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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a process of targeted monitoring of a patient in a bed to predict pressure based on posture, in the reply filed on 8/10/26 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/10/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea comprises a mental process.
For sole independent claim 1, the claim(s) recite(s) a process of predicting a patient-bed pressure score based on contact regions and posture.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to predict pressure-based bedsores or pressure ulcers of a bedridden patient.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like. Although the preamble recites a computer-implemented method, the Examiner respectfully notes neither the computer nor computer-implementation are required in the body of the claim. The human mind is a well-known predictor and/or computer, particularly based on received images from the eyes and wherein human based indications may be physical and/or verbal based on the ocular input and mental prediction. Not only would the mental of a medical professional be more than fairly and reasonably able to execute the claimed invention, the Examiner respectfully notes that, as broadly as claimed, even a mere layperson would be able to predict a pressure score of contact regions and posture of a patient contributing to pressure based ulcers and/or bedsores based on viewing the patient in bed.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (i) the preliminary step of receiving an image is well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity and (ii) the post solution step of providing an indication is well-known, routine and conventional amounting to insignificant post solution activity. These elements are well known, routine and conventional such that even a layperson, let alone any degree of trained medical professional, would recognize they are not additional elements amounting to significantly more than the abstract idea.
Depending claims 2-17 and do not remedy the non-statutory deficiency noted above. Despite specifying further steps relating to – generating a pressure map, inferring contact regions, receiving patient data, data based threshold achievement over time, notification specifics, pressure classification, machine learning scoring model, detecting or analysis –, the steps do not integrate into a practical application and do not recite additional elements amounting to significantly more than the abstract idea.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ostadabbas et al. (US 2022/0386898 A1, hereinafter Ostadabbas).
For claim 1, Ostadabbas discloses a computer-implemented (via 100) method for targeted monitoring of a patient (111) in a bed (115) ([0010-0039, 0109-0171]), comprising inter alia:
receiving an image (via 107) of the bed ([0109-0122]);
predicting, based on a posture of the patient in the image, a pressure score for one or more contact regions between the patient and the bed ([0109-0122, 0134-0164]); and
providing an indication of the pressure score for the one or more contact regions ([0165-1070]).
For claim 2, Ostadabbas discloses the method of claim 1, wherein the step of providing the indication of the pressure score further comprises generating a pressure map based on the pressure score for the one or more contact regions ([0109-0122]).
For claim 3, Ostadabbas discloses the method of claim 1, wherein the step of predicting the pressure score further comprises:
detecting, in the image, the patient on the bed ([0109-0122, 0134-0164]);
analyzing the image to determine the posture of the patient ([0109-0122, 0134-0164]); and
inferring one or more contact regions between the patient and the bed ([0109-0122, 0134-0164]).
For claim 4, Ostadabbas discloses the method of claim 1, further comprising:
receiving an indication of a weight of the patient (Table 4) ([0143-0152]); and
using the indication of the weight when predicting the pressure score ([0109-0122, 0134-0164]).
For claim 5, Ostadabbas discloses the method of claim 1, further comprising:
receiving a three dimensional morphology of the patient ([0159-0163]); and
using the three dimensional morphology when predicting the pressure score ([0159-0163]).
For claim 6, Ostadabbas discloses the method of claim 5, further comprising one of obtaining or creating the three dimensional morphology of the patient using a depth sensing device (imaging device 107 includes depth sensor imaging, [0117]).
For claim 7, Ostadabbas discloses the method of claim 1, further comprising:
receiving patient demographic data (Table 4) ([0143-0152]); and
using the patient demographic data when predicting the pressure score ([0109-0122, 0134-0164]).
For claim 8, Ostadabbas discloses the method of claim 1, further comprising:
receiving one or more further images of the bed (imaging devices 107 include optical and video cameras, infrared camera and video cameras, depth sensor, LIDAR scanner, 3D camera, etc.) ([0109-0122]);
predicting, based on a further posture of the patient in the one or more further images, the pressure score for the one or more contact regions between the patient and the bed ([0109-0122, 0134-0164]); and
providing the indication of the pressure score for the one or more contact region ([0165-1070])s.
For claim 9, Ostadabbas discloses the method of claim 8, further comprising determining whether the pressure score based on the posture of the patient in the image or the further posture of the patient in the one or more further images, exceeds a threshold ([0123-0131]).
For claim 10, Ostadabbas discloses the method of claim 9, wherein the threshold is based on one or more of: a maximum pressure score; and a time in which a same contact region is determined to be in contact between a first image and a later image ([0123-0131]).
For claim 11, Ostadabbas discloses the method of claim 9, further comprising issuing a notification when the pressure score exceeds the threshold ([0165-1070]).
For claim 12, Ostadabbas discloses the method of claim 11, wherein the notification comprises one or more ([0165-1070]) of:
sounding an alarm or warning message;
turning on a light; and
advising the patient or a care provider to adjust the posture of the patient at least in relation to the one or more contact regions .
For claim 13, Ostadabbas discloses the method of claim 9, further comprising receiving at least one of patient physiological data or patient clinical data and using the patient physiological data or patient clinical data to determine the threshold (Table 4) ([0143-0152]).
For claim 14, Ostadabbas discloses the method of claim 1, further comprising one of receiving the image as a still image or extracting the image from a video stream (imaging devices 107 include optical and video cameras, infrared camera and video cameras, depth sensor, LIDAR scanner, 3D camera, etc.) ([0109-0122]).
For claim 15, Ostadabbas discloses the method of claim 1, further comprising applying a classification procedure to classify the pressure score as one of representative of or indicative of a low pressure, a medium pressure or a high pressure ([0123-0131]).
For claim 16, Ostadabbas discloses the method of claim 1, wherein at least a step of predicting the pressure score, detecting the patient, or analyzing the image is carried out by one or more trained machine learning models ([0109, 0127-0138, 0153-0161]).
For claim 17, Ostadabbas discloses the method of claim 16, wherein the one or more trained machine learning models comprises one or more of: a decision tree, a k-nearest neighbors (kNN) algorithm, an Adaptive Boosting (AdaBoost) technique, a Random Forest algorithm, a neural network, a Support Vector Machine (SVM), a deep learning model, a convolutional neural network, a recurrent neural network, a transformer model ([0109, 0127-0138, 0153-0161]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for predicting, scoring, and providing indication of pressure based ulcers of a patient in a bed based machine learning and image classification of images and/or video.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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