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 .
Status of the Application
Claims 1-18 have been examined in this application. This communication is the first action on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/083,197 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
For instance, claim 1 of the current application recites:
1. A cardiovascular health management system, the system comprising:
a communication module configured to receive biometric information of a user including information about a heartbeat; and
a processor configured to generate cardiovascular monitoring and prediction information based on the received biometric information, wherein the processor is configured to:
analyze the biometric information and record a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the user when the abnormal pulse is detected;
provide a user terminal with a number of times that the abnormal pulse occurs during a predetermined time; and
provide a phased notification to the user terminal depending on the number of times that the abnormal pulse occurs.
And claim 1 of the reference application recites:
1. A cardiovascular health management system for monitoring and predicting cardiovascular condition of a patient in real time in a smart hospital environment, the system comprising:
a sensor module configured to collect biometric information from the patient;
a communication module configured to receive the biometric information of the patient including information about a heartbeat; and
a processor configured to: analyze the biometric information and record a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the patient when the abnormal pulse is detected;
provide a medical staff terminal with a number of times that the abnormal pulse occurs during a predetermined time; and
provide a phased notification to the medical staff terminal depending on the number of times that the abnormal pulse occurs.
Claim 10 of the current application recites:
10. A control method performed by a processor of a cardiovascular health management system, the method comprising:
receiving biometric information of a user including information about a heartbeat;
analyzing the biometric information and recording a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the user when the abnormal pulse is detected;
providing a user terminal with a number of times that the abnormal pulse occurs during a predetermined time; and
providing a phased notification to the user terminal depending on the number of times that the abnormal pulse occurs.
And claim 10 of the reference application recites:
10. A control method performed by a processor of a cardiovascular health management system for monitoring and predicting cardiovascular condition of a patient in real time in a smart hospital environment, the method comprising:
collecting, through a sensor module, biometric information of a patient;
receiving, from the sensor module, the biometric information including information about a heartbeat of the patient;
analyzing the biometric information and recording a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the patient when the abnormal pulse is detected;
providing a medical staff terminal with a number of times that the abnormal pulse occurs during a predetermined time; and
providing a phased notification to the medical staff terminal depending on the number of times that the abnormal pulse occurs.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-18 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 Memorandums of August 4, 2025 and December 5, 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 10 is directed to a statutory category, because a series of recited steps 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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of analyzing biometric information and outputting results. The claim recites:
10. A control method performed by a processor of a cardiovascular health management system, the method comprising:
receiving biometric information of a user including information about a heartbeat;
analyzing the biometric information and recording a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the user when the abnormal pulse is detected;
providing a user terminal with a number of times that the abnormal pulse occurs during a predetermined time; and
providing a phased notification to the user terminal depending on the number of times that the abnormal pulse occurs.
The limitations of receiving biometric information; analyzing the information; recording data; outputting the data, and outputting a notification regarding the data, 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, such as following rules or instructions, but for the recitation of generic computer components. (Note: Examiner’s language (e.g. “receiving biometric information”; “analyzing the information”; 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). Here, the claimed subject matter is directed to the abstract idea of manipulating existing information (e.g., “biometric information”) to generate additional information (e.g., “a notification”). See id. 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 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).
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 10, 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 steps of receiving biometric information; analyzing the information; recording data; outputting the data, and outputting a notification regarding the data. 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)).
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, storing, comparing and outputting data.
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.
Therefore, claim 10 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).
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 steps of receiving biometric information; analyzing the information; recording data; outputting the data, and outputting a notification regarding the data 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. Based on the Specification, the invention utilizes 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).
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 1 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 10 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. The claim does not recite unconventional data structures, improved signal processing, machine-learning innovations, reduced processor usage, improved sensor operations, or any technical solution to a technical problem. Even when considering the ordered combination as a whole, the recited elements are routine: biometric monitoring; abnormal heartbeat detection; event logging; occurrence counting; threshold-based alerts, and user notification. These are standard, conventional features in wearable health systems and cardiac monitoring platforms.
Applicant, also, 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). Again, 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).
Furthermore, 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 control method performed by a processor” 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 10 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 11-18 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 11-18 each merely add further details of the abstract steps recited in claim 10 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 11-18 are also directed to non-statutory subject matter.
Because Applicant’s apparatus claims 1-9 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 1-6, 8, 10-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Valys et al. (US 2024/0099593 A1) in view of Wiesel (US 7,020,514 B1).
Claims 1 and 10. Valys et al. (Valys) cardiovascular health management system, the system comprising:
a communication module configured to receive biometric information of a user including information about a heartbeat; [0023], and a processor configured to generate cardiovascular monitoring and prediction information based on the received biometric information, [0025]; [0028] wherein the processor is configured to:
analyze the biometric information and record a time at which an abnormal pulse is detected, heartbeat information at a corresponding time, and state information of the user when the abnormal pulse is detected; [0023]-[0026];
provide a user terminal with a number of times that the abnormal pulse occurs during a predetermined time; [0025]; [0029]-[0031], and
provide a phased notification to the user terminal depending on the number of times that the abnormal pulse occurs. [0061]; [0025];
Further, Wiesel discloses providing a phased notification to the user terminal depending on the number of times that the abnormal pulse occurs. C. 6, L. 45-55.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Valys to include the recited limitations, as disclosed in Wiesel, because it would advantageously allow to detect irregular pulse rhythms during a time period and store this information so that comparisons may be made with the pulse rate rhythms at later times, as specifically stated in Wiesel. C. 4, L. 36-39.
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 Valys to include the recited limitations, as disclosed in Wiesel, 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).
Claims 2 and 11. The system of claim 1, wherein the processor is configured to: determine a state of the user by analyzing the biometric information, wherein the state of the user is determined to be one of a resting state, an activity state, and a sleep state; when the number of the abnormal pulse occurring during the predetermined time is greater than or equal to a predetermined count and the state of the user is the resting state or the activity state, provide a notification through the user terminal; and when the number of the abnormal pulse occurring during the predetermined time is greater than or equal to the predetermined count and the state of the user is the sleep state, provide a notification to the user terminal and a guardian terminal of the user. Valys, [0004]; [0034]; [0040]; [0044]; [0048]; [0096]-[0098]
Claims 3 and 12. The system of claim 2, wherein the processor is configured to: receive a resting heart rate of the user, which is measured while the user is at rest, and an activity heart rate of the user measured while the user is moving; set an activity reference heart rate based on the measured resting heart rate and the measured activity heart rate; and analyze the biometric information of the user and determine the state of the user as the activity state when a heart rate is greater than or equal to the activity reference heart rate. Valys, [0025]; [0029]-[0031]; [0034]; [0044]; [0048]; [0096]-[0098]
Claims 4 and 13. The system of claim 1, wherein the processor is configured to: analyze the biometric information and detect an abnormal pulse when the heartbeat is irregular; and analyze the biometric information and provide a notification to the user terminal when a heart rate is greater than or equal to a predetermined tachycardia reference heart rate and the heart rate is less than or equal to a predetermined bradycardia reference heart rate, and wherein when the heart rate is greater than or equal to the predetermined tachycardia reference heart rate but the user is in an activity state, and the heart rate is less than or equal to the predetermined bradycardia reference heart rate but the user is in a sleep state, not provide a notification to the user terminal. Valys, [0090]; [0034]; [0040]; [0044]; [0048]; [0096]-[0098]
Claims 5 and 14. The system of claim 1, wherein the processor is configured to: derive a condition that the abnormal pulse occurs in the user, based on the time at which the abnormal pulse is detected, the heartbeat information at the corresponding time, and the state information of the user; analyze the biometric information and provide the user terminal with a notification requiring attention when the condition is satisfied; determine whether the abnormal pulse is detected, by analyzing the biometric information after providing the notification, and update the condition when the abnormal pulse is not detected. Valys, [0023]-[0026]; [0029]-[0031]; [0040]; [0044]; [0048]; [0096]-[0098]
Claims 6 and 15. The system of claim 1, wherein the processor is configured to: provide the user terminal with a phased notification with respect to the abnormal pulse for a plurality of respective predetermined counts, wherein content included in a notification is changed as a number of the abnormal pulse increases; provide the user terminal with a notification for requesting an acknowledgement that a corresponding notification is acknowledged, together with a notification for recommending a rest when the number of the abnormal pulse occurring during the predetermined time is greater than or equal to a highest count among predetermined counts; and provide a notification to a guardian terminal of the user when not receiving an acknowledgement signal that a corresponding notification is acknowledged, from the user terminal. Valys, [0025]; [0029]-[0031], [0061]; Wiesel, C. 4, L. 36-39. Same rationale as applied to claims 1 and 10.
Claims 8 and 17. The system of claim 6, wherein the biometric information of the user further includes at least one of blood pressure information, blood sugar information, body fat percentage information, cholesterol level information, age information, weight information, respiratory rate information, and exercise information as additional information, wherein the processor is configured to: calculate a cardiovascular health index based on the number of times that the abnormal pulse occurs during the predetermined time, and the additional information; and adjust the highest count among the predetermined counts to be low as the cardiovascular health index decreases. Same rationale as applied to claims 1, 6, 10 and 15.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Valys in view of Wiesel and further in view of Burnette et al. (US 2023/0414180 A1).
Claims 7 and 16. The system of claim 6, wherein the biometric information of the user further includes information about an electrode temperature, and wherein the processor is configured to: provide the user terminal with the notification for requesting the acknowledgement that a corresponding notification is acknowledged, together with the notification for recommending the rest when the electrode temperature is out of a predetermined temperature range even though the number of times that the abnormal pulse occurring during the predetermined time is greater than or equal to a count less than the highest count among the predetermined counts; and provide a notification to a guardian terminal of the user when not receiving an acknowledgement signal that a corresponding notification is acknowledged, from the user terminal.
Regarding claims 7 and 16, Valys does not specifically teach monitoring electrode temperature to be within a predetermined range, which is disclosed in Burnette et al. (Burnette): [0177] Method 16: An embodiment of Method 1, wherein the change in the signal comprises a fluctuation caused by temperature drift of an analyte sensor for measuring the analyte concentration in the host. [0178] Method 17: An embodiment of Method 16, further comprising performing temperature calibration to compensate for variations in an offset current added to the signal indicative of the analyte concentration in the host due to temperature. [0179] Method 18: An embodiment of Method 16, wherein the temperature drift of the analyte sensor is determined based upon an impedance measurement of a reference electrode of the analyte sensor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Valys to include the recited limitations, as disclosed in Burnette, 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).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Valys in view of Wiesel and further in view of Kidron et al. (US 2014/0377725 A1).
Claims 9 and 18. The system of claim 1, wherein the biometric information of the user includes cardiovascular scale information about the user, basic information of the user, and diet information of the user, wherein the cardiovascular scale information includes at least one of whether an abnormal pulse occurs, blood pressure information, blood sugar information, body fat percentage information, and cholesterol level information, and the basic information includes at least one of age information, weight information, respiratory rate information, exercise information, body temperature information, information about smoking, and information about drinking, and wherein the processor is configured to: analyze a cardiovascular health state of the user based on the received cardiovascular scale information and the basic information, and generate and provide customized health information of the user based on the cardiovascular health state; when the cardiovascular health state of the user is analyzed as being out of a normal scope, calculate information about a calorie consumed by the user based on the diet information; calculate a target intake calorie for adjusting the cardiovascular scale information of the user to a normal range based on a correlation between the consumed calorie and the cardiovascular scale information; and generate customized diet information corresponding to the calculated target intake calorie as the customized health information.
Regarding claims 9 and 18, Valys does not specifically teach generating and providing customized health recommendations based on diet information, which is disclosed in Kidron et al. (Kidron). [0080]; Cl. 1
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Valys to include the recited limitations, as disclosed in Kidron, 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).
Citations of pertinent art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Catherine J. O’Shea et. al. “Remote Monitoring Alert Burden An Analysis of Transmission in >26,000 Patients”, discloses remote monitoring of patients with cardiac implantable electronic cardioverter-defibrillators, including receiving patient data, analyzing the data, and upon determining an abnormality generating alerts.
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 5/31/2026
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