DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/26/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed 02 June 2026. As directed by the amendment: claims 1-29 remain pending in this application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 02 June 2026, with respect to the rejection(s) of claim(s) 1-9, 12 and 17-19 under 35 US 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lee et al. (US 2012/010325).
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 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of Lee et al. (US 2012/0101325).
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 housing and extension.
Lee teaches a drug delivery device for treating fibrosis by delivering a depot to a targeted tissue area. Lee teaches 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 housing and extension (¶[0155], where a stylet moves a solid depot through the housing and interior of the delivery device 19 and the needle portion or extension as shown in Figure 1). This implanting method would be obvious as the device of Silverman already uses a syringe type injector and the only real modification would be to move a solid through the body and extension portion. The use of a stylet is not a new concept and is well-known in the art. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Silverman to include 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 housing and extension (¶[0155] from Lee).
Regarding claim 2, Silverman and Lee teach the system of claim 1, Silverman further teaches 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 Lee teach the system of claim 1, Silverman further teaches comprising a trigger (98) (Fig. 1) configured to secure the extension relative to the housing (¶[0083]).
Regarding claim 4, Silverman and Lee teach the system of claim 1, Silverman further teaches 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 Lee teach the system of claim 4, Silverman further teaches 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 Lee teach the system of claim 5, Silverman further teaches 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 Lee teach the system of claim 1, Silverman further teaches 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 Lee teach the system of claim 1, Silverman further teaches 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 Lee teach the system of claim 1, Silverman further teaches 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 17, Silverman and Lee teach the system of claim 1, Silverman further teaches 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 Lee teach the system of claim 1, Lee further teaches further comprising a loading chamber configured to receive the solid depot or a depot cartridge(Fig. 1, 18,19, where the solid depot is configured to be received from the syringe device and depot area).
Regarding claim 19, Silverman and Lee teach the system of claim 1, Silverman further teaches wherein the fluidic supply is a syringe (91, 97)(Fig. 1).
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 Lee et al. (US 2012/0101325). as applied to claim 1 above, and further in view of Makower et al. (US 2014/0288414).
Regarding claim 10, Silverman and Lee 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 Lee’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 Lee 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 Lee’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) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Silverman et al. (US 2003/0171645) in view of in view of Lee et al. (US 2012/0101325) as applied to claim 1 above, and further in view of Leng et al. (US 2022/0134067).
Regarding claim 12, Silverman and Lee teach the system of claim 1, Silverman and Lee do not specifically teach wherein the solid depot includes one or more extra-luminal pull-tabs.
Leng teaches a medical drainage stent for insertion into a patient. Leng teaches the solid depot (Fig. 1, 1) includes one or more extra-luminal pull-tabs (Fig. 2, 4). This feature is well known in the art and would be an obvious addition as it would improve the combination by allowing the solid depot to change arrangement or be removed easily (¶[0047] from Leng.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Silverman and Lee to have the solid depot (Fig. 1, 1 from Leng) including one or more extra-luminal pull-tabs (Fig. 2, 4 from Leng).
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 Lee et al. (US 2012/0101325) as applied to claim 1 above, and further in view of Cafferata (US 2004/0186423).
Regarding claim 13, Silverman and Lee 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 Lee et al. (US 2012/0101325) as applied to claim 1 above, and further in view of Abbate et al. (US 2014/0074238).
Regarding claim 14, Silverman and Lee 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 Lee’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 Lee 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 Lee’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 Lee 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 Lee’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
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/ /BHISMA MEHTA/Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783
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