DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on May 12, 2026. As directed by the amendment: claim(s) 1, 3, 5 and 19 have been amended, claim(s) 2 have been cancelled, and no claim(s) have been added. Thus, claims 1 and 3-20 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pgs. 6-9, filed May 12, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1 and 3-20 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1 and 3-20 has been withdrawn.
Applicant's arguments filed May 12, 2026 have been fully considered but they are not persuasive. The applicant principally argues that the amended claims now recite more than an abstract idea because the “additional elements” in the amended claims are integrated significantly into a practical application and because a special algorithm is recited, thus providing “significantly more” than any abstract idea. The examiner respectfully disagrees. The amended limitations in the independent claims are directed (1) to additional elements that generic sensors and (2) are an observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) as detailed in the 35 U.S.C. 101 rejection below. Specifically, determining the risk of the PPH based on the collected patient data from the electrical potential sensors appears to be merely utilizing additional elements for mere data gathering which is insignificant extra-solution activity. Additionally, the applicant details that a special algorithm is recited; however, the claims fail to detail a special algorithm that provides “significantly more” than any abstract idea. The citations to the instant specification [0103]-[0105] that details a technical improvement appears to be merely insignificant extra-solution activity and selecting a particular data source or type of data to be manipulated. In order to determine whether the additional elements add more than insignificant extra-solution activity to the judicial exception there are three considerations per MPEP 2106.05(g). However, what the applicant has described appears to fall into an example that courts have found to be insignificant extra-solution activity, more specifically:
Mere Data Gathering:
i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989);
Selecting a particular data source or type of data to be manipulated:
iii. Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);
This appears to fall into this category of selecting a particular data source that fits a particular need to be manipulated and presented to the user. Furthermore, the additional elements fail to effect a particular treatment or prophylaxis for a disease or medical condition. Per the MPEP 2106.04(d)(2), Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. However, these claims merely display/output the determined risk of the PPH based on the sensor data captured. Therefore, the examiner is not convinced and the 35 U.S.C. 101 rejection of the claims is maintained and the newly added limitations and claims addressed below.
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 and 3-20 are rejected under 35 U.S.C. 101 because the claimed invention details a system and method (Step 1) directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1 and 3-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1 and 3-20 recites at least one step or instruction for determining risk of postpartum hemorrhage to a patient, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). Accordingly, each of Claims 1 and 3-20 recites an abstract idea.
Specifically, Claim 1 recites
A monitoring system configured for determining risk of postpartum haemorrhage to a patient, the monitoring system comprising:
an electrical potential sensor for collecting patient data; (additional element)
at least one electrode for attaching the electrical potential sensor to a body of the patient; and (additional element)
a communications module for transmitting the patient data to a detection controller, (additional element)
wherein the detection controller (additional element) is configured to determine the risk of the postpartum haemorrhage (PPH) based on the patient data. (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
wherein the electrical potential sensor is a sensor selected from the set of sensors consisting of an electromyography (EMG) sensor, an electrohepatogram (EHG) sensor and electrocardiogram (ECG) sensor, (additional element)
wherein the detection controller is configured to determine the risk of the postpartum haemorrhage (PPH) based on if uterine activity or a contraction metric has increased in the collected patient data from the electrical potential sensor, and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
wherein the detection controller is configured to output a PPH likelihood indication, based on the determined risk of the PPH, that enables clinicians to take suitable steps for effective treatment of the PPH. (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Additionally, Claim 19 recites
A method of detecting a high risk of postpartum haemorrhage in a patient, the method comprising:
collecting patient data from a monitor having a plurality of medical electrode members attached to a body of a patient, the patient data being collected from at least one sensor type, wherein the at least one sensor type includes a sensor selected from the set of sensors consisting of an electromyography (EMG) sensor, an electrohepatogram (EHG) sensor and electrocardiogram (ECG) sensor, (additional element)
estimating a likelihood of the postpartum haemorrhage by processing the patient data from the at least one sensor type to form a plurality of descriptors for data points in the patient data, the plurality of descriptors being processed by a machine learning model to estimate the likelihood; and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
displaying the determined postpartum haemorrhage risk to an operator (additional element),
wherein the estimating of the likelihood of the postpartum haemorrhage (PPH) is based on if uterine activity or a contraction metric has increased in the collected patient data from the electrical potential sensor, and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
wherein the displaying of the determined PPH risk enables clinicians to take suitable steps for effective treatment of the PPH. (additional element)
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 19 (and their respective dependent Claims 3-18 and 20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 19), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: electrical potential sensor, electrode, detection controller, communications module and display are generic and used for data gathering adding insignificant extra-solution activity to the judicial exception in independent Claims 1 and 19 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 19 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., external programming device or computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 19 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 19 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1 and 3-20 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: electrical potential sensor, electrode, detection controller, communications module and display. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, [0007]-[0014] details that the electrical potential sensor could consist of an electromyography (EMG) sensor, an electrohepatogram (EHG) sensor and electrocardiogram (ECG) sensor which are generic and commercially available items. Per Applicant’s specification, [0055]-[0063] details the use of electrodes (electrode assembly) wherein the electrodes could be a flexible sheet made of an insulating material (i.e. cloth plastic, closed cell foam and etc.) that may include various shapes and attachments that c. Further, in applicant’s specification [0049]-[0050] and [0068] cites the detection controller as being generic and commercially available items such as a notebook computer, tablet, server or PDA. Per Applicant’s specification, [0050]-[0052] details a communications module that can utilize a variety of communication networks such as LAN, WAN, ethernet, mobile telephone networks wired and wireless which details the generality of what can be utilized. Per applicant’s specification [0047], the display can be a visual display such as a monitor or a printer or could also be a tablet, smartphone or other computing device which are generic and commercially available.
Accordingly, in light of Applicant’s specification, the claimed term computer is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for computers. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 and 19 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of Claims 1 and 3-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 19 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1 and 3-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 and 3-20 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough August 5, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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