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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-28 in the reply filed on 10/22/2025 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-28 are directed to a system, which is a statutory category of invention (Step 1: YES).
Claim 1 recites the limitations of:
A user feedback system for a user of a delivery device within a delivery ecosystem, comprising:
An obtaining processor adapted to obtain one or more user factors indicative of a user state, wherein the one or more user factors are based upon at least a first aspect of a situation of the suer separate to their handling or operation of the device,
an estimation processor adapted to identify corresponding feedback action expected to alter the user state,
The above limitations, under their broadest reasonable interpretation, cover performance of the limitations as certain methods of organizing human activity. The claim recites elements, in non-bold above, which covers performance of the limitations as managing personal behavior. The claimed “obtaining one or more user factors indicative of a user state”, “behavioral feedback action for affecting at least a first behavior of the user”, and “to cause a modification of a state of the user” is abstract as managing personal behavior by following rules or instructions (e.g. obtaining a state of a user, identifying feedback action of a user) and teaching (modifying operations according to a selected feedback action,). Therefore, the claim as a whole is directed to “treating a patient”, which is an abstract idea because it is organizing human activity. “Treating a patient” is considered to be organizing human activity because it is managing personal behavior (as noted above). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation has managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites and abstract idea (Step 2A-Prong 1: YES. The claims are abstract).
In as much as the claims are obtaining factors, identifying and selecting a feedback action (analyzing the data), and modifying operations (providing a result), the claims are also abstract under mental processes grouping of abstract ides. The claims are no different than a person detecting (mental observation) their own metal state of nicotine withdrawn through being agitated (obtaining a state), determining (metal observation) their own treatment of said state (identifying a first feedback), wherein said treatment includes the inhalation of nicotine from an inhaler by providing relevant information through thought based on previous actions (selecting a feedback action), and then personally inhaling the amount of nicotine over an amount of time (cause a modification) based on the identified feedback action.
This judicial exception is not integrated into a practical application. In particular, the claims only recite: delivery device, delivery ecosystem, estimation processor and feedback processor in claim 1. The hardware is recited at a high-level of generality (e.g., as generic processors for performing generic computer functions) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, when considered separately and as n ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claim 1 is directed to an abstract idea without a practical application (Step 2A-Prong 2: NO. the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as an ordered combination, they do not add significantly more (also known as an “inventive concept”) to the exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of using hardware amounts to no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106, 05(d), II.
Thus, claim 1 is not patent eligible (Step 2B: NO. The claims do not provide significantly more).
Dependent claims 2-28 further define the abstract idea that is present in the independent claim and thus correspond to Certain Methods of Organizing Human activity and Mental Processes and hence are abstract for the reasons presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination.
Claim 2 recites a feedback processor adapted to select at least a first feedback action identified by the estimation processor. Like claim 1, The above limitations, under their broadest reasonable interpretation, cover performance of the limitations as certain methods of organizing human activity. The claim recites elements, in non-bold above, which covers performance of the limitations as managing personal behavior. The claimed “obtaining one or more user factors indicative of a user state”, “behavioral feedback action for affecting at least a first behavior of the user”, and “to cause a modification of a state of the user” is abstract as managing personal behavior by following rules or instructions (e.g. obtaining a state of a user, identifying feedback action of a user) and teaching (modifying operations according to a selected feedback action,). Therefore, the claim as a whole is directed to “treating a patient”, which is an abstract idea because it is organizing human activity. “Treating a patient” is considered to be organizing human activity because it is managing personal behavior (as noted above). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation has managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites and abstract idea (Step 2A-Prong 1: YES. The claims are abstract).
In as much as the claims are obtaining factors, identifying and selecting a feedback action (analyzing the data), and modifying operations (providing a result), the claims are also abstract under mental processes grouping of abstract ides. The claims are no different than a person detecting (mental observation) their own metal state of nicotine withdrawn through being agitated (obtaining a state), determining (metal observation) their own treatment of said state (identifying a first feedback), wherein said treatment includes the inhalation of nicotine from an inhaler by providing relevant information through thought based on previous actions (selecting a feedback action), and then personally inhaling the amount of nicotine over an amount of time (cause a modification) based on the identified feedback action.
This judicial exception is not integrated into a practical application. In particular, the claims only recite: delivery device, delivery ecosystem, estimation processor and feedback processor in claim 1. The hardware is recited at a high-level of generality (e.g., as generic processors for performing generic computer functions) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, when considered separately and as n ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claim 1 is directed to an abstract idea without a practical application (Step 2A-Prong 2: NO. the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as an ordered combination, they do not add significantly more (also known as an “inventive concept”) to the exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of using hardware amounts to no more than mere instructions to apply the exception using a generic computer component. See MPEP 2106, 05(d), II.
Claims 3 and 4 recite various modifications, which performed mentally and does not amount to significantly more.
Claims 5-24 and 26 recite the conditions and types of selected feedback, which are related to organizing human activity. In addition, the inclusion of various generic sensors to monitor are recited at a high level of generality and do not amount to more.
Claim 25 is related to machine learning one mentioned with a high level of generality and thus can be performed mentally.
Claims 26, 27 and 28 are related to high-level disclosures of the structures of the system, which are recited at a high level of generality. Therefore, these claims are directed to an abstract idea.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
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Claims 1-4, 26, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 14, 20, 21, 26 and 28 of copending Application No. 18/002,938.
With respect to claims 1 and 2, copending Application No. 18/002,938 claims a user feedback system for a user of a delivery device within a delivery ecosystem, comprising: an estimation processor adapted to identify at least a first feedback action based upon one or more user factors, the at least first feedback action comprising a behavioral feedback action for affecting at least a first behavior of the user, the at least first feedback action being expected to alter a state of the user as indicated at least in part by the one or more user factors; and a feedback processor adapted to select at least a first identified feedback action, and to cause a modification of one or more operations of the delivery device within the delivery ecosystem, according to the or each selected at least first identified feedback action (Claim 1); an obtaining processor adapted to obtain one or more user factors indicative of a state of the user, for use by the estimation processor (Claim 20); a respective one of the one or more user factors is based upon one selected from the list consisting of :at least a first physical property associated with at least a first user inhalation action; at least a first physical property associated with user behavior other than inhalation; at least a first physical property associated with user physiology other than in relation to inhalation; and at least a first aspect of the user's situation that is separate to the user's handling or operation of the delivery device (Claim 21).
With respect to claims 3 and 4, copending Application No. 18/002,938 claims the selected at least first identified feedback action comprises causing modification of one or more selected from the list consisting of: i. a selection of a flavoring included in an aerosol or oral product delivered by the delivery device; and ii. a flavor concentration in an aerosol or oral product delivered by the delivery device (Claim 3). The selection of flavoring is a modification of an operation of the device (e.g., mixing ratio).
With respect to claim 26¸ copending Application No. 18/002,938 claims the estimation processor is operable to identify one or more further proposed feedback actions relating to one or more selected from the list consisting of: i. a pharmaceutical feedback action for affecting the consumption of an active ingredient by the user; and ii. a non-consumption feedback action for affecting one or more non-consumption operations of the delivery ecosystem (Claim 14).
With respect to claim 27, copending Application No. 18/002,938 claims that the delivery ecosystems include a wearable device (Claims 26).
With respect to claim 28, copending Application No. 18/002,938 claims that the feedback processor is located within the deliver device (Claim 28).
This is a provisional nonstatutory double patenting rejection.
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) 1-9, 13, 14 and 16-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DAGNELLO et al. (US 2019/0167927).
With respect to claims 1-3 and 21, DAGNELLO et al. discloses a system and method for a user of a delivery device within a delivery ecosystem comprising: an ecosystem (Paragraphs [0028]-[0037], [0108]; Figure 5); an estimation processor adapted to identify a feedback action expected to alter a user state (Paragraphs [0011]-[0012], [0092], [0103]). DAGNELLO et al. discloses that the obtaining processor is capable of obtaining a state of the user by having the user to provide feedback to the feedback system in relation to the use of the device and their experience of their use (Paragraph [0082]). The first factor includes blood pressure data and blood oxygen data (Paragraphs [0078]) as physiological data. Data is measured and then used to prompt use of the device (Paragraph [0104]) and thus the property is associated with the user’s physiology other than in relation to inhaling.
Specifically, the sensors (Paragraph [0010]-[0015]), capture all of the input variables and send them to a software system, which uses machine learning, data mining, and/or statistical techniques to produce an optimum set of substance and vapor characteristics and corresponding changes to the affective and physiological states achieved. The one or more processors themselves are within delivery device or network (Paragraphs [0014], [0015], [0028], [0059], [0082]).
The processors receive information from a sensor platform having at least one sensor operable to detect a first physical property associated with the user that record data during the period of use and during the period immediately surrounding use as well as data during periods of non-use (Paragraphs [0010]-[0012], [0047], [0078], [0079]). The data include physiological data (e.g., one or more factors) (Paragraphs [0010]-[0013]) including heart rate, galvanic skin response, blood pressure data blood volume pulse and blood oxygen data (e.g. estimation processor is operable to use a plurality of user factors as input, as required by Claim 21) (Paragraphs [0078]-[0079]). The data is then use to modify the delivery of substances (e.g., feedback action) (Paragraphs [0104] and [0108])
DAGNELLO et al. further discloses a processor adapted to submit data of the detected first physical property to a processor (e.g., feedback processor, as required by claim 2) (Paragraphs [0033], [0084], [0085], [0092]; Figure 5) and is adapted to selected at least the first feedback action identified by the estimation processor to generate an output that causes an adjustment to be made in the quantity of a tangible substance introduced into the receptacle, in at least one of the substance characteristics, or to a time duration or time period of usage of the vapor device (Paragraphs [0011], [0012], [0092], [0102] and [0103]) such that a modification is made within the ecosystem according to the selected first feedback action (as required by claim 3). The estimation processor is then configured to prompt the user to inhale and exhale (Paragraph [0069]) (behavioral feedback that effects users’ behavior).
With respect to claim 4, DAGNELLO et al. further discloses a processor adapted to submit data of the detected first physical property to a processor (e.g., feedback processor) (Paragraphs [0033], [0084], [0085], [0092]; Figure 5) and is adapted to selected at least the first feedback action identified by the estimation processor to generate an output that causes an adjustment to be made in the quantity of a tangible (modification of delivery device) substance introduced into the receptacle, in at least one of the substance characteristics, or to a time duration or time period of usage of the vapor device (Paragraphs [0011], [0012], [0092], [0102] and [0103]) such that a modification is made within the ecosystem according to the selected first feedback action.
With respect to claim 5, DAGNELLO et al. discloses sensors (e.g., physical sensors) (Paragraph [0010]-[0015]), capture all of the input variables and send them to a software system, which uses machine learning, data mining, and/or statistical techniques to produce an optimum set of substance and vapor characteristics and corresponding changes to the affective and physiological states achieved. The one or more processors themselves are within delivery device or network (Paragraphs [0014], [0015], [0028], [0059], [0082]).
With respect to claim 6, DAGNELLO et al. discloses that ambient noise (e.g., background noise) is detected (Paragraph [0010]) using a microphone (Claim 110).
With respect to claim 7, DAGNELLO et al. discloses that the sensor includes a camera (Claim 110; Paragraph [0058]) and can capture facial expression (Paragraph [0079]).
With respect to claims 8 and 9, DAGNELLO et al. discloses that the factor is based on commentary (Paragraph [0010]), and social media posts (Paragraph [0075]).
With respect to claim 13, DAGNELLO et al. discloses that the factors include nearby inhalers (Paragraph [0010]) (e.g, other delivery devices in the ecosystem).
With respect to claim 14, DAGNELLO et al. discloses that the interaction includes interacting with an app of the device to change various settings (e.g., type of interaction) (Paragraph [0083]).
With respect to claims 15 and 16, DAGNELLO et al. disclose that the data includes an environment of the user (Paragraphs [0010], [0011]), such as weather conditions (e.g., barometric pressure, elevation, humidity, location (Paragraphs [0048]).
With respect to claims 17 and 18, DAGNELLO et al. discloses that the first aspect includes a social situation of the user, such as if they are with others (e.g., within reading of the sensors) (Paragraph [0010]).
With respect to claims 19 and 20, DAGNELLO et al. discloses that the factor includes a person’s history (Paragraphs [0087], [0088]), such as religious affiliation.
With respect to claim 22, DAGNELLO et al. discloses that the factor is self-reported state of the user (Paragraphs [0010], [0011]).
With respect to claim 23, DAGNELLO et al. discloses that the sensor data is from the delivery device, such as the state of the pre-vapor substance (Paragraph [0010]).
With respect to claim 24, DAGNELLO et al. does not disclose an explicit estimation of user state as an interim operation in the identification of the one or more proposed feedback action.
With respect to claim 25, DAGNELLO et al. discloses two machine learning systems (e.g., BRAD and VID) datasets (Paragraph [0075])
With respect to claim 26, DAGNELLO et al. discloses the feedback action includes earning rewards through behavior through and app (Paragraph [0083]).
With respect to claim 27, DAGNELLO et al. discloses an ancillary device, such as a wearable device (Paragraph [0037]).
With respect to claim 28, DAGNELLO et al. discloses that the device includes one or more processors (Paragraph [0014]; figure 4).
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.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over DAGNELLO et al. (US 2019/0167927) in view of ALARCON (US 2020/0022416).
With respect to claims 10 and 11, DAGNELLO et al. does not explicitly disclose that the content comprises calendar events the user is about to attend. ALARCON discloses a vaporizing device (Abstract) that gathers information related to calendar events of the user (Paragraph [0236]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use calendar events of the user so that the user can be notified to of their sensation goals.
With respect to claim 12, DAGNELLO et al. does not explicitly disclose the claimed questionnaire. ALARCON discloses a vaporizing device (Abstract) that provides the user with a set of questions (e.g., questionnaire) to identify the users pain level (Paragraph [0156]). 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 the user with a questionnaire, as taught by ALARCON so that the device can determine the user’s pain level.
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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/ALEX B EFTA/Primary Examiner, Art Unit 1745