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 .
Response to Arguments
Claims 2-3, 10, 14 are canceled. Claims 1, 4-6, 8-9, 11, 13, 15-20 are amended. Claims 1, 4-9, 11-13, and 15-20 are pending in this action.
Specification
Applicant’s arguments, filed 01/02/2026, with respect to the abstract objection have been fully considered and are persuasive. The abstract objection of 10/01/2025 has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. Regarding the 35 USC § 101 rejection, Applicant argues that the human mind cannot measure a potential difference across a predetermined distance inside a human body. However, it is reminded that the claims are directed to abstract ideas but for the recitation of generic computer elements, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally determine a property of an electrical field by observing and evaluating data based on measured potential difference and the predetermined distance. A person could also mentally store data by mentally taking note of data and memorizing the data, or by making note by pen and paper. The instant claims pertain to the judicial exception of abstract ideas (mental processes) which a human can perform; the location of the device/system inside the body does not factor into what a human can/cannot do, but 35 USC § 101 pertains to what the device/system does, and whether or not a human can perform the judicial exception (abstract idea – mental process). Since the system/device/method are directed to mental processes, specifically directed to determining and storing which can be performed in the human mind, the claims are therefore directed to a judicial exception and are thus not patent eligible under 35 USC § 101.
Secondly, Applicant asserts that the claims are directed to a specific improvement in the capability of medical devices to measure electric fields inside the human body. However, it is reminded that since the claims are directed to abstract ideas (mental processes), specifically to determining electric field properties, the claims are not tied to improvement in the technology, but merely to the abstract ideas themselves, where abstract ideas are not considered improvements to technology which makes the claims not patent eligible, see MPEP2106.05(a). Furthermore, as stated in the rejection below, the claims recite the elements of a probing device comprising electrodes and a controller comprising a first processor, a first communication device, and a first non-transitory computer-readable medium, and a computer system comprising a second processor, a second communication device, and a second non-transitory computer-readable medium; however, these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes), as well as insignificant extra-solution for data gathering by adding nominal or tangential additions to the claim (i.e. measuring potential difference) without meaningful limitations on practicing the mental processes (e.g. electrical stimulation treatment). Furthermore, the claims are not only rooted in physical technology, but are rooted in physical technology which perform functions that can be performed by the human mind; claims 9 and 11-12 are also not merely rooted in physical technology but to method/process claims performing mental processes using the technology. Therefore, it is maintained that the claims are not directed to any improvements to technology, but are merely directed to abstract ideas (mental processes), and are thus not patent eligible under 35 USC § 101.
Third, Applicant argues to the particularity of the machine to the claims. However, the recited additional elements in the claims are, as stated in the rejection below, well-understood, routine and conventional, and as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). The references of Van Dam (US 20100010338 A1 – hereinafter Van Dam) and Ternes (US 20170196458 A1 – hereinafter Ternes) as stated in the rejection below are relied upon to prove these additional features are well-understood, routine and conventional, and merely define the field of use for the abstract ideas as tools to implement the steps of the method and/or as extra-solution for data gathering, see 2106.05(b) Particular Machine.
Therefore, when looked at individually and as a whole, the claim limitations are determined to be an abstract idea (mental processes) without significantly more, and thus claims 1, 4-9, 11-13, and 15-20 stand rejected under 35 USC § 101.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the combination of Dopierala and LEE would fundamentally change Dopierala’s principle of operation, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Dopierala teaches the structural elements of the device/system which includes the biocompatible outer surface configured to be implanted, plurality of electrodes spaced apart by a distance on the housing, and a controller. Dopierala also teaches the required functions of measuring potential differences of the electrodes and transmitting data. Lee, in the same field of endeavor in implantable systems/devices measuring potential differences between electrodes, is then relied upon to merely teach the known elements of a processor and a non-transitory computer-readable medium storing processor-executable code, as well as the functions to determine a property of an electric field based at least in part on the potential difference and the predetermined distance (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field), as stated in the rejection below. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the inventions of Dopierala and Lee to result, with a reasonable expectation of success, in determining a property of an electric field, based on the similar data and structural mechanisms the two share.
Furthermore, it is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the combined invention of Dopierala and Lee teaches the structural elements of the claims as stated in the rejection below, as well as the processing functions as stated in the rejection below, the combination is interpreted to read on the claim 1, as accordingly to independent claims 9 and 13.
Information Disclosure Statement
The information disclosure statement(s) filed November 26, 2024 has/have been considered by the Examiner.
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, 4-9, 11-13, and 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1, 4-8 recite a device, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 9, 11-12 recite a method, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 13, 15-20 recite a system, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A device comprising: a housing having a biocompatible outer surface configured to be at least one of ingestible by or implantable into a patient; a plurality of electrodes supported by the housing; and a controller supported within the housing, the controller comprising a processor, a communication device, and a non-transitory computer-readable medium storing processor-executable code that when executed causes the processor to: measure a potential difference between a first electrode and a second electrode of the plurality of electrodes while the housing is located inside the patient, the first electrode and the second electrode being spaced a predetermined distance apart; determine a property of an electric field based at least in part on the potential difference and the predetermined distance; and transmit, with the communication device, at least one of first data indicative of the potential difference and second data indicative of the property of the electric field.
Independent claim 9 recites:
A method comprising: measuring a potential difference between a first electrode and a second electrode of a plurality of electrodes supported by a housing placed into a patient, the housing having a biocompatible outer surface configured to be at least one of ingestible by or implantable into the patient, the first electrode and the second electrode being spaced a predetermined distance apart; and determining a property of an electric field based at least in part on the potential difference and the predetermined distance.
Independent claim 13 recites:
A system comprising: a probing device, comprising: a housing having a biocompatible outer surface; a plurality of electrodes supported by the housing; a controller supported within the housing, the controller comprising a first processor, a first communication device, and a first non-transitory computer-readable medium storing first processor-executable code that when executed causes the first processor to: measure a potential difference between a first electrode and a second electrode of the plurality of electrodes, the first electrode and the second electrode being spaced a predetermined distance apart; and transmit, with the first communication device, first data indicative of the potential difference; and a computer system comprising a second processor, a second communication device, and a second non-transitory computer-readable medium storing second processor-executable code that when executed causes the second processor to: responsive to receiving the first data with the second communication device, store second data indicative of a property of an electric field based at least in part on the first data and the predetermined distance.
Independent claims 1, 9 and 13 are all directed to MENTAL PROCESSES of determining and storing, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally determine a property of an electrical field by observing and evaluating data based on measured potential difference and the predetermined distance. A person could also mentally store data by mentally taking note of data and memorizing the data, or by making note by pen and paper.
Dependent claims 4-8, 11-12 and 15-20 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Dependent claims 4-8, 11-12 and 15-20 only further define the abstract ideas in determining a property of an electric field, further includes abstract ideas (i.e. “providing a recommended arrangement” in claim 12) and/or contain additional elements of which are well-understood, routine and conventional in the art, as stated in step 2B below.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1, 4-9, 11-13, and 15-20 do not disclose using the result of the mental process steps (i.e. receiving and determining), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation pulses, electric field therapy, drug therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps of determining and storing data indicative of a property of an electric field. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to mental processes (i.e. determining, storing). Accordingly, claims 9-20 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1, 4-9, 11-13, and 15-20 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of a probing device comprising electrodes and a controller comprising a first processor, a first communication device, and a first non-transitory computer-readable medium, and a computer system comprising a second processor, a second communication device, and a second non-transitory computer-readable medium, however these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). Furthermore, the elements of a controller comprising a processor, transmitter and non-transitory computer-readable medium AND a computer system comprising a second processor, a second communication device and a second non-transitory computer-readable medium are all elements which are recited at a high-level of generality, and amount to nothing more than parts of a generic computer. By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis and data transfer). Conventional computer elements performing basic data analysis are directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements in the claims further include measuring potential differences between electrodes, measuring an orientation of at least one of one or more orientation sensor, and transmitting data/instruction with the communication device, all of which can be considered insignificant extra-solution activity, which does not add any meaningful limitations to the claim. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 4-8, 11-12 and 15-20 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited probe device with electrodes, controller comprising a first processor, a first communication device, and a first non-transitory computer-readable medium, and a computer system comprising a second processor, a second communication device and a second non-transitory computer-readable medium, are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry. As shown in the reference as taught by Van Dam (US 20100010338 A1 – hereinafter Van Dam), which teaches an implantable measurement medical device 10 (IMD) with electrical leads 18 (Van Dam figure 1) comprising an accelerometer 22 in the IMD 10, and further comprises memory 26 and processor 24 in the IMD 10 (Van Dam figure 1), and further includes an external computing device 36 for transmitting data to the external device 36 from the IMD 10 (Van Dam paragraph 0019 – “…external device 36 may comprise an external medical device, a programming device, a remote telemetry station, a physician-activated device, a patient-activated device, a display device or any other type of device capable of sending and receiving signals to and from IMD 10…external device 36 may comprise a personal computer or mobile phone having a software program installed thereon configured for receiving data from IMD 10, processing such data and/or further communicating such data to a remote location or clinician for further analysis and/or processing”).
Additionally, Ternes (US 20170196458 A1 – hereinafter Ternes) similarly teaches a measuring IMD 302 (Ternes figure 3) with electrodes (Ternes paragraph 0114 – “The IMD 302 may sense physiological parameters using a sensing component 312 that may include, for example, one or more electrodes”), and further comprising a controller 308 with processor and memory (Ternes paragraph 0112 – “In embodiments, the controller 308 may be a programmable micro-controller or microprocessor…In some implementations, the controller 308 may include memory as well”) as well we communication device (Ternes figure 3, communication component 314). Ternes further teaches a separate computer system (Ternes figure 3, management server 306), which receives data from the IMD (Ternes figure 3) and includes memory (Ternes figure 3, storage 336), processor (Ternes figure 3, analysis component 332) and communication device (Ternes figure 3, communication component 338).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1, 4-9, 11-13, and 15-20 are not patent eligible under 35 USC § 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, 4-7, 9, 13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dopierala (US 20220087593 A1 – hereinafter Dopierala), cited in the IDS filed November 26, 2024, in view of in view of Lee (US 6496715 B1 – hereinafter Lee).
Re. claim 1, Dopierala teaches a device (abstract – “A device (1) for measuring congestion of the digestive tract…”; figure 1, device 1),
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comprising:
a housing (figure 1, housing 2) having a biocompatible outer surface configured to be at least one of ingestible by or implantable into a patient (Dopierala paragraph 0020 – “The housing and the set of electrodes are configured to be internalized, that is to say, implanted in the user”);
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a plurality of electrodes supported by the housing (figure 1, electrode set 3 comprising first electrode 6 and second electrode 7 on the housing 2);
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and a controller supported within the housing (figure 13 shows the device 1 comprising a control unit with submodules 300-302; paragraph 0131 – “FIG. 13 illustrates a control unit comprising a plurality of submodules 300, 301, 302 respectively forming a control chip integrating the current generator and the means for measuring the difference in electrical potential”),
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the controller comprising:
a communication device (paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”).
Dopierala further teaches the processor configured to:
measure a potential difference between a first electrode and a second electrode of the plurality of electrodes while the housing is located inside the patient (paragraph 0031 – “Arranging the set of electrodes at the ends of the housing makes it possible to measure the difference in electrical potential locally, that is to say, over the distance of a few centimeters presented by the housing”; paragraph 0105 – “Such a measuring device 1 generates two local measurements of the difference in electrical potential, carried out between two immediately adjacent electrodes by the means for measuring a difference in electrical potential”; figure 4 shows the measuring device 1 implanted in tissue 14),
the first electrode and the second electrode being spaced a predetermined distance apart (figure 1);
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and transmit, with the communication device, at least one of first data indicative of the potential difference and second data indicative of the property of the electric field (electric potential data can be transferred as shown by the waves 12, paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”).
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Dopierala does not explicitly teach a processor, and a non-transitory computer-readable medium storing first processor-executable code, AND the processor to determine a property of an electric field based at least in part on the potential difference and the predetermined distance.
Lee teaches a system for an implantable medical device (Lee abstract – “A system and method for determining the optimal positioning of an implantable system for sensing physiologic signals within a body”). Lee further teaches a handheld device 90 (Lee figure 11) comprising a second processor (Lee figure 11, processing circuit 206) and memory (Lee figure 11, memory 208) which stores data pertaining to measurements of electrode pairs (Lee column 11, lines 67-68: “Measurements various ones of the electrode pairs may be stored in a memory 208 for later retrieval, if desired”),
Comprising a first processor (Lee figure 11, processing circuit 206), and a first non-transitory computer-readable medium storing first processor-executable code (Lee figure 11, memory 208),
and further teaches the processor to: determine a property of an electric field based at least in part on the potential difference and the predetermined distance (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field.
Dopierala and Lee all teach within the field of implantable medical devices, particularly with measuring potential differences between electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, to incorporate the second processor functions of measuring, storing and transmitting electric field measurements based on potential difference and electrode distance, as taught by Lee as stated above, since such modification would predictably result in, for example, determining an optimal position for the implantation of an implantable medical device (Lee column 17, lines 64-67).
Re. claim 4, the combined invention of Dopierala, and Lee (hereinafter the combined invention) further teaches wherein the step of determining the property of the electric field is further defined as determining a magnitude of the electric field based at least in part on a quotient determined by dividing the potential difference by the predetermined distance, and wherein the second data is indicative of the magnitude of the electric field (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field.
Re. claim 5, the combined invention teaches wherein the potential difference is a first potential difference, and the predetermined distance is a first predetermined distance as stated above in claim 1. The combined invention further teaches measuring potential difference between first and second electrodes (Dopierala paragraph 0105 – “Such a measuring device 1 generates two local measurements of the difference in electrical potential, carried out between two immediately adjacent electrodes by the means for measuring a difference in electrical potential”) being spaced a predetermined distance apart (Dopierala figure 1), and transmitting data indicative of the potential difference (Dopierala paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”), as stated above in claim 1.
The combined invention does not explicitly teach wherein the processor-executable code when executed further causes the processor to: measure a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes, the third electrode and the fourth electrode being spaced a second predetermined distance apart; measure a third potential difference between a fifth electrode and a sixth electrode of the plurality of electrodes, the fifth electrode and the sixth electrode being spaced a third predetermined distance apart; and transmit, with the communication device, at least one of second data indicative of the second potential difference and third data indicative of the third potential difference.
It has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. VI. B. Duplication of Parts. As stated above, the combined invention teaches the functional limitations of measuring potential difference between electrodes, and transmitting data indicative of the potential difference; duplicating the electrodes of the combined invention into six electrodes would not change the operation of the device, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and ultimately determining/storing electric field data based on the electrode potential differences and the distances between the electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the two electrodes of the combined invention to try duplicating the electrodes into six electrodes, since such modification would still predictably result in measuring electric fields at the duplicated six electrodes in a patient based on their potential differences and distances, and in turn increase electric field treatment efficacy in a patient.
Re. claim 6, the combined invention further teaches that the and wherein the processor-executable code when executed further causes the processor to:
transmit, with the communication device, at least one of the second data, the second data indicative of a property of an electric field based at least in part on the first data and the predetermined distance (Lee column 11, lines 67-68 to column 12, lines 1-2: “Measurements various ones of the electrode pairs may be stored in a memory 208 for later retrieval, if desired. Alternatively, these measurements could be immediately transferred via a communication circuit 210 to an external system such as a programmer”; column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”).
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The newly combined invention teaches transmitting fourth data based on first data and the first predetermined distance as stated above, but does not explicitly teach transmitting fourth data indicative of a property of an electric field based at least in part on the second data, the third data, the second predetermined distance, and the third predetermined distance.
It has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. VI. B. Duplication of Parts. As stated above, the combined invention teaches the functional limitations of measuring potential difference between electrodes, and transmitting electric field data based on first data and the first predetermined distance; duplicating the electrodes of the combined invention into six electrodes would not change the operation of the device, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and transmitting electric field data based on the electrode potential differences and the distances between the duplicated electrodes, or in the instant case: six electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the two electrodes of the combined invention to try duplicating the electrodes into six electrodes, since such modification would still predictably result in measuring electric fields at the duplicated six electrodes, and transmitting electric field data of the duplicated six electrodes in a patient based on their potential differences and distances, and in turn increase electric field treatment efficacy in a patient.
Re. claim 7, the combined invention further teaches wherein the first electrode and the second electrode are supported by the biocompatible outer surface along a first axis of the housing (Dopierala figure 1),
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And teaches the obvious modification of duplicated six electrodes as stated above in claim 5.
The combined invention does not explicitly teach the third electrode and the fourth electrode are supported by the biocompatible outer surface along a second axis of the housing, the fifth electrode and the sixth electrode are supported by the biocompatible outer surface along a third axis of the housing, the first axis, the second axis, and the third axis being pairwise perpendicular.
It has been held that the positions of the other four electrodes are held to be unpatentable since shifting the electrode positions would not modify operation of the device, in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the instant case, shifting the duplicated third-fourth electrodes along a second axis, and fifth-sixth electrodes along a third axis would not modify operation of the device in measuring and storing electric fields, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and ultimately determining/storing electric field data based on potential differences and the distances between the electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of the combined invention to try placing third-fourth electrodes on a second axis, and fifth-sixth electrodes on a third axis, since such modification would still predictably result in measuring electric fields in a patient.
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Re. claim 9, Dopierala teaches a method, comprising:
measuring a potential difference between a first electrode and a second electrode of a plurality of electrodes supported by a housing placed into a patient, the housing having a biocompatible outer surface configured to be at least one of ingestible by or implantable into the patient having a biocompatible outer surface (Dopierala paragraph 0020 – “The housing and the set of electrodes are configured to be internalized, that is to say, implanted in the user”),
the first electrode and the second electrode being spaced a predetermined distance apart (figure 1).
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Dopierala does not explicitly teach determine a property of an electric field based at least in part on the potential difference and the predetermined distance.
Lee teaches a system for an implantable medical device (Lee abstract – “A system and method for determining the optimal positioning of an implantable system for sensing physiologic signals within a body”). Lee further teaches a handheld device 90 (Lee figure 11) comprising a second processor (Lee figure 11, processing circuit 206) and memory (Lee figure 11, memory 208) which stores data pertaining to measurements of electrode pairs (Lee column 11, lines 67-68: “Measurements various ones of the electrode pairs may be stored in a memory 208 for later retrieval, if desired”),
and further teaches determine a property of an electric field based at least in part on the potential difference and the predetermined distance (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field.
Dopierala and Lee all teach within the field of implantable medical devices, particularly with measuring potential differences between electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, to incorporate the second processor functions of measuring, storing and transmitting electric field measurements based on potential difference and electrode distance, as taught by Lee as stated above, since such modification would predictably result in, for example, determining an optimal position for the implantation of an implantable medical device (Lee column 17, lines 64-67).
Re. claim 13, Dopierala teaches a system (abstract – “A device (1) for measuring congestion of the digestive tract…”) comprising:
a probing device (figure 1, device 1),
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comprising:
a housing (figure 1, housing 2) having a biocompatible outer surface configured to be ingestible by or implantable into a patient (paragraph 0084 – “The housing 2 is made of a biocompatible material”);
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a plurality of electrodes supported by the housing (figure 1, electrode set 3 comprising first electrode 6 and second electrode 7 on the housing 2; paragraph 0081 – “FIG. 1, a first electrode 6 of the set 3 of electrodes is arranged at the first longitudinal end 9 of the housing 2 and a second electrode 7 of the set 3 of electrodes is arranged at the second longitudinal end 10 of the housing 2”);
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a controller supported within the housing (figure 13 shows the device 1 comprising a control unit with submodules 300-302; paragraph 0131 – “FIG. 13 illustrates a control unit comprising a plurality of submodules 300, 301, 302 respectively forming a control chip integrating the current generator and the means for measuring the difference in electrical potential”),
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the controller comprising:
a first communication device (paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”).
Dopierala further teaches the first processor configured to:
measure a potential difference between a first electrode and a second electrode of the plurality of electrodes while the housing is located inside the patient (paragraph 0105 – “Such a measuring device 1 generates two local measurements of the difference in electrical potential, carried out between two immediately adjacent electrodes by the means for measuring a difference in electrical potential”; figure 4 shows the measuring device 1 implanted in tissue 14), the first electrode and the second electrode being spaced a predetermined distance apart (figure 1; paragraph 0081 – “FIG. 1, a first electrode 6 of the set 3 of electrodes is arranged at the first longitudinal end 9 of the housing 2 and a second electrode 7 of the set 3 of electrodes is arranged at the second longitudinal end 10 of the housing 2”);
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and transmit, with the first communication device, first data indicative of the potential difference (paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”);
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and a computer system (figure 1, calculation module 5)
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comprising:
a second processor (paragraph 0021 – “The calculating module is configured to process the measurement data for the difference in electrical potential, and in particular to process the evolution of these measured data with respect to predefined thresholds”),
a second communication device (paragraph 0085 – “The calculating module 5 is shown here as being externalized with respect to the housing 2. It comprises means of communication so as to receive the measured electrical potential. For example, the calculating module 5 comprises a receiver”),
and a second non-transitory computer-readable medium storing second processor-executable code (paragraph 0098 – “The combination of these two values, and in particular the combination of the comparisons of these values with a threshold value associated with them and stored in a memory of the calculating module”) that when executed causes the second processor to:
receive, with the second communication device, the first data (paragraph 0085 – “The calculating module 5 is shown here as being externalized with respect to the housing 2. It comprises means of communication so as to receive the measured electrical potential. For example, the calculating module 5 comprises a receiver”);
and, store second data indicative of the property of the electric field (paragraph 0098 – “The combination of these two values, and in particular the combination of the comparisons of these values with a threshold value associated with them and stored in a memory of the calculating module”; paragraph 0085 – “The calculating module 5 is shown here as being externalized with respect to the housing 2. It comprises means of communication so as to receive the measured electrical potential. For example, the calculating module 5 comprises a receiver”).
Dopierala does not explicitly teach determine a property of an electric field based at least in part on the potential difference and the predetermined distance.
Lee teaches a system for an implantable medical device (Lee abstract – “A system and method for determining the optimal positioning of an implantable system for sensing physiologic signals within a body”). Lee further teaches a handheld device 90 (Lee figure 11) comprising a second processor (Lee figure 11, processing circuit 206) and memory (Lee figure 11, memory 208) which stores data pertaining to measurements of electrode pairs (Lee column 11, lines 67-68: “Measurements various ones of the electrode pairs may be stored in a memory 208 for later retrieval, if desired”),
Comprising a first processor (Lee figure 11, processing circuit 206), and a first non-transitory computer-readable medium storing first processor-executable code (Lee figure 11, memory 208),
and further teaches the first processor configured to determine a property of an electric field based at least in part on the potential difference and the predetermined distance (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field.
Dopierala and Lee all teach within the field of implantable medical devices, particularly with measuring potential differences between electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, to incorporate the second processor functions of measuring, storing and transmitting electric field measurements based on potential difference and electrode distance, as taught by Lee as stated above, since such modification would predictably result in, for example, determining an optimal position for the implantation of an implantable medical device (Lee column 17, lines 64-67).
Re. claim 15, the combined invention further teaches wherein the first electrode and the second electrode are supported by the biocompatible outer surface at antipodal points of the housing (Dopierala figure 1, electrodes 6 and 7 of electrode set 3 are supported at opposite sides, or “antipodal” of the housing 2),
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And further teaches wherein the step of determining the property of the electric field is further defined as determining a magnitude of the electric field based at least in part on a quotient determined by dividing the potential difference by the predetermined distance, and wherein the step of storing the second data is further defined as storing the second data indicative of the magnitude of the electric field (Lee column 18, lines 50-56: “Recall that S1 and S2 are the voltage signals measured empirically between the respective electrode pairs…the electric fields existing between the first pair of electrodes 502 and 504 may be defined as E1=S1/D1, wherein D1 is the distance between electrodes 502 and 504. Similarly, the electric field measured between the second pair of electrodes 504 and 506 may be defined as E2=S2/D2, wherein D2 is the distance between electrodes 504 and 506”. It is noted that potential difference is known to refer to voltage). Examiner further interprets “electric field measured” as taught by Lee of the combined invention to reasonably teach the magnitude of the electric field.
Re. claim 16, the combined invention as stated above teaches wherein the potential difference is a first potential difference, and the predetermined distance is a first predetermined distance, as stated above in claim 13. The combined invention further teaches measuring potential difference between first and second electrodes (Dopierala paragraph 0105 – “Such a measuring device 1 generates two local measurements of the difference in electrical potential, carried out between two immediately adjacent electrodes by the means for measuring a difference in electrical potential”) being spaced a predetermined distance apart (Dopierala figure 1), transmitting data indicative of the potential difference (Dopierala paragraph 0085 – “The set 3 of electrodes is then connected to a transmitter making it possible to transmit the information measured by the means for measuring the difference in electrical potential to the calculating module 5, as illustrated by waves 12”) and storing the data as stated above in claim 13.
The combined invention does not explicitly teach the first processor-executable code when executed further causes the first processor to: measure a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes, the third electrode and the fourth electrode being spaced a second predetermined distance apart; transmit, with the first communication device, third data indicative of the second potential difference; measure a third potential difference between a fifth electrode and a sixth electrode of the plurality of electrodes, the fifth electrode and the sixth electrode being spaced a third predetermined distance apart; and transmit, with the first communication device, fourth data indicative of the third potential difference; wherein the second processor-executable code when executed further causes the second processor to receive, with the second communication device, the third data and the fourth data; and wherein the step of determining the property of the electric field is further defined as determining the property of the electric field based at least in part on the first potential difference, the second potential difference, the third potential difference, the first predetermined distance, the second predetermined distance, and the third predetermined distance.
It has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. VI. B. Duplication of Parts. As stated above, the combined invention teaches the functional limitations of measuring potential difference between electrodes, transmitting data indicative of the potential difference, and storing data indicative of electric field magnitude based on the potential differences and the predetermined distances; duplicating the electrodes of the combined invention into six electrodes would not change the operation of the device, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and ultimately determining/storing electric field data based on the electrode potential differences and the distances between the electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the two electrodes of the combined invention to try duplicating the electrodes into six electrodes, since such modification would still predictably result in measuring electric fields at the duplicated six electrodes in a patient based on their potential differences and distances, and in turn increase electric field treatment efficacy in a patient.
Re. claim 17, the combined invention further teaches wherein the first electrode and the second electrode are supported by the housing along a first axis (Dopierala figure 1).
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and further teaches wherein the step of storing the second data (Lee column 11, lines 67-68: “Measurements various ones of the electrode pairs may be stored in a memory 208 for later retrieval, if desired”) is further defined as storing the second data indicative of the direction of the electric field (Lee column 18, lines 63-65: “It is known that these two electric fields can be used to approximate the electric field E having the direction vector U between electrode 504 and the selected point 514”; figure 27 shows the vectors U for electrodes 502, 504 and 506. It is also known that vectors include a component of electric field magnitude, which is taught in claim 13 as stated above, as well as direction).
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The combined invention teaches that it would have been obvious to modify the two electrodes of the combined invention to try duplicating to six electrodes as stated above in claim 16, but does not explicitly teach the third electrode and the fourth electrode are supported by the housing along a second axis, the fifth electrode and the sixth electrode are supported by the housing along a third axis, the first axis, the second axis, and the third axis being pairwise perpendicular.
It has been held that the positions of the other four electrodes are held to be unpatentable since shifting the electrode positions would not modify operation of the device, in re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), see MPEP 2144.04. VI. C. Rearrangement of Parts. In the instant case, as stated above in claim 16, shifting the third-fourth electrodes along a second axis, and fifth-sixth electrodes along a third axis would not modify operation of the device in measuring and storing electric field data, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and ultimately determining/storing electric field data based on potential differences and the distances between the electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of the combined invention to try placing third-fourth electrodes on a second axis, and fifth-sixth electrodes on a third axis, since such modification would still predictably result in measuring electric fields at their electrode positions in a patient.
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The combined invention teaches storing data indicative of a direction of the electric field based at least in part on a vector having a first component based at least in part on the first data and the first predetermined distance as stated above, but does not teach storing the second data indicative of a direction of the electric field based at least in part on a vector having: a second component based at least in part on the second potential difference and the second predetermined distance, and a third component based at least in part on the third potential difference and the third predetermined distance.
However as stated above in claim 16, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. VI. B. Duplication of Parts. As stated above, the combined invention teaches the functional limitations of measuring potential difference between electrodes, transmitting data indicative of the potential difference, and storing data indicative of electric field magnitude based on the potential differences and the predetermined distances of the electrodes. The combined invention further teaches vectors measured at electrodes 502, 504, and 506;
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duplicating the electrodes of the combined invention into six electrodes to determine a direction of an electric field based on first-third components and their electrode distances would not change the operation of the device, and would not produce any new and unexpected result in measuring potential differences in the electrodes, and ultimately storing electric field data, including the direction of the electric fields, based on potential differences and the distances between the electrodes. Furthermore, the first-third components of the claim refer to the electric field magnitudes, as vectors require magnitudes as a vector component, in addition to direction, in which the electric field magnitudes are measured and stored as taught by the combined invention as stated above in claim 16 and claim 13. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the two electrodes of the combined invention to try duplicating the electrodes into six electrodes, since such modification would still predictably result in measuring and storing electric field data, including their directions via vectors, at the duplicated electrodes in a patient.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dopierala (US 20220087593 A1 – hereinafter Dopierala) in view of Lee (US 6496715 B1 – hereinafter Lee), and in further view of Van Dam (US 20100010338 A1 – hereinafter Van Dam).
Re. claim 8, the combined invention of Dopierala, Lee (hereinafter the combined invention) teaches the claimed invention of claim 1 as stated above, and further teaches the device further comprising: one or more orientation sensor supported in a known location within the housing (Dopierala figure 1, accelerometer 100), wherein the data is first data (see claim 1 rejection above).
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The combined invention does not explicitly teach wherein the processor-executable code when executed further causes the processor to: measure, with at least one of the one or more orientation sensors, an orientation of the at least one of the one or more orientation sensors; and transmit, with the communication device, third data indicative of the orientation.
Van Dam teaches an implantable medical device which also comprises an orientation sensor (van Dam figure 2, IMD 10 comprises an accelerometer sensor 22), processor 24, and memory 26 (van Dam paragraph 0017 – “IMD 10 is shown as including magnetic sensor 20, accelerometer sensor 22, processor or controller 24, memory 26, battery 28, telemetry module 30, and other components as appropriate to produce the desired functionalities of the device”).
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Van Dam further wherein the processor-executable code when executed further causes the processor to: measure, with at least one of the one or more orientation sensor, an orientation of the orientation sensor (van Dam paragraph 0021 – “Controller 24 may comprise any of a wide variety of hardware or software configurations capable of executing algorithms to utilize data received from magnetic sensor 20 or accelerometer sensor 22 to compute the implanted orientation of IMD 10”, the implant 10 which includes the accelerometer 22, and therefore would compute the orientation of the sensor);
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And transmit, with the first communication device, third data indicative of the orientation (van Dam paragraph 0020 – “In any event, telemetry module 30 facilitates wireless data transfer between IMD 10 and external device 36”);
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The combined invention and van Dam all teach within the field of implantable medical devices, particularly with orientation sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, particularly orientation sensor accelerometer 100 and processor of Dopierala of the combined invention, to substitute with the accelerometer 22 and processor/processing functions of determining the sensor orientation in the implant and transmitting the orientation data, as taught by van Dam, since such modification would predictably result in assisting patients and/or patient caregivers in detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation (van Dam paragraph 0005 – “A method and device are provided for detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation”).
Re. claim 18, the combined invention of Dopierala, Lee (hereinafter the combined invention) further teaches wherein the probing device further comprises:
one or more orientation sensor (Dopierala figure 1, accelerometer 100),
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And receive, with the second communication device, the third data (paragraph 0085 – “The calculating module 5 is shown here as being externalized with respect to the housing 2. It comprises means of communication so as to receive the measured electrical potential. For example, the calculating module 5 comprises a receiver”).
The combined invention does not explicitly teach wherein the first processor-executable code when executed further causes the first processor to: measure, with at least one of the one or more orientation sensor, an orientation of at least a portion of the probing device; transmit, with the first communication device, third data indicative of the orientation; and wherein the second processor-executable code when executed further causes the second processor to, responsive to receiving the third data with the second communication device, store the third data.
Van Dam teaches an implantable medical device which also comprises an orientation sensor (van Dam figure 2, IMD 10 comprises an accelerometer sensor 22), processor 24, and memory 26 (van Dam paragraph 0017 – “IMD 10 is shown as including magnetic sensor 20, accelerometer sensor 22, processor or controller 24, memory 26, battery 28, telemetry module 30, and other components as appropriate to produce the desired functionalities of the device”).
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Van Dam further teaches the first processor-executable code when executed further causes the first processor to:
measure, with at least one of the one or more orientation sensor, an orientation of at least a portion of the probing device (van Dam paragraph 0021 – “Controller 24 may comprise any of a wide variety of hardware or software configurations capable of executing algorithms to utilize data received from magnetic sensor 20 or accelerometer sensor 22 to compute the implanted orientation of IMD 10”);
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transmit, with the first communication device, third data indicative of the orientation (van Dam paragraph 0020 – “In any event, telemetry module 30 facilitates wireless data transfer between IMD 10 and external device 36”);
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and wherein the second processor-executable code when executed further causes the second processor to, responsive to receiving the third data with the second communication device, store the third data (van Dam paragraph 0019 – “Telemetry module 30 may comprise any unit capable of facilitating wireless data transfer between IMD 10 and an external device 36, where external device 36 may comprise an external medical device, a programming device, a remote telemetry station, a physician-activated device, a patient-activated device, a display device or any other type of device capable of sending and receiving signals to and from IMD 10”).
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The combined invention and Van Dam all teach within the field of implantable medical devices, particularly with orientation sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined invention, particularly orientation sensor accelerometer 100 and processor of Dopierala of the combined invention, to substitute with the accelerometer 22 and processor/processing functions of determining the orientation of at least a portion of the implant, as taught by van Dam, since such modification would predictably result in assisting patients and/or patient caregivers in detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation (van Dam paragraph 0005 – “A method and device are provided for detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation”).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dopierala (US 20220087593 A1 – hereinafter Dopierala) in view of Lee (US 6496715 B1 – hereinafter Lee) and Van Dam (US 20100010338 A1 – hereinafter Van Dam).
Re. claim 11, the combined invention of Dopierala and Lee (hereinafter the combined invention) further teaches an orientation sensor (Dopierala figure 1, accelerometer 100),
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But does not explicitly teach the method of measuring an orientation of at least one of one or more orientation sensor supported by the housing.
Van Dam teaches an implantable medical device which also comprises an orientation sensor (van Dam figure 2, IMD 10 comprises an accelerometer sensor 22), processor 24, and memory 26 (van Dam paragraph 0017 – “IMD 10 is shown as including magnetic sensor 20, accelerometer sensor 22, processor or controller 24, memory 26, battery 28, telemetry module 30, and other components as appropriate to produce the desired functionalities of the device”).
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Van Dam further teaches the method of measuring an orientation of at least one of one or more orientation sensor supported by the housing (van Dam paragraph 0021 – “Controller 24 may comprise any of a wide variety of hardware or software configurations capable of executing algorithms to utilize data received from magnetic sensor 20 or accelerometer sensor 22 to compute the implanted orientation of IMD 10”, the implant 10 which includes the accelerometer 22, and therefore would compute the orientation of the sensor);
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The combined invention and van Dam all teach within the field of implantable medical devices, particularly with orientation sensors. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify combined invention, particularly orientation sensor accelerometer 100 and processor of Dopierala, to substitute with the accelerometer 22 and processor/processing functions of determining the sensor orientation in the implant, as taught by van Dam, since such modification would predictably result in assisting patients and/or patient caregivers in detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation (van Dam paragraph 0005 – “A method and device are provided for detecting the implanted orientation of an implantable medical device in a patient and then optimizing or compensating for such implanted orientation”).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dopierala (US 20220087593 A1 – hereinafter Dopierala) in view of in view of Lee (US 6496715 B1 – hereinafter Lee) and Palti (US 20040176804 A1 – hereinafter Palti).
Re. claim 12, the combined invention of Dopierala and Lee (hereinafter the combined invention) teaches the claimed invention of claim 9 as stated above, but does not explicitly teach wherein prior to measuring the potential difference between the first electrode and the second electrode, the method further comprises: providing a recommended arrangement for applying at least two conductive electrode elements to a patient; supplying an electrical signal having an alternating current waveform at a frequency in a range from 50 kHz to 1 MHz to each of the conductive electrode elements; and subsequent to determining the property of the electric field based at least in part on the potential difference and the predetermined distance, providing an updated arrangement for applying the at least two conductive electrode elements to the patient, the updated arrangement based at least in part on the property of the electric field.
Palti similarly teaches a method of measuring electric fields (Palti paragraph 0089 – “At step 430, this inputted information is used to compute the necessary field intensity in the tumor…At step 450, the maximal allowed field intensity at the various areas is determined and then based on the information inputted in steps 400 through 450, an optimal field map is computed at step 460”).
Palti further teaches providing a recommended arrangement for applying at least two conductive electrode elements to a patient (Palti paragraph 0082 – “In order to optimize the field distribution, the isolects 230 are configured differently depending upon the application in which the isolects 230 are to be used”; paragraph 0089 – “At step 470, the selected isolects (those present in the optimal field map) are computed as well as their position and waveform and the voltage that is to be delivered to each isolect”);
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supplying an electrical signal having an alternating current waveform at a frequency in a range from 50 kHz to 1 MHz to each of the conductive electrode elements (Palti paragraph 0068 – “According to one exemplary embodiment, the electric fields that are used in the present apparatus are alternating fields having frequencies that in the range from about 50 KHz to about 500 KHz, and preferably from about 100 KHz to about 300 KHz”);
and subsequent to determining the property of the electric field based at least in part on the potential difference and the predetermined distance, providing an updated arrangement for applying the at least two conductive electrode elements to the patient, the updated arrangement based at least in part on the property of the electric field (Palti teaches that the isolects are modified based on the deviation of the electric field from a threshold, paragraph 0068 – “In order to further minimize the field map, the number of isolects is preferably reduced in step 480 to produce a modified field map and then the deviation of the modified map from the optimum is calculated”).
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The combined invention and Palti all teach within the field of methods of measuring electric fields. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the combined invention, to incorporate the recommended electrode placements and supplying an electrical signal having an alternating current waveform, as taught by Palti, since such modification would predictably result in, for example, to optimize the voltage and the position of each electrode so that one gets the desired spatial arrangement of the electric field (Palti paragraph 0093).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dopierala (US 20220087593 A1 – hereinafter Dopierala) in view of in view of Lee (US 6496715 B1 – hereinafter Lee), and in further view of Brown (US 20160038074 A1 – hereinafter Brown).
Re. claim 19, the combined invention Dopierala, Lee (hereinafter the combined invention) further teaches wherein the steps of measuring the potential difference and transmitting the first data are performed when the probing device is in the measurement mode (Dopierala FIG. 2 is a view of the implanted elements of the measuring device shown in FIG. 1 in an operating mode, or otherwise the default measurement mode, paragraph 0105 – “Such a measuring device 1 generates two local measurements of the difference in electrical potential, carried out between two immediately adjacent electrodes by the means for measuring a difference in electrical potential”).
The combined invention does not explicitly teach wherein the second processor-executable code when executed further causes the second processor to: transmit, with the second communication device, an instruction to transition the probing device into a measurement mode; and wherein the first processor-executable code when executed further causes the first processor to: receive, with the first communication device, the instruction; responsive to receiving, with the first communication device, the instruction transition the probing device into the measurement mode, wherein the steps of measuring g the potential difference and transmitting the first data are performed when the probing device is in the measurement mode; and transition the probing device into a standby mode.
Brown teaches a similar probe measurement device (Brown abstract – “A stimulation probe device including a first electrode, a stimulation module, a control module and a physical layer module”). Brown further teaches sensors 400 and sensing modules 200 which communicate with nerve integrity monitoring (NIM) systems (figures 1-2 and 18) to transmit information (Brown paragraph 0055 – “the NIM device 18 wirelessly communicates directly with the sensors 12, 13 and the stimulation probe device 14”).
Brown further teaches the NIM device to transmit an instruction to transition the probing device into a measurement mode (Brown paragraph 0141 – “Once linked to the CIM and/or NIM device 402, the sensor 400 may now be controlled by the CIM and/or NIM device 402 via transmission of updated SYNC requests. The CIM and/or NIM device 402 may control, for example, output data rates and transitions between power modes of the sensor 400”);
And wherein the first processor-executable code when executed further causes the first processor to: receive, with the first communication device, the instruction, and responsive to receiving, with the first communication device, transitioning the probing device into the measurement mode (Brown teaches in a similar embodiment the sensing module 200 can transition to a high-power mode from the internal modules 202, 204, 206 to sense measurements, Brown paragraph 0077 – “The sensing module 200 may operate in: a high-power mode (fully powered mode), a low (or idle) power mode (partially powered or transmitting less frequently then when in the high-power mode), a sleep mode, or OFF… Operation in and transition between these modes may be controlled by one or more of the modules 202, 204, 206”),
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and transition the probing device into a standby mode (Brown paragraph 0077 – “The sensing module 200 may operate in: a high-power mode (fully powered mode), a low (or idle) power mode (partially powered or transmitting less frequently then when in the high-power mode), a sleep mode, or OFF”).
The combined invention and Brown all teach within the field of measurement probe devices. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor/processing functions of the combined invention, to incorporate the processing functions of transitioning the probing device into a measurement mode and standby mode, as taught by Brown, since such modification would predictably result in measuring a desired measurement parameter via the probing device.
Re. claim 20, the newly combined invention of Dopierala, Lee, and Brown further teach wherein the instruction is a first instruction (see the claim 19 rejection above), and wherein the second processor-executable code when executed further causes the second processor to:
transmit, with the second communication device, a second instruction to transition the probing device into the standby mode, wherein the first processor-executable code when executed further causes the first processor to receive, with the first communication device, the second instruction (Brown paragraph 0141 – “Once linked to the CIM and/or NIM device 402, the sensor 400 may now be controlled by the CIM and/or NIM device 402 via transmission of updated SYNC requests. The CIM and/or NIM device 402 may control, for example, output data rates and transitions between power modes of the sensor 400”; Brown paragraph 0077 – “The sensing module 200 may operate in: a high-power mode (fully powered mode), a low (or idle) power mode (partially powered or transmitting less frequently then when in the high-power mode), a sleep mode, or OFF”);
and wherein the step of transitioning the probing device into the standby mode is further defined as, responsive to receiving, with the first communication device, receiving the second instruction, transitioning the probing device into the standby mode (Brown paragraph 0090 – “The control module 202 and/or the power module 206 may periodically transition between operating in a low power (or sleep) mode”; paragraph 0078 – “Transitioning to the low power mode, the sleep mode and/or to OFF decreases power consumption and can aid in minimizing size of the power source 208”).
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.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796