Patent Application 18933888 - INJECTION SPRING FOR AGED PREFILLED SYRINGE AND - Rejection

Patent Application 18933888 - INJECTION SPRING FOR AGED PREFILLED SYRINGE AND

Title: INJECTION SPRING FOR AGED PREFILLED SYRINGE AND AUTO INJECTOR

Application Information

• Invention Title: INJECTION SPRING FOR AGED PREFILLED SYRINGE AND AUTO INJECTOR
• Application Number: 18933888
• Submission Date: 2025-05-16T00:00:00.000Z
• Effective Filing Date: 2024-10-31T00:00:00.000Z
• Filing Date: 2024-10-31T00:00:00.000Z
• Examiner Employee Number: 84168
• Art Unit: 3783
• Tech Center: 3700

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 9

Cited Patents

The following patents were cited in the rejection:

• US 0200442🔗
• US 0080157🔗
• US 0308386🔗
• US 0140781🔗
• US 0243508🔗
• US 0322142🔗
• US 0165129🔗
• US 0158455🔗
• US 0303985🔗
• US 0010969🔗
• US 0031748🔗

Office Action Text

    DETAILED ACTION
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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) 1-8, 16-18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455) in view of Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), and McPhee (US 5,599,315).
With regard to claims 1-4, 8, and 21, Oakley et al. teach an auto injector apparatus (Fig. 1, (200)) comprising: a prefilled syringe (Fig. 1, (14)) comprising: a barrel comprising a proximal end and a distal end and that extends along a longitudinal axis between the proximal end and the distal end (seen in Fig. 1, wherein syringe (14) has proximal and distal ends, and comprises a barrel containing therapeutic fluid/drug aged up to 24 months which includes any amount of time up to 24 months (31)); a needle disposed at the distal end of the barrel ([0044] wherein a needle or needle-assembly can be provided at the distal end, but is not explicitly indicated); a therapeutic fluid held within the barrel having a volume between about 1.51 mL and about 1.66 mL ([0039]); a stopper (Fig. 1, (19)) disposed within the barrel (14), the stopper (19) being configured to move axially within the barrel (14) along a path of travel between a first position and a second position to expel at least some of the volume of the therapeutic fluid (31) from the prefilled syringe ([0045] wherein the (stopper) piston (19) is moved distally (axially) inside the (syringe) cartridge (14) in order to dispense (therapeutic) drug (31) from the delivery device (auto injector)), the first position being an initial position of the stopper (19) before a delivery of the therapeutic fluid (31), and the second position being a final position of the stopper (19) at the end of the delivery of the therapeutic fluid (19); and an auto injector (200) that holds the prefilled syringe (14), the auto injector comprising: a piston rod (Fig. 1, (6, 17)) configured to abut the stopper (19); and an injection spring (Fig. 1, (13) adjacent to the stopper) configured to drive the piston rod (6, 17) into abutment with the stopper (19) to apply a dispensing force ([0045] wherein the stopper would obviously be driven by a dispensing force from the rod to dispense drug (31) from the device) to the stopper (19), wherein: the injection spring (13), upon an actuation of the auto injector (200), is configured to provide, via the piston rod (6, 17) a dispensing force to the stopper (19) to move the stopper from the first position to the second position ([0047] wherein the injection spring (13) provides a driving force to move the stopper from a first position to a second position). 
Oakley et al. do not explicitly teach wherein the barrel has an inner diameter of about 8.65 mm.  In related prior art, Berg teaches an injection device (Berg Fig. 1, (10)) including a syringe (Berg Fig. 1, (10)) having a needle (Berg Fig. 1, (30)) at the distal end of the barrel (Berg Fig. 1, (20)), and a stopper (Berg Fig. 1, (40)) within the barrel of the syringe. Berg teaches the syringe having a sealing surface with a diameter between about 5mm and about 14mm (Berg [0052]); thus, if Berg has a stopper with a diameter of about 8mm or about 9mm, the syringe barrel inner diameter would have to accordingly be about 8.65mm, to creating the sliding seal (sealing surface) of the stopper (Berg (40)). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel inner diameter of Oakley et al. to be about 8.65 mm, as taught by Berg, for the motivation of having an ideal compressibility ratio between the outer diameter of the stopper and the inner surface of the syringe barrel (Berg [0054]) when delivering therapeutic contained within the syringe barrel.
Oakley et al. do not explicitly teach the dimensions of the needle.  However, Row teaches the syringe (Row (104)) having a needle (Row Fig. 2A, (406)) on a distal end of the syringe barrel, further teaching the needle can be any of a range of gauges including 7 gauge through 33 gauge, having needle lengths of 3mm through 40mm or more (Row [0085]). As a 25-gauge needle is taught among the possible needles claimed by Row, and as it is well known in the art that a 25-gauge needle has an inner diameter that is about 0.26mm to 0.28mm, Row also teaches having a needle inner diameter of about 0.27mm. 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle inner diameter/length of Oakley et al. to have a needle inner diameter of about 0.25mm-.29mm as taught by Row, for the motivation of reducing/controlling the amount of user force required to deliver the injection to the patient (Row [0049]).
Oakley et al. do not disclose a viscosity as recited.  However, Cabiri et al. teach agents may have various viscosities, for example between 1-15cP and that viscosity may vary which can vary injection properties ([0192]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a viscosity as recited as Cabiri et al. disclose the viscosity may vary and is a factor which may be altered and adjust injection properties as such it is further obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
Oakley et al. do not disclose the specific substance recited.  However, Bigal and Strassman teaches a therapeutic for injection to adult patients, wherein the therapeutic being injected is fremanezumab (Bigal [0029] wherein anti-CGRP is an antagonist antibody, known as antibody G1 or also known as “fremanezumab” (Strassman, pg. 10588, [Col. 2, line 40], which further teaches that anti-CGRP antibody is known as “fremanezumab”)), Bigal teaching anti-CGRP/fremanezumab has a viscosity of 8.8cP among a range from 0.5cP to 15cP (Bigal [0155], where centipoise is equivalent to centistokes) wherein the viscosity measurements are done in a temperature range of 20-25°C (room temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic delivered by the modified device of Oakley, Berg and Row, to be fremanezumab an anti-CGRP with a viscosity as claimed, as taught by Bigal and Strassman, for the motivation of it being known and established in the prior art to deliver subcutaneous preventative treatments for common ailments such as migraines (Bigal [0033]).
Oakley et al. do not teach a spring configured to move the stopper within a period of 5 to 25 seconds, an initial force of between 20 N and 30 N, and a final dispensing force of between 12 N to about 20 N.
However, Cabiri et al. teach an auto injector apparatus (seen in Fig. 4A) comprising a stopper (Fig. 4A, (426)) and a spring ([0186] wherein the power supply (for delivering a single dose payload) can be mechanical means such as a spring). Cabiri et al. [0188] teaches a range of force may be applied to the stopper (plunger) during injection, anywhere between 5N - 60N, depending upon factors such as injection rate and/or the viscosity of the drug and/or the syringe geometry and/or the needle dimensions. Cabiri et al. teach the payload may be delivered over a time period of 20-120 seconds ([0186]) and that timing depends on fill volume and viscosity ([0192]).
Further, related prior art Kronestedt et al.  ([0004-0005]) teaches when a force is applied to a piston during medicament delivery by a pre-tensioned spring associated with the plunger rod, that force is obtained in accordance with Hooke's law. Hooke’s law states force exerted by a spring is a function of displacement of the spring from its original position, multiplied by the spring constant. Therefore, from Hooke’s law it follows that force acting on the piston will decline linearly as the piston moves forward during injection, due to a decompressing spring naturally having reduced dispensing force. Additionally, McPhee teaches that as a spring decompresses the force decreases by about 20% to the final dispensing position (Col. 3 line 21-26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have timing and force values as recited in Oakley et al. as Cabiri et al. teach the spring may be selected to deliver a force as desired based on variables including injection rate, viscosity, syringe geometry, and needle dimensions.  Further, delivery time would also be a result of factors tied to the spring selection including viscosity and fill volume.  As the initial force value would be selected as taught by Cabiri et al. it would follow that the final dispensing force would be between 12 N to 20 N as Kronestedt et al. teach from Hooke’s law it follows that the force decreases as the piston moves during injection and McPhee discloses that the force decreases by about 20%, thus it would be about 80% of the initial force.  
It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).  As Cabiri et al. teach that the spring may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach spring behavior as recited one of ordinary skill in the art would have had a reasonable expectation of success in modifying Oakley et al. to have the necessary spring characteristics to achieve the desired force and timing.  Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use such a range for timing and force as claimed in Oakley et al. as Cabiri et al. teach such to be result effective variables that may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach known spring behavior selecting the spring to have the timing and force fall within the claimed range would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
With regard to claim 5, wherein the combination teaches the injection spring (82) has a stored energy, before the auto injector is actuated, of between about 0.9 J and about 2 J (wherein if the initial position injection spring force is about 20 N, the about 0.9 J to about 2 J of stored energy would also exist within the injection spring).
With regard to claims 6 and 7, Oakley et al. teach a device substantially as claimed and the injection spring would necessarily have a stored spring constant. The combination doesn’t explicitly teach before the auto injector is actuated, the stored spring constant between about 0.28 N/mm and about 0.32 N/mm and has a compressed length of between about 75 mm and about 95 mm. 
However, the provided disclosure sets forth that the spring constant and compress length are result effective variables, wherein the provided disclosure merely describes the range of spring constants and compressed lengths are a preferable range and are variable depending on varying embodiments. 
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the spring constant and spring compressed length of the spring of Oakley et al. for the purpose of providing a desired force as Kronestedt et al. ([0004-0005]) teach that according to Hooke’s Law, the spring constant and spring compression length are factors effecting the force provided by any spring; and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(11)(A), In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
With regard to claim 16, Oakley et al. teach the modified auto injector apparatus of claim 1. 
The combination doesn’t explicitly teach wherein a distance between the first position and the second position is between about 25.7 mm and about 30 mm.
However, applicant’s provided disclosure [0058] sets forth that “a distance between the first position and the second position is between about 25.7 mm and about 30 mm” is a result effective variable that is optimized through routine experimentation, wherein “the path of travel P can be in the range from about 25.7 mm to about 28.2 mm, from about 25 mm to about 29 mm, or from about 25 mm to about 40 mm. In some embodiments, the path of travel, P, can be 29.6 mm. In other embodiments, the length of the path of travel, P, can be a distance outside these ranges”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper length of Oakley et al. to have a distance between the first position and the second position is between about 25.7 mm and about 30 mm, as Cabiri [0188] teaches a range of force may be applied to the stopper (plunger) during injection, depending upon factors such as injection rate and/or the viscosity of the drug and/or the syringe geometry and/or the needle dimensions. Thus, syringe geometry, (which determines a distance between the first position of the stopper and the second position of the stopper when, for example, defining a dose size), is a result effective variable which can be determined though routine experimentation; since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
With regard to claim 17, Oakley et al. teach the modified auto injector apparatus of claim 1, wherein Oakley teaches: the auto injector (200) further comprises a housing (Fig. 1, (24)), and the auto injector (200) holds the prefilled syringe (14) stationary with respect to the housing (seen in Fig. 1, where (200) holds (14) fixed to (stationary in) the housing at a distal end of (14)).
With regard to claim 18, Oakley et al. teach the modified auto injector apparatus of claim 17, wherein Oakley teaches the auto injector (200) is configured to hold the prefilled syringe (14) stationary (seen in Fig. 1 wherein (14) is fixed within the housing (24) at a distal end) with respect to the housing (24) from the actuation of the auto injector (200) through the delivery of the therapeutic fluid (31).

Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), and McPhee (US 5,599,315) as applied to claim 1 above, and further in view of Wotton et al. (US 2013/0303985) and Bicker et al. (US 2014/0010969).
With regard to claims 9 and 11, Oakley et al. teach the modified auto injector apparatus of claim 1.  Oakley et al. do not explicitly teach the barrel comprises an inner surface comprising glass, and the syringe comprises an oil on the inner surface.  In related prior art, Wotton [0057] teaches a prefilled syringe of an injector apparatus comprised of glass defining a barrel and inner surface.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel of Oakley et al. to be glass, as taught by Wotton, as glass syringes are known in the art and have been used historically to contain preservative-free medicament such as steroid hormones or other androgens (Wotton [0002] and [0006]) without reacting.  In related prefilled syringe prior art, Bicker teaches silicone-based oil lubricating layers for syringe barrel interiors is well known in various industry prior arts (Bicker [0003]).  Bicker teach that the lubricant has a viscosity in the range of 1cSt to 10,000cSt, therefore including a viscosity of about 1000cSt at the standard ASTMD index temperature (which is between 20-25°C) (Bicker [0107]).  It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel of Oakley et al. to include silicone-based oil lubricating layers on the syringe barrel interior with a viscosity as recited, as taught by Bicker, for the motivation of having beneficial breakaway (break-loose) force or static friction reduction (Bicker [0007]).
With regard to claims 10 and 12, while Bicker doesn’t provide an exact amount of silicone oil to be used, the provided disclosure sets forth that the thickness and amount of silicone oil is a result effective variable, wherein no reasoning is provided for the intended amount, but rather, a general range is claimed ([0061]-[0063]).  It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of silicone oil applied to lubricate the interior of the syringe barrel, of Oakley et al. for the purpose of reducing breakaway force or static friction within the syringe barrel (Bicker [0007]), to reduce the amount of static friction or breakaway force between the inner surface of the syringe barrel and the stopper; since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. 

Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), and McPhee (US 5,599,315) as applied to claim 1 above, and further in view of Sudo et al. (US 5,009,646). 
With regard to claim 13, Oakley et al. teach a device substantially as claimed.  Oakley et al. do not disclose the stopper length.
In related prior art, Sudo teaches an injector (Fig. 3, (8)) having a stopper (Fig. 3, (1)), and further Sudo [Col. 2, lines 47-60] teaches that the sealability or tightness of the sliding stopper to resist variation of the inner diameter or shape of the barrel, and to resist incorrect operation of the syringe, can be made sufficient (tailored to a preferable range of values) by providing a specific relationship between the length (Y) of the contact surface between an inner wall of the syringe barrel and the outer circumferential part of the stopper, and, a specific relationship between the length (L) of the sliding part of the stopper (stopper length) and the outer diameter (D) of the stopper. That is, the specific relationship of the ratio Y/L should be in a preferred range 0.80-1.00, and another specific relationship of the ratio L/D should be in a preferred range of 0.25-1.00. Therefore, Sudo teaches a known relationship between stopper length (L), stopper outer diameter (D), and the contact surface area (Y) over which the stopper contacts the inner wall of the syringe barrel, for determining how well a sliding stopper can sealingly engage with said inner wall. 
The claimed limitation sets forth that “the stopper having a length in the range from about 7.3 mm to about 8.1 mm”. Regarding the provided specification, (SPEC [0052]) sets forth “the stopper 157 may have a length in the range from about 7.3 mm to about 8.1 mm, or from about 7 mm to about 9 mm. Alternative embodiments of the stopper 157 can have a length that is longer or shorter than these ranges” as originally filed. Therefore, there is a lack of criticality in the dimensions set forth by the claim. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper length of Oakley et al. to be ‘about 7.3 mm to about 8.1 mm’; since Sudo [Col. 2, lines 47- 60] teaches there is a known relationship between the contact surface length of a stopper with an inner wall of a syringe barrel (Y), and the stopper length (L), as well as a known relationship between the stopper length (L) and the stopper outer diameter (D), such that based on these predetermined values, ideal ratios between Y/L and L/D can be calculated to create preferable sliding sealability or tightness of the stopper against the inner surface of the syringe barrel; and, as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A). 

Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), and Sudo et al. (US 5,009,646) as applied to claim 13 above, and further in view of Wotton et al. (US 2013/0303985).
With regard to claim 14, Oakley et al. teach the modified auto injector apparatus of claim 1. Oakley et al. teach a stopper having a main body that is substantially cylindrical (seen in Fig. 1, wherein (19) is substantially cylindrical). 
The combination doesn’t explicitly teach wherein: the stopper is configured to compress to a compressed state and relax to an uncompressed state, and the stopper comprises: a main body that has a diameter in the uncompressed state of between about 8.85 mm and about 9.05 mm; and an annular rib extending radially from the main body, the annular rib having an outer diameter in the uncompressed state of between about 9.25 mm and about 9.45 mm. 
In related prior art, Wotton teaches an auto injector (Fig. 2) having a syringe (Fig. 2, (18) including (20)) and a stopper (Fig. 2, (28)) wherein the stopper has a compressed state (seen in Fig. 6D, wherein the stopper is compressed at the end of delivery by the (ram) piston rod (60)) and an uncompressed state (seen in Fig. 6A, wherein the stopper is uncompressed in the pre - delivery state), and the stopper comprises: a main body (Fig. 6A, (28)), the main body being substantially cylindrical (seen in Fig. 2 and Fig. 6A, wherein the stopper (28) has a substantially cylindrical body). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Oakley et al. to have a compressed and uncompressed state, as taught by Wotton, since it is well known in the art that stoppers are often made of flexible material.
The combination doesn’t teach the stopper comprises: a diameter in the uncompressed state of between about 8.85 mm and about 9.05 mm; and an annular rib extending radially from the main body, the annular rib having an outer diameter in the uncompressed state of between about 9.25 mm and about 9.45 mm. 
In related prior art, Row teaches an auto injector (Fig. 1, (100)) having a stopper (Fig. 2E, (410)) wherein the stopper has at least one annular rib (Row Fig. 2E, wherein the stopper main boy is (410)), the annular rib extending radially from the main body (Row Fig. 2E, annular ribbing is show extending radially from the main body of stopper (410)). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Oakley et al. to have an annular rib extending radially from the main body, as taught by Row, for the motivation of creating an effective seal with the inner surface of the syringe body reservoir to limit the contents of the syringe cavity from flowing or otherwise moving proximally (Row [0077]). 
While Oakley et al. do not explicitly teach the stopper having a diameter in the uncompressed state in the range from about 8.85 mm to about 9.05 mm; the annular rib having an outer diameter in the uncompressed state in the range from about 9.25 mm to about 9.45 mm, the provided disclosure sets forth that “a stopper uncompressed diameter in the range from about 8.85 mm to about 9.05 mm” and “a stopper annular rib outer diameter in the range from about 9.25 mm to about 9.45 mm” area result effective variable, wherein the provided disclosure merely describes the range of stopper diameters which may be any value within the provided ranges. 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper and annular rib outer diameters in uncompressed states, of Oakley et al. for the purpose of providing greater or lesser force to therapeutics contained within the prefilled syringes depending upon their viscosities, which decreases overall injection time to increase patient compliance, and thus, the patient will experience less pain (Wotton [0078]); also since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), and Sudo et al. (US 5,009,646) as applied to claim 13 above, and further in view of Bicker et al. (US 2014/0010969) and Atterbury et al. (US 2018/0200442). 
With regard to claim 15, Oakley et al. teach a device substantially as claimed.  The combination is silent to wherein the stopper is coated with a first coating comprising ethylene tetrafluoroethylene, and a second coating comprising silicone, and the first coating coats a first portion of the stopper and the second coating coats a second portion of the stopper that is different from the first portion of the stopper. 
In related prior art, Atterbury teaches an auto injector apparatus (Figs 1 and 5) with a stopper (Fig. 5, (72)) and spring (Fig. 1, (22)) wherein a first portion of the stopper is coated with silicone ([0067] wherein portions of the injector are lubricated with a lubricant, such as silicone oil, between surfaces that slide over each other during operation. Hence the stopper).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Oakley et al. have a coating of silicone on at least a first portion, as taught by Atterbury, for the motivation of lubricant such as silicone oil allowing surfaces to slide over each other during operation (Atterbury [0067]), hence allowing easier movement of the stopper. 
The combination still doesn’t explicitly teach another second portion of the stopper is coated in ethylene tetrafluoroethylene. 
In related prefilled syringe prior art, Bicker teaches silicone-based oil lubricating layers for syringe barrel interiors is well known in various industry prior arts (Bicker [0003]), and teaches coating a stopper with ethylene tetrafluoroethylene (Bicker [0071] wherein silicone - free ethylene combinations are also used as lubricant). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stopper of Oakley et al., such that the lubricants on other (second) portions of stoppers could be ethylene tetrafluoroethylene, as taught by Bicker, for the motivation of reducing the amount of static friction or breakaway force between the inner surface of the syringe barrel and the stopper (Bicker [0007]).

Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), and McPhee (US 5,599,315) as applied to claim 1 above, and further in view of Wotton et al. (US 2013/0303985).
With regard to claim 19, Oakley et al. teach the auto injector (200) further comprises a housing (24) and a cover sleeve ([0045] wherein the drug delivery device may comprise a cap (not explicitly indicated) to cover the distal end). 
However, the combination doesn’t explicitly teach the cover sleeve is configured, when the auto injector is situated in a ready-to-use state and pressed onto a puncture site by pressure applied onto the housing, to be displaced in a proximal, axial direction into the housing to release the needle, which is stationary relative to the housing, to pierce the puncture site.
In related prior art, Wotton teaches an autoinjector ([0063] and Figs 6A-6D, (12)) having a syringe ([0057] and Figs 6A-6D, (18)) and a housing ([0057] and Figs 6A-6D, (14)) and a cover sleeve ([0063] and Figs 6A-6D, (66)), wherein when the auto injector (12) is situated in a ready-to-use state and pressed onto a puncture site by pressure applied onto the housing ([0068] wherein the injector is pressed against the patient’s skin to push the needle into the skin at an insertion location and trigger injection of medicament), to be displaced in a proximal, axial direction into the housing ([0070] wherein in such embodiments, the needle guard retracts from the protecting position (exemplified in Fig. 6A) to an injecting position (seen in Figs 6B-6C) to release/expose the needle (24)) to release the needle ([0068] and Fig. 2, having a needle (24)), which is stationary relative to the housing (seen in Figs 6A-6D and in [0070] wherein needle-assisted injection maintains a needle stationary relative to the housing), to pierce the puncture site ([0068] and [0070], wherein the needle penetrates the puncture site at a predetermined penetration depth in the skin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the autoinjector of Oakley et al. have a cover sleeve to be displaced in a proximal, axial direction into the housing when the autoinjector is ready-to-use and pressed onto a puncture site; all as taught by Wotton, for the motivation of preventing accidental needle exposure (Wotton [0084]), such as after injection.

Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oakley et al. (US 2016/0158455), Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), and McPhee (US 5,599,315) as applied to claim 1 above, and further in view of Kemp et al. (US 2018/0140781).
With regard to claim 22, Oakley et al. teach the modified auto injector apparatus of claim 1. 
The combination doesn’t explicitly teach wherein: the auto injector further comprises a cover sleeve spring, and the injection spring is concentrically disposed within the cover sleeve spring. 
In related prior art, Kemp teaches an autoinjector (Figs 2A-2B, (1)) having a syringe (Fig. 2A, (3) and [0067-0068] wherein the syringe is prefilled with medicament (M)) and a housing (Fig. 2A, (2)) and a cover sleeve (Fig. 2A, (7)), wherein: the auto injector (1) further comprises a cover sleeve spring (Fig. 2A, (8)). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the autoinjector of Oakley et al. to have a cover sleeve to be displaced in a proximal, axial direction into the housing when the autoinjector is ready-to-use and pressed onto a puncture site; all as taught by Kemp, for the motivation of protecting the needle via the needle sheath and supporting the syringe in its final position during injection (Kemp [0040]), thus preventing accidental needle sticks and preventing accidental firing of an injection unless said needle sheath is telescopically retracted into the housing (Kemp [0069] & [0072] wherein the plunger can’t move distally (fire the injection) until (7) is telescopically retracted within the case (2)).

Claim(s) 1 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kemp et al., (US 2018/0140781) in view of Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315).
With regard to claims 1, 20, and 21, Kemp et al. teach an auto injector apparatus (Figs 2A-2B, (1)) comprising: a prefilled syringe (Fig. 2A, (3) and [0067-0068] wherein the syringe is prefilled with medicament (M)) comprising: a barrel ([0067-0068] wherein (3) includes a barrel) comprising a proximal end and a distal end and that extends along a longitudinal axis between the proximal end and the distal end (seen in Figs 2A-2B, wherein syringe (3) has proximal and distal ends, and comprises a barrel (3) along a longitudinal axis therebetween, containing therapeutic fluid/drug (M)); a needle disposed at the distal end of the barrel (Fig. 1 member 14); a therapeutic fluid held within the barrel (Fig. 1 M), the therapeutic fluid having a volume of about between 1.51 mL and about 1.66 mL (Kemp [0124] wherein the cartridge may contain a volume between 1mL and 2mL, therefore reads on the range of about 1.51mL and about 1.66mL); a stopper (Figs 2A-2B, (6)) disposed within the barrel (3), the stopper (6) being configured to move axially within the barrel (3) along a path of travel between a first position and a second position to expel at least some of the volume of the therapeutic fluid (M) from the prefilled syringe ([0068] wherein the (stopper) piston (6) is moved distally (axially) inside the (syringe) cartridge (3) in order to dispense (therapeutic) drug (M) from the delivery device (auto injector) via needle (4)), the first position being an initial position of the stopper (6) before a delivery of the therapeutic fluid (M), and the second position being a final position of the stopper (6) at the end of the delivery of the therapeutic fluid (M); and an auto injector (1) that holds the prefilled syringe (3), the auto injector (1) comprising: a piston rod (Figs 2A-2B, (10)) configured to abut the stopper (6); and an injection spring (Figs 2A-2B, (9), within the barrel in the second position and adjacent the stopper) configured to drive the piston rod (10) into abutment with the stopper (6) to apply a dispensing force ([0072] wherein the stopper (6) is driven by a dispensing force from the piston rod (10)) to the stopper (6), wherein: the injection spring (9), upon an actuation of the auto injector (1), is configured to provide, via the piston rod (10) a dispensing force to the stopper (6) to move the stopper (6) from the first position to the second position ([0072] wherein the injection spring (9) provides a driving force to move the stopper (6), and [0068] wherein (6) is intended to move from a first position to a second position to deliver medicament (M) via the needle (4)). 
Kemp et al. do not explicitly teach wherein the barrel has an inner diameter of about 8.65 mm.  In related prior art, Berg teaches an injection device (Berg Fig. 1, (10)) including a syringe (Berg Fig. 1, (10)) having a needle (Berg Fig. 1, (30)) at the distal end of the barrel (Berg Fig. 1, (20)), and a stopper (Berg Fig. 1, (40)) within the barrel of the syringe. Berg teaches the syringe having a sealing surface with a diameter between about 5mm and about 14mm (Berg [0052]); thus, if Berg has a stopper with a diameter of about 8mm or about 9mm, the syringe barrel inner diameter would have to accordingly be about 8.65mm, to creating the sliding seal (sealing surface) of the stopper (Berg (40)). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel inner diameter of Kemp et al. to be about 8.65 mm, as taught by Berg, for the motivation of having an ideal compressibility ratio between the outer diameter of the stopper and the inner surface of the syringe barrel (Berg [0054]) when delivering therapeutic contained within the syringe barrel.
Kemp et al. do not explicitly teach the dimensions of the needle.  However, Row teaches the syringe (Row (104)) having a needle (Row Fig. 2A, (406)) on a distal end of the syringe barrel, further teaching the needle can be any of a range of gauges including 7 gauge through 33 gauge, having needle lengths of 3mm through 40mm or more (Row [0085]). As a 25-gauge needle is taught among the possible needles claimed by Row, and as it is well known in the art that a 25-gauge needle has an inner diameter that is about 0.26mm to 0.28mm, Row also teaches having a needle inner diameter of about 0.27mm. 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle inner diameter/length of Kemp et al. to have a needle inner diameter of about 0.25mm-.29mm as taught by Row, for the motivation of reducing/controlling the amount of user force required to deliver the injection to the patient (Row [0049]).
Kemp et al. do not disclose a viscosity as recited.  However, Cabiri et al. teach agents may have various viscosities, for example between 1-15cP and that viscosity may vary which can vary injection properties ([0192]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a viscosity as recited as Cabiri et al. disclose the viscosity may vary and is a factor which may be altered and adjust injection properties as such it is further obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
Kemp do not disclose the specific substance recited.  However, Bigal and Strassman teaches a therapeutic for injection to adult patients, wherein the therapeutic being injected is fremanezumab (Bigal [0029] wherein anti-CGRP is an antagonist antibody, known as antibody G1 or also known as “fremanezumab” (Strassman, pg. 10588, [Col. 2, line 40], which further teaches that anti-CGRP antibody is known as “fremanezumab”)), Bigal teaching anti-CGRP/fremanezumab has a viscosity of 8.8cP among a range from 0.5cP to 15cP (Bigal [0155], where centipoise is equivalent to centistokes) wherein the viscosity measurements are done in a temperature range of 20-25°C (room temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic delivered by the modified device of Kemp et al. to be fremanezumab an anti-CGRP with a viscosity as claimed, as taught by Bigal and Strassman, for the motivation of it being known and established in the prior art to deliver subcutaneous preventative treatments for common ailments such as migraines (Bigal [0033]).
Kemp et al. do not teach a spring configured to move the stopper within a period of 5 to 25 seconds, an initial force of between 20 N and 30 N, and a final dispensing force of between 12 N to about 20 N.
However, Cabiri et al. teach an auto injector apparatus (seen in Fig. 4A) comprising a stopper (Fig. 4A, (426)) and a spring ([0186] wherein the power supply (for delivering a single dose payload) can be mechanical means such as a spring). Cabiri et al. [0188] teaches a range of force may be applied to the stopper (plunger) during injection, anywhere between 5N - 60N, depending upon factors such as injection rate and/or the viscosity of the drug and/or the syringe geometry and/or the needle dimensions. Cabiri et al. teach the payload may be delivered over a time period of 20-120 seconds ([0186]) and that timing depends on fill volume and viscosity ([0192]).
Further, related prior art Kronestedt et al.  ([0004-0005]) teaches when a force is applied to a piston during medicament delivery by a pre-tensioned spring associated with the plunger rod, that force is obtained in accordance with Hooke's law. Hooke’s law states force exerted by a spring is a function of displacement of the spring from its original position, multiplied by the spring constant. Therefore, from Hooke’s law it follows that force acting on the piston will decline linearly as the piston moves forward during injection, due to a decompressing spring naturally having reduced dispensing force. Additionally, McPhee teaches that as a spring decompresses the force decreases by about 20% to the final dispensing position (Col. 3 line 21-26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have timing and force values as recited in Kemp et al. as Cabiri et al. teach the spring may be selected to deliver a force as desired based on variables including injection rate, viscosity, syringe geometry, and needle dimensions.  Further, delivery time would also be a result of factors tied to the spring selection including viscosity and fill volume.  As the initial force value would be selected as taught by Cabiri et al. it would follow that the final dispensing force would be between 12 N to 20 N as Kronestedt et al. teach from Hooke’s law it follows that the force decreases as the piston moves during injection and McPhee discloses that the force decreases by about 20%, thus it would be about 80% of the initial force.  
It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).  As Cabiri et al. teach that the spring may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach spring behavior as recited one of ordinary skill in the art would have had a reasonable expectation of success in modifying Oakley et al. to have the necessary spring characteristics to achieve the desired force and timing.  Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use such a range for timing and force as claimed in Kemp et al. as Cabiri et al. teach such to be result effective variables that may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach known spring behavior selecting the spring to have the timing and force fall within the claimed range would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
With regard to claims 17 and 18, see housing 16 (Fig. 2B).
With regard to claims 19 and 22, Kemp et al. teach a housing 2 (Fig. 2A), a cover sleeve 7, and a cover sleeve spring 8 (Fig. 2A, [0069], [0071]).

Claims 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kemp et al., (US 2018/0140781) in view of Berg et al. (US 2018/0243508), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Strassman et al. (“Fremanezumab — A Humanized Monoclonal Anti-CGRP Antibody — Inhibits Thinly Myelinated (AS) But Not Unmyelinated (C) Meningeal Nociceptors”, The Journal of Neuroscience (2017), 37(44):10587-10596), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), and Chai et al. (US 2019/0031748).
With regard to claims 23-25, Kemp et al. teach an auto injector apparatus (Figs 2A-2B, (1)) comprising: a prefilled syringe (Fig. 2A, (3) and [0067-0068] wherein the syringe is prefilled with medicament (M)) comprising: a barrel ([0067-0068] wherein (3) includes a barrel) comprising a proximal end and a distal end and that extends along a longitudinal axis between the proximal end and the distal end (seen in Figs 2A-2B, wherein syringe (3) has proximal and distal ends, and comprises a barrel (3) along a longitudinal axis therebetween, containing therapeutic fluid/drug (M)); a needle disposed at the distal end of the barrel (Fig. 1 member 14); a therapeutic fluid held within the barrel (Fig. 1 M), the therapeutic fluid having a volume of about between 1.51 mL and about 1.66 mL (Kemp [0124] wherein the cartridge may contain a volume between 1mL and 2mL, therefore reads on the range of about 1.51mL and about 1.66mL); a stopper (Figs 2A-2B, (6)) disposed within the barrel (3), the stopper (6) being configured to move axially within the barrel (3) along a path of travel between a first position and a second position to expel at least some of the volume of the therapeutic fluid (M) from the prefilled syringe ([0068] wherein the (stopper) piston (6) is moved distally (axially) inside the (syringe) cartridge (3) in order to dispense (therapeutic) drug (M) from the delivery device (auto injector) via needle (4)), the first position being an initial position of the stopper (6) before a delivery of the therapeutic fluid (M), and the second position being a final position of the stopper (6) at the end of the delivery of the therapeutic fluid (M); and
an auto injector (1) that holds the prefilled syringe (3), the auto injector (1) comprising: 
a piston rod (Figs 2A-2B, (10)) configured to abut the stopper (6); and 
an injection spring (Figs 2A-2B, (9)) configured to drive the piston rod (10) into abutment with the stopper (6) to apply a dispensing force ([0072] wherein the stopper (6) is driven by a dispensing force from the piston rod (10)) to the stopper (6), wherein: 
the injection spring (9), upon an actuation of the auto injector (1), is configured to provide, via the piston rod (10) a dispensing force to the stopper (6) to move the stopper (6) from the first position to the second position ([0072] wherein the injection spring (9) provides a driving force to move the stopper (6), and [0068] wherein (6) is intended to move from a first position to a second position to deliver medicament (M) via the needle (4)). 
Kemp et al. do not explicitly teach wherein the barrel has an inner diameter of about 8.65 mm.  In related prior art, Berg teaches an injection device (Berg Fig. 1, (10)) including a syringe (Berg Fig. 1, (10)) having a needle (Berg Fig. 1, (30)) at the distal end of the barrel (Berg Fig. 1, (20)), and a stopper (Berg Fig. 1, (40)) within the barrel of the syringe. Berg teaches the syringe having a sealing surface with a diameter between about 5mm and about 14mm (Berg [0052]); thus, if Berg has a stopper with a diameter of about 8mm or about 9mm, the syringe barrel inner diameter would have to accordingly be about 8.65mm, to creating the sliding seal (sealing surface) of the stopper (Berg (40)). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe barrel inner diameter of Kemp et al. to be about 8.65 mm, as taught by Berg, for the motivation of having an ideal compressibility ratio between the outer diameter of the stopper and the inner surface of the syringe barrel (Berg [0054]) when delivering therapeutic contained within the syringe barrel.
Kemp et al. do not explicitly teach the dimensions of the needle.  However, Row teaches the syringe (Row (104)) having a needle (Row Fig. 2A, (406)) on a distal end of the syringe barrel, further teaching the needle can be any of a range of gauges including 7 gauge through 33 gauge, having needle lengths of 3mm through 40mm or more (Row [0085]). As a 25-gauge needle is taught among the possible needles claimed by Row, and as it is well known in the art that a 25-gauge needle has an inner diameter that is about 0.26mm to 0.28mm, Row also teaches having a needle inner diameter of about 0.27mm. 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle inner diameter/length of Kemp et al. to have a needle inner diameter of about 0.25mm-.29mm as taught by Row, for the motivation of reducing/controlling the amount of user force required to deliver the injection to the patient (Row [0049]).
Kemp et al. do not disclose a viscosity as recited.  However, Cabiri et al. teach agents may have various viscosities, for example between 1-15cP and that viscosity may vary which can vary injection properties ([0192]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a viscosity as recited as Cabiri et al. disclose the viscosity may vary and is a factor which may be altered and adjust injection properties as such it is further obvious since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A).
Kemp do not disclose the specific substance recited.  However, Bigal and Strassman teaches a therapeutic for injection to adult patients, wherein the therapeutic being injected is fremanezumab (Bigal [0029] wherein anti-CGRP is an antagonist antibody, known as antibody G1 or also known as “fremanezumab” (Strassman, pg. 10588, [Col. 2, line 40], which further teaches that anti-CGRP antibody is known as “fremanezumab”)), Bigal teaching anti-CGRP/fremanezumab has a viscosity of 8.8cP among a range from 0.5cP to 15cP (Bigal [0155], where centipoise is equivalent to centistokes) wherein the viscosity measurements are done in a temperature range of 20-25°C (room temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic delivered by the modified device of Kemp et al. to be fremanezumab an anti-CGRP with a viscosity as claimed, as taught by Bigal and Strassman, for the motivation of it being known and established in the prior art to deliver subcutaneous preventative treatments for common ailments such as migraines (Bigal [0033]).
The combination doesn’t explicitly teach wherein the anti-CGRP antibody comprises a heavy chain variable region that is at least 90% identical in amino acid sequence to SEQ ID NO: 1 and a light chain variable region that is at least 90% identical in amino acid sequence to SEQ ID NO: 2. 
In related therapeutic delivery prior art, Chai teaches various antibodies that bind calcitonin gene-related peptide (CGRP), wherein the anti-CGRP antibody comprises a heavy chain variable region that is at least 90%, 95%, or 100% identical in amino acid sequence to SEQID NO: 1 and a light chain variable region that is at least 90%, 95%, or 100% identical in amino acid sequence to SEQ ID NO: 2 ([0005] wherein a combination of heavy chain variable regions and light chain variable regions of SEQ ID NO: 1 and SEQ ID NO: 2 is taught in the prior art). 
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-CGRP antibody of Kemp et al. to be a heavy chain variable region at least 90%, 95%, or 100% identical to SEQID NO: 1 and a light chain variable region at least 90%, 95%, or 100% identical to SEQ ID NO: 2; all as taught by Chai, as these and various other combinations are known in the prior art for treating migraines, cluster headaches, and osteoarthritis pain (Chai [0002]). 
Kemp et al. do not teach a spring configured to move the stopper within a period of 5 to 25 seconds, an initial force of between 20 N and 30 N, and a final dispensing force of between 12 N to about 20 N.
However, Cabiri et al. teach an auto injector apparatus (seen in Fig. 4A) comprising a stopper (Fig. 4A, (426)) and a spring ([0186] wherein the power supply (for delivering a single dose payload) can be mechanical means such as a spring). Cabiri et al. [0188] teaches a range of force may be applied to the stopper (plunger) during injection, anywhere between 5N - 60N, depending upon factors such as injection rate and/or the viscosity of the drug and/or the syringe geometry and/or the needle dimensions. Cabiri et al. teach the payload may be delivered over a time period of 20-120 seconds ([0186]) and that timing depends on fill volume and viscosity ([0192]).
Further, related prior art Kronestedt et al.  ([0004-0005]) teaches when a force is applied to a piston during medicament delivery by a pre-tensioned spring associated with the plunger rod, that force is obtained in accordance with Hooke's law. Hooke’s law states force exerted by a spring is a function of displacement of the spring from its original position, multiplied by the spring constant. Therefore, from Hooke’s law it follows that force acting on the piston will decline linearly as the piston moves forward during injection, due to a decompressing spring naturally having reduced dispensing force. Additionally, McPhee teaches that as a spring decompresses the force decreases by about 20% to the final dispensing position (Col. 3 line 21-26).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have timing and force values as recited in Kemp et al. as Cabiri et al. teach the spring may be selected to deliver a force as desired based on variables including injection rate, viscosity, syringe geometry, and needle dimensions.  Further, delivery time would also be a result of factors tied to the spring selection including viscosity and fill volume.  As the initial force value would be selected as taught by Cabiri et al. it would follow that the final dispensing force would be between 12 N to 20 N as Kronestedt et al. teach from Hooke’s law it follows that the force decreases as the piston moves during injection and McPhee discloses that the force decreases by about 20%, thus it would be about 80% of the initial force.  
It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).  As Cabiri et al. teach that the spring may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach spring behavior as recited one of ordinary skill in the art would have had a reasonable expectation of success in modifying Oakley et al. to have the necessary spring characteristics to achieve the desired force and timing.  Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use such a range for timing and force as claimed in Kemp et al. as Cabiri et al. teach such to be result effective variables that may be selected for the desired conditions and performance and Kronestedt et al. and McPhee teach known spring behavior selecting the spring to have the timing and force fall within the claimed range would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955).
With regard to claims 26 and 27, see housing 16 (Fig. 2B).
With regard to claim 28, Kemp et al. teach a housing 2 (Fig. 2A) and a cover sleeve 7 (Fig. 2A, [0069]).
With regard to claim 29, Kemp et al. teach the modified auto injector apparatus of claim 23, wherein Kemp teaches the injection spring (9), when the stopper (6) is in the second position, is within the barrel (as seen in annotated Fig. 2A below, where Kemp’s injection spring (9) would be within the barrel (3) when the stopper (6) is in the second position (9-2*)).

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With regard to claim 30, Kemp et al. teach the modified auto injector apparatus of claim 23, wherein Kemp teaches a distal end of the injection spring (9) is adjacent to the stopper (6) during movement of the stopper (6) from the first position to the second position (also exemplified in annotated Kemp Fig. 2A, wherein (9) remains adjacent the stopper (6) throughout delivery).

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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). 
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.

Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-17 of U.S. Patent No. 11,541,177. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent teach each limitations of the instant claims, the claims have a slight different in the viscosity recitation, the claims of the patent teach the limitations of the instant application.
Response to Arguments
The Examiner notes the grounds of rejections have changed.  Generally, regarding Applicant’s discussion and remarks to the protocol for determining the necessary spring force, the Examiner notes particularly MPEP 716.02 regarding unexpected results. Evidence must be commensurate in scope with the claims, claim 1 does not recite any claim language drawn to an aspect of aging, claim 2 recites “aged up to 24 months” meaning this includes unaged substances/devices and a substance aged beyond that is not required nor is a specific shelf life claimed. Though particular dispensing forces may be recited the claim does not recite this in the context of aging. Regarding Applicant’s arguments with respect to Cabiri, though Cabiri does not explicitly disclose aging as a considered factor, the Examiner maintains that as a force range is disclosed which encompasses the scope of the claim and given the numerous factors which are recited for consideration one of ordinary skill may still arrive at the claimed force values. The factors considered by the reference are not required to be the same as required by Applicant. 
Conclusion

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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783