DETAILED ACTION
Response to Amendment
Claim Objections
Claim 18 is objected to because of the following informalities:
On line 5 of claim 18, “a -container” should read “a container” to fix a minor typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-10, 14-15, and 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Askarinya et al. (US 8,979,799; hereafter Askarinya).
In regard to claim 1, Askarinya discloses an-body drug delivery device (192), comprising: a container (1070 and 1306 in combination with 1100 and 1312; these numbers refer to the same structure; see at least col. 14, lines 54-67 and col. 15, line 17-col. 16, line 49; the pressurized reservoir feeds the bolus reservoirs; in combination they are considered the container) configured to store a liquid drug, wherein the container is user fillable (via fill port 1050 and 1304; again these numbers refer to the same structure; see at least col. 13, lines 17-19 and col. 15, lines 27- col. 16, line 49); a drive component (1110) configured to expel at least a portion of the liquid drug from the container (see col. 14, lines 54-67), wherein the at least a portion of the liquid drug is less than all of the liquid drug stored in the container (the bolus reservoir delivers a bolus which is less than all of the liquid in the container for basal delivery); a housing (1010) to cover at least one of the container or the drive component, wherein the housing includes a top portion having a patient interaction component (1030) (shown at least in Fig. 28), wherein the patient interaction component is a push button (see at least col. 13, lines 20-43), and wherein the drive component is configured to be responsive to actuation of the patient interaction component (see col. 14, lines 54-67).
The on-body injector is highlighted for illustrative purposes. The examiner also notes that the on-body injector 1900 includes similar features and reads on the claims as well. Applicant is encouraged to consider embodiment 1900 if responding with arguments and amendments.
In regard to claim 3, Askarinya discloses wherein the patient interaction component is further operable to activate the drug delivery device (see col. 14, lines 54-67; pushing the bolus button 1030 to deliver a bolus is activating the drug delivery device).
In regard to claim 4, Askarinya discloses wherein the patient interaction component (1030) 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 bolus button can be pushed to administer boluses multiple times).
In regard to claim 5, Askarinya discloses wherein the drive component is operable to: deliver a bolus of the liquid drug in response to actuation of the patient interaction component by the patient (see col. 14, lines 54-67).
In regard to claim 6, Askarinya discloses wherein actuation of the patient interaction component (1030) causes the drive component to deliver the liquid drug to the patient in discrete doses over a series of start and stop intervals (1030 is a bolus button, pressing the button multiple times will cause a series of discrete doses).
In regard to claim 7, Askarinya discloses wherein actuation of the patient interaction component (1030) causes the drive component (1110) to deliver one or more doses of the stored liquid drug, wherein each of the one or more doses is a predetermined liquid drug dose amount stored in or defined by the on-body drug delivery device (see col. 14, lines 54-67).
In regard to claim 8, Askarinya discloses wherein times between delivery of multiple doses is approximately equal (functional limitation; the button 1030 can be pressed at equal intervals).
In regard to claim 9, Askarinya discloses having an idle state (no bolus delivery), an activation state (button 1030 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 col. 14, lines 54-67).
In regard to claim 10, Askarinya discloses, wherein the on-body drug delivery device operates in the delivery state based on patient input via the patient interaction component (see col. 14, lines 54-67).
In regard to claim 14, Askarinya 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, Askarinya discloses further comprising a sensor for monitoring operation of the on-body drug delivery device (see col. 26, lines 14-22).
In regard to claim 18, Askarinya discloses a drug delivery device, comprising: a plurality of housing components (100, 192) including a top portion (192) and a base (100), wherein the top portion and base are configured to couple together (see col. 5, lines 20-26) and the top portion includes a patient interaction component (1030); a container (1070 and 1306 in combination with 1100 and 1312; these numbers refer to the same structure; see at least col. 14, lines 54-67 and col. 15, line 17-col. 16, line 49; the pressurized reservoir feeds the bolus reservoirs; in combination they are considered the container) configured to store a liquid drug and fit within the plurality of housing components, wherein the container is user fillable (via fill port 1050 and 1304; again these numbers refer to the same structure; see at least col. 13, lines 17-19 and col. 15, lines 27- col. 16, line 49); and a drive component (1110) configured to expel a portion of the liquid drug from the container and fit within the plurality of housing components (see col. 14, lines 54-67), wherein the drive component is responsive to actuation of the patient interaction component (see at least col. 13, lines 20-43), and the portion of the liquid drug is less than all of the liquid drug stored in the container (the bolus reservoir delivers a bolus which is less than all of the liquid in the container for basal delivery).
The on-body injector is highlighted for illustrative purposes. The examiner also notes that the on-body injector 1900 includes similar features and reads on the claims as well. Applicant is encouraged to consider embodiment 1900 if responding with arguments and amendments.
In regard to claim 19, Askarinya discloses a drug delivery device, comprising: a drive system including a drive component (1110) configured to expel a portion of a liquid drug from a user fillable container (1070 and 1306 in combination with 1100 and 1312; these numbers refer to the same structure; see at least col. 14, lines 54-67 and col. 15, line 17-col. 16, line 49; the pressurized reservoir feeds the bolus reservoirs; in combination they are considered the container), wherein the liquid drug is stored within the container after being filled by a user (via fill port 1050 and 1304; again these numbers refer to the same structure; see at least col. 13, lines 17-19 and col. 15, lines 27- col. 16, line 49); and a patient interaction (1030) component operable to, in response to an activation input (pressing the button 1030), cause the drive component to expel the portion of the liquid drug as a discrete dose, wherein the discrete dose is a predetermined liquid drug dose amount and is less than all of the liquid drug stored within the container (see col. 14, lines 54-67).
The on-body injector is highlighted for illustrative purposes. The examiner also notes that the on-body injector 1900 includes similar features and reads on the claims as well. Applicant is encouraged to consider embodiment 1900 if responding with arguments and amendments.
In regard to claim 20, Askarinya discloses wherein multiple doses are expelled as a plurality of discrete doses over a series of start and stop intervals (pressing the bolus button 1030 repeatedly to administer boluses reads on this limitation).
In regard to claim 21, Askarinya discloses wherein the drug delivery device does not deliver the liquid drug in the absence of actuation of the patient interaction component (if the button 1030 is not pressed while the basal delivery is not actuated, no drug will be delivered).
In regard to claim 22, Askarinya discloses wherein the patient interaction component comprises the sole user interface on the on-body drug delivery device for initiating liquid drug delivery (1030 is the only button).
In regard to claim 23, Askarinya discloses 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 bolus button 1030 repeatedly to administer boluses reads on this limitation).
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) 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Askarinya in view of Dechellette et al. (US 2019/0167895; hereafter Dechellette).
In regard to claim 11, Askarinya 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 Askarinya 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, Askarinya fails to expressly 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 Askarinya with the LED of Dechellette in order to provide a visual means for feedback.
In regard to claim 13, Askarinya discloses further comprising a mechanism for providing audio feedback to the user (see col. 26, lines 14-22).
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
The applicant should consider US 2019/0167895 to Dechellette as a valid reference which discloses the claimed features. Applicant should consider the reference when deciding how to proceed.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
Prosecution Insights