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, 3-5, 7-11 and 22-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horsch (US 2020/0289759) in view of Vogt (US 2019/0201630).
Regarding claims 1 and 26, Horsch discloses syringe comprising: a barrel 2 configured to hold a therapeutic agent 10 (fig 1; ¶93); a plunger rod 6 positioned at least partially within the barrel, the plunger rod including a stopper 3 (fig 1), the stopper comprising: an elastomeric body (¶50); a solid lubricant on at least a portion of an exterior of the elastomeric body (¶49); and the solid lubricant is a fluoropolymer (¶49 - PTFE).
While Horsch substantially discloses the invention as claimed, it does not disclose the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein a mass of the thin film lubricant on the stopper is from about 0.3 to about 100 micrograms, the thin film lubricant is silicone or silicone oil
Horsch discloses use of thin film lubricant such as silicone, but applied to the barrel (¶61). Horsch also discloses a balance of forces to allow for sliding vs leakage vs pain caused to user (¶24), which is a function of lubrication.
Vogt discloses the barrel may either be a silicone lubricant layer or a silicone-free lubricant layer (¶92). A reason for silicone free is use of drugs which are sensitive to silicone particles (¶3). Vogt further discloses the plunger stopper consists of an outer crosslinked silicone layer on a fluoropolymer coating (¶103). Vogt is also concerned with balancing forces (¶4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein a mass of the thin film lubricant on the stopper is from about 0.3 to about 100 micrograms, the thin film lubricant is silicone or silicone oil (crosslinked with the fluoropolymer coating so that there are not free silicone particles) as taught by Vogt to decrease the likelihood of negative drug interactions with the silicone lubricant while maintaining desirable sliding properties/forces.
Regarding claim 3, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the solid lubricant and the thin film lubricant on the stopper represent the total lubricant in the syringe.
Vogt discloses the barrel is usually coated with a lubricant layer to affect the sliding of the plunger (¶92). Meaning there are instances where the barrel is not coated.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Vogt such that the solid lubricant and the thin film lubricant on the stopper represent the total lubricant in the syringe as suggested by Vogt as part of balancing sliding forces vs possible negative interactions of the drug with lubricant in the barrel.
Regarding claim 4, wherein the stopper is configured to be slidably moved within the barrel with a dry breakaway force less than about 15 N (¶79).
Regarding claim 5, Horsch discloses syringe comprising: a barrel 2 configured to hold a therapeutic agent 10 (fig 1; ¶93); a plunger rod 6 positioned at least partially within the barrel, the plunger rod including a stopper 3 (fig 1), the stopper comprising: an elastomeric body (¶50); a solid lubricant on at least a portion of an exterior of the elastomeric body (¶49); wherein the solid lubricant is a fluoropolymer (¶49 - PTFE).
While Horsch substantially discloses the invention as claimed, it does not disclose the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein an area density of the thin film lubricant on the stopper is about 0.15 µg/cm2 to about 50 µg/cm2, the thin film lubricant is silicone or silicone oil
Horsch discloses use of thin film lubricant such as silicone, but applied to the barrel (¶61). Horsch also discloses a balance of forces to allow for sliding vs leakage vs pain caused to user (¶24), which is a function of lubrication.
Vogt discloses the barrel may either be a silicone lubricant layer or a silicone-free lubricant layer (¶92). A reason for silicone free is use of drugs which are sensitive to silicone particles (¶3). Vogt further discloses the plunger stopper consists of an outer crosslinked silicone layer on a fluoropolymer coating (¶103). Vogt is also concerned with balancing forces (¶4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein an area density of the thin film lubricant on the stopper is about 0.15 µg/cm2 to about 50 µg/cm2, the thin film lubricant is silicone or silicone oil (crosslinked with the fluoropolymer coating so that there are not free silicone particles) as taught by Vogt to decrease the likelihood of negative drug interactions with the silicone lubricant while maintaining desirable sliding properties/forces.
Regarding claims 7-10 and 23-25, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the thin film lubricant is configured to reduce reduces an insertion force required to insert the stopper into the barrel by at least about 10%, the thin film lubricant is configured to reduce reduces a breakaway force required to move the stopper in the barrel by at least about 10%, the thin film lubricant is configured to reduce reduces an average glide force required to move the stopper in the barrel by at least about 2%, nor an average wet glide force between the stopper and the barrel is less than 5 N.
Horsch discloses a device which optimizes glide force versus break loose force (see ¶8-10 for example). Further, one of ordinary skill in the art recognizes one of the primary purposes of lubricant is to decrease frictional forces between two other structures.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the thin film lubricant is configured to reduce reduces an insertion force required to insert the stopper into the barrel by at least about 10%, the thin film lubricant is configured to reduce reduces a breakaway force required to move the stopper in the barrel by at least about 10%, the thin film lubricant is configured to reduce reduces an average glide force required to move the stopper in the barrel by at least about 2%, and an average wet glide force between the stopper and the barrel is less than 5 N as suggested by Horsch itself as part of optimizing the break loose force and glide force, allowing for easier sliding of the stopper but not so easy that the stopper will move when it is not supposed to.
Regarding claim 11, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the mass of the thin film lubricant is present on the stopper in an amount from about 0.3 μg to about 50 μg (¶61).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the mass of the thin film lubricant is present on the stopper in an amount from about 0.3 μg to about 50 μg (¶61) as suggested by Horsch itself as part of balancing/achieving desired sliding forces.
Regarding claim 22, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the stopper is configured to be slidably moved within the barrel with a dry breakaway force less than about 15 N.
Horsch discloses a device which optimizes glide force versus break loose force (see ¶8-10 for example). Further, one of ordinary skill in the art recognizes one of the primary purposes of lubricant is to decrease frictional forces between two other structures.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the stopper is configured to be slidably moved within the barrel with a dry breakaway force less than about 15 N as suggested by Horsch itself (and Vogt) as part of achieving/balancing desired slide properties.
Regarding claim 27, wherein the thin film lubricant is configured to have a greater affinity for the solid lubricant than the barrel or the therapeutic agent (due to crosslinking between thin film lubricant and solid lubricant as addressed in claims 1 and 26 above).
Claim(s) 12, 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horsch (US 2020/0289759) in view of Sigg et al (US 2014/0012227) and Vogt (US 2019/0201630).
Regarding claim 12, Horsch discloses an injection device comprising: a barrel 2 configured to hold a therapeutic agent 10 (fig 1; ¶93); a plunger rod 6 positioned at least partially within the barrel (fig 1), the plunger rod including a stopper 3 (fig 1), the stopper comprising: an elastomeric body (¶50); a solid lubricant on at least a portion of an exterior of the elastomeric body (¶49); and the solid lubricant is a fluoropolymer (¶49 – PTFE)
While Horsch substantially discloses the invention as claimed, it does not disclose the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein an average number of particles present in the therapeutic agent with a diameter equal to or greater than 10 µm is about 600 or less, and with a diameter equal to or greater than 25 µm is about 60 or less, the thin film lubricant is silicone or silicone oil.
Horsch discloses use of thin film lubricant such as silicone, but applied to the barrel (¶61). Horsch also discloses a balance of forces to allow for sliding vs leakage vs pain caused to user (¶24), which is a function of lubrication.
Vogt discloses the barrel may either be a silicone lubricant layer or a silicone-free lubricant layer (¶92). A reason for silicone free is use of drugs which are sensitive to silicone particles (¶3). Vogt further discloses the plunger stopper consists of an outer crosslinked silicone layer on a fluoropolymer coating (¶103). Vogt is also concerned with balancing forces (¶4).
Sigg discloses a syringe which also looks to minimize silicone lubricant (¶29), but also meet certain requirements for particulate content (¶30). Which includes a therapeutic agent with a diameter equal to or greater than 10 µm is about 600 or less (no more than 50 in Sigg - ¶30), and with a diameter equal to or greater than 25 µm is about 60 or less (no more than 5 in Sigg - ¶30).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the barrel is non-siliconized, a thin coat lubricant applied to the solid lubricant and positioned between the solid lubricant and an interior of the barrel, wherein an average number of particles present in the therapeutic agent with a diameter equal to or greater than 10 µm is about 600 or less, and with a diameter equal to or greater than 25 µm is about 60 or less, the thin film lubricant is silicone or silicone oil (crosslinked with the fluoropolymer coating so that there are not free silicone particles) as taught by Vogt and Sigg to decrease the likelihood of negative drug interactions with the silicone lubricant while maintaining desirable sliding properties/forces.
Regarding claim 14, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the amount of thin film lubricant present on the stopper is from about 0.3 µg to about 100 µg (¶61).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Horsch such that the mass of the thin film lubricant is present on the stopper in an amount from about 0.3 μg to about 50 μg (¶61) as suggested by Horsch itself as part of balancing/achieving desired sliding forces.
Regarding claim 21, while Horsch substantially discloses the invention as claimed, it does not disclose wherein the solid lubricant and the thin film lubricant on the stopper represent the total lubricant in the syringe.
Vogt discloses the barrel is usually coated with a lubricant layer to affect the sliding of the plunger (¶92). Meaning there are instances where the barrel is not coated.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Vogt such that the solid lubricant and the thin film lubricant on the stopper represent the total lubricant in the syringe as suggested by Vogt as part of balancing sliding forces vs possible negative interactions of the drug with lubricant in the barrel.
Response to Arguments
Applicant’s amendments overcome the previous rejections. However, newly introduced reference Vogt renders the new limitations obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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