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 .
This Final Office Action is in Reply to the arguments/amendment (hereinafter “Response”) dated 05/22/2026. Claim(s) 1-6, 8-15, and 17-22 are presently pending. Claim(s) 7 and 16 is/have been cancelled. Claim(s) 22 is/are new.
Response to Arguments
Regarding the rejection of claim(s) 1-6, 8-10, 12-14, and 17-21 under 35 U.S.C. 102(a)(1) as being anticipated by Lin (U.S. Pat. Pub. No. 2020/0069889 A1), of claim 11 under 35 U.S.C. 103 as being unpatentable over Lin in view of Kosinski (U.S. Pat. Pub. No. 2011/0009830 A1), and of claims 15-16 under 35 U.S.C. 103 as being unpatentable over Lin in view of Leibinsohn (U.S. Pat. No. 4,064,879), the applicant(s) argues that these references do not teach that the spring (interpreted as biasing element 50 of Lin) is arranged between a distal end of the plunger rod and the stopper, as required by the claims. Specifically, the applicant(s) allege that the biasing element 50 of Lin cannot be considered to be arranged between a distal end of the plunger rod (body of plunger 30 extending from the finger flange to sheath 304) and the stopper (piston 40) because the biasing element 50 extends partially within and is thus covered partially by the sheath 304 portion of the plunger 30.
The Office respectfully considers this argument not persuasive. The Office's interpretation is reasonable under broadest reasonable interpretation (BRI). First, the claim does not define explicitly what "a distal end of the plunger rod" entails. Neither does the specification give a unique definition to this phrase. Since "the distal end" is not defined within the claim to require a single flat end face (the narrowest possible interpretation), “the distal end” of the plunger rod may instead be interpreted under BRI as comprising the distal end region of the component, such as including the entirety of the sheath 304 structure, which is provided at the distal end portion of the plunger rod. Under this interpretation, the inner surface of the sheath/plunger rod which forms the proximal end of the cavity defined by the sheath 304 (wherein the elastic member 50 is anchored) may be considered part of the distal end of the plunger rod, whereupon it is clear from Fig. 1A-9B that the entire biasing element 50 is arranged between a portion of the distal end of the plunger rod (this inner surface of the sheath/plunger rod) and the stopper/piston 40 at all times.
Applicant(s) also argue that when the biasing element 50 is compressed (in the “sensing mode” of Fig. 6B), it no longer extends between the distal end of the plunger rod and the stopper/piston 40, since the biasing element 50 has been contained within the sheath 304, which slides over the biasing element 50. Applicant(s) allege that such disqualifies the biasing element 50 from exhibiting the claimed configuration, since “the biasing element 50 does not move axially between the distal end of the plunger rod and the stopper as claimed” and “the biasing element 50 extends inside the plunger 30 (within the sheath 304), and the distal end of the plunger (sheath 304) moves relative to the biasing element 50 rather than the spring being arranged between them.” Such allegation is built upon limitations that are not present within the claims – the claims do not contain any limitation requiring that the spring “move axially” relative to the distal end of the plunger rod and the piston, nor does the claim prohibit that a portion of the distal end of the plunger rod may slide over the spring during operation of the device. The allegation is also built upon the premise that “the distal end” of the plunger rod must only include the distal-most end surface of the sheath 304 of the plunger rod (the narrowest possible interpretation), whereupon, when sheath 304 slides over the biasing element 50, the distal-most end surface of sheath 304 passes the distal end of the biasing element 50 and contacts the stopper/piston 40 directly, thus eliminating any gap between “the distal end” of the plunger rod and the stopper into which the biasing element 50 may be arranged. However, as discussed above, the claim does not limit the scope of the phrase “the distal end” in this manner.
Yet, even if the narrowest definition of “the distal end” of the plunger rod were used, it is clear from Fig. 5A-6D that, at least when the device is at rest (non-sensing mode of Fig. 6A) and in all other operating conditions, excluding the “sensing mode” of Fig. 6B (see Fig. 6C-6D), at least a portion of the biasing element 50 extends within the gap/space separating the distal-most end surface of sheath 304 and the stopper/piston 40. The claim does not require that the biasing element (50) extend exclusively between the distal end face of the plunger and the stopper (i.e. the claim does not explicitly prohibit that some portion of the spring may extend within some portion of the distal end of the plunger). Thus, even under the narrowest interpretation of "the distal end of the plunger rod", it is clear that the biasing element 50 of Lin meets the claimed limitation in that at least a portion of the biasing element 50 extends within a gap between the distal end face of the plunger rod and the stopper at many points during operation of the device, as well as when the device is at rest.
Finally, applicant(s) assertion that the biasing element 50 of Lin merely "extends inside the plunger 30 (within the sheath 304), and the distal end of the plunger (sheath 304) moves relative to the biasing element 50 rather than the spring being arranged between them" entirely mischaracterizes the function and configuration of the biasing element 50 of Lin. It is quite clear from Fig. 3B-3C and 6A-6B, [0058-0060] and [0064-0066] of Lin that the biasing element 50 elastically connects the plunger rod 30 to the piston/stopper 40, thereby enabling a distal movement of the plunger rod 30 to compress the biasing element 50, which in turn may expand against the piston/stopper 40 to drive medicament out through the needle hub in the manner described in the prior Non-Final rejection, para. 8, ln 18-26.
Applicant(s) also argue, in re the modification of Lin in view of Kosinski, that it would not have been obvious to one of ordinary skill in the art to incorporate Kosinski’s rail/tab configuration within the device of Lin, since the proposed modification would allegedly fundamentally alter Lin’s sensing mechanism by interfering with the free sliding relationship between the sheath 304 and cylindrical body 404 of Lin. Applicant(s) allege that adding rails to Lin’s sheath 304 and pins to Lin’s cylindrical body 404 would constrain the relative movement between the sheath 304 and cylindrical body 404 to guided linear motion along the rails, allegedly introducing friction and mechanical constraint that would interfere with Lin’s primary function of sensing pressure changes through visual observation of relative movement between the sheath 304 and cylindrical body 404.
The Office respectfully considers this argument not persuasive. It is clear from Fig. 2-6 and 14-16, and [0070-0076] of Kosinski (as well as common knowledge of how a pin and rail function) that the pin/rail configuration taught by Kosinski would only constrain relative movement between the sheath 304 and cylindrical body 404 in the rotational direction (preventing rotation about the axial axis of the plunger rod), a direction entirely irrelevant to the pressure sensing purpose of Lin (see [0058-0059], [0064], and [0066], wherein axial motion between the cylindrical body 404 and sheath 304 are indicative of pressure, not rotational motion). Applicant asserts that such features would significantly increase friction between the two components but provides no evidence showing that significant increase in friction is the expected result of implementing such a pin/rail connection. Rather, such tab/rail or pin/slot connections are common in many fields and devices familiar to the average consumer and are not associated with a significant increase in friction. Further, it is well within the skill of one of ordinary skill in the art to design such a connection in a manner allowing the tabs/pins to slide freely in the axial direction within the rails/slots.
Applicant(s) also allege that adding protruding pins to the cylindrical body 404 would alter its outer surface geometry, potentially interfering with the sheath 304’s ability to fully cover the cylindrical body 404 during compression.
The Office respectfully considers this argument not persuasive. The situation described by the applicant(s) would only occur if the rails/slots of the proposed modification were designed to be so short in length as to prematurely stop the axial translation of the sheath 304 over the cylindrical body 404 by the tab reaching the end of the slot prior to full envelopment of the cylindrical body 404 by the sheath 304. It is well within the skill of one of ordinary skill in the art to design such a tab/rail connection appropriately to avoid this obvious design blunder.
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 structure 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]).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lin as modified by Kosinski according to claim 11 (U.S. Pat. Pub. No. 2011/0009830 A1).
Regarding claim 22, Lin further discloses that the sleeve (sheath 304) is engaged with a proximal end of the casing to allow relative translational movement of the sleeve over the casing (cylindrical body 404) (see Fig. 5A-6D and [0063-0066]); the sleeve is axially fixed to the plunger rod such that distal movement of the sleeve over the casing causes distal movement of the plunger rod inside the casing and relative to the casing (see Fig. 6A-6B and [0063-0066], wherein it is clear that the sleeve – sheath 304 – is axially fixed to the distal end of the plunger rod, and that a raised portion of the plunger rod which engages the proximal end of the elastic member 50 is configured to move distally inside of the cylindrical body 404 when the plunger rod moves distally into the “sensing mode” of Fig. 6B); the distal end of the spring abuts a distal end portion of the casing (see Fig. 5A-6D and [0063-0066]), the distal end portion of the casing engaging the stopper (see Fig. 5A-6D and [0063-0066], wherein the distal end of the cylindrical body 404 comprises the structures which anchor the cylindrical body within the elastic portion of the piston 40); and the distal end of the plunger rod abuts a proximal end of the spring, thereby providing a direct coupling between the proximal end of the spring and the distal end of the plunger rod (see Fig. 5A-6D and [0063-0066], wherein a raised portion of the plunger rod located at the proximal end of the chamber formed by sheath 304 engages the proximal end of the elastic member 50 to directly couple the elastic member 50 to the plunger rod).
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 extension fee 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 date of this final action.
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 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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