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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 30 July 2026. As directed by the amendment: Claims 1, 2, and 4-12 currently stand pending in the application.
Response to Arguments
Applicant's arguments with respect to the rejections under 35 U.S.C 112 have been fully considered but they are not persuasive. As to claim 2, Applicant contends that the instant application does provide suitable support for comparing a second input relative to one or more of the first electrical current draw value, the first threshold value, and a second threshold value to determine access to the medullary cavity, and references various sections of the specification for support. Examiner respectfully submits that the specification broadly allows for one or more sensors, and that the sensor (i.e. one sensor) can detect a first and a second input; this does not provide support for a second sensor providing a second input that is compared specifically to one or more of the first electrical current draw value, the first threshold value, and a second threshold value. The specification discloses comparing a first input, e.g. a first electrical current draw value, and a second input, e.g. a second electrical current draw value; this does not provide support for a second sensor providing the second input, or for comparing an electrical current draw value to another electrical current draw value as well as to a threshold value (as required by claim 1). Comparing an input with a threshold value does not provide support for a second sensor providing a second input compared to the threshold value (since claim 1 requires the first electrical current draw value to be compared with the first threshold value so the second input must be a different input that is compared to the threshold value, i.e. two inputs compared to the same threshold value).
As to claims 4, 5, 7, and 9, the rejections under 35 U.S.C 112 have been fully considered and are persuasive. The rejections under 35 U.S.C 112 of claims 4, 5, 7, and 9 have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C 103 have been fully considered but they are not persuasive. Applicant contends that the current drop in Xie (US 2019/0150954) corresponds to having accessed the medullary cavity is speculative. Applicant contends that Xie fails to provide any teaching or suggestion of detecting access to the medullary cavity. Instead, Applicant contends that Xie only contemplates a device configured to detect when a drill bit tip penetrates a distal surface of the bone cortex, i.e. when the drill bit tip exits the far side of the entire bone. Examiner respectfully submits that Xie teaches that the exiting of the drill bit tip through the far side of the entire bone, which is detected by a current drop when the drill bit tip bores through the distal side of the bone, occurs “eventually” (par. [0154]) after the “drill bit 180 is positioned against the proximal side 492 of the bone 490” (par. [0152]) and actuated so that “(c)ontinued rotation of the drill bit and axial loading causes the drill bit tip 183 to penetrate through the bone and bone marrow 496 and to approach the distal side 494 of bone 490” (par. [0153]), with a sensor measuring current levels throughout the procedure. The reference to the distal side of the bone as “distal” indicates that the drill bit has passed through the entire bone, including the side of the bone proximal to the surgeon, i.e. the proximal side of the bone. Since the bone marrow is between the proximal and distal sides of the bone, and the current drop is measured when the drill bit tip bores through the distal side of the bone, then the access assembly would have thus accessed and passed through a medullary cavity 496, as shown in FIG. 14B. The claims do not require detecting access to the medullary cavity. Rather, claim 1 requires a first sensor configured to detect a first electrical current draw value from the first motor, and the processing unit configured to determine access to a medullary cavity. In Xie, the current sensor 464 detects a first electrical current draw value (where the value is a current drop over a time period) from the first motor (par. [0152]-[0154]), FIGS. 14A-14C; and the processing unit configured to determine access to a medullary cavity (since the first electrical current draw value is a current drop that corresponds to the access assembly passing through the distal side of the bone, after having already passed through the proximal side of the bone, par. [0152]-[0154]; between the proximal and distal sides of the bone, the access assembly would have thus accessed and passed through a medullary cavity 496, FIG. 14B). In other words, if the drill bit tip has passed through the distal side of the bone as indicated by the current drop, it has, in Xie’s system, passed through the medullary cavity and it can thus be determined that the medullary cavity has been accessed.
The rejection does not assert that the current drop corresponds directly to medullary cavity access. Rather, the rejection relies upon the teaching in Xie that if a particular current drop associated with the distal side of the bone has been detected, it can be determined that the medullary cavity has already been accessed prior to the drill bit cutting the distal side of the bone. This does not rely on any assumption that the drill bit may have passed through a medullary cavity in the process of traversing the bone, because Xie explicitly teaches that in their system, once the drill bit passes through the distal side of the bone, it has already penetrated through the bone marrow before approaching the distal side of the bone (par. [0153]). That is why it’s referred to as the distal side of the bone.
Applicant further contends that neither Coppedge (US 2019/0314059) nor Xie teach a processing unit configured to (i) compare the first electrical current draw value with a first threshold value and (ii) determine access to a medullary cavity, as required. Applicant contends that Xie’s current drop comparison only determines that the drill bit has broken through the distal side of the bone to trigger a brake and prevent over-penetration, and Xie does not disclose determining access to a medullary cavity by any means. Examiner respectfully submits that the claims require that the processing unit is configured to compare the first electrical current draw value with a first threshold value, and, separately, to determine access to a medullary cavity. The claims do not require that the determining access to a medullary cavity is based directly on the comparison. Xie teaches comparing the first electrical current draw value with a first threshold value (the pre-determined threshold change in current) (par. [0154], [0164]), and Xie teaches determining access to a medullary cavity, as discussed above.
Applicant further contends that the combination prevents Coppedge from functioning as intended, since Coppedge requires intramedullary space access while Xie’s tip passes through the distal side of the bone. Examiner respectfully submits that Coppedge itself discloses a sensor configured to (ii) determine access to a medullary cavity (by reading a drop in torque after the increased torque required to pass through the cortical bone), and (iii) modify a rotational speed of the first motor (effectively stopping the motor once the medullary cavity has been reached) (par. [0031]). Coppedge refers to the accessing of the medullary cavity as passing or penetrating through the target bone (par. [0031]), i.e. through a cortical wall of the bone and into the medullary cavity. Any references in the rejection to providing indication that the access assembly has passed through the bone thus uses this language from Coppedge that the access assembly has passed through a cortical wall of the bone and into the medullary cavity. Since Coppedge itself discloses determining access to a medullary cavity and that torque requirements indicate the type of tissue the access assembly is disposed in (par. [0031]), Xie is relied upon as a teaching that the current drawn by a motor indicates the type of tissue the access assembly is disposed in (harder bone requires more current). Coppedge is not modified in view of Xie to have the drill bit pass through the distal side of the bone. Rather, Coppedge is modified in view of Xie to use a current sensor and processing unit that can compare the change in current drawn to a threshold value, to indicate to the practitioner that the access assembly has passed through the bone so that further cutting of the bone can be stopped. As disclosed in Coppedge and discussed above, the passing or penetrating through the target bone means passing through a cortical wall of the bone and into the medullary cavity. Therefore, Coppedge would still achieve intramedullary space access while using Xie’s sensor and processing unit to determine that the drill bit has passed through a harder material and into a softer material.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2, 4-9, and 11 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 2, the limitation that “the processing unit is further configured to compare a second input from a second sensor relative to one or more of the first electrical current draw value, the first threshold value, and a second threshold value to determine the access to the medullary cavity” is not supported by the specification as originally filed. Although the specification recites that a second sensor detects a mechanical measurement, this mechanical measurement is not compared relative to electrical measurements such as the first electrical current draw value or the first threshold value. The detection of mechanical and electrical values are recited in the alternative and not compared to each other.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2019/0314059 to Coppedge et al. (hereinafter, “Coppedge”), in view of U.S. Patent Application Publication No. US 2019/0150954 to Xie.
As to claim 1, Coppedge discloses an intraosseous access system, FIGS. 5-12, comprising: a driver comprising: a housing (112), FIG. 5; an access assembly having a needle (114) supported by a needle hub (152), FIG. 12, an obturator (116) supported by an obturator hub (166), the obturator hub engaging the needle hub (par. [0129]), FIGS. 13-14, and the obturator slidably engaged with a lumen of the needle (par. [0129]), FIGS. 11-12, to prevent tissue from entering the needle lumen and obstructing fluid flow therethrough (interpreted as language of intended use; the obturator is fully capable of preventing tissue from entering the needle lumen and obstructing fluid flow due to their nested concentric configuration shown in FIG. 11, since the obturator fills the needle lumen); a first motor (122) in a fixed longitudinal relationship with the housing, FIGS. 5-8, and operably coupled to a coupling interface (119) configured to engage the obturator hub (at least functionally engaged as part of the whole), the first motor rotating the coupling interface to rotate the needle of the access assembly about a longitudinal axis (the coupling interface 119 rotates the obturator 116 and attached needle 114 about a longitudinal axis of the obturator/needle, par. [0127]); and an energy source (battery, par. [0019], [0024]); a sensor configured to (ii) determine access to a medullary cavity (by reading a drop in torque after the increased torque required to pass through the cortical bone), and (iii) modify a rotational speed of the first motor (effectively stopping the motor once the medullary cavity has been reached) (par. [0031]).
As to claim 2, Coppedge discloses the intraosseous access system according to claim 1, wherein the sensor is a second sensor (torque sensor) (par. [0031]).
As to claim 4, Coppedge discloses the intraosseous access system according to claim 2, wherein the second sensor configured to detect one of an electrical measurement or a mechanical measurement (torque) (par. [0031]).
As to claim 5, Coppedge discloses the intraosseous access system according to claim 4, wherein the second sensor includes one of an ammeter, ohmmeter, voltmeter, torque meter (par. [0031]), or tachometer.
As to claim 6, Coppedge discloses the intraosseous access system according to claim 4, wherein the second sensor is located within the driver (since the sensor is on the motor which is within the driver).
Coppedge is silent as to a first sensor configured to detect a first electrical current draw value from the first motor; and a processing unit communicatively coupled with the first sensor, the processing unit configured to (i) compare the first electrical current draw value with a first threshold value (claim 1); wherein the processing unit is further configured to compare a second input from a second sensor relative to one or more of the first electrical current draw value, the first threshold value, and a second threshold value to determine the access to the medullary cavity (claim 2); wherein one or both of the first threshold value and the second threshold value is a predetermined value (claim 8).
As to claim 1, Xie teaches an intraosseous access system, comprising: a driver, FIG. 1, comprising: a housing (103) (par. [0106]); an access assembly (180) (par. [0113]); a first motor (122) configured to rotate the access assembly about a longitudinal axis (par. [0152]); and an energy source (150) (par. [0112]); a first sensor (464) configured to detect a first electrical current draw value (where the value is a current drop over a time period) from the first motor (par. [0152]-[0154]), FIGS. 14A-14C; and a processing unit (452) communicatively coupled with the first sensor (par. [0154]; communicatively coupled in order to compare the first value), the processing unit configured to (i) compare the first electrical current draw value with a first threshold value (the pre-determined threshold change in current) (par. [0154], [0164]), (ii) determine access to a medullary cavity (since the first electrical current draw value is a current drop that corresponds to the access assembly passing through the distal side of the bone, after having already passed through the proximal side of the bone, par. [0152]-[0154]; between the proximal and distal sides of the bone, the access assembly would have thus accessed and passed through a medullary cavity 496, FIG. 14B). In another embodiment, Xie teaches that when the first value is determined to be greater than the first threshold value, the processor modifies a rotational speed of the first motor (turns off the motor) (par. [0322]).
As to claim 2, Xie teaches a second input from a second sensor (torque sensor) to determine the access to the medullary cavity (par. [0332]).
As to claim 4, Xie teaches the intraosseous access system according to claim 2, wherein the second sensor configured to detect one of an electrical measurement or a mechanical measurement (torque) (par. [0332]).
As to claim 5, Xie teaches the intraosseous access system according to claim 4, wherein the second sensor includes one of an ammeter, ohmmeter, voltmeter, torque meter (par. [0332]), or tachometer.
As to claim 6, Xie teaches the intraosseous access system according to claim 4, wherein one or more of the first sensor, the second sensor, and the processing unit are located within the driver.
As to claim 8, Xie teaches the intraosseous access system according to claim 2, wherein one or both of the first threshold value and the second threshold value is a predetermined value (the first threshold value is a predetermined value) (par. [0154], [0164]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Coppedge’s system a first sensor configured to detect a first electrical current draw value from the first motor; and a processing unit communicatively coupled with the first sensor, the processing unit configured to (i) compare the first electrical current draw value with a first threshold value, since as taught by Xie, the current drawn by a motor indicates the type of tissue the access assembly is disposed in (harder bone requires more current), and a sensor that detects a change in the current drawn, in communication with a processing unit that compares the change in the current drawn to a threshold value, would provide indication to the practitioner that the access assembly has passed through the bone so that further cutting of the bone can be stopped, thereby preventing damage to surrounding tissue. Since the sensor can detect the current drawn as the procedure is being performed, there is no lag time in detecting the current draw and comparing to the threshold value using the processing unit, and therefore no delay in stopping the cutting of the bone. Computer processing is faster and more reliable than manual measurement taking and assessment by the user.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to turn off the motor (modify a rotational speed of the first motor) when the processing unit indicates that the first current draw value is within a certain range relative to the first threshold value, since this indicates that the access assembly has passed through the bone and cutting should be stopped, as also contemplated by Coppedge.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide both the first sensor as taught by Xie and a second sensor, a torque sensor (as disclosed by Coppedge and taught by Xie), to provide the signal indicating that the access assembly has penetrated the bone, as taught by Xie, to provide a backup sensing means to indicate the completion of the procedure and that the motor and cutting should be stopped, in the event that the first sensor fails or as a complementary signal to confirm the detected values of the first sensor, therefore preventing premature or delayed stopping of the cutting. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the processing unit to compare a second input from the second torque sensor to a second threshold value to determine the access to the medullary cavity, since Xie teaches comparing the value detected by a sensor to a predetermined threshold value to determine when the desired outcome has been achieved, in this case the complete passing of the access assembly through the bone. The torque measured by the second sensor would be within a certain range relative to the second threshold value to indicate that the procedure is complete and the cutting should stop.
Claims 7, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Coppedge in view of Xie (hereinafter, “Coppedge/Xie”), as applied to claims 1, 2, 4-6, and 8 above, and further in view of U.S. Patent Application Publication No. US 2021/0393337 to Zucker.
As to claim 7, Coppedge/Xie disclose the second sensor is located within the driver (since the sensor is on the motor which is within the driver), but are silent as to the processing unit is located remotely from the driver and is in wireless communication with one or more of the first sensor, the second sensor, the first motor, and the energy source.
Zucker teaches a system comprising a driver (power tool 132); a sensor; and a processing unit (computing device 102) that receives sensor input (torque data) and transmits instructions to the power tool (par. [0037]), FIG. 1, wherein the processing unit is located remotely from the driver, FIG. 1, and is in wireless communication with one or more of the sensor, the motor, and the energy source (the communication interface of the processing unit is in wireless communication to transmit information such as the instructions to the power tool, par. [0037], including stopping the power tool, par. [0009] and [0088], and therefore is in wireless communication with the motor or the energy source).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to locate the processing unit remotely from the driver in order to reduce bulk of the driver so that the user is not fatigued while carrying the driver and so that the processing unit need not be exposed to the operating theater, and to connect the processing unit wirelessly to the sensor and the motor or the energy source so that the processing unit can still receive inputs from the sensor and correspondingly modify operation of the motor or the energy source to start or stop the device when necessary when the measured input satisfies a predetermined criterion, as required by Coppedge/Xie and taught by Zucker, without cumbersome wires connecting the processing unit and driver that would get in the way in the operating theater. The wireless communication can also be used to receive from and send information to the cloud so that the information can be stored safely without fear of hardware crashes and is easily accessible even remotely.
As to claim 9, Coppedge/Xie are silent as to wherein one or both of the first threshold value and the second threshold value is derived by the processing unit relative to one or both of the first electrical current draw value and the second input.
Zucker teaches modifying a pre-operative plan based on a measured value (par. [0043], [0074], [0081]-[0083], [0089], [0091]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pre-operative plan of Coppedge/Xie based on a measured value, e.g. the first electrical current draw value or the second input, where the pre-operative plan includes the first and second threshold values and therefore the first or second threshold values can be modified by the processing unit relative to a respective one of the inputs, to tailor the first or second threshold values to the particular patient so that the access to the medullary cavity can be more accurately determined by comparison to a more patient-specific threshold value. For example, the first electrical current draw value may comprise the high end value of the current drawn as the tool cuts the bone, which is later associated with a change or drop in current drawn to establish medullary cavity access or completion of the cut, i.e. the high end value is the peak or max of the change/drop; modifying the pre-operative plan, including the first threshold value, based on this first high end value that is detected by the first sensor, would tailor the first threshold value to the particular patient in which the first value is detected. For example, if the first current draw value is higher or lower than expected, the plan and threshold value should be adjusted accordingly by the processing unit (e.g. as a percentage of the first current draw) so that the completion of the cutting is accurately determined. The same could be said for the torque sensor’s second input which would have an affect on the second threshold value. The threshold values in this case would correspond to the lower current or torque required once the access assembly has passed through the far side of the bone, and could be non-zero but derived by the processing unit based on the patient and relative to the input(s).
As to claim 12, Coppedge/Xie are silent as to wherein the processing unit includes a network communications logic to provide wired or wireless communication with an external computing device or network.
Zucker teaches the processing unit (102) includes a network communications logic to provide wired or wireless communication with the external computing device or network (wireless communication with a cloud that represents a network, par. [0050]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Coppedge/Xie’s processing unit a network communications logic to provide wireless communication with a network such as a cloud, so that information can be received from and sent to the cloud so that the information can be stored safely without fear of hardware crashes and is easily accessible even remotely.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Coppedge in view of Xie (hereinafter, “Coppedge/Xie”), as applied to claims 1, 2, 4-6, and 8 above, and further in view of U.S. Patent Application Publication No. US 2018/0132754 to Kusumoto.
As to claim 10, Coppedge/Xie are silent as to wherein the first threshold value is calibrated for electrical current draws required to drive the intraosseous access system through tissues to access the medullary cavity.
Kusumoto teaches that, in a surgical procedure when it is desired to penetrate some tissues while not penetrating others, the tool is prevented from penetrating those tissues that should not be penetrated by monitoring an output from a sensor and keeping it in a certain range of a threshold (par. [0162]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to calibrate the first threshold value for electrical current draws required to drive the intraosseous access system through tissues to access the medullary cavity, so that the tool can pass through tissues in which the current draws are within a certain range of the threshold, while indicating that the tool should not pass through tissues in which the current draws are outside of the certain range of the threshold, since as taught by Kusumoto and contemplated by Coppedge/Xie, it is desirable to penetrate some tissue while not penetrating others. As applied to Coppedge/Xie, the first threshold value would thus be calibrated for current draws required to drive the system through those tissues that are desired to be penetrated, i.e. that allow the tool to access the medullary cavity/cut through the cortical bone. The term calibrate means to adjust for a particular function; in this case, the first threshold value is adjusted in view of the function of allowing particular tissues to be cut, i.e. those that allow access to the medullary cavity/cut through the cortical bone. The first threshold value should be adjusted such that values of current draw as detected by the sensor that are required by those tissues that are desired to be cut are within the certain range of the threshold in which cutting is allowed, whereas values of current draw that are required by tissues that should not be cut are outside of the certain range of the threshold in which cutting is allowed, indicating that cutting should be stopped.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Coppedge in view of Xie (hereinafter, “Coppedge/Xie”), as applied to claims 1, 2, 4-6, and 8 above, and further in view of Zucker and U.S. Patent Application Publication No. US 2020/0275880 to Kopperdahl et al. (hereinafter, “Kopperdahl”).
As to claim 11, Coppedge/Xie are silent as to wherein one or both of the first threshold value and the second threshold value are normalized for an age, sex, or health condition of a patient.
Zucker teaches modifying a pre-operative plan based on a measured value (par. [0043], [0074], [0081]-[0083], [0089], [0091]).
Kopperdahl teaches that measured values are normalized for an age of a patient (par. [0072]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pre-operative plan of Coppedge/Xie based on a measured value, e.g. the first electrical current draw value or the second input, where the pre-operative plan includes the first and second threshold values and therefore the first or second threshold values can be modified by the processing unit relative to a respective one of the inputs, to tailor the first or second threshold values to the particular patient so that the access to the medullary cavity can be more accurately determined by comparison to a more patient-specific threshold value. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to normalize the measured values for an age of the patient, as taught by Kopperdahl, to standardize the data for later use across different populations and ensure that the comparisons and analyses are fair and accurate and remove bias introduced by differences in age distribution.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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