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 .
Response to Amendment
This office action is responsive to the amendment filed on 8/15/2025. As directed by the amendment: claim 11 has been amended. Thus, claims 11-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 8/15/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the 102 rejection of the independent claim on page 5-7:
Applicant alleges that "the Office appears to have conceded that Wanger does not have a handle with a free end that is disposed adjacent the syringe finger tabs", however this is not true, and examiner's preceding office action is clear in that such an interpretation is provided only for the sake of applicant's interpretation of the prior art of record as presented in their preceding arguments.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"the handle extends along the syringe barrels with the free end of the handle disposed adjacent the finger tabs of the syringes"
Examiner has been clear in that the broadest reasonable interpretation of the claim term "adjacent" is so broad, and the claims continue to be silent regarding further structural relationships to distinguish how the free end of the handle is considered adjacent to the finger tabs relative to other structures of the invention, such that prior art of Wagner's free end of its handle may be considered adjacent the finger tabs of the syringe.
Further, the handle of Wagner, actuator 630, can be considered to extend along the syringe barrels of Wagner, enclosures 612 614, as the broadest reasonable interpretation of the claim term "extend along" is broad such that since the actuator 630 has a dimension extending parallel to a dimension which enclosures 612 614 extend along, the handle of Wagner may be considered to extend along the syringe barrels of Wagner.
"[the free end of the handle disposed in a manner] enabling an operator holding the syringes in one hand with the fingers of that hand engaged with the finger tabs of a syringe and simultaneously enable the thumb of the same hand to either operate the handle or depress a syringe plunger"
Applicant particularly argues that this "structure" is not expressly or inherently disclosed/taught by the prior art of record. Further alleging that office's reference toward an operator of having hands of sufficient proportions to operate the invention int the same manner is a mere probability and does not meet the standard for inherency to state the claimed "structure" is disclosed.
As Examiner clearly expressed in the preceding office actions, the claim language of "enabling an operator holding", "simultaneously enable", and "operate - or depress" implies a functional language and the structure of the prior art must at least be capable of performing the recited function. Regarding the inherency of this functional capability, see MPEP 2112(iv) and MPEP 2112.01, which provides that inherency of a piece of prior art to anticipate a given function in applicant's claim may be satisfied by the structures of the prior art and claimed invention having structural similarities for performing this function. As discussed above, and presented in the examiner's rejection as necessitated by the amendment below, the prior art of Wagner is in possession of the claimed structure of "the handle extends along the syringe barrels with the free end of the handle disposed adjacent the finger tabs of the syringes". Accordingly, that disclosed structure of Wagner is rendered functionally capable of being operated in the claimed manner by an operator with hands of a size proportional to the invention to operate due to the structural similarities between the claimed invention and disclosed invention of Wagner.
Accordingly, the examiner's 102 rejection as necessitated by the amendment, below, stands in view of the previously presented prior art of record.
Regarding applicant’s argument regarding the 103 rejection of the independent claim on page 7-10:
Applicant’s arguments with respect to the 103 rejection of claim(s) 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, particularly the sole reliance on MPEP 2144.04(IV)(A) for the obvious teaching of and motivation to lengthen the claimed handle of the invention.
Regarding applicant’s argument regarding dependent claims on page 10-11:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Claim Rejections - 35 USC § 103
Claims 11-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 20080167621 A1, henceforth written as Wagner or, in the alternative, under 35 U.S.C. 103 as obvious over Wagner in view of “Simple Machines – Levers” from Let’s Talk Science published: 3/9/2020, henceforth written Levers-LTS.
Regarding claim 11, Wagner discloses:
A valve for controlled delivery of medical fluids to a patient from two or more syringes, each syringe having a barrel with a coupling end and a plunger end and finger tabs located at the plunger end, the valve comprising:
(paragraph 85; multi-barrel syringe 602 having barrels 612 614 with conduits 640 642 extending from passages 624 626 adjacent sides of flange 618; fig 11)
a valve body,
(valve controlled manifold 604; fig 11)
the valve body having a needle port
(paragraph 86; third port 636 connects to tubing 646 extending to a needle; fig 12)
and at least two syringe ports,
(first port 632 and second port 634; fig 11)
the needle port configured to be communicably joined to the patient,
(paragraph 86; third port 636 joins to a patient via a needle)
each syringe port configured to connect to the coupling end of a syringe to be communicably joined therewith,
(fig 12, shows mating of ports 632 634 with conduits 640 642)
and wherein each syringe port being arranged such that when syringes are connected to the syringe ports, the barrels of the syringes are disposed parallel to each other;
(fig 11-12, shows barrels 612 614 in parallel when ports 632 634 mate with conduits 640 642)
a stop cock mounted rotatably within the valve body,
(paragraph 91; rotatable core 690; fig 14)
the stop cock having at least one flow passage
(paragraph 91; passages 698 700 702 704; fig 14)
and being rotatable between various states to selectively align only one syringe port at time with the needle port for fluidic communication therebetween, while isolating the remaining syringe ports from fluidic communication with the needle port;
(paragraph 71+88+91; valve selectively controls flow such that one -or multiple- ports may be in fluidic communication with third port 636; fig 14-18)
a handle attached to the stop cock and extending outwardly from the valve body and terminating at a free end,
(actuator 630 terminating at a narrow end (not enumerated) on the right of fig 13)
the handle having a length such that when the syringes are connected to the respective syringe ports the handle extends along the syringe barrels with the free end of the handle disposed adjacent the finger tabs of the syringes,
(actuator 630 extending towards flange 618 such that its narrow end (not enumerated) approximates flange 618, therein is adjacent to; fig 11-12; actuator 630 can be considered to extend along enclosures 612 614 by the manner by which actuator 630 has a dimension extending parallel to a dimension which enclosures 612 614 extend along)
enabling an operator holding the syringes in one hand with the fingers of that hand engaged with the finger tabs of a syringe and simultaneously enable the thumb of the same hand to either operate the handle or depress a syringe plunger.
As examiner noted above, the present amendments to the claims rely upon functional claim language such as "enabling an operator holding", "simultaneously enable", and "operate - or depress" which implies a functional language and the structure of the prior art must at least be capable of performing the recited function.
As examiner noted above, an operator’s hand of a sufficient proportion relative to the claimed invention would render the claimed structure of the handle free end and syringe plunger relatively near enough for an operator such that they are functionally capable of being simultaneously capable of being actuated by that operator’s thumb.
(paragraph 84; actuator 630 can be hand-operated, therein actuator 630 can be manipulated by a thumb when held in one hand; paragraph 61+89; plungers 620 622 may be depressed via the thumb; an operator of a sufficient hand/digital size/proportion relative to the invention would be allowed to have their fingers engaging the finger tabs and operating the handle or depressing the plunger with the same hand’s thumb)
However for the sake of compact prosecution, if applicant disagrees with the above interpretation and believes Wagner is silent regarding:
“the handle having a length such that when the syringes are connected to the respective syringe ports the handle extends along the syringe barrels with the free end of the handle disposed adjacent the finger tabs of the syringes, enabling an operator holding the syringes in one hand with the fingers of that hand engaged with the finger tabs of a syringe and simultaneously enable the thumb of the same hand to either operate the handle or depress a syringe plunger. “
However, Levers-LTS teaches that a longer lever creates a mechanical advantage such that a force applied further away from a fulcrum, or point of rotation, has a greater mechanical advantage than a same size force applied to a shorter lever. Accordingly, where an amount of load must be overcome by a force applied to an end of a lever to rotate the lever, i.e. the friction forces which must be overcome to pivot a valve between valve positions, a lever which is longer will require less force applied at its end to overcome the resisting load as compared to a shorter lever.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the teachings of Levers-TLS to lengthen the handle disclosed by Wagner, such that it’s free end is disposed at a same axial position along the injection axis of the invention as the claimed finger tabs therein arriving at the claimed invention, in order to advantageously arrive at an invention which provides additional leverage to an operator such that an operator can pivot the handle to change valve positions with less force, see MPEP 2144.02 and Levers-TLS, and therein improve the efficiency of an operator using the invention and reduce the fatigue on an operator from changing positions of the valve of the invention.
Regarding claim 12, Wagner discloses:
The valve of claim 11, wherein the at least two syringe ports comprise two syringe ports.
(first port 632 and second port 634; fig 11)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wagner as applied to claims 11 above.
Regarding Claim 13,
Wagner discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Wagner does not disclose:
The valve of claim 11, wherein the at least two syringe ports comprise three syringe ports.
However, Wagner teaches
wherein the at least two syringe ports comprise three syringe ports.
(paragraph 84-85, manifold 604 may include "a set of three, four, five, six, seven, eight, nine, ten, or more ports" for "one or more additional syringes")
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate an additional syringe port for supporting additional syringes conveying fluid through the valve body, see paragraph 84-85 of Wagner.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner as applied to claims 11 above, and further in view of US 20080319401 A1, henceforth written as Funamura.
Regarding Claim 14,
Wagner discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Wagner is silent regarding:
the at least two syringe ports comprise four syringe ports.
Notably Wagner teaches
the at least two syringe ports comprise four syringe ports.
(paragraph 84-85, manifold 604 may include "a set of three, four, five, six, seven, eight, nine, ten, or more ports" for "one or more additional syringes")
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate an additional syringe port for supporting additional syringes conveying fluid through the valve body, see paragraph 84-85 of Wagner.
However, Wagner remains silent regarding:
wherein the valve body is spherically shaped, the stop cock is spherically shaped
However, Funamura teaches a valve
wherein the valve body is spherically shaped,
(paragraph 33-34; chamber part 11 is spherically shaped; fig 1-11)
the stop cock is spherically shaped,
(paragraph 40; valve main body 21 is spherically shaped; fig 1-11)
It would be similarly obvious to apply the spherically shape teachings of Funamura to the valve body and stopcock of Wagner in order to improve the manufacturability of the valve as a spherical shape uses less material to manufacture than that of a cylinder.
Regarding Claim 15,
Wagner discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Wagner does not disclose:
wherein the valve body is spherically shaped, and the stop cock is spherically shaped.
However, Funamura teaches a valve
wherein the valve body is spherically shaped,
(paragraph 33-34; chamber part 11 is spherically shaped ; fig 1-11)
and the stop cock is spherically shaped.
(paragraph 40; valve main body 21 is spherically shaped; fig 1-11)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply the spherically shape teachings of Funamura to the valve body and stopcock of Wagner in order to improve the manufacturability of the valve as a spherical shape uses less material to manufacture than that of a cylinder.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Funamura as applied to claim 14 above, and further in view of US 4819694 A, henceforth written as Jiang.
Regarding Claim 16,
Wagner in view of Funamura discloses all of the elements of the current invention which the present claim is dependent upon, as described above, however, Wagner in view of Funamura is silent regarding:
The valve of claim 14, wherein the stop cock is movable in the valve body about two axes of motion to selectively connect a syringe port to the needle port by pivoting the handle about a first axis and rotating the handle about a second axis.
Notably, Wagner does disclose in paragraph 84-85 that the invention may contain more than the two illustrated system ports for supporting additional syringes conveying fluid through the valve body, as is incorporated in claim 14 above, however Wagner was silent as to the positional disposition of the syringes on a singular or multiple planes relative to the stopcock.
However, Jiang teaches a ball valve with handle:
wherein the stop cock is movable in the valve body about two axes of motion to selectively connect a [inlet] to the [outlet] by pivoting the handle about a first axis and rotating the handle about a second axis.
(col 2 line 21 to col 3 line 37; control member 6 is either rotated about arrow 22 or pivoted about arrow 21 to control which port(s) are conveying fluid to through valve ball 7 at any given time; fig 3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multi-planar fluid valve control member taught by Jiang to the invention of Wagner in view of Funamura rearranging multiple syringes and corresponding ports across multiple planes of the stopcock would only involve routine skill in the art, see MPEP 2144.04(VI)(B-C) and providing a fluid control member actuatable over multiple planes only involves applying a known technique to a known device ready for improvement to yield the predictable results of a fluid valve which can govern flow received from multiple planes, see MPEP 2143(I)(D).
Regarding Claim 18,
Wagner in view of Funamura discloses all of the elements of the current invention which the present claim is dependent upon, as described above, however, Wagner in view of Funamura is silent regarding:
The valve of claim 15, wherein the stop cock is movable in the valve body about two axes of motion to selectively connect a syringe port to the needle port by pivoting the handle about a first axis and rotating the handle about a second axis.
Notably, Wagner does disclose in paragraph 84-85 that the invention may contain more than the two illustrated system ports for supporting additional syringes conveying fluid through the valve body.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate an additional syringe port for supporting additional syringes conveying fluid through the valve body, see paragraph 84-85 of Wagner.
However, in such a modification of Wagner, Wagner remains silent as to the positional disposition of the syringes on a singular or multiple planes relative to the stopcock.
However, Jiang teaches a ball valve with handle:
wherein the stop cock is movable in the valve body about two axes of motion to selectively connect a [inlet] to the [outlet] by pivoting the handle about a first axis and rotating the handle about a second axis.
(col 2 line 21 to col 3 line 37; control member 6 is either rotated about arrow 22 or pivoted about arrow 21 to control which port(s) are conveying fluid to through valve ball 7 at any given time; fig 3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the multi-planar fluid valve control member taught by Jiang to the invention of Wagner in view of Funamura having the further multiple syringe ports, as providing a fluid control member actuatable over multiple planes only involves applying a known technique to a known device ready for improvement to yield the predictable results of a fluid valve which can govern flow received from multiple planes, see MPEP 2143(I)(D).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wagner as applied to claim 11 above, and further in view of US 3156260 A, henceforth written as Harvey.
Regarding Claim 20,
Wagner discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
herein the at least one flow passage includes first and second proximal flow passages each connected to a distal flow passage,
(see connected proximal flow passages and distal flow passage in fig 14-17)
However, Wagner is silent regarding:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the needle port such that the frustoconical shaped portion remains fluidically connected to the needle port when the stop cock is rotated.
However, Harvey teaches a ball valve:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the [outlet] port such that the frustoconical shaped portion remains fluidically connected to the [outlet] port when the stop cock is rotated.
(col 2 line 65 to col 3 line 5; a round and cone shaped port 30, therein frustoconical, allows for complete movement of the rotatably about its center without affecting delivery through the port 22; fig 2-3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the flow passage shape teachings of Harvey to the outlet flow passage disclosed by Wagner, therein arriving at the claimed invention, in order to advantageously arrive at invention which can select which inlet media is conveyed from without affecting delivery of media out of the outlet during the transition between inlets, see col 2 line 65 to col 3 line 5 of Harvey.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Funamura and Jiang as applied to claim 16 and 18 above, and further in view of US 3156260 A, henceforth written as Harvey.
Regarding Claim 17,
Wagner in view of Funamura and Jiang discloses all of the elements of the current invention which the present claim is dependent upon, as described above, however, Wagner in view of Funamura and Jiang is silent regarding:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the needle port such that the frustoconical shaped portion remains fluidically connected to the needle port when the stop cock is rotated.
However, Harvey teaches a ball valve:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the [outlet] port such that the frustoconical shaped portion remains fluidically connected to the [outlet] port when the stop cock is rotated.
(col 2 line 65 to col 3 line 5; a round and cone shaped port 30, therein frustoconical, allows for complete movement of the rotatably about its center without affecting delivery through the port 22; fig 2-3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the flow passage shape teachings of Harvey to the outlet flow passage disclosed by Wagner, therein arriving at the claimed invention, in order to advantageously arrive at invention which can select which inlet media is conveyed from without affecting delivery of media out of the outlet during the transition between inlets, see col 2 line 65 to col 3 line 5 of Harvey.
Regarding Claim 19,
Wagner in view of Funamura and Jiang discloses all of the elements of the current invention which the present claim is dependent upon, as described above, however, Wagner in view of Funamura and Jiang is silent regarding:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the needle port such that the frustoconical shaped portion remains fluidically connected to the needle port when the stop cock is rotated.
However, Harvey teaches a ball valve:
wherein the at least one flow passage includes frustoconical shaped portion that tappers from narrow to wide in a direction toward the [outlet] port such that the frustoconical shaped portion remains fluidically connected to the [outlet] port when the stop cock is rotated.
(col 2 line 65 to col 3 line 5; a round and cone shaped port 30, therein frustoconical, allows for complete movement of the rotatably about its center without affecting delivery through the port 22; fig 2-3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the flow passage shape teachings of Harvey to the outlet flow passage disclosed by Wagner, therein arriving at the claimed invention, in order to advantageously arrive at invention which can select which inlet media is conveyed from without affecting delivery of media out of the outlet during the transition between inlets, see col 2 line 65 to col 3 line 5 of Harvey.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST BLAKE DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783