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 .
Claim Objections
Claims 14 and 15 are objected to because of the following informalities:
In relation to claim 14, the term "container" is used, which is likely a typographical error and should be "cartridge" to maintain consistency with the rest of the claims. The specification, paragraph [0187], and other claims consistently refer to a "cartridge" for holding the medication. Appropriate correction is required.
In relation to claim 15, The phrase "adhered the wearer's skin" contains a grammatical error and should be corrected to "adhered to the wearer's skin." Appropriate correction is required.
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 7, 14, 15, and 19 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.
Claim 7 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. The claim recites "the skin sensor," but there is no antecedent basis for this term in the claim or any preceding claim. Claim 1, from which claim 7 depends, introduces "a sensor," not "a skin sensor."
Claim 14 is rejected under 35 U.S.C. § 112(b) as being indefinite. The claim recites "medication is moved out of the container," but the term "container" lacks antecedent basis and is inconsistent with the term "cartridge" used throughout the claims and specification. This inconsistency renders the claim indefinite.
Claim 15 is rejected under 35 U.S.C. § 112(b) as being indefinite. The phrase "adhered the wearer's skin" is grammatically incorrect and fails to clearly define the relationship
between the patch pump and the wearer's skin, rendering the claim indefinite.
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 1, 2, 3, 5, 6, 7, 8, 10, 11, 13, 14, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (US 8,287,495B2; hereinafter “Tandem '495”) in view of Rytz et al. (US2020/0405952A1; hereinafter “Ypsomed”).
In relation to independent claim 1, Tandem '495 discloses a medication infusion device comprising:
A pump configured to deliver doses of medication from a cartridge through a
transcutaneous portion, the pump comprising a pump housing:
Tandem '495 teaches "portable infusion devices, systems, and methods of using the
same for dispensing materials" (Abstract) and a pump device including a housing configured to accept a disposable fluid cartridge (Col. 4, lines 63-67).
Tandem '495 further discloses "the infusion cartridge 16 may also include a delivery
mechanism 90 that functionally and operably interfaces with the drive mechanism 92 of
the pump devices" (Col. 23, lines 13-16).
A pump motor disposed within the pump housing and configured to pump the
medication in the cartridge towards the transcutaneous portion:
Tandem '495 explicitly discloses "a drive mechanism including a motor disposed in the housing and detachably coupled to a spool member of the delivery mechanism" (Col. 4, lines 44-46).
Tandem '495 further teaches "[t]he housing 124 may be configured to house a drive mechanism 150 including a motor 152 and gear box 154 disposed in the housing 124" (Col. 25, starting in line 65).
Tandem '495 also states "[t]he drive mechanism 150 includes a rack and pinion mechanism actuated by an electric motor 152 through a gear box 154" (Col. 35, lines 9-11).
A controller operatively coupled to the pump motor:
Tandem '495 discloses "a controller operatively coupled to the drive mechanism" (Claim 1) and "[t]he controller 168 may then transmit instructions to the motor 152 of the delivery mechanism 132" (Col. 32, lines 12-14).
Tandem '495 does not explicitly disclose:
A patch pump configured to be removably adhered to a wearer's skin with a sensor configured to detect the wearer's skin and to generate information on whether there is a detection of the wearer's skin; and
The controller configured to cause the patch pump to act based on the information on
whether there is the detection of the wearer's skin.
Ypsomed teaches:
A patch pump configured to be removably adhered to a wearer's skin:
Ypsomed discloses "a patch delivery device such as a patch pump or patch injector includes a bottom housing part or base plate, a delivery element or cannula for subcutaneous delivery of a liquid to a patient, an adhesive patch for attaching the bottom housing part to the skin of the patient" (paragraph [0012]).
A sensor configured to detect the wearer's skin and to generate information on
whether there is a detection of the wearer's skin:
Ypsomed teaches "a capacitive sensor with an electrode configuration including a
plurality of electrodes sensitive to skin contact as disjoint areas independently
connected or interfaced to a capacitance measuring unit of the device" (paragraph [0012]).
Ypsomed further discloses "enables the device to automatically detect removal of the
release liner" and "determining a degradation in the adhesion to the human skin" (paragraph
[0013]).
The controller configured to cause the patch pump to act based on the information on whether there is the detection of the wearer's skin:
Ypsomed teaches that the sensor information is used for "confirmation of complete
adherence and/or absence of partial detachment" (paragraph [0014]) and that the device can
"identify test or dummy skin contacts" to prevent "inadvertent triggering or other
handling errors" (paragraph [0013]).
Motivation to Combine: it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the motor-driven infusion pump of Tandem '495 to incorporate the patch pump configuration with capacitive skin sensor as taught by Ypsomed. One of ordinary skill would have been motivated to make this combination because Ypsomed teaches that the skin sensor "enables the device to automatically detect removal of the release liner" and allows "determining a degradation in the adhesion to the human skin" (paragraph [0013]), thereby improving patient safety by ensuring proper skin contact before and during drug delivery and preventing medication delivery errors when the device is not properly attached to the patient. Both references are
in the analogous art of portable drug delivery devices.
In relation to independent claim 20, Tandem '495 discloses a method of using a medication infusion device for delivering doses of medication from a cartridge through a transcutaneous portion, the method comprising:
Providing a pump configured to deliver the doses of medication from the cartridge
through the transcutaneous portion, the pump comprising a pump motor disposed
within a pump housing, the pump motor configured to pump the medication in the
cartridge towards the transcutaneous portion:
Tandem '495 teaches "portable infusion devices, systems, and methods of using the
same for dispensing materials" (Abstract) and a pump device including a housing configured to accept a disposable fluid cartridge (Col. 4, lines 63-67).
Tandem '495 further discloses "the infusion cartridge 16 may also include a delivery
mechanism 90 that functionally and operably interfaces with the drive mechanism 92 of
the pump devices" (Col. 23, lines 13-16).
Tandem '495 teaches "[t]he housing 124 may be configured to house a drive mechanism
150 including a motor 152" (Col. 25, lines 66-67).
Tandem '495 does not explicitly disclose:
Providing a patch pump configured to be removably adhered to a wearer's skin;
Sensing, using a sensor of the patch pump, whether the wearer's skin is detected;
Generating information based on whether there is detection of the wearer's skin; and
Causing the patch pump to act based on the information on whether there is the
detection of the wearer's skin.
Ypsomed teaches:
Providing a patch pump configured to be removably adhered to a wearer's skin:
Ypsomed discloses "a patch delivery device such as a patch pump... includes a bottom
housing part or base plate... an adhesive patch for attaching the bottom housing
part to the skin of the patient" (Para [0012]).
Sensing, using a sensor of the patch pump, whether the wearer's skin is detected:
Ypsomed teaches "a capacitive sensor with an electrode configuration including a
plurality of electrodes sensitive to skin contact" (paragraph [0012]).
Generating information based on whether there is detection of the wearer's skin:
Ypsomed discloses "gives rise to a discernible change in capacitive response of the
sensor electrodes" (paragraph [0013]).
Ypsomed teaches "time-resolved capacitance tracking" (paragraph [0014]).
Causing the patch pump to act based on the information on whether there is the
detection of the wearer's skin:
Ypsomed teaches that the sensor information is used for "confirmation of complete
adherence" (paragraph [0014]) and to prevent "inadvertent triggering or other handling
errors" (paragraph [0013]).
Motivation to Combine: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of using the motor-driven infusion pump of Tandem '495 to incorporate the patch pump configuration with capacitive skin sensing as taught by Ypsomed. One of ordinary skill would have been motivated to make this combination because Ypsomed teaches that skin sensing "enables the device to automatically detect removal of the release liner" and allows "determining a degradation in the adhesion to the human skin" (paragraph [0013]), thereby improving patient safety by ensuring proper skin contact before and during drug delivery.
In relation to claims 2 and 3, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Moreover, Tandem '495 teaches alert mechanisms:
Tandem '495 discloses "vibratory motor 175, speaker 178" (Col. 26, lines 19-22)
operatively coupled to the controller.
Tandem '495 teaches "[i]f such a clog is detected, an auditory, vibratory, or visual
signal may be generated to warn the patient" (Col. 43, lines 64-66).
As discussed above, Ypsomed teaches that the sensor information can be used to identify issues with skin adhesion (paragraph [0037]). Accordingly, it would have been obvious for a person of ordinary skill in the art to modify the apparatus of Tandem '495 to provide an alert(s) if there is a detection of the wearer’s skin. The combination would have enhanced patient safety.
In relation to claim 5, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed further teaches an adhesive pad configured to be adhered to the wearer's skin for removably adhering the patch pump to the wearer's skin:
Ypsomed discloses "an adhesive patch for attaching the bottom housing part to the
skin of the patient" (paragraph [0012]).
Ypsomed further teaches "a release liner covering and protecting a patient-side
adhesive layer of the adhesive patch prior to adhering to the skin of the patient" (Para
[0012]).
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 6, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 5. Ypsomed further teaches wherein the adhesive pad comprises a pad opening configured to allow direct sensing of the wearer's skin by the sensor:
Ypsomed discloses "the capacitive sensor includes a first aperture electrode and a
second aperture electrode arranged on opposite sides of an aperture of the adhesive
patch corresponding to a location of the delivery element" (paragraph [0015]).
Ypsomed further teaches "[t]he plurality of electrodes may be arranged laterally offset
from each other in an electrode layer parallel to a skin contact surface of the bottom
housing part" (paragraph [0013]).
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 7, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 6. Ypsomed further teaches wherein the skin sensor is disposed in the pump housing so as to be positioned at the pad opening when the patch pump is coupled to the adhesive pad:
Ypsomed discloses "the capacitive sensor includes an aperture electrode and an auxiliary electrode, the electrodes being arranged adjacent to, or facing, separate portions or halves or distinct portions or halves of a skin contact area of the bottom housing part" (paragraph [0014]).
Ypsomed teaches that the electrodes are integrated with the bottom housing part/base
plate of the patch pump (paragraph [0018]).
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 8, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed further teaches wherein the sensor comprises a capacitive circuit configured to continuously detect whether the patch pump is adhered to the wearer's skin:
Ypsomed discloses "a capacitive sensor with an electrode configuration including a
plurality of electrodes sensitive to skin contact" (Para [0012]).
Ypsomed teaches the sensor is used for "determining a degradation in the adhesion to
the human skin" (Para [0013]), indicating continuous monitoring capability.
Ypsomed further discloses "time-resolved capacitance tracking" (Para [0014]), indicating continuous detection.
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 10, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed further teaches wherein the sensor is located on a skin-facing side of the patch pump such that the sensor is configured to detect whether the skin-facing side of the patch pump is touching skin:
Ypsomed discloses "[t]he plurality of electrodes may be arranged laterally offset from each other in an electrode layer parallel to a skin contact surface of the bottom housing part" (paragraph [0013]).
Ypsomed teaches the electrodes are "sensitive to skin contact" (paragraph [0012]).
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 11, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed further teaches wherein the sensor is configured to measure capacitance:
Ypsomed explicitly discloses "a capacitive sensor with an electrode configuration"
(paragraph [0012]).
Ypsomed teaches "time-resolved capacitance tracking" (paragraph [0014]).
Motivation to Combine: The motivation to combine remains the same as stated for claim 1.
In relation to claim 13, as discussed above, the combination of Tandem and Ypsomed discloses a pumping system. The addition of a conventional second pumping system would have been considered a duplication of parts. In the case, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the case at hand, the addition of the second pump does not appear to produce an unexpected result, and therefore, has no patentable significance.
In relation to claim 14, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Tandem '495 further teaches a pusher configured to be coupled to a plunger of the cartridge, wherein the pump motor is coupled to the pusher and configured to move the pusher towards the plunger of the cartridge such that medication is moved out of the container:
Tandem '495 discloses "the pinion 192 can drive the rack or drive shaft 190 in an axial
direction until the ball feature 194 applies an axial force against the coupling element
196 and moves the spool 156 in a distal direction" (Col. 32, lines 4-8).
Tandem '495 teaches "the second seal 250 moves or translates axially in step with axial
translation of the spool 156 and drive shaft 190" (Col. 35, lines 11-13).
Tandem '495 further discloses "[t]he drive mechanism 150 includes a rack and pinion mechanism actuated by an electric motor 152 through a gear box 154. As such, the second seal 250 moves or translates axially in step with axial translation of the spool 156 and drive shaft 190” (Col. 35, 9-13).
Accordingly, since the enhancement was well-known in the art at the time of filing, its implementation
in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 16, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed further teaches a controller configured to act by causing the pump motor to activate to pump the medication in the cartridge towards the transcutaneous portion if the information indicates that the wearer's skin is detected:
Ypsomed discloses that the sensor information is used to prevent "inadvertent triggering or other handling errors" (paragraph [0013]), implying that the device only activates when proper skin contact is confirmed.
Ypsomed teaches "confirmation of complete adherence" (paragraph [0014]) as a prerequisite
for device operation.
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to configure the controller to only activate the pump motor when skin detection is confirmed, as taught by Ypsomed, to prevent medication delivery when the device is not properly attached to the patient, thereby improving patient safety.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (US 8,287,495B2; hereinafter “Tandem '495”) in view of Rytz et al. (US2020/0405952A1; hereinafter “Ypsomed”), as discussed above, and in further view of Pinsker (US 2013/0332196A1).
In relation to claim 4, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 2. Moreover, Tandem '495 teaches wireless communication:
Tandem '495 discloses "[t]he data may be transmitted wirelessly such as by a
transmitter/receiver" (Col. 24, lines 4-5).
Pinsker further teaches:
Pinsker discloses a diabetes monitoring system with a smartphone application that
communicates wirelessly with a drug delivery device [paragraph (0020)].
Pinsker teaches providing alerts and notifications through the mobile application (paragraphs [0026] and [0032]).
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to configure the controller (168) in Tandem '495 to provide alerts via a mobile application as taught by Pinsker. One of ordinary skill would have been motivated to make this combination because mobile applications provide a convenient and familiar interface for patients to receive alerts and monitor their medication delivery device, and smartphones are ubiquitous devices that patients typically carry with them.
Claims 9, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (US 8,287,495B2; hereinafter “Tandem '495”) in view of Rytz et al. (US2020/0405952A1; hereinafter “Ypsomed”), as discussed above, and in further view of Marlin et al. (US 2017/0281877A1; hereinafter “Marlin”).
In relation to claim 9, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed teaches detection of skin contact states:
Ypsomed discloses "enables the device to automatically detect removal of the release
liner" (paragraph [0013]).
Ypsomed teaches "determining a degradation in the adhesion to the human skin" (paragraph
[0013]).
Marlin further teaches wherein the controller is configured to detect whether the patch pump is secured to an adhesive pad, held by the wearer, and/or not touching skin based on the information from the sensor:
Marlin discloses a skin sensor system for a drug delivery device that can detect multiple states including whether the device is attached to skin, held by the user, or not in contact with skin (Abstract).
Marlin teaches using multiple electrodes to distinguish between different contact states (paragraph [0090]).
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to configure the controller to detect multiple functionalities as taught by Marlin. One of ordinary skill would have been motivated to make this combination because distinguishing between different contact functionalities (secured to adhesive pad, held by wearer, not touching skin) allows the device to respond appropriately to each situation, improving both safety and user experience.
In relation to claim 15, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Ypsomed teaches multiple electrodes:
Ypsomed discloses "the capacitive sensor includes an aperture electrode and an
auxiliary electrode" (Para [0014]).
Ypsomed teaches "the capacitive sensor includes a first aperture electrode and a
second aperture electrode arranged on opposite sides of an aperture" (Para [0015]).
Marlin further teaches:
Marlin discloses multiple skin sensors disposed at different locations on the drug delivery device (paragraphs [0062], [0063], [0089]).
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to include a second sensor on a different side of the pump housing as taught by Marlin. One of ordinary skill would have been motivated to make this combination because multiple sensors at different locations provide redundancy and more comprehensive detection of skin contact and device adhesion, improving reliability and patient safety.
In relation to claim 17, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Marlin further teaches a second sensor configured to detect information on whether the patch pump is adhered the wearer's skin, wherein the controller is configured to act by
causing the pump motor to activate to pump the medication in the cartridge towards the transcutaneous portion if the information from the sensor indicates that the wearer's skin is detected and the information from the second sensor indicates that the patch pump is adhered the wearer's skin:
Marlin discloses using multiple sensors to confirm skin contact before activating drug
Delivery (Abstract).
Marlin teaches that the controller requires confirmation from multiple sensors before
initiating delivery (Abstract, paragraphs [0052].
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to require confirmation from multiple sensors before activating the pump motor as taught by Marlin. One of ordinary skill would have been motivated to make this combination because requiring multiple sensor confirmations provides an additional safety check to ensure the device is properly attached before delivering medication, reducing the risk of medication delivery errors.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (US 8,287,495B2; hereinafter “Tandem '495”) in view of Rytz et al. (US2020/0405952A1; hereinafter “Ypsomed”), as discussed above, and in further view of Yap et al. (US 2016/0106910A1; hereinafter “Medtronic”).
In relation to claim 12, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Tandem '495 teaches circuit boards:
Tandem '495 discloses "[c]onnective circuitry may include conductive wiring such as copper wiring, fiber optic conduits, RF conduits and the like" (Col. 26, lines 22-24).
Medtronic further teaches wherein the sensor is electrically coupled to a circuit board disposed on a flexible substrate configured to bend and fold to fit within the pump housing:
Medtronic discloses an insulin pump with a flexible circuit board that can bend and fold to fit within the compact pump housing (paragraph [0045]).
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to use a flexible circuit board substrate as taught by Medtronic. One of ordinary skill would have been motivated to make this combination because flexible circuit boards allow for more compact device designs, which is desirable for wearable patch pumps that should be small and unobtrusive for patient comfort and convenience.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Michaud et al. (US 8,287,495B2; hereinafter “Tandem '495”) in view of Rytz et al. (US2020/0405952A1; hereinafter “Ypsomed”), as discussed above, and in further view of Newberry et al. (US 9,636,457; hereinafter “Sanmina”).
In relation to claim 18, the combination of Tandem '495 and Ypsomed discloses the medication infusion device of claim 1. Sanmina further teaches a photoplethysmography module incorporating the sensor:
Sanmina discloses a drug delivery patch with a PPG (photoplethysmography)
biosensor for monitoring patient physiological parameters (Col. 5, lines 3-19).
Sanmina teaches incorporating PPG sensors into wearable drug delivery devices for
patient monitoring.
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to incorporate a PPG module as taught by Sanmina. One of ordinary skill would have been motivated to make this combination because PPG sensors can provide additional physiological monitoring (such as heart rate and blood oxygen levels) that can be useful for diabetes management and overall patient health monitoring.
In relation to claim 19, the combination of Tandem '495, Ypsomed, and Sanmina discloses the medication infusion device of claim 18. Sanmina further teaches wherein the controller is configured to cause the pump motor to activate if both the sensor and the photoplethysmography module detect the
wearer's skin:
Sanmina discloses using PPG sensor data in conjunction with other sensors for device operation.
Sanmina’ PPG sensors are capable of detecting skin through the presence of a physiological signal.
Motivation to Combine: It would have been obvious to one of ordinary skill in the art to require both the capacitive sensor and the PPG module to detect skin before activating the pump motor. One of ordinary skill would have been motivated to make this combination because requiring confirmation from multiple different sensor types provides a more robust and reliable skin detection system, reducing the risk of false positives and improving patient safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783