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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
Response to Amendment
The amendment filed 03/06/2026 has been entered. Claims 1-10, 12-17, 20, 22-24 are pending in the application.
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 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.
Claims 1, 5-6, 8-10, 14-17, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and further in view of Mazal (US 4,350,477).
Regarding claim 1, Dhami discloses a microfluidic pump system (100, Fig 1) for administering a liquid medication from a liquid reservoir (12, Fig 13) to a subject (Para 0003), the microfluidic pump system comprising: a housing (11 and 31, Fig 1) configured to be worn by the subject (Para 0006); a pump tube (23, Fig 4B) comprising an inlet (See annotated Fig 4B), an outlet (See annotated Fig 4B), and a pump chamber (See annotated Fig 4B), the pump tube configured to receive the liquid medication from the liquid reservoir (Para 0055; Para 0101); and an actuation system comprising a camshaft (2, Fig 6) and actuators (34, Fig 6) (Para 0081)
Dhami is silent regarding a first cantilever arm, and a second cantilever arm, the first cantilever arm configured to allow, responsive to a first spring force provided by the first cantilever arm and responsive to rotation of the camshaft, the liquid medication to enter the pump chamber via the inlet such that the liquid medication causes the pump chamber to expand to an expanded state having a cross-sectional area Ap that is larger than a cross-sectional area Ai of the pump tube at the inlet and the outlet, and the second cantilever arm configured to cause, responsive to a second spring force provided by the second cantilever arm and responsive to rotation of the camshaft, the liquid medication to move in the pump chamber towards the outlet for subcutaneous administration to the subject.
Chenvainu teaches a microfluidic pump system (12, Fig 1) for administering a liquid medication from a liquid reservoir (60, Fig 4A) to a subject (Para 0005), the microfluidic pump system comprising: an actuation system (Para 0059) comprising a camshaft (48, Fig 4B), a first cantilever arm (56a, Fig 7A), and a second cantilever arm (56g, Fig 7A), the first cantilever arm configured to allow, responsive to a first spring force provided by the first cantilever arm and responsive to rotation of the camshaft, the liquid medication to enter the pump chamber via the inlet (Para 0068), and the second cantilever arm configured to cause, responsive to a second spring force provided by the second cantilever arm and responsive to rotation of the camshaft, the liquid medication to move in the pump chamber towards the outlet for administration to the subject (Para 0068), wherein the actuation system further comprises an inlet valve (compression element 57 for cantilever arm 56a, Fig 9) and an outlet valve (compression element 57 for cantilever arm 56g, Fig 9) in the form of pinch valves configured to bias against the pump tube to pinch the pump tube into a closed position on an inlet side and an outlet side of the pump chamber (Para 0069), respectively, the inlet pinch valve being operated by movement from the first cantilever arm and the outlet pinch valve being operated by movement from the second cantilever arm (Para 0062, 0069).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify actuators of the actuation system disclosed by Dhami to instead be cantilever arms with a common base and pinch valves as taught by Chenvainu in order to reduce the number of components that comprise the actuators to simplify manufacturing while still reducing rolling and sliding wear against the pump tube (Para 0061).
The modified invention of Dhami and Chenvainu discloses all of the elements of the invention as discussed above, however, is silent regarding the liquid medication to enters the pump chamber via the inlet such that the liquid medication causes the pump chamber to expand to an expanded state having a cross-sectional area Ap that is larger than a cross-sectional area Ai of the pump tube at the inlet and the outlet.
Mazal teaches a pump tube (5, Fig 4) comprising an inlet (portion of tube near inlet 59, Fig 4), an outlet (portion of tube near inlet 61, Fig 4), and a pump chamber (17, Fig 4); wherein the liquid medication enters the pump chamber via the inlet such that the liquid medication causes the pump chamber to expand to an expanded state (“relaxed position” of 17 depicted in dotted lines, Fig 4) having a cross-sectional area Ap that is larger than a cross-sectional area Ai of the pump tube at the inlet and the outlet (See Fig 4; Col 6, lines 33-39).
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 tube to have an enlarged pump chamber as taught by Mazal in order to determine or control the amount of fluid pumped through the tube (Col 6, lines 33-39).
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Regarding claim 5, the modified invention of Dhami, Chenvainu, and Mazal discloses the housing (11 and 31, Fig 1 -Dhami) is a micropump housing configured to house the pump tube (23, Fig 4B -Dhami) and the actuation system (Para 0067-0068 -Dhami).
Regarding claim 6, the modified invention of Dhami, Chenvainu, and Mazal discloses the microfluidic pump system comprises a reusable part (30, Fig 1 -Dhami) and a disposable part (10, Fig 1 -Dhami) (Para 0074 -Dhami).
Regarding claim 8, the modified invention of Dhami, Chenvainu, and Mazal discloses the reusable part (30, Fig 1 -Dhami) comprises a drive unit (3, FIG 6 -Dhami) and an electronic control system (See Fig 5B -Dhami) (Para 0069; Para 0081 -Dhami).
Regarding claim 9, the modified invention of Dhami, Chenvainu, and Mazal discloses the pump tube (23, Fig 13 -Dhami) comprises a monolithic blow-molded pump tube (Para 0097, lines 14-17; also see Fig 13 -Dhami).
Examiner notes the claimed phase “blow molded pump tube” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though is silent as to the process used to form the pump tube, it appears that Dhami’s product would be the same or similar as that claimed, especially since both applicant’s product and the prior art product is made to be part of a peristaltic pump system.
Regarding claim 10, the modified invention of Dhami, Chenvainu, and Mazal discloses the pump tube (23, Fig 13 -Dhami) comprises a continuous piece of tube made of a supple material (Para 0097, lines 14-17; also see Fig 13 -Dhami).
Regarding claim 14, the modified invention of Dhami, Chenvainu, and Mazal discloses the first cantilever arm (56a, Fig 7A -Chenvainu) and the second cantilever arm (56g, Fig 7A -Chenvainu) each comprises an elongated, flat portion (See Fig 5A -Chenvainu).
Regarding claim 15, the modified invention of Dhami, Chenvainu, and Mazal discloses the first cantilever arm (56a, Fig 7A -Chenvainu) and the second cantilever arm (56g, Fig 7A -Chenvainu) are configured to independently move, responsive to the first spring force provided by the first cantilever arm and the second spring force provided by the second cantilever arm, respectively, relative to the pump tube (Para 0068 -Chenvainu).
Regarding claim 16, the modified invention of Dhami, Chenvainu, and Mazal discloses the actuation system further comprises a third cantilever arm (56d, Fig 7A -Chenvainu) configured to move, responsive to a third spring force provided by the third cantilever arm, relative to the pump tube (Para 0068 -Chenvainu).
Regarding claim 17, the modified invention of Dhami, Chenvainu, and Mazal discloses the actuation system comprises one or more tube coupling interface elements (56e-f, Fig 7A – Chenvainu; the cantilever arms 56e-f interface with the pump tube and thus can be considered tube coupling interface elements).
Regarding Claim 22, the modified invention of Dhami, Chenvainu, and Mazal discloses the actuation system further comprises a pinch valve actuator (portion of screw 48 that interfaces with arm 56a -Chenvainu) configured to operate the inlet pinch valve responsive to movement of the first cantilever arm and a pinch valve actuator (portion of screw 48 that interfaces with arm 56g -Chenvainu) configured to operate the outlet pinch valve responsive to movement of the second cantilever arm (Para 0059 -Chenvainu).
Regarding Claim 23, the modified invention of Dhami, Chenvainu, and Mazal discloses the inlet pinch valve (compression element 57 for cantilever arm 56a, Fig 9 -Chenvainu) is located further from a free end of the first cantilever arm than the corresponding pinch valve actuator and the outlet pinch valve (compression element 57 for cantilever arm 56g, Fig 9 -Chenvainu) is located further from a free end of the second cantilever arm than the corresponding pinch valve (the lower face of the pinch valve 57 is located further from free end of the cantilever arm than the pinch valve actuator when in the actuated position and the enlarged region 50 is in contact with the free end as the lower face of the pinch valve 57 does not contact the free end (See Figs 8 and 9A -Chenvainu)).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and in further view of Hanson (US 8377002).
Regarding claim 2, the modified invention of Dhami, Chenvainu, and Mazal discloses all of the elements of the invention as discussed above, however, is silent regarding further comprising an adhesive surface configured to adhere to skin of the subject.
Hanson teaches a microfluidic pump system (10, Fig 2) comprising an adhesive surface (20, Fig 2) configured to adhere to skin of a patient (Col 12, lines 25-32), an outlet portion (56, Fig 2) coupled to a delivery tube (54, Fig 2) and needle (52, Fig 2) for subcutaneous administration of liquid to the patient having the micropump adhered thereto via the adhesive surface (Col 13, lines 39-46).
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 microfluidic pump system disclosed by Dhami and Chenvainu to include an adhesive surface on the base as taught by Hanson in order to have a device that can easily be attached to the user’s skin (Col 12, lines 25-40).
Regarding claim 3, the modified invention of Dhami, Chenvainu, and Mazal discloses the microfluidic pump system is a patch pump (See Fig 1 -Dhami), however, is silent regarding the liquid medication is insulin, the patch pump configured to administer the insulin to the subject.
Hanson teaches a microfluidic pump system (10, Fig 2) comprising a patch pump wherein the patch pump configured to administer the insulin to the subject (Col 10, lines 8-18).
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 liquid medication to be insulin as taught by Hanson in order to have a device that can treat diabetes (Col 10, lines 8-18).
Regarding claim 4, the modified invention of Dhami, Chenvainu, and Mazal discloses all of the elements of the invention as discussed above, however, is silent regarding a needle coupled to the outlet for subcutaneous administration of the liquid medication.
Hanson teaches a microfluidic pump system (10, Fig 2) comprising a needle (52, Fig 2) for subcutaneous administration of liquid to the patient having the micropump adhered thereto via the adhesive surface (Col 13, lines 39-46).
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 microfluidic pump system disclosed by Dhami and Chenvainu to include a needle coupled to the delivery tube as taught by Hanson in order to have a device that can provide medication into the body of the patient (Col 13, lines 39-46).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and further in view of Mazal (US 4,350,477) and in further view of Flaherty (US 2002/0040208).
Regarding claim 7, the modified invention of Dhami, Chenvainu, and Mazal discloses the disposable part comprises the housing (portion of the housing 11, Fig 1 -Dhami), the pump tube (23, Fig 4B -Dhami), however, is silent regarding the actuation system being part of the disposable part.
Flaherty teaches a microfluidic pump system comprising a disposable part (94, Fig 9) and a reusable part (93, Fig 9), wherein the disposable part comprises the housing (20D, Fig 9), pump tube (tube connecting reservoir 30 to the actuation system 48 and exit port assembly 70, Fig 9), and actuation system (48, Fig 9).
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 disposable part to include the actuation system as taught by Flaherty in order to have a device that is inexpensive and easy to manufacture as well as reducing cost of the device (Para 0013).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and further in view of Mazal (US 4,350,477) and in further view of Borsanyi ‘347 (US 4482347)
Regarding claim 12, the modified invention of Dhami, Chenvainu, and Mazal discloses a support structure (82, Fig 4A), however, is silent regarding the pump chamber is bonded to a wall of a support structure via welding, brazing, adhesive bonding, or cold or hot heading.
Borsanyi ‘347 teaches a peristaltic pump (device of Fig 11) including a support structure (151, Fig 11), a pump tube (112a, Fig 11), and an actuation system (28, Fig 11) comprising one or more pump chamber actuators (29, Fig 10) (Col 5, lines 13-37), the pump tube comprising a pump chamber portion (portion of tube 112a in opening 150, Fig 12), an inlet portion (portion of tube 112a directly coupled to sleeve 154), and an outlet portion (portion of tube 112a directly coupled to sleeve 155), the pump chamber bonded to the support structure via welding (Col 8, lines 18-33; the sleeves or joints that are coupled to the tube are bonded to the support structure via ultrasonic welding, therefore, the pump chamber is at least indirectly bonded to the support structure via welding).
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 joints 24 disclosed by Dhami to instead be joints that are ultrasonically welded to the support structure as taught by Borsanyi ‘347 in order to ensure a uniform stretching of the pump tube (Col 8, lines 18-20).
Regarding claim 13, the modified invention of Dhami, Chenvainu, Mazal, and Borsanyi ‘347 discloses the pump chamber is bonded to the wall of the support structure via ultrasonic welding, however, fail to teach laser welding.
Chenvainu teaches ultrasonic welding and laser welding are commonly known joining processes (Para 0090).
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 pump tube to be laser welded to the support structure as Chenvainu teaches that ultrasonic welding and laser welding could be used to achieve the same result (joining two components) and thus ultrasonic welding and laser welding were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and further in view of Mazal (US 4,350,477) and in further view of Raines (US 5252044).
Regarding claim 20, the modified invention of Dhami, Chenvainu, and Mazal discloses all of the elements of the invention as discussed above, however, is silent regarding a position sensor configured to determine a state of operation of the microfluidic pump.
Raines discloses an analogous pump (60, Fig 7) comprising position sensors (98, Fig 7) configured to determine a state of operation of the micropump (Col 4, lines 48-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify microfluidic pump system disclosed by Dhami and Chenvainu to include a position sensor as taught by Raines in order to have a system that can shut down in response to improper movement of the outlet valve to ensure safe functioning of the device (Col 5, lines 41-50).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Dhami (US 2015/0182689) in view of Chenvainu (US 2005/0272002) and further in view of Mazal (US 4,350,477) and in further view of Phelps (US 2,105,200).
Regarding Claim 24, the modified invention of Dhami, Chenvainu, and Mazal discloses the actuation system further comprises a spring (portion of finger 66 that biases the finger towards the screw 48 -Chenvainu) biasing each of the inlet pinch valve and the outlet pinch valve (Para 0059 -Chenvainu), however is silent regarding the spring biasing the pinch valves against the pump tube.
Phelps teaches a lever-based actuation system wherein a spring (65, Fig 3) biasing each of the inlet pinch valve (left most stop member 60, Fig 4) and the outlet pinch valve (right most stop member 51, Fig 4) against the pump tube (Col 3, lines 21-22).
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 cam and fingers disclosed by Chenvainu to have the springs portion of the fingers bias towards the pump tube and the cam open the pinch valves as taught by Phelps as it has been found to function better in this orientation (Col 3, lines 21-22).
Response to Arguments
Applicant's arguments filed 03/06/2026, on pages 6-10, regarding Chenvainu failing to teach a pinch valve have been fully considered but are moot in view of the current rejection that relies on a different embodiment of Chenvainu to teach the pinch valve. Specifically, Figs 9 and 9A show a compression element that is actuated by the cantilever arms to pinch the tubing as described in Para 0057.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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