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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 09/13/23, 07/19/24, 12/17/24, and 11/19/25 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rotary actuation wheel integral with the rotor as in at least claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. See claim objections below.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 14 and 22 are objected to because of the following informalities:
Claim 14 recites “a rotary actuation wheel” in line 15. “a rotary actuation wheel” in claim 14 and all subsequent recitations thereof should likely be “an/the actuation disc” 34 as shown in FIG. 4b, 5a and described in [0159] to best align the claim language with the language as set forth in the specification and to provide antecedent basis for “actuation disc” in the depending claims (see 112b rejections of actuation disc below).
Claim 22 reads “extending from the rotatably support ring” and should likely read “extending from the [[rotatably]] rotatable support ring” for grammatical reasons and to align with the language as originally set forth in claim 20 from which claim 22 depends
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 14-26 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 14 recites the limitation "it", “the locked position”, and “the unlocked position” in line 16. There is insufficient antecedent basis for these limitations in the claim. Therefore, the examiner interprets claim 14 lines 15-16 “an actuation lever coupled to the blocking organ to move it from the locked position to the unlocked position,” to read “an actuation lever coupled to the blocking organ to move [[it from the locked position to the unlocked position]] the blocking organ from the blocking position to the actuated position,” which aligns with Applicant disclosure in [0158-0160] and FIGs. 5a-e.
Due to claim dependency from claim 14, claims 15-26 are subsequently rejected under 112b.
Claim 16 recites the limitation "the blocking finger" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner will interpret that claim 16 reads “The drug delivery device according to claim [[14]] 15” because claim 15 first introduces the structure of a “blocking finger” to provide antecedent basis for the structure as recited in claim 16.
Regarding claim 18, lines 1-2 recite “comprising an injection delivery system including an injection needle”. However, it is unclear to the examiner if the “an injection delivery system” and the “an injection needle” recited in claim 18 are referring to the same structure as recited in claim 14 or if the “an injection delivery system” and the “an injection needle” refer to a secondary injection needle and delivery system. According to Applicant disclosure (see FIG. 4c and [0141] of the current Application), it appears there is only one injection delivery system (13) and one injection needle (15). Therefore, for purposes of examination that best align with Applicant disclosure, the examiner interprets claim 18 lines 1-2 to read “comprising [[an]] the injection delivery system including [[an]] the injection needle…”.
Claim 19 recites the limitation "the injection needle actuation mechanism" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets claim 19 lines 1-2 to read “the injection needle [[actuation mechanism]] delivery system” because the injection delivery system is recited in claim 18 to provide antecedent basis.
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.
Claim 20 recites the limitation "the actuation disc" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the actuation disc” to be “the [[actuation disc]] rotary actuation wheel” because it appears that “rotary actuation wheel” is used in claim 14 in place of an/the actuation disc 34 as shown in FIG. 4b, 5a and described in [0159] (see drawing and claim objections above).
Claim 22 recites the limitation "the actuation disc" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the actuation disc” to be “the [[actuation disc]] rotary actuation wheel” because it appears that “rotary actuation wheel” is used in claim 14 in place of an/the actuation disc 34 as shown in FIG. 4b, 5a and described in [0159] (see drawing and claim objections above).
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 blocking 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 actuated 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 a rotary actuation wheel (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 [[it from the locked position to the unlocked position]] the blocking organ (20) from the blocking position (see FIG. 7) to the actuated 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 rotary actuation wheel 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 rotary actuation wheel 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 a rotary actuation wheel (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 rotary actuation wheel (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 further discloses comprising [[an]] the injection delivery system (see [0104]: assembly 3 has needle 21 with two ends, 39/38, see FIG. 2) including [[an]] the injection needle (second end 38 of needle 21, see [0102]: needle 21 inserted into skin to deliver drug, such as seen in Fig. 8) and 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 14, 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 rotary actuation wheel (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]] rotary actuation wheel 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]] rotary actuation wheel (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]] rotary actuation wheel 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 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 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 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 rotatably support ring configured to engage an indent in the [[actuation disc]] rotary actuation wheel 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 rotatably 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]] rotary actuation wheel (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 rotatably support ring configured to engage an indent in the [[actuation disc]] rotary actuation wheel 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 the 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 the 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.
Claim 16 is interpreted under 112b as depending from claim 15 and is subsequently indicated as having allowable subject matter.
Claim 17 depends from claim 15 and is subsequently indicated as having allowable subject matter.
Conclusion
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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