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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/26/2025 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks page 6, filed 12/26/2025, with respect to the 35 USC 112 rejection of claims 15 and 18-20 have been fully considered and are persuasive. The amendment resolves the 35 USC 112 issues. The 35 USC 112 rejection of claims 15 and 18-20 has been withdrawn.
Applicant’s arguments, see Remarks pages 6-10, filed 12/26/2025, with respect to the rejection(s) of claim(s) 1-13, 15, 18-20, and 22 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bodnyk (US 20190265139 A1).
In response to the applicant’s argument that prior art reference, Boyden, fails to teach comparing the before and after images to monitor the healing process of a fracture, the examiner notes that Boyden discloses imaging before and during surgery. It could be reasonably understood that these images are an inherent part of monitoring the fracture healing process. For example, Duda (US 20080154265 A1) discloses in para. 0003 “The evaluation of X-ray photos is the standard method for the documentation of the healing progress where bone fracture healing is concerned”.
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.
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.
Claims 1-3, 5-7, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden (US 20120157830 A1) in view of Chisena (US 20120330091 A1), Taylor (US 20130041288 A1), and Bodnyk (US 20190265139 A1).
Regarding claim 1, Boyden teaches a fracture testing system, comprising:
an imaging device [0108 “Compton scattered Xray”] configured to image a bone fracture in a bone to obtain a first image of an unloaded bone fracture before an application of a controlled force [0108 “with orthopedic embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100, the position of broken or injured bones, spinal column, etc. can be visualized, imaged, or have information provided thereabout”] to the bone fracture and a second image of a loaded bone fracture during the application of the controlled force to the bone fracture [0132, “Such depth visualizing, imaging, or information providing of spine (as well as associated plates, pins, blood vessels, muscles, etc.) can be performed prior to, during, and/or following surgery…”];
one or more processors [0597 “processor 803”] and a non-transitory computer-readable storage medium [0597 “memory 807”] storing instructions [0597 “…the memory 807 can be configurable as RAM, flash memory, semiconductor-based memory, of any other type of memory that can be configurable to store data pertaining to depth visualizations, images, and/or provided information”], wherein when executed by the one or more processors, the instructions cause the one or more processors to:
compare the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108 “…based upon the actual position of the broken or injured bones, spinal column, etc. as compared with their respective desired position, certain tools, probes, scope fittings, etc. can operate based on the visualization, image, or information provided by certain embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100 (e.g., apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction)”];
a force application mechanism configured to apply the controlled force to the bone fracture [0346 “… the Compton scattered X-ray visualizer, imager, or information provider 100 can be associated with a tool, probe, etc. such that the tool, probe, etc. can apply a pressure against at least some matter of the at least the portion of the individual. Such precise control of directing pressure or force using mechanical, electromechanical, or other techniques may be suited to such orthopedic surgery to move bone(s)…”].
Boyden teaches supporting bones [0421 “…pressure applied against bones, tissue, or other matter may be useful in repositioning bones, tissue, or other matter; as well supporting bones, tissue, or other matter at desired positions”], but fails to teach distal supports configured to support the bone at locations proximal and distal of the bone fracture.
Chisena teaches proximal and distal supports [See Fig. 5 Items 16, two instances], wherein the bone fracture is supported between the proximal and distal supports during the application of the controlled force, the proximal and distal supports configured to support the bone at locations proximal and distal of the bone fracture [0026 “The one or more pressure applying elements 16, to be described in detail below, is configured to be adjustably positioned on to the holder 2 and configured to adjustably apply pressure to the soft tissue adjacent to the bone fracture”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Chisena to include proximal and distal supports, wherein the bone fracture is supported between the proximal and distal supports during the application of the controlled force, the proximal and distal supports configured to support the bone at locations proximal and distal of the bone fracture. Doing so configures the system to provide resistance points along the bone so that a bending test may be performed on said bone to measure the mechanical properties of said bone so that a diagnosis of the bones condition may be performed.
Boyden teaches “visualizing or examining” displacements [0421 “Displacements and actions resulting from such pressure being applied by certain embodiments of the ablating device 380 may be visualized or examined…”], but fails to teach the amount of bone strain or displacement correlating to a stage of healing of the bone fracture.
Taylor teaches the amount of bone strain or displacement correlating to a stage of healing of the bone fracture [0023 “…fracture site stiffness or specific activity associated strain, multiple assessments over time could provide important information about progression, stagnation, or even regression of healing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and incorporate the teachings of Taylor to include the amount of bone strain or displacement correlating to a stage of healing of the bone fracture. Doing so allows a user to “confirm adequacy of current treatment or alert the surgeon to the possible need of intervention” [Taylor 0023].
Boyden teaches receiving the first image of the unloaded bone fracture [0108] and receiving the second image of the loaded bone fracture [0132], comparing the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108], but fails to teach the comparison is used to measure an amount of bone strain or displacement of the bone fracture.
Bodnyk teaches wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture [0048 “The process described thus far may be repeated 670, 680. In other words, the platen may be incrementally displaced to incrementally bend the sample. At each increment, force/displacement data and micro-CT images (e.g., with a 2.98 micron pixel size) may be obtained. This incremental bending and obtaining data/images may continue until the sample breaks or until some specified condition has been met (e.g., maximum bending displacement or until the bone fractures unstably). At the conclusion of the repeated process, bone-fracture information may be obtained 660, which including images indicating the propagation of fractures”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Bodnyk to include wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture. Doing so configures the system to obtain bone-fracture information may be obtained 660, which including images indicating the propagation of fractures, as recognized by Bodnyk 0048.
Regarding claim 2, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 1, wherein the force application mechanism includes an expandable member [Chisena 0064, Figure 14 Item 8C].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the teachings of Boyden to include wherein the force application mechanism includes an expandable member. Doing so configures the expandable member to allow “…for the maintenance of a relatively uniform and constant pressure over the soft tissue” so that accurate mechanical properties may be obtained from the region of interest, as recognized by Chisena para. 0064.
Regarding claim 3, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 2, wherein the expandable member is configured to inflate using a pneumatic system that can be adjusted manually [Chisena 0064 “valve”] or electronically such that the expandable member applies the controlled force to the bone fracture [Chisena 0064, Fig. 14].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the teachings of Boyden to include wherein the expandable member is configured to inflate using a pneumatic system that can be adjusted manually or electronically such that the expandable member applies the controlled force to the bone fracture. Doing so configures the expandable member to allow “…for the maintenance of a relatively uniform and constant pressure over the soft tissue” so that accurate mechanical properties may be obtained from the region of interest, as recognized by Chisena para. 0064.
Regarding claim 5, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 1, wherein the force application mechanism is configured to bend the bone to cause a displacement of the fracture [Boyden 0108 “…apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction”].
Regarding claim 6, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 5, but fail to teach the displacement is between about 82 microns and about 500 microns. Upon review of the disclosure, the displacement range of about 82 and about 500 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 7, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 5, but fails to teach the displacement is between about 164 microns and about 250 microns. Upon review of the disclosure, the displacement range of about 164 and about 250 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 15, Boyden teaches a method of analyzing a bone fracture, comprising:
imaging the bone having the bone fracture to obtain a first image of an unloaded bone fracture prior to an application of a controlled force thereto [0108 “with orthopedic embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100, the position of broken or injured bones, spinal column, etc. can be visualized, imaged, or have information provided thereabout”];
applying the controlled force to an area of the bone having the bone fracture to cause a displacement of the bone to load the bone fracture [Boyden 0108 “…apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction”];
imaging the bone to obtain a second image of a loaded bone fracture during the application of the controlled force thereto [0132 “…depth visualizing, imaging, or information providing of spine (as well as associated plates, pins, blood vessels, muscles, etc.) can be performed prior to, during, and/or following surgery…”].
Boyden teaches supporting bones [0421 “…pressure applied against bones, tissue, or other matter may be useful in repositioning bones, tissue, or other matter; as well supporting bones, tissue, or other matter at desired positions”], but fails to teach stabilizing a bone having a bone fracture including a first support located distal of the fracture and a second support point located proximal of the fracture.
Chisena teaches stabilizing a bone having a bone fracture including a first support point [Fig. 5 Item 14] located distal of the fracture and a second support point [Figure 5 Item 15] located proximal of the bone fracture.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Chisena to include stabilizing a bone having a bone fracture including a first support located distal of the fracture and a second support point located proximal of the fracture. Doing so configures the system to provide resistance points along the bone so that a bending test may be performed on said bone to measure the mechanical properties of said bone so that a diagnosis of the bones condition may be performed.
Boyden teaches “visualizing or examining” displacements [0421 “Displacements and actions resulting from such pressure being applied by certain embodiments of the ablating device 380 may be visualized or examined…”], but fails to teach the amount of bone strain or displacement correlating to a stage of healing of the bone fracture.
Taylor teaches the amount of bone strain or displacement correlating to a stage of healing of the bone [0023 “…fracture site stiffness or specific activity associated strain, multiple assessments over time could provide important information about progression, stagnation, or even regression of healing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and incorporate the teachings of Taylor to include the amount of bone strain or displacement correlating to a stage of healing of the bone. Doing so allows a user to “confirm adequacy of current treatment or alert the surgeon to the possible need of intervention” [Taylor 0023].
Boyden teaches receiving the first image of the unloaded bone fracture [0108] and receiving the second image of the loaded bone fracture [0132], comparing the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108], but fails to teach the comparison is used to measure an amount of bone strain or displacement of the bone fracture.
Bodnyk teaches wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture [0048 “The process described thus far may be repeated 670, 680. In other words, the platen may be incrementally displaced to incrementally bend the sample. At each increment, force/displacement data and micro-CT images (e.g., with a 2.98 micron pixel size) may be obtained. This incremental bending and obtaining data/images may continue until the sample breaks or until some specified condition has been met (e.g., maximum bending displacement or until the bone fractures unstably). At the conclusion of the repeated process, bone-fracture information may be obtained 660, which including images indicating the propagation of fractures”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Bodnyk to include wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture. Doing so configures the system to obtain bone-fracture information may be obtained 660, which including images indicating the propagation of fractures, as recognized by Bodnyk 0048.
Regarding claim 18, Boyden, Chisena, Taylor, and Bodnyk teach the method of claim 15, but fail to teach the displacement is between about 82 microns and about 500 microns. Upon review of the disclosure, the displacement range of about 82 and about 500 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 19, Boyden, Chisena, Taylor, and Bodnyk teach the method of claim 15, but fail to teach wherein the displacement is between about 164 microns and about 250 microns. Upon review of the disclosure, the displacement range of about 164 and about 250 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 20, Boyden, Chisena, Taylor, and Bodnyk teach the method of claim 15, wherein the application of the force results in bending of the bone to cause the displacement of the bone fracture [Boyden 0108 “…apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction”].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Boyden, Chisena, Taylor, and Bodnyk as applied to claim 1 above, and further in view of Akhter (US 5383474 A).
Regarding claim 4, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 1, but fails to teach a strain gauge or load cell to measure bone strain.
Akhter teaches a strain gauge [Figure 1 Item 32, “lever arm strain gauge”] to measure bone strain [abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden, Chisena, Taylor, and Gardner and incorporate the teachings of Ahkter to include a strain gauge or load cell to measure a strain on the bone. Doing so configures the system to record the forces acting upon the bone so that a diagnosis may be performed on said bones structural integrity.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Boyden, Chisena, Taylor, and Bodnyk as applied to claim 1 above, and further in view of Bowman (US 20160058365 A1).
Regarding claim 8, Boyden, Chisena, Taylor, and Bodnyk teach the fracture testing system of claim 1, but fails to teach the imaging device is High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT).
Bowman teaches the imaging device is High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) [0008].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden, Chisena, Taylor, and Bodnyk and incorporate the teachings of Bowman to include the imaging device to be High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT). Doing so creates a method to create a 3-dimensional representation of the bone fracture to aid in the diagnosis of bones structural integrity.
Claims 9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chisena in view Boyden, Taylor, Bodnyk, and Kagami (US 20070260243 A1).
Regarding claim 9, Chisena teaches a fracture testing system comprising:
a base [Figure 1 Item 2] configured to receive an arm [Figure 1] of a patient having a bone fracture;
a force application platform [Figure 1 Item 5];
a force applicator [Figure 14 Item 8C] disposed on a side of the force application platform facing the base, such that the force applicator can be positioned in contact with the arm of the patient, wherein the force applicator is configured to apply a controlled force on the bone fracture [0038 “…to achieve the desired pressure application pattern over the fracture area”, see also 0063-0065].
Chisena fails to teach an imaging device configured to image a bone fracture in a bone to obtain a first image of an unloaded bone fracture before the application of the controlled force to the bone fracture and a second image of a loaded bone fracture during the application of the controlled force to the bone fracture and one or more processors and a non-transitory computer-readable storage medium storing instructions, wherein when executed by the one or more processors, the instructions cause the one or more processors to: compare the first image of the unloaded bone fracture to the second image of the loaded bone fracture.
Boyden teaches an imaging device [0108 “Compton scattered Xray”] configured to image a bone fracture in a bone to obtain a first image of an unloaded bone fracture before an application of a controlled force [0108 “with orthopedic embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100, the position of broken or injured bones, spinal column, etc. can be visualized, imaged, or have information provided thereabout”] to the bone fracture and a second image of a loaded bone fracture during the application of the controlled force to the bone fracture [0132, “Such depth visualizing, imaging, or information providing of spine (as well as associated plates, pins, blood vessels, muscles, etc.) can be performed prior to, during, and/or following surgery…”]; and
one or more processors [0597 “processor 803”] and a non-transitory computer-readable storage medium [0597 “memory 807”] storing instructions [0597 “…the memory 807 can be configurable as RAM, flash memory, semiconductor-based memory, of any other type of memory that can be configurable to store data pertaining to depth visualizations, images, and/or provided information”], wherein when executed by the one or more processors, the instructions cause the one or more processors to:
compare the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108 “…based upon the actual position of the broken or injured bones, spinal column, etc. as compared with their respective desired position, certain tools, probes, scope fittings, etc. can operate based on the visualization, image, or information provided by certain embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100 (e.g., apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction)”];
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and incorporate the teachings of Boyden to include an imaging device configured to image a bone fracture in a bone to obtain a first image of an unloaded bone fracture before the application of the controlled force to the bone fracture and a second image of a loaded bone fracture during the application of the controlled force to the bone fracture. Doing so configures the system to monitor “…the actual position of the broken or injured bones, spinal column, etc. as compared with their respective desired position…” to ensure that a proper, safe bending test is performed on the patient’s bone, as recognized by Boyden.
Chisena teaches a force applicator [Chisena 0038 “…one or more pressure applying elements 16…”], but fails to teach the force application platform is moveable relative to the base along one or more guide rods.
Kagami teaches the force application platform [Figure 1 Item 1] is moveable relative to the base along one or more guide rods [Figure 1 Item 8, 0008].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and incorporated the teachings of Kagami to include the force application platform is moveable relative to the base along one or more guide rods. Doing so provides a rigid guide on which the platform may be moved to adjust the desired location on which to apply pressure to the patient.
Chisena fails to teach the amount of bone strain or displacement correlating to a stage of healing of the bone fracture.
Taylor teaches the amount of bone strain or displacement correlating to a stage of healing of the bone fracture [0023 “…fracture site stiffness or specific activity associated strain, multiple assessments over time could provide important information about progression, stagnation, or even regression of healing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and incorporate the teachings of Taylor to include the amount of bone strain or displacement correlating to a stage of healing of the bone fracture. Doing so allows a user to “confirm adequacy of current treatment or alert the surgeon to the possible need of intervention” [Taylor 0023].
A combination of Chisena and Boyden teach receiving the first image of the unloaded bone fracture [Boyden 0108] and receiving the second image of the loaded bone fracture [Boyden 0132], comparing the first image of the unloaded bone fracture to the second image of the loaded bone fracture [Boyden 0108], but fail to teach the comparison is used to measure an amount of bone strain or displacement of the bone fracture.
Bodnyk teaches wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture [0048 “The process described thus far may be repeated 670, 680. In other words, the platen may be incrementally displaced to incrementally bend the sample. At each increment, force/displacement data and micro-CT images (e.g., with a 2.98 micron pixel size) may be obtained. This incremental bending and obtaining data/images may continue until the sample breaks or until some specified condition has been met (e.g., maximum bending displacement or until the bone fractures unstably). At the conclusion of the repeated process, bone-fracture information may be obtained 660, which including images indicating the propagation of fractures”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Chisena and Boyden and incorporate the teachings of Bodnyk to include wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture. Doing so configures the system to obtain bone-fracture information may be obtained 660, which including images indicating the propagation of fractures, as recognized by Bodnyk 0048.
Regarding claim 11, Chisena, Boyden, Taylor, Bodnyk, and Kagami teach the fracture testing system of claim 9, wherein the force application mechanism is configured to bend the bone to cause a displacement of the fracture [Chisena 0047, “align and treat bone fractures”].
Regarding claim 12, Chisena, Boyden, Taylor, Bodnyk, and Kagami teach the fracture testing system of claim 11, but fail to teach the displacement is between about 82 microns and about 500 microns. Upon review of the disclosure, the displacement range of about 82 and about 500 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Regarding claim 13, Chisena, Boyden, Taylor, Bodnyk, and Kagami teach the fracture testing system of claim 11, but fail to teach the displacement is between about 164 microns and about 250 microns. Upon review of the disclosure, the displacement range of about 164 and about 250 microns is not stated as critical or important (see paragraphs 0060-0061).
However, Chisena teaches a similar system in the same field of endeavor wherein the displacement is caused by “adjustably apply[ing] pressure” to displace the fracture to a preferential healing position [0026].
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to adjust the displacement to an optimal range/value, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is the displacement which achieves the recognized result of applying strain on the bone to diagnose it’s structural integrity, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chisena, Boyden, Taylor, Bodnyk, and Kagami as applied to claim 9 above, and further in view of Ahkter.
Regarding claim 10, Chisena, Boyden, Taylor, Bodnyk, and Kagami teach the fracture testing system of claim 9, but fail to teach a strain gauge or load cell to measure bone strain.
Akhter teaches a strain gauge [Figure 1 Item 32, “lever arm strain gauge”] to measure bone strain [abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings Chisena, Boyden, Taylor, Bodnyk, and Kagami and incorporate the teachings of Ahkter to include a strain gauge or load cell to measure a strain on the bone. Doing so configures the system to record the forces acting upon the bone so that a diagnosis may be performed on said bones structural integrity.
Claims 15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boyden, Chisena, Taylor, Bodnyk, and Sztefek (Sztefek, P. et.al., " Using digital image correlation to determine bone surface strains during loading and after adaptation of the mouse tibia" [online] 2010. [retrieved on 12/20/2024] Retrieved from the Internet <URL: https://www.sciencedirect.com/science/article/pii/S0021929009006290> <DOI: https://doi.org/10.1016/j.jbiomech.2009.10.042.>.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Boyden in view of Chisena, Bodnyk, and Thompson (Thompson, M,S,, et.al., "Digital image correlation: A technique for determining local mechanical conditions within early bone callus" [online] 14 June 2006. [retrieved on 12/19/2024] Retrieved from the Internet <URL: https://www.sciencedirect.com/science/article/pii/S1350453306001810> <DOI: https://doi.org/10.1016/j.medengphy.2006.08.012>).
Regarding claim 22, Boyden teaches a fracture testing system, comprising:
an imaging device [0108 “Compton scattered Xray”] configured to image a bone fracture in a bone to obtain a first image of an unloaded bone fracture before an application of a controlled force to the bone fracture [0108 “with orthopedic embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100, the position of broken or injured bones, spinal column, etc. can be visualized, imaged, or have information provided thereabout”] and a second image of a loaded bone fracture during after the application of the controlled force to the bone fracture [0132 “Such depth visualizing, imaging, or information providing of spine (as well as associated plates, pins, blood vessels, muscles, etc.) can be performed prior to, during, and/or following surgery…”];
one or more processors [0597 “processor 803”] and a non-transitory computer-readable storage medium [0597 “memory 807”] storing instructions [0597 “…the memory 807 can be configurable as RAM, flash memory, semiconductor-based memory, of any other type of memory that can be configurable to store data pertaining to depth visualizations, images, and/or provided information”], wherein when executed by the one or more processors, the instructions cause the one or more processors to:
compare the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108 “…based upon the actual position of the broken or injured bones, spinal column, etc. as compared with their respective desired position, certain tools, probes, scope fittings, etc. can operate based on the visualization, image, or information provided by certain embodiments of the Compton scattered X-ray visualizer, imager, or information provider 100 (e.g., apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction)”];
a force application mechanism configured to apply the controlled force to the bone fracture [Boyden 0108 “…apply a certain pressure against a bone segment to displace the injured bones, spinal column, etc. a desired distance/direction”].
Boyden teaches supporting bones [0421 “…pressure applied against bones, tissue, or other matter may be useful in repositioning bones, tissue, or other matter; as well supporting bones, tissue, or other matter at desired positions”], but fails to teach proximal and distal supports configured to support the bone at locations proximal and distal of the bone fracture.
Chisena teaches proximal and distal supports configured to support the bone at locations proximal and distal of the bone fracture [0027, “holder”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Chisena to include proximal and distal supports configured to support the bone at locations proximal and distal of the bone fracture. Doing so configures the system to provide resistance points along the bone so that a bending test may be performed on said bone to measure the mechanical properties of said bone so that a diagnosis of the bones condition may be performed.
Boyden teaches receiving the first image of the unloaded bone fracture [0108] and receiving the second image of the loaded bone fracture [0132], comparing the first image of the unloaded bone fracture to the second image of the loaded bone fracture [0108], but fails to teach the comparison is used to measure an amount of bone strain or displacement of the bone fracture.
Bodnyk teaches wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture [0048 “The process described thus far may be repeated 670, 680. In other words, the platen may be incrementally displaced to incrementally bend the sample. At each increment, force/displacement data and micro-CT images (e.g., with a 2.98 micron pixel size) may be obtained. This incremental bending and obtaining data/images may continue until the sample breaks or until some specified condition has been met (e.g., maximum bending displacement or until the bone fractures unstably). At the conclusion of the repeated process, bone-fracture information may be obtained 660, which including images indicating the propagation of fractures”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Bodnyk to include wherein the second image captures a change of the bone fracture as the controlled force is applied to the bone fracture by the force application mechanism and the comparison is used to measure an amount of bone strain of the bone fracture. Doing so configures the system to obtain bone-fracture information may be obtained 660, which including images indicating the propagation of fractures, as recognized by Bodnyk 0048.
Boyden teaches imaging bone fragments to provide information [0277 “…the Compton scattered X-ray visualizer, imager, or information provider 100 can be configured to be used to visualize, image, and/or provide information at least portions of certain matter that is relatively "hard", considering the applied X-rays 120, such as bones, bone fragments or portions, spinal portions, cranial portions, metal, implants, etc.”], but fails to teach measuring fragments of the bone fracture to estimate a measurement of callus stiffness of the bone fracture.
Thompson teaches measuring fragments of the bone fracture to estimate a measurement of callus stiffness of the bone fracture [abstract, “Digital image correlation (DIC) is a computer-based image analysis technique that enables the non-contact measurement of strains on material surfaces and is finding application in many areas of biomechanics. Here we report a DIC technique to investigate the local distribution of mechanical strain within regenerating soft tissue sections. We provide exemplary data from analysis of a section of sheep bone callus”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Boyden and incorporate the teachings of Thompson to include measuring fragments of the bone fracture to estimate a measurement of callus stiffness of the bone fracture. Doing so allows a user to measure the mechanical properties of the fracture site to aid in diagnosis of bone condition.
Conclusion
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791