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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
From claim 5 - “receiving the pressure measurements at a user device in batch upon the user device establishing a connection with the sensor grid.”
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.
Claim 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.
Claims 1, 13 and 19 recite “detection criteria” however the specification provides no support for detection criteria being used which in view of MPEP 2163(II)(A)(3)(a)(ii) does not provide sufficient disclosure as it is does not represent a representative number species to satisfy a sufficient description. The MPEP definition of a “[a] "representative number of species" means that the species which are adequately described are representative of the entire genus”. “Detection criteria” in the claim appears to be the only time it is discussed. While the claims recite the genus of a “detection criteria” which is broad encompassing a variety of possible criteria including time windowing, min threshold, max threshold, range etc. Thus, the specification does not provide support for enough species to fulfill the written description for the breadth of the genus term “detection criteria”. Examiner notes that to have “possession,” “the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Ariad, 598 F.3d at 1351. In order to satisfy the written description requirement, the Specification must describe a sufficient number of species to claim the genus. Id. at 1349 (“the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus”). In addition, original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function. Id. (“[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.”) (citing Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997)). For the above reasons the claims do not provide sufficient written description, the claims depending from these claims share the issue and are therefore rejected for the same reasons.
Additionally, regarding claim 12, per MPEP 2161.01 "It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)" and "Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. ". Claim 12 recites “applying a recommendation algorithm to generate, based on the two-dimensional array of pressure measurements, a patient-specific shift recommendation”. The specification recites algorithms such as machine learning (ML) may be “implemented” or applied see [0023], without disclosing how they are determined beyond stating they learn a relationship. There is no discussion of what type of model is doing this, whether it’s supervised or unsupervised, the features being entered into a model etc. The specification recites a functional intent, to implement an algorithm, without disclosing how the intent is achieved.
Claim Rejections - 35 USC § 112b
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 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, 13 and 19 recite “to identify weight shifts meeting detection criteria” however it is unclear what this entails. Turning to the specification for clarification there is no discussion of “detection criteria”, as such it is unclear what the scope of the term is. For the above reasons the claim does not clearly define the metes and bounds of the claims and the claims are indefinite. The claims depending from these claims share this issue and are rejected for the same reason.
Claims 1, 13 and 19 recite “receiving by a compliance management application” however it is unclear what this entails. The confusion is compounded in the dependent claims which recite elements such as a user device and server etc. which receive, process or transmit data. For example, claim 11 recites “communicating the compliance levels to a remote processing server; and obtaining information for the electronic notifications from the remote processing server.”. It is unclear what is initially receiving the readings in the independent claims is it the later claimed “user device”, the “remote processing server” or is it the microprocessor connected to the sensor pad. Likewise in claim 11 example, it’s unclear what is communicating the compliance levels to the “remote processing server”. Without knowing where the data is it’s unclear what needs to be shown/reads on the receiving, transmitting and communicating steps. Phrased different it’s unclear what the metes and bounds are. For the above reason it’s unclear what the metes and bounds of the claims are and the claims are indefinite. The claims depending from claim 1, 13 and 19 share these issues and are rejected for the same reasons.
Claim 3 contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “Bluetooth” and, accordingly, the identification/description is indefinite.
Claim 5 recites “receiving the pressure measurements at a user device in batch” it is unclear what the scope of this term is. Turning to the specification there is no discussion of a “receiving the pressure measurements at a user device in batch”. Is a batch one set of grid pressure readings? Or maybe it requires two sets of grid pressure readings at different times? Is it two or more sets of grid pressure readings? There is no discussion of what this entails in the specification and while it has 112a support from the originally filed claim, the recitation does not clearly define the metes and bounds of the claim. Therefore, the claim is indefinite.
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 101 as being directed to the abstract idea of a mental process and/or mathematical concept see the analysis below.
Step 1
The invention claimed in claims 1-20 the claims recite an apparatus or process.
Step 2A, Prong 1
Regarding Claims 1/13/19, the recited steps of “processing” the measurements to identify shifts based on detection criteria and “comparing” the weight shifts with compliance criteria, is a process that, under its broadest reasonable interpretation, is directed to a mental process of performing concepts in the human mind (including by a human using the aid of pen and paper) and/or a mathematical process (dependent claims explicitly recite mathematical processes such as averaging etc.). That is nothing in the claim element precludes the step from practically being performed in the mind. For example, “processing” the measurements to identify shifts based on detection criteria and “comparing” the weight shifts with compliance criteria in the context of this claim encompasses the user manually using pen a paper mentally identifying shifts by reviewing data in view of some known detection criteria to determine detection and mentally comparing those determined shifts to some compliance criteria to determine a compliance level.
Step 2A, Prong 2
Regarding Claims 1/13/19, the judicial exception is not integrated into a practical application. The claim includes the additional elements of data gathering (i.e. “receiving”) and “generating” a notification (also elements of claims 2-5, 9, 11 and 17). The limitations of sensors “receiving” or “obtaining” data is pre-solution activity of mere data gathering; and the “generating” a notification is merely post solution activity of generating an output. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding Claims 1/13/19, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above, The claim includes the additional elements of data gathering (i.e. “receiving”) and “generating” a notification (also elements of claims 2-5, 9, 11 and 17). The limitations of sensors “receiving” or “obtaining” data is pre-solution activity of mere data gathering; and the “generating” a notification is merely post solution activity of generating an output. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Additionally, per the Berkheimer requirement, the pressure sensor grid on a wheelchair and processor/memory (or separate processing): (1) Smith cited below, see citations provided in the rejection below; (2) Shalom cited below, see citations provided in the rejection below; (3) Dunn cited below, see citations provided in the rejection below; (4) Sugla cited below, see citations provided in the rejection below. As such the elements are shown to be WRC.
The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 2-12, 14-18, 20 only further define the extrasolution of activity of data gathering or outputting the notification (insignificant, extra-solution activity - claims 2-5, 9, 11-12) or further define elements of the processing/comparing (i.e., only further define the mental process/mathematical concept – claims 6-10, 14-18). Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims are ineligible.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 6-10, 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040046668 to Toby Smith et al. (hereinafter Smith) in further view of US 20150173667 to Amir Shalom et al. (hereinafter Shalom).
Regarding claim 1, an interpretation of Smith discloses method for managing shift compliance for preventing pressure ulcers in a wheelchair user (abstract, [0075]), the method comprising:
receiving by a compliance management application at each of a sequence of time points, a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082]);
processing ([0041]-[0042], [0045], [0075], [0092]) the pressure measurements to identify weight shifts meeting detection criteria ([0045], [0048], [0055]; determining if the shift is significant is the meeting of the detection criteria);
An interpretation of Smith may not explicitly disclose comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user; and generating electronic notifications based on the detected compliance level.
However, in the same field of endeavor (medical devices), Shalom teaches a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region and receiving the data at processor with software ([0074], [0076], [0079], [0165], [0218] including “a matrix of pixels, each pixel representing one sensor of the pressure-detection sheet. The pressure detected by each pixel is represented by a visual indication.”, Figs. 8A, 9A-10B See also [0027], [0064]) comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user ([0163]-[0164], [0166]-[0168], [0188], [0200], [0202]-[0204], Figs. 10A-B see also [0172]; Determines if your targeted goal/compliance level of weight shifts is achieved); and
generating electronic notifications based on the detected compliance level ([0025], [0032], [0200], [0202]-[0204], Figs. 10A-B).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 3, an interpretation of Smith discloses the above in claim 1 including receiving sensor grid measurements.
An interpretation of Smith may not explicitly disclose receiving the pressure measurements over a Bluetooth Low Energy connection with the sensor grid.
However, in the same field of endeavor (medical devices), Shalom teaches receiving the pressure measurements over a Bluetooth Low Energy connection with the sensor grid ([0075], [0076] including “in a wheelchair or the like, wired data cables may be inappropriate and data transmission via wireless means may be preferred, for example via radio waves using protocols such as WIFI, BLUETOOTH, ZIGBEE or the like.”, [0079] see also [0144]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include transmitting data using Bluetooth, comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on a user device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 4, an interpretation of Smith discloses the above in claim 1 including receiving sensor grid measurements.
An interpretation of Smith may not explicitly disclose receiving the pressure measurements at a user device in substantially real-time while the user device is communicatively coupled with the sensor grid.
However, in the same field of endeavor (medical devices), Shalom teaches receiving the pressure measurements at a user device in substantially real-time while the user device is communicatively coupled with the sensor grid ([0064] including “allow caregivers and patients to have real-time pressure distribution monitoring accessible on an individual handheld device”, [0079], [0139], [0164]-[0165] see also [0144]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the current pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 6, an interpretation of Smith further discloses detecting at least a first time period when the wheelchair user is seated and detecting at least a second time period when the wheelchair user is not seated ([0045] including “As a next preferred step, the CPU 310 will attempt to determine whether or not a patient is present in the bed, chair, etc. This might be done many ways, but in the case where the sensor is a pressure sensitive bed mat 100 or chair mat 200 this step 415 is easily accomplished by checking to see if the patient's weight has “closed” the switch.”, [0056]; determine when the person sits down and gets up off the mat it is recites checking repeatedly each time period. Determine someone sitting down in one time period and getting up in a later time period).
Regarding claim 7, an interpretation of Smith further discloses detecting a shift period when the patient's weight shifts from a baseline seated position ([0019], [0055], [0089], [0093], Fig. 4).
Regarding claim 8, an interpretation of Smith further discloses detecting a pressure change of at least a predefined magnitude relative to a baseline sitting pressure that occurs in at least a predefined number of pressure sensors ([0018]-[0019] including “a patient movement threshold”, [0049] subtracting sensor measurements at different points in time to determine a shift, [0055] including “a grid of individual sensor points 1020 might be used to more precisely determine the location of the patient.”, [0061]; tracks the difference from previous readings and where on the grid, to determine for example shifting from those on the right side to the left to ensure the shift is significant) and lasts at least a predefined time period ([0019], [0055], [0089], [0093], Fig. 4).
Regarding claim 9, an interpretation of Smith further discloses obtaining a predefined recommended duration for a first time interval ([0021], [0055], [0089] see also [0022]; setting parameters such as time intervals); and
detecting, during the first time interval, a duration of the weight shift ([0055], [0089]).
An interpretation of Smith may not explicitly disclose determining the compliance level based on the duration of the weight shift relative to the predefined recommended duration.
However, in the same field of endeavor (medical devices), Shalom teaches durations of weight shifts within a time interval ([0191], [0203]-[0204], Fig. 8C) determining the compliance level based on the duration of the weight shift relative to the predefined recommended duration ([0191], [0203]-[0204]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria including durations to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 10, an interpretation of Smith may not explicitly disclose determining respective compliance levels for each of a sequence of time intervals.
However, in the same field of endeavor (medical device), Shalom teaches determining respective compliance levels for each of a sequence of time intervals ([0143], [0163], [0191], [0200], [0202]-[0204]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level including current readings, readings over time, and/or daily/weekly etc. target compliance as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 12, an interpretation of Smith may not explicitly disclose applying a recommendation algorithm to generate, based on the two-dimensional array of pressure measurements, a patient-specific shift recommendation; and sending the patient-specific shift recommendation to a user device.
However, in the same field of endeavor (medical devices), Shalom teaches applying a recommendation algorithm to generate, based on the two-dimensional array of pressure measurements, a patient-specific shift recommendation ([0024] including “when referencing output data, the notification mechanism is operable to initiate a display of a series of pressure distribution maps representing the data sequentially. Additionally, the notification mechanism is also operable to generate a recommendation plan of a weight shift schedule”, [0025]; the device is making determinations using the processor and software to generate a recommendation plan. While not currently relied upon Dunn (cited below in a 103) also discloses based on the array of sensor data to generate “a patient-specific shift recommendation” for example see [0060] see also the ‘622 reference mentioned in the conclusion); and sending the patient-specific shift recommendation to a user device ([0024]-[0025], [0074], [0102]; providing the plan/recommendation to the user device ).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level including current readings, readings over time, and/or daily/weekly etc. target compliance as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 13, an interpretation of Smith discloses non-transitory computer-readable storage medium storing instructions for managing shift compliance for preventing pressure ulcers in a wheelchair user (abstract, [0075], [0095]), the instructions when executed by a processor causing the processor to perform steps including:
receiving by a compliance management application at each of a sequence of time points, a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082]);
processing ([0041]-[0042], [0045], [0075], [0092]) the pressure measurements to identify weight shifts meeting detection criteria ([0045], [0048], [0055]; determining if the shift is significant is the meeting of the detection criteria);
An interpretation of Smith may not explicitly disclose comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user; and generating electronic notifications based on the detected compliance level.
However, in the same field of endeavor (medical devices), Shalom teaches a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region and receiving the data at processor with software ([0074], [0076], [0079], [0165], [0218] including “a matrix of pixels, each pixel representing one sensor of the pressure-detection sheet. The pressure detected by each pixel is represented by a visual indication.”, Figs. 8A, 9A-10B See also [0027], [0064]) comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user ([0163]-[0164], [0166]-[0168], [0188], [0200], [0202]-[0204], Figs. 10A-B see also [0172]; Determines if your targeted goal/compliance level of weight shifts is achieved); and
generating electronic notifications based on the detected compliance level ([0025], [0032], [0200], [0202]-[0204], Figs. 10A-B).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 14, an interpretation of Smith further discloses detecting at least a first time period when the wheelchair user is seated and detecting at least a second time period when the wheelchair user is not seated ([0045] including “As a next preferred step, the CPU 310 will attempt to determine whether or not a patient is present in the bed, chair, etc. This might be done many ways, but in the case where the sensor is a pressure sensitive bed mat 100 or chair mat 200 this step 415 is easily accomplished by checking to see if the patient's weight has “closed” the switch.”, [0056]; determine when the person sits down and gets up off the mat it is recites checking repeatedly each time period. Determine someone sitting down in one time period and getting up in a later time period).
Regarding claim 15, an interpretation of Smith further discloses detecting a shift period when the patient's weight shifts from a baseline seated position ([0019], [0055], [0089], [0093], Fig. 4).
Regarding claim 16, an interpretation of Smith further discloses detecting a pressure change of at least a predefined magnitude relative to a baseline sitting pressure that occurs in at least a predefined number of pressure sensors ([0018]-[0019] including “a patient movement threshold”, [0049] subtracting sensor measurements at different points in time to determine a shift, [0055] including “a grid of individual sensor points 1020 might be used to more precisely determine the location of the patient.”, [0061]; tracks the difference from previous readings and where on the grid, to determine for example shifting from those on the right side to the left to ensure the shift is significant) and lasts at least a predefined time period ([0019], [0055], [0089], [0093], Fig. 4).
Regarding claim 17, an interpretation of Smith further discloses obtaining a predefined recommended duration for a first time interval ([0021], [0055], [0089] see also [0022]; setting parameters such as time intervals); and
detecting, during the first time interval, a duration of the weight shift ([0055], [0089]).
An interpretation of Smith may not explicitly disclose determining the compliance level based on the duration of the weight shift relative to the predefined recommended duration.
However, in the same field of endeavor (medical devices), Shalom teaches durations of weight shifts within a time interval ([0191], [0203]-[0204], Fig. 8C) determining the compliance level based on the duration of the weight shift relative to the predefined recommended duration ([0191], [0203]-[0204]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria including durations to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Regarding claim 18, an interpretation of Smith may not explicitly disclose determining respective compliance levels for each of a sequence of time intervals.
However, in the same field of endeavor (medical device), Shalom teaches determining respective compliance levels for each of a sequence of time intervals ([0143], [0163], [0191], [0200], [0202]-[0204]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level including current readings, readings over time, and/or daily/weekly etc. target compliance as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
Claim Rejections - 35 USC § 103
Claim(s) 2, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Shalom in further view of US 20190104982 to Raymond Dunn et al. (hereinafter Dunn).
Regarding claim 2, an interpretation of Smith discloses receiving data for each pressure sensor with the sensor grid ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082]) a microcontroller integrated with the sensor grid ([0041]-[0042], Figs. 2-3; Examiner notes that Fig. 3 is the same concept as Applicants Fig. 2b showing the PCB connected to the layers. This is also shown by Shalom in Fig. 7A)
An interpretation of Smith may not explicitly disclose a microcontroller integrated in the sensor grid; a time-averaged pressure measurement averaged over time per sensor.
However, in the same field of endeavor (medical devices), Dunn teaches a microcontroller/processor integrated in a pressure sensor ([0054], [0099], [0102]-[0103], Figs. 2A-2b, 5, 12a-12b see also [0047], [0078]) a time-averaged pressure measurement averaged over time ([0008], [0045] including “moving averages”, [0078], [0099], [0102]-[0104]; recites analyzing data from each sensor including using various elements such averages).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include having the processor integrated in the sensor and taking calculating an average over time each sensor positions measurements as recited by Dunn because having information of the pressure on different subportions of the total measured area can provide an indication to the user of the areas at greater risk of pressure wounds and allow them to take action to avoid pressure ulcers ([0004], [0063], [0078])
Regarding claim 5, an interpretation of Smith in view of Shalom as discussed in claim 1 discloses the receiving the data at a user device ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082]; Shalom also discloses this [0076], [0079] Fig. 1b).
An interpretation of Smith may not explicitly disclose receiving the data in batch upon the user device establishing a connection.
However, in the same field of endeavor (medical devices), Dunn teaches receiving the data in batch upon the user device establishing a connection ([0054] including “the sensor device 110 can store measurement data in the memory and specifically if the connection between the communications interface 118 of the sensor device 110 and an external device is interrupted. The stored measurement data can be transmitted at a later time when the connection is re-established.” See also [0007], [0043]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include providing data to a user device when a connection is reestablished as recited by Dunn because having information of the pressure on different subportions of the total measured area can be used to provide an indication to the user of the areas at greater risk of pressure wounds and allow them to take action to avoid pressure ulcers ([0004], [0063], [0078])
Claim Rejections - 35 USC § 103
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Shalom in further view of US 20160228050 to Binay Sugla et al. (hereinafter Sugla) or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Smith in view of Shalom in further view of Sugla in further view of Dunn.
Regarding claim 11, an interpretation of Smith may not explicitly disclose communicating the compliance levels to a remote processing server.
However, in the same field of endeavor (medical devices), Shalom teaches communicating compliance levels to a remote processing server ([0076]-[0077], [0079], [0153]; data from the local device is stored on the server).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance, transferring data for processing and/or storage to a remote computing device and outputting a notification based on compliance level including current readings, readings over time, and/or daily/weekly etc. target compliance as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
An interpretation of Smith may not explicitly disclose obtaining information for the electronic notifications from the remote processing server.
However, in the same field of endeavor (medical devices), Sugla teaches obtaining information for the electronic notifications from the remote processing server ([0044], [0052] Figs. 2, 3A; obtains data for notifications from server).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array, processing data and communicating compliance levels to a server as recited by Smith in view of Shalom to include receiving notifications from the remote processing server as recited by Sugla because it is merely combining prior art elements according to known methods to yield predictable results; the elements above are known as shown by Smith in view Shalom and the Sugla references respectively combining the transfer of information from the remote server to a device for display yields the predictable result of presenting data to a user on the device based on the data transferred from a server.
While Examiner believes the elements are disclosed above if it is determined that the processed data is not communicated to the server, then in the alternative Dunn teaches data storage and processing steps can occur locally, remotely or a combination of both ([0007] including “Data can be processed onboard the sensor device or on the local device, or remotely or combinations thereof.”, [0043], [0071] see also [0054]-[0055], [0072]; the storage data and/or processing can occur on a computing device or across the computing elements local or remote. It also discusses that each of the steps including a computing device with memory and processing).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include processing and storage on whichever device or combination of devices as desired as recited by Dunn because having information of the pressure on different subportions of the total measured area can provide an indication to the user of the areas at greater risk of pressure wounds and allow them to take action to avoid pressure ulcers ([0004], [0063], [0078]). Additionally, in view of the discussion of Dunn providing processing/storage on one computing device as opposed to another computing device is merely a simple substitution of one known element for another to obtain predictable results; processing devices with associated storage devices are disclosed using them to process data and store data is a predictable result of their use.
Claim Rejections - 35 USC § 103
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Shalom in further view of US 20090070939 to Elly Hann (hereinafter Hann).
Regarding claim 19, an interpretation of Smith discloses a shift compliance management system (abstract, [0075]) comprising:
a sensing device for individually sensing pressure at different locations ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082])
a processing device ([0041]-[0042], [0045], [0075], [0092]) comprising:
a processor ([0041]-[0042], [0045], [0075], [0092]); and
a non-transitory computer-readable storage medium storing instructions for managing shift compliance for preventing pressure ulcers in a wheelchair user (abstract, [0075], [0095]), the instructions when executed by a processor causing the processor to perform steps including:
receiving by a compliance management application at each of a sequence of time points, a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region ([0045], [0064]-[0065], [0075], Figs. 2, 10b see also [0082]);
processing ([0041]-[0042], [0045], [0075], [0092]) the pressure measurements to identify weight shifts meeting detection criteria ([0045], [0048], [0055]; determining if the shift is significant is the meeting of the detection criteria);
An interpretation of Smith may not explicitly disclose comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user; and generating electronic notifications based on the detected compliance level.
However, in the same field of endeavor (medical devices), Shalom teaches a two-dimensional array of pressure measurements from a sensor grid placed underneath a gluteal region and receiving the data at processor with software ([0074], [0076], [0079], [0165], [0218] including “a matrix of pixels, each pixel representing one sensor of the pressure-detection sheet. The pressure detected by each pixel is represented by a visual indication.”, Figs. 8A, 9A-10B See also [0027], [0064]) comparing the weight shifts with compliance criteria to detect a compliance level of the wheelchair user ([0163]-[0164], [0166]-[0168], [0188], [0200], [0202]-[0204], Figs. 10A-B see also [0172]; Determines if your targeted goal/compliance level of weight shifts is achieved); and
generating electronic notifications based on the detected compliance level ([0025], [0032], [0200], [0202]-[0204], Figs. 10A-B).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include comparing the data to shift compliance criteria to detect compliance and outputting a notification based on compliance level as recited by Shalom because it provides the user (patient, caregiver or etc.) with the ability to track the pressure on the body and body shifts on their device to prevent pressure wounds ([0006]-[0007], [0203]) it also allows for the user the ability for patient to be credited for their success throughout the day when targets are achieved ([0188]).
An interpretation of Smith may not explicitly disclose a sensor device comprising a lower layer comprising a substantially rigid material; an interior sensor layer comprising a sensor grid for individually sensing pressure at different locations; and an upper layer comprising a cushioning material.
However, in the same field of endeavor (medical devices), Hann teaches a sensor device comprising a lower layer comprising a substantially rigid material ([0055] including “a pressure re-distribution surface such as resilient foam”, Fig. 3 see also [0051]; The specification does not recite “rigid” anywhere but in discussing the layer in [0030] recites “a substantially stiff underlayment 222 (e.g., a plastic such as ABS, rubber, or foam)” thus reading the claim in view of the specification the claim element is being interpreted in view of the disclosure); an interior sensor layer comprising a sensor grid material ([0055], Fig. 3 see also [0051]; and an upper layer comprising a cushioning material ([0055], Fig. 3 see also [0051]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include the particular aspects of the embedding of the sensor array within layers as recited by Hann because the layers provide a resilient protective cover for the sensor array ([0055]).
Claim Rejections - 35 USC § 103
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Shalom in further view of Hann in further view of Dunn.
Regarding claim 20, Smith discloses the above in claim 19. An interpretation of Smith may not disclose a controller and a processing device. However, in the same field of endeavor (medical devices), Dunn teaches a controller including a data cache for temporarily storing the pressure measurements obtained from the sensors ([0054]-[0055], [0081], Figs. 1, 6c); and a communication interface for wireless communicating the sensor measurements from the data cache to the processing device ([0053]-[0055], [0081], Figs. 1, 6c).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified receiving pressure sensor readings from a sensor array and processing the data as recited by Smith to include processing and storage on whichever device or combination of devices as desired as recited by Dunn because having information of the pressure on different subportions of the total measured area can provide an indication to the user of the areas at greater risk of pressure wounds and allow them to take action to avoid pressure ulcers ([0004], [0063], [0078]). Additionally, in view of the discussion of Dunn providing processing/storage on one computing device as opposed to another computing device is merely a simple substitution of one known element for another to obtain predictable results; processing devices with associated storage devices are disclosed using them to process data and store data is a predictable result of their use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
John Peifer et al., US 20050131318
US 20200214622 – discloses at least applying a recommendation algorithm to generate a patient-specific shift recommendation – [0047], [0058] including “Information regarding each patient's pressure ulcer history, Braden score, and other conditions of the patient can be entered into the monitoring system. The computer can recommend an optimal repositioning schedule based on patient-specific data.”
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/James Moss/Examiner, Art Unit 3792
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