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 .
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 1-3, 6 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2003/0225344 in view of Muschler US 2007/0055282.
Regarding claims 1 and 21, Miller discloses a device comprising: a needle assembly comprising:
a hollow tubular sleeve having a proximal end and a distal end and a hollow opening therethrough forming a sleeve conduit and one or more side openings fluidly connected to the sleeve conduit, and ([FIG1a][¶35] shaft 14 with side openings),5
a stylet positionable within the hollow opening of the hollow tubular sleeve, the stylet having a first conduit therethrough, one or more end-openings ([¶35,36][FIG1c] stylet 19) the one or more end-openings are extendable through the distal end of the hollow tubular sleeve ([FIG1]), and
wherein the device is configured to aspirate bone marrow through the one or more side opening of the hollow tubular sleeve ([¶40] opening 23), when the device is inserted in bone marrow so that the one or more side openings are exposed to the bone marrow and a suction generator applies suction to the sleeve conduit, at least a portion of the bone marrow is withdrawn into the device through the one or more side openings ([¶41,43][FIG3B] for at least a portion of the suction sampling the trocar is within the hollow tubular sleeve as the marrow obtained from port 13 is collected via port 23).
Miller discloses a conduit in the needle and a conduit in the outer sleeve that are not in fluid communication ([FIG1A][¶40] port 13 of the needle conduit is separate from the sleeve conduit of 14 even though they can be lined up).
Miller does not specifically disclose the stylet is configured such that the sharp tip configured to penetrate cortical bone by puncturing through the cortical bone surface and a liquid pressure generator in fluid communication with the first conduit of the stylet and configured to apply pressure to liquid in the first conduit, such that the liquid is forcible through the first conduit and out the one or more end-openings of the stylet. Muschler teaches a sharp tip that extends through the hollow tube ([¶48][FIG3] bit 50 is rotated to cut through and puncture cortical bone) and a pressure generator ([¶56,64] irrigation control 142 or anticoagulant control 132 control the flow and pressure of the delivered fluid). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Miller with the teachings of Muschler in order to allow for better harvesting of bone marrow samples ([¶15]).
Regarding claim 2, Miller discloses a conduit in the needle and a conduit in the outer sleeve that are not in fluid communication ([FIG1A][¶40] port 13 of the needle conduit is separate from the sleeve conduit of 14 even though they can be lined up).
Regarding claim 3, Miller discloses the stylet is removable and wherein the sleeve conduit is configured to obtain a bone core sample when the stylet is removed ([¶41]).
Regarding claim 6, Miller discloses that the stylet comprises a distal end portion that is engaged to a tip of the hollow tubular sleeve ([FIG2A]).
Regarding claim 22, Muschler teaches a device comprising a liquid pressure generator connected to the proximal opening of the stylet conduit and configured to drive a liquid through the stylet conduit ([FIG4]).
Regarding claim 23, Miller discloses a device comprising a suction generator connected to the proximal opening of the sleeve conduit and configured to draw a biological material through the at least one side opening of the sleeve and through the sleeve conduit ([¶41,43][FIG3B]).
Claims 10, 12-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller US 2003/0225344 in view of Muschler US 2007/0055282 further in view of Stauber 2013/0046200.
Regarding claim 10, Muschler teaches a needle assembly drilling into the bone as the needle assembly configured to penetrate cortical bone by puncturing through the cortical bone and aspirating bone marrow from the bone through the needle assembly without removing the needle assembly30 from the site of drilling ([FIG4][¶55] the samples are suctioned through the passage 76 [¶48,57-59] while fluid is delivered through lumen 42 to and holes 58 in the tip 50).
Miller as modified by Muschler does not disclose administering a liquid anesthetic to a site of drilling in a bone through an opening in a tip of the needle assembly. Stauber teaches a similar bone biopsy device that does deliver anesthetic ([¶38]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Miller with the anesthetic of Stauber in order to alleviate pain ([¶3]).
Regarding claim 12, Miller discloses a device comprising: a needle assembly comprising:
a hollow tubular sleeve having a proximal end and a distal end and a hollow opening therethrough forming a sleeve conduit and one or more side openings fluidly connected to the sleeve conduit, and ([FIG1a][¶35] shaft 14 with side openings),5
a stylet positionable within the hollow opening of the hollow tubular sleeve, the stylet having a first conduit therethrough, one or more end-openings ([¶35,36][FIG1c] stylet 19) the one or more end-openings are extendable through the distal end of the hollow tubular sleeve ([FIG1]), and
wherein the device is configured to aspirate bone marrow through the one or more side opening of the hollow tubular sleeve ([¶40] opening 23), when the device is inserted in bone marrow so that the one or more side openings are exposed to the bone marrow and a suction generator applies suction to the sleeve conduit, at least a portion of the bone marrow is withdrawn into the device through the one or more side openings ([¶41,43][FIG3B] for at least a portion of the suction sampling the trocar is within the hollow tubular sleeve as the marrow obtained from port 13 is collected via port 23).
Miller discloses a conduit in the needle and a conduit in the outer sleeve that are not in fluid communication ([FIG1A][¶40] port 13 of the needle conduit is separate from the sleeve conduit of 14 even though they can be lined up).
Miller does not specifically disclose the stylet is configured such that the sharp tip configured to penetrate cortical bone by puncturing through the cortical bone surface and a liquid pressure generator in fluid communication with the first conduit of the stylet and configured to apply pressure to liquid in the first conduit, such that the liquid is forcible through the first conduit and out the one or more end-openings of the stylet. Muschler teaches a sharp tip that extends through the hollow tube ([¶48][FIG3] bit 50 is rotated to cut through and puncture cortical bone) and a pressure generator ([¶56,64] irrigation control 142 or anticoagulant control 132 control the flow and pressure of the delivered fluid). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Miller with the teachings of Muschler in order to allow for better harvesting of bone marrow samples ([¶15]).
Regarding claims 13, Miller discloses a conduit in the needle and a conduit in the outer sleeve that are not in fluid communication ([FIG1A][¶40] port 13 of the needle conduit is separate from the sleeve conduit of 14 even though they can be lined up).
Regarding claim 14, Miller discloses the stylet is removable and wherein the sleeve conduit is configured to obtain a bone core sample when the stylet is removed ([¶41]).
Regarding claim 17, Stauber teaches a biopsy device that injects lidocaine ([¶45]).
Claims 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Muschler and Stauber US 2013/0046200 further in view of Popa-Simil et al. US 2014/0228661.
Regarding claims 5 and 16, Miller as modified by Stauber teaches the pressure generator is a syringe for delivering fluid but does not teach the suction generator is a syringe. Popa teaches a similar biopsy device that uses a syringe to aspirate the marrow ([¶3]). Therefore it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the syringe of Popa with the device of Miller as modified because a syringe is already disclosed for delivering the anesthesia. The combination is no more than the predictable use of prior art elements via known methods for their established purpose. Muschler teaches that the suction and the pressure generator can be of any suitable construction for use by the surgeon ([¶55,56]).
Response to Arguments
Applicant's arguments filed 12/5/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Miller does not disclose that penetrating cortical bone, Examiner respectfully disagrees. Muschler is now relied on to teach the stylet puncturing the surface of the cortical bone.
Regarding Applicant’s argument that Miller teaches away from using the stylet to penetrate cortical bone, Examiner respectfully disagrees. Miller only teaches away from using manual pressure to force the sampling needle into the bone via hand/arm pressure that can fracture bone or the needle. Millers’ solution to this is drilling into the bone and Muschler teaches a similar bone sampling device that uses drilling action on the cutting stylus to cut through the bone. Muschler’s cutting stylet also provides the advantage of preserving sampling of marrow by cutting through it ([¶59]).
Regarding Applicant’s arguments that the trocar must be removed to sample the tissue, Examiner respectfully disagrees. For at least a portion of the suction sampling the trocar is within the hollow tubular sleeve as the marrow obtained from port 13 is collected via port 23 ([¶41,43][FIG3B]). In a broadest reasonable interpretation, a sample in port 13 is drawn up through the sleeve to remove the sample or suctioned up and the trocar is still in the sleeve for a portion of that.
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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached on 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791