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 Arguments
Applicant's arguments filed 2/18/2026 have been fully considered.
Regarding the amendments to the independent claims, Applicant argues that Groeschke teaches the touch element attached to the actuation button, not the rotatable dosage knob and therefore the touch element does not rotate to set the dose. The examiner agrees with this characterization of Groeschke and therefore the argument is convincing and the rejection is withdrawn. However, upon further consideration in light of the amendments to the claims, a new rejection is made over Groeschke in view of Krulevitch et al (US 8,556,867).
Regarding claim 23, Applicant argues that claim 23 recites a unique combination of subject matter not disclosed or rendered obvious by the cited references. Applicant has provided no further argument regarding any deficiencies in the prior rejection, other than those addressed with regard to independent claim 16, and therefore the argument is not convincing.
Claim Objections
Claim 32 is objected to because of the following informalities: the last line in claim 32 includes a typo – “awhere”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16-22, 27, 28, 31-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groeschke et al (US 20140005950) in view of Krulevitch et al (US 8,556,867).
Regarding claim 16, Groeschke discloses a touch sensor (fig. 2), comprising: a rigid element 22; a touch element 20/210 arranged in relation to the rigid element such that a gap between at least one part of the rigid element and a flexible part 210 of the touch element is provided (fig. 2); and at least one pressure sensitive element 211/2100 arranged in the gap between the at least one part of the rigid element and the flexible part of the touch element such that a pressure applied to the flexible part of the touch element deforms the flexible part to at least partly reduce the gap and at least partly transmit the applied pressure to the at least one pressure sensitive element (fig. 2; page 6, para. 0102); wherein the at least one pressure sensitive element is configured to generate an output signal (e.g., light) upon detecting the pressure applied to the at least one pressure sensitive element, the generated output signal being provided for signaling that the flexible part of the touch element has been touched (page 6, para. 0100, 0102).
Claim 16 further calls for rotation of the touch element to cause a drug dosage to be selected. Groeschke discloses that rotation of a knob 12 causes the drug dosage to be selected (fig. 1; page 6, para. 0091), but fails to disclose that rotation of the touch element is associated with the knob and setting of the drug dosage. Krulevitch teaches a drug delivery add-on module wherein the add-on module extends 202 extends over the proximal end of the injection pen including over the dose knob 220 such that rotation of the proximal end 220 of the add-on module causes rotation of the dose knob to set the dose (col. 9, line 66 – col. 10, line 2; figs. 3, 7). This allows the dose tracking and logging electronics to be located in the reusable add-on module thereby reducing the cost of the disposable pen (col. 7, line 40- col. 8, line 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on module of Groeschke to include a portion that extends over the dose knob such that rotation of the proximal end including the touch element causes a drug dosage to be selected as taught by Krulevitch so that the dose tracking and logging elements can be housed in the add-on module thereby reducing the cost of the disposable pen.
Regarding claim 17, Groeschke discloses that rigid element comprises at least in part a cylindrical shape (fig. 2: disk 22 is cylindrical) and the touch element is shaped as a sleeve coaxially arranged to surround the cylindrically shaped part of the rigid element (fig. 2: portion 20 of touch element is a sleeve coaxially arranged around the cylinder 22).
Regarding claim 18, Groeschke discloses that the touch sensor is included in a drug delivery device 10 or a drug delivery add-on device 2 (fig. 1).
Regarding claim 19, Groeschke discloses that the rigid element and the touch element may be permanently affixed to the housing of the drug delivery device (page 6, para. 0096) and therefore they both form at least a part of a housing of the drug delivery device.
Regarding claim 20, Groeschke discloses that the rigid element and the touch element both form at least a part of a housing of the drug delivery add-on device 2 (page 6, para. 0095).
Regarding claim 21, Groeschke discloses that the at least one pressure sensitive element comprises a vibration element configured to generate vibrations of the touch element and change the generated vibrations upon detecting a pressure applied to the at least one pressure sensitive element (page 3, para. 0029; page 7, para. 0111).
Regarding claim 22, Groeschke discloses that the at least one pressure sensitive element comprises one of a piezoelectric actuator or an electromechanical element (page 3, para. 0033).
Regarding claim 27, Groeschke discloses that the pressure sensitive element comprises a piezoelectric sensor (page 3, para. 0033).
Regarding claim 28, Groeschke discloses the touch sensor comprises a processor configured to process the output signal of the at least one pressure sensitive element by detecting a change of a parameter of the output signal (page 8, para. 0117).
Regarding claim 31, Groeschke discloses that the touch sensor comprises an interface for transmitting the output signal, wherein the interface comprises one or more of the following: a wireless interface including a Bluetooth (page 4, para. 0044).
Regarding claim 32, Groeschke discloses a drug delivery device 1 comprising a touch sensor (fig. 2), wherein the touch sensor comprises: a rigid element 22; a touch element 20/210 arranged in relation to the rigid element such that a gap between at least one part of the rigid element and a flexible part of the touch element is provided (fig. 2); and at least one pressure sensitive element 211/2100 arranged in the gap between the at least one part of the rigid element and the flexible part of the touch element such that a pressure applied to the flexible part of the touch element deforms the flexible part to at least partly reduce the gap and at least partly transmit the applied pressure to the at least one pressure sensitive element (fig. 2; page 6, para. 0102); wherein the at least one pressure sensitive element is configured to generate an output signal (e.g., light) upon detecting the pressure applied to the at least one pressure sensitive element, the generated output signal being provided for signaling that the flexible part of the touch element has been touched (page 6, para. 0100, 0102).
Claim 32 further calls for rotation of the touch element to cause a drug dosage to be selected. Groeschke discloses that rotation of a knob 12 causes the drug dosage to be selected (fig. 1; page 6, para. 0091), but fails to disclose that rotation of the touch element is associated with the knob and setting of the drug dosage. Krulevitch teaches a drug delivery add-on module wherein the add-on module extends 202 extends over the proximal end of the injection pen including over the dose knob 220 such that rotation of the proximal end 220 of the add-on module causes rotation of the dose knob to set the dose (col. 9, line 66 – col. 10, line 2; figs. 3, 7). This allows the dose tracking and logging electronics to be located in the reusable add-on module thereby reducing the cost of the disposable pen (col. 7, line 40- col. 8, line 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on module of Groeschke to include a portion that extends over the dose knob such that rotation of the proximal end including the touch element causes a drug dosage to be selected as taught by Krulevitch so that the dose tracking and logging elements can be housed in the add-on module thereby reducing the cost of the disposable pen.
Regarding claim 33, Groeschke discloses an electronics configured for one of the following: processing an output signal generated by the at least one pressure sensitive element for determining a user input (page 8, para. 0117); transmitting an output signal generated by the at least one pressure sensitive element for determining a user input via an interface; or storing a user input determined by processing an output signal generated by the at least one pressure sensitive element (page 3, para. 0029).
Regarding claim 34, Groeschke discloses a drug delivery add-on device 2 comprising a touch sensor (fig. 2), wherein the touch sensor comprises: a rigid element 22; a touch element 20/210 arranged in relation to the rigid element such that a gap between at least one part of the rigid element and a flexible part of the touch element is provided (fig. 2); and at least one pressure sensitive element 211/2100 arranged in the gap between the at least one part of the rigid element and the flexible part of the touch element such that a pressure applied to the flexible part of the touch element deforms the flexible part to at least partly reduce the gap and at least partly transmit the applied pressure to the at least one pressure sensitive element (fig. 2; page 6, para. 0102); wherein the at least one pressure sensitive element is configured to generate an output signal (e.g., light) upon detecting the pressure applied to the at least one pressure sensitive element, the generated output signal being provided for signaling that the flexible part of the touch element has been touched (page 6, para. 0100, 0102).
Claim 34 further calls for rotation of the touch element to cause a drug dosage to be selected. Groeschke discloses that rotation of a knob 12 causes the drug dosage to be selected (fig. 1; page 6, para. 0091), but fails to disclose that rotation of the touch element is associated with the knob and setting of the drug dosage. Krulevitch teaches a drug delivery add-on module wherein the add-on module extends 202 extends over the proximal end of the injection pen including over the dose knob 220 such that rotation of the proximal end 220 of the add-on module causes rotation of the dose knob to set the dose (col. 9, line 66 – col. 10, line 2; figs. 3, 7). This allows the dose tracking and logging electronics to be located in the reusable add-on module thereby reducing the cost of the disposable pen (col. 7, line 40- col. 8, line 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the add-on module of Groeschke to include a portion that extends over the dose knob such that rotation of the proximal end including the touch element causes a drug dosage to be selected as taught by Krulevitch so that the dose tracking and logging elements can be housed in the add-on module thereby reducing the cost of the disposable pen.
Regarding claim 35, Groeschke discloses electronics configured for one of the following: processing an output signal generated by the at least one pressure sensitive element for determining a user input (page 8, para. 0117); transmitting an output signal generated by the at least one pressure sensitive element for determining a user input via an interface; or storing a user input determined by processing an output signal generated by the at least one pressure sensitive element (page 3, para. 0029).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groeschke in view of Krulevitch as applied to claim 22 above, and further in view of Sala Cunill et al (US 10,431,068).
Regarding claim 23, Groeschke discloses that the pressure sensitive element includes a vibrational element as discussed above, but fails to disclose a vibration motor. Sala Cunill teaches an injection device including a haptic alert that is generated by a vibrator motor (col. 5, lines 64-65). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vibrational device of Groeschke to include a vibrator motor as taught by Sala Cunill to provide vibrational haptic feedback in a low cost and space saving manner.
Allowable Subject Matter
Claims 24-26, 29, 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: see prior office action.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783