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 .
Response to Amendment
The amendment filed 07/21/26 has been entered. Claims 14-19, 21-22, and 24 have been amended. Claims 20, 23, and 25-26 are in the original form. Claims 1-13 are cancelled. Thus, claims 14-26 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed, except for the 112b rejection related to claim 19 (see 112b rejections below).
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.
Claim 19 is 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 19 recites the limitation "actuation lever of the septum needle actuation mechanism" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets claim 19 lines 2-3 to read “actuation lever of the [[septum needle]] blocking organ actuation mechanism” because the blocking organ actuation mechanism is the structure reciting the actuation lever as recited again in claim 19 (see claim 14 “wherein the actuation mechanism of the blocking organ comprises an actuation disc and an actuation lever…”).
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.
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 14 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Moller (U.S. PGPUB No. 2019/0022305) in view of Scheurer et al. (U.S. PGPUB No. 2021/0138151), hereinafter Scheurer, and Marbet et al. (U.S. PGPUB No. 2016/0184512), hereinafter Marbet.
Regarding claim 14, Moller discloses a drug delivery device (1, see Fig. 2 and [0102-0103]) comprising a delivery unit including a drug container (13) in the form of a drug cartridge containing a liquid drug therein (see [0102]: 13 described as cartridge and contains a medical agent to be injected),
a liquid flow system (3),
a pumping system (2, see [0110-0112]: osmotic actuator drives drug delivery with a “push force”) and a casing (5, see FIG. 2 and [0102-0103]) within which the drug container (13), the pumping system (2) and at least a part of the liquid flow system (3) are mounted (see Fig. 2 with components mounted within cover 5 and [0102-0103]: casing 5 encloses and protects all internal components),
the drug container (13) comprising a septum (see [0108]: septum of the cartridge penetrated by second end 39 of needle 21) sealing an end (see ‘Modified FIG. 2’ below) of the drug container (13),
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the liquid flow system (3) comprising an injection delivery system (see [0104]: assembly 3 has needle 21 with two ends, 39/38, see FIG. 2) including an injection needle (second end 38 of needle 21, see [0102]: needle 21 inserted into skin to deliver drug, such as seen in Fig. 8) configured for injection of the drug in an actuated state of the drug delivery device (see actuated state in FIG. 8 and [0108]: second end 38 moved by trigger into position of FIG. 8 to deliver drug),
the liquid flow system (3) further comprising a container fluidic connection system (see FIG. 7&8) including a septum needle (39, numeral seen in FIG. 2) mounted on a movable septum needle support (12), the movable septum needle support (12) pressing the septum needle support towards (see [0108]: “the second end 39 (see FIG. 2) of the needle 21 will thereby be pushed to penetrate the septum of the cartridge 13”) the septum (septum as in [0108]) of the drug container (13), and a blocking organ (20) movable by an actuation mechanism (trigger 17 with protrusion 44, see [0108] and [0102]. Protrusion 44 best seen in FIG. 3 and is described in [0105] &[0107-0108]: protrusion 44 moves arm 24 which, as seen in FIG. 7and 8, moves blocking organ 20) from a locked position (see FIG. 7) in which the septum needle support (12) is held in a retracted position (see Fig. 7 and [0108]. See ‘Modified FIG. 7(left) and FIG. 8(right)’ below for immediate reference)
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where the septum needle is not in contact with the septum (see [0108]: second end 39 of needle does not penetrate cartridge until FIG. 8 after device is triggered to move horizontally movable part 12), to an unlocked position (see FIG. 8) in which the septum needle support (12) is released and allowed to travel towards (see arrow in ‘Modified FIG. 8’ above in direction towards drug container such as shown in FIG.2 relative to the liquid flow system 3 and [0108] describing release) the drug container septum (see [0108]: septum of cartridge 13) such that the septum needle (second end 39) pierces through the septum (see [0108]) under the force of the septum needle support (12), and
wherein the actuation mechanism (protrusion 44 initiates movement of 24 and 20, see FIG. 3 and [0105] & [0107-0108]) of the blocking organ (20) comprises an actuation disc (see ‘Modified FIG. 8i’ below, wheel/ cylindrical portion fixed on the axis of 12)
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and an actuation lever (see ‘Modified FIG. 8i’ above, arm portion of 24) coupled to (lower face of lever of 24 coupled to upper face of blocking organ 20) the blocking organ (20) to move the blocking organ (20) from the locked position (see FIG. 7) to the unlocked position (see Fig. 8 and [0108]).
Moller is silent to “a spring” pressing the septum needle support towards the septum of the drug container and the septum needle pierces through the septum under the force of the “spring”, “wherein the pumping system comprises a pump engine comprising a rotor”, and “the actuation disc being directly coupled or integrally formed with the rotor of the pump engine of the pumping system”.
However, Scheurer teaches a drug delivery device (see [0002]) comprising a septum needle support (80, see FIG. 9 and [0106]) holding a septum needle (70, see [0106]) and a septum (5, see Fig. 9 and [0106]: piercable wall of product container 4) of a drug container (4, full view of container 4 shown in FIG. 1). Scheurer further teaches a spring (90) pressing (see [0106-0107]: spring 90 moves support between positions in FIG. 9 and 11) the septum needle support (80) towards the septum (5) of the drug container (4) and the septum needle (70) pierces through (see FIG. 11 or ‘Modified FIG.11’ below for immediate reference) the septum under the force of the spring (90, see [0106-0107]).
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Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the horizontally movable septum needle support disclosed in Moller to be movable under a force of a spring as taught by Scheurer (such as by providing a protrusion of the septum needle support through the spring, see Scheurer in [0108]). A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a needle support moved by a horizontally applied force as in Moller) for another known element (a needle support moved by a horizontally applied spring force as in Scheurer) in the art to obtain the predictable result of actuating a needle support from a retracted position to an extended position under a horizontally applied force in order to penetrate a cartridge septum (see MPEP § 2143.I.B), thus achieving “a spring” pressing the septum needle support towards the septum of the drug container and the septum needle pierces through the septum under the force of the “spring”.
Moller in view of Scheurer remain silent to “wherein the pumping system comprises a pump engine comprising a rotor”, and “the actuation disc being directly coupled or integrally formed with the rotor of the pump engine of the pumping system”.
However, Marbet teaches a drug delivery device (1, see Figure 1 and [0051]) comprising a pumping system (7, see Figure 3 and [0083]), wherein the pumping system (7) comprises a pump engine (72, see [0082]: pump engine 72) comprising a rotor (102, see [0084]: 102 mounted onto pump engine 72). Marbet further teaches an actuation mechanism of a blocking organ (106) comprises an actuation disc (104, see ‘Modified Figure 8’ below and FIG. 3 and [0086-0087])
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and an actuation lever (22) coupled to (see [0091]) the blocking organ (106) to move (see [0091-0093]) the blocking organ (106) from a blocking position (see Figure 8a) to an actuated position (see Figure 8c), the actuation disc (104) being directly coupled (see Figure 8 and Figure 3: 102/104 same element/ integrally formed. See also [0086]) or integrally formed with the rotor (102) of the pump engine (72) of the pumping system (see FIG. 3).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the pumping system disclosed in Moller with a pumping system comprising a pumping engine and a rotor directly coupled to the rotary actuation wheel of the actuation mechanism of the blocking organ as taught by Marbet for the purpose of initiating fluid delivery and needle insertion/retraction by a single means of rotation/ actuation of the pump system (see [0083-0084], [0086], and [0096]) or to form the pumping system as a disposable unit (see [0044] and [0081]), thus achieving “wherein the pumping system comprises a pump engine comprising a rotor”, and “the rotary actuation wheel being directly coupled or integrally formed with the rotor of the pump engine of the pumping system”.
Regarding claim 18, the modified system of Moller teaches the drug delivery device according to claim 14, and Moller discloses further comprising an injection needle actuation mechanism (17 moves 15 which allows needle hub 23 within housing 18 to move from position in FIG. 7 to FIG. 8, see [0108]) configured to move the injection needle (second end 38 of needle 21) from a retracted position (see ‘Modified FIG. 7i (left) and FIG. 8i(right)’ below)
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within a housing (18) of the drug delivery device to an extended delivery position (see ‘Modified FIG. 7i (left) and FIG. 8i(right)’ above) where the injection needle (38) projects through a base wall (see ‘Modified FIG. 7i (left) and FIG. 8i(right)’ above) of the housing (18).
Regarding claim 19, the modified system of Moller teaches the drug delivery device according to claim 18, and Moller further discloses wherein the injection needle actuation mechanism (17 moves 15 which allows needle hub 23 of housing 18 to move from position in FIG. 7 to FIG. 8, see [0108]) includes the actuation disc (see ‘Modified FIG. 8ii’ below. rotary actuation wheel included in housing 18 with hub 23)
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and actuation lever (see ‘Modified FIG. 8ii’ above) of the [[septum needle]] blocking organ actuation mechanism (trigger 17 with protrusion 44, see [0108] and [0102]. Protrusion 44 best seen in FIG. 3 and is described in [0105] &[0107-0108]: protrusion 44 moves arm 24 which, as seen in FIG. 7and 8, moves blocking organ 20), the actuation lever (see ‘Modified FIG. 8ii’ above) coupled to a slidable injection needle support (23) on which the injection needle (38) is mounted (see FIGs. 2, 7, & 8).
Regarding claim 20, the modified system of Moller teaches the drug delivery device according to claim 14, but Moller is silent to “wherein the actuation lever comprises a rotatable support ring and a lever arm extending therefrom configured to engage an indent in the actuation disc upon initial actuation of the drug delivery device.”
However, Marbet teaches a drug delivery device (1, see Figure 1 and [0051]) comprising a pumping system (7, see Figure 3 and [0083]), wherein the pumping system (7) comprises a pump engine (72, see [0082]: pump engine 72) comprising a rotor (102, see [0084]: 102 mounted onto pump engine 72). Marbet further teaches an actuation mechanism of a blocking organ (106) comprises a rotary actuation wheel (104, see FIG. 8 and FIG. 3 and [0086-0087]) and an actuation lever (22), wherein the actuation lever (22) comprises a rotatable support ring (114, see ‘Modified FIG. 8’ above in the rejection of claim 14 for clarity) and a lever arm (lever arm extending to tip 22) extending therefrom configured to engage an indent (105a/b, see Figs. 8a-c and [0086]: tip 22 engages shoulders 105a/b) in the actuation disc (102) upon initial actuation of the drug delivery device (initial actuation seen in FIGs. 8a-c).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the pumping system disclosed in Moller with a pumping system comprising a pumping engine and a rotor directly coupled to the rotary actuation wheel and an actuation lever comprising a rotatable support ring and a lever arm as taught by Marbet for the purpose of initiating fluid delivery and needle insertion/retraction by a single means of rotation/ actuation of the pump system (see [0083-0084], [0086], and [0096]) or to form the pumping system as a disposable unit (see [0044] and [0081]), thus achieving “wherein the actuation lever comprises a rotatable support ring and a lever arm extending therefrom configured to engage an indent in the actuation disc upon initial actuation of the drug delivery device.”
Regarding claim 21, the modified system of Moller teaches the drug delivery device according to claim 20, but Moller is silent to “wherein the rotatable support ring is mounted around a shroud portion of the casing receiving the septum end of the drug container therein.”
However, Marbet teaches a drug delivery device (1, see Figure 1 and [0051]) comprising a pumping system (7, see Figure 3 and [0083]), wherein the pumping system (7) comprises a pump engine (72, see [0082]: pump engine 72) comprising a rotor (102, see [0084]: 102 mounted onto pump engine 72). Marbet further teaches an actuation mechanism of a blocking organ (106) comprises a rotary actuation wheel (104, see FIG. 8 and FIG. 3 and [0086-0087]) and an actuation lever (22), wherein the actuation lever (22) comprises a rotatable support ring (114, see ‘Modified FIG. 8’ above in the rejection of claim 14 for clarity), wherein the rotatable support ring (114) is mounted around a shroud portion (3, see Figure 11) of a casing (35, see FIGURE 2) receiving the septum end of the drug container therein (see [0082]: bore 36 of coupling system 3 receives cartridge and has needle 40 for fluid transfer from cartridge reservoir).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support ring taught by Moller in view of Marbet to be mounted on a shroud portion of the casing as taught by Marbet for the purpose of mounting the cartridge to the pumping system and blocking organ actuation system in a hermetically sealed manner (see [0082]), thus achieving “wherein the rotatable support ring is mounted around a shroud portion of the casing receiving the septum end of the drug container therein.”
Regarding claim 22, the modified system of Moller teaches the drug delivery device according to claim 20, but Moller is silent to “wherein the actuation lever comprises a lever arm extending from the rotatable support ring configured to engage an indent in the actuation disc upon initial actuation of the drug delivery device.”
However, Marbet teaches a drug delivery device (1, see Figure 1 and [0051]) comprising a pumping system (7, see Figure 3 and [0083]), wherein the pumping system (7) comprises a pump engine (72, see [0082]: pump engine 72) comprising a rotor (102, see [0084]: 102 mounted onto pump engine 72). Marbet further teaches an actuation mechanism of a blocking organ (106) comprises a rotary actuation wheel (104, see FIG. 8 and FIG. 3 and [0086-0087]) and an actuation lever (22), wherein the actuation lever (22) comprises a lever arm (lever arm extending to tip 22) extending from (see Figs. 8a-c) the rotatable support ring (114) configured to engage an indent (105a/b, see Figs. 8a-c and [0086]: tip 22 engages shoulders 105a/b) in the actuation disc (102) upon initial actuation of the drug delivery device (initial actuation seen in FIGs. 8a-c).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the pumping system disclosed in Moller with a pumping system comprising a pumping engine and a rotor directly coupled to the rotary actuation wheel and an actuation lever comprising a a lever arm extending from the rotatably support ring as taught by Marbet for the purpose of initiating fluid delivery and needle insertion/retraction by a single means of rotation/ actuation of the pump system (see [0083-0084], [0086], and [0096]) or to form the pumping system as a disposable unit (see [0044] and [0081]), thus achieving “wherein the actuation lever comprises a lever arm extending from the rotatable support ring configured to engage an indent in the actuation disc upon initial actuation of the drug delivery device.”
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Moller in view of Sheurer and Marbet as applied to claim 14 above, and further in view of Ryser et al. (U.S. PGPUB No. 2007/0071596, corresponding to WO2005039674 as cited in [0083] of Marbet), hereinafter Ryser.
Regarding claim 23, the modified system of Moller teaches the drug delivery device according to claim 14, but Moller is silent to “further including a drive unit comprising an electronic control system, a power source, and a pump drive, wherein the pump drive comprises a rotary electrical motor and a coupling interface coupled to an output shaft of the rotary electrical motor, the coupling interface coupling to a drive coupling interface of the pumping system of the delivery unit, the pump drive providing torque to a rotor of the pumping system.”
However, Marbet teaches a drug delivery device (1, see Figure 1 and [0051]) further including a drive unit (see [0083]: drive unit incorporated by reference as in WO2005039674) comprising a pump drive (see [0083]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the pumping system disclosed in Moller with a pumping system comprising a pumping engine and a drive unit comprising a pump drive as taught by Marbet for the purpose of initiating fluid delivery and needle insertion/retraction by a single means of rotation/ actuation of the pump system (see [0083-0084], [0086], and [0096]) or to form the pumping system as a disposable unit (see [0044] and [0081]), thus achieving further including a drive unit comprising… a pump drive”.
Modified Moller remain silent to the drive unit “comprising an electronic control system, a power source, and a pump drive, wherein the pump drive comprises a rotary electrical motor and a coupling interface coupled to an output shaft of the rotary electrical motor, the coupling interface coupling to a drive coupling interface of the pumping system of the delivery unit, the pump drive providing torque to a rotor of the pumping system”.
However, Ryser teaches a drug delivery device (see FIG. 1c and [0010]) further including a drive unit (see [0035-0040]) comprising an electronic control system (see [0035-0036]), a power source (see [0036]: chip and coil to generate electrical energy), and a pump drive (10), wherein the pump drive (10) comprises a rotary electrical motor (30 & 18, see [0040]: rotor 30, [0044]: rotor displaced by motor coils 18, and [0047]: rotor 30 rotates) and a coupling interface (28) coupled to (see Fig. 3c and [0042]: rotor 30 comprises extension 46 and see [0040]) an output shaft (46) of the rotary electrical motor (30), the coupling interface (28) coupling to a drive coupling interface (64, see [0048]) of a pumping system (2) of the delivery unit, the pump drive (10) providing torque (see [0044]) to a rotor (30) of the pumping system (2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drive unit of Modified Moller with the drive unit as taught by Ryser. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a drive unit as in Marbet) for another known element (a drive unit as in Ryser) in the art to obtain the predictable result of driving a pumping system of a delivery device (see MPEP § 2143.I.B), thus achieving the drive unit “comprising an electronic control system, a power source, and a pump drive, wherein the pump drive comprises a rotary electrical motor and a coupling interface coupled to an output shaft of the rotary electrical motor, the coupling interface coupling to a drive coupling interface of the pumping system of the delivery unit, the pump drive providing torque to a rotor of the pumping system”.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Moller in view of Sheurer and Marbet as applied to claim 14 above, and further in view of Kamen et al. (U.S. PGPUB No. 2013/0204188), hereinafter Kamen.
Regarding claim 24, the modified system of Moller teaches the drug delivery device according to claim 14, but Modified Moller is silent to “comprising an electronic control system and a plunger sensing system including an optical sensor comprising a transmitter and a receiver, the transmitter configured for transmitting an optical signal to a back end of the plunger and the receiver configured to receive the optical signal reflected off the plunger back end, the plunger sensing system connected to the electronic control system configured to measure a time of flight of the optical signal from the transmitter to the receiver and to determine therefrom a position of the plunger within a cylinder portion of the drug container.”
However, Kamen teaches a drug delivery device (see FIG. 8) comprising an electronic control system (16, see FIG. 2, [0092-0094]: FIG. 2 shows control system of Embodiments in figs. 3-10, and [0117]) and a plunger sensing system (115) including an optical sensor (116) comprising a transmitter and a receiver (see [0117]: 116 shines light and senses reflected light), the transmitter (116) configured for transmitting an optical signal to a back end (113, see [0117]: 116 shines light onto target 113 seen on backside of plunger 118 in FIG. 8) of the plunger (118) and the receiver (117) configured to receive the optical signal reflected off the plunger back end (113, see [0117]: 116 senses reflected light from target 113 seen on backside of plunger 118 in FIG. 8), the plunger sensing system (115) connected to the electronic control system (see [0117]: by way of processor 21, such as in [0113]: FIG. 7) configured to measure a time of flight of the optical signal from the transmitter to the receiver and to determine therefrom a position of the plunger (see [0117]: plunger sensing system uses time of flight to estimate position of plunger) within a cylinder portion (see [0058]: reservoir with cylindrical cross section) of the drug container (111, see [0115]: reservoir 111).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery device disclosed by Moller to include an electronic control system and a plunger sensing system including an optical sensor with a transmitter and receiver as taught by Kamen for the purpose of using light to estimate the position of the plunger in a modulated manner that can reduce power consumption (see [0117-0118]), thus achieving “comprising an electronic control system and a plunger sensing system including an optical sensor comprising a transmitter and a receiver, the transmitter configured for transmitting an optical signal to a back end of the plunger and the receiver configured to receive the optical signal reflected off the plunger back end, the plunger sensing system connected to the electronic control system configured to measure a time of flight of the optical signal from the transmitter to the receiver and to determine therefrom a position of the plunger within a cylinder portion of the drug container.”
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Moller in view of Sheurer and Marbet as applied to claim 14 above, and further in view of Moberg (U.S. PGPUB No. 2019/0328965), Lauchard et al. (U.S. PGPUB No. 2009/0216182), hereinafter Lauchard, and Li et al. (U.S. PGPUB No. 2014/0088555), hereinafter Li.
Regarding claim 25, the modified system of Moller teaches the drug delivery device according to claim 14, and Moller further discloses comprising a housing (4, see FIG. 2), but Modified Moller is silent to “a control unit mounted within the housing, the control unit comprising an on-body sensing system including an electrode connected to an electronic control system of the control unit for measuring a capacitance value configured to detect whether the drug delivery device is positioned against a patient's skin, a skin contact wall of the housing having an inner side facing an inside of the housing in which the delivery unit and control unit are mounted, and an outer mounting side facing the outside of the housing and intended to be placed against the skin of a patient, wherein the electrode comprises a layer of metal mounted directly against the inner side of the skin contact wall.”
However, Moberg teaches a drug delivery device (see [0036]) comprising a housing (52, see FIG. 2), a control unit (60) mounted within (see FIG. 2 and [0047]) the housing (52), the control unit (60) comprising an on-body sensing system (see [0049]) including an electrode (103, see [0039]) connected to an electronic control system (105, see [0049-0050]) of the control unit (60, see [0050-0052]) for measuring a capacitance value (see [0049-0052]: 105 detects electrical current travel/ when circuit is complete and thus can be “for” measuring a capacitance value via control unit) configured to detect whether the drug delivery device is positioned against a patient's skin (see [0049-0052]), a skin contact wall (70, see [0041]) of the housing (52) having an inner side (90) facing an inside (82) of the housing (52) in which a delivery unit (150 & 152) and control unit (60) are mounted (see FIG. 2: 150, 152, and 60 mounted inside of housing), and an outer mounting side (92, see [0041]) facing the outside of the housing (52) and intended to be placed against the skin of a patient (P, see FIG. 2 and [0042]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Modified Moller to include a control unit comprising an on-body sensing system including an electrode as taught by Moberg for the purpose of detecting that the device is properly positioned against a patient’s skin before deploying a needle of the device (see [0052-0053]), thus achieving “a control unit mounted within the housing, the control unit comprising an on-body sensing system including an electrode connected to an electronic control system of the control unit for measuring a capacitance value configured to detect whether the drug delivery device is positioned against a patient's skin, a skin contact wall of the housing having an inner side facing an inside of the housing in which the delivery unit and control unit are mounted, and an outer mounting side facing the outside of the housing and intended to be placed against the skin of a patient”.
Modified Moller in view of Moberg remains silent to “wherein the electrode comprises a layer of metal mounted directly against the inner side of the skin contact wall.”
However, Lauchard teaches a drug delivery device (see FIG.1 and [0014]) comprising a housing (1) having a skin contact wall (2) with an inner side (11, see FIG. 2 and [0016]) and an electrode (12/13) for measuring capacitance to detect skin contact (see [0017]) via a circuit (30), wherein the electrode (12/13) is mounted directly against (see [0016]) the inner side (11) of the skin contact wall (2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode taught by Modified Moller in view of Moberg to be mounted directly against the inner side of the skin contact wall as taught by Lauchard for the purpose of protecting the electrode within the device such that it does not inadvertently contact undesirably materials (see [0018]), thus achieving “wherein the electrode” is “mounted directly against the inner side of the skin contact wall.”
Modified Moller in view of Moberg and Lauchard remain silent to wherein the electrode “comprises a layer of metal”.
However, Li teaches a drug delivery device (see FIG.1A and [0002-0003]) with an electrode (116, see [0037]) provided on an inner surface (see FIG. 1A) of the housing (112, see [0032]), the electrode (116) comprises a layer of metal (see [0036]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode taught by Modified Moller in view of Moberg and Lauchard to include a metal layer as taught by Li for the purpose of providing the device with high electrode stability imperative for high flow rate applications (See [0036]), thus achieving the electrode “comprises a layer of metal”.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Moller in view of Sheurer and Marbet as applied to claim 14 above, and further in view of Anderson et al. (U.S. PGPUB No. 2014/0148784), hereinafter Anderson.
Regarding claim 26, the modified system of Moller teaches the drug delivery device according to claim 14, and Moller further discloses comprising a housing (4, see FIG. 2) within which the delivery unit (delivery unit comprises drug container 13) is assembled (see [0102-0103]), the housing (4) comprising a skin contact wall (see [0102]: outer side of base plate 4) for mounting against a patient's skin (see [0102]), the skin contact wall (outer side of base plate 4) comprising an adhesive layer (see [0102]: adhesive tape), but Moller is silent to the adhesive layer being “with a protective film.”
However, Anderson teaches a drug delivery device (100, see Figure 1A) comprising a housing (102) within which a delivery unit is assembled (see [0125-0126]), the housing (102) comprising a skin contact wall (see [0128]: a patient contact portion on bottom of housing) for mounting against a patient’s skin (see [0128-0129]), the skin contact wall (a patient contact portion on bottom of housing) comprising an adhesive layer (124) with a protective film (128, see [0129]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive layer of the skin contact wall disclosed in Moller to be covered by a protective film as taught by Anderson for the purpose of preserving the adhesive nature of the adhesive layer until the device is attached to the skin (see [0129]), thus achieving the adhesive layer being “with a protective film.”
Allowable Subject Matter
Claims 15-17 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 15, the prior art of record fails to teach “the blocking organ comprises a rotatable support ring and a blocking finger extending from the support ring and rotatable movable…” Further, it is unclear to the examiner how the blocking organ of the prior art of record, particularly Moller, could be modified to include “a rotatable support ring and a blocking finger extending from the support ring” without requiring extensive reengineering of Moller’s blocking organ.
Claims 16-17 depend from claim 15 and are subsequently indicated as having allowable subject matter.
Response to Arguments
Applicant's arguments filed 07/21/26 have been fully considered but they are not persuasive.
On pages 8-11, Applicant argues that Moller fails to disclose “a blocking organ movable by an actuation mechanism from a blocking locked position in which the septum needle support is held in a retracted position where the septum needle is not in contact with the septum, to an actuated unlocked position in which the septum needle support is released and allowed to travel towards the drug container septum such that the septum needle pierces through the septum”. The examiner is not persuaded by this argument because the argument does not align with the breadth of the claim language (see following paragraphs). Therefore, the examiner has maintained the 35 U.S.C. § 103 claim rejection of claim 14.
Applicant first argues that Moller fails to disclose the “blocking organ” structure. The examiner is not persuaded by this argument because the argument does not align with the breadth of the claim language. Claim 14 does not recite any particular structures of the blocking organ, only “a blocking organ”. Therefore, the examiner relies on the broadest reasonable interpretation of “blocking organ”. In this case, the broadest reasonable interpretation is derived from the definition of “organ”: a subordinate group or organization that performs specialized functions (see Merriam-Webster dictionary 3). Thus a “blocking organ” is a structure that performs the specialized function of “blocking”. Therefore, the examiner maintains that Moller’s structure 20 is reasonably a “blocking organ” because the structure blocks other structures from moving.
Next, Applicant asserts that Moller’s needle support does not “carry” the septum piercing needle during septum penetration. The examiner is not persuaded by this argument because the argument does not align with the breadth of the claim language. Claim 14 only recites that the septum needle is “held” in the retracted position and then “is released and allowed to travel towards the drug container septum”. The definition of “held” (past tense of hold) is to support in a particular position or keep from falling or moving (see merriam-webster definition 4b). Thus, the blocking organ 20 supports/holds the needle carrier of Moller until the trigger is pressed (see Moller paragraphs cited in the rejection above). There is no recitation that the blocking organ is required to be in contact/ “carry” the needle during septum penetration. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. the blocking organ must be in contact/carry the needle throughout the entirety of the septum penetration process and/or the blocking organ directly triggering the septum penetration event) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the examiner maintains that the blocking organ of Moller performs the function as claimed.
On pages 11-12, Applicant argues that Schuerer and Marbet teach separate “dedicated carrier and guiding mechanism”s for the needle. Applicant states that Moller has a double-ended needle actuation mechanism, Schuerer requires a spike along a longitudinal axis to carry the spring, and Marbet requires separate guiding structures for the septum and injection needles. Therefore, Applicant concludes that a person of ordinary skill in the art would “not have known where exactly a spring as disclosed in Scheurer would be positioned”. However, the examiner is not persuaded by this argument because “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." (see MPEP § 2145.III). The examiner also argues that “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…” (see MPEP § 2123.I) and the threshold for reasonable expectation of success is predictability (see MPEP § 2143.02: “the expectation of success need only be reasonable, not absolute” and “Obviousness does not require absolute predictability, but at least some degree of predictability is required. ”). Therefore, a person of ordinary skill in the art would have found reasonable suggestion from Schuerer that a spring can be used to apply a longitudinal/ horizontal force to carry a needle along the same longitudinal/horizontal direction. Moller already discloses a component applying a longitudinal/horizontal force on the needle to carry the needle longitudinally to pierce a septum. Therefore, a person of ordinary skill in the art would have a reasonable expectation of success from the teaching of Schuerer for substituting the horizontal force component of Moller with a horizontal force component of a spring as taught by Scheurer (see the modification of Moller in view of Scheurer in the rejection of claim 14 above). Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 14.
On pages 11-12, Applicant argues that neither Schuerer nor Marbet teach “a blocking organ…”. However, a blocking organ is already taught in Moller. Schuerer is only relied upon to teach the “a spring” pressing the septum needle support under a force of a “spring”. Marbet is only used to teach the pumping system with a pump engine/rotor with the actuation disc directly coupled/integrally formed with the rotor. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 14.
On page 12, Applicant argues that modifying Moller to include “an additional spring and a pump engine” as taught in Scheurer and Marbet would render Moller inoperable. However, the examiner is not persuaded by this argument because it is a mischaracterization of the rejection. The modification of Moller in view of Scheuer merely substitutes a needle support moved by a horizontally applied force disclosed in Moller for a needle support moved by a horizontally applied spring force as taught in Scheurer. Therefore, the argument that there is an “additional” spring is moot because the modification is a substitution of elements, not an incorporation of additional structural elements. Similarly, the modification of Moller in view of Marbet substitutes the pumping system disclosed in Moller for the pumping system taught in Marbet (both pumping mechanisms use a single trigger for device actuation). Therefore, the examiner is not persuaded that such asserted “additional” components would render the single triggering operation of Moller’s device inoperable. Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 14.
Lastly, on page 12, Applicant summarizes that due to the structural and functional differences between the references, there is no reasonable expectation of success for their combination. Again, the examiner argues that “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…” (see MPEP § 2123.I) and the threshold for reasonable expectation of success is predictability (see MPEP § 2143.02: “the expectation of success need only be reasonable, not absolute” and “Obviousness does not require absolute predictability, but at least some degree of predictability is required. ”). A person of ordinary skill in the art would have found reasonable suggestion from Schuerer that a spring can be used to apply a longitudinal/ horizontal force to carry a needle along the same longitudinal/horizontal direction. Moller already discloses a component applying a longitudinal/horizontal force on the needle to carry the needle longitudinally to pierce a septum. Therefore, a person of ordinary skill in the art would have a reasonable expectation of success from the teaching of Schuerer for substituting the horizontal force component of Moller with a horizontal force component of a spring as taught by Scheurer (see the modification of Moller in view of Scheurer in the rejection of claim 14 above). A person of ordinary skill in the art would have found reasonable suggestion from Marbet that the disclosed pumping system performs all the same critical functions as Moller’s pumping system (i.e.: fluid delivery and needle actuation). Therefore, a person of ordinary skill in the art would have a reasonable expectation of success for substituting the pumping system of Moller with the pumping system of Marbet while maintaining critical device functionality and operation (see the modification of Moller in view of Marbet in the rejection of claim 14 above). The modification merely results in the device utilizing a different kind of pumping system (the rotor/ pump engine system of Marbet) instead of the syringe-type pumping system of Moller. Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 claim rejection of claim 14.
No other arguments are presented. Therefore, the examiner has subsequently maintained all depending claim rejections.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
