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
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, 6, 9, 10, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A).
Regarding claim 1, Yairi discloses a medicament delivery device (Fig 5A-5B) comprising: a delivery assembly ([0057]) comprising a plurality of microneedles (Claim 16) configured to transdermally deliver medicament (drugs or agents; abstract) to a patient, and a system (fluid detector 510; Fig 5A-5B) configured to provide information about a volume of the medicament (volume of fluid; [0058]) in the medicament delivery device (Fig 5A-5B), the system comprising: a sensing unit (fluid detector 510; Fig 5A-5B) configured to measure at least one physical parameter (resistivity; [0058]) dependent on the volume of the medicament in the medicament delivery device (presence of fluid or air within at least one of the microchannels 506; whether reservoir 501 is empty; and/or the resistivity between the electrodes, [0058]), wherein the sensing unit (510) comprises: a first electrode (1000, Annotated Fig 1); a second electrode (1001, Annotated Fig 1); and a current source connected to the first and second electrodes and configured to generate a voltage between the first and second electrodes ([0058]; a current source is needed for the device to function as intended), wherein the first electrode (1000) is arranged upstream of the second electrode (1001) (Annotated Fig 1).
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Yairi is silent regarding a fluid flowing between the first and second electrodes flows in a direction from the first electrode and towards the second electrode.
Cohen teaches a system (Fig 1) comprising a fluid (fluid 14, Fig 1) flowing between the first (plate 10, Fig 1) and second (plate 12, Fig 1) electrodes flows in a direction (2000, Annotated Fig 3) from the first electrode (10) and towards the second electrode (12).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the electrodes of device of Yairi with similar electrodes having sequence position and orientation along the fluid flow as taught by cohen for the purpose of determine the presence of fluid based on variations in capacitance (Col 5, lines 3-15)
Regarding claim 2, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi discloses wherein the first (1000, Annotated Fig 1) and second electrodes (1000, Annotated Fig 2) are arranged to form a capacitor (electrodes 1000 and 1001 can be configured to form a capacitor; [0058]).
Regarding claim 6, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi discloses wherein the first electrode (1000, Annotated Fig 1) is disposed upstream of the second electrode (1001, Annotated Fig 1).
Regarding claim 9, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi discloses wherein the first (1000, Annotated Fig 2) and second electrodes (1001) extend substantially perpendicular to a direction (1003, Annotated Fig 2) of a medicament flow between the first (1000, Annotated Fig 2) and second (1001, Annotated Fig 2) electrodes.
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Regarding claim 10, Yairi/Cohen discloses the medicament delivery device of claim 1. Yairi discloses further comprising a tube (microchannel 506, Fig 5A-B), a hose dispatcher, or a manifold, wherein the first and second electrodes are arranged downstream of the tube, the hose dispatcher, or the manifold (See Fig 5B; 510 is located downstream to the upper section of 506).
Regarding claim 15, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi discloses further comprising a medicament pump mechanism (pump 502, Fig 5A-B) configured to pump the medicament towards the delivery assembly ([0057]; claim 16).
Regarding claim 16, Yairi/Cohen discloses the medicament delivery device according to claim 15. Yairi discloses wherein the medicament pump mechanism (502) is configured to operate based on information about the volume of the medicament in the medicament delivery device provided by the system ([0058]).
Claims 3 are rejected under 35 U.S.C. 103 as being unpatentable over by Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A) in further view of Li (US 20130184675 A1).
Regarding claim 3, Yairi/Cohen discloses the medicament delivery device according to claim 2. Yairi is silent wherein the current source is a direct current source, wherein the sensing unit is configured to measure a capacitance of the capacitor formed by the first and second electrodes, wherein the system is configured to determine information about the volume of the medicament between the first and second electrodes based on the measured capacitance.
Li teaches a medicament delivery device (Infusion Monitoring Device; Fig 2-6) comprising a sensing unit (capacitance measurement unit 11, Fig 2-6) wherein a current source (power supply 40; [0035], Fig 2-3) is a direct current source ([0035]: “button batteries can be used as the power supply 40”), wherein the sensing unit (11) is configured to measure a capacitance of the capacitor (plates 10 forming the capacitor, Fig 6) formed by the first and second electrodes (plates 10, Fig 6), wherein the system (Fig 2-6) is configured to determine information about the volume of the medicament (medical solution 55, Fig 6) between the first and second electrodes (plates 10) based on the measured capacitance ([0040-0041]; [0013]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with a similar DC power Supply and similar configuration of the sensing unit as taught by Li for the purpose of providing power to the system and measure the rate and volume of the medicament being delivered based on capacitance values (abstract; [0035]; [0040-0041]).
Claims 7, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A) in further view of Coffee (US 6318640 B1).
Regarding claim 7, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi discloses that a fluid reservoir can be configured as an elongate microchannel ([0055]). Yairi is silent wherein the first electrode is permeable, the second electrode is permeable, or the first and second electrodes are permeable.
Coffee teaches medicament delivery device (pump; Fig 7) comprising a porous membrane (volume of powder silica 9 inside tube 7a, Fig 7); a first electrode (electrode 8a, Fig 7) and a second electrode (electrode 8b, Fig 7), wherein the first electrode (8a) is permeable, the second electrode (8b) is permeable, or the first and second electrodes are permeable (Col 8 lines 16-38).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with similar permeable electrodes as taught by Coffee for the purpose of adjust the passage of liquid at a desired flow rate (Col 6, lines 59-63)(Col 8 lines 16-38).
Regarding claim 12, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi is silent regarding further comprising a porous membrane configured to retain the medicament.
Coffee teaches medicament delivery device (pump; Fig 7) comprising a first electrode (8a) and a second electrode (8b); a porous membrane (volume of powder silica 9 inside tube 7a, Fig 7) configured to retain the medicament)(Col 8 lines 16-38; selection of mesh size of silica membrane will affect the flow rate and the amount of time that the is needed for a certain volume of liquid to pass through).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with similar permeable electrodes having a silica mesh membrane as taught by Coffee for the purpose of adjust the passage of liquid at a desired flow rate (Col 6, lines 59-63)(Col 8 lines 16-38).
Regarding claim 13, Yairi/Cohen/Coffee discloses the medicament delivery device according to claim 12. Yairi is silent wherein the porous membrane is disposed between the first electrode and second electrode.
Coffee teaches medicament delivery device (pump; Fig 7) comprising a first electrode (8a) and a second electrode (8b); a porous membrane (volume of powder silica 9 inside tube 7a) wherein the porous membrane is disposed between the first electrode (8a) and second electrode (8b).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with similar permeable electrodes having a silica mesh membrane as taught by Coffee for the purpose of adjust the passage of liquid at a desired flow rate (Col 6, lines 59-63)(Col 8 lines 16-38).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over by Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A) in further view of Thomas et al. (US 20140309577 A1).
Regarding claim 8, Yairi/Cohen discloses the medicament delivery device according to claim 1. Yairi is silent wherein the first electrode comprises a perforated plate or a hole mask, the second electrode comprises a perforated plate or a hole mask, or the first and second electrodes each comprise a perforated plate or a hole mask.
Thomas teaches a medicament delivery device (Fig 7b) comprising a first electrode (electrode 2, Fig 7b) and a second electrode (electrode 4, Fig 7b) wherein the first electrode (2) comprises a perforated plate (electrode 2 has perforation shown in Fig 7b that allows passage of fluid into the capacitor plates) or a hole mask, the second electrode comprises a perforated plate or a hole mask, or the first and second electrodes each comprise a perforated plate or a hole mask.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with similar electrode having a perforation and positioned along the fluid path as taught by Thomas for the purpose of detecting change in variation of the dielectric constants providing indication of the presence of a fluid in the plates and its composition (claim 13; [0080]).
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over by Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A) in further view of Gonzalez et al. (US 20120123387 A1).
Regarding claim 11, Yairi/Cohen discloses the medicament delivery device of claim 1. Yairi is silent regarding comprising a manifold comprising an inlet and a dispense outlet.
Gonzalez teaches a medicament delivery device (Fig 10) comprising a manifold (manifold carrier 162, Fig 12-13c)comprising an inlet (manifold inlet tube or cannula 165; [0073]) and a dispense outlet (fluid pathway 168 which connects to microneedle array; [0073] Fig 13b).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with a similar manifold as taught by Gonzalez for the purpose of having a fluid connection from the reservoir to the microneedles ([0073]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over by Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A) in further view of Coffee (US 6318640 B1) in further view of Demandolx et al. (EP 0065442 A1).
Regarding claim 14, Yairi/Cohen/Coffee discloses the medicament delivery device according to claim 12. Yairi/Cohen/Coffee are silent wherein the porous membrane defines a funnel-shaped passage.
Demandolx teaches a device (Abstract) comprising a porous membrane (membrane 6’ having pores 7’, Fig 1D) defines a funnel-shaped passage (Fig 1C-D; Page 2, paragraph 4:“ In FIG. 1C (…) the pores 7, 7 ', 7 "initially of cylindrical shape, take a conical shape narrowing towards the inside, which tends to hinder the passage of particles from the inside to the outside.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen/Coffee with of funnel shape pores as taught by Demandolx for the purpose of having a one-way flow of the medicament and hinder passage in the opposite direction (Page 2, paragraph 4; Fig 1C-1D).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over by Yairi (US 20090259176 A1) in view of Cohen et al. (US 5135485 A).
Regarding claim 17, Yairi/Cohen discloses the medicament delivery device according to claim 1. The embodiment of Fig 5A-B of Yairi is silent regarding further comprising a cartridge containing the medicament.
Yairi embodiment of Fig 10 teaches a medicament delivery device (Fig 10) further comprising a cartridge (removable package or cartridge 1006, Fig 10) containing the medicament ([0064]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi/Cohen with a removable cartridge as taught by embodiment of Fig 10 of Yairi for the purpose of having the reservoir completely removable from the pump ([0064]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Yairi (US 20090259176 A1) in view of Coffee (US 6318640 B1).
Regarding claim 28, Yairi discloses a medicament delivery device (Fig 5A-5B) comprising: a delivery assembly ([0057]) comprising a plurality of microneedles (Claim 16) configured to transdermally deliver medicament to a patient (drugs or agents; abstract), and a system (fluid detector 510; Fig 5A-5B) configured to provide information about a volume (volume of fluid; [0058]) of the medicament (drug delivery; [0008]) in the medicament delivery device (Fig 5A-5B), the system comprising: a sensing unit (fluid detector 510; Fig 5A-5B) configured to measure at least one physical parameter (resistivity; [0058]) dependent on the volume of the medicament in the medicament delivery device (presence of fluid or air within at least one of the microchannels 506; whether reservoir 501 is empty; and/or the resistivity between the electrodes, [0058]), wherein the sensing unit (510) comprises: a first electrode (1000, Annotated Fig 1), and a second electrode (1001, Annotated Fig 1).
Yairi is silent wherein at least one of the first and second electrodes is permeable to a medicament.
Coffee teaches medicament delivery device (pump; Fig 7) comprising a porous membrane (volume of powder silica 9 inside tube 7a, Fig 7); a first electrode (electrode 8a, Fig 7) and a second electrode (electrode 8b, Fig 7), wherein at least one of the first and second electrodes is permeable to a medicament (Col 8 lines 16-38).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Yairi with similar permeable electrodes in contact with the fluid as taught by Coffee for the purpose of adjust the passage of liquid at a desired flow rate (Col 6, lines 59-63)(Col 8 lines 16-38) .
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive.
Applicant submits:
A. Neither of Cohen nor Yairi, alone or in combination discloses a fluid flowing between the first and second electrodes flows in a direction from the first electrode and towards the second electrode.
B. The plates taught by Cohen function in a different way than the metallic surfaces of Yairi.
C. It is unclear whether the conductive plates of Cohen are physically suitable for use with the microchannel Yairi due to size.
Examiner respectfully disagrees.
A. Cohen discloses the fluid 14 flowing in the direction shown in Annotated Fig 3. The fluid is flowing between first plate 10 and second plate 12 as shown in Annotated Fig 3 below.
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Cohen teaches a system (Fig 1) comprising a fluid (fluid 14, Fig 1) flowing between the first (plate 10, Fig 1) and second (plate 12, Fig 1) electrodes flows in a direction (2000, Annotated Fig 3 above) from the first electrode (10) and towards the second electrode (12). As bag 13 empties, fluid 14 inside the bag 13 flows in the direction 2000, Annotated Fig 3.
B. Both the plates of Cohen (Col 5, lines 3-15) and Yairi are ([0059]: “to detect the presence of fluid or air within at least one of the microchannels 506”) are capable of detecting fluid. The plates of Cohen are not required to exhibit all the functions of the plates of Yairi such as detection of air. They are analogous art since they both address detecting the presence of fluid.
C. Applicant argues that the difference between the plates of Cohen and Yairi differ significantly in size. However the rejection relies in the position of the plates of Cohen to detect the presence of fluid 14, not for its specific dimensions. The implementation of the teaching is not limited by scale and its adaptation to the primary reference is within the ordinary skill in the art.
Regarding Claim 28, applicant submits that one of ordinary skill in the art would not have been motivated to modify the metallic surfaces so that they are permeable to medicament in view of the teachings of Coffee (or another reference). Examiner respectfully disagrees.
Yairi discloses all limitation of claim 28 except: “(…)wherein at least one of the first and second electrodes is permeable to a medicament.”. Teaching of Coffee would provide the benefit of adjusting the passage of liquid to a desired flow rate (Col 6, lines 59-63)(Col 8 lines 16-38). Yairi/Coffee as modified would exhibit the measuring function of Yairi and the incorporated teaching of Coffee.
Conclusion
THIS ACTION IS MADE FINAL. 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 GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783