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 Amendment
The Amendment filed 3/24/2026 has been entered. Claims 1-13 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 11/4/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/13/2026 was filed after the mailing date of the Non-Final Office Action on 11/4/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-2, 4, 5, 7-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sall et al. (US 2018/0361067 A1).
Regarding claim 1, Sall teaches an injection device 1 (figure 1a) for delivering a dose of medicament to a user, the injection device comprising:
a container 12 having an open proximal end (end from where element 66 gets inserted), a substantially closed distal end (end connected to element 13), and a reservoir (hollow portion inside element 12 that contains medicament) defined between the open proximal end and the substantially closed distal end, the reservoir including the medicament (paragraph 0093, lines 8-14);
a mobile component (integrated structure formed by elements 60 and 66) provided in the container 12 and movable with respect to the container 12, a movement of the mobile component 60, 66 causing the medicament to be expelled from the container 12;
a spring 40, 145 (paragraph 0133) connected to the mobile component 60, 66, wherein the spring 40, 145 is configured to cause the mobile component to move within the container 12 to cause the medicament to be expelled from the container;
a sensor 101, 102 (figure 3a, physically connected to an end of element 145 via element 103 attached on one end of element 145) connected to an end of the spring, wherein the sensor (paragraph 0114) is configured to measure a parameter associated with an injection operation of the injection device;
a wireless communication device (paragraph 0118, lines 9-15) configured to communicate, to a computing device, information associated with the injection operation of the injection device; and
an electrically conductive trace (all the lines that conduct electricity in device shown in figure 2a including element 145) that connects the sensor to the wireless communication device;
characterized in that
the spring 145 forms at least a portion of the electrically conductive trace to communicate a signal from the sensor to the wireless communication device (paragraph 0114, due to closure of the circuit, a signal from the sensor to the wireless communication device is transferred, claim as written does not need spring actively communicating a signal instead spring needs to form a part of electrically conductive trace to communicate a signal).
Regarding claim 2, Sall teaches wherein the mobile component 60, 66 includes a plunger rod 60 and a stopper 66.
Regarding claim 4, Sall teaches wherein the end (end of element 145 with which element 103 is connected) of the spring connected to the sensor is opposite another end of the spring 40, 145 in contact with the stopper 66.
Regarding claim 5, Sall teaches further comprising a first housing (housing of element 1) including the container 12, the mobile component 60, 66, the spring 40, 145, the sensor 101, 102 and the wireless communication device (paragraph 0118, lines 9-15), wherein the sensor 101, 102 is spaced (some distance exist between 101, 102 and 104, 105) apart from the wireless communication device within the housing (housing of element 1).
Regarding claim 7, Sall teaches further comprising: a battery 106 configured to power to the sensor 101, 102 via the electrically conductive trace.
Regarding claim 8, Sall teaches wherein the sensor 101, 102 includes an adapter plate having a hollow cylinder shape (shape of element 101, 102 in figure 10b is a hollow cylindrical shape).
Regarding claim 9, Sall teaches further comprising: one or more processors (paragraph 0105, lines 1-4) programmed and/or configured to determine, based on the measured parameter, the information associated with the injection operation of the injection device.
Regarding claim 11, Sall teaches further comprising a user feedback device, wherein the user feedback device (paragraph 0137) includes at least one of the following: a display, a light-emitting diode, an audio output device, or any combination thereof.
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sall et al. (US 2018/0361067 A1) in view of Helmer et al. (US 2018/0353699 A1).
Regarding claim 6, Sall discloses the claimed invention substantially as claimed, as set forth above in claim 1. Sall further discloses further comprising: a first housing (housing formed by elements 10 and 22) including the container 18, the mobile component (integrated structure formed by elements 36 and 26), the spring 38 and the sensor 58 but is silent regarding a second housing including the wireless communication device, wherein the second housing is connected to an external surface of the first housing.
However, Helmer teaches a design of an injection device (figure 3) comprising a second housing 20 including a wireless communication device 28, wherein the second housing is connected an external surface of the first housing 11 for the purpose of using a well-known alternative configuration to releasably connect the wireless communication device with the injection device (paragraph 0052).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the injection device of Sall to incorporate a second housing including the wireless communication device, wherein the second housing is connected to an external surface of the first housing as taught by Sall for the purpose of using a well-known alternative configuration to releasably connect the wireless communication device with the injection device (paragraph 0052).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sall et al. (US 2018/0361067 A1) in view of Flaherty et al. (US 2004/0092865 A1).
Regarding claim 10, Sall discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 9. Sall is silent regarding wherein the information associated with the injection operation of the injection device includes at least one of the following: a start time of the injection operation, a duration of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, or any combination thereof.
However, Flaherty teaches a design of an injection device (figure 2) wherein the information associated with the injection operation of the injection device includes at least one of the following: a start time of the injection operation, a duration of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, or any combination thereof (paragraph 0064) for the purpose of determining parameters such as flow, blockage in flow path or other fluid motion indicators (paragraph 0064).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the injection device of Sall to incorporate wherein the information associated with the injection operation of the injection device includes at least one of the following: a start time of the injection operation, a duration of the injection operation, a speed of the injection operation, a back pressure profile of the injection operation, or any combination thereof as taught by Flaherty for the purpose of determining parameters such as flow, blockage in flow path or other fluid motion indicators (paragraph 0064).
Regarding claim 12, Sall discloses the claimed invention substantially as claimed, as set forth above in claim 1. Sall is silent regarding the sensor includes a force sensor configured to measure a force associated with the injection operation of the injection device.
However, Flaherty teaches the sensor includes a force sensor configured to measure a force associated with the injection operation of the injection device (paragraph 0064) for the purpose of determining parameters such as flow, blockage in flow path or other fluid motion indicators (paragraph 0064).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the injection device of Sall to incorporate the sensor includes a force sensor configured to measure a force associated with the injection operation of the injection device as taught by Flaherty for the purpose of determining parameters such as flow, blockage in flow path or other fluid motion indicators (paragraph 0064).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sall et al. (US 2018/0361067 A1) in view of Yu et al. (US 2016/0259913 A1).
Regarding claim 13, Sall discloses the claimed invention substantially as claimed, as set forth above in claim 1. Sall is silent regarding wherein the sensor includes an accelerometer configured to measure an acceleration associated with the injection operation of the injection device.
However, Yu teaches a design of an injector (figure 1) wherein the sensor includes an accelerometer configured to measure an acceleration associated with the injection operation of the injection device (paragraph 0070, lines 1-6) for the purpose of ensuring that the medication is delivered at an appropriate speed/acceleration (paragraph 0056, lines 9-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the sensor of Sall to incorporate wherein the sensor includes an accelerometer configured to measure an acceleration associated with the injection operation of the injection device as taught by Yu for the purpose of ensuring that the medication is delivered at an appropriate speed/acceleration (paragraph 0056, lines 9-11).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
Allowable Subject Matter
Claim 3 is 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:
The closest prior art of record, Sall et al. (US 2018/0361067 A1), is silent regarding wherein the sensor connected to the end of the spring is in contact with the stopper in combination with other claimed limitations of claim 3.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM 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, CHELSEA STINSON can be reached at 571-270-1744. 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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights