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 .
This Office action is responsive to an amendment filed April 2, 2026. Claims 1-17 & 30-31 are pending. Claims 1-9 are withdrawn. Claims 10-11, 16 & 30-31 have been amended. Claims 18-29 have been canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-17 & 30-31 is/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.
In regards to claim 10, at line 17, the claim requires the limitations “the microprocessor configured with software to…use physical activity data to monitor the health of the foot of the patient” [emphasis added], which are not disclosed in the original specification. For example, par 0091 of the original specification reads as follows:
[0091] Models can be continually improved as additional data is gathered, and updated to reflect state-of-the-art clinical research. The models also can be designed to take into account a variety of potentially confounding factors, such as physical activity (e.g., running), environmental conditions (e.g., a cold floor), personal baselines, past injuries, predisposition to developing problems, and problems developing in other regions (e.g., a rise in temperature recorded by a sensor 26 may be due to an ulcer 12 developing in a neighboring region measured by a different sensor). In addition to using these models for delivering real-time analysis of users, they also may be used off-line to detect significant patterns in large archives of historical data. For example, a large rise above baseline temperature during a period of inactivity may precede the development of an ulcer 12. [Emphasis added]
The specification completely fails to teach a microprocessor that uses physical activity, let alone physical activity data. Instead, the specification describes models that take physical activity into account, e.g., without a microprocessor itself necessarily using physical activity, physical activity data or taking physical activity into account. Instead, the microprocessor may be pre-programmed with user-customized software that accounts for the physical activity of each individual user in accordance with the models, without the microprocessor itself actively taking physical activity into account.
Moreover, while the specification describes “tak[ing] into account a variety of potentially confounding facts such as physical activity (e.g., running),” the specification clearly fails to disclose “us[ing] a physical activity data” as currently claimed, as well as how such “use” is applied in any of a number of different hardware, software, firmware, or other non-known technologies (see at least par 0053 & 0056) including estimation models such as switching Kalman filters (see par 0090) and an Otsu filter (see at least par 0092) as described in the original specification. For example, “taking into account” does not necessarily mean using physical activity or physical activity data. Instead, it may mean conditioning the temperature data to account for the physical activity of the user in accordance with the models by (i) filtering out temperature data that falls outside a predetermined passband or threshold or (ii) using a user-personalized algorithm for analyzing temperature data for users that typically engage in physical activities that is different from the user-personalized algorithm for analyzing temperature data for users that do not typically engage in physical activities.
For examination purposes, any consideration of a physical activity that results in differently categorizing or handling temperature data due to physical activity would be construed as “using” said physical activity data including but not limited to discarding or removing said physical activity-level-related temperature data (i.e., the data is treated as noise).
In regards to claims 30-31, at lines 1-3, the claim requires the limitations “the microprocessor is also configured to take into account at least one confounding factor relating to the foot” [emphasis added], which are not disclosed in the original specification. For example, par 0091 of the original specification reads as follows:
[0091] Models can be continually improved as additional data is gathered, and updated to reflect state-of-the-art clinical research. The models also can be designed to take into account a variety of potentially confounding factors, such as physical activity (e.g., running), environmental conditions (e.g., a cold floor), personal baselines, past injuries, predisposition to developing problems, and problems developing in other regions (e.g., a rise in temperature recorded by a sensor 26 may be due to an ulcer 12 developing in a neighboring region measured by a different sensor). In addition to using these models for delivering real-time analysis of users, they also may be used off-line to detect significant patterns in large archives of historical data. For example, a large rise above baseline temperature during a period of inactivity may precede the development of an ulcer 12. [Emphasis added]
The specification completely fails to teach a microprocessor takes into account at least one cofounding factor related to the foot. Instead, the specification describes models that take at least one cofounding factor related to the foot into account, e.g., without a microprocessor itself necessarily doing so. As such, while the specification describes “tak[ing] into account a variety of potentially confounding facts such as… at least one cofounding factor related to the foot,” the specification clearly fails to disclose a microprocessor that actively does so. Instead, the microprocessor may be pre-programmed with user-personalized software that accounts for environmental conditions and/or past injuries of each individual user in accordance with the models, without the microprocessor itself actively taking the environmental conditions and/or past injuries into account.
For examination purposes, any consideration of at least one cofounding factor related to the foot that results in differently categorizing or handling temperature data would be construed as taking said at least one cofounding factor related to the foot into account.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 10, 16-17 & 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (WO 2009/005373) in view of Rangel et al. (US 2010/0324455) (“Rangel” hereinafter).
In regards to claim 10, Russell discloses a system for monitoring the health of a foot of a patient including predicting emergence of an ulcer on the foot, the foot having a sole and an arch, the system comprising:
a closed platform 2 (i.e., flexible inserts enclosed in shoes, sandals, or boots) configured to generate a plurality of discrete temperature data values of the sole of the foot of the patient (see at least fig. 1 and pg. 5, lines 32-34), which temperature data values are information to be used for determining the health of the foot, the closed platform 2 (i.e., flexible inserts enclosed in shoes, sandals, or boots) comprising a plurality of temperature sensors 4 (see at least pg. 6, lines 10-18), the closed platform 2 (i.e., flexible inserts enclosed in shoes, sandals, or boots) also comprising a flexible material (i.e., mylar) (see at least pg. 6, lines 19-21);
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a microprocessor (see at least fig. 4) configured with software to use said temperature data values for determining the health of the foot, the microprocessor configured with software to:
receive a baseline temperature profile of the foot of the patient (i.e., via self-learning), and to determine whether at least one of the plurality of discrete temperature data values presents one of a plurality of patterns predictive of emergence of an ulcer by comparing the plurality of discrete temperature data values against the baseline temperature profile of the patient (see at least pg. 9, lines 1-6 & 11-34), and
use physical activity data (the Office notes that walking or standing on foot for a length of time requires different levels of physical activity, see at least pg. 8, lines 19-25) of the patient to monitor the health of the foot of the patient including determining whether at least one of the plurality of discrete temperature data values presents one of a plurality of patterns predictive of emergence of an ulcer (see at least pg. 9, lines 17-23); and
produce output information indicating a result of the determinations of whether the plurality of discrete temperature data values present one of the plurality of patterns predictive of emergence of an ulcer (see at least fig. 5 and pg. 10, lines 17-29).
Russell discloses a system, as described above, that fails to explicitly teach a system with the closed platform also comprising a flexible material configured to conform the array of temperature sensors substantially to said arch of the foot.
However, Rangel teaches that it is known to provide a system comprising a closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) configured to generate a plurality of discrete temperature data values of the sole of the foot of the patient, the closed platform comprising a plurality of temperature sensors, the closed platform also comprising a flexible material 106 configured to conform the array of temperature sensors substantially to said arch of the foot (see at least par 0040-0041 & 0151-0152).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Russell with the closed platform also comprising a flexible material 106 configured to conform the array of temperature sensors substantially to said arch of the foot as taught by Rangel since such a modification would amount to applying a known technique (i.e., as taught by Rangel) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as providing support and cushioning for the foot as well as shielding for the electronics from damage (see at least par 0113 of Rangel)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Russell discloses the system as defined by claim 10 wherein said microprocessor (see at least fig. 4) is configured also to use a different plurality of discrete temperature data values (i.e., from temperature values between adjacent areas on the same foot or between feet) to determine whether at least one of the plurality of discrete temperature data values presents one of a plurality of patterns indicative of emergence of an ulcer of the sole of the foot of the patient (see at least pg. 9, lines 11-34).
In regards to claim 17, Russell discloses the system as defined by claim 10 wherein the closed platform 2 (i.e., flexible inserts enclosed in shoes, sandals, or boots) comprises an insole, a shoe, or a sock (see at least fig. 1 and pg. 4, lines 3-6 and pg. 5, lines 32-34).
In regards to claim 30, Russell discloses a system as defined in claim 10, wherein the microprocessor (see at least fig. 4) is also configured to take into account at least one confounding factor relating to the foot, said at least one confounding factor including an environmental (i.e., external) temperature (see at least pg. 8, lines 19-25 and pg. 9, lines 11-34).
In regards to claim 31, Russell discloses the system as defined by claim 10, wherein the microprocessor (see at least fig. 4) is also configured to take into account at least one confounding factor relating to the foot, said at least one confounding factor a past injury (i.e., patient-specific circulatory problems) (see at least pg. 9, lines 1-6).
Claim(s) 11-13 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (WO 2009/005373) in view of Rangel et al. (US 2010/0324455) (“Rangel” hereinafter) further in view of Schmidt (US 2011/0122251).
In regards to claim 11, Russell as modified by Rangel discloses the system as defined by claim 10, that fails to explicitly teach a system wherein the microprocessor is further configured with software to apply at least one transformation to at least the first plurality of discrete temperature data values to align the first features of first plurality of discrete temperature data values with corresponding second features of the second plurality of discrete temperature data values. However, Schmidt teaches that it is known to provide a system wherein the microprocessor is further configured with software to apply at least one affine transformation to at least the first plurality of discrete temperature data values 404 to align the first features of first plurality of discrete temperature data values with corresponding second features of the second plurality of discrete temperature data values 414 (see at least abstract; figs. 1-5B; par 0009-0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the system of Russell as modified by Rangel wherein the microprocessor is further configured with software to apply at least one transformation to at least the first plurality of discrete temperature data values to align the first features of first plurality of discrete temperature data values with corresponding second features of the second plurality of discrete temperature data values as taught by Schmidt since such a modification would amount to applying a known technique (i.e. as taught by Schmidt) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as correlating the first and the second IR image data, e.g. resulting in aligned or registered corresponding IR images (see par 0060 of Schmidt)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 12, Russell as modified by Rangel discloses the system as defined by claim 11, that fails to provide a system wherein the at least one transformation comprises at least one affine transformation. However, Schmidt teaches that it is known to provide a system wherein the at least one transformation comprises an affine transformation (see at least abstract; figs. 1-5B; par 0009-0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the system of Russell as modified by Rangel wherein the at least one transformation comprises an affine transformation as taught by Schmidt since such a modification would amount to applying a known technique (i.e. as taught by Schmidt) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as correlating the first and the second IR image data, e.g. resulting in aligned or registered corresponding IR images (see par 0060 of Schmidt)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 13, Russell as modified by Rangel discloses the system as defined by claim 12, that fails to explicitly teach a system wherein the at least one affine transformation comprises at least one of reflection, rotation, scaling and translation. However, Schmidt teaches that it is known to provide a system wherein the at least one affine transformation comprises at least one of reflection, rotation, scaling and translation (see at least abstract; figs. 1-5B; par 0009-0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the system of Russell as modified by Rangel wherein the at least one affine transformation comprises at least one of reflection, rotation, scaling and translation as taught by Schmidt since such a modification would amount to applying a known technique (i.e. as taught by Schmidt) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as correlating the first and the second IR image data, e.g. resulting in aligned or registered corresponding IR images (see par 0060 of Schmidt)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Russell as modified by Rangel discloses the system as defined by claim 11, that fails to explicitly teach a system wherein the at least one transformation aligns the first features and the second features to a common coordinate system, said orientation module being configured to change the orientation, relative to the common coordinate system, of at least one of the first and second plurality of discrete temperature data values for one or more of X-axis translation, X-axis rotation, Y-axis translation, Y-axis rotation, Z-axis translation, and Z-axis rotation. However, Schmidt teaches that it is known to provide a system wherein the at least one transformation aligns the first features and the second features to a common coordinate system, said controlling comprising changing the orientation, relative to the common coordinate system, of at least one of the first and second plurality of discrete temperature data values for one or more of X-axis translation, X-axis rotation, Y-axis translation, Y-axis rotation, Z-axis translation, and Z-axis rotation (see at least abstract; figs. 1-5B; par 0009-0063). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the system of Russell as modified by Rangel wherein the at least one transformation aligns the first features and the second features to a common coordinate system, said controlling comprising changing the orientation, relative to the common coordinate system, of at least one of the first and second plurality of discrete temperature data values for one or more of X-axis translation, X-axis rotation, Y-axis translation, Y-axis rotation, Z-axis translation, and Z-axis rotation as taught by Schmidt since such a modification would amount to applying a known technique (i.e. as taught by Schmidt) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as correlating the first and the second IR image data, e.g. resulting in aligned or registered corresponding IR images (see par 0060 of Schmidt)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell (WO 2009/005373) in view of Rangel et al. (US 2010/0324455) (“Rangel” hereinafter), Schmidt (US 2011/0122251) further in view of Owen et al. (US 2006/0126085) (“Owen” hereinafter).
Russell as modified by Rangel and Schmidt discloses the system as defined by claim 11, that fails a system wherein the at least one transformation comprises a non-affine transformation.
However, Owen teaches that it is known to provide a system wherein the at least one transformation comprises a non-affine (i.e., non-linear) transformation (see at least abstract and figs. 1A-D & 2-3 and par 0041-0043).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Russell as modified by Rangel and Schmidt wherein the at least one transformation comprises a non-affine transformation as taught by Owen since such a modification would amount to applying a known technique (i.e., as taught by Owen) to a known device (i.e., as taught by Russell) ready for improvement to achieve a predictable result such as changing the color of the temperature profile in a non-linear fashion in order to highlight desired thermal aspects of the resulting temperature profile--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed April 2, 2026 have been fully considered but they are not persuasive. Applicant contends that the prior art fails to teach a closed platform comprising a flexible material configured to conform the array of temperature sensors substantially to said arch of the foot. The Office respectfully traverses.
For example, Rangel clearly teaches that the layer 106 is "a conforming top layer" (see at least par 0041-0042 & 00151-0152). In par 0029, Rangel further teaches that the sensor array including the temperature sensors can be formed in the top layer, which is part of the sole portion (see par 0040), which lies underneath the foot when the footwear orthotic is placed on the foot of a wearer (see par 0044). Therefore, the top or upper layer 106, as stated verbatim in Rangel, "is a conforming top material having a hardness of 40 shore 00 to 45 shore A" (see par 0151 thereof). The Office takes Official notice that a shore 00 scale is known to measure the softest elastomers, gels and foams1. Therefore, a 40 shore 00, as called for in Rangel, refers to a highly flexible and extremely soft material, especially when considering that said material is merely used as a thin, upper or top layer 106 of the insole of Rangel rather than the entire insole itself. Therefore, Rangel clearly anticipates a top or upper layer 106 that conforms to the shape of the foot and therefore facilitates contact between the sensors therein and the shape of the foot as claimed. In view of the foregoing, the rejections over at least Rangel and Russell are maintained.
In view of the foregoing, the rejections over at least Russell are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
1 See at least WO 03/061420
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