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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 18 September 2025, the following has occurred: Claims 1-6, 8-13 and 15 have been amended; Claims 7 and 14 have been cancelled.
Claims 1-6, 8-13 and 15 are pending.
Priority
This application claims priority to WIPO Application No. PCT/EP2022/056423 dated 14 March 2022 which claims priority to U.S. Provisional Patent Application No. 63/167,706 dated 30 March 2021.
Claim Objections
Claims 2 and 4 utilize the acronym AU. The Examiner believes this should be AI. Appropriate correction/clarification is required.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 15 is rejected because it does not sufficiently recite a non-transitory computer readable storage medium. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claims 1-6, 8-13, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 9, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a system, method, and computer readable data carrier (“CRM”) for collecting and processing data, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes, see non-transitory rejection, supra).
Step 2A1
The limitations of (Claim 1 being representative) store data collected by at least one medical device and at least one HCP remote device, process the stored data, provide data search functionality, receive a trigger for a communication session for providing remote programming to the medical device
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting (Claims 1, 9) a server having a communications module, central data repository, and at least one processor or (Claim 15) a computer readable data carrier having a memory, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the noted generic computer components, the claims encompass a person storing data, processing the data, searching the data, and receiving an initiation of communication for providing programming in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of (Claims 1, 9) a server having a communications module, central data repository, and at least one processor or (Claim 15) a computer readable data carrier having a memory that implements the identified abstract idea. These items are not described by the applicant and are recited at a high-level of generality (i.e., a generic server or CRM) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim further recites the additional element of an Artificial Intelligence module. This represents mere instructions to implement the abstract idea on a generic computer (the RMS). Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. See, e.g., Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 10 (Fed. Cir. April 18, 2025) (finding that claims that do no more than apply established methods of machine learning to a new data environment are ineligible). Alternatively, or in addition, the implementation of the Artificial Intelligence module to process the data, control communication of the data, or search the data merely confines the use of the abstract idea to a particular technological environment or field of use (Artificial Intelligence) and thus fails to add an inventive concept to the claims.
The claim further recites the two additional elements of (1) at least one medical device and (2) at least one health care professional (HCP) remote device. Each of these devices merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using (Claims 1, 9) a server having a communications module, central data repository, and at least one processor or (Claim 15) a computer readable data carrier having a memory to perform the noted steps/functions amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of an Artificial Intelligence module was found to represent mere instructions to implement the abstract idea on a generic computer (the RMS) and/or confine the use of the abstract idea (i.e., the trained model) to a particular technological environment or field of use (e.g., a random forest algorithm, Spec. Pg. 6). This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer and/or confining the use of the abstract idea to a particular technological environment or field of use cannot provide significantly more. See also Recentive Analytics, Inc. v. Fox Corp., No. 2023-2437 at 17 (Fed. Cir. April 18, 2025) (finding that applying machine learning to an abstract idea does not transform a claim into something significantly more).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) at least one medical device and (2) at least one health care professional (HCP) remote device were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2-6, 8, and 10-13 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 10 merely describe(s) additional functions that the AI model is deigned to perform.
Claim(s) 3, 11 merely describe(s) sending and receiving data.
Claim(s) 3, 11 also includes the additional element(s) of “one or more data management systems” which generally links the abstract idea to a particular technological environment or field of use in the same manner as the devices. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 4, 12 merely describe(s) managing data reports by creating, arranging, storing, presenting, and/or exporting data.
Claim(s) 5, 13 merely describe(s) ranking and distributing/serving search results in response to a query.
Claim(s) 6 merely describe(s) providing data for use.
Claim(s) 8 merely describe(s) the additional element of the at least one HCP.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-13 and 15 are rejected for lack of adequate written description.
Claims 1, 9, and 15 are rejected for lack of adequate written description. The claims recite functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of ordinary skill in the art to conclude that the Applicant had possession of the invention.
MPEP 2161.01(I): When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. [...] If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2161.01- § 2163.07(b). […]
Specifically, the claims recite (Claim 1 being representative) an “Al module is configured to process data stored in the central data repository, control data communication using the communication module, and provide services of a search engine.”
Claim 2 describes the processing of the data as one or more of “indexing data, comparing data, creating an envelope for received data, displaying data, and/or managing data reports.” Specification at Pg. 6-7 discusses indexing but provides to description as to how it is actually done by the AI module. Specification at Pg. 6 discusses comparing of data but provides no description as to how it is actually done by the AI module. Specification at Pg. 7 discusses creating an envelope for each data record, but provides no description as to how it is actually done by the AI module.
Claim 3 describes the controlling of data as one or more of “receive data imports from and send data exports to one or more data management systems.” Specification at Pg. 8 discusses using converters and generators to perform data converting but contains no actual description as to how the AI module performs these functions.
Claim 5 describes the providing services of a search. Specification at Pg. 9 discusses serving and rankling but provides to description as to how the AI module performs these tasks.
The Applicant has provided no disclosure of how the AI module processes the data, controls a communications module, or provides a search engine. The claimed AI module amounts to a black box into which information is inputted and a result is received; however, there is no disclosure as to what occurs in the box. As such, the claimed invention lacks adequate written description. MPEP 2161.01.
The Examiner prospectively notes that this written description rejection is not based on whether one skilled in the art would know how to program a computer to include an AI that performs any form of the noted functions (i.e., an enablement rejection), but rather is directed to the Applicant’s lack of specificity as to how the various functions of Applicant’s AI are specifically performed with respect to the Applicant’s claimed invention.
By virtue of their dependence from Claim 1, 7, or 9, this basis of rejection also applies to dependent Claims 2-6, 8, and 10-13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102 and 103 (or as subject to pre-AIA 35 U.S.C. §§ 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 8-12, and 15 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Heckerman et al. (U.S. Pre-Grant Patent Publication No. 2007/0112598) in view of Haubrich et al. (U.S. Pre-Grant Patent Publication No. 2005/0283198).
REGARDING CLAIM 1
Heckerman teaches the claimed system comprising:
remote monitoring server (RMS), [Para. 0039, 0043 teaches a computer (server) used in a system. Para. 0070 also teaches a server.]
at least one medical device, and [Para. 0046, 0072 teaches that data is received from a plurality of medical devices. Para. 0026, 0046 teaches that the device is a pacemaker.]
at least one health care professional (HCP) remote device comprising a HCP User Interface (CUI), [Para. 0036, 0046 teaches receiving data from input means such as cell phones or computers (user devices). Para. 0035 teaches that a user is a consumer (patient) or provider.]
wherein the RMS comprises a communication module configured to communicate with the at least one HCP remote device, [Para. 0036 teaches that data is received from the user device(s) by the computer (server) and thus there is a communication component; computers are known in the art to contain a communication module (which is not defined).]
wherein the RMS comprises a central data repository and at least one processor, [Para. 0034 teaches a database that stores received data. Para. 0074, 0078 teaches that the computer has a processor.]
wherein the central data repository is configured to store data collected by the at least one medical device and the at least one HCP remote device, [Para. 0034, 0046 teaches that the collection component collects data from the user computer(s) and medical device(s) and stores it in the database.]
wherein the RMS further comprises an artificial intelligence (Al) module, [Para. 0039, 0061 teaches that AI techniques are used to determine patterns such as health-observations. Para. 0034, 0039 teaches that the AI is part of the aggregation component which is part of the computer (server).]
wherein the Al module is configured to
process data stored in the central data repository, [Para. 0038, 0039, 0061, 0066 teaches that AI techniques used to determine patterns, health-observations, and/or conclusions (interpreted to occur via an AI module, the Examiner noting that the Applicant has not claimed or described what the AI module entails) from data stored on the database (i.e., medical data). Alternately, throughout Heckerman, ML (a form of AI) is used to process the data.]
control data communication using the communication module, and [Para. 0075 teaches that AI is used to draw conclusions and provide conclusions to users (i.e., transmit the results via the computer which necessarily has a communication module).]
to provide services of a search engine, and [Para. 0068, 0069, 0071 teaches that a health and/or wellness inquiry received (a search) and an inference is provided. Para. 0055, 0075 teaches that the conclusion are provided by the AI.]
Heckerman may not explicitly teach
wherein the HCP remote device is configured to trigger a communication session for providing remote programming of the medical device when a session request is sent from the HCP remote device to the RMS through the CUI.
Haubrich at Para. 0031, 0040 teaches that it was known in the art of computerized healthcare, at the time of filing, to engage in remote programming of an IMD using a provider computer system
wherein the HCP remote device is configured to trigger a communication session for providing remote programming of the medical device when a session request is sent from the HCP remote device to the RMS through the CUI. [Haubrich at Para. 0031 teaches a centralized programming instrument (hereinafter “CPI;” the user computer of Heckerman) in communication with a host server (the server of Heckerman), which is then in communication with an EMD/IMD (the medical device(s) of Heckerman). Haubrich at Para. 0031 teaches that the CPI is an internet-enabled computer system. Hubrich at Para. 0031, 0040 teaches that a clinician initiates a remote programming session at the CPI (a session request), which one having skill in the art would understand as being performed using the display of the CPI (i.e., “through the CUI”). The Examiner notes that “for providing” is an intended use of the communications session and is not required to occur; however, Haubrich at Para. 0031 has been cited for completeness.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the data collection and AI analysis system of Heckerman to engage in remote programming of an IMD using a provider computer system as taught by Haubrich, with the motivation of providing a safe, secure programming of devices at a remote location (see Haubrich at Para. 0024)
REGARDING CLAIM 2
Heckerman/Haubrich teaches the claimed system of Claim 1. Heckerman/Haubrich further teaches
wherein the AU module is configured to process data by
indexing data, [Heckerman at Para. 0039 teaches that the AI aggregates received data to discern patterns (interpreted as indexing).]
comparing data, [Heckerman at Para. 0061 teaches that correlations between data (comparison of data) is provided by the AI.]
creating an envelope for received data,
displaying data, and/or [Heckerman at Para. 0025, 0075 teaches that AI is used to draw conclusions and provide conclusions to users along with other data (interpreted as display of data).]
managing data reports. [Heckerman at Para. 0025, 0075 teaches that AI is used to draw conclusions and provide conclusions to users along with other data (interpreted as managing data reports, which is undefined).]
The Examiner notes that only one of the above steps is required to meet the claim.
REGARDING CLAIM 3
Heckerman/Haubrich teaches the claimed system of Claim 1. Heckerman/Haubrich further teaches
wherein the Al module is configured to cause the at least one communication module to
receive data imports from and send data exports to one or more data management systems data, [Heckerman at Fig. 1, Para. 0034, 0038, 0039 teaches that the AI receives data from the aggregation component (one or more data management systems, which are undefined) and sends the result of the data analysis to the aggregation component.]
REGARDING CLAIM 4
Heckerman/Haubrich teaches the claimed system of Claims 1 and 2. Heckerman/Haubrich further teaches
wherein the AU module is configured to manage data reports by
creating presentation objects, [Heckerman at Para. 0075 teaches that conclusions are reached by the AI and that this data is presented to the user, meaning the presented data was created. The presented data is interpreted as presentation objects, which is undefined by the Applicant.]
arranging presentation objects in a data report template, creating and storing a data report template,
executing of a presentation object or a data report template thereby creating an individual data report and/or
exporting data report templates for use in a remote device.
The Examiner notes that only one of the above steps is required to meet the claim.
REGARDING CLAIM 8
Heckerman/Haubrich teaches the claimed system of Claim 1. Heckerman/Haubrich further teaches
wherein the at least one HCP remote device comprises a software subscription module configured to use Al. [Heckerman at Para. 0049, 0051, 0058 teaches that the system, which uses AI, can be implemented as a subscription service accessed by a consumer (patient) or provider device. The subscription service is interpreted as a module on the device, as is known in the art. Again, the Examiner notes that there is no functionality ascribed to the software subscription module; it does nothing functionally in the claim.]
REGARDING CLAIM(S) 9
Claim(s) 9 is/are analogous to Claim(s) 1, thus Claim(s) 9 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
REGARDING CLAIM(S) 10-12
Claim(s) 10-12 is/are analogous to Claim(s) 2-4, respectively, thus Claim(s) 10-12 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2-4.
REGARDING CLAIM(S) 15
Claim(s) 15 is/are analogous to Claim(s) 1, thus Claim(s) 15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
Heckerman at Para. 0078 further teaches that the system can be embodied in a computer-readable medium.
Claim(s) 5 and 13 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Heckerman et al. (U.S. Pre-Grant Patent Publication No. 2007/0112598) in view of Haubrich et al. (U.S. Pre-Grant Patent Publication No. 2005/0283198) in view of Knickerbocker et al. (U.S. Pre-Grant Patent Publication No. 2020/0199235).
REGARDING CLAIM 5
Heckerman/Haubrich teaches the claimed system of Claim 1. Heckerman/Haubrich further teaches
wherein the AI module is configured to provide services of the search engine […]. [Heckerman at Para. 0068, 0069, 0071 teaches that a health and/or wellness inquiry received (a search) and an inference is provided. Para. 0055, 0075 teaches that the conclusion are provided by the AI.]
Heckerman/Haubrich may not explicitly teach
by serving and ranking search results after receiving a search query.
Knickerbocker at Para. 0052 teaches that it was known in the art of computerized healthcare, at the time of filing, to rank search query results and display the ranked results
by serving and ranking of search results after receiving a search query. [Knickerbocker at Para. 0052 teaches determining and displaying a ranked list of answers to a patient based on analysis of a question (the query of Heckerman).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the data collection and AI analysis system of Heckerman having the remote programming of an IMD using a provider computer system of Haubrich to rank search query results and display the ranked results as taught by Knickerbocker, with the motivation of reducing costs and time requirements which improves patient data access (see Knickerbocker at Para. 0004).
REGARDING CLAIM(S) 13
Claim(s) 13 is/are analogous to Claim(s) 5, thus Claim(s) 13 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 5.
Claim(s) 6 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Heckerman et al. (U.S. Pre-Grant Patent Publication No. 2007/0112598) in view of Haubrich et al. (U.S. Pre-Grant Patent Publication No. 2005/0283198) in view of Morris et al. (U.S. Pre-Grant Patent Publication No. 2021/0118547).
REGARDING CLAIM 6
Heckerman/Haubrich teaches the claimed remote monitoring server (RMS) configured to be used in a system of Claim 1. Heckerman/Haubrich may not explicitly teach
wherein the AI module is configured to provide Al submodules for use in the at least one HCP remote device.
Morris at Para. 0042, 0086, 0088 teaches that it was known in the art of computerized healthcare, at the time of filing, to download to a patient device AI models that interacts with a server in a client configuration
wherein the AI module is configured to provide Al submodules for use in the at least one HCP remote device. [Morris at Para. 0042, 0086, 0088 teaches that a patient computing device downloads (is provided) AI models (AI submodules, which are undefined) for patient care that interacts with the server in a client configuration. The Examiner notes that for use in the at least one HCP remote device is an intended use of the AI submodules, which is not required to occur.]
The Examiner notes that the AI submodules are not recited to perform any function in the claim. Should the Applicant amend the claim to recite that the submodules perform functions, an inquiry as to whether written description as to how they perform their functions will be warranted.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the data collection and AI analysis system of Heckerman having the remote programming of an IMD using a provider computer system of Haubrich to download to a device AI models that interacts with a server in a client configuration as taught by Morris, with the motivation of improving monitoring of patient health conditions (see Morris at Para. 0046).
Alternatively, and assuming that “for use in the at least one HCP remote device” is functional, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the provision of AI models (submodules) to a device with teaching of Heckerman since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the HCP device of Heckerman as the location to which the AI models are provided for the patient device of Morris. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Response to Arguments
Claim Objections
Regarding the objection(s) to Claims 3, 5, 8, and 13, the Applicant has amended the claims to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the software per se rejection of Claim 14, the Applicant has cancelled the claim rendering the rejection moot.
Regarding the “non-transitory” rejection of Claim 15, the Applicant has amended the claim to recite that the “computer-readable data carrier” is “non-volatile” memory; however, the memory may still be transitory and thus the rejection is maintained. The Examiner suggests reciting that the memory is “non-transitory.”
Regarding the subject matter eligibility rejection of Claims 1-15, Applicant has cancelled claims 7 and 14 rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
[T]he claims further prescribe operational constraints requiring these component parts to interact with each other in a novel way to produce a technical result that is a technological improvement to systems in this technical field.
Regarding (a), the Examiner respectfully disagrees. Initially, the examiner notes that the interaction of the additional elements is not novel as demonstrated by the prior art rejection. The Background section of applicant’s disclosure also indicates that medical devices, provider devices (i.e., HCP), and web-servers (i.e., RMS) are all known in the art. See Published Application Para. 0003, 0004, 0010. However, this is a moot point because the interactions alluded to by the Applicant are the abstract idea. And, there is no discussion in the Specification that the arrangement of additional elements is non-routine and/or non-conventional and thus this argument is mere conjecture on the part of the Applicant. There is also no physical improvement to the technological environment to which the claim(s) is confined (the RMS).
For instance, the system requires the HCP remote device to trigger a communication session for providing remote programming of the medical device when a session request is sent from the HCP remote device to the RMS. This addresses the problems plagued by existing systems [cited to Spec. Para. 0012.]
Regarding (b), the Examiner respectfully disagrees. Requesting access to a device is part of the abstract idea and thus cannot provide the improvement. The additional element of an HCP is a location from which data is received and generally links the claimed invention to a particular technological environment or field of use. Generally linking cannot provide a practical application or significantly more. Published application Para. 0012 does not describe a technical problem caused by the technological environment to which the claim(s) is confined (the RMS). The RMS did not cause the problem(s) described in that paragraph.
First, the claims are clearly directed to a physical system of interacting component parts, as opposed to the alleged abstract idea of managing personal behavior. Second, requiring the HCP remote device to trigger a communication session for providing remote programming of the medical device when a session request is sent from the HCP remote device to the RMS (see Applicant's published application ¶ [0052]), amounts to an integration of any alleged abstract idea into a practical application.
Regarding (c), the Examiner respectfully disagrees. Taking these arguments in turn, the claim is directed to an abstract idea performed on a generic computer. The recited addition elements generally link the claim to a particular technological environment or field of use. That the claim contains “a physical system of interacting component parts” does not negate this finding. Regarding the second argument, it is unclear what practical application this feature might fall under. There is no physical improvement to the RMS. There is no improvement to the HCP. There is no technologic problem that the claims are solving. The argued feature is merely the RMS receiving data from a particular location. Of special note, nothing ever comes of this request, it is just received.
Rejection under 35 U.S.C. § 112
Regarding the written description rejection of Claims 1-15, Applicant has cancelled claims 7 and 14 rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
For instance, the Specification adequately describes the AI model's architecture in conjunction with the AI process of transforming input data through the AI module so as to generate the claimed resulting output. Development and use of AI models, in general, are well known and thus specific disclosure of various AI techniques involved and the requisite hardware and software environment is not necessary.
The Examiner respectfully disagrees. There is no written description as to how the AI module performs these tasks as detailed in the basis of rejection. This indicates that the Applicant was not in possession of the invention at the time of filing. The argument that “[d]evelopment and use of AI models, in general, are well known and thus specific disclosure of various AI techniques involved and the requisite hardware and software environment is not necessary” is an enablement argument. The Examiner has no doubt that a person having skill in the art could figure out a way to program a computer to perform some sort of the noted task (an enablement rejection); however, Applicant has not described how the particular tasks are performed with respect to their invention and thus a written description – possession rejection has been given. The basis of rejection is maintained.
Regarding the indefiniteness of Claims 3-5, 7, and 9-15, Applicant has amended the claims to overcome the bases of rejection.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1-15, Applicant has cancelled claims 7 and 14 rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments; however, the arguments are moot given the new grounds of rejection as necessitated by amendment.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Webb et al. (U.S. Pre-Grant Patent Publication No. 2002/0123673) which discloses the and IMD remote programming system.
Bevan et al. (U.S. Pre-Grant Patent Publication No. 2010/0125174) which discloses a GUI that supports remote interrogation of an IMD.
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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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683