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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (U.S. Patent 4,338,925) in view of Lidgren (U.S. Publication 2007/0217282) and in view of Swanson (U.S. Patent 2,735,431).
Miller discloses a device (for example see Figure 1) comprising:
(claim 1) an actuation mechanism (1, 2, etc.)
(claim 1) a tube (10) defining a lumen and an open end
(claim 1) wherein the tube is configured to receive graft material through the open end
(claim 1) a plunger (7) positioned within the lumen of the tube and coupled to the actuation mechanism
(claim 1) wherein the actuation mechanism is configured to advance the plunger toward the open end to deliver graft material through the open end
Miller fails to disclose the device wherein the tube comprises a pressure relief opening (claim 1), wherein the tube includes a dosage window (claim 1), and wherein a portion of the plunger comprises a dose scale visible through the dosage window (claim 1).
Regarding the tube comprising a pressure relief opening, Lidgren teaches a device (for example Figure 1) comprising an actuation mechanism (13), a tube (3) including a lumen and an open end, and a plunger (9, 10, 11, etc.) within the lumen of the tube, wherein the tube further comprises a pressure relief opening (48; paragraph 43) disposed in the wall of the tube defining a pressure chamber (the area of the lumen in the tube between element 48 and the open end) in order to permit the passage of a fluid, such as gas, while dispensing the graft material (paragraph 44). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Miller wherein the tube further comprises a pressure relief opening in the wall of the tube in view of Lidgren in order to permit passage of gas while dispensing a graft material.
Regarding the tube comprising a dosage window (claim 1) and a portion of the plunger comprising a dose scale visible through the dosage window, Swanson teaches a device comprising an actuation mechanism (11, 12, etc.), a tube (15) including a lumen and an open end, and a plunger (14, 16, etc.) positioned within the lumen and coupled to the actuation mechanism, wherein the tube further comprises a dosage window (24) and the plunger comprises a portion having a dose scale visible through the dosage window (for example see Figure 2) in order to determine the amount of material dispensed from the device. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Miller as modified by Lidgren wherein the tube further comprises a dosage window and a portion of the plunder comprises a dose scale visible through the dosage window in view of Swanson in order to determine the amount of material dispensed from the device.
The invention of Miller as modified by Lidgren as further modified by Swanson discloses a method of using the device discussed above comprising:
(claim 1) configuring the device to receive graft material
(claim 1) loading graft material into the pressure chamber of the graft delivery device
(claim 1) compacting the graft material to remove voids, i.e. gas in the material
(claim 3) wherein compacting the graft material includes compacting the graft material until graft material exits the pressure relief opening (for example see claim 18 of Lidgren)
(claim 1) positioning the open end of the tube at the target site
(claim 1) actuating the actuation mechanism while observing the dose scale through the dosage window
Claims 4, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (U.S. Patent 4,338,925) in view of Lidgren (U.S. Publication 2007/0217282) further in view of Swanson (U.S. Patent 2,735,431) further in view of Flores (U.S. Publication 2018/0125558).
The device of Miller as modified by Lidgren as further modified by Swanson discloses the invention as claimed except for the device further comprising a graft loading device secured to a retention mechanism of the tube. Flores teaches a device (for example see Figure 1) comprising an actuating mechanism (122, 180, etc.), a tube (140), and a plunger (160), wherein the device further comprises graft delivery device (194) secured to a retention mechanism of the tube (for example see paragraph 75; the funnel is coupled to the proximal end of the tube) in order to prevent spilling bone graft material while loading the bone graft material. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Miller as modified by Lidgren as further modified by Swanson wherein the device further includes a graft delivery device secured to a retention mechanism of the tube in view of Flores in order to prevent spilling bone graft material while loading the bone graft material.
The invention of Miller as modified by Lidgren as further modified by Swanson as further modified by Flores discloses the method as discussed above further comprising:
(claim 4) wherein the loading graft material into the pressure chamber includes loading graft material using a graft loading device secured to a retention mechanism of the tube
(claim 7) wherein the loading graft material into the pressure chamber includes
(claim 7) attaching a graft loading device to the tube
(claim 7) transferring graft material from the graft loading device to the tube
(claim 12) wherein the loading graft material into the pressure chamber includes
(claim 12) engaging the graft delivery device with a graft loading device
(claim 12) loading the graft from the graft loading device into the graft delivery device
Claims 5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (U.S. Patent 4,338,925) in view of Lidgren (U.S. Publication 2007/0217282) further in view of Swanson (U.S. Patent 2,735,431) further in view of Crawford (U.S. Publication 2017/0258535).
The invention of Miller as modified by Lidgren as further modified by Swanson discloses the invention as claimed except for the positioning of the open end of the device at the target site includes inserting a portion of the device in a guide sleeve or a robotic system (claim 5), interfacing the device with a robotic system configured to position and orient the device (claim 9), wherein interfacing includes interfacing the tube with a guide sleeve of the robotic system (claim 10), wherein positioning the open end of the device at the target site includes using the robotic system to position and orient the device. Crawford teaches a method of using a robotic system during a surgical procedure including the steps of interfacing a surgical instrument with the robotic system (for example see paragraph 12), wherein the interfacing includes inserting a portion of a tube of the instrument into a guide sleeve of the robotic system such that the robotic system positions and orients the instrument to a target site (for example see Figures 15A-15B), wherein the instrument is a bone graft delivery device (for example see paragraph 136) in order to assist with or perform a surgical procedure. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Miller as modified by Lidgren as further modified by Swanson wherein the method includes the steps of interfacing the device with the robotic system, wherein the interfacing includes inserting a portion of the tube of the device into a guide sleeve of the robotic system such that the robotic system positions and orients the device to a target site in view of Crawford in order to assist with or perform a surgical procedure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (U.S. Patent 4,338,925) in view of Lidgren (U.S. Publication 2007/0217282) further in view of Swanson (U.S. Patent 2,735,431) further in view of Oktavee (U.S. Publication 2012/0253316).
The invention of Miller as modified by Lidgren as further modified by Swanson discloses the invention as claimed except for the target site being a facet of a vertebra. Oktavee teaches a method of using a bone graft delivery device on a target site (for example see the abstract), wherein the target site includes a facet of a vertebrae (for example see paragraph 44) in order to treat the facet of a patient. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Miller as modified by Lidgren as further modified by Swanson wherein the target site is a facet of a vertebrae in view of Oktavee in order to treat the facet of a patient.
Allowable Subject Matter
Claims 2, 8, 13, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
