DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The action is in response to amendments filed on 12/09/2025. Claims 16 and 21 has been amended. Claims 30-40 have been cancelled. Claims 41-49 have been added. Claims 16-17, 19-29, 41-49 are pending and examined below.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 16-29 is/are rejected under 35 U.S.C. 103 as being anticipated by US 20120226181 A1 (hereinafter referred to as “Vallee”) in view of US 20100130842 A1 (hereinafter referred to as “Hayoz”) and US 20080183059 A1 (hereinafter referred to as “LaPlante”).
Regarding claim 16, Vallee, a non-invasive method for assessing tissue perfusion in a patient, teaches a device for obtaining an indicator of a microcirculatory condition of a patient (abstract), comprising:
at least one first sensor for measuring data indicative of first carbon dioxide levels, the first sensor comprising a measurement area to be contacted with the patient's tissue, and adapted for a transcutaneous carbon dioxide measurement at a first temperature, wherein the measurement area is kept below 38° C. (abstract; paragraphs [0023]-[0028]);
at least one second sensor for measuring data indicative of second carbon dioxide levels, the second sensor comprising a measurement area to be contacted with the patient's tissue and adapted for a transcutaneous carbon dioxide measurement at a second temperature being higher than the first temperature (paragraphs [0023]-[0028], [0032]-[0036]); and
a control unit (calculator means; paragraph [0022]) for detecting changes in skin perfusion, the control unit having at least one input for receiving a measured or estimated first carbon dioxide level value, at least one input for receiving a measured or estimated second carbon dioxide level value from the second sensor (paragraphs [0023]-[0028], [0032]-[0036]); and wherein the first sensor is a first sensing unit and the second sensor is a second sensing unit different from the first sensing unit (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Vallee does not explicitly teach the measurement area of the second sensor is heated above 38C and at least one output interface for outputting an indicator of a microcirculatory condition of a patient based on the received inputs.
However, Hayoz, a device for transcutaneous determination of blood gases, teaches the measurement area of the second sensor is heated above 38C (paragraph [0045]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, to teach the measurement area of the second sensor is heated above 38C, as taught by Hayoz, because heating tissues above body temperature for better perfusion is widely known within the art.
Further, LaPlante teaches at least one output interface for outputting an indicator of a microcirculatory condition of a patient based on the received inputs (paragraph [0034]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, in view of Hayoz, to have an output, as taught by LaPlante, because doing so allows a user to view sensor results.
Regarding claim 17, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit has at least one input for receiving a tissue carbon dioxide level value from the first sensor, and/or at least one input for receiving an arterial blood carbon dioxide level value (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 19, Vallee, in view of Hayoz, teaches wherein the device comprises at least one addition.
However, LaPlante teaches wherein the device comprises at least one additional sensor adapted for measuring data indicative of a further parameter (paragraph [0053]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, in view of Hayoz, to have an additional sensor, as taught by LaPlante because an sensor adapted for measuring data indicative of a further parameter related to blood flow circulation.
Regarding claim 20, Vallee, in view of Hayoz and LaPlante, teaches wherein the additional sensor is adapted for measuring data indicative a temperature, the oxygen level or a pH-value of the blood and/or another blood parameter (paragraph [0053]; in view of LaPlante).
Regarding claim 21, Vallee, in view of Hayoz and LaPlante, teaches wherein the sensors are adapted for continuous and/or intermittent and/or alternating measurement (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 22, Vallee, in view of Hayoz and LaPlante, teaches wherein the first sensor and the second sensor are arranged in a common housing (paragraphs [0043]-[0046]; as taught by Hayoz). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, to have the sensors in a single housing, as taught by Hayoz, because doing so provides more convenience.
Regarding claim 23, Vallee, in view of Hayoz and LaPlante, teaches wherein the first sensor and the second sensor are adapted to be placed on a part of the skin (paragraph [0013]; as taught by Vallee).
Regarding claim 24, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for inducing a measurement of the first carbon dioxide level at a first temperature and for inducing a measurement of the second carbon dioxide level, with the measurement area being heated to the second temperature, the second temperature being higher than the first temperature (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee),
wherein the control unit is adapted for controlling at least one heating element for keeping the measurement site of the skin at a certain temperature (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee) and wherein
the control unit comprises an output for controlling the heating element, the first sensor and/or the second sensor (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 25, Vallee, in view of Hayoz and LaPlante, teaches wherein the second temperature is above 38° C (paragraph [0045]; as taught by Hayoz).
Regarding claim 26, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for estimation of an arterial partial carbon dioxide pressure PaCO2 based on a transcutaneous partial carbon dioxide pressure tcPCO2, obtained by a measurement by the second sensor, wherein the measurement area is heated to temperature above 38° C. and/or a temperature that achieves arterialization (paragraphs [0029], [0037]; as taught by Vallee).
Regarding claim 27, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for estimation of tissue partial carbon dioxide pressure PcCO2 based on a transcutaneous partial carbon dioxide pressure PcCO2, obtained by a measurement by the first sensor, wherein the measurement area is kept below 38° C (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 28, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for determining the indicator of a microcirculatory condition of a patient based on
the difference between the first and the second carbon dioxide level,
the ratio of the first and the second carbon dioxide level and/or
an index based on the first and the second carbon dioxide level (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 29, Vallee, in view of Hayoz and LaPlante teaches wherein the output interface of the control unit is connected or connectable to an output device (Paragraph [0058]; as taught by LaPlante).
Regarding claim 41, Vallee, in view of Hayoz and LaPlante, teaches comprising a heating element (paragraph [0045]; as taught by Hayoz).
Regarding claim 42, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for displaying over time at least one of - the first and second carbon dioxide levels,- a difference between the first and second carbon dioxide levels,- a ratio of the first and second carbon dioxide levels and - an index based on the first and second carbon dioxide levels (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee).
Regarding claim 43, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted to determine a change over time (paragraphs [0023]-[0028], [0032]-[0036], [0038]; as taught by Vallee).
Regarding claim 44, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for displaying over time at least one of - the first and second carbon dioxide levels,- a difference between the first and second carbon dioxide levels,- a ratio of the first and second carbon dioxide levels and - an index based on the first and second carbon dioxide levels (paragraphs [0023]-[0028], [0032]-[0036], [0038]; as taught by Vallee; paragraph [0034]; as taught by LaPlante).
Regarding claim 45, Vallee, in view of Hayoz and LaPlante, teaches wherein the control unit is adapted for prediction of sepsis depending on the temporal trend of a measured change of the microcirculatory condition (paragraphs [0030], [0038], [0047]-[0048]; as taught by Vallee).
Regarding claim 48, Vallee, in view of Hayoz and LaPlante, teaches comprising at least one output interface for outputting the indicator of a microcirculatory condition of a patient based on the received inputs,and an output device, which is adapted to display a confidence index, which is based on the quantity of data used and which is derived from a deviationof measurement data over a period of time, the confidence index being high,if the deviation is relatively low over a sustained period of time (paragraphs [0023]-[0028], [0032]-[0036], [0038]; as taught by Vallee; paragraph [0034]; as taught by LaPlante).
Regarding claim 49, Vallee, a non-invasive method for assessing tissue perfusion in a patient, teaches a device for obtaining an indicator of a microcirculatory condition of a patient (abstract), comprising:
at least one first sensor for measuring data indicative of first carbon dioxide levels, the first sensor comprising a measurement area to be contacted with the patient's tissue, and adapted for a transcutaneous carbon dioxide measurement at a first temperature, wherein the measurement area is kept below 38° C. (abstract; paragraphs [0023]-[0028]);
at least one second sensor for measuring data indicative of second carbon dioxide levels, the second sensor comprising a measurement area to be contacted with the patient's tissue and adapted for a transcutaneous carbon dioxide measurement at a second temperature being higher than the first temperature (paragraphs [0023]-[0028], [0032]-[0036]); and
a control unit (calculator means; paragraph [0022]) for detecting changes in skin perfusion, the control unit having at least one input for receiving a measured or estimated first carbon dioxide level value, at least one input for receiving a measured or estimated second carbon dioxide level value from the second sensor (paragraphs [0023]-[0028], [0032]-[0036]); and wherein the first sensor is a first sensing unit and the second sensor is a second sensing unit different from the first sensing unit (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee); and at least one of - the first and second carbon dioxide levels,- a difference between the first and second carbon dioxide levels,- a ratio of the first and second carbon dioxide levels and - an index based on the first and second carbon dioxide levels (paragraphs [0023]-[0028], [0032]-[0036]; as taught by Vallee)
Vallee does not explicitly teach the measurement area of the second sensor is heated above 38C and at least one output interface for outputting an indicator of a microcirculatory condition of a patient based on the received inputs.
However, Hayoz, a device for transcutaneous determination of blood gases, teaches the measurement area of the second sensor is heated above 38C (paragraph [0045]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, to teach the measurement area of the second sensor is heated above 38C, as taught by Hayoz, because heating tissues above body temperature for better perfusion is widely known within the art.
Further, LaPlante teaches at least one output interface for outputting an indicator of a microcirculatory condition of a patient based on the received inputs (paragraph [0034]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Vallee, in view of Hayoz, to have an output, as taught by LaPlante, because doing so allows a user to view sensor results.
Allowable Subject Matter
Claim 46-47 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 12/09/2025 in regards to the prior art rejection have been fully considered but they are not persuasive.
Applicant traverse the prior art rejection of claim 16.
Specifically, Applicant argues that the prior art of record does not explicitly teach wherein the first sensor is a first sensing unit and the second sensor is a second sensing unit different from the first sensing unit. Examiner respectfully disagrees.
Vallee teaches wherein the first sensor is a first sensing unit and the second sensor is a second sensing unit different from the first sensing unit (“a first carbon dioxide sensor for detecting a partial pressure of carbon dioxide (PCO2), the sensor being adapted for being attached on the ear lobe and/or the scalp and measuring the cutaneous PCO2 (cPCO2) of a patient” and “a second carbon dioxide sensor for detecting a partial pressure of carbon dioxide (PCO2), the sensor being adapted for measuring the end-tidal PCO2 (EtPCO2) of an intubated patient”; paragraphs [0032]-[0036]; as taught by Vallee). Thus the sensors are different as they are capable of measuring different parameters. As such Applicant’s argument is found to be unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791