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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/29/25 is acknowledged.
Claims 23, 25-26, 38, 40-41, 52-56, 60-61, 64-66, 68-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/29/25.
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) 5, 7, 8, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et al. (US 2014/0011717 A1) in view of Bicker et al. (US 2014/0305830 A1).
With regard to claim 5, Thornton discloses a plastic syringe barrel ([0038], [0044, olefin polymer syringe barrel, this material is a plastic) comprising: a plastic syringe barrel ([0044]) treated with a downstream plasma ([0021], [0028], [0044]) and coated with a polysiloxane-based lubricant ([0035], [0044]) treated with a downstream plasma ([0044]).
However, Thornton does not disclose a specific surface density.
Bicker teaches the use of a plastic syringe ([0033]) that is also treated with plasma ([0004]) and coated and seeks to have a surface density of less than 50 particles per cm2 ([0025], [0040], [0165], [0166], the claimed range falls within the range taught by Bicker), wherein the particles are greater than 8 microns (([0025], [0040], [0165], [0166], the claimed range fall within the range taught by Bicker), and wherein the plastic syringe barrels are empty when the particles are counted (([0025], [0040], [0165], [0166], surface density is measured prior to a medication fluid being placed in the barrel). While Bicker teaches a wider range than the claimed range it would be prima facie obvious to optimize the surface density to be that of the claimed range because the primary reference Thornton teaches the same surface treatment to a plastic syringe as that of the claims and would be able to be optimized to have the claimed surface density. The claims have not provided a significance to the particular range and therefore it would be prima facie obvious to optimize the surface density because doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface density of Thornton to be less than 50 particles per cm2 as taught by Bicker for the purpose of ensuring low particulate emission ([0025]) and also because the optimization of the surface density is well-known in the art and would not alter the overall function of the device.
With regard to claim 7 and 8, Thornton discloses the claimed invention except for the specific surface density.
Bicker teaches the treated syringe surface can have a surface density of less than 35 or 30 particles per cm2, wherein the particles are greater than 8 microns in diameter, and wherein the plastic syringe barrels are empty when particles are counted ([0025], [0040], [0165], [0166]). While Bicker teaches a wider range than the claimed range it would be prima facie obvious to optimize the surface density to be that of the claimed range because the primary reference Thornton teaches the same surface treatment to a plastic syringe as that of the claims and would be able to be optimized to have the claimed surface density. The claims have not provided a significance to the particular range and therefore it would be prima facie obvious to optimize the surface density because doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface density of Thornton to be less than 35 or 30 particles per cm2 as taught by Bicker for the purpose of ensuring low particulate emission ([0025]) and also because the optimization of the surface density is well-known in the art and would not alter the overall function of the device.
With regard to claim 9, Thornton discloses a plastic syringe barrel ([0038], [0044, olefin polymer syringe barrel, this material is a plastic) comprising: a plastic syringe barrel ([0044]) treated with a downstream plasma ([0021], [0028], [0044]) and coated with a polysiloxane-based lubricant ([0035], [0044]) treated with a downstream plasma ([0044]). Thornton further teaches a plunger rod ([0010]).
However, Thornton does not disclose a specific surface density.
Bicker teaches the use of a plastic syringe ([0033]) that is also treated with plasma ([0004]) and coated and seeks to have a surface density of less than 50 particles per cm2 ([0025], [0040], [0165], [0166], the claimed range falls within the range taught by Bicker), wherein the particles are greater than 8 microns (([0025], [0040], [0165], [0166], the claimed range fall within the range taught by Bicker), and wherein the plastic syringe barrels are empty when the particles are counted (([0025], [0040], [0165], [0166], surface density is measured prior to a medication fluid being placed in the barrel). While Bicker teaches a wider range than the claimed range it would be prima facie obvious to optimize the surface density to be that of the claimed range because the primary reference Thornton teaches the same surface treatment to a plastic syringe as that of the claims and would be able to be optimized to have the claimed surface density. The claims have not provided a significance to the particular range and therefore it would be prima facie obvious to optimize the surface density because doing so would not alter the overall function of the device. Bicker further explicitly teaches a plunger stopper ([0002]) and needle ([0219]). It is also inherent for a syringe such as the one taught in Thornton to have these structures as part of a standard syringe.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface density of Thornton to be less than 50 particles per cm2 as taught by Bicker for the purpose of ensuring low particulate emission ([0025]) and also because the optimization of the surface density is well-known in the art and would not alter the overall function of the device.
Claim(s) 17, 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et al. (US 2014/0011717 A1) in view of Bicker et al. (US 2014/0305830 A1) in view of Kurose (US 2016/0206832 A1).
With regard to claim 17, Thornton/Bicker teach the claimed invention except for an ophthalmic solution.
Kurose teaches a syringe ([0004]) containing ophthalmic solution ([0004], Kurose teaches an intravitreal injection which is one used for the eye and thus the solution is an ophthalmic solution as the term ophthalmic is defined as relating to the eye) and the particle level in the ophthalmic solution is less than 50 particles per ml for any particles greater than 10um in diameter ([0004]) or less than 5 particles for any particles greater than 25um ([0004]), Kurose teaches a broader range such that for all particles sizes the solution less than 50 particles per ml. However it would be prima facie obvious to optimize the specific particle level as doing so would not alter the overall functions of the device and the claims have not provided a significance to this particular range.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thornton/Bicker with an ophthalmic solution have a particular particle count as taught by Kurose because the optimization of ophthalmic solution is well-known in the art for use specifically in ophthalmic surgery via intravitreal injection ([0005]).
With regard to claim 20, Thornton/Bicker teach the claimed invention except for the size of the plastic syringe.
Kurose teaches the plastic syringe having a maximum fill volume of 1ml ([0004]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thornton/Bicker with a syringe barrel having 1ml or less in volume as taught by Kurose for the purpose of use in intravitreal injection where larger volumes would not be tolerated ([0004]).
With regard to claim 21, Thornton/Bicker teach the syringe barrel as taught in claim 5. However, Thornton/Bicker do not teach specifically administering an ophthalmic solution.
Kurose teaches a method of treating the eye ([0005], [0004]) comprising intravitreally administering the ophthalmic solution ([0004]) to an eye with the syringe of claim 17 (as described above).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thornton/Bicker with an ophthalmic solution have a particular particle count as taught by Kurose because the substitution and use of one type of medication for another is well-known in the art and is a simple substitution that does not alter the overall function of the device ([0004], [0005]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et al. (US 2014/0011717 A1) in view of Bicker et al. (US 2014/0305830 A1) in view of Terumo (WO 2017/086366 A1).
With regard to claim 11, Thornton teaches the use of silicone oil ([0035]).
However, Thornton/Bicker do not teach the specific amount of silicone oil.
Terumo teaches applying silicone oil to a syringe barrel in the amount of 0.02 to 0.2 mg/cm2 which falls in the claimed range ([0077]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thornton/Bicker with the specific amount of silicone oil as taught by Terumo for the purpose of being able to applying a uniform amount of oil on the inner surface without excessively applying the silicone oil ([0077]).
Response to Arguments
Applicant's arguments filed 3/9/26 have been fully considered but they are not persuasive. It should be noted that it is unclear whether claim 5 was supposed to have been amended or not. The remarks on p. 9 mention “based on the foregoing amendments and the following remarks…”. If claims were to have been amended then a new rejection may be warranted however, if claims were intended to be previously presented below is a response to Applicant’s arguments.
Applicant states that Blicker would have led away from the use of silicone lubricants and there not combined with the disclosure of Thornton. While this may be true, Blicker is the not the primary reference. If Blicker was the primary and Thornton was being used to teach the addition of silicone lubricants then it would be agreed that Blicker’s teaching away from the use of silicone lubricants would prohibit the combination with Thornton to add silicone lubricants. However, in this case Thornton is the primary and Thornton teaches all the claimed limitations except for the specific claimed range. Thus Blicker is only being used to teach that an interior surface can have this specific range of surface density for use in a syringe. Additionally, even without the Blicker reference, the claims could be rejected under a 103 rejection over Thornton alone because the only limitation missing from Thornton is the specific range. Thornton already discloses all the claimed elements except for this range and it would still be prima facie obvious to optimize the surface density to be that of the claimed range as doing so would not alter the overall function of the device. It is suggested that the significance of the claimed range be added to the claims in order to help overcome the current rejection. Alternatively, further defining the interior surface of the syringe after downstream plasma such as other properties of the inner surface may also help to overcome the current rejection. Examiner is open to an Interview to help further prosecution.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
Prosecution Insights