DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. This office action is responsive to the preliminary amendment filed on 03/21/24. As directed by the amendment: claims 4, 6, 9-14, 19, and 21 have been amended, claim 3 has been cancelled, and no claims have been added. Thus, claims 1-2 and 4-21 are presently pending in this application.
Claim Rejections - 35 USC § 112
3. 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 4-8 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.
Regarding claim 4, the limitation “having a user-accessible configuration mode” in lines 1-2 is unclear if it is referring to the controller or the inhaler. Further, the term “having” seems to be formatted as a method claim, and it is suggested to add the structure and functional language to clarify that the claim is directed to a device. This limitation is being interpreted as –the controller is configured to have a user-accessible configuration mode--.
Regarding claim 5, the limitation “in which the user must move the inhaler” in line 1 is unclear if it is referring to the controller, the user-accessible configuration mode, or is trying to claim the user. It is suggested to add structure to clarify that the claim is directed to a device. This limitation is being interpreted as –the controller, in a user-accessible configuration mode, is configured to record the predetermined motion sequence once the user moves the inhaler in the predetermined motion sequence at least twice--.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claim(s) 1-2, 9-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Jackson et al. (US 2019/0240430).
Regarding claim 1, Jackson discloses an inhaler for delivery of a therapeutic substance (fig. 2a, smart inhaler 11) comprising:
an actuator configured to interact with a container to selectively release the therapeutic substance for inhalation (fig. 2a, pump actuator button 23);
a controller configured to switch the inhaler between (fig. 2a, microprocessor 11c):
a locked condition in which release of the substance from the container is either inhibited, or permitted within at least one locked constraint ([0057] states that microprocessor 11c controls pump unit 11a to move an abutment 35, see fig. 3a, to block pump actuator 23); and,
an unlocked condition, in which release of the substance from the container is either permitted, or permitted within at least one unlocked constraint being less restrictive than the at least one locked constraint ([0057] states that microprocessor can lock and unlock inhaler using abutment 35); and
a motion sensor attached to the inhaler (fig. 2a, accelerometer 11e);
wherein: the controller is configured to store a predetermined motion sequence ([0068] states the microprocessor reads a shake protocol from an on board memory); and
upon detection of the predetermined motion sequence by the motion sensor, the controller is configured to switch the inhaler from the locked condition to the unlocked condition (fig. 8, step 83, [0068] states that the inhaler only activates for dosing once the inhaler has been properly shaken).
Regarding claim 2, Jackson discloses an inhaler according to claim 1, and further reads on wherein the motion sensor is configured to sense motion in at least two directions ([0068] states that the onboard accelerometer provides and acceleration signal to determine if the inhaler is properly shaken, where shaking inherently requires movement in at least two directions).
Regarding claim 9, Jackson discloses an inhaler according to claim 1, and further reads on wherein the predetermined motion sequence includes: a minimum number of reversals of direction in each direction ([0100] states that the dispensing button may activate only after the device is shaken 5 or more times, where shaking constitutes a reversal of direction).
Regarding claim 10, Jackson discloses an inhaler according to claim 1, and further reads on wherein: in the locked condition release of the substance from the container is inhibited (fig. 8, step 83, [0068] states the button is locked until the device is properly shaken); and in the unlocked condition, release of the substance from the container is permitted ([0068] states that after proper shaking the device is unlocked for a dosing event).
Regarding claim 11, Jackson discloses an inhaler according to claim 1, and further reads on wherein: in the locked condition, release of the substance from the container is inhibited (fig. 8, step 83, [0068] states the button is locked until the device is properly shaken); and in the unlocked condition, release of the substance from the container is permitted within at least one unlocked constraint ([0068] states that after proper shaking the device is unlocked for a dosing event where proper shaking is the unlocked constraint).
Regarding claim 12, Jackson discloses an inhaler according to claim 1, and further reads on wherein: in the locked condition, release of the substance from the container is inhibited within at least one locked constraint (fig. 8, step 83, [0068] states the button is locked until the device is properly shaken where the proper shaking of the device is the locked constraint); and in the unlocked condition, release of the substance from the container is permitted within at least one unlocked constraint being less restrictive than the at least one locked constraint ([0068] states that after proper shaking the device is unlocked for a dosing event where the device no longer needs to be shaken).
Regarding claim 13, Jackson discloses an inhaler according to claim 1, and further reads on wherein the actuator is electrically powered ([0057] states that the microprocessor moves an abutment 35, see fig. 3b) to selectively release the substance for inhalation ([0057] states that the abutment 35 is used when locking and unlocking the inhaler), and wherein the controller electronically controls the actuator when switching between the locked and unlocked conditions ([0057] states that when switching between locked an unlocked conditions, the abutment 35 moves which allows use of the actuator 23, see fig. 3b).
Regarding claim 15, Jackson discloses a method of using an inhaler for delivery of a therapeutic substance (fig. 8), the method comprising:
providing an inhaler (fig. 2a, smart inhaler 11) comprising:
an actuator configured to interact with a container to selectively release the therapeutic substance for inhalation (fig. 2a, pump actuator button 23);
a controller configured to switch the inhaler between (fig. 2a, microprocessor 11c):
a locked condition in which release of the substance from the container is either inhibited, or permitted within at least one locked constraint ([0057] states that microprocessor 11c controls pump unit 11a to move an abutment 25, see fig. 3a, to block pump actuator 23); and,
an unlocked condition, in which release of the substance from the container is either permitted, or permitted within at least one unlocked constraint being less restrictive than the at least one locked constraint ([0057] states that microprocessor can lock and unlock inhaler using abutment 35); and
a motion sensor attached to the inhaler (fig. 2a, accelerometer 11e);
wherein the controller is configured to store a predetermined motion sequence ([0068] states the microprocessor reads a shake protocol from an on board memory);
moving the inhaler in a motion sequence (fig. 8, step 83 comprises the accelerometer detects shaking);
determining by the controller whether the motion sequence matches the predetermined motion sequence ([0068] states that in step 83 the inhaler determines if the inhaler is properly shaken according to onboard accelerometer data and shake protocol from the on board memory); and
if the motion sequence matches the predetermined motion sequence, switching the inhaler from the locked condition to the unlocked condition (fig. 8, step 84 where the inhaler is unlocked).
7. Claim(s) 1 and 14 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Wilson et al. (US 2020/0147325).
Regarding claim 1, Wilson discloses an inhaler for delivery of a therapeutic substance (fig. 4a, inhalant dispensing system) comprising:
an actuator configured to interact with a container to selectively release the therapeutic substance for inhalation (fig. 4a, actuator 240);
a controller configured to switch the inhaler between (fig. 4a, electronics module 230):
a locked condition in which release of the substance from the container is either inhibited, or permitted within at least one locked constraint ([0069] states that actuation of the canister is only allowed after proper shaking via a lock 231); and,
an unlocked condition, in which release of the substance from the container is either permitted, or permitted within at least one unlocked constraint being less restrictive than the at least one locked constraint ([0069] states that actuation is allowed after proper shaking); and
a motion sensor attached to the inhaler ([0069] states that electronics module includes an accelerometer);
wherein: the controller is configured to store a predetermined motion sequence ([0069] states that electronics module stores minimum mixing thresholds); and
upon detection of the predetermined motion sequence by the motion sensor, the controller is configured to switch the inhaler from the locked condition to the unlocked condition ([0069] states that once proper mixing is achieved, the lock is released allowing dosing).
Regarding claim 14, Wilson discloses an inhaler according to claim 1, and further reads on comprising a lock (fig. 4a, safety mechanism 231) configured to inhibit actuation of the actuator to selectively release the substance for inhalation ([0069] states the canister is blocked until proper shaking is achieved), wherein the controller electronically controls the lock when switching between the locked and unlocked conditions ([0070] states electronics module 230 works in conjunction with safety mechanism 231, and [0069] states the electronics module 230 stores the minimum mixing thresholds).
Claim Rejections - 35 USC § 103
8. 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.
9. Claim(s) 4-8 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson in view of Borgman (US 2014/0082569).
Regarding claim 4, Jackson discloses an inhaler according to claim 1, and further reads on having a user- accessible configuration mode ([0046] states that an authorized user may be required to enter pre-dose identification information, and [0042] states that the inhaler can be configured for multiple prescriptions using passwords or the like), but does not expressly that that the identification information comprises the user moves the inhaler in the predetermined motion sequence which is detected by the motion sensor and recorded and stored by the controller.
However, Borgman teaches of a security system that allows securing of a device ([0009]) that uses an accelerometer ([0017]) to detect movements as a security feature to limit the device’s functionality.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Jackson with the motion password and software as taught by Borgman to ensure the inhaler is only used by the authorized user as contemplated by Jackson (Jackson [0003]-[0005] and [0042])
The modified inhaler of Jackson reads on the inhaler having a user-accessible configuration mode in which the user moves the inhaler in the predetermined motion sequence (Borgman fig. 2, 220 states the user can move to make the password) which is detected by the motion sensor (Jackson fig. 2a, accelerometer 11e) and recorded and stored by the controller (Borgman fig. 2, step 225 states the motion password is stored).
Regarding claim 5, the modified inhaler of Jackson reads on the limitations of claim 4 and further reads on in which the user must move the inhaler in the predetermined motion sequence at least twice to record the predetermined motion sequence (Borgman fig. 2, step 215 can set a user generated password which requires a first 220 and second 222 movement to confirm to password 225).
Regarding claim 6, the modified inhaler of Jackson reads on the limitations of claim 4 and further reads on the controller is configured to assess the input predetermined motion sequence (Borgman fig. 3, user moves device 320) against at least one predetermined criterion (Borgman [0041] states that an entered motion password is compared to previously stored data for the motion password), and if the input predetermined motion sequence does not meet the at least one predetermined criterion, it is rejected (Borgman fig. 3, shows that if the motion passwords do not match, security is not disabled).
Regarding claim 7, the modified inhaler of Jackson reads on the limitations of claim 6 and further reads on wherein the at least one predetermined criterion includes at least two-dimensional motion (Borgman fig. 2, the user movement in step 220 can be two dimensional motion, see also Borgman [0038] which contemplates predefined motions that can be used such as common two-dimensional figures).
Regarding claim 8, the modified inhaler of Jackson reads on the limitations of claim 7 wherein the at least one predetermined criterion includes three-dimensional motion (Borgman fig. 2, the user movement in step 220 can be three dimensional motion, see also Borgman [0038] which contemplates three dimensional predefined motions that can be used such as a spiral).
Regarding claim 16, Jackson discloses a method of using an inhaler for delivery of a therapeutic substance (fig. 8), the method comprising:
providing an inhaler (fig. 2a, smart inhaler 11) comprising:
an actuator configured to interact with a container to selectively release the therapeutic substance for inhalation (fig. 2a, pump actuator button 23);
a controller configured to switch the inhaler between (fig. 2a, microprocessor 11c):
a locked condition in which release of the substance from the container is either inhibited, or permitted within at least one locked constraint ([0057] states that microprocessor 11c controls pump unit 11a to move an abutment 25, see fig. 3a, to block pump actuator 23); and
an unlocked condition, in which release of the substance from the container is either permitted, or permitted within at least one unlocked constraint being less restrictive than the at least one locked constraint ([0057] states that microprocessor can lock and unlock inhaler using abutment 35); and
a motion sensor attached to the inhaler (fig. 2a, accelerometer 11e);
wherein the controller is configured to store a predetermined motion sequence ([0068] states the microprocessor reads a shake protocol from an on board memory);
moving the inhaler in a motion sequence (fig. 8, step 83);
The inhaler of Jackson further discloses that the shake protocol can be downloaded from cloud systems ([0068]) and a validation step (fig. 8, 82) for validating the user, but does not expressly state the controller is configured to record the motion sequence, store the motion sequence as a predetermined motion sequence, and switch the inhaler from the locked condition to the unlocked condition upon movement of the inhaler in the predetermined motion sequence.
However, Borgman teaches of a security system that allows securing of a device ([0009]) that uses an accelerometer ([0017]) to detect movements as a security feature to limit the device’s functionality.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the microprocessor of Jackson with the motion password and software as taught by Borgman to ensure the inhaler is only used by the authorized user as contemplated by Jackson (Jackson [0003]-[0005] and [0042])
The modified inhaler of Jackson reads on the steps of: recording the motion sequence using the controller (Borgman fig. 2, 220 states the user can move to make the password); storing the motion sequence as a predetermined motion sequence (Borgman fig. 2, step 225 states the motion password is stored); and switching the inhaler from the locked condition to the unlocked condition upon movement of the inhaler in the predetermined motion sequence (Borgman fig. 3, upon entering the motion password the device can be accessed).
Regarding claim 17, the modified method of Jackson reads on the limitations of claim 16 and further reads on assessing the input motion sequence (Borgman fig. 3, user moves device 320) against at least one predetermined criterion (Borgman [0041] states that an entered motion password is compared to previously stored data for the motion password); and if the input motion sequence does not meet the at least one predetermined criterion, rejecting the input motion sequence (Borgman fig. 3, shows that if the motion passwords do not match, security is not disabled).
Regarding claim 18, the modified method of Jackson reads on the limitations of claim 17 and further reads on moving the inhaler in the motion sequence for a second time (Borgman fig. 2, step 222 requires the same movement password to be entered again); recording the second motion sequence using the controller (Jackson [0068] states the accelerometer communicates to the microprocessor); assessing the second input motion sequence against the first input motion sequence (Borgman fig. 2, the first and second entries of the motion password are compared in step 223); if the first and second input motion sequences do not match, rejecting the first and second input motion sequences (Borgman fig. 2, if the motion sequences do not match, step 224, then an error is displayed, step 228, before the device returns to an original menu).
Regarding claim 19, the modified method of Jackson reads on the limitations of claim 17 and further reads on wherein the at least one predetermined criterion includes at least two-dimensional motion (Borgman fig. 2, the user movement in step 220 can be two dimensional motion, see also Borgman [0038] which contemplates predefined motions that can be used such as common two-dimensional figures).
Regarding claim 20, the modified method of Jackson reads on the limitations of claim 19 and further reads on wherein the at least one predetermined criterion includes three-dimensional motion (Borgman fig. 2, the user movement in step 220 can be three dimensional motion, see also Borgman [0038] which contemplates three dimensional predefined motions that can be used such as a spiral).
Regarding claim 21, the modified method of Jackson reads on the limitations of claim 16 and further reads on wherein the predetermined motion sequence (fig. 8, steps 82 and 83 where step 82 includes the motion password set in Borgman fig. 2) comprises one or more of the following: a minimum number of reversals of direction in each direction (Jackson [0100] states that the dispensing button may activate only after the device is shaken 5 or more times, where shaking constitutes a reversal of direction).
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ferrie et al. (US 2022/0061399) discloses a smoking substitute system that unlocks with a predetermined movement such as a swirling motion. Kane et al. (US 2013/0087142) discloses an inhaler that allows use only after specific movements. Strutt et al. (WO-2016009202) discloses an inhaler that dispenses only after sensing a predetermined start-up sequence of movement gestures.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/ Examiner, Art Unit 3785
/TIMOTHY A STANIS/ Supervisory Patent Examiner, Art Unit 3785
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