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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22, 2026 has been entered.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, in line 1, --- modality --- should be inserted after “treatment”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the extracted information" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 13-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mantri et al. (“Photoacoustic monitoring of angiogenesis predicts response to therapy in healing wounds”, October 17, 2021), as cited by Applicant.
With regards to claim 13, Mantri et al. disclose a method for treating a wound comprising:
obtaining a photoacoustic ultrasound image of a wound on a patient (pg. 4, Section “Photoacoustic-Ultrasound Imaging”, referring to use of LED-based photoacoustic imaging system to acquire images of a wound surface/region);
processing the photoacoustic ultrasound image to calculate a temporal rate of change in at least one of hemoglobin concentration, oxygen saturation, or photoacoustic intensity over multiple time points (pgs. 4-5, Sections “Image Processing” and “Statistics”, referring to processing the images to obtain changes in PA intensity and referring to plotting the rate of PA change per day vs. the healing time; pg. 6, Section “Results”, referring to measuring changes in PA intensity over time; Figures 1-4, which depict photoacoustic (PA) intensity changes over multiple time points (i.e. “Time (days)”);
determining a degree of wound healing based at least in part on the calculated temporal rate of change (Abstract, referring to the use of PA-US to monitor angiogenesis and stratify patients “responding vs. non-responding” to therapy (i.e. degree of wound healing), wherein patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase, wherein rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring; pg. 11, 2nd paragraph, referring to rate of PA change being indicative of the rate of angiogenesis in the wound bed, wherein responding patients had a mean rate of PA change intensity that was significantly higher than non-responders; pg. 14, Section “Conclusions”, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels and non-healing wounds showed no correlation between PA intensity and wound area); and
selecting, modifying, or controlling a treatment modality based on the determined degree of wound healing (pg. 12, first paragraph, referring to PA classification of patients according to their response (i.e. healing/non-responding which are degrees of wound healing) would allow specialists to change their course of treatment if the wound is not responding to conventional treatment protocols; pg. 12, last paragraph, referring to patients not responding to therapy can be more efficiently directed to other wound treatment interventions or therapeutic modalities; pg. 3, last paragraph, referring to an early angiogenesis tool helping directing treatment protocols, which helps clinicians make early and better-informed decisions on whether a particular treatment regimen should be continued; Abstract, referring to the early response detection system helping inform management and treatment strategies while improving outcomes and reducing costs); and
treating the wound based at least in part based on the selected, modified or controlled treatment modality (pg. 12, last paragraph, referring to patients not responding to therapy can be more efficiently directed to other wound treatment interventions or therapeutic modalities; pg. 3, last paragraph, referring to an early angiogenesis tool helping directing treatment protocols, which helps clinicians make early and better-informed decisions on whether a particular treatment regimen should be continued; Abstract, referring to the early response detection system helping inform management and treatment strategies while improving outcomes and reducing costs; pg. 12, first paragraph, referring to PA classification allowing wound specialists to change their course of treatment if the wound Is not responding to conventional treatment protocols).
With regards to claim 14, Mantri et al. disclose that the treatment is selected from the group including skin grafts, debridement and hyperbaric therapy (pg. 3, last paragraph, pg. 12, last paragraph, referring to the treatment protocols including hyperbaric oxygen therapy, debridement, etc.).
With regards to claim 15, Mantri et al. disclose that the extracted information is a measure of intensity of the photoacoustic ultrasound image (pgs. 4-5, Sections “Image Processing”, “Statistics”, referring to processing the images to obtain/extract photoacoustic intensity as a function of time; Figures 1-4).
With regards to claim 16, Mantri et al. disclose that the measure of intensity is correlated with wound healing (pg. 7, referring to the caption for Figure 1, which sets forth “PA intensity increases linearly as the wound heals suggesting that angiogenesis is correlated to wound closure”; pg. 14, Section “Conclusions”, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels; Figures 1-4).
With regards to claim 17, Mantri et al. disclose that the measure of intensity is a mean gray scale value of the photoacoustic ultrasound image (pg. 4, Sections “Photoacoustic-Ultrasound Imaging” and “Image Processing”, referring to the images being processed to obtain the photoacoustic intensity; Figures 1-3, wherein the photoacoustic ultrasound images are in gray scale, and thus the intensity values are gray scale values; pg. 7, caption under Figure 2 referring to the use of “mean US intensity”; pg. 11, 2nd paragraph, pg. 12, second paragraph, referring to the use of mean US intensity/mean rate of PA changes).
With regards to claim 18, Mantri et al. disclose that the method further comprises monitoring the treatment over time by obtaining and processing additional photoacoustic ultrasound images at subsequent times (pg. 4, Sections “Photoacoustic -Ultrasound Imaging”, “Image Processing”, referring to obtaining images at 30 frames/s, wherein all frames were reconstructed and visualized and the ROIs were drawn for every frame).
With regards to claim 19, Mantri et al. disclose that the method further comprises determining that the wound is healing if a measure of intensity of the photoacoustic ultrasound image extracted from the additional photoacoustic ultrasound images increases over time (pg. 14, first paragraph, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels; Figures 1-4).
With regards to claim 20, Mantri et al. disclose that the method further comprises predicting if the wound is or is not responding to the treatment based on the monitoring (Abstract, referring to the use of PA-US to monitor angiogenesis and stratify patients “responding vs. non-responding” to therapy (i.e. degree of wound healing), wherein patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase, wherein rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring; pg. 11, 2nd paragraph, referring to rate of PA change being indicative of the rate of angiogenesis in the wound bed, wherein responding patients had a mean rate of PA change intensity that was significantly higher than non-responders; pg. 14, Section “Conclusions”, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels and non-healing wounds showed no correlation between PA intensity and wound area; Figures 1-4).
With regards to claim 21, Mantri et al. disclose that the predicting is performed within 30 days of initiation of the monitoring (pg. 14, first paragraph, referring to PA imaging being used to classify therapy responders and non-responders within 30-days from the start of treatment; Figure 1, see caption which refers to PA intensity over 1, 7 and 29 days and further the PA-intensity vs Time(days) graph depicts 30 days).
With regards to claim 22, Mantri et al. disclose that the predicting further predicts a time needed for the wound to heal (pg. 14, first paragraph, referring to a higher rate of PA increase was associated with an exponential reduction in healing times; Figure 4, wherein photoacoustic imaging is used to predict wound healing and response to therapy, wherein the rate PA increase per day within the first 30 days is an effective imaging marker to predict wound healing time).
With regards to claim 23, Mantri et al. disclose that the method further comprises predicting if the wound is or is not responding to treatment based on a change in a measure of intensity of the photoacoustic ultrasound image over time (Abstract, referring to the use of PA-US to monitor angiogenesis and stratify patients “responding vs. non-responding” to therapy (i.e. degree of wound healing), wherein patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase, wherein rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring; pg. 11, 2nd paragraph, referring to rate of PA change being indicative of the rate of angiogenesis in the wound bed, wherein responding patients had a mean rate of PA change intensity that was significantly higher than non-responders; pg. 14, Section “Conclusions”, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels and non-healing wounds showed no correlation between PA intensity and wound area).
With regards to claim 24, Mantri et al. disclose that the method further comprises predicting that the wound is responding to treatment if the measure of intensity indicates that the intensity is increasing over time (Abstract, referring to the use of PA-US to monitor angiogenesis and stratify patients “responding vs. non-responding” to therapy (i.e. degree of wound healing), wherein patients responding to therapy showed clear signs of angiogenesis and an increased rate of PA increase, wherein rate of PA increase and hence the rate of angiogenesis was able to predict healing times within 30 days from the start of monitoring; pg. 11, 2nd paragraph, referring to rate of PA change being indicative of the rate of angiogenesis in the wound bed, wherein responding patients had a mean rate of PA change intensity that was significantly higher than non-responders; pg. 14, Section “Conclusions”, referring to an increase in PA intensity correlates with wound closure due to the formation of new blood vessels and non-healing wounds showed no correlation between PA intensity and wound area).
With regards to claim 25, Mantri et al. disclose that obtaining the photoacoustic ultrasound image of the wound on the patient includes performing a photoacoustic ultrasound scan of the wound (pg. 4, Section “Photoacoustic-Ultrasound Imaging”, referring to use of LED-based photoacoustic imaging system to acquire images/scans of a wound surface/region; Figures 1-4).
With regards to claim 26, Mantri et al. disclose that the wound is of a type selected from the group including a decubitus ulcer, a diabetic ulcer and an insufficiency injury (pg. 3, last paragraph, referring to diabetic ulcers; pg. 8, Figure 3 caption, referring to stage III pressure ulcer (i.e. decubitus ulcer)).
Response to Arguments
Applicant’s arguments with respect to claim(s) 13-26 have been considered but are 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. Previously cited Mantri has been introduced to reject claims 13-26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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