DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-7, 11-19, 21, 30 and 44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCullough et al. (hereinafter “McCullough”, US 2023/0138654).
Regarding claim 1, McCullough discloses an autoinjector (Fig. 1; 100, ¶[0031]) for injecting a formulation into a subject in need thereof, wherein the autoinjector comprises:
(a) a plunger rod (Fig. 1; 172 160) comprising a first surface of the plunger rod (Fig. 5B; where the rod 172 has an outer surface),
(b) an energy source mechanism comprising an energy source (Fig. 1; 180, ¶[00310]) and a trigger button (Fig. 1; 174, where portion 174 is displaced relative to 160 during actuation and align components, as well as allows dispensing, ¶[0046]-[0047]),
(c) a damping mechanism (Fig. 5B, damper mechanism comprising inner surface 102 and viscous fluid 190a, ¶[0031]) comprising a second surface (Fig. 5B; 102, inner surface, ¶[0053]) and a damping medium (Fig. 5B; 190a, ¶[0052]) that is located between the first surface and the second surface (190a is between 102 and rod 172, ¶[0053]), and
(d) a delivery section comprising a drug cartridge (Fig. 1; 112, ¶[0032]), wherein upon applying a force on the trigger button, the trigger button triggers a release of energy from the energy source to a plunger rod (174 aligns the moving components, ¶[0047]; 180 exerts a torque on rod 172 and causes the plunger assembly to advance, ¶[0063] which is configured to transmit more than about 10% of released energy to the drug cartridge and causes at least a portion of the formulation to be delivered from the drug cartridge to the subject.
Regarding claim 2, McCullough discloses the autoinjector of claim 1, wherein the first surface and the second surface are in contact with the damping medium (the viscous fluid 190a is disposed between the inner housing 102 and the rod portion 172 surfaces, ¶[0053]) and wherein after applying the force on the trigger button, a relative motion between the first surface and the second surface results in Couette flow that damps out force and pressure spikes during delivery of the formulation (the viscous fluid is disposed between the components which have relative motion during extrusion of the formulation, ¶[0053]; see how relative motion between 172 and 102 cylinders results in Couette flow of fluid 190a, Fig 5B; the damping mechanism reduces the force during delivery, ¶[0030]).
Regarding claim 3, McCullough discloses the autoinjector of claim 1, wherein the energy source comprises electrical energy, mechanical springs, or compressed gas (torque spring 180, ¶[0031]).
Regarding claim 4, McCullough discloses the autoinjector of claim 1, wherein the damping medium is a Newtonian or non-Newtonian fluid or material (the damping medium is Newtonian such that higher speeds create higher damping force, ¶[0052]).
Regarding claim 5, McCullough discloses the autoinjector of claim 4, wherein the damping medium has a viscosity of less than about 100,000,000 CP (suitable viscous fluids include Nyemed 7325 which has a viscosity less than 100,000,000 cP, ¶[0052]).
Regarding claim 6, McCullough discloses the autoinjector of claim 1, herein the delivery section further comprises a distal end of a plunger rod (see distal end of plunger rod 164, Fig 1), a stopper (stopper, ¶[0058]), a needle (see needle 118, Fig 1), an orifice (see orifice at bottom of housing 102, Fig 1), and a housing with a distal end (see outer surface of housing 102 with bottom distal end, Fig 1).
Regarding claim 7, McCullough discloses the autoinjector of claim 1, wherein the formulation is administered intravenously, subcutaneously, intramuscularly, or intradermally (the medicament m is delivered through the needle 118 to the user, ¶[0034]; injected into the user, ¶[0029]).
Regarding claim 11, McCullough discloses the autoinjector of claim 1, wherein the autoinjector is a single-dose disposable device, a multi-dose disposable device, or a multi-dose refillable device (the syringe barrel is a container that is filled for treatment so the device can be a multi -dose refillable device, ¶[0070]).
Regarding claim 12, McCullough discloses the autoinjector of claim 11, wherein the autoinjector is self-contained and portable (see how the autoinjector 100 is self-contained and portable, Fig 1).
Regarding claim 13, McCullough discloses the autoinjector of claim 12, wherein the autoinjector comprises a self-contained energy source (see box VIII) (the autoinjector comprises a self-contained self- energy source of the spring 180, ¶[0050]).
Regarding claim 14, McCullough discloses the autoinjector of claim 1, wherein the formulation is provided in liquid, liquid solution, liquid suspension, semi-solid, gel, hydrogel, solid, gas, vapor, or powder form (the pharmaceutical product is in liquid form, ¶[0073]).
Regarding claim 15, McCullough discloses the autoinjector of claim 14, wherein the formulation is a liquid formulation (the pharmaceutical product is in liquid form, ¶[0073]).
Regarding claim 16, McCullough discloses the autoinjector of claim 15, wherein the liquid formulation comprises a drug and a carrier and wherein the formulation has a viscosity of at least about 1 cP (the drug delivery device is used with various pharmaceutical products, ¶[0071]; high viscosity medicament so greater than about 1 cP, ¶[0039]).
Regarding claim 17, McCullough discloses the autoinjector of claim 1, wherein the first surface and the second surface are each comprised of a section of a cylinder (see how surfaces 172 and inner 102 are cylindrical, Fig 5B).
Regarding claim 18, McCullough discloses the autoinjector of claim 1, wherein the first surface and the second surface are each comprised of a section of a right circular cylinder (see how surfaces 172 and 102 are cylindrical, Fig 5B), and wherein the right circular cylinders have axes which are substantially collinear and overlap (see how the cylinders 172 and 102 have longitudinal axes which are collinear and overlap, Fig 5B).
Regarding claim 19, McCullough discloses an autoinjector for injecting a formulation into a subject in need thereof (autoinjector 100, ¶[0031]), wherein the autoinjector comprises:
(a) a plunger rod (see plunger rod including portion 172 and 160, Fig 1) comprising a first surface of the plunger rod (see outer surface of plunger rod 172, Fig 5B),
(b) an energy source mechanism comprising an energy source (see torque spring 180, Fig 1, ¶[0031]) and a trigger button (see portion 174, Fig 1; portion 174 is axially displaced relative to 160 during actuation to align components and allow the plunger to dispense medication from the syringe barrel, ¶[0046]-[0047]);
(c) a damping mechanism (see damper mechanism comprising inner surface 102 and viscous fluid 190a, Fig 5B, ¶[0031]) comprising a second surface (see inner housing surface 102, Fig 58, ¶[0053]) and a damping medium (see viscous fluid 190a, Fig 5B, ¶[00521) that is located between the first surface and the second surface (see how viscous fluid 190a is disposed between inner surface 102 and rod 172, Fig 5B, ¶[0053]); and
(d) a delivery section comprising a drug cartridge (see syringe barrel 112, Fig 1, syringe barrel 112 stores a drug to be injected, ¶[0032]); and
wherein the autoinjector comprises at least one of the following characteristics:
(x) the autoinjector is used as a multi-dose autoinjector and the autoinjector does not require that the damping medium be replaced or restored between doses (the damper mechanism damps out the force when the plunger contacts the drug cartridge during delivery, ¶[0030]; the device allows similar injection times and repeatability for different formulation viscosities, ¶[0049]; the damping mechanism only requires the damping medium, ¶[0052]).
Regarding claim 21, McCullough discloses the autoinjector of claim 19, wherein the damping medium has a viscosity greater than or between about 10,000 cP and about 500,000 cP (suitable viscous fluids include Nyemed 7325 which has a viscosity greater than 10,000 cP, ¶[0052]).
Regarding claim 30, McCullough discloses the autoinjector of claim 1, wherein the first surface and the second surface are in contact with the damping medium (the viscous fluid 190a is disposed between the inner surface 102 and the rod portion 172 surfaces, ¶[0053]) and wherein after applying the force on the trigger button, a relative motion between the first surface and the second surface results in Couette flow that damps out force and pressure spikes during delivery from the autoinjector (the viscous fluid is disposed between the components which have relative motion during extrusion of the formulation, ¶[0053]; see how relative motion between cylinders portions of 172 and 102 results in Couette flow of fluid 190a, Fig 5B; the damping mechanism reduces the force during delivery, ¶[0030]).
Regarding claim 44, McCullough discloses the autoinjector of claim 15, wherein the liquid formulation comprises a drug and a carrier and wherein the formulation has a viscosity of at least about 1 cP (the drug delivery device is used with various pharmaceutical products, ¶[0071]; high-viscosity medicament so at least 1 cP, ¶[0039]).
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(s) 8-10, 26, 36-38 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 2023/138654).
Regarding claim 8, McCullough teaches the autoinjector of claim 1, but does not explicitly teach wherein a force is exerted by the energy source in the range of about 10N to about 200N. McCullough teaches where the force from the energy source may be adjusted depending on the formulation of the drug (the energy the torque spring delivers and thus the force is adjusted as desired to deliver drugs of different viscosities, ¶[0050]).
There is no evidence of record that establishes that changing the force which is exerted would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of forces. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the force may be within the claimed range, and offering other acceptable ranges, as well as stating the force is “about” 10N to “about” 200N and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the force exerted by the spring to be 10-200 N in order to deliver a drug as desired as an obvious matter of design choice within the skill of the art.
Regarding claim 9, McCullough teaches the autoinjector of claim 1, but does not explicitly teach wherein more than about 20% of the released energy is absorbed by the damping medium.
McCullough teaches where the damping mechanism may be configured to provide a desired amount of dampening (varying viscosities for the damping medium may be provided to achieve a desired amount of dampening, ¶[0052]).
There is no evidence of record that establishes that changing the amount of energy absorbed by the dampening medium would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of energy absorption. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the absorption may be within the claimed range, and offering other acceptable ranges, as well as stating the absorption is “about” 20% of the released energy and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the viscosity of the damping medium such that more than 20% of the released energy is absorbed by the damping medium in order to provide a desired amount of damping as an obvious matter of design choice within the skill of the art.
Regarding claim 10, McCullough teaches the autoinjector of claim 1, but does not explicitly teach wherein between about 10% and about 90% of the released energy is absorbed by the damping medium.
McCullough teaches where the damping mechanism may be configured to provide a desired amount of dampening (varying viscosities for the damping medium may be provided to achieve a desired amount of dampening, ¶[0052]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the viscosity of the damping medium such that 10-90% of the released energy is absorbed by the damping medium in order to provide a desired amount of damping as an obvious matter of design choice within the skill of the art.
Regarding claim 26, McCullough teaches the autoinjector of claim 19, but does not explicitly teach wherein between about 20% and about 40% of the released energy is absorbed by the damping medium.
McCullough teaches where the damping mechanism may be configured to provide a desired amount of dampening (varying viscosities for the damping medium may be provided to achieve a desired amount of dampening, ¶[0052]).
There is no evidence of record that establishes that changing the amount of energy absorbed by the dampening medium would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of energy absorption. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the absorption may be within the claimed range, and offering other acceptable ranges, as well as stating the absorption is between “about” 20% and “about” 40% of the released energy and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the viscosity of the damping medium such more than 20% of the released energy is absorbed by the damping medium in order to provide a desired amount of damping as an obvious matter of design choice within the skill of the art.
Regarding claim 36, McCullough discloses the autoinjector of claim 19, but does not explicitly teach wherein a force is exerted by the energy source in the range of about 10N to about 200N.
McCullough teaches where the force from the energy source may be adjusted depending on the formulation of the drug (the energy the torque spring delivers and thus the force is adjusted as desired to deliver drugs of different viscosities, ¶[0050]).
There is no evidence of record that establishes that changing the force which is exerted would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of forces. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the force may be within the claimed range, and offering other acceptable ranges, as well as stating the force is “about” 10N to “about” 200N and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the force exerted by the spring to be 10-200 N in order to deliver a drug as desired as an obvious matter of design choice within the skill of the art.
Regarding claim 37, McCullough discloses the autoinjector of claim 19, but does not explicitly teach wherein more than about 20% of the released energy is absorbed by the damping medium.
McCullough teaches where the damping mechanism may be configured to provide a desired amount of dampening (varying viscosities for the damping medium may be provided to achieve a desired amount of dampening, ¶[0052]).
There is no evidence of record that establishes that changing the amount of energy absorbed by the dampening medium would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of energy absorption. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the absorption may be within the claimed range, and offering other acceptable ranges, as well as stating the absorption is “about” 20% of the released energy and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the viscosity of the damping medium such more than 20% of the released energy is absorbed by the damping medium in order to provide a desired amount of damping as an obvious matter of design choice within the skill of the art.
Regarding claim 38, McCullough discloses the autoinjector of claim 19, but does not explicitly teach wherein between about 10% and about 90% of the released energy is absorbed by the damping medium.
McCullough teaches where the damping mechanism may be configured to provide a desired amount of dampening (varying viscosities for the damping medium may be provided to achieve a desired amount of dampening, ¶[0052]).
There is no evidence of record that establishes that changing the amount of energy absorbed by the dampening medium would result in a difference in function of the McCullough device. Further, a person having ordinary skill in the art, being faced with modifying the device of McCullough, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the range of energy absorption. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the absorption may be within the claimed range, and offering other acceptable ranges, as well as stating the absorption is between “about” 10% and “about” 90% of the released energy and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the viscosity of the damping medium such 10-90% of the released energy is absorbed by the damping medium in order to provide a desired amount of damping as an obvious matter of design choice within the skill of the art.
Regarding claim 55, McCullough discloses a method for operating the autoinjector of claim 6 wherein the method comprises the following steps:
(a) a patient or a caregiver presses the distal end of the housing with the orifice against a target injection site (see how housing 102 has a bottom orifice aligned with needle 118, Fig 1; the syringe assembly comprises a medicament to be injected into a user so the bottom of the housing will be positioned at the desired injection site, ¶[0029]) [and presses the trigger button releasing a spring which drives the plunger rod forward].
(b) the plunger rod moves forward relative to the housing (the plunger assembly 160 advances within the housing towards the syringe barrel 112, ¶[0063]),
(c) Couette shear flow sets up in the damping medium (the viscous fluid is disposed between the components which have relative motion during extrusion of the formulation, ¶[0053]; the damper mechanism exerts a damping force, ¶[0063]; see how relative motion between cylinders 172 and 102 results in Couette flow of fluid 190a, Fig 5B),
(d) the plunger rod contacts the stopper and drives the stopper and the drug cartridge forward (the plunger distal portion 164 advances to contact stopper of the syringe barrel 112, ¶[0058]) urging the needle through the orifice and into the target injection site (see how advancing the syringe barrel bar 112 downward causes it to advance the coupled needle 118 down through the orifice in housing 102 and into the target site, Fig 1).
(e) the drug cartridge bottoms out against the housing and stops (see how the barrel 112 will bottom out against the housing and stop when the needle 118 has been inserted, Fig 1), and
(f) the plunger rod advances the stopper through the drug cartridge under continued urging of the spring (see how the plunger rod 164 advances into the barrel 112, Fig 1), delivering at least some of the formulation in the drug cartridge through the needle (the medicament is urged out of the barrel 112 and into the needle assembly to be delivered, ¶[0063], ¶[0034]).
However McCullough fails to teach where the patient or caregiver presses the trigger button to release a spring which drives the plunger rod forward. However, a trigger button coupled to a spring is a commonly known mechanism provided in autoinjectors.
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the trigger button of McCullough to be an external trigger button engaged by the user to release the spring in order to provide more control over when to actuate the autoinjector to deliver the medication top a target site.
Claim(s) 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 2023/0138654) in view of Melander et al. (hereinafter “Melander”, US 2020/0114082).
Regarding claim 52, McCullough discloses a method of optimizing the autoinjector of any of the preceding claims for use with a specific formulation (the damping mechanism used depends on the formulation within syringe barrel 112, ¶[0052]), the method comprises:
(a) supplying a [multiplicity of ]damping mechanism (see dampening mechanism comprising co inner surface 102 and damping fluid 190a, Fig 5B) [components each of which comprises a second surface, wherein each of the damping mechanism components can be installed in the autoinjector without making any other changes to the mechanical design of the autoinjector, and wherein the damping mechanism components in the multiplicity differ from each other in that when installed in the autoinjector they define a range of average first gaps between the first surface and the second surface ];
(b) selecting [one of the damping mechanisms (the damping fluid is chosen based on the desired amount of dampening, ¶[0052]);
(c) installing the damping mechanism selected in step (b) in the autoinjector (the damping viscous fluid 190a is installed in the location desired, ¶[0052]); and
(d) applying a force on the trigger button which triggers aa release of energy from the energy source to the plunger rod (180 exerts a force on rod and portion 174 and causes the plunger assembly to advance, ¶[0063]), wherein the plunger rod is configured to transmit between about 10% and about 90% of released energy to the drug cartridge (the damper mechanism exerts an opposing force while the plunger assembly advances towards the syringe barrel 112, ¶[0063]; as modified with the chosen damping fluid viscosity, about 10- 90% of the released energy is transmitted to the syringe barrel, ¶[0052]), and wherein the transmission causes at least a portion of the formulation to be delivered from the drug cartridge to the subject (the medicament is delivered from the syringe barrel 112 through a needle assembly 114 to the subject, ¶[0063).
McCullough teaches where the damping mechanism comprises a second surface (see inner surface 102 of the damping mechanism, Fig 5B), wherein the damping mechanism is installed without making any other changes to the mechanical design of the autoinjector (the viscous fluid 190a is the only component so the mechanical design doesn't change, ¶[0052]), and where the damping mechanism defines a gap between the first surface and the second surface (see mechanism with gap between first surface 172 and inner surface 102, Fig 5B).
However, McCullough does not explicitly teach supplying a multiplicity of damping mechanism components each comprising a second surface and which differ in a range of gaps between the first surface and the second surface.
Melander further teaches a damping mechanism for an autoinjector (Abstract) comprising a body which attaches to the plunger drive mechanism (see damper member 142 coupled to plunger guide rod 126, Fig 2, ¶[0057]) and a damping medium (see damper fluid 151, Fig 2, ¶[0059]) between a housing surface and a plunger rod (see fluid 151 in chamber 160 between frame member 150 and plunger guide rod 126, Fig 2, ¶[0059]) where the body component defines the gap of the chamber (see how the width of body 142 defines the width of chamber 160 between 126 and 150, Fig 2). Melander further teaches where the damper mechanism has a simple design with minimal parts to reduce assembly complexity (¶[0061]), where the mechanism may be assembled and tested prior to being used (¶[0061]), and where the size of the gap that defines the chamber impacts the shear rate of damping (¶[0062]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the damping mechanism of McCullough to further comprise a body attachable to the drive mechanism as taught by Melander in order to provide a second damping mechanism with a different gap for the fluid and to adjust the size of the gap that defines the chamber for the damping medium to provide an adjustable damping mechanism without making any other changes to the mechanical design.
Regarding claim 53, McCullough and Melander teach the method of claim 52, and McCullough teaches wherein the optimization is based on at least one component of the list comprising: formulation viscosity, formulation volume, needle gauge, needle length, and delivery time (the damping mechanism is chosen based on the medicament viscosity contained within syringe barrel 112, ¶[0052]).
Regarding claim 54, McCullough and Melander teach the method of claim 52, and McCullough teaches wherein the optimization further comprises changing one or more of the parameters chosen from a list comprising: energy contained in the energy source, the power provided by the energy source, the viscosity of the damping medium, a second gap between two components of the autoinjector, volume of the drug cartridge, needle gauge, and needle length (the spring energy is optimized based on the drug volume and viscosity, ¶[0049]-[0050]).
Conclusion
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/10/2026