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 .
DETAILED ACTION
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-11, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0098942 (Greter).
Regarding claim 1-5, 8-11, 18, Greter teaches a syringe (Fig 1, 6, para 45-49), comprising: a container body including an inner wall (body 110 with inner wall 111); a plunger including a plunger rod (plunger 120 with rod 121), the plunger rod being disposed at least partially within the container body (Fig 1, 6); and a locking arrangement configured for locking a position of the plunger rod relative to the container body and for being operable between at least a locked position and an unlocked position (locking arrangement including securing element 130; the locked position is construed as the securing element 130 being attached to the plunger; the unlocked position is when the securing element 130 is detached from the plunger), the locking arrangement including at least one deformable element which is configured for applying a locking force between the plunger rod and the inner wall of the container body when the locking arrangement is in the locked position and for releasing the locking force between the plunger rod and the inner wall of the container body when the locking arrangement is changed from the locked position to the unlocked position (para 53-54: deformable element is sealing element 141 which is compressed against both the sidewall 111 and the plunger rod 121; this is the same arrangement/locking mechanism as Applicant; therefore if Applicant’s can be construed as a locking arrangement, so too can Greter; also, para 58-59: while the securing element 130 is coupled to the plunger 120, the piston 140 is also coupled to the plunger, and the piston may be immovable due to friction forces; “the advancement element 120 is pulled from the housing 110 to such an extent that the carrier sleeve 145 of the piston 140 forms a proximal end stop in the region of the proximal end of the housing 110”, which locks a position of the plunger rod relative to the container body; the piston 140 is “immovable relative to the housing 110 because of the resulting frictional forces”), the locking arrangement including a sliding member which is configured for moving relative to the plunger rod and for applying a pressing force on the at least one deformable element, the sliding member being elongate and thereby extending beyond the container body when the at least one deformable element is positioned between the distal end and the proximal end of the container body (para 53-54; sliding member including elements 130 and 145; both movable relative to the plunger rod 121; 130 extends beyond the container body – see Fig 1), wherein the locking arrangement is attached to the plunger rod (Fig 1, 6, para 53-54), wherein the container body includes an inner periphery, the at least one deformable element being arranged to extend along the inner periphery of the container body (Fig 3-4), wherein (i) the inner periphery of the container body is essentially circular, and the at least one deformable element has an essentially circular shape (Fig 3-4, para 45), or (ii) the inner periphery of the container body is essentially polygonal, and the at least one deformable element has an essentially polygonal shape, wherein the at least one deformable element is further configured to seal a gap between the inner wall of the container body and the plunger rod when the locking arrangement is in the locked position (para 15, 53-54), wherein the locking arrangement further comprises a lateral protuberance which extends from a portion of the plunger rod, and wherein the at least one deformable element is arranged to be pressed towards the lateral protuberance when the locking arrangement is in the locked position (Fig 3; the lateral protuberance is the radially extending flange extending from the rod 121; deformable element 141 is pressed towards the protuberance), wherein the sliding member is configured to apply a pressing force on the at least one deformable element towards the lateral protuberance when the locking arrangement is in the locked position (para 53-54), wherein at least one of the lateral protuberance and the sliding member are configured to cause at least one of deformation and displacement of at least a portion of the at least one deformable element towards the inner wall of the container body when the locking arrangement is in the locked position (para 54), wherein at least one of: the lateral protuberance extends from the plunger rod (Fig 3), and the sliding member comprises a tube in which the plunger rod extends at least partially (para 50, Fig 3); and the locking arrangement further comprises at least one actuating member configured for at least one of (a) moving the sliding member towards the at least one deformable element when bringing the locking arrangement to the locked position, and (b) releasably holding the locking arrangement in the locked position (actuating member 130, 131 engages the sliding member 145 when going to the locked position, and releasably holds the locking arrangement in the locked position by being attachable and detachable from the plunger), a stopper, wherein the at least one deformable element is not in direct contact with the stopper (stopper 122; in the position of Fig 2, the deformable element does not contact the stopper).
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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2020/0282130 (Hemminger) and US 2020/0149948 (McDermott).
Regarding claim 6-7, Greter fails to teach the at least one deformable element is configured to seal the gap between the inner wall of the container body and the plunger rod against a pressure difference of at least 500 Millibars, at a temperature of minus 80 degrees Celsius or wherein the pressure difference is at least 600 Millibars or at least 800 Millibars. However, it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" (see MPEP 2114 [R-1]). In this case, the pressure difference and temperature do not differentiate the claimed apparatus from Greter because Greter teaches all the structural limitations of the claim (e.g. container body, plunger, locking arrangement, etc.). The limitation, “configured to seal the gap … against a pressure difference of at least 500 Millibars, at a temperature of minus 80 degrees Celcius” and that of claim 7 claims the manner in which the claimed apparatus is intended to be employed and does not provide a structural limitation.
However, Hemminger further teaches that a syringe may be configured to seal against a pressure difference of at least 500 Millibars, wherein the pressure difference is at least 600 Millibars or at least 800 Millibars (para 43-44). Furthermore, McDermott teaches that the temperature and pressure of a syringe are results-effective variables, affecting system capacitance (para 58). 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), MPEP 2144.05 IIA. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the at least one deformable element is configured to seal the gap between the inner wall of the container body and the plunger rod against a pressure difference of at least 500 Millibars, at a temperature of minus 80 degrees Celsius or wherein the pressure difference is at least 600 Millibars or at least 800 Millibars in order to achieve a desired system capacitance, as taught by McDermott.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2009/0259198 (Chong).
Regarding claim 12, Greter fails to teach at least one of: (a) the container body is uncoated or silicone-free coated in an area of the container body contacting with the at least one deformable element when the locking arrangement is in the locked position; and (b) at least one of (i) a material of the at least one deformable element comprises a silicone, and (ii) the at least one deformable element is silicone oil-free coated. However, Chong teaches that a deformable sealing element may comprise silicone (para 141, 149; seal element 524 or 624 may be made of silicone). It would have been obvious to one of ordinary skill in the art at the time of the invention to make a material of the at least one deformable element comprises a silicone, as taught by Chong. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making a material of the at least one deformable element comprise a silicone yields predictable results.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2009/0259198 (Chong), and further in view of US 2017/0296756 (Giraud).
Regarding claim 13, Greter in view of Chong fails to teach wherein the at least one deformable element is silicone oil-free coated, liquid-free coated, or uncoated. However, Giraud teaches that deformable sealing elements may be uncoated (Fig 38A, para 110; sealing section 951 is analogous to the deformable sealing element of Greter and is uncoated – “no film coating”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the at least one deformable element uncoated, as taught by Giraud. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the at least one deformable element uncoated yields predictable results.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2020/0410897 (Baker).
Regarding claim 14, Greter fails to teach the container being pre-filled. However, Baker teaches that syringes may comprise pre-filled containers (para 1, 90). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the container pre-filled, as taught by Baker. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the container pre-filled yields predictable results.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2020/0282130 (Hemminger) and US 2020/0149948 (McDermott).
Regarding claim 15, Greter teaches the locking arrangement is configured to reduce a motion of the plunger relative to the container body to less than 3 millimeters but fails to teach when applying a pressure difference of 500 Millibars, at a temperature of minus 20 degrees Celsius.
However, Hemminger further teaches that a syringe may be configured to seal against a pressure difference of at least 500 Millibars (para 43-44). Furthermore, McDermott teaches that the temperature and pressure of a syringe are results-effective variables, affecting system capacitance (para 58). 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), MPEP 2144.05 IIA. It would have been obvious to one of ordinary skill in the art at the time of the invention to apply a pressure difference of 500 Millibars, at a temperature of minus 20 degrees Celsius in order to achieve a desired system capacitance, as taught by McDermott.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter) in view of US 2014/0350517 (Dominguez).
Regarding claim 16, Greter fails to teach the locking arrangement is configured to apply the locking force in a range of 5 to 15 newtons. However, Dominguez teaches that the locking force of the locking arrangement may be chosen depending on the application, and on the desired stress level (para 51-63; the force at which the locking system locks movement is determined and optimizable for the application; the maximum allowable pressure also determines the force at which the locking system locks the plunger). It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the locking force in a range of 5 to 15 newtons in order to achieve a desired stress level and pressure, as taught by Dominguez. 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), MPEP 2144.05 IIA. In this case, the locking force is a results-effective variable, affecting normal and shear stresses and pressure.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0098942 (Greter)
Regarding claim 17, Greter fails to teach at least one of: (a) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 0 to 1 millimeters, when the locking arrangement is in the unlocked position; and (b) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 2 to 20 millimeters, when the locking arrangement is in the locked position. However, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (MPEP 2144.04IV.A.; In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). It would have been obvious to one of ordinary skill in the art at the time of the invention to make at least one of: (a) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 0 to 1 millimeters, when the locking arrangement is in the unlocked position; and (b) a contact length between the at least one deformable element and the inner wall of the container body is in a range of 2 to 20 millimeters, when the locking arrangement is in the locked position, as the claimed locking arrangement would not perform differently than Greter’s device, which provides a contact length, a seal, and locking when the locking force is applied.
Allowable Subject Matter
Claims 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach, in combination with the other claim limitations, the locking arrangement is in the locked position and the following parameters are fulfilled: a brimful volume of the container body is 0.5 to 100 milliliters; the container is configured for being prefilled with a liquid; the container further comprises a headspace of gas of 0 to 40 millimeters; wherein a movement of the plunger rod is 3 millimeters or less, after at least one of the following test conditions has been applied: (i) a pressure outside the container with regard to an inside of the container is reduced by 100 to 1000 millibars, for 1 second to 1 week; (ii) the container is stored at -210°C to 25°C, for 1 second to 7 days.
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 ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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