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 .
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 2, 4 and 11 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.
Claim 2 recites the limitation "The non-thermal" in line 1. There is insufficient antecedent basis for this limitation in the claim.
It is also unclear if claim 2 is meant to be dependent form claim 1, given “The non-thermal” language used in the claim. This would appear to be the case. However, given the lack of dependency in claim 2, claim 2 could also be an independent claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation less than 20%, and the claim also recites less than 10% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 11 recites the limitation "the second delivering learning mode" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 is also indefinite because a first learning mode has not been recited. Thus, it is unclear if there is necessarily a first learning mode.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LACOUR-GAYET et al. (US 2021/0260312).
With respect to claims 1 and 2, LACOUR-GAYET et al. discloses a non-thermal aerosol generating device (Abstract; Paragraph [0008]) comprising an aerosol generating liquid store, 104 (Paragraphs [0046] and [0015]-[0018]); a mouthpiece 101 (Paragraphs [0045]-[0047]; Figure 1) and an aerosol generating unit, 108, 118, 109 and 110 (Paragraphs [0047]-[0050]). The device comprises a controller (Paragraph [0048]-0049], [0078], [0083]) so that in operation mode 1110 (Figure 11) the aerosol is generated in proportion to an amount of airflow. Thus, during inhalation, airflow may increase from zero to a maximum value, then decrease back to zero (Paragraph [0150]).
The courts have generally held that an "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP 2114, II, If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). MPEP 2114, I.
In the instant case, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). Thus, the device is capable of operating in any mode that is determined by a user’s inhalation pattern. Specifically, if the user inhales at an amount that generates a first rate of aerosol collected mass, the device is capable of generating a proportional rate (e.g., more than the maximum) simply by providing said rate for the given inhalation airflow amount. Moreover, should the user inhale at a progressive inhalation rate, by inhaling at a second rate lower than the first rate, progressing regularly from the second rate toward the first rate, reaching the first inhalation rate and then keeping at the first rate, then the controller is capable of providing a proportional amount of aerosol to each of said rates. As the amount of aerosol is proportional to said rates, then the amount of aerosol released through the mouthpiece would also follow the same progression.
With respect to claim 3, The courts have generally held that an "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP 2114, II, If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). MPEP 2114, I.
In the instant case, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). Thus, the aerosol generating unit is capable of ejecting the aerosol outside the mouthpiece by progressing regularly from the second rate towards the first rate, and during a number of user’s puffs which is comprised between 5 and 30 puffs, simply by having the user perform the progression in their inhalation rate accordingly.
With respect to claim 4¸ LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). Thus, the aerosol generating unit is capable of ejecting the aerosol outside the mouthpiece by second rate that is less than 20% of the first rate, simply by having the user perform the progression in their inhalation rate accordingly.
With respect to claim 5, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). Thus, the aerosol generating unit is capable of ejecting the aerosol outside the mouthpiece by first rate that is more than 80 % of the maximum rate, simply by having the user perform the progression in their inhalation rate accordingly.
With respect to claim 6, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). Thus, the aerosol generating unit is capable of ejecting the aerosol outside the mouthpiece keeping on at the first rate, once the first rate has been reached, during a number of user’s puffs which is more than 5 puffs, simply by having the user perform the progression in their inhalation rate accordingly.
With respect to claim 7, LACOUR-GAYET et al. discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]).
With respect to claim 8, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity, the number of user’s puffs during which the aerosol generating unit progresses regularly from the second rate towards the first, simply by having the user perform the progression accordingly with their inhalation intensity.
With respect to claim 9¸ LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity, the value reached in the first state, simply by having the user perform the progression accordingly with their inhalation intensity.
With respect to claim 10, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity, steepness variation of the progression from the second rate towards the first via a feedback loop based on the intensity, simply by having the user perform the progression accordingly with their inhalation intensity. Specifically, by having the user provide the steepness in variation, as claimed, through their inhalation, the sensor senses the intensity and controls the output of aerosol proportional to the users puff intensity.
With respect to claim 12, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity progressing regularly from the second rate toward the first rate, following a straight ramp, simply by having the user perform the progression accordingly with their inhalation intensity.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Claim(s) 11, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over LACOUR-GAYET et al. (US 2021/0260312) in view of THORENS (US 2017/0318861).
With respect to claim 11, LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity progressing regularly from the second rate toward the first rate, following a straight ramp, simply by having the user perform the progression accordingly with their inhalation intensity.
However, LACOUR-GAYET et al. does not explicitly disclose a learning mode in which the value of the first rate is set.
THORENS discloses an inhaling device with user recognition based on inhalation behavior (Abstract; Title). The device has a set-up procedure before the first use thereof (Paragraphs [0012], [0083]) in which a user’s inhalation signature is recorded (Paragraphs [0083]-[0084]) and operational parameters are set based on the profile recorded (Paragraphs [0083]-[0091]), whereby discrete operational parameter profiles can be set for each recorded puff signature. It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a learning mode in LACOUR-GAYET et al., in which puff signatures can be measured and recorded, as taught by THORENS so that different temperature profiled can be chosen based on the puff action of the user.
By pre-setting the temperature profile to the corresponding signature, the value of the first is set by the learning mode.
With respect to claim 13¸ LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity progressing regularly from the second rate toward the first rate, following a straight ramp, simply by having the user perform the progression accordingly with their inhalation intensity.
However, LACOUR-GAYET et al. does not explicitly disclose a learning mode in which the value of the first rate is set.
THORENS discloses an inhaling device with user recognition based on inhalation behavior (Abstract; Title). The device has a set-up procedure before the first use thereof (Paragraphs [0012], [0083]) in which a user’s inhalation signature is recorded (Paragraphs [0083]-[0084]) and operational parameters are set based on the profile recorded (Paragraphs [0083]-[0091]), whereby discrete operational parameter profiles can be set for each recorded puff signature. It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a learning mode in LACOUR-GAYET et al., in which puff signatures can be measured and recorded, as taught by THORENS so that different temperature profiled can be chosen based on the puff action of the user.
By pre-setting the temperature profile to the corresponding signature, the value of the first is set by the learning mode.
Thus, the second delivery mode is capable of being imposed (e.g., self-imposed) by the user simply by performing the second delivery mode during the first use, after the start-up has been performed.
With respect to claim 14¸ LACOUR-GAYET et al. discloses that the rate of aerosol generated (and then inhaled) is set proportional to the amount of airflow (during inhalation by the user), by the controller, and controlled as such (Paragraph [0150]). LACOUR-GAYET et al. further discloses a sensor, 111 and 303, at the mouthpiece that detects air drawn through a user’s inhalation (e.g., puff sensor) (Paragraph [0150]) and measures intensity of the user’s inhalation (Paragraph [0143]). Thus, the sensor is capable of adapting, as depending on the sensed intensity progressing regularly from the second rate toward the first rate, following a straight ramp, simply by having the user perform the progression accordingly with their inhalation intensity.
However, LACOUR-GAYET et al. does not explicitly disclose a learning mode in which the value of the first rate is set.
THORENS discloses an inhaling device with user recognition based on inhalation behavior (Abstract; Title). The device has a set-up procedure before the first use thereof (Paragraphs [0012], [0083]) in which a user’s inhalation signature is recorded (Paragraphs [0083]-[0084]) and operational parameters are set based on the profile recorded (Paragraphs [0083]-[0091]), whereby discrete operational parameter profiles can be set for each recorded puff signature. It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a learning mode in LACOUR-GAYET et al., in which puff signatures can be measured and recorded, as taught by THORENS so that different temperature profiled can be chosen based on the puff action of the user.
By pre-setting the temperature profile to the corresponding signature, the value of the first is set by the learning mode. The set-up procedure represents the claimed shipping mode.
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Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over LACOUR-GAYET et al. (US 2021/0260312) in view of TALUSKIE et al. (US 2022/0364932).
With respect to claim 15, LACOUR-GAYET et al. does not disclose that the vibrating mesh (Paragraphs [0191]-[0193]) is a perforated delivery element.
TALUSKIE et al. discloses an aerosol delivery device (Abstract) wherein the vibrating mesh membrane is perforated (Paragraphs [0126]-[0128]) for the purposes of providing the desired aerosol properties.
LACOUR-GAYET et al. does not explicitly disclose that the liquid transport device is a capillary wick. TALUSKIE et al. discloses that the liquid transfer element is one adapted to wick via capillary action (e.g., capillary wick) (Paragraph [0104]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a capillary wick in the device of LACOUR-GAYET et al., as taught by TALUSKIE et al. so that additional moving parts within the device can be avoided, either for cost reasons or durability reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX B EFTA whose telephone number is (313)446-6548. The examiner can normally be reached 8AM-5PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Tucker can be reached at 571-272-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEX B EFTA/ Primary Examiner, Art Unit 1745
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