DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. The applicants arguments were with respect to McShirley, which has been replaced in the instant Office action.
Claim Rejections - 35 USC § 112
Claims 21-30, 32, 33, 37 and 41-45 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.
Regarding Claim 21, the limitation “said open end of said sleeve” renders the claim indefinite. The amendments filed 6/25/2026 changed “its open end” to “an open end”, which cures the “its” ambiguity, but creates a new one. Claim 21 now recites two open ends – the housing’s and the sleeve’s. The later phrase “said open end of the sleeve” has no antecedent basis, because the housing is previously recited as both “with an open end”, a sleeve “protruding from the open end” and doesn’t specifically attribute the object contacting portion being rested against the object with “an open end”. It is unclear whether this limitation refers back to that recitation or to the housing’s open end. For purposes of examination the indefinite limitation has been deemed to claim “wherein said sleeve has an open end, where said sleeve is adapted for resting against said object with at least an object contacting portion of the open end”.
Regarding Claim 25, the limitation “adapted to rest on a surface of said object different from said object contacting portion of said sleeve” renders the claim indefinite. This limitation compares a surface of the object to a portion of the sleeve. These are not comparable referents. For purposes of examination the indefinite limitation has been deemed to claim that the claim intends to imply that a surface different from the surface contacted by the object contacting portion.
Regarding Claim 32, the limitation “said device” renders the claim indefinite. As claimed, the sleeve is part of said device. Reciting the element as mounted “between said sleeve and said device” is indefinite, it is unclear how something can be a component and the assembly at the same time. For purposes of examination the indefinite limitation has been deemed to claim that the mounting device is between the sleeve and the drive mechanism (or housing).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 21-24, 28, 29, 30, 32, 33, 37, 41 and 42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 6120466 A to Earthman in view of US 20070060844 A1 to Alvarez-Icaza et at. (hereinafter, Alvarez).
Regarding Claims 21, 23, 32 and 33, Earthman discloses a system for determining structural characteristics of an object, comprising inter alia:
(Claim 21) a device comprising:
a housing (handpiece 104) with an open end (space in which tapping rod 120 resides, FIG. 1) and a longitudinal axis (axis along center of device, FIG. 1);
an energy application tool (tapping rod 120) mounted inside the housing (col. 3, lines 43-45 “…tapping rod 120 inside the handpiece 104…) for applying an amount of energy to the object (col. 7, lines 56-60 “The kinetic energy of the tapping rod 120 prior to impact is determined by measuring the mass and velocity of the tapping rod 120… the average value was determined to be about 3.3xl0-6 joules.”), said energy application tool comprising an active configuration (col. 5, lines 53-55 “a movable tapping rod 120 is driven by a propulsion coil 156 through an orifice in the sleeve 108 to impact the specimen 112 sixteen times in four seconds”) and a resting configuration (col. 3, lines 49-53 “the head 128 of the tapping rod 120 in its retracted stationary position ranges generally from about 3.5 millimeters to about 5.5 millimeters, and preferably from about 3.75 millimeters to about 4.5 millimeters”); and
a drive mechanism (propulsion coil 156) supported inside the housing (propulsion coil 156 is located in handpiece 104, FIG. 1) adapted for moving the energy application tool (col. 5, lines 52-55 “…a movable tapping rod 120 is driven by a propulsion coil 156 through an orifice in the sleeve 108 to impact the specimen 112 sixteen times in four seconds.”), said drive mechanism comprising a measuring or sensing device (accelerometer 160) coupled to said energy application tool for measuring effects of energy application on the object (col. 5, lines 57-61 “The acceleration of the tapping rod 120 is measured by the accelerometer 160. An accelerometer 160 produced signals corresponding to the shock wave resulting from each impact.”);
a sleeve (sleeve 108) protruding from the open end of the housing for a distance (col. 3, lines 46-48 “… the polymer sleeve 108 of the handpiece 104 extends out…”), said sleeve adapted for resting against said object with at least an object contacting portion of an open end (via tip 116), and
an orifice with said energy application tool of said device is adapted to be driven through to contact said object (col. 5, lines 52-55 “…a movable tapping rod 120 is driven by a propulsion coil 156 through an orifice in the sleeve 108 to impact the specimen 112 sixteen times in four seconds.”) (Claim 10 “wherein said sleeve comprises an orifice through which a tapping rod travels, said orifice with a decreasing diameter”; and a manual switch mechanism (finger switch 124);
a manual switch
Earthman discloses the claimed invention except for expressly disclosing (Claim 21) where the switch mechanism is triggered by applied pressure to the object by an operator through the object contacting portion of said open end of said sleeve, said switch mechanism comprising at least one force measuring element mounted between said sleeve and said device, (Claim 23) wherein said at least one force measurement element is adapted for monitoring an amount of force between said sleeve and object when said sleeve rests on the object, (Claim 32) where said at least one force measuring element is mounted to a mounting device between said sleeve and said device, and (Claim 33), where said at least force measuring element measures said amount of force within a predetermined range.
However, Alvarez teaches (Claim 21) an applied pressure sensing cap (cap 100) for a handheld device, the cap body 102 attaching at proximal end 106 to the device housing and having an aperture therethrough (paragraph [0022]) through which the tool is driven, and a target sit contact surface 108 at a distal end 104 pressure against the target. A moveable cap body portion 102a carrying a moveable surface portion 108a travels in guide recess 118 against spring 120 of a predetermined spring constant, where contact pads 112 and 114 touch “thus completing an electrical circuit and, thereby, sending an electrical signal via electrical signal wire 116 to the lancing device” (paragraph [0027]), which initiates the drive. The predetermined force “can be, for example, in the range of 2 Newtons to 20 Newtons” (paragraph [0023]).
Alvarez also teaches (Claim 23) where said at least one force measurement element is adapted for monitoring an amount of force between said sleeve and object when said sleeve rests on the object (paragraph [0032] “lancing is only initiated when a predetermined pressure has been applied to target site contact surface 108”) ([0023] “The predetermined force can be, for example, in the range of 2 Newtons to 20 Newtons.”) (e.g., moveable cap body portion 102a, carrying contact surface portion 108a, moves against spring 120 of predetermined spring constant only when the contact surface resting on the target site is loaded by the predetermined force, at which point pads 112 and 114 close, therefore, there is monitoring of the force between the object contacting portion and the object). Alvarez teaches that with this cap “a user… is not required to press a button or a switch to initiate landing. Also, lancing is only initiated when a predetermined pressure has been applied to target site contact surface 108” ([0032])
Alvarez also teaches (Claim 32) where said at least one force measuring element (contact pads 112 and 114 and also spring 120) is mounted to a mounting device (cap body 102 having guide recess 118 in which moveable cap body portion 102a travels) between said sleeve and said device (cap 102 lies in the load path between target site contact surface 108 and the device, proximal end 106 being “configured for attachment to a lancing device”, e.g., to a housing of a lancing device).
Alvarez also teaches (Claim 33) where said at least force measuring element measures said amount of force within a predetermined range (paragraph [0023] “The predetermined force can be, for example, in the range of 2 Newtons to 20 Newtons.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the manual switch mechanism of Earthman to be the contact-force actuated switch of Alvarez, because Earthman teaches that aberrant readings result from “the shacking of the device derived from pressing of the finger switch located on the handpiece” (col. 2, lines 5-17 and col. 4, lines 49-62) and Alvarez’s arrangement both eliminates the finger pressure and ensures actuation occurs at consistent forces, furthering Earthman’s objective to ensure “consistent and reproducible positioning of the tip with respect to the specimen creates consistent and reproducible conditions which produced precise and accurate results” (col. 2, lines 64-67).
Regarding Claim 22, Earthman in view of Alvarez teach the system of claim 21 further comprising a computer (Earthman: computer 164) coupled to said device adapted for determining structural characteristics of said object from an energy return graph representing the effects of energy application on said object (Earthman: col. 6, line 53 to col. 7, line 25).
Regarding Claim 24, Earthman in view of Alvarez teach the system of claim 21 wherein said object comprises anatomical or non-anatomical object (Earthman: specimen 112).
Regarding Claim 28, Earthman in view of Alvarez teach the system of claim 23, further comprising digital output mechanisms (Earthman: computer monitor 332) coupled to said at least one force measuring element (Earthman:computer monitor 332 is capable of a digital output, and is coupled to the force measuring element, e.g., all elements in the device are functionally “coupled” to one another).
Regarding Claim 29, Earthman in view of Alvarez teach the system of claim 21 wherein said object comprises a natural tooth, a prosthetic dental implant structure, a dental structure, an orthopedic structure or an orthopedic implant (Earthman: col. 4, line 54).
Regarding Claim 30, Earthman in view of Alvarez teach the system of claim 21 wherein said structural characteristics of the object comprises densities; bone densities or a level of osseointegration; defects, inherent or otherwise; cracks, fractures, microfractures, microcracks; loss of cement seal; cement failure; bond failure; microleakage; lesion; decay; cement failure; bond failure; vibration damping; acoustic damping; delamination; or combinations thereof of said object or a foundation to which said object is attached (Earthman: col. 8, lines 42-58).
Regarding Claim 37, Earthman in view of Alvarez teach where said drive mechanism (Earthman: propulsion coil 156) is adapted to drive said energy application tool between a retracted position within said sleeve (Earthman: col. 3, lines 47-51 “the distance from the tip 116 of the polymer sleeve 108 in contact with the specimen 112 to the head 128 of the tapping rod 120 in its retracted stationary position ranges generally from about 3.5 millimeters to about 5.5 millimeters”) and an extended position adapted to contact said object through said orifice of said sleeve (Earthman: col. 5, lines 53-55 “a movable tapping rod 120 is driven by a propulsion coil 156 through an orifice in the sleeve 108 to impact the specimen 112 sixteen times in four seconds”).
Regarding Claim 41, Earthman in view of Alvarez teach where said energy application tool is driven by said drive mechanism axially within said housing between said retracted and extended positions (Earthman: col. 5, lines 53-55 “a movable tapping rod 120 is driven by a propulsion coil 156 through an orifice in the sleeve 108 to impact the specimen 112 sixteen times in four seconds”) (Earthman: col. 4, lines 23-25 “Decreasing inner diameters helped guide the tapping rod 120 to strike the specimen 112 in a 25 consistent location and at a consistent angle of inclination.”).
Regarding Claim 42, Earthman in view of Alvarez teach wherein said measuring or sensing device is adapted to receive said effects of energy application on said object (Earthman: col. 5, lines 59-61 “produced signals corresponding to the shock wave resulting from each 60 impact.”), and where said sleeve comprises a vibration attenuating material adapted to reduce transmission of stress waves from said object through said sleeve (col. 5, lines 18-24 “the use of a polymer for the sleeve 108 of the handpiece 104 results in a cleaner signal by keeping stress waves from propagating up the case 132 of 20 the handpiece 104. In one preferred embodiment, PTFE is used as the sleeve 108 polymer. PTFE is autoclavable and is of sufficiently high damping capacity to attenuate stress waves from the specimen 112.”).
Claims 26, 27, 43 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Earthman in view of Alvarez, and further in view of US 4482324 A to Wohlgemuth.
Earthman in view of Alvarez teach the claimed invention except for expressly disclosing (Claim 26) wherein said energy application tool having a front portion that is substantially perpendicular to the longitudinal axis of the housing and oscillates from a substantially parallel position to the housing to a position at an acute angle with the housing about a pivot point, (Claim 27) where said at least one force measuring element comprises at least one piezoelectric element, (Claim 43) wherein said measuring or sensing device is disposed proximal to a tip of said energy application tool and (Claim 44) wherein said measuring or sensing device comprises a piezoelectric force sensor.
However, Wohlgemuth teaches a percussion instrument for use in dental practice (Abstract), Wohlgemuth teaches (Claim 26) a front portion (test head 3) that is perpendicular to a longitudinal axis that runs through housing 17 and oscillates from a parallel position to the housing (e.g., the very distal tip of test head is parallel to housing 17) to an acute angle with the housing (via pivot 18), (Claim 27) where their instrument has a piezo-ceramic wafer 22, where “substantially the entire mass of the oscillating lever influences the piezo-ceramic elements 22 as inertial forces” (col. 4, lines 33-35), (Claim 43) where “an acceleration pickup 20 is mounted at the test head 3 in direct proximity to the object to be tested” (col. 4, lines 13-15), the test head being the portion that strikes the object, and (Claim 44) teaches piezo-ceramic wafers 22 respond to impact against the object, as set forth above the Wohlgemuth citation of Claim 27).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the energy application tool of Earthman to have the perpendicular, pivoting front portion of Wohlgemuth, retraining the tool’s path through the orifice of sleeve 108 to contact the specimen, because Wohlgemuth teaches that this would have allowed a velocity to be a more constant value than traditional energy application devices that are linear (col. 1, lines 52-66), which furthers Earthman’s stated objective of obtaining consistent and reproducible measurement conditions. Also, one would have been motivated to relocate the measuring or sensing device of Earthman to a position proximal to the tip of the tapping rod as taught by Wohlgemuth, because Wohlgemuth “because greatest movement of the lever 19 occurs at that location, the highest acceleration signal can be obtained. Also, one would have been motivated to implement the measuring or sensing device of Earthman as the piezoelectric force sensor of Wohlgemuth, as this would have been a simple substitution for one known-impact sensing element for another to obtain the predictable result of detecting the effects of energy application on the object, and for the increased signal magnitude. The acceleration pickup 20 can thus be very small” (col. 4, lines 21-24) yielding “a useful signal increased by several powers of 10 over conventional signals” (col. 4, lines 35-37).
Allowable Subject Matter
Claims 25, 32 and/or 45 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.
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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