DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 12/23/25. As directed by the amendment: claims 1, 12, 25, 28, 40, 41, 42, 45 and 49 have been amended. Claims 11, 16-18, 21-24, 29-39, 44 have been cancelled. Claims 60-118 have been added.
Thus, claims 1-10, 12-15, 19, 20, 25-28, 40-43, 45-118 are pending in this application.
Applicant’s amendments to the specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 08/28/2025.
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.
Claims 1, 3-9, 12-15, 20, 25-28, 59-61, 69, 70, 72, 76, 77, 79, and 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Novakovic et al (US 20150238687 A1).
Regarding claim 1, Novakovic et al disclose an injector (40, para 0008, see fig 1A) comprising: a housing (42); a push rod (108) disposed at least partially within the housing (see fig 6); a lumen (lumen of 84 and 56) defined within the housing (see fig 7A), the lumen configured to slidingly receive the push rod and at least one implant (68) therein (para 0144 and fig 7A-B); a gate (106) disposed within the housing (figs 7A-B), wherein the gate (106) has a closed configuration in which it prevents passage of the at least one implant in a distal direction through the lumen (fig 7A and para 0136) and an open configuration in which it does not prevent passage of the at least one implant through the lumen in the distal direction (see fig 7B and para 0136 and 0139); a cannula (56) having a distal end that is disposed outside of the housing (see figs 7A-B) and is configured to be inserted into an eye (para 0017-20, see fig 29); and an actuator (64), wherein actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the pushrod (para 0118, 0139, 0157, 0162, see fig 7B); and wherein the push rod (108) is configured to distally advance the at least one implant through the lumen only after the actuator moves the gate from the closed configuration to the open configuration (para 0136 and 162, fig 7B).
Regarding claim 3, Novakovic et al disclose the injector of claim 1, wherein the housing has a generally tubular construction with an asymmetrical fin that includes a height that is greater than a height of the remaining length of the housing (see figs 1A-B).
Regarding claim 4, Novakovic et al disclose the injector of claim 1, wherein the distal end of the cannula is beveled (see figs 7A-B, para 0010).
Regarding claim 5, Novakovic et al disclose the injector of claim 1, wherein the push rod (108) is attached to a shuttle body (136) that is slidingly disposed within the housing (see fig 24 and para 0130) and the shuttle body is coupled to a spring (134, para 0150), the spring including a non-extended configuration (see fig 17A-C) and an extended configuration (see fig 21A) and being biased to the non-extended configuration (para 0147, see fig 24).
Regarding claim 6, Novakovic et al disclose the injector of claim 5, wherein the spring is coiled in the non-extended configuration (see fig 24, para 0150).
Regarding claim 7, Novakovic et al disclose the injector of claim 5, wherein the actuator in a non-deployed position holds the shuttle body such that the spring is in the extended configuration (see fig 21A-B, translation movement of releaser 136 is allowed until it is stopped by rail 138 making spring 134 in extended position, see para 0160).
Regarding claim 8, Novakovic et al disclose the injector of claim 7, wherein actuation of the actuator from the non-deployed position to a deployed position releases the shuttle body and permits the spring to resume the non-extended configuration (see fig 17A-B, rail 138 is released upward and spring 134 is non-extended configuration).
Regarding claim 9, Novakovic et al disclose the injector of claim 8, wherein when the actuator is in the non-deployed position, the actuator contacts and engages the shuttle body (see fig 21A-B, actuator 64 contact releaser 136 via rail 138) and when the actuator is in the deployed position, the actuator does not contact the shuttle body and is disengaged therefrom (see figs 17A-B, rail 138 disengages with said actuator 64).
Regarding claim 12, Novakovic et al disclose the injector of claim 1, wherein the injector further includes a magazine tube (84) disposed in the housing (figs 7A-B), the magazine tube defining at least a portion of the lumen (lumen of 84), and wherein the cannula (56) defines at least a portion of the lumen (lumen of 56), and wherein the cannula and the magazine tube are coaxially aligned and a transition gap extends between an outlet of the magazine tube and an inlet of the cannula (figs 7A, there is a space between the outlet of holder 84 and inlet 62 of cannula 62).
Regarding claim 13, Novakovic et al disclose the injector of claim 12, wherein a portion of the gate (106) is disposed within the transition gap when the gate is in the closed configuration (see fig 7A) and wherein the portion of the gate is not disposed within the transition gap when the gate is in the open configuration (see fig 7B, gate 106 is opened thus a portion is inside 84 which is not in the space between the outlet of holder 84 and inlet 62 of cannula 62).
Regarding claim 14, Novakovic et al disclose the injector of claim 1, wherein the housing includes a window (86) formed thereon to permit visual feedback relating to the translation of the pushrod (see para 0129 and fig 1A-B).
Regarding claim 15, Novakovic et al disclose the injector of claim 14, wherein the push rod (108) is attached to a shuttle body (136) that is slidingly disposed within the housing (see fig 6) and an outer surface of the shuttle body includes a status indicator (fig 14A, red indicator) thereon for providing the visual feedback through the window (para 0130, See figs 14A-B).
Regarding claim 20, Novakovic et al disclose the injector of claim 1, further comprising the at least one implant (68).
Regarding claim 25, Novakovic et al disclose method of using an injector (40, see fig 1A) to deliver at least one implant (68) into an eye (see fig 29, para 0008), the method comprising: positioning the injector near the eye (see fig 29), the injector including a housing (40), a push rod (108), a lumen (lumen of 84 and 56) defined within the housing (see fig 7A) and having the least one implant (68) therein, the lumen configured to slidingly receive the push rod and at least one implant (68) therein (para 0144 and fig 7A-B), the magazine tube having the at least one implant disposed therein (implant 68), a gate (106) in a closed configuration in which it prevents passage of the at least one implant in a distal direction through the lumen (fig 7A and para 0136), a cannula (56), and an actuator (64); inserting a distal end of the cannula into tissue of the eye (para 0017-20, see fig 29); and actuating the actuator to deliver the at least one implant into the tissue of the eye (para 0118), wherein actuation of the actuator moves the gate from the closed configuration to an open configuration in which the gate does not prevent passage of the at least one implant through the lumen in the distal direction (see fig 7B and para 0136 and 0139) and wherein actuation of the actuator also causes translation of the pushrod through the lumen to push the at least one implant (para 0118, 0139, 0157, 0162), and wherein the push rod (108) is configured to distally advance the at least one implant through the lumen only after the actuator moves the gate from the closed configuration to the open configuration (para 0136 and 162, fig 7B).
Regarding claim 26, Novakovic et al disclose the method of claim 25, wherein the at least one implant includes exactly three implants (see para 0140- some embodiments the implant holder is loaded with two or more rod-shaped, drug-containing, intraocular implants and 0171, thus the injector can hold exactly three implants if intended).
Regarding claim 27, Novakovic et al disclose the method of claim 25, wherein the tissue of the eye includes a vitreous of the eye (para 0098-99).
Regarding claim 28, Novakovic et al disclose the method of claim 25, wherein the injector further includes a magazine tube (84) disposed in the housing (figs 7A-B), the magazine tube defining at least a portion of the lumen (lumen of 84), and wherein the cannula (56) defines at least a portion of the lumen (lumen of 56), and wherein a lumen of the cannula is in fluid communication with the lumen of the magazine tube when the gate is in the open configuration (see figs 7A-B, para 0139).
Regarding claim 59, Novakovic et al disclose the injector of claim 1, wherein the cannula (56) defines at least a portion of the lumen (see figs 7A-B).
Regarding claim 60, Novakovic et al disclose the injector of claim 59, wherein the injector (40) further includes a magazine tube (84) disposed in the housing (40) and wherein the magazine tube defines at least a portion of the lumen (figs 7A-B).
Regarding claim 61, Novakovic et al disclose the injector of claim 60, wherein the gate (106) in the closed configuration covers an outlet of the magazine tube (fig 7A), the gate in the open configuration does not cover the outlet of the magazine tube (fig 7B), and wherein the cannula is in fluid communication with the magazine tube when the gate is in the open configuration (see fig 7B, para 0139).
Regarding claim 69, Novakovic et al disclose the injector of claim 20, wherein the at least one implant comprises an API selected from the following group: a tyrosine kinase inhibitor, a VEGF inhibitor, a VE-PTP inhibitor, an Ang-1 inhibitor, an ang-2 inhibitor, a Tie-2 activator, a steroidal anti-inflammatory agent, a prostaglandin, a prostaglandin analog, a prostaglandin agonist, an alpha-2 adrenergic receptor agonist, a beta-blocker, a carbonic anhydrase inhibitor (CAI), a non-steroidal anti-inflammatory drug (NSAID), a COX-2 inhibitor, a rho khinase inhibitor, a neuroprotectant, an antibiotic, an antibacterial agent, a compliment inhibitor, an anesthetic agent, and an analgesic agent (para 0174).
Regarding claim 70, Novakovic et al disclose the injector of claim 20, wherein the at least one implant comprises an API selected from the following group: alitretinoin, rebastinib, afatinib, alectinib, apatinib, ASP-3026, axitinib, bafetinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, canertinib, cediranib, CEP- 11981, CEP-37440, ceritinib, cobimetinib, copanlisib, crenolanib, crizotinib, CYT387, dabrafenib, damnacanthal, dasatinib, doramapimod, enterctinib, erlotinib, everolimus, filgotinib, foretinib, fostamatinib, gefitinib, grandinin, ibrutinib, icotinib, idelalisib, imatinib, IPI-145, JSI-124, lapatinib, lenvatinib, lestaurtinib, linifanib, masitinib, motesanib, mubritinib, neratinib, nilotinib, nintedanib, pacritinib, palbociclib, pazopanib, pegaptanib, perifosine, pexmetinib, PF-06463922, ponatinib, PX-866, quizartinib, radotinib, razuprotafib, regorafenib, ruxolitinib, selumetinib, semaxanib, sirolimus, sorafenib, sorafenib tosylate, staurosporine, sunitinib, sunitinib malate, SU6656, temsirolimus, TG101348, tivozanib, toceranib, tofacitinib, trametinib, TSR-011, vandetanib, vatalanib, vemurafenib, vorolanib, X-396, fluocinolone acetonide, hydrocortisone, hydrocortisone acetate, triamcinolone acetonide, methylprednisolone, dexamethasone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, bimatoprost, latanoprost, latanoprostene bunod, tafluprost, travoprost, brimonidine, brimonidine tartrate, brimonidine pamoate, timolol, acetazolamide, brinzolamide, dorzolamide, methazolamide, netarsudil, diclofenac, etoldolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indoprofen, ketoprofen, ketorolac, lomoxicam, morazone, naproxen, perisoxal, pirprofen, pranoprofen, suprofen, suxibuzone, tropesin, ximoprofen, zaltoprofen, zileuton, zomepirac, valdecoxib, rofecoxib, celecoxib, nimodipine, tetracycline, chlortetracycline, bacitracin, neomycin, polyrnyxin, gramicidin, oxytetracycline, chloramphenicol, gentamycin, erythromycin, sulfonamide, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate, lidocaine, and pharmaceutically acceptable salts, esters, prodrugs or codrugs, thereof (para 0175-176).
Regarding claim 72, Novakovic et al disclose the injector of claim 20, wherein the at least one implant comprises vorolanib, axitinib, razuprotafib, or pharmaceutically acceptable salt, ester, prodrug, or codrug, thereof (para 0175-176).
Regarding claim 76, Novakovic et al disclose the method of claim 25, wherein the at least one implant comprises an API selected from the following group: a tyrosine kinase inhibitor, a VEGF inhibitor, a VE-PTP inhibitor, an Ang-1 inhibitor, an ang-2 inhibitor, a Tie-2 activator, a steroidal anti-inflammatory agent, a prostaglandin, a prostaglandin analog, a prostaglandin agonist, an alpha-2 adrenergic receptor agonist, a beta-blocker, a carbonic anhydrase inhibitor (CAI), a non-steroidal anti-inflammatory drug (NSAID), a COX-2 inhibitor, a rho khinase inhibitor, a neuroprotectant, an antibiotic, an antibacterial agent, a compliment inhibitor, an anesthetic agent, and an analgesic agent (para 0174).
Regarding claim 77, Novakovic et al disclose the method of claim 25, wherein the at least one implant comprises an API selected from the following group: altiratinib, rebastinib, afatinib, alectinib, apatinib, ASP-3026, axitinib, bafetinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, canertinib, cediranib, CEP- 11981, CEP-37440, ceritinib, cobimetinib, copanlisib, crenolanib, crizotinib, CYT387, dabrafenib, damnacanthal, dasatinib, doramapimod, enterctinib, erlotinib, everolimus, filgotinib, foretinib, fostamatinib, gefitinib, grandinin, ibrutinib, icotinib, idelalisib, imatinib, IPI-145, JSI-124, lapatinib, lenvatinib, lestaurtinib, linifanib, masitinib, motesanib, mubritinib, neratinib, nilotinib, nintedanib, pacritinib, palbociclib, pazopanib, pegaptanib, perifosine, pexmetinib, PF-06463922, ponatinib, PX-866, quizartinib, radotinib, razuprotafib, regorafenib, ruxolitinib, selumetinib, semaxanib, sirolimus, sorafenib, sorafenib tosylate, staurosporine, sunitinib, sunitinib malate, SU6656, temsirolimus, TG101348, tivozanib, toceranib, tofacitinib, trametinib, TSR-011, vandetanib, vatalanib, vemurafenib, vorolanib, X-396, fluocinolone acetonide, hydrocortisone, hydrocortisone acetate, triamcinolone acetonide, methylprednisolone, dexamethasone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate,fluoromethalone, betamethasone, bimatoprost, latanoprost, latanoprostene bunod, tafluprost, travoprost, brimonidine, brimonidine tartrate, brimonidine pamoate, timolol, acetazolamide, brinzolamide, dorzolamide, methazolamide, netarsudil, diclofenac, etoldolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indoprofen, ketoprofen, ketorolac, lomoxicam, morazone, naproxen, perisoxal, pirprofen, pranoprofen, suprofen, suxibuzone, tropesin, ximoprofen, zaltoprofen, zileuton, zomepirac, valdecoxib, rofecoxib, celecoxib, nimodipine, tetracycline, chlortetracycline, bacitracin, neomycin, polyrnyxin, gramicidin, oxytetracycline, chloramphenicol, gentamycin, erythromycin, sulfonamide, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate, lidocaine, and pharmaceutically acceptable salts, esters, prodrugs or codrugs, thereof (para 0175-176).
Regarding claim 79, Novakovic et al disclose the method of claim 25, wherein the at least one implant comprises vorolanib, axitinib, razuprotafib, or pharmaceutically acceptable salt, ester, prodrug, or codrug, thereof (para 0175-0176).
Regarding claim 83, Novakovic et al disclose the method of claim 77, wherein the at least one implant is administered for the treatment or prevention of an ocular condition or disease of the eye in an eye in need thereof (para 0109-0111).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Crawford (US 20160303352 A1).
Regarding claim 2, Novakovic et al disclose the injector of claim 1, further comprising a safety cap (44) that is configured to be removably coupled to the housing to cover the distal end of the cannula when the safety cap is coupled to the housing (see fig 1A, para 0115), wherein the safety cap includes a tab (finger 90).
Novakovic et al fail to teach said tab extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator.
However, Crawford discloses a needle safety shield (see fig 1) comprising a safety cap (18) that extends into a slot (34) formed in an actuator (44) when the safety cap is coupled to the device to prevent actuation of the actuator (see figs 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Crawford to have said tab extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator. The modification would provide the benefit of having a better and secured engagement between said injector and safety cap until it is actuated by an user (para 0075).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Coleman et al (US 20150142048 A1).
Regarding claim 10, Novakovic et al disclose the limitations of claims 1 and 8 but fail to teach the actuator is configured to rotate relative to the shuttle body to transition between the non-deployed position and the deployed position.
However, Coleman et al teach an actuator to deploy an implant (see fig 2) comprises an actuator (lever 130) and body (ring 128, see fig 8B) wherein the actuator is configured to rotate relative to the body to transition between the non-deployed position and the deployed position (para 0120, see fig 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Coleman et al to have the actuator is configured to rotate relative to the shuttle body to transition between the non-deployed position and the deployed position. This would provide the benefit of holding said actuator into locked configuration until actuating by user which enables rotation of said actuator into deployed position to inject said implant for said injector (see para 0120).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Nazzaro et al (US 8790293 B2).
Regarding claim 19, Novakovic et al disclose the limitations of claim 1 but fail to teach the push rod is formed from stainless steel.
However, Nazzaro et al disclose push rod (56) is formed from stainless steel (col 5, lines 66-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the push rod of Novakovic et al and incorporate the teachings of Nazzaro et al to have said push rod formed from stainless steel. This would provide the benefit of having a rigid material so that it can eject an implant from the cannula needle (see col 6, lines 1-2).
Claims 40-43, 45-52, 55, 86, 87, 89, 93, 94, 96 and 100 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Painchaud et al (US 20190321615 A1).
Regarding claim 40, Novakovic et al disclose an injector (40) comprising: a housing (42) including a window (86) formed thereon (fig 3); a push rod (108) disposed at least partially within the housing (see fig 6); wherein the push rod (108) is attached to a shuttle body (136) that is slidingly disposed within the housing (figs 17A-C) and an outer surface of the shuttle body includes a status indicator thereon (fig 14A-B, red indicator, para 0130); a lumen (lumen of 84 and 56) defined within the housing (figs 7A-B), the lumen configured to slidingly receive the push rod and at least one implant therein (para 0144 and fig 7A-B); a gate (106) disposed within the housing (figs 7A-B), wherein the gate (106) has a closed configuration in which it prevents passage of the at least one implant in a distal direction through the lumen (fig 7A and para 0136) and an open configuration in which it does not prevent passage of the at least one implant through the lumen in the distal direction (see fig 7B and para 0136 and 0139); a cannula (56) having a distal end that is disposed outside of the housing (see figs 7A-B) and is configured to be inserted into an eye (para 0017-20, see fig 29), and an actuator (64), wherein actuation of the actuator causes translation of the pushrod through the lumen and moves the gate from the closed configuration to the open configuration (para 0118, 0139, 0157, 0162, see fig 7B), wherein, via the status indicator on the shuttle body, the window (86) permits visual feedback of translation of the pushrod through the housing, the visual feedback providing an indication that delivery of the at least one implant is complete (para 0129-30).
Novakovic et al fail to teach the push rod is fixedly attached to the shuttle body but disclose since the distal end of release lever 136 is sized so that it cannot slide over push rod conveyor 116, it must instead push against conveyor 116 when the release lever is forced forward (para 0149).
However, Painchaud et al disclose an injector (10) comprising a shuttle body (54) and a push rod (52) wherein the push rod is fixedly attached to the shuttle body (figs 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al to have the push rod fixedly attached to the shuttle body. This would provide the benefit of having no intermediary element that could resist the pushing force between said shuttle body and push rod during ejection of implant (para 0080).
Regarding claim 41, Novakovic et al in view of Painchaud et al disclose the injector of claim 40,
Novakovic et al further disclose wherein the injector further includes a magazine tube (84) disposed in the housing (figs 7A-B), the magazine tube defining at least a portion of the lumen (lumen of 84), and wherein the cannula (56) defines at least a portion of the lumen (lumen of 56), and wherein the cannula is in fluid communication with the magazine tube when the gate is in the open configuration (see figs 7A-B, para 0139).
Regarding claim 42, Novakovic et al in view of Painchaud et al disclose the injector of claim 41,
Novakovic et al further disclose wherein the cannula (56) and the magazine tube (84) are coaxially aligned and a transition gap extends between an outlet of the magazine tube and an inlet of the cannula (see fig 7A, there is a space between the outlet of holder 84 and inlet 62 of cannula 62).
Regarding claim 43, Novakovic et al in view of Painchaud et al disclose the injector of claim 42,
Novakovic et al further disclose wherein a portion of the gate (membrane 106) is disposed within the transition gap when the gate is in the closed configuration (see fig 7A) and wherein the portion of the gate is not disposed within the transition gap when the gate is in the open configuration (see fig 7B, gate 106 is opened thus a portion is inside 84 which is not in the space between the outlet of holder 84 and inlet 62 of cannula 62).
Regarding claim 45, Novakovic et al disclose in view of Painchaud et al disclose the injector of claim 40,
Novakovic et al further disclose wherein the at least one status indicator includes a first status indicator and a second status indicator, the first status indicator being disposed proximal to the second status indicator, and wherein the first status indicator is displayed through the window prior to actuation of the actuator and the second status indicator is displayed through the window when the delivery of the at least one implant is complete (see para 0130- two discrete sections along the lateral edge of release lever 136 can be labeled with two different colors, patterns, and/or text symbols).
Regarding claim 46, Novakovic et al in view of Painchaud et al disclose the injector of claim 45,
Novakovic et al further disclose wherein the at least one status indicator further includes a third status indicator disposed between the first status indicator and the second status indicator, and wherein the second status indicator is disposed through the window while the shuttle body is moving within the housing (para 0130- release lever may, optionally, be further labeled with text to clearly indicate when this region of the release lever slides into view of the delivery feedback window following activation of the apparatus).
Regarding claim 47, Novakovic et al in view of Painchaud et al disclose the injector of claim 46,
Novakovic et al further disclose wherein the first status indicator is a first color, the second status indicator is a second color, and the third status indicator is a third color (para 0130).
Regarding claim 48, Novakovic et al in view of Painchaud et al disclose the injector of claim 40,
Novakovic et al further disclose further comprising the at least one implant (68).
Regarding claim 49, Novakovic et al disclose method of using an injector (40, see fig 1A) to deliver at least one implant (68) into an eye (see fig 29), the method comprising: positioning a distal tip (tip of cannula 56) of the injector adjacent to an injection site of the eye (see fig 29), the injector (40) including a housing (42) including a window (86) formed thereon (fig 3, a push rod (108), a lumen (lumen of 84 and 56) defined within the housing (figs 7A-B) and having the at least one implant disposed therein (68, fig 7A), the lumen configured to slidingly receive the push rod and at least one implant therein (para 0144 and fig 7A-B), a gate (106) disposed within the housing (figs 7A-B), wherein the gate (106) has a closed configuration in which it prevents passage of the at least one implant in a distal direction through the lumen (fig 7A and para 0136), a cannula (56), and an actuator (64) and status indicator (para 0130), wherein the push rod (108) is attached to a shuttle body (136) that is slidingly disposed within the housing (figs 17A-C) and an outer surface of the shuttle body includes the status indicator thereon (fig 14A-B, red indicator, para 0130); advancing a distal end of the injector into tissue of the eye at the injection site (para 0017-20, see fig 29); actuating the actuator to deliver the at least one implant into the tissue of the eye (para 0118), wherein actuation of the actuator moves the gate from the closed configuration to an open configuration in which the gate does not prevent passage of the at least one implant through the lumen in the distal direction (see fig 7B and para 0136 and 0139) and wherein actuation of the actuator also causes translation of the pushrod through the lumen to push the at least one implant (para 0118, 0139, 0157, 0162), maintaining the position of the distal end of the injector within the tissue of the eye until the status indicator of the injector indicates completion of implant delivery, wherein, via the status indicator on the shuttle body, the window (86) permits visual feedback of translation of the pushrod through the housing (para 0129-0130); and removing the injector from the tissue of the eye after the status indicator of the injector indicates completion of implant delivery (para 0130 and 0170).
Novakovic et al fail to teach the push rod is fixedly attached to the shuttle body but disclose since the distal end of release lever 136 is sized so that it cannot slide over push rod conveyor 116, it must instead push against conveyor 116 when the release lever is forced forward (para 0149).
However, Painchaud et al disclose an injector (10) comprising a shuttle body (54) and a push rod (52) wherein the push rod is fixedly attached to the shuttle body (figs 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al to have the push rod fixedly attached to the shuttle body. This would provide the benefit of having no intermediary element that could resist the pushing force between said shuttle body and push rod during ejection of implant (para 0080).
Regarding claim 50, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the at least one implant includes exactly three implants (see para 0140- some embodiments the implant holder is loaded with two or more rod-shaped, drug-containing, intraocular implants and 0171, thus the injector can hold exactly three implants if intended).
Regarding claim 51, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further wherein the at least one implant is used to treat chronic non- infectious uveitis affecting the posterior segment of the eye in an eye in need thereof (para 0182).
Regarding claim 52, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the tissue of the eye includes a vitreous of the eye (para 0182).
Regarding claim 55, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the at least one implant is used to treat a retinal disease in an eye in need thereof (para 0098 and 0182).
Regarding claim 86, Novakovic et al in view of Painchaud et al disclose the injector of claim 48,
Novakovic et al further disclose wherein the at least one implant comprises an API selected from the following group: a tyrosine kinase inhibitor, a VEGF inhibitor, a VE-PTP inhibitor, an Ang-1 inhibitor, an ang-2 inhibitor, a Tie-2 activator, a steroidal anti-inflammatory agent, a prostaglandin, a prostaglandin analog, a prostaglandin agonist, an alpha-2 adrenergic receptor agonist, a beta-blocker, a carbonic anhydrase inhibitor (CAI), a non-steroidal anti-inflammatory drug (NSAID), a COX-2 inhibitor, a rho khinase inhibitor, a neuroprotectant, an antibiotic, an antibacterial agent, a compliment inhibitor, an anesthetic agent, and an analgesic agent (para 0174).
Regarding claim 87, Novakovic et al in view of Painchaud et al disclose the injector of claim 48,
Novakovic et al further disclose wherein the at least one implant comprises an API selected from the following group: altiratinib, rebastinib, afatinib, alectinib, apatinib, ASP-3026, axitinib, bafetinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, canertinib, cediranib, CEP- 11981, CEP-37440, ceritinib, cobimetinib, copanlisib, crenolanib, crizotinib, CYT387, dabrafenib, damnacanthal, dasatinib, doramapimod, enterctinib, erlotinib, everolimus, filgotinib, foretinib, fostamatinib, gefitinib, grandinin, ibrutinib, icotinib, idelalisib, imatinib, IPI-145, JSI-124, lapatinib, lenvatinib, lestaurtinib, linifanib, masitinib, motesanib, mubritinib, neratinib, nilotinib, nintedanib, pacritinib, palbociclib, pazopanib, pegaptanib, perifosine, pexmetinib, PF-06463922, ponatinib, PX-866, quizartinib, radotinib, razuprotafib, regorafenib, ruxolitinib, selumetinib, semaxanib, sirolimus, sorafenib, sorafenib tosylate, staurosporine, sunitinib, sunitinib malate, SU6656, temsirolimus, TG101348, tivozanib, toceranib, tofacitinib, trametinib, TSR-011, vandetanib, vatalanib, vemurafenib, vorolanib, X-396, fluocinolone acetonide, hydrocortisone, hydrocortisone acetate, triamcinolone acetonide, methylprednisolone, dexamethasone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, bimatoprost, latanoprost, latanoprostene bunod, tafluprost,travoprost, brimonidine, brimonidine tartrate, brimonidine pamoate, timolol, acetazolamide, brinzolamide, dorzolamide, methazolamide, netarsudil, diclofenac, etoldolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indoprofen, ketoprofen, ketorolac, lomoxicam, morazone, naproxen, perisoxal, pirprofen, pranoprofen, suprofen, suxibuzone, tropesin, ximoprofen, zaltoprofen, zileuton, zomepirac, valdecoxib, rofecoxib, celecoxib, nimodipine, tetracycline, chlortetracycline, bacitracin, neomycin, polyrnyxin, gramicidin, oxytetracycline, chloramphenicol, gentamycin, erythromycin, sulfonamide, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate, lidocaine, and pharmaceutically acceptable salts, esters, prodrugs or codrugs, thereof (para 0175-176).
Regarding claim 89, Novakovic et al in view of Painchaud et al disclose the injector of claim 48,
Novakovic et al further disclose wherein the at least one implant comprises vorolanib, axitinib, razuprotafib, or pharmaceutically acceptable salt, ester, prodrug, or codrug, thereof (para 0175-0176).
Regarding claim 93, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the at least one implant comprises an API selected from the following group: a tyrosine kinase inhibitor, a VEGF inhibitor, a VE-PTP inhibitor, an Ang-1 inhibitor, an ang-2 inhibitor, a Tie-2 activator, a steroidal anti-inflammatory agent, a prostaglandin, a prostaglandin analog, a prostaglandin agonist, an alpha-2 adrenergic receptor agonist, a beta-blocker, a carbonic anhydrase inhibitor (CAI), a non-steroidal anti-inflammatorydrug (NSAID), a COX-2 inhibitor, a rho khinase inhibitor, a neuroprotectant, an antibiotic, an antibacterial agent, a compliment inhibitor, an anesthetic agent, and an analgesic agent (para 0174).
Regarding claim 94, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the at least one implant comprises an API selected from the following group: altiratinib, rebastinib, afatinib, alectinib, apatinib, ASP-3026, axitinib, bafetinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, canertinib, cediranib, CEP- 11981, CEP-37440, ceritinib, cobimetinib, copanlisib, crenolanib, crizotinib, CYT387, dabrafenib, damnacanthal, dasatinib, doramapimod, enterctinib, erlotinib, everolimus, filgotinib, foretinib, fostamatinib, gefitinib, grandinin, ibrutinib, icotinib, idelalisib, imatinib, IPI-145, JSI-124, lapatinib, lenvatinib, lestaurtinib, linifanib, masitinib, motesanib, mubritinib, neratinib, nilotinib, nintedanib, pacritinib, palbociclib, pazopanib, pegaptanib, perifosine, pexmetinib, PF-06463922, ponatinib, PX-866, quizartinib, radotinib, razuprotafib, regorafenib, ruxolitinib, selumetinib, semaxanib, sirolimus, sorafenib, sorafenib tosylate, staurosporine, sunitinib, sunitinib malate, SU6656, temsirolimus, TG101348, tivozanib, toceranib, tofacitinib, trametinib, TSR-011, vandetanib, vatalanib, vemurafenib, vorolanib, X-396, fluocinolone acetonide, hydrocortisone, hydrocortisone acetate, triamcinolone acetonide, methylprednisolone, dexamethasone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, bimatoprost, latanoprost, latanoprostene bunod, tafluprost, travoprost, brimonidine, brimonidine tartrate, brimonidine pamoate, timolol, acetazolamide, brinzolamide, dorzolamide, methazolamide, netarsudil, diclofenac, etoldolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indoprofen, ketoprofen, ketorolac, lomoxicam, morazone, naproxen, perisoxal, pirprofen, pranoprofen, suprofen, suxibuzone, tropesin, ximoprofen, zaltoprofen, zileuton, zomepirac, valdecoxib, rofecoxib, celecoxib, nimodipine, tetracycline, chlortetracycline, bacitracin, neomycin, polyrnyxin, gramicidin, oxytetracycline, chloramphenicol, gentamycin, erythromycin, sulfonamide, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, sodium propionate, lidocaine, and pharmaceutically acceptable salts, esters, prodrugs or codrugs, thereof (para 0175-176).
Regarding claim 96, Novakovic et al in view of Painchaud et al disclose the method of claim 49,
Novakovic et al further disclose wherein the at least one implant comprises vorolanib, axitinib, razuprotafib, or pharmaceutically acceptable salt, ester, prodrug, or codrug, thereof (para 0175-0176).
Regarding claim 100, Novakovic et al in view of Painchaud et al disclose the method of claim 94,
Novakovic et al further disclose wherein the at least one implant is administered for the treatment or prevention of an ocular condition or disease of the eye in an eye in need thereof (para 0109-0111).
Claims 53, 54 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Painchaud et al (US 20190321615 A1) and further in view of Robinson et al (US 20140341966 A1).
Regarding claim 53, Novakovic et al in view of Painchaud et al disclose the limitations of claim 49 but fail to teach the implant is an intravitreal implant comprising about 0.18 mg fluocinolone acetonide.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the implant is an intravitreal implant comprising fluocinolone acetonide (para 0024).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Novakovic et al in view of Painchaud et al and incorporate the teachings of Robinson et al to have an intravitreal implant comprising fluocinolone acetonide which is used for its anti-inflammatory, anti-pruritic, and vasoconstrictive properties for treating diabetic macular edema (DME) and chronic non-infectious uveitis affecting the back of the eye (see para 0024 and 0079).
Novakovic et al in view of Painchaud et al and Robinson et al fail to teach an intravitreal implant comprising about 0.18 mg fluocinolone acetonide.
However, Robinson et al teach intravitreal placement of 0.59 mg fluocinolone acetonide (para 0061).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the intravitreal implant of Robinson et al by making the intravitreal implant comprising about 0.18 mg fluocinolone acetonide as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 54, Novakovic et al in view of Painchaud et al and Robinson et al disclose the method of claim 53,
Robinson et al further disclose the implant also comprises polyvinyl alcohol, silicone adhesive, a polyimide tube and may comprise water (para 0004 and 0116).
Regarding claim 56, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 55 but fail to teach wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion (para 0079 and 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al in view of Painchaud et al and incorporate the teachings of Robinson et al to have the retinal disease selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion to use said injector to avoid vison loss or blindness of the eye (see para 0079).
Claims 57 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Painchaud et al (US 20190321615 A1) and further in view of Kurisawa et al (US 20240390503 A1).
Regarding claim 57, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 55 but fail to teach wherein the implant is an intravitreal implant comprises about 400 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises vorolanib (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have an intravitreal implant comprises vorolanib which has been shown to improve the visual acuity of AMD patients who completed treatment (see para 0006).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach an intravitreal implant comprises about 400 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose participants had to discontinue the treatment due to severe systemic adverse effects caused by high oral dosages.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Novakovic et al in view of Painchaud et al to have an intravitreal implant comprises about 400 pg to about 2800 pg vorolanib. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the method of Novakovic et al would not operate differently with an intravitreal implant comprises about 400 pg to about 2800 pg vorolanib. Further, applicant places no criticality on the range claimed, indicating simply that an intravitreal implant comprises about 400 pg to about 2800 pg vorolanib. (specification pp. [00147]).
Regarding claim 58, Novakovic et al in view of Painchaud et al and Kurisawa et al disclose the method of claim 57,
Kurisawa et al further disclose the implant also comprises polyvinyl alcohol (para 0056).
Claims 71, 73, 74, 75, 78, and 80-82 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Kurisawa et al (US 20240390503 A1).
Regarding claim 71, Novakovic et al disclose the limitations of claims 1, 20 and 70 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 73, Novakovic et al disclose the limitations of claims 1, 20 and 72 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 74, Novakovic et al disclose the limitations of claims 1 and 20 but fail to teach wherein the implant is an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises vorolanib (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have an intravitreal implant comprises vorolanib which has been shown to improve the visual acuity of AMD patients who completed treatment (see para 0006).
Novakovic et al and Kurisawa et al fail to teach an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose participants had to discontinue the treatment due to severe systemic adverse effects caused by high oral dosages.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the injector of Novakovic et al to have an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the method of Novakovic et al would not operate differently with an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. Further, applicant places no criticality on the range claimed, indicating simply that an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. (specification pp. [00147]).
Regarding claim 75, Novakovic et al in view of Kurisawa et al disclose the injector of claim 74,
Kurisawa et al further disclose the implant also comprises polyvinyl alcohol (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 78, Novakovic et al disclose the limitations of claims 25 and 77 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 80, Novakovic et al disclose the limitations of claims 25 and 79 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 81, Novakovic et al disclose the limitations of claim 25 but fail to teach wherein the implant is an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises vorolanib (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al and incorporate the teachings of Kurisawa et al to have an intravitreal implant comprises vorolanib which has been shown to improve the visual acuity of AMD patients who completed treatment (see para 0006).
Novakovic et al and Kurisawa et al fail to teach an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose participants had to discontinue the treatment due to severe systemic adverse effects caused by high oral dosages.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Novakovic et al to have an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the method of Novakovic et al would not operate differently with an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. Further, applicant places no criticality on the range claimed, indicating simply that an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib (specification pp. [00147]).
Regarding claim 82, Novakovic et al disclose the limitations of claims 25 and 81 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 84 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Robinson et al (US 20140341966 A1).
Regarding claim 84, Novakovic et al disclose the limitations of claims 25 and 79 but fail to teach wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion (para 0079 and 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al and incorporate the teachings of Robinson et al to have the retinal disease selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion to use said injector to avoid vison loss or blindness of the eye (see para 0079).
Regarding claim 85, Novakovic et al disclose the limitations of claims 25 and 81 but fail to teach wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion (para 0079 and 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al and incorporate the teachings of Robinson et al to have the retinal disease selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion to use said injector to avoid vison loss or blindness of the eye (see para 0079).
Claims 88, 90, 91, 92, 95, 97, 98, 99 and 101 are rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view of Painchaud et al (US 20190321615 A1) and further in view of Kurisawa et al (US 20240390503 A1).
Regarding claim 88, Novakovic et al in view of Painchaud et al disclose the limitations of claims 40, 48 and 87 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al in view of Painchaud et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 90, Novakovic et al in view of Painchaud et al disclose the limitations of claims 40, 48 and 89 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al in view of Painchaud et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 91, Novakovic et al in view of Painchaud et al disclose the limitations of claims 40 and 48 but fail to teach wherein the implant is an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises vorolanib (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have an intravitreal implant comprises vorolanib which has been shown to improve the visual acuity of AMD patients who completed treatment (see para 0006).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose participants had to discontinue the treatment due to severe systemic adverse effects caused by high oral dosages.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the injector of Novakovic et al in view of Painchaud et al to have an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the injector of Novakovic et al would not operate differently with an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. Further, applicant places no criticality on the range claimed, indicating simply that an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. (specification pp. [00147]).
Regarding claim 92, Novakovic et al in view of Painchaud et al disclose the limitations of claims 40, 48 and 91 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 95, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 94 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al in view of Painchaud et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 97, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 96 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al in view of Painchaud et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 98, Novakovic et al in view of Painchaud et al disclose the limitations of claim 49 but fail to teach wherein the implant is an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises vorolanib (para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have an intravitreal implant comprises vorolanib which has been shown to improve the visual acuity of AMD patients who completed treatment (see para 0006).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib.
However, Kurisawa et al disclose participants had to discontinue the treatment due to severe systemic adverse effects caused by high oral dosages.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Novakovic et al in view of Painchaud et al to have an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the method of Novakovic et al would not operate differently with an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib. Further, applicant places no criticality on the range claimed, indicating simply that an intravitreal implant comprises about 100 pg to about 2800 pg vorolanib (specification pp. [00147]).
Regarding claim 99, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 98 but fail to teach wherein the at least one implant further comprises polyvinyl alcohol and the at least one implant has a length of about 3 mm to about 10 mm.
However, Kurisawa et al disclose an eye disease treatment (abstract) wherein the implant is an intravitreal implant comprises polyvinyl alcohol (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector of Novakovic et al in view of Painchaud et al and incorporate the teachings of Kurisawa et al to have the intravitreal implant comprises polyvinyl alcohol. This would provide the benefit of having a biocompatible flexible polymer for controlled and long-term drug delivery (para 0056).
Novakovic et al in view of Painchaud et al and Kurisawa et al fail to teach the at least one implant has a length of about 3 mm to about 10 mm.
However, Novakovic et al disclose a rod-shaped intracameral implant can be 0.5 mm to 3 mm in length (para 0100).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the injector of Novakovic et al in view of Painchaud et al by making the length of the at least one implant of about 3 mm to about 10 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 101, Novakovic et al in view of Painchaud et al disclose the limitations of claims 49 and 96 but fail to teach wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion (para 0079 and 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al and incorporate the teachings of Robinson et al to have the retinal disease selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion to use said injector to avoid vison loss or blindness of the eye (see para 0079).
Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over Novakovic et al (US 20150238687 A1) in view Painchaud et al (US 20190321615 A1) and Kurisawa et al (US 20240390503 A1) and further in view of in view of Robinson et al (US 20140341966 A1).
Regarding claim 102, Novakovic et al in view of Kurisawa et al disclose the limitations of claims 49 and 98 but fail to teach wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion.
However, Robinson et al disclose devices and methods to treat an eye of a patient (para 0002) wherein the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion (para 0079 and 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Novakovic et al in view of Kurisawa et al and incorporate the teachings of Robinson et al to have the retinal disease selected from wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion to use said injector to avoid vison loss or blindness of the eye (see para 0079).
Allowable Subject Matter
Claims 103-118 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 103, Novakovic et al disclose an injector (40) comprising: a housing (42); a push rod (108) disposed at least partially within the housing (figs 7A-B); at least one tubular component (84) defining a lumen (lumen of 84), the lumen configured to slidingly receive at least one implant (68) therein and slidingly receive the push rod therein (para 0144 and fig 7A-B), wherein the at least one tubular component (84) is fixedly secured to the housing (fig 7A)); a gate (106) disposed within the housing (figs 7A-B), wherein the gate (106) has a closed configuration (fig 7A) in which it prevents passage of the at least one implant in a distal direction through the lumen (para 0136) and an open configuration (fig 7B) in which it does not prevent passage of the at least one implant through the lumen in the distal direction (para 0136 and 0139); and an actuator (64), wherein actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the push rod through the lumen (para 0118, 0139, 0157, 0162, see fig 7B), and wherein the at least one implant (68) is disposed within the at least one tubular component prior to actuation of the actuator (fig 7A) and wherein the push rod moves relative to the at least one tubular component upon actuation of the actuator (fig 7B).
Novakovic et al fail to teach/disclose or render obvious “the at least one tubular component does not move relative to the housing during operation of the injector and the actuator being configured to contact the gate to move the gate from the closed configuration to the open configuration” in addition to other limitations.
Claims 104-116 are allowed for incorporating the above limitations due to their respective dependencies on the independent claim 103.
Regarding claim 117, Novakovic et al an injector (40) comprising: a housing (42); a push rod (108) disposed at least partially within the housing (fig 7A); a lumen (lumen of 84) defined within the housing (fig 7A), the lumen configured to slidingly receive the push rod and at least one implant therein (fig 7A-B, para 0144); a gate (106) disposed within the housing (fig 7A), wherein the gate has a closed configuration (fig 7A) in which a distal end surface thereof prevents passage of the at least one implant in a distal direction through the lumen (para 0136) and an open configuration (fig 7B) in which the distal end surface does not prevent passage of the at least one implant through the lumen in the distal direction (para 0136 and 0139); a cannula (56) having a distal end that is disposed outside of the housing and is configured to be inserted into an eye (para 0017-20, see fig 29); and an actuator (64), wherein actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the push rod (para 0118, 0139, 0157, 0162, see fig 7B).
Novakovic et al fail to teach/disclose or render obvious “wherein the gate includes a distal portion having an L-shaped cross-section, the distal portion including an integral bend proximal to the distal end surface, the integral bend being configured to orient the distal end surface along a plane perpendicular to a longitudinal axis of the injector when the gate is in the closed configuration and wherein the actuator is configured to contact the gate to move the gate from the closed configuration to the open configuration” in addition to other limitations.
Claim 118 are allowed for incorporating the above limitations due to their respective dependencies on the independent claim 117.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 62-68 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed on 12/23/2025 have been fully considered but they are not persuasive.
With regards to arguments that the reference cited fail to teach “each of independent claims 1 and 25 is amended herein to recite that the push rod is configured to distally advance the at least one implant through the lumen [of the housing] only after the actuator moves the gate from the closed configuration to the open configuration”. Examiner respectfully disagrees as Novakovic et al discloses said injector holds implant 68 until actuation of actuator 64 for it to move through the lumen of the push rod when the gate 106 is slit or open as discussed above and see fig 7A-B.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 40 and 49 been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Novakovic et al (US 20150238687 A1) in view of Painchaud et al (US 20190321615 A1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783