DETAILED ACTION
This office action is responsive to the amendment filed March 4, 2026, and Request for Continued Examination filed March 16, 2026. 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 Claims 1-13, 15, 16, and 18-22 are pending, though claims 1-9, 12, 13, 15, and 16 were previously withdrawn from consideration.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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 16, 2026, has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10, 11, and 18-22 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejections are necessitated by the amendments to the claims of March 4, 2026.
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 10, 11 and 18-22 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.
Claims 10 and 18 require an implant of a set of implants at lines 3; then refer to an “implant receiving section” at lines 15. As claimed, it is unclear if the implant receiving section is required to correspond to the same implant (or set of implants) previously recited. Examiner is of the position that any implant (including one which is distinct from those referred to at lines 3) reads on these claims, and treats the claims as such for examination purposes. Clarification is required to either clarify that these are one of the same implants, or any implant which is capable of being received in this section is intended by the claim language.
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 (when used in a different manner):
as presently claimed, there are no limitations as to how the ‘implant receiving section’ is to be used, configured, or even with which implant this section is required to work with (see the rejection under 35 USC 112(b), above). 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.)
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 in a different manner):
as presently claimed, there are no limitations as to how the ‘implant receiving section’ is to be used, configured, or even with which implant this section is required to work with (see the rejection under 35 USC 112(b), above). 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.)
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
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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/DAVID W BATES/Primary Examiner, Art Unit 3799
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