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 .
Election/Restrictions
Claims 18, 20, 22-24, 26-27, and 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 9th, 2026.
Applicant’s election without traverse of Group I (Claims 1, 3, 5-7, 9-10, and 16-17) in the reply filed on March 9th, 2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "the equation" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the interpolation" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “are angular stiffness” in line 9. It is unclear as to whether this limitation is referring to the previously introduced “angular stiffness” from Claim 1, or a new element. Furthermore, it is unclear as to whether this limitation should recite “are angular stiffnesses” or “are angular stiffness values”, or if the two aforementioned coefficients are only referring to a singular “angular stiffness” or “angular stiffness value”.
Claim 17 recites “are respective flexibility” in line 11. It is unclear as to whether this limitation should recite “are respective flexibilities” or “are respective flexibilities values”, or if the two aforementioned coefficients are only referring to a singular “respective flexibility” or “respective flexibility value”.
Claim 17 recites “mathematical model with the two elastic properties” in lines 11-12. It is unclear as to whether this limitation is referring to the previously introduced “mathematical model of the implant system under two assumed elastic properties” from line 10 of Claim 17, or a separate element. Furthermore, it is unclear as to what exactly these “elastic properties” are referring to. Further clarification is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-7, 9-10, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1, 5-7, 9-10, and 17 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1, 5-7, 9-10, and 17 recite a device for measuring a stability of an implant system. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1, 5-7, 9-10, and 17 recites at least one step or instruction for measuring a stability of an implant system, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Claim 1 recites abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Determining an angular stiffness of an implant system based on motion data may be performed by a human.
Accordingly, each of Claims 1, 5-7, 9-10, and 17 recites an abstract idea.
Specifically, Claim 1 recites:
a housing configured to be positioned adjacent the implant system;
an actuator coupled to the housing, wherein the actuator is configured to vibrate the implant system when actuated;
a motion sensor coupled to the housing; and
a controller in communication with the motion sensor and the actuator, wherein the controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor, cause the controller to perform functions including:
receiving motion data from the motion sensor when the actuator is actuated; and
determining an angular stiffness of the implant system based on the motion data.
Further, dependent Claims 5-7, 9-10, and 17 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea (underlined above) in independent Claim 1 (and dependent Claims 1, 5-7, 9-10, and 17) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in bold in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “housing”, “implant system”, “actuator”, “motion sensor”, “controller”, “at least one processor”, and “data storage” are generically recited computer elements in independent Claim 1 (and its dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “controller” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1, 5-7, 9-10, and 17 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “housing”, “implant system”, “actuator”, “motion sensor”, “controller”, “at least one processor”, and “data storage” as recited in independent Claim 1.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g. Pages 12 and 17) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. receiving and determining) that are well-understood, routine, and conventional activities previously known to the pertinent industry; Applicant’s Background in the specification; and the non-patent literature of record in the application.
Cucchiaro et al (U.S. Patent No. 5,518,008; cited by Applicant) teaches a structural analyzer, in particular for medical implants, comprising a probe tip for contacting the structure, an accelerometer coupled to the probe tip for measuring an acceleration time history of the structure; and a hammer for impacting the probe tip against the structure, the probe tip being mechanically isolated from the hammer such that the probe tip can move independently from the hammer after the structure is impacted; and an actuator for firing the hammer.
Heyman (U.S. Patent No. 4,881,552) teaches a tooth stability monitor, comprising means for sinusoidally moving the tooth under investigation at a small constant amplitude comprising a hand held tooth probe including a probe tip mounted in a probe mount for making contact with the tooth, a hand held probe body, and means for sinusoidally moving said probe mount relative to said hand held probe body; means for generating a first electrical signal representing the resulting displacement of the tooth; means for generating a second electrical signal representing the force applied to said tooth to produce the movement of the tooth; means for generating a third electrical signal proportional to vibrations of said hand held probe body; and means receiving said first, second and third electrical signals for modifying said first and second electrical signals to remove the effects of the hand held probe body vibrations, and for computing the tooth modulus using the modified first and second electrical signals.
Accordingly, in light of Applicant’s specification, the claimed term “controller” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “controller”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1, 5-7, 9-10, and 17 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the device of Claims 1, 5-7, 9-10, and 17 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1, 5-7, 9-10, and 17 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 5-7, 9-10, and 17 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 5-7, 9-10, and 17 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 5-7, 9-10, and 17 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 5-7, 9-10, and 17 are not patent eligible and rejected under 35 U.S.C. 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 18 of U.S. Patent No. 11,944,452 and WO 2018/165674.
Regarding Claim 1, U.S. Patent No. 11,944,452 discloses a device for measuring a stability of an implant system (A system for detecting stability of a medical implant; Claim 11 of U.S. Patent No. 11,944,452), the device comprising:
a housing configured to be positioned adjacent the implant system (a probe configured to measure a force applied to the medical implant and a vibration of the medical implant based on the applied force; Claim 11 of U.S. Patent No. 11,944,452);
an actuator coupled to the housing, wherein the actuator is configured to vibrate the implant system when actuated (wherein the probe comprises a first transducer and a second transducer positioned on a first surface of the probe at a distal end of the probe, wherein the computing device is further configured to drive the first transducer and the second transducer out of phase to generate the vibration of the medical implant; Claim 18 of U.S. Patent No. 11,944,452);
a controller in communication with the motion sensor and the actuator, wherein the controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor (a computing device in communication with the probe; Claim 11 of U.S. Patent No. 11,944,452), cause the controller to perform functions including:
receiving motion data from the motion sensor when the actuator is actuated (compare the measured vibration based on the applied force with a computer model of the medical implant; Claim 11 of U.S. Patent No. 11,944,452); and
determining an angular stiffness of the implant system based on the motion data (based on the comparison, determine an angular stiffness coefficient of the medical implant, wherein the angular stiffness coefficient corresponds to a stiffness of a rotation about an axis perpendicular to a centerline of the medical implant, and wherein the angular stiffness coefficient indicates a stability of the medical implant; Claim 11 of U.S. Patent No. 11,944,452).
Claims 11 and 18 of U.S. Patent No. 11,944,452 fail to specifically teach a motion sensor coupled to the housing.
WO 2018/165674 teaches methods and systems to measure and evaluate stability of medical implants (Abstract), comprising a motion sensor coupled to the housing (At the tip of the hammer 312, a load cell 316 serves as a force sensor to measure the force acting on the target object; Page 25 Lines 26-28; the piezoelectric actuator 402 may serve as a vibration sensor; Page 26 Lines 31-32; piezo-block 702B as a sensor to measure a frequency response curve; Page 28 Lines 21-22 of WO 2018/165674).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the motion sensor teachings of WO 2018/165674 into those of U.S. Patent No. 11,944,452 as they are both systems for measuring and evaluating the stability of medical implants through determining a response signal associated with a vibration of a medical implant based on an applied force.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 5-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al (WO2018165674A1).
Regarding Claim 1, Shen discloses a device for measuring a stability of an implant system (Methods and systems to measure and evaluate stability of medical implants; Abstract), the device comprising:
a housing configured to be positioned adjacent the implant system (The probe 104 may be used to apply a mechanical force or displacement to a surface of a medical implant or bone within which the medical implant is implanted; Page 7 Lines 14-15);
an actuator coupled to the housing, wherein the actuator is configured to vibrate the implant system when actuated (The probe 104 may be configured to deliver a mechanical force, for example, via one or more piezoelectric transducers, toward a distal end of the probe 104, for example, for detecting properties of an area or region of a medical implant disposed proximate to the distal end of probe 104. In addition, the probe 104 may be configured to detect, for example, via one or more optical or piezoelectric sensors, mechanical movement for further processing. The probe 104 may be configured to detect a response signal associated with a vibration of the medical implant in response to a force applied to the medical implant…the computing device 102 and the probe 104 may be provided in the same physical housing; Page 7 Line 14 – Page 8 Line 1);
a motion sensor coupled to the housing (The probe 104 may be configured to deliver a mechanical force, for example, via one or more piezoelectric transducers, toward a distal end of the probe 104, for example, for detecting properties of an area or region of a medical implant disposed proximate to the distal end of probe 104. In addition, the probe 104 may be configured to detect, for example, via one or more optical or piezoelectric sensors, mechanical movement for further processing. The probe 104 may be configured to detect a response signal associated with a vibration of the medical implant in response to a force applied to the medical implant; Page 7 Lines 15-22; This driving signal may be converted into a mechanical force by one or more transducers, such as piezoelectric transducers. Such a force may induce mechanical motion in the medical implant to which the force is applied. The mechanical motion may be detected via one or more transducers and a corresponding response signal may be sent back to the base station for processing and/or analysis; Page 10 Lines 10-14); and
a controller in communication with the motion sensor and the actuator, wherein the controller includes at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor (The probe 104 may be communicatively coupled to the computing device 102. In an example embodiment, computing device 102 communicates with the probe 104 using a communication link 106 (e.g., a wired or wireless connection). The probe 104 and the computing device 102 may contain hardware to enable the communication link 106, such as processors, transmitters, receivers, antennas, etc. The computing device 102 may be any type of device that can receive data and display information corresponding to or associated with the data…computing device 102 may include a communication interface 108, a user interface 110, a processor 112, data storage 114, a drive signal source 116, and a spectrum analyzer 118, all of which may be communicatively linked together by a system bus, network, or other connection mechanism 120; Page 7 Line 24 – Page 8 Line 16), cause the controller to perform functions including:
receiving motion data from the motion sensor when the actuator is actuated (At block 202, the method 200 includes applying a force to a medical implant with a probe…At block 204, the method 200 includes determining a response signal associated with a vibration of the medical implant based on the applied force; Page 12 Lines 5-24; Page 26 Lines 7-20); and
determining an angular stiffness of the implant system based on the motion data (At block 208, the method 200 includes, based on the comparison of the determined response signal with the computer model, determining an angular stiffness coefficient of the medical implant, wherein the angular stiffness coefficient indicates a stability of the medical implant; Page 13 Line 27 – Page 15 Line 6).
Regarding Claim 3, Shen discloses wherein the implant system includes an implant implanted in a bone (The probe 104 may be used to apply a mechanical force or displacement to a surface of a medical implant or bone within which the medical implant is implanted; Page 7 Lines 14-15; The medical implant may comprise one of a dental implant, a dental crown, a dental restoration, a bone screw, a plate, a hip implant, or a knee implant, as non-limiting examples; Page 12 Lines 6-7) and an abutment coupled to the implant (the method 200 further includes removably coupling an abutment to the medical implant. In such an example, the force is applied indirectly to the medical implant by applying the force to the abutment; Page 12 Lines 13-16) wherein at least a portion of the abutment (abutment 306) is exposed and not directly coupled to the bone (bone 304) (In the embodiments shown in FIGS. 22-26, the medical implant comprises a dental implant 302 positioned in the bone 304 of the patient. An abutment 306 is coupled to the dental implant 302 via threads 308. A dental crown 310 is then positioned over the abutment 306; Page 25 Lines 11-14; Examiner’s Note: Figures 22-23 show wherein the abutment 306 is partially exposed and not directly coupled to the bone, as only the bottom portion is coupled to the bone), wherein the housing includes a cutout (support structure 408), and wherein the abutment is configured to be positioned at least partially within the cutout (the support structure 408 is configured to physically couple the probe 400 to a side of the dental crown 310, opposite a location at which the actuator 402 is configured to contact the dental crown 310. Such a support structure 408 may include a first portion 412 that extends a distance above and beyond the dental crown 310. The support structure 408 may also include a second portion 414 that extends from the first portion 412 at a substantially perpendicular angle, wherein the second portion 414 is configured to contact the opposite side of the dental crown 310. Moreover, the second portion 414 may have a compliant surface 416 in contact with the dental crown 310 allowing the dental crown 310 to move under the force of the piezoelectric actuator 402; Page 26 Lines 21-29; Examiner’s Note: Figure 23 shows wherein the abutment 306 is configured to be positioned at least partially within the cutout of support structure 408).
Regarding Claim 5, Shen discloses wherein the implant system includes a longitudinal axis extending from a first surface to a second surface opposite the first surface, wherein the implant system includes a second axis that is perpendicular to the longitudinal axis, and wherein the angular stiffness corresponds to a stiffness of a rotation of the implant system with respect to the second axis (The medical implant includes a longitudinal axis extending from a first surface of the medical implant to a second surface opposite the first surface along the center line of the medical implant. The longitudinal axis may be defined along and/or parallel to a longest dimension of the medical implant. In one embodiment, the second surface of the medical implant is implanted in a bone of a patient (e.g., a jaw bone if the medical implant is a dental implant), and the first surface of the medical implant is exposed and not physically coupled to the bone. The medical implant further includes a second axis that is perpendicular to the longitudinal axis. The angular stiffness coefficient may correspond to a stiffness of a rotation of the medical implant with respect to the second axis; Page 14 Lines 12-20).
Regarding Claim 6, Shen discloses wherein the controller is further configured to: provide a binary indication of whether or not the implant system is stable based on the determined angular stiffness of the implant system (The angular stiffness coefficient as obtained above may be used to determine the stability associated with the medical implant in question. For example, a value of the coefficient may vary between stable and unstable medical implants…the direct indication of the angular stiffness may provide a green, yellow, or red indicator on a display, where the green indicates a very stable medical implant, yellow indicates an average stability of the medical implant, and red indicates an unstable medical implant. An indirect indication of the coefficient may also be provided, such as binary good or bad indicator determined, for example, based on whether the coefficient exceeds a predetermined threshold; Page 14 Line 21 – Page 15 Line 1).
Regarding Claim 7, Shen discloses wherein the controller is further configured to: provide a notification of a degree of stability of the implant system based on the determined angular stiffness of the implant system (The angular stiffness coefficient as obtained above may be used to determine the stability associated with the medical implant in question. For example, a value of the coefficient may vary between stable and unstable medical implants…the direct indication of the angular stiffness may provide a green, yellow, or red indicator on a display, where the green indicates a very stable medical implant, yellow indicates an average stability of the medical implant, and red indicates an unstable medical implant; Page 14 Lines 21-33).
Regarding Claim 9, Shen discloses wherein the actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data (At block 202, the method 200 includes applying a force to a medical implant with a probe…The amplitude of the applied force may be increased incrementally until critical physical properties, such as natural frequencies and linear stiffness coefficient, of the medical implant are detected with reasonable fidelity. The force may be applied, for example, by a piezoelectric transducer as further discussed below. The force may be applied in various and/or multiple directions relative to the medical implant, as multiple measurements may provide a better assessment of stability of the medical implant; Page 12 Lines 5-22; Three major vibration modes were seen, as shown in FIGS. 18A-18C. The first mode, shown in FIG. 18A, represents a forward and backward movement of the abutment-implant assembly. Since the motion occurs in a direction parallel to the two sides that are partially fixed (as the boundary conditions), the block experiences relatively minor strain leading to a smaller stiffness. Therefore, this mode has the lowest natural frequency. The second mode, shown in FIG. 18B, stands for a sideways movement of the abutment-implant assembly. In the second mode, the motion occurs in a direction normal to the two sides that are partially fixed. Therefore, the block experiences relatively larger strain resulting in a higher stiffness and higher natural frequency. The third mode, shown in FIG. 18C, represents a twisting motion of the Sawbones®. Each vibration mode has its own natural frequency; Page 23 Line 27 – Page 24 Line 3), and wherein the controller determines the angular stiffness of the implant system based on both the first motion data and the second motion data (a mathematical model is needed to extract the angular stiffness of the medical implant-tissue-bone system from the measured natural frequencies and linear stiffness…The angular stiffness coefficient as obtained above may be used to determine the stability associated with the medical implant in question; Page 13 Line 14 – Page 14 Line 22).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al.
Regarding Claim 10, Shen discloses, in another embodiment, wherein the actuator comprises a first actuator (transducer 702A), the device further comprising: a second actuator (transducer 702B) coupled to the housing (probe 700), wherein the second actuator is configured to vibrate the implant system when actuated, wherein the first actuator is configured to vibrate at a first frequency which is measured by the motion sensor to define a first motion data, wherein the second actuator is configured to vibrate at a second frequency which is measured by the motion sensor to define a second motion data (The two transducers 702A, 702B may be driven in an out-of-phase manner, such as by drive signal source 116, to generate angular excitation; Page 28 Lines 6-9), and wherein the controller determines the angular stiffness of the implant system based on both the first motion data and the second motion data (the target object may also be the dental implant 302, the abutment 306, or any other medical implant. Ideally, the centerline of the two transducers 702A, 702B should pass through the base of the dental crown 310, and the angular stiffness measured in this condition is the most accurate measurement; Page 28 Lines 14-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the multiple actuator embodiment teachings of Shen in order to obtain the most accurate measurement through the generation of angular excitation via the two transducers being driven in an out-of-phase manner (Shen Page 28 Lines 6-17).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al in view of Shrivastav (U.S. Patent No. 9,341,512 B2).
Regarding Claim 16, Shen fails to disclose one or more bypass capacitors positioned between the motion sensor and the controller.
In a similar technical field, Shrivastav teaches a frequency response of vibration sensors (Abstract), comprising one or more bypass capacitors positioned between the motion sensor and the controller (A vibration signal coming from the vibration sensor 204 is presented to a bypass capacitor 218. The bypass capacitor 218 decouples the vibration sensor 204 from the rest of the analog front end 200 a by stopping noise and a power signal supplied by the power supply 202 from passing into the analog front end 200 a. The bypass capacitor 218 permits high frequency current representative of a portion of interest of the vibration signal to flow to the rest of the analog front end 200 a; Column 4 Lines 5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the bypass capacitors teachings of Shrivastav into the invention of Shen in order to lower signal noise and permit high frequency current representative of a portion of interest of the vibration signal to flow (Shrivastav Column 4 Lines 6-13).
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791