DETAILED ACTION
This action is in response to Applicant’s amendment filed February 17, 2026.
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 .
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 2,3, 22-24, 26-29 is 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 claims 22-24, 26 and 27, “the selection point” lacks a proper antecedent. It is unclear if it is a new limitation or referring back to “a selected point of the curve”.
In Claims 2, 22, 26, “receiving a selection point” lacks a structural element for receiving. There are many elements in the system and it is unclear which element is receiving the selection point.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meneghini et al. (U.S. Publication No. 2008/0125671) in view of Slocum et al. (U.S. Publication No. 2022/0240946).
Meneghini et al. discloses a system, comprising: an impactor (118); a force transducer (paragraph 15, 18) configured to measure a resistive force of at least one of: a broach, an implant, or a broach/implant handle during impaction by an automatic impactor (paragraph 18, “a force transducer, such as Piezotronics Model No. PCB 086C05, with a sensitivity of approximately 1 mV/lbf, a frequency range of approximately 5 kHz and an amplitude range of 5,000 lbf, the hammer 118 is placed in communication with the data acquisition and analysis device 114 as shown in FIG. 1 to enable the data acquisition and analysis device 114 to record input force generated by the hammer 118"); and a processor (124, Laptop computer) electrically coupled to memory and the force transducer (paragraph 19, Figure 1), wherein the processor is configured to execute operations stored in the memory (paragraph 19, “The computer 124 also executes instructions stored on a computer readable medium, such as a hard drive or CD-ROM”), the operations comprising: receiving resistive force data generated from the force transducer (paragraph 19, “The data acquisition and analysis device 114 is configured to receive the impaction data from the accelerometers 108, 110, 112, the hammer 118 and/or the punch 120, normalize the impaction data into a usable format as normalized impaction data, calculate an impaction monitoring metric and output femoral component fit and stability data based on the impaction monitoring metric”.); generating a curve connecting a plurality of force data peaks of the generated resistive force data; and outputting the curve to a display (paragraph 24 and as illustrated in figures 3A-3B).
Meneghini et al. fails to disclose that the impactor is an automatic impactor. Slocum teaches an electric surgical hammer impact tool (100) that solves the problem of fatigue in a surgeon caused by the use of a standard hammer or mallet (Paragraph 3). It would have been obvious to one skilled in the art at to include in the system of Meneghini et al. an automatic impactor in view of Slocum so as to reduce fatigue in the surgeon.
Regarding claim 2, the system further comprising receiving a selection point in advance or in near real-time, wherein the selection point indicates an automatic impactor shut off point before, at, or after an inflection point in the curve (paragraph 25, “The dotted lines in each graph represent the actual percentage of distance of the femoral component to its final seated position as measured from the top of the prosthesis to the opening of the femoral canal, while the solid lines in each graph represent the percentage of the total norm of an impaction signal as calculated in Eq. 2 above. As shown in FIGS. 3A-3C, calculation of the 99% to norm metric represents an accurate method of determining when the femoral component is seated.”). It is noted that the determining when the femoral component is seated indicates an automatic impactor shut off point at an inflection point (shaded area in figures 3A-3B).
Regarding claim 3, the operations further comprise: triggering a notification to stop impaction when the automatic impactor is approaching, or has met, the selection point (Figure 2, element 208, The output of the fit and stability data is itself a notification, since the data notifies a user of the fit of the implant and such will allow a user to decide stop impacting or continue impacting).
Regarding claim 4, the force transducer is one of: a flexible, a capacitive, a resistive, a Linear Variable Differential Transformer (LVDT), a mechanical, or a piezoelectric force transducer (paragraph 18).
Regarding claim 5, the force transducer is disposable or reusable (paragraph 16).
Regarding claim 6-9, it is noted that claim 1 recites, “the processor is configured to execute operations stored in the memory.” Therefore, the limitation only requires a processor The “operations stored in the memory” are currently not germane to the structure of the apparatus. This is analogous to a claim that claims, “A screwdriver configured to insert a screw into bone, the screw comprising a thread.” In the example, only a screwdriver needs to be found to anticipate the claim.
Claim(s) 21-27, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meneghini et al. (U.S. Publication No. 2008/0125671) in view of Slocum et al. (U.S. Publication No. 2022/0240946) and further in view of Chiang (U.S. Publication No. 2017/0348010).
Meneghini et al. and Slocum et al. disclose the invention of claim 21 as per claim 1 above, however, fail to disclose triggering an automatic stop to impaction when the automatic impactor is approaching, or has met, a selected point of the curve. Chiang teaches an electric surgical drill having a smart module to control automatic stopping of the drill (paragraph 11). Electrical surgical drills are analogous to electric surgical impactors as both are used in surgical setting that require precise control to protect the healthy surrounding tissue of a patient. The electric drill of Chiang has a smart module (20) that is able to monitor electrical signals and send a stop command when a certain threshold is sensed (paragraph 35). This allows the bone drill to be stopped instantaneously to avoid damage to surrounding tissue (paragraph 3). It would have been obvious to one skilled in the art at to trigger an automatic stop to impaction in the system of Meneghini et al. as modified by Slocum in view of Chiang so as to preserve the health of the surrounding tissue of the surgical site.
The following claims are unpatentable over Meneghini et al., in view of Slocum et al. and further in view of Chiang, however, only the relevant publications are cited per limitation.
Regarding claim 22, Meneghini et al. discloses the system further comprising receiving the selection point in advance or in near real-time, wherein the selection point indicates an automatic impactor shut off point before, at, or after an inflection point in the curve (paragraph 25, “The dotted lines in each graph represent the actual percentage of distance of the femoral component to its final seated position as measured from the top of the prosthesis to the opening of the femoral canal, while the solid lines in each graph represent the percentage of the total norm of an impaction signal as calculated in Eq. 2 above. As shown in FIGS. 3A-3C, calculation of the 99% to norm metric represents an accurate method of determining when the femoral component is seated.”). It is noted that the determining when the femoral component is seated indicates an automatic impactor shut off point at an inflection point (shaded area in figures 3A-3B).
Regarding claim 23, the operations further comprise: triggering a notification when the automatic impactor is approaching, or has met, the selection point. It can be construed from Meneghini et al., Slocum et al. and Chiang that the automatic stop is a notification in itself.
Regarding claim 24, Meneghini et al. discloses that the selection point is based on a patient physiological information and historical data of a surgeon using the automatic impactor (paragraph 32-33).
Meneghini et al. and Slocum et al. disclose the invention of claim 21 as per claim 1 above, however, fail to disclose triggering an automatic stop to impaction when the automatic impactor is approaching, or has met, a selected point of the curve. Chiang teaches an electric surgical drill having a smart module to control automatic stopping of the drill (paragraph 11). Electrical surgical drills are analogous to electric surgical impactors as both are used in surgical setting that require precise control to protect the healthy surrounding tissue of a patient. The electric drill of Chiang has a smart module (20) that is able to monitor electrical signals and send a stop command when a certain threshold is sensed (paragraph 35). This allows the bone drill to be stopped instantaneously to avoid damage to surrounding tissue (paragraph 3). It would have been obvious to one skilled in the art at to trigger an automatic stop to impaction in the system of Meneghini et al. as modified by Slocum in view of Chiang so as to preserve the health of the surrounding tissue of the surgical site. Regarding “applying a predetermine force at a predetermined rate of impaction,” such is considered functional and the device of Chiang is capable of such function.
Regarding claim 26, Meneghini et al. discloses the system further comprising receiving the selection point in advance or in near real-time, wherein the selection point indicates an automatic impactor shut off point before, at, or after an inflection point in the curve (paragraph 25, “The dotted lines in each graph represent the actual percentage of distance of the femoral component to its final seated position as measured from the top of the prosthesis to the opening of the femoral canal, while the solid lines in each graph represent the percentage of the total norm of an impaction signal as calculated in Eq. 2 above. As shown in FIGS. 3A-3C, calculation of the 99% to norm metric represents an accurate method of determining when the femoral component is seated.”). It is noted that the determining when the femoral component is seated indicates an automatic impactor shut off point at an inflection point (shaded area in figures 3A-3B).
Regarding claim 27, Meneghini et al. discloses that the selection point is based on a patient physiological information and historical data of a surgeon using the automatic impactor (paragraph 32-33).
Regarding claim 30, the predetermine rate of impaction only further limits functional language and thus considered that the combination is capable of having the claimed predetermined rate.
Allowable Subject Matter
Claims 28 and 29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose the historical data used to determine the selection point includes all the elements of common impaction rate, a reaction time, and a historical number of impactions for the surgeon for a particular orthopedic surgery type.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/ Primary Examiner, Art Unit 3775