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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-9 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O'Connor et al. (US 20170173261 A1).
Regarding claim 1, O'Connor discloses a drug delivery device (medical device 102, Fig 1A) comprising: a housing (housing of medical device 102, Fig 1A); a processor (processor,[0011]), disposed in the housing (1001, Annotated Fig 1) a vibration sensor ([0045]; acceleration sensor), disposed in the housing (1001, Annotated Fig 1); one or more reservoirs (reservoir; [0014]) containing one or more liquid drugs (insulin; [0014]); one or more pumps (insulin pump 102, Fig 1A) associated with the one or more respective reservoirs (reservoir; [0014]); and software ([0016]; device 102 software executed by processor), which, when executed by the processor, performs the functions of: receiving signals from the vibration sensor ([0045], acceleration sensor) indicating a pattern of taps on the housing of the device ([0046]: “tapping the medical device 102 one or more times (as sensed by the acceleration sensor”); interpreting the pattern of taps as a command (taps indicates an authorization command; [0053]) indicating a particular delivery of the one or more liquid drugs stored in the one or more reservoirs ([0053]:authorization command indicates the delivery of the insulin from reservoir); and executing the command indicated by the pattern of taps ([0053]; authorization command is executed indicated by the pattern of taps).
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Regarding claim 2, O'Connor discloses the device of claim 1 wherein the software ([0016]; software) performs the further function of: providing feedback regarding the analysis of the pattern of taps ([0039]; [0021]: “The medical device 102 may transmit a confirmation message back to the electronic device 106 upon receipt of the command and/or after completion of the action.”; processor execute the software instructions; once input from taps pattern is received is processed and the feedback confirmation is sent to the user)
Regarding claim 3, O'Connor discloses the device of claim 2 wherein the feedback is provided using one or more of a vibration transducer, an audio transducer or one or more visible indicators (feedback confirmation is provided by output device; [0039]: “The alert can be an alarm or notification provided visually, audibly, or by other means (e.g., such as vibrating)”)
Regarding claim 8, O'Connor disclose the device of claim 1, the device further comprising: one or more reservoirs (reservoir; [0014]) containing one or more liquid drugs (insulin; [0032]); and one or more pumps (medical device 102, includes a pump; [0014]) associated with the one or more respective reservoirs (reservoir; [0014]); wherein the software is further configured to: analyze patterns of taps representing commands indicating a particular delivery of the one or more liquid drugs (insulin; [0032]) stored in the one or more reservoirs ([0011];[0016];[0046] processor execute software instructions; pattern of taps, representing a command indicating authorization of a delivery of insulin, is analyzed and processed)
Regarding claim 9, O'Connor disclose the device of claim 8 wherein at least one of the one or more liquid drugs is insulin ([0032]) and wherein recognizing the pattern of taps is interpreted as a command indicating that the device should administer a bolus dose of the insulin (processor execute software instructions [0011]; [0046]: “(e.g., delivery of a bolus) is not carried out until input is received from the user. (…) The input may include (…) tapping the medical device 102 one or more times (as sensed by the acceleration sensor); therefore pattern of taps is recognized as an authorization command indicating administration of bolus of insulin).
Regarding claim 15, O'Connor discloses the device of claim 1, the software performing the further function of: recognizing a command indicating that the device should connect to a new personal computing device (recognition of pair or connection command needs to be identify by software of device 102 to stablish link 104; [0020]) and should thereafter receive commands from the new personal computing device (106), wherein the device (102) connects to the new personal computing device (106) via one of a BLUETOOTH® interface, a WI-FI® interface and a near-field interface ([0018]: WI-FI® or BLUETOOTH®).
Regarding claim 16, O'Connor discloses the device of claim 15 wherein the new personal computing device (106) issues commands to the device (102) using at least one of a web browser or an installed application (application; [0022]).
Claim Rejections - 35 USC § 103
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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over O'Connor et al. (US 20170173261 A1) in view of Beuthel et al. (EP 3435267 A1).
Regarding claim 4, O'Connor discloses the device of claim 1 wherein entry of an authentication phrase indicated by a particular pattern of taps is required before any commands may be entered ([0053]: Confirmation includes a particular tapping pattern the delivery device 102 is required for confirmation.
O'Connor is silent regarding the tapping pattern indicates a phrase.
Beuthel teaches a device (technical device 14, Fig 4) for input of an authentication phrase indicated by a tapping pattern ([0011]; [0024]; repeated tapping of sensor field 10 using Morse code will result in input of letter or numbers; therefore a phrase using a series of pattern can be inputted).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure processor the device of O'Connor to be capable of interpret the tapping pattern of a morse code as taught by Beuthel for the purpose of having high security and any number of combinations becomes possible by means of such a Morse code ([0024]).
Regarding claim 5, O'Connor/Beuthel discloses the device of claim 4 wherein the authentication comprises one or more patterns ([0053]: Confirmation includes a particular tapping pattern the delivery device 102 is required for confirmation.
O'Connor is silent regarding the tapping pattern a phrase indicating digits of a PIN separated by short pauses
Beuthel teaches a device (technical device 14, Fig 4) for input of an authentication phrase indicated by a tapping pattern indicating digits of a PIN separated by short pauses (([0011]; [0024]; repeated tapping of sensor field 10 using Morse code will result in input of letters or numbers; therefore a phrase using a series of patterns spaced apart by short pauses corresponds to a pin. A short pause is necessary to indicate a new pattern is about to initiate representing the next number of the pin).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure processor the device of O'Connor/Beuthel to be capable of interpret the tapping pattern of a morse code as taught by Beuthel for the purpose of having high security and any number of combinations becomes possible by means of such a Morse code ([0024]).
Regarding claim 6, O'Connor/Beuthel disclose the device of claim 4. O'Connor discloses wherein the pattern of taps indicating the authentication ([0039]: “The wearable insulin pump 102 or the electronic device 106 can further include a user input device for receiving a confirmation input from the user. For example, the user input can be provided by tapping or pressing a button or by receiving an input using an accelerometer provided on the wearable insulin pump 102 or the electronic device 106”; Therefore the tapped authentication can be indicated via electronic device 106) may be specified using an application ([0022]; device installed software allow notification of authentication for command to be specified as output requesting input from user) installed on a personal computing device (electronic device 106, Fig 1A) and communicated to the drug delivery device (102) via a wireless interface (wireless link 104, Fig 1A; [0018]) ([0021]: “The medical device 102 may transmit a confirmation message back to the electronic device 106 upon receipt of the command and/or after completion of the action.”)
O'Connor is silent regarding the tapping pattern indicates a phrase.
Beuthel teaches a device (technical device 14, Fig 4) for input of an authentication phrase indicated by a tapping pattern ([0024]; repeated tapping of sensor field 10 using Morse code will result in input of letter or numbers; therefore a phrase using a series of pattern can be inputted).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure processor the device of O'Connor/Beuthel to be capable of interpret the tapping pattern of a morse code as taught by Beuthel for the purpose of having high security and any number of combinations becomes possible by means of such a Morse code ([0024]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over O'Connor et al. (US 20170173261 A1) in view Mekid (US 20130032415 A1).
Regarding claim 7, O'Connor disclose the device of claim 1. O'Connor is silent wherein the pattern of taps may include patterns indicating one or more characters in accordance with a predetermined table of characters, and characters are expressed by patterns of taps indicating a row number and a column number of the table separated by a short pause, the row and column number indicating a character positioned at the specified row and column of the table.
Mekid teaches a device (Fig 1) wherein the pattern of taps (tap code, claim 1) may include patterns indicating one or more characters (claim 2) in accordance with a predetermined table of characters ([0005];[0018]: The code can be a Tap Code comprising a 5x5 grid of letters, representing all the letters of the Latin alphabet), and characters are expressed by patterns of taps indicating a row number and a column number of the table separated by a short pause, the row and column number indicating a character positioned at the specified row and column of the table ([0005]: “tapping two numbers, the first designating the row (horizontal) and the second designating the column (vertical) (…) For example, to specify the letter "A", one taps once, pause, and then taps once again.”); [0018]: indication of implementation of the Tap Code.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure the device of O'Connor with similar predetermined table of the Tap Code system as taught by Mekid for the purpose of having means to send a coded information to the device ([0021]; [0004]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over O'Connor et al. (US 20170173261 A1) in view of Yodfat (WO 2016181384 A2).
Regarding claim 10, O'Connor disclose the device of claim 9. O'Connor is silent regarding the software performing the further function of: recognizing a pattern of taps representing a number of whole or fractional units that should be administered as a bolus dose.
Yodfat teaches a device (pump 6, Fig 31) a software (software of microprocessor; [0088]) performing the further function of: recognizing a pattern of taps (tap sequences; [0088]) representing a number of whole or fractional units that should be administered as a bolus dose (number of taps represent the units of insulin in a bolus dose; [0088]: “For example, if each tap is preprogrammed to 1 unit of insulin, administration of 6 units requires 6 taps.”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of O'Connor with of tapping patterns to indicate quantity of drug to be dispensed as taught by Yodfat for the purpose of improving user experience by having additional means for indicating the bolus dose in a swift manner using tapping sequences ([0088]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over O'Connor et al. (US 20170173261 A1) in view of O'Connor et al. (US 20200113515 A1), hereinafter O'Connor-2.
Regarding claim 11, O'Connor discloses the device of claim 8 wherein at least one of the one or more liquid drugs is insulin ([0032]).
O'Connor is silent wherein the software performs the further function of: recognizing a pattern of taps representing at least one of a command indicating a temporary change in a basal dose of the insulin, or a number of units that should be administered as a basal dose.
O’Connor-2 teaches a software performs the further function of: recognizing a pattern of taps representing at least one of a command indicating a temporary change in a basal dose of the insulin ([0083]-[0084]; device has a certain basal rate delivery; the series of taps to confirm delivery of the bolus indicate a temporary change in the basal rate of insulin), or a number of units that should be administered as a basal dose.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of O'Connor with a basal rate being temporarily changed by a tapping pattern indicative of confirmation of delivery of bolus as taught by O'Connor-2 for the purpose of having a an easier and/or less socially awkward manner of continuous background supply of insulin being temporarily changed at certain instances or before meals by discrete tapping sequence of user ([0083]-[0084]).
Regarding claim 12, O'Connor/O'Connor-2 disclose the device of claim 11. O'Connor is silent wherein the device returns to a default setting for the delivery of basal doses of insulin after a predetermined period of time.
O'Connor-2 teaches wherein the device returns to a default setting for the delivery of basal doses of insulin after a predetermined period of time ([0083]-[0084]: device has a certain basal rate delivery; the series of taps to confirm delivery of the bolus indicate a temporary change in the basal rate of insulin; the device is then designed to return the basal rate afterwards to continue normal delivery)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of O'Connor/O'Connor-2 to return the basal rate after bolus delivery as taught by O'Connor-2 for the purpose of having a an easier and/or less socially awkward manner of continuous background supply of insulin being temporarily changed at certain instances or before meals by discrete tapping sequence of user ([0083]-[0084])
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over O'Connor et al. (US 20170173261 A1) in view of Williams et al. (US 20130060513 A1).
Regarding claim 13, O'Connor disclose the device of claim 1. O'Connor is silent wherein the vibration sensor is maintained in a low-power state and further wherein the vibration sensor is woken up by a single tap the housing of the device and is moved to a high-power state.
Williams teaches a device (device 102, Fig 2) wherein a vibration sensor (accelerometer 112, Fig 2) is maintained in a low-power state ([0019]: “the product is programmed to be in a deep sleep mode. In deep sleep mode, it is typical that certain interrupt events will wake the device to transition into a higher operational level.”) and further wherein the vibration sensor (accelerometer 112, Fig 2) is woken up by a single tap ([0019]: “The accelerometer device utilized in various embodiments has additional capabilities than simply decoding single and double tap events.”) the housing of the device (housing of mobile device 102, Fig 1) and is moved to a high-power state ([0019]; higher level of functionality).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to configure the device of O'Connor with similar low power mode capable to transition to a high-power mode as result of waking signal received by the accelerometer as taught by Williams for the purpose of reducing battery consumption when the device is not being used ([0019]).
Regarding claim 14, O'Connor/Williams disclose the device of claim 13. O'Connor are silent regarding the software performing the further function of: recognizing a pattern of taps indicating that the device is to enter a mode in which commands may be accepted.
Williams teaches a device the software (software of controller 124, Fig 2) performing the further function of: recognizing a pattern of taps ([0019]; [0022]:“For example, the filter 114 may be configured to require at least two acceleration events to occur within a window of 2 seconds in order to further process the received acceleration events.([0019]; tap is an acceleration event) indicating that the device is to enter a mode (mode allowing further processing; [0022]) in which commands may be accepted (Claim 1; functions of device are invoked which are controlled by user through commands)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of O'Connor/Williams with similar filter configure to detect tap pattern or double tap to further process commands invoking functions of device as taught by Williams for the purpose of preventing unwanted tapping to activate or invoke functions of device ([0022]; Claim1).
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive. Applicant submits that the taps are only authorization to proceed with a command received from elsewhere which is different from interpreting the taps themselves as a command for a particular delivery of the drug. Examiner respectfully disagrees please see relevant portion of amended claim 1:
(…)and software ([0016]; device 102 software executed by processor), which, when executed by the processor, performs the functions of: receiving signals from the vibration sensor ([0045], acceleration sensor) indicating a pattern of taps on the housing of the device ([0046]: “tapping the medical device 102 one or more times (as sensed by the acceleration sensor”); interpreting the pattern of taps as a command (taps indicates an authorization command; [0053]) indicating a particular delivery of the one or more liquid drugs stored in the one or more reservoirs ([0053]:authorization command indicates the delivery of the insulin from reservoir); and executing the command indicated by the pattern of taps ([0053]; authorization command is executed indicated by the pattern of taps).
Claim limitation of command and amended functional language under BRI do not exclude the command from being an authorization command. Authorization command indicates delivery of the bolus [0046] of O'Connor et al. (US 20170173261 A1).
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783