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 13 February 2026. As directed by the amendment: claims 1-29 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 20-29 remain withdrawn as the invention as described in claims 1-20 is not allowable.
Regarding claims 10 and 11, Makower teaches that the dispensed fluid is a solid at some point during operation of the device and when combined with the solid depot as described by Imran in the updated rejection of claim 1 below would be combinable for the series of depots and the filament type depot. These teachings can be combined with the art of Imran to modify the device of Silverman.
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) 1-9, 12, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of Imran (US 2020/0276426).
Regarding claim 1, Silverman discloses a system for delivering a depot within a submucosal pocket (¶[0089]), the system comprising:
a housing (112) (Fig. 1), including a fluidic connector configured to secure to a fluidic supply (97, 108) (Fig. 1)(where the manifold 98 of the housing has a fluid connector 108 for securing the fluid supply 97, ¶[0057);
an extension (171, 173) (Fig. 1) configured to at least partially collapse within the housing (where slide bar 171 is configured to collapse within the housing and 173 is the coupler, ¶[0057];
a supply conduit (242) (Fig. 1-2, Fig. 14) configured to extend through the housing and the extension (extends through 173 and connector 81, ¶[0108]), the supply conduit (242) configured to deliver a lift solution configured to form a submucosal pocket within a subject (where 242 is configured to deliver a lift agent from syringe 97 to from a submucosal pocket 266/267, ¶[0111]);
a depot conduit (243) (Fig. 1-2, 14) configured to extend through the housing and the extension and to deposit a depot within the submucosal pocket (where the conduit 243 is configured to extend through coupler 173 and connector 81 and 243 is configured to deposit or implant 228 within a submucosal pocket ¶[0111], [0112]); and
wherein when the extension (171, 173) is configured to at least partially collapse within the housing (112), whereby at least one of the supply conduit and the depot conduit advance distally past a distal end of an endoscope (where when the extension 171,173 collapses within the housing, the supply conduit 242 and depot conduit 243 advance distally past a distal end 31b of the endoscope 22, ¶[0044]), [0112]).
Silverman does not specifically teach the depot is a solid or a stylet arranged at least partially in the depot conduit, the stylet configured to advance the solid depot through the depot conduit. Imran teaches a propulsive drug delivery that includes a solid drug being moved from one position to another for delivery to a patient. Specifically, Imran teaches a drug delivery capsule (Fig. 3, 24) including a stylet (Fig. 3, 38, where a stylet is defined as a driving object) for driving a solid depot (Fig. 3, 40, where the drug 40 is a solid) through a cylinder (Fig. 3, 36) into the body of a patient (¶[0051]). By modifying the device of Silverman to include a stylet (Fig. 3, 38 from Imran) configured to advance a solid depot (¶[0051] & [0056] from Imran) through a cylindrical object (Fig. 3, 36 from Imran) it would allow the device of Silverman to deliver a wider variety of drugs as well as have a more targeted delivery as well as treating a wider variety of problems (¶[0056] & Abstract from Imran).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effect filing date of the claimed invention to modify the device of Silverman to include a stylet for advancing a solid depot through a depot conduit (Abstract, ¶[0051], [0056] from Imran).
Regarding claim 2, the system of claim 1, further comprising a sheath (248) (Fig. 1-2, 14) connected to a distal end of the extension, (where sheath 248 is connected to a distal end of the extension 171, 173 via the connector 82, ¶[0057], [0109]), wherein when the extension at least partially collapses within the housing, the at least one of the supply conduit and the depot conduit advance past a distal end of the sheath (where when the extension at least partially collapses within the housing, the supply and depot conduits 242 and 243 advance past the distal end of the sheath 248, since the sheath 248 gets pulled rearward with the extension, ¶[0057], [0109]).
Regarding claim 3, Silverman and Imran teach the system of claim 1, further comprising a trigger (98) (Fig. 1) configured to secure the extension relative to the housing (¶[0083]).
Regarding claim 4, Silverman and Imran teach the system of claim 1, wherein the housing (112) includes at least one of a supply conduit recess (252)(Fig. 14) and a depot conduit recess (252)(Fig. 14).
Regarding claim 5, Silverman and Imran teach the system of claim 4, wherein the supply conduit recess is configured to at least partially direct the supply conduit towards an extension lumen of the extension and/or a distal connector (¶[0109]).
Regarding claim 6, Silverman and Imran teach the system of claim 5, wherein the depot conduit recess is configured to at least partially direct the depot conduit towards an extension lumen of the extension and/or a distal connector (¶[0109]).
Regarding claim 7, Silverman and Imran teach the system of claim 1, further comprising an endoscope connector configured to secure the delivery system to the endoscope (Fig. 1, where the connection between 26 and 82 forms a secure connection that allows fluid delivery with the side port 52 of the device 22).
Regarding claim 8, Silverman and Imran teach the system of claim 1, wherein the supply conduit is concentric with the depot conduit (Fig. 1, where the center of 81 and ¶ are similarly circular and on the same axis, however ¶ is larger in diameter than 81).
Regarding claim 9, Silverman and Imran teach the system of claim 1, wherein a distal tip (246) of the supply conduit (242) is staggered from the distal tip of the depot conduit (243)(Fig. 14) (where the tip 246 of the supply conduit 242 is staggered from the tip 246 of the conduit 243, ¶[0018]).
Regarding claim 12, Silverman and Imran teach the system of claim 1, wherein the solid depot (Fig. 3, 40 from Imran) includes one or more extra-luminal pull-tabs (248)(Fig. 14)(where 248 is a sleeve to hold both needles together and also allows for a pulling or pushing motion ¶[0109]).
Regarding claim 17, Silverman and Imran teach the system of claim 1, wherein the housing includes a second fluidic supply (91)(Fig. 1, 14) configured to hold at least one of a drug and an activation agent (¶[0111], where the fluidic supply 91 contains the augmenting solution).
Regarding claim 18, Silverman and Imran teach the system of claim 1, further comprising a loading chamber configured to receive the solid depot (Fig. 3, 40 from Imran) or a depot cartridge(112) (Fig. 1) (where there is a loading chamber formed by the housing 112 for receiving the syringe barrel ¶ of the syringe 91, said chamber capable of receiving the depot or a depot cartridge; ¶[0053]).
Regarding claim 19, Silverman and Imran teach the system of claim 1, wherein the fluidic supply is a syringe (91, 97)(Fig. 1).
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) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of in view of Imran (US 2020/0276426) as applied to claim 1 above, and further in view of Makower et al. (US 2014/0288414).
Regarding claim 10, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot is a series of depots configured to advance inline.
Makower discloses a similar system for delivering a depot (12) (Fig. 2-3A, ¶[0052], ¶[0067], ¶[0095], ¶[0114]), and further teaches wherein the depot is a series of depots configured to advance inline (Fig. 2-3A - where the depot can be a series of depots configured to advance inline, ¶[0019], ¶[0114]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman and Imran’s delivery system by employing the depot as taught by Makower, in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device (¶[0095], [0114] from Makower).
Regarding claim 11, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot is a continuous filament configured to curl within the submucosal pocket.
Makower discloses a similar system for delivering a depot (12)(Fig. 2-3A, ¶[0052], ¶[0067], ¶[0095], ¶[0114]), and further teaches wherein the depot is a continuous filament configured to curl within the submucosal pocket (Fig. 2-3A, where the depot can be a continuous filament capable of curling within the pocket; ¶[0019], ¶[0114]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman and Imran’s delivery system by employing the depot as taught by Makower, in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device (¶[0095], [0114]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of in view of Imran (US 2020/0276426) as applied to claim 1 above, and further in view of Cafferata (US 2004/0186423).
Regarding claim 13, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot includes two or more depots having differing Young's Modulus.
Cafferata discloses a similar system for delivering a depot (Fig. 1-2B; ¶[0016], ¶[0038]), and further teaches wherein the depot includes two or more depots have differing Young's Modulus (Fig. 1-2B - where the depot can include a plurality of different depots 22 having differing Young's Modulus, since the pellets can all be different compositions with different purposes, ¶[0030], ¶[0031], ¶[0054], ¶[0059]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman' and Imran’s delivery system by employing the depots with differing Young's Modulus as taught by Cafferata (¶[0053]-[0054], [0119]), in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device.
Claim(s) 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of in view of Imran (US 2020/0276426) as applied to claim 1 above, and further in view of Abbate et al. (US 2014/0074238).
Regarding claim 14, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot includes two or more depots having differing doses of a same drug or a different drug.
Abbate discloses a similar system for delivering a depot (Fig. 2A-2E, ¶[0081], ¶[0203], ¶[0204], ¶[0205]), and further teaches wherein the depot includes two or more depots have differing doses of a same drug or a different drug (Fig. 2A-2E, where the depot can include two or more depots with different drugs or doses; ¶[0081]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman and Imran’s delivery system by employing the implant with integrated depots as taught by Abbate, in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device.
Regarding claim 15, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot includes a programmed degradation window of greater than 3 months.
Abbate discloses a similar system for delivering a depot (Fig. 2A-2E; ¶[0081], ¶[0203] ¶[0204], ¶[0205]), and further teaches wherein the depot includes a programmed degradation window of greater than 3 months (Fig. 2A-2E, where the depot includes a programmed degradation window that can months long; ¶[0081], ¶[0082], ¶[0091], ¶[0114]-[0119]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman and Imran’s delivery system by employing the implant with integrated depots with programmed degradation windows as taught by Abbate, in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device.
Regarding claim 16, Silverman and Imran teach the system of claim 1, however, Silverman does not specifically disclose wherein the solid depot includes a programmed depot release cadence having more than one crest in delivered drug concentration.
Abbate discloses a similar system for delivering a depot (Fig. 2A-2E; ¶[0081], ¶[0203], ¶[0204], ¶[0205]), and further teaches wherein the depot includes a programmed depot release cadence having more than one crest in delivered drug concentration (Fig. 2A-2E, where the depot includes a programmed degradation window that can months long; ¶[0081], ¶[0082], ¶[0091], ¶[0114]-[0119]). Accordingly, it would have been obvious to one of ordinary skill in the art to have modified the deposit/implant of Silverman and Imran’s delivery system by employing the implant with integrated depots with programmed depot release cadence as taught by Abbate, in order to have allowed for a wider variety of uses and treatments for the submucosal implantation device.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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