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) 65, 79, 84, 85, 88-94, 101, 103, 105-107, 109, 113, 114, 116, 117, and 119 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendek et al. (US 2017/0173264 A1) in view of Bicker et al. (US 2014/0010969), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Chai et al. (US 2019/0031748), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), Wotton et al. (US 2013/0303985 A1), and Reb et al. (US 2015/001880).
With regard to claims 65, 84, 94, 113, 114, 116, 117, Bendek et al. teach an auto injector apparatus comprising: a syringe (Fig. 2 member 20) comprising: a barrel comprising an inner surface (Fig. 1 barrel of 20); a needle at the distal end of the barrel (Fig. 5 needle 134); and a stopper disposed within the barrel, the stopper being configured to move axially within the barrel between an initial position before a delivery of the therapeutic fluid and a final position at an end of the delivery of the therapeutic fluid (Fig. 3 member 21); and an auto injector that holds the syringe (Fig. 2 at least member 10), the auto injector comprising; a rod configured to drive the stopper axially within the barrel (Fig. 6 member 76); and an injection spring configured drive the rod and the stopper axially within, the injection spring is configured to drive the rod to move the stopper from the initial position to the final position when the syringe is unaged (Fig. 6 member 82).
Bendek et al. do not disclose a lubricant. 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 Bendek 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]).
Bendek et al. teach various volumes may be delivered and the movement of the stopper is taken to correspond to one dose ([0010], [0016]) but do not specifically teach a volume as recited. Bendek et al. teach a needle (Fig. 5 needle 134) but do not recite the specific length or diameter of the needle. However, Row et al. teach the volume of a syringe reservoir may vary ([0077]). Row et al. teach 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; the needle is sized to provide flow as appropriate for the intended use (Row [0085]). As a 25-gauge needle is taught among the possible needles claimed by Row et al., and as it is well known in the art that a 25-gauge needle has an inner diameter that is about 0.25mm to 0.29mm, Row et al. 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 volume and needle inner diameter/length of Bendek et al. as recited as Row et al. teach the volume recited and that needle length and gauge may be selected as appropriate for the intended use 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(II)(A). Further, it is well known that the dose is based on various treatment factors including the substance being delivered and particular patient parameters.
Benedek et al. teach delivering a medicament (abstract) but do not disclose the specific substance and viscosity delivered. In related prior art, Bigal et al. teach a therapeutic for injection to adult patients, wherein the therapeutic being injected is an anti-calcitonin gene-related peptide antibody (Bigal [0029] wherein anti-CGRP is an antagonist antibody, known as antibody G1). Bigal et al. teach the volume may vary based on various conditions ([0209]). Bigal et al. teach the viscosity may vary depending on desired efficacy, safety, and storage considerations ([0155]). 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 device of Bendek et al., to be anti-CGRP, as taught by Bigal et al., for the motivation of delivering subcutaneous preventative treatments for common ailments such as migraines (Bigal [0033]) and additionally to use a volume and viscosity as recited as it is a known treatment volume depending on desired conditions and viscosity may be selected depending on desired efficacy, safety, and storage considerations.
Bendek et al. and Bigal et al. do not explicitly teach wherein the anti-CGRP antibody comprises a heavy chain variable region that is at least 90%-100% identical in amino acid sequence to SEQ ID NO: 1 and a light chain variable region that is at least 90%-100% 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%-100% identical in amino acid sequence to SEQID NO: 1 and a light chain variable region that is at least 90% 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 Bendek et al. to be a heavy chain variable region at least 90%-100% identical to SEQID NO: 1 and a light chain variable region at least 90% 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]).
Bendek 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 40 (30) N, and a final dispensing force between 12 N to 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 Bendek 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 in the range recited as taught by Cabiri et al. it would follow that the final dispensing force would be in the range recited 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 Bendek 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).
Bendek et al. do not teach the spring to be configured to drive the rod after the syringe has been aged artificially or a particular shelf life. However, Row et al. teach a syringe may have modifications to the syringe body and seal and that the shelf life of a therapeutic may vary between 1 to 5 years ([0084]). Additionally, Wotton et al. teach constructing a syringe spring out of a material that is resilient so as to not lose force over time during the shelf life of the syringe ([0080]). Further, Reb et al. teach artificially aging syringes using heat to simulate one to three years of natural aging and that when syringes sit with a substance it can interfere with the loading ([0024], [0025], [0048], [0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a shelf life of the fluid in Bendek et al. to be 24 months as Row et al. teach such is a suitable storage time for a therapeutic agent and to test the conditions in an artificially aged syringe of Bendek et al. as in Reb et al. as this allows the necessary factors to be determined for actual shelf life and to select a suitable spring material as in Wotton et al. such that the spring is able to eject a fluid during the shelf life of the syringe. Further, one of ordinary skill would recognize the shelf life would vary depending on known factors such as the agent itself and storage conditions and it would further be 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). As combined the spring would be selected which would be configured to actuate the stopper over the shelf life (aged artificially or naturally) of the syringe. Further, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
With regard to claim 74, 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 75 and 76, Bendek 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 0.2 N/mm and about 0.4 N/mm or 0.28 N/mm and about 0.32 N/mm and has a compressed length of between about 50 mm and about 100 mm.
However, the provided disclosure sets forth that “a spring constant in the range from about 0.2 N/mm to about 0.4 N/mm” and “a compressed length in the range from about 50 mm to about 100 mm” is a result effective variable, 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 Bendek 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 79, as combined above, Kronestedt ([0004]-[0005]) teaches that, according to Hooke’s Law, the stored spring energy (spring constant) of an injection spring relates to spring length and overall force the spring can provide. Thus, one of ordinary skill in the art would have considered the actual stored spring energy of the injection spring is at least 25% greater than a minimum stored spring energy required to move the stopper from the initial position to the final position without stalling in a prefilled syringe to be a result effective variable that is optimized through routine experimentation, 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(II)(A). One of ordinary skill would be able to select spring characteristics to result in the desired force to achieve delivery.
With regard to claim 85, Bendek et al. teach an injector (Fig. 5, (20)) having a stopper (Fig. 3, (21)), and further Bendek et al. ([0016]) teach the linear distance the plunger rod (and hence stopper) moves during expelling of medicament is a distance which corresponds to dose volume; it is advantageous that the dose volume can be determined and also altered by choosing the linear distance the plunger rod (and hence the stopper) can travel when acting on a medicament container with a certain total volume.
The claimed limitations set forth that the “the distance between the first position and the second position is between about 25 mm and about 40 mm”. Regarding the provided specification, (SPEC [0057]) sets forth “The path of travel, P, can be about 29.6 mm, which is sometimes referred to as a "30mm" path of travel. In alternative embodiments, 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” 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 distance between the first and second positions of the stopper to be between about 25.7 mm and about 30 mm or about 35 mm to about 55 mm, since Bendek et al. ([0016]) teach the linear distance the plunger rod and stopper moves during expelling of medicament is a distance which corresponds to dose volume, and thus can be predetermined to have a set volume delivered per dose; 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(II)(A).
With regard to claims 88-93, the shoulder of the barrel is viewable at the distal tip (Fig. 15). The stopper is necessarily adjacent/proximal to the fluid prior to dispensing in order for delivery to occur. Bendek et al. teach the final location of the stopper may vary depending on the dose delivered ([0010], [0016], [0036], [0053]). As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the stopper may be adjacent to/spaced from/in contact with the shoulder in the final position as Bendek et al. teach the positioning of the stopper is dependent on the desired dose; 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(II)(A).
With regard to claims 100, 102, and 104, Bendek et al. and Bicker et al. teach the modified auto injector apparatus of claim 65 using a silicone oil. Bendek et al. do not explicitly teach the barrel comprises an inner surface comprising glass. 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 Bendek 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.
With regard to claims 101 and 103, 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 prior to the effective filing date to adjust the amount of silicone oil applied to lubricate the interior of the syringe barrel, to be as recited in Bendek 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.
With regard to claims 105 and 106, see exemplary transition from Fig. 11 to Fig. 15.
With regard to claim 107, see Fig. 6 second spring 124.
With regard to claim 109, as combined Reb et al. teach using a temperature of 40 or 56 degrees ([0048], [0053]). Reb et al. do not explicitly determine how the period of time is calculated, however, as stated above it would be obvious to use a period of time associated with 24 months of natural aging. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
With regard to claim 119, the stopper would necessarily experience a maximum resistance force. Numerical values for the final dispensing force are listed and rejected in claim 65, as specific values are already claimed these are presumed to be at least 25% greater than the maximum dispensing force.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Bendek et al. (US 2017/0173264 A1) in view of Bicker et al. (US 2014/0010969), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Chai et al. (US 2019/0031748), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), Wotton et al. (US 2013/0303985 A1), and Reb et al. (US 2015/001880) as applied to Claim 65 above, and further in view of Sudo et al. (US 5009646).
With regard to claim 81, Bendek et al. teach a device substantially as claimed. Bendek 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 Bendek 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 83 is rejected under 35 U.S.C. 103 as being unpatentable over B Bendek et al. (US 2017/0173264 A1) in view of Bicker et al. (US 2014/0010969), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Chai et al. (US 2019/0031748), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), Wotton et al. (US 2013/0303985 A1), and Reb et al. (US 2015/001880) as applied to Claim 65 above, further in view of Bicker et al. (US 2014/0010969) and Atterbury et al. (US 2018/0200442).
With regard to claim 83, Bendek 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 Bendek 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 Bendek 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 115 is rejected under 35 U.S.C. 103 as being unpatentable over Bendek et al. (US 2017/0173264 A1) in view of Bicker et al. (US 2014/0010969), Row et al. (US 2015/0165129), Bigal et al. (US 2015/0322142), Chai et al. (US 2019/0031748), Cabiri et al. (US 2017/0080157), Kronestedt et al. (US 2009/0308386), McPhee (US 5,599,315), Wotton et al. (US 2013/0303985 A1), and Reb et al. (US 2015/001880) as applied to Claim 65 above, further in view of Lazar et al., (US 2017/0252437).
With regard to claim 115, Bendek et al. teach the modified auto injector apparatus of claim 65, wherein the therapeutic fluid (Bendek (31)) comprises a liquid pharmaceutical combination (Bendek [0066] wherein the antibody or peptide or protein, or a mixture of the above-mentioned pharmaceutically active compounds are liquid pharmaceutical combinations). Bendek et al. as combined with Chai et al. teach the anti-CGRP antibody
Bendek et al. do not explicitly teach the liquid pharmaceutical composition comprising about 0.204 mg disodium ethylenediaminetetraacetic acid dihydrate (EDTA); about 0.815 mg L-histidine; about 3.93 mg L- histidine hydrochloride monohydrate; about 0.3 mg polysorbate -80; about 99 mg sucrose; and water, wherein liquid pharmaceutical composition for injection has a pH of 5.5.
In related prior art, Lazar teaches various formulations of anti-CGRP antibody, formulated at 225 mg (Lazar [0040]) including histidine (Lazar [0025]), sucrose (Lazar [0116]), disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (Lazar [0025] and [0128]) and polysorbate-80, all of which have a pH in range of 5 - 5.5 (Lazar [0025]).
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 Bendek et al. to be formulated at 225 mg having a pH 5.5; all as taught by Lazar, as these and various other combinations are already established in the prior art for treating known conditions such as migraines, cluster headaches, and osteoarthritis pain (Chai [0002]).
Response to Arguments
Applicant's arguments filed January 19, 2026 have been fully considered but they are not persuasive. Applicant argues Bicker fails to disclose any contribution of the lubricant or interactions between the lubricant and the recite fluid that would increase the resistive forces. The claims recite a lubricant is present and the type of lubricant. The claims limitations to the lubricant are met by Bicker. The Examiner maintains that the totality of the claim limitations is taught, the same syringe components regarding the rate, geometry, dimensions, and volume with the same contents provided at the same viscosity are shown by the art. As such in consideration with the references that teach factors considered with shelf life and testing syringes in conditions to determine the effects of aging, the same resultant syringe would be considered by one of ordinary skill in the art. The references are considered together. One of ordinary skill would be able to arrive at a syringe with the features and substance as provided by the claims, one of ordinary skill would be motivated to test that syringe to determine the effects of aging and would be able to adjust the spring accordingly. Regarding Reb, Applicant remarks that Reb discloses the syringe had reproducible mechanical behavior regardless of aging. The Examiner interprets this to mean that, when tested, the aged syringes provided results which were reproducible as a group of aged syringes. However, even if Applicant’s contention that Reb is disclosing that the unaged and aged syringes behaved the same, the syringe as provided by the prior art references is not the same as tested by Reb. Were the known syringe features provided by the references tested the force results would be different. One of ordinary skill in the art would be able to determine the necessary force values based on the test results. The objection to the claims is overcome.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783