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 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gopal et al. (US 2017/0281629 A1) in view of Maeda et al. (US 2013/0053786 A1) and Le et al. (US 2021/0212321 A1).
With regard to claim 1, Gopal et al. teach a pre-filled syringe, comprising: a barrel having a first, proximal end and a second, distal end with a medicament disposed therein (see at least [0027], [0033] a syringe is used to deliver the medicament which would necessarily have a proximal end and distal end with the medicament), wherein the medicament is a suspension of paliperidone palmitate ([0002]), and a stopper disposed within the barrel adjacent the first end of the barrel, the stopper having a body with a distal end and a proximal end and having an outer sidewall extending therebetween ([0027], the syringe includes a plunger stopper which would necessarily have proximal and distal ends and a sidewall).
The details of the delivery syringe are not disclosed. Gopal et al. teach various dosages may be used ([0011], [0027]) but do not disclose the volume delivered, the syringe to have a nominal capacity of 5 mL, or a stopper with two adjacent sealing rings as recited. However, Maeda et al. teach a known size for a pre-filled syringe is 5mL with an inner diameter of 12.45mm ([0069]) and the plunger has two protrusions which can improve sealing performance (Fig. 1C members 117, [0004]). As Gopal et al. teach various dosages may be used depending on the patient and the particular treatment it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention that one of ordinary skill would be able to select a dose as desired, as it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980), such that a volume of medicament of 3.5 mL or 5 mL would be presented and to further use a 5mL syringe to contain such doses as Maeda et al. teach such syringes are commercially known for pre-filled syringe doses. Further, 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 two sealing rings on the stopper as Maeda et al. teach this is beneficial for enhancing sealing performance.
Gopal et al. and Maeda et al. do not disclose a head space distance. However, Gopal et al. disclose that the substance in the syringe should be shaken or agitated prior to delivery to ensure homogenous suspension and prevent clogging ([0033]). Further, Le et al. teach that when a substance needs to be shaken to re-suspend the substance a headspace of 15%-18% of the volume of the container is necessary to allow for re-suspension ([0085]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a head space distance between the medicament and the stopper in Gopal et al. as Gopal et al. teach shaking the substance is necessary and Le et al. teach including a headspace is beneficial for ensuring a shaken substance is properly re-suspended. As Le et al. teach the head space is beneficial for shaking or agitating the suspension and the other features are the same as in the claim the headspace would provide sufficient space for shaking and would minimize frothing or clogging.
As combined the head space distance can be calculated. Maeda et al. teach the radius of the syringe (half the diameter is equal to 6.255 mm). Using a fill volume of 3.5 mL, taken to be the container volume as the syringe would not be filled fully, 18% of this volume is .63 mL which is equal to 630 mm3. Using the formula for the volume of a cylinder the height/distance of the headspace volume can be calculated which would be 5.17 mm. This results in a ratio of 1.48 mm/mL. Using a fill volume of 5 mL, 15% of this volume is .75 mL which is equal to 750 mm3. Using the formula for the volume of a cylinder the height/distance of the headspace volume can be calculated which would be 6 mm. This results in a ratio of 1.2 mm/mL.
Conclusion
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
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