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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 4, 2026 has been entered.
Response to Amendment
The amendment filed April 1, 2026 has been entered. Claims 1-13 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 102/103 rejections previously set forth in the Final Office Action mailed February 11, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 103 Rejections below.
Claim Rejections - 35 USC § 102
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 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, 6, 9-10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060058665 A1 (Chapman, James Vincent).
Regarding claim 1, Chapman teaches a method for treating a skin wound, comprising:
obtaining an ultrasound image of a skin wound on a patient ([0014] “The computer controlled ultrasound system 12 allows the clinician to perform area length or circumference measurements to evaluate the dimensions of the wound 8”);
processing the ultrasound image to extract information that is correlated to a degree of wound healing ([0009] “applying a computer based measurement package of an ultrasound equipment system to measure either the wounds linear parameters, or the circumference and depth for volume determination.”);
assessing the degree of wound healing based at least in part on changes in the extracted information over time ([0004] “In order to document the progress or regression in the size of the wound, the clinician can accurately measure, length, width, depth, and circumference of the wound, and compare to previous scans”); and
treating the skin wound based at least in part based on the assessed degree of wound healing ([0009] “evaluate the efficacy of a particular treatment in the reduction of the wound area.”).
Regarding claim 6, Chapman teaches the method of claim 1, further comprising monitoring the treatment over time by obtaining and processing additional ultrasound images at subsequent times ([0004] “document the progress or regression in the size of the wound, the clinician can accurately measure, length, width, depth, and circumference of the wound, and compare to previous scans”; [0009] “This information is used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area.”).
Regarding claim 9, Chapman teaches the method of claim 1 wherein obtaining the ultrasound image of the skin wound on the patient including performing an ultrasound scan of the skin wound ([0009]; [0014] “The computer controlled ultrasound system 12 allows the clinician to perform area length or circumference measurements to evaluate the dimensions of the wound 8.”).
Regarding claim 10, Chapman teaches a method of monitoring treatment of a skin wound, comprising:
obtaining an ultrasound image of a skin wound on a patient ([0014] “The computer controlled ultrasound system 12 allows the clinician to perform area length or circumference measurements to evaluate the dimensions of the wound 8”);
processing the ultrasound image to extract information that is reflective of wound size ([0009] “applying a computer based measurement package of an ultrasound equipment system to measure either the wounds linear parameters, or the circumference and depth for volume determination.”);
assessing a degree of wound healing based at least in part on changes in the extracted information over time ([0004] “In order to document the progress or regression in the size of the wound, the clinician can accurately measure, length, width, depth, and circumference of the wound, and compare to previous scans”);
treating the skin wound based at least in part based on the assessed degree of wound healing ([0009] “evaluate the efficacy of a particular treatment in the reduction of the wound area.”); and
monitoring the treatment over time by obtaining and processing additional ultrasound images at subsequent times ([0004] “document the progress or regression in the size of the wound, the clinician can accurately measure, length, width, depth, and circumference of the wound, and compare to previous scans”; [0009] “This information is used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area.”).
Regarding claim 13, Chapman teaches the method of claim 10 wherein obtaining the ultrasound image of the skin wound on the patient including performing an ultrasound scan of the skin wound ([0009]; [0014] “The computer controlled ultrasound system 12 allows the clinician to perform area length or circumference measurements to evaluate the dimensions of the wound 8.”).
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 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060058665 A1 (Chapman, James Vincent) in view of US 20120243757 A1 (Funka-Lea et al.).
Regarding claim 2, Chapman teaches the method of claim 1.
Chapman does not explicitly teach wherein the extracted information is a measure of intensity of the ultrasound image.
However,
Funka-Lea teaches wherein the extracted information is a measure of intensity of the ultrasound image ([0004]; [0025] “usable pixels have intensity values substantially representative of one or more anatomical structures.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include measuring the intensity of the ultrasound image. One would have been motivated to make this modification because the intensity of the ultrasound image can accurately indicate specific regions of tissue with different properties to aid in medical diagnosis, as suggested by Funka-Lea [0004, 0012].
Regarding claim 3, Chapman teaches the method of claim 2.
Chapman does not teach wherein the measure of intensity is inversely correlated with wound size.
However,
Funka-Lea wherein the measure of intensity is inversely correlated with wound size ([0026] “extracting one or more features from the at least one part of the ultrasound image includes labeling each pixel in the at least one part with a label that is inversely proportional to the size of the region to which it belongs”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include intensity being inversely correlated with wound size. One would have been motivated to make this modification because the intense, dark regions pixels are inversely proportional to the size of the region by determining the pixels that are usable to detect the edge of the region, and thus the size of the region, as suggested by Funka-Lea [0026].
Regarding claim 4, Chapman teaches the method of claim 2.
Chapman does not explicitly teach wherein the measure of intensity is a mean gray scale value of the ultrasound image.
However,
Funka-Lea teaches wherein the measure of intensity is a mean gray scale value of the ultrasound image ([0026] “assigning a grayscale value to each pixel indicating the length of the at least one part to which the pixel belongs”; [0065]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include intensity being a mean gray scale value of the ultrasound image. One would have been motivated to make this modification because the grayscale value is able to determine the brightness and darkness of the ultrasound image in order to identify regions of the image, as suggested by Funka-Lea [0026].
Regarding claim 11, Chapman teaches the method of claim 10
Chapman does not explicitly teach wherein the extracted information that is reflective of wound size is a measure of intensity of the ultrasound image, the measure of intensity being inversely correlated with wound size.
However,
Funka-Lea teaches wherein the extracted information that is reflective of wound size is a measure of intensity of the ultrasound image ([0004]; [0025] “usable pixels have intensity values substantially representative of one or more anatomical structures.”), the measure of intensity being inversely correlated with wound size ([0026] “extracting one or more features from the at least one part of the ultrasound image includes labeling each pixel in the at least one part with a label that is inversely proportional to the size of the region to which it belongs”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include measuring the intensity of the ultrasound image, and the intensity being inversely correlated with wound size. One would have been motivated to make this modification because the intensity of the ultrasound image can accurately indicate specific regions of tissue with different properties to aid in medical diagnosis, and the intense, dark regions pixels are inversely proportional to the size of the region by determining the pixels that are usable to detect the edge of the region, and thus the size of the region, as suggested by Funka-Lea [0004, 0012, 0026].
Claims 5, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060058665 A1 (Chapman, James Vincent) in view of US 20190050991 A1. (Ross et al.)
Regarding claim 5, Chapman teaches the method of claim 1.
Chapman does not explicitly teach wherein treating the skin wound includes performing a skin graft.
However, Ross teaches wherein treating the skin wound includes performing a skin graft ([0003] “The foundation of burn wound care is determining whether a patient has a deep burn, i.e., a third or fourth degree, full thickness burn, which requires excision and skin grafting for optimal healing”; [0010] “The methods and systems of the invention are advantageous in providing improved assessment of burn wound depth, and particularly for distinguishing between second and third degree burns, and thereby allowing improved treatment decisions to be made, for example, avoiding unnecessary surgical treatment of second degree burns and ensuring appropriate treatment of third degree wounds.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include skin graft treatment. One would have been motivated to make this modification because the depth of a burn wound indicates that skin grafting would be required for optimal healing, as suggested by Ross [0003].
Regarding claim 8, Chapman teaches the method of claim 6.
Chapman does not explicitly teach further comprising predicting wound deterioration due to tissue loss based on the monitoring.
However,
Ross teaches the method of claim 6 further comprising predicting wound deterioration due to tissue loss based on the monitoring ([0013] “Burn injury denatures proteins and ultrasound allows detection of changes in the elastic property of the subcutaneous tissue beneath the skin surface”; [0015]; [0017]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to evaluating tissue loss to predict wound deterioration. One would have been motivated to make this modification because burn wounds cause the denaturing of proteins and the depth of the wounds are measured to predict a burn wound as full or partial thickness, as suggested by Ross [0013-0017].
Regarding claim 12, Chapman teaches the method of claim 10.
Chapman does not explicitly teach further comprising modifying the treatment of the skin wound or performing an additional treatment of the skin wound based on the monitoring.
However,
Ross teaches modifying the treatment of the skin wound or performing an additional treatment of the skin wound based on the monitoring ([0003]; [0008]; [0010] ‘improved assessment of burn wound depth, and particularly for distinguishing between second and third degree burns, and thereby allowing improved treatment decisions to be made, for example, avoiding unnecessary surgical treatment of second degree burns and ensuring appropriate treatment of third degree wounds.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to modifying treatment based on the monitoring. One would have been motivated to make this modification because the assessment of burn wound depth allows for classification of burns to ensure appropriate treatment after ultrasound imaging, as suggested by Ross [0008, 0010].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 20060058665 A1 (Chapman, James Vincent) in view of US 20210145359 A1 (Hunt et al.).
Regarding claim 7, Chapman teaches the method of claim 6
Chapman does not teach further comprising determining that the skin wound is healing if a measure of intensity extracted from the additional ultrasound images increases over time.
However,
Hunt teaches further comprising determining that the skin wound is healing if a measure of intensity extracted from the additional ultrasound images increases over time ([0226] “the response to the treatment parameter measurements may be self-optimizing such the software may explore optimum responses, per a change in treatment parameter by examining the treatment/response curve.”; [0180] “the image intensity at position x and time t.”; [0235] “as the tissue heals, the area showing a tissue parameter/delta value of healthy tissue should increase.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Chapman to include determining wound healing when intensity increases over time. One would have been motivated to make this modification because when the tissue parameters increase and the tissue is healing, the treatment can be maintained or modified in order to promote healing, as suggested by Hunt [0235].
Response to Arguments
Applicant's arguments filed April 1, 2026 have been fully considered but they are not persuasive. With respect to the 102 and 103 Rejections in the Final Office Action (See Pages 4-5 of Applicant’s Response “Rejection Under 35 USC 102 and 103”), Applicant argues that Ross does not disclose monitoring a wound over multiple time points, extracting information at multiple times and assessing healing based on changes in that information.
There are new grounds of claim rejections that were necessitated by the claim amendments. Chapman teaches utilizing ultrasound to measure wound healing based on changes over time gathered from ultrasound as described above.
Claims 2-9 and 11-13 are rejected because the rejections of claims 1 and 10 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 102 and 103 Rejections.
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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