DETAILED ACTION
This office action is responsive to the amendment filed July 1, 2026. By that amendment, claims 10 and 18 were amended. Claims 1-13, 15, 16, and 18-22 are pending, though claims 1-9, 12, 13, 15 and 16 were previously withdrawn from consideration.
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 Arguments
The outstanding rejection of claims 10, 11, and 18-22 under 35 USC 112(b) was overcome by the amendments to the claims of July 1, 2026.
Applicant's arguments filed July 1, 2026, related to the rejections under 35 USC 103 of claims 10 and 18-22 in view of Coon (US 2005/0124998) and Aram (US 2009/0088763; and the rejection of claim 11 in view of Coon, Aram and Porzel (US 2015/0366677) have been fully considered but they are not persuasive.
All arguments are based on the claims, as amended, on July 1, 2026. The arguments state that “no combination of Coon and Aram renders obvious” the limitation of the guide tool being adapted to receive one or more inserts for enabling precision in creation of the implant receiving surface at the site of the diseased cartilage and/or bone.” (p. 9)
Initially, it is noted that the newly claimed inserts are inferentially recited, such that they do not actually exist in the claim – only the ability for the guide tool to receive some insert is actually required. Examiner takes the position that various portions of Aram’s guide tool 600 are capable of receiving some sort of insert – e.g. cut slots 614, 618, 622, 620 are all capable of receiving some sort of insert; pin holes 612 are capable of receiving an insert; and even negative contour 610 is capable of receiving an insert, therein; any of those inserts being capable of use in ‘enabling precision’, as claimed.
The rejection of record will be maintained, below, as modified only to correlate to the claim amendments. Additionally, a drawing objection will now be issued in view of the ‘adapted to receive one or more inserts’ limitation – it is unclear in the drawings what this adaptation is intended to be, look like, or how it is to function. It is unclear what the inserts are intended to be shaped like, where they are to be inserted, and how they function.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features which are related to the “adapted to receive one or more inserts” limitation of claims 10 and 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 10 and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coon et al. (US 2005/0124998 A1) in view of Aram et al. (US 2009/0088763 A1).
Regarding claim 10, Coon teaches a surgical kit as at figs. 5-7 for articulating surface repair in an anatomical joint of a patient, comprising:
an implant P selected from a predefined set of implants having varying dimensions (examiner interprets teaching at [0025] of size correlation between 10 and P to indicate that various sizing options exist; examiner takes official notice of various patients having differently sized anatomies and different sized implants used in different patients);
an insert tool 10 corresponding to the selected implant P [0025], selected from a predefined set of insert tools, each having an implant engaging portion 22 that has a surface curvature 24A/B that substantially corresponds to the surface curvature of the articulating surface of an implant P in region 26A/B in the predefined set of implants [0019], wherein the insert tool 10 is configured to be used for pressing said implant P to a suitably shaped implant receiving surface that has been e.g. drilled, milled, and/or sawed into the joint at the site of diseased cartilage and/or bone (bone engaging surfaces 44-48 [0029]; discussion of resected surfaces and prepared distal femur (claim 1; [0003]; [0001].
Coon does not teach a guide tool as claimed. The claimed guide tool is for creation of a prepared surface on the bone. Coon makes mention of resected, prepared surfaces on femoral bone [0001, 0003], making clear that the demonstrated instrument will be used during a surgery in which additional equipment is also utilized for forming the prepared bone.
Aram teaches a guide tool 600 as at figs. 35-36 having a contact surface 610 having a shape and contour that is designed to correspond to and to fit the surface curvature of the bone 602 in a predetermined area including and surrounding the site of diseased bone (e.g. the joint; [0313], [0316]) that is located to allow the guide tool 600 to guide a tool along trajectories through apertures 614, 616, 618, 620, 622 for creating an implant receiving surface that is shaped for receiving an implant at the site of diseased bone [0316]. The guide tool 600 is taught including provision for cartilage in the negative contours 610 [0113], [0116], etc. The guide tool 600 includes an attachment section including the contact surface 610 and at least two through-holes 612 for guiding and supporting attachment means (e.g. pins) and through which attachment means can be inserted to attach the guide tool to the anatomical joint. The guide tool further includes an implant receiving section 610 capable of receiving the selected implant therein (when used as follows):
as presently claimed, there are no limitations as to how the ‘implant receiving section’ is to be used or configured. Examiner is of the position that the surface 610 of Aram’s guide will be configured to match with the contour the selected implant (especially a patient-matched implant), for example to permit use as a matter of verifying the correct conformational shape of the implant to be inserted. Examiner further notes there is no reason that a patient-matched implant does not read on at least one of the claimed set of implants. Further, examiner notes that Aram discusses both patient-specific implants and other implants in his disclosure (e.g. [0248], etc.)
Further, the Aram guide tool 600 is capable of receiving one or more inferred inserts for enabling precision in creation of the implant receiving surface at the site of the diseased cartilage and/or bone. (See comments in the response to arguments section, above)
It would have been obvious to one with ordinary skill in the art to use the Aram device in the same surgery as the Coon device, in order to provide the prepared/resected surfaces referenced by Coon. One would have done so in order to achieve preparing the bone into the proper configuration to receive the Coon implant prior to use of the Coon insert tool.
Regarding claims 18 and 20, Coon teaches a surgical kit as at figs. 5-7 for articulating surface repair in an anatomical joint of a patient comprising:
an implant P selected from a predefined set of implants (examiner interprets teaching at [0025] of size correlation between 10 and P to indicate that various sizing options exist; examiner takes official notice of various patients having differently sized anatomies and different sized implants used in different patients);
an insert tool 10 corresponding to the selected implant P [0025], selected from a predefined set of insert tools, each having an implant engaging portion 22 that has a surface curvature 24A/B that substantially corresponds to the surface curvature 26A/B of the articulating surface of an implant P in the predefined set of implants [0019].
Coon does not teach a guide tool as claimed. The claimed guide tool is for creation of a prepared surface on the bone. Coon makes mention of resected, prepared surfaces on femoral bone [0001, 0003], making clear that the demonstrated instrument will be used during a surgery in which additional equipment is also utilized for forming the prepared bone.
Aram teaches a guide tool 600 as at figs. 35 and 36 having a contact surface 610 having a shape and contour that is designed to correspond to and to fit the surface curvature of cartilage and bone 602 in a predetermined area including and surrounding the site of diseased bone (e.g. the joint; guide 600 is taught matching bone and cartilage [0313], [0316], [0113], [0116]) that is located to allow the guide tool 600 to guide a tool along trajectories through apertures 614, 616, 618, 620, 622, for creating an implant receiving surface that is shaped for receiving an implant at the site of diseased bone and cartilage. The guide tool 600 includes an attachment section including the contact surface 610 and at least two through-holes 612 for guiding and supporting attachment means (e.g. pins) and through which attachment means can be inserted to attach the guide tool to the anatomical joint. The guide tool further includes an implant receiving section 610 (when used the following manner):
as presently claimed, there are no limitations as to how the ‘implant receiving section’ is to be used or configured. Examiner is of the position that the surface 610 of Aram’s guide will be configured to match with the contour of some inferred implant (especially a patient-matched implant), for example to permit use as a matter of verifying the correct conformational shape of the implant to be inserted. Examiner further notes there is no reason that a patient-matched implant does not read on at least one of the claimed set of implants. Further, examiner notes that Aram discusses both patient-specific implants and other implants in his disclosure (e.g. [0248], etc.)
Further, the Aram guide tool 600 is capable of receiving one or more inferred inserts for enabling precision in creation of the implant receiving surface at the site of the diseased cartilage and/or bone. See comments above in the response to arguments section.
It would have been obvious to one with ordinary skill in the art to use the Aram guide device in the same surgery as the Coon device, in order to provide the prepared/resected surfaces referenced by Coon. One would have done so in order to achieve having the bone in the proper configuration to receive the Coon implant prior to use of the Coon insert tool.
Regarding claim 19, the insert tool 10 is configured to be used for pressing said implant P to a suitably shaped implant receiving surface that has sawed into the joint at the site of diseased cartilage and/or bone (e.g. for receipt of a prosthesis P with the inner configuration of fig. 9; this requires preparation of the bone as described at [0003].
Regarding claim 21, the predetermined area comprises and surrounds the site of diseased cartilage and/or bone - As can be seen at fig. 36, the guide 600 includes an inner contour 610 for the diseased area (at the joint).
Regarding claim 22, the guide tool is individualized (e.g. the surface 610 shape-matches the patient’s bone).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coon in view of Aram and Porzel et al. (US 2015/0366677 A1).
Regarding claim 11, the combination of Coon and Aram suggests the kit of claim 10. However, the combination does not suggest use of a dummy implant, as claimed.
Porzel teaches a dummy implant 1 used with an insert tool 10. The trial is taught being “generally in the shape of a femoral component implant…” [0006]. The trial is taught being for “the purpose of seating the trial instrument on a distal end of a femur of a patient”. [0006] The trial can be provided in multiple sizes to “judge the appropriate size of a device to ultimately be implanted.” [0014]
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide a dummy implant along with the combination kit. One would have done so in order to permit testing of the fitment between the implant and bone; and further evaluation of proper implant sizes for a particular patient.
Conclusion
THIS ACTION IS MADE FINAL. 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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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