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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/23/2026 has been entered.
Acknowledgment
Claims 21, 35, 39 are amended and filed on 3/23/2026.
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) 21-22, 24, 27-34, 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boschetti. (US. 5342308) in view of Andino et al. (US. 20150051581A1) (“Andino”).
Re claim 21, Boschetti discloses a system (Fig. 1-5) comprising: a syringe barrel (2) forming a lumen from a distal end (top end close to 25 ) to a proximal end of the syringe barrel ( lower end ); a piston (4) arranged at a distal end of a plunger (3) such that the piston is configured to form a seal in the lumen of the syringe barrel (Fig. 3. Col. 2, lines 19-26); a floating seal (15, 22, 21, 25) arranged in the lumen distal of the piston to define a fluid chamber between the floating seal and the piston (chamber between 21 and 4); and a needle (12) fixedly attached to and moveable with the floating seal (Fig, 1-5), the needle including a passage extending (lumen of the needle) from a proximal end connected to the floating seal (close to 20) to a distal end (top end of 12) having an opening for the fluid to flow from the lumen (Fig, 3), through the floating seal, and through the distal end of the syringe barrel via the needle (Col. 3, lines 30-50); wherein the syringe barrel, the piston, and the floating seal are configured such that, upon a force being applied on the piston in a distal direction (a force applied to the lounger during the injection Col. 3, lines 30-50), during a tissue penetration phase (needle insertion into the tissue), a distal end of the needle advances through a tissue ( as the tissue blocking the opening of the needle, the flowrate is zero), but it fails to disclose that during the tissue penetration phase, the distal end of the needle advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, during a cavity penetration phase, the distal end of the needle extends through the tissue and into a cavity such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the needle is maintained due to a second opposing force different than the first opposing force.
However, Andino discloses a system (Figs.1-6, Figs. 84a-b, ¶0316) and the system comprising a syringe (2000) and a plug (attached to the plunger 23320) and wherein during a tissue penetration phase, the distal end of the needle advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, (¶0316, Fig. 84a) and during a cavity penetration phase (Fig. 84b), the distal end of the needle extends through the tissue and into a cavity (SCS, Fig. 94b, ¶0316 ) such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the needle is maintained due to a second opposing force different than the first opposing force (¶0316).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti so that during a tissue penetration phase, the distal end of the needle advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, during a cavity penetration phase, the distal end of the needle extends through the tissue and into a cavity such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the needle is maintained due to a second opposing force different than the first opposing force as taught by Andino for the purpose of delivering the medication at the desired location in the tissue by adjusting the force on the actuation plunger (Andino, ¶0316).
Re claim 22, the modified Boschetti discloses wherein the cavity is pressurized, empty, fluid filled, porous, or potential space created by delamination of layers (SCS suprachoroidal space Andino, ¶0316).
Re claim 24, Boschetti discloses the syringe barrel forms a single-handed injector ( Fig. 1 can be handled in single hand).
Re claim 27, Boschetti discloses further comprising at least one of: a fluid connection extending through the piston to deliver the force via the fluid connection (the lower portion of the piston and the head of the plunger); a plunger arm (3, Fig. 3, Boschetti) extending from the piston to apply the force through the plunger arm (Fig. 3); and a mechanical actuator configured to deliver the force by releasing potential energy stored in the mechanical actuator ( lower end of the plunger).
Re claim 28, Boschetti discloses wherein the needle is configured to extend beyond the distal end of the syringe barrel to expose a portion of the needle for insertion into the tissue of the subject before applying the force (Boschetti, Fig.3).
Re claim 29, Boschetti discloses wherein the needle extends through the floating seal or is aligned with a passage extending through the floating seal to present a fluid passage from the lumen in the syringe barrel to the opening in the needle (Fig. 3).
Re claim 30, Boschetti discloses wherein the needle includes threads forming a drill or a sharpened tip forming a knife point ( top end of the needle 12 is sharped tip, Fig. 3).
Re claim 31, Boschetti discloses wherein the fluid includes a liquid, a gas, a combination of liquid and gas, liquid-suspended particles, gel, gel-suspended particles, micro-particles, or nano-particles (liquid/ solution, Col. 3, lines 41-50).
Re claim 32, Boschetti fails to disclose wherein a portion of the lumen between the piston and the floating seal forms a volume of one of 1 ml, 3 ml, 5 ml, or 10 ml prior to displacement of the fluid.
However, Andino discloses a system (Figs.1-6, Figs. 84a-b, ¶0316) and the system comprising a syringe (2000) and a plug (attached to the plunger 23320) and wherein a portion of the lumen between the plug and the floating seal forms a volume of one of 1 ml, 3 ml, 5 ml, or 10 ml prior to displacement of the fluid (¶0183, greater than 0.5 ml).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti so that a portion of the lumen between the plug and the floating seal forms a volume of one of 1 ml, 3 ml, 5 ml, or 10 ml prior to displacement of the fluid as taught by Andino for the purpose of using a standardized cartridge with volume (Andino, ¶0183).
Re claim 33, the modified Boschetti discloses wherein the first opposing force includes at least one of a frictional force between the floating seal and the syringe barrel, a frictional force of the tissue of the subject or a spring based mechanical force (¶0317 of Andino, the friction force to insert the needle in the tissue).
Re claim 34, Boschetti discloses floating seal is operably connected to a plug configured to frictionally engage than interior of the barrel top ring of 25 Fig. 3).
Re claim 39, Boschetti discloses a system (Fig. 1-5) comprising: a syringe barrel (2) forming a lumen from a distal end (top end close to 25 ) to a proximal end of the syringe barrel ( lower end ); a piston (4) arranged at the distal end of a plunger (3) such that the piston is configured to form a seal in the lumen of the syringe barrel (Fig. 3. Col. 2, lines 19-26); a floating seal (15, 22, 21, 25) arranged in the lumen distal of the piston to define a fluid chamber between the floating seal and the piston (chamber between 21 and 4); and a penetrating device (12) fixedly attached to and moveable with the floating seal (Fig, 1-5), the penetrating device including a passage extending (lumen of the needle) from a proximal end connected to the floating seal (close to 20) to a distal end (top end of 12) having an opening for the fluid to flow from the lumen (Fig, 3), through the floating seal, and through the distal end of the syringe barrel via the penetrating device (Col. 3, lines 30-50); and wherein the syringe barrel, the piston, and the floating seal are configured such that, upon a force being applied on the piston in a distal direction (a force applied to the lounger during the injection Col. 3, lines 30-50), during a tissue penetration phase (needle insertion into the tissue), a distal end of the needle advances through a tissue ( as the tissue blocking the opening of the penetrating device, the flowrate is zero), but it fails to disclose that during the tissue penetration phase, the distal end of the penetrating device advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, during a cavity penetration phase, the distal end of the penetrating device extends through the tissue and into a cavity such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the penetrating device is maintained due to a second opposing force different than the first opposing force.
However, Andino discloses a system (Figs.1-6, Figs. 84a-b, ¶0316) and the system comprising a syringe (2000) and a plug (attached to the plunger 23320) and wherein during a tissue penetration phase, the distal end of the penetrating device advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, (¶0316, Fig. 84a) and during a cavity penetration phase (Fig. 84b), the distal end of the penetrating device extends through the tissue and into a cavity (SCS, Fig. 94b, ¶0316 ) such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the penetrating device is maintained due to a second opposing force different than the first opposing force (¶0316).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti so that during a tissue penetration phase, the distal end of the penetrating device advances at a threshold rate without releasing the fluid from the lumen due to a first opposing force, during a cavity penetration phase, the distal end of the penetrating device extends through the tissue and into a cavity such that the fluid is injected from the fluid chamber into the cavity at a threshold flowrate as a position of the distal end of the penetrating device is maintained due to a second opposing force different than the first opposing force as taught by Andino for the purpose of delivering the medication at the desired location in the tissue by adjusting the force on the actuation plunger (Andino, ¶0316).
Re claim 40, Boschetti discloses wherein the needle extends through the floating seal or is aligned with a passage (Fig. 3 ) extending through the floating seal to present a fluid passage from the lumen in the syringe barrel to the opening in the needle before the force is applied to the piston (Fig. 3).
Re claim 41, Boschetti discloses wherein a channel of the floating seal (inner lumen at 22, Fig. 3) has a width larger than a width of the passage of the needle (Fig. 3); and wherein the channel is fluidly coupled to the lumen (Fig. 3).
Claim(s) 23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boschetti in view of Andino and further in view of Brunet (US. 20150051581A1).
Re claim 23, Boschetti discloses wherein the fluid is a first fluid ( fluid in chamber, Fig. 3), but it fails to discloses that the system further comprising a drainage of a second fluid.
However, Brunet discloses a system (Figs.1-5, abstract) and the system comprising a syringe (16 and 66) and a plug (60) and wherein the system discloses a first fluid (C1) and further comprising a drainage of a second fluid (C2, drainage 46).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti to include a drainage so that the system further comprising a drainage of a second fluid as taught by Brunet for the purpose of injecting a plurality of different substances in succession (Brunet, Col. 4, lines 45-60).
Re claim 25, Boschetti fails to disclose wherein the syringe barrel is formed of two barrels coupled together by a lock connector, a flexible tube, or a rigid tube.
However, Brunet discloses a system (Figs.1-5, abstract) and the system comprising a syringe (16 and 66) and the syringe barrel is formed of two barrels (16, 66) coupled together by a lock connector, a flexible tube, or a rigid tube (connector tube at 67 and 18).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti to include two barrels so that the syringe barrel is formed of two barrels coupled together by a lock connector, a flexible tube, or a rigid tube as taught by Brunet for the purpose of automatically injecting a plurality of different substances in succession (Brunet, Col. 4, lines 45-60).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boschetti in view of Andino and further in view of Cazzini (US.20100114039A1).
Re claim 26, Boschetti fails to disclose further comprising a back support extending into the lumen of the syringe barrel to restrict the floating seal from extending through the lumen toward the proximal end of the syringe barrel beyond the back support.
However, Cazzini discloses a system (Figs.1-5) and comprising a syringe (2) and a back support (5) extending into the lumen of the syringe barrel (2) to restrict the floating seal (9) from extending through the lumen toward the proximal end of the syringe barrel beyond the back support (Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Boschetti to include a back support so that the system further comprising a back support extending into the lumen of the syringe barrel to restrict the floating seal from extending through the lumen toward the proximal end of the syringe barrel beyond the back support as taught by Cazzini for the purpose of positing the floating seal at desired location (Cazzini, ¶0026, Fig. 3-5).
Claim(s) 35-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino et al. (US. 20150051581A1) (“Andino”) in view of Boschetti.
Re claim 35, Andino discloses a method (Fig. 1-6, 84a-b, abstract) comprising: inserting a distal end of a needle (right end of 23240) of a syringe (23000) into a tissue (tissue S, ¶00316, ¶00317, Fig. 84a), the syringe comprising a syringe barrel (barrel of 23000) forming a lumen from a distal end (close to 23240) to a proximal end of the syringe barrel ( left end ) and a piston (piston of the plunger 23320) arranged at the distal end of the plunger (23320) such that the piston is configured to form a seal in the lumen of the syringe barrel (Fig. 84a) and a floating seal (attached to the needle 23240 and sealing the distal end of the barrel 23000) distal of the piston to define a fluid chamber (wherein the fluid is located in the syringe, Fig. 84a) between the floating seal and the piston (Fig. 84a), wherein the needle configured to allow a fluid from the fluid chamber to flow from the lumen (¶0317); advancing a distal end of the needle ( Fig. 84a-b), during a tissue penetration phase (Fig. 84a), through the tissue at a threshold rate without releasing the fluid from the lumen due to a first opposing force (¶0316); and injecting the fluid from the fluid chamber, during a cavity penetration phase when the distal end of the needle extends through the tissue and into a cavity (Fig. 84b, ¶0316), into the cavity at a threshold flowrate such that a position of the distal end of the needle is maintained due to a second opposing force different than the first opposing force (¶031), but it fails to disclose that floating seal is arranged in the lumen and wherein the needle is fixedly attached to and movable with the floating seal and extends distally from the floating seal.
However, Boschetti discloses a system (Fig. 1-3) comprising: a syringe barrel (3) forming a lumen from a distal end (close to 25, Fig. 3) to proximal end ( lower end of 2) and a floating seal (21, 22, 20, 25) is arranged in the lumen (Fig. 3) and wherein the needle (12) is fixedly attached to and movable with the floating seal (20) and extends distally from the floating seal (Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Andino so that floating seal is arranged in the lumen and wherein the needle is fixedly attached to and movable with the floating seal and extends distally from the floating seal.as taught by Boschetti for the purpose of fixing the needle with the syringe similar to the ordinary syringe (Boschetti, Fog. 3, lines 35-40).
Re claim 36, Andino discloses wherein the cavity is formed by a suprachoroidal space between a sclera and a choroid of an eye of the subject (SCS, ¶0006).
Re claim 37, Andino discloses wherein the fluid includes a therapeutic for a posterior segment eye disease (¶0003).
Re claim 38, Andino discloses wherein the posterior segment eye disease includes one of macular degeneration (AMD), diabetic retinopathy (DR), diabetic macular edema (DME), retinal vein occlusion (RVO), uveitis, or endophthalmitis (¶0003, such as macular degeneration, diabetic retinopathy, uveitis).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andino in view of Boschetti and further in view of Cazzini (US.20100114039A1).
Re claim 42, Andino fails to disclose wherein a spacing is located between a distal end of the floating seal and a proximal end of the syringe barrel while the fluid is injected from the fluid chamber.
However, Cazzini discloses a system (Figs.1-5) and comprising a syringe (2) and a spacing (5) extending into the lumen of the syringe barrel (2) to restrict the floating seal (9) and the spacing is located between a distal end of the floating seal and a proximal end of the syringe barrel while the fluid is injected from the fluid chamber. (Fig. 3).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Andino to include a spacing between a distal end of the floating seal and a proximal end of the syringe barrel while the fluid is injected from the fluid chamber as taught by Cazzini for the purpose of positing the floating seal at desired location (Cazzini, ¶0026, Fig. 3-5).
Response to Arguments
Applicant’s arguments, see remark, filed 382382026, with respect to claim 21, 35, 39 and newly added limitation and the 103 rejection under Lanin have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Boschetti. in view of Andino. For claims 21, 39 and Andino in view of Boschetti. For claim 35.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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