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 .
Amendment Entered
This Office action is responsive to the Amendment filed on February 16th, 2026. The examiner acknowledges the amendments to claims 1, 9, 12, and 13, as well as the cancellation of claims 2, 14-16 and 21. Claims 1, 3-13, and 17-20 remain pending in the application.
Response to Arguments
Applicant's arguments filed, February 16th, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
At pages 5-6, Applicant argues that Jamshidi teaches away from a pointed stylet tip projecting from the cutting edge of the needle because Jamshidi teaches that the distal end of the assembly presents a closed end surface which is disposed in a substantially single oblique plane. Examiner respectfully disagrees. Jamshidi does not disclose a particular reason the distal end of the assembly presents a closed end surface which is disposed in substantially a single oblique plane. Rather, Jamshidi discloses that the symmetrical closed end in substantially a single oblique plane facilitates insertion of the needle into a patient and collection of a biopsy specimen and that the needle may be inserted into the patient until the tissue to be removed is engaged by the distal end of the needle, and then the stylet is removed so that a biopsy tissue will be collected (Jamshidi, Abstract, co. 2 lines 35-44). Jamshidi does not teach or suggest any particular reason that the stylet tip cannot project from the cutting edge or that projecting the tip from the cutting edge would hinder the needle from penetrating the tissue. Doppelt discloses that the trocar 33 is applied to the introducer 20, that the sharp end 36 of the trocar enables the trocar to penetrate soft tissue and to act as a guide for locating the tubular portion 22 of the introducer against the surface of the bone which is to be biopsied (Doppelt, col. 3 line 67-col. 4 line 6), and that in operation the tube 22 of the introducer 20 is guided along the rod 34 until the teeth 24 also come to rest against the bone which is to be biopsied, the trocar is then removed from the patient, and then drilling to obtain a bone sample (Doppelt, col. 5 line 60-col. 6 line 30). Both the stylet of Jamshidi and the trocar of Doppelt are used for penetrating tissue until the tissue to be removed/bone which is to be biopsied is engaged. Furthermore, modifying the stylet 18 of Jamshidi such that the pointed tip projects from the cutting edge when the stylet is in the operating position, in view of the teachings of Doppelt, would aid in penetrating soft tissue and acting as a guide for locating the introducer/needle against the surface of the bone which is to be biopsied (Doppelt, col. 3 line 67-col. 4 line 5).
At page 6, Applicant argues that the proposed modification changes the principle of operation of Jamshidi, because the stylet of Jamshidi serves as a plug to keep material from entering the needle, and that the tyle of Jamshidi does not function in any way to seat the needle in the bone. Examiner respectfully disagrees. Jamshidi discloses that the symmetrical closed end facilitates insertion of the needle into a patient and collection of a biopsy specimen and that the needle may be inserted into the patient until the tissue to be removed is engaged by the distal end of the needle, and then the stylet is removed (Jamshidi, Abstract, co. 2 lines 35-44). Furthermore, Jamshidi discloses the stylet 18 is inserted into the needle 10, interlocking of the stylet 18 and the needle 10 and inserting the needle into the patient until the tissue to be removed is engaged by the distal end of the needle, and then removing the stylet from the needle (col. 2 lines 35-61). Therefore, Jamshidi does disclose that the stylet is used to seat the cutting edge of the needle because both the stylet and the needle forming the closed distal end is used to penetrate tissue until the tissue to be removed is engaged. Doppelt discloses the trocar 33 is applied to the introducer 20, that the sharp end 36 of the trocar enables the trocar to penetrate soft tissue and to act as a guide for locating the tubular portion 22 of the introducer against the surface of the bone which is to be biopsied (Doppelt, col. 3 line 67-col. 4 line 6), and that in operation the tube 22 of the introducer 20 is guided along the rod 34 until the teeth 24 also come to rest against the bone which is to be biopsied, the trocar is then removed from the patient, and then drilling to obtain a bone sample (Doppelt, col. 5 line 60-col. 6 line 30). Doppelt further discloses removing the trocar from the patient, and then drilling to obtain a bone sample (Doppelt, col. 5 line 60-col. 6 line 30). Doppelt’s trocar aids in penetrating tissue and guiding the introducer and also functions as a plug similar to Jamshidi because a biopsy is not obtained until after the trocar is removed. Both the stylet of Jamshidi and the trocar of Doppelt are used to penetrate tissue and then are removed when the tissue to be removed/bone which is to be biopsied is engaged such that drilling can be performed to obtain the bone sample. Therefore, it is unclear how modifying the stylet 18 of Jamshidi such that the pointed tip projects from the cutting edge when the stylet is in the operating position, in view of the teachings of Doppelt would change the principle of operation as the function of the stylet does not affect the obtaining of the bone sample, but rather aids in penetrating through tissue until engagement of the tissue to be removed/bone which is to be biopsied occurs. Therefore, 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 stylet 18 of Jamshidi such that the pointed tip projects from the cutting edge when the stylet is in the operating position, in view of the teachings of Doppelt, as this would aid in penetrating soft tissue and acting as a guide for locating the introducer/needle against the surface of the bone which is to be biopsied (Doppelt, col. 3 line 67-col. 4 line 5).
At pages 6-7, Applicant argues that Jamshidi does not disclose seating a cutting edge of the needle because the stylet of Jamshidi is in congruent relationship with respect to the distal end of the needle 13 and presents a closed end surface and therefore does not and cannot engage the bone as set forth in claim 17. Examiner respectfully disagrees. As seen in fig. 3 of Jamshidi, the closed distal end is formed of both the distal end 20 of the stylet 18 and the distal cutting edge 13. When the closed distal end engages the tissue to be removed, both of the distal end 20 and the cutting edge 13 would be engaged with the tissue to be removed. Furthermore, Jamshidi discloses the stylet 18 is inserted into the needle 10, interlocking of the stylet 18 and the needle 10 and inserting the needle into the patient until the tissue to be removed is engaged by the distal end of the needle, and then removing the stylet from the needle (col. 2 lines 35-61). Therefore, Jamshidi does disclose that the stylet is used to seat the cutting edge of the needle because both the stylet and the needle having the closed distal end is used to penetrate tissue until the tissue to be removed is engaged.
Claim Rejections - 35 USC § 103
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 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi (US 3628524 A) in view of Kurc (US 20040030343 A1), and further in view of Doppelt (US 4798213 A).
Regarding claim 1, Jamshidi a bone biopsy system (figs. 1-2), comprising: a bladeless stylet (stylet 18 having bevelled distal end 20, fig. 1, co. 1 line 72-75) including an elongated body (elongate stylet 18, , fig. 1) having a pointed tip at a distal end (bevelled distal end 20, fig. 1) and a proximal end (proximal end member 21, fig. 1); and a trephine needle (biopsy needle 10, fig. 1) including an elongated shaft (cylindrical body 11, fig. 1) having a lumen (lumen 11a, fig. 3), a cutting edge at a first end (distal cutting edge 13, fig. 1) and a tool connector at a second end (proximal end member 14 have notch 17, fig. 1) wherein (a) said stylet is received in said lumen when in an operating position (“stylet 18 … inserted into the needle … interlocked”, col. 2 lines 35-61), said bone biopsy system being adapted to procure an intact bone core sample after removing the stylet from the trephine needle (“bone or bone marrow specimen”; “bone matter sample … stylet 18 will be removed … needle may again be revolved … specimen to be collected … will not be crushed”, col. 2 lines 22-24 & 35-61 & col. 3 lines 24-38).
Jamshidi does not disclose the bladeless stylet including a first drive connector at a proximal end.
However, Kurc directed to bone recuperating drilling device discloses a stylet (9, fig. 4) including a first drive connector at the proximal end (rotation drive stem 5 for connection to a rotation drive system, para. [0044, 0053], as seen in figs. 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi such that the bladeless stylet further includes a first drive connector at the proximal end, similar to that taught by Kurc, for the obvious advantage of connecting the stylet to a rotation drive system for cutting into the bone.
Jamshidi, as modified by Kurc hereinabove, does not disclose wherein (b) the pointed tip projects from the cutting edge when the stylet is in the operating position.
However, Doppelt directed to an apparatus for obtaining a bone biopsy discloses an elongated tube 22 having a plurality of sharp holding teeth 24 and an elongated rod 34 having a pointed front end 36 (as seen in fig. 5) discloses wherein (a) said stylet (trocar 33, fig. 5) is received in said lumen when in an operating position (as seen in fig. 5, col. 5 line 60-col. 6 line 30) and (b) the pointed tip (pointed front end 36, fig. 5) projects from the cutting edge (teeth 24, fig. 5) when the stylet is in the operating position (col. 2 lines 60-63 & col. 3 lines 52-66, “operating position”, pointed front end 36 extends forwardly of the gripping teeth 24 as shown in FIG. 5). Doppelt further discloses sharp end 36 of the trocar enables the trocar to penetrate soft tissue and to act as a guide for locating the tubular portion 22 of the introducer against the surface of the bone which is to be biopsied (col. 3 line 67-col. 4 line 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc hereinabove, such that (a) said stylet is received in said lumen when in an operating position and (b) the pointed tip projects from the cutting edge when the stylet is in the operating position, in view of the teachings of Doppelt, as this would aid in penetrating soft tissue and act as a guide for locating the tubular portion of the biopsy needle against the surface of the bone which is to be biopsied (Doppelt, col. 3 line 67-col. 4 line 5).
Regarding claim 3, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses the bone biopsy system of claim 1, wherein said stylet (18, figs. 1 & 3) includes a needle connector (locking pin 22, figs. 1 & 3) that releasably engages with the tool connector when the stylet is in the operating position (“releasably interlock”, col. 2 lines 8-15, fig. 3).
Regarding claim 4, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses bone biopsy system of claim 1, wherein said lumen is tapered toward the cutting edge (tapered end portion 12, fig. 1).
Regarding claim 5, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses the bone biopsy system of claim 1, wherein the cutting edge is located on an outer surface of the trephine needle (as seen in figs. 1 &3-4, col. 1 lines 49-63).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Kurc and Doppelt, as applied to claim 1 above, and further in view of Masseglia (US 20080243163 A1).
Regarding claim 6, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses the bone biopsy system of claim 1. Jamshidi, as modified by Kurc hereinabove, does not disclose wherein the cutting edge is a low-helix.
However, Masseglia directed to a perforating trocar having a helical cutting edge discloses wherein the cutting edge is a low-helix (tube 2 having lips 10, 11 … helical cutting ridge, para. [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc and Doppelt hereinabove, such that the cutting edge is a low-helix, in view of the teachings of Masseglia, as such a modification would have been merely a substitution of the cutting edge of Jamshidi for helical cutting ridges of Masseglia for cutting into bone.
Regarding claim 7, Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, discloses the bone biopsy system of claim 6. Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, does not expressly wherein the low-helix has a rake angle of between 34 and 36 degrees.
However, Masseglia directed to a perforating trocar having a helical cutting edge discloses wherein the low-helix has a rake angle of between 34 and 36 degrees (“helical ramp inclined by … 1 to 45°, para. [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, such that the low-helix has a rake angle of between 34 and 36 degrees, in view of the teachings of Masseglia, as such a modification would have been merely a substitution of the cutting edge of Jamshidi for helical cutting ridges inclined by 1 to 45° of Masseglia for cutting into bone.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Kurc, Doppelt, and Masseglia, as applied to claim 7 above, and further in view of Goldenberg (US 20090082697 A1).
Regarding claim 8, Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, discloses the bone biopsy system of claim 7. Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, does not disclose wherein the cutting edge tapers in both directions from a midline.
However, Goldenberg directed to a biopsy needle discloses wherein the cutting edge tapers in both directions from a midline (tapered regions 120 & 130 as seen in fig. 4 (see also para. [0032]). Goldenberg further discloses that the gradual taper of region 130 further decreases the resistance of penetration during needle insertion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, and Masseglia hereinabove, such that the cutting edge tapers in both directions from a midline, in view of the teachings of Goldenberg, for the obvious advantage of decreasing the resistance of penetration during needle insertion (Goldenberg, para. [0032]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Kurc, Doppelt, Masseglia, and Goldenberg, as applied to claim 8 above, and further in view of Oostman Jr. (US 20080234699 A1).
Regarding claim 9, Jamshidi, as modified by Kurc, Doppelt, Masseglia, and Goldenberg hereinabove, discloses the bone biopsy system of claim 8. Jamshidi, as modified by Kurc, Doppelt, Masseglia, and Goldenberg hereinabove, does not disclose wherein the cutting edge is reduced to a thickness of .05 mm at a cutting terminal and .2 mm at an opposite end.
However, Oostman Jr. discloses directed to a biological unit removal tool 70 having a distal taper 80 converging to a knife edge (fig. 5B) discloses wherein the cutting edge is reduced to a thickness of .05 mm at a cutting terminal and .2 mm at an opposite end (“distal taper 80 having a maximum thickness at its proximal end 82 and a minimum thickness at the distal tip 76 … converges to a knife edge at the cutting segments 84 … nominal wall thickness is 0.006 inches (0.15 mm) … radial thickness of each relief segment 86 is about 0.002 inches (0.051 mm)”, para. [0099-0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, Masseglia, and Goldenberg hereinabove, such that the cutting edge is reduced to a thickness of .05 mm at a cutting terminal and .2 mm at an opposite end, in view of the teaching of Oostman Jr., as such a modification would have been the result of routine optimization of the distal taper converging to the knife edge of the cutting segments for cutting bone.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Kurc, and Doppelt, as applied to claim 4 above, further in view of Schwery (US 20210177438 A1), and further in view of Finer (US 20020198467 A1).
Regarding claim 10, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses the bone biopsy system of claim 4. Jamshidi, as modified by Kurc and Doppelt hereinabove, does not disclose wherein the lumen taper is .75 mm in total and terminates within 13.2 mm of the first end.
However, Schwery discloses wherein the lumen taper is .75 mm in total (“taper of, e.g., .02 to 0.1 mm, para. [0065]). Schwery further discloses the taper may help to further reduce lateral friction on impaction (para. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc and Doppelt hereinabove, such that the lumen taper is .75 mm in total, in view of the teachings of Schwery, for the obvious advantage of reducing lateral friction on impaction (Schwery, para. [0065]).
Jamshidi, as modified by Kurc, Doppelt, and Schwery hereinabove, does not disclose wherein the lumen taper terminates within 13.2 mm of the first end.
However, Finer discloses wherein the lumen taper terminates within 13.2 mm of the first end (“diameter … decrease … 0.0-20 mm from the distal end of the needle”, para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, and Schwery hereinabove, such that the lumen taper terminates within 13.2 mm of the first end, in view of the teachings of Finer, as such a modification would have been the result of routine optimization of the lumen of the trephine to form the cutting opening (Finer, para. [0031]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Kurc, as applied to claim 1 above, and further in view of Cervi (US 20020042581 A1).
Regarding claim 11, Jamshidi, as modified by Kurc and Doppelt hereinabove, discloses the bone biopsy system of claim 1. Jamshidi, as modified by Kurc and Doppelt hereinabove, does not disclose the bone biopsy system further including a second drive connector having a needle connector that releasably engages with the tool connector when the stylet is removed from the lumen of the trephine needle.
However, Cervi directed to improved bone biopsy needles discloses a second drive connector (removable motor drive coupling 17, para. [0058]) having a needle connector (drive portion 19, para. [0058]) that releasably engages with a tool connector (“removable”, recess 6, para. [0058]) when a stylet (stylet 13, fig. 3B) is removed from a lumen (lumen 1, para. [0044]) of a trephine needle (cannula 3, fig. 3A) (as seen in fig. 3A, “stylet … removed”, para. [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc and Doppelt hereinabove, such that the bone biopsy system further includes a second drive connector having a needle connector that releasably engages with the tool connector when the stylet is removed from the lumen of the trephine needle, in view of the teachings of Cervi, in order to rotate the whole biopsy needle such that it is advanced through the cancellous bone and allows the specimen to be collected.
Regarding claim 12, Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, discloses the bone biopsy system of claim 11, further including a push rod (stylet 23, fig. 2) adapted for forcing the intact bone core sample from the lumen of the trephine needle (“biopsy specimen will not be crushed … 23 … inserted into the distal end to urge … outwardly”, col. 2 lines 22-34 & 52-61).
Regarding claim 13, Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, discloses the bone biopsy system of claim 12. Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, does not disclose the bone biopsy system further including a powered driver releasably connected to (a) the first drive connector of the stylet connected to the trephine needle when seating the cutting edge of the trephine needle in a bone of a patient and (b) the second drive connector connected to the trephine needle when procuring the intact bone core sample in the lumen.
However, Kurc directed to a bone recuperating drilling device discloses a powered driver (“rotation drive system”, para. [0053]) releasably connected to (a) the first drive connector (stem 5) of the stylet (blade 9) connected to the trephine needle (trephine 1) when seating the cutting edge of the trephine needle in a bone of a patient (para. [0044, 0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, such that the bone biopsy system further includes a powered driver releasably connected to (a) the first drive connector of the stylet connected to the trephine needle when seating the cutting edge of the trephine needle in a bone of a patient, in view of the teachings of Kurc, as such a modification would have yielded predictable results, namely performing a drilling operation to penetrate a bone by driving the stylet and needle in rotation.
Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, does not disclose the bone biopsy system further including the powered driver releasably connected to (b) the second drive connector connected to the trephine needle when procuring the intact bone core sample in the lumen.
However, Cervi directed to improved bone biopsy needles discloses a powered driver (motor drive 27, fig. 4B) releasably connected to (b) a second drive connector (removable motor drive coupling 17 having drive portion 19, fig. 4B) connected to the trephine needle when procuring the intact bone core sample in the lumen (para. [0058, 0064] as seen in figs. 4B &7D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Kurc, Doppelt, and Cervi hereinabove, such that the bone biopsy system further includes the powered driver releasably connected to (b) the second drive connector connected to the trephine needle when procuring the intact bone core sample in the lumen, in view of the teachings of Cervi, in order to rotate the whole biopsy needle such that it is advanced through the cancellous bone and allows the specimen to be collected.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Cervi.
Regarding claim 17, Jamshidi discloses a method of procuring a bone core sample from a bone (“bone or bone marrow specimen is to be obtained …in use …”, col. 2 lines 22-61), comprising: seating a cutting edge (cutting edge 13, fig. 1) of a trephine needle (biopsy needle 10, fig. 1) in the bone (“needle … inserted into the patient … penetration of a bone”, col. 2 lines 35-61) by first engaging a stylet (stylet 18, fig. 1) in the bone (“interlocked … inserted into a patient … penetration of bone”, col. 2 lines 35-61 (Examiner note: As seen in fig. 3 of Jamshidi, the closed distal end is formed of both the distal end 20 of the stylet 18 and the distal cutting edge 13. When the closed distal end engages the tissue to be removed, both of the distal end 20 and the cutting edge 13 would be engaged with the tissue to be removed)) and thereby holding the trephine needle in a seating position (“reached the tissue from which the specimen is to be removed”, col. 2 lines 35-61); removing the stylet from the trephine needle (“stylet 18 will be removed from the needle”, col. 2 lines 35-61); and driving the trephine needle into the bone (“needle … revolved … forwardly”, col. 2 lines 35-61) and securing an intact bone core sample within a lumen of the trephine needle (“specimen to be collected interiorly of the needle … will not be crushed”, col. 2 lines 35-61).
Jamshidi does not expressly disclose connecting a drive connector to the trephine needle.
However, Cervi directed to a biopsy needle provided with a removable motor drive coupling 17 (para. [0058]) discloses connecting a drive connector (removable motor drive coupling 17, figs. 1B & 3A & 4B, para. [0058-0060, 0062]) to the trephine needle (cannula 3, fig. 4B) (removable motor drive coupling 17 and motor drive 27; “motor drive attached”, para. [0058,0062- 0064], figs. 1B & 4A & 7D). Cervi further discloses that the motor drive rotates the whole biopsy needle, that is both the cannula and the handle (para. [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, such that the method further includes connecting a drive connector to the trephine needle, in view of the teaching of Cervi, as this would aid in collecting the specimen interiorly of the needle by rotating the whole biopsy needle to produce a cutting action of the tissue.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jamshidi in view of Cervi, as applied to claim 17 above, and further in view of Kurc.
Regarding claim 18, Jamshidi, as modified by Cervi hereinabove, discloses the method of claim 17. Jamshidi, as modified by Cervi hereinabove, does not disclose the method including connecting a powered driver to the stylet before seating the cutting edge in the bone.
However, Kurc directed to a bone recuperating drilling device having a trephine needle 1 and a stylet 9 comprising a stem 5 discloses connecting a powered driver (“rotation drive system”, para. [0053]) to the stylet (“removably mounted”; stem 5 & blade 9, para. [0024, 0046]) before seating the cutting edge in the bone (“guide the trephine while drilling”, para. [0023-0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Cervi hereinabove, such that the method further includes connecting a powered driver to the stylet before seating the cutting edge in the bone, in view of the teachings of Kurc, as this would aid in guiding the trephine needle while drilling (Kurc, para. [0023-0025]).
Regarding claim 19, Jamshidi, as modified by Cervi and Kurc hereinabove, discloses the method of claim 18. Jamshidi, as modified by Cervi and Kurc hereinabove, does not disclose the method including connecting the powered driver to the drive connector before driving the trephine needle into the bone.
However, Cervi directed to an improved bone biopsy needles having a cannula 3 having a removable motor drive coupling 17 and a motor drive 27 discloses connecting a powered driver (motor drive 27, para. [0029, 0062], fig. 4B) to the drive connector (removable motor drive coupling 17) before driving the trephine needle into the bone (“adapted for … motor-assisted insertion”, “rotates”, para. [0029, 0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Cervi and Kurc hereinabove, such that the method further includes connecting the powered driver to the drive connector before driving the trephine needle into the bone, in view of the teaching of Cervi, as this would aid in collecting the specimen interiorly of the needle by rotating the whole biopsy needle to produce a cutting action of the bone.
Regarding claim 20, Jamshidi, as modified by Cervi and Kurc hereinabove, discloses the method of claim 19, including removing the trephine needle from the bone (needle 10 may be removed from the biopsy tract, col. 2 lines 35-61), and inserting a push rod into the lumen of the trephine needle to force the bone core sample from the lumen (“stylet 23 may be inserted … urge specimen gently … outwardly”, col. 2 lines 35-61) and inserting the stylet into the lumen of the trephine needle and connecting the stylet to the trephine needle before seating the cutting edge (“stylet 18 will be inserted into the needle 10 … interlocked … inserted into the patient”, col. 2 lines 35-61).
Jamshidi, as modified by Cervi and Kurc hereinabove, does not disclose removing the drive connector from the trephine needle.
However, Cervi directed to an improved bone biopsy needles discloses removing a drive connector from a trephine needle (removable motor drive coupling 17, para. [0058], as seen in figs. 7D-E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jamshidi, as modified by Cervi and Kurc hereinabove, such that the method further comprises removing the drive connector from the trephine needle, in view of the teachings of Cervi, as this would aid in enabling the removal of the needle having the collected specimen from the biopsy tract.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791