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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites “an INR level measurement device”, “a first device comprising a display”, and “a second device” but it also is also performing any of the methods of claim 1. These devices are included in the method of claim 1 so it is unclear if the devices recited in claim 13 are supposed to be different devices than the one in claim 1. There can potentially be an antecedent issue as claim 1 also “a” device for each one of the above devices. Examiner is interpreting that each device corresponds to the each recitation in claim 1, meaning that each “an INR level measurement device” refers to the same device, “a first device comprising a display” refers to the same device, and “a second device” refers to the same device.
Additionally, claims 13 and 14 recite “to perform any of the methods of claim 1” where claim 1 is a singular method. Claims 13-14 have been deemed unclear, and accordingly, indefinite. Examiner interprets this limitation to mean “to perform the method of claim 1”
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-12 are drawn to a method, claim 13 is drawn to a system, and claim 14 is drawn to a medium, each of which is within the four statutory categories. Claims 1-14 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method for monitoring international normalized ratio (INR) level of a patient, comprising:
a) at a first device associated with the patient:
1) receiving, from b) an INR level measurement device at a first location, first INR data associated with the INR level of the patient;
2) receiving, from the patient, an input indicating warfarin dosage associated with the patient;
3) transmitting the first INR data and the warfarin dosage to c) a second device;
4) receiving a warfarin dosage recommendation from the second device, wherein the warfarin dosage recommendation is determined based on the transmitted first INR data and the transmitted warfarin dosage;
5) receiving second INR data associated with the INR level of the patient, wherein the second INR data is collected at a second location different the first location; and
6) presenting, on a1) a display of the device associated with the patient, one or more user interfaces comprising:
a first user interface element indicating the warfarin dosage recommendation,
a second user interface element indicating a wellness of the INR level of the patient, the wellness of the INR level of the patient determined based on one or more of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location, and
a third user interface element indicating a trend of the INR level of the patient, the trend determined based on a composite analysis of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location.
Claim 1 recites, in part, performing the steps of 1) receiving, from a first location, first INR data associated with the INR level of the patient, 2) receiving, from the patient, an input indicating warfarin dosage associated with the patient, 3) transmitting the first INR data and the warfarin dosage, 4) receiving a warfarin dosage recommendation, wherein the warfarin dosage recommendation is determined based on the transmitted first INR data and the transmitted warfarin dosage, 5) receiving second INR data associated with the INR level of the patient, wherein the second INR data is collected at a second location different the first location, and 6) presenting one or more user interfaces comprising: a first user interface element indicating the warfarin dosage recommendation, a second user interface element indicating a wellness of the INR level of the patient, the wellness of the INR level of the patient determined based on one or more of the first INR data received at the first location and the second INR data collected at the second location, and a third user interface element indicating a trend of the INR level of the patient, the trend determined based on a composite analysis of the first INR data received at the first location and the second INR data collected at the second location. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, an individual can determine and share trend data.
Depending claims 2-14 include all of the limitations of claim 1, and therefore likewise incorporate the above described abstract idea. Depending claims 2, 4-5, 7, and 9-11 add additional steps to the claims. Additionally, the limitations of depending claims 3, 8, and 12 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Claims 6-7 and 9 add additional elements which are further addressed in Prong Two. Thus, depending claims 2-14 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a first device associated with the patient comprising a1) a display, b) an INR level measurement device, c) a second device, d) wherein the first INR data is received via a wireless connection (from claim 6), e) a third device, different from the first device and the second device (from claim 7), and f) a machine learning model (from claim 9) to perform the claimed steps.
The a) first device associated with the patient comprising a1) a display in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that it amount to no more than mere instructions to apply the exception using a generic computer component (see: Applicant’s specification for a lack of discussion for anything but what may be considered as generic computing components for the first device, see MPEP 2106.05(f)).
Additionally, the b) an INR level measurement device, c) a second device, the limitation of d) wherein the first INR data is received via a wireless connection, and e) a third device, different from the first device and the second device in these steps adds insignificant extra-solution activity to the abstract idea which amounts to mere data gathering, see MPEP 2106.05(g).
Lastly, the f) machine learning model in these steps generally links the abstract idea to a particular technological environment or field of use (such as machine learning, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, 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. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a first device associated with the patient comprising a1) a display, b) an INR level measurement device, c) a second device, d) wherein the first INR data is received via a wireless connection, e) a third device, different from the first device and the second device, and f) a machine learning model to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity), a general linking to a particular technological field, and mere instructions to apply the exception using a generic computer component that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d), MPEP 2106.05(f), and MPEP 2106.05(h) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)); and
Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
The current invention indicates a trend utilizing a) a first device associated with the patient comprising a1) a display, thus this device is adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the b) INR level measurement device, c) second device, the limitation of d) wherein the first INR data is received via a wireless connection, and e) third device, different from the first device and the second device in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives measurement/recommendation data, and transmits the data to device over a network, for example the Internet.
Lastly, the f) machine learning model generally links the abstract idea to a particular technological environment or field of use. The following represent an example that courts have identified as generally linking the abstract idea to a particular technological environment (e.g. see MPEP 2106.05(h)): Limiting the abstract idea data to a machine learning model, because limiting application of the abstract idea to machine learning is simply an attempt to limit the use of the abstract idea to a particular technological environment, e.g. see Electric Power Group, LLC v. Alstom S.A.
Mere instructions to apply an exception using a generic computer component, a general linking to a particular technological field, or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-14 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0234674 to Wurster in view of U.S. 2021/0020294 to Bharmi et al. further in view of C.N. 111243704 to Yang.
As per claim 1, Wurster teaches a method for monitoring international normalized ratio (INR) level of a patient, comprising:
--at a first device associated with the patient (see: paragraph [0015] where there is a system (first device) which has access to a POS device (INR measurement device)):
--receiving, from an INR level measurement device at a first location, first INR data associated with the INR level of the patient; (see: paragraph [0016] and FIGS. 13-14 where there is a POS device which is used to measure the INR level associated with a patient at a clinic)
--receiving, from the patient, an input indicating warfarin dosage associated with the patient; (see: paragraph [0070] where there is reception of input from the patient indicating the warfarin dosage in the form of warfarin type and most recent warfarin dosage schedule)
--transmitting the first INR data and the warfarin dosage to a second device; (see: FIG. 13 and paragraphs [0078] – [0079] where there is transmission of the above data to the CoagClinic using a mathematical calculation)
--receiving a warfarin dosage recommendation from the second device, wherein the warfarin dosage recommendation is determined based on the transmitted first INR data and the transmitted warfarin dosage; (see: paragraphs [0078] – [0079] where the INR data and the warfarin data is used to determine a new warfarin dosage by a mathematical probability calculation)
--receiving second INR data associated with the INR level of the patient (see: paragraph [0070] where new INR data is being entered, and therefore second/new INR data is being received for the patient).
Wurster may not further, specifically teach:
1) --wherein the second INR data is collected at a second location different the first location; and
2) --presenting, on a display of the device associated with the patient, one or more user interfaces comprising:
2a) --a first user interface element indicating the warfarin dosage recommendation,
2b) --a second user interface element indicating a wellness of the INR level of the patient, the wellness of the INR level of the patient determined based on one or more of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location, and
2c) --a third user interface element indicating a trend of the INR level of the patient, the trend determined based on a composite analysis of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location.
Bharmi et al. teaches:
1) --wherein the second INR data is collected at a second location different the first location (see: paragraph [0153] where there is there is one or more core laboratories in which data can be collected/received from).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) wherein the second INR data is collected at a second location different the first location as taught by Bharmi et al. in the method as taught by Wurster with the motivation(s) of identifying the patient’s INR level to make adjustments in prescriptions to maintain the INR level at a prescribed level (see: paragraph [0349] of Bharmi et al.).
Yang teaches:
2) --presenting, on a display of the device associated with the patient, one or more user interfaces (see: page 8 where there is presentation of one or more interfaces) comprising:
2a) --a first user interface element indicating the warfarin dosage recommendation, (see: page 8 where there is presentation of an element which indicates a warfarin dosage recommendation)
2b) --a second user interface element indicating a wellness of the INR level of the patient, (see: page 4 where the INR is being displaying of a graph as part of a curve drawing) the wellness of the INR level of the patient determined based on one or more of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location, (see: page 4 where the INR levels are graphed. The levels being collected at different locations was taught above in the Bharmi et al. reference) and
2c) --a third user interface element indicating a trend of the INR level of the patient, (see: pages 4 and 8 where there is a curve trend being displayed to the user on a graph) the trend determined based on a composite analysis of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location (see: pages 4 and 8 where the curve is based on the INR levels collected. The levels being collected at different locations was taught above in the Bharmi et al. reference).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 2) present, on a display of the device associated with the patient, one or more user interfaces comprising: 2a) a first user interface element indicating the warfarin dosage recommendation, 2b) a second user interface element indicating a wellness of the INR level of the patient, the wellness of the INR level of the patient determined based on one or more of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location, and 2c) a third user interface element indicating a trend of the INR level of the patient, the trend determined based on a composite analysis of the first INR data received from the INR level measurement device at the first location and the second INR data collected at the second location as taught by Yang in the method as taught by Wurster and Bharmi et al. in combination with the motivation(s) of showing compliance of a patient taking medicine (see: page 4 of Yang).
As per claim 2, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Wurster further teaches receiving secondary data, wherein the warfarin dosage recommendation is determined further based on the secondary data (see: paragraphs [0070] and [0078] where there is INR goal data taken into account (secondary data), and the goal data is used to determine a new warfarin dosage by a mathematical probability calculation).
As per claim 3, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 2, see discussion of claim 2. Bharmi et al. further teaches wherein the secondary data comprises Virtual Health Record (VHR) (see: paragraphs [0188] – [0189] where there is virtual health record data of BGA Index data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 4, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Yang further teaches:
--in accordance with a determination that the INR level of the patient is below a target INR level, presenting, on the display, a first user interface element indicating that the INR level is below the target INR level; (see: page 4 where there is displaying when the INR is below a target level) and
--in accordance with a determination that the INR level of the patient is not below the target INR level, presenting, on the display, a second user interface element indicating that the INR level is not below the target INR level (see: page 4 where there is displaying when the INR exceeds a target level).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 5, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Yang further teaches presenting, on the display, a user interface element indicating a target INR level and a target time for reaching the target INR level, (see: page 4 where there is presentation of a target INR level and a target time to reach that INR level as time is being presented at the same time as the INR levels) wherein the target INR level and the target time are determined based on one or more of the INR level of the patient, the warfarin dosage, and the warfarin dosage recommendation (see: page 4 where the target INR level and the time are determined based on at least the warfarin dosage).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 6, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Bharmi et al. further teaches wherein the first INR data is received via a wireless connection (see: paragraphs [0128] and [0168] where there is wireless communication to receive data).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute wherein the first INR data is received via a wireless connection as taught by Bharmi et al. for the reception of data as disclosed by Wurster since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Wurster already teaches of receiving data therefore one could receive this data wirelessly and achieve predictable results of receiving data. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 7, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Bharmi et al. further teaches wherein the warfarin dosage recommendation is received by a third device, different from the first device and the second device (see: paragraph [0249] where there is a third device which receives the recommendation and this device is different than the other devices displayed in FIGS. 5A and 5B).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 8, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Bharmi et al. further teaches wherein the first INR data comprises clotting data of the patient, (see: paragraph [0028] where there is INR data comprising of clotting data/BGA) and the INR level of the patient is determined based on the clotting data of the patient (see: paragraphs [0028] and [0030] where the INR level is determined based on the blood clotting information (BC)).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 9, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Bharmi et al. further teaches inputting the first INR data and the warfarin dosage into a machine learning model (see: paragraphs [0016] and [0207] where there is a machine learning model which takes in all the inputted data).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute inputting the first INR data and the warfarin dosage into a machine learning model as taught by Bharmi et al. for the model as disclosed by Wurster since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Wurster already teaches of using a model with data to make a determination thus one can replace that model with a machine learning model and obtain predictable results of making a determination using model and data. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 10, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Wurster further teaches wherein the warfarin dosage recommendation is determined based on an input provided to the second device in response to the transmission of the first INR data and the warfarin dosage (see: paragraph [0079] where there is an equation which can be updated via the second device and then it can be rerun using the data in order to determine a new warfarin dosage as stated in paragraph [0078]).
As per claim 11, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Wurster further teaches wherein the warfarin dosage recommendation is determined by the second device (see: paragraphs [0078] – [0079] where the INR data and the warfarin data is used to determine a new warfarin dosage by a mathematical probability calculation).
As per claim 12, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Yang further teaches wherein the third user interface element further indicates a correlation between the INR level and secondary data (see: pages 4 and 8 where there is a curve trend being displayed to the user on a graph. The curve is based on the INR goal data/doctor’s recommended dose).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 13, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Wurster further teaches a system comprising:
--an INR level measurement device at a first location, (see: FIG. 13 where there is a POS device)
--a first device comprising a display, (see: paragraph [0043] where there is a display of a device)
--a second device, (see: paragraph [0078] where there is a second device which contains the software application of the system) and
--one or more processors, wherein the one or more processors are configured to perform any of the methods of claim 1 (see: paragraph [0015] where there is a computer).
As per claim 14, Wurster, Bharmi et al., and Yang in combination teaches the method of claim 1, see discussion of claim 1. Bharmi et al. further teaches a non-transitory computer-readable medium storing instructions that, when executed by one or more processors, cause the one or more processors to perform any of methods of claim 1 (see: paragraph [0372] where there is such a non-transitory medium).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
