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 .
Claims 1-23 are hereby under examination.
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.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over US20180153440A1 (Lee et. al), previously cited and hereto referred as Lee, and in view of Gutiérrez, J. J., Leturiondo, M., Ruiz de Gauna, S., Ruiz, J. M., Leturiondo, L. A., González-Otero, D. M., Zive, D., Russell, J. K., & Daya, M. (2018). Enhancing ventilation detection during cardiopulmonary resuscitation by filtering chest compression artifact from the capnography waveform. PLOS ONE, 13(8). doi.org/10.1371/journal.pone.0201565, previously cited and hereto referred as Gutierrez.
As to claims 1, 12, and 13, Lee teaches a breath monitoring apparatus (Lee, title) for producing a capnogram for a patient (Lee, Fig. 4B), comprising a tube arrangeable such that air flowing into and out of a patient during a breathing cycle of the patient are conducted through the tube (Lee, Fig. 1A, flow tube 116);
a CO2 monitor for repeatedly determining a presence, and level, of CO2 in the air within the tube (Lee, [0061], “pulmonary mechanics measurement controller contains pressure sensors”);
an airflow direction sensor located within the tube (Lee, [0061], “In other implementations, sensors or other devices for evaluating pulmonary mechanics may be integrated into or attached to flow tube 116… The pulmonary mechanics measurement sub-system may generally include the apparatus and electronics configured to perforin a spirometry test”; [0062], “Spirometry is a pulmonary function test (PFT) that measures the volume and/or speed (flow rate) of air that can be exhaled and/or inhaled.”),
the airflow direction sensor for providing airflow direction data distinguishing between periods when air is flowing into the patient, when air is flowing out of the patient, and when air in the tube is stationary (Lee, [0062], “Spirometry is a pulmonary function test (PFT) that measures the volume and/or speed (flow rate) of air that can be exhaled and/or inhaled.”);
a display (Lee, Fig. 1A, display 104); and
a processor for producing a graph on the display (Lee, Fig. 2, single board computer 202 is functionally connected to display screen 104) of an indication of CO2 levels versus time, wherein the display includes different graphical qualities to distinguish between the level of CO2 in the air flowing out of the patient, the level of CO2 in the stationary air between breaths, and the level of CO2 in the air flowing into the patient (Lee, [0017], “FIG. 5B is a diagram illustrating an exemplary output display”).
However, Lee does not teach the display includes different colours to distinguish between the air flowing out of the patient, the stationary air between breaths, and the air flowing into the patient. Gutiérrez teaches a relevant art of determining capnography (Gutiérrez, title). Gutiérrez teaches different colours to distinguish between the air flowing out of the patient, the stationary air between breaths, and the air flowing into the patient (pg. 3, Fig. 1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee in view of Gutiérrez to include display includes different colours to distinguish between the air flowing out of the patient, the stationary air between breaths, and the air flowing into the patient because Lee already teaches using a display, and adding a color graph would allow the user to easily identify the different features of the breaths as taught by Gutierrez.
As to claims 2 and 14, Lee-Guiterrez teaches the tube includes a mask (Lee, Fig. 1B, Face mask 130; [0048]).
As to claims 3 and 15, Lee-Guiterrez teaches the airflow direction sensor includes one or more of a pressure sensor, a temperature sensor, a micro-flow sensor, and an acoustic sensor (Lee, [0062], “pressure transducers, ultrasonic flow measurement, water gauge, mechanical turbines, or other devices”).
As to claims 4 and 16, Lee-Guiterrez teaches the processor is arranged to determine the airflow direction from signals sent by an airflow direction sensor (Lee, Fig. 1A, control unit 102; [0046]).
As to claims 5 and 17, Lee-Guiterrez teaches the processor is configured to display the level of CO2, as received from the CO2 monitor at a first sampling time, with the airflow direction data received from the airflow direction sensor from a second sampling time (Lee, Fig. 4B, sampling time shown in the x-axis; the examiner interprets one breath cycle as one sample).
As to claims 6 and 18, Lee-Guiterrez teaches the first sampling time is the same as the second sampling time (Lee, Fig. 4B, one breath cycle).
As to claims 7 and 19, Lee-Guiterrez teaches the first sampling time is later than the second sampling time (Lee, Fig. 4B, breath cycle including the second peak is later than the breath cycling including the first peak).
As to claims 8 and 20, Lee-Guiterrez teaches the first sampling time is later than the second sampling time by 10 milliseconds to 30 seconds (Lee, Fig. 4B, breath cycle including the second peak is later than the breath cycling including the first peak by 10 milliseconds to 30 seconds).
As to claims 9 and 21, Lee-Guiterrez teaches the levels of CO2 are expressed on the display as either or both of a percentage of CO2 in the airflow, and a partial pressure of CO2 (Lee, Fig. 4E, pCO2 Y-axis).
As to claim 10, Lee-Guiterrez teaches the display includes different colours to distinguish between the level of CO2 in the air flowing out of the patient, the level of CO2 in the stationary air between breaths, and the level of CO2 in the air flowing into the patient (Guiterrez, Fig. 1A ; flowing out of the patient is dark green and neon green; flowing into the patient is red and black; when the air is stationary, it is the point where neon green changes to red.)
As to claims 11 and 22, Lee-Guiterrez teaches the airflow direction sensor and the CO2 monitor are combined in a single unit (Lee, [0061], “pulmonary mechanics measurement controller contains pressure sensors”; Fig. 1A, control unit 102).
As to claim 23, Lee-Guiterrez teaches different colors included by the display indicate: the air flowing out of the patient, the stationary air between breaths, and the air flowing into the patient (Guiterrez, Fig. 1A; flowing out of the patient is dark green and neon green; flowing into the patient is red and black; when the air is stationary, it is the point where neon green changes to red. The examiner notes, the specific colors, i.e., the colour white to indicate the air flowing out of the patient; the colour yellow to indicate the stationary air between breaths; and the colour blue to indicate the air flowing into the patient, are aesthetic design change that does not have any patentable weight. See MPEP 2144.04 (I): “matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art”. Additionally, it would have been obvious to a person of ordinary skills to use a variety of colors to indicate the different states of breathing including white, yellow, and blue)
Response to Arguments
Applicant's arguments filed 7/23/2025 have been fully considered but they are not persuasive.
Regarding the drawing objections, applicant amends the specification to overcome the objection. The drawing objection is withdrawn.
Regarding the 112b rejections, Applicant amends the claims to overcome the 112b rejections. The 112b rejections are withdrawn.
Regarding the 103 rejections, Applicant alleges on pg. 12: “Applicant respectfully submits that spirometry measures only air flow volume or speed, not "direction"”. However, the examiner disagrees. Lee measures flow rate (Lee, [0062], “Spirometry is a pulmonary function test (PFT) that measures the volume and/or speed (flow rate) of air that can be exhaled and/or inhaled.”), but measurement of speed of air that is exhaled and/or inhaled contains the directional information as exhalation or inhalation would be either negative or positive flow rate. Moreover, flow rate is calculated by multiplying the cross-sectional area of the flow by the average velocity, which contains the directional component. Lee clarifies this further: (Lee, [0099], "As the patient exhales, the pulmonary mechanics measurement controller may monitor and record a volumetric flow rate of exhaled (and/or inhaled) air and elapsed time.") wherein a volumetric flow rate would contain the negative or positive direction of the airflow, indicating exhalation or inhalation.
Additionally Applicant alleges on pg. 13: “There is no processor configured to add this material as in claim 13”. However, Lee teaches a processor and display (Lee, [0049], "microprocessor or controller 210"; Lee, Fig. 1A, display 104). Gutierrez is relied on to provide the display in colors to distinguish the airflow as Lee is silent on this matter. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As such, the 103 rejections are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791