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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 June 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12 June 2025. As directed by the amendment: claims 1, 11-12, and 15 have been amended, claim 8 has been or remains canceled. Thus claims 1-7 and 9-27 are presently pending in this application, and claims 19-27 remain withdrawn. Applicant’s amendments to the Claims have not overcome the 35 U.S.C. 112(b) rejections previously set forth in the Final Office Action mailed 14 March 2025. The examiner notes the amendments described in REMARKS on page 10 address the internal fluid passageway instead of the flow path/linear flow path.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1, 11, 12, and 15 are objected to because of the following informalities:
Claims 1 and 11 recite “said output port”, this should instead recite “said outlet port”.
Claims 1 and 12 recite “said internal passageway”. For consistency, these should instead recite “said internal fluid passageway”.
Claim 15 recites “a hand piece body”. A hand piece body was already introduced in claim 11 so this should instead recite “said hand piece body”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites "so that the internal surface of the hand piece body forms a flow path from the inlet port to the outlet port" and "defining a linear flow path extending along said longitudinal axis from said inlet port to said outlet port of said hand piece body". It is unclear if the two flow paths are intended to be the same flow path or different flow paths as they are both described as linear and extending from the inlet port to the outlet port. For the purpose of examination, they are being interpreted as the same flow path.
Claims 2-7 and 9-10 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart (US 3,749,090 A).
Regarding claim 11, Stewart discloses a bone preparation system (Fig 1) comprising: a hand piece (Fig 4) having an inlet port (40 Fig 4), an outlet port (46 Fig 4), said hand piece having said hand piece body including an internal surface (see the surface of 34 Fig 4) that defines an internal fluid passageway (34 Fig 4) extending through said hand piece body from said inlet port to said outlet port so that the internal surface of the hand piece body forms a flow path from said inlet port to said outlet port (Col 4 lines 65-67 “irrigating passage 34 extends from supply end 40 of handle 32 to its opposite tool receiving end 46 of the handle”), the internal surface of the hand piece body that defines the internal fluid passageway being in contact with fluid as the fluid flows through the flow path from the inlet port to the outlet port (Col 4 lines 67-68 “completely enclosed by the material of the handle.”, see Fig 4 there is no intervening structure between the flow path and the internal surface of the hand piece body), said internal fluid passageway having a longitudinal axis (see the longitudinal axis from left to right of path 34 Fig 4) extending there through and defining a linear flow path extending along said longitudinal axis from said inlet port to said outlet port (Col 4 line 68- col 5 line 2 “Irrigating passage 34 includes a uniformly cylindrical main section 48 that extends the greater length of handle 32”, Col 6 lines 62-65 “the upstream and downstream sections 79 and 83 are axially aligned along the axis of passage 34”), said hand piece having a valve stem (82 Fig 5) supported therein for movement across and at least partially within said internal fluid passageway (as shown in Fig 5, valve stem 82 extends across passageway 34) for opening and closing said internal fluid passageway wherein flow along said flow path is blocked by said valve stem (Col 7 lines 1-2 “intercepts passage 34 in a fluid flow preventing position as illustrated in FIG. 5.”), and said hand piece having a trigger (114 Fig 5) configured to move said valve stem at least partially within said internal fluid passageway to thereby control the flow of fluid through said hand piece (Col 7 lines 33-41 “To operate the valve means, pressure is applied to actuator 114 to overcome the bias of coil spring 124 and move plunger 82 toward valve cap 94. Movement of plunger 82 toward the valve cap displaces valve seal 84 from conical surface 76 of valve housing 66 and enables inlet opening 77 of the valve housing to communicate with outlet opening 81 of the valve housing and thereby permits fluid under pressure to pass out through irrigating tube 12.”); a nozzle (10 Fig 1) coupled to said hand piece at said output port (Col 8 lines 3-4 “a sterilized work tool 10 is inserted into tool receiving end 46 of the handle”), said nozzle having a nozzle tip (24 Fig 1); and tubing coupled to said hand piece at said input port for coupling said bone preparation system to a supply of fluid (Col 4 lines 47-48 “Fitting 42 is a coupling for a hose unit connected to a supply of sterile irrigating solution, see the tubing in Fig 1 connected to supply end 40).
Regarding claim 12, Stewart discloses the bone preparation system according to claim 11. Stewart further teaches wherein said trigger (114 Fig 5) is movable from a fully open position wherein said internal passageway is fully open (Col 7 lines 35-41 “Movement of plunger 82 toward the valve cap displaces valve seal 84 from conical surface 76 of valve housing 66 and enables inlet opening 77 of the valve housing to communicate with outlet opening 81 of the valve housing and thereby permits fluid under pressure to pass out through irrigating tube 12.”, the trigger pushed in all the way corresponds to the fully open position) and a fully closed position wherein said internal fluid passageway is fully closed (Col 7 lines 1-2 “intercepts passage 34 in a fluid flow preventing position as illustrated in FIG. 5.”), further comprising a spring (124 Fig 5) to bias said trigger in its fully closed position (Col 7 line 28 “bias valve seal 84 against conical surface 76.”).
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, 3, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Oudshoorn chirurgische techniek (NPL Video- Instructievideo PL 2000 OCT B EuroPulse pulse lavage batterij system), hereinafter Oudshoorn.
Regarding claim 1, Stewart discloses a bone preparation system kit comprising: a bone preparation system (Fig 1) comprising: a hand piece (Fig 4) having an inlet port (40 Fig 4), an outlet port (46 Fig 4), said hand piece having a hand piece body (32 Fig 4) that forms said inlet port and said outlet port (40 and 46 are part of the body 32 as shown in Fig 4), said hand piece body including an internal surface (see the surface of 34 Fig 4) that defines an internal fluid passageway (34 Fig 4) extending through said hand piece body from said inlet port to said outlet port so that the internal surface of the hand piece body forms a flow path from the inlet port to the outlet port (Col 4 lines 65-67 “irrigating passage 34 extends from supply end 40 of handle 32 to its opposite tool receiving end 46 of the handle”), the internal surface of the hand piece body that defines the internal fluid passageway being in contact with fluid as the fluid flows through the flow path from the inlet port to the outlet port (Col 4 lines 67-68 “completely enclosed by the material of the handle.”, see Fig 4 there is no intervening structure between the flow path and the internal surface of the hand piece body), said internal passageway having a longitudinal axis (see the longitudinal axis from left to right of path 34 Fig 4) extending there through and defining a linear flow path extending along said longitudinal axis from said inlet port to said outlet port of said hand piece body (Col 4 line 68- col 5 line 2 “Irrigating passage 34 includes a uniformly cylindrical main section 48 that extends the greater length of handle 32”, Col 6 lines 62-65 “the upstream and downstream sections 79 and 83 are axially aligned along the axis of passage 34”), said hand piece having a valve stem (82 Fig 5) supported therein for movement across and at least partially within said internal fluid passageway (as shown in Fig 5, valve stem 82 extends across passageway 34) for opening and closing said internal passageway wherein flow along said flow path is blocked by said valve stem (Col 7 lines 1-2 “intercepts passage 34 in a fluid flow preventing position as illustrated in FIG. 5.”), and said hand piece having a trigger (114 Fig 5) configured to move said valve stem at least partially within said internal fluid passageway to thereby control the flow of the fluid through said hand piece (Col 7 lines 33-41 “To operate the valve means, pressure is applied to actuator 114 to overcome the bias of coil spring 124 and move plunger 82 toward valve cap 94. Movement of plunger 82 toward the valve cap displaces valve seal 84 from conical surface 76 of valve housing 66 and enables inlet opening 77 of the valve housing to communicate with outlet opening 81 of the valve housing and thereby permits fluid under pressure to pass out through irrigating tube 12.”); a nozzle (10 Fig 1) coupled to said hand piece at said output port (Col 8 lines 3-4 “a sterilized work tool 10 is inserted into tool receiving end 46 of the handle”), said nozzle having a nozzle tip (24 Fig 1); and tubing coupled to said hand piece at said input port (Col 4 lines 47-48 “Fitting 42 is a coupling for a hose unit connected to a supply of sterile irrigating solution, see the tubing in Fig 1 connected to supply end 40), said hand piece, said nozzle, and said tubing being sterilized (Col 7 line 65-col 8 line 7 “Work tool 10 is then detached from handle 32, […] both it and the handle are sterilized. After sterilization is completed, handle 32 is again connected to the appropriate hose units and a sterilized work tool 10 is inserted into tool receiving end 46 of the handle to provide a sterilized surgical instrument”, Col 4 lines 47-48 “a hose unit connected to a supply of sterile irrigating solution” at least the interior of the tubing would be sterilized to supply sterile irrigating solution) wherein said bone preparation system is sterilized (the system is made up of the hand piece, nozzle and tubing which are all sterilized).
However, Stewart is silent to a package enclosing said bone preparation system, and wherein said package is configured to maintain the sterilization of said bone preparation system.
Oudshoorn teaches a bone preparation system kit (See Fig 1 showing the kit), a hand piece (See Figs 5 and 6 showing the hand piece), a nozzle (See Figs 5 and 8 showing the nozzle), and tubing (See Figs 5-7 showing the tubing) being sterilized (See in Fig 3, the sterile employee removes the internal blister packaging, everything inside the outer pouch would need to be sterile) wherein said bone preparation system is sterilized (See the system with all the components in Fig 7 being handled by the sterile employee); and a package (See the package in Fig 4) enclosing said bone preparation system, and wherein said package is configured to maintain the sterilization of said bone preparation system (the package shown in Fig 4 would maintain the sterilization of the contents, when it is removed from the outer pouch, it is only touched by the sterile employee to maintain sterility of the contents, it is well known in the art to use packaging to maintain a medical device’s sterility to prevent infection of the patient, the video shows all the claimed components are maintained within the packaging together). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the components of Stewart to be enclosed within a package as taught by Oudshoorn to provide all the necessary components in one place to reduce complicated assembly and the possibility of breaking sterility by requiring more packaging to be handled.
Regarding claim 3, modified Stewart teaches the bone preparation system kit according to claim 1. Modified Stewart further teaches wherein said package comprises a pouch (Oudshoorn- the outer layer being removed in Fig 2 is a pouch).
Regarding claim 9, modified Stewart teaches the bone preparation system kit according to claim 1. Modified Stewart further teaches wherein said nozzle (10 Fig 1) is coupled to said hand piece at said outlet port (Col 8 lines 3-4 “work tool 10 is inserted into tool receiving end 46 of the handle”) by a snap fit coupling (Col 5 lines 27-32 “Side walls 60 and 62, as best seen in FIGS. 3 and 8, partially wrap around extension 31 of suction member 14 and provide a snap or friction-type fit when the work tool is inserted into handle 32.”).
Regarding claim 10, modified Stewart teaches the bone preparation system kit according to claim 1. Modified Stewart further teaches wherein said hand piece body includes a spring arm (60 Fig 8) adjacent said outlet port (See Figs 2 and 3, the side walls forming the spring arms in Fig 8 is shown at the position of the valve in Fig 2, this is adjacent the outlet port 46 as shown in Fig 4) to form a snap fit connection (Col 5 lines 27-32 “Side walls 60 and 62, as best seen in FIGS. 3 and 8, partially wrap around extension 31 of suction member 14 and provide a snap or friction-type fit when the work tool is inserted into handle 32.”).
Claims 2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Oudshoorn and Lampropoulos et al. (US 2008/0116106 A1).
Regarding claim 2, modified Stewart teaches the bone preparation system kit according to claim 1. However, modified Stewart is silent to wherein said package is formed from a material that allows sterilization of said bone preparation system while enclosed as assembled in said package.
Lampropoulos et al. teaches a kit wherein said package is formed from a material that allows sterilization of the medical system while enclosed as assembled in said package ([0007], [0028] “bombarded with gamma radiation, which penetrates through all materials in packaging 110, pen 120 and labels 130, sterilizing each component both internally and externally. As some materials are sensitive to gamma radiation, such that they become brittle and/or discolored, the materials selected for PAL kit 100 may be selected for their resistance to damage by gamma radiation.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the package of modified Stewart to be formed from a material with the limitations as taught by Lampropoulos et al. to allow gamma sterilization to sterilize with a fast cycle and gamma irradiating ensures that all elements, even the internal components are sterilized throughout. [0007]
Regarding claim 4, modified Stewart teaches the bone preparation system kit according to claim 2. Modified Stewart further teaches further comprising a carrier (Oudshorn- the carrier is shown with the top cover removed in Fig 6) to support said bone preparation system in said package (Oudshorn- the carrier is supporting the system in Fig 6).
Regarding claim 5, modified Stewart teaches the bone preparation system kit according to claim 2. Modified Stewart further teaches wherein said carrier supports said bone preparation system in a planar arrangement (Oudshoorn- the carrier is supporting the system in a planar arrangement shown at least in Figs 1, 4, and 6).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Oudshoorn, Lampropoulos et al. (US 2008/0116106 A1), and Bell et al. (US 2020/00102133 A1).
Regarding claim 6, modified Stewart teaches the bone preparation system kit according to claim 2. Modified Stewart further teaches wherein said carrier includes a plurality of couplers to couple each of said nozzle, said hand piece and said tubing to said carrier (Oudshoorn- as shown in Fig 8 the carrier is molded to have coupling elements formed into the plastic base, shaped to hold all of the elements to the carrier).
However, modified Stewart is silent to wherein the plurality of couplers are arranged in a planar array.
Bell et al. teaches a carrier (10 Fig 3) includes a plurality of couplers (38, 39 Fig 13, [0061]) arranged in a planar array (38 and 39 are cut out of the planar sheet and shown flat in Fig 2B) to couple each component of the system (70 Fig 13) to said carrier. It would have been obvious to one of ordinary skill in the art at the time of effective filing for the plurality of couplers of modified Stewart to be arranged in a planar array so that the carrier can be flattened and stacked to take up less space when not assembled, requiring less storage and shipping space [0004].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Oudshoorn, Lampropoulos et al. (US 2008/0116106 A1), and Henniges et al. (US 2003/0036723 A1).
Regarding claim 7, modified Stewart teaches the bone preparation system kit according to claim 4. However, modified Stewart fails to teach further comprising a splash shield for mounting to the nozzle, the shield being supported by said carrier and enclosed in said package.
Henniges et al. teaches a splash shield (181 Fig 10A) for mounting to a nozzle (179 Fig 10, ([0072] “spray shield 181 is snap fitted to the rest of the tip assembly 30.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of modified Stewart to include a splash shield and mounting as taught by Henniges et al. “to limit fluid discharge” (abstract) and to allow the device to also be used with suction in a way that “it eliminates the extent to which matter in the discharge chamber 210 obstructs the application of pulses of fluid to the surface to which the irrigator 20 is applied” [0070]. The snap fit mounting “makes it possible to provide different shields that can be used with a single discharge tube-suction tube subassembly. Consequently, a medical facility does not have to maintain an inventory of different tip assemblies, the only difference between the individual assemblies being their spray shields.” [0072]
Modified Stewart teaches all of the elements of the system are supported by said carrier and enclosed in said package, this would include the shield of the modified system (Oudshoorn- all the elements of the system are supported by the carrier and enclosed in the package, including a shield as shown in Fig 8, the shield itself best shown in Fig 12).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Fox et al. (US 5,520,634 A).
Regarding claim 13, Stewart discloses the bone preparation system according to claim 12. Stewart further teaches wherein said valve stem moves along a valve axis (Col 7 line 35 “move plunger 82 toward valve cap 94”, see the axis along 82 Fig 5).
However, Stewart fails to teach wherein said spring applies a biasing force to said trigger along an axis adjacent to said valve axis.
Fox et al. teaches a spring (98 Fig 2) applies a biasing force to said trigger (22 Fig 2) along an axis adjacent to said valve axis (the long axis of valve 64 is parallel to spring 98 as shown in Fig 2). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the valve stem and the spring of Stewart to have the axes as taught by Fox et al. as such a modification is the result of a simple substitution of one known element (a trigger biased by a spring positioned along the valve long axis of Stewart) for another (a trigger biased by a spring positioned along an axis adjacent to the spring of Fox et al.) to achieve a predictable result (a trigger biased by a spring to actuate a valve).
Regarding claim 14, modified Stewart teaches the bone preparation system according to claim 13. Modified Stewart further teaches wherein said spring applies a biasing force to said trigger along an axis parallel to said valve axis (the axes of the spring and the valve of Rosenberger are parallel as shown in Fig 2).
Regarding claim 15, modified Stewart teaches the bone preparation system according to claim 13. Modified Stewart further teaches wherein said hand piece has a hand piece body (32 Fig 4), said hand piece body forming said inlet port, said outlet port and said internal fluid passageway (34, 40 and 46 are part of the body 32 as shown in Fig 4), said hand piece body having a spring arm (60 Fig 8) adjacent said outlet port (See Figs 2 and 3, the side walls forming the spring arms in Fig 8 is shown at the position of the valve in Fig 2, this is adjacent the outlet port 46 as shown in Fig 4) to form a snap fit connection (Col 5 lines 27-32 “Side walls 60 and 62, as best seen in FIGS. 3 and 8, partially wrap around extension 31 of suction member 14 and provide a snap or friction-type fit when the work tool is inserted into handle 32.”).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 3,749,090 A) in view of Henniges et al. (US 2003/0036723 A1).
Regarding claim 16, Stewart discloses the bone preparation system according to claim 11. However, Stewart fails to teach further comprising a splash shield for mounting to said nozzle, said splash shield configured to form a snap fit mounting to said nozzle.
Henniges et al. teaches a splash shield (181 Fig 10A) for mounting to a nozzle (179 Fig 10), said splash shield configured to form a snap fit mounting to said nozzle ([0072] “spray shield 181 is snap fitted to the rest of the tip assembly 30.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the system of Stewart to include a splash shield and mounting as taught by Henniges et al. “to limit fluid discharge” (abstract) and to allow the device to also be used with suction in a way that “it eliminates the extent to which matter in the discharge chamber 210 obstructs the application of pulses of fluid to the surface to which the irrigator 20 is applied” [0070]. The snap fit mounting “makes it possible to provide different shields that can be used with a single discharge tube-suction tube subassembly. Consequently, a medical facility does not have to maintain an inventory of different tip assemblies, the only difference between the individual assemblies being their spray shields.” [0072]
Regarding claim 17, modified Stewart teaches the bone preparation system according to claim 16, wherein said nozzle includes guide structures (Henniges et al.- 180 Fig 10) to guide mounting said splash shield to said nozzle (annular groove 180 guides the shield 181 to be mounted appropriately to the nozzle 179).
Regarding claim 18, modified Stewart teaches the bone preparation system according to claim 17, wherein one of said guide structures forms a stop to stop said splash shield from moving along said nozzle once mounted to said nozzle (Henniges et al.- 180 Fig 10 is an annular groove that stops the shield by providing the snap fit connection, once the lip 206 Fig 10A is positioned within the groove 180, further rearward movement would be prevented [0060] “To facilitate the securement of the spray shield to the discharge tube/suction tube sub-assembly, base section 200 is formed to have an annular lip 206 that extends inside bore 202. When the spray shield 181 is fitted over discharge tube 32, lip 206 in the annular groove 180 between the discharge tube 32 and nozzle 179.”).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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