DETAILED ACTION
This Office Action is a continuation of U.S. Patent Application No. 17/372,191 filed July 9, 2021.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed July 25, 2023 has been received and made of record. Note the acknowledged PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “50b” is in Fig. 3B, but is not present in the specification; and “54a” in Fig. 7 is not present in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because “50” in Fig. 6A should read --50’--; “50” in Fig. 6B should read --50’-- . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites “Disclosed herein” which can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: para. [0048], line 1, “40” should read --46--. Appropriate correction is required.
Claim Objections
Claims 79-97 are objected to because of the following informalities: in each of clams 79-97 the term “Claims” should read --claims-- since it is not a proper noun. 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.
Claims 86-97 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.
Regarding claims 86 and 92 the recitation of “a second sensor” is indefinite since a first sensor has not been recited.
Regarding claim 87, the claim depends from claim 83 which recites “the blood flow rate is detected via a sensor”. Claim 87 recites “the sensor is configured to detect an amount of oxygen in a portion of the blood flowing into or adjacent to the wound. It is unclear how the sensor detects both the blood flow rate and an amount of oxygen in a portion of the blood flowing into or adjacent to the wound. The specification in paragraphs. [0102, 0103 and 0106] disclose the blood flow rate sensor and the sensor to detect amount of oxygen in a portion of blood are different sensors. For the purpose of compact prosecution, claim 87 and the claims which depend therefrom will be interpreted as if claim 87 introduces an additional sensor, namely an oxygen sensor.
Claims 88-91 and 93-97 are necessarily rejected by virtue of their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 78 and 83 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2003/0216672 (“Rastegar”) in view of U.S. Patent No. 6,058,331 (“King”).
Regarding claim 78, Rastegar discloses system and method for healing skin injuries that anticipates Applicant’s claimed invention. More specifically, Rastegar discloses a method of treating a wound (see the abstract which discloses “a method of the healing of damaged skin of a patient”), comprising: positioning a wound cover over a wound to define a space between at least a portion of the wound cover and the wound (note para. [0072], which discloses “an enclosure 100 that seals a segment of the body 101 to form an enclosed chamber 102”); applying negative pressure to a space between the wound cover and the wound (not para. [0072], which discloses a “tubing system 150 preferably consists of one or more tubes to provide an inflow of gas into the enclosed chamber 102, preferably at a high relative (gage) pressure and to also provide for an outflow of gas from the enclosed chamber 102 to generate a relative (gage) negative pressure within the enclosed chamber 102. A means 160 for generating the required relative vacuum and pressurized gas”); detecting blood flow pulses adjacent to the wound and selectively controlling the level of negative pressure between the wound cover and the wound based on the blood flow pulses (see para. [0072] which discloses “One or more sensors 180 are provided to sense the blood flow pulses and send appropriate signals through the one or more signal lines 181 to the control unit 170 to preferably synchronize the pressurization and vacuum generation cycles within the enclosed chamber 102 with the pulses of the blood flow”).
Rastegar fails to teach detecting blood flow rate adjacent to the wound and selectively controlling the level of negative pressure between the wound cover and the wound based on the blood flow rate.
However, King in the disclosure of an analogous wound treatment method teaches it is known to provide a system for use in treating a user with a sensor for monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. (see the abstract and claim 8).
In view of King, it would have been obvious to one having ordinary skill in the art to have modified the method of Rastegar with the addition of a sensor to measure and monitor blood flow rate in order to determine the extent of ischemia being suffered (see col. 4, lines 3-12 of King).
Once added, it would have been further obvious to send appropriate signals through one or more signal lines to the control unit to preferably synchronize the pressurization and vacuum generation cycles within the enclosed chamber with blood flow rate as is done with the blood flow pulse signals; thereby selectively controlling the level of negative pressure between the wound cover and the wound based on the blood flow rate.
Regarding claim 83, modified Rastegar discloses the method of claim 78, wherein the blood flow rate is detected via a sensor (note the disclosure of the blood flow rate sensor in the rejection of claim 78 above).
Claim 84 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rastegar in view of King as applied to claim 83 above, and further in view of translation JP H07299043 A (“Masanori”).
Regarding claim 84, modified Rastegar method of claim 83, except wherein the sensor comprises a light emitting sensor. However, Masanori in its analogous disclosure of a sensor teaches it is known to use light emitting sensors to detect blood flow rate (see page 4, the fifth full paragraph which recites “FIG. 3 is a block diagram of processing the output signals from the plurality of sensors to detect the pulse. The sensors (1) and 11a including the light emitting element 2a and the light receiving element 3a output signals according to the blood flow rate”.
Absent a critical teaching and/or a showing of unexpected results, and in view of it Masanori, it would have been obvious design choice to one having ordinary skill in the art to have utilized a light emitting sensor to detect blood flow rate in modified Rastegar’s method of treating since it appears the sensor would perform equally well.
Claim 85 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rastegar in view of King as applied to claim 83 above, and further in view of (“Mah”).
Regarding claim 85, modified Rastegar discloses the method of claim 83, except wherein the sensor comprises a laser doppler sensor. However, Mah in it analogous disclosure of a sensor teaches it is known use a laser doppler blood flow sensor for measuring the fate of blood flow (see col. 7, lines 56-58).
Absent a critical teaching and/or a showing of unexpected results and in view of Mah, it would have been obvious design choice to one having ordinary skill in the art to have utilized a laser doppler to detect blood flow rate in modified Rastegar’s method of treating since it appears the sensor would perform equally well.
Claims 78-83 and 87-97 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 2004/0073151 (“Weston”) in view of King.
Regarding claim 78, Weston discloses a reduced pressure treatment system, that during use, substantially discloses Applicant’s claimed invention. More specifically, Weston discloses a method of treating a wound (see the abstract which discloses a method for treating wounds using reduce pressure is provided), comprising: positioning a wound cover (wound cover 40, see Figs. 1, 7 and para. [0041]) over a wound (wound site 25, see para. [0040] to define a space between at least a portion of the wound cover and the wound (see Fig. 1 which shows a space having absorbable matrix 32, therein, see para. [0041]; applying negative pressure to a space between the wound cover and the wound (see the abstract which discloses a vacuum pump supplies suction within the wound cover over the treatment site); detecting temperature adjacent to the wound (temperature sensors 81 are used to detect temperature adjacent the wound site); and selectively controlling the level of negative pressure between the wound cover and the wound based on temperature (the temperature sensors are connected to an alarm system which is connect to the vacuum supply 50, that upon production of a predetermined alarm (caused by blood flow rate reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will cause the pump (51) to cease operation by the alarm device 86 (see para [0069]).
Weston fails to disclose detecting blood flow rate adjacent the wound and selectively controlling the level of negative pressure between the wound cover and the wound based on the blood flow rate. However, King in the disclosure of an analogous wound treatment method teaches it is known to provide a system with a sensor measuring and monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. with a sensor (see the abstract and claim 8).
In view of King, it would have been obvious to one having ordinary skill in the art to modify the method of Westin with the addition of a sensor to measure and monitor blood flow rate in order to determine the extent of ischemia being suffered (see col. 4, lines 3-12 of King). Once added it would have been further obvious to connect the blood flow rate sensor to the alarm system, which is connected to the vacuum supply (50), that upon production of a predetermined alarm (caused by blood flow rate reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will causes the pump (51) to cease operation (see para. [0069] of Weston).
Regarding claim 79, modified Weston discloses the method of claim 78, but fails to disclose increasing the amount of negative pressure when the detected blood flow rate exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected blood flow rate exceeds a predetermined amount in order to constrict blood vessels and decrease blood flow.
Regarding claim 80, modified Weston discloses the method of claim 78, except decreasing the amount of negative pressure when the detected blood flow rate exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decrease the amount of negative pressure when the detected blood flow rate exceeds a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 81, modified Weston discloses the method of claim 78, except increasing the amount of negative pressure when the detected blood flow rate falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected blood flow rate falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 82, modified Weston discloses the method of claim 78, except decreasing the amount of negative pressure when the detected blood flow rate falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decrease the amount of negative pressure when the detected blood flow rate falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 83, modified Weston discloses the method of Claim 78, wherein the blood flow rate is detected via a sensor (note the rejection of claim 78 above, which discloses the use of a sensor to detect the blood flow rate).
Regarding claim 86, modified Weston discloses the method of claim 78, further comprising changing the configuration of the wound cover when the detected blood flow rate crosses a threshold determined by a second sensor (temperature sensor 81, see Fig. 7, see para. [0067]). As can be read from para. [0011] of Weston, “areas of tissue having an increased level of blood circulation generally have a higher temperature than areas that have a comparatively lower level of blood circulation. It is therefore desirable to have a means of monitoring the relative temperature within the area of the wound”. Therefore, when the temperature exceeds a certain measurement, so too will the blood flow rate, and when the temperature exceeds a certain measurement, the alarm will sound and the vacuum pump will cease; thus negative pressure stops and the cover, which during implementation of negative, has protrusions recessed as shown in Fig. 5c, but changes to the protrusions shown in Fig. 5a when vacuum is no longer implemented.
Regarding claim 87, modified Weston discloses the method of claim 83, except further comprising an additional sensor configured to detect an amount of oxygen in a portion of the blood flowing into or adjacent to the wound. King in the disclosure of an analogous wound treatment method teaches it is known to provide a system with a sensor measuring and monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. with a sensor (see the abstract and claim 8).
In view of King, it would have been obvious to one having ordinary skill in the art to modify the method of Westin with the addition of an oxygen saturation sensor to measure and monitor oxygen in the blood at the wound site in order blood flow rate in order to determine the amount oxygen flowing to the wound so as to prevent tissue deterioration (col.1, lines 30-42 of King). Once added it would have been further obvious to connect the oxygen saturation sensor to the alarm system, which is connected to the vacuum supply (50), that upon production of a predetermined alarm (caused by an oxygen saturation sensor reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will causes the pump (51) to cease operation (see para. [0069] of Weston).
Regarding claim 88, Weston discloses the method of claim 87, except increasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 89, modified Weston discloses the method of claim 87, except increasing the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 90, modified Weston discloses the method of claim 87, except decreasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decreasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 91, modified Weston disclose the method of claim 87, except decreasing the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decrease the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 92, modified Weston discloses the method of claim 78, except a second sensor configured to detect an amount of oxygen in a portion of the blood flowing into or adjacent to the wound. However, King in the disclosure of an analogous wound treatment method teaches it is known to provide a system with a sensor measuring and monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. with a sensor (see the abstract and claim 8). Further disclosed is that two or more different types of sensors my implemented to sense indicia of blood flow ischemia (see col. 7, lines 1-12)
In view of King, it would have been obvious to one having ordinary skill in the art to modify the method of Westin with the addition of a second sensor in the form of an oxygen saturation sensor to measure and monitor oxygen in the blood at the wound site in order blood flow rate in order to determine the amount oxygen flowing to the wound so as to prevent tissue deterioration (col.1, lines 30-42 of King) and to sense indicia of blood flow ischemia. Once added it would have been further obvious to connect the oxygen saturation sensor to the alarm system, which is connected to the vacuum supply (50), that upon production of a predetermined alarm (caused by an oxygen saturation sensor reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will causes the pump (51) to cease operation (see para. [0069] of Weston).
Regarding claim 93, Weston discloses the method of claim 92, except increasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 93, modified Weston discloses the method of claim 92, except increasing the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to increase the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 95, modified Weston discloses the method of claim 92, except decreasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decreasing the amount of negative pressure when the detected amount of oxygen exceeds a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Regarding claim 96, modified Weston disclose the method of claim 92, except decreasing the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount. However, Weston discloses in para. [0082] that “[s]upplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system 50.”
Therefore, it would have been obvious to one having ordinary skill in the art to have programmed the treatment system to decrease the amount of negative pressure when the detected amount of oxygen falls below a predetermined amount in order to manage tissue edema, inflammation and to balance perfusion and tissue damage.
Alternate Embodiment: Regarding claim 78, Weston discloses a reduced pressure treatment system, that during use, substantially discloses Applicant’s claimed invention. More specifically, Weston discloses a method of treating a wound (see the abstract which discloses a method for treating wounds using reduce pressure is provided), comprising: positioning a wound cover (wound cover 40 having protrusions 60, see Figs. 5a- 5, 7, para. [0041] and [0054]) over a wound (wound site 25, see para. [0040] to define a space between at least a portion of the wound cover and the wound (see Fig. 5a which shows a space having matrix therein, see para. [0041]; applying negative pressure to a space between the wound cover and the wound (see the abstract which discloses a vacuum pump supplies suction within the wound cover over the treatment site); detecting temperature adjacent to the wound (temperature sensors 81 are used to detect temperature adjacent the wound site); and selectively controlling the level of negative pressure between the wound cover and the wound based on temperature (the temperature sensors are connected to an alarm system which is connect to the vacuum supply 50, that upon production of a predetermined alarm (caused by blood flow rate reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will cause the pump (51) to cease operation by the alarm device 86 (see para [0069]).
Weston fails to disclose detecting blood flow rate adjacent the wound and selectively controlling the level of negative pressure between the wound cover and the wound based on the blood flow rate. However, King in the disclosure of an analogous wound treatment method teaches it is known to provide a system with a sensor measuring and monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. with a sensor (see the abstract and claim 8).
In view of King, it would have been obvious to one having ordinary skill in the art to modify the method of Westin with the addition of a sensor to measure and monitor blood flow rate in order to determine the extent of ischemia being suffered (see col. 4, lines 3-12 of King). Once added it would have been further obvious to connect the blood flow rate sensor to the alarm system, which is connected to the vacuum supply (50), that upon production of a predetermined alarm (caused by blood flow rate reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will causes the pump (51) to cease operation (see para. [0069] of Weston).
Regarding claim 83, modified Weston discloses the method of claim 78, wherein the blood flow rate is detected via a sensor (note the rejection of claim 78 above, which discloses the use of a sensor to detect the blood flow rate).
Regarding claim 87, modified Weston discloses the method of claim 83, except further comprising an additional sensor configured to detect an amount of oxygen in a portion of the blood flowing into or adjacent to the wound. King in the disclosure of an analogous wound treatment method teaches it is known to provide a system with a sensor measuring and monitoring a physiological characteristic selected from the group consisting of blood flow rate, blood oxygen saturation, etc. with a sensor (see the abstract and claim 8).
In view of King, it would have been obvious to one having ordinary skill in the art to modify the method of Westin with the addition of an oxygen saturation sensor to measure and monitor oxygen in the blood at the wound site in order blood flow rate in order to determine the amount oxygen flowing to the wound so as to prevent tissue deterioration (col.1, lines 30-42 of King). Once added it would have been further obvious to connect the oxygen saturation sensor to the alarm system, which is connected to the vacuum supply (50), that upon production of a predetermined alarm (caused by an oxygen saturation sensor reaching below or above a certain measurement) by the alarm device (86), the vacuum pump controller (52) will causes the pump (51) to cease operation (see para. [0069] of Weston).
Regarding claim 97, modified Weston discloses the method of claim 87, further comprising changing the configuration of the wound cover when a detected amount of oxygen in a portion of the blood flowing into or adjacent to the wound is above or below a predetermined value (as discussed the rejection of claim 87 above, when the alarm sounds because oxygen saturation exceeds a certain measurement, the pump will cease; thus negative pressure stops and the cover, which during implementation of negative, has protrusions recessed as shown in Fig. 5c, and changes to the protrusion shown in Fig. 5a when vacuum is no longer implemented).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786