DETAILED ACTION
This office action is responsive to the amendment filed 6/20/2025. Claims 1-20 remain pending and under prosecution.
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 .
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-20 are all within at least one of the four categories.
The independent claims 1, 8, 17and recite:
Claim 1 –
obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information;
determine a first biomarker from a first data stream and a second biomarker from a second data stream;
determine that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity;
determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker, the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream,
determine an inclusion criteria and an exclusion criteria based on at least one of a patient characteristic;
determine a weighted distribution based on the procedural step information;
determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and the weighted distribution;
determine one or more cooperative measures related to the physiologic function or the morbidity using the first biomarker and the second biomarker, and the conflict resolution;
generate a directional measure to indicate a contextual summary of the one or more cooperative measures; and;
Claim 8 –
obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information;
determining a first biomarker from a first data stream and a second biomarker from a second data stream;
determining that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity;
determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker, wherein the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream,
determine an inclusion criteria and an exclusion criteria based on at least one of a patient characteristic;
determine a weighted distribution based on the procedural step information;
determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and the weighted distribution;
determining a contextual summary related to the physiologic function or the morbidity using the first biomarker and the second biomarker and the conflict resolution;
generating a directional measure to indicate a trend associated with the contextual summary; and;
Claim 17 –
obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information;
determine a first biomarker from a first data stream and a second biomarker from a second data stream;
determine that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity;
determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker, wherein the first result is associated with a first reliability of the first data stream, wherein the second result is associated with a second reliability of the second data stream, and wherein the conflict is determined based on a first weight for the first biomarker and a second weight for the second biomarker;
determine an inclusion criteria and an exclusion criteria based on at least one of a patient characteristic;
determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, the first weight for the first biomarker, and the second weight for the second biomarker;
determine a cooperative measure related to the physiologic function or the morbidity using the first biomarker, the second biomarker, a first weight for the first biomarker, a second weight for the second biomarker, and the conflict resolution.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of determining and generating, can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
With respect to the pending claims, for example, a doctor can perform the claimed step of determining by mentally obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information and mentally selecting a first and second biomarker from the respective data streams. The doctor can then determine that they are interlinked to a physiologic function or a morbidity based on their prior experience and knowledge. A doctor can then mentally determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker, the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream, wherein reliability can be determined mentally as well. A doctor can also mentally determine a weighted distribution based on the procedural step information, mentally determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and the weighted distribution, and mentally determine one or more cooperative measures related to the physiologic function or the morbidity using the first biomarker and the second biomarker, and the conflict resolution, as the claims do not specify how said concepts must be determined in a way that ties the abstract ideas to a particular machine.
Thus, the claims can be readily interpreted as being a mere application of a mental process on a generic, routine, and conventional computer.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. For example, dependent claim 2 recite steps (e.g. determining) that can be performed in the mind. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in claims 1-20 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for determining and generating merely invoke a computer as a tool.
• The data-gathering step and the data-output step (sending) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for _determining and generating.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a contextual summary of cooperative measures of the physiological function or morbidity.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine 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 not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for determining generating. The claims do not apply the obtained contextual summary of the one or more cooperative measures to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: a memory, and a processor; and a display to indicate a directional measure to indicate a contextual summary of one or more cooperative measures.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant' s Background in the specification;
• Applicant' s specification (para [00241] and Fig. 3) which discloses that the processor and memory comprise generic computer components that are configured to perform the generic computer functions (e.g. determining and generating) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to Claims 1, 8, and 17, the recitation of determining one or more cooperative measures related to the physiologic function or the morbidity using the first biomarker, the second biomarker, and the conflict resolution” does not appear supported by the disclosure. Paragraphs 0005, 0432, 0450, 0459, 0502, 0503, 0504, 0506, 0535, and abstract (published specification) expressly disclose determining cooperative measures but do not have any mention of taking into account the conflict resolution or how it is incorporated into the cooperative measure. Given the length of the specification, applicant is requested to show where this limitation is supported, if it exists. It is noted that applicant did not provide any citations for support of the amendments in the filing dated 4/12/2024.
Claims 2-7, 9-16, and 18-20 are rejected by virtue of dependency on Claims 1, 8, and 17.
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 14 and 16 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.
In regard to Claim 14, the recitation of “a first weight” and “a second weight” are indefinite because it unclear if said first and second weight are the same different from that introduced in Claim 8. In the rejection that follows, it is assumed that both refer to the same. However, clarification is requested.
In regard to Claim 16, the recitation of “surgical procedure” is indefinite because it is unclear if said surgical procedure refers to the same or different as that in Claim 8. Furthermore, the recitation of “surgical procedure” in Claims 1 and 8 is related to the conflict resolution, whereas the recitation of “surgical procedure” in Claims 5 and 16 is related to determining the context. It is unclear that the same surgical procedure is used in both instances. Clarification is requested.
Claim Objections
Claims 11 and 16 are objected to because of the following informalities:
In regard to Claim 11, the preamble should read “The method of claim 8.”
In regard to Claim 16, the limitation should recite “determining” a context, and “a” third biomarker.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton IV et al. (US 20190201124).
In regard to Claim 1, Shelton IV et al teaches a computing system for contextually transforming data into an aggregated display feed, the computing system comprising:
a memory 250, best seen in Figure 10 (0251), and
a processor 244, best seen in Figure 10 (0251), the processor configured to:
obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information – “diseased tissue that is being operated on” (0355);
determine a first biomarker from a first data stream (primary effects in Figure 21A) – biomarkers that determine medical device parameters such as activation speed (0355) and
a second biomarker from a second data stream (secondary effects in Figure 21A) – evidence of disease (“a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on” – 0355);
determine that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity – patient condition is determined by appropriate activation rate of the medical device (0355);
determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker – “a first set of primary contextual information relevant to a medical device may include managing the speed of a medical device that leads to an instruction to not exceed an initial activation rate of 10 mm/sec. However, a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on, and leads to an instruction to not exceed an initial activation rate of 8 mm/sec” (0355),
wherein the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream – conflict resulting from valid vs invalid data (“the inability to authenticate the data or the ability to determine that the data is inauthentic” – 0343, also 0342-352);
determine an inclusion criteria, i.e. situational awareness of past conflict (“situational awareness may be utilized to refer back to past instances of such conflict” – 0355) and
an exclusion criteria, i.e. tertiary set of contextual information excludes 20% of speed (“a tertiary set of contextual information about patient parameters may lead to an instruction to decrease speed by an additional 20% – 0357) based on at least one of a patient characteristic “due to a diseased tissue state” (0357);
determine a weighted distribution, i.e. hierarchy, based on the procedural step information – “The hierarchical conflict resolution scheme 24505 may include logic to create a combined set of instructions that satisfies all combined constraints. In this case, the resolved primary set of contextual information therefore leads to an instruction to have the initial activation rate of the medical instrument not exceed 8 mm/sec” (0355);
determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and the weighted distribution – e.g. initial activation rate of the medical instrument not exceed 8 mm/sec (0355) – the system takes all the factors into account to determine a conflict resolution, it is noted that the example in paragraph 0355 is only one specific example but it is clear that the specification of this invention is meant to take into account an unlimited number of necessary factors into the conflict resolution given the interconnections between all the device hubs and the processor, best seen in Figure 9-11 and 21 (0355-0359);
determine one or more cooperative measures related to the physiologic function or the morbidity using the first biomarker and the second biomarker and the conflict resolution by suggesting next steps after the conflict resolution – “The situational awareness system also improves surgeons' efficiency in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 in the surgical theater according to the specific context of the procedure” (0295) – also see 112(a) rejection above;
generate a directional measure to indicate a contextual summary of the one or more cooperative measures – specific recommendation (0272), request for more information (0279), “verify the steps being taken by the medical personnel” (0297), or provide “prompts (e.g., via a display screen) that may be pertinent for the particular procedural step” (0297); and
send the directional measure to a display 215, 217, 237, best seen in Figure 9-10 – “display screens that display data or recommendations provided by the cloud 7004” (0272); “the cloud 7004 can transmit a request (e.g. a push message) through the hub application servers for additional data from corresponding surgical instruments 7012. The push message can result in a notification displayed on the corresponding hubs 7006 for requesting supporting or additional data” (0279); “provide data or prompts (e.g., via a display screen) that may be pertinent for the particular procedural step” (0297), also see 0291.
2. The computing system of claim 1, wherein the processor 244 is further configured to determine a context for the first biomarker and the second biomarker, wherein the context is associated with a patient, and wherein the processor is configured to determine that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on the context – patient condition is determined by appropriate activation rate of the medical device through “layered contextual information that may be accounted for” (0355).
3. The computing system of claim 1, wherein the processor 244 is further configured to classify the first biomarker and the second biomarker, and wherein the processor is configured to determine that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on at one or more of a classification of the first biomarker and a classification of the second biomarker – e.g. classification based on tissue type (0295), data validity (0342-0352), or hierarchy (0355).
4. The computing system of claim 1, wherein the processor 244 is further configured to: determine a context that is associated with a patient, and prioritize one or more of the first biomarker and the second biomarker based on the context that is associated with the patient due to the hierarchal logic/rules (0355).
5. The computing system of claim 1, wherein the processor 244 is further configured to: determine a context for a patient, wherein the context is determined based on one or more of a third biomarker, patient data, or surgical procedure information, e.g. “diseased tissue that is being operated on” (0355).
6. The computing system of claim 1, wherein the processor 244 is further configured to determine that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on one or more of a context for the patient or the conflict resolution – patient condition is determined by appropriate activation rate of the medical device through “layered contextual information that may be accounted for” (0355).
7. The computing system of claim 1, wherein the conflict resolution for the conflict is further based one or more of a detected anomaly, a predefined recovery, and a predefined analysis – higher tier contextual information “In other cases where instructions directly contradict one another, contextual information at a higher tier in the hierarchy may take precedence” (0355).
In regard to Claim 8, Shelton IV et al teaches a method performed by a computing system for contextually transforming data into an aggregated display feed, the method comprising:
obtaining surgical procedure information, wherein the surgical procedure information comprises procedural step information – “diseased tissue that is being operated on” (0355);
determining a first biomarker from a first data stream (primary effects in Figure 21A) – biomarkers that determine medical device parameters such as activation speed (0355) and
a second biomarker from a second data stream (secondary effects in Figure 21A) – evidence of disease (“a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on” – 0355);
determining that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity – patient condition is determined by appropriate activation rate of the medical device (0355);
determining a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker – “a first set of primary contextual information relevant to a medical device may include managing the speed of a medical device that leads to an instruction to not exceed an initial activation rate of 10 mm/sec. However, a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on, and leads to an instruction to not exceed an initial activation rate of 8 mm/sec” (0355),
wherein the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream – conflict resulting from valid vs invalid data (“the inability to authenticate the data or the ability to determine that the data is inauthentic” – 0343, also 0342-352);
determining e an inclusion criteria, i.e. situational awareness of past conflict (“situational awareness may be utilized to refer back to past instances of such conflict” – 0355) and
an exclusion criteria, i.e. tertiary set of contextual information excludes 20% of speed (“a tertiary set of contextual information about patient parameters may lead to an instruction to decrease speed by an additional 20%” – 0357) based on at least one of a patient characteristic “due to a diseased tissue state” (0357);
determining a weighted distribution, i.e. hierarchy, based on the procedural step information – “The hierarchical conflict resolution scheme 24505 may include logic to create a combined set of instructions that satisfies all combined constraints. In this case, the resolved primary set of contextual information therefore leads to an instruction to have the initial activation rate of the medical instrument not exceed 8 mm/sec” (0355);
determining a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and the weighted distribution – e.g. initial activation rate of the medical instrument not exceed 8 mm/sec (0355) – the system takes all the factors into account to determine a conflict resolution, it is noted that the example in paragraph 0355 is only one specific example but it is clear that the specification of this invention is meant to take into account an unlimited number of necessary factors into the conflict resolution given the interconnections between all the device hubs and the processor, best seen in Figure 9-11 and 21 (0355-0359);
determining a contextual summary related to the physiologic function or the morbidity using the first biomarker and the second biomarker and the conflict resolution by suggesting next steps after the conflict resolution – “The situational awareness system also improves surgeons' efficiency in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 in the surgical theater according to the specific context of the procedure” (0295) – also see 112(a) rejection above;
generate a directional measure to indicate a trend associated with the contextual summary as broadly as has been claimed – specific recommendation (0272), request for more information (0279), “verify the steps being taken by the medical personnel” (0297), or provide “prompts (e.g., via a display screen) that may be pertinent for the particular procedural step” (0297); and
send the directional measure to a user – “display screens that display data or recommendations provided by the cloud 7004” (0272); “the cloud 7004 can transmit a request (e.g. a push message) through the hub application servers for additional data from corresponding surgical instruments 7012. The push message can result in a notification displayed on the corresponding hubs 7006 for requesting supporting or additional data” (0279); “provide data or prompts (e.g., via a display screen) that may be pertinent for the particular procedural step” (0297), also see 0291.
9. The method of claim 8, wherein the context is associated with a patient, and wherein the method further comprises determining a context associated with the patient for the first biomarker and the second biomarker and determining that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on the context – patient condition is determined by appropriate activation rate of the medical device through “layered contextual information that may be accounted for” (0355).
10. The method of claim 8, wherein the method further comprises classifying the first biomarker and the second biomarker, and wherein determining that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity is based on one or more of a classification of the first biomarker and a classification of the second biomarker – e.g. classification based on tissue type (0295), data validity (0342-0352), or hierarchy (0355).
11. The computing system of claim 8, wherein the method further comprises: determining a context, wherein the context is associated with a patient, and prioritizing one or more of the first biomarker and the second biomarker based on the context that is associated with the patient due to the hierarchal logic/rules (0355).
12. The method of claim 8, wherein the method further comprises generating the aggregated display feed for a patient that comprises the directional measure – “The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization systems 208. The hub display also may display data received from devices connected to the modular control tower in conjunction with images and overlaid images” (0248).
13. The method of claim 8, the method further comprises determining the weighted distribution to apply to one or more of the first data stream and the second data stream, and wherein determining that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity is based on the weighted distribution due to the hierarchal logic/rules that inform the patient condition is determined by appropriate activation rate of the medical device (0355).
14. The method of claim 8, wherein the method further comprises: determining a first weight to be applied to the first data stream due to the hierarchal logic/rules (0355); determining a second weight to be applied to the second data stream due to the hierarchal logic/rules (0355); and determining that the first biomarker has priority over the second biomarker based on the first weight and the second weight due to the hierarchal logic/rules (0355).
15. The method of claim 14, wherein the method further comprises determining that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on the determination that the first biomarker has priority over the second biomarker due to the hierarchal logic/rules that inform the patient condition is determined by appropriate activation rate of the medical device (0355).
16. The method of claim 14, wherein the method further comprises determining a context for a patient, wherein the context is determined based on one or more of a third biomarker, patient data, or surgical procedure information, e.g. “diseased tissue that is being operated on” (0355), wherein the conflict resolution for the conflict is further based on the context for the patient through “layered contextual information that may be accounted for” (0355).
In regard to Claim 17, Shelton IV et al teaches a computing system for contextually transforming data into an aggregated display feed, the computing system comprising:
a memory 250, best seen in Figure 10 (0251), and
a processor 244, best seen in Figure 10 (0251), the processor configured to:
obtain surgical procedure information, wherein the surgical procedure information comprises procedural step information – “diseased tissue that is being operated on” (0355);
determine a first biomarker from a first data stream (primary effects in Figure 21A) – biomarkers that determine medical device parameters such as activation speed (0355) and
a second biomarker from a second data stream (secondary effects in Figure 21A) – evidence of disease (“a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on” – 0355);
determine that the first biomarker and the second biomarker are interlinked to a physiologic function or a morbidity – patient condition is determined by appropriate activation rate of the medical device (0355);
determine a conflict between a first result indicated by the first biomarker and a second result indicated by the second biomarker – “a first set of primary contextual information relevant to a medical device may include managing the speed of a medical device that leads to an instruction to not exceed an initial activation rate of 10 mm/sec. However, a second set of primary contextual information may be entered that relates to diseased tissue that is being operated on, and leads to an instruction to not exceed an initial activation rate of 8 mm/sec” (0355),
wherein the first result is associated with a first reliability of the first data stream, and wherein the second result is associated with a second reliability of the second data stream – conflict resulting from valid vs invalid data (“the inability to authenticate the data or the ability to determine that the data is inauthentic” – 0343, also 0342-352),
wherein the conflict is determined based on first weight for the first biomarker and a second weight for the second biomarker, i.e. tiered hierarchy – “In other cases where instructions directly contradict one another, contextual information at a higher tier in the hierarchy may take precedence” (0355);
determine an inclusion criteria, i.e. situational awareness of past conflict (“situational awareness may be utilized to refer back to past instances of such conflict” – 0355) and
an exclusion criteria, i.e. tertiary set of contextual information excludes 20% of speed (“a tertiary set of contextual information about patient parameters may lead to an instruction to decrease speed by an additional 20% – 0357) based on at least one of a patient characteristic “due to a diseased tissue state” (0357);
determine a conflict resolution for the conflict based on surgical procedure information, the first reliability of the first data stream, the second reliability of the second data stream, the inclusion criteria, the exclusion criteria, and first weight of the first biomarker, and the second weight of the second biomarker – e.g. initial activation rate of the medical instrument not exceed 8 mm/sec (0355) – the system takes all the factors into account to determine a conflict resolution, it is noted that the example in paragraph 0355 is only one specific example but it is clear that the specification of this invention is meant to take into account an unlimited number of necessary factors into the conflict resolution given the interconnections between all the device hubs and the processor, best seen in Figure 9-11 and 21 (0355-0359);
determine a cooperative measure related to the physiologic function or the morbidity using the first biomarker and the second biomarker, their weights, and the conflict resolution by suggesting next steps after the conflict resolution – “The situational awareness system also improves surgeons' efficiency in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 in the surgical theater according to the specific context of the procedure” (0295) – also see 112(a) rejection above;
send the cooperative measure to a display 215, 217, 237, best seen in Figure 9-10 – “display screens that display data or recommendations provided by the cloud 7004” (0272); “the cloud 7004 can transmit a request (e.g. a push message) through the hub application servers for additional data from corresponding surgical instruments 7012. The push message can result in a notification displayed on the corresponding hubs 7006 for requesting supporting or additional data” (0279); also see 0291 and 0297.
18. The computing system of claim 17, wherein the processor 244 is further configured to determine that the first biomarker has a priority over the second biomarker based on the first weight and the second weight due to the hierarchal logic/rules (0355).
19. The computing system of claim 18, wherein the processor 244 is further configured to determine that the first biomarker and the second biomarker are interlinked to the physiologic function or the morbidity based on the determination that the first biomarker has priority over the second biomarker due to the hierarchal logic/rules that inform the patient condition is determined by appropriate activation rate of the medical device (0355).
20. The computing system of claim 18, wherein the processor 244 is further configured to generate a directional measure to indicate a trend associated with the cooperative measure as broadly as has been claimed – specific recommendation (0272), request for more information (0279), “verify the steps being taken by the medical personnel” (0297), or provide “prompts (e.g., via a display screen) that may be pertinent for the particular procedural step” (0297).
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Sheldon IV et al (US Pub No. 20190201124) has been set forth above.
Regarding the 101 rejection, applicant contends that the 101 rejection is remedied with the new amendment. This is not found persuasive because the addition of the limitations reciting additional “determining” limitations merely add additional abstract ideas (mental concepts) that do not amount to significantly more (there is no specialized structure nor practical application of said abstract ideas). The abstract ideas have merely been elaborated upon. Therefore, the 101 rejection is maintained.
Regarding the 112(a) rejection of Claims 1, 8, and 17 for lacking support for the recitation of determining “one or more cooperative measures related to the physiologic function or the morbidity using the first biomarker, the second biomarker, and the conflict resolution,” applicant’s arguments have been fully considered but are not persuasive. Applicant states that “Paragraph [00408] describes that aggregation and contextual transformation may include conflict resolution. Paragraph [00473] describes that “data aggregation may include determining one or more cooperative measures related to physiologic function and/or morbidity” and may involve generating “a directional measure to indicate a contextual summary of one of the one or more cooperative measures.” Also, FIG. 13 illustrates that conflict resolution 29409 is involved in outputting the aggregated data stream” (Remarks pg. 9).
It is noted that applicant’s cited paragraphs do not appear to correspond to the text listed above. Additionally, applicant’s arguments again appear to be more broad than the limitation recited in the claims. The disclosure that “aggregation” may include conflict resolution and that data aggregation may include cooperative measures does not necessarily provide support for the relationship of “cooperative measures being related to the conflict resolution.” Therefore, the rejection is maintained.
New 112 rejections are set forth above.
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.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791