DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office action is responsive to an amendment filed October 29, 2025. Claims 4-34 are pending. Claims 1-3 have been canceled. No claim has been amended. New claims 30-34 have been added.
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: claim 4 requires the limitations “ascertaining a level of physical activity of the patient,” and “the ulcer prediction model using…the level of physical activity of the patient” that are not described in the specification and thus lack proper antecedent basis. For example, the body of the specification never discusses a level of physical activity.
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.
Claims 4-25 & 27-34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rangel et al. (US 2010/0324455) (“Rangel” hereinafter) in view of Russell et al. (WO 2009/005373).
In regards to claim 4, Rangel discloses a method of predicting emergence of an ulcer on at least one foot of a patient who engages in physical activity, wherein the at least one foot has a bottom surface, the method comprising:
positioning the at least one foot within a closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151), the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) having a plurality of temperature sensors, the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprising a flexible material 106 configured to conform substantially to at least a portion of the bottom surface of the at least one foot (see at least par 0040-0041 & 0151-0152), said conforming causing the plurality of temperature sensors to make contact with the at least a portion of the bottom of the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134);
generating, using the plurality of temperature sensors, a plurality of discrete temperature data values of the at least one foot after said positioning the at least one foot within the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134);
ascertaining a level of physical activity of the patient (see at least par 0058, 0087 & 0133-0134); and
determining whether the plurality of discrete temperature data values presents at least one of a plurality of prescribed patterns indicative of an ulcer or pre-ulcer on the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134),
said determining comprising:
evaluating, using the plurality of discrete temperature data values and an ulcer prediction model, whether a temperature variation of the at least one foot exceeds a pre-determined threshold, the ulcer prediction model inherently being a function of the level of physical activity of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134), and
producing, as a function of evaluating, output information predicting emergence of an ulcer or pre-ulcer on the at least one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
Rangel discloses a method, as described above, that fails to explicitly teach a method comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient.
However, Russell teaches that it is known to provide a method comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient (see at least figs. 1 & 4-5 and pg. 4, lines 14-28, pg. 8, lines 14-34 and pg. 9, lines 10-34).
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 method of Rangel comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient as taught by Russell since such a modification would amount to applying a known technique (i.e., Russell) to a known device (i.e., as taught by Rangel) ready for improvement to achieve a predictable result such as removing errors introduced by the user’s activity--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 5, Rangel discloses the method as defined by claim 4 further comprising receiving an additional set of discrete temperature data values representing temperature values of a second foot of the at least one foot, said evaluating comprising using the additional plurality of discrete temperature data values to evaluate whether a temperature variation of the at least one foot exceeds the pre-determined threshold (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 6, Rangel discloses the method as defined by claim 4 wherein the closed platform comprises a sock (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151).
In regards to claim 7, Rangel discloses the method as defined by claim 4 wherein the closed platform comprises an insole (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151).
In regards to claim 8, Rangel discloses the method as defined by claim 4 wherein the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprises an accelerometer to detect movement of the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151).
In regards to claim 9, Rangel discloses the method as defined by claim 4 wherein the at least one foot comprise an arch, the flexible material 106 configured to conform the flexible material 106 to the arch of the at least one foot (see at least par 0040-0041 & 0151-0152).
In regards to claim 10, Rangel discloses the method as defined by claim 4 wherein the plurality of temperature sensors are formed in an array (see at least par 0029).
In regards to claim 11, Rangel discloses the method as defined by claim 4 wherein the plurality of temperature sensors are not formed in an array (see at least par 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 12, Rangel discloses the method as defined by claim 4 wherein the at least one foot of the patient comprises one foot, further wherein the plurality of prescribed patterns comprises the difference in temperatures being between two locations on one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 13, Rangel discloses the method as defined by claim 4 wherein the at least one foot of the patient comprises two feet of the patient, further wherein the plurality of prescribed patterns comprises the difference in temperatures being between two contralateral (symmetric) locations on the two feet of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 14, Rangel discloses the method as defined by claim 4 further comprising making temporally successive thermal scans of one foot of the at least one foot, wherein the plurality of prescribed patterns comprises the difference in temperatures at substantially the same location of the one foot across the sequential thermal scans of the one foot(see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 15, Rangel discloses the method as defined by claim 4 further comprising forwarding the plurality of discrete temperature data values of the at least one foot to one or more remote computing devices,the one or more remote computing devices performing the act of determining whether the plurality of discrete temperature data values presents at least one of the plurality of prescribed patterns (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 16, Rangel discloses the method as defined by claim 4 wherein predicting emergence of an ulcer or pre-ulcer includes predicting the location of emergence of an ulcer or pre-ulcer on the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 17, Rangel discloses the method as defined by claim 4 wherein the at least one foot comprises a first foot and a second foot, said evaluating comprising evaluating, using the plurality of discrete temperature data values and an ulcer prediction model, whether a temperature variation between the first foot and second foot exceeds the pre-determined threshold, said producing comprising producing, as a function of evaluating, output information predicting emergence of an ulcer or pre-ulcer on the first foot of the patient or on the second foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 18, Rangel discloses a system for predicting emergence of an ulcer on at least one foot of a patient who engages in physical activity, wherein the at least one foot has a bottom surface, the system comprising:
a closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) configured to receive the at least one foot of the patient and having a plurality of temperature sensors, the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprising a flexible material 106 carrying the temperature sensors (see at least par 0040-0041 & 0151-0152), the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) configured to conform the flexible material 106 substantially to at least a portion of the bottom surface of the at least one foot to contact the plurality of temperature sensors with the at least a portion of the bottom of the at least one foot, the plurality of temperature sensors configured to generate a plurality of discrete temperature data values of the at least one foot after the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) receives the at least one foot, the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) further comprising an accelerometer configured to produce motion data indicative of a level of physical activity of the patient (see at least par 0058, 0087 & 0133-0134), the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) further comprising a communication interface configured to communicate with a communication network; and
one or more processors configured to be in communication with the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) via the communication interface to receive the plurality of discrete temperature data values of the at least one foot of the patient and the motion data, said one or more processors configured to determine whether the plurality of discrete temperature data values presents at least one of a plurality of prescribed patterns indicative of an ulcer or pre-ulcer on the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134), said processor configured to determine by:
evaluating, using the plurality of discrete temperature data values and an ulcer prediction model, whether a temperature variation of the at least one foot exceeds a pre-determined threshold, the ulcer prediction model inherently being a function of the level of physical activity as specified by the motion data (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134); and
when the temperature variation is evaluated to exceed the pre-determined threshold, producing output information predicting emergence of an ulcer or pre-ulcer on the at least one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
Rangel discloses a system, as described above, that fails to explicitly teach a system comprising a processor configured to determine by evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model taking into account both the plurality of discrete temperature data values and the level of physical activity of the patient.
However, Russell teaches that it is known to provide a system comprising a processor 8 configured to determine by evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model taking into account both the plurality of discrete temperature data values and the level of physical activity of the patient (see at least figs. 1 & 4-5 and pg. 4, lines 14-28, pg. 8, lines 14-34 and pg. 9, lines 10-34).
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 Rangel comprising a processor configured to determine by evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model taking into account both the plurality of discrete temperature data values and the level of physical activity of the patient as taught by Russell since such a modification would amount to applying a known technique (i.e., Russell) to a known device (i.e., as taught by Rangel) ready for improvement to achieve a predictable result such as removing errors introduced by the user’s activity--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 19, Rangel discloses the system as defined by claim 18 wherein the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprises an insole.
In regards to claim 20, Rangel discloses the system as defined by claim 18 wherein the at least one foot comprise an arch, the flexible material 106 configured to conform the flexible material 106 to the arch of the at least one foot (see at least par 0040-0041 & 0151-0152).
In regards to claim 21, Rangel discloses the system as defined by claim 18 wherein the plurality of temperature sensors are formed in an array (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 22, Rangel discloses the system as defined by claim 18 wherein the plurality of temperature sensors are not formed in an array (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 23, Rangel discloses the system as defined by claim 18 wherein the one or more processors comprises means for evaluating whether a temperature variation of the at least one foot exceeds a pre-determined threshold (i.e., >2.2 degree Celsius) (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 24, Rangel discloses the system as defined by claim 18 wherein the one or more processors comprises means for producing the output information (see at least par 0144, 0149 & 0151).
In regards to claim 25, Rangel discloses the system as defined by claim 18 wherein the communication interface comprises a wireless interface with the network (see at least par 0146-0147).
In regards to claim 27, Rangel discloses the system as defined by claim 18 wherein the plurality of prescribed patterns comprises the difference in temperatures being between two locations on one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 28, Rangel discloses the system as defined by claim 18 wherein the plurality of prescribed patterns comprises the difference in temperatures being between two contralateral (symmetric) locations on the two feet of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 29, Rangel discloses the system as defined by claim 18 wherein the plurality of prescribed patterns comprises the difference in temperatures at substantially the same location of one foot across time (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 30, Rangel discloses a method of predicting emergence of an ulcer on at least one foot of a patient who engages in physical activity, wherein the at least one foot has a bottom surface, the method comprising:
positioning the at least one foot within a closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151), the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) having a plurality of temperature sensors, the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprising a flexible material 106 configured to conform substantially to at least a portion of the bottom surface of the at least one foot (see at least par 0040-0041 & 0151-0152), said conforming causing the plurality of temperature sensors to make contact with the at least a portion of the bottom of the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134);
generating, using the plurality of temperature sensors, a plurality of discrete temperature data values of the at least one foot after said positioning the at least one foot within the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134);
ascertaining a level of physical activity of the patient (see at least par 0058, 0087 & 0133-0134); and
determining whether the plurality of discrete temperature data values presents at least one of a plurality of prescribed patterns indicative of an ulcer or pre-ulcer on the at least one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134),
said determining comprising:
evaluating, using the plurality of discrete temperature data values and a measure of the patient’s physical activity as inputs to an ulcer prediction model, whether a temperature variation of the at least one foot exceeds a pre-determined threshold, the ulcer prediction model inherently being a function of the level of physical activity of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134), and
producing, as a function of evaluating, output information predicting emergence of an ulcer or pre-ulcer on the at least one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
Rangel discloses a method, as described above, that fails to explicitly teach a method comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient.
However, Russell teaches that it is known to provide a method comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient (see at least figs. 1 & 4-5 and pg. 4, lines 14-28, pg. 8, lines 14-34 and pg. 9, lines 10-34).
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 method of Rangel comprising a step of evaluating, using the plurality of temperature data values, the level of physical activity of the patient, and an ulcer prediction model, the ulcer prediction model using both the plurality of discrete temperature data values and the level of physical activity of the patient as taught by Russell since such a modification would amount to applying a known technique (i.e., Russell) to a known device (i.e., as taught by Rangel) ready for improvement to achieve a predictable result such as removing errors introduced by the user’s activity--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 31, Rangel discloses the method as defined by claim 30 wherein the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151) comprises an accelerometer to detect movement of the closed platform (i.e., shoes, boots, sandals, socks, insoles, see par 0021, 0076, 0091, 0093, 0096, 0112 & 0151).
In regards to claim 32, Rangel discloses the method as defined by claim 30 wherein the at least one foot of the patient comprises one foot, further wherein the plurality of prescribed patterns comprises the difference in temperatures being between two locations on one foot of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 33, Rangel discloses the method as defined by claim 30 wherein the at least one foot of the patient comprises two feet of the patient, further wherein the plurality of prescribed patterns comprises the difference in temperatures being between two contralateral (symmetric) locations on the two feet of the patient (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
In regards to claim 34, Rangel discloses the method as defined by claim 30 further comprising making temporally successive thermal scans of one foot of the at least one foot, wherein the plurality of prescribed patterns comprises the difference in temperatures at substantially the same location of the one foot across the sequential thermal scans of the one foot (see at least par 0029, 0053-0054, 0085, 0094, 0131-0132 & 0134).
Claim 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rangel (‘455) in view of Russell (‘373) further in view of Pool et al. (US 2008/0172072) (“Pool” hereinafter).
Rangel as modified by Russell discloses the system as defined by claim 18 that fails to explicitly tech a system wherein the plurality of temperature sensors comprises a plurality of temperature sensitive resistors.
However, Pool teaches that it is known to provide a system wherein the plurality of temperature sensors comprises a plurality of temperature sensitive resistors (see at least par 0138).
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 Rangel as modified by Russell wherein the plurality of temperature sensors comprises a plurality of temperature sensitive resistors as taught by Pool since Pool teaches that temperature sensitive resistors are only one of a few alternative types of thermal sensors.
Response to Arguments
Applicant's arguments filed October 29, 2025 have been fully considered but they are not persuasive. Applicant contends that Russell fails to teach an ulcer prediction model” that uses both temperature and activity data as inputs. The Office respectfully traverses. Russell clearly describes an ulcer predication model or algorithm, i.e., one that detects and compares differences between the user’s feet temperature to determine the likelihood of ulceration (see at least abstract and pg. 5, lines 19-24 thereof). The prediction model of Russell clearly uses the level of the user’s physical activity by self-learning physical activities such as a temperature change due to the individual walking and standing on the forefoot for a length of time (see at least pg. 8, lines 19-25) and then subtracting, filtering out or deleting temperature data resulting from said self-learned physical activities (see at least pg. 8, lines 20-21) to determine the likelihood of ulceration. As such, the Office submits that Russell does indeed teach an ulcer prediction model that uses the level of physical activity of the patient as claimed.
Applicant implies that filtering of data is not a consideration and/or a “use” of that data. The Office respectfully disagrees. For starters, the Applicant’s own specification does not lay out how the prediction model uses the activity data, let alone such that use involves anything other than filtering out of said data. The Office submits that the deletion and/or removal of physical activity data from the full data set is in itself part of the analysis as well. Said another way, Russell discloses a prediction model that uses physical activity data to isolate non-physical activity data, which helps with ulcer prediction. Therefore, the Applicant’s argument to the contrary is erroneous.
In view of the foregoing, the rejections over at least Rangel and 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.
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/RENE T TOWA/Primary Examiner, Art Unit 3791