DETAILED ACTION
The amendment of September 30, 2025, is under consideration. Claims 1 and 15 were amended. Claims 1-7, 9-21, and 23, stand pending.
Examiner notes that claims 24-29, previously canceled, are not indicated in the claim listing, and must be shown, even thought they were previously canceled.
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 Arguments
The outstanding objection to claim 1 was overcome by the amendment of September 30, 2025.
The outstanding rejection of claim 15 under 35 USC 112(b) was overcome by amendment to the claim. The outstanding rejection of claims 13 and 14 under 35 USC 112(b) was overcome by the clarifying statements in the response of September 30, 2025.
Applicant's arguments filed September 30, 2025, related to the rejection of claims 1-7, 9, 12, 15-21, and 23 under 35 USC 102(a)(1) in view of Behzadi (US 2018/0078201 A1) have been fully considered. Examiner has carefully read and considered the arguments. He understands what is being argued, but, respectfully, disagrees with the conclusions that applicant arrived at in making the arguments. The arguments are not considered persuasive.
At p. 6 of the remarks, it is argued that Behzadi does not teach “an oscillating engine controllable to rotate a prosthesis about a longitudinal axis of the prosthesis to a desired angle.” Rather, it is asserted that the entire system 700 is rotated to cause rotation of the prosthesis. Examiner agrees that this may be the case in certain instances as cited by applicant, but 1) also finds that there are instances in the disclosure in which the prosthesis is rotated by the instrument; and 2) finds that the claim does not exclude rotation of the tool, itself, by the user, to provide the claimed torque.
Regarding the tool causing its own rotation
For example, examiner points to several citations which indicate rotation of the prosthesis about its longitudinal axis:
[0025]
“Another embodiment includes a third gun-like device that combines the functions of the first gun-like device and the second gun-like device. This embodiment enables the surgeon to accurately locate, insert, orient, and otherwise position the acetabular component with the single tool.”
[0119] (examiner believes reference numeral “146” in Behzadi to have been in error):
“There may be continuous movement or oscillations in one or more of six degrees of freedom including translation(s) and/or rotation(s) of adapter 146 about the X, Y, Z axes (e.g., oscillating translation(s) and/or oscillating/continuous rotation(s) which could be different for different axes such as translating back and forth in the direction of the longitudinal axis of the central support while rotating continuously around the longitudinal axis). This installation motion may include continuous or intermittent very high frequency movements and oscillations of small amplitude that allow the operator to easily install the prosthetic component in the desired location, and preferably also to allow the operator to also set the desired angles for abduction and anteversion.” (examiner’s emphasis)
[0125]:
“Pulse direction may include motion having any of six degrees of freedom—translation along one or more of any axis of three orthogonal axes and/or rotation about one or more of these three axes. “ (Similar language in [0126], [0129])
Based at least on this disclosure, examiner respectfully disagrees with the assertions that the Behzadi device is not capable of providing rotation for torquing the prosthesis.
Regarding Claim Language Interpreted as Not Requiring a Separate Rotational Movement to cause the Torquing – Permitting Rotation of Entire Apparatus
The claim requires “a torquing system controllable to apply torque to rotate the stem… about the longitudinal axis of the stem during insertion or extraction of the stem…” and “a controller operable to control the vibrator, the torquing system, and the driver to respectively generate vibrations in and apply force to the stem that cooperate to insert the stem into or extract the stem…”
Examiner interprets manual rotation of the apparatus, which a controller instructs to be halted, to read on this set of limitations. The claim requires the vibrator to generate vibrations; but requires the torque system only to ‘apply torque’ (line 7) and ‘apply force’ (line 11). Stating that the torquing system is required to function by vibration is simply not claimed.
[0149] describes a situation in which the rotation is enabled while vibrations occur: “Final corrective positioning is easily achievable using lateral hand pressure to rotate the cup within the substrate while power was applied to the oscillation engine.” (examiner’s emphasis) Vibrations are clearly controlled, such that it can be said the torquing is only permitted when the controller is permitting the vibration to occur.
Further Arguments
At p. 7 of the remarks, the arguments continue that the Behzadi controller is not the controller of claim 1 since the adapter 705, identified in the remarks as being cited in the prior office action, is merely a passive adapter.
Examiner states that 705 was not identified as a controller in the rejection, and points to the rejection of claim 1 in which the controller was referred to as being disclosed in [0125]. The rejection refers to 705 of Behzadi as a driver at p. 3 of the Non-Final Rejection, and identifies the controller as being taught in the specification at [0125] of Behzadi. See p. 4 of the Non-Final Rejection.
[0125] teaches: “Oscillation engine 710 includes a controller coupled to a vibratory machine that generates an original series of pulses having a generation pattern.”
Additional disclosure of the controller can be found throughout the specification:
Figs. 3-6 demonstrate how a controlled force is utilized to seat a prosthesis
Figs. 20 and 26 demonstrate a flow charts for control and measurement, and fig. 22 demonstrates control hardware associated therewith
[0117] states: “The installation gun may be used to control precisely one or both of (i) insertion, and (ii) abduction and anteversion angles of a prosthetic component. Installation gun 100 preferably allows both installation of an acetabular cup into an acetabulum at a desired depth and orientation of the cup for both abduction and anteversion to desired values.”
[0120] “In some implementations, the controller includes a stored program processing system that includes a processing unit that executes instructions retrieved from memory. Those instructions could control the selection of the motion parameters autonomously to achieve desired values for depth, abduction and anteversion entered into by the surgeon or by a computer aided medical computing system such as the computer navigation system. Alternatively those instructions could be used to supplement manual operation to aid or suggest selection of the motion parameters.”(examiner’s emphasis)
[0121] “…. One set of motion parameters may be used when primarily setting the depth of the implant and then another set used when the desired depth is achieved so that fine tuning of the abduction and anteversion angles is accomplished more efficiently, all without use of impact forces in setting the depth and/or angle adjustment(s).”
Much other disclosure related to the controllers is present, but examiner believes this is a sufficient and persuasive showing.
Examiner disagrees that Behzadi does not include a controller, as claimed.
The arguments continue at p. 7 to address claim 4. The arguments state that the series of pulses is not continuous. They elaborate that a series of pulses (impacts) are not a continuous force.
Examiner points to Behzadi:
[0119] “There may be continuous movement or oscillations in one or more of six degrees of freedom including translation(s) and/or rotation(s) of adapter 146 about the X, Y, Z axes (e.g., oscillating translation(s) and/or oscillating/continuous rotation(s) which could be different for different axes such as translating back and forth in the direction of the longitudinal axis of the central support while rotating continuously around the longitudinal axis). This installation motion may include continuous or intermittent very high frequency movements and oscillations of small amplitude that allow the operator to easily install the prosthetic component in the desired location, and preferably also to allow the operator to also set the desired angles for abduction and anteversion.” (Examiner’s emphasis)
Behzadi teaches a continuous force, and if applicant believes the forces created by Behzadi are not continuous, then the claim should be amended to identify how these disclosed continuous forces are distinct from the continuous forces he is claiming.
The instant disclosure has been studied looking for use of a special definition for the term “continuous force”. The only clarification as to what makes a continuous force this type of force is at [0005] which states “a continuous force is a non-impact force”. Examiner finds that Behzadi has discussed impaction by his device as distinct from impacting forces throughout his specification. See e.g. [0012] of Behzadi, etc.
The arguments continue at pp. 7-8 to address claims 5, 6, and 9. The argument reiterates the point related to claim 1 that no controller is present. Examiner has disagreed, as above, in relation to claim 1. Those same points apply, here.
The arguments continue at p. 8 to argue that the claimed sensor of claims 12 and 15-18 is not properly disclosed by Behzadi. The arguments state that examiner took official notice in stating that the sensor 730 was sensitive to and generates signals responsive to vibration frequencies… Examiner disagrees.
Behzadi explicitly discloses that sensor 730 has these capabilities at at least [0132]:
“Installation system 700 includes an optional sensor 730 (e.g., a flex sensor or the like) to provide a measurement (e.g., quantitative and/or qualitative) of the installation pulse pattern communicated by pulse transfer assembly 705. This measurement may be used as part of a manual or computerized feedback system to aid in installation of a prosthesis. For example, in some implementations, the desired applied pulse pattern of the applied series of pulses (e.g., the vibrational motion of the prosthesis) may be a function of a particular installation pulse pattern, which can be measured and set through sensor 730. In addition to, or alternatively, other sensors may aid the surgeon or an automated installation system operating installation system 700, such as a bone density sensor or other mechanism to characterize the bone receiving the prosthesis to establish a desired applied pulse pattern for optimal installation. In some implementations, sensor 730 measures force magnitude as part of the installation pulse pattern.” (Examiner’s emphasis)
Further discussion of use of a sensor at at least [0162] is considered relevant to this discussion.
Related to claim 15, Examiner does consider inherent that data presented by a sensor, processed in any way by a controller has determined “at least one characteristic of the vibrations”. (e.g. do the vibrations exist?). “A characteristic” is taken as an extremely broad limitation in this claim.
Related to claim 16, examiner does consider inherent that a “feature of a frequency spectrum” of the vibrations is determined by the sensor. (e.g. the vibrations exist and have a certain frequency and amplitude; the interface between the prosthesis and bone is described as being determined, and driving of the device controlled, based on insertion into the bone. See, e.g. figs. 3-6) “A feature of a frequency spectrum” is taken as an extremely broad limitation in this claim.
Related to claim 17, it is argued that the controller does not determine from sensor signals the resonant frequency of the stem in the bone. Examiner points to [0165] where it is contemplated to analyze resonant frequency of the bone and its dynamic responses during the insertion of the prosthesis into the bone.
Related to claim 18, the controller is demonstrated as controlling the vibrator based on the characteristic (the vibration sensor signal).
Regarding claim 18, Examiner now notes that “the at least one characteristic” fails to find support in claim 12. Examiner suggests the claim was intended to depend from claim 15. An objection to the claim will be presented to require remedying this situation. This is not considered to have changed scope of the rejection, as examiner previously understood the claim to have depended from claim 15, and it is clear that this is the only possible proper interpretation, based on the claim language.
Related to claim 21, it is argued at p. 9 that the rejection is based on speculation.
Examiner agrees, generally, but believes such speculation is permitted by the claim language requiring inferred structures and intended use limitations. Examiner’s understanding is that if portion 725 is a mandrel, as stated in the rejection, the remainder of the limitations argued are intended use functionalities. Examiner treats “configured to” language as “capable of” in this instance. As such, the claim is interpreted as requiring:
Some inferred stem is capable of being mounted to the mandrel
The mandrel is capable of generating sonophoresis sound waves capable of delivering an inferred medicant
The inferred stem is capable of having the medicant on a surface of the stem
There is no reason some inferred stem cannot be mounted to the mandrel 725, if that stem was properly configured.
There is no reason the mandrel 725 is not capable of being driven at a particular wavelength of vibration (as by a vibratory driver) to cause the claimed delivery of some inferred medicant on the inferred stem
There is no reason an inferred medicant cannot be placed on a surface of the inferred stem.
As such, examiner disagrees that the limitations are not met by the Behzadi disclosure. Behzadi is capable of performing each of the functions if used with the inferred structures. Positive recitation of any of these components (e.g. the stem or the medicant) or any structural limitation of the mandrel which distinguishes over the mandrel 725 of Behzadi would overcome this rejection.
The rejection of other dependent claims under 35 USC 102(a)(1) in view of Behzadi and claims 10 and 11 under 35 USC 103 in view of Behzadi were not further argued. These rejections therefore stand or fall with the rejections discussed, above.
The rejections of record are maintained, as below, modified only for clarification of the rejection, and due to any amendments to the claims.
Claim Objections
Claim 18 is objected to for dependence upon claim 12 which does not provide antecedent basis for “the at least one characteristic”. It is clear that this claim was intended to depend from claim 15, and amendment to recite such is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, 12-21 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Behzadi (US 2018/0078201 A1).
Regarding claim 1, Behzadi teaches an apparatus 700 capable of use in performing a joint replacement procedure [0124], the apparatus comprising:
a vibrator 710 configured to be coupled to a stem at 725 and be excited to generate vibrations in the stem during a joint replacement operation to insert the stem into and/or to extract the stem out from a bone canal, the stem having a longitudinal axis [0125];
a driver 705 operable to apply force to the stem;
a torquing system of 710 controllable to apply torque to rotate the stem when in the canal to a desired azimuthal angle about the longitudinal axis of the stem during insertion and/or extraction of the stem from the canal (it is noted that the vibrator forms both longitudinal and rotational motions, such that portions of 700 which permit rotation of the implant as a result of the rotational vibrations are considered to be a torquing system [0129], [0131], [0029]; alternatively, use of the apparatus in its entirety to perform rotation is disclosed, which rotation is only permitted at such time as the vibrator operates [0149]); and
a controller [0125] operable to control the vibrator 710, the torquing system of 710, and the driver 705 to respectively generate vibrations in and apply force to the stem that cooperate to insert the stem into or extract the stem out from the canal [0126].
Regarding claims 2 and 3, the vibrations comprise longitudinal and transverse vibrations, as claimed [0125], [0126].
Regarding claim 4, [0125] describes a series of pulses. This series is considered to be continuous at least until the series ends. [0119] describes use of continuous force, and [0012] describes advantages of such forces.
Regarding claims 5, 6 and 9, by virtue of the controller of 710 (described at [0125]) functioning to maintain vibrations in the desired form, vibrations passed through 705 are simultaneously or non-simultaneously modified (controlled by the controller) to apply the force to the stem ([0127]-[0130]: the pulses through 705 can be identical or “very different” from the original series).
Regarding claim 7, device of fig. 7 is described as a BMD3 device [0050]. [0243] goes on to state that BMD3 devices generally use motors and piezo transducers to create their waveforms.
Regarding claims 12-18, the device includes a vibration sensor 730. The sensor transmits “vibration sensor signals” to the controller which signals are responsive to vibrations of the stem. [0132] It is considered inherent that these frequencies include a spectrum and include frequencies that are resonant frequences of the stem attached to the device. Further discussion of use of the sensor at [0162] is considered relevant, as is discussion of determination of resonant frequencies of the prosthesis within the bone at [0165].
Regarding claims 19 and 20, it is noted that this claim does not depend from claim 12, thereby permitting an alternate interpretation of sensor 730. There sensor 730 can be used to derive force data. [0132]
Regarding claim 21, there is no reason that portion 725 cannot be considered to be a mandrel. There is no reason that 725 cannot be considered to be capable of generating sonophoresis sound waves, or that 725 cannot carry a medicant thereon. The stem and medicant are inferred limitations. The mounting, generation of waves, release of medicant, and medicant located on the stem, are all intended uses which properly sized and shaped versions of the inferred structures are capable of performing when driven by a certain vibratory wave.
Regarding claim 23, the claim is considered only to be an intended use limitation since it further limits an inferentially referred to component (the stem). There is no reason that a broach cannot be attached to the device at 725.
Examiner notes that once a first alternative is met, the further alternative is given no further consideration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behzadi.
Regarding claims 10 and 11, the device is taught being used with a robotic attitude control system (e.g. fig. 35) which is capable of functioning to control a direction along which a longitudinal axis of a stem extends during insertion. The robot is taught including a controller 3505. There is no reason that the controller in the robot could not be programmed to perform each of the claimed functions. Behzadi teaches his device can be used as part of a robotic system [0105], [0107], etc.
It is well known and old in the art for a single controller to be used to control multiple elements in a system in which all the components are connected together into a single structure. It would have been obvious to cause the Behzadi device to use a single controller to both manipulate the robot and the vibrator in order to arrive at a tool which is cheaper to produce and uses fewer components.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799