DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The term “medicament reservoir” in claim 1 is not given a special definition within the applicant’s specification, therefore the term is interpreted herein according to the commonly understood definition within the art. In the field of syringes, this term is understood to mean a cavity configured to (i.e. capable to) hold a medicament or other fluid.
In claim 1, the limitation “containing a medicament” is not given patentable weight. MPEP 2115 establishes that an apparatus claim is only limited by positively recited elements of the apparatus. “Thus, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); and In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). In the present claim, the apparatus being claimed is a syringe. Applicant(s) specification does not provide an alternative or special definition of “a syringe”, thus the commonly understood definition within the art is used for purposes of claim interpretation. A syringe is defined within the art to be a device (apparatus) which works upon (withdraws, holds, and/or dispenses) a liquid or gaseous load, such as a liquid or gaseous medicament. Thus, “a medicament” does not form an element of the syringe device claimed, but rather the load/material upon which the claimed device works in its intended use. For examination purposes, this limitation is therefore interpreted to be functional language describing the intended use (the load withdrawn/held/dispensed) of the syringe.
In claim 15, the limitation “the medicament” as used throughout the claim is interpreted as referring to the medicament to be stored within “a medicament reservoir” as defined in claim 1. As such, the limitation “all of the medicament” in claim 15 is interpreted to refer to all of the medicament stored within the medicament reservoir.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-10, 12-14, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (U.S. Pat. Pub. No. 2020/0069889 A1), with evidence provided by Leibinsohn (U.S. Pat. No. 4,064,879) and Liang (CN108578832B).
Regarding claim 1, Lin discloses a syringe (device 10, which may be a syringe – see Fig. 1A-9B and [0053]) comprising: a barrel (barrel 20) defining a medicament reservoir (portion of barrel 20 extending between connecting tube 202 and plunger stopper 40) capable of containing a medicament (see Fig. 1A-9B and [0056], wherein it is clear that the barrel 20 may draw in liquid or gaseous substance, such as liquid/gaseous medicament, and see also the example of Liang, Fig. 1-5 and English Translation, pg. 5, ln 14 – pg. 6, ln 19, wherein a similar configuration of syringe is provided as described as capable of withdrawing, containing, and dispensing medicament from within a similar reservoir space) in fluid communication with a needle hub (connecting tube 202) at a distal end of the barrel (see Fig. 1A-9B and [0053]); and a plunger assembly (30) comprising a stopper (piston 40) sealing a proximal end of the medicament reservoir and slidable inside the barrel toward the distal end (see Fig. 1A-9B, [0054], [0058-0059], and [0063-0066]), a plunger rod (see Fig. 1A-9B, wherein in each embodiment, the primary body of the plunger 30 is formed by a plunger rod extending from the finger flange at the proximal end of the plunger to a sheath 304 portion), and a spring (biasing element 50) arranged between a distal end of the plunger rod and the stopper (see Fig. 1A-9B, wherein in each embodiment, the biasing element 50 is arranged as extending between the plunger rod and the piston 40), wherein distal movement of the plunger rod is configured to compress and energize the spring, whereby the spring is configured to expand to force the stopper to slide distally through the medicament reservoir to expel the medicament through the needle hub (see Fig. 3B-3C and 6A-6B, [0058-0060], and [0064-0066], wherein under conditions in which a fluid, such as medicament, occupies at least a portion of the barrel and there is some pressure upon that fluid resisting the dispensation of the fluid, as would occur at an injection site, a sufficient force applied to the plunger rod will first compress the biasing element 50, and then if the pressure applied by the plunger rod exceeds that of the fluid within the barrel, the biasing element 50 will gradually expand, transferring that pressure to the fluid and causing the fluid to dispense through the connecting tube 202 – see also Leibinsohn, Fig. 2-3, Col. 3, ln 28-64, and Col. 6, ln 3-9, and Liang, Fig. 1-5 and English Translation, pg. 5, ln 14 – pg. 6, ln 19, wherein syringes of similar configuration to that of Lin are described as capable of operating in this manner), and wherein the plunger rod is axially movable between a proximal extremal position (S1 - a position of maximum separation relative to the piston/plunger 40 – see Fig. 3B and 6A, [0058-0060], and [0064-0066]) and a distal extremal position (S2 – a position of minimum separation relative to the piston/plunger 40 – see Fig. 3C and 6B, [0058-0060], and [0064-0066]), the plunger rod being limited from fully compressing the spring throughout an entirety of axial movement from the proximal extremal position to the distal extremal position (see Fig. 3C and 6B, [0058-0060], and [0064-0066], wherein it is clear that due to the presence of sheath 304, which abuts the piston/stopper 40 on its proximal surface when the plunger rod is in its distal extremal position, the biasing member 50 is prevented from fully compressing at any time).
Regarding claim 2, Lin further discloses that the syringe further comprises an abutment at the proximal end of the medicament reservoir, the abutment stopping distal movement of the plunger (see Fig. 3C and 6B, [0058-0060], and [0064-0066]). Here, it is clear that distal movement of the plunger relative to the piston/stopper 40 is stopped when the sheath 304 portion of the plunger abuts against the proximal surface of the piston/stopper 40, which is located at the proximal end of the medicament reservoir by virtue of the fact that the piston/stopper 40 forms the proximal boundary thereof. Thus, this proximal surface of the piston/stopper 40 may be considered an abutment at the proximal end of the medicament reservoir which stops distal movement of the plunger as claimed.
Regarding claim 3, Lin further discloses that a length of the distal movement of the stopper within the medicament reservoir is proportional to a length of the distal movement of the plunger rod (see Fig. 3B-3C, 4A-4B, and 6A-6C, [0058-0060], and [0064-0066]). Here, under conditions in which a pressure resisting dispensation of the liquid in the barrel is less than the pressure applied to the plunger rod, the elastic member 50 will first compress in response to a distal movement of the plunger rod, and then expand, transferring the applied pressure to the piston/stopper 40, thereby driving it to move in the distal direction, as described above and depicted in the cited figures. Under many circumstances, the elastic member 50 may return to its full extension (S1 position), thereby imparting all distal movement of the plunger rod to the piston/stopper 40, a process depicted in Fig. 4A-4B, and 6A-6C. Such an occurrence represents a 1:1 proportion between a length of the distal movement of the stopper within the medicament reservoir and a length of the distal movement of the plunger rod. It should be noted, however, that even if the elastic member 50 does not extend to its full extension (S1 position), any amount of distal movement which the elastic member 50 imparts upon the plunger/stopper 40 would result in the length of the distal movement of the stopper within the medicament reservoir being proportional to the length of the distal movement of the plunger rod, since any ratio of two lengths may be described, or at least approximated, as a proportion of some value.
Regarding claim 4, Lin further discloses that a relaxed length of the spring substantially equals a length of the barrel (see 6A). Here, the claimed barrel structed may be interpreted to correspond to the portion of barrel tube 20 in Lin which defines the fluid/medicament reservoir, the length of which being at greatest extent the length between the distal end of the medicament reservoir and the proximal end of the piston/stopper 40 when the plunger is at its maximum withdrawal position, shown in 6A for the embodiment of Fig. 5A-6D. It is visually apparent from Fig. 6A that at least for the embodiment of Fig. 5A-6D, the elastic member 50 extends to a length substantially (interpreted herein as approximately) equal to the length of the barrel at greatest extent under this interpretation.
Regarding claim 5, Lin further discloses that a difference between a relaxed length and a fully compressed length of the spring is greater than an axial distance between the proximal extremal position and the distal extremal position of the plunger rod (see Fig. 3B-6B, wherein it is visually apparent that the elastic member 50 is not compressed to its maximum – i.e. fully compressed – when the plunger rod is in its distal extremal position relative to the piston/stopper 40 and is therefore prevented from further compressing the elastic member 50, thus it is clear that the difference in length between the relaxed length of the elastic member 50 – seen when the plunger rod is in its proximal extreme position in Fig. 3D, 4B, 5B, and 6A – and the fully compressed length, which would occur at a position more distal than the plunger rod’s distal extreme position, must be greater than an axial distance between the proximal extremal position and the distal extremal position of the plunger rod.
Regarding claim 6, Lin further discloses that the spring is configured to limit a rate at which the stopper moves distally within the medicament reservoir (see Fig. 3B-6B and above comments, wherein it is clear that the compression and expansion behavior exhibited by the elastic member 50 in response to a sudden movement of the plunger arm, as discussed above, would result in a limitation in the rate at which the piston/stopper 40 moves distally relative to the movement of the plunger, such limitation being in the same manner as is described in Liang, Fig. 1-5 and English Translation, pg. 6, ln 1-19, which exhibits a similar elastic member 8 extending between the plunger arm 7 and stopper 6 of a similar syringe).
Regarding claim 8, Lin further discloses that the plunger assembly further comprises a casing (cylindrical body 404, which is formed by cylindrical walls extending from a proximal flared-out end through the elastic piston/stopper 40 to an enclosed end on the distal side thereof) slidable inside the barrel, the spring being arranged inside the casing, and a distal end of the casing engaging the stopper (see Fig. 5A-6D and [0063-0066]).
Regarding claim 9, Lin further discloses that the plunger rod is slidable inside the casing (see Fig. 6B, wherein a small portion of the plunger rod located at and engaging with the proximal end of the elastic member 50 is slidable into the cylindrical body 404).
Regarding claim 10, Lin further discloses that the spring has windings arranged in contact with an inner surface of the casing (the inner surface of the cylindrical walls of the cylindrical body 404 - see Fig. 5A-6D), and the distal end of the spring abuts the distal end of the casing (see Fig. 5A-6D, wherein the elastic member 50 extends internally within the hollow cavity formed by cylindrical walls of the cylindrical body 404 to internally abut the distal end portion of the cylindrical body 404 which extends from its abutment with elastic member 50 through the elastic piston/stopper 40), and the distal end of the plunger rod abuts the proximal end of the spring (see Fig. 5A-6D, wherein the small portion of the plunger rod which slides into the cylindrical body 404 also may be considered the distal end of the plunger rod and engages the proximal end of the elastic member 50).
Regarding claim 12, Lin further discloses that the spring is made of metal ([0055], ln 18-19).
Regarding claim 13, Lin further discloses that the spring is in a relaxed state when the plunger rod is at the proximal extremal position (see Fig. 1A-1B, Fig. 3A-3D, and [0054], ln 20-32, wherein it is clear from Fig. 1A-1B and the associated text that the elastic member 50 is in a relaxed state in Fig. 1B, there being on force applied to it, and that the spring remains at the same length in when the plunger rod is at its proximal extreme position within the syringe, as shown in Fig. 1B, 3B, and 3D).
Regarding claim 14, Lin further discloses that the syringe comprises a flange (204) at a proximal end of the barrel (see Fig. 1B-6B, and [0053]).
Regarding claim 17, Lin discloses a syringe comprising: a barrel defining a medicament reservoir (see in re claim 1); and a plunger assembly configured to slide within the barrel (see in re claim 1), the plunger assembly comprising: a casing (see in re claim 8); a stopper at a distal end of the casing (see in re claim 8); a plunger rod configured to slide within the casing (see in re claims 8-10); a spring arranged inside the casing between a distal end of the plunger rod and a distal end of the casing (see Fig. 5A-6D and [0063-0066]); and a sleeve (sheath 304) fixed to the plunger rod and configured to slide over the casing (see Fig. 5A-6D and [0063-0066]).
Regarding claim 18, Lin further discloses that the plunger rod is axially movable between a proximal extremal position and a distal extremal position (see in re claim 1), and wherein a travel distance of the plunger rod between the proximal extremal position and the distal extremal position is less than a relaxed length of the spring (see Fig. 5A-6D and [0063-0066], wherein the travel distance of the plunger rod between the proximal extremal position relative to the piston/stopper 40 and the distal extremal position relative to the piston/stopper 40 is limited to approximately half of the relaxed length S1 of the spring due to the sheath 304 abutting against the proximal end surface of the piston/stopper 40 and thereby preventing greater distal movement of the plunger arm relative to the piston/stopper 40).
Regarding claim 19, Lin further discloses that the distal end of the casing is received within the stopper (see Fig. 5A-6D, wherein the distal end of the casing/cylindrical body 404 extends within the piston/stopper 40).
Regarding claim 20, Lin further discloses that a proximal end of the barrel comprises a flange (see Fig. 5A-6D and [0063], wherein it is clear that the syringe of this embodiment comprises a ridge internal to the proximal end of the barrel in a similar manner to flange 204 of the embodiment of Fig. 1A-4B, and for the same purpose – that of locking the plunger arm in position relative to the barrel), and wherein a distal end of the sleeve is configured to engage the flange to limit distal movement of the plunger rod relative to the barrel (see Fig. 5B-6A and [0063], ln 5-16, wherein an elastic ring 310 and several ridge/flanges are provided at the distal end of the sheath/sleeve 304, the sheath ridges/flanges forming a groove therebetween capable of engaging with the internal ridge/flange of the barrel at the proximal end of the barrel to thereby limit distal and proximal movement of the plunger rod relative to the barrel).
Regarding claim 21, Lin further discloses a needle hub (202) and needle (604) extending from the needle hub (see Fig. 5A-6D and [0064]).
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) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Kosinski (U.S. Pat. Pub. No. 2011/0009830 A1).
Regarding claim 11, Lin discloses the plunger assembly further comprises a sleeve (sheath 304) fixed to the plunger rod and slidable over the casing (see Fig. 5A-6D and [0063-0066]). Lin fails to teach that the sleeve comprises one or more rails each guiding a respective pin of the casing, however, Lin teaches that a primary goal of the syringe of Lin is to allow the user to visualize the relative movement of the piston/stopper 40 with respect to the plunger arm, thereby allowing the user to visually appreciate/measure the changes in pressure exerted on the fluid within the barrel (and thus the changing pressure on the elastic element 50 which causes said relative movement) due to the depth of the needle within a patient’s body at the injection site ([0015], [0034], and [0063-0065]). In line with this goal, Lin teaches that the sleeve (sheath 304) may comprise an indicator window and that the casing (cylindrical body 404), which is attached to the piston/stopper 40, may comprise markers corresponding with said window and allowing the user to visualize/measure the movement of the piston/stopper 40 relative to the plunger arm ([0066]).
Kosinski exhibits a syringe (100) of similar configuration to that of Lin, wherein the syringe comprises a plunger arm (130) connected to a thumb press (170) elastically in a similar manner to the connection between the plunger arm and piston/stopper of Lin (see Fig. 1-16 and [0069-0076]). Here, Kosinski’s plunger arm comprises a sleeve (proximal wall 152) extending from the end of the plunger arm in a similar manner to the sleeve and plunger arm of Lin, Kosinski’s thumb press comprises a casing (portion 174, comprising fingers 176) in a similar manner to the piston/stopper of Lin, and there being an elastic member (192) connecting the plunger arm and the thumb press in a similar manner to the elastic member of Lin, which connects the plunger arm and piston/stopper of Lin (see Fig. 1-16 and [0069-0076]). Kosinski teaches that the sleeve may comprise rails (openings 154) each guiding a respective pin (engagement tab 180) of the casing (see Fig. 2-6 and 14-16, and [0070-0076]) in order to provide a visual indication to the user of the amount of compression of the elastic member, and thereby of the movement between the casing and the sleeve ([0015] and [0076], ln 11-14).
Because the rail/tab configuration of Kosinski represents an alternative known means within the art of allowing the user to visualize/measure the relative movement between a sleeve and casing such as those of Lin, 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 sleeve and casing of Lin to comprise the rail/tab configuration taught by Kosinski, such that the sleeve comprises rails each guiding a respective pin of the casing, as taught by Kosinski, as a matter of simple substitution of one known configuration (that of Kosinski) for another (that of Lin) in order to obtain predictable results - in this case, a visual indication to the user that is visible from multiple sides/angles of the syringe showing the amount of compression of the elastic member of Lin, and therefore of the relative movement between the plunger arm of Lin and the piston/stopper of Lin, such being in accordance with one of the primary goals of Lin, as described above. See MPEP 2143(I)(B).
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Leibinsohn and Liang.
Regarding claim 15, Lin discloses the syringe of claim 1, wherein it is clear that the syringe of Lin is capable of withdrawing a liquid, such as a medicament, from a source, such as a vial (it is well known within the art that medicament may be stored in vials) by inserting a needle of the syringe in the vial (see [0053-0056], wherein the process of drawing liquid into the syringe is presented, showing that the syringe of Lin is capable and intended to withdraw liquid from a source, through the needle hub, which may comprise a needle, and into the barrel), of inserting the needle at injection location ([0057] and [0063-0065]), and of the user pressing the plunger assembly until the plunger assembly abuts an abutment of the barrel (see Fig. 1B-6B and [0065], wherein no structure prevents the plunger arm from being pressed to a distal extent where the piston/stopper 40 is pushed into abutment with the distal end of the barrel) and holding the plunger assembly until all of the medicament has been expelled (see Fig. 1B-6B and [0065], and see Leibinsohn, Col. 6, ln 3-9, and Liang, Fig. 1-5 and English Translation, pg. 5, ln 14 – pg. 6, ln 19, wherein a syringe of similar configuration to that of Lin is described as capable of such a use). Lin fails to teach the method of doing so, since Lin is primarily concerned with a different use of the syringe (that of pressure change detection), however, in view of references such as Leibinsohn, which teaches that a syringe of the same configuration as that of Lin and indented for the same purpose (that of pressure change detection) may also be used for continuous slow rate injection of fluid into the patient (Col. 6, ln 3-9), and of Liang, which teaches that such a syringe of the same configuration as that of Lin may be used for slow rate injection of medicament into a patient (Liang, English Translation, pg. 5, ln 14 – pg. 6, ln 19), it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the syringe of Lin for slow-rate injection of medicament into a patient in the manner claimed, since some drugs and some injection sites require such slow rate injection in order to prevent discomfort or injury to the patient, as taught by Liang (English Translation, pg. 1, ln 8-15), and since the syringe of Lin is clearly capable of such a task in addition to its intended use.
Regarding claim 16, Lin further discloses that a needle (604) may extend from the needle hub (202) (see Fig. 1B-6B and [0053]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3745
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783