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 .
Response to Amendment
This Office Action is in response to the amendments filed on 11/21/2025, as directed by the Non-Final Rejection on 05/22/2025. Claims 1, 3, 6, 10-11, 13, 16, 20-21 are amended. Claims 22-24 are canceled. Claims 25-27 are new. Claims 1-21, 25-27 are pending in the instant application.
Response to Arguments
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “data integrity mechanism” in claims 25-27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 5, 8, 13, 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Finke (U.S 2016/0346489 A1) in view of Thomas (U.S 5,151,899 A).
Regarding claim 1, Finke discloses a control device for controlling an operation of an aerosol nebulizer system (Claim 1 and Paragraph 0010), said aerosol nebulizer system comprising an aerosol generator for nebulizing a liquid or an aerosol source for dispensing aerosol (Fig. 1-2 and Paragraph 0010, the aerosol nebulizer 30 includes an aerosol generator 31),
said control device comprising:
a communication unit, configured to establish a first wireless communication connection and to perform a first data transmission with the aerosol nebulizer system (Paragraph 0013 and Fig. 1-2, communication unit 100 establishes wireless communication with the nebulizer 30), and
a control unit (Paragraph 0013, the control device includes a control unit 200), configured to evaluate a progression of identifications received via the first data transmission and received in association with aerosol nebulizer data units respectively related to a usage of the aerosol nebulizer system (Fig. 6 and Paragraph 0077, inhalation data may be communicated via the wireless communication; The data can be transmitted including controlling bytes, such as a check sum, hash sum, etc. and with redundancy checks for verification of the receipt of the complete data; The communication is met with ACK or NAK protocols depending on if the check matches, such as when check sums do or do not confirm with what is sent; also see Paragraph 0015, the inhalation data is measurement data obtained during the use of the aerosol nebulizer and thus is related to usage).
Finke is silent regarding wherein the progression of identifications includes a sequence of identifications received in association with nebulizer data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated nebulizer data unit is missing.
However, Thomas teaches a method of data integrity verification wherein the progression of identifications includes a sequence of identifications received in association with data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated data unit is missing (Abstract; Sequence numbering involves labeling/assigning packets a number in order to track their receipt, ordering, and to identify lost/duplicated entries; The sequence numbering is a linear set of numbers and thus is a sequence of identifications; also see Col. 2 lines 5-24, Col 4 lines 1-29; A control unit of the transmitter determines the sequence numbers to be applied to the packets, which is received/interpreted by the receiver to determine completeness; also see Col. 4 line 63 – Col. 5 line 11 and Abstract regarding detection of lost/duplicated packets using sequence numbers).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to include a progression of identifications which includes a sequence of identifications received in association with data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated data unit is missing, such as that taught by Thomas, in order to use a known method of data transmission to ensure data completeness and data ordering (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29).
Regarding claim 2, the modified device of Finke discloses the device of claim 1.
Finke further discloses wherein the communication unit is further configured to establish a second wireless communication connection and to perform second data transmission with an external device (see Fig. 1 and Paragraph 0018-0021, the control unit 10 may establish communication with a second communication device 20, which may be a hub, smartphone, tablet, etc.).
Regarding claim 3, the modified device of Finke discloses the device of claim 2.
Finke is silent regarding wherein the control unit is further configured to forward the received identifications and aerosol nebulizer data units to the external device.
However, Finke teaches that error correction functionalities such as checksums or controlling bytes should be used during data transmission to ensure data integrity (Paragraph 0033; also see rejection of claim 1 above). Checksums are beneficial for any wireless communication and thus are equally beneficial between the external device and the control unit. The progression of identifications would equally be beneficially shared as taught above in Thomas.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Finke to have forwarded checksums to the external device during the wireless communication, such as that taught by Finke ‘473, in order to check for and ensure data transmission integrity (Paragraph 0013).
Furthermore, Thomas teaches wherein the control unit forwards the sequence numbering assigned to the packets to the receiving device (Abstract, Col. 1 lines 1-64).
Regarding claim 4, the modified device of Finke discloses the device of claim 1.
Finke is silent regarding wherein the control unit is further configured to request a re-transmission of a specific aerosol nebulizer data unit which has been determined to be missing in the progression of identifications.
However, Finke also teaches that when data is determined to be missing or is incorrect according to the data integrity checks, that a NAK message can be delivered to prompt another attempt at sending the data (see Fig. 6 and Paragraph 0073; A NAK message can be sent when the checksums are incorrect and thus the data was transmitted incorrectly or incompletely; The NAK message response then prompts another attempt at sending information next time a connection is established). Finke also teaches re-transmission in the case of no receipt of an ACK message (Paragraph 0043).
Thus, it would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified the device of Finke to include prompting a re-transmission of the missing or incomplete data when there are found to be data integrity issues, such as that taught by Finke, in order to ensure that the necessary data has been received when the connection has been reestablished (Fig. 6 and Paragraph 0073).
Regarding claim 5, the modified device of Finke discloses the device of claim 1.
Finke further discloses wherein the control unit is further configured to use the received usage data units for adherence evaluation without awaiting re-transmission of a missing usage data unit (see Fig. 2 and Paragraph 0047; An operation unit 500 of the control unit can monitor and evaluate adherence based on the received nebulizer information and configuration data; The configurations for duration, number, date/time, etc. may be compared to the usage data to assess compliance with the set therapy; The adherence evaluation can be provided to the user via visual/audible indications when in agreement with the therapy; The adherence can be assessed without waiting for a particular missing data, for example, if data is complete, the adherence can be evaluated without the waiting).
Regarding claim 8, the modified device of Finke discloses the device of claim 1.
Finke further discloses wherein the control unit is further configured to provide a plurality of specific report generating functionalities respectively related to a specific recipient (see Paragraph 0047-0048, the control unit may provide an adherence report based on a specific drug and the user for visualization; The report may be audible or visual if the nebulization agrees with the preset protocol and thus encompasses a plurality of report generating functionalities).
Regarding claim 13, Finke discloses an aerosol nebulizer system (Fig. 1-2), comprising:
an aerosol generator for nebulizing a liquid or an aerosol source for dispensing aerosol (Fig. 1-2 and Paragraph 0015, the nebulizer system comprises aerosol generator 31);
a storage unit for storing a plurality of aerosol nebulizer data units respectively related to a usage of the aerosol nebulizer system (storage unit 300, see Fig. 1-2 and Paragraph 0023, the storage unit can store wireless communication identification codes and also received configuration data and inhalation/measurement data from the aerosol delivery device for data transfer to an external device), wherein each of the aerosol nebulizer data units being stored in association with a corresponding identification so that a progression of identifications is stored in association with the plurality of aerosol nebulizer data units (see Paragraph 0033-0034 and 0059; The inhalation/measurement data may be sent with check sums or other control bytes to verify data integrity during transmission, the checksums being associated/stored with the inhalation/measurement data at least before transmission).
Finke is silent regarding a sequence of identifications received in association with nebulizer data units and wherein the identifications identify a sequence in which the aerosol nebulizer data units have been generated and/or stored and wherein the progression of identifications is configured to indicate whether there is a missing identification in the sequence of identifications.
However, Thomas teaches a method of data integrity verification wherein the progression of identifications includes a sequence of identifications received in association with data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated data unit is missing (Abstract, Col. 1 lines 10-64; Sequence numbering involves labeling/assigning packets a number in order to track their receipt, ordering, and to identify lost/duplicated entries; The sequence numbering is a linear set of numbers and thus is a sequence of identifications; also see Col. 2 lines 5-24, Col 4 lines 1-29; A control unit of the transmitter determines the sequence numbers to be applied to the packets, which is received/interpreted by the receiver to determine completeness; also see Col. 4 line 63 – Col. 5 line 11 and Abstract regarding detection of lost/duplicated packets using sequence numbers).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to include a progression of identifications which includes a sequence of identifications received in association with data units which are used to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated data unit is missing, such as that taught by Thomas, in order to use a known method of data transmission to ensure data completeness and data ordering (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29).
Regarding claim 14, the modified device of Finke discloses the device of claim 1.
Finke further discloses an aerosol nebulizer communication interface configured to establish a wireless communication connection with a control device (see Fig. 2 and Paragraph 0015, the system includes a communication interface 33 which provides inhalation data to the control device 10).
Finke is silent regarding receiving a request for re-transmission of a specific aerosol nebulizer data unit which has been determined to be missing in the progression of identifications transmitted to the control device.
However, Finke also teaches that when data is determined to be missing or is incorrect according to the included data integrity checks, that a NAK message can be delivered to prompt another attempt at sending the data (see Fig. 6 and Paragraph 0073; A NAK message can be sent when the checksums are incorrect and thus the data was transmitted incorrectly or incompletely; The NAK message response then prompts another attempt at sending information next time a connection is established). Finke also teaches re-transmission in the case of no receipt of an ACK message (Paragraph 0043).
Thus, it would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified the device of Finke to include prompting a re-transmission of the missing or incomplete data when there are found to be data integrity issues, such as that taught by Finke, in order to ensure that the necessary data has been received when the connection has been reestablished (Fig. 6 and Paragraph 0073).
Regarding claim 15, the modified device of Finke discloses the device of claim 14.
Finke further teaches wherein the aerosol nebulizer communication interface is further configured to re-transmit the specific aerosol nebulizer data unit (see rejection of claim 14 above; Per the modification, the device receiving the NAK message would re-transmit the information in order for the control device to have the complete data; also see Fig. 6, where the NAK message prompts a re-transmission upon next communication establishment).
Regarding claim 16, Fink further discloses a server (Paragraph 0019, the communication device 20 may be connected to a server which provides feedback according to the obtained measurement/inhalation data), comprising a server communication interface configured to establish a wireless communication connection with one or more control devices according to claim 1 and to perform data transmission with the one or more control devices (see Fig. 1-2 and Paragraph 0019, the server can be connected wirelessly with the control device 10 and the aerosol device and thus must have a server communication interface to send/receive the signals), and a server control unit (see Paragraph 0019, 0032; The server can provide feedback and can establish communication with the control device 10 and thus must have a server control unit or processor).
Finke is silent regarding server control unit configured to evaluate a progression of identifications received via the data transmission and received in association with aerosol nebulizer data units respectively related to a usage of the nebulizer system.
However, Finke teaches evaluation of a progression of identifications received via the data transmission and received in association with aerosol nebulizer data units respectively related to a usage of the nebulizer system (Fig. 6 and Paragraph 0077, inhalation data may be communicated via the wireless communication; The data can be transmitted including controlling bytes, such as a check sum, hash sum, etc. and with redundancy checks for verification of the receipt of the complete data; The communication is met with ACK or NAK protocols depending on if the check matches, such as when check sums do or do not confirm with what is sent; also see Paragraph 0015, the inhalation data is measurement data obtained during the use of the aerosol nebulizer and thus is related to usage).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Finke to include the server evaluating the progression of identifications associated with aerosol nebulizer data, such as that taught by Finke, in order to ensure complete data transfer (Fig. 6 and Paragraph 0077).
Finke is silent regarding wherein the progression of identifications includes a sequence of identifications received in association with nebulizer data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated nebulizer data unit is missing.
However, Thomas teaches a method of data integrity verification wherein the progression of identifications includes a sequence of identifications received in association with data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated data unit is missing (Abstract, Col. 1 lines 10-64; Sequence numbering involves labeling/assigning packets a number in order to track their receipt, ordering, and to identify lost/duplicated entries; The sequence numbering is a linear set of numbers and thus is a sequence of identifications; also see Col. 2 lines 5-24, Col 4 lines 1-29; A control unit of the transmitter determines the sequence numbers to be applied to the packets, which is received/interpreted by the receiver to determine completeness).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to include a progression of identifications which includes a sequence of identifications received in association with nebulizer data units and wherein the control unit is configured to evaluate whether an identification in the received sequence of identifications is missing and determine which identification and associated nebulizer data unit is missing, such as that taught by Thomas, in order to use a known method of data transmission to ensure data completeness and data ordering (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29).
Regarding claim 17, the modified device of Finke discloses the device of claim 16.
Fink is silent regarding wherein the server control unit is further configured to request a re-transmission of a specific aerosol nebulizer data unit which has been determined to be missing in the progression of identifications.
However, Finke also teaches that when data is determined to be missing or is incorrect according to the included checksums, that a NAK message can be delivered to prompt another attempt at sending the data (see Fig. 6 and Paragraph 0073; A NAK message can be sent when the checksums are incorrect and thus the data was transmitted incorrectly or incompletely; The NAK message response then prompts another attempt at sending information next time a connection is established). Finke also teaches re-transmission in the case of no receipt of an ACK message (Paragraph 0043).
Thus, it would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified the device of Finke to include the server prompting a re-transmission of the missing or incomplete data when checksums don’t match, such as that taught by Finke, in order to ensure that the necessary data has been received when the connection has been reestablished (Fig. 6 and Paragraph 0073).
Regarding claim 25, the modified device of Finke discloses the device of claim 1.
Thomas further teaches wherein the first data transmission further includes a first data integrity mechanism, wherein the first data integrity mechanism is configured to ensure that data within a single data unit is correctly transmitted (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29; also see Figs. 4-7A; The data transmission includes a check for data integrity wherein individual data units are verified as being correctly transmitted according to sequence numbering; If certain sequence numbers within the provided range are not received, then those individual data units are known to be lost).
Regarding claim 26, the modified device of Finke discloses the device of claim 13.
Thomas further teaches wherein each individual single data unit further includes a first data integrity mechanism, wherein the first data integrity mechanism is configured to ensure that data within a single data unit is correctly transmitted (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29; also see Figs. 4-7A, the data transmission includes a check for individual data unit integrity based on the individual sequence numbers within the entire sequence number range).
Regarding claim 27, the modified device of Finke discloses the device of claim 16.
Thomas further teaches wherein each individual single data unit further includes a first data integrity mechanism, wherein the first data integrity mechanism is configured to ensure that data within a single data unit is correctly transmitted (Abstract, Col. 1 lines 1-64, Col. 2 lines 5-24, Col 4 lines 1-29; also see Figs. 4-7A, the data transmission includes a check for individual data unit integrity based on the individual sequence numbers within the entire sequence number range).
Claims 6-7, 11-12, 18, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Finke (U.S 2016/0346489 A1) in view of Thomas (U.S 5,151,899 A), as applied to claims 1 and 16, in view of Hogg (U.S 2017/0140125 A1).
Regarding claim 6, the modified device of Finke discloses the device of claim 1.
Finke is silent regarding wherein the control unit is further configured to trigger an issuance of a notification to the user of the control device and/or to an external terminal device to switch on the aerosol nebulizer system when a specific time period is expired.
Hogg teaches a control unit for a respiratory inhaler device wherein the control unit is further configured to trigger an issuance of a notification to the user of the control device and/or to an external terminal device to switch on the aerosol nebulizer system when a specific time period is expired (Paragraphs 0115-0121; When an application supporting server does not receive the inhalation events set by a protocol or within a certain window and there is a lack of data over a set time period, notifications may be sent to the user to reactivate or reconnect any hardware, such as the sensor of the inhaler device, or the client device, etc. to reestablish communication for the server to receive the dose data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Finke to have included issuing a notification to the user to switch on the aerosol nebulizer system when a specific time period is expired, such as that taught by Hogg, in order to allow for reconnection and data recording when data has not been able to be received for evaluation (Paragraph 0117-0121).
Regarding claim 7, the modified device of Finke discloses the device of claim 2.
Finke is silent regarding wherein the control unit (22a) is further configured to allow a user to select a specific report generating functionality and wherein the control unit (22) is further configured to request a transmission of report-related aerosol nebulizer data units stored at the external device (40).
However, Hogg teaches wherein a control unit of medicament delivery device is configured to allow a user to select a specific report generating functionality and wherein the control unit is configured to request a transmission of report-related aerosol nebulizer data units stored at an external device (see Paragraph 0081, the user may select to view a report of adherence over a set time period including data about the individual inhalation events; also see Paragraph 0084-0085, where the application server receives and stores the information regarding inhalation events or other events; also see Paragraph 0026, 0041, the application server receives the use data for generation of analysis and notifications).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to include allowing the user to select a specific report generating functionality and requesting transmission of report-related nebulizer data stored at an external server, such as that taught by Hogg, in order to allow the user to see the logged events and edit details or include additional information (Paragraph 0081) for improved analysis or evaluation.
Regarding claim 11, the modified device of Finke discloses the device of claim 1.
Finke is silent regarding wherein the control unit is further configured to trigger an escalation chain if the user/patient does not transmit aerosol nebulizer data units and/or if the user/patient does not adhere to a therapy protocol or if an evaluation of the aerosol nebulizer data units indicates a change in the patient status or a change in the nebulizer status.
However, Hogg teaches wherein the control unit is further configured to trigger an escalation chain if the user/patient does not transmit aerosol nebulizer data units and/or if the user/patient does not adhere to a therapy protocol or if an evaluation of the aerosol nebulizer data units indicates a change in the patient status or a change in the nebulizer status (Examiner is interpreting escalation chain as a process involving higher-level authority to resolve issues; see Paragraph 0008, 0030 where the analytics system may alert patient and healthcare providers when a patient does not adhere to a medication plan or from other respiratory events).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to have included triggering an escalation chain if the user does not report or adhere to the therapy protocol, such as that taught by Hogg, in order to alert healthcare providers when a patient is at risk or isn’t medicating properly (Paragraph 0008).
Regarding claim 12, the modified device of Finke discloses the device of claim 1.
Finke is silent regarding wherein the control device (20, 20a) is a mobile device or a server.
However, Hogg teaches wherein the control device connected to the medical inhaler is a mobile device (see Fig. 1 and Paragraph 0034, 0067; The control device connected to the inhaler may be a client device 110 which may be a smart phone to enable viewing of adherence data and control signals to adjust therapy or other parameters related to inhaler usage).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Finke to have included the control device being a mobile device, such as that taught by Hogg, in order to leverage the input interfaces and displays suitable for user input of data and receipt/display/interaction with notifications provided by the adherence analyzing server (Paragraph 0067).
Regarding claim 18, the modified device of Finke discloses the device of claim 16.
Finke is silent regarding wherein the server control unit is further configured to trigger an issuance of a request to transmit further aerosol nebulizer data units when a predetermined time period is expired.
Hogg teaches a control unit for a respiratory inhaler device wherein the control unit is further configured to trigger an issuance of a notification of a request to the user of the control device to switch on/reset the aerosol nebulizer system when a specific time period is expired to communicate the aerosol nebulizer usage data (Paragraphs 0115-0121; When an application supporting server does not receive the inhalation events set by a protocol or within a certain window and there is a lack of data over a set time period, notifications may be sent to the user to reactivate or reconnect any hardware, such as the sensor of the inhaler device, or the client device, etc. to reestablish communication for the server to receive the dose data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Finke to have included issuing a notification to the user to switch on the aerosol nebulizer system when a specific time period is expired for transmission of the aerosol nebulizer units, such as that taught by Hogg, in order to allow for reconnection and data recording when data has not been able to be received for evaluation (Paragraph 0117-0121).
Regarding claim 21, the modified device of Finke discloses the device of claim 16.
Finke is silent regarding wherein the server control unit is further configured to trigger an escalation chain if the user/patient does not transmit aerosol nebulizer data units and/or if the user/patient does not adhere to a therapy protocol or if an evaluation of the aerosol nebulizer data units indicates a change in the patient status or a change in the nebulizer status.
However, Hogg teaches wherein the server control unit is further configured to trigger an escalation chain if the user/patient does not transmit aerosol nebulizer data units and/or if the user/patient does not adhere to a therapy protocol or if an evaluation of the aerosol nebulizer data units indicates a change in the patient status or a change in the nebulizer status (Examiner is interpreting escalation chain as a process involving higher-level authority to resolve issues; see Paragraph 0008, 0030 where the analytics system may alert patient and healthcare providers when a patient does not adhere to a medication plan or from other respiratory events).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to have included triggering an escalation chain if the user does not report or adhere to the therapy protocol, such as that taught by Hogg, in order to alert healthcare providers when a patient is at risk or isn’t medicating properly (Paragraph 0008).
Claims 9-10, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Finke (U.S 2016/0346489 A1) in view of Thomas (U.S 5,151,899 A), as applied to claims 1 and 16, in view of Tunnell (U.S 8,807,131 B1).
Regarding claim 9, the modified device of Finke discloses the device of claim 1.
Finke is silent regarding wherein the control unit is further configured to determine an adherence-related patient type based on one or more machine-learning algorithms.
However, Tunnell teaches a compliance monitor for an inhaler and wherein the control unit is further configured to determine an adherence-related patient type based on one or more machine-learning algorithms (Col. 34 lines 37 - Col. 35 line 60; A neural network may categorize a patient according to their location, local weather, medical history, altitude, genetics, etc. that may be risk factors and thus will change the provided or recommended dosage regime to improve efficacy; It is noted that such risk factors can be a determination for a change in adherence to a protocol and thus high-risk or genetically predisposed to sickness/allergens are an adherence-related patient type).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to have included determining an adherence-related patient type based on one or more machine-learning algorithms, such as that taught by Tunnell, in order to adjust patient dosage regimens for specific patients based on predicative markers or patient categorization (Col. 34 lines 37 - Col. 35 line 60).
Regarding claim 10, the modified device of Finke discloses the device of claim 9.
Tunnell further teaches wherein the control unit is further configured to determine an appropriate adherence stimulus, in particular with regard to the determined adherence-related patient type, based on the one or more machine-learning algorithms (Col. 34 lines 37 - Col. 35 line 60; The patient may be shown their risk factors in a report which is determined by the neural network; Alternatively, the dosage regimen may be modified according to known risk factors identified by the neural network, such as location, local weather, medical history, altitude, genetics, etc.).
Regarding claim 19, the modified device of Finke discloses the device of claim 16.
Finke is silent regarding wherein the server control unit is further configured to determine an adherence-related patient type based on one or more machine-learning algorithms.
However, Tunnell teaches a compliance monitor for an inhaler and wherein the server control unit is further configured to determine an adherence-related patient type based on one or more machine-learning algorithms (Col. 34 lines 37 - Col. 35 line 60; A neural network may categorize a patient according to their location, local weather, medical history, altitude, genetics, etc. that may be risk factors and thus will change the provided or recommended dosage regime to improve efficacy; It is noted that such risk factors can be a determination for a change in adherence to a protocol and thus high-risk or genetically predisposed to sickness/allergens are an adherence-related patient type).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Finke to have included determining an adherence-related patient type based on one or more machine-learning algorithms, such as that taught by Tunnell, in order to adjust patient dosage regimens for specific patients based on predicative markers or patient categorization (Col. 34 lines 37 - Col. 35 line 60).
Regarding claim 20, Finke discloses the device of claim 16.
Tunnell further teaches wherein the server control unit is further configured to determine an appropriate adherence stimulus, in particular with regard to the determined adherence-related patient type, based on the one or more machine-learning algorithms (Col. 34 lines 37 - Col. 35 line 60; The patient may be shown their risk factors in a report which is determined by the neural network; Alternatively, the dosage regimen may be modified according to known risk factors identified by the neural network, such as location, local weather, medical history, altitude, genetics, etc.).
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 THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785