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 6/10/2026 have been fully considered but they are not persuasive.
Applicant’s arguments concerning claim amendments are addressed in the rejections below.
The applicant argues that Cohen does not disclose stopping the delivery operation. This is incorrect. Paragraph 0095 of Cohen discloses that when a dosage is reached, the device may allow continued consumption for that smoking session or lock out the device. It is clear that in this instance, “locking out” is the same as stopping delivery and preventing use.
Claim Rejections - 35 USC § 112
Claims 1-5 and 7-26 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 1 recites the limitation "wherein the feedback action comprises stopping the delivery operation of the delivery device" in the last two lines. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 7-9, 13, 15, 17, 18, and 19, are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The feedback action in claim 1 comprises stopping delivery operation of the delivery device. Therefore, changes that occur over a sequence of inhalation actions, changing of ratios of ingredients, switching ingredients, or selection of the feedback action fail to further limit claim 1 because they cannot occur because claim 1 requires the feedback action of stopping of the delivery operation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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.
Claim(s) 1-4, 10-12, 13-14, 16, and 20-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cohen (US 20190387796 A1).
Regarding claims 1, 14, and 16, Cohen discloses an aerosol generation system with user feedback, stating:
In some implementations, the controller 105, 205, a connected application (e.g., an app on the user device 305 and/or in the cloud), and/or the processor 610 may be configured to toggle between reservoirs and/or chambers and/or mix the different nicotine concentration vaporizable material. This toggling and/or mixing may beneficially allow the vaporizer and/or vaporizer system to control a concentration of nicotine in each puff of the user. [0108]
In one example of a nicotine dose control, the user could set a target cap for how much nicotine he/she wants in a day. In some implementations, the device won't lock the user out from having more, but it will notify if a target has been exceeded. Alternatively, the device may lock the user out. [0095]
In some implementations of the current subject matter, the app may also allow a user to log other health related activities, such as from a fitness app, and/or may suggest correlations between nicotine or THC usage and alcohol consumption, heart rate, blood pressure, workout time or weight changes, etc. For example, a user may enter a preferred unit dose (e.g., using presets, or estimated/recorded/programmable data as described above), and a dosage interval or total daily target. The vaporizer and/or app may then lock out after each dosage, and an alert may pop up on a user computing device (e.g., phone, smartwatch, tablet, etc.) when it's time for a next dosage, with the vaporizer automatically unlocking to allow delivery of this next dosage. Such an approach may be applied as a user-elected reduction approach (step-down or cessation), or to maintain a prescribed therapeutic regimen (e.g., X mg of agent every Y hours, not to exceed Z mg/day). [0126] (emphasis added).
Cohen expressly discloses adjusting user feedback based on user factors such as dosage (amount or nature of an active ingredient) and that the action is expected to alter the state of the user (i.e. not allow consumption). One of the possible actions disclosed by Cohen is locking out the user from using the device. Please note that Cohen discloses the effect of “not locking out” involves allowing the user to have more and notifying the user (see [0095] above). Locking out of the user is interpreted as being the opposite of allowing the user to have more, meaning that the device does not allow further delivery operations. This is supported by paragraph 0126 which discloses that the app may lock out the user after each dosage and not unlock for the next dosage until a certain time. Therefore, locking out in the prior art of Cohen is considered to be the same as stopping delivery operation of the device.
Regarding claims 2-4, when a user is locked out of the device the concentration or amount of the active ingredient provided by the device will be inherently adjusted to zero (i.e. no delivery will occur).
Regarding claim 10-12, Cohen anticipates a user’s state such as exceeding a dosage threshold (see [0126] above) and modify the amount of active ingredient for a predetermined period of time (i.e. session control over a certain time period [0132]).
Regarding claims 20, 21, and 22, Cohen discloses that an app (and therefore a processor adapted) obtains user inputs about the state of the user [0111], including height, weight, etc., which is a physical/physiological property other than in relation to inhalation.
Regarding claim 23, Cohen does not explicitly disclose that the estimation processor does not generate an explicit estimation of user state as an interim step. However, steps and parameters for the process for determining the state of the user do not add patentable details to this invention, as no structural characteristics are association with the step in the specification. As such, this is a “product by process” claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113).
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) …
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claim 24-26, Cohen discloses using the vaporizer having a processor with hand-held mobile devices such as a smartphone (mobile terminal), smartwatch (wearable), or a remote server [0048].
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 MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael J Felton/Primary Examiner, Art Unit 1747
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