FINAL REJECTION
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 .
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive.
The applicant argues that (pages 7-8, remarks):
“Applicant notes that amended Claim 22 requires “the representation includes a graph showing the level of carbon monoxide as a percentage of carboxyhemoglobin in the user’s blood”.
Claim 22 additionally requires that the graphical representation is of the level of carbon dioxide “in comparison to an average level of the carbon monoxide with a population of non- smokers.”
Neither Cohen nor Lawson discloses or suggests these features.
For instance, Cohen describes a device for providing risk evaluation and mitigation strategies for use with modified risk products or other tobacco products, and in particular, associated with nicotine and tobacco products.
However, Cohen simply represents the diagnostic test result as a binary result, that is, to “pass” or not pass a pre-determined threshold. There is no graph and no comparison to a population of non-smokers shown on a graph.
Lawson exhibits the result through one or more of:
a result giving means 8 which comprises three lights 18, 20, 22
a message giving means 6 comprising a speaker 24 and a recorded messages storage device 26
a display panel 10 which displays a carbon monoxide concentration following a user exhaling on the mouthpiece 4
However, Lawson provides no indication that the apparatus 2 is capable of representing the percentage of carboxyhemoglobin in the blood measured from the user in a graph where the graph provides a comparison between a measurement from a user and an average population of non-smokers.
Therefore, no combination of Cohen and Lawson arrives at the features of amended Claim 22. Accordingly, the invention of Claim 22 cannot be obvious staring from Cohen in view of Lawson.
Applicant emphasizes that the distinguishing feature of the claims provide the user with a Starker and more precise comparison with an average population of non-smokers. A user may therefore find a graph more motivating than other forms of information.
Notably, the result giving means 8 in Lawson defines three smoker levels (see paragraph [0040]). Each smoker level is formed of carbon monoxide ppm bands (see paragraph {0014]). A user may have improved their smoking habit and lowered the carbon monoxide in their system but stay in the same band. For example, a user may start at 15 ppm then after a period of time lower to 12 ppm, however they would still be in the high dosage category as per [0014], both tests would result in a ‘red’ light. A user may be discouraged by this. Furthermore, they cannot see from the display in Lawson that their level of carbon monoxide may be many times greater than that of a typical non-smoker. They only know that that their level is higher but not the quantitative degree to which their level is higher.”
The examiner respectfully disagrees. Claim 22 currently recites “wherein the processing device provides to the display device a graphical representation of the level of the carbon monoxide detected by the toxicant testing device in comparison to an average level carbon monoxide within a population of non-smokers”. Therefore, prior art is required to teach a processor which is configured to display a value of carbon monoxide detected from a user and compare this value to what may be considered to be an “average level” of carbon monoxide within a population of non-smokers. When the claim language is given its plain meaning in view of the specification, the language of “an average level of the carbon monoxide within a population of non-smokers” may be interpreted to be any value of carbon monoxide which may be lower than a carbon monoxide level of a smoker.
Cohen as modified by Lawson is interpreted as teaching the claimed limitation of “wherein the processing device provides to the display device a graphical representation of the level of the carbon monoxide detected by the toxicant testing device in comparison to an average level carbon monoxide within a population of non-smokers” because Cohen teaches displaying readings or light that is a representation of the level of CO detected by the testing device compared to a cutoff CO value that is an average level of the CO in a non-smoker (paragraphs 305 and 311). The device displaying “pass” on the device may be interpreted as being above or below a comparison to a carbon monoxide value of a non-smoker.
Also, Lawson teaches an apparatus having measuring means 4 for measuring the carbon monoxide on the person's breath and a display panel 10 for displaying visual messages, the measuring means 4 includes a signal conditioning circuit 14 and a processor control circuit 16, and also includes result giving means 8 for giving the result of the measured carbon monoxide on the person's breath where the result giving means 8 may select an appropriate result from a plurality of results contained in the apparatus 2 and may light up one of a plurality of different lights including three lights 18, 20, 22. Where light 18 may be a green light for indicating a non-smoker, the light 20 may be an orange light for indicating a light-smoker, the light 22 may be a red light for indicating a heavy-smoker. The light indicators are interpreted as being based on values that represent average levels of CO detected of a non-smokers and smokers (the three different lights being interpreted as a “graphical representation” of a level of CO detected, paragraphs 35-40, figure 1).
With respect to the applicants arguments Cohen as modified by Lawson fails to teach “wherein the graphical representation includes a graph showing the level of carbon monoxide as a percentage of carboxyhemoglobin in the user’s blood”, the applicant’s arguments with respect to claim(s) 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.
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.
Claim(s) 22 and 24, 26, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen U.S. Patent Application Publication 2014/0378790 in view of Lawson U.S. Patent Application Publication 2005/0081601 and further in view of Utley et al. U.S. Patent Application Publication 2017/0055573.
With respect to claims 22, Cohen teaches a toxicant testing station comprising: a toxicant testing device configured to detect a level of carbon monoxide in a user (monitoring device 20 which includes a gas sensor 22 to detect CO concentration in the expelled air from a user, paragraph 302, figure 3D); a processing device connected to the toxicant testing device (interpreted as the processing and diagnostic test which reads the sensors 22 outputs and determines the CO concentration and analysis from the determined concentration, paragraphs 302-305); and a display device connected to the processing device (display 24, paragraph 305, figure 3D), wherein the processing device is configured to provide to the display device a level of the carbon monoxide detected by the toxicant testing device in comparison to an average level of the toxicant within a population (the device display indicates a “pass” based on diagnostic test from the sensor readings from the user and analysis of values that includes comparing to an average non-smokers values, paragraphs 305 and 311).
Cohen fails to teach wherein the processing device provides to the display device a graphical representation of the level of a carbon monoxide detected the toxicant testing device in comparison to an average level of carbon monoxide within a population of non-smokers, and wherein the graphical representation includes a graph showing the level of carbon monoxide as a percentage of carboxyhemoglobin in the user’s blood.
Lawson teaches an apparatus 2 for measuring carbons monoxide on a person’s breath wherein the apparatus 2 comprises measuring means 4 for measuring the carbon monoxide on the person's breath, a display panel 10 for displaying visual messages, the measuring means 4 includes a signal conditioning circuit 14 and a processor control circuit 16, and also includes result giving means 8 for giving the result of the measured carbon monoxide on the person's breath where the result giving means 8 may select an appropriate result from a plurality of results contained in the apparatus 2 and may light up one of a plurality of different lights including three lights 18, 20, 22 where the light 18 may be a green light for indicating a non-smoker, the light 20 may be an orange light for indicating a light-smoker, the light 22 may be a red light for indicating a heavy-smoker (the terms “non-smoker”, “light smoker”, and “heavy smoker” are interpreted as being values that are representative average levels of CO detected of a non-smoker and the three lights are interpreted as a “graphical representation” of a level of CO detected, paragraphs 35-40, figure 1).
Accordingly, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the testing station of Cohen with the measuring means and lights for displaying different levels of measured smoking behavior as taught by Lawson in order to clearly visually indicate to a user a level of toxicant measured.
Utley teaches a system and method for monitoring of biometric and contextual variables to assist in screening for, quantification of, and prediction of smoking behavior, and for assisting in smoking cessation (abstract) wherein the exemplary embodiment 100 the system includes a device 102, device 104, and server 106 in communication with devices 102 and 104, where the device 102 assists in detecting a patient's smoking behavior and includes a processor, a memory, and a communications link for sending and receiving data from device 104 and/or server 106, and also includes one or more sensors to measure the patient's smoking behavior based on measuring one or more of the patient's CO, eCO, SpCO (carboxyhemoglobin), SpO2, heart rate, respiratory rate, blood pressure, body temperature, sweating, heart rate variability, electrical rhythm, pulse velocity, galvanic skin response, pupil size, geographic location, environment, ambient temperature, stressors, life events, and other suitable parameters. The device includes showing measurements such as SpCO 1002 (carboxyhemoglobin percentage), SpO2 1004, heart rate 1006, respiratory rate 1008, blood pressure 1010, and body temperature 1012, as well as warning indicators 1014 and 1016 may be provided for atypical measurements, possibly indicating effects of smoking on the body (paragraphs 9, 57, 75, and 108, and figures 10 and 11).
Accordingly, it would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the invention Cohen as modified by Lawson and further configure the processor to provide a graphical display of percentage of carboxyhemoglobin in the users blood as taught by Utley in order to provide a device and system used to build, update and improve the model for smoking behavior as well as to provide perturbations to assist in ultimately reducing the individual's smoking behavior (paragraph 190, Utley).
With respect to claim 24, Cohen teaches wherein the toxicant testing device is a blood testing device (paragraph 209 and 301-302).
With respect to claim 26, Cohen teaches a data entry device configured to receive user information including one or more of smoking history, occupation, lifestyle, home location, working location, medical conditions, and diet (the device may comprise an identification recognition system which may have a fingerprint scanner, a lip print scanner, face recognition, a retinal scan, a combination code, an activation code, security key fob, or dongle, paragraph 125), wherein the processing device is further configured to send or receive data to/from a central server, the central server being configured to host a central database storing user data, the user data relating to toxicant level and the user information (sensed data may be sent/received from a third party which monitors the device/user, paragraphs 146, 278).
With respect to claim 27, Cohen teaches an interface for an electronic smoking device (modified risk system 100 which includes an electric cigarette, figure 6), wherein the display device is configured to display usage data from the electronic smoking device together with the level of the toxicant detected (the modified risk system 100 which includes further includes a smart phone having a display and the usage activity is monitored via a third party which interfaces with the device/system, paragraph 146).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen U.S. Patent Application Publication 2014/0378790 in view of Lawson U.S. Patent Application Publication 2005/0081601 and further in view of Utley et al. U.S. Patent Application Publication 2017/0055573 and further in view of Dennis et al. U.S. Patent Application Publication 2017/0074857.
With respect to claim 23, Cohen teaches wherein the toxicant testing device is a breath testing device into which a user exhales (paragraph 302), but Cohen as modified by Lawson and further modified by Utley fails to teach wherein the toxicant testing station further comprises a plurality of disposable mouthpieces for the toxicant testing device.
Dennis teaches a Medication Adherence Monitoring System (MAMS) referred to as SMART that comprises an optimized device, medication composition, and method of making and using the system and its components where the system 100 has a housing 110, a display 120 which may also include a photographic image capture device 121 to concurrently document the image of the subject exhaling into the device, an exhaled breath receiving mouthpiece 130, inert to VOCs in the exhaled breath, that is a “straw”, which is inserted into the mouthpiece receiver port 131 (paragraph 225).
Accordingly, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Cohen as modified by Lawson as modified by Utley with the portable device having disposable straw mouthpieces as taught by Dennis in order to provide an easy to use user testing system.
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 FREDDIE KIRKLAND III whose telephone number is (571)272-2232. The examiner can normally be reached 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Breene can be reached at (571) 272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
FREDDIE KIRKLAND III
Primary Examiner
Art Unit 2855
/Freddie Kirkland III/Primary Examiner, Art Unit 2855 11/12/2025