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 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 1-20 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-14, 16-20, recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03. Claim 15 recites a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03.
2A – Prong 1: The independent claims 1 and 11 recite a judicial exception by reciting the limitations of “to run a test on the sensor data to identify an implantation site from at least one candidate implantation site for the medical device”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1 and 11 recite the additional limitations of “medical tool comprising: a housing for one or more sensors, the housing comprising a rigid body”, “the one or more sensors”, “a medical device”, “communication circuitry”, “ computing device” , etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above 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’I, 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 2-10, 12-14, 16-20 depend on claims 1 and 11. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “cardiac monitoring device”, “insertable cardiac monitor”, “one or more connectors”, “at least one wire or optical fiber”, “wireless connection”, , etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
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.
2A – Prong 1: The independent claim 15 recite a judicial exception by reciting the limitations of “determining whether at least one criterion is satisfied;”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claim 15 recite the additional limitations of “communication circuitry”, “one or more sensor of a medical device” , etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above 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’I, 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)).
Thus, claims 1-20 are directed to an abstract idea and are therefore rejected.
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.
Claim(s) 1, 3-6, 8-9, 11, 13-15, 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20180168686A1 to Jin et al. (hereinafter “Jin” – on IDS).
Regarding Claim 1. (Original): Jin discloses a medical tool (abstract, para 0001, para 0044-0045, figs 1A-B, 6A, 7-9) comprising: a housing for one or more sensors (para 0083-0087 “insertion housing”, “at least one electrode”), the housing comprising a rigid body configured to be at least partially inserted into a body of a patient (para 0070), the one or more sensors having a corresponding configuration to one or more sensors of a medical device to be implanted in the body of the patient (para 0089-0090); and communication circuitry configured to transmit, to a computing device, sensor data generated from signals captured by the one or more sensors (para 0093), wherein the computing device is configured to run a test on the sensor data to identify an implantation site from at least one candidate implantation site for the medical device (para 0081-0082, 0093, 0096 “implant location mapping operation to determine whether an ICM candidate location (e.g. region where the ICM is planned to be implanted) and orientation (e.g. vertical, diagonal, horizontal) would yield physiologic signals”; it is noted that the claim as recited does not provide any details of the test or the steps of how such test is performed.).
Regarding Claim 3. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the medical device comprises a cardiac monitoring device (para 0081 “monitor cardiac activity”).
Regarding Claim 4. (Original): Jin discloses the medical tool of claim 3, wherein the cardiac monitoring device comprises an insertable cardiac monitor (e.g., para 0004, etc. “ICM”).
Regarding Claim 5. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the communication circuitry comprises one or more connectors comprised of a conductive material and configured to couple with one or more corresponding connectors of the medical device (para 0091, 0093, 0104, contacts 636, 637).
Regarding Claim 6. (Original): The medical tool of claim 5, wherein the communication circuitry is configured to transmit the sensor data to the computing device via the one or more connectors and communication circuitry of the medical device (para 0091, 0093, 0104, contacts 636, 637).
Regarding Claim 8. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the communication circuitry is configured to couple to the computing device via a wireless connection, and wherein the communication circuitry is configured to communicate the sensor data via the wireless connection to the computing device (para 0095-0096).
Regarding Claim 9. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the medical tool is configured to insert the medical device into the body of the patient (para 0001, fig. 6A insert ICM 608 into the body”).
Regarding Claim 11. (Original): Jin discloses a medical system comprising: a medical tool, the medical tool (abstract, para 0001, para 0044-0045, figs 1A-B, 6A, 7-9) comprising a housing for one or more sensors (para 0083-0087 “insertion housing”, “at least one electrode”), the housing comprising a rigid body configured to be at least partially inserted into a body of a patient (para 0070), the one or more sensors having a configuration corresponding to one or more sensors of a medical device to be implanted in the body of the patient (para 0089-0090), and communication circuitry configured to transmit, to a computing device, sensor data generated from signals captured by the one or more sensors (para 0093); and the computing device, wherein the computing device is configured to run a test on the sensor data to identify an implantation site from at least one candidate implantation site for the medical device (para 0081-0082, 0093, 0096 “implant location mapping operation to determine whether an ICM candidate location (e.g. region where the ICM is planned to be implanted) and orientation (e.g. vertical, diagonal, horizontal) would yield physiologic signals”; it is noted that the claim as recited does not provide any details of the test or the steps of how such test is performed.).
Regarding Claim 13. (Currently Amended): Jin discloses the medical system of claim 11, wherein the medical device comprises a cardiac monitoring device (para 0081 “monitor cardiac activity”).
Regarding Claim 14. (Currently Amended): Jin discloses the medical system of claim 11, wherein the communication circuitry comprises one or more connectors comprised of a conductive material and configured to couple with one or more corresponding connectors of the medical device, and wherein the communication circuitry is configured to transmit the sensor data to the computing device via the one or more connectors and communication circuitry of the medical device (para 0091, 0093, 0104, contacts 636, 637).
Regarding Claim 15. (Original): Jin discloses a method comprising: receiving, via communication circuitry (para 0104, step 1004, fig. 10; para 0096 “the ICM 608 may convey an indication to an external monitor (e.g. via a Bluetooth or other wireless communications link)”), sensor data generated from signals captured by one or more sensors of a medical tool (para 0083-0087 “insertion housing”, “at least one electrode”) the one or more sensors having a corresponding configuration to one or more sensors of a medical device to be implanted in a body of a patient (para 0089-0090); determining whether at least one criterion is satisfied (para 0107-0110, steps 1006 and 1008); and outputting an indication of whether the at least one criterion is satisfied (para 0110-0111 “step 1010 and 1012).
Regarding Claim 17. (New): Jin discloses the medical system of claim 11, wherein the communication circuitry is configured to couple to the computing device via a wireless connection, and wherein the communication circuitry is configured to communicate the sensor data via the wireless connection to the computing device (para 0095-0096).
Regarding Claim 18. (New): Jin discloses the medical system of claim 11, wherein the test comprises determining whether at least one aspect of the sensor data satisfies at least one criterion (para 0110-0111 “step 1010 and 1012).
Regarding Claim 19. (New): Jin discloses the medical system of claim 18, wherein the at least one criterion comprises at least one of an R-wave amplitude threshold, an impedance threshold, a wireless signal strength threshold, a heart sound volume threshold, or a respiration sound volume threshold (para 0096).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 7, 10, 12, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US20180168686A1 to Jin et al. (hereinafter “Jin”).
Regarding Claim 2. (Original): Jin discloses the medical tool of claim 1, wherein the identified implantation site is in a thoracic cavity of the body of the patient (para 0004 “ICM implanted in patient’s chest area”).
Regarding Claim 7. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the communication circuitry comprises at least one port configured to couple with at least one corresponding port of the computing device via at least one wire or optical fiber, and wherein the communication circuitry is configured to transmit the sensor data to the computing device via the at least one port (para 0100-0101, contacts 934/935 and para 0104 “wired connection”; it is further noted that using optical fibers are well known in the art and an obvious variation MPEP 2143).
Regarding Claim 10. (Currently Amended): Jin discloses the medical tool of claim 1, wherein the corresponding configuration comprises at least one of a same sensor type, a same electrode spacing, or a same electrode impedance (para 0090; mere rearrangement of the electrodes are considered obvious; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Regarding Claim 12. (Original): Jin discloses the medical system of claim 11, wherein the identified implantation site is in a thoracic cavity of the body of the patient (para 0004 “ICM implanted in patient’s chest area”).
Regarding Claim 16. (New): Jin discloses the medical system of claim 11, wherein the communication circuitry comprises at least one port configured to couple with at least one corresponding port of the computing device via at least one wire or optical fiber, and wherein the communication circuitry is configured to transmit the sensor data to the computing device via the at least one port (para 0100-0101, contacts 934/935 and para 0104 “wired connection”; it is further noted that using optical fibers are well known in the art and an obvious variation MPEP 2143).
Regarding Claim 20. (New): Jin discloses the medical system of claim 18, wherein satisfying the at least one criterion comprises satisfying more than one criterion (para 0088; see MPEP 2143 “obvious to try”).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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