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 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.
Claim(s) 21, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) in view of Dhami (US 2015/0184648 A1).
With regard to claim 21, Vazquez et al. teach a medication infusion device comprising: a patch pump configured to be removably adhered to a wearer's skin (Fig. 2 member 100, adhesive 114) for delivering doses of medication from a cartridge (Fig. 3 cartridge 116) through a transcutaneous portion (Fig. 3 160), the patch pump comprising a pump housing (Fig. 1 housing 106); a pump motor disposed within the pump housing (Fig. 9 member 138), the pump motor configured to pump the medication towards the transcutaneous portion ([0064]); a sensor configured to sense a parameter ([0056], [0065], [0079], [0082], [0097], [0100], Fig. 18 406 and 408); a vibration motor separate (Fig. 9 member 132 coupled via device structure/operation) from and coupled with the pump motor; and a controller operatively coupled to the sensor and the vibration motor, the controller configured to cause the vibration motor to vibrate to alert the wearer based at least in part on the parameter sensed by the sensor ([0066], [0085], [0087], [0135], Fig. 18 processor 420, couple to the sensors and vibration motor 410 which provides alerts which can be generated, for example, in a scenario when the cartridge sensor has not detected a cartridge); a circuit board including the controller and the motor driver thereon, the circuit board configured as a flexible substrate, wherein the circuit board has a plurality of sections having electrical components thereon, each of the plurality of sections connected by flexible electrical connections (see [0064], [0066], Figs. 8-10 flexible substrate 130. As combined the motor driver would also be included with the circuit board. As the entirety of the substrate is flexible the connections would necessarily be flexible, there is more than one component on such a substrate). Vazquez et al. teach the substrate to be flexible but do not explicitly show it bent or folded around the motors. However, Dhami teaches a circuit board which is flexible between sections so it may conform and fold to fit the enclosure of a pump and provide functionality proximate a point of use (Fig. 9, [0129], [0133]-[0136]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention that the substrate would in some way bend and fold around the motors in Vazquez et al. as Dhami teaches this is beneficial to conform to the pump enclosure and allow components to be proximate their point of use. Further as the substrate of Vazquez et al. is entirely flexible this necessarily allows the substrate to conform around components for space and allows flexion for electrical attachments.
With regard to claim 28, Vazquez et al. teach sensors may be used to detect occlusions based on a compared change in the rate ([0098]). As rejected above the circuit board is folded and the sensor would necessarily be adjacent the dosing pathway as no specific distance is recited. Such a sensor would necessarily be disposed on a section of the circuit board.
With regard to claim 30, Vazquez et al. teach a micro pump 136 for dosing fluid ([0136]) status sensors 408 monitor the delivery of the pump ([0082], [0097]). As rejected above the circuit board is folded and the sensor would necessarily be adjacent the microdosing system as no specific distance is recited. Such a sensor would necessarily be disposed on a section of the circuit board.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) and Dhami (US 2015/0184648 A1) as applied to claim 21 above, and further in view of Yavorsky et al. (US 2016/0369790 A1).
With regard to claim 29, Vazquez et al. teach providing a sensor to determine the fluid level based on the plunger or piston location ([099], [0100]) but does not disclose a pressure sensor. However, Yavorsky et al. teach a patch pump and determining if a reservoir is empty based on pressure to alert the user ([0234]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to measure pressure to provide an alert to the user in Vazquez et al. as Yavorsky et al. teach this is beneficial for determining if the cartridge is empty. As rejected above the circuit board is folded and the sensor would necessarily be adjacent the pushing mechanism as no specific distance is recited. Such a sensor would necessarily be disposed on a section of the circuit board.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) and Dhami (US 2015/0184648 A1) as applied to claim 21 above, and further in view of Newberry et al. (US 2017/0014572 A1).
With regard to claim 31, Vazquez et al. teach a device substantially as claimed. Vazquez et al. do not disclose a photoplethysmographic sensor. However, Newberry et al. teach a patch pump which includes a photoplethysmographic sensor to monitor a user heart rate and other physiologic parameters which are used to compare to threshold values to determine delivery and provide alerts (see at least [0035], [0076]-[0078], [0144]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to alert the user in Vazquez et al. when values detected by the photoplethysmographic sensor fall outside threshold values as in Newberry et al. as this would be beneficial for allowing the user to seek medical attention if necessary. As rejected above the circuit board is folded and the sensor would necessarily be placed proximate to its function, a photoplethysmographic sensor would need to face the skin to work. Such a sensor would necessarily be disposed on a section of the circuit board.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) and Dhami (US 2015/0184648 A1) as applied to claim 21 above, and further in view of Caspers (US 2017/0259015 A1).
With regard to claim 32, Vazquez et al. teach a device substantially as claimed. Vazquez et al. teach the device is adhered to the skin ([0049]) but do not disclose a skin detector. However, Caspers teaches using skin contact sensors to alert the user if the device becomes detached and stop injection to ensure safety (abstract). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a skin contact sensor in Vazquez et al. as Caspers teaches this is beneficial to enhance safety as it prevents delivery if the device is not attached. As rejected above the circuit board is folded and the sensor would necessarily be placed proximate to its function, a skin contact sensor would need to face the skin to work. Such a sensor would necessarily be disposed on a section of the circuit board.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) in view of Flaherty (US 2002/0072733 A1).
With regard to claim 22, Vazquez et al. teach a medication infusion device comprising: a patch pump configured to be removably adhered to a wearer's skin (Fig. 2 member 100, adhesive 114) for delivering doses of medication from a cartridge (Fig. 3 cartridge 116) through a transcutaneous portion (Fig. 3 160), the patch pump comprising a pump housing (Fig. 1 housing 106); a pump motor disposed within the pump housing (Fig. 9 member 138), the pump motor configured to pump the medication towards the transcutaneous portion ([0064]); a sensor configured to sense a parameter ([0056], [0065], [0079], [0082], [0097], [0100], Fig. 18 406 and 408); a vibration motor separate (Fig. 9 member 132 coupled via device structure/operation) from and coupled with the pump motor; and a controller operatively coupled to the sensor and the vibration motor, the controller configured to cause the vibration motor to vibrate to alert the wearer based at least in part on the parameter sensed by the sensor ([0066], [0085], [0087], [0135], Fig. 18 processor 420, couple to the sensors and vibration motor 410 which provides alerts which can be generated, for example, in a scenario when the cartridge sensor has not detected a cartridge). Vazquez et al. teach the housing is made of a plastic shell ([0064]) and protects the components from water ([0066]) but do not explicitly disclose a separate dry and wet zone. However, Flaherty teaches the electronics in an infusion pump to be encased in a housing within a pump housing which is beneficial for making the electronic modules waterproof, the electronics in the housing can be encapsulated by a potting material which would be plastic (Fig. 8 housing 301 encasing electronics 300 within pump housing 20, [0081]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to encase the electronics in a waterproof zone within the pump housing in Vazquez et al. as Flaherty teaches this is beneficial for providing the electronics in a waterproof compartment.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vazquez et al. (US 2015/0265768 A1) and Flaherty (US 2002/0072733 A1) as applied to claim 22 above, and further in view of Chiu et al. (US 2020/0384197 A1).
With regard to claims 23 and 24, Vazquez et al. as combined with Flaherty teach providing the electronics in a waterproofed area, further Flaherty teaches a gasket material may be used ([0081]) but do not specifically teach an o-ring seal. However, Chiu et al. teach using an o-ring between the fluid reservoir compartment and the pump compartment to prevent the ingress of fluid ([0212]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to additionally use a seal between the fluid and electronic pump components of Vazquez et al. as combined with Flaherty as Chiu et al. teach this is beneficial for preventing the ingress of fluid into where the pump is located. This would provide an additional safety measure to ensure the electronics stay dry.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive regarding claim 21. At the outset the Examiner would note the term “around” has various definitions including “in or near one’s present place or situation” (Merriam-Webster). At the very least the combination of references shows a flexible substrate that is bent and folded near the pump motor. However, considering a narrower interpretation of the term “around” such that the flexible substrate is configured to be folded about multiple sides of the pump motor, the Examiner maintains this is taught by Vazquez et al. and Dhami when viewing the references together as opposed to individually. Applicant argues the PCB of Dharmi which is folded to conform to fit an enclosure is not done so around a motor. However, given the placement of the circuit in Vazquez relative to the motor, the teaching of Vazquez et al. to a flexible substrate at the outset, in light of additional teachings regarding folding the substrate to better fit within a housing from Dhami the Examiner finds one of ordinary skill would arrive at the substrate configured as such which is bent to fit in the housing about the motor to conform to the housing/motor.
Applicant’s arguments with respect to claim(s) 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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