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 .
Response to Amendment
The Amendments filed 23rd January 2026 have been entered. Claims 1-12 & 14-20 are pending. Claim 13 is canceled.
Response to Arguments
In response to the Applicant’s arguments regarding the rejection under 35 U.S.C. § 101 of claims 2-4 & 19-20; Applicant argues that the human mind cannot practically detect a pressure applied to a pressure sensor, nor can it transmit a detected pressure to a monitoring device. The Applicant is pointed to the 101 rejection below, maintained as previously rejected, where the abstract ideas and additional elements are defined through underlining and bold text, respectively. The pressure sensors are not part of the abstract idea, they are identified as additional elements that are generically recited within the claims and do not provide significantly more, and remain so, without amendments. The abstract ideas underlined in the 101 rejection fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind including observation, evaluation, judgement, and evaluation/opinion. See MPEP 2106.04(a)(2), subsection III.
Specifically, claim 2 recites detecting a pressure and transmitting detected pressure, which can be practically performed in the human mind using at least one of observation, evaluation, judgement, or opinion. The claimed ‘detect a pressure’ encompasses observing data, and ‘transmit the detected pressure’ encompasses outputting data through observation. Claims 3 & 4 recite the same limitations with the added ‘continuously’, ‘store’ and ‘periodically’ requirements, which still encompasses observing data and outputting observed data. Claim 19 recites ‘transform at least one of the pressures detected by the array of pressure sensors into a parameter indicative of a potential pressure injury to tissue’ which encompasses making a determination via judgement, well within the capability of the human mind. Claim 20 is stated to include limitations that further define the abstract idea, but a narrow abstract idea is still an abstract idea.
Applicant further argues that the claims include additional limitations that integrate the alleged exception into a practical application, and a purported improvement in the technical field is described. Examiner respectfully disagrees with Applicant, the additional limitations incorporate generically recited additional elements, and the purported improvement to a technical field is not currently reflected in the claims as amended.
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field. See MPEP § 2106.05(a)
The evaluation of whether the claims as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is ‘directed to’ the judicial exception is performed by identifying additional elements recited in the claim beyond the judicial exception and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The claims recite additional elements of an array of pressure sensors, and memory. The claims recite that the memory stores instructions for a processor to execute the limitations using the pressure sensors.
The limitations as underlined in the rejection below are mere data gathering, and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claims. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
Further, the limitations are executed on a processor and utilize pressure sensors. The processor and pressure sensors are recited at a high level of generality. The process and pressure sensors are used to perform an abstract idea, such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.05(f). There is no indication that the claim as a whole includes an improvement to a computer or to a technological field, as a technical explanation of the asserted improvement presented in the specific is not reflected in the claims. See MPEP 2106.04(d)(1). According to the specification and the Applicant’s arguments, existing systems are manually conducted and do not account for differences in patient body habitus, illness, ability to shift position, and ability of a patient to sense painful pressure secondary to ischemia. Applicant also cites comparison to known pressure mats however, citing that the invention of the instant application improves upon known pressure mats via being smaller, more flexible, more portable, and being self-contained. The claimed invention fails to reflect this improvement in the technological field as currently amended. Thus the claim as a whole does not integrate the judicial exception into a practical application such that the claim is not directed to the judicial exception. The additional elements, when considered in combination, do not integrate the abstract idea into a practical application because the claims do not improve the functioning of a computer or technical field. Thus, Applicant’s arguments regarding the rejection under 35 U.S.C. § 101 of claims 2-4 & 19-20 are unpersuasive and the rejection is maintained below.
In response to Applicant’s arguments regarding the rejections under 35 U.S.C. § 102 & 103; Applicant argues that Ben-Shalom fails to teach including the controller within the same housing that encloses the array of pressure sensors, and does not include a fPCB including two or more separate surfaces interconnected by flexible, conductive interconnects, wherein the array of pressure sensors, the controller, and the communication interface are electrically mounted on the fPCB. Further, Applicant argues the additional references cited in the Office Action do not overcome the deficiencies of Ben-Shalom with respect to claim 1. Applicants arguments are not persuasive, US 20220395229 A1 to Everett et al. teaches this as shown in the rejection below, updated to account for amendments.
Applicant further argues that Ben-Shalom does not include a housing configured for attaching the mat to a patient’s body, Applicants argument has been considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Rejections - 35 USC § 101
Claims 2-4 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 2-4 and 19-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 2-4 and 19-20 recites at least one step or instruction for receiving and transmitting data, and/or making determinations based on data, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 2-4 and 19-20 recites an abstract idea.
Specifically:
Claim 2: wherein the memory stores instructions that, when executed by the processor, configure the controller to: detect a pressure applied (Observation) to each pressure sensor of the array of pressure sensors; and transmit the detected pressure applied (Observation) to each pressure sensor to a monitoring device using the communication interface.
Claim 3: wherein the instructions stored in the memory further configure the processor to continuously detect the pressure applied (Observation) to each pressure sensor and to continuously transmit the detected pressure applied (Observation) to each pressure sensor to the monitoring device.
Claim 4: wherein the instructions stored in the memory further configure the processor to: continuously detect the pressure applied (Observation) to each pressure sensor; store the detected pressures applied (Observation) to each pressure sensor in the memory; and periodically transmit the stored detected pressures applied (Observation) to each pressure sensor to the monitoring device.
Claim 19: wherein the monitoring device is configured to store signals indicative of pressures detected by the array of pressure sensors and to transform at least one of the pressures detected by the array of pressure sensors into a parameter indicative of a potential pressure injury to tissue (Judgement) adjacent the CBPM.
(additional element); (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
Further, dependent Claim 20 merely includes limitations that further define the abstract idea (and thus don’t make the abstract idea any less abstract).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of Claims 2-4 and 19-20 is not integrated into a practical application under 2019 PEG because the additional elements identified above in Claims 2-4 and 19-20, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: Processor, memory storing instructions, controller, fPCB, pressure sensor (array; each of), monitoring device, communication interface, CBPM
are generically recited computer elements in Claims 2-4 and 19-20 which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 2-4 and 19-20 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Claims 2-4 and 19-20 is not integrated into a practical application under the 2019 PEG.
Accordingly, Claims 2-4 and 19-20 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 2-4 and 19-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: processor ([0046];[0070]), memory storing instructions ([0046]; [0070]), controller ([0046]; [0055]), pressure sensor (array; each of) ([0059-0061]), monitoring device ([0066]), communication interface ([0055]), CBPM ([0055]; [0066]).
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, processor ([0046];[0070]), memory storing instructions ([0046]; [0070]), controller ([0046]; [0055]), pressure sensor (array; each of) ([0059-0061]), monitoring device ([0066]), communication interface ([0055]), CBPM ([0055]; [0066]).
Accordingly, in light of Applicant’s specification, the claimed term processor; monitoring device; communication interface is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor; monitoring device; communication interface. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 2-4 and 19-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and system, of Claims 2-4 and 19-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 2-4 and 19-20 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in Claims 2-4 and 19-20 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 2-4 and 19-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 2-4 and 19-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 2-4 and 19-20 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claim(s) 1-3, 5-8, 10-12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2010119441 A2 to Ben-Shalom et al. (hereinafter, Ben-Shalom) in view of US 20220395229 A1 to Everett et al. (hereinafter, Everett) in further view of US 20190104982 A1 to Dunn et al. (hereinafter, Dunn).
Regarding Claim 1, Ben-Shalom discloses a continuous bedside pressure monitoring (CBPM) device (Ben-Shalom: Abstract) comprising: an array of pressure sensors (Ben-Shalom: Fig. 1a shows a pressure sensor array 132, all sensors are labeled item 132 in the array);
a controller (Ben-Shalom: Fig. 1a items 140/150/160 combined) including a processor (Ben-Shalom: Pg. 2, lines 26-28; Fig. 1a item 150) and a memory (Ben-Shalom: Pg. 3, lines 3-4; item 160),
the controller operatively coupled to the array of pressure sensors (Ben-Shalom: Pg. 2, lines 26-27; Fig. 1a shows the controller 140/150/160 combined operatively coupled to pressure sensor array 132, all sensors are labeled item 132 in the array);
a communication interface operatively coupled to the controller (Ben-Shalom: Pg. 6, lines 2-3; Examiner’s note: wireless data transmission would require a communication interface ); and
a flexible housing (Ben-Shalom: Pg. 9, lines 10-16) enclosing the array of pressure sensors, the controller, and the communication interface (Ben-Shalom: Fig. 1a; Pg. 5, lines 17-19; Pg. 5, lines 29-30).
Ben-Shalom is silent on a flexible printed circuit board (fPCB), wherein the array of pressure sensors, the controller and the communication interface are electrically mounted on the fPCB, the housing configured for attaching the CBPM device to a patient’s body.
However, Everett teaches a flexible printed circuit board (fPCB) including two or more separate surfaces interconnected by flexible, conductive interconnects, wherein the array of pressure sensors, the controller, and the communication interface are electrically mounted on the fPCB (Everett: Para. [0228]-[0229]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the circuitry of Ben-Shalom by substituting the flexible PCB taught by Everett to improve flexibility, durability, and reduce stress/strain to the circuit board while in use (Everett: Para. [0229])
Further, Dunn teaches the housing configured for attaching the CBPM device to a patient’s body (Dunn: Para. [0047]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the housing of Ben-Shalom to be configured for attaching to a patient’s body as taught by Dunn to account for specific locations on the body that are prone to developing pressure ulcers (Dunn: Para. [0047]).
Regarding Claim 2, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom further discloses wherein the memory stores instructions that, when executed by the processor, configure the controller to: detect a pressure applied to each pressure sensor of the array of pressure sensors (Ben-Shalom: Pg. 12, line 29-Pg.13, line 2); and
transmit the detected pressure applied to each pressure sensor to a monitoring device using the communication interface (Ben-Shalom: Pg. 12, line 29-Pg.13, line 2; Pg. 5, lines 26-28 [monitoring device]; Pg. 6, lines 2-3; Examiner’s note: wireless data transmission would require a communication interface).
Regarding Claim 3, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 2. Ben-Shalom further discloses wherein the instructions stored in the memory further configure the processor to continuously detect the pressure applied to each pressure sensor (Ben-Shalom: Pg. 12, lines 29-31; Pg. 13, lines 5-6) and
to continuously transmit the detected pressure applied to each pressure sensor to the monitoring device (Ben-Shalom: Pg. 13, lines 5-6; Pg. 5, lines 26-28 [monitoring device]; Pg. 12, lines 29-31).
Regarding Claim 5, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom further discloses further comprising a power source coupled to the controller to provide power for the controller (Ben-Shalom: Pg. 5, lines 17-19; Fig. 1a),
Ben-Shalom does not explicitly disclose the power source being located within the flexible housing.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the power source and the flexible housing of Ben-Shalom so that the power source is located within the flexible housing. The use of one piece construction instead of the structure disclosed in Ben-Shalom would be merely a matter of obvious engineering choice. See MPEP 2144.04 V. B.. Further, rearranging the position of the power source to be held within the flexible housing would not modify the operation of the device. The particular placement of a power source in a flexible housing is held to be an obvious matter of design choice. See MPEP 2144.04 VI. C.
Regarding Claim 6, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 5. Ben-Shalom further discloses wherein the power source comprises a rechargeable battery (Ben-Shalom: Pg. 11, lines 17-20).
Regarding Claim 7, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 6. While Ben-Shalom discloses a rechargeable battery (Ben-Shalom: Pg. 11, lines 17-26), but a charging interface is absent from Ben-Shalom.
However, Everett teaches further comprising a charging interface coupled to the rechargeable battery to provide power to recharge the rechargeable battery (Everett: Para. [0238] and [0244]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the power source of Ben-Shalom to specify having a charging interface to provide power to recharge the rechargeable battery as taught by Everett, it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case, the means to provide power to recharge the rechargeable battery and would yield predictable results of allowing the rechargeable battery taught by Ben-Shalom to be recharged.
Regarding Claim 8, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 7. Ben-Shalom does not explicitly state structure of a charging interface comprising a planar coil for wireless charging.
However, Everett further teaches wherein the charging interface comprises a planar coil for wireless charging (Everett: Para. [0238] and [0244]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the power source of Ben-Shalom to include a charging interface comprising a planar coil for wireless charging as taught by Everett to enable wireless charging as a charging option for the device thus enabling flexibility (Everett: Para. [0163]) and would yield predictable results of allowing the rechargeable battery taught by Ben-Shalom to be recharged.
Regarding Claim 10, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom discloses a communication interface (Ben-Shalom: Pg. 3, lines 17-18), but the embodiment does not explicitly disclose the communication interface being wireless.
However, another embodiment of Ben-Shalom further discloses wherein the communication interface comprises a wireless communication interface (Ben-Shalom: Pg. 6, lines 22-32).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the communication interface of Ben-Shalom to be wireless as taught by another embodiment of Ben-Shalom to configure the device to move as where the subjected is seated in a wheelchair or the like, where wired data cables may be inappropriate and data transmission via wireless means may be preferred (Ben-Shalom: Pg. 6, lines 28-32).
Regarding Claim 11, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom discloses a communication interface (Ben-Shalom: Pg. 3, lines 17-18), but the embodiment does not explicitly disclose the communication interface comprising a wireless transceiver operating according to a Bluetooth specification.
However, another embodiment of Ben-Shalom further discloses wherein the wireless communication interface comprises a wireless transceiver operating according to a Bluetooth specification (Ben-Shalom: Pg. 6, lines 22-32).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the communication interface of Ben-Shalom to be wireless comprising Bluetooth as taught by another embodiment of Ben-Shalom to configure the device to move as where the subjected is seated in a wheelchair or the like, where wired data cables may be inappropriate and data transmission via wireless means may be preferred (Ben-Shalom: Pg. 6, lines 28-32).
Regarding Claim 12, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom further discloses further comprising a temperature sensor within the flexible housing (Ben-Shalom: Pg. 2, lines 20-22) and
operatively coupled to the controller and to the power source (Ben-Shalom: Pg. 5, lines 16-19; Pg. 2, lines 20-23;).
Regarding Claim 16, Ben-Shalom discloses a continuous bedside pressure monitoring (CBPM) system (Ben-Shalom: Abstract), the system comprising: a CBPM device (Ben-Shalom: Pg. 2, lines 7-9) including:
an array of pressure sensors (Ben-Shalom: Fig. 1a shows a pressure sensor array 132, all sensors are labeled item 132 in the array);
a controller (Ben-Shalom: Fig. 1a items 140/150/160 combined)) including a processor (Ben-Shalom: Pg. 2, lines 26-28; Fig. 1a item 150) and a memory (Ben-Shalom: Pg. 3, lines 3-4; Fig. 1a item 160),
the controller operatively coupled to the array of pressure sensors (Ben-Shalom: Pg. 2, lines 26-27; Fig. 1a shows the controller 140/150/160 operatively coupled to pressure sensor array 132, all sensors are labeled item 132 in the array);
a communication interface operatively coupled to the controller (Ben-Shalom: Pg. 6, lines 2-3; Examiner’s note: wireless data transmission would require a communication interface); and
a flexible housing (Ben-Shalom: Pg. 9, lines 10-16) enclosing the array of pressure sensors, the controller, and the communication interface (Ben-Shalom: Fig. 1a; Pg. 5, lines 17-19; Pg. 5, lines 29-30); and
a monitoring device operatively coupled to the CBPM device (Ben-Shalom: Pg. 3, lines 5-8; Pg. 15, lines 10-14; Fig. 1a Display Unit 170 shown operatively coupled to the device).
Ben-Shalom is silent on a flexible printed circuit board (fPCB), wherein the array of pressure sensors, the controller and the communication interface are electrically mounted on the fPCB, the housing configured for attaching the CBPM device to a patient’s body.
However, Everett teaches a flexible printed circuit board (fPCB) including two or more separate surfaces interconnected by flexible, conductive interconnects, wherein the array of pressure sensors, the controller, and the communication interface are electrically mounted on the fPCB (Everett: Para. [0228]-[0229]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the circuitry of Ben-Shalom by substituting the flexible PCB taught by Everett to improve flexibility, durability, and reduce stress/strain to the circuit board while in use (Everett: Para. [0229])
Further, Dunn teaches the housing configured for attaching the CBPM device to a patient’s body (Dunn: Para. [0047]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the housing of Ben-Shalom to be configured for attaching to a patient’s body as taught by Dunn to account for specific locations on the body that are prone to developing pressure ulcers (Dunn: Para. [0047]).
Regarding Claim 17, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 16. Ben-Shalom further discloses wherein the CBPM device and the monitoring device are operatively coupled by a wireless connection (Ben-Shalom: Pg. 3, lines 5-9; Pg. 6, lines 2-3; Examiner’s note: wireless data transmission would require a communication interface).
Regarding Claim 18, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 17. Ben-Shalom further discloses wherein the monitoring device comprises at least one of a personal computer, a server system, a tablet, a cellular telephone, a cloud-based storage system, an electronic medical record (EMR) system, or any combination thereof (Ben-Shalom: Pg. 3, lines 5-9).
Regarding Claim 19, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 16. Ben-Shalom further discloses wherein the monitoring device is configured to store signals indicative of pressures detected by the array of pressure sensors (Ben-Shalom: Pg. 14, line 30-Pg. 15, line 1) and
to transform at least one of the pressures detected by the array of pressure sensors into a parameter indicative of a potential pressure injury to tissue adjacent the CBPM (Ben-Shalom: Pg. 7, lines 19-21; Pg. 14, line 30-Pg. 15, line 8).
Regarding Claim 20, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 19. Ben-Shalom further discloses wherein the parameter indicative of the potential pressure injury comprises at least one of a tissue pressure exceeding a pressure injury threshold and a cumulative pressure dosage exceeding a dosage threshold (Ben-Shalom: Pg. 13, lines 9-13).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Shalom in view of Everett in view of Dunn in further view of US 20100100160 A1 to Edman et al. (hereinafter, Edman)
Regarding Claim 4, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 2. Ben-Shalom further discloses wherein the instructions stored in the memory further configure the processor to: continuously detect the pressure applied to each pressure sensor (Ben-Shalom: Pg. 12, lines 29-31; Pg. 13, lines 5-6);
store the detected pressures applied to each pressure sensor in the memory (Ben-Shalom: Pg. 2, lines 25-28; Pg. 3, lines 3-4); and
While Ben-Shalom discloses continuously transmitting the detected pressure applied to each pressure sensor to the monitoring device (Ben-Shalom: Pg. 13, lines 5-6; Pg. 5, lines 26-28 [monitoring device]; Pg. 12, lines 29-31), transmitting the stored detected pressures periodically is absent from Ben-Shalom.
However, Edman teaches periodically transmitting the stored detected pressures applied to each pressure sensor (Edman: Para: [0042] ‘Once activated, device 200 may periodically take sensor measurement data utilizing preprogrammed instructions and store measured values. These measured data and/or analysis characterizing the measured body regions within the inspected zone may then be displayed either periodically, upon determination that measurements from one or more regions exceeding preset parameters, or upon command, e.g. signals transmitted to the receiving antenna to initiate display activities..’ ).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the data transmission of Ben-Shalom to incorporate periodic transmission as taught by Edman, it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case, to transmit data to a device that may display, further analyze, combine/analyze with other stored data or inputted data or store for future use and review (Edman: Para. [0042] ‘said data and analysis in certain embodiments may be wirelessly transmitted to a local device that may display, further analyze, combine/analyze with other stored data or inputted data or store for future use and review. In response to said displayed or transmitted data and analysis, one or more therapeutic actions may be enabled to target one or more regions.’).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Shalom in view of Everett in view of Dunn in further view of US 20170020438 A1 to Wang.
Regarding Claim 9, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. Ben-Shalom does not explicitly disclose wherein each pressure sensor comprises a force sensitive resistor.
However, Wang further teaches wherein each pressure sensor comprises a force sensitive resistor (Wang: Para. [0070] ‘For Pressure Sensing this embodiment uses Force-Sensitive Resistor (FSR) sensors’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pressure sensors of Ben-Shalom to use the force-sensitive resistor sensors as taught by Wang, it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the sensors of Ben-Shalom with those of Wang, to detect pressure and body movement changes (Wang: Para. [0070] ‘For Pressure Sensing this embodiment uses Force-Sensitive Resistor (FSR) sensors and an Arduino platform to detect postural changes.’)
Claim(s) 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Shalom in view of Everett in view of Dunn in further view of US 20200352501 A1 to Hunt et al. (hereinafter, Hunt).
Regarding Claim 14, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 1. While Ben-Shalom teaches the flexible housing (Ben-Shalom: Pg. 9, lines 10-16) being washable and water resistant (Ben-Shalom: Pg. 9, lines 20-22), a flexible waterproof casing is absent from Ben-Shalom.
However, Hunt teaches wherein the flexible housing comprises a flexible waterproof casing (Hunt: Para. [0255] ‘Some or all of the sensors and electrical or electronic components may be potted or encapsulated (for example, rendered waterproof or liquid-proof) with a polymer, for example, silicone or epoxy based polymers.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the flexible housing of Ben-Shalom to be waterproof to prevent fluids leaking into the components (Hunt: Para. [0255] ‘The encapsulation with a polymer can prevent ingress of fluid and leaching of chemicals from the components’).
Regarding Claim 15, Ben-Shalom in view of Everett in further view of Dunn discloses the invention as discussed in Claim 14. While Ben-Shalom teaches the flexible housing (Ben-Shalom: Pg. 9, lines 10-16) being washable and water resistant (Ben-Shalom: Pg. 9, lines 20-22), a flexible waterproof casing comprising silicone is absent from Ben-Shalom.
However, Hunt further teaches wherein the flexible waterproof casing comprises silicone (Hunt: Para. [0255] ‘Some or all of the sensors and electrical or electronic components may be potted or encapsulated (for example, rendered waterproof or liquid-proof) with a polymer, for example, silicone or epoxy based polymers.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the flexible housing of Ben-Shalom to comprise silicone as one alternative to prevent fluids leaking into the components (Hunt: Para. [0255] ‘The encapsulation with a polymer can prevent ingress of fluid and leaching of chemicals from the components’).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791