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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 10/12/2023. Claims 1-7 are currently pending and being examined.
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 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.
Application 16404895 became an AIA case, subsequently all following cases became AIA cases.
Claim Rejections - 35 USC § 112
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 6 and 7 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.
The term bolus implies there is a single dose delivered to the patient. However, the term “bolus” in claims 6 and 7 is used by the claim to mean “multiple doses”, as a result the claim language appears to contradict itself. The term is indefinite because the specification does not clearly and completely redefine the term “bolus”. In order to further prosecution the term is interpreted to mean multiple doses as claimed.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (USPN 6,349,232) in view of Vogeley (USPAP 2005/0219302).
In reference to independent claim 1, Vogeley discloses delivery device comprising: a collar device for wearing on an animal (col 5, lines 67-5 discloses “mounted inside a housing 80 mounted onto a collar strap 82, there is shown an electronic controller 84 which controls the operation of a dispenser 86, having an outlet conduit 88 which preferably communicates with pet care substance outlets 90 on the underside of collar strap 82, in contact with the fur, hair, or skin of an animal wearing the collar.”),
said collar device (fig 4A and 4B) comprising a dosing chamber (outlet conduit 88) for delivering a substance therefrom (“substance” in the cite above);
an actuator (portion of 86) for causing said substance to be delivered from said dosing chamber (outlet conduit 88); and a controller (84) for controlling delivery of said substance from said dosing chamber (disclosed above the controller activates the dispenser to dispense a substance out thru 90); however
Gordon does not disclose the controller is configured to operate said actuator with energy pulses, wherein said energy pulses comprise a series of energy pulses to correspond with a treatment protocol.
Vogeley, a similar fluid delivery device that can be used to give medicine, teaches an actuator (14, fig 2 and 3) for causing said substance to be delivered from said dosing chamber (30); and a controller (18) for controlling delivery of said substance from said dosing chamber (para 0061 discloses “the piezoelectric actuator drive circuit 18 of FIG. 3 (and of all other embodiments of drive circuits described herein) outputs a digital pulse stream (e.g., series of charge packets) which are integrated by the piezoelectric actuator 14”)
controller (18, fig 3) is configured to operate said actuator (14) with energy pulses (via 100), wherein said energy pulses comprise a series of energy pulses to correspond with a treatment protocol (para 0294 discloses “signals are entirely under software control and thus, the drive amplitude and frequency can be manipulated in real-time and in an unlimited number of ways. For example, a piezoelectric pump can be driven in a traditional fashion of (for example) 400 volts at 60 Hz to produce a continuous flow, or it can be driven in an entirely unconventional and much more complex fashion of say 60 Hz for {fraction (1/30)} of a second (1 pump "stroke") at 400 volts every 1 minute to reliably deliver a drop of medication to a patient on schedule”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pump and controller as taught in Vogeley in the delivery device of Gordon “thereby ensuring optimum performance under varying pressures and flows” para 0306, Vogeley. To be clear the modification is done by merging the controllers and using the pump of Vogeley.
In reference to dependent claim 2, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a controller (18, fig 3) wherein a first energy pulse has a relatively larger magnitude or longer duration than magnitudes or durations of subsequent energy pulses (para 0204 discloses “FIG. 8A-FIG. 8D show the period PB as being shorter than the period PA in view of a new (smaller) value for the variable PumpRate.” So the first energy pulse is longer/larger than the subsequent value. Furthermore, examiner takes the position this is functional language which Gordon in view of Vogeley is capable of completing.).
In reference to dependent claim 3, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a controller (18, fig 3), wherein said controller (18, fig 3) uses pulse-width modulation or pulse-duration modulation to determine a width or a duration of the energy pulses (para 0017 discloses “The controller controls pulse widths of the pulse width modulated signal so that the ascertainable electrical charge is applied to the piezoelectric actuator”).
In reference to dependent claim 4, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a controller (18, fig 3) wherein at least some of said energy pulses follow a step function (fig. 11b, claim 10 discloses “varying the drive signal through a step function”).
In reference to dependent claim 5, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a controller (18, fig 3) wherein at least some of said energy pulses have a gradual increase (para 0199 discloses “if the user input value of VoltInput is increased, then the PWM value is incremented (step 6D-11). FIG. 7A-FIG. 7D show such incrementation of the pulse width affecting the period P.sub.2, so that in period P.sub.2 the width of the digital pulses of signals PWM-A and PWM-B (shown in FIG. 7A and FIG. 7B, respectively) is increased from W to W'. As a result of the increased pulse width of the pulses of signals PWM-A and PWM-B, the amplitude of the pulse output applied on line drive signal applied on line 104, and the amplitude of the sine wave which results from the integration by piezoelectric actuator 14, is increased from A to A' during period P.sub.2” fig 7A-7D shows a gradual increase. Furthermore, examiner takes the position this is functional language which Gordon in view of Vogeley is capable of completing.).
In reference to dependent claim 6, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a system wherein said delivery of said substance comprises a bolus drug delivery which comprises a series of multiple small doses (para 0294 discloses “signals are entirely under software control and thus, the drive amplitude and frequency can be manipulated in real-time and in an unlimited number of ways. For example, a piezoelectric pump can be driven in a traditional fashion of (for example) 400 volts at 60 Hz to produce a continuous flow, or it can be driven in an entirely unconventional and much more complex fashion of say 60 Hz for {fraction (1/30)} of a second (1 pump "stroke") at 400 volts every 1 minute to reliably deliver a drop of medication to a patient on schedule”
the drug delivery discloses a series of small doses, furthermore para 0296 goes onto disclose “the microcontroller and delivery scheduler 160 are further employed to control piezo actuators in certain applications in ways that are related to world clock time such as using a piezo pump to water a plant once a day” again giving a small dose repeatedly. Even though, this example is not medical, it still shows the controller has the capability to operate in the claimed way.).
In reference to dependent claim 7, Gordon in view of Vogeley discloses the delivery device according to claim 1, Vogeley further discloses a system wherein said delivery of said substance comprises a bolus drug delivery which comprises a series of multiple small doses delivered over an extended period of time (para 0294 discloses “signals are entirely under software control and thus, the drive amplitude and frequency can be manipulated in real-time and in an unlimited number of ways. For example, a piezoelectric pump can be driven in a traditional fashion of (for example) 400 volts at 60 Hz to produce a continuous flow, or it can be driven in an entirely unconventional and much more complex fashion of say 60 Hz for {fraction (1/30)} of a second (1 pump "stroke") at 400 volts every 1 minute to reliably deliver a drop of medication to a patient on schedule”;
The cite discloses delivering multiple doses on a schedule over an “extended period of time”, the time. Furthermore para 0296 goes onto disclose “the microcontroller and delivery scheduler 160 are further employed to control piezo actuators in certain applications in ways that are related to world clock time such as using a piezo pump to water a plant once a day” giving small doses over a long time horizon, such as a drop every day for a month. Even though, this example is not medical, it still shows the controller has the capability to operate in the claimed way.).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huang (USPAP 2006/0271020) discloses a drug delivery device.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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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.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783