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 action is in response to the filing on 10/21/2025. Since the previous filing, claim 1 has been amended and no claims have been added or cancelled. Thus, claims 1-20 are pending in the application.
In regards to the previous 103 Rejections, Applicant’s amendments do not overcome the previous rejections and they are therefore maintained, modified for the amendment, below.
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.
Claim(s) 1-10, 13-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2017/0312165) in view of Pancholy (US 2020/0390448) and Reid (US 2009/0234262).
In regards to claim 1, Johnson discloses a method of providing a compression therapy to a patient who is suffering from venous leg ulcers (paragraph 236), comprising: identifying a peripheral arterial disease in a patient having venous leg ulcers (paragraph 183); determining an arterial condition of the patient in real-time at least by plethysmography before and after applying the compression therapy to measure volume changes in the body caused by blood flow using one or more sensors or blood pressure cuffs (paragraph 57-59); and applying compression pressure to a part of the body of the patient to improve blood circulation based on real-time data of both the venous condition and the arterial condition of the patient (paragraph 117 and 140).
Johnson does not disclose wherein the arterial condition is determined by digital volume plethysmography or wherein assessment of the arterial condition guides the compression therapy such that the compression therapy does not cause arterial compromise exceeding a pre-determined threshold level.
However, Pancholy teaches that digital volume plethysmography is a known method by which to monitor arterial condition (paragraph 57-58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein the arterial condition is determined by digital volume plethysmography as taught by Pancholy as this is a known method by which to acquire arterial condition information.
Further, Reid teaches a compression device wherein assessment of the arterial condition guides the compression therapy such that the compression therapy does not cause arterial compromise exceeding a pre-determined threshold level (paragraph 55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein assessment of the arterial condition guides the compression therapy such that the compression therapy does not cause arterial compromise exceeding a pre-determined threshold level as taught by Reid as this would ensure that the device does not accidentally injure the user.
In regards to claim 2, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein the plethysmography provides real-time vascular assessment in the patient in response to the compression therapy (paragraph 139-140).
In regards to claim 3, Johnson in view of Pancholy and Reid teaches the method of claim 1 and the combination further teaches wherein the arterial compromise comprises a blood flow change under compression (Reid: paragraph 55).
In regards to claim 4, Jonson in view of Pancholy and Reid teaches the method of claim 1 and the combination further teaches wherein the digital volume plethysmography is measured in form of digital pressures (Pancholy: paragraph 57).
In regards to claim 5, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses comprising modifying an amount of compression pressure based on disease progression of venous leg ulcers (paragraph 173 line 15-17).
In regards to claim 6, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein the compression pressure is applied through a compression bandage or stocking (paragraph 117).
In regards to claim 7, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein the compression pressure is applied by a gradient compression system (paragraph 220).
In regards to claim 8, Johnson in view of Pancholy and Reid teaches the method of claim 5.
While Johnson does not explicitly disclose wherein the amount of compression pressure applied to the patient is from 20 mmHg to 30 mmHg or from 30 mmHg to 40 mmHg, it does teach wherein the amount of compression applied to the patient is between 20 to 40 mmHg (paragraph 139).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein the amount of compression pressure applied to the patient is from 20 mmHg to 30 mmHg or from 30 mmHg to 40 mmHg as taught by Johnson as it has been held that wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05 I).
In regards to claim 9, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses further comprising determining an amount of compression pressure to the body of the patient by a trained model (paragraph 159 and 171).
In regards to claim 10, Johnson in view of Pancholy and Reid teaches the method of claim 9 and Johnson further discloses wherein the trained model comprises a machine learning model (paragraph 159 and 171).
In regards to claim 13, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein the part of the body of the patient comprises a foot of the patient (paragraph 213 line 15-17).
In regards to claim 14, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein the method is performed in a point-of-care setting (device may be used in a hospital setting, paragraph 215).
In regards to claim 15, Johnson in view of Pancholy and Reid teaches the method of claim 1.
Johnson does not disclose wherein the method is performed in a mobile care setting.
However, Reid teaches wherein the method is performed in a mobile care setting (paragraph 48 line 6-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein the method is performed in a mobile care setting as taught by Reid as his would allow the patient to use the method outside of the restrictions of a hospital setting.
In regards to claim 17, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses wherein determining the arterial condition is not performed based on Ankle-Brachial Index (ABI) / Toe-Brachial Index (TBI) (no mention of usage of this technique when discussing plethysmography information acquisition, paragraph 140 and 161-163).
In regards to claim 18, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further wherein determining the arterial condition is not performed by pulse volume recording (no mention of usage of this technique when discussing plethysmography information acquisition, paragraph 140 and 161-163).
In regards to claim 19, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses a system for providing a compression therapy to a patient who is suffering from venous leg ulcers, comprising one or more processors configured to implement the method of claim 1 (compression systems 300, paragraph 118).
In regards to claim 20, Johnson in view of Pancholy and Reid teaches the method of claim 1 and Johnson further discloses a non-transitory computer-readable medium comprising instructions that, when executed by one or more processors, cause the one or more processors to perform the method of claim 1 (paragraph 209 column 2 line 16-19).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2017/0312165) in view of Pancholy (US 2020/0390448) and Reid (US 2009/0234262) as applied above and in further view of Dai (US 2023/0201068).
In regards to claim 11, Johnson in view of Pancholy and Reid teaches the method of claim 10.
Johnson does not disclose wherein the machine learning model comprises a supervised or unsupervised machine learning model.
However, Dai teaches wherein the machine learning model comprises a supervised or unsupervised machine learning model (device utilizes deep learning and neural networks, paragraph 61 and 82).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein the machine learning model comprises a supervised or unsupervised machine learning model as taught by Dai as this is a known means by which to control application of such therapy.
In regards to claim 12, Johnson in view of Reid, Pancholy and Dai teaches the method of claim 11 and the combination further teaches wherein the machine learning model comprises Deep Learning algorithm (Dai: paragraph 61 and 82), Neural Networks (Dai: paragraph 61 and 82).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2017/0312165) in view of Pancholy (US 2020/0390448) and Reid (US 2009/0234262) as applied above and in further view of Marks (US 2021/0393153) and LaPlante (US 2016/0029900).
In regards to claim 16, Johnson in view of Pancholy and Reid teaches the method of claim 1.
Johnson does not disclose wherein the step of determining the arterial condition comprises determining the arterial condition based on Ankle-Brachial Index (ABI) / Toe-Brachial Index (TBI) and/or by pulse volume recording.
However, Marks teaches wherein the step of determining the arterial condition comprises determining the arterial condition based on Ankle-Brachial Index (ABI) / Toe-Brachial Index (TBI) (abstract, paragraph 44).
Further, LaPlante teaches rein the step of determining the arterial condition comprises determining the arterial condition based on pulse volume recording (paragraph 6 and 47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson wherein the step of determining the arterial condition comprises determining the arterial condition based on Ankle-Brachial Index (ABI) / Toe-Brachial Index (TBI) and/or by pulse volume recording as taught by Marks and LaPlante as those are known means in the art by which to monitor arterial condition of patients.
Response to Arguments
In regards to the arguments concerning the independent claim, these arguments are not persuasive. Applicant argues that the primary references are silent with regards to the real time collection of plethysmography data and the application of therapy in response to said real time data collection. Examiner disagrees. As seen in the cited paragraph, Johnson teaches real time data collection, and specifically mentions plethysmography though not the specifical method, being used to control the application of pressure to the limb. Pancholy is further used to determine the condition of the artery using specifically digital plethysmography and guide compression application using that data, and while the phrase “real time” is not present in Pancholy, the device is used to monitor arterial condition during a critical event to ensure that the arterial condition is maintained during that event. It follows, then, that Pancholy uses real time data collection. Reid, in addition, also describes active monitoring and adjustment based on sensed data with regards to the arterial/venous conditions based around predetermined thresholds.
Arguments concerning the dependent claims are in regards to their dependency on above argued independent claim and are addressed therein.
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 Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785