DETAILED ACTION
This Office Action is in response to the amendment, filed on August 18, 2026. Primary Examiner acknowledges Claims 1-16 are pending in this application, with Claims 1, 5, and 9 having been currently amended and Claims 13-15 having been withdrawn from consideration; thus, leaving Claims 1-12 and 16 to be examined.
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 .
Claim Objections
Claims 1, 2, 5, 7, 8, and 11 are objected to because of the following informalities:
Claim 1, Line 4 recites “the mouthpiece” which appears to refer back to the “interchangeable mouthpiece” in the preamble; however, it is noted Claim 1, Line 6 also states the term “an inhaler mouthpiece”. Primary Examiner presumes Claim 1, Line 4 and all generic recitations within the claim listing of “the mouthpiece” refers back to “interchangeable mouthpiece” of the preamble and only in the instances of the specific “inhaler mouthpiece” Applicant is referring to the mouthpiece of an MDI. Primary Examiner notes only Claim 1, Line 6 and Claim 2 refer to the specific “inhaler mouthpiece” of the MDI; whilst Claim 1, Line 4, and Claims 5 (3 – instances), 7 (4 – instances), 8, and 11 (2 – instances) appear to only refer to the “interchangeable mouthpiece” of the preamble. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Wachter et al. (5,794,612).
As to Claim 1, Wachter discloses an interchangeable mouthpiece (Figures 1-2) for an inhaler (1, “a standard metered-dose-inhaler (MDI) package 1” Column 2, Line 65 thru Column 3, Line 20), comprising: a housing (2, “Connected to an aerosol holding chamber 2 such as the Aero Chamber from Forest Pharmaceuticals of St. Louis, Mo., is a standard metered-dose-inhaler (MDI) package 1 (such as the Ventolin inhalation aerosol package from Allen and Hanbury's of Research Triangle Park, N.C.). In the present invention, a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20) which forms an interior (defined by the lumen of 2) and comprises an air inlet opening (via 2 proximate 1, best seen Figure 1) and an air outlet opening (via 2 proximate 4/6, best seen Figure 1), an adapter (3, “a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20) via which the mouthpiece (Figures 1-2) is either connectable to a mouthpiece side end of the inhaler (1) so that the air inlet opening (via 2 proximate 1, best seen Figure 1) is fluidly coupled to the inhaler (1) in a connected state or the adapter (3) is adapted to be connected to an inhaler mouthpiece (4, “the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20”), and a data acquisition device (Figure 4) comprising at least one sensor (14, best seen Figures 2, 3A, 3B, and 4, “Measurement of the flow rate is made using a differential pressure sensor 14 which measures the pressure drop owing to flow through a channel 15.” Column 3, Lines 35-55), a data storage device (35, “The digital stream is fed to a microprocessor 27 where the signal level and timing is compared to data stored in memory 35 built into the microprocessor 27. … An example of a suitable low-power microprocessor 27 containing both timing circuitry and integrated A/D conversion as well as on-board EPROM (erasable, programmable memory) is the MC1468705G2 from Motorola Inc. of Mesa, Ariz., an integrated package is shown as 28 in FIG. 4.” Column 4, Lines 20-55; “The controller is associated with a microprocessor where the signal level the duration and time of actuation is stored in memory.” (Abstract); “The sensor package sends data to the microprocessor 12 where both the flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 40-55), a processor (27, best seen Figure 4, “The digital stream is fed to a microprocessor 27 where the signal level and timing is compared to data stored in memory 35 built into the microprocessor 27. … The digital output of the threshold detector 33 is passed to a digital input of the microprocessor 27 where it is counted so as to record an actuation and where it triggers an on-board timer 34. An example of a suitable low-power microprocessor 27 containing both timing circuitry and integrated A/D conversion as well as on-board EPROM (erasable, programmable memory) is the MC1468705G2 from Motorola Inc. of Mesa, Ariz., an integrated package is shown as 28 in FIG. 4.” Column 4, Lines 20-55), and an energy storage device (13, best seen Figures 2, 3A, 3B, and 4, “The electronic package is powered by batteries 13 enclosed within the assembly and accessible via an access door 16.” Column 3, Lines 20-40), wherein a flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A) is formed inside (defined by the lumen of 2) the housing (2) by a partition (via 15, whereby the passage of fluid from 1 to 2 to 10 to 4 is separated proximate 10 in order to “Measurement of the flow rate is made using a differential pressure sensor 14 which measures the pressure drop owing to flow through a channel 15.” Column 3, Lines 40-50), fluidly connecting to the air inlet opening (via 2 proximate 1, best seen Figure 1) with the air outlet opening (via 2 proximate 3/4, best seen Figure 1), and wherein the data acquisition device (Figure 4) is adapted to store a data set comprising at least one operating parameter (“the signal level the duration and time of actuation” Abstract; “flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 35-50; “signal level and timing is compared to data stored in memory 35” Column 4, Lines 20-55) on the data storage device (35) in dependence of fluidic condition inside the flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A)
Regarding the limitation to “interchangeable”, Wachter discloses, the structure of the “electronics and measuring package of the invention can readily be adapted to any commercial inhaler.” (Column 3, Lines 45-55) and further the configuration whereby the “a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” (Column 2, Line 65 thru Column 3, Line 20). Thus, the structure of the “electronics and measuring package” is able to be interchangeable utilized with any housing (2), mouthpiece (4), or inhaler mouthpiece (1).
Thus, it appears Wachter meets the limitations of the claimed invention of Claim 1.
As to Claim 2, Wachter discloses the adapter (3) is adapted to be connected to an inhaler mouthpiece (4).
As to Claim 3, Wachter discloses the data acquisition device (Figure 4) is adapted to detect an inhalation puff (“The sensor package sends data to the microprocessor 12 where both the flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 35-50; “If the inhalation rate and timing is satisfactory, a LED 8, which is, for example, green, is illuminated. If the inhalation rate or timing is unsatisfactory, a LED 9, for example, red, is illuminated.” Column 2, Line 65 thru Column 3, Line 20) based on the fluidic conditions in the flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A).
As to Claim 4, Wachter discloses the storing of the data set takes place in dependence on the detection of an inhalation puff (“flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 35-50).
As to Claim 5, Wachter discloses the one or more sensors (14) is a pressure sensor (“a differential pressure sensor 14” Column 3, Lines 35-55) for detecting air pressure in the flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A).
As to Claim 6, Wachter discloses the data acquisition device (Figure 4) is adapted to provide the data set with a time stamp (“time of actuation” Abstract; “the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded” Column 3, Lines 35-50).
As to Claim 7, Wachter discloses the stored data set comprises an inhalation puff duration (“the duration and time of actuation” Abstract; “flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 35-50).
As to Claim 8, Wachter discloses the mouthpiece (Figures 1-2) comprises a data interface (5, “ A liquid crystal (LC) display panel 5 shows the count of the number of actuations of the MDI as sensed remotely by an ultrasonic transducer 6 embedded in the wall of the package facing the MDI. … If the red LED is illuminated, a diagnostic code is displayed on the LC display 5.” Column 2, Line 65 thru Column 3, Line 20; “The signal conditioning is carried out in an embedded electronics package 11 which sends a digital pulse to an embedded microprocessor 12 located behind the LC display 5.” Column 3, Lines 20-40; “Output is then sent to the LEDs 8, 9, and the LC display 5.” Column 3, Lines 35-50; “The microprocessor drives the LC display 5, as well as the LED's 8, 9, via current drivers 29 and 30.” (Column 4, Lines 55-60).
As to Claim 9, Wachter discloses the data interface (5) is a wireless interface. The nature of the data interface being a screen provides a wireless interface upon which the patient, and health care professional can visually receive the data as presented on the data interface.
As to Claim 10, Wachter discloses the adapter (3) is formed by a part of the housing (2), as a function of the “interposed” connection (“a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20).
As to Claim 11, Wachter discloses the air inlet opening (via 2 proximate 1, best seen Figure 1) is arranged on a first end face of the mouthpiece (Figures 1-2) associated with the adapter (3), and the air outlet opening (via 2 proximate 3/4, best seen Figure 1) is arranged on a second mouth side end face of the mouthpiece (Figures 1-2) facing away from the adapter (3).
As to Claim 12, Wachter discloses flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A) connects the air inlet opening (via 2 proximate 1, best seen Figure 1) in a direct path to the air outlet opening (via 2 proximate 3/4, best seen Figure 1).
As to Claim 16, Wachter discloses an interchangeable mouthpiece (Figures 1-2) for use with a medical inhaler (1, “a standard metered-dose-inhaler (MDI) package 1” Column 2, Line 65 thru Column 3, Line 20), comprising: a housing (2, “Connected to an aerosol holding chamber 2 such as the Aero Chamber from Forest Pharmaceuticals of St. Louis, Mo., is a standard metered-dose-inhaler (MDI) package 1 (such as the Ventolin inhalation aerosol package from Allen and Hanbury's of Research Triangle Park, N.C.). In the present invention, a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20) which forms an interior (defined by the lumen of 2) and comprises an air inlet opening (via 2 proximate 1, best seen Figure 1) and an air outlet opening (via 2 proximate 4/6, best seen Figure 1), an adapter (3, “a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20) via which the mouthpiece (Figures 1-2) is either connectable to a mouthpiece side end of the inhaler (1) so that the air inlet opening (via 2 proximate 1, best seen Figure 1) is fluidly coupled to the inhaler (1) in a connected state or the adapter (3) is adapted to be connected to an inhaler mouthpiece (4, “the mouthpiece 4 and the chamber 2.” Column 2, Line 65 thru Column 3, Line 20”), and a data acquisition device (Figure 4) comprising at least one sensor (14, best seen Figures 2, 3A, 3B, and 4, “Measurement of the flow rate is made using a differential pressure sensor 14 which measures the pressure drop owing to flow through a channel 15.” Column 3, Lines 35-55), a data storage device (35, “The digital stream is fed to a microprocessor 27 where the signal level and timing is compared to data stored in memory 35 built into the microprocessor 27. … An example of a suitable low-power microprocessor 27 containing both timing circuitry and integrated A/D conversion as well as on-board EPROM (erasable, programmable memory) is the MC1468705G2 from Motorola Inc. of Mesa, Ariz., an integrated package is shown as 28 in FIG. 4.” Column 4, Lines 20-55; “The controller is associated with a microprocessor where the signal level the duration and time of actuation is stored in memory.” (Abstract); “The sensor package sends data to the microprocessor 12 where both the flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 40-55), a processor (27, best seen Figure 4, “The digital stream is fed to a microprocessor 27 where the signal level and timing is compared to data stored in memory 35 built into the microprocessor 27. … The digital output of the threshold detector 33 is passed to a digital input of the microprocessor 27 where it is counted so as to record an actuation and where it triggers an on-board timer 34. An example of a suitable low-power microprocessor 27 containing both timing circuitry and integrated A/D conversion as well as on-board EPROM (erasable, programmable memory) is the MC1468705G2 from Motorola Inc. of Mesa, Ariz., an integrated package is shown as 28 in FIG. 4.” Column 4, Lines 20-55), and an energy storage device (13, best seen Figures 2, 3A, 3B, and 4, “The electronic package is powered by batteries 13 enclosed within the assembly and accessible via an access door 16.” Column 3, Lines 20-40), wherein a flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A) is formed inside (defined by the lumen of 2) the housing (2) by a partition (via 15, whereby the passage of fluid from 1 to 2 to 10 to 4 is separated proximate 10 in order to “Measurement of the flow rate is made using a differential pressure sensor 14 which measures the pressure drop owing to flow through a channel 15.” Column 3, Lines 40-50), fluidly connecting to the air inlet opening (via 2 proximate 1, best seen Figure 1) with the air outlet opening (via 2 proximate 3/4, best seen Figure 1), and wherein the data acquisition device (Figure 4) is adapted to store a data set comprising at least one operating parameter (“the signal level the duration and time of actuation” Abstract; “flow rate, and the time of the onset of the flow rate with respect to the actuation and the duration of inhalation are recorded and compared to acceptable values stored in the microprocessor's memory.” Column 3, Lines 35-50; “signal level and timing is compared to data stored in memory 35” Column 4, Lines 20-55) on the data storage device (35) in dependence of fluidic condition inside the flow channel (defined by the passage of fluid from 1 to 2 to 10 to 4, best seen Figures 1, 2, and 3A)
Regarding the limitation to “interchangeable”, Wachter discloses, the structure of the “electronics and measuring package of the invention can readily be adapted to any commercial inhaler.” (Column 3, Lines 45-55) and further the configuration whereby the “a measurement and electronics package 3 is interposed between the mouthpiece 4 and the chamber 2.” (Column 2, Line 65 thru Column 3, Line 20). Thus, the structure of the “electronics and measuring package” is able to be interchangeable utilized with any housing (2), mouthpiece (4), or inhaler mouthpiece (1).
Thus, it appears Wachter meets the limitations of the claimed invention of Claim 16.
Response to Arguments
Applicant’s arguments with respect to claims 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.
In order to advance prosecution of this application, it may behoove Applicant to positively recite the structure and relationship of each of the interchangeable mouthpiece components in an manner that is distinguished from Wachter. For Example: “the data acquisition device is also arranged within the housing .. both the data acquisition device and the flow channel within the housing” (Page 4, Lines 1-5); “the adapter is formed by a receptacle into which the inhaler can protrude and in such a way that slipping out of the inhaler is prevented by a force closure between the mouthpiece and the inhaler” (Page 7, Lines 15-25); “Due to the partition, the flow channel is fluidically separated from the rest of the interior, preferably the flow channel is hermetically separated from the rest of the interior by the partition” (Page 3, Lines 10-20); ”AND “the data acquisition device is supported by a carrier, which is supported on the inner wall of the housing, and by an outer surface of the partition forming the flow channel” (Page 8, Lines 5-15).
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 ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
