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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS document(s) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is invited to point out any particular references in the submitted IDS documents which they believe may be of particular relevance to the instant claimed invention in response to this Office action.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 6, 7, 13, 14, 21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/081952 (Moffett).
Regarding claim 1, Moffett teaches a method for treating pre-ulcerative lesions (method for providing wound repair treatment via PEMF, including pre-ulcerative treatment: abstract; pg. 4, lines 2-7; pg. 6, lines 26-28; PEMF treatment delivered to “diabetic foot wound”, pg. 38, line 30-pg. 39, line 6), the method comprising:
performing a scan to determining a location of a pre-ulcerative lesion prior to ulcer formation (since “scan” is not further defined as claimed, evaluation of the patient’s skin and identification of a wound target for repair, including pre-ulcerative tissue, constitutes “performing a scan”, pg. 6, lines 8-12 and lines 26-28; “diabetic foot wound” identified, thus a “scan” to determine the wound is present is performed, pg. 38, line 28-pg. 39, line 4); and
delivering a first pulsed electromagnetic field (PEMF) treatment to the determined location of the pre-ulcerative lesion (PEMF delivered to wound target site including lesion: pg. 7, lines 14-24; claim 11; PEMF treatment delivered to “diabetic foot wound”, pg. 38, line 30-pg. 39, line 6).
Regarding claim 3, Moffatt teaches the pre-ulcerative lesion is an unerupted diabetic foot ulcer, an unerupted pressure ulcer, a venous leg ulcer, or a combination thereof (pg. 6, lines 26-28; pg. 7, lines 5-7; “diabetic foot wound”, pg. 38, line 8).
Regarding claim 6, Moffatt teaches the first PEMF treatment comprises applying 27.12 MHz pulses lasting between 35-50 microseconds and delivered at between 800-1200 times per second (carrier frequency of about 27.12 MHz, pulse rate of about 1000 Hz, pulse width of about 42 microseconds, pg. 8, line 24-pg. 9, line 1).
Regarding claim 7, Moffatt teaches the method further comprises performing a second scan of the body location and delivering a second PEMF treatment based at least in part on the second scan (“weekly evaluations in the clinic” encompasses a “second scan” to evaluate the wound to determine treatment progress, pg. 39, lines 7-10).
Regarding claim 13, Moffatt teaches a method for treating pre-ulcerative lesions (method for providing wound repair treatment via PEMF, including pre-ulcerative treatment: abstract; pg. 4, lines 2-7; pg. 6, lines 26-28; PEMF treatment delivered to “diabetic foot wound”, pg. 38, line 30-pg. 39, line 6), the method comprising:
performing a scan to determining a location of a pre-ulcerative lesion prior to ulcer formation on a patient's foot (since “scan” is not further defined as claimed, evaluation of the patient’s skin and identification of a wound target for repair, including pre-ulcerative tissue, constitutes “performing a scan”, pg. 6, lines 8-12 and lines 26-28; “diabetic foot wound” identified, thus a “scan” to determine the wound is present is performed, pg. 38, line 28-pg. 39, line 4); and
delivering a pulsed electromagnetic field (PEMF) treatment to the determined location of the pre-ulcerative lesion, wherein the treatment comprises applying 27.12 MHz pulses lasting between 35-50 microseconds and delivered at between 800-1200 times per second at least once per day (PEMF delivered to wound target site including lesion: pg. 7, lines 14-24; claim 11; carrier frequency of about 27.12 MHz, pulse rate of about 1000 Hz, pulse width of about 42 microseconds, pg. 8, line 24-pg. 9, line 1; PEMF treatment delivered to “diabetic foot wound”, pg. 38, line 30-pg. 39, line 6).
Regarding claim 14, Moffatt teaches a pulsed electromagnetic field (PEMF) system (pg. 7, lines 14-24; Provant device, pg. 39, lines 2-17) comprising:
a detection sub-system configured to perform a first scan to determine a location of a pre-ulcerative lesion prior to ulcer formation (pg. 6, lines 8-12 and lines 26-28; “detection sub-system” construed as camera documenting wound changes during baseline and weekly visits, pg. 39, lines 14-17);
a PEMF generator configured to generate a PEMF treatment output (“electromagnetic energy generator”, pg. 7, lines 14-17); and
a PEMF applicator coupled to the PEMF generator and configured to deliver a PEMF treatment to the determined location of the pre-ulcerative lesion (“applicator”, pg. 7, line 14-pg. 8, line 1; pg. 9, lines 14-27; pg. 39, lines 2-6).
Regarding claim 21, Moffatt teaches the PEMF generator is configured to generate 27.12 MHz pulses lasting between 35-50 microseconds and delivered at between 800-1200 times per second (carrier frequency of about 27.12 MHz, pulse rate of about 1000 Hz, pulse width of about 42 microseconds, pg. 8, line 24-pg. 9, line 1).
Regarding claim 23, Moffatt teaches a pulsed electromagnetic field (PEMF) system (pg. 7, lines 14-24; Provant device, pg. 39, lines 2-17) comprising:
a detection sub-system configured to perform a first scan to determine a location of a pre-ulcerative lesion prior to ulcer formation (pg. 6, lines 8-12 and lines 26-28; “detection sub-system” construed as camera documenting wound changes during baseline and weekly visits, pg. 39, lines 14-17);
a PEMF generator configured to generate a PEMF treatment comprising 27.12 MHz pulses having a pulse duration of between 35-50 microseconds and delivered at between 800-1200 times per second (“electromagnetic energy generator”, pg. 7, lines 14-17; carrier frequency of about 27.12 MHz, pulse rate of about 1000 Hz, pulse width of about 42 microseconds, pg. 8, line 24-pg. 9, line 1);
a PEMF applicator coupled to the PEMF generator and configured to deliver the PEMF treatment to the determined location of the pre-ulcerative lesion (“applicator”, pg. 7, line 14-pg. 8, line 1; pg. 9, lines 14-27; pg. 39, lines 2-6); and
a processor configured to receive input from the detection sub-system and to control the application of the PEMF treatment from the PEMF applicator (“processor” construed as the power controller and sensing and control circuits of the system, pg. 7, lines 14-22; Provant device, pg. 39, lines 2-17; control system of PEMF applicator “configured to”, i.e. capable of, indirectly receiving input from the camera documenting wound changes in the form of treatment parameters input via user for subsequent treatments, pg. 39, lines 5-17).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4, 5, 8, 10, 12, 17-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/081952 (Moffett) in view of U.S. Patent Application Publication No. 2015/0190059 (Petersen et al.).
Regarding claims 2, 4, 5, 8, 10, and 12, Moffett teaches all the limitations of claim 1. Moffett does not specify the scan includes a thermal scan.
However, Petersen teaches a method for detecting pre-ulcerative lesions, comprising: performing a thermal scan to determine a location of a pre-ulcerative lesion prior to ulcer formation ([0053]; [0075]; [0080]-[0083]); determining the location comprises determining a difference between scans of two or more contralaterally-matched body locations (left and right feet thermal images compared, [0053], [0078]); wherein the determined difference comprises determining a temperature difference is greater than a threshold ([0075]; [0081]); wherein the second scan comprises a thermal scan showing an increase or decrease in a temperature difference between two or more contralaterally-matched body locations, with respect to the first thermal scan (temperature at a given spot higher or lower than a normal average range may indicate pre-ulcer condition, [0084]); wherein the first scan is performed via a foot temperature monitoring mat, a conforming temperature sensing mat, a thermal camera, or a combination thereof (thermal camera, [0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Moffett to such that the scan includes a thermal scan in order to determine the location of a pre-ulcerative lesion when the temperature difference between the patient’s left and right feet is greater than a threshold and shows either an increase or decrease in temperature in successive scans, as taught by Petersen, because comparing thermal images of contralaterally matched locations of the patient’s body, such as the left and right feet, enables detection of areas of inflammation having a temperature outside its normal range, to thereby identify areas with an increased risk of ulceration so intervention may be performed “to significantly reduce the likelihood of the ultimate emergence of an ulcer” ([0075]; [0080]-[0084]; [0095]).
Regarding claims 17-20 and 22, Moffatt teaches all the limitations of claim 14. Moffatt does not teach the detection sub-system comprises a thermal detection sub-system including a thermal camera; wherein the thermal detection sub-system is configured to determine temperatures of two or more body locations; wherein the thermal detection sub-system is configured to determine a temperature difference between two or more contralaterally-matched body locations; wherein the determined temperature difference is greater than a threshold.
However, Petersen teaches a system for determining a location of a pre-ulcerative lesion prior to ulcer formation (abstract; [0029]), comprising: a detection sub-system configured to perform a first scan to determine a location of a pre-ulcerative lesion prior to ulcer formation, wherein the detection sub-system comprises a thermal detection sub-system including a thermal camera ([0034]; Figure 2); wherein the thermal detection sub-system is configured to determine temperatures of two or more body locations, wherein the thermal detection sub-system is configured to determine a temperature difference between two or more contralaterally-matched body locations (left and right feet thermal images compared, [0053], [0078]); wherein the determined temperature difference is greater than a threshold ([0075]; [0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Moffatt such that the detection sub-system includes a thermal camera configured to determine a temperature difference between two or more contralaterally-matched body locations, and wherein the determined temperature difference is greater than a threshold, as taught by Petersen, because comparing thermal images of contralaterally matched locations of the patient’s body, such as the left and right feet, enables detection of areas of inflammation having a temperature greater than a threshold, to thereby identify areas with an increased risk of ulceration so intervention may be performed “to significantly reduce the likelihood of the ultimate emergence of an ulcer” ([0075]; [0080]-[0084]; [0095]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/081952 (Moffett) as applied to claim 14 above, and further in view of WO 2015/195746 (McQuilkin et al.).
Regarding claim 16, Moffett teaches all the limitations of claim 14. Moffett does not teach the detection sub-system comprises a tissue oximetry detection sub-system.
However, McQuilkin teaches a detection sub-system for determining a location of an ulcer ([000290]), wherein the detection sub-system comprises a tissue oximetry detection sub-system ([000290]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detection sub-system of Moffett to include a tissue oximetry detection sub-system as taught by McQuilkin, as “such a tool is useful both for an immediate evaluation of tissue perfusion surrounding the wound, and also as a benchmark comparison over a longer time period to evaluate progress of wound healing” as “[t]he healing ability of an ulcer or wound is largely dependent upon the blood supply available” ([000290]).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/081952 (Moffett) in view of U.S. Patent Application Publication No. 2015/0190059 (Petersen et al.) as applied to claim 1, and further in view of WO 2012/123584 (Jordan).
Regarding claims 9 and 11, Moffett in view of Petersen teaches all the limitations of claim 1. Moffett as modified does not specify the second PEMF treatment includes one or more of: an increased treatment duration, an increased number of treatments per day, or an increased pulsed energy signal strength, with respect to the first PEMF treatment; and one or more of: a decreased treatment duration, a decreased number of treatments per day, or a decreased pulsed energy signal strength, with respect to the first PEMF treatment.
However, Jordan teaches a method for treating tissue (abstract), comprising: delivering first and second pulsed electromagnetic field (PEMF) treatments to the tissue; wherein the second PEMF treatment includes an increased treatment duration or an increased pulsed energy signal strength with respect to the first PEMF treatment (frequency increased for second cycle with a continuous stimulus with no relaxation, pg. 15, paragraphs 1-3; “The duration may be adjusted depending on a treatment progress and may last for example for the first treatment step 7 days and for the second treatment step 14 days”, pg. 15, paragraph 5); and wherein the second PEMF treatment includes one or more of: a decreased treatment duration or a decreased pulsed energy signal strength with respect to the first PEMF treatment (treatment settings can be increased or decreased in subsequent treatment cycles: pg. 15, paragraphs 1-3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the second PEMF treatment of Moffat as modified to include one or more of increased or decreased treatment duration or pulsed energy signal strength with respect to the first PEMF treatment as taught by Jordan, in order to adapt the treatment to meet the needs of the individual patient as the treatment series progresses.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/081952 (Moffett) in view of U.S. Patent Application Publication No. 2015/0066104 (Wingeier et al.).
Regarding claim 15, Moffett teaches all the limitations of claim 14. Moffett teaches monitoring the pre-ulcerative lesion over time (“weekly evaluations in the clinic to assess pain management and wound healing progression”, pg. 39, paragraph 3; pg. 39, paragraph 7). Moffett does not specify a processor is configured to perform the monitoring, and to adjust the PEMF treatment based on a progression of the pre-ulcerative lesion.
However, Wingeier teaches a pulsed EMF system (abstract), comprising: a processor configured to monitor the targeted tissue over time and to adjust the PEMF treatment based on a progression and response of the targeted tissue (processor monitors target tissue response, and automatically adjusts treatment parameters for subsequent treatment(s) based on response, [0101]-[0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Moffett to include a processor configured to monitor the pre-ulcerative lesion over time and to adjust the PEMF treatment based on a progression of the lesion in light of the teachings of Wingeier in order to adapt the treatment based on the patient’s response in order to optimize the efficacy of the treatment.
Conclusion
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791