DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/2025 has been entered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7, 9-10, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeRuntz et al. (US 20060206057 A1).
Regarding Claim 1, DeRuntz discloses a non-slip dose delivery mechanism (injector pen 20, Fig 1) comprising: a housing (protective housing 60, Fig 5); a non-rotating piston rod (axially advanceable drive member 62, Fig 6) having a threaded outer surface (helical threading 84, Fig 5) ([0044]: “Drive member 62 is in the form of a screw that is axially translatable and rotatably fixed during dosing and injecting”); a nut (Nut 64, Fig 6) comprising an inner surface (internal threading 100) in threaded engagement with the threaded outer surface (84) of the non-rotating piston rod (62) ([0046]: “The distal region of body 92 is formed with an internal threading 100 that threadedly engages in a friction locking fashion the drive screw threading 84”), the nut (64) configured to rotate and translate axially in a distal direction (opposite from the injection site; examiner notes that the distal and proximal ends of instant application and prior art are defined oppositely. Therefore, a proximal movement as shown by DerRuntz is equivalent to a movement in the distal direction in the instant application) relative to the non-rotating piston rod (62) during dose setting ([0059]); a piston rod guide (collar 78 and tabs 80, Fig 6) rotationally fixed relative to the housing (60) and configured to prevent rotation of the piston rod (62) ([0043]: “The shown anti-rotation element is provided in the form of a pair of diametrically opposed elements or tabs 80 having squared off inward ends that each slidably fit within longitudinal keyways 82 in drive member 62. (…) Tabs 80 prevent drive member 62 from rotating within housing 60 during pen use, but permit drive member 62 to be shifted longitudinally, such as in the distal direction toward the cartridge. Although tabs 80 and shoulder 77 are shown integrally formed and therefore rotatably fixed with housing 60, a shoulder with tabs may be separately formed and then assembled to the housing to be rotatably fixed relative thereto”); a driver (nut-engaging sleeve 110, Fig 5) that does not rotate during dose delivery ([0074]: Actuator 70 comprises 110 and button 126. During injection, the actuator is axially plunged without rotation by the user by the plunging of button 126); a ratchet (ring of bi-directional, longitudinal ribs 170, Fig 6) rotationally fixed to relative to the housing ([0056]: “Drive sleeve 66 is keyed to the pen housing 60 to be rotatably fixed and axially moveable relative thereto”; ratchet (170) is integral with drive sleeve 66, which is rotationally fix to housing 60. Therefore, ratchet (170) is rotationally fixed to housing 60); and a brake (Rib 172, Fig 6) positioned between the nut (64) and the driver (110) and being not integral with the nut (64) and the driver (110).
Regarding Claim 2, DeRuntz discloses the non-slip dose delivery mechanism of claim 1, wherein the piston rod (62) has a non-circular cross-section (cross-section is non-circular due to longitudinal keyways 82) that is held non-rotational relative to the housing (60) by the piston rod guide rotationally fixed relative to the housing ([0043]: “housing 60 is formed with an inner annular shoulder 77. A central opening of shoulder 77 is ringed by a proximally extending collar 78 that provides support for drive member 62. At least one drive member anti-rotation element extends radially inward from collar 78 into hollow 72 and projects distally of the collar 78. The shown anti-rotation element is provided in the form of a pair of diametrically opposed elements or tabs 80 having squared off inward ends that each slidably fit within longitudinal keyways 82 in drive member 62”).
Regarding Claim 3, DeRuntz discloses the non-slip dose delivery mechanism of claim 1, wherein rotation the nut (64) during dose setting is through a clutch (clutch connection by the intermeshing teeth 114 and 154, Fig 6; [0059]) operatively connected to a dose knob (button 126, Fig 5) configured to be rotated by a user of the dose setting mechanism ([0059]).
Regarding Claim 4, DeRuntz discloses the non-slip dose delivery mechanism of claim 3, wherein the nut (64) has one or more flexible arms (flexible convex webs 106, Fig 6; [0049]) that releasably engage the ratchet (170) during dose setting and dose cancellation ([0092]: “clicker function during dose setting in either dose increasing or dose decreasing directions”, dose cancellation occurs when the dose is decrease completely by rotation in the decrease direction of the knob (button 126))
Regarding Claim 5, DeRuntz discloses the non-slip dose delivery mechanism of claim 4, wherein relative movement and engagement of the one or more flexible arms (106) with the ratchet (170) is configured to generate a tactile or audible signal to a user of the non-slip dose delivery mechanism ([0049]).
Regarding Claim 7, DeRuntz discloses the non-slip dose delivery mechanism of claim 1, wherein axial movement of the driver (110) is configured to push the nut (64) axially in a proximal direction relative to the housing (60) ([0074]) during dose delivery ([0074]: Actuator 70 comprises 110 and button 126. During injection, the actuator is axially plunged without rotation by the user by the plunging of button 126, causing movement of the dial 68, driver 66 and nut 64 in the distal (proximal in terms of instant application) direaction)
Regarding Claim 9, DeRuntz discloses the non-slip dose delivery mechanism of claim 1, wherein the brake (172) is a ring (Fig 6; shows the brake (172) is a ring) having a through hole (center hole of brake (172) Fig 6) to accept a proximal end of the nut (Annotated Fig 1).
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Annotated Fig 1
Regarding Claim 10, DeRuntz the non-slip dose delivery mechanism of claim 1, wherein the ratchet (170) is fixed to the piston rod guide (78 and 80) ([0043]: “Although tabs 80 and shoulder 77 are shown integrally formed and therefore rotatably fixed with housing 60”; guide (78 and 80) is fix to the housing (60), ratchet (170) is rotationally fixed to the housing (60),[0056]; therefore ratchet (170) is rotationally fix to guide (78 and 80)) and is fixed to an inside surface of the housing ([0056]: “Drive sleeve 66 is keyed to the pen housing 60 to be rotatably fixed and axially moveable relative thereto”; ratchet (170) is fixed to driver (66), which is rotationally fix to an inside surface (holes 79) of housing 60. Therefore, ratchet (170) is rotationally fix to housing 60.).
Regarding Claim 16, DeRuntz discloses the non-slip dose delivery mechanism of claim 1. DeRuntz discloses the brake (172) is a ring or washer like structure (Fig 6; shows the brake (rib 172) is a ring or washer like structure) having a through hole (center hole of brake (rib 172), Fig 6) to accept a proximal end of the nut (64) (Annotated Fig 1).
Regarding Claim 18, DeRuntz discloses the non-slip dose delivery mechanism of claim 1, wherein during dose delivery, the nut (64) moves only axially with the piston rod ([0074]: “ The advancement of drive sleeve 66, due to the abutting or direct engagement of rib 172 with the nut rib face 95, advances nut 64 without rotation, which due to its threaded connection with the screw advances the screw axially without rotation, which screw advancement shifts cartridge piston 52 to expel medication from the cartridge reservoir.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over DeRuntz et al. (US 20060206057 A1) in view of Cronenberg et al. (US 20120283647 A1).
Regarding Claim 17, DeRuntz discloses the non-slip dose delivery mechanism of claim 16. DeRuntz is silent regarding wherein the brake is made of rubber.
Cronenberg teaches a non-slip dose delivery mechanism (injection pen, Fig 1; [0072]) comprising a brake (134, Fig 13) made of rubber (Fig 13; [0072]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the brake device of DeRuntz to be made of a rubber material as taught by Cronenberg to improve braking due to increase friction between the components in direct contact ([0072]).
Claim 19 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over DeRuntz et al. (US 20060206057 A1) in view of Kiilerich (US 20180064880 A1).
Regarding Claim 19, DeRuntz discloses the non-slip dose delivery mechanism of claim 1. DeRuntz is silent regarding wherein the ratchet is part of an inner surface of the housing.
Kiilerich discloses a dose delivery mechanism (embodiment of pen device 100, Fig 14) comprising: a housing (housing 401, Fig 14); a piston rod (piston rod 420, Fig 1) having a threaded outer surface (Fig 21); a ratchet (405, Fig 14) that is part of an inner surface of the housing (401) ([0074]: “Corresponding to each spline segment a circumferential ratchet segment 405 is formed on the inner surface of the housing wall distally of the ratchet segments. As will be described below the ratchet segments are arranged to engage the piston drive member”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of DeRuntz a similar ratchet as taught by Kiilerich to have audible or tactile feedback while the dose is being adjusted ([0074], [0077]).
Regarding claim 26, DeRuntz discloses a non-slip dose delivery mechanism (injector pen 20, Fig 1) comprising: a housing (protective housing 60, Fig 5); a non-rotating piston rod (axially advanceable drive member 62, Fig 6) having a threaded outer surface (helical threading 84, Fig 5) ([0044]); a nut (Nut 64, Fig 6) comprising an inner surface (internal threading 100) in threaded engagement with the threaded outer surface (84) of the non-rotating piston rod (62) ([0046], the nut (64) configured to rotate and translate axially in a distal direction relative to the non-rotating piston rod (62)during dose setting ([0059]), and the nut (64) having one or more flexible arms (clicker members 98, [0049], Fig 7) that releasably engage the ratchet (170, Fig 6) during dose setting and dose cancellation ([0049]; rotation in one direction to increase the dose and the opposite direction to cancel the dose); a piston rod guide (collar 78 and tabs 80, Fig 6) rotationally fixed relative to the housing (60) and configured to prevent rotation of the piston rod (62) ([0043]); a driver (nut-engaging sleeve 110, Fig 5) that does not rotate during dose delivery ([0074]: Actuator 70 comprises nut-engaging sleeve 110 and button 126. During injection, the actuator is axially plunged without rotation by the user by the plunging of button 126); a ratchet (ring of bi-directional, longitudinal ribs 170, Fig 6); a ratchet (ring of bi-directional, longitudinal ribs 170, Fig6) rotationally fixed to relative to the housing (([0056]); ratchet (170) is fixed to driver sleeve 66, which is rotationally fixed to housing 60. Therefore, ratchet (170) is rotationally fixed to housing 60); and a brake (Rib 172, Fig 6) positioned between the nut (64) and the driver (110), the brake (172) being not integral with the nut (64) and the driver (110).
However, DeRuntz is silent regarding wherein the ratchet is integral on an inner surface of the housing.
Kiilerich discloses a dose delivery mechanism (embodiment of pen device 100, Fig 14) comprising: a housing (housing 401, Fig 14); a piston rod (piston rod 420, Fig 1) having a threaded outer surface (Fig 21); an integral ratchet (circumferential ratchet segment 405, Fig 14) on an inner surface thereof (401) ([0074]: “Corresponding to each spline segment a circumferential ratchet segment 405 is formed on the inner surface of the housing wall distally of the ratchet segments. As will be described below the ratchet segments are arranged to engage the piston drive member”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of DeRuntz a similar ratchet as taught by Kiilerich to have audible or tactile feedback while the dose is being adjusted ([0074], [0077]).
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 7, 9-10, 16-19 and 26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New ground of rejection relies on an alternative interpretation of DeRuntz et al. (US 20060206057 A1) where the nut-engaging sleeve 110, Fig 5 of DeRuntz is considered the claimed driver element.
Conclusion
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