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 .
Claim Objections
Claim 5 is objected to because of the following informalities: line 2 recites, “comprise” and should state, “comprises” Appropriate correction is required.
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 3 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 3 recites the limitation "wherein the at least one controller is configured to transmit the control signals to the plurality of transducers" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the invention’s controller transmits the control signals or if the invention’s control output interface transmits the controllers to the plurality of transducers as initially recited in claim 2. It is further unclear if there are multiple control signals, some transmitted from the control output interface and some transmitted from the controller.
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 1-16 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. Claims 1-16 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Regarding claim 1:
Step 1: Claim 1 is directed to an apparatus.
at least one data input interface configured to receive data from a plurality of transducers during implantation of a device on or in a recipient;
at least one controller in operative communication with the at least one data input interface, the at least one controller configured to access a probabilistic model of a parameterized description of a pose of the device relative to a body portion and to generate an estimate of a current pose of the device in response at least in part to the data and the probabilistic model;
at least one output interface in operative communication with the at least one controller, the at least one output interface configured to provide information regarding the estimated pose of the device
Step 2A – Prong 1: Claim 1 recites limitations directed to the judicial exception. The bolded limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper.
Step 2A – Prong 2: Claim 1 recites additional elements that do not integrate the exception into a practical application of the exception because they are either directed to insignificant extra-solution activity or are generically recited such that it is no more than using a computer as a tool to perform the abstract idea. The underlined limitations of a data input interface, a controller and at least one output interface are recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). The providing of information regarding the estimated pose of the device does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The medical information display apparatus and processing apparatus are recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). The providing information is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-9 depend on and recite the same abstract idea as claim 1. Furthermore, claims 2-7 contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). The status communicator recited in claim 8 does not integrate the exception into a practical application of the exception because they do not amount to more than generally linking the use of the exception into a particular technological environment or field of use (MPEP 2106.05(h)) and do not show an improvement to technology (MPEP 2106.05(a)). The automated insertion system recited in claim 9 configured to respond to the information is regarded as well-understood, routine and conventional activity as evidenced by Duindam et al. (US 2017/0014194).
Regarding claim 10:
Step 1: Claim 11 is directed to an apparatus reciting substantially the same limitations as claim 1.
Steps 2A - Prong 1-2, 2B: the judicial exceptions and additional elements identified for claim 1 correspond to the judicial exceptions and additional elements recited in claim 10 and are similarly not eligible under 35 U.S.C. 101.
Claims 11-16 depend on and recite the same abstract idea as claim 10. The additional elements recited in the dependent claims are directed to insignificant extra-solution activity for the same reasons as identified above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-11, 17-19 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Duindam et al. (US 2017/0014194).
Regarding claim 1, Duindam et al. discloses a system comprising: at least one data input interface 142 (fig. 1b; [0032]) configured to receive data from a plurality of transducers (“multiple shape sensors 120” [0033]) during implantation of a device 110 on or in a recipient; at least one controller 143 in operative communication with the at least one data input interface, the at least one controller configured to access a probabilistic model (“expected values (e.g., desired values or values predicted from a mathematical model)” [0054]) of a parameterized description of a pose of the device relative to a body portion and to generate an estimate of a current pose of the device in response at least in part to the data and the probabilistic model ([0052-0054]); and at least one output interface 148 in operative communication with the at least one controller, the at least one output interface configured to provide information regarding the estimated pose of the device ([0054]).
Regarding claim 2, Duindam et al. discloses at least one control output interface 141 in operative communication with the at least one controller, the at least one control output interface configured to transmit control signals to the plurality of transducers, the plurality of transducers responsive to the control signals by generating the data ([0052]).
Regarding claim 3, Duindam et al. discloses wherein the at least one controller is configured to transmit the control signals to the plurality of transducers automatically during the implantation of the device ([0052]).
Regarding claim 4, Duindam et al. discloses wherein the at least one controller comprises at least one processor 143 and at least one storage medium (“memory within processor 140”) in operative communication with the at least one processor (fig. 1b), the at last one storage medium configured to collect and store the data ([0052]).
Regarding claim 6, Duindam et al. discloses wherein the device comprises at least some of the plurality of transducers 120 (fig. 1a).
Regarding claim 7, Duindam et al. discloses at least one user input interface ([0044]) in operative communication with the at least one controller, the at least one controller configured to receive triggering signals from the at least one user input interface intermittently during the implantation of the device, wherein the at least one controller is configured to respond to the triggering signals by transmitting the control signals to the plurality of transducers ([0051-0052]).
Regarding claim 8, Duindam et al. discloses wherein the at least one output interface is configured to be in operative communication with at least one status communicator configured to respond to the information by communicating a status signal indicative of the pose of the device ([0054]).
Regarding claim 9, Duindam et al. discloses wherein the at least one output interface is configured to be in operative communication with an automated insertion system configured to respond automatically and in real-time to the information by manipulating the device (“This adjustment can be provided to the surgeon… or can be provided automatically to the system to cause automatic correction of the needle trajectory (e.g., providing appropriate control signals to the needle actuator” [0063]).
Regarding claim 10, Duindam et al. discloses a non-transitory computer readable storage medium having stored thereon a computer program that instructs a computer system to provide real-time information regarding a structure as the structure is being inserted into a body portion of a recipient by at least: receiving data from a plurality of transducers (“multiple shape sensors 120” [0033]) while the structure 110 is being inserted into the body portion; accessing a probabilistic model (“expected values (e.g., desired values or values predicted from a mathematical model)” [0054]) of a parameterized description of a pose of the structure relative to the body portion; and generating, based at least in part on the data and the probabilistic model, an estimated pose of the structure relative to the body portion ([0052-0054]).
Regarding claim 11, Duindam et al. discloses wherein the structure comprises the plurality of transducers 120 (fig. 1a).
Regarding claim 17, Duindam et al. discloses a method comprising: receiving data from a plurality of transducers (“multiple shape sensors 120” [0033]) while a device 110 is being implanted on or in a recipient ([0032]); assessing a probabilistic model (“expected values (e.g., desired values or values predicted from a mathematical model)” [0054]) of a parameterized description of a pose of the device relative to a body portion; generating, based at least in part on the data and the probabilistic model, an estimated pose of the device relative to the body portion ([0052-0054]); and using the estimated pose, in real-time ([0056], [0061]) while the device is being implanted on or in the recipient, to manipulate the device ([0055]).
Regarding claim 18, Duindam et al. discloses receiving the data from the plurality of transducers while the device is being retracted from the recipient ([0055]); accessing the probabilistic model of the parameterized description of the pose of the device relative to the body portion ([0054]); generating, in real-time, based at least in part on the data and the probabilistic model, an estimated pose of the device relative to the body portion ([0052-0054]); and using the estimated pose, in real-time while the device is being implanted on or in the recipient, to manipulate the device ([0055]).
Regarding claim 19, Duindam et al. discloses wherein the at least one output interface is configured to be in operative communication with an automated insertion system configured to respond automatically and in real-time to the information by manipulating the device (“This adjustment can be provided to the surgeon… or can be provided automatically to the system to cause automatic correction of the needle trajectory (e.g., providing appropriate control signals to the needle actuator” [0063]).
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(s) 1, 5, 10, 12-14, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi et al. (US 2016/0059015) in view of Duindam et al. (US 2017/0014194).
Regarding claims 1, 5, 10, 12, Risi et al. discloses a device comprising a stimulation assembly of a cochlear implant auditory prosthesis 118 configured to be implanted into a cochlea of the recipient (fig. 2b), but does not expressly disclose the remainder of the limitations of claim 1. Duindam et al. teaches these limitations (see claim 1). Given both prior art references disclose the insertion of an elongated structure into the body of a recipient, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Risi et al. to use the system with its limitations as taught by Duindam et al. in order to enhance a minimally invasive surgical procedure ([0044]) as it is a known work in one field of endeavor that prompts variations of it for use in either the same field or a different one based on design incentives (enhanced insertion process) given the variations are predictable to one of ordinary skill in the art.
Regarding claim 13, Duindam et al. discloses wherein the computer program is further configured to instruct the computer system to generate a status signal indicative of the estimated pose to at least one of a medical professional ([0054]) and an automated insertion system while the stimulation assembly is being inserted into the cochlea and/or retracted from the cochlea by the at least one of the medical professional and the automated insertion system ([0054]).
Regarding claim 14, Duindam et al. discloses wherein the status signal comprises at least one of: an alarm; an alert; a message; information regarding the estimated pose ([0054]).
Regarding claim 20, Risi et al. discloses a method of receiving data from a stimulation assembly of a cochlear implant auditory prosthesis 118 configured to be implanted into a cochlea of the recipient (fig. 2b), but does not expressly disclose the remainder of the method of claim 17. Duindam et al. discloses a method comprising: receiving data from a plurality of transducers (“multiple shape sensors 120” [0033]) while a device 110 is being implanted on or in a recipient ([0032]); assessing a probabilistic model (“expected values (e.g., desired values or values predicted from a mathematical model)” [0054]) of a parameterized description of a pose of the device relative to a body portion; generating, based at least in part on the data and the probabilistic model, an estimated pose of the device relative to the body portion ([0052-0054]); and using the estimated pose, in real-time ([0056], [0061]) while the device is being implanted on or in the recipient, to manipulate the device ([0055]). Given both prior art references disclose the insertion of an elongated structure into the body of a recipient, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Risi et al. to use the method with its limitations as taught by Duindam et al. in order to enhance a minimally invasive surgical procedure ([0044]) as it is a known work in one field of endeavor that prompts variations of it for use in either the same field or a different one based on design incentives (enhanced insertion process) given the variations are predictable to one of ordinary skill in the art.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam et al. (US 2017/0014194) in view of Tolstonogov et al. (US 2020/0380446).
Regarding claim 15, Duindam et al. does not expressly disclose wherein said generating the estimated pose comprises using the probabilistic model of the structure relative to the body portion to calculate a probability distribution for various possible poses and using the probability distribution to derive the estimated pose. Tolstonogov et al. teaches it is known in the art to use a Gaussian probability distribution of various time points and to determine a mean of the probability distribution to estimate a predicted parameter ([0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duindam et al. to generate the predicted/estimated pose parameters using the probabilistic model to calculate a known Gaussian probability distribution for various possible poses and using that probability distribution to derive the estimated pose as taught by Tolstonogov et al. it is a known technique to yield similar predicted parameters in the same way, the results of such a modification being predictable in the art.
Regarding claim 16, Duindam et al. in view of Tolstonogov et al. discloses wherein the estimated pose corresponds to at least one of a mean of the probability distribution ([0069]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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