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 .
Claims Accounting
Applicant' s arguments, filed 11/11/2025, have been fully considered.
The following rejections are reiterated. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/11/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 71 and 77 have been amended.
Claim 75 has been cancelled.
Claims 71-74, 76-84 and 86-90 are hereby under consideration.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim limitation “at least two affixing means” first recited in claim 71, line 11 invokes interpretation under 35 U.S.C. 112(f) for the following reasons:
The limitation uses the term “means”.
The limitation is modified by functional language (claim 71, line 12: “for affixing the device to an implant”).
The term means is not modified by sufficient structure (“at least two affixing” describes the intended use of the means but does not modify the means with sufficient structure).
The corresponding structure for the “at least two affixing means” is found in pars. [0033-0034], [0036], and [0110] of the published application as: through holes, a plurality of through holes, or clamps. The “at least two affixing means” are interpreted as its corresponding structure and equivalents thereof.
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.
Claims 71-74, 76-84 and 86-90 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2018/0055444 by Windolf – previously cited (hereinafter “Windolf”) in view of US Patent Publication 2008/0160646 by White et al. –previously cited (hereinafter “White”) in view of US Patent 4,814,661 by Ratzlaff et al. – previously cited (hereinafter “Ratzlaff”).
Regarding claim 71, Fig. 5 of Windolf teaches a device for measuring, processing and transmitting implant parameters in osteosynthesis, the device comprising:
a biocompatible sterilizable housing ([0072]; biocompatible sterilizable housing 9);
a strain sensor ([0079]; sensor 5 may be a strain gauge); and
an electronic unit electrically connected to the strain sensor ([0072]; electronic data processing device 2 is electronically connectable to sensor 5) and configured to process electrical signals provided by the strain sensor (Abstract; data processing device 2 is programmed to calculate statistical data based on measurement data received from sensor 5);
wherein the housing comprises
a measurement portion ([0092]; portion of the housing where sensor 5 is arranged) having a height H5 (the height of this portion can be considered height H5), an upper surface (the surface not facing the implant 100), a lower contact surface (the surface contacting the implant) and a measurement portion cavity (the inside of the housing must have a cavity where the sensor 5 is), and
a compartment portion (stepped portion of the housing) having a height H6 (the height of this portion can be considered height H6) with a compartment portion cavity (the inside of the housing must have a cavity where the electronic data processing device 2 and other electronic components are),
wherein the measurement portion comprises at least two affixing means for affixing the device to a medical implant ([0092] through hole 12 (with fastener 13) and hole for terminal bone screw (hole in the housing corresponding to screw hole 101 of the implant)),
wherein the at least two affixing means are spaced apart from each other by a distance D (the distance between the holes can be considered distance D),
wherein the cavity of the measurement portion is arranged between the at least two affixing means (the cavity in the housing containing sensor 5 is between the two holes),
wherein the strain sensor is positioned in the measurement portion cavity (the measurement portion cavity is defined as the space in the housing where the sensor 5 is), and
wherein the electronic unit is positioned in the compartment portion cavity (the compartment portion cavity is defined as the space in the housing where the electronic data processing device 2 and other electronic components are).
It is noted that the embodiment of Fig. 5 taught by Windolf varies from the embodiments taught by Figs. 1 to 3 only by the configuration of the housing ([0092]).
Windolf does not teach wherein the measurement portion is provided with a slot adjacent to the compartment portion, wherein the measurement portion has a length L5 measured along a line connecting centers of the at least two affixing means, and wherein the slot extends along 30% to 90% of the length L5 of the measurement portion. It is noted that the stepped configuration of Fig. 5 of Windolf results in the compartment portion overhanging the terminal edge of the bone plate.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the compartment portion of Windolf to overhang the side edge of an implant such that the compartment section is adjacent to the measurement portion, and the measurement portion has a length L5 measured along a line connecting centers of the at least two affixing means, as the courts have held that the particular placement of an element was held to be an obvious matter of design choice. See MPEP 2144.04.VI.C. It is noted that this change in configuration would lead to the compartment section being adjacent to the measurement portion, and the measurement portion having a length L5 measured along a line connecting centers of the at least two affixing means (the line connecting the centers of the affixing means would be parallel with the adjacent sides of the measurement and compartment portions, and the length can be considered L5).
Modified Windolf does not teach wherein the measurement portion is provided with a slot adjacent to the compartment portion, wherein the slot extends along 30% to 90% of the length L5 of the measurement portion.
White teaches that stress and strain within electronic components, such as circuits, can have undesired adverse effects on the circuit, causing the circuit to fail ([0002]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have modified Windolf to limit the amount of stresses and strains on the electronic circuits.
Fig. 3 of Ratzlaff teaches a plate with multiple sensors mounted and stress isolation slots 59, which extend across approximately half of plate (i.e., 50%). The stress isolation slots minimize the transfer of bending stresses between sections (Ratzlaff; Col. 6, lines 3-20).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of modified Windolf to provide the measurement portion with a slot adjacent to the compartment portion, wherein the slot extends along 30% to 90% of the length L5 of the measurement portion, as taught by Ratzlaff and White, to prevent undesired adverse effects due to stress and strain to the electronic components (housed in the compartment portion), as taught by White (White; [0002]). It is noted that the configuration of Fig. 5 of Windolf comprises separate portions for the electronic components and the sensors. Therefore it would have been prima facie obvious to one of ordinary skill in the art to isolate the portion with the electronic components (e.g., the compartment portion) with a stress isolation slot.
Regarding claim 72, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the at least two affixing means are configured for releasably affixing the device to the implant (Windolf; through hole 12 and hole coinciding with the terminal screw hole can have their respective fasteners removed).
Regarding claim 73, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the height H5 of the measurement portion is smaller than the height H6 of the compartment portion (Windolf, [0092]; the stepped configuration means that the portion of the housing on the second end 19, containing the electronics, has a larger height which coincides with the sum of the heights of the first portion and the implant 100).
Regarding claim 74, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, but is silent regarding wherein the height H5 of the measurement portion does not exceed 4 mm.
It is noted that Applicant has failed to provide details of criticality or unexpected results in their specification with regard to the particularly claimed height of the measuring portion. As such, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal thickness of the measuring portion. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 76, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the compartment portion has a top surface, wherein the upper surface of the measurement portion and the top surface of the compartment portion form a planar, upper free surface of the device. As shown in Fig. 5 of Windolf, the top surface of the measurement portion and compartment portions are at the same height, forming a planar, upper free surface of the device.
Regarding claim 77, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the implant to which the device is affixable is a bone plate (Windolf, implant 100 is a bone plate), wherein the device has an L-shaped cross-sectional area (Windolf, the cross sectional area of the device is L-shaped along a plane parallel to a line connecting the centers of the two affixing means) wherein the upper surface of the measurement portion and a top surface of the compartment portion form an upper free surface of the device (Windolf, the top surface of the measurement portion and compartment portions are at the same height, forming a planar, upper free surface of the device) wherein the measurement portion lies within a first leg of the L-shaped cross-sectional area of the device (Windolf, measurement portion lies within the first leg (closer to first end 18)) and the compartment portion lies within a second leg of the L-shaped cross-sectional area of the device (Windolf, compartment portion lies within the first leg (closer to second end 19)), wherein the height H5 extends from the upper free surface of the device measured parallel to the second leg (Windolf, the dimension in which the first and second portions have different dimensions is parallel to the second leg (i.e., parallel to the axis of the through holes)) and the height H6 extends from the upper free surface of the device through the second leg and protrudes beyond the lower surface of the measurement portion (Windolf, [0092]; the stepped configuration means that the portion of the housing on the second end 19, containing the electronics, has a larger height which coincides with the sum of the heights of the first portion and the implant 100) such that the lower surface of the measurement portion is positionable on a top surface of the bone plate (lower portion of the measurement portion is in contact with the bone plate) while the compartment portion extends beside the bone plate (Windolf, [0092]; the stepped configuration of the housing of Fig. 5 results in the compartment portion extending beside, and pressing against, the side of bone plate).
The combination of Windolf, White, and Ratzlaff does not teach wherein the device has an L-shaped cross-sectional area orthogonal to a line connecting centers of the at least two affixing means. It is noted that the stepped configuration of Fig. 5 of Windolf results in the compartment portion overhanging the terminal edge of the bone plate.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the compartment portion of the combination of Windolf, White, and Ratzlaff to overhang the side edge of an implant such that the device has an L-shaped cross-sectional area orthogonal to a line connecting centers of the at least two affixing means, as the courts have held that the particular placement of an element was held to be an obvious matter of design choice. See MPEP 2144.04.VI.C.
Regarding claim 78, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the measurement portion comprises a strain concentration area located in between the at least two affixing means (Windolf, [0081]; Ridge 17 is located between the through holes and the fastening of the fasteners create pretension along the housing and maximally at the ridge 17.), and wherein the strain sensor is configured to measure strain at the strain concentration area (Windolf, [0081]; the pretension is applied to the sensor 5 to improve the sensing ability of small strains).
Regarding claim 79, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the compartment portion is mechanically connected to the measurement portion by means of a connection portion (Windolf; The portion between the measurement portion and compartment portion is the connection portion. The connection portion is integrally formed with the measurement and compartment portions, which is a form of mechanical connection as there are mechanical forces connecting the portions.).
Regarding claim 80, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the strain sensor is sealed within the measurement portion cavity by a cover (Windolf, [0073]; the housing 9 can be configured as containment for the sensor 5, and therefore acts as a cover for sensor 5).
Regarding claim 81, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the at least two affixing means are through holes in the measurement portion for receiving fasteners (Windolf, through hole 12 and the hole in the housing corresponding to screw hole 101 of the implant are both through holes for receiving fasteners).
Regarding claim 82, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, but does not teach wherein the at least two affixing means are a subset of a plurality of through holes in the measurement portion for accommodating hole patterns of a plurality of different implants.
Fig. 4 of Windolf teaches a housing of the data acquisition device where the through holes 12 comprise multiple overlapping bore holes. This configuration of through holes permits a fixation of the housing on a variety of implants ([0091]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of the combination of Windolf, White, and Ratzlaff so that the at least two affixing means are a subset of a plurality of through holes in the measurement portion for accommodating hole patterns of a plurality of different implants, as this would permit fixation to a variety of implants, as taught by Windolf ([0092]).
Regarding claim 83, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein an undersurface of the at least two affixing means is configured to abut with a circular flat surface (Windolf, the undersurface of the through hole is a flat surface that can abut with any flat surface).
Regarding claim 84, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the at least two affixing means includes at least one fastener or at least one clamp (Windolf, the through hole 12 is configured to receive fastener 13).
Regarding claim 86, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the electronic unit comprises an electronic data processing device electrically connectable or connected to the strain sensor (as applied to claim 71), a data memory electrically connected to the data processing device for storing data received from the data processing device (Windolf, [0072]; data memory 16 is electrically connected to the data processing device 2), a data transmission device electrically connected to the data memory (Windolf, [0072]; data transmission device 4 is electrically connected to the data memory 16), and a power supply (Windolf, power supply 3).
Regarding claim 87, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the device further comprises an antenna for wireless data transmission (Windolf, [0075]; wireless data transmitter is an antenna), which is recessed in a pocket in the housing (Windolf, the data transmission device 4 is in the compartment cavity (i.e., recessed pocket)).
Regarding claim 88, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein at least one strain sensor is attached to an inner wall of the measurement portion cavity (Windolf, [0079]; The sensor 5 may be a strain gauge can be attached to the inner wall of the housing. The sensor 5 is also housed in the measurement portion cavity (as applied in claim 71)), which is closest to the lower contact surface (Windolf, to monitor the strain of the implant the sensor must be located on the bottom of the housing (surface contacting the implant)).
Regarding claim 89, the combination of Windolf, White, and Ratzlaff teaches the device according to claim 71, wherein the housing is made of a biocompatible non-biodegradable metallic or polymeric material (Windolf, [0072]; “Preferably, the housing 9 is made of a biocompatible but non-biodegradable metallic or polymeric material”).
Regarding claim 90, the combination of Windolf, White, and Ratzlaff teaches a method for monitoring a medical implant using a device according to claim 86 (data acquisition device taught by Windolf applied in claim 86) affixed to the medical implant, the method comprising the following steps:
A) obtaining measurement data by means of the strain sensor;
B) performing real-time processing on the measurement data obtained in step A) by means of the data processing device;
C) calculating statistical data based on the measurement data as processed in step B);
D) storing the statistical data calculated in step C) in the data memory;
E) inquiring and downloading selected statistical data stored in the data memory in step D) by means of an external data receiver; and
F) transmitting the downloaded selected statistical data from the external data receiver to a computer for further data management and processing.
All of these method steps of monitoring an implant using the data acquisition device 1 are described in steps A-F of par. [0086] of Windolf.
Response to Arguments
Applicant’s arguments, filed 11/11/2025 have been fully considered.
The amendments to claim 77 overcomes the objection of record.
The amendments to the drawings overcome the rejections of record.
Applicant’s arguments regarding the rejection of amended claim 71 (corresponding to previous claim 75) under 35 U.S.C. 103 are acknowledged. The argument that Ratzlaff is non-analogous art is not found persuasive. Although Ratzlaff is drawn to components within a shoe, the prior art of Ratzlaff was found as it is classified under A61B 2562/02, drawn to art pertaining to details of sensors specially adapted for in-vivo measurements. Further, Ratzlaff is directed towards solving a problem of managing the concentration and isolation of stress, which is a problem faced by the instant invention.
Applicant’s arguments that neither Ratzlaff nor White recite strain sensors are not found persuasive. White is relied upon to teach that stresses and strains transferred to electronic circuits can damage the circuits and cause them to fail. Ratzlaff teaches stress isolation slots that prevent the transfer of stresses a across the slots, thereby isolating the stresses and strains among sections. Because stress and strain are correlated through Young’s modulus, isolating stress to a section is analogous to isolating strain. Further, the Windolf reference teaches a measurement portion containing strain sensors configured to experience and measure strains, and a separate compartment portion configured to house electronic components, it would have been prima facie obvious to one of ordinary skill in the art to have combined include a stress isolation slot to prevent the transfer of stresses and strains to the compartment portion. To this end, the rejection of amended claim 71 (corresponding to previous claim 75) has been reworded to better reflect and reiterate this combination and rationale.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791