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 on 03/23/2026 have been fully considered but they are not persuasive.
The applicant argues that the prior arts cited fail to teach "the injection device comprises a passive electronic arrangement, a portion of the passive electronic arrangement operatively coupled to a moveable component of the injection device", examiner respectfully disagrees.
Connaughton et al disclose a portion (86) of the passive electronic arrangement (42) operatively coupled to a moveable component of the injection device (para 0045 and 0085). It is the opinion of the examiner that said portion 86 is also part the passive electronic arrangement 42 because it has to extend through opening 45 to accommodate the sensor to determine information correlating to a dose of medicament injected (see para 0068-69). In other words, in order for the sensor to sense data, it has to be accommodated in opening 45 when the device is assembled during operation meaning it is a portion of the component. The claim only requires a portion of the passive electronic arrangement operatively coupled to a moveable component of the injection device but this limitation does not preclude said portion to be also part of the accessory.
Thus, the rejection of claims 16 and 26 are maintained.
By virtue of dependency, claims 17-25 and 27-35 are also rejected.
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)(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 16-22, 24, 26-28, 30-33 and 35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Connaughton et al (US 20220134013 A1).
Regarding claim 16, Connaughton et al disclose an apparatus (10, figs 1-2) comprising: an accessory (56) and an injection device (11) wherein: the accessory (56) attaches and detaches to the injection device (fig 2, para 0079), the accessory housing a control unit (76, examiner notes: electronic assembly 76 comprises a controller which is housed by cover 56, para 0069-70 and 0090); the injection device comprises a passive electronic arrangement (42, figs 2 and 5, support 42 comprising a sensor 86 and para 0071), a portion (86) of the passive electronic arrangement operatively coupled to a moveable component (32+38) of the injection device (para 0045 and 0085); and the control unit is configured to use the passive electronic arrangement to determine information correlating to a dose of medicament injected, wherein the control unit of the accessory is configured to apply an electrical signal to the passive electronic arrangement of the injection device to determine the information correlating to the dose of medicament injected (para 0068-69, 0083 and 0089).
Regarding claim 17, Connaughton et al disclose the apparatus of claim 16, wherein the accessory (56) forms a cap (fig 2) that attaches to and covers an end of the injection device (fig 4, para 0080).
Regarding claim 18, Connaughton et al disclose the apparatus of claim 16, wherein the injection device comprises a cartridge (20) containing the dose of medicament (para 0042 and 0043).
Regarding claim 19, Connaughton et al disclose the apparatus of claim 16, wherein one of the accessory and injection device comprises a catch (57) and the other of the accessory and injection device comprises a part (43) arranged to be caught by the catch (fig 5, para 0079), wherein one of the catch or the part moves relative to the other of the catch or the part to activate a switch of the control unit and the switch being arranged to, in response to attachment or detachment of the accessory from the injection device, trigger the control unit to use the passive electronic arrangement to determine the information correlating to the dose of medicament injected (para 0089 and 0091).
Regarding claim 20, Connaughton et al disclose the apparatus of claim 16, wherein the accessory houses a first connector (77) and the injection device comprises a second connector (see annotated figure below) for cooperating with the first connector of the accessory to electrically connect the control unit to the passive electronic arrangement (para 0069-70).
PNG
media_image1.png
638
636
media_image1.png
Greyscale
Regarding claim 21, Connaughton et al disclose the apparatus of claim 20, wherein the control unit of the accessory comprises a controller and a power supply (79), and the controller controls the power supply to apply the electrical signal to the passive electronic arrangement via the first connector (para 0069-70).
Regarding claim 22, Connaughton et al disclose the apparatus of claim 20, wherein the control unit of the accessory comprises a controller and a communications module, and the controller controls the communications module to communicate with a remote device (para 0072 and 0122).
Regarding claim 24, Connaughton et al disclose the apparatus of claim 16, wherein the passive electronic arrangement comprises a variable electronic resistor or wherein the passive electronic arrangement comprises a capacitive sensor (para 0086).
Regarding claim 26, Connaughton et al disclose an accessory (56) comprising: a body housing a control unit (76), wherein the accessory attaches to an injection device including a passive electrical arrangement (42 with sensor 86, fig 5), a portion (86) of the passive electronic arrangement operatively coupled to a moveable component (32+38) of the injection device (see figs 1-5, para 0045 and 0085), and the control unit is configured to use the passive electrical arrangement to determine information correlating to a dose of medicament injected, wherein the control unit is configured to apply an electrical signal to the passive electronic arrangement to determine the information correlating to the dose of medicament injected (para 0068-69, 0083 and 0089).
Regarding claim 27, Connaughton et al disclose the accessory of claim 26, wherein the control unit includes a switch (para 0089), and the accessory includes one of a catch (57) or a corresponding part and movement of one of the catch or the corresponding part activates the switch (para 0089 and 0091).
Regarding claim 28, Connaughton et al disclose the accessory of claim 26, wherein the control unit comprises a controller and a communications module, and the controller controls the communications module to communicate with a remote device (para 0072 and 0122).
Regarding claim 30, Connaughton et al disclose the accessory of claim 26, wherein the control unit of the accessory comprises a controller and a power supply (79), and the controller controls the power supply to apply the electrical signal to the passive electronic arrangement via the first connector (para 0069-70).
Regarding claim 31, Connaughton et al disclose the accessory of claim 26, wherein the accessory (56) forms a cap (fig 2) that attaches to and covers an end of the injection device (fig 4, para 0080).
Regarding claim 32, Connaughton et al disclose an injection device (11) comprising: a passive electronic arrangement (86) that can be used by the accessory of claim 26, to provide information corresponding to a position of a part that moves during an injection (para 0067).
Regarding claim 33, Connaughton et al disclose the injection device of claim 32, wherein the passive electronic arrangement comprises a variable electronic resistor or wherein the passive electronic arrangement comprises a capacitive sensor (para 0086).
Regarding claim 35, Connaughton et al disclose the injection device of claim 32, wherein the injection device comprises a cartridge (20) containing the dose of medicament (para 0042 and 0043).
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.
Claims 23 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Connaughton et al (US 20220134013 A1) in view of Miller et al (US 20190321547 A1).
Regarding claim 23, Connaughton et al disclose the limitations of claims 16 and 20 and further teach said control unit comprises a controller (para 0068-69) but fail to teach wherein the control unit of the accessory comprises a display, and the controller controls the display to display the information correlating to the dose of medicament injected.
However, Miller et al disclose an accessory (108) comprising a control unit (fig 9) wherein the control unit of the accessory comprises a display (110), and the controller controls the display to display the information correlating to the dose of medicament injected (para 0027-28, 0087 and claim 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the accessory of Connaughton et al to have a display, and the controller controls the display to display the information correlating to the dose of medicament injected. This would provide the benefit of visually displaying to an user information correlating to the dose of medicament injected such as information related to the time the dose was injected and its size (para 0027).
Regarding claim 29, Connaughton et al disclose the limitations of claims 26and further teach said control unit comprises a controller (para 0068-69) but fail to teach wherein the control unit of the accessory comprises a display, and the controller controls the display to display the information correlating to the dose of medicament injected.
However, Miller et al disclose an accessory (108) comprising a control unit (fig 9) wherein the control unit of the accessory comprises a display (110), and the controller controls the display to display the information correlating to the dose of medicament injected (para 0027-28, 0087 and claim 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the accessory of Connaughton et al to have a display, and the controller controls the display to display the information correlating to the dose of medicament injected. This would provide the benefit of visually displaying to an user information correlating to the dose of medicament injected such as information related to the time the dose was injected and its size (para 0027).
Claims 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Connaughton et al (US 20220134013 A1) in view of Larsen (US 20190117900 A1).
Regarding claim 25, Connaughton et al disclose the limitations of claims 16 and 24,
Connaughton et al teach wherein the passive electronic arrangement is the capacitive sensor (para 0086) but fail to teach the capacitive sensor comprises first and second opposed metallic layers, and wherein the metallic layers are formed in a label applied around a cartridge assembly or housing of the injection device.
However, Larsen discloses an apparatus (see figs 8 and 9) wherein the passive electronic arrangement comprises a capacitive sensor (see para 0095) and the capacitive sensor comprises first and second opposed metallic layers (see fig 9, plates 451), and wherein the metallic layers are formed in a label (label 450) applied around a cartridge assembly or housing of the injection device (see fig 8 and para 0095).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor of Connaughton et al and incorporate the teachings of Larsen to have the capacitive sensor comprises first and second opposed metallic layers, and wherein the metallic layers are formed in a label applied around a cartridge assembly or housing of the injection device. This would provide the benefit of having an identifier that includes information about the medicament included within the injection device and ensure that the size of an expelled dose is reliably captured (para 0092 and 0093).
Regarding claim 34, Connaughton et al disclose the limitations of claims 26, 32 and 33,
Connaughton et al teach wherein the passive electronic arrangement is the capacitive sensor (para 0086) but fail to teach the capacitive sensor comprises first and second opposed metallic layers, and wherein the metallic layers are formed in a label applied around a cartridge assembly or housing of the injection device.
However, Larsen discloses an apparatus (see figs 8 and 9) wherein the passive electronic arrangement comprises a capacitive sensor (see para 0095) and the capacitive sensor comprises first and second opposed metallic layers (see fig 9, plates 451), and wherein the metallic layers are formed in a label (label 450) applied around a cartridge assembly or housing of the injection device (see fig 8 and para 0095).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sensor of Connaughton et al and incorporate the teachings of Larsen to have the capacitive sensor comprises first and second opposed metallic layers, and wherein the metallic layers are formed in a label applied around a cartridge assembly or housing of the injection device. This would provide the benefit of having an identifier that includes information about the medicament included within the injection device and ensure that the size of an expelled dose is reliably captured (para 0092 and 0093).
Conclusion
THIS ACTION IS MADE FINAL. 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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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, 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.
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.
/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights