DETAILED ACTION
Response to Amendment
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/13/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-15, and 18-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 1, the limitations “a portion of the liquid drug from the container, wherein the at least a portion of the liquid drug is less than all of the liquid drug stored in the container” and “a bolus of the liquid drug from the container” is confusing because it appears the claim is referencing the same element with different terms. The former limitation is essentially a bolus while the latter element explicitly recites a bolus. For the purposes of this action, the examiner is interpreting the limitations to reference the same element. Clarifying amendments are strongly encouraged if this is the intended interpretation.
Claims 18 and 19 include similar limitations and are rejected for the same reasons.
All of the dependent claims are rejected by virtue of their dependency on the rejected independent claim.
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.
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.
Claim(s) 1, 3-10, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 5,527,288; hereafter Gross) in view of Ray et al. (US 6,109,895; hereafter Ray).
In regard to claim 1, Gross discloses an on-body drug delivery device (see Figs. 1-3), comprising: a container (10) configured to store a liquid drug (see col. 7, lines 42-45), wherein the container is user fillable (via injection plug 24; see col. 8, lines 1-4); a drive component (16, 8) configured to expel at least a portion of the liquid drug from the container (see col. 7, lines 62-67), wherein the at least a portion of the liquid drug is less than all of the liquid drug stored in the container (see col. 4, lines 58-62; “intermittent doses” is less than the full amount); and a housing (2) to cover at least one of the container or the drive component (see Figs. 1-3), wherein the housing includes a top portion having a patient interaction component (22), wherein the patient interaction component is a push button (see col. 7, lines 65-67), wherein the drive component is configured to be responsive to actuation of the patient interaction component (see col. 7, lines 62-67),
Although Gross discloses delivering in intermittent doses and discloses a start button to activate the delivery, Gross fails to expressly disclose wherein to stop the delivery of the bolus in response to a further actuation of the patient interaction component received during the delivery of the bolus as is recited in claim 1. Gross teaches that the button 22 will start the delivery and that intermittent doses are possible but does not expressly teach that the start button 22 is also a stop button that can stop the injection.
In a similar art, Ray discloses a pump (100) that includes a start/stop button (105), wherein the starting and stopping of the delivery is controlled by actuation of the button (105) (see col. 4, lines 6-8, col. 5, lines 29-32, col. 7, lines 6-13).
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 start button of Gross to be a start/stop button as taught by Ray in order to provide the start button of Gross the ability to administer intermittent doses while also keeping the patient interaction component a single element and not increasing the buttons on the top of the Gross device.
In regard to claim 3, the combination teaches wherein the patient interaction component is further operable to activate the drug delivery device (see citations above; both references teach a start button to activate delivery).
In regard to claim 4, the combination teaches wherein the patient interaction component (105 of Ray) is operable to: start, stop, and/or restart the flow of the liquid drug from the container for delivery of the liquid drug to the patient to enable the patient to dispense multiple doses of the liquid drug (the start/stop button incorporated into Gross can be activated to deliver intermittent doses as disclosed by Gross).
In regard to claim 5, the combination teaches wherein the drive component is operable to: at least partially the bolus of the liquid drug in response to an actuation of the patient interaction component by the patient (see citations above; both references teach a start button to activate delivery).
In regard to claim 6, the combination teaches, wherein successive actuations of the patient interaction component (105 of Ray) cause the drive component to deliver the liquid drug to the patient in discrete doses over a series of start and stop intervals (the start/stop button incorporated into Gross can be activated to deliver the intermittent doses as disclosed by Gross).
In regard to claim 7, the combination teaches wherein an actuation of the patient interaction component causes the drive component to deliver one or more doses of the stored-liquid drug stored in the container, wherein each of the one or more doses is up to a predetermined liquid drug dose amount stored in or defined by the on-body drug delivery device (see citations above; both references teach a start button to activate delivery).
In regard to claim 8, the combination teaches wherein times between delivery of multiple doses are approximately equal (functional limitation; the start/stop button incorporated into Gross can be activated to deliver the intermittent doses as disclosed by Gross; the times of the actuation are capable of being controlled by the user by pressing the button at approximately equal times).
In regard to claim 9, the combination teaches having an idle state (no bolus delivery; see col. 4, lines 50-52), an activation state (start button being pushed), and a delivery state (bolus being delivered), wherein the on-body drug delivery device enters the activation state based upon user input via the patient interaction component (see citations above; both references teach a start button to activate delivery).
In regard to claim 10, the combination teaches wherein the on-body drug delivery device operates in the delivery state based on patient input via the patient interaction component (see citations above; both references teach a start button to activate delivery).
In regard to claim 18, please see the rejection of claim 1 as substantially similar limitations are recited. Gross discloses a plurality of housing components (2a, 2b) including a top portion (2a) with the button (22) and a base (2b).
In regard to claim 19, please see the rejection of claim 1 as substantially similar limitations are recited.
In regard to claim 20, the combination teaches wherein multiple doses are expelled as a plurality of discrete doses over a series of start and stop intervals (pressing the modified start/stop button repeatedly to administer boluses reads on this limitation).
In regard to claim 21, the combination teaches wherein the drug delivery device does not deliver the liquid drug in the absence of actuation of the patient interaction component (if the start/stop button is not pressed, no drug will be delivered).
In regard to claim 22, the combination teaches wherein the patient interaction component (22) comprises the sole user interface on the on-body drug delivery device for initiating liquid drug delivery (see Fig. 1 of Gross)).
In regard to claim 23, the combination teaches wherein the activation input causes the drive component to mechanically expel the discrete liquid drug dose, and wherein multiple discrete doses are delivered in response to repeated activation inputs (pressing the start/stop button repeatedly to administer boluses reads on this limitation).
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gross and Ray in view of Dechellette et al. (US 2019/0167895; hereafter Dechellette).
In regard to claim 11, the combination fails to expressly disclose wherein the housing further comprises: an opening enabling viewing of an amount of the liquid drug stored in the container.
In a similar art, Dechellette discloses an on-body injector (10) comprising a window (18) through which the drug container (50) can be seen. See par. [0047]-[0054] and Figures 1-2.
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 device of Gross with the window of Dechellette in order to provide a means for viewing the internal components of the injector including the fill level of the drug container such that a determination to refill can be made.
In regard to claim 12, the combination fails to teach disclose further comprising a light emitting diode (LED) for providing feedback to the user in response to a user input to the patient interaction component.
In a similar art, Dechellette discloses an on-body injector (10) comprising a light emitting diode (LED) for providing feedback to the user in response to a user input to the patient interaction component. See [0053].
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 device of Gross with the LED of Dechellette in order to provide a visual means for feedback.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gross and Ray and Dechellette in view of Askarinya et al. (US 8,979,799; hereafter Askarinya).
In regard to claim 13, the combination fails to teach further comprising a mechanism for providing audio feedback to the user
In a similar art, Askarinya discloses further comprising a mechanism for providing audio feedback to the user (see col. 26, lines 14-22).
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 device of Gross with the audio feedback of Dechellette in order to provide an audio means for feedback.
Claim(s) 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gross and Ray in view of Askarinya.
In regard to claim 14, the combinations fails to teach discloses further comprising a mechanism for providing haptic or vibrational feedback to the user (see col. 26, lines 14-22).
In regard to claim 15, the combination fails to teach further comprising a sensor for monitoring operation of the on-body drug delivery device (see col. 26, lines 14-22).
In a similar art, Askarinya discloses further comprising a mechanism for providing haptic or vibrational feedback to the user (see col. 26, lines 14-22) and further comprising a sensor for monitoring operation of the on-body drug delivery device (see col. 26, lines 14-22).
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 device of Gross with the feedback means of Askarinya in order to provide an haptic means for feedback and means for identifying proper operation of the device.
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.
Claims 1, 3-15, and 18-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,129,943. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patented claims.
Response to Arguments
Applicant’s arguments with respect to the 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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