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 .
Response to Amendment
This office action is responsive to the amendment filed on 2/27/26. As directed by the amendment: claims 1, 11-13, and 19 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1, 11-13, and 19 are presently pending in this application.
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.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsen (US 5037437) in view of Applicant’s Admitted Prior Art (AAPA) and Landesberg et al. (US 6322785).
Regarding claim 1, Matsen discloses a method of preparing a bone surface of a bone of a patient for an arthroplasty surgery of an arthroplasty implant (col. 4, ln. 53-58), said method comprising the steps of: providing a material (bone cement; col. 5, ln. 1-8); resecting or shaping the bone surface of the bone for acceptance of the arthroplasty implant (col. 4, ln. 53-68); applying a dry gas to the bone surface (col. 6, ln. 5-18); and after applying the dry gas, applying the material to the bone surface and/or to the implant (col. 6, ln. 49-56), except for the arthroplasty being cementless, where the material is an orthobiologic material prepared from the patient which is applied to promote osseointegration between the bone surface and the cementless arthroplasty implant. However, AAPA teaches that cementless arthroplasty is a common alternative to bone cement-based arthroplasty in which utilizes integration between the implant and the bone surface for fixation (“BACKGROUND” section of the specification, par. 0005-0006). Furthermore, Landesberg et al. teaches utilizing an orthobiologic material prepared from the patient (col. 3, ln. 28-46) in joint reconstruction (col. 6, ln. 36-42) and more particularly to promote osteointegration for implants (col. 1, ln. 61 – col. 2, ln. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Matsen to utilize the common alternative of a cementless arthroplasty procedure as opposed to utilization of bone cement, as taught by AAPA, since AAPA identifies the two types of procedures as known alternatives for providing the predictable result of arthroplasty implantation, and to further utilize an orthobiologic material as claimed, as taught by Landesberg et al., instead of cement in a cementless procedure, since such a material is taught by Landesberg et al. to promote integration between bone and an implant (col. 1, ln. 61 – col. 2, ln. 7; col. 6, ln. 36-42), which is identified by AAPA as a necessary component of cementless procedures (“BACKGROUND” section of the specification, par. 0005-0006).
Regarding claim 2, Matsen discloses cleaning the bone surface prior to applying the dry gas (col. 5, ln. 46 – col. 6, ln. 16).
Regarding claim 3, Matsen discloses said applying a dry gas includes applying a medical-grade carbon dioxide gas to the bone surface (col. 6, ln. 3-27).
Regarding claim 4, Matsen discloses said cleaning includes applying saline solution (col. 1, ln. 11-26).
Regarding claim 5, Matsen discloses applying suction to suction away fat, marrow and blood, and/or saline solution, from a region of the bone, the region including the bone surface (col. 1, ln. 11-26; col. 5 ln. 46 – col. 6, ln. 16).
Regarding claim 6, Matsen discloses said applying a dry gas includes applying a medical-grade carbon dioxide gas to the bone surface (col. 6, ln. 3-27).
Regarding claim 7, directing the flow of the dry gas to the bone surface at an angle of between about 0 degrees to 90 degrees relative to the bone surface of the bone is inherent to the method disclosed by Matsen, since the claimed range encompasses every possible angle relative to a surface.
Regarding claims 8 and 9, Matsen discloses said applying a dry gas includes applying a dry gas with a constant flow, and said applying a dry gas includes applying a dry gas with a pulsed flow (col. 6, ln. 15-16).
Regarding claim 10, Matsen, as modified by AAPA and Landesberg et al., teaches said applying the orthobiologic material includes injecting orthobiologic material into the bone surface (col. 2, ln. 19-39 and col. 4, ln. 8-17 describe injection of material into bone).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsen in view of AAPA and Landesberg et al., and further in view of Turner (US 3208145).
Regarding claim 13, Matsen discloses a bone preparation system for preparing a bone surface of a bone of a patient for an arthroplasty surgery of an implant (including various tools required for performing the steps disclosed, see at least col. 1, ln. 11-26 and col. 4, ln. 53-58), said bone preparation system comprising at least a source of gas including a nozzle (col. 7, ln. 5-16) and a supply of material (bone cement; col. 5, ln. 1-8), except for disclosing a hand piece having a hand piece body having an inlet port, an outlet port, and an internal passageway extending there through from said inlet port to said outlet port forming a flow path, said hand piece having a valve for opening and closing said internal passageway, and said hand piece having a trigger configured to adjust said valve; a nozzle coupled to said hand piece at said output port; tubing coupled to said hand piece at said input port, said tubing coupling to a supply of dry gas to deliver dry gas to said internal passageway for flowing from said outlet port to apply the dry gas onto the bone surface; and the supply of orthobiologic material to promote osseointegration between the bone surface and the arthroplasty implant in a cementless procedure.
However, AAPA teaches that cementless arthroplasty is a common alternative to bone cement-based arthroplasty in which utilizes integration between the implant and the bone surface for fixation (“BACKGROUND” section of the specification, par. 0005-0006). Furthermore, Landesberg et al. teaches utilizing an orthobiologic material prepared from the patient (col. 3, ln. 28-46) in joint reconstruction (col. 6, ln. 36-42) and more particularly to promote osteointegration for implants (col. 1, ln. 61 – col. 2, ln. 7). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Matsen for use in the common alternative procedure of a cementless arthroplasty as opposed to utilization of bone cement, as taught by AAPA, since AAPA identifies the two types of procedures as known alternatives for providing the predictable result of arthroplasty implantation, and to further utilize an orthobiologic material as claimed, as taught by Landesberg et al., instead of cement in a cementless procedure, since such a material is taught by Landesberg et al. to promote integration between bone and an implant (col. 1, ln. 61 – col. 2, ln. 7; col. 6, ln. 36-42), which is identified by AAPA as a necessary component of cementless procedures (“BACKGROUND” section of the specification, par. 0005-0006).
Additionally, Turner teaches a hand piece 12 (fig. 1-3) having a body (comprising 32, 34, and 36) having an inlet port 52a, an outlet port (entrance of tubular member 28; col. 4, ln. 59-69), and an internal passageway 54 extending there through from said first inlet port to said outlet port forming a flow path forming a flow path (flow path between 52a, 54, and 28; col. 4, ln. 59-69), said hand piece having a valve 66 for opening and closing said internal passageway (col. 4, ln. 59-69), and said hand piece having a trigger 110 configured to adjust said valve (col. 4, ln. 59-69); a nozzle 28 coupled to said handpiece at said output port; tubing 106 coupled to said hand piece at said input port and coupling to a supply of dry gas 18 to deliver as claimed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the device disclosed by Turner in the system of Matsen, since Matsen specifically identifies the Turner device for providing gas in its surgical methodology (col. 3, ln. 38-49).
Claim(s) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsen in view of AAPA, Landesberg et al., and Turner, and further in view of Earle (US 5514135).
Regarding claims 12 and 13, Matsen, as modified by AAPA, Landesberg et al., and Turner, teach the apparatus as claimed (see analysis of claim 11 above), except for specifically disclosing or teaching a dispenser for the orthobiologic material. However, Earle teaches an example of a dispenser utilized for delivering material during joint surgery (device of fig. 1-3; col. 1, ln. 16-67). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize any known dispenser for providing material during an arthroplasty, such as the one taught by Earle, in the system and method of Matsen, as modified by AAPA, Landesberg et al., and Turner, since Matsen requires pressurization of delivered material and Earle provides sufficient structure for such pressurization.
Regarding claim 14, Matsen further discloses a method of using the bone preparation system of claim 13 comprising applying suction to suction away fat, marrow and blood, and/or saline, from a region of the bone, the region including the bone surface (col. 1, ln. 11-26; col. 5 ln. 46 – col. 6, ln. 16).
Regarding claim 15, Matsen as modified by AAPA and Landesberg et al. further teaches applying the orthobiologic material to the bone surface (Matsen col. 6, ln. 49-56; Landesberg et al. col. 3, ln. 28-46 and col. 6, ln. 36-42)
Regarding claim 16, Matsen further discloses applying a dry gas to the bone surface with the hand piece through the nozzle (col. 6, ln. 3-27; col. 3, ln. 38-49).
Regarding claim 17, Matsen further discloses a method of using the bone preparation system of claim 13 comprising applying a dry gas to the bone surface with the hand piece through the nozzle ((col. 6, ln. 3-27; col. 3, ln. 38-49).
Reagarding claim 18, Matsen further discloses applying a dry gas includes applying a medical-grade carbon dioxide gas to the bone surface (col. 6, ln. 3-27).
Regarding claim 19, directing the flow of the dry gas to the bone surface at an angle of about 0 degrees to 90 degrees relative to the bone surface of the bone is inherent to the method disclosed by Matsen, since the claimed range encompasses every possible angle relative to a surface.
Regarding claim 20, Matsen discloses said applying a dry gas includes applying a dry gas with a pulsed flow (col. 6, ln. 15-16).
Response to Arguments
Applicant's arguments filed 2/27/26 have been fully considered but they are not persuasive. Regarding applicant’s arguments as directed to the amended limitations of independent claims 1, 11, and 13, those limitations have been addressed in the respective rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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