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 .
Claims 1-20 are the currently pending claims hereby under examination.
Claim Interpretations
The Examiner interprets "open chamber" (as recited in claims 1 and 3 with respect to aspects of the elongate member) under the broadest reasonable interpretation, consistent with the instant disclosure, as an open space, cavity, channel, or slot in the elongated member that is configured to receive the ratcheting rod and prevent longitudinal movement of the ratcheting rod therein. The specification describes ratcheting rod 113 as being received in open chamber 146 of body 109 (Instant Application, ¶[0040]). Accordingly, “open chamber” does not require a fully enclosed bore and does not require that the ratcheting rod be externally visible along the full length of the chamber. However, the examiner does not interpret “open chamber”, by itself, as requiring that the ratcheting-teeth side of the ratcheting rod be exposed through the open chamber because that additional exposure feature is separately recited in claim 3.
The Examiner interprets "twisting" (as recited in claims 8, 11, and 12 with respect to the plunger attachment) under the broadest reasonable interpretation, consistent with the instant disclosure, as rotation or pivoting of the plunger attachment about an offset axis from an open position to a closed/locked position that captures the flange of the plunger. The specification describes plunger attachment 116 as "rotatable about an axis" and connected to the device body by "a screw, bolt, rivet, or other fastener" at an attachment region 156 that is "offset from an edge of the ratcheting rod 113" (Instant Application, ¶[0033]–[0034]). The specification further describes that plunger attachment 116 is initially in a first position permitting the syringe to be loaded and, after loading, "can be rotated" to a second position in which it is "secured to" the plunger, and that the plunger attachment "can be twisted such that the flange is fitted securely" within the attachment (Instant Application, ¶[0034], [0037]). Accordingly, "twisting" does not require rotation of the plunger attachment about a central or longitudinal axis of the plunger or rod; it encompasses rotation/pivoting of the plunger attachment about an offset axis to move the plunger attachment between an open position and a closed/locked position that captures the plunger flange. (The Examiner notes that "twisting the syringe" in claim 13 refers to a separate motion, rotation of the syringe so that a barrel flange seats in a receiving slot, and is not governed by this interpretation.)
Claim Objections
Claims 1, 8, and 20 are objected to because of the following informalities:
In claim 1, line 4: "moveably" should be revised to "movably";
In claim 1, line 11: "to extract the plunger of the syringe" should be revised to "to retract the plunger of the syringe" or "to withdraw the plunger of the syringe" to more accurately describe the proximal movement of the plunger recited in the claim;
In claim 8, line 11: "to raise the plunger of the syringe" should be revised to "to retract the plunger of the syringe" or "to withdraw the plunger of the syringe" for consistency with the aspiration operation described in the claim; and
In claim 20, lines 1-2: "ratchet mechanism" is inconsistent with "ratcheting mechanism" as recited in claim 14 and should be revised to "ratcheting mechanism”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7, 12, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 7 recites "wherein unlocking the ratcheting lever releases the ratchet mechanism back to a starting position" in lines 1-2. The specification describes ratcheting rod 113 as being received in open chamber 146 of body 109 and having ratcheting teeth 126, and describes ratcheting lever 123 as having a foot 136 suited to fit between ratcheting teeth 126 (Instant Application, ¶[0038]-[0040]). The specification also describes lever 119 driving ratcheting rod 113 via ratcheting lever 123 when lever 119 is squeezed (Instant Application, ¶[0033], ¶[0039]). However, the specification does not reasonably convey possession of a structure or mechanism for unlocking ratcheting lever 123 or ratcheting rod 113 such that the ratchet mechanism is released back to a starting position. In particular, the specification does not identify what structure locks ratcheting lever or rod, what structure is actuated to unlock the ratcheting lever or rod, how unlocking ratcheting lever/rod disengages foot 136 from ratcheting teeth 126, or what structure returns the ratchet mechanism back to a starting position. The specification also does not describe a return spring, biasing member, pawl-release member, cam, clutch, rotatable rod-release structure, or other mechanism that would cause the ratchet mechanism to return to a starting position after unlocking. Accordingly, the specification does not reasonably convey that Applicant was in possession of the claimed functional relationship in which unlocking the ratcheting rod releases the ratchet mechanism back to a starting position. Claim 7 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claim 12 recites "wherein twisting the plunger attachment into an unlocked position releases the ratcheting rod back to a starting position" in lines 1-2. The specification describes plunger attachment 116 as being rotatable and configured to receive and secure the flange of the plunger of syringe 106 (Instant Application, ¶[0033]). The specification further describes that plunger attachment 116 is initially in a first position that leaves space for syringe 106 to be loaded, and after loading syringe 106, plunger attachment 116 can be rotated to a second position in which plunger attachment 116 is secured to the plunger of syringe 106 (Instant Application, ¶[0037]). The specification also describes ratcheting rod 113 having ratcheting teeth 126 and being driven by ratcheting lever 123 when lever 119 is squeezed (Instant Application, ¶[0033], ¶[0038]-[0039]). However, the specification does not reasonably convey possession of a structure or mechanism by which twisting plunger attachment 116 into an unlocked position releases ratcheting rod 113 back to a starting position. In particular, the specification does not describe a linkage, cam, clutch, sleeve, pawl-release member, return spring, biasing member, or other structure operatively connecting rotation of plunger attachment 116 to disengagement of ratcheting teeth 126 from ratcheting lever 123 or to return of ratcheting rod 113 to a starting position. Further, the specification describes and depicts ratcheting rod 113 as having a square or rectangular shape in several embodiments, which would tend to maintain the angular orientation of ratcheting rod 113 within open chamber 146 rather than permit rotation of the ratcheting rod to move ratcheting teeth 126 out of engagement with ratcheting lever 123 (Instant Application, ¶[0038], ¶[0040]). Accordingly, the specification does not reasonably convey that Applicant was in possession of the claimed functional relationship in which twisting the plunger attachment into an unlocked position releases the ratcheting rod back to a starting position. Claim 12 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claim 20 recites "wherein unlocking the ratcheting rod releases the ratchet mechanism back to a starting position" in lines 1-2 and has the same issues as claim 7 above.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 12, and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1 recites “a ratcheting lever hingedly connected to a distal end of the lever handle” in line 8. The scope of the limitation is unclear because the figures and the written description show the ratcheting lever attachment spaced from the distal end of the lever handle, rather than at the distal end of the lever handle. In particular, the specification describes the ratcheting lever attachment as being “positioned a distance from the distal end” of the handle (Instant Application, ¶[0043]). Further, if the hinge for the lever handle and the hinge for the ratcheting lever were both located at the same distal end position, it is unclear how compression of the lever handle would actuate the ratcheting lever to drive the ratcheting rod, because the handle would not appear to impart a driving moment to the ratcheting lever as required by the claim. The Examiner interprets the limitation under the broadest reasonable interpretation as encompassing a ratcheting lever hinge connected to the lever handle at a distal end region of the lever handle including a position spaced from the lever handle end as shown in the described specification (Instant Application, ¶ [0043], FIG. 2B).
Claims 2-7 are rejected by virtue of their dependence from claim 1.
Claim 5 recites "the lever can be pumped repeatedly to modulate a volume pulled by the syringe" in lines 1-2. Claim 1 recites both "a lever handle" and "a ratcheting lever," and therefore it is unclear whether "the lever" refers to the lever handle, the ratcheting lever, or another lever. The phrase "modulate a volume pulled by the syringe" is also unclear because it does not specify whether the modulation refers to aspirated volume, plunger displacement, aspiration rate, or another parameter. The Examiner is interpreting "the lever" under a broadest reasonable interpretation (BRI) to mean the lever handle and is interpreting "modulate a volume pulled by the syringe" to mean controlling a volume aspirated into the syringe by repeated pumping of the lever handle. However, this interpretation is not compelled by the claim language, leaving the scope subject to multiple reasonable interpretations.
Claim 7 recites "unlocking the ratcheting lever releases the ratcheting rod back to a starting position" in lines 1-2. The claim does not previously recite that the ratcheting lever is locked, does not identify the structure that locks or unlocks the ratcheting lever, and does not define what position constitutes the "starting position" of the ratcheting rod. The Examiner interprets the limitation under the broadest reasonable interpretation (BRI) as requiring that unlocking the ratcheting lever releases or disengages the ratcheting engagement between the ratcheting lever and the ratcheting rod so that the ratcheting rod is released for return/reset to an initial position relative to the device body. However, because the claim does not clearly identify the locked structure, the unlocking action, or the starting position to which the ratcheting rod is released, the metes and bounds of the claim are unclear. Accordingly, claim 7 is indefinite under 35 U.S.C. § 112(b).
Claim 12 recites "twisting the plunger attachment into an unlocked position releases the ratcheting rod back to a starting position" in lines 2-3. The claim does not clarify whether twisting the plunger attachment itself releases the ratcheting rod, whether twisting the plunger attachment also actuates a separate ratcheting release, or what position constitutes the "starting position" of the ratcheting rod. The Examiner interprets the limitation under the broadest reasonable interpretation as requiring that twisting the plunger attachment into the unlocked position both unlocks the plunger attachment from the plunger of the syringe and releases or disengages the ratcheting rod for return/reset to a starting position. However, because the claim does not specify how twisting the plunger attachment is operatively related to release of the ratcheting rod, whether any separate ratcheting release structure is required, or what position constitutes the starting position, the metes and bounds of the claim are unclear. Accordingly, claim 12 is indefinite under 35 U.S.C. § 112(b).
Claim 19 recites "unlocking the ratcheting rod" in lines 1-2. Claim 14 recites that the ratcheting rod, when in a locked position, is attached to a plunger of the syringe, but does not clearly recite that the ratcheting rod itself is locked, does not identify what structure locks the ratcheting rod, and does not identify what unlocking operation disconnects the ratcheting rod from the syringe. The Examiner interprets "unlocking the ratcheting rod" under the broadest reasonable interpretation as unlocking or releasing a plunger attachment or ratcheting engagement associated with the ratcheting rod so that the syringe can be removed from the device body. However, because the claim does not identify the structure being unlocked or the mechanism by which unlocking the ratcheting rod permits syringe removal, the metes and bounds of the claim are unclear. Accordingly, claim 19 is indefinite under 35 U.S.C. § 112(b).
Claim 20 recites "unlocking the ratcheting rod releases the ratchet mechanism back to a starting position" in lines 1-2. The claim does not define what structure locks the ratcheting rod, what unlocking operation is performed, or what constitutes the "starting position" of the ratchet mechanism. The Examiner interprets the limitation under the broadest reasonable interpretation as requiring that unlocking or releasing the ratcheting rod disengages the ratcheting engagement associated with the ratcheting rod so that the ratchet mechanism is released for return/reset to an initial position relative to the device body. However, because the claim does not identify the structure being unlocked, the mechanism by which unlocking the ratcheting rod releases the ratchet mechanism, or the starting position to which the ratchet mechanism is released, the metes and bounds of the claim are unclear. Accordingly, claim 20 is indefinite under 35 U.S.C. § 112(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein.
Regarding claim 1, Radwin teaches a device (Radwin, ¶[0002]: “syringe attachment devices” and “syringe adapters” that “facilitate aspirating fluid to and/or dispensing fluid from a syringe”; ¶[0005]: “a one-handed syringe adapter” including “a syringe holder and an actuator”) comprising: a device body suitable to hold a syringe, the device body having an elongated member with a distal support and a proximal support (Radwin, ¶[0080], [0083], [0102]: adapter 100 includes housing 102, syringe holder 108, and syringe support 128; “syringe 200 [is] received in the fixed portion 124 and the adjustable portion 126 of the syringe holder 108”; barrel 202 is supported by syringe support 128; barrel flange 206 is received in barrel flange slot 140; and plunger flange 208 is received in plunger flange slot 142, wherein housing 102 and syringe holder 108 correspond to the claimed device body/elongated member suitable to hold the syringe, fixed portion 124 and syringe support 128 correspond to the claimed distal support for the syringe barrel side, and adjustable portion 126 corresponds to the claimed proximal support for the plunger side); and a ratcheting rod having a proximal end configured to connect to a plunger of the syringe (Radwin, FIG. 10; ¶[0083], [0091], [0096], [0098]-[0099], [0102]-[0103]: gear system 152 includes rack 162; ratchet system 158 “may be a unidirectional ratchet or a reversible ratchet”; driven pinion 160 engages teeth of rack 162 and “cause[s] the rack 162 to translate longitudinally”; rack 162 is “connected to and/or in communication with” and “secured to or secured relative to” adjustable portion 126; adjustable portion 126 includes plunger flange slot 142 for receiving plunger flange 208 of plunger 204; and longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126 and plunger 204 relative to barrel 202, wherein rack 162 corresponds to the claimed ratcheting rod under the broadest reasonable interpretation as an elongate ratcheting member configured to transmit force along its length, FIG. 10 shows adjustable portion 126 at one end of rack 162, and comparison of the trigger/actuator orientation in FIG. 10 with the syringe orientation shown in Radwin’s syringe-loaded figures (such as FIG. 4 and 11) identifies the adjustable portion 126 end of rack 162 as the proximal end of the rack, such that the proximal end of rack 162 is configured to connect to plunger 204 through adjustable portion 126 and plunger flange slot 142).
Also regarding claim 1, Radwin teaches or at least suggests the ratcheting rod configured to fit moveably within an open chamber in the elongated member (Radwin, FIG. 10; ¶[0084], [0089], [0098]-[0099], [0141]-[0142]: actuation system 150 includes rack 162 and linear guide track 146; adjustable portion 126 may be adjusted “along a linear guide track 146”; driven pinion 160 engages teeth of rack 162 and “cause[s] the rack 162 to translate longitudinally”; rack 162 may be secured to linear guide 151, which is configured to adjust along linear guide track 146 so that rack 162 and adjustable portion 126 are longitudinally adjusted in a linear and consistent manner; and the alternative embodiment of rack 362, linear guide 351, and linear guide track 346 further supports guided linear longitudinal movement, wherein rack 162/362 corresponds to the claimed ratcheting rod, the rack-receiving and guide region adjacent linear guide track 146 that receives and guides longitudinal movement of the rack/linear-guide assembly corresponds to, or at least suggests, the claimed open chamber in the elongated member, and FIG. 10 and the engagement of driven pinion 160/360 with the teeth of rack 162/362 show that the toothed side of the rack remains open or accessible for mechanical engagement).
To the extent Radwin does not expressly teach that the rack-receiving and guide region is an open chamber, Sturtz teaches that it was known in a hypodermic syringe hand-grip actuator to provide a longitudinal open slot or guide region in the hand-grip body for receiving and guiding a movable rack/gear block connected to a syringe plunger. In particular, Sturtz teaches an actuating mechanism for hypodermic syringes that permits injection and aspiration and includes a gun-type operating mechanism for a hypodermic syringe (Sturtz, col. 1, lines 15-18, 19-27, 37-43; col. 2, lines 17-37). Sturtz further teaches that plunger head 21 is secured to holder 32 by a U-shaped yoke secured to longitudinally movable gear block 35; gear block 35 has “slidable engagement within a longitudinally disposed slot 36” of the gun; the gun has a “longitudinally extending groove 38” along each side; pins 40 on gear block 35 slidably engage grooves 38; and the bottom of gear block 35 includes oppositely directed rack gears 43 and 45 for forward and reverse movement of gear block 35 (Sturtz, col. 2, lines 17-50). Sturtz further teaches pawl 53 engaging rack gear 45 to effect rearward movement of gear block 35 and connected plunger 20, and pawl 74 engaging rack gear 43 to push gear block 35 forwardly (Sturtz, col. 2, lines col. 2-3, lines 50-30). Thus, Sturtz teaches the known syringe-actuator detail of a movable toothed rack/gear block slidably received in a longitudinal open slot/open guide region of a syringe hand-grip body, with the toothed rack side accessible for engagement by a pawl.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement or understand Radwin’s rack-receiving and guide region as an open longitudinal slot or open guide chamber in view of Sturtz, because Radwin already requires rack 162 to translate longitudinally relative to the syringe-holder body and already requires the teeth of rack 162 to remain accessible for mechanical engagement by driven pinion 160 (Radwin, FIG. 10; ¶[0089], [0098]-[0099]). Sturtz teaches that, in syringe hand-grip actuators, a known way to guide a longitudinally movable toothed rack/gear block connected to a syringe plunger was to place the rack/gear block in a longitudinally disposed slot/open guide region of the hand-grip body while leaving the rack teeth accessible for engagement by a pawl (Sturtz, col. 2-3, lines 17-30). Applying this known open-slot/open-guide implementation detail to Radwin’s rack-receiving region would have predictably provided guided longitudinal movement of Radwin’s rack/adjustable plunger-holding assembly while maintaining access to the rack teeth for the actuator drive member. Therefore, Radwin in view of Sturtz teaches or at least suggests the claimed ratcheting rod configured to fit movably within an open chamber in the elongated member.
Also regarding claim 1, the modified Radwin teaches a manually actuated plunger-withdrawing mechanism including a handle/trigger-type actuator for moving the plunger, but Radwin does not expressly teach a lever handle hingedly connected to a distal end of the device body and does not expressly teach a ratcheting lever hingedly connected to a distal end of the lever handle and positioned to interact with the ratcheting rod in the manner claimed. In particular, Radwin teaches actuator 106 including grip portion 118, first support 120, and second support 122, wherein applying force to second support 122 in direction 138 actuates actuator 106 and causes adjustable portion 126 to positionally adjust relative to fixed portion 124, and wherein directions 136 and 138 “may be opposite lateral and/or rotational directions” and “are depicted with a rotational element” (Radwin, ¶[0082], [0087]-[0088]). Thus, Radwin teaches a manually depressed handle/trigger-type actuator for actuating the syringe adapter and withdrawing the syringe plunger. However, Radwin does not teach the claimed lever handle hingedly connected to a distal end of the device body because Radwin’s actuator 106 is located at least partially toward the first end 100a of adapter 100 relative to gripping portion 104, rather than being hinged at the distal end of the syringe-holding device body in the manner claimed (Radwin, ¶[0087]). Radwin also does not teach the claimed ratcheting lever hingedly connected to a distal end of the lever handle and positioned to engage the ratcheting teeth of the ratcheting rod because Radwin converts movement of actuator 106 into longitudinal movement of rack 162 using gear system 152, including drive gear 154, drive pinion 156, ratchet system 158, driven pinion 160, and rack 162, wherein driven pinion 160 engages teeth of rack 162 and causes rack 162 to translate longitudinally, but driven pinion 160 is a rotatable gear member mounted in Radwin’s gear system rather than a ratcheting lever hingedly connected to the lever handle (Radwin, ¶[0089], [0091]-[0099]). Radwin further teaches, however, that “[a]lthough the actuation system 150 is depicted and described as having the gear system 152”, the actuation system may include “one or more additional or alternative suitable systems for causing movement of the adjustable portion 126 in response to movement of the actuator 106”, including a system with “different gears” or “no gears” (Radwin, ¶[0089]). Radwin also teaches that ratchet system 158 “may be a unidirectional ratchet or a reversible ratchet”, thereby showing that Radwin already contemplates ratchet-based manual actuation as part of the actuator-to-rack drive path (Radwin, ¶[0096]).
Epstein teaches a handle/linkage/pawl/rack actuation arrangement in a medical suctioning/fluid applicator device (Epstein, FIG. 5; ¶[0055]: actuating assembly 100 includes “trigger (105)” mechanically coupled to plungers 142, 144; ¶[0056]: “trigger (105) is coupled to pawl (120) via lever arm (110)” and pawl 120 includes hook 122 having flat distal face 124; ¶[0057]: rack 130 includes “a plurality of teeth (132)” with gaps “adapted to receive hook (122)”; ¶[0067]: depressing trigger 105 moves the lever arm 110/pawl 120/hook 122 combination and engages teeth 132 such that depressing the handle/trigger 105 linearly moves rack 130, wherein the pivoted end of trigger 105 corresponds to the hinged end of the claimed lever handle, the linkage including lever arm 110, pawl 120, and hook 122 corresponds to the claimed ratcheting lever, the connection of the lever arm 110/pawl 120 linkage to trigger 105 at a position spaced from the pivoted end of trigger 105 corresponds to the ratcheting lever being hingedly connected to the lever handle at a position spaced from the distal hinged end of the lever handle, and hook 122 engaging teeth 132 of rack 130 corresponds to the ratcheting lever being positioned to engage the ratcheting teeth of the ratcheting rod).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Radwin’s syringe attachment device to replace Radwin’s gear-based actuator-to-rack drive path with Epstein’s trigger/lever-arm/pawl/rack drive path, with the pivoted end of Epstein’s trigger 105 oriented at the distal end of Radwin’s device body and with Epstein’s lever arm 110/pawl 120/hook 122 linkage maintained at a position spaced from the pivoted end of trigger 105. This modification would have been a simple substitution of one known mechanical actuation means, Epstein’s manually depressed lever/pawl advancing a toothed rack, for another known mechanical actuation means, Radwin’s gear train driving a toothed rack, to obtain the predictable result of converting manual squeeze/trigger input into longitudinal rack and plunger travel. Radwin expressly teaches that actuation system 150 may include “one or more additional or alternative suitable systems for causing movement of the adjustable portion 126 in response to movement of the actuator 106”, including systems having “different gears” or “no gears”, and Epstein’s pawl-and-rack actuation path is a known no-gear actuation system for moving a toothed rack in response to manual depression of a trigger (Radwin, ¶[0089], [0091]-[0099], [0101]-[0103]; Epstein, FIG. 5; ¶[0055]-[0057], [0067]).
It further would have been obvious to orient Epstein’s lever/pawl/rack actuation path so that compression of the handle drives Radwin’s rack/adjustable portion assembly proximally. Epstein teaches that depressing trigger 105 drives pawl 120 through lever arm 110 such that hook 122 engages teeth 132 and moves rack 130 in Epstein’s dispensing direction (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). Radwin’s aspiration operation requires proximal movement of rack 162 and adjustable portion 126 to withdraw plunger 204 from barrel 202 and aspirate fluid (Radwin, ¶[0098]-[0099], [0101]-[0103]). Therefore, to use Epstein’s pawl-and-rack actuation to produce Radwin’s proximal plunger-withdrawal for aspiration, one of ordinary skill would orient the pawl stroke to drive Radwin’s rack/adjustable portion assembly proximally, thereby placing the lever-handle pivot at the distal end of the device body and maintaining the ratcheting lever assembly at a position spaced from that pivot. Such orientation would have been a predictable reversal or rearrangement of mechanical parts to provide the required direction of rack travel while preserving the same trigger-to-pawl-to-rack force path. The Sturtz open-slot/open-guide teaching further supports the mechanical feasibility of this modification because Sturtz shows that a toothed rack/gear block in a syringe hand-grip actuator may be guided in a longitudinal open slot/open guide region while remaining accessible for pawl engagement (Sturtz, col. 2, lines 33-47; col. 2, lines 48-72; col. 3, lines 3-30).
The modification would not change Radwin’s principle of operation. Radwin’s principle of operation is manual-actuator-driven longitudinal adjustment of adjustable portion 126 relative to fixed portion 124 so that the syringe plunger is withdrawn to aspirate fluid and/or create vacuum (Radwin, ¶[0082], [0089], [0098]-[0099], [0101]-[0103]). Replacing Radwin’s gear-based drive path with Epstein’s pawl-and-rack drive path, while using the known Sturtz open-slot/open-guide implementation detail for the rack-receiving region, would still use manual actuation to longitudinally move the rack and adjustable plunger-holding portion. Further, Radwin already includes ratchet system 158, which “may be a unidirectional ratchet or a reversible ratchet”, and Radwin expressly contemplates alternative systems having “different gears” or “no gears” (Radwin, ¶[0089], [0096]). Thus, substituting Epstein’s pawl-ratchet drive and implementing the rack-receiving guide as an open slot/open chamber of the type taught by Sturtz would implement known actuator-to-rack and rack-guide details of the type used in syringe hand-grip actuators, rather than changing the basic operation of Radwin’s syringe adapter.
Finally regarding claim 1, the modified Radwin device teaches compression of the lever handle forces the ratcheting lever to extend the ratcheting rod in a proximal direction and to extract the plunger of the syringe (Radwin, ¶[0101]-[0103]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; syringe 200 is received in fixed portion 124 and adjustable portion 126 with plunger flange 208 in plunger flange slot 142; actuator 106 is moved to a loaded position so that a desired amount of fluid will be aspirated upon actuation; and actuation adjusts adjustable portion 126 to withdraw, i.e., retract/extract, plunger 204 from barrel 202 to aspirate fluid and/or create vacuum), because, in the modified device discussed above, compression of the distally hinged Epstein-type lever handle would drive the Epstein-type lever arm 110/pawl 120/hook 122 ratcheting lever assembly, connected to the lever handle at a position spaced from the distal hinged end of the handle, into engagement with the teeth of Radwin’s rack, thereby moving Radwin’s rack/adjustable portion assembly proximally and withdrawing plunger 204 from barrel 202 to aspirate fluid and/or create vacuum.
Regarding claim 3, the modified Radwin teaches or at least suggests that the ratcheting rod comprises a plurality of ratcheting teeth along a first side of the ratcheting rod, and wherein the first side of the ratcheting rod is exposed through the open chamber in the elongated member. As discussed above for claim 1, Radwin teaches rack 162 corresponding to the claimed ratcheting rod. Radwin further teaches that rack 162 includes teeth along a side of the rack that are engaged by driven pinion 160 to cause rack 162 to translate longitudinally (Radwin, FIG. 10; ¶[0091], ¶[0098]-[0099]). Although Radwin’s rack teeth are engaged by a pinion rather than expressly described as ratcheting teeth, Epstein teaches a toothed rack/pawl ratcheting arrangement in which rack 130 includes a rack face having a plurality of teeth 132 with gaps 134 adapted to receive hook 122 of pawl 120, and depressing trigger 105 moves pawl 120 so that hook 122 engages teeth 132 and drives rack 130 longitudinally (Epstein, FIG. 5; ¶[0056]-[0057], ¶[0067]). Epstein therefore teaches a toothed first side of a rack/ratcheting rod exposed or accessibly presented to a pawl/ratcheting lever within the housing so that the pawl/ratcheting lever can engage the teeth and drive the rack/ratcheting rod longitudinally.
The modified Radwin further teaches or at least suggests that the toothed first side of the ratcheting rod is exposed through the open chamber in the elongated member. As discussed above for claim 1, Sturtz teaches a syringe hand-grip actuator having a movable toothed rack/gear block guided in a longitudinal open slot/open guide region of the device body. In particular, Sturtz teaches gear block 35 extending from slidable engagement within longitudinally disposed slot 36, with gear block 35 including rack gears 43 and 45, and pawls 53 and 74 selectively engaging the rack gears to move gear block 35 rearwardly or forwardly (Sturtz, col. 2-3, lines 17-30). Sturtz therefore teaches the known syringe-actuator arrangement of guiding a movable toothed rack/gear block in an open slot/open guide region while allowing a pawl to access the toothed portion of the rack/gear block.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the ratcheting rod of the modified Radwin device with Epstein-type ratcheting teeth along a first side exposed through the open chamber in the elongated member, because Radwin teaches a longitudinally translating toothed rack, Epstein teaches that pawl/hook engagement with teeth on a rack face is used to drive the rack longitudinally, and Sturtz teaches guiding a movable toothed rack/gear block in an open slot/open guide region of a syringe hand-grip body. In order for the Epstein-type pawl/ratcheting lever to engage and drive the rack in the modified Radwin/Sturtz device, the toothed side of the rack would have been predictably oriented toward, and exposed or accessibly presented through, the open chamber region facing the pawl. Such a configuration would have predictably permitted pawl engagement with the ratcheting teeth while the ratcheting rod remained guided for longitudinal movement within the elongated member. Therefore, the modified Radwin device in view of Sturtz and Epstein teaches or at least suggests wherein the ratcheting rod comprises a plurality of ratcheting teeth along a first side of the ratcheting rod, and wherein the first side of the ratcheting rod is exposed through the open chamber in the elongated member.
Regarding claim 4, the modified Radwin teaches the device of claim 1, but does not expressly teach that the lever handle has grooves configured to fit fingers of a hand. As discussed above for claim 1, the modified Radwin includes an Epstein-type trigger 105 corresponding to the claimed lever handle. Epstein teaches that trigger 105 is manually depressed to move lever arm 110/pawl 120/hook 122 and drive rack 130 longitudinally (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). However, the modified Radwin does not expressly teach that trigger 105 includes grooves configured to fit fingers of a hand.
Radwin teaches that hand-engaged grip surfaces on a one-handed syringe adapter may include digit-receiving ergonomic features. In particular, Radwin teaches that actuator 106 may include grip portion 118 and that, "[t]o facilitate actuation of the actuator 106 with one or more digits of a user," grip portion 118 may include first support 120 and/or second support 122 (Radwin, ¶[0057]). Radwin further teaches that "the grip portion 118 of the actuator 106 may have a length configured to receive one or more digits of a user's hand" (Radwin, ¶[0088]). Radwin also teaches that hand-grip portions configured to receive digits of a user may have indents, contours, bumps, lines, smooth surfaces, and/or other gripping features to facilitate receiving one or more digits of a user (Radwin, ¶[0054]-[0055]). Radwin further teaches a digit-receiving contour 132 configured to receive a user's digit as anatomically positioned when grasping or pinching an object (Radwin, ¶[0076]). Thus, Radwin teaches using finger-receiving contours, indents, lines, or other gripping features on hand-engaged surfaces of a one-handed syringe adapter to facilitate digit placement and actuation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the Epstein-type lever handle/trigger 105 of the modified Radwin device with finger-receiving grooves, contours, indents, lines, or other digit-receiving gripping features of the type taught by Radwin, because the Epstein-type trigger 105 is the hand-actuated lever surface compressed by the user's fingers to drive the rack/ratcheting rod, and Radwin teaches providing digit-receiving ergonomic grip features on hand-engaged surfaces of a one-handed syringe adapter to facilitate receiving one or more digits of the user's hand and to facilitate actuation. The benefit of such a modification would have been to improve finger placement, grip stability, and ergonomic one-handed compression of the lever handle during aspiration. Therefore, the modified Radwin device in view of Epstein and Radwin's digit-receiving grip-feature teachings teaches or at least suggests wherein the lever handle has grooves configured to fit fingers of a hand.
Regarding claim 5, the modified Radwin teaches the device of claim 1, but does not expressly teach wherein the lever can be pumped repeatedly to modulate a volume pulled by the syringe. Radwin teaches an actuator/rack arrangement for aspirating fluid into a syringe and controlling the amount of fluid aspirated (Radwin, ¶[0101]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; ¶[0103]: while actuator 106 is translated to a loaded position, “a user may count a number of audible and/or tactile indications to determine an amount fluid that will be aspirated”; ¶[0104]: actuator 106 “has been actuated to aspirate fluid into the syringe 200”, and actuation causes adjustable portion 126 to withdraw plunger 204 from barrel 202, “thereby creating a vacuum in the barrel 202 and aspirating fluid”). As discussed above for claim 1, the modified Radwin includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally.
Epstein further supports that the modified lever/trigger-operated rack mechanism is suitable for incremental hand-trigger actuation. In particular, Epstein teaches that “[b]y gripping handle (505) and actuating trigger (520) in a user’s hand, compressing the trigger against the handle actuates the dispensing assembly within the device to dispense fluids a predetermined incremental amount” (Epstein, ¶[0118]). Thus, Epstein teaches that repeated hand-trigger compression may produce controlled incremental fluid movement.
Sturtz expressly teaches repeated pumping of a syringe hand-grip trigger to control the amount withdrawn into the syringe (Sturtz, col. 3-4, lines 70–11: “the trigger finger piece 65 may be depressed a sufficient number of times to withdraw the plunger rearwardly of the gun to fill the syringe to the desired capacity”). Sturtz also teaches repeated trigger actuation to control the amount discharged from the syringe (Sturtz, col. 3-4, lines 70–11: “the finger piece 65 of the trigger may be depressed a sufficient number of times to discharge the desired quantity of medication”). Thus, Sturtz teaches that repeated trigger/lever pumping can cumulatively move the syringe plunger to control the volume moved by the syringe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the lever handle of the modified Radwin device to be pumped repeatedly to modulate the volume pulled by the syringe, because Radwin teaches an actuator/rack syringe adapter for aspirating fluid and determining the amount of fluid that will be aspirated, Epstein teaches that a handheld trigger/rack mechanism may provide a predetermined incremental amount of fluid movement with each trigger compression, and Sturtz expressly teaches repeatedly depressing a syringe hand-grip trigger a sufficient number of times to withdraw the plunger and fill the syringe to a desired capacity. Such a configuration would have provided the predictable benefit of allowing the user to finely control the aspirated volume by selecting the number of lever-handle pumping strokes, with each stroke producing incremental plunger movement and the cumulative strokes producing the desired volume pulled into the syringe. Therefore, the modified Radwin device in view of Epstein and Sturtz teaches or at least suggests wherein the lever can be pumped repeatedly to modulate a volume pulled by the syringe.
Regarding claim 6, the modified Radwin teaches that the syringe can be removed by disconnecting the proximal end of the ratcheting rod from the plunger of the syringe and removing the syringe from the device body (Radwin, ¶[0083]: adjustable portion 126 includes plunger flange slot 142 for receiving a plunger flange, and plunger flange slot 142 may create "a friction fit or other engaging fit" with the plunger flange; Radwin, ¶[0098]-[0099]: rack 162 is "connected to and/or in communication with" and "secured to or secured relative to" adjustable portion 126, and longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126; Radwin, ¶[0102]-[0104]: plunger flange 208 is received in plunger flange slot 142, and actuation causes adjustable portion 126 to withdraw plunger 204 from barrel 202; Radwin, ¶[0083]: "other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism"; Radwin, ¶[0122]: locking mechanism 370 releasably engages a syringe received within adapter 300, and applying force to locking arm 372 facilitates release of locking arm 372 and "removal of the syringe from the adapter 300," wherein Radwin's rack 162/adjustable portion 126 corresponds to the proximal end of the ratcheting rod assembly, Radwin's plunger flange slot 142/friction fit corresponds to the connection between the proximal end of the ratcheting rod assembly and the plunger, removal of plunger flange 208 from plunger flange slot 142 corresponds to disconnecting the proximal end of the ratcheting rod from the plunger of the syringe, and removal of the syringe from adapter 300 corresponds to removing the syringe from the device body).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Pfahnl et al. (US 2015/0209821 A1), hereto referred as Pfahnl.
The modified Radwin teaches claim 1 as described above.
Regarding claim 2, the modified Radwin teaches the device of claim 1, but does not expressly teach that the syringe is a 60CC syringe. Radwin teaches that the syringe holder may be configured to receive different sizes of syringes. In particular, Radwin teaches that the fixed portion and/or adjustable portion of the syringe holder may include adjustable components that are adjustable to facilitate different sizes of syringes, and may include inserts or sub-adapters for accommodating and/or securing different sizes of plunger flanges, barrel flanges, or other components of a syringe within the syringe holder (Radwin, ¶[0121]).
Pfahnl teaches a syringe holding and actuation device used with a syringe to aspirate or dispense syringe contents on demand, wherein a first portion holds the plunger, a second portion holds the syringe body, and the first and second portions move relative to each other so that the plunger can be moved into and pulled from the syringe body (Pfahnl, ¶[0019], ¶[0022]-[0027]). Pfahnl expressly teaches that preferred embodiments allow single-handed aspiration and dispensing of even very large syringes that otherwise would have a large plunger stroke or require much actuation force (Pfahnl, ¶[0021]). Pfahnl further identifies 60 mL syringes as the relevant large syringe example, teaching that larger size syringes, such as 60 mL syringes, are common and well-suited for many procedures, but are more challenging to use manually with one hand (Pfahnl, ¶[0011]). Pfahnl also specifically explains that, when the syringe is larger in length and cross-section size, such as a 60 mL syringe, one-handed dispensing and one-handed aspiration become difficult due to the increased reach required between the syringe body flange and the plunger flange (Pfahnl, ¶[0084]-[0085]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified Radwin device to hold and operate with a 60CC syringe, because Radwin teaches a syringe attachment device configured to facilitate one-handed aspirating and/or dispensing and teaches syringe holder structures configurable for different syringe sizes, while Pfahnl teaches a syringe holding and actuation device for single-handed aspiration and dispensing of very large syringes and specifically identifies 60 mL syringes as a common large syringe size for which one-handed actuation is difficult and for which such actuation devices provide a benefit. Thus, selecting a 60CC syringe for the modified Radwin device would have been a predictable use of a known syringe size in the same one-handed syringe aspiration/dispensing device context, and would have required only routine dimensional configuration of Radwin's syringe holder components, inserts, or sub-adapters to accommodate the selected syringe size. Therefore, the modified Radwin device in view of Pfahnl teaches or at least suggests wherein the syringe is a 60CC syringe.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Bunce (WO 93/03860), hereto referred as Bunce.
The modified Radwin teaches claim 1 as described above.
Regarding claim 7, although claim 7 is also rejected under 35 U.S.C. 112(a) and 112(b) as set forth above, the following prior-art rejection applies under the Examiner's broadest reasonable interpretation of unlocking the ratcheting lever releases the ratcheting rod back to a starting position. Under this interpretation, the limitation encompasses unlocking or disengaging the ratcheting engagement between the ratcheting lever and the ratcheting rod so that the ratcheting rod is free for longitudinal return/reset to a starting position. The modified Radwin teaches the device of claim 1, but does not expressly teach this limitation.
Radwin teaches that ratchet system 158 may be a unidirectional ratchet or a reversible ratchet, and that, when ratchet system 158 is reversible, gear system 152 may drive adjustable portion 126 of syringe holder 108 in two opposite or substantially opposite directions (Radwin, ¶[0096]-[0097]). Radwin further teaches that suitable adapters may be configured in other manners to facilitate driving adjustable portion 126 in two opposite or substantially opposite directions to drive a syringe plunger in two directions, including an aspirating direction and a dispensing direction (Radwin, ¶[0097]). Thus, Radwin teaches that the syringe-plunger drive can be configured for reverse/reset motion.
As discussed above for claim 1, the modified Radwin includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally. Epstein teaches that trigger 105 is coupled to pawl 120 via lever arm 110, that rack 130 includes a plurality of teeth 132 having gaps adapted to receive hook 122 of pawl 120, and that depression of trigger 105 causes pawl 120/hook 122 to engage teeth 132 and drive rack 130 longitudinally (Epstein, FIG. 5; ¶[0056]-[0057], [0067]). Thus, Epstein teaches the ratcheting lever/rack engagement used in the modified Radwin device.
Bunce teaches a dose dispensing gun having a plunger rod advanced by a trigger-operated ratchet and pawl mechanism, and further teaches resetting the plunger rod by rotating the plunger rod to disengage the ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop position. In particular, Bunce teaches a gun for dispensing discrete doses of a fluid product from a cartridge, wherein the cartridge includes piston 10 engaged by plunger head 12 at the forward end of plunger rod 14, and wherein advance of plunger rod 14 is effected by trigger 26 cooperating with plunger rod 14 through a ratchet and pawl mechanism to advance the rod through a discrete step at each actuation of trigger 26 (Bunce, p. 3, lines 1-9, 22-30). Bunce further teaches that first pawl 32 is spring-biased into engagement with teeth of ratchet 34 formed along the underside of plunger rod 14 to cause advance of plunger rod 14, and that second pawl 36 is spring-biased into engagement with the ratchet teeth to hold plunger rod 14 against retraction when trigger 26 has been released (Bunce, p. 3, line 30-p. 4, line 7). Bunce also teaches that plunger rod 14 projects from the rear of the gun body and carries knob 46 at its rear end, and that plunger rod 14 is reset into its rear position after reaching the forward end of its stroke by rotating knob 46 and thereby rotating plunger rod 14 to disengage the ratchet teeth from pawls 32 and 36, whereby rod 14 can be withdrawn to its rear stop position and then rotated to re-engage the pawls with the ratchet teeth in preparation for a fresh cartridge (Bunce, p. 4, line 28-p. 5, line 18). Bunce further recites that knob 46 permits the plunger to be rotated out of engagement with the ratchet mechanism, whereby the plunger rod can then be withdrawn rearwardly (Bunce, p. 7, claim 10). Thus, Bunce teaches unlocking or releasing a ratcheting engagement associated with a plunger rod by rotating the plunger rod out of engagement with the pawls, thereby freeing the plunger rod for withdrawal/reset to a rear stop position in preparation for a fresh cartridge.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the ratcheting lever/rack engagement of the modified Radwin device with a Bunce-type ratchet release, because the modified Radwin device uses an Epstein-type pawl/ratcheting lever engaging a toothed rack/ratcheting rod to drive the syringe plunger longitudinally, and Bunce teaches a trigger-operated ratchet/pawl plunger-rod drive in which rotating a knob and plunger rod disengages ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop/reset position in preparation for a fresh cartridge. The benefit of such a modification would have been to allow the user, after an aspiration stroke or other ratcheting operation, to release the ratcheting engagement and quickly return/reset the ratcheting rod for reuse, reloading, or syringe removal/replacement without having to back-drive the ratcheting mechanism tooth-by-tooth. Radwin further supports this modification because Radwin teaches reversible or two-direction movement of the adjustable plunger-holding portion, indicating that returning/resetting the plunger-holding drive structure was a contemplated operating mode. Bunce is relied upon for teaching that the ratcheting engagement associated with a plunger rod may be released by rotating the plunger rod out of engagement with the pawls so that the rod is free for longitudinal withdrawal/reset to a rear stop position, not for requiring an automatic spring-driven return of the ratcheting rod all the way to the starting position. Therefore, the modified Radwin device in view of Bunce teaches or at least suggests wherein unlocking the ratcheting lever releases the ratcheting rod back to a starting position.
Claims 8, 10-11, 14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Nerney (US 2005/0215956 A1), hereto referred as Nerney.
Regarding claim 8, Radwin teaches a method for aspiration (Radwin, ¶[0002]: “syringe attachment devices” and “syringe adapters” that “facilitate aspirating fluid to and/or dispensing fluid from a syringe”; ¶[0101]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe received within adapter 100”) comprising: placing a syringe in a device body suitable to hold a syringe, the device body having an elongated member with a distal support and a proximal support (Radwin, ¶[0080], [0083], [0102]: adapter 100 includes housing 102, syringe holder 108, and syringe support 128; “syringe 200 [is] received in the fixed portion 124 and the adjustable portion 126 of the syringe holder 108”; barrel 202 is supported by syringe support 128; barrel flange 206 is received in barrel flange slot 140; and plunger flange 208 is received in plunger flange slot 142, wherein placing syringe 200 in housing 102 and syringe holder 108 corresponds to the claimed placing a syringe in a device body suitable to hold the syringe, housing 102 and syringe holder 108 correspond to the claimed device body/elongated member, fixed portion 124 and syringe support 128 correspond to the claimed distal support for the syringe barrel side, and adjustable portion 126 corresponds to the claimed proximal support for the plunger side).
Also regarding claim 8, Radwin teaches or at least suggests inserting a ratcheting rod in a chamber of the elongated member of the device body (Radwin, FIG. 10; ¶[0084], [0089], [0091], [0096], [0098]-[0099], [0141]-[0142]: actuation system 150 includes rack 162 and linear guide track 146; gear system 152 includes rack 162; ratchet system 158 “may be a unidirectional ratchet or a reversible ratchet”; driven pinion 160 engages teeth of rack 162 and “cause[s] the rack 162 to translate longitudinally”; rack 162 may be secured to linear guide 151, which is configured to adjust along linear guide track 146 so that rack 162 and adjustable portion 126 are longitudinally adjusted in a linear and consistent manner; and the alternative embodiment of rack 362, linear guide 351, and linear guide track 346 further supports guided linear longitudinal movement, wherein rack 162 corresponds to the claimed ratcheting rod under the broadest reasonable interpretation as an elongate ratcheting member configured to transmit force along its length, and the placement/advancement of rack 162 within the rack-receiving and guide region adjacent linear guide track 146 corresponds to inserting the ratcheting rod in a chamber of the elongated member of the device body).
To the extent Radwin does not expressly teach that the rack-receiving and guide region is a chamber, Sturtz teaches that it was known in a hypodermic syringe hand-grip actuator to provide a longitudinal open slot or guide region in the hand-grip body for receiving and guiding a movable rack/gear block connected to a syringe plunger. In particular, Sturtz teaches an actuating mechanism for hypodermic syringes that permits injection and aspiration and includes a gun-type operating mechanism for a hypodermic syringe (Sturtz, col. 1, lines 15-18, 19-27, 37-43; col. 2, lines 17-37). Sturtz further teaches that plunger head 21 is secured to holder 32 by a U-shaped yoke secured to longitudinally movable gear block 35; gear block 35 has “slidable engagement within a longitudinally disposed slot 36” of the gun; the gun has a “longitudinally extending groove 38” along each side; pins 40 on gear block 35 slidably engage grooves 38; and the bottom of gear block 35 includes oppositely directed rack gears 43 and 45 for forward and reverse movement of gear block 35 (Sturtz, col. 2, lines 17-50). Sturtz further teaches pawl 53 engaging rack gear 45 to effect rearward movement of gear block 35 and connected plunger 20, and pawl 74 engaging rack gear 43 to push gear block 35 forwardly (Sturtz, col. 2-3, lines 50-30). Thus, Sturtz teaches the known syringe-actuator detail of a movable toothed rack/gear block slidably received in a longitudinal open slot/open guide region of a syringe hand-grip body, with the toothed rack side accessible for engagement by a pawl.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement or understand Radwin’s rack-receiving and guide region as an open longitudinal slot or open guide chamber in view of Sturtz, because Radwin already requires rack 162 to translate longitudinally relative to the syringe-holder body and already requires the teeth of rack 162 to remain accessible for mechanical engagement by driven pinion 160 (Radwin, FIG. 10; ¶[0089], [0098]-[0099]). Sturtz teaches that, in syringe hand-grip actuators, a known way to guide a longitudinally movable toothed rack/gear block connected to a syringe plunger was to place the rack/gear block in a longitudinally disposed slot/open guide region of the hand-grip body while leaving the rack teeth accessible for engagement by a pawl (Sturtz, col. 2-3, lines 17-30). Applying this known open-slot/open-guide implementation detail to Radwin’s rack-receiving region would have predictably provided guided longitudinal movement of Radwin’s rack/adjustable plunger-holding assembly while maintaining access to the rack teeth for the actuator drive member. Therefore, Radwin in view of Sturtz teaches or at least suggests inserting the claimed ratcheting rod in a chamber of the elongated member.
Also regarding claim 8, the modified Radwin teaches a plunger attachment function but does not expressly teach twisting a plunger attachment on the ratcheting rod into a locked position causing the plunger attachment to attach to a plunger of the syringe in the manner claimed. In particular, Radwin teaches that rack 162 is “connected to and/or in communication with” and “secured to or secured relative to” adjustable portion 126; adjustable portion 126 includes plunger flange slot 142 for receiving plunger flange 208 of plunger 204; and longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126 and plunger 204 relative to barrel 202 (Radwin, FIG. 10; ¶[0083], [0098]-[0099], [0102]-[0103]). Radwin further teaches that the fixed portion 124 and adjustable portion 126 may include slots configured to receive a flange or other portion of a syringe, and that the barrel flange slot 140 and/or plunger flange slot 142 may be configured to create “a friction fit or other engaging fit” with the received barrel flange or plunger flange (Radwin, ¶[0083]). Thus, Radwin expressly contemplates that the plunger-side slot may provide an engaging attachment fit with the plunger flange, although Radwin does not expressly teach the claimed twisting/rotating of a plunger attachment into a locked position.
Radwin further teaches a rotatable and releasable locking structure for securing a received syringe structure in the adapter. In particular, Radwin teaches that “other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism” and further teaches a locking arm 372 configured to rotate about pivot pin 374, engage a syringe received within the adapter, and lock the received syringe in the adapter (Radwin, ¶[0083], [0122]). Thus, Radwin teaches a releasable locking mechanism that rotates about a pivot into a locked position to secure a received syringe structure.
Nerney teaches applying a plunger-flange capturing structure at the plunger end of a syringe-control connector. In particular, Nerney teaches a syringe adaptor having an elongate connector 38 and a flange-engaging housing for engaging flange 28 formed on the trailing end of plunger 20 (Nerney, ¶[0018], [0039]-[0040], [0045]-[0046]). Nerney teaches that flange housing 40 includes a top wall, leading wall, trailing wall, side walls, and an open bottom creating a cavity for receiving and capturing plunger flange 28 (Nerney, ¶[0046]). Nerney further teaches a second embodiment in which flange-engaging housing 41 has a top half 41a and a bottom half 41b hingedly connected by hinge 43, wherein the housing is open to receive flange 28 and closed so that flange 28 is captured in sandwiched relation between the top and bottom halves of the flange-engaging housing (Nerney, FIGS. 8A-8B; ¶[0053]). Thus, Nerney teaches that a syringe-control connector may include a plunger-end flange-engaging housing for capturing the plunger flange, and further shows a plunger-end flange-capturing structure that moves about a hinge from an open position to a closed position.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the plunger-attachment end of the modified Radwin rack/adjustable portion assembly to include a rotatable, releasable plunger-flange attachment, because Radwin already teaches a movable rack/adjustable portion assembly that receives and moves plunger flange 208 of plunger 204, including a plunger flange slot 142 that may create “a friction fit or other engaging fit” with the received plunger flange, and Radwin further teaches a releasable locking mechanism including a locking arm that rotates about a pivot into a locked position to secure a received syringe structure (Radwin, FIG. 10; ¶[0083], [0098]-[0099], [0102]-[0103], [0122]). Nerney confirms that the plunger flange is a known structure and location for a syringe-control connector to hold or capture at the plunger end, including by teaching a plunger-end flange-engaging housing for receiving and capturing the plunger flange (Nerney, FIGS. 8A-8B; ¶[0018], [0046], [0053]). Thus, the proposed modification would have implemented a lockable plunger-flange attachment at a location where Radwin already provides an engaging fit with the plunger flange, while using Nerney only to confirm that a syringe-control connector may hold or capture the plunger flange at the plunger end, rather than bodily incorporating Nerney’s entire connector assembly or making Nerney’s permanent clamshell embodiment releasable. Such a modification would have predictably allowed the plunger attachment at the plunger-attachment end of the ratcheting rod assembly to be rotated/twisted into a locked position to attach to and securely retain the syringe plunger during proximal plunger withdrawal, while preserving releasability consistent with Radwin’s releasable locking mechanism. Therefore, the modified Radwin in view of Nerney teaches or at least suggests twisting a plunger attachment on the ratcheting rod into a locked position causing the plunger attachment to attach to a plunger of the syringe.
Also regarding claim 8, the modified Radwin teaches applying pressure on a lever handle hingedly connected to the elongated member of the device body, the lever handle being coupled to the ratcheting rod. In particular, it teaches a manually actuated plunger-withdrawing mechanism including a handle/trigger-type actuator for moving the plunger. Radwin teaches actuator 106 including grip portion 118, first support 120, and second support 122, wherein applying force to second support 122 in direction 138 actuates actuator 106 and causes adjustable portion 126 to positionally adjust relative to fixed portion 124, and wherein directions 136 and 138 “may be opposite lateral and/or rotational directions” and “are depicted with a rotational element” (Radwin, ¶[0082], [0087]-[0088]). Thus, Radwin teaches applying pressure on a manually depressed handle/trigger-type actuator for actuating the syringe adapter and withdrawing the syringe plunger. However, it does not expressly teach the claimed lever handle hingedly connected to the elongated member of the device body in the manner claimed because Radwin’s actuator 106 is located at least partially toward the first end 100a of adapter 100 relative to gripping portion 104, rather than being hinged at the distal end of the syringe-holding device body in the manner claimed (Radwin, ¶[0087]). The modified Radwin also does not expressly teach the lever handle coupled to the ratcheting rod through a ratcheting lever/pawl arrangement because Radwin converts movement of actuator 106 into longitudinal movement of rack 162 using gear system 152, including drive gear 154, drive pinion 156, ratchet system 158, driven pinion 160, and rack 162, wherein driven pinion 160 engages teeth of rack 162 and causes rack 162 to translate longitudinally, but driven pinion 160 is a rotatable gear member mounted in Radwin’s gear system rather than a ratcheting lever hingedly connected to the lever handle (Radwin, ¶[0089], [0091]-[0099]). Radwin further teaches, however, that “[a]lthough the actuation system 150 is depicted and described as having the gear system 152”, the actuation system may include “one or more additional or alternative suitable systems for causing movement of the adjustable portion 126 in response to movement of the actuator 106”, including a system with “different gears” or “no gears” (Radwin, ¶[0089]). Radwin also teaches that ratchet system 158 “may be a unidirectional ratchet or a reversible ratchet”, thereby showing that Radwin already contemplates ratchet-based manual actuation as part of the actuator-to-rack drive path (Radwin, ¶[0096]).
Epstein teaches a handle/linkage/pawl/rack actuation arrangement in a medical suctioning/fluid applicator device (Epstein, FIG. 5; ¶[0055]: actuating assembly 100 includes “trigger (105)” mechanically coupled to plungers 142, 144; ¶[0056]: “trigger (105) is coupled to pawl (120) via lever arm (110)” and pawl 120 includes hook 122 having flat distal face 124; ¶[0057]: rack 130 includes “a plurality of teeth (132)” with gaps “adapted to receive hook (122)”; ¶[0067]: depressing trigger 105 moves the lever arm 110/pawl 120/hook 122 combination and engages teeth 132 such that depressing the handle/trigger 105 linearly moves rack 130, wherein trigger 105 corresponds to the claimed lever handle, the pivoted end of trigger 105 corresponds to the hinged connection of the lever handle to the elongated member of the device body, the linkage including lever arm 110, pawl 120, and hook 122 couples the lever handle to the rack, and hook 122 engaging teeth 132 of rack 130 corresponds to the lever handle being coupled to the ratcheting rod through a ratcheting lever/pawl engagement).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Radwin’s syringe attachment device to replace Radwin’s gear-based actuator-to-rack drive path with Epstein’s trigger/lever-arm/pawl/rack drive path, with the pivoted end of Epstein’s trigger 105 oriented at the distal end of Radwin’s device body and with Epstein’s lever arm 110/pawl 120/hook 122 linkage maintained at a position spaced from the pivoted end of trigger 105. This modification would have been a simple substitution of one known mechanical actuation means, Epstein’s manually depressed lever/pawl advancing a toothed rack, for another known mechanical actuation means, Radwin’s gear train driving a toothed rack, to obtain the predictable result of converting manual squeeze/trigger input into longitudinal rack and plunger travel. Radwin expressly teaches that actuation system 150 may include “one or more additional or alternative suitable systems for causing movement of the adjustable portion 126 in response to movement of the actuator 106”, including systems having “different gears” or “no gears”, and Epstein’s pawl-and-rack actuation path is a known no-gear actuation system for moving a toothed rack in response to manual depression of a trigger (Radwin, ¶[0089], [0091]-[0099], [0101]-[0103]; Epstein, FIG. 5; ¶[0055]-[0057], [0067]).
It further would have been obvious to orient Epstein’s lever/pawl/rack actuation path so that compression of the handle drives Radwin’s rack/adjustable portion assembly proximally. Epstein teaches that depressing trigger 105 drives pawl 120 through lever arm 110 such that hook 122 engages teeth 132 and moves rack 130 in Epstein’s dispensing direction (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). Radwin’s aspiration operation requires proximal movement of rack 162 and adjustable portion 126 to withdraw plunger 204 from barrel 202 and aspirate fluid (Radwin, ¶[0098]-[0099], [0101]-[0103]). Therefore, to use Epstein’s pawl-and-rack actuation to produce Radwin’s proximal plunger-withdrawal for aspiration, one of ordinary skill would orient the pawl stroke to drive Radwin’s rack/adjustable portion assembly proximally, thereby placing the lever-handle pivot at the distal end of the device body. Such orientation would have been a predictable reversal or rearrangement of mechanical parts to provide the required direction of rack travel while preserving the same trigger-to-pawl-to-rack force path. The Sturtz open-slot/open-guide teaching further supports the mechanical feasibility of this modification because Sturtz shows that a toothed rack/gear block in a syringe hand-grip actuator may be guided in a longitudinal open slot/open guide region while remaining accessible for pawl engagement (Sturtz, col. 2, lines 33-47; col. 2, lines 48-72; col. 3, lines 3-30).
The modification would not change Radwin’s principle of operation. Radwin’s principle of operation is manual-actuator-driven longitudinal adjustment of adjustable portion 126 relative to fixed portion 124 so that the syringe plunger is withdrawn to aspirate fluid and/or create vacuum (Radwin, ¶[0082], [0089], [0098]-[0099], [0101]-[0103]). Replacing Radwin’s gear-based drive path with Epstein’s pawl-and-rack drive path, while using the known Sturtz open-slot/open-guide implementation detail for the rack-receiving region and the known Nerney plunger-flange locking structure for the plunger attachment, would still use manual actuation to longitudinally move the rack and adjustable plunger-holding portion. Further, Radwin already includes ratchet system 158, which “may be a unidirectional ratchet or a reversible ratchet”, and Radwin expressly contemplates alternative systems having “different gears” or “no gears” (Radwin, ¶[0089], [0096]). Thus, substituting Epstein’s pawl-ratchet drive, implementing the rack-receiving guide as an open slot/open chamber of the type taught by Sturtz, and using Nerney’s plunger-flange locking structure would implement known actuator-to-rack, rack-guide, and plunger-attachment details of the type used in syringe hand-grip actuators, rather than changing the basic operation of Radwin’s syringe adapter.
Finally regarding claim 8, the modified Radwin method teaches wherein compression of the lever handle transmits force through the ratcheting rod to raise the plunger of the syringe (Radwin, ¶[0101]-[0103]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; syringe 200 is received in fixed portion 124 and adjustable portion 126 with plunger flange 208 in plunger flange slot 142; actuator 106 is moved to a loaded position so that a desired amount of fluid will be aspirated upon actuation; and actuation adjusts adjustable portion 126 to withdraw, i.e., retract/extract or raise, plunger 204 from barrel 202 to aspirate fluid and/or create vacuum), because, in the modified method discussed above, applying pressure to and compressing the distally hinged Epstein-type lever handle would drive the Epstein-type lever arm 110/pawl 120/hook 122 ratcheting lever assembly into engagement with the teeth of Radwin’s rack, thereby transmitting force through Radwin’s rack/adjustable portion assembly and moving plunger 204 proximally relative to barrel 202, i.e., raising/withdrawing the plunger to aspirate fluid and/or create vacuum.
Regarding claim 10, the modified Radwin teaches the method of claim 8, but does not expressly teach wherein applying pressure on the lever handle comprises repeatedly pumping the lever handle to modulate a volume pulled by the syringe. Radwin teaches an actuator/rack arrangement for aspirating fluid into a syringe and controlling the amount of fluid aspirated (Radwin, ¶[0101]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; ¶[0103]: while actuator 106 is translated to a loaded position, “a user may count a number of audible and/or tactile indications to determine an amount fluid that will be aspirated”; ¶[0104]: actuator 106 “has been actuated to aspirate fluid into the syringe 200”, and actuation causes adjustable portion 126 to withdraw plunger 204 from barrel 202, “thereby creating a vacuum in the barrel 202 and aspirating fluid”). As discussed above for claim 8, the modified Radwin includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally.
Epstein further supports that the modified lever/trigger-operated rack mechanism is suitable for incremental hand-trigger actuation. In particular, Epstein teaches that “[b]y gripping handle (505) and actuating trigger (520) in a user’s hand, compressing the trigger against the handle actuates the dispensing assembly within the device to dispense fluids a predetermined incremental amount” (Epstein, ¶[0118]). Thus, Epstein teaches that repeated hand-trigger compression may produce controlled incremental fluid movement.
Sturtz expressly teaches repeated pumping of a syringe hand-grip trigger to control the amount withdrawn into the syringe (Sturtz, col. 3-4, lines 70-11: “the trigger finger piece 65 may be depressed a sufficient number of times to withdraw the plunger rearwardly of the gun to fill the syringe to the desired capacity”). Sturtz also teaches repeated trigger actuation to control the amount discharged from the syringe (Sturtz, col. 3-4, lines 70-11: “the finger piece 65 of the trigger may be depressed a sufficient number of times to discharge the desired quantity of medication”). Thus, Sturtz teaches that repeated trigger/lever pumping can cumulatively move the syringe plunger to control the volume moved by the syringe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the applying-pressure step of the modified Radwin method to include repeatedly pumping the lever handle to modulate the volume pulled by the syringe, because Radwin teaches an actuator/rack syringe adapter for aspirating fluid and determining the amount of fluid that will be aspirated, Epstein teaches that a handheld trigger/rack mechanism may provide a predetermined incremental amount of fluid movement with each trigger compression, and Sturtz expressly teaches repeatedly depressing a syringe hand-grip trigger a sufficient number of times to withdraw the plunger and fill the syringe to a desired capacity. Such a configuration would have provided the predictable benefit of allowing the user to finely control the aspirated volume by selecting the number of lever-handle pumping strokes, with each stroke producing incremental plunger movement and the cumulative strokes producing the desired volume pulled into the syringe. Therefore, the modified Radwin method in view of Epstein and Sturtz teaches or at least suggests wherein applying pressure on the lever handle comprises repeatedly pumping the lever handle to modulate a volume pulled by the syringe.
Regarding claim 11, the modified Radwin teaches the method of claim 8, but does not expressly teach twisting the plunger attachment of the ratcheting rod into an unlocked position causing the plunger attachment to detach from the plunger of the syringe; and removing the syringe from the device body. As discussed above for claim 8, Radwin teaches that rack 162 is “connected to and/or in communication with” and “secured to or secured relative to” adjustable portion 126; adjustable portion 126 includes plunger flange slot 142 for receiving plunger flange 208 of plunger 204; and longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126 and plunger 204 relative to barrel 202 (Radwin, FIG. 10; ¶[0083], [0098]-[0099], [0102]-[0103]). Radwin further teaches that the barrel flange slot 140 and/or plunger flange slot 142 may be configured to create “a friction fit or other engaging fit” with the received barrel flange or plunger flange (Radwin, ¶[0083]). Thus, Radwin expressly contemplates that the plunger-side slot may provide an engaging attachment fit with the plunger flange.
Radwin further teaches releasable attachment and removal of a syringe from the device body. In particular, Radwin teaches that “other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism” (Radwin, ¶[0083]). Radwin further teaches locking mechanism 370 configured to releasably engage a syringe received within adapter 300, and teaches that applying force to locking arm 372 facilitates release of locking arm 372 and “removal of the syringe from the adapter 300” (Radwin, ¶[0122]). Therefore, Radwin teaches or at least suggests removing the syringe from the device body after the syringe and plunger are released from their respective attachments.
Nerney teaches a plunger-flange capturing structure at the plunger end of a syringe-control connector. In particular, Nerney teaches a syringe adaptor having an elongate connector 38 and a flange-engaging housing for engaging flange 28 formed on the trailing end of plunger 20 (Nerney, ¶[0018], [0039]-[0040], [0045]-[0046]). Nerney teaches that flange housing 40 includes a top wall, leading wall, trailing wall, side walls, and an open bottom creating a cavity for receiving and capturing plunger flange 28 (Nerney, ¶[0046]). Nerney further teaches a second embodiment in which flange-engaging housing 41 has a top half 41a and a bottom half 41b hingedly connected by hinge 43, wherein the housing is open to receive flange 28 and closed so that flange 28 is captured in sandwiched relation between the top and bottom halves of the flange-engaging housing (Nerney, FIGS. 8A-8B; ¶[0053]). Thus, Nerney teaches that a syringe-control connector may include a plunger-end flange-engaging housing for capturing the plunger flange, and further shows a plunger-end flange-capturing structure that moves about a hinge between an open position and a closed position.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the plunger-flange connection of Radwin’s rack/adjustable portion assembly as a movable, unlockable plunger-flange attachment of the type suggested by Nerney, because Radwin already locates the plunger-driving connection at plunger flange slot 142 of adjustable portion 126 and expressly contemplates that this location provides an engaging fit with the plunger flange, while Nerney shows that a syringe-control connector can hold or capture that same type of plunger flange at the trailing end of a syringe plunger using a flange-engaging housing that moves between open and closed positions. The combination would have required only substituting or adapting Radwin’s plunger flange slot/friction-fit connection to include a flange-capturing, openable/releasable plunger-end attachment, while maintaining Radwin’s same rack-to-adjustable-portion force path for moving the plunger during aspiration. The benefit of such a modification would have been to securely retain the plunger flange during proximal plunger withdrawal while allowing the same plunger-flange attachment to be unlocked and detached to facilitate syringe removal or replacement. The proposed modification would have implemented that benefit at a location where Radwin already provides an engaging fit with the plunger flange, rather than bodily incorporating Nerney’s entire connector assembly or making Nerney’s permanent clamshell embodiment releasable.
Such a modification would have predictably allowed the plunger attachment at the plunger-attachment end of the ratcheting rod assembly to be moved from a locked/attached position to an unlocked/detached position to release the syringe plunger, while preserving releasability consistent with Radwin’s releasable locking mechanism. Once the plunger attachment is unlocked and detached from the plunger, Radwin’s releasable syringe-holding structures allow the syringe to be removed from the adapter/device body. Therefore, the modified Radwin in view of Nerney teaches or at least suggests twisting the plunger attachment of the ratcheting rod into an unlocked position causing the plunger attachment to detach from the plunger of the syringe, and removing the syringe from the device body.
Regarding claim 14, Radwin teaches a system for aspiration, comprising: a syringe; and a one-handed aspirator device comprising: a device body suitable to hold the syringe (Radwin, ¶[0002]: “syringe attachment devices” and “syringe adapters” that “facilitate aspirating fluid to and/or dispensing fluid from a syringe”; ¶[0005]: “a one-handed syringe adapter” including “a syringe holder and an actuator”; ¶[0101]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe received within adapter 100”; ¶[0102]: “syringe 200 [is] received in the fixed portion 124 and the adjustable portion 126 of the syringe holder 108”, wherein syringe 200 corresponds to the claimed syringe, and housing 102 and syringe holder 108 correspond to the claimed device body suitable to hold the syringe).
Also regarding claim 14, Radwin teaches a longitudinally movable toothed rack/rod disposed within the device body, but Radwin does not expressly teach a ratcheting mechanism including a ratcheting rod in the manner claimed. In particular, Radwin teaches actuation system 150 including rack 162 and linear guide track 146; gear system 152 including rack 162; ratchet system 158, which “may be a unidirectional ratchet or a reversible ratchet”; driven pinion 160 engaging teeth of rack 162 and “cause[s] the rack 162 to translate longitudinally”; and rack 162 secured to linear guide 151, which is configured to adjust along linear guide track 146 so that rack 162 and adjustable portion 126 are longitudinally adjusted in a linear and consistent manner (Radwin, FIG. 10; ¶[0084], [0089], [0091], [0096], [0098]-[0099]). Thus, Radwin teaches a toothed rack/rod configured to transmit force along its length and move the plunger-holding adjustable portion, but Radwin uses driven pinion 160 and gear system 152 to engage rack 162 rather than the claimed ratcheting lever/ratcheting rod arrangement.
Epstein teaches a ratcheting mechanism including a ratcheting lever configured to engage a toothed rack/rod. In particular, Epstein teaches a handle/linkage/pawl/rack actuation arrangement in which trigger 105 is coupled to pawl 120 via lever arm 110, pawl 120 includes hook 122 having flat distal face 124, rack 130 includes “a plurality of teeth (132)” with gaps “adapted to receive hook (122)”, and depressing trigger 105 moves the lever arm 110/pawl 120/hook 122 combination and engages teeth 132 such that depressing the handle/trigger 105 linearly moves rack 130 (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). Thus, Epstein teaches a ratcheting mechanism including a ratcheting lever and a toothed rack/rod engaged by the ratcheting lever.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Radwin’s toothed rack/rod and actuator-to-rack drive path to use Epstein’s lever arm 110/pawl 120/hook 122 ratcheting lever assembly to engage and move Radwin’s rack 162. Radwin already teaches a syringe adapter in which manual movement of actuator 106 causes movement of rack 162 and adjustable portion 126 to withdraw syringe plunger 204, and Radwin expressly teaches that actuation system 150 may include “one or more additional or alternative suitable systems for causing movement of the adjustable portion 126 in response to movement of the actuator 106”, including systems having “different gears” or “no gears” (Radwin, ¶[0089], [0091]-[0099], [0101]-[0103]). Epstein teaches a known no-gear ratcheting lever/pawl/rack actuation path for moving a toothed rack in response to manual depression of a trigger (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). This modification would have been a simple substitution of one known mechanical actuation means, Epstein’s manually depressed lever/pawl advancing a toothed rack, for another known mechanical actuation means, Radwin’s gear train driving a toothed rack, to obtain the predictable benefit of converting manual squeeze/trigger input into controlled longitudinal rack and plunger travel without requiring Radwin’s gear train. The modification would also provide the benefit expressly contemplated by Radwin’s disclosure of alternative actuation systems having “different gears” or “no gears”, namely allowing the syringe adapter to use a different mechanical drive path while still moving adjustable portion 126 in response to actuator movement (Radwin, ¶[0089]).
It further would have been obvious to orient Epstein’s lever/pawl/rack actuation path so that compression of the handle drives Radwin’s rack/adjustable portion assembly proximally, because Epstein teaches that depressing trigger 105 drives pawl 120 through lever arm 110 such that hook 122 engages teeth 132 and moves rack 130, while Radwin’s aspiration operation requires proximal movement of rack 162 and adjustable portion 126 to withdraw plunger 204 from barrel 202 and aspirate fluid (Radwin, ¶[0098]-[0099], [0101]-[0103]; Epstein, FIG. 5; ¶[0055]-[0057], [0067]). Therefore, to use Epstein’s pawl-and-rack actuation to produce Radwin’s proximal plunger-withdrawal for aspiration, one of ordinary skill would orient the pawl stroke to drive Radwin’s rack/adjustable portion assembly proximally, thereby placing the lever-handle pivot at the distal end of the device body and maintaining the ratcheting lever assembly at a position spaced from that pivot. Such orientation would have been a predictable reversal or rearrangement of mechanical parts to provide the required direction of rack travel while preserving the same trigger-to-pawl-to-rack force path and achieving Radwin’s intended aspiration benefit of withdrawing the syringe plunger to aspirate fluid and/or create vacuum. Accordingly, Radwin in view of Epstein teaches or at least suggests the claimed ratcheting mechanism including a ratcheting rod, wherein Radwin’s rack 162 corresponds to the ratcheting rod of the modified ratcheting mechanism and Epstein’s lever arm 110/pawl 120/hook 122 assembly corresponds to the ratcheting lever of the modified ratcheting mechanism.
To the extent Radwin does not expressly teach that the rack-receiving and guide region of the ratcheting mechanism is within the device body in the manner claimed, Sturtz teaches that it was known in a hypodermic syringe hand-grip actuator to provide a longitudinal open slot or guide region in the hand-grip body for receiving and guiding a movable rack/gear block connected to a syringe plunger. In particular, Sturtz teaches an actuating mechanism for hypodermic syringes that permits injection and aspiration and includes a gun-type operating mechanism for a hypodermic syringe (Sturtz, col. 1, lines 15-18, 19-27, 37-43; col. 2, lines 17-37). Sturtz further teaches that plunger head 21 is secured to holder 32 by a U-shaped yoke secured to longitudinally movable gear block 35; gear block 35 has “slidable engagement within a longitudinally disposed slot 36” of the gun; the gun has a “longitudinally extending groove 38” along each side; pins 40 on gear block 35 slidably engage grooves 38; and the bottom of gear block 35 includes oppositely directed rack gears 43 and 45 for forward and reverse movement of gear block 35 (Sturtz, col. 2, lines 17-50). Sturtz further teaches pawl 53 engaging rack gear 45 to effect rearward movement of gear block 35 and connected plunger 20, and pawl 74 engaging rack gear 43 to push gear block 35 forwardly (Sturtz, col. 2-3, lines 50-30). Thus, Sturtz teaches the known syringe-actuator detail of a movable toothed rack/gear block slidably received in a longitudinal open slot/open guide region of a syringe hand-grip body, with the toothed rack side accessible for engagement by a pawl.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement or understand Radwin’s rack-receiving and guide region as an open longitudinal slot or open guide chamber in view of Sturtz, because Radwin already requires rack 162 to translate longitudinally relative to the syringe-holder body and already requires the teeth of rack 162 to remain accessible for mechanical engagement by driven pinion 160 or, in the modified system, the Epstein-type ratcheting lever (Radwin, FIG. 10; ¶[0089], [0098]-[0099]; Epstein, FIG. 5; ¶[0055]-[0057], [0067]). Sturtz teaches that, in syringe hand-grip actuators, a known way to guide a longitudinally movable toothed rack/gear block connected to a syringe plunger was to place the rack/gear block in a longitudinally disposed slot/open guide region of the hand-grip body while leaving the rack teeth accessible for engagement by a pawl (Sturtz, col. 2-3, lines 17-30). Applying this known open-slot/open-guide implementation detail to Radwin’s rack-receiving region would have provided the predictable benefits of guiding longitudinal movement of Radwin’s rack/adjustable plunger-holding assembly, maintaining alignment of the rack during plunger withdrawal, and preserving access to the rack teeth for the actuator drive member. Therefore, Radwin in view of Sturtz teaches or at least suggests the ratcheting rod disposed within the device body.
Also regarding claim 14, the modified Radwin teaches a ratcheting rod assembly having a plunger attachment function, but does not expressly teach wherein the ratcheting rod, when in a locked position, is attached to a plunger of the syringe in the manner claimed. In particular, Radwin teaches that rack 162 is “connected to and/or in communication with” and “secured to or secured relative to” adjustable portion 126; adjustable portion 126 includes plunger flange slot 142 for receiving plunger flange 208 of plunger 204; and longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126 and plunger 204 relative to barrel 202 (Radwin, FIG. 10; ¶[0083], [0091], [0098]-[0099], [0102]-[0103]). Thus, Radwin teaches the plunger-attachment end of the rack/adjustable portion assembly attaching to the syringe plunger through adjustable portion 126 and plunger flange slot 142, but does not expressly teach that the plunger-attachment end is in a locked position.
Radwin further teaches a releasable locking mechanism for securing a received syringe structure in the adapter. In particular, Radwin teaches that fixed portion 124 and adjustable portion 126 may include slots configured to receive a flange or other portion of a syringe, and that the slots may be configured to create a friction fit or other engaging fit (Radwin, ¶[0083]). Radwin further teaches that “other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism”, and teaches a locking arm 372 configured to rotate about pivot pin 374, engage a syringe received within the adapter, and lock the received syringe in the adapter (Radwin, ¶[0083], [0122]). Thus, Radwin teaches a releasable and rotatable locking mechanism for securing a received syringe structure to the adapter.
Nerney teaches applying a plunger-flange capturing structure at the plunger end of a syringe-control connector. In particular, Nerney teaches a syringe adaptor having an elongate connector 38 and a flange-engaging housing for engaging flange 28 formed on the trailing end of plunger 20 (Nerney, ¶[0018], [0039]-[0040], [0045]-[0046]). Nerney teaches that flange housing 40 includes a top wall, leading wall, trailing wall, side walls, and an open bottom creating a cavity for receiving and capturing plunger flange 28 (Nerney, ¶[0046]). Nerney further teaches a second embodiment in which flange-engaging housing 41 has a top half 41a and a bottom half 41b hingedly connected by hinge 43, wherein the housing is open to receive flange 28 and closed so that flange 28 is captured in sandwiched relation between the top and bottom halves of the flange-engaging housing (Nerney, FIGS. 8A-8B; ¶[0053]). Thus, Nerney teaches that a syringe-control connector may include a plunger-end flange-engaging housing for capturing the plunger flange.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the plunger-attachment end of the modified Radwin rack/adjustable portion assembly to include a plunger-flange capturing structure of the type taught by Nerney, implemented with Radwin’s releasable and rotatable locking mechanism, because the modified Radwin already teaches a movable rack/adjustable portion assembly that receives and moves plunger flange 208 of plunger 204, Radwin teaches a releasable locking mechanism including a locking arm that rotates about a pivot into a locked position to secure a received syringe structure, and Nerney teaches that a syringe-control connector may include a plunger-end flange-engaging housing for capturing the plunger flange (Radwin, FIG. 10; ¶[0083], [0098]-[0099], [0102]-[0103], [0122]; Nerney, FIGS. 8A-8B; ¶[0018], [0046], [0053]). This modification would have provided the predictable benefits of securely capturing the plunger flange at the plunger-attachment end of the ratcheting rod assembly during plunger withdrawal, reducing the risk that the plunger flange would disengage from the movable rack/adjustable portion assembly during aspiration, and preserving the ability to release the syringe/plunger attachment using a releasable locking mechanism of the type already contemplated by Radwin. Therefore, the further modified Radwin teaches that the ratcheting rod, when in a locked position provided by the releasable plunger-flange locking structure at the plunger-attachment end of the rack/adjustable portion assembly, is attached to the plunger of the syringe.
Also regarding claim 14, the further modified Radwin teaches a lever handle on an exterior of the device body coupled to the ratcheting lever. In particular, Radwin teaches actuator 106 including grip portion 118, first support 120, and second support 122, wherein applying force to second support 122 in direction 138 actuates actuator 106 and causes adjustable portion 126 to positionally adjust relative to fixed portion 124, and wherein directions 136 and 138 “may be opposite lateral and/or rotational directions” and “are depicted with a rotational element” (Radwin, ¶[0082], [0087]-[0088]). Thus, Radwin teaches a manually depressed handle/trigger-type actuator on the exterior of the device body for actuating the syringe adapter and withdrawing the syringe plunger. Further, Epstein teaches that trigger 105 is coupled to pawl 120 via lever arm 110, that pawl 120 includes hook 122, and that depressing trigger 105 moves the lever arm 110/pawl 120/hook 122 combination to engage teeth 132 and linearly move rack 130 (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). In the further modified Radwin system, Epstein’s trigger 105 corresponds to the claimed lever handle on an exterior of the device body, Epstein’s lever arm 110/pawl 120/hook 122 assembly corresponds to the claimed ratcheting lever, and Epstein’s coupling of trigger 105 to pawl 120 via lever arm 110 corresponds to the lever handle being coupled to the ratcheting lever.
The modification would not change Radwin’s principle of operation. Radwin’s principle of operation is manual-actuator-driven longitudinal adjustment of adjustable portion 126 relative to fixed portion 124 so that the syringe plunger is withdrawn to aspirate fluid and/or create vacuum (Radwin, ¶[0082], [0089], [0098]-[0099], [0101]-[0103]). Replacing Radwin’s gear-based drive path with Epstein’s pawl-and-rack drive path, while using the known Sturtz open-slot/open-guide implementation detail for the rack-receiving region and using a releasable plunger-flange locking structure at the plunger-attachment end based on Radwin’s releasable/rotatable locking mechanism and Nerney’s plunger-end flange-capturing structure, would still use manual actuation to longitudinally move the rack and adjustable plunger-holding portion. Further, Radwin already includes ratchet system 158, which “may be a unidirectional ratchet or a reversible ratchet”, and Radwin expressly contemplates alternative systems having “different gears” or “no gears” (Radwin, ¶[0089], [0096]). Thus, substituting Epstein’s pawl-ratchet drive, implementing the rack-receiving guide as an open slot/open chamber of the type taught by Sturtz, and using the plunger-flange locking structure discussed above would implement known actuator-to-rack, rack-guide, and plunger-attachment details of the type used in syringe hand-grip actuators, rather than changing the basic operation of Radwin’s syringe adapter.
Finally regarding claim 14, the further modified Radwin system teaches wherein compression of the lever handle forces the ratcheting lever to extend the ratcheting rod and to extract the plunger of the syringe (Radwin, ¶[0101]-[0103]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; syringe 200 is received in fixed portion 124 and adjustable portion 126 with plunger flange 208 in plunger flange slot 142; actuator 106 is moved to a loaded position so that a desired amount of fluid will be aspirated upon actuation; and actuation adjusts adjustable portion 126 to withdraw, i.e., retract/extract, plunger 204 from barrel 202 to aspirate fluid and/or create vacuum), because, in the further modified system discussed above, compression of the Epstein-type lever handle on the exterior of the device body would drive the Epstein-type lever arm 110/pawl 120/hook 122 ratcheting lever assembly into engagement with the teeth of Radwin’s rack, thereby extending/moving Radwin’s rack/adjustable portion assembly proximally and withdrawing plunger 204 from barrel 202 to aspirate fluid and/or create vacuum.
Regarding claim 16, the modified Radwin teaches the system of claim 14, wherein the ratcheting mechanism is linear. As discussed above for claim 14, the modified Radwin includes an Epstein-type ratcheting mechanism including a ratcheting rod disposed within the device body and a ratcheting lever for driving the ratcheting rod. Radwin teaches that actuation system 150 includes rack 162 and linear guide track 146, that driven pinion 160 engages teeth of rack 162 and “cause[s] the rack 162 to translate longitudinally,” and that rack 162 may be secured to linear guide 151, which is configured to adjust along linear guide track 146 so that rack 162 and adjustable portion 126 are longitudinally adjusted in a linear and consistent manner (Radwin, FIG. 10; ¶[0084], [0089], [0098]-[0099]). Epstein further teaches a pawl-and-rack actuation mechanism in which depressing trigger 105 causes pawl 120/hook 122 to engage teeth 132 and linearly move rack 130 (Epstein, FIG. 5; ¶[0056]-[0057], [0067]). Sturtz likewise teaches a longitudinally movable gear block 35 slidably received in longitudinally disposed slot 36, with pawls selectively engaging rack gears 43 and 45 to move the gear block rearwardly or forwardly (Sturtz, col. 2-3, lines 17-30). Thus, the modified Radwin system includes a ratcheting lever/pawl engaging a toothed rack/ratcheting rod that translates longitudinally along a linear guide/slot path. Therefore, the modified Radwin system teaches or at least suggests wherein the ratcheting mechanism is linear.
Regarding claim 17, the modified Radwin teaches the system of claim 14, but does not expressly teach that the lever handle has grooves configured to fit fingers of a hand. As discussed above for claim 14, the modified Radwin includes an Epstein-type trigger 105 corresponding to the claimed lever handle. Epstein teaches that trigger 105 is manually depressed to move lever arm 110/pawl 120/hook 122 and drive rack 130 longitudinally (Epstein, FIG. 5; ¶[0055]-[0057], [0067]). However, the modified Radwin does not expressly teach that trigger 105 includes grooves configured to fit fingers of a hand.
Radwin teaches that hand-engaged grip surfaces on a one-handed syringe adapter may include digit-receiving ergonomic features. In particular, Radwin teaches that actuator 106 may include grip portion 118 and that, "[t]o facilitate actuation of the actuator 106 with one or more digits of a user," grip portion 118 may include first support 120 and/or second support 122 (Radwin, ¶[0057]). Radwin further teaches that "the grip portion 118 of the actuator 106 may have a length configured to receive one or more digits of a user's hand" (Radwin, ¶[0088]). Radwin also teaches that hand-grip portions configured to receive digits of a user may have indents, contours, bumps, lines, smooth surfaces, and/or other gripping features to facilitate receiving one or more digits of a user (Radwin, ¶[0054]-[0055]). Radwin further teaches a digit-receiving contour 132 configured to receive a user's digit as anatomically positioned when grasping or pinching an object (Radwin, ¶[0076]). Thus, Radwin teaches using finger-receiving contours, indents, lines, or other gripping features on hand-engaged surfaces of a one-handed syringe adapter to facilitate digit placement and actuation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the Epstein-type lever handle/trigger 105 of the modified Radwin system with finger-receiving grooves, contours, indents, lines, or other digit-receiving gripping features of the type taught by Radwin, because the Epstein-type trigger 105 is the hand-actuated lever surface compressed by the user's fingers to drive the rack/ratcheting rod, and Radwin teaches providing digit-receiving ergonomic grip features on hand-engaged surfaces of a one-handed syringe adapter to facilitate receiving one or more digits of the user's hand and to facilitate actuation. The benefit of such a modification would have been to improve finger placement, grip stability, and ergonomic one-handed compression of the lever handle during aspiration. Therefore, the modified Radwin system in view of Epstein and Radwin's digit-receiving grip-feature teachings teaches or at least suggests wherein the lever handle has grooves configured to fit fingers of a hand.
Regarding claim 18, the modified Radwin teaches the system of claim 14, but does not expressly teach wherein the lever handle can be pumped repeatedly to modulate a volume pulled by the syringe. Radwin teaches an actuator/rack arrangement for aspirating fluid into a syringe and controlling the amount of fluid aspirated (Radwin, ¶[0101]: FIGS. 11-13 depict “loading and actuating an actuator to aspirate fluid into a syringe”; ¶[0103]: while actuator 106 is translated to a loaded position, “a user may count a number of audible and/or tactile indications to determine an amount fluid that will be aspirated”; ¶[0104]: actuator 106 “has been actuated to aspirate fluid into the syringe 200”, and actuation causes adjustable portion 126 to withdraw plunger 204 from barrel 202, “thereby creating a vacuum in the barrel 202 and aspirating fluid”). As discussed above for claim 14, the modified Radwin includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally.
Epstein further supports that the modified lever/trigger-operated rack mechanism is suitable for incremental hand-trigger actuation. In particular, Epstein teaches that “[b]y gripping handle (505) and actuating trigger (520) in a user’s hand, compressing the trigger against the handle actuates the dispensing assembly within the device to dispense fluids a predetermined incremental amount” (Epstein, ¶[0118]). Thus, Epstein teaches that repeated hand-trigger compression may produce controlled incremental fluid movement.
Sturtz expressly teaches repeated pumping of a syringe hand-grip trigger to control the amount withdrawn into the syringe (Sturtz, col. 3-4, lines 70-11: “the trigger finger piece 65 may be depressed a sufficient number of times to withdraw the plunger rearwardly of the gun to fill the syringe to the desired capacity”). Sturtz also teaches repeated trigger actuation to control the amount discharged from the syringe (Sturtz, col. 3-4, lines 70-11: “the finger piece 65 of the trigger may be depressed a sufficient number of times to discharge the desired quantity of medication”). Thus, Sturtz teaches that repeated trigger/lever pumping can cumulatively move the syringe plunger to control the volume moved by the syringe.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the lever handle of the modified Radwin system to be pumped repeatedly to modulate the volume pulled by the syringe, because Radwin teaches an actuator/rack syringe adapter for aspirating fluid and determining the amount of fluid that will be aspirated, Epstein teaches that a handheld trigger/rack mechanism may provide a predetermined incremental amount of fluid movement with each trigger compression, and Sturtz expressly teaches repeatedly depressing a syringe hand-grip trigger a sufficient number of times to withdraw the plunger and fill the syringe to a desired capacity. Such a configuration would have provided the predictable benefit of allowing the user to finely control the aspirated volume by selecting the number of lever-handle pumping strokes, with each stroke producing incremental plunger movement and the cumulative strokes producing the desired volume pulled into the syringe. Therefore, the modified Radwin system in view of Epstein and Sturtz teaches or at least suggests wherein the lever handle can be pumped repeatedly to modulate a volume pulled by the syringe.
Regarding claim 19, although claim 19 is also rejected under 35 U.S.C. 112(b) as set forth above, the following prior-art rejection applies under the Examiner's broadest reasonable interpretation of the syringe can be removed by unlocking the ratcheting rod and pulling the syringe out of the device body. Under this interpretation, the limitation encompasses unlocking or releasing a plunger attachment or ratcheting-rod-associated attachment that connects the ratcheting rod to the syringe plunger, followed by removing the syringe from the device body. The modified Radwin teaches the system of claim 14, but does not expressly teach this limitation.
Radwin teaches that the syringe can be removed by releasing the syringe from the adapter/device body. In particular, Radwin teaches that adjustable portion 126 includes plunger flange slot 142 for receiving a plunger flange, and that plunger flange slot 142 may create “a friction fit or other engaging fit” with the plunger flange (Radwin, ¶[0083]). Radwin further teaches that rack 162 is “connected to and/or in communication with” and “secured to or secured relative to” adjustable portion 126, and that longitudinal movement of rack 162 causes longitudinal movement of adjustable portion 126 (Radwin, ¶[0098]-[0099]). Radwin also teaches that plunger flange 208 is received in plunger flange slot 142, and that actuation causes adjustable portion 126 to withdraw plunger 204 from barrel 202 (Radwin, ¶[0102]-[0104]). Thus, Radwin's rack 162/adjustable portion 126 corresponds to the ratcheting rod assembly, and Radwin's plunger flange slot 142/friction fit corresponds to a connection between the ratcheting rod assembly and the plunger of the syringe.
Radwin further teaches releasable syringe attachment and syringe removal. In particular, Radwin teaches that “other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism” (Radwin, ¶[0083]). Radwin also teaches locking mechanism 370 configured to releasably engage a syringe received within adapter 300, and teaches that applying force to locking arm 372 facilitates release of locking arm 372 and “removal of the syringe from the adapter 300” (Radwin, ¶[0122]). Thus, Radwin teaches releasing a received syringe structure and removing the syringe from the adapter/device body.
Nerney teaches a plunger-flange capturing structure at the plunger end of a syringe-control connector. In particular, Nerney teaches a syringe adaptor having an elongate connector 38 and a flange-engaging housing for engaging flange 28 formed on the trailing end of plunger 20 (Nerney, ¶[0018], [0039]-[0040], [0045]-[0046]). Nerney teaches that flange housing 40 includes a top wall, leading wall, trailing wall, side walls, and an open bottom creating a cavity for receiving and capturing plunger flange 28 (Nerney, ¶[0046]). Nerney further teaches a second embodiment in which flange-engaging housing 41 has a top half 41a and a bottom half 41b hingedly connected by hinge 43, wherein the housing is open to receive flange 28 and closed so that flange 28 is captured in sandwiched relation between the top and bottom halves of the flange-engaging housing (Nerney, FIGS. 8A-8B; ¶[0053]). Thus, Nerney teaches that a syringe-control connector may include a plunger-end flange-engaging housing for capturing the plunger flange, and further shows a plunger-end flange-capturing structure that moves about a hinge between an open position and a closed position.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the plunger-flange connection of Radwin’s rack/adjustable portion assembly as an unlockable or releasable plunger-flange attachment of the type suggested by Nerney, because Radwin already locates the plunger-driving connection at plunger flange slot 142 of adjustable portion 126 and expressly contemplates that this location provides an engaging fit with the plunger flange, while Nerney shows that a syringe-control connector can hold or capture that same type of plunger flange at the trailing end of a syringe plunger. The combination would have required only substituting or adapting Radwin’s plunger flange slot/friction-fit connection to include a flange-capturing, openable/releasable plunger-end attachment, while maintaining Radwin’s same rack-to-adjustable-portion force path for moving the plunger during aspiration. The benefit of such a modification would have been to securely retain the plunger flange during proximal plunger withdrawal while allowing the plunger-flange attachment associated with the ratcheting rod to be unlocked or released to facilitate syringe removal or replacement. Such a modification would have predictably allowed the user to unlock or release the plunger-flange attachment associated with the ratcheting rod, thereby disconnecting the ratcheting rod assembly from the syringe plunger, and then pull the syringe out of the device body after releasing the syringe from Radwin's syringe-holding structures. Therefore, the modified Radwin system in view of Nerney teaches or at least suggests wherein the syringe can be removed by unlocking the ratcheting rod and pulling the syringe out of the device body.
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Nerney (US 2005/0215956 A1), hereto referred as Nerney, further in view of Pfahnl et al. (US 2015/0209821 A1), hereto referred as Pfahnl.
The modified Radwin teaches claim 8 as described above.
The modified Radwin teaches claim 14 as described above.
Regarding claim 9, the modified Radwin teaches the method of claim 8, but does not expressly teach that the syringe comprises a 60 CC syringe. Radwin teaches that the syringe holder may be configured to receive different sizes of syringes. In particular, Radwin teaches that the fixed portion and/or adjustable portion of the syringe holder may include adjustable components that are adjustable to facilitate different sizes of syringes, and may include inserts or sub-adapters for accommodating and/or securing different sizes of plunger flanges, barrel flanges, or other components of a syringe within the syringe holder (Radwin, ¶[0121]).
Pfahnl teaches a syringe holding and actuation device used with a syringe to aspirate or dispense syringe contents on demand, wherein a first portion holds the plunger, a second portion holds the syringe body, and the first and second portions move relative to each other so that the plunger can be moved into and pulled from the syringe body (Pfahnl, ¶[0019], ¶[0022]-[0027]). Pfahnl expressly teaches that preferred embodiments allow single-handed aspiration and dispensing of even very large syringes that otherwise would have a large plunger stroke or require much actuation force (Pfahnl, ¶[0021]). Pfahnl further identifies 60 mL syringes as the relevant large syringe example, teaching that larger size syringes, such as 60 mL syringes, are common and well-suited for many procedures, but are more challenging to use manually with one hand (Pfahnl, ¶[0011]). Pfahnl also specifically explains that, when the syringe is larger in length and cross-section size, such as a 60 mL syringe, one-handed dispensing and one-handed aspiration become difficult due to the increased reach required between the syringe body flange and the plunger flange (Pfahnl, ¶[0084]-[0085]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a 60 CC syringe in the modified Radwin method, because Radwin teaches a syringe attachment device configured to facilitate one-handed aspirating and/or dispensing and teaches syringe holder structures configurable for different syringe sizes, while Pfahnl teaches a syringe holding and actuation device for single-handed aspiration and dispensing of very large syringes and specifically identifies 60 mL syringes as a common large syringe size for which one-handed actuation is difficult and for which such actuation devices provide a benefit. Thus, selecting a 60 CC syringe for use in the modified Radwin method would have been a predictable use of a known syringe size in the same one-handed syringe aspiration/dispensing device context, and would have required only routine dimensional configuration of Radwin's syringe holder components, inserts, or sub-adapters to accommodate the selected syringe size. Therefore, the modified Radwin method in view of Pfahnl teaches or at least suggests wherein the syringe comprises a 60 CC syringe.
Regarding claim 15, the modified Radwin teaches the system of claim 14, but does not expressly teach that the syringe is a 60CC syringe. Radwin teaches that the syringe holder may be configured to receive different sizes of syringes. In particular, Radwin teaches that the fixed portion and/or adjustable portion of the syringe holder may include adjustable components that are adjustable to facilitate different sizes of syringes, and may include inserts or sub-adapters for accommodating and/or securing different sizes of plunger flanges, barrel flanges, or other components of a syringe within the syringe holder (Radwin, ¶[0121]).
Pfahnl teaches a syringe holding and actuation device used with a syringe to aspirate or dispense syringe contents on demand, wherein a first portion holds the plunger, a second portion holds the syringe body, and the first and second portions move relative to each other so that the plunger can be moved into and pulled from the syringe body (Pfahnl, ¶[0019], ¶[0022]-[0027]). Pfahnl expressly teaches that preferred embodiments allow single-handed aspiration and dispensing of even very large syringes that otherwise would have a large plunger stroke or require much actuation force (Pfahnl, ¶[0021]). Pfahnl further identifies 60 mL syringes as the relevant large syringe example, teaching that larger size syringes, such as 60 mL syringes, are common and well-suited for many procedures, but are more challenging to use manually with one hand (Pfahnl, ¶[0011]). Pfahnl also specifically explains that, when the syringe is larger in length and cross-section size, such as a 60 mL syringe, one-handed dispensing and one-handed aspiration become difficult due to the increased reach required between the syringe body flange and the plunger flange (Pfahnl, ¶[0084]-[0085]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified Radwin system to hold and operate with a 60CC syringe, because Radwin teaches a syringe attachment device configured to facilitate one-handed aspirating and/or dispensing and teaches syringe holder structures configurable for different syringe sizes, while Pfahnl teaches a syringe holding and actuation device for single-handed aspiration and dispensing of very large syringes and specifically identifies 60 mL syringes as a common large syringe size for which one-handed actuation is difficult and for which such actuation devices provide a benefit. Thus, selecting a 60CC syringe for the modified Radwin system would have been a predictable use of a known syringe size in the same one-handed syringe aspiration/dispensing device context, and would have required only routine dimensional configuration of Radwin's syringe holder components, inserts, or sub-adapters to accommodate the selected syringe size. Therefore, the modified Radwin system in view of Pfahnl teaches or at least suggests wherein the syringe is a 60CC syringe.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Nerney (US 2005/0215956 A1), hereto referred as Nerney, further in view of Bunce (WO 93/03860), hereto referred as Bunce, and further in view of Roche et al. (US 2015/0105754 A1), hereto referred as Roche.
The modified Radwin teaches claim 8 as described above.
Regarding claim 12, although claim 12 is also rejected under 35 U.S.C. 112(a) and 112(b) as set forth above, the following prior-art rejection applies under the Examiner's broadest reasonable interpretation of twisting the plunger attachment into an unlocked position releases the ratcheting rod back to a starting position. Under this interpretation, the limitation encompasses an unlocking operation associated with the plunger-attachment/ratcheting-rod assembly that both detaches the plunger attachment from the plunger and releases the ratcheting engagement so that the ratcheting rod is free for longitudinal return/reset to a starting position. The combination of the modified Radwin method, Nerney, Bunce, and Roche teaches or at least suggests this limitation.
As discussed above for claim 11, the modified Radwin method in view of Nerney teaches or at least suggests a plunger attachment at the plunger-attachment end of the ratcheting rod assembly that is moved from a locked/attached position to an unlocked/detached position to release the syringe plunger. In particular, Radwin teaches a movable rack/adjustable portion assembly that receives and moves plunger flange 208 of plunger 204, including a plunger flange slot 142 that may create “a friction fit or other engaging fit” with the received plunger flange, and Radwin further teaches releasable locking mechanisms for securing and releasing received syringe structures (Radwin, FIG. 10; ¶[0083], [0098]-[0099], [0102]-[0103], [0122]). Nerney confirms that the plunger flange is a known structure and location for a syringe-control connector to hold or capture at the plunger end, including by teaching a plunger-end flange-engaging housing for receiving and capturing the plunger flange (Nerney, FIGS. 8A-8B; ¶[0018], [0046], [0053]). Thus, the modified Radwin method in view of Nerney teaches or at least suggests twisting the plunger attachment into an unlocked position to detach the plunger attachment from the plunger of the syringe.
However, the modified Radwin method in view of Nerney does not expressly teach that twisting the plunger attachment into the unlocked position also releases the ratcheting rod back to a starting position. Radwin teaches that ratchet system 158 may be a unidirectional ratchet or a reversible ratchet, and that, when ratchet system 158 is reversible, gear system 152 may drive adjustable portion 126 of syringe holder 108 in two opposite or substantially opposite directions (Radwin, ¶[0096]-[0097]). Radwin further teaches that suitable adapters may be configured in other manners to facilitate driving adjustable portion 126 in two opposite or substantially opposite directions to drive a syringe plunger in two directions, including an aspirating direction and a dispensing direction (Radwin, ¶[0097]). Thus, Radwin teaches that the syringe-plunger drive can be configured for reverse/reset motion.
As discussed above for claim 8, the modified Radwin method includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally. Epstein teaches that trigger 105 is coupled to pawl 120 via lever arm 110, that rack 130 includes a plurality of teeth 132 having gaps adapted to receive hook 122 of pawl 120, and that depression of trigger 105 causes pawl 120/hook 122 to engage teeth 132 and drive rack 130 longitudinally (Epstein, FIG. 5; ¶[0056]-[0057], [0067]). Thus, Epstein teaches the ratcheting lever/rack engagement used in the modified Radwin method.
Bunce teaches a dose dispensing gun having a plunger rod advanced by a trigger-operated ratchet and pawl mechanism, and further teaches resetting the plunger rod by rotating the plunger rod to disengage the ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop position. In particular, Bunce teaches a gun for dispensing discrete doses of a fluid product from a cartridge, wherein the cartridge includes piston 10 engaged by plunger head 12 at the forward end of plunger rod 14, and wherein advance of plunger rod 14 is effected by trigger 26 cooperating with plunger rod 14 through a ratchet and pawl mechanism to advance the rod through a discrete step at each actuation of trigger 26 (Bunce, p. 3, lines 1-9, 22-30). Bunce further teaches that first pawl 32 is spring-biased into engagement with teeth of ratchet 34 formed along the underside of plunger rod 14 to cause advance of plunger rod 14, and that second pawl 36 is spring-biased into engagement with the ratchet teeth to hold plunger rod 14 against retraction when trigger 26 has been released (Bunce, p. 3, line 30-p. 4, line 7). Bunce also teaches that plunger rod 14 projects from the rear of the gun body and carries knob 46 at its rear end, and that plunger rod 14 is reset into its rear position after reaching the forward end of its stroke by rotating knob 46 and thereby rotating plunger rod 14 to disengage the ratchet teeth from pawls 32 and 36, whereby rod 14 can be withdrawn to its rear stop position and then rotated to re-engage the pawls with the ratchet teeth in preparation for a fresh cartridge (Bunce, p. 4, line 28-p. 5, line 18). Bunce further recites that knob 46 permits the plunger to be rotated out of engagement with the ratchet mechanism, whereby the plunger rod can then be withdrawn rearwardly (Bunce, p. 7, claim 10). Thus, Bunce teaches unlocking or releasing a ratcheting engagement associated with a plunger rod by rotating the plunger rod out of engagement with the pawls, thereby freeing the plunger rod for withdrawal/reset to a rear stop position in preparation for a fresh cartridge.
Roche further confirms that, in syringe devices, an operating rod may both carry rack-type teeth and be rotationally coupled to a plunger head, such that rotation of the operating rod/plunger assembly disengages rack-type teeth from stop structures to permit free sliding movement. In particular, Roche teaches a syringe for medical applications having plunger 100 comprising plunger head 110 and operating rod 120, wherein operating rod 120 includes first and second racks 122 and 123 having protruding teeth 122A and 123A that cooperate with first and second stops 32 and 33 to allow tooth-by-tooth upward movement of the plunger and prevent downward movement of the plunger (Roche, ¶[0020]-[0028], [0080]-[0088], [0124]-[0133]). Roche further teaches that the first and second racks 122 and 123 are disengaged by rotating plunger 100 in syringe body 20 about longitudinal axis A1 to bring racks 122 and 123 opposite blank surfaces 22 and 23 of inner wall 21, so that the plunger can slide without hindrance along the inner wall of the syringe body (Roche, ¶[0134]-[0136]). Roche also teaches that operating rod 120 includes connection element 124 received in receiving recess 130 of plunger head 110, and that, once nested into receiving recess 130, connection element 124 can no longer rotate in receiving recess 130, such that operating rod 120 is rotationally integral with plunger head 110 about longitudinal axis A1 and translationally integral with plunger head 110 along longitudinal axis A1 (Roche, ¶[0115]-[0119]). Thus, Roche confirms that, in a syringe device, an operating rod may carry rack-type teeth and be rotationally coupled to the plunger head, with rotation of the operating rod/plunger assembly disengaging rack-type teeth from stop structures to permit free sliding movement.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified Radwin method such that the unlocking operation for the plunger attachment also releases the ratcheting engagement of the ratcheting rod, because the modified Radwin method uses an Epstein-type pawl/ratcheting lever engaging teeth of a toothed rack/ratcheting rod to drive the syringe plunger longitudinally, Radwin and Nerney teach a releasable plunger-flange attachment at the plunger end of the ratcheting rod assembly, Bunce teaches a trigger-operated ratchet/pawl plunger-rod drive in which rotating a knob and plunger rod disengages ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop/reset position in preparation for a fresh cartridge, and Roche confirms that an operating rod in a syringe device may both carry rack-type teeth and be rotationally coupled to a plunger head so that rotation of the operating rod/plunger assembly disengages rack-type holding features.
The benefit of coupling or coordinating the plunger-attachment unlocking operation with the ratchet-release operation would have been to provide a single unloading/reset operation after aspiration, in which the user could detach the plunger attachment from the plunger and release the ratcheting engagement so that the ratcheting rod could be quickly returned/reset for reuse, reloading, or syringe removal/replacement without having to separately back-drive the ratcheting mechanism tooth-by-tooth. Because Radwin’s rack/adjustable portion assembly already provides the plunger-driving connection at the plunger flange, and Nerney confirms a plunger-end attachment for capturing the plunger flange, it would have been a predictable mechanical design choice to configure that same ratcheting rod/plunger-attachment assembly so that rotation of the assembly performs both release functions. Roche further supports the proposed coordination because Roche shows that, in syringe devices, rotation may be transmitted through an operating-rod/plunger-head connection to disengage rack-type holding features and permit free sliding movement. In view of these teachings and benefits, it would have been a predictable mechanical integration to configure the modified Radwin/Nerney ratcheting rod/plunger-attachment assembly so that, when the plunger attachment is twisted into an unlocked position to detach from the plunger, the ratcheting engagement is also released and the ratcheting rod is free for longitudinal return/reset.
Bunce is relied upon for teaching that the ratcheting engagement associated with a plunger rod may be released by rotating the plunger rod out of engagement with the pawls so that the rod is free for longitudinal withdrawal/reset to a rear stop position. Roche is relied upon for confirming that, in syringe devices, an operating rod may carry rack-type teeth and be rotationally coupled to a plunger head, and that rotation of the operating rod/plunger assembly may disengage rack-type holding features to permit free sliding movement. Roche is not relied upon for teaching that the operating rod is detached from the plunger head by twisting. Neither Bunce nor Roche is relied upon for requiring an automatic spring-driven return of the ratcheting rod all the way to the starting position. Therefore, the modified Radwin method in view of Nerney, Bunce, and Roche teaches or at least suggests wherein twisting the plunger attachment into an unlocked position releases the ratcheting rod back to a starting position.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Nerney (US 2005/0215956 A1), hereto referred as Nerney, further in view of Fago et al. (US 6,569,127 B1), hereto referred as Fago.
The modified Radwin teaches claim 8 as described above.
Regarding claim 13, the modified Radwin method teaches the method of claim 11, but does not expressly teach that placing the syringe in the device body further comprises twisting the syringe such that a flange of the syringe locks into a receiving slot on the device body. Radwin teaches receiving and securing a syringe barrel flange in a receiving slot of the device body. In particular, Radwin teaches that fixed portion 124 includes barrel flange slot 140 for receiving barrel flange 206 of syringe 200, and that barrel flange slot 140 may be configured to create “a friction fit or other engaging fit” with the received barrel flange (Radwin, FIG. 8; ¶[0083], [0102]). Radwin further teaches that “other mechanisms for attaching a syringe to the adapter 100 are contemplated including, but not limited to, a releasable locking mechanism” (Radwin, ¶[0083]). Thus, Radwin teaches receiving the syringe barrel flange in a slot of the device body and contemplates releasable locking mechanisms for securing the received syringe.
Fago teaches locking a syringe to a medical injector by rotating or twisting the syringe so that syringe flanges engage grooves or slots of the injector. In particular, Fago teaches that the members on the face of the injector may be radially disposed tabs for receiving flanges on an outer surface of the syringe, and that “[t]he flanges on the syringe are rotated into and out of engagement with the tabs on the face of the injector” (Fago, col. 2, lines 27-41). Fago further teaches that tabs on the injector may have grooves for receiving syringe flanges and that locking members on the syringe may form a channel for receiving tabs on an interior surface of the injector housing “so that the sealing structure may be inserted into the housing and rotated to lock the syringe to the injector” (Fago, col. 2, lines 58-64). Fago also teaches that syringe 12 is installed by first translating the syringe along its axis and then rotating the syringe clockwise to guide tabs on the rearward end of the syringe into grooves on the face plate, and that when the syringe is rotated ninety degrees clockwise, a tab engages a stop at the end of the groove, thereby indicating that the syringe is fully installed (Fago, FIGS. 1-2; col. 4, lines 51-67). Thus, Fago teaches placing a syringe by twisting/rotating the syringe so that a syringe flange or locking flange locks into a receiving groove/slot on the injector body.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified Radwin method such that placing the syringe in the device body further comprises twisting the syringe so that a syringe barrel flange locks into Radwin's barrel flange slot 140 or an associated receiving slot of the device body, because Radwin already teaches receiving barrel flange 206 in barrel flange slot 140 and securing the received flange by a friction fit or other engaging fit, and Radwin further contemplates releasable locking mechanisms for securing a received syringe, while Fago teaches that syringe flanges may be rotated into engagement with grooves/slots on a medical injector to lock the syringe to the injector. The benefit of this modification would have been to securely retain the syringe barrel flange in the device body during proximal plunger withdrawal and aspiration, while allowing the syringe to be installed and removed by a simple twist-lock/twist-release motion. Therefore, the modified Radwin method in view of Fago teaches or at least suggests wherein placing the syringe in the device body further comprises twisting the syringe such that a flange of the syringe locks into a receiving slot on the device body.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Radwin et al. (US 2018/0369487 A1), hereto referred as Radwin, in view of Sturtz (US 2,892,457), hereto referred as Sturtz, further in view of Epstein (US 2002/0173744 A1), hereto referred as Epstein, further in view of Nerney (US 2005/0215956 A1), hereto referred as Nerney, further in view of Bunce (WO 93/03860), hereto referred as Bunce.
The modified Radwin teaches claim 14 as described above.
Regarding claim 20, although claim 20 is also rejected under 35 U.S.C. 112(a) and 112(b) as set forth above, the following prior-art rejection applies under the Examiner's broadest reasonable interpretation of unlocking the ratcheting rod releases the ratchet mechanism back to a starting position. Under this interpretation, the limitation encompasses unlocking or disengaging the ratcheting engagement associated with the ratcheting rod so that the ratcheting rod and/or ratchet mechanism is free for longitudinal return/reset to a starting position relative to the device body. The modified Radwin teaches the system of claim 14, but does not expressly teach this limitation.
Radwin teaches that ratchet system 158 may be a unidirectional ratchet or a reversible ratchet, and that, when ratchet system 158 is reversible, gear system 152 may drive adjustable portion 126 of syringe holder 108 in two opposite or substantially opposite directions (Radwin, ¶[0096]-[0097]). Radwin further teaches that suitable adapters may be configured in other manners to facilitate driving adjustable portion 126 in two opposite or substantially opposite directions to drive a syringe plunger in two directions, including an aspirating direction and a dispensing direction (Radwin, ¶[0097]). Thus, Radwin teaches that the syringe-plunger drive can be configured for reverse/reset motion.
As discussed above for claim 14, the modified Radwin system includes an Epstein-type lever/trigger-operated ratcheting pawl-and-rack mechanism for driving the rack/ratcheting rod longitudinally. Epstein teaches that trigger 105 is coupled to pawl 120 via lever arm 110, that rack 130 includes a plurality of teeth 132 having gaps adapted to receive hook 122 of pawl 120, and that depression of trigger 105 causes pawl 120/hook 122 to engage teeth 132 and drive rack 130 longitudinally (Epstein, FIG. 5; ¶[0056]-[0057], [0067]). Thus, Epstein teaches the ratcheting lever/rack engagement used in the modified Radwin system.
Bunce teaches a dose dispensing gun having a plunger rod advanced by a trigger-operated ratchet and pawl mechanism, and further teaches resetting the plunger rod by rotating the plunger rod to disengage the ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop position. In particular, Bunce teaches a gun for dispensing discrete doses of a fluid product from a cartridge, wherein the cartridge includes piston 10 engaged by plunger head 12 at the forward end of plunger rod 14, and wherein advance of plunger rod 14 is effected by trigger 26 cooperating with plunger rod 14 through a ratchet and pawl mechanism to advance the rod through a discrete step at each actuation of trigger 26 (Bunce, p. 3, lines 1-9, 22-30). Bunce further teaches that first pawl 32 is spring-biased into engagement with teeth of ratchet 34 formed along the underside of plunger rod 14 to cause advance of plunger rod 14, and that second pawl 36 is spring-biased into engagement with the ratchet teeth to hold plunger rod 14 against retraction when trigger 26 has been released (Bunce, p. 3, line 30-p. 4, line 7). Bunce also teaches that plunger rod 14 projects from the rear of the gun body and carries knob 46 at its rear end, and that plunger rod 14 is reset into its rear position after reaching the forward end of its stroke by rotating knob 46 and thereby rotating plunger rod 14 to disengage the ratchet teeth from pawls 32 and 36, whereby rod 14 can be withdrawn to its rear stop position and then rotated to re-engage the pawls with the ratchet teeth in preparation for a fresh cartridge (Bunce, p. 4, line 28-p. 5, line 18). Bunce further recites that knob 46 permits the plunger to be rotated out of engagement with the ratchet mechanism, whereby the plunger rod can then be withdrawn rearwardly (Bunce, p. 7, claim 10). Thus, Bunce teaches unlocking or releasing a ratcheting engagement associated with a plunger rod by rotating the plunger rod out of engagement with the pawls, thereby freeing the plunger rod for withdrawal/reset to a rear stop position in preparation for a fresh cartridge.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the ratcheting rod/rack engagement of the modified Radwin system with a Bunce-type ratchet release, because the modified Radwin system uses an Epstein-type pawl/ratcheting lever engaging a toothed rack/ratcheting rod to drive the syringe plunger longitudinally, and Bunce teaches a trigger-operated ratchet/pawl plunger-rod drive in which rotating a knob and plunger rod disengages ratchet teeth from the pawls so that the rod can be withdrawn to a rear stop/reset position in preparation for a fresh cartridge. The benefit of such a modification would have been to allow the user, after an aspiration stroke or other ratcheting operation, to release the ratcheting engagement and quickly return/reset the ratcheting rod and ratchet mechanism for reuse, reloading, or syringe removal/replacement without having to back-drive the ratcheting mechanism tooth-by-tooth. Radwin further supports this modification because Radwin teaches reversible or two-direction movement of the adjustable plunger-holding portion, indicating that returning/resetting the plunger-holding drive structure was a contemplated operating mode. Bunce is relied upon for teaching that the ratcheting engagement associated with a plunger rod may be released by rotating the plunger rod out of engagement with the pawls so that the rod is free for longitudinal withdrawal/reset to a rear stop position, not for requiring an automatic spring-driven return of the ratcheting rod or ratchet mechanism all the way to the starting position. Therefore, the modified Radwin system in view of Bunce teaches or at least suggests wherein unlocking the ratcheting rod releases the ratchet mechanism back to a starting position.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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