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
Claims 21-38 and 50-61 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/12/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 'A'. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 39-45, 47 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Young (US 2013/0138112 A1).
Regarding claim 39, Young teaches a tibial trial implant (figs. 6-9) for use in a knee joint replacement operation (fig. 9), comprising:
a lower part (302, base plate, fig. 7), which is provided for tibial fixation;
an upper part (304, distraction plates, fig. 7), which is arranged above the lower part in the height direction and has a glide face that is arranged on the upper side for gliding interaction with a femoral component (¶ [0058], fig. 9); and
a height adjustment mechanism (364, drive ring, 306a/b, intermediate stages, 316, distraction screw threads, fig. 7), which is actively connected to the upper part and the lower part and by which the upper part is displaceably guidable relative to the lower part in the height direction between (¶ [0057-0059]):
a first adjustment position, in which the glide face is positioned at a first height above the lower part (fig. 8, right-hand side), and
a second adjustment position, in which the glide face is positioned at a second height above the lower part (fig. 8, lest-hand side),
wherein the height adjustment mechanism comprises a cam gear (364, drive ring, 316, distraction screw threads, 320a/b, distraction screw threads, 318a/b, distraction screw threads, fig. 7, ¶ [0060-0061]) having at least one drive wheel (364, drive ring, fig. 7), which is mounted rotatably on the lower part about a first rotation axis oriented parallel to the height direction (¶[0063], figs.7-8) and comprises a control cam (366, internal screw thread, 320a/b, distraction screw threads, 318a/b, distraction screw threads, fig. 7) rising in the height direction, and having at least one driven element (316, distraction screw threads, fig. 7), which is firmly connected to the upper part and comprises a supporting section (316, distraction screw threads, fig. 7) glidingly supported on the control cam, so that the upper part is displaceable by rotational movement of the drive wheel between the first adjustment position and the second adjustment position (¶ [0057-0063]),
wherein a scale display is formed between the lower part and the at least one drive wheel, which comprises a reading element and a scale (¶ [0044] and ¶ [0066])and allows reading of the adjustment position of the upper part and/or of the height of the glide face (¶ [0044] and ¶ [0066]).
Regarding claim 40, Young further teaches the control cam is formed by a control face helically extending with a constant pitch coaxially around the first rotation axis (318a/b, distraction screw threads, fig. 7¶ [0045], the top slope of the threads serves as the face).
Regarding claim 41, Young further teaches the supporting section is formed by a supporting face helically extending with a constant pitch coaxially around the first rotation axis (316, distraction screw threads, ¶ [0045], the bottom slope of the threads serves as the face).
Regarding claim 42, Young further teaches the at least one drive wheel comprises a cylindrical bore extending coaxially with the first rotation axis (fig. 7), into which a complementary plug cylinder of the at least one driven element (112, distraction plate post, fig. 2) is releasably plugged so as to form the plug connection (fig. 8).
Regarding claim 43, Young further teaches the height adjustment mechanism comprises a worm gear preceding the cam gear (350, worm gear, fig. 7).
Regarding claim 44, Young further teaches the worm gear comprises self-retention (¶ [0060]).
Regarding claim 45, Young further teaches the worm gear comprises a worm drive shaft (354, shaft, fig. 7), which is mounted rotatably on the lower part about a second rotation axis oriented perpendicularly to the height direction (fig. 7), the worm drive shaft interacting with a toothed outer circumferential section of the at least one drive wheel or with a worm wheel preceding the at least one drive wheel (372, external gear, fig. 7).
Regarding claim 47, Young further teaches the worm drive shaft comprises on one end a rotation actuation section (358, spur gears, fig. 7) configured for manual and/or tool-driven rotation actuation of the worm drive shaft about the second rotation axis (¶ [0060]).
Regarding claim 49, Young further teaches the height adjustment mechanism is configured at least substantially mirror- symmetrically with respect to a vertical mid-length plane (figs. 7-8), and wherein the at least one drive wheel comprises at least two drive wheels (figs. 7-8), the tibial trial implant further comprising at least two driven elements (figs. 7-8).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 46 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Trabish (US 2018/0177612 A1).
Regarding claim 46, Young fails to teach two shells. However, Trabish teaches a tibia implant that includes the lower part is configured as two shells and comprises an upper shell (302, support structure, fig. 23) and a lower shell (304, support structure, fig. 23), the worm drive shaft being held between the upper shell and the lower shell (fig. 23).Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the lower part of Young to include comprising two shells as taught by Trabish in order to form a housing for the sensor, power source and circuitry (Trabish, ¶ [0126]) and to protect the cam gear.
Regarding claim 48, Young fails to teach two shells. However, Trabish teaches a tibia implant that includes the lower part is configured as two shells and comprises an upper shell (302, support structure, fig. 23) and a lower shell (304, support structure, fig. 23), the at least one drive wheel being held between the upper shell and the lower shell (fig. 23). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the lower part of Young to include comprising two shells as taught by Trabish in order to form a housing for the sensor, power source and circuitry (Trabish, ¶ [0126]) and to protect the cam gear.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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