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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/25/2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2026.
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.
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, 5-7, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (U.S Patent Pub. No. 20040039289 A1, “Christensen”) in view of Pedersen et al. (U.S Patent Pub. No. 20230381426 A1, “Pedersen”).
Regarding claim 1, Christensen discloses the limitations of (Claim 1) an injector medical device (1 in Fig. 1-2, see Abstract and para. 0010):
a cover (housing of 1 in Fig. 1) including:
an engaging surface (4 in Fig. 1-2) including a needle outlet (see Fig. 1-2 and para. 0017 – needle 3 extends through the engagement face 4 and thus there is an outlet for said needle 3); and
a handle (proximal portion of 1 in Fig. 1-2) formed in the cover (housing of 1) at an opposite end of the cover (housing of 1) as the engaging surface (4, see para. 0009 and 0024 – examiner is interpreting the handle as the proximal portion of the housing of cover 1 where the user’s hand is placed);
a needle (3 in Fig. 1-2) configured to translate through the needle outlet (see Fig. 1-2 and para. 0037 – the needle 3 may be configured to move into and out of the doser 1 and thus is configured to translate through said outlet in the engaging face 4);
a first sensor electrode (5 in Fig. 1-2) disposed on the engaging surface (4) and adjacent the needle outlet (see Fig. 1-2 and para. 0009 and 0016); and
a second sensor electrode (6 in Fig. 1) disposed on the handle (proximal portion of 1, see para. 0009 and 0024).
However, Christensen is silent to the mechanism of activation of the doser (1), and thus does not explicitly disclose it as an autoinjector.
Pedersen discloses a drug delivery device (10 in Fig. 1) in the form of an autoinjector which comprises an actuator button (16 in Fig. 1) at its proximal end that when depressed, automatically activates a drive assembly (30 in Fig. 1) which drives a plunger stopper (21 in Fig. 1) within a syringe barrel (22 in Fig. 1) to dispense medicament (24 in Fig. 1) from a needle (26 in Fig. 1, see para. 0045-0046 and 0048).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injector of Christensen to have an actuator button (16) at its proximal end which when actuated automatically activates the dispensing mechanism of the injector as taught by Pedersen to yield an autoinjector medical device. Pedersen teaches that autoinjectors offer several benefits in delivery of medicaments such as simplicity of use compared to convention syringes and may be used to delivery many different medicaments with varying viscosities and/or desired volumes (see para. 0003).
Regarding claim 5, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above. In modified Christensen, Christensen discloses (Claim 5) wherein the first sensor electrode (5) and the second sensor electrode (6) are each electrode sensors configured to measure and record electrical signals produced by a heart or body of a user (see para. 0020-0021 and 0024).
Regarding claim 6, modified Christensen discloses the autoinjector medical device of claim 5, as discussed above. In modified Christensen, Christensen discloses (Claim 6) wherein the first sensor electrode (5) and the second sensor electrode (6) are configured to measure and record electrical signals produced by the heart of the user before, during, or after insertion of the needle into the user (see para. 0020 and 0025 – the sensors are configured to measure and record heart rate signals of the user when the doser 1 is in contact with the target site and thus may be done before, during, or after insertion of the needle).
Regarding claim 7, modified Christensen discloses the autoinjector medical device of claim 5, as discussed above. In modified Christensen, Christensen discloses (Claim 7) wherein the first sensor electrode (5) and the second sensor electrode (6) are configured to measure and record one or more of heart rate, heart rate variability, physiological stress, energy expenditure, atrial fibrillation, arrhythmia, body fat content, and hydration level in the user (see para. 0024-0026).
Regarding claim 11, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above. In modified Christensen, Christensen discloses (Claim 11) wherein the medical device (1 in Fig. 1-2) is an electro-mechanical medical device including a power source (12 in Fig. 2) configured to supply electrical energy to an actuator (7 in Fig. 2, see para. 0029), the actuator (7) being coupled to the needle (3) and the actuator (7) being configured to cause the needle (3) to translate through the needle outlet (see para. 0029 and 0037 – piston rod 7 is capable of being configured to translate the needle 3 through needle outlet of the doser 1 as the doser 1 may be configured to push/pull the needle into the doser 1 as needed).
In modified Christensen, Pedersen discloses the autoinjector medical device (10) which is also in the form of an electro-mechanical medical device (see para. 0046).
Regarding claim 13, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above. In modified Christensen, Christensen discloses (Claim 13) further comprising an input-output device (13 in Fig. 2) configured to transfer data collected by the autoinjector medical device (1) to a device separate and remote from the autoinjector medical device (1, see para. 0028 and 0033).
Claim(s) 2-3, 8, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen in view of Pedersen as applied to claims 1, 5, and 13 above, and further in view of Albert et al. (U.S Patent Pub. No. 20230240531 A1, “Albert”).
Regarding claim 2, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above.
However, modified Christensen fails to disclose (Claim 2) further comprising a third electrode disposed on the handle.
Albert discloses a physiological monitoring system in the form of a handheld smartphone (2000 in Fig. 2A-2K) with a protective case (2200 in Fig. 2A-2C and 2G-2K, see para. 0206), wherein, one embodiment of the protective case (2200 in Fig. 2J) comprises a first electrode lead (2230 in Fig. 2J) on a front, engaging surface of the case (2200), a second electrode lead (2210 in Fig. 2J) on a first side of a handle of the case (2200, examiner notes Fig. 2J has a typo where the side electrode labeled 2230 should be labeled as 2210 as described in para. 0210), and a third electrode lead (2220 in Fig. 2J) on a second side, opposite the first side, of the handle of the case (2200, see para. 0210). Albert further discloses that this embodiment of the case (2200 in Fig. 2J) is used by the user holding the system (2000) with their hands contacting the second electrode lead (2210) and the third electrode lead (2220) and the first electrode lead (2230) placed in contact with the leg of the user to measure one or more physiological parameters such as a heart rate or an ECG (see Fig. 2K and para. 0211).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the autoinjector medical device of modified Christensen having a first electrode on a front, engaging surface and a second electrode on a handle to instead have the second and a third electrode disposed opposite of one another on opposite sides of the autoinjector medical device as taught by Albert. In combination, modified Christensen would have the first electrode (5) remain on the engaging surface (4) with the second electrode (6) moved to one side of the autoinjector medical device (1) and a third electrode placed on an opposite side of the autoinjector medical device as taught by Albert in Fig. 2K. Albert teaches that three electrodes rather than two allows for both heart rate and ECG sensing to be done by the device, and allows the user to take up to six leads using a single hand-held device, which is easily held by the patient while simultaneously observing the display of the device (see para. 0086-0088 and 0224).
Regarding claim 3, modified Christensen discloses the autoinjector medical device of claim 2, as discussed above. In modified Christensen, Albert discloses (Claim 3) wherein the third electrode (2220 in Fig. 2J) is positioned on an opposite side of the handle as the second sensor electrode (2210 in Fig. 2J, see Fig. 2J and para. 0210).
Regarding claim 8, modified Christensen discloses the autoinjector medical device of claim 5, as discussed above.
However, modified Christensen fails to disclose (Claim 8) further comprising an alarm configured to alert the user when the measured and recorded electrical signals exceed a pre-defined threshold limit.
Albert discloses a physiological monitoring system (2000 in Fig. 2A-2K) in the form of a handheld smartphone (2100 in Fig. 2A-2K) with a protective case (2200 in Fig. 2A-2K, see para. 0206), wherein, one embodiment of the protective case (2200 in Fig. 2J) comprises three sensor electrode leads (2210, 2220, and 2230 in Fig. 2J) used as seen in Fig. 2K for measuring heart rate and ECG (see para. 0210-0211), wherein the system (2000) is a specific example of the generic system (1000 in Fig. 1) which implements a first application (1170 in Fig. 1) on its processor (1110 in Fig. 1) for analyzing the physiological data from the sensors and may alert the user or a remote healthcare provider if an arrhythmia is detected (see para. 0005, 0187 and 0190 – arrhythmias may be detected when electrical activity of the heart is faster than normally indicated an excess from a pre-defined threshold limit).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the signal processing/calculation means (10 in Fig. 2) of the autoinjector medical device of modified Christensen to incorporate an alarm configured to alert the user when the measured and recorded electrical signals exceed a pre-defined threshold limit as taught by Albert. Albert teaches an automatic alert protocol if arrhythmia’s are detected to notify a user or healthcare provider to ensure proper medical interventions are administered (see para. 0005 and 0190).
Regarding claim 12, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above.
However, modified Christensen fails to disclose (Claim 12) further comprising a display disposed on or coupled to the cover, the display being configured to provide a visual presentation of data collected by the autoinjector medical device.
Albert discloses a physiological monitoring system (2000 in Fig. 2A-2K) in the form of a handheld smartphone (2100 in Fig. 2A-2K) with a protective case (2200 in Fig. 2A-2K, see para. 0206), wherein, one embodiment of the protective case (2200 in Fig. 2J) comprises three sensor electrode leads (2210, 2220, and 2230 in Fig. 2J) used as seen in Fig. 2K for measuring heart rate and ECG (see para. 0210-0211), wherein the Albert teaches (Claim 12) further comprising a display (2140 in Fig. 2A) disposed on or coupled to the cover (2200 in Fig. 2A, see para. 0206-0207 – display 2140 on smartphone 2100 is coupled to case 2200), the display (2140) being configured to provide a visual presentation of data collected by system (2000, see Fig. 2E-2F and para. 0073 and 0190).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the autoinjector medical device of modified Christensen to incorporate a display coupled to the cover as taught by Albert. Albert discloses that the display allows for visual display of the measured cardiac parameter in real time to provide the user or healthcare provider (see para. 0209).
Regarding claim 14, modified Christensen discloses the autoinjector medical device of claim 13, as discussed above. While modified Christensen discloses the input-output device (13 in Fig. 2) which may comprise wire and wire-less communication links (see para. 0028), Christensen fails to disclose (Claim 14) wherein the input-output device transfers collected data through one or more of a wireless network protocol (Wi-Fi), a cellular signal, a Bluetooth standard, and a cloud-based data transfer service.
Albert discloses a physiological monitoring system (2000 in Fig. 2A-2K) in the form of a handheld smartphone (2100 in Fig. 2A-2K) with a protective case (2200 in Fig. 2A-2K, see para. 0206), wherein, one embodiment of the protective case (2200 in Fig. 2J) comprises three sensor electrode leads (2210, 2220, and 2230 in Fig. 2J) used as seen in Fig. 2K for measuring heart rate and ECG (see para. 0210-0211), wherein the Albert teaches (Claim 14) wherein the input-output device (1140 in Fig. 1) transfers collected data through one or more of a wireless network protocol (Wi-Fi), a cellular signal, a Bluetooth standard, and a cloud-based data transfer service (see para. 0188 – the system may comprise a network interface 1140 that transfers collected data through cellular data signals or WIFI).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the input-output device of modified Christensen to explicitly transfer the collected data through cellular data signals or WIFI as taught by Albert according to known methods to yield predictable results. Both communication units of Christensen and Albert are used to transmit and receive data for the system, and thus one of ordinary skill in the art would have recognized that modifying the communication unit of Christensen to be a known type of service such as cellular data signals or WIFI as taught by Albert would yield results that were predictable.
Claim(s) 2, 4, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen in view of Pedersen as applied to claims 1 and 5 above, and further in view of Banet et al. (U.S Patent Pub. No. 20170188875 A1, “Banet”).
Regarding claim 2, modified Christensen discloses the autoinjector medical device of claim 1, as discussed above.
However, modified Christensen fails to disclose (Claim 2) further comprising a third electrode disposed on the handle.
Banet discloses a handheld physiological monitoring device (100 in Fig. 1-5) comprising a first electrode (160A-160B in Fig. 2A-3) disposed on the engagement surface (110 in Fig. 2A, see para. 0078), a second electrode (150A-150B in Fig. 3) disposed on the handle (104, 160 in Fig. 3, see para. 0064 – examiner is interpreting the handle as the combined write portion 104 and neck 106, see para. 0081), wherein the first electrode (160A-160B) and the second electrode (150A-150B) are used to measure ECG waveforms (see para. 0081). Banet teaches (Claim 2) further comprising a third electrode (111 in Fig. 3) disposed on the handle (104, 106, see para. 0069).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the autoinjector medical device of modified Christensen to incorporate a third electrode on the handle as taught by Banet. Banet teaches that an additional electrode is typically used as a drive electrode to reduce 60 Hz noise typically caused by common mode interference and thus improves the handheld device’s physiological measuring circuitry (see para. 0069).
Regarding claim 4, modified Christensen discloses the autoinjector medical device of claim 2, as discussed above. In modified Christensen, Banet discloses (Claim 4) wherein the third electrode (111 in Fig. 3) is a right-leg drive electrode configured to implement common-mode powerline interference suppression (see para. 0069).
Regarding claim 9, modified Christensen discloses the autoinjector medical device of claim 5, as discussed above.
While modified Christensen discloses that the first sensor electrode (5) may comprise two electrodes (5a and 5b in Fig. 3) which together may be used to measure impedance of the tissue contacted at the engagement face (4, see para. 0018-0019), modified Christensen fails to disclose (Claim 9) wherein the first sensor electrode and the second sensor electrode can further be configured for at least one of biometric authentication and bio-impedance analysis of the user.
Banet discloses a handheld physiological monitoring device (100 in Fig. 1-5) comprising a first electrode (160A-160B in Fig. 2A-3) disposed on the engagement surface (110 in Fig. 2A, see para. 0078), a second electrode (150A-150B in Fig. 3) disposed on the handle (104, 160 in Fig. 3, see para. 0064 – examiner is interpreting the handle as the combined write portion 104 and neck 106, see para. 0081), wherein the first electrode (160A-160B) and the second electrode (150A-150B) are used to measure both ECG waveforms and bio-impedance measurements (see para. 0081-0082). Thus, Banet teaches (Claim 9) wherein the first sensor electrode (160A-160B) and the second sensor electrode (150A-150B) can further be configured for at least one of biometric authentication and bio-impedance analysis of the user (see para. 0082 – the electrodes may be used in a bio-impedance measurement system of the user).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the autoinjector medical device of modified Christensen such that the first and second sensor electrodes are configured for bio-impedance analysis of the user as taught by Banet. Banet teaches that electrodes capable of performing both ECG measurements and bio-impedance measurements are thus able to analyze cardiac function alongside other organ functions such as respiratory effort and stroke volume (SV) which modulate the TBI waveform (see para. 0082-0085) which together assist in identifying underlying conditions (see para. 0004).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen in view of Pedersen as applied to claim 5 above, and further in view of Lee (U.S Patent Pub. No. 20170245377 A1).
Regarding claim 10, modified Christensen discloses the autoinjector medical device of claim 5, as discussed above.
While modified Christensen discloses signal processing/calculation means (10 in Fig. 2) which may include application-specific integrated circuits (see para. 0028), modified Christensen fails to disclose (Claim 10) further comprising an analog front-end stage configured to precondition the electrical signals measured and recorded by the first sensor electrode and the second sensor electrode before processing and outputting results regarding the electrical signals.
Lee discloses handheld physiological monitoring devices (see Fig. 12A-12B) that comprise three electrodes for contacting the user’s skin to measure ECG (see para. 0196), wherein the device may further comprise the circuitry seen in Fig. 13 (see para. 0198). Lee teaches (Claim 10) further comprising an analog front-end stage (1350 in Fig. 13) configured to precondition the electrical signals measured and recorded by the sensor electrodes (1310, 1320, 1330 in Fig. 13) before processing and outputting results regarding the electrical signals (see para. 0198-0200).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the signal processing/calculations means (10) of modified Christensen to incorporate an analog front-end stage as taught by Lee according to known methods to yield predictable results. Lee teaches incorporating an analog-front end as a pre-processing circuit for ECG signal measurements is a known method in the art for pre-processing bio-signals using different filters and an analog-to-digital converter (see para. 0200), and thus one of ordinary skill in the art would have recognized that incorporated an analog front-end into the signal processing circuitry of modified Christensen would yield predictable results.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen in view of Pedersen in view of Clemente et al. (U.S Patent Pub. No. 20250352731 A1, “Clemente”).
Regarding claim 21, Christensen discloses the limitations of (Claim 21) an injector medical device (1 in Fig. 1-2, see Abstract and para. 0010):
a cover (housing of 1 in Fig. 1) including:
an engaging surface (4 in Fig. 1-2) including a needle outlet (see Fig. 1-2 and para. 0017 – needle 3 extends through the engagement face 4 and thus there is an outlet for said needle 3); and
a handle (proximal portion of 1 in Fig. 1-2) formed in the cover (housing of 1) at an opposite end of the cover (housing of 1) as the engaging surface (4, see para. 0009 and 0024 – examiner is interpreting the handle as the proximal portion of the housing of cover 1 where the user’s hand is placed);
a needle (3 in Fig. 1-2) configured to translate through the needle outlet (see Fig. 1-2 and para. 0037 – the needle 3 may be configured to move into and out of the doser 1 and thus is configured to translate through said outlet in the engaging face 4);
a first sensor electrode (5a in Fig. 3) disposed on the engaging surface (4) and adjacent the needle outlet (see Fig. 1-3 and para. 0018-0020); and
a second sensor electrode (5b in Fig. 3) disposed on the engaging surface (4, see Fig. 1-3 and para. 0018-0020), wherein the first sensor electrode (5a) and the second sensor electrode (5b) are adapted to measure a bio-electrical impedance of a body of a user (see para. 0019).
However, Christensen is silent to the mechanism of activation of the doser (1), and thus does not explicitly disclose it as an autoinjector nor does Christensen disclose the second sensor electrode disposed adjacent the needle outlet.
Pedersen discloses a drug delivery device (10 in Fig. 1) in the form of an autoinjector which comprises an actuator button (16 in Fig. 1) at its proximal end that when depressed, automatically activates a drive assembly (30 in Fig. 1) which drives a plunger stopper (21 in Fig. 1) within a syringe barrel (22 in Fig. 1) to dispense medicament (24 in Fig. 1) from a needle (26 in Fig. 1, see para. 0045-0046 and 0048).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injector of Christensen to have an actuator button (16) at its proximal end which when actuated automatically activates the dispensing mechanism of the injector as taught by Pedersen to yield an autoinjector medical device. Pedersen teaches that autoinjectors offer several benefits in delivery of medicaments such as simplicity of use compared to convention syringes and may be used to delivery many different medicaments with varying viscosities and/or desired volumes (see para. 0003).
Clemente discloses an autoinjector (300 in Fig. 3) for automatically delivering a dose of medication (see para. 0002 and 0050), wherein the autoinjector (300) comprises an engaging surface (111 in Fig. 4B) comprising a first and second electrode (16) disposed on opposite sides of a needle outlet (21 in Fig. 4B) and configured to contact a user’s skin and measure information arising therefrom (see para. 0050 and 0054).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second electrode of modified Christensen to be disposed on opposite sides of the needle outlet such that they are both adjacent said needle outlet as taught by Clemente according to known methods to yield predictable results. Both Christensen and Clemente comprise skin sensors configured to contact the user’s skin and measure information arising therefrom, and thus one of ordinary skill in the art would have recognized that modifying the configuration of said sensors relative to the needle outlet as taught by Clemente would yield results that were predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 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, 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.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights