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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2026 has been entered.
Response to Arguments
Claims 21-31 are new. Claims 1, 4, 6, 9, 12-13, 15, and 19-31 are pending in this action.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive. Regarding the 35 USC § 101 rejection, 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, transmitting 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 direction, the claims are not tied to improvement in the technology, but merely to the abstract ideas, or mental processes, where abstract ideas cannot be 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 the electrodes positioned as claimed, 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 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) but for the recitation of generic computer elements used to perform the abstract ideas and/or provide insignificant extra-solution activity, 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, 6, 9, 12-13, 15, and 19-31 stand rejected under 35 USC § 101.
Claim Rejections - 35 USC § 103
Applicant’s arguments, filed 05/19/2026, with respect to the prior art rejections under 35 USC § 103 have been fully considered and are persuasive. The prior art rejections of 10/01/2025 have been withdrawn.
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, 6, 9, 12-13, 15, and 19-31 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, 6, 21-24 recite a device, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 9, 12, 25-26 recite a method, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 13, 15, 19-20, 27-31 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; an orientation sensor supported in a known location within the housing; a plurality of electrodes supported by the housing, the plurality of electrodes including a first pair of electrodes spaced a first predetermined distance apart and defining a first axis therebetween, a second pair of electrodes spaced a second predetermined distance apart and defining a second axis therebetween, and a third pair of electrodes spaced a third predetermined distance apart and defining a third axis therebetween, the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes fixed in known locations and orientations relative to the orientation sensor, the first axis, the second axis, and the third axis being pairwise perpendicular; 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 first potential difference between the first pair of electrodes, a second potential difference between the second pair of electrodes, and a third potential difference between the third pair of electrodes while the housing is located inside the patient, measure, with the orientation sensor, an orientation of the orientation sensor; determine a direction of an electric field based at least in part on the orientation of the orientation sensor and a vector having a first component based at least in part on the first potential difference and the first predetermined distance, 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; and transmit, with the communication device, data indicative of the direction of the electric field.
Independent claim 9 recites:
A method, comprising: measuring a first potential difference between a first pair of electrodes a second potential difference between a second pair of electrodes and a third potential difference between a third pair of electrodes of a plurality of electrodes supported by a housing, the housing having a biocompatible outer surface configured to be at least one of ingestible by or implantable into a patient, the first pair of electrodes spaced a first predetermined distance apart and defining a first axis there between, the second pair of electrodes determining a direction of an electric field based at least in part on the orientation of the orientation sensor and a vector having a first component based at least in part on the first potential difference and the first predetermined distance, 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; and transmitting, with a communication device supported within the housing, data indicative of the direction of the electric field.
Independent claim 13 recites:
A system, comprising: a probing device, comprising: a housing having a biocompatible outer surface configured to be ingestible by or implantable into a patient; an orientation sensor supported in a known location within the housing; a plurality of electrodes supported by the housing, the plurality of electrodes including a first pair of electrodes spaced a first predetermined distance apart and defining a first axis therebetween, a second pair of electrodes spaced a second predetermined distance apart and defining a second axis therebetween, and a third pair of electrodes spaced a third predetermined distance apart and defining a third axis therebetween, the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes fixed in known locations and orientations relative to the orientation sensor, the first axis, the second axis, and the third axis being pairwise perpendicular; 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 first potential difference between the first pair of electrodes a second potential difference between the second pair of electrodes, and a third potential difference between the third pair of electrodes while the housing is located inside the patient; measure, with the orientation sensor, an orientation of the orientation sensor; and transmit, with the first communication device, first data indicative of the first potential difference, the second potential difference, the third potential difference, and the orientation of the orientation sensor; 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: receive, with the second communication device, the first data; determine a direction of an electric field based at least in part on the orientation of the orientation sensor and a vector having a first component based at least in part on the first potential difference and the first predetermined distance, 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; and store second data indicative of the direction of the electric field.
Independent claims 1, 9 and 13 are all directed to MENTAL PROCESSES of determining, transmitting 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 direction of an electrical field by mentally observing and evaluating data and ascertaining direction based on measured electrode potential differences and the predetermined distances, or doing so by pen and paper. 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. A person could also interpretably transmit data by writing down and distributing data with pen and paper.
Dependent claims 4, 6, 12, 15, and 19-31 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 4, 6, 12, 15, and 19-31 only further define the abstract ideas in determining a direction 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, 6, 9, 12-13, 15, and 19-31 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 1, 4, 6, 9, 12-13, 15, and 19-31 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, 6, 9, 12-13, 15, and 19-31 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, 6, 12, 15, and 19-31 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) to detect IMD orientation (Van Dam abstract – “A method and device for detecting the implanted orientation of an implantable medical device (IMD) in a patient”) 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) comprising accelerometers (Ternes paragraphs 0069-0070; paragraph 0115 – “In embodiments, the sensing component 312 may include temperature sensors (e.g., thermocouples or thermistors), barometers, acoustic sensors, pressure sensors, optical sensors, motion or impact sensors (e.g., accelerometers, inertial measuring units (IMUs)), strain sensors, Doppler systems, ultrasound sensors, and/or the like, in any number of various types of configurations”), and 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, 6, 9, 12-13, 15, and 19-31 are not patent eligible under 35 USC § 101.
Allowable Subject Matter
Claims 1, 4, 6, 9, 12-13, 15, and 19-31 allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not expressly teach claimed subject matter of claims 1, 9 and 13 including at least to the plurality of electrodes supported by a housing, the plurality of electrodes including a first pair of electrodes spaced a first predetermined distance apart and defining a first axis therebetween, a second pair of electrodes spaced a second predetermined distance apart and defining a second axis therebetween, and a third pair of electrodes spaced a third predetermined distance apart and defining a third axis therebetween, the first pair of electrodes, the second pair of electrodes, and the third pair of electrodes fixed in known locations and orientations relative to the orientation sensor, the first axis, the second axis, and the third axis being pairwise perpendicular, and a processor configured to measure, with the orientation sensor, an orientation of the orientation sensor; determine a property direction of an electric field based at least in part on the orientation of the orientation sensor and a vector having a first component based at least in part on the first potential difference and the first predetermined distance, 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, in combination with the other limitations as claimed in independent claims 1, 9 and 13. Dependent claims 4, 6, 12, 15, and 19-31 are further allowed for their dependencies to the independent claims.
Claims 1, 4, 6, 9, 12-13, 15, and 19-31 remain rejected under 35 USC 101 as stated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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