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 invention I in the reply filed on 10 June 2025 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10 June 2025.
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 Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “the risk of the patient for developing the pressure comprises”; this appears to have omitted the word “injury” and should read “developing the pressure injury comprises”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-7, 9 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 2 refers to “a second threshold” twice; if this is the same threshold the second recitation should refer to “the” second threshold, whereas if these are different thresholds they should be identified as such. Clarification is required.
Claim 2 also recites “identifying the risk of the patient”; there is no antecedent basis for this limitation in the claim. It appears this should refer to “determining the risk” as set forth in claim 1 and for the purposes of examination will be treated as such but correction is required. This issue is also found in claims 3-7.
Claim 9 recites “the risk of the patient for developing the pressure injury is correlated to the frequency that the at least one care provider changes the bedding or the incontinence pads of the patient” – is this part of the determination of risk? Or does this take place subsequent to the determination of risk, generating some other evaluation of risk? How is the risk “correlated” to the frequency? Clarification is required. The Examiner notes that this “frequency” of bedding changes appears wholly unrelated to any physical condition of the patient or any identified need for a change and response thereto, where following a set routine of every 12 hours might be sufficient “frequency” even if it results in a patient experiencing wet bedding for 11.5 hours.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) determining a risk of a patient developing a pressure injury based on data indicative of the patient’s position over time and weight, which falls into the grouping of mental processes. This judicial exception is not integrated into a practical application because:
The recited determining of risk does not provide any improvement to technology; no details of performance of the determination are recited and the result is not used in any manner
The recited determining of risk is not applied or used to effect a particular treatment; the result is not used for any purpose
The recited determining of risk does not effect any transformation or reduction of an article; it is simply manipulation of data
The recited determining of risk is not applied or used in any meaningful way beyond generally linking it to a generic technological environment for its execution (“processor”, “memory”) - see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element are conventional sensing and data capture devices (camera, load cell) used only for the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.), and an unspecified, disembodied “report” that is output by the processor (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity). As such, considered individually and as a whole, the claim elements do not amount to significantly more than the abstract idea itself.
The dependent claims also fail to provide anything significantly more, as claims 2-4 are also directed to insignificant extrasolution data gathering, and claims 2-10 are directed to aspects of the judicial exception of determination of risk itself.
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, 3, 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rush (US 10600204).
Regarding claim 1, Rush discloses a system comprising:
a camera (elements 100, 102) configured to capture images of a patient disposed on a support structure (column 1, lines 25-49);
a load cell integrated into the support structure and configured to determine a weight of the patient on the support structure (element 124; column 22 line 48 to column 23 line 8; the Examiner notes that the disclosure of the instant invention indicates that “the load cell(s) 118 can include… any device configured to output a signal indicative of an amount of pressure applied to the device”, paragraph [0033] as filed)
a processor communicatively coupled to the camera and the load cell (element 106);
memory communicatively coupled to the processor (element 108) and storing instructions that, when executed by the processor, cause the processor to perform operations comprising:
tracking, based on the images of the patient, a position of the patient over time (column 16, lines 13-16 and 48-62);
determining a risk of the patient for developing a pressure injury based on the position of the patient over time and the weight of the patient (column 21, lines 4-10; column 22, lines 20-61);
determining that the risk of the patient for developing the pressure injury is greater than a threshold (column 16, lines 13-29; column 21, lines 2-10; column 23 line 35 to column 24 line 5);
generating a report based on determining that the risk of the patient developing for the pressure injury is greater than the threshold (column 23 line 35 to column 24 line 5); and
outputting the report (column 23, lines 35-36, “issuance of an electronic communication”).
Regarding claim 3, Rush further discloses:
a transceiver communicatively coupled to the processor and configured to receive, from an electronic medical record (EMR) system, at least a portion of an EMR of the patient that comprises at least one of a medication prescribed to the patient, an incontinence management device prescribed to the patient, a diagnosis of the patient, a demographic of the patient, a mobility level of the patient, a medical device used in the care of the patient, a nutritional intake of the patient, or a previous pressure injury experienced by the patient, wherein determining the risk of the patient developing the pressure injury is further based on the at least the portion of the EMR of the patient (column 14, lines 15-38, 60-67; column 15 lines 1-2; column 26, lines 47-63).
Regarding claim 6, Rush further discloses that tracking the position of the patient in the images comprises determining a pose of the patient in the images and that identifying the risk of the patient for developing the pressure injury is also based on the pose of the patient and comprises increasing the risk based on determining that a first limb of the patient is in contact with a second limb of the patient (“arms folded”, column 16, lines 48-62).
Regarding claim 7, Rush further discloses that the operations further comprise detecting, based on the images, an object or bedding fold disposed between the patient and the support structure (column 20, lines 39-54), and determining the risk of the patient developing the pressure injury comprises increasing the risk based on detecting the object or the bedding fold disposed between the patient and the support structure (column 20, lines 48-54).
Regarding claim 8, Rush further discloses that tracking the portion of a patient over time comprises identifying at least one of an amount of movement of the patient or a number of times that the patient has moved over time (column 32, lines 51-63).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush in view of Bly (US 2010/0312076).
Regarding claim 2, Rush does not disclose the system further comprising a transceiver communicatively coupled to the processor and configured to receive, from a medical device, data indicating a vital sign of the patient, the vital sign comprising a heart rate, a respiration rate, or a blood oxygenation of the patient, wherein identifying the risk of the patient for developing the pressure comprises determining whether the vital sign exceeds a second threshold or is lower than a second threshold. Bly teaches a system with a processor configured to determine a risk of a patient for developing a pressure injury (paragraph [0008], [0012]), the system comprising a transceiver communicatively coupled to the processor and configured to receive, from a medical device, data indicating a vital sign of the patient (paragraph [0018], [0034], [0040]), the vital sign comprising a heart rate, a respiration rate, or a blood oxygenation of the patient, wherein determining the risk of the patient for developing the pressure injury comprises determining whether the vital sign exceeds or is lower than a vital sign threshold (paragraphs [0055], [0060]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rush and configured the system to receive vital sign data including a heart rate, respiration rate, or blood oxygenation, and incorporated the vital sign data’s relationship to a threshold as part of determining the risk of developing the pressure injury, as taught by Bly, in order to increase the accuracy of determination based on the patient’s condition.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush in view of Jayaraman (US 2020/0405217).
Regarding claim 4, Rush does not disclose the system further comprising a moisture sensor and a temperature sensor, where the risk of the patient developing the pressure injury further comprises increasing the risk based on detected moisture or temperatures. Jayaraman teaches a system comprising a camera configured to capture images of a patient disposed on a support structure (paragraph [0076]), a moisture sensor configured to detect moisture disposed on the support structure (paragraph [0045]), a temperature sensor configured to detect a temperature of the patient on the support structure (paragraph [0008], temperature at the interface location), and a processor configured to determine a risk of the patient for developing a pressure injury based on the patient’s position and increasing the risk based on the moisture disposed on the support structure (paragraphs [0009], [0047]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rush, and included temperature and moisture sensors such that the risk determination can take data from these sensors into account, as taught by Jayaraman, in order to account for additional risk factors.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush in view of Kemp (US 2018/0197632).
Regarding claim 5, Rush further discloses that the operations further comprise identifying, based on the images and the weight, a weight of the patient (column 22 line 48 to column 23 line 8). Rush does not further disclose that determining the risk of the patient developing the pressure injury comprises increasing the risk based on a bony protrusion; or increasing the risk based on determining that the weight of the patient exceeds a second threshold or is lower than a third threshold. Kemp teaches a system configured to determine a risk of a patient developing a pressure injury which includes determining a weight of the patient and increasing the risk based on determining the weight exceeding a weight threshold (paragraph [0077]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rush and included use of a weight threshold as part of determining the risk of developing a pressure injury, as taught by Kemp, as patient weight is a standard part of the Braden scale for determining risk of pressure injuries.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush in view of Receveur (US 2021/0219873).
Regarding claim 10, Rush does not disclose the operations further comprising determining a shear force between skin of the patient and the support structure based on the images, the shear force being positively correlated with the risk. Receveur teaches a system comprising a camera configured to capture images of a patient disposed on a support structure (element 108) and a processor (paragraph 0037]) configured to track a position of the patient over time based on the images and to determine a shear force between the skin of the patient and the support structure based on the images (paragraph 0031]-[0032]), and determining a risk of the patient developing a pressure injury based on the positioning and shear force (paragraph [0032]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Rush and also determined a shear force that is positively correlated with the risk of developing a pressure injury, as taught by Receveur, in order to account for more potential determining factors.
Conclusion
No art has been applied against claim 9 at this time; however, as the claim is rejected under 112b and 101 it is not presently allowable and the question of prior art will be revisited upon resolution of these other issues.
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/KAREN E TOTH/Examiner, Art Unit 3791