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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/12/2025 has been entered.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7, 9-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Miller ‘857 (U.S. Patent Pub. No. 20080045857) (previously cited) in view of Muse (U.S. Patent Pub. No. 20190328370) (previously cited), Goldenberg (JP H09510630) (previously cited), Landey (U.S. 20180280660) (previously cited), and Miller (WO 03101306).
Regarding claim 1, Miller ’857 teaches a bone biopsy device (Figure 2), comprising: a handle assembly (214), comprising a motor (218); a transmission operably (gear assembly 220) coupled to the motor (218); an intermediate cannula (Figure 4E, 110c); and a penetration member (Fig. 4E, stylet 120c) operably coupled to the transmission (Fig. 5A, penetration member is depicted at first end 101 would be coupled to gear assembly 220 of Fig. 2, which is contained in the housing 210), the penetration member having … a distal end comprising a penetrating tip (125, 126) (Paragraph [0191]); wherein the penetrating tip (123) of the penetration member is positioned within the outer coax cannula (Fig. 3G, outer penetrator 110g) in the retracted configuration and extending distally beyond the outer coax cannula in the extended configuration. (Figures 3I and 3J; Paragraphs [0009], [0180]-[0181]).
However, Miller ‘857 does not teach “an inner cannula coaxially disposed within the intermediate cannula”, “a penetration member…coaxially disposed within the inner cannula, the penetration member having a proximal end positioned within the handle assembly, a laterally extending protrusion within the handle assemble and disposed on the penetration member at least proximate to the proximal end,” “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration; and a coax assembly, comprising an outer coax cannula operably coupled to the transmission and coaxially disposed over the intermediate cannula” and “the proximal end and laterally extending protrusion of the penetration member are positioned within the handle assembly when the penetration member is in the extended configuration and when the penetration member is in the retracted configuration; and the motor is offset from the intermediate cannula. the inner cannula, the penetration member, the outer coax cannula, and the penetrating tip”.
Muse, in a related field of endeavor, teaches a bone biopsy system (Figure 1) comprising an inner cannula (extraction cannula 144) coaxially disposed within the intermediate cannula (coring cannula 134), and a coax assembly, comprising an outer coax cannula (cutting cannula 124) coaxially disposed over the intermediate cannula (134). (Fig. 5B, Paragraphs [0126], [0128]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “an inner cannula coaxially disposed within the intermediate cannula” and “a coax assembly, comprising an outer coax cannula” of Muse “operably coupled to the transmission” of Miller ‘857 as it provides a means to rotate and drive the coring and extraction assembly, such as with a powered driver. (Paragraph [0127] of Muse). Hence, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a coax assembly, comprising an outer coax cannula” of Muse “operably coupled to the transmission” of Miller ‘857 and “coaxially disposed over the intermediate cannula” of Muse. Doing so provides a mechanism that defines an inner diameter that is sufficiently larger than an outer diameter of the coring cannula to avoid frictional engagement of sufficient strength to achieve rotation of the cutting cannula and further enables collection of the sample such that its structural integrity can be maintained. (Paragraphs [0142], [0144] of Muse).
Goldenberg, in a related field of endeavor, teaches a needle (Figures 1-2) for extracting bone marrow comprising a penetration member (stylet 20) coaxially disposed within the inner cannula (inner tube 14). (Page 3, 42-44; Page 4, lines 20-21 of Machine Translation).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a penetration member…coaxially disposed within the inner cannula” of Goldenberg. Doing so enables the thin penetrating needle member to be guided toward the bone during extraction such that it obtains only a liquid aspirate of bone marrow material, a procedure which is less painful than bone marrow biopsy. (Page 1, lines 16-19 of Description of Machine Translation).
Landey, in a related field of endeavor, teaches a core biopsy device (Figures 4C-4D, 4F) comprising the penetration member (shaft 420, elongate member 422) having a proximal end and a laterally extending protrusion (423) positioned within the handle assembly (405) and a distal end comprising a penetrating tip (not shown); and a member (grip portion 411) configured to displace the laterally extending protrusion (423) of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration and wherein the proximal end and the laterally extending protrusion (423) of the penetration member (420, 422) are positioned within the handle assembly (405) when the penetration member is in the extended configuration and when the penetration member is in the retracted configuration. (Paragraphs [0086]-[0088]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a laterally extending protrusion within the handle assemble and disposed on the penetration member at least proximate to the proximal end” and “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration” as taught by Landey. Doing so provides a mechanism which provides extension and retraction of the tool such that controlled linear motion is achieved. (Paragraph [0089]).
Miller ‘306, in a related field of endeavor, illustrates an apparatus for removing portions of bone marrow (Fig. 1A) wherein the motor (38) is offset from the drive assembly, i.e., hollow drive shaft (14) and removable trocar (19).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive assembly of Miller ‘857 such that “the motor is offset”, as taught by Miller ‘306, from the intermediate cannula, the inner cannula, the penetration member, the outer coax cannula, and the penetrating tip of Miller ‘857. Doing so yields predictable results of rotating the drive shaft.
Regarding claim 2, Miller ’857 teaches (Figure 2) wherein the handle assembly further comprises a handle housing (210); and a motor activation switch (Paragraph [0138] a trigger assembly 244 disposed within housing 210 proximate handle 214, comprising a trigger or contact switch 246).
Regarding claim 3, Miller ’857 teaches wherein the transmission comprises a plurality of gears.
(Paragraph [0132] housing may accommodate various types of gear assemblies such as “reduction gears” or “planetary gears”).
However, Miller ‘857 does not teach “the proximal end and the laterally extending protrusion of the penetration member are positioned proximally of at least one gear of the plurality of gears that is configured to rotate the penetration member”.
Landey teaches (Figs. 4C-4D, 4G-4H) the proximal end and the laterally extending protrusion (423) of the penetration member (420, 422) are positioned proximally of at least one gear (helical cam 430) that is configured to rotate the penetration member (420, 422). (Paragraph [0090]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide wherein “the proximal end and the laterally extending protrusion of the penetration member are positioned proximally of at least one gear” of Landey of the plurality of gears of Miller ‘857, that is configured to rotate the penetration member. Doing so provides a mechanism that achieves the desired linear motion of the shaft for a given amount of twist on the cam. (Paragraph [0090] of Landey).
Regarding claim 4, Miller ’857 teaches a gear reduction ratio of the transmission ranges from 50:1 to 20:1. (Paragraph [0135] powered drivers used to provide intraosseous access during emergency medical procedures may operate at a higher speed and may include gear assemblies having a smaller speed reduction ratio, for example between 10:1 and 30:1, resulting in higher drive shaft RPM's.).
Regarding claim 5, Miller ’857 teaches (Figure 3D) wherein the penetration member (120) further comprises a tip (123) configured to drill into the bone. (Paragraph [0160]).
Regarding claim 7, Miller ’857 teaches (Figure 3I) that the penetrator may be a trocar (120g). (Paragraph [0181]).
Regarding claim 9, Miller ‘857 as modified does not teach “wherein the handle assembly further comprises a member slidingly coupled to a handle housing”.
Landey teaches wherein the handle assembly (Figure 5A) further comprises a member (slider 510, tab 512) slidingly coupled to a handle housing (500A). (Paragraph [0094]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein the handle assembly further comprises a member slidingly coupled to a handle housing” of Landey. Doing so provides a mechanism to translate the assembly during a biopsy.
Regarding claim 10, Miller ’857 teaches (Figure 3H) wherein the outer coax cannula (outer cannula 110h) comprises a trephine tip (cylindrical cutting head) comprising a plurality of distally extending teeth, wherein a first tooth of the plurality of teeth is biased radially inward and an adjacent tooth of the plurality of teeth is biased radially outward.
Regarding claim 12, Miller ‘857 teaches a power pack (216) comprising a power source. (Paragraph [0129]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Landey, and Miller ‘306, further in view of Crocker (AU 2008254464) (previously cited).
Regarding claim 6, Miller ’857 as modified does not teach “wherein the outer coax assembly is removably coupled to the handle assembly”.
Crocker, in a related field of endeavor, teaches (Figure 1) a device for body tissue extraction wherein the outer coax assembly (aspiration cannula 105) is removably coupled to the handle assembly (102, 302). (Paragraphs [0070]-[0071]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein the outer coax assembly is removably coupled to the handle assembly” of Crocker. Doing so enables the coax assembly to couple and decouple from the drill, which allows that coax assembly to be disposable and drill to be reusable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Landey, and Miller ‘306 further in view of Fumex (FR 3007636) (previously cited).
Regarding claim 8, Miller ‘857 as modified does not teach “wherein the penetration member further comprises a groove extending from a proximal end to a distal end.”
Fumex, in a related field of endeavor, teaches (Figures 4-5) wherein the penetration member (Abstract, trocar device comprising outer sheath 5 comprising rigid tube 8, and mandrel 6 comprising rod 18 with piercing tip 21, 33), further comprises a groove (20) extending from a proximal end to a distal end. (Abstract; Page 4, lines 19-22 the rod 18 is a grooved rod that has a longitudinal groove 20 in extending from a proximal end to a distal end).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein the penetration member further comprises a groove extending from a proximal end to a distal end” of Fumex. Doing so provides a mechanism that is configured to provide for passage through the lumen.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Landey, and Miller ‘306, further in view of Swisher (EP 1731103) (previously cited).
Regarding claim 11, Miller ‘857 as modified does not teach “wherein the coax assembly further comprises a depth limiting member slidingly disposed on the outer coax cannula”.
Swisher, in a related field of endeavor, teaches (Figures 1, 3) a bone penetrating needle assembly comprising wherein the coax assembly further comprises a depth limiting member (depth stop unit 50) slidingly disposed on the outer coax cannula. (Paragraphs [0025], [0032]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “a depth limiting member slidingly disposed on the outer coax cannula” of Swisher. Doing so provides a mechanism to limit penetration of the needle into the subject and expose a greater or lesser length of the needle for penetration into the body. (Paragraph [0004]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Landey, and Miller ‘306, further in view of Morgan (U.S. Patent Pub. No. 20150230823) (previously cited).
Regarding claim 13, Miller ‘857 as modified does not teach “wherein at least one of the power pack or the motor are selectively removeable from the handle assembly.”
Morgan, in a related field of endeavor, teaches (Figure 3A) wherein at least one of the power pack is selectively removeable from the handle assembly. (Paragraph [0055] a power driver appropriate for bone biopsy comprising batteries (40), which may be removeable).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein at least one of the power pack [is] selectively removeable from the handle assembly” of Morgan. Doing so enables replacement and/or recharging of the batteries. (Paragraph [0055]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Landey, and Miller ‘306, further in view of Morgan.
Regarding claim 14, Miller ‘857 as modified does not teach “wherein at least one of the power pack is reusable or the motor is reusable.”
Morgan, as previously discussed, teaches removing at least one of the power pack from the biopsy device; re-using the at least one of the power pack). (Figure 3A; Paragraph [0055] a power driver appropriate for bone biopsy comprising batteries 40 which may be removeable for replacement and/or recharging).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Muse as modified to provide the steps of “wherein at least one of the power pack is reusable or the motor is reusable” of Morgan. Doing so provides a modular and renewable power source that has the well-known feature of frequent reuse of the device. (Paragraph [0055]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Morgan, Landey, and Miller ‘306.
Regarding claim 15, Miller ’857 teaches a bone biopsy device (Figure 2) comprising a handle assembly (214) comprising a motor (218); a transmission (gear assembly 220) operably coupled to the motor (218); an intermediate cannula (Figure 4E, 110c); and a penetration member (Fig. 4E, stylet 120c) operably coupled to the transmission (Fig. 5A, penetration member is depicted at first end 101 would be coupled to gear assembly 220 of Fig. 2, which is contained in the housing 210), the penetration member having …. a distal end comprising a penetrating tip (125, 126) (Paragraph [0191]); a power pack (216) comprising a power source (Paragraph [0129]); wherein the penetrating tip (123) of the penetration member is positioned within the outer coax cannula (Fig. 3G, outer penetrator 110g) in the retracted configuration and extending distally beyond the outer coax cannula in the extended configuration. (Figures 3I and 3J; Paragraphs [0009], [0180]-[0181]).
However, Miller ‘857 does not teach “an inner cannula coaxially disposed within the intermediate cannula”, “a penetration member…coaxially disposed within the inner cannula, the penetration member having a proximal end, a laterally extending protrusion disposed on the penetration member at least proximate to the proximal end of the penetration member,” and “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration”; “an outer coax cannula operably coupled to the transmission and coaxially disposed over the intermediate cannula”, “wherein at least one of the power pack or the motor are selectively removeable from the handle assembly, the power pack and the motor are offset from the intermediate cannula, and wherein at least one of the power pack is reusable or the motor is reusable” and “the proximal end and laterally extending protrusion of the penetration member are positioned within the handle assembly when the penetration member is in the extended configuration and when the penetration member is in the retracted configuration”.
Muse teaches (Figure 1) a bone biopsy system comprising an inner cannula (extraction cannula 144) coaxially disposed within the intermediate cannula (coring cannula 134), and a coax assembly, comprising an outer coax cannula (cutting cannula 124) coaxially disposed over the intermediate cannula (134). (Fig. 5B, Paragraphs [0126], [0128]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “an inner cannula coaxially disposed within the intermediate cannula” and “a coax assembly, comprising an outer coax cannula” of Muse “operably coupled to the transmission” of Miller ‘857 as it provides a means to rotate and drive the coring and extraction assembly, such as with a powered driver. (Paragraph [0127] of Muse). Hence, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a coax assembly, comprising an outer coax cannula” of Muse “operably coupled to the transmission” of Miller ‘857 and “coaxially disposed over the intermediate cannula” of Muse. Doing so provides a mechanism that defines an inner diameter that is sufficiently larger than an outer diameter of the coring cannula to avoid frictional engagement of sufficient strength to achieve rotation of the cutting cannula and further enables collection of the sample such that its structural integrity can be maintained. (Paragraphs [0142], [0144] of Muse).
Goldenberg, as previously discussed, teaches (Figures 1-2) a needle for extracting bone marrow comprising a penetration member (stylet 20)… coaxially disposed within the inner cannula (inner tube 14). (Page 3, 42-44; Page 4, lines 20-21 of Machine Translation).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a penetration member…coaxially disposed within the inner cannula” of Goldenberg. Doing so enables the thin penetrating needle member to be guided toward the bone during extraction such that it obtains only a liquid aspirate of bone marrow material, a procedure which is less painful than bone marrow biopsy. (Page 1, lines 16-19 of Description of Machine Translation).
Morgan, as previously discussed, teaches (Figure 3A) wherein at least one of the power pack is selectively removeable from the handle assembly. (Paragraph [0055] a power driver appropriate for bone biopsy comprising batteries (40), which may be removeable), and wherein at least one of the power pack is reusable.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein at least one of the power pack [is] selectively removeable from the handle assembly and wherein at least one of the power pack is reusable or the motor is reusable” of Morgan. Doing so provides a modular and renewable power source that has the well-known feature of frequent reuse of the device. (Paragraph [0055]).
Miller ‘306 illustrates an apparatus for removing portions of bone marrow (Fig. 1A) wherein the power pack (39) and the motor (38) are offset from the intermediate cannula (hollow drive shaft 14)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive assembly of Miller ‘857 such that “the power pack and the motor are offset from the intermediate cannula”, as taught by Miller ‘306. Doing so yields predictable results of rotating the drive shaft.
Landey, as previously discussed, teaches a core biopsy device (Figures 4C-4D, 4F) comprising the penetration member (shaft 420, elongate member 422) having a proximal end, a laterally extending protrusion (423) disposed on the penetration member (420, 422) at least proximate to the proximal end of the penetration member (420, 422) and a member (grip portion 411) configured to displace the laterally extending protrusion (423) of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration and wherein the proximal end and the laterally extending protrusion (423) of the penetration member (420, 422) are positioned within the handle assembly (405) when the penetration member is in the extended configuration and when the penetration member is in the retracted configuration. (Paragraphs [0086]-[0088]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a laterally extending protrusion disposed on the penetration member at least proximate to the proximal end of the penetration member” and “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration”; and “the proximal end and laterally extending protrusion of the penetration member are positioned within the handle assembly when the penetration member is in the extended configuration and when the penetration member is in the retracted configuration” as taught by Landey. Doing so provides a mechanism which provides extension and retraction of the tool such that controlled linear motion is achieved. (Paragraph [0089]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Miller ’857 in view of Muse, Goldenberg, Morgan, Landey, and Miller ‘306 further in view of Fumex.
Regarding claims 16-17, Miller ‘857 as modified does not teach “wherein the penetration member further comprises a groove extending from a proximal end to a distal end” and “wherein the groove is V-shaped.”
Fumex, in a related field of endeavor, teaches (Figures 4-5) wherein the penetration member (Abstract, trocar device comprising outer sheath 5 comprising rigid tube 8, and mandrel 6 comprising rod 18 with piercing tip 21, 33), further comprises a groove (20) extending from a proximal end to a distal end, wherein the groove is V-shaped. (Abstract; Page 4, lines 19-22 the rod 18 is a grooved rod that has a longitudinal groove 20 in the shape of a V extending from a proximal end to a distal end).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 as modified to provide “wherein the penetration member further comprises a groove extending from a proximal end to a distal end” and “wherein the groove is V-shaped” of Fumex. Doing so provides a mechanism that is configured to provide for passage through the lumen.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Landey, Miller ‘306, and Lampropoulos (U.S. Patent Pub. No. 20140171826) (previously cited).
Regarding claim 18, Muse teaches a method of obtaining a core tissue sample from a patient (Figures 1, 4, 5C-5E), comprising: obtaining a bone biopsy device (100), comprising a handle assembly (172), wherein the handle assembly comprises: an inner cannula (extraction cannula 144); an intermediate cannula (coring cannula 134); a penetration member (trocar 114) having a proximal end and a distal end comprising a penetrating tip (cutting tip 116); a motor (driver 170); a coax assembly, wherein the coax assembly comprises an outer coax cannula (cutter tube 124); and a power pack (i.e., a powered drill contemplates a power pack) (Paragraph [0137]); inserting the outer coax cannula (124), the inner cannula (144), the intermediate cannula (134), and the penetration member (144) into the patient (See Figures 5A-5E); inserting the intermediate cannula (134) and the inner cannula (144) into at least one of a bone lesion or bone marrow (52). (Figures 5D-5E); removing the inner cannula, the intermediate cannula…from the patient (Figure 5F; Paragraph [0149] the cutting cannula, coring cannula, and extraction cannula can be removed from the patient, in unison or serially) and removing the penetration member from the patient (Paragraphs [0157], [0251] trocar (114) is simply an elongated insert that can be removed from the cutting cannula); and to eject the core tissue sample from the inner cannula. (Paragraph [0149] a push rod 160 can be inserted through a channel through the hub 142, through the extraction cannula 144, and into contact with a proximal end of the sample 54. The push rod 160 is advanced distally to push the sample 54 through the distal end of the extraction cannula 144).
However, Muse does not teach “a laterally extending protrusion disposed on the penetration member at least proximate to the proximal end of the penetration member”, “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration”, a motor “offset from the intermediate cannula”, “retracting the penetration member from the extended configuration having the penetrating tip outside the outer coax cannula and the proximal end of the penetration member positioned within the handle assembly to the retracted configuration having the penetrating tip positioned within the outer coax cannula and the proximal end and the laterally extending protrusion of the penetration member positioned within the handle assembly” and “displacing the penetration member from the retracted configuration” to the extended configuration to eject the core tissue sample from the inner cannula.
Landey, as previously discussed, teaches a core biopsy device (Figures 4C-4D, 4F) comprising a laterally extending protrusion (423) disposed on the penetration member (420, 422) at least proximate to the proximal end of the penetration member (420, 422) and a member (grip portion 411) configured to displace the laterally extending protrusion (423) of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration and wherein the proximal end and the laterally extending protrusion (423) of the penetration member (420, 422) are positioned within the handle assembly (405). (Paragraphs [0086]-[0088]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Miller ‘857 to provide “a laterally extending protrusion disposed on the penetration member at least proximate to the proximal end of the penetration member” and “a member configured to displace the laterally extending protrusion of the penetration member to adjust the penetration member from a retracted configuration to an extended configuration and wherein the proximal end and the laterally extending protrusion of the penetration member are positioned within the handle assembly” as taught by Landey. Doing so provides a mechanism which provides extension and retraction of the tool such that controlled linear motion is achieved. (Paragraph [0089]).
Miller ‘306, as previously discussed, illustrates an apparatus for removing portions of bone marrow (Fig. 1A) wherein the motor (38) is offset from the intermediate cannula (hollow drive shaft 14).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive assembly of Miller ‘857 such that “the motor is offset from the intermediate cannula”, as taught by Miller ‘306. Doing so yields predictable results of rotating the drive shaft.
Lampropoulos, in a related field of endeavor, teaches a biopsy assembly (150) (Figure 20) comprising a handle (155) configured to manipulate, fire, or otherwise operate other components of the biopsy assembly (150), such as needles, trocars, stylets, cannulas, in order to obtain a tissue sample, and further teaches retracting the penetration member from an extended configuration having the penetrating tip (162) outside the outer coax cannula (170), having the penetrating tip (162) positioned within the outer coax cannula, and displacing the penetration member (160) from the retracted configuration to the extended configuration. (Fig. 20; Paragraphs [0107]-[0109] biopsy assembly 150 further comprises a stylet 160 disposed within a cannula 170, comprising a penetrating tip 162. The stylet 160 and cannula 170 may be operably coupled to handle 155 such that manipulation or actuation of the handle 155 is configured to advance or retract the stylet 160 and/or cannula 170 in order to obtain a tissue sample.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Muse to provide the steps of “retracting the penetration member from an extended configuration having the penetrating tip outside the outer coax cannula … having the penetrating tip positioned within the outer coax cannula” and “displacing the penetration member from the retracted configuration” of Lampropoulos under simple substitution of a tissue biopsy sample retainment mechanism, wherein the retention area of the collected sample is a trough. (Paragraph [0108]).
Regarding claim 19, Muse teaches that inserting the outer coax cannula (124), the inner cannula (144), the intermediate cannula (134), and the penetration member (144) into the patient comprises rotating the outer coax cannula (124), the inner cannula (144), the intermediate cannula (134), and the penetration member (144) via powered drill. (Abstract, Paragraphs [0127], [0133]-[0135], [0148]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Landey, Miller ‘306, and Lampropoulos, further in view of Morgan.
Regarding claim 20, Muse as modified does not teach “removing at least one of the power pack or the motor from the biopsy device and re-using the at least one of the power pack or the motor.”
Morgan, as previously discussed, teaches removing at least one of the power pack from the biopsy device; re-using the at least one of the power pack). (Figure 3A; Paragraph [0055] a power driver appropriate for bone biopsy comprising batteries 40 which may be removeable for replacement and/or recharging).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Muse as modified to provide the steps of “removing at least one of the power pack from the biopsy device and re-using the at least one of the power pack” of Morgan. Doing so provides a modular and renewable power source that has the well-known feature of frequent reuse of the device. (Paragraph [0055]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 8/12/2025 with respect to the rejection of claims 1-20 under U.S.C. 103 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Miller ‘306 is relied upon for the amended feature.
Conclusion
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791