DETAILED ACTION
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not persuasive.
Applicant argues that Kyrias doesn’t disclose the claimed core arrangement. Examiner disagrees and submits block 76 (moveable) slides within casing 28 (fixed), casing 28 detachably couples to and is axially blocked by cover 30.
Applicant argues that carriage 56 reciprocates, so it can’t be a fixed portion. Examiner disagrees and submits the fixed portion is mapped to casing 28, not carriage 56.
Applicant argues casing 28/cover 30 isn’t a core portion, isn’t slidably joined, and isn’t wire/sheath associated. Examiner disagrees and submits casing 28 is part of the core, block 76 slides relative to it (slideably joined), and casing 28/block 76 are associated with sleeve 108/wire 110 to produce their relative longitudinal displacement, all as mapped.
Applicant argues that the wire/sheath arrangement of Kyrias doesn’t produce the claimed relative displacement between moveable and fixed portions because Kyrias’s arrangement is drawn to rotary and/or threaded transmission. Examiner disagrees and submits that Applicant’s arguments are not commensurate in scope with the claimed invention because the claims do not exclude the use or rotary and/or threaded transmission. Examiner has already demonstrated that wire 110/sleeve 108 are associated with block 76/casing 28 to displace them relative to each other along the longitudinal axis. The claims do not exclude rotary or threaded transmission.
The rejections are the claims are maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 48-62 and 65-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 3720211 A to Kyrias.
Regarding Claims 48, 66 and 67, Kyrias discloses a hypodermic syringe driving system and method (Abstract “Apparatus for manipulating a hypodermic syringe…”) comprising inter alia:
a remote actuator (control box 22) operatively connected to a handheld body (probe 20) through a Bowden cable (flexible cable 24), wherein the handheld body comprises inter alia:
a core (main casing 28 and carriage assembly 56, and internal assemblies thereof) and a cover (cover 30) to shield the core at least partially (cover 30 shields carriage 56 when cover is mounted on casing 28), the cover comprises a distal opening (at shank portion 38) to receive a barrel of a syringe (as seen fully assembled in FIG. 3) and a proximal opening to receive the Bowden cable (at section 32);
the cover (cover 30) being cylindrically shaped (FIG. 2), and the distal opening (at shank portion 38) and the proximal opening (at section 32) being located at opposite ends of the handheld body relative to a longitudinal axis of the handheld body (shank portion and section 32 are at respective opposite distal and proximal ends);
wherein the core (main casing 28 and all internal plunger moving components, FIG. 2) has a movable portion (block 76 which receives flange 54 of plunger) to secure a plunger of the syringe and a fixed portion (main casing 28), the moveable portion (block 76 which receives flange 54 of plunger) and the fixed portion (main casing 28) of the core being slideably joined to each other (element 76 is retained within and reciprocates longitudinally relative to, and within, casing 28, therefore element 76 and element 28 are “slideably joined” to each other), wherein the fixed portion (main casing 28) of the core (main casing 28 and all internal plunger moving components, FIG. 2) is detachably coupled to the cover (main casing 28 is detachably coupled to the cover 30, FIG. 2), such that the fixed portion of the core is axially blocked with respect to the cover (element 28 detachably couples to cover 30 and, once coupled (e.g., via the half-sleeve 34 tab engaging the ledge on the casing), is held against axial movement relative to the cover)
wherein the Bowden cable has a sheath (outer sleeve 108) and a wire (cable 110), the wire being displaceable with respect to the sheath (col. 4, lines 40-54), the movable (block 76 which receives flange 54 of plunger) and the fixed portion (main casing 28) of the core being associated respectively with one of the wire and the sheath in such a way that the movable portion and the fixed portion are displaceable relative to each other along the longitudinal axis of the handheld body (col. 6, lines 1-7);
(Claim 66) A method for carrying out a fine needle aspiration biopsy using a hypodermic syringe driving system (structure of which is disclosed above in the rejection of Claim 48) comprising:
receiving operational data (switch input via actuator 186 operating switches 190/192);
determining working parameters of the motor based on the received operational data, wherein the working parameters comprise duration, speed and direction of rotation (via potentiometer that is employed to adjust timing period of aspiration step, the speed of drive motor 164 is controlled by the potentiometer, energizing motor 164 to drive in reverse direction and reverse polarity of the connections to motor 164; see all of CONTROL SYSTEM);
activating the motor to displace the movable portion with respect to the fixed portion (energizing motor 164 to drive in a reverse direction which rotates cable 110 to pull plunger out of syringe);
inserting a needle of the syringe into a body of a patient, activating the motor to displace the movable portion with respect to the fixed portion (the injection of the needle by actuation of forward solenoid 142), and generating a suction force in the barrel of the syringe (the pulling of the plunger to cause the syringe to aspirate fluid which is also timed);
obtaining a fluid sample of the patient (final fluid aspirated from the patient).
(Claim 67) A method for injecting a substance and carrying out a fine needle aspiration biopsy using a hypodermic syringe driving system (structure of which is disclosed above in the rejection of Claim 48) comprising:
receiving operational data (switch input via actuator 186 operating switches 190/192);
determining working parameters of the motor based on the received operational data, wherein the working parameters comprise duration, speed and direction of rotation (via potentiometer that is employed to adjust timing period of aspiration step, the speed of drive motor 164 is controlled by the potentiometer, energizing motor 164 to drive in reverse direction and reverse polarity of the connections to motor 164; see all of CONTROL SYSTEM);
activating the motor to displace the movable portion with respect to the fixed portion (energizing motor 164 to drive in a reverse direction which rotates cable 110 to pull plunger out of syringe);
inserting a needle of the syringe into a body of a patient, activating the motor to displace the movable portion with respect to the fixed portion (the injection of the needle by actuation of forward solenoid 142) to push the plunger of the syringe to inject an oncolytic virus substance into the body of the patient (the energizing of the motor to drive forward to inject fluid into the patient);
activating the motor to displace the movable portion with respect to the fixed portion to pull the plunger of the syringe to obtain a fluid sample of the patient (the pulling of the plunger to cause the syringe to aspirate fluid which is also timed) (final fluid aspirated from the patient).
Regarding Claim 49, Kyrias discloses wherein the cover comprises a retainer slot (spaced within stepped portion between main casing 28/cover 30 and outer sleeve 108, FIG. 3) to receive a retainer (proximal end of sleeve 98 received in stepped portion between main casing 28/cover 30 and outer sleeve 108, FIG. 3), the retainer being attached to the sheath (via retainer slot body), wherein the retainer comprises a bore to pass the wire (distal portion of wire 112 that is in bore in proximal end of sleeve 98 received in stepped portion between main casing 28/cover 30 and outer sleeve 108, FIG. 3) through.
Regarding Claim 50, Kyrias discloses wherein the retainer (proximal end of sleeve 98 received in stepped portion between main casing 28/cover 30 and outer sleeve 108, FIG. 3) comprises a generally flat anchor (bore in sleeve 98 as described above in Claim 49) having a rounded face (outer surface of sleeve 98) to be received by the retainer slot.
Regarding Claim 51, Kyrias discloses the system according to claim 48, wherein the core (main casing 28 and carriage assembly 56, and internal assemblies thereof) comprises a main spring arranged between the movable portion (block 76 which receives flange 54 of plunger) and the fixed portion (main casing 28) such that the movable portion is biased away from the fixed portion (in the alternative embodiment, the compression spring 250 would have biased the two elements relative to one another).
Regarding Claim 52, Kyrias discloses wherein the cover (cover 30) is divided in at least two shells along the longitudinal axis of the handheld body (cover 30 and tube section 40).
Regarding Claim 53, Kyrias discloses wherein the two shells are detachably joined to each other along the longitudinal axis of the handheld body (via threaded bore 36).
Regarding Claim 54, Kyrias discloses wherein each of the shells of the cover comprise respectively a holding pad protruding from an inner face of the shell, the holding pads of each shell being arranged at different points along the longitudinal axis of the handheld body (corresponding threads on body 30 and tube section 40) such that a barrel flange of the syringe is sandwiched between the holding pads (when syringe is inserted into body 30 and tube section 40).
Regarding Claim 55, Kyrias discloses the system according to claim 52, wherein the cover comprises a securing mechanism to secure the two of the at least two shells to each other, the securing mechanism comprising cooperating shapes in such a way that the shapes cooperate to secure the shells when one shell moves relative to the other shell along the longitudinal axis of the handheld body to a closed status of the handheld body (when corresponding threads on body 30 and tube section 40 engage and the body 30 and tube section 40 move relative to one another when the thread is engaged),wherein the cooperating shapes comprise a pin arranged in one shell and a hole arranged in the other shell (threadings are both “pin” shaped with holes between each of the raised threads).
Regarding Claim 56, Kyrias discloses a releasable clip (half sleeve section 34) in such a way that the fixed portion (main casing 28) is releasably secured to an inner wall of the cover (cover 30), wherein the releasable clip has a tab to engage a ledge (half sleeve section 34 engages the “ledge (e.g., top distal most end of main casing 28).
Regarding Claim 57, Kyrias discloses wherein the distal opening (at shank portion 38) comprises a seal (half sleeve section 34) to surround the barrel.
Regarding Claim 58, Kyrias discloses wherein the fixed portion (main casing 28) of the core (main casing 28 and carriage assembly 56, and internal assemblies thereof) has a side elongated cut-out arranged to insert the plunger of the syringe in an expanded status (cut out as seen in FIG. 2 where cover 30 is placed).
Regarding Claim 59, Kyrias wherein the cut-out is disposed in a distal end of the fixed portion (cut out is located at the distal end of main casing, FIG. 2).
Regarding Claim 60, Kyrias discloses wherein the remote actuator comprises a motor (motor 164) to drive a pulley to wind and unwind the wire (solenoids 140, 142, lever 129, rod 118, all connected to cable 110), and the motor and the pulley are connected through a gearbox (shaft 160, stud 154, nut 166, block 152), wherein the remote actuator comprises a control unit to control the operation of the motor (relays 204, 206, SCR 216, 226, mode switch 180, potentiometers 182, 184).
Regarding Claim 61, Kyrias discloses a confirmation switch (switch 186 and switch 190/192 in electrical or data communication with the control unit to operate the motor.
Regarding Claim 62, Kyrias discloses wherein the remote actuator comprises a force sensor to sense a force applied to the wire (the clutch assembly including threaded stud 165, nut 166, and switch 196 detect increased torsional resistance resulting from the plunger block, thereby functioning as a load-responsive sensing mechanism).
Regarding Claim 65, Kyrias discloses wherein the wire is associated with the fixed portion of the core and the sheath is associated with movable portion of the core (all portions of the devise are “associated” with one another, because the exist in a single device).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyrias in view of US 20030191372 A1 to Dobrovolny.
Kyrias discloses the claimed invention except for expressly disclosing
wherein the core comprises a spring-loaded wedge rotatably attached to the movable portion of the core, the wedge being able to move from a retracted status to allow a relative displacement between the movable portion and the fixed portion of the core, to an expanded status biased by a wedge spring to block the relative displacement between the movable portion and the fixed portion. However, Dobrovolny discloses a spring-loaded wedge/spring bias ([0019] “…the compression spring 22 urges the wedge 20 into contact with the cammed member 14…), the wedge being able to move from a retracted status to allow a relative displacement between a movable portion and a fixed portion ([0021] “When the wedge 20 moves past the initial engaging position 42, the wedge 20 disengages from the cammed member 14, and the cammed member 14 is freely rotatable in either direction.”) to an expanded status biased by a wedge spring to block the relative displacement between the movable portion and the fixed portion ([0035] Reverse-rotation of the cammed member 120 in the direction from the second downward position 118 to the first upward position 116 is not possible because the cammed surface 136 of the cammed member 120 will be forced against the inclined surface 138 of the wedge 122.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the movable portion and fixed portion of Kyrias with the spring-loaded wedge of Dobrovolny to prevent unintended relative displacement under injection or aspiration forces, as such wedge mechanism are know to prevent reverse movement and provide stabilization ([0005] “…prevents reverse rotation…”).
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyrias in view of US 4413760 A to Paton.
Kyrias discloses the claimed invention except for expressly disclosing a spring-loaded pawl to engage a number of teeth arranged along the plunger of the syringe in such a way that the plunger is blocked, and a button operatively connected to the pawl in such a way that the pawl is disengaged from the teeth upon actuation of the button. However, Paton teaches a pivotably mounted pawl in engagement with a series of teeth along a drive member (col. 2, lines 54-65), the pawl bring spring biased (col. 5, lines 51-60) with a button that allows the pawl to move in and out of engagement with the teeth (via lever 24).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the plunger of Kyries with the teeth and spring-loaded pawl of Paton, as Paton teaches this would have allowed for better control of the device (col. 1, lines 17-27).
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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