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 .
According to the Amendment filed on 12/11/25, Claims 1, 22-24, 26 are amended.
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 1-13, 21-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
The new matter issue is “registering a geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor”
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.
2. Claims 1-13, 21-26 rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility.
The following steps of “continuously emitting an electromagnetic field in a surgical volume incorporating the at least one electromagnetic sensor on the bone and/or tool; continuously receiving a signal indicative of a position and/or orientation of the at least one electromagnetic sensor relative to the emitting of electromagnetic field; and outputting a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor” lack patentable utility , since the claims fails to show what utility is used in emitting an electromagnetic field, nor what utility is used in receiving a signal, and nor what utility is used in outputting a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor.
3. Claims 1-13, 21-26 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.
In accordance with MPEP 2106.04, each of Claims1-13, 21-26 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Claims 1 and 26 recite at least one step or instruction for registering geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor; processing the signal to determine the position and/or orientation of the at least one electromagnetic sensor; and continuously tracking a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I).
Accordingly, Claims 1 and 26 recite an abstract idea.
Specifically, Claim 1 recites calibrating a surface of a bone and/or tool relative to at least one electromagnetic sensor by registering geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor; processing the signal to determine the position and/or orientation of the at least one electromagnetic sensor; and continuously tracking a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); and (involves managing interactions between people, namely, humans following rules, which is grouped as a certain method of organizing human activity in MPEP 2106.04(a)(2)(II)(C) and/or a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); [[It is ok to have two abstract ideas for one claim limitation]]
Further, dependent Claims 2-13, 21-26 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 claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 26 (and their respective dependent Claims 2-13, 21-26) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above 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 according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a processing unit; and a non-transitory computer-readable memory are generically recited computer elements in independent Claims 1 and 26 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 26 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and 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., a processing unit; and a non-transitory computer-readable memory 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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 Claims 1 and 26 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 26 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
For at least the above reasons, the system of Claims 1-13, 21-26 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 providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 and 26 (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 according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-13, 21-26 amounts to significantly more than the abstract idea itself. Accordingly,
Claims 1-13, 21-26 are not patent eligible and rejected under 35 U.S.C. 101.
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) 1-4, 8-13, 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Groszmann et al. (US. 20110152676) in view of Cheung et al. (US. 20120316486) .
Groszmann discloses a system for tracking at least one tool relative to a bone in computer-assisted surgery fig. 2, comprising: a processing unit 90; and anon-transitory computer-readable memory 92 communicatively coupled to the processing unit and comprising computer-readable program instructions executable by the processing unit for: continuously emitting an electromagnetic field in a surgical volume incorporating at least one electromagnetic sensor on a bone and/or tool (paragraph 5); sensing the electromagnetic field with the at least one electromagnetic sensor and continuously receiving a signal indicative of a position and/or orientation of the electromagnetic sensor relative to the emitting of electromagnetic field (paragraphs 5-7): processing 90 the signal to determine the position and/or orientation of the at least one electromagnetic sensor: obtaining geometrical data relating the at least one electromagnetic sensor to the bone and/or tool (paragraph 31); and continuously tracking and outputting a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor (paragraph 5), wherein continuously emitting includes continuously emitting electromagnetic fields of different frequencies (paragraph 31-32, 36), wherein the outputting includes imaging the bone and/or tool (abstract), a robot arm is capable of being moved based on the outputting of the first position and/or orientation of the bone and/or tool, further comprising comparing the first position and/or orientation of the bone and/or tool to the second position and/or orientation of the bone and/or tool (paragraph 46), further comprising generating an alert upon determining a difference exceeding a threshold between the first and second positions and/or orientations of the bone and/or too (paragraph 46), further comprising continuously displaying 98 the first position and/or orientation of the bone and/or tool on a display screen, further comprising an indicator indicating the alert within the surgical volume (paragraph 46), wherein obtaining geometrical data relating the at least one electromagnetic sensor to the bone and/or tool includes obtaining points of a surface of the bone and/or tool relative to the electromagnetic sensor, and merging the points with a 3D model of the bone and/or tool including a position and orientation of the electromagnetic sensor (para. 30, 45, 46, 55), wherein obtaining points of a surface of the bone and/or tool relative to the electromagnetic sensor includes obtaining the points using a registration pointer (para. 29), wherein obtaining geometrical data relating the at least one electromagnetic sensor to the bone and/or tool includes obtaining the geometrical data after receiving said signal (para. 30, 45, 46, 55).
Groszmann fails to teach calibrating a surface of a bone and/or tool relative to at least one electromagnetic sensor by registering geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor.
Cheung et al. teaches “It is also possible that the sensors 12a, 12b, 12c (which can be located on the tool surface as shown on fig. 2b) can communicate directly with the other sensors 14a, 14b, 14c (which are electromagnetic sensors) to provide information about the relative positions of the devices, as indicated by the dotted lines extending between the sensor arrays 12 and 14 (see fig. 4). For example, the sensors 12a, 12b, and 12c could be configured to include an EM source to emit a tracking signal to the sensors 14a, 14b, and 14c, and the sensors 14a, 14b, and 14c could be configured to include an RFID receptor configured to interact with the EM field generated by the EM source based on the position of the RFID receptors. Therefore, Cheung et al is considered to teach calibrating a surface of a tool 11’, fig. 2b relative to at least one electromagnetic sensor 14a-c, fig. 4 by registering geometrical relation (para. 57) of points 12a’-c’, fig. 2b of the surface of the tool relative to the at least one electromagnetic sensor 14a-c (para. 57).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the system of Groszmann with the step of calibrating a surface of a tool relative to at least one electromagnetic sensor by registering geometrical relation of points of the surface of the tool relative to the at least one electromagnetic sensor in view of Cheung et al. for accurately calculate the relative positions and orientations of the devices and bone.
Groszmann in view of Cheung fails to teach that the at least one electromagnetic sensor is secured to the bone and/or tool via an adhesive.
it would have been an obvious matter of design choice to one skilled in the art at the time the invention was made to construct the at least one electromagnetic sensor of Groszmann in view of Cheung to be secured to the bone and/or tool via an adhesive, since applicant has not disclosed that such provides an advantage, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the invention of Groszmann in view of Cheung, and applicant’s invention, to perform equally well and to perform the same function of securing the electromagnetic sensor to the bone and/or tool, a person ordinary skill in the art would find obvious for the purpose of providing an effective system for tracking the position and orientation of the tool with respect to the bone. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groszmann in view of in view of Cheung et al. and further in view of MCDONELL (US. 20190029759).
Groszmann in view of Cheung et al. fail to teach an optical waveguide modeling system having at least one multicore optical fiber with at least one portion attached to the bone and/or tool, the computer-assisted surgery controller generating a waveguide model representing the multicore optical fiber as attached to the bone and/or tool; and continuously tracking and outputting a second position and/or orientation of the bone and/or tool using the waveguide model.
MCDONELL teaches an optical waveguide modeling system fig. 3 having at least one multicore optical fiber 92, fig. 1 with at least one portion attached to the bone and/or tool fig. 1, the computer-assisted surgery controller (100, para. 41) generating a waveguide model representing the multicore optical fiber as attached to the bone and/or tool fig. 3; and continuously tracking and outputting a second position and/or orientation of the bone and/or tool using the waveguide model (para. 67).
It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the system of Groszmann in view of Cheung et al. with an optical waveguide modeling system further in view of MCDONELL in order to tracking of bones and tools to guide an operator or robot in performing accurate and precise bone alterations in surgery.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues that the rejection under 101 is improper because “Independent claims 1 and 26 pertain to statutory subject matter in the form of a system."
Examiner disagrees, since claims 1 and 26 are rejected under 101 because The following steps of “continuously emitting an electromagnetic field in a surgical volume incorporating the at least one electromagnetic sensor on the bone and/or tool; continuously receiving a signal indicative of a position and/or orientation of the at least one electromagnetic sensor relative to the emitting of electromagnetic field; and outputting a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor” lack patentable utility , since the claims fails to show what utility is used in emitting an electromagnetic field, nor what utility is used in receiving a signal, and nor what utility is used in outputting a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor.
And the step of “processing the signal to determine the position and/or orientation of the at least one electromagnetic sensor” can be performable in the human mind.
Applicant further argues that “ the instant claims are nor practically performable in the human mind and are therefore not directed to an abstract idea.”
Examiner disagrees, since Claims 1 and 26 recite at least one step or instruction for registering geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor; processing the signal to determine the position and/or orientation of the at least one electromagnetic sensor; and continuously tracking a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I).
In addition, the claims fails to show what utility is used in registering geometrical relation of points, nor what utility is used in processing the signal, and nor what utility is used in tracking a first position and/or orientation of the bone and/or tool using the geometrical data and the position and/or orientation of the at least one electromagnetic sensor.
Applicant argues that “the Applicant points out that Cheung discusses calibration. The expression "calibrate*" is mentioned three times in the description of Cheung, all in paragraph [0040]” and “Accordingly, when discussing calibration, Cheung omits any reference to an electromagnetic signal, or to any one of the sensors identified by the Office, i.e., 12a, 12b, 12c, or 14a, 14b, 14c.”
Examiner respectfully disagrees, since in claim 1, applicant explained how the calibration occurs, which is “by registering geometrical relation of points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor” (claim1. Lines 7-8) , and wherever/ whenever the prior art teaches the step of “obtaining geometrical data including points of the surface of the bone and/or tool relative to the at least one electromagnetic sensor”, it means calibration is taking place even though the word “calibrate” is not presenting.
And Cheung et al. teaches in (para. 57) the following: “It is also possible that the sensors 12a, 12b, 12c (which can be located on the tool surface as shown on fig. 2b) can communicate directly with the other sensors 14a, 14b, 14c (which are electromagnetic sensors) to provide information about the relative positions of the devices, as indicated by the dotted lines extending between the sensor arrays 12 and 14 (see fig. 4). For example, the sensors 12a, 12b, and 12c could be configured to include an EM source to emit a tracking signal to the sensors 14a, 14b, and 14c, and the sensors 14a, 14b, and 14c could be configured to include an RFID receptor configured to interact with the EM field generated by the EM source based on the position of the RFID receptors.” Therefore, Cheung et al is considered to teach calibrating a surface of a tool 11’, fig. 2b relative to at least one electromagnetic sensor 14a-c, fig. 4 by registering geometrical relation of (para. 57) including points 12a’-c’, fig. 2b of the surface of the tool relative to the at least one electromagnetic sensor 14a-c (para. 57).
Applicant argues that there is no motivation for combining Groszmann and Cheung since as per paragraph [0007] thereof, inter alia, Groszmann already teaches "a method of surgical navigation [...] Two or more fluoroscopic images are acquired using a C-arm imaging system. The C-arm imaging system comprises a second electromagnetic device and a calibration target." Stated differently, Groszmann already teaches a calibration method, featuring C-arm imaging.
The C-arm is known to be accurate, as confirmed by Grozsmann:
"The radiopaque markers 70 are usually fixed in relation to one another, such that their respective positions may be used to provide an accurate reference between the coordinate frames of EM sensors 24, 54 and 56 and each 2D fluoroscopic image." (Grozsmann, paragraph
[0030]) “
In response to applicant’s argument that there is no motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Therefore, It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify/combine the system of Groszmann with the step of calibrating a surface of a tool relative to at least one electromagnetic sensor by obtaining geometrical data including points of the surface of the tool relative to the at least one electromagnetic sensor in view of Cheung et al. for accurately simplifying calculate the relative positions and orientations of the devices and bone.
Applicant argues that “Cheung places no weight and assigns no particular advantage to using EM signals over, for example, LED light signals, which are described as the best mode. A person skilled in the art would therefore not be motivated to modify Groszmann to implement the EM signals of Cheung, as Cheung specifically highlights its preference towards LED light signals.”
Examiner respectfully disagrees, since Cheung teaches " The tracking signal may take the form of an infrared light signal (IR), electromagnetic (EM) signal, Bluetooth signal, Wi-Fi signal, or other known or later developed wired or wireless signal.”
Also Cheung teaches “it is presumed for convenience of description that the propagating signal is an LED light signal transmitted from the emitting device 17 to the
sensors 12 and 14." (Paragraph [0039] of Cheung) , there is nowhere Cheung teaches that the LED light signal is the preferred tracking signal type.
Applicant argues that “the Office changes the principle of operation of Cheung, which is impermissible according to applicable law and is a clear contravention of MPEP 2143.01”
Examiner respectfully disagrees, since applicant fails to show and prove how the Office changes the principle of operation of Cheung.
Applicant argues that “the Office has ignored the teachings of Cheung regarding calibration to suggest a path divergent from Cheung. The person skilled in the art would thus not be motivated to modify Groszmann in view of Cheung, as Cheung specifically teaches away from the Office's proposed combination.”
Examiner respectfully disagrees, since Cheung et al. teaches in (para. 57) the following: “It is also possible that the sensors 12a, 12b, 12c (which can be located on the tool surface as shown on fig. 2b) can communicate directly with the other sensors 14a, 14b, 14c (which are electromagnetic sensors) to provide information about the relative positions of the devices, as indicated by the dotted lines extending between the sensor arrays 12 and 14 (see fig. 4). For example, the sensors 12a, 12b, and 12c could be configured to include an EM source to emit a tracking signal to the sensors 14a, 14b, and 14c, and the sensors 14a, 14b, and 14c could be configured to include an RFID receptor configured to interact with the EM field generated by the EM source based on the position of the RFID receptors.” Therefore, Cheung et al is considered to teach calibrating a surface of a tool 11’, fig. 2b relative to at least one electromagnetic sensor 14a-c, fig. 4 by registering geometrical relation of (para. 57) including points 12a’-c’, fig. 2b of the surface of the tool relative to the at least one electromagnetic sensor 14a-c (para. 57).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775