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 .
According to the Amendment filed on 10/20/25, Claims 1, 7-8 are amended, claim 16 is added.
Claim Rejections - 35 USC § 112
Claims 1-15 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 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-AlA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant has amended claims 1, 7 and 8 to overcome the rejection, therefore, the rejection is moot.
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)(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.
2. Claim(s) 1-6, 9-10, 13-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Neichel (US 20190015221 A1).
Neichel discloses a kit comprising: a patient-specific tracker device fig.5, with a trackable reference 108, the patient specific tracker device having at least one contact surface being a negative of a pre-operative surface of a bone (para. 8, 9, 12) , whereby the patient specific tracker device is configured for being applied against the pre-operative surface of the bone in a first patient-specific unique coupling engagement for subsequent tracking of the pre- operative surface of the bone fig. 5; a validation tracker device fig. 8 with a trackable reference 108, the validation tracker device having at least one contact surface for mating with an altered (reamed) surface on the bone for validation of a location of the altered surface (para. 115); and an implant 58 configured for being installed against the altered surface of the bone fig. 10, wherein the patient-specific tracker device includes at least one attachment bore 198 for receiving a pin 208, wherein the validation tracker device includes at least one attachment bore 294 for being installed on the pin positioned using the patient-specific tracker device, wherein the patient-specific tracker device includes at least one bore (through tubular body 144) for drilling a hole in the bone, wherein the validation tracker device includes at least one bore 294 for receiving a peg 208 for validating a position of the hole in the bone, wherein the validation tracker device includes at least one peg 208 for validating a position of the hole in the bone, wherein the patient-specific tracker device includes at least one bore 198 for receiving a fastener 208, wherein the fastener is sized so as to penetrate the bone at most to plane corresponding to the altered surface on the bone fig. 5, wherein the validation tracker device 290 is pinless, further including another validation tracker device 54a, fig. 9 with a trackable reference 78, the validation tracker device having at least one contact surface 390 for mating with another altered surface on the bone, wherein the implant 58 is configured for being installed against the altered surface of the bone and the other altered surface of the bone, wherein the at least one contact surface of the patient specific tracker device is a negative of a pre-operative surface of a glenoid surface of a scapula (para. 8, 9, 12).
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.
Claim(s) 7-8, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neichel in view of MILLAHN et al. (US 20120330135 A1).
Neichel fails to teach that a processing unit, and a non- transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit, the computer-readable program instructions including a model of the validation tracker device or the patient- specific tracker device and of the patient-specific unique coupling engagement between the validation tracker device and the altered surface of the bone.
MILLAHN teaches a processing unit, and a non- transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit (para. 37), the computer-readable program instructions including a model (para. 66, 16) of the bone and the cutting block.
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the kit of Neichel with a processing unit, and a non- transitory computer-readable memory communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit, the computer-readable program instructions including a model in view of MILLAHN for effectively providing a virtual tracking of live data of the position and orientation of the devices with respect to the bone.
Neichel fails to teach that the trackable references are optically detectable references, wherein the optically detectable references are retroreflective.
MILLAHN teaches trackable references 9, fig. 3 comprising four marker spheres 10a to 10d which are optically detectable references, and are retroreflective 10a-c, para. 59.
it would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to modify the trackable references of Neichel with marker spheres in view of MILLAHN for effectively enhancing tracking and navigating the bone and devices locations, respectively.
Response to Arguments
Applicant’s arguments, filed on 10/20/25, with respect to the rejection(s) of claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Neichel.
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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775