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 .
Elections/Restrictions
Applicant’s election without traverse of Group I (claims 1-18) in the reply filed on 6/24/2026 is acknowledged. Accordingly, claims 19-37 and 51 are withdrawn by the Examiner.
Claim Objections
Claims 1-4, 6-8, 10, and 12 are objected to because of the following informalities:
-Claim 1, line 8: please correct “of injection” to “of an injection”
-Claim 1, line 13: please correct “the injection system” to “the injection assembly”
-Claim 1, line 14: please correct “to operate” to “operate”
-Claim 2, line 5: please correct “them” to “the first sealing element and the second sealing element”
-Claim 3, line 2: please correct “the force” to “a force”
-Claim 4, line 2: please correct “the force” to “a force”
-Claim 6, line 2: please correct “measure force” to “measure a force”
-Claim 7, line 2: please correct “measure force” to “measure a force”
-Claim 8, line 2: please correct “force sensor” to “a force sensor”
-Claim 8, line 2: please correct “strain sensor” to “a strain sensor”
-Claim 8, line 2: please correct “position sensor” to “a position sensor”
-Claim 8, line 2: please correct “low rate sensor” to “a low rate sensor”
-Claim 10, line 4: please correct “force” to “a force”
-Claim 10, line 5: please correct “force” to “the force”
-Claim 12, line 2: please correct “an injection” to “the injection”
Appropriate correction is required.
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 1-5, 8, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1).
Regarding claim 1, Karp discloses an injection system comprising:
an injection assembly (900) (see Figs. 9, 11A, 11C) comprising a syringe barrel (barrel 908) defining a lumen between a proximal end and a distal end (see Fig. 11A) and a second sealing element (plunger 902) moveably disposed within the lumen to dispense an injection agent from an injection chamber defined in the syringe barrel (barrel 908), and a puncture element (needle 906) configured to deliver the injection agent into a space (cavity 1108) in a tissue (tissue 1100) of a patient, the tissue (tissue 1100) being less permeable to the injection agent than the space (cavity 1108) (see Figs. 11A and 11C, par. [0079]-[0080], [0083]);
wherein advancement of the puncture element (needle 906) through the tissue (tissue 1100) toward the space (cavity 1108) occurs such that the injection agent remains in the injection chamber until the puncture element (needle 906) fluidly connects the injection chamber with the space (cavity 1108) (see Figs. 11A and 11C, par. [0079]-[0080], [0083]).
However, Karp fails to state a support platform configured to support the injection assembly and anchor the injection assembly relative to a site of injection; a drive assembly configured to operate the injection assembly; one or more sensors configured to monitor one or more forces on the injection assembly; and a controller in communication with the one or more sensors to receive information about the one or more forces on the injection system, and being configured to, based on the information, to operate the drive assembly to advance the puncture element.
Bang teaches an injection system (see Figs. 1-2) comprising a support platform (drug injection supporting portion 300) configured to support the injection assembly (syringe 304) and anchor the injection assembly (syringe 304) relative to a site of injection (see Figs. 1-2, par. [0016], [0019]); a drive assembly (motor 306, screw gear shaft 301, screw gear bolt 302, syringe piston pusher 303) configured to operate the injection assembly (syringe 304) (see Figs. 1-2, par. [0016], [0019]); one or more sensors (pressure sensor 500) configured to monitor one or more forces on the injection assembly (syringe 304) (see Figs. 1-2, par. [0016], [0019]); and a controller (drug injection controller 501) in communication with the one or more sensors (pressure sensor 500) to receive information about the one or more forces on the injection system (syringe 304), and being configured to, based on the information, to operate the drive assembly (motor 306, screw gear shaft 301, screw gear bolt 302, syringe piston pusher 303) to inject the injection agent (see Figs. 1-2, par. [0016], [0019]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of Karp to include a support platform configured to support the injection assembly and anchor the injection assembly relative to a site of injection; a drive assembly configured to operate the injection assembly; one or more sensors configured to monitor one or more forces on the injection assembly; and a controller in communication with the one or more sensors to receive information about the one or more forces on the injection system, and being configured to, based on the information, to operate the drive assembly to inject the injection agent, as taught by Bang, in order to secure the injection assembly and control operation of the injection assembly in a motorized manner which includes receiving sensor feedback and injecting the injection agent based on the sensor feedback which enables the practitioner to focus on the treatment and the injection site rather than the injection of the injection agent (see Bang par. [0016], [0019]-[0021]).
Regarding claim 2, modified Karp teaches the injection system of claim 1 substantially as claimed. Karp further teaches wherein the injection assembly further comprises:
a first sealing element (floating seal 904) moveably disposed within the lumen distal to the second sealing element (plunger 902), wherein the first sealing element (floating seal 904) and the second sealing element (plunger 902) form a seal with the lumen and define the injection chamber between them (see Figs. 9, 11A, 11C), the puncture element (needle 906) being in fluid communication with the injection chamber to deliver the injection agent from the injection chamber into the space (cavity 1108) in the tissue (tissue 1100) of the patient (see Figs. 9, 11A, 11C, par. [0076]-[0080]),
wherein when a force is applied on the second sealing element (plunger 902) in a distal direction,
in response to a first opposing force as the puncture element (needle 906) advances through the tissue (tissue 1100), the first sealing element (floating seal 904) moves in the distal direction to advance the puncture element (needle 906) in the distal direction, without conveying the injection agent through the puncture element (needle 906) (see Figs. 9, 11A, 11C, 14A, par. [0076]-[0080], [0086]), and
in response to a second opposing force when the injection chamber is fluidly connected to the space (cavity 1108), the first sealing element (floating seal 904) remains stationary and the injection agent is conveyed from the injection chamber through the puncture element (needle 906) (see Figs. 9, 11A, 11C, 14B, par. [0076]-[0080], [0087]).
Regarding claim 3, modified Karp teaches the injection system of claim 1 substantially as claimed. Modified Karp further teaches wherein the drive assembly (Bang, motor 306, screw gear shaft 301, screw gear bolt 302, syringe piston pusher 303) is linked to the second sealing element (Karp, plunger 902) to apply the force on the second sealing element (Karp, plunger 902) to translate the second sealing element (Karp, plunger 902) in a distal direction (see previous modifications in rejection of claim 1 above, see Bang par. [0016], [0019]).
Regarding claim 4, modified Karp teaches the injection system of claim 1 substantially as claimed. Modified Karp further teaches wherein the drive assembly (Bang, motor 306, screw gear shaft 301, screw gear bolt 302, syringe piston pusher 303) comprises a linear actuator (Bang, par. [0019] describes a linear actuator which converts rotation of screw gear shaft 301 into linear displacement of syringe piston 305) linked the second sealing element (Karp, plunger 902) to apply the force on the second sealing element (Karp, 902) to translate the second sealing element (Karp, plunger 902) in a distal direction (see previous modifications in rejection of claim 1 above, see Bang par. [0016], [0019]).
Regarding claim 5, modified Karp teaches the injection system of claim 1 substantially as claimed. Modified Karp further teaches wherein the drive assembly (Bang, motor 306, screw gear shaft 301, screw gear bolt 302, syringe piston pusher 303) comprises a first driver configured to translate the syringe barrel (Karp, barrel 908) relative to the support platform (Bang, drug injection supporting portion 300) and a second driver linked to the second sealing element (Karp, plunger 902) to translate the second sealing element (Karp, plunger 902) relative to the syringe barrel (Karp, barrel 908) (see previous modifications in rejection of claim 1 above, see Bang par. [0016], [0019], motor 306, screw gear shaft 301, screw gear bolt 302, and syringe piston pusher 303 are each distinct driver portions which cause a relative driver motion of the system).
Regarding claim 8, modified Karp teaches the injection system of claim 1 substantially as claimed. Modified Karp further teaches wherein the one or more sensors (Bang, pressure sensor 500) comprise a pressure sensor (see Bang par. [0016], [0019], see previous modifications in rejection of claim 1 above, note: only one of a pressure sensor, force sensor, strain sensor, position sensor, or low rate sensor is required by the claim since this limitation is written in the alternative).
Regarding claim 16, modified Karp teaches the injection system of claim 1 substantially as claimed. Karp further teaches injection system of claim 1, where the tissue is sclera and the space is suprachoroidal space (see Fig. 24, par. [00103]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claim 5 above, further in view of Hochman (US 2006/0122555 A1).
Regarding claim 6, modified Karp teaches the injection system of claim 5 substantially as claimed. However, modified Karp fails to state wherein the one or more sensors comprise a first load cell configured to measure force on the syringe barrel.
Hochman teaches an injection system (see Figs. 1-3A) wherein the one or more sensors (see par. [0062]-[0064]) comprise a first load cell (load cell 78) configured to measure force on the syringe barrel (barrel 92) (see Fig. 3, par. [0062]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the one or more sensors comprise a first load cell configured to measure force on the syringe barrel, as taught by Hochman, in order to add additional sensor functions to detect stress and strain of the injection assembly (see Hochman par. [0062]).
Regarding claim 7, modified Karp teaches the injection system of claim 5 substantially as claimed. However, modified Karp fails to state wherein the one or more sensors comprise a second load cell configured to measure force on the second sealing element.
Hochman teaches an injection system (see Figs. 1-3A) wherein the one or more sensors (see par. [0062]-[0064]) comprise a second load cell (load cell 78B) configured to measure force on the second sealing element (syringe plunger 94) (see Fig. 3, par. [0064]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the one or more sensors comprise a second load cell configured to measure force on the second sealing element, as taught by Hochman, in order to add additional sensor functions to measure force or strain resultant from the force applied by the driver assembly on the second sealing element (see Hochman par. [0064]).
Claims 9-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claims 1-2 above, further in view of Chowdhury (US 2019/0125984 A1).
Regarding claim 9, modified Karp teaches the injection system of claim 2 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to implement one or more feedback loops to monitor the first opposing force and the second opposing force.
Chowdhury teaches an injection system (see Figs. 1A-5, par. [0056], [0081]) wherein the controller (feedback control box 7) is programmed to implement one or more feedback loops to monitor the first opposing force and the second opposing force (see par. [0031], [0062]-[0063], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the controller is programmed to implement one or more feedback loops to monitor the first opposing force and the second opposing force, as taught by Chowdhury, in order to automatically alter the driving forces used to insert the puncture element and inject the injection agent (see Chowdhury par. [0031], [0062]-[0063], [0081]).
Regarding claim 10, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to implement one or more feedback loops to monitor a pre-insertion of the puncture element into the tissue, the one or more feedback loops being configured to monitor an increase in force onto the puncture element, to detect a drop in force on the puncture element, and based on the drop, to cause an advancement of the puncture element by a pre-determined distance to imbed the puncture element into the tissue.
Chowdhury teaches an injection system (see Figs. 1A-5, par. [0056], [0081]) wherein the controller (feedback control box 7) is programmed to implement one or more feedback loops to monitor a pre-insertion of the puncture element (needle 5) into the tissue, the one or more feedback loops being configured to monitor an increase in force onto the puncture element (needle 5), to detect a drop in force on the puncture element (needle 5), and based on the drop, to cause an advancement of the puncture element (needle 5) by a pre-determined distance to imbed the puncture element into the tissue (see par. [0031], [0062]-[0063], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the controller is programmed to implement one or more feedback loops to monitor a pre-insertion of the puncture element into the tissue, the one or more feedback loops being configured to monitor an increase in force onto the puncture element, to detect a drop in force on the puncture element, and based on the drop, to cause an advancement of the puncture element by a pre-determined distance to imbed the puncture element into the tissue, as taught by Chowdhury, in order to automatically alter the driving forces used to insert the puncture element and inject the injection agent (see Chowdhury par. [0031], [0062]-[0063], [0081]).
Regarding claim 11, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to implement one or more feedback loops to monitor an advancement of the puncture element through the tissue, the one or more feedback loops being configured to measure a load on the second sealing element and detect a drop in the load once the puncture element reaches the space in the tissue.
Chowdhury teaches an injection system (see Figs. 1A-5, par. [0056], [0081]) wherein the controller (feedback control box 7) is programmed to implement one or more feedback loops to monitor an advancement of the puncture element (needle 5) through the tissue, the one or more feedback loops being configured to measure a load on the second sealing element (plunger mechanism 20) and detect a drop in the load once the puncture element (needle 5) reaches the space in the tissue (see par. [0031], [0062]-[0063], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the controller is programmed to implement one or more feedback loops to monitor an advancement of the puncture element through the tissue, the one or more feedback loops being configured to measure a load on the second sealing element and detect a drop in the load once the puncture element reaches the space in the tissue, as taught by Chowdhury, in order to automatically alter the driving forces used to insert the puncture element and inject the injection agent (see Chowdhury par. [0031], [0062]-[0063], [0081]).
Regarding claim 12, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to implement one or more feedback loops to monitor an injection of the injection agent into the space, the one or more feedback loops being configured to control a velocity or an advancement distance of the second sealing element.
Chowdhury teaches an injection system (see Figs. 1A-5, par. [0056], [0081]) wherein the controller (feedback control box 7) is programmed to implement one or more feedback loops to monitor an injection of the injection agent into the space, the one or more feedback loops being configured to control a velocity or an advancement distance of the second sealing element (plunger mechanism 20) (see par. [0031], [0062]-[0063], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the controller is programmed to implement one or more feedback loops to monitor an injection of the injection agent into the space, the one or more feedback loops being configured to control a velocity or an advancement distance of the second sealing element, as taught by Chowdhury, in order to automatically alter the driving forces used to insert the puncture element and inject the injection agent (see Chowdhury par. [0031], [0062]-[0063], [0081]).
Regarding claim 14, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to control a stopping distance of the puncture element as the puncture element enters the space.
Chowdhury teaches an injection system (see Figs. 1A-5, par. [0056], [0081]) wherein the controller (feedback control box 7) is programmed to control a stopping distance of the puncture element (needle 5) as the puncture element (needle 5) enters the space (see par. [0030]-[0031], [0062]-[0063], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the controller is programmed to implement one or more feedback loops to monitor an injection of the injection agent into the space, the one or more feedback loops being configured to control a velocity or an advancement distance of the second sealing element, as taught by Chowdhury, in order to automatically alter the driving forces used to insert the puncture element and inject the injection agent (see Chowdhury par. [0031], [0062]-[0063], [0081]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claim 1 above, further in view of Nekouzadeh et al. (US 2022/0031939 A1).
Regarding claim 13, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the controller is programmed to cause a retraction of the puncture element by a pre-determined distance when the one or more sensors detect a drop in load on the second sealing element.
Nekouzadeh teaches an injection system (see Figs. 1-3) wherein the controller (controller 119) is programmed to cause a retraction of the puncture element (drug delivery member 113) by a pre-determined distance when the one or more sensors (force sensor 210) detect a drop in load on the second sealing element (plunger stopper 106 and plunger rod/piston 110) (see Figs. 1-3, par. [0021]-[0024], a force equal to a threshold could include a drop in load).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include state wherein the controller is programmed to cause a retraction of the puncture element by a pre-determined distance when the one or more sensors detect a drop in load on the second sealing element, as taught by Nekouzadeh, in order to continuously monitor force data as a feedback loop which alters the insertion depth of the puncture element based on sensed forces (see Nekouzadeh par. [0021]-[0024]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claim 1 above, further in view of Allingham et al. (US 2020/0384212 A1).
Regarding claim 15, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the tissue is conjunctiva and the space is subconjunctival space.
Allingham teaches an injection system (see Figs. 1A-D) wherein the tissue is conjunctiva and the space is subconjunctival space (see par. [0003], [0027]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the tissue is conjunctiva and the space is subconjunctival space, as taught by Allingham, in order to allow for sustained release and higher bioavailability when injecting injection agents for treating additional eye disorders such as glaucoma (see Allingham par. [0002]-[0003], [0027]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claim 1 above, further in view of Lerner (US 2013/0296825 A1).
Regarding claim 17, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the tissue is sclera and choroid and the space is intravitreal space.
Lerner teaches an injection system (see Figs. 8 and 19-20) wherein the tissue is sclera and choroid and the space is intravitreal space (see par. [0004], [0007], [0087], [0139]-[0140]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the tissue is sclera and choroid and the space is intravitreal space, as taught by Lerner, because intravitreal injection agents are widely available and can treat additional eye disorders such as acute macular degeneration and choroidal neovascularization in a manner which maintains a controlled intraocular pressure (see Lerner par. [0004], [0007], [0087], [0139]-[0140]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Karp et al. (WO 2018/112305 A1) in view of Bang (US 2015/0182700 A1), as applied to claim 1 above, further in view of Feinsod et al. (US 2018/0271701 A1).
Regarding claim 18, modified Karp teaches the injection system of claim 1 substantially as claimed. However, modified Karp fails to state wherein the tissue is cornea and the space is an anterior chamber of an eye.
Feinsod teaches an injection system (see Fig. 1A) wherein the tissue is cornea and the space is an anterior chamber of an eye (see par. [0003], [0014], [0018], [0025]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection system of modified Karp to include wherein the tissue is cornea and the space is an anterior chamber of an eye, in order to offer a safe injection system to treat additional eye problems such as a low intraocular pressure or infection (see Feinsod par. [0003], [0014], [0018], [0025]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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