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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/10/2026 have been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/10/2026. As directed by the amendment: claims 1, 2, 20, 23, 24, 26, 33-38, 40, 43, 44, 52, 54-57, 60, 61, 63, 66, 70, 73, 75 have been amended. Claims 78-82 have been added and 3-6, 8-14, 17-19, 21, 22, 27, 29, 41, 45, 53, 58, 59, 62, 64, 65, 67-69, 74 and 77 are cancelled.
Thus, claims 1, 2, 7, 15, 16, 20, 23-26, 28, 30-40, 42-44, 46-52, 54-57, 60, 61, 63, 66, 70-73, 75, 76 and 78-82 are pending in this application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 15, 16, 23-25 and 71-73 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1).
Regarding claim 1, Lee et al disclose a drug delivery device (1000, fig 10), the drug delivery device comprising: an elastic body (1002 and para 0045-elastic structure), wherein the elastic body comprises (i) an outer tube (1012) comprising an elongated outer wall (see fig 10), and (ii) an elongated, arcuate inner wall (wall of tube 1020) located within the outer tube (see fig 10) and integrally connected to an inner surface of the outer wall along two opposed edges of the inner wall (see fig 10), the outer and inner walls together defining (a) a guidewire lumen (1022, para 0045) on a first side of the inner wall (see fig 10), and (b) a drug reservoir lumen (1014) on an opposed second side of the inner wall (see fig 10), the drug reservoir lumen being closed off at its opposed ends (see fig 10); and a drug payload (1024 and para 0034) disposed in the drug reservoir lumen (see fig 10), wherein the drug payload comprises at least one drug (para 0033 and 0034 and 0045), wherein the drug delivery device is elastically deformable between a deployment shape for passage of the whole drug delivery device, and a retention shape which is configured to retain the elastic body wholly (para 0030 and 0076- a configuration may limit or prevent accidental expulsion of the device 100 from the body under expected forces) and wherein, in the retention shape, the outer tube of the elastic body has two coils spaced apart by a single intermediate straight section (see annotated figure below).
Lee et al fail to expressly teach said device is for deployment in a renal pelvis of a patient by passing through a ureter and in retention shape which is configured to retain the elastic body wholly within the renal pelvis.
Lee et al, however, teach the device may be implanted, inserted, or deployed at any desired site (para 0092) and may deliver a therapeutically effective amount of one or more drugs to other genitourinary sites within the body, such as other locations within urological or reproductive systems of the body, including one or both of the kidneys (para 0096) and further teach the drug(s) may be selected to treat pain and/or to promote dissolution of renal stones (para 0064).
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 device of Lee et al to have the device be implanted, inserted, or deployed at a renal pelvis of a patient which would need to pass through the ureter when it is intended for treatments of kidney/renal stones or other kidney diseases.
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Regarding claim 2, Lee et al disclose the drug delivery device of claim 1, wherein the elastic body is (i) thermally shape set to have the retention shape (fig 1A), and (ii) is-biased to be in the retention shape in the absence of a guidewire inserted into the guidewire lumen (para 0031 and 0035).
Regarding claim 15, Lee et al disclose the drug delivery device of claim 1, wherein the drug reservoir lumen has a crescent cross-sectional shape (fig 10, drug reservoir 1014 is designed like a crescent moon).
Regarding claim 16, Lee et al disclose the drug delivery device of claim 1, wherein the guidewire lumen has a circular cross-sectional shape (fig 2- lumen 222).
Regarding claim 23, Lee et al disclose the drug delivery device of claim 1, further comprising a retrieval string attached to the elastic body (para 0080).
Regarding claim 24, Lee et al disclose the drug delivery device of claim 23, wherein the retrieval string has a length sufficient for an end of the retrieval string to reside in the patient’s bladder when the elastic body is wholly retained within the renal pelvis (para 0080, the retrieval string may extend to facilitate manual removal of the device from the patient).
Regarding claim 25, Lee et al disclose the drug delivery device of claim 1, wherein the drug payload is in a solid or a semi-solid form (para 0086).
Regarding claim 71, Lee et al disclose the drug delivery device of claim 1, wherein the at least one drug comprises a tyrosine kinase inhibitor (para 0069).
Regarding claim 72, Lee et al disclose the drug delivery device of claim 71, wherein the tyrosine kinase inhibitor comprises a fibroblast growth factor receptor-3 (FGFR3)-selective kinase inhibitor (para 0069).
Regarding claim 73, Lee et al disclose the drug delivery device of claim 1, wherein the guidewire lumen (1022) is defined on a concave side of the inner wall and the drug reservoir lumen is defined on an opposed convex side of the inner wall (see figs 2 and 10).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Anderson et al (US 4813925 A).
Regarding claim 7, Lee et al disclose the limitations of claim 1 but fail to teach wherein one or both ends of the device body is tapered.
However, Anderson et al disclose a medical device (see fig 9) wherein the end of the device body is tapered (tip 42).
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 device of Lee et al and incorporate the teachings of Anderson et al to have one or both ends of the device body is tapered. The modification would provide the benefit of facilitating insertion of said device into renal pelvis (col 4, lines 47-50).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Li (US 20040215169 A1).
Regarding claim 20, Lee et al disclose the limitations of claim 1 but fail to teach wherein each of the opposed ends of the drug reservoir lumen is sealed by an end spacer.
However, Li discloses a drug delivery device (500, fig 6) comprising a drug reservoir lumen (511) wherein each of the opposed ends of the drug reservoir lumen is sealed by an end spacer (560 and 550).
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 device of Lee et al and incorporate the teachings of Li to have said each of the opposed ends of the drug reservoir lumen is sealed by an end spacer. This would provide the benefit of having the opening sealed with a radiopaque material or sealed by a biodegradable material to prevent the liquid from escaping during the loading process (para 0011 and 0056).
Claims 26, 52, 54-57, 60, 66, 70, 75 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1).
Regarding claim 26, Lee et al disclose the limitations of claims 1 and 25 but fail to teach wherein the drug payload is in the semi-solid form and comprises a suspension.
However, Lee et al (US 20160339217 A1) disclose a drug delivery device (100) comprising a drug payload wherein the drug payload is in the semi-solid form and comprises a suspension (para 0117).
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 device of Lee et al and incorporate the teachings of Lee et al to have the drug payload in the semi-solid form and comprises a suspension. This would provide the benefit of having a highly viscous drug to allow a prolonged and controlled release of the drug (para 0117).
Regarding claim 52, Lee et al disclose a drug delivery device (1000, fig 10), the drug delivery device comprising: an elastic body (1002 and para 0045-elastic structure), wherein the elastic body comprises (i) an outer tube (1012) comprising an elongated outer wall (see fig 10), and (ii) an elongated, arcuate inner wall (wall of tube 1020) located within the outer tube (see fig 10) and integrally connected to an inner surface of the outer wall along two opposed edges of the inner wall (see fig 10), the outer and inner walls together defining (a) a guidewire lumen (1022, para 0045) on one side of the inner wall (see fig 10), and (b) a drug reservoir lumen (1014) on an opposed second side of the inner wall (see fig 10), the drug reservoir lumen on an opposing second side of the inner wall, the drug reservoir lumen being closed off at its opposed ends (see fig 10); and a drug payload (1024 and para 0034) disposed in the drug reservoir lumen (see fig 10), wherein the drug payload comprises a drug (para 0033 and 0034 and 0045), a retrieval string attached to the elastic body (para 0080), wherein the drug delivery device is elastically deformable between a deployment shape for passage of the whole drug delivery device, and a retention shape configured to retain the elastic body wholly (para 0030 and 0076- a configuration may limit or prevent accidental expulsion of the device 100 from the body under expected forces) and wherein, in the retention shape, the outer tube of the elastic body has two coils spaced apart by a single intermediate straight section (see annotated figure above), wherein the elastic body is (i) thermally shape set to have the retention shape (fig 1A), and (ii) biased to be in the retention shape in the absence of a guidewire inserted into the guidewire lumen (para 0031 and 0035).
Lee et al fail to expressly teach said device is for deployment in a renal pelvis of a patient by passing through a ureter and in retention shape which is configured to retain the elastic body wholly within the renal pelvis.
Lee et al, however, teach the device may be implanted, inserted, or deployed at any desired site (para 0092) and may deliver a therapeutically effective amount of one or more drugs to other genitourinary sites within the body, such as other locations within urological or reproductive systems of the body, including one or both of the kidneys (para 0096) and further teach the drug(s) may be selected to treat pain and/or to promote dissolution of renal stones (para 0064).
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 device of Lee et al to have the device be implanted, inserted, or deployed at a renal pelvis of a patient which would need to pass through the ureter when it is intended for treatments of kidney/renal stones or other kidney diseases.
Lee et al (US 20170165460 A1) fail to teach wherein the drug payload is in the semi-solid form.
However, Lee et al (US 20160339217 A1) disclose a drug delivery device (100) comprising a drug payload wherein the drug payload is in the semi-solid form (para 0117).
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 device of Lee et al and incorporate the teachings of Lee et al to have the drug payload is in the semi-solid form. This would provide the benefit of having a highly viscous drug to allow a prolonged and controlled release of the drug (para 0117).
Regarding claim 54, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20170165460 A1) disclose wherein the retrieval string has a length sufficient for an end of the retrieval string to reside in the patient’s bladder when the elastic body is wholly retained within the renal pelvis (para 0080, the retrieval string may extend to facilitate manual removal of the device).
Regarding claim 55, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20160339217 A1) disclose the semi-solid form comprises a suspension (para 0117).
Regarding claim 56, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20170165460 A1) disclose the drug delivery device of claim 52, wherein the elongated outer wall comprises a thermoplastic polyurethane configured to permit urine to diffuse into the drug reservoir lumen to contact the drug payload (para 0039).
Regarding claim 57, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20170165460 A1) disclose the drug delivery device of claim 56, wherein the elongated outer wall adjacent to the drug reservoir lumen comprises a thermoplastic polyurethane configured to permit the drug, in solution, to diffuse out of the device (para 0039).
Regarding claim 60, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20160339217 A1) disclose a drug delivery device (100) wherein the elongated outer wall comprises a polyether-based thermoplastic polyurethane (para 0059).
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 device of Lee et al and incorporate the teachings of Lee et al to have the elongated outer wall comprises a polyether-based thermoplastic polyurethane. This would provide the benefit of having a hydrophilic polymer to achieve a particular drug release profile such as water and drug permeation rates (para 0059).
Regarding claim 66, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20170165460 A1) further disclose wherein the guidewire lumen (1022) is defined on a concave side of the inner wall and the drug reservoir lumen is defined on an opposed convex side of the inner wall (fig 10).
Regarding claim 70, Lee et al (US 20170165460 A1) disclose the limitations of claim 1 but fail to teach wherein the outer wall comprises a polyether-based thermoplastic polyurethane.
Lee et al (US 20160339217 A1) disclose a drug delivery device (100) wherein the outer wall comprises a polyether-based thermoplastic polyurethane (para 0059).
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 device of Lee et al and incorporate the teachings of Lee et al to have the outer wall comprises a polyether-based thermoplastic polyurethane. This would provide the benefit of having a hydrophilic polymer to achieve a particular drug release profile such as water and drug permeation rates (para 0059).
Regarding claim 75, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 52,
Lee et al (US 20170165460 A1) further disclose wherein the at least one drug comprises a tyrosine kinase inhibitor (para 0069).
Regarding claim 76, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the drug delivery device of claim 75,
Lee et al (US 20170165460 A1) further disclose wherein the tyrosine kinase inhibitor comprises a fibroblast growth factor receptor-3 (FGFR3)-selective kinase inhibitor (para 0069).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20160310715 A1).
Regarding claim 28, Lee et al disclose the limitation of claim 1 but fail to teach wherein the outer tube and the inner wall are formed together by a co-extrusion process.
However, Lee (US 20160310715 A1) disclose a drug delivery device wherein the outer tube and the inner wall are formed together by a co-extrusion process (para 0155 and 0156 and claim 6).
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 device of Lee et al and incorporate the teachings of Lee et al to have the outer tube and the inner wall formed together by a co-extrusion process since this process is modifiable thus rate, diffusion of drug for release are controlled (para 0050).
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Boyko et al (US 20110218488 A1).
Regarding claim 30, Lee et al disclose the limitations of claim 1 and further teach a system for administration of a drug to a patient in need thereof, the system comprising: the drug delivery device of claim 1 (abstract); wherein the guidewire has a cross-sectional area dimensioned to pass through the guidewire lumen of the drug delivery device (para 0008) but fail to teach a guidewire deployment system for deploying the drug delivery device in a renal pelvis of the patient, wherein the guidewire deployment system including (i) a guidewire configured for operable association with the drug delivery device and having a distal end portion capable of extending into the renal pelvis while an opposed proximal end portion extends out of the patient’s urethra, and (ii) a plunger device for pushing the drug delivery device over the guidewire and off of the distal end and into the renal pelvis.
However, Boyko et al disclose systems and methods for implanting devices in the bladder and other genitourinary sites (para 0002 and fig 36A, device 3500) comprising teach a guidewire deployment system (system 3600) for deploying the drug delivery device genitourinary sites in the body, wherein the guidewire deployment system including (i) a guidewire (guidewire 3602) configured for operable association with the drug delivery device and having a distal end portion capable of extending into bladder while an opposed proximal end portion extends out of the patient’s urethra (para 0150), and (ii) a plunger device (plunger device 3604) for pushing the drug delivery device over the guidewire and off of the distal end and into the bladder (see para 0152 and fig 36B).
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 device of Lee et al and incorporate the teachings of Boyko et al to have a guidewire deployment system for deploying the drug delivery device in a renal pelvis of the patient, wherein the guidewire deployment system including (i) a guidewire configured for operable association with the drug delivery device and having a distal end portion capable of extending into the renal pelvis while an opposed proximal end portion extends out of the patient’s urethra, and (ii) a plunger device for pushing the drug delivery device over the guidewire and off of the distal end and into the renal pelvis. The modification would provide the benefit of having a tool which helps pushing said device to be wholly implanted into the kidney (see para 0153).
Regarding claim 31, Lee et al in view of Boyko et al disclose the system of claim 30,
Boyko et al further disclose the plunger device comprises: a plunger (plunger 3606); a handle (handle 3608); a sheath (sheath 3610) extending between the plunger and the handle (see fig 36A), the sheath transferring to the plunger a driving force applied to the handle (para 0151); and an internal bore for receiving the guidewire, such that the plunger device can travel over the guidewire (para 0151).
Regarding claim 32, Lee et al in view of Boyko et al disclose the system of claim 31,
Boyko et al disclose the plunger further comprises a stop (stop 3612) configured to indicate that the drug delivery device has separated from the guidewire (para 0153).
Claims 61 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and further in view of Lee (US 20160310715 A1).
Regarding claim 61, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the limitations of claims 52 and 60 but fail to teach wherein the polyether-based thermoplastic polyurethane comprises EG-100A or EG-80A.
However, Lee (US 20160310715 A1) discloses a drug delivery device (fig 2) comprising an elongated outer wall adjacent to the drug reservoir lumen (206) comprising a polyether-based thermoplastic polyurethane wherein the polyether-based thermoplastic polyurethane comprises EG-100A or EG-80A (para 0074).
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 device of Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and incorporate the teachings of Lee (US 20160310715 A1) to have the polyether-based thermoplastic polyurethane comprises EG-80A. This would provide a benefit of having a thermoplastic that has an excellent mechanical properties ensuring durability under stress (para 0074).
Regarding claim 78, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the limitations of claims 1 and 70 but fail to teach wherein the polyether-based thermoplastic polyurethane comprises EG-100A or EG-80A.
However, Lee (US 20160310715 A1) discloses a drug delivery device (fig 2) comprising an elongated outer wall adjacent to the drug reservoir lumen (206) comprising a polyether-based thermoplastic polyurethane wherein the polyether-based thermoplastic polyurethane comprises EG-100A or EG-80A (para 0074).
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 device of Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and incorporate the teachings of Lee (US 20160310715 A1) to have the polyether-based thermoplastic polyurethane comprises EG-80A. This would provide a benefit of having a thermoplastic that has an excellent mechanical properties ensuring durability under stress (para 0074).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and further in view of Li (US 20040215169 A1).
Regarding claim 63, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the limitations of claim 52 but fail to teach wherein the opposed ends of the drug reservoir lumen is sealed by an end spacer.
However, Li discloses a drug delivery device (500, fig 6) comprising a drug reservoir lumen (511) wherein each of the opposed ends of the drug reservoir lumen is sealed by an end spacer (560 and 550).
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 device of Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and incorporate the teachings of Li to have said each of the opposed ends of the drug reservoir lumen is sealed by an end spacer. This would provide the benefit of having the opening sealed with a radiopaque material or sealed by a biodegradable material to prevent the liquid from escaping during the loading process (para 0011 and 0056).
Claims 79 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20150088150 A1).
Regarding claim 79, Lee et al disclose the limitations of claim 1 and 23 but fail to teach wherein the retrieval string is a monofilament retrieval string and an end of the monofilament retrieval string is attached at the end of the elastic body.
However, Lee et al (US 20150088150 A1) disclose a drug delivery device (10) comprising an elastic body (para 0065) and a retrieval string (12) wherein the retrieval string is a monofilament retrieval string and an end of the monofilament retrieval string is attached at the end of the elastic body (para 0034-35).
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 device of Lee et al (US 20170165460 A1) and incorporate the teachings of Lee et al (US 20150088150 A1) to have the retrieval string to be a monofilament retrieval string and an end of the monofilament retrieval string attached at the end of the elastic body. This would provide the benefit of having a monofilament string which may reduce bacterial growth due to its smooth surface and has a relatively thin diameter to minimize patient discomfort, but with high enough tensile strength to resist breaking when being pulled to withdraw the attached medical device from the patient (para 0028).
Regarding claim 80, Lee et al (US 20170165460 A1) in view of Lee et al (US 20150088150 A1) disclose the drug delivery device of claim 79,
Lee et al (US 20150088150 A1) further disclose wherein an end of the monofilament retrieval string (12) is secured between the elastic body and an end spacer (end piece) disposed within an end of the drug reservoir lumen (para 0035).
Claims 81 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and further in view of Lee (US 20150088150 A1).
Regarding claim 81, Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) disclose the limitations of claim 52 but fail to teach wherein the retrieval string is a monofilament retrieval string and an end of the monofilament retrieval string is attached at the end of the elastic body.
However, Lee et al (US 20150088150 A1) disclose a drug delivery device (10) comprising an elastic body (para 0065) and a retrieval string (12) wherein the retrieval string is a monofilament retrieval string and an end of the monofilament retrieval string is attached at the end of the elastic body (para 0034-35).
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 device of Lee et al (US 20170165460 A1) in view of Lee et al (US 20160339217 A1) and incorporate the teachings of Lee et al (US 20150088150 A1) to have the retrieval string to be a monofilament retrieval string and an end of the monofilament retrieval string attached at the end of the elastic body. This would provide the benefit of having a monofilament string which may reduce bacterial growth due to its smooth surface and has a relatively thin diameter to minimize patient discomfort, but with high enough tensile strength to resist breaking when being pulled to withdraw the attached medical device from the patient (para 0028).
Regarding claim 82, Lee et al (US 20170165460 A1) in view of Lee et al (US 20150088150 A1) and Lee et al (US 20150088150 A1) disclose the drug delivery device of claim 81,
Lee et al (US 20150088150 A1) further disclose wherein an end of the monofilament retrieval string (12) is secured between the elastic body and an end spacer (end piece) disposed within an end of the drug reservoir lumen (para 0035).
Allowable Subject Matter
Claims 33-40, 42-44 and 46-51 are allowed.
The closest prior is Boyko et al (US 20110218488 A1).
Regarding claim 33, Boyko et al disclose a method of administering a drug to a patient (abstract) in need thereof, the method comprising: deploying a drug delivery device into a body of the patient (para 0004), wherein the drug delivery device is wholly contained in a site (para 0049 and 0051), with the optional exception of a retrieval string (para 0171); and releasing a drug from the drug delivery device into the desire site (para 0049), wherein the drug delivery device has an elastic body (para 0054) which is elastically deformable between a deployment shape for passage of the whole drug delivery device (fig 1), and a retention shape (fig 2), and wherein, in the retention shape, the outer tube of the elastic body has two coils spaced apart by a single intermediate straight section (fig 1).
Boyko et al fail to teach/disclose or render obvious “said method is for deployment in a renal pelvis of a patient and said device is elastically deformable between a deployment shape for passage of the whole drug delivery device through a ureter and into the renal pelvis, and a retention shape which is configured to retain the elastic body wholly within the renal pelvis” in addition to other limitations.
Claims 34-40, 42-44 and 46-51 are allowed for incorporating the above limitations due to their respective dependencies on the independent claim 33.
Response to Arguments
Applicant's arguments filed 04/10/2026 have been fully considered but they are not persuasive.
With regard to the arguments that applicant disagrees with the Advisory Action's statement that the intravesical device of Lee "is fully capable of contacting a portion of the wall of the renal pelvis in its deployed position if it is intended to be used in the renal pelvis", examiner respectfully disagrees.
In response to the arguments, the limitation “a retention shape which is configured to retain the elastic body wholly within the renal pelvis” is a functional limitation. The prior art of Lee et al is configured to be inserted in a straight configuration and then transform into a retention deployed configuration to maintain the device in a body cavity, thus the device of Lee et al is capable to be fully retained within the renal pelvis.
Applicant is reminded that “configured” as simply meaning “capable of” so that the prior art doesn’t need to explicitly teach the device performing the claimed function but capable of performing the function.
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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