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 without traverse of the invention of Group I (claims 1-14) in the reply filed on August 3, 2026, is acknowledged. Accordingly, claims 1-14 have been examined on the merits in this office action and claims 15-19 have been withdrawn from further consideration.
Drawings
The drawings are objected to because of shading and lack of contrast making details difficult to understand (for e.g. Figs. 1A, 7A and 7B). 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 § 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 5-6 and 13 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.
In claim 5, the recitation “handle threaded into the peg hole” and in claim 6, the recitation “peg-shaped handle” renders the claims vague and indefinite because it appears different terminology is being used for the same handle.
In claims 13 and 14, the recitation “a second hole” renders the claim vague and indefinite because claims 1-3 do not recite a first hole.
In claims 13 and 14, the recitation “the second flat surface” lacks antecedent basis.
Appropriate correction is required.
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.
(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.
Claim(s) 1-6, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dungy (US 20170325868 A1).
Regarding claim 1, Dungy discloses a reference-point providing device capable of being used in conversion of unicompartmental knee arthroplasty (UKA) to total knee arthroplasty (TKA), including: a wedge (spacer body 102) having a joint surface (defined by the surface of spacer 120, Fig. 1E), a bottom flat surface (Fig. 1C), and a second surface, the second surface (side surface, Fig. 1E) extending from the bottom flat surface to the joint surface at a thick end of the wedge; a mounting flange (defined by t-channel 107, Fig. 3A) coupled to the wedge; and wherein the wedge is configured to fit in a space remaining after removal of a UKA implant, i.e. the resected surfaces of the joint after removal of the UKA implant, with the joint surface providing a reference point for determining alignment of a TKA implant (paras [0033]-[0043]).
Regarding claim 2, Dungy discloses a snap-off (interpreted to mean a snap-fit handle that can be readily detached or removed) handle 101 coupled to the wedge (spacer body 102 and spacer 120) (para [0031]).
Regarding claims 3-6, Dungy discloses the handle or peg handle to be removably connected to the wedge (spacer body 102 and spacer 120) by means of a threaded fit (para [0031]).
Regarding claims 9 and 10, the wedge (spacer body 102 and spacer 120) is an arcuate wedge (Fig. 1E) wherein the wedge has an adjustable thickness.
Claim(s) 1-2, 3, and 6-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Harris et al. (US 12011179).
Regarding claim 1, Harris et al. disclose a reference-point providing device capable of being used in conversion of unicompartmental knee arthroplasty (UKA) to total knee arthroplasty (TKA), including: a wedge (45M, 25b) having a joint surface (defined by the bottom surface of 25b, Fig. 12A), a bottom flat surface (Figs. 12B and 12C), and a second surface, the second surface (side surface, Fig. 12C ) extending from the bottom flat surface to the joint surface at a thick end of the wedge; a drill guide or mounting flange 30 coupled to the wedge (Figs. 13A-13B); and wherein the wedge is configured to fit in a space remaining after removal of a UKA implant, i.e. the resected surfaces of the joint after removal of the UKA implant, with the joint surface providing a reference point for determining alignment of a TKA implant (col. 19, lines 37-67, col. 20 and col. 21, lines 1-21).
Regarding claim 2, Harris et al. disclose a modular or removable handle 41 (interpreted to mean snap-off because it can be readily detached or removed) coupled to the wedge (Figs. 12A-12C).
Regarding claims 3 and 6, the mounting flange in the wedge has a hole or peg hole to receive a peg-shaped handle 41 (Fig. 12A-12C).
Regarding claim 7, the joint surface of the wedge (surface contacting the tibia) is an arcuate surface.
Regarding claim 8, the wedge has adjustable thickness because of a plurality of thicknesses of snap-on gap spacers 25b (col. 19, lines 37-67 and col. 20).
Regarding claims 9 and 10, the wedge is an arcuate wedge because the outer surface of portions 25b are curved wherein the wedge has an adjustable thickness because of a plurality of thicknesses of snap-on gap spacers 25b (col. 19, lines 37-67 and col. 20).
Regarding claims 11 and 12, the mounting flange coupled to the wedge has at least one hole for accepting a mounting pin 27 (Fig. 13C).
Regarding claims 13 and 14, the wedge has a second hole 13b between a second flat surface (upper surface of mounting flange) and the bottom flat surface (upper surface of either of the complementary femoral engagement members 13) to accept a mounting pin or screw.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
September 4, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
Prosecution Insights