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 .
Claim Objections
Claim 18 is objected to due to the following informalities:
In claim 18, line 10, “wherein in the actuating of the actuator” should be corrected to “wherein upon the actuation of the actuator” for grammatical correctness.
In claim 18, line 10, “moved forward and backwards” should be corrected to “moved forward and backward” for grammatical correctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim(s) 27 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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 27, line 2 recites “the volume of the fluid”. Claim 27 depends on claim 18, however claim 18 does not introduce “a volume”. It is unclear if the Applicant intended for claim 27 to depend on claim 20, which introduced “a volume” or introduce a new volume in claim 27. For the sake of Examination, it is being interpreted that “the volume” of claim 27 is being intended to refer to “a volume” of claim 18. Therefore, Applicant is suggested to amend claim 27 to depend on claim 20 to overcome rejection.
Claim Rejections - 35 USC § 102
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 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) 1, 2, 3, 10-11, 14, 16, 18-20, 22, 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Axelrod (US 20120259237 A1).
Regarding claim 1, Axelrod discloses an injection system (injection system 10 in Fig. 1), comprising:
a syringe (syringe 320 of syringe assembly 300 in Fig. 1) into which a fluid is filled (the pre-filled syringe 320 comprises therapeutics fluids [0060]) and from which the fluid is discharged to an injection site (inject fluids through a relatively small needle into a region of the anatomy [0054]);
a stopper (plunger 330 in Fig. 6A) coupled to and slidable within an interior of the syringe (the plunger assembly 330 is urged within an interior of the syringe 320 [0084]);
an actuator (actuator member 50 in cassette 20 in Fig. 8) configured to control the stopper within the syringe (movement of actuator member 50 causes terminal 240 to move, resulting in a corresponding movement of the plunger assembly [0086]), wherein the syringe is located remote from the actuator (syringe assembly 300 is located remotely from actuator member 50 in cassette 20 in Fig. 1); and
a drive cable (cable 200 in Fig. 1) connecting the actuator and the syringe (cable 200 is connected to syringe assembly 300 and cassette 20 in Fig. 1),
wherein the drive cable includes:
a flexible inner wire (inner core 210 in Fig. 6A; inner core 210 comprise materials that provide necessary flexibility [0067]); and
a flexible outer sleeve (outer conduit 220 in Fig. 6A; outer conduit 220 comprise materials that provide necessary flexibility [0067]) enclosing the flexible inner wire (inner core 210 is surrounded by outer conduit 220 [0064]; see also Fig. 6A).
Regarding claim 2, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein a first end of the flexible inner wire (terminal 240 is secured to inner core 210 [0065]; terminal 240 is interpreted as first end of inner core 210) is connected to the stopper (terminal 240 is removably attached to plunger 330 [0076]) and a second end of the flexible inner wire (terminal 230 is secured to inner core 210 [0065]; ) is configured to be releasably connected to the actuator (terminal 230 is connected to riser 54 of actuator member 50 with the help of nuts 42 [0083]; it is interpreted that terminal 230 is removably connected to cassette 20 due to use of nuts 42).
Regarding claim 3, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein a minimal gap is formed between the flexible inner wire and the flexible outer sleeve (a gap G is provided between the terminal 230 and the outer conduit 220 in Fig. 4 [0070]; it is interpreted that inner core 210 and outer conduit 220 also has gap since terminal 230 is the second end of inner core 210 as set forth in [0065]).
Regarding claim 10, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein the syringe is releasably coupled to the drive cable (terminal 240 is removably attached to plunger 330 [0076]; terminal 240 is secured to inner core 210 [0065]).
Regarding claim 11, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein the actuator is connected to a controller (actuator member 50 in cassette 20 is connected to fluid delivery module 100 as set forth in para [0061], and fluid delivery module 100 can comprise and in communication with one or more processors [0117]) configured to execute an operation program of the injection system (the module 100 adequately processes data and control the operation of the various components of the fluid injection system [0117]).
Regarding claim 14, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein the actuator is actuated by a foot pedal or a button (the injection system comprises buttons which regulate delivery procedure, which is located on a touchscreen 130 of fluid delivery module 100 [0059]).
Regarding claim 16, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein the syringe is configured to connect to a cannula tip (needle assembly secured to the distal end of the syringe assembly 300 [0078]) through which the fluid is discharged into the injection site (advanced through the skin and other tissues of a patient so as to adequately reach a targeted joint [0078]; inject fluids through needle [0054])
Regarding claim 18, Axelrod discloses a method of injecting a fluid to an injection site (methods of delivering fluid to anatomical locations [0052]), comprising:
connecting a syringe (syringe 320 in syringe assembly 300 in Fig. 1) to a drive cable (cable 200 is connected to syringe assembly 300 in Fig. 1), wherein the drive cable includes a flexible inner wire ((inner core 210 in Fig. 6A; inner core 210 comprise materials that provide necessary flexibility [0067]) and a flexible outer sleeve (outer conduit 220 in Fig. 6A; outer conduit 220 comprise materials that provide necessary flexibility [0067]) enclosing the flexible inner wire (inner core 210 is surrounded by outer conduit 220 [0064]; see also Fig. 6A);
connecting the drive cable to an actuator (actuator member 50 of cassette 20 in Fig. 8) connected to a controller (cassette 20 which is coupled to fluid delivery module 100 as set forth in [0057]);
injecting a cannula tip connected to the syringe (needle assembly secured to the distal end of the syringe assembly 300 [0078]) into the injection site (advanced through the skin and other tissues of a patient so as to adequately reach a targeted joint [0078]);
receiving, at the controller, an operation program (the module 100 adequately processes data and control the operation of the various components of the fluid injection system [0117]); and
actuating the actuator to activate a stopper (plunger 330 in Fig. 6A; movement of actuator member 50 causes terminal 240 to move, resulting in a corresponding movement of the plunger assembly [0086]) coupled to and slideable within an interior of the syringe (the plunger assembly 330 is urged within an interior of the syringe 320 [0084]) based on the operation program to discharge (the module 100 adequately processes data and control the operation of the various components of the fluid injection system [0117]) a fluid stored within the syringe (the pre-filled syringe 320 comprises therapeutics fluids [0060]) into the injection site (inject fluids through a relatively small needle into a region of the anatomy [0054]),
wherein in the actuating of the actuator, the actuator is moved forward and backwards to push and pull the flexible inner wire (movement of the actuator member 50 relative to the cassette housing 22 can cause the terminals 230, 240 and the inner core 210 to linearly [0086]; it is interpreted that actuator 50 also moves linearly) and move the stopper within the syringe (movement of actuator member 50 causes terminal 240 to move, resulting in a corresponding movement of the plunger assembly [0086]).
Regarding claim 19, Axelrod disclosed all limitations of claim 18. Axelrod further discloses wherein a first end (terminal 240 is secured to inner core 210 [0065]; terminal 240 is interpreted as first end of inner core 210) of the flexible inner wire is connected to the stopper (terminal 240 is removably attached to plunger 330 [0076]) and a second end (terminal 230 is secured to inner core 210 [0065]; ) of the flexible inner wire is releasably connected to the actuator (terminal 230 is connected to riser 54 of cassette 20 with the help of nuts 42; it is interpreted that terminal 230 is removably connected to cassette 20 due to use of nuts 42).
Regarding claim 20, Axelrod disclosed all limitations of claim 18. Axelrod further discloses wherein the operation program includes a volume and a flow rate of the fluid to be discharged from the syringe (user pre-select a desired injection protocol, which includes the rate of delivery and the volume to be delivered [0101]; it is set forth in [0103] that control module is configured to communicate with fluid delivery module 100 and is interpreted to program the volume and rate of delivery into fluid delivery module 100).
Regarding claim 22, Axelrod disclosed all limitations of claim 18. Axelrod further discloses wherein the syringe is pre-filled with the fluid (pre-filled syringe 320 include therapeutic fluid [0060]).
Regarding claim 24, Axelrod disclosed all limitations of claim wherein the actuator is actuated via a foot pedal or a button (the injection system comprises buttons which regulate delivery procedure, which is located on a touchscreen 130 of fluid delivery module 100 [0059]).
Regarding claim 25, wherein the foot pedal or the button are located remote from the syringe (syringe assembly 300 is located remotely cassette 20 in Fig. 1; which is coupled to fluid delivery module 100 as set forth in [0057]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 20120259237 A1), and further in view of Scheeff (US 20230210351 A1).
Regarding claim 4, Axelrod discloses all limitations of claim 3. However, Axelrod fails to explicitly disclose wherein the minimal gap is about 0.001 to 0.002 inches.
However, Scheeff teaches a layer 103 is a radial gap space which provide space for other layers to move within the gap layer 103 has a thickness of 0.0002 – 0.04” [0112]. One of ordinary skill in the art teaches the injection system of Axelrod to be configured to have a minimal gap within 0.001-0.002” which falls within the range of 0.0002 – 0.04” as taught by Scheeff.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include wherein the minimal gap is about 0.001 to 0.002 inches as taught by Scheeff since such a modification enables the device of Axelrod to have a gap thickness that ensures the inner wire to easily slip and bugle relative to the outer sleeve to ensure flexibility [Scheeff, 0112].
Claim(s) 5, 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 20120259237 A1), and further in view of Hera (US 20160331360 A1).
Regarding claim 5, Axelrod disclosed all limitations of claim 1. However, Axelrod failed to explicitly disclose wherein the flexible outer sleeve includes a reinforcing wire braid configured to suppress axial and lateral expansion of the flexible outer sleeve.
However, Hera teaches sheath 24 in Fig. 1 includes a plurality of filaments 26 woven together. Filaments 26 comprise flexible wires braiding [0032].
Hera further teaches filaments 26 is woven together tightly so as to form a dense mesh having narrow (e.g., small area) openings 28 therebetween [0033]. One of ordinary skill in the art recognizes the tightly braided narrow opening of filament 26 can be interpreted due to sheath 24 being suppressed from freely expanding as required by claim 5.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include wherein the flexible outer sleeve includes a reinforcing wire braid configured to suppress axial and lateral expansion of the flexible outer sleeve as taught by Hera since such a modification enables the device of Axelrod to allow selective expansion of its outer sleeve [Hera, 0008].
Regarding claim 6, Axelrod disclosed all limitations of claim 1. Axelrod however failed to explicitly disclose wherein the flexible outer sleeve comprises a polyimide material.
However, Hera teaches sheath 224 of insertion device 200 is constructed of polyimides [0048]. One of ordinary skill in the art teaches the outer sleeve of Axelrod is to be configured to be comprised of polyimide material as taught by Hera.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include wherein the flexible outer sleeve comprises a polyimide material as taught by Hera since such a modification enables the device of Axelrod to have lubricious and low coefficient of friction material for outer sleeve to facilitate passage within the sleeve [Hera, 0048].
Regarding claim 9, Axelrod disclosed all limitations of claim 1. Axelrod further discloses wherein an inner lumen of the flexible outer sleeve (it is interpreted that outer sheath 220 has an inner lumen since inner core 210 is slidably moved inside outer sheath 220 [0064]) but fails to explicitly disclose the inner lumen include a polytetrefluoroethylene (PTFE) layer configured to reduce friction between the flexible inner wire and the flexible outer sleeve during movement of the flexible inner wire.
However, Hera teaches sheath 224 of insertion device 200 is constructed of a lubricious and low coefficient of friction material polytetrafluoroethylene [0048]. One of ordinary skill in the art teaches the outer sleeve of Axelrod is to be configured to be comprised of polytetrafluoroethylene material as taught by Hera.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include wherein an inner lumen of the flexible outer sleeve includes a polytetrefluoroethylene (PTFE) layer configured to reduce friction between the flexible inner wire and the flexible outer sleeve during movement of the flexible inner wire as taught by Hera since such a modification enables the device of Axelrod to have lubricious and low coefficient of friction material for outer sleeve to facilitate passage within the sleeve [Hera, 0048].
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 20120259237 A1), and further in view of Khanicheh (US 20230110619 A1).
Regarding claim 7, Axelrod disclosed all limitations of claim 1. Axelrod however failed to explicitly disclose wherein the flexible inner wire comprises a nitinol material.
However, Khanicheh teaches portion 68 is formed from a wire comprising thin nitinol [0058]. One of ordinary skill in the art teaches the inner wire of Axelrod is to be configured to be made of nitinol as taught by Khanicheh.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include wherein the flexible inner wire comprises a nitinol material as taught by Khanicheh since such a modification enables the device of Axelrod to have inner wire flexible for retraction into channels, like the outer sleeve of Axelrod [Khanicheh, 0057].
Claim(s) 23 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 20120259237 A1), and further in view of Spinello (US 4747824 A).
Regarding claim 23, Axelrod disclosed all limitations of claim 18. Axelrod however failed to explicitly disclose prior to injecting the cannula tip connected to the syringe into the injection site, operating the actuator to advance the stopper to purge air bubbles within the syringe and/or the cannula tip.
However, Spinello teaches microcontroller 26 of pumping apparatus in Fig. 5 which includes manual push switches 29 and 30 for effecting rapid reverse of the piston rod for purging the system of air [Col. 7, lines 1-4]. One of ordinary skill in the art the purging operation of Spinello to be incorporated into the method of Axelrod to remove air from the syringe as taught by Spinello.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Axelrod to include prior to injecting the cannula tip connected to the syringe into the injection site, operating the actuator to advance the stopper to purge air bubbles within the syringe and/or the cannula tip as taught by Spinello since such a modification enables the device of Axelrod to maintain constant discharge pressure [Spinello, Col 7, lines 14-15].
Regarding claim 29, Axelrod discloses a cable driven injection system (injection system 10 in Fig. 1), comprising:
a syringe (syringe 320 of syringe assembly 300 in Fig. 1) including a stopper (plunger 330 in Fig. 6A) disposed within an interior cavity thereof (the plunger assembly 330 is urged within an interior of the syringe 320 [0084]), the syringe being configured to receive a fluid (the pre-filled syringe 320 comprises therapeutics fluids [0060]) and discharge the fluid at a surgical site (inject fluids through a relatively small needle into a region of the anatomy [0054]);
an actuator assembly (fluid delivery module 100 in Fig. 9) including an electric motor (stepper motor 180 in Fig. 9) and a block (pusher block 190 in Fig. 9) in a longitudinal direction (pusher block 190 is configured to move linearly [0092]);
a drive wire (cable 200 in Fig. 1) coupled to the block (terminal end 230 of cable 200 is connected to actuator member 50 via riser 54 [0083]; actuator member 50 engages with block 190 [0093]) and the stopper (terminal 240 of cable 200 is removably attached to plunger 330 [0076]), the drive wire being configured to move forward upon activation of the actuator assembly (movement of actuator member 50 cause terminal 230 and inner core 210 to linearly move [0086]) thereby moving the stopper forward and causing the syringe to discharge the fluid (resulting in a corresponding movement of the plunger assembly [0086]); and
a control box (housing 110 of fluid delivery module 100 in Fig. 9) having a computing system (fluid delivery module has wireless connection with computing systems [0116]) including at least one controller (fluid delivery module comprise one or more processors) and a non-transitory memory storage (fluid delivery module 100 comprises one or more memory [0116]) containing an operation program comprising computer executable code (the module 100 adequately processes data and control the operation of the various components of the fluid injection system [0117]), the operation program containing target volume information for the discharge of the fluid (user pre-select a desired injection protocol, which includes the rate of delivery and the volume to be delivered [0101]; it is set forth in [0103] that control module is configured to communicate with fluid delivery module 100 and is interpreted to program the volume and rate of delivery into fluid delivery module 100),
wherein the controller is configured to supply a target power to the electric motor (fluid delivery module 100 and other components of injection system 10 is electrically energized by an external power source [0114]) such that a volume of fluid discharged from the syringe corresponds to the target volume information of the operation program (motor that is configured to accurately move the motion transfer cable in order to transfer a volume of fluid and/or other material from the syringe to or near a joint or another targeted anatomical location of a patient [0088]; a user can pre-select a desired injection protocol, which includes the volume to be delivered [0101]; it is interpreted that the motor accurately delivers volume of fluid via transfer cable to correspond to the volume to be delivered that is pre-selected). Axelrod however failed to explicitly disclose a rotatable shaft configured to linearly translate the block.
However, Spinello teaches the piston rod 22 of pumping apparatus in Fig. 5 is internally threaded to receive a drive shaft 23 coupled to a reversible stepper motor 24. The piston rod 22 is driven in and out upon activation of the stepper motor 24 to pump or aspirate depending upon the direction of rotation of the drive screw [Col 6, lines 34-42].
Spinello further teaches threaded shaft 23 is mounted to drive a threaded block follower carrying the piston rod in a laterally offset position relative to the threaded shaft and carried in its independent slide bearings [Col. 7, lines 19-22]. One of ordinary skill in the art teaches the shaft of Spinello to be configured to be rotated by the motor of Axelrod to move the block of Axelrod as taught by Spinello.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the injection system of Axelrod to include a rotatable shaft configured to linearly translate the block as taught by Spinello since such a modification enables device of Axelrod to constraint the block against rotation but maintain linear translation of the block through rotation of the shaft [Spinello, Col. 6, lines 37-40].
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 20120259237 A1), and further in view of Duffy (US 5800387 A).
Regarding claim 26, Axelrod disclosed all limitations of claim 18. Axelrod however failed to explicitly disclose wherein the discharge of the fluid is stopped automatically in response to determining that the operation program is complete.
However, Duffy teaches a primary processor 110 of an infusion pump 100 in Fig. 1, wherein the user presets a Volume To Be Infused (VTBI). Primary processor communicates this preset VTBI to safety processor 102 through communication link 240. Primary processor utilizes motion sense signal 234 and its clock 280 to keep track of the total volume being infused. Once the total volume infused reaches the preset VTBI, primary processor 102 will stop fluid delivery by infusion pump unit 100 [Col 10, lines 57-65]. One of ordinary skill in the art teaches a processor capable of stopping fluid delivery when predetermined volume is reached is to be configured to be used with the device of Axelrod to automatically stop fluid discharge when programmed operation is determined to be complete.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Axelrod to include wherein the discharge of the fluid is stopped automatically in response to determining that the operation program is complete as taught by Duffy since such a modification enables the device of Axelrod to regulate delivery of fluid [Duffy, Col. 10, lines 46-47].
Regarding claim 27, Axelrod disclosed all limitations of claim 18. Axelrod however failed to explicitly disclose wherein the discharge of the fluid is stopped when the volume of the fluid reaches a predetermined threshold.
However, Duffy teaches a primary processor 110 of an infusion pump 100 in Fig. 1, wherein the user presets a Volume To Be Infused (VTBI). Primary processor communicates this preset VTBI to safety processor 102 through communication link 240. Primary processor utilizes motion sense signal 234 and its clock 280 to keep track of the total volume being infused. Once the total volume infused reaches the preset VTBI, primary processor 102 will stop fluid delivery by infusion pump unit 100 [Col 10, lines 57-65]. One of ordinary skill in the art teaches a processor capable of stopping fluid delivery when predetermined volume is reached is to be configured to be used with the device of Axelrod to automatically stop fluid discharge when predetermined threshold is reached.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Axelrod to include wherein the discharge of the fluid is stopped when the volume of the fluid reaches a predetermined threshold as taught by Duffy since such a modification enables the device of Axelrod to regulate delivery of fluid [Duffy, Col. 10, lines 46-47].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
WO 2023084090 A1 (Creixams) related to a syringe driving system
US 20190117881 A1 (Yang) related to a unilateral driving system for an infusion device.
WO 2018146467 A1 (Howarth) related to a piston pump driven by shape memory allow wire.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. 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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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