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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Response to Amendment
Amendment received on 07/07/2026 is acknowledged and entered. Claim 3 has been canceled. Claims 1 and 13 have been amended. Claims 1-2 and 4-20 are currently pending in the application.
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 1-2 and 4-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandum of August 4, 2025.
Step 1
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. ____ (2014).
The broadest reasonable interpretation of claim 1 encompasses a computer system (e.g., hardware such as a processor and memory) that implements the recited functions. If assuming that the system comprises a device or set of devices, then the system is directed to a machine, which is a statutory category of invention.
Claim 13 is directed to a statutory category, because a series of steps for routing patient data satisfies the requirements of a process (a series of acts).
(Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Step 2A – Prong 1
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of routing patient data associated with a medical device to a device data translator. The claim recites:
13. A computer implemented method, comprising:
utilizing one or more processors that, when executing specific program instructions, perform:
receiving patient data, the patient data comprising physiological data and at least one corresponding unique device identifier (ID) associated with a first medical device, wherein the first medical device is configured to acquire the physiological data from a patient;
determining whether the first medical device is assigned to a first regional system from within n regional systems, wherein n is at least two; and
in response to determining that the first medical device is assigned to the first regional system,
comparing the unique ID to a global device index associated with the n regional systems to determine a medical device type or a type of medical data to be processed;
determining whether the unique ID is associated with a first DDT associated with the first regional system or a second DDT associated with the first regional system, wherein the first DDT is configured to process data from a first type of medical device and the second DDT is configured to process data from a second type of medical device that is different from the first type of medical device; and
routing patient data associated with the first medical device to the first DDT or the second DDT that is associated with the unique ID.
The limitations of receiving physiological data and unique device ID; determining whether the first device is assigned to a first regional system; comparing the ID to a global index; determining whether the unique ID is associated with a first or a second DDT; and routing patient data to the first or the second DDT, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity but for the recitation of generic computer components. (Note: Examiner’s language (e.g. “receiving physiological data and unique device ID;” etc.) is an abbreviated reference to the detailed claim steps and is not an oversimplification of the claim language; the Examiner employing such shortcuts (that refer to more specific steps) when attempting to explain the rejection). That is, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or certain methods of organizing human activity processes, and the mere nominal recitation of a generic network appliance (e.g. an interface for inputting or outputting data, or generic network-based storage devices and displays) does not take the claim limitation out of the mental processes and/or certain methods of organizing human activity grouping.
Specifically, the utilizing statistical tools to process data and to output the estimated values - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
As per the use of the artificial intelligence or machine-learning (AI/ML) as recited in claim 20, said recitation does not make the claim patent eligible, because said tools are utilized merely for data gathering and comparing, and are not utilized in express manipulation and control of functional aspects and/or hardware components/equipment of real-world processes and systems using output of AI models (e.g., manufacturing processes and equipment, medical treatments, communications processes and systems, logistics systems and hardware, interactive smart phone apps, etc.).
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025), wherein the court noted that "iterative training," a claimed feature, was inherent to all machine learning models and thus did not confer eligibility. Additionally, applying machine learning to event scheduling, an activity predating computers, did not transform the abstract idea into a patent-eligible invention. See, also, Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)—tailoring sales information presented to a user based on, e.g., user data and time data; TLI Communications LLC v. AV Automotive LLC 823 F.3d 607, 118 U.S.P.Q.2d 1744 (Fed. Cir. 2016) - recording, transmitting and administering digital images; DataTreasury Corp. v. Fidelity National Information Services 669 Fed. Appx. 572 (Fed. Cir. 2016) - remote image capture with centralized processing and storage; RecogniCorp LLC v. Nintendo Co. 855 F.3d 1322, 122 U.S.P.Q.2d 1377 (Fed Cir. 2017) - encoding and decoding image data; Intellectual Ventures I LLC v. Erie Indemnity Co. 850 F.3d 1315, 121 U.S.P.Q.2d 1928 (Fed Cir. 2017) - mobile interface for accessing remotely stored documents, and retrieving data from a database using an index of XML tags and metafiles.
As per receiving, storing and outputting data limitations, it has been held that “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018) (citation omitted); see also In re Jobin, 811 F. App’x 633, 637 (Fed. Cir. 2020) (claims to collecting, organizing, grouping, and storing data using techniques such as conducting a survey or crowdsourcing recited a method of organizing human activity, which is a hallmark of abstract ideas).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 13, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that this judicial exception is not integrated into a practical application, because there are no meaningful limitations that transform the exception into a patent eligible application. In particular, the claim recites additional elements – using a processor to perform the recited steps. However, the processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Thus, while the additional elements have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
Furthermore, there is no improvement in the claim, - no improvement to the medical devices themselves; to improvement to computer architecture; no new networking protocol; no improvement in database technology, and routing is based on conventional identifiers and lookup tables. Thus, the recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, comparing, storing and outputting data.
Regarding the use of AI/ML techniques, said steps are nothing more than an attempt to recycle preexisting artificial intelligence or machine-learning technologies to apply for a particular computing application. There are no improvements in said AI/ML techniques, such as advances in the field of computer science itself, or designing a new neural network, and there is no controlling of a technological process using the outcome of said AI/ML operations. Thus, the use of a trained machine learning models does not integrate the abstract idea of limitation into a practical application, because, under its broadest reasonable interpretation when read in light of the specification, the recited steps encompasses mental processes practically performed in the human mind by observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. Similar to Recentive Analytics, the claim recites conventional machine learning models without specific improvements to the technology itself. The court noted that "iterative training," a claimed feature, was inherent to all machine learning models and thus did not confer eligibility. Claim 13 does not articulate "how" a technological improvement is achieved.
As per receiving, storing and/or outputting data limitations, these recitations amount to mere data gathering and/or outputting, is insignificant post-solution or extra-solution component and represents nominal recitation of technology. Insignificant "post-solution” or “extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. However, “(c) Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility”. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)). Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230.
Thus, claim 13 as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself). "[T]he relevant question is whether the claims here do more than simply instruct the practitioner to implement the abstract idea on a generic computer." Alice, 573 U.S. at 225. They do not.
The Examiner determined that 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 element of using a processor to perform the recited steps amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be construed at the highest level of generality. The Specification discloses:
[0032] The term “programmer” as used herein refers to any and all electronic devices utilized by a clinician, technician, physician, caregiver, nurse, doctor, or the like. The electronic device can be a central processing unit (CPU), desktop computer, laptop computer, tablet, smartphone, smart watch, monitor console, etc. The electronic device includes one or more processors configured to follow
instructions, and a transceiver configured to communicate over a network, in a cloud, wirelessly, over the air, through a wire, or the like. In one example, the clinician programing device communicates with a patient device and at least one system, e.g., healthcare system and data processing system.
Based on the Specification, the invention utilizes existing, conventional sensors, communication networks, and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity. Specifically, regarding the recited functions, MPEP 2106.05(d)(II) defines said functions as routine and conventional, or as insignificant extra-solution activity:
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) (“The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.”); collecting and comparing known information in Classen 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
iii. Electronic recordkeeping, Alice Corp., 134 S. Ct. at 2359, 110 USPQ2d at 1984 (creating and maintaining “shadow accounts”); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Regarding the use of AI/ML technologies, said steps are nothing more than an attempt to recycle preexisting AI/ML; there are no improvements in said AI/ML techniques, such as advances in the field of computer science itself, or designing a new neural network, and there is no controlling of a technological process using the outcome of said AI/ML operations. Claim 13 neither specifies a specific technical purpose for which the method is used, nor the claim defines a specific technical implementation of the method, nor the claimed method is particularly adapted for that implementation in that its design is motivated by technical considerations of the internal functioning of the computer. Said AI/ML algorithms and computations are done inside of a computer, and do not have a real-world impact and are not tied to the functionality of the computer. Further, there is no evidence that the invention lies in the training phase or execution phase or both; said AI/ML recitation represents merely conventionally applying an existing model to an existing data from publicly accessible databases, with the result being not technological, but purely entrepreneurial.
Thus, the background of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here).
Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces, as asserted, by receiving information from an external source of data. The receiving of data from an external source over a network, such as via the Internet, can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular asserted inventive technology for performing those functions. They are therefore directed to an abstract idea. As such, the additional elements, considered individually and in combination with the other claim elements, do not make the claim as a whole significantly more than the abstract idea itself.
Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 13 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 13 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, storing, comparing and transmitting data—see the Specification as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. “However, it is not apparent how appellant’s programmed digital computer can produce any synergistic result. Instead, the computer will simply do the job it is instructed to do. Where is there any surprising or unexpected result? The unlikelihood of any such result is merely one more reason why patents should not be granted in situations where the only novelty is in the programming of general purpose digital computers”. See Sakraida v. Ag. Pro, Inc., 425 U.S. 273 [ 96 S.Ct. 1532, 47 L.Ed.2d 784], 189 USPQ 449 (1976) and A P Tea Co. V. Supermarket Corp., 340 U.S. 147 [ 71 S.Ct. 127, 95 L.Ed. 162], 87 USPQ 303 (1950).
Moreover, there is no transformation recited in the claim as understood in view of 35 USC 101. The recited steps merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “A computer implemented method” recitations, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 13 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claims 14-20 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 14-20 each merely add further details of the abstract steps recited in claim 13 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claims 14-20 are also directed to non-statutory subject matter.
Because Applicant’s apparatus claims 1-2 and 4-12 add nothing of substance to the underlying abstract idea, they too are patent ineligi-ble under §101.
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, 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.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Holschbach et al. (US 2010/0114993 A1) (IDS of 9/13/2024) in view of Bardot (US 2022/0215948 A1) (IDS of 9/13/2024).
Claims 1 and 13. Holschbach et al. (Holschbach) discloses a healthcare system, the system comprising: memory configured to store program instructions; a first device data translator (DDT) and a second DDT, the first DDT configured to process data from a first type of medical device, the second DDT configured to process data from a second type of medical device that is different from the first type of medical device; Fig. 2; [0022], and one or more processors that, when executing the program instructions, are configured to:
receive patient data, the patient data comprising physiological data (and at least one corresponding unique device identifier (ID) associated with a first medical device) wherein the first medical device is configured to acquire the physiological data from a patient; Fig. 2; [0022],
While Holschbach discloses identifying a particular/unique manufacturer/device so that data can be transmitted in native format, Holschbach does not explicitly teach the use of unique device identifier (ID) associated with said particular/unique manufacturer/device, which is disclosed in Bardot. [0055]; [0106]; [0406]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Holschbach to include the recited limitations, as disclosed in Bardot, because it would advantageously allow to perform medical apparatuses (MA) group-level analyses, assists with relay of confidential information to only appropriate recipient devices, or allows network data system (NDS) to only relay applications that are approved under regulatory requirements in the particular group/area (or comply with requirements of IEs that own/operate MA groups), as specifically stated in Bardot.
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Holschbach to include the recited limitations, as disclosed in Bardot, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson's-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Holschbach, as modified by Bardot, further teaches:
determining whether the first medical device is assigned to a first regional system from within n regional systems, wherein n is at least two; Bardot; [0127]; [0353]; [0392]; [0405]
in response to determining that the first medical device is assigned to the first regional system, Bardot; [0127]; [0353]; [0392]
comparing the unique ID to a global device index associated with the n regional systems to determine a medical device type or a type of medical data to be processed; Bardot; (Bardot discloses MA and NDS level in which MA-D and NDS-AD derived from different IE MAGs are identified by various data “tagging” methods, such as identifying the source of MA at one or more levels (such as a specific device level, device type level, device functional status level, an IE level, or other levels such as a regional or national level). In aspects, engines, units, or functions applied/performed at the device level, system level, or both, also identify other levels of association that can define MAGs to which each MA belongs (e.g., a hospital treatment group, a hospital, a hospital system, a town, a metropolitan area, a county, a state/province, etc.) [0127]; [0353]; [0392]; [0405], thereby at least suggesting said global device index and, therefore, suggesting the recited limitations.
determining whether the unique ID is associated with a first DDT associated with the first regional system or a second DDT associated with the first regional system, wherein the first DDT is configured to process data from a first type of medical device and the second DDT is configured to process data from a second type of medical device that is different from the first type of medical device; Holschbach; Fig. 2; [0022]; Bardot; [0055]; [0106]; [0406], and
route patient data associated with the first medical device to the first DDT or the second DDT that is associated with the unique ID. Fig. 2; [0022]; Bardot; [0055]; [0106]; [0406].
Claim 2. The system of claim 1, wherein the unique ID includes at least one of i) a model number, ii) a serial number, iii) a unique key, iv) a second unique key, v) medical device type, or vi) type of medical data to be processed. Same rationale as applied to claim 1.
Claim 4. The system of claim 1, further comprising: wherein the memory is configured to store a routing cache based on device model numbers or type of medical data to be processed, the routing cache configured to identify which of the first or second DDT processes the associated patient data; and wherein the one or more processors are configured to compare the unique ID to the routing cache. Same rationale as applied to claim 1.
Claims 5 and 14-15. The system of claim 1, wherein the one or more processors are configured to route the patient data to a queue configured to feed an associated one of the first DDT or the second DDT, wherein the queue is configured to temporarily store the patient data for the associated DDT. Bardot; [0241]; [0275]; [0283]; [0446]. Same rationale as applied to claims 1 and 13.
Claim 6 and 16-17. The system of claim 1, wherein the one or more processors are further configured to: route processed data from the first DDT to one of a report generator or a file generator; and route processed data from the second DDT to one of the report generator or the file generator. Same rationale as applied to claims 1 and 13.
Claim 7. The system of claim 1, wherein the one or more processors are further configured to route processed data from the first and second DDTs to a queue configured to feed an associated one of a report generator or a file generator, wherein the queue is configured to temporarily store the processed data for the associated one of the report generator or the file generator. Bardot; [0241]; [0275]; [0283]; [0446]. Same rationale as applied to claims 1 and 13.
Claim 8. The system of claim 1, wherein the one or more processors are further configured to: generate an electronic health record (EHR) based on processed data output by the first and second DDTs; and output the EHR. Holschbach; [0004]; [0013]; Bardot; [0245]; [0246]; [0309]; [0332]. Same rationale as applied to claim 1.
Claim 9. The system of claim 1, further comprising a third DDT configured to process data from a third type of medical device that is different from the first and second types of medical devices. Holschbach discloses a plurality unique DDT from different manufactures, each DDT receives data in a native format. Same rationale as applied to claim 1.
Claim 10. The system of claim 1, further comprising a third DDT configured to process data from the first type of medical device. Same rationale as applied to claim 1.
Claim 11. The system of claim 1, further comprising a transmitter, wherein the one or more processors are configured to generate a report or a file based on processed data output by at least one of the first and second DDTs, the transmitter configured to transmit the report or file to i) a predetermined electronic address associated a medical device that is associated with the processed data, ii) a location associated with a type of data in the report or file, or iii) a location associated with a type of medical device that is associated with the processed data. Holschbach; [0004]; [0013]; Bardot; [0245]; [0246]; [0309]; [0332]. Same rationale as applied to claim 1.
Claims 12. The system of claim 1, further comprising a second memory configured to store processed patient data and electronic health records, wherein the second memory is configured to be accessed by a clinician application. Bardot; [0245]; [0246]; [0309]; [0332]. Same rationale as applied to claims 1.
Claim 18. The method of claim 13, further comprising: responsive to receiving the patient data, storing the patient data in a memory; responsive to the DDTs outputting processed data, storing the processed data in a second memory; and responsive to receiving a request for either the patient data or the processed data, transmitting the patient data or the processed data to a location remote from the one or more processors. Holschbach; [0004]; [0013]; Bardot; [0245]; [0246]; [0309]; [0332]. Same rationale as applied to claim 13.
Claim 19. The method of claim 13, further comprising adding a third DDT configured to receive the patient data, the patient data comprising the unique ID associated with the third DDT, wherein the third DDT is configured to process data that is different from the first and second types of medical devices. Holschbach discloses a plurality unique DDT from different manufactures, each DDT receives data in a native format. Bardot; [0241]; [0275]; [0283]; [0446]. Same rationale as applied to claim 13.
Claim 20. The method of claim 13, further comprising: responsive to the DDTs outputting processed data, storing the processed data in a memory; processing at least a portion of the processed data in the memory based on at least one of artificial intelligence, machine learning, and data analytics; and responsive to storing the further processed data in the memory: i) output, to a location remote from the one or more processors, recommendations for setting changes associated with one of the first or second medical devices, ii) output, to a location remote from the one or more processors, instructions to implement programmed settings associated with one of the first or second medical devices, iii) output, to a location remote from the one or more processors, instructions to automatically remotely program one of the first or second medical devices, or iv) output, to a location remote from the one or more processors, an alert. Holschbach; [0004]; [0013]; Bardot; [0245]; [0246]; [0309]; [0332]. Same rationale as applied to claim 13.
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
Applicant argues that claims 1 and 13 are not directed to abstract or mental processes, because the recited limitations are not practically performed in the human mind.
The Examiner respectfully disagrees, and maintains that the recited limitations is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity but for the recitation of generic computer components. Said mental processes, as recited in the claims, remain
unpatentable even when automated to reduce the burden on the user of what once could have been done with pen and paper. CyberSource Corp. at 1375 (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalkv. Benson, [409 U.S. 63 (1972)].”). In Content Extraction & Transmission LLC v. Wells Fargo Bank, National Ass’n, Nos. 13-1588,-1589, 14-1112, -1687 (Fed. Cir. Dec. 23, 2014) the Federal Circuit affirmed that such limitations (parsing and extracting data) were generally directed to “the abstract idea of 1) collecting data, 2) recognizing certain data within the collected data set, and 3) storing that recognized data in a memory.” The Court explained that ”[t]he concept of data collection, recognition, and storage is undisputedly well-known,” and noted that “humans have always performed these functions.” Id. The Court then rejected CET’s argument that the claims were patent eligible because they required hardware to perform functions that humans cannot, such as processing and recognizing the stream of bits output by the scanner. Comparing the asserted claims to “the computer-implemented claims in Alice,” the Court concluded that the claims were “drawn to the basic concept of data recognition and storage,” even though they recited a scanner. Id. at 8. Mental processes, as recited in the claims, remain unpatentable even when automated to reduce the burden on the user of what once could have been done with pen and paper. CyberSource Corp. at 1375 (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalkv. Benson, [409 U.S. 63 (1972)].”).
Further, even accepting Applicant’s argument regarding the hardware used, it also is insufficient, without more, to establish patent eligibility that “[t]he human mind is not equipped to execute the claimed method”. Again, although “a method that can be performed by human thought alone is merely an abstract idea and is not patent-eligible under § 101,” CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1373 (Fed. Cir. 2011), it does not automatically follow, that methods requiring physical components, i.e., methods that arguably cannot be performed entirely in the human mind, are, therefore, not directed to abstract ideas. See, e.g., In re TLI Commc'ns LLC Patent Litig., 823 F.3d 607, 611 (Fed. Cir. 2016) (“[N]ot every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry.”); FairWarning IP, LLC v. Latric Sys., Inc., 839 F.3d 1089, 1098 (Fed. Cir. 2016) (“[T]he inability for the human mind to perform each claim step does not alone confer patentability.”).
Applicant argues that the DDTs are NOT generic computer components, because each DDT can be configured to process data from a particular medical device (e.g. defibrillator data, arterial sensor data, etc.).
The Examiner respectfully disagrees and maintain his previous assessment, that in view of the Specification [0032], the invention utilizes existing, conventional sensors, transceivers, communication networks, and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity.
Applicant argues that that the claims present a practical application – solving problems associated with receiving data from multiple types of medical devices, from multiple vendors, from different geographical regions, and routing and processing the data efficiently.
The Examiner respectfully disagrees and maintains that there are no meaningful limitations that transform the exception into a patent eligible application. The processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, - their collective functions merely provide conventional computer implementation. None of the additional elements "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
Furthermore, there is no improvement in the claim, - no improvement to the medical devices themselves; to improvement to computer architecture; no new networking protocol; no improvement in database technology, and routing is based on conventional identifiers and lookup tables. Thus, the recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, comparing, storing and outputting data. The claims as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Regarding inventive concept argument, the Examiner notes that the Federal Circuit, in accordance with Alice, has “repeatedly recognized the absence of a genuine dispute as to eligibility” where claims have been defended as involving an inventive concept based “merely on the idea of using existing computers or the Internet to carry out conventional processes, with no alteration of computer functionality.” Berkheimer, 890 F.3d at 1373 (Moore, J., concurring). The Specification of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here).
Also, the claim does not involve a non-conventional and non-generic arrangement of known, conventional pieces, as asserted, by receiving information from an external source of data. The receiving of data from an external source over a network, such as via the Internet, can fairly be characterized as insignificant extra-solution activity that does not receive patentable weight. See Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d sub nom Bilski v. Kappos, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Similar to Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014): “And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.”
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. And looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Applicant further argues that Holschbach already discloses “specific patient’s data”, and there is no need to apply Bardot for the “unique device identifier”.
The Examiner notes that said “specific patient’s data” may or may not include said “unique device identifier”, and this is the reason why Bardot was used in the rejection. Further, regardless whether Holschbach teaches or suggest said limitation, MPEP (2141, 2144, 2145) allows examiners to use multiple references for claim limitations in 103 rejections including alternative teachings or cumulative evidence for the same feature. Thus Obviousness does not require limiting to exactly one reference per limitation. The question is whether a POSITA would be motivated to combine teachings with a reasonable expectation of success. KSR, 550 U.S. at, 82 USPQ2d at 1395. And the Examiner provided articulated reasoning and motivation.
Applicant further argues that Holschbach does not teach relaying confidential information to appropriate devices.
The Examiner notes Holschbach teaches that at Fig. 2; [0022], and Bardot teaches that at [0055]; [0106]; [0406].
Applicant argues that Holschbach does not teach or disclose Applicant's claimed first regional system associated with a first geographical region and second regional system associated with a second geographical region. Instead, Holschbach discloses a single system for processing data.
The Examiner respectfully notes that Bardot discloses various specific device levels, such as a regional or national level. In aspects, engines, units, or functions applied/performed at the device level, system level, or both, also identify other levels of association that can define MAGs to which each MA belongs (e.g., a hospital treatment group, a hospital, a hospital system, a town, a metropolitan area, a county, a state/province, etc.), and each level has policies, protocols, encryption, etc, requirements [0127]; [0353]; [0392]; [0405], thereby disclosing or suggesting the recited limitations.
Remaining Applicant’s arguments essentially repeat the arguments presented above; therefore, the responses presented by the Examiner above are equally applicable to the remaining Applicant’s arguments.
Citations of pertinent art
Joseph Drozda et al. “Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD)” JAMIA Open, 5(2), 2022, https://doi.org/10.1093/jamiaopen/ooac035, pp. 1-11, - discloses Unique Device Identifiers (UDI); distributed regional databases; multiple institutions; common data model; device lookup; linking device identity to processing; interoperability across healthcare systems without exposing patient-identifying information.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Igor Borissov whose telephone number is 571-272-6801. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Kambiz Abdi can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 7/24/2026
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