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 .
Election/Restrictions
Applicant’s election of Group I and Species A in the reply filed on November 25th, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 10, 15, 16, and 29-34 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and/or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 25th, 2025.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 9, 14, and 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (U.S. Publication 2021/0353313).
Regarding claims 1-7, 9, 14, and 17-20:
Lee discloses a device (for example see Figures 76-79 and 88) comprising:
(claim 1) a body (see annotated figure below) including
(claim 1) a shape corresponding to a shape of an implant
(claim 1) a first opening
(claim 1) at least one hole size and configured to receive a tool
(claim 14) wherein the at least one hole includes a first hole, a second hole, and a third hole
(claim 1) a first side
(claim 1) a second side
(claim 2) a third side
(claim 3) a fourth side
(claim 17) an anterior side
(claim 17) a posterior side
(claim 17) wherein one of the anterior or posterior sides includes a notch capable of providing a visual indication of a location of at least one surface of an implant in the sagittal plane
(claim 18) a joint line indicator (for example see Figure 78)
(claim 19) wherein the joint line indicator includes at least one projection extending into the first opening
(claim 20) wherein the joint line indicator includes a notch (the notch discussed relative to claim 17) in at least one of the anterior or posterior side
(claim 1) a first alignment feature
(claim 1) wherein the first alignment feature is coupled to at least one side of the body
(claim 1) wherein the first alignment feature is capable of aligning the device with a first anatomic plane (the feature is capable of aligning the device in a sagittal plane with the top surface of the feature used to determine if the device is level in the sagittal plane)
(claim 3) wherein the first alignment feature extends from the second side
(claim 9) wherein the first plane is a sagittal plane
(claim 2) a second alignment feature
(claim 2) wherein the second alignment feature is coupled to the body
(claim 2) wherein the second alignment feature is capable of aligning the device with a second anatomic plane different from the first (the feature is capable of aligning the device in a frontal plane with the bore by aligning the openings in the front plane)
(claim 4) wherein the second alignment feature extends from the second side
(claim 5) a first leg and a second leg
(claim 5) wherein the first and second legs extend from the first side
(claim 5) wherein each leg defines a respective hole sized and configured to receive a connection feature of another surgical guide
(claim 6) wherein at least one of the first leg or the second leg includes a first step capable of providing visual indication of a location of a surface of a prosthesis
(claim 7) wherein the first and second legs include a plurality of steps (each leg includes one step which is a plurality of steps)
Regarding claims 20 and 21:
Lee discloses a device (for example see Figures 76-79 and 88) comprising:
(claim 21) a first guide including
(claim 21) a first guide body (3000; see annotated figure below) having
(claim 21) a first side
(claim 21) a second side
(claim 21) a third side
(claim 21) a fourth side
(claim 21) a first hole
(claim 21) a second hole
(claim 21) wherein the first and second holes are capable of receiving at least one of a fixation device or a cutting tool
(claim 26) a third hole
(claim 27) wherein the third hole is between the first hole and the second hole
(claim 21) a first alignment feature extending from the body configured to facilitate alignment of the first guide with a first anatomic plane
(claim 21) a second alignment feature extending from the body configured to facilitate alignment of the first guide with a second anatomic plane different from the first anatomic plane
(claim 22) a first leg
(claim 22) a second leg
(claim 22) wherein the first and second legs extend from the first side
(claim 22) wherein a gap is defined between the first leg, the second leg, and the first side
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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 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (U.S. Publication 2021/0353313) in view of Stemniski (U.S. Publication 2012/0130434).
Lee discloses the invention as claimed except for the device further comprising a second guide coupled to the first guide. Stemniski teaches a device (for example see Figures 25C and 29) comprising a first guide (200), wherein the device further comprises a second guide (400) coupled to the first guide having a transverse beam (402) extending between a first arm (408) defining at least one connection feature (412) for receiving an elongate radiopaque device and a second arm (410) defining at least one connection feature (414; paragraph 109) for receiving an elongate radiopaque device and wherein first and second protrusions (dowels 70 are being interpreted as part of element 400) extending from the transverse beam and received within respective connection features in the first guide body in order to couple other tools to the first guide of 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 Lee further comprising a second guide coupled to the first guide in view of Stemniski in order to couple other tools to the first guide of the device.
Regarding the first and second protrusions being received in respective connection features in the first and second legs of the first guide. The first guide of Lee discloses connection features as discussed above capable of receiving protrusions of a second guide as taught by Stemniski. 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 Lee as modified by Stemniski wherein the protrusions of the second guide are received within the respective connection features of the first guide body, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (U.S. Publication 2021/0353313) in view of Haessler (U.S. Patent 7,210,933).
The device of Lee discloses the device further comprising a drill (for example see paragraph 170) extending from a first end to a second end, wherein the first end is configured to be couple to a driving tool and the second end includes at least one cutting surface (standard generic structure of a bone drill) and is configured to be received within the third hole defined by the first guide. Lee fails to disclose the device wherein the drill bit further includes at least one indicia. Haessler teaches a device comprising a drill bit, wherein the drill bit further includes at least one indicia located along a length of the drill bit corresponding to a length of an implant (see claims 5 and 15) in order to determine the depth of the drill bit during use. 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 Lee wherein the drill bit further includes at least one indicia in view of Haessler in order to determine the depth of the drill bit during use.
Regarding the drill bit including a plurality of indicia corresponding to a respective implant, 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 Lee as modified by Haessler wherein the drill bit includes a plurality of indicia corresponding to a respective implant, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Allowable Subject Matter
Claims 11-13 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