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
Applicant’s Information Disclosure Statement did not include the below applied publication from one of the present inventors.
Drawings
Figures 10 and 11 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). See, e.g., US20260069367A1 and US20230355301A1 that include the same figures without any common inventors. In other words, if there are no common inventors, then any common material is not inventive because it is not the situation that one person thought of it and shared it with the others. Further, the technology depicted is well known. Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Specifically, A) the invention is directed to local monitoring and B) is not specific enough to what is being done here (e.g., use of an implantable medical device to request photographs of skin to determine heart failure)
The abstract of the disclosure is objected to because it does not “enable the Office and the public generally to determine quickly from a cursory inspection the nature and gist of the technical disclosure.” 37 CFR 1.72(b). Specifically, it is not clear how the invention accomplishes the stated goal (e.g., the implant instructs the user to take a particular photo).
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification [0004] is objected to for not being labeled “background.”
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 (all claims) 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.
Claims 1, 19, and 20 recite “process the one or more images; determine a result based on the processing,” but this is unlimited functional claiming because the claim only recites a result rather than the structure or steps that accomplish the result. MPEP 2173.05(g).
Claims 1, 4, 6, 7, 9, 11, and 18-20 recite various steps “based on,” but these are also unlimited functional claiming.
Claim 6, 15, and 18 recite determinations, but these are also unlimited functional claiming.
Claims 1, 19, and 20 recite “capture one or more images of a region of interest of the patient via the camera sensor,” but this is also unlimited functional claiming because it is not specified how the camera focused on the region of interest.
Claims 1-20 are rejected for lack of written description. “Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention.” MPEP 2163(I). The present disclosure lacks the identifying characteristics that one would expect from one having possession of a machine learning invention. Compare, for example, the Chen reference (see the prior art) that details the architecture, the training and the performance of the machine learning, whereas the present disclosure lacks these details. Further, even if the present disclosure taught a particular architecture, the performance numbers are critical identifying characteristics because they are central to understanding what the machine learning does. Without performance numbers, a machine learning structure is closer to a wish or plan because one needs to perform undue experimentation to learn whether or not this machine learning structure/architecture is worth pursing.
Dependent claims are likewise rejected.
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 1-20 (all claims) 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.
Claims 1, 19, and 20 recite “region of interest,” but the claim does not provide sufficient context to understand how to determine this region. In other words, a region of interest is understood in the context of a convolutional neural network, or for medical imaging, the region of interest may be the relevant body part.
Claims 1, 19, and 20 recite “related,” but this is subjective. MPEP 2173.05(b)(IV).
Dependent claims are likewise rejected.
Claim Interpretation
The various claim elements relating to communicating with the user (e.g., claim 4’s instructions, or the meaning of the various indications) are nonfunctional descriptive material because they are “directed toward conveying meaning to the human reader rather than towards establishing a functional relationship between recorded data and the computer.” MPEP 2111.05(III).
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 (all claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Step 1:
Claim 1 (and its dependents) recite a system, and machines satisfy Step 1 of the eligibility test.
Claim 19 recites a method, and processes satisfy Step 1 of the eligibility test.
Claim 20 recites a non-transitory computer-readable storage media, and manufactures satisfy Step 1 of the eligibility test.
Step 2A, prong one: All of the elements of the claims are a mental process this is automating the manual process (see specification [0004] or the Chen reference from the prior art). MPEP 2106.04(a)(2)(III)(C) explains that use of a generic computer or in a computer environment is still a mental process. In particular, this section begins by citing Gottschalk v. Benson, 409 US 63 (1972). “The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea.” In Benson the Supreme Court did not separately analyze the computer hardware at issue; the specifics of what hardware was claimed is only included in an appendix to the decision.
Because there are no additional elements, no further analysis is required for Step 2A, prong two or Step 2B.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 (all claims) are rejected under 35 U.S.C. 103 as being unpatentable over US20180126172A1 (“Sarkar”) in view of Chen J, Mao T, Qiu Y, Zhou D, Creber RM, Kostic Z. Camera-based peripheral edema measurement using machine learning. In2018 IEEE International Conference on Healthcare Informatics (ICHI) 2018 Jun 4 (pp. 115-122). IEEE. (“Chen”). A copy of Chen can be found with Applicant’s January 28, 2025 IDS.
Claim 1. (Original): A system for monitoring a heart failure status of a patient, the system comprising:
a memory configured to store one or more images; (Sarkar, Fig. 6, memory 82)
and
processing circuitry communicatively coupled to the memory, and the camera sensor, the processing circuitry being configured to: (Sarkar, Fig. 6, processor 80. See also, [0107] “or may be a remote sensor in communication with IMD 16” (because the camera could be a remote sensor))
determine a result based on the processing, the result being related to the heart failure status of the patient; and (Sarkar, abstract, “Techniques for using multiple physiological parameters to provide an early warning for worsening heart failure are described.”)
generate a first indication for output regarding the result. (Sarkar, abstract, “an early warning for worsening heart failure”)
Sarkar is not relied on for the below claim language.
However, Chen teaches a camera sensor; (Chen, title, “Camera-Based Peripheral Edema Measurement Using Machine Learning”)
capture one or more images of a region of interest of the patient via the camera sensor; (Chen, Fig. 2, “Videos”)
process the one or more images; (Chen, Fig. 5)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Chen to the teachings of Sarkar such that Chen’s methods are used to evaluate Sarkar’s worsening heart failure “for averting episodes of acute decompensation and hospitalizations.” Chen, abstract.
Based on the above, this is an example of “combining prior art elements according to known methods to yield predictable results.” MPEP 2143.
Claim 2. (Original): The system of claim 1, wherein the first indication comprises at least one of a ranking on a heart failure status scale or the one or more images, and (Sarkar, Fig. 17, “Heart Failure Risk Score.” The examiner notes that the word “or” may be a typo.)
wherein the processing circuitry is further configured to output the first indication to one or more users. (Sarkar, abstract, “an early warning for worsening heart failure”)
Claim 3. (Original): The system of claim 2, wherein the one or more users comprise the patient. (Sarkar, [0063] “Server 314 may provide alerts relating to worsening heart failure of patient 16 via network 312 to patient 14”)
Claim 4. (Currently Amended): The system of claim 1, wherein the processing circuitry is further configured to:
receive a trigger from an implantable medical device; and (Sarkar, abstract, “The parameters preferably include are least one parameter acquired from an implanted device, such as intrathoracic impedance. The system device derives an index of the likelihood of worsening heart failure based upon the parameters using a Bayesian approach and displays the resultant index for review by a physician.”)
based on receiving the trigger from the implantable medical device, output instructions via a user interface to a user, the instructions comprising instructions to take the one or more images using the camera sensor of the region of interest. (Sarkar, [0063] “Server 314 may provide alerts relating to worsening heart failure of patient 16 via network 312 to patient 14.” A) the patient may understand the alert to mean to use the camera, B) this claim limitation (and its dependents) is nonfunctional descriptive material. MPEP 2111.05.)
Claim 5. (Original): The system of claim 4, wherein the instructions further comprise a map of the region of interest. (Chen, Fig. 3. That the finger is in the photo teaches the claimed map)
Claim 6. (Currently Amended): The system of claim 4, wherein the processing circuitry is further configured to: determine a heart failure score based on sensor signals from the implantable medical device and the result; and output the heart failure score to one or more users. (Sarkar, abstract, “The parameters preferably include are least one parameter acquired from an implanted device, such as intrathoracic impedance. The system device derives an index of the likelihood of worsening heart failure based upon the parameters using a Bayesian approach and displays the resultant index for review by a physician.”)
Claim 7. (Currently Amended): The system of claim 4, wherein the trigger is based on one or more sensor signals from one or more sensors of the implantable medical device. (Sarkar, abstract, “The parameters preferably include are least one parameter acquired from an implanted device, such as intrathoracic impedance. The system device derives an index of the likelihood of worsening heart failure based upon the parameters using a Bayesian approach and displays the resultant index for review by a physician.”)
Claim 8. (Original): The system of claim 7, wherein the one or more sensors comprise a respiration sensor. (Sarkar, [0074] “Example secondary diagnostic parameters include … respiratory rate.”)
Claim 9. (Currently Amended): The system of claim 7, wherein the processing circuitry is further configured to tune at least one of the one or more sensors based on the result. (Chen, Fig. 9. That the accuracy values change with more inputs teaches the claimed tuning.)
Claim 10. (Currently Amended): The system of claim 1, wherein the region of interest comprises:
an ankle of the patient; (Chen, section I.A, “The most routinely used clinical method for assessing peripheral edema by nurses is the pitting-test applying digital pressure for at least 5 seconds against a bony prominence.” The ankle can be at once envisaged (MPEP 2131.02(III). Alternatively, it’s a known substitute. MPEP 2144.06.)
a hand of the patient;
a leg of the patient; (Chen, section I.A, “measurement of surface imprint [11]”)
a foot of the patient; (Chen, section I.A, “measurement of surface imprint [11]”)
a face of the patient;
a neck of the patient;
an eye of the patient; or
an eyelid of the patient.
Claim 11. (Currently Amended): The system of claim 1, wherein the processing circuitry is further configured to monitora use of medication of the patient,
wherein the use of medication comprises at least one of
a type of the medication, (Sarkar, [0074] “medication history” (From the list of example secondary diagnostic parameters that the IMD monitors)
a time of taking of the medication, (Sarkar, [0074] “medication history”)
an amount taken of the medication, and (Sarkar, [0074] “medication history”)
wherein the result is further based on the use of medication of the patient. (Sarkar, [0074] “Thus, IMD 16 may, in various embodiments, monitor either intrathoracic impedance or pressure and one, all, or any combination of the previously recited secondary diagnostic parameters.”)
Claim 12. (Currently Amended): The system of claim 1, wherein as part of processing the one or more images, the processing circuitry is configured to compare the one or more images to one or more baseline images, (Chen, Table I. Chen’s dataset from Table I serves as the baseline images, the use of the machine learning model teaches the claimed comparison because the model was trained on the data from Table I.)
wherein the one or more baseline images comprise one or more previous images captured by a clinician via a cellular phone, a tablet computer, or a digital camera. (Chen, Table I)
Claim 13. (Original): The system of claim 12, wherein as part of processing the one or more images, the processing circuitry is configured to apply an artificial intelligence model to the one or more images. (Chen, title, “Camera-Based Peripheral Edema Measurement Using Machine Learning”)
Claim 14. (Currently Amended): The system of claim 1, wherein the one or more images comprise:
at least one image of the region of interest while a user is applying pressure to the region of interest; and (Chen, Fig. 3)
at least one image of the region of interest after the user releases the pressure from the region of interest. (Chen, Fig. 3)
Claim 15. (Original): The system of claim 14, wherein as part of processing the one or more images, the processing circuitry is configured to determine at least one of:
a change in size of tissue in the region of interest between the at least one image of the region of interest while the user is applying pressure to the region of interest and the at least one image of the region of interest after the user releases the pressure from the region of interest; (Chen, Fig. 3)
a change in color of the tissue in the region of interest between the at least one image of the region of interest while the user is applying pressure to the region of interest and the at least one image of the region of interest after the user releases the pressure from the region of interest;
a rate of change in the color of the tissue in the region of interest between the at least one image of the region of interest while the user is applying pressure to the region of interest and the at least one image of the region of interest after the user releases the pressure from the region of interest; or
a rate of change in a slope of a skin surface of the tissue in the region of interest between the at least one image of the region of interest while the user is applying pressure to the region of interest and the at least one image of the region of interest after the user releases the pressure from the region of interest. (Chen, Fig. 5)
Claim 16. (Currently Amended): The system of claim 1, wherein the system further comprises a flash, and wherein the one or more images comprise a video of light from the flash reflected back to the camera sensor when at least one of the flash or the camera sensor is in contact with the region of interest. (Chen, section IV.C, “Lighting conditions were varied.” The flash can be at once envisaged (MPEP 2131.02(III). Alternatively, it’s a known substitute. MPEP 2144.06.)
Claim 17. (Currently Amended): The system of claim 1, wherein the result comprises a prediction of worsening heart failure. (Sarkar, abstract, “an early warning for worsening heart failure”)
Claim 18. (New): The system of claim 1, wherein the one or more images comprise a first one or more images, wherein the result is a first result, and wherein the processing circuitry is further configured to:
store the first one or more images in memory; (Sarkar, Fig. 6, memory 82)
capture a second one or more images of the region of interest of the patient via the camera sensor after a time period; (Chen, Fig. 3)
compare the second one or more images to the first one or more images; (Chen, Fig. 3)
determine a second result based on the comparison, the second result being related to the heart failure status of the patient; and (Sarkar, abstract, “Techniques for using multiple physiological parameters to provide an early warning for worsening heart failure are described.”)
generate a second indication for output regarding the second result. (Sarkar, abstract, “an early warning for worsening heart failure”)
Claims 19 and 20 are rejected as per claim 1.
Conclusion
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/DAVID ORANGE/Primary Examiner, Art Unit 2663
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