A1 to Miller et al. (pages 10-11)
The Applicant argues at pages 10-11 that Miller lacks the combination of a biasing element, linear actuator and a solid internal slider and that there is no indication of a first actuator operably connected to advance the needle. The Examiner disagrees and respectfully submits that Miller discloses biasing element (spring located driver), linear actuator (“Sears” chuck release mechanism) and a solid internal slider (tissue penetrator 12). Furthermore, the Applicant’s arguments that “there is no indication of a first actuator operably connected to advance the needle” are not commensurate in scope with the claimed invention, because the claims merely set forth that the actuator is connected to the penetrating needle, and does not set forth that the actuator advances the penetrating needle.
The Applicant argues at page 11 that Miller does not take samples in the same way as present in the claims, that Miller is a is a powered drill and that Miller does not use a spring and linear actuator combination. The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention because the claims do not set forth that the tissue coring device as claimed is not a powered drill, does not describe in any terms how samples as taken, and does not describe a spring in combination with a linear actuator.
The Applicant further mentions at page 11 that the Examiner has equated the biasing element of the present claims to the quick release mechanism of Miller and further explains how the device of Miller is intended to operate, but does not present any arguments with respect to the biasing element. Therefore, the Examiner is unable to determine the purpose of this biasing element/quick release comment.
The Applicant argues at page 12 that the outer sleeve 13a (equated to the hollow shaft of Claim 1) of Miller does not impact bone because it is part of the quick release mechanism, and further argues that shield 13 retracts into the body of the device and not into the subject. The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention, because the claimed invention does not set forth that the hollow shaft is not part of a quick release mechanism, and does not claim any sort of retraction or placement thereof, it merely needs to be capable of/configured to impact a bone in an axial direction. As described in paragraph [0103] and shown in Figs. 19 and 20, hollow shaft 13a in combination with 13a and 12, is capable of impacting bone in an axial direction, because while 13a does not explicitly touch bone, this is not what is being claimed. Claim 1 merely sets forth that it “impacts” bone, and in combination with elements 13b and 12, element 13a is a supporting device that most certainly “impacts” bone, as it helps drive the needle 12 into the bone. Therefore, Miller discloses a slider (12) within a hollow needle (13b) within a hollow shaft (13a) configured to impact bone (see Figs. 19 and 20).
Arguments with respect to Claim 1 as rejected by US 2017/0340401 A1 to Miller in view of US 2006/0030785 A1 to Field et al. (page 12).
The Applicant argues that Miller fails to disclose the hollow shaft, the biasing element or the placement of the slider. The Examiner disagrees and respectfully submits Miller discloses a slider (12) within a hollow needle (13b) within a hollow shaft (13a) configured to impact bone (see Figs. 19 and 20).
The Applicant argues that Miller does not disclose where the internal protrusions reduce an interior diameter of the hollow needle, as amended. The Examiner disagrees and respectfully submits that the spacing between the thread 190 are now being interpreted as the internal protrusions, because with respect to the thread, they are inward and effectively reduces the inner diameter of the cannula (diameter of cannula between inward thread 190, spacing of the cannula diameter between the thread 190 are “inward” with respect to the thread 190 and effectively reduces the diameter of the hollow needle).
All rejections are therefore maintained.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0340401 A1 to Miller at al. (hereinafter, Miller)
Regarding Claim 1, Miller discloses a tissue coring device comprised of inter alia:
a handle (combination of housing 210 and hub 250a; Fig. 5A);
a hollow shaft (hub assembly 130a; Fig. 5A) extending from a device body (via attachment to hub 250a), the hollow shaft configured to impact a bone in an axial direction (hub 250a is capable of impacting bone in an axial direction as the first hub transfer force while the handle is being advanced into the patient);
a biasing element (coiled spring 274), said biasing element housed in the handle (as best seen in Fig. 5E), said biasing element coupled to a linear advancement mechanism (end 224; [0224]);
a first actuator (trigger assembly 244);
a hollow penetrating needle (cannula 110c of biopsy needle 100c) disposed within the hollow shaft (as best seen in Fig. 5E), said first actuator operably connected to the hollow penetrating needle ([0141] Motor 218 may be energized … by alternately depressing … trigger 246), said hollow penetrating needle terminates at a distal end with a sharp tip for bone penetration (as best seen in Fig. 4E), and
further including a solid first slider (trocar 120g), said first slider positioned within the hollow penetrating needle to provide structural support (as best seen in Fig. 4E).
Regarding Claim 2, Miller discloses the tissue coring device of claim 1 wherein the penetrating needle has an angled tip (as best seen in Fig. 5E).
Regarding Claim 3, Miller discloses the tissue coring device of claim 1 wherein a distal portion of the hollow shaft has a curve for accessing a coring location (hub assembly 130a is cylindrical and therefore curved for accessing a coring location).
Regarding Claim 4, Miller discloses the tissue coring device of claim 1 wherein the biasing element is operably connected to an indexing (collecting container 314) and an impactor mechanism (flow control device 328).
Regarding Claim 5, Miller discloses the tissue coring device of claim 4 wherein the linear advancement mechanism of the biasing element is an oscillating swash plate mechanism ([0224]).
Regarding Claim 6, Miller discloses the tissue coring device of claim 1 further including a second actuator (electric circuit board 247), said second actuator operably connected to the hollow penetrating needle for retraction ([0141] Electrical circuit board 247 may also be disposed within housing 210. Electrical circuit board 247 may be electrically coupled with trigger assembly 244, motor 218, power supply 216 and indicator light 248).
Regarding Claim 7, Miller discloses the tissue coring device of claim 1 further including a toggle (releasing of switch 246) and a secondary mode for the first actuator ([0141] Motor 218 may be … deenergized by … releasing trigger 246).
Regarding Claim 8, Miller discloses the tissue coring device of claim 1, where the hollow shaft is removable from the handle and exchangeable with other attachments (as best seen in Fig. 5A).
Regarding Claim 9, Miller discloses the tissue coring device of claim 1, where the hollow shaft includes a hollow tube (vacuum tubing 316) with a port for suction (collection tubing 316).
Regarding Claim 10, Miller discloses the tissue coring device of claim 1, where the elongate slider includes a cutting tip (as best seen in Fig. 4E).
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0171504 A1 to Miller.
Regarding Claims 1 and 2, Miller discloses a tissue coring device comprised of inter alia:
a handle (housing 14; Fig. 6);
a hollow shaft (outer sleeve 13a; Figs. 19 & 20) extending from a device body (as demonstrated in Fig. 5B), the hollow shaft configured to impact a bone in an axial direction ([0003] The present invention is related in general to a medical device to access the bone marrow);
a biasing element (see discussion of spring-loaded driver, [0010] & [0102]), said biasing element housed in the handle (as demonstrated in Fig. 5B), said biasing element coupled to a linear advancement mechanism ([0103] FIG. 18 shows a standard "Sears" chuck release mechanism. The outer sleeve 13a is spring loaded and ball bearings 23 on inner sleeve 13b hold the target device (IO needle; not expressly shown) in place.);
a first actuator (lever trigger 15b; Fig. 7), said first actuator is a lever disposed within the handle (as demonstrated in Fig. 7); and
a hollow penetrating needle (inner sleeve 13b) disposed within the hollow shaft (as demonstrated in Figs. 19 & 20), said first actuator operably connected to the hollow penetrating needle ([0103] FIG. 18 shows a standard "Sears" chuck release mechanism. The outer sleeve 13a is spring loaded and ball bearings 23 on inner sleeve 13b hold the target device (IO needle; not expressly shown) in place), and further including a solid first slider (tissue penetrator 12), said first slider positioned within the hollow penetrating needle to provide structural support (as demonstrated in Figs. 19 & 20).
The embodiments as best seen in Figs. 19 and 20 do not expressly disclose where the hollow penetrating needle terminates at a distal end with a sharp tip for bone penetration, wherein the penetrating needle has an angled tip. However, the embodiment as best seen in Fig. 55 teach a sharp angled tip (cleats 52) on the distal end of a hollow penetrating needle (sleeve 13). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the hollow penetrating needle as set forth in Figs. 19 and 20 with the sharp angled tip as set forth in Fig. 52, as it is taught in that the sharp angled tip would have stabilized and provided adhesion to the skin of the patient ([0161]). As best seen in Fig. 20, the distal end of the hollow penetrating needle would have been further stabilized on the skin with the addition of the sharp angled tip.
Regarding Claim 3, Miller discloses the tissue coring device of claim 1 wherein a distal portion of the hollow shaft has a curve for accessing a coring location (The inner sleeve 13b is cylindrical and therefore curved for accessing a coring location).
Regarding Claim 4, Miller discloses the tissue coring device of claim 1 wherein the biasing element is operably connected to an indexing (holding balls 23 and detents 24 “index” the respective cannulas and needle with respect to one another) and an impactor mechanism (check mechanism 27).
Regarding Claim 5, Miller discloses the tissue coring device of claim 4 wherein the linear advancement mechanism of the biasing element is a slider crank ([0103] FIG. 18 shows a standard "Sears" chuck release mechanism. The outer sleeve 13a is spring loaded and ball bearings 23 on inner sleeve 13b hold the target device (IO needle; not expressly shown) in place).
Regarding Claim 6, Miller discloses the tissue coring device of claim 1 further including a second actuator, said second actuator operably connected to the hollow penetrating needle for retraction (release mechanism, [0101-0102]).
Regarding Claim 7, Miller discloses the tissue coring device of claim 1 further including a toggle (threaded shaft 12a) and a secondary mode for the first actuator [0100] FIG. 17 depicts a "sure fast" type of IO needle, which has a threaded shaft 12a. In this case, counting the revolutions with a stepper motor or a shaft encoder controls depth of needle placement. Parameters of depth can be controlled based on the size and weight of the patient. Depth can also be computer controlled and would be more precise).
Regarding Claim 8, Miller discloses the tissue coring device of claim 1 wherein the hollow shaft is removable from the handle and exchangeable with other attachments (Abstract, The apparatus includes a housing, a penetrator assembly, operable to penetrate the bone marrow, a connector operable to releasably attach the penetrator assembly to a drill shaft).
Regarding Claim 9, Miller discloses the tissue coring device of claim 1 wherein the hollow shaft includes a hollow tube with a port for suction (empty space with outer sleeve 13a).
Regarding Claim 10, Miller discloses the tissue coring device of claim 1 wherein the elongate slider includes a cutting tip (tissue penetrator 12 is shown with a sharp cutting tip as demonstrated in Figs 19 & 20).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US
US 2017/0340401 A1 to Miller at al. (hereinafter, Miller) in view of US 2006/0030785 A1 to Field et al. (hereinafter, Field).
Regarding Claim 15, Miller discloses a tissue coring device comprised of inter alia:
a handle (combination of housing 210 and hub 250a; Fig. 5A);
a hollow shaft (hub assembly 130a; Fig. 5A) extending from a device body (via attachment to hub 250a), the hollow shaft configured to impact a bone in an axial direction (hub 250a is capable of impacting bone in an axial direction as the first hub transfer force while the handle is being advanced into the patient);
a biasing element (coiled spring 274), said biasing element housed in the handle (as best seen in Fig. 5E), said biasing element coupled to a linear advancement mechanism (it is noted that [0209] discusses how the spring interacts with various elements of the device, including elements of the first housing segment 280 and second housing segment 290 – such elements and interact with the spring are linear advancement mechanisms, as once the first and second housings are coupled to one another, linear advancement of the device may begin);
a first actuator (trigger assembly 244) disposed within the handle (as best seen in Fig. 2); and
a hollow penetrating needle (cannula 110c of biopsy needle 100c) with a sharp tip at the distal end (as best seen in Fig. 5E);
the first actuator operably connected to advance the sharp tip of the hollow penetrating needle into a bone ([0141] Motor 218 may be energized … by alternately depressing … trigger 246);
the hollow needle including one or more internal protrusions at a distal end to hold a sample, said internal protrusions reducing an interior of the hollow needle (diameter of cannula between inward thread 190, spacing of the cannula diameter between the thread 190 are “inward” with respect to the thread 190 and effectively reduces the diameter of the hollow needle).
Miller discloses the claimed invention as set forth and cited above except for expressly disclosing where the first actuator is a lever disposed within the handle. However, Field discloses a puncture device that includes a lever 166 to actuate the assembly to perform a puncturing action ([0128]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the actuator of Miller to be the lever of Field, as field teaches at [0128] that a lever would have been one of several mechanisms for actuating a puncture device. Furthermore, one having an ordinary skill in the art would have recognized that the substitution of the push button of Miller with the lever of Field would have been a simple substitution of one known element for another to obtain the predictable result of actuating a puncture motion.
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791