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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/15/2025 has been entered.
Acknowledgment
Claims 1, 18, 25 are amended and filed on 8/15/2025.
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, 5-7, 9-10, 16-18, 20-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldenberg (WO2019/222121) in view of Silvestrin et al. (WO. 2009012406A1) (“Silvestrin”).
Re claim 1, Goldenberg discloses a removable self-retaining implantable drug delivery device (abstract, Figs. 2a-4e, ¶038) comprising: a) an uncoated anchor portion (110 body of 100 Fig. 3 and 180s, Fig. 2b, ¶025) being cylindrical in shape and having a first anchor end (top 180), a second anchor end (lower 180, Fig. 2b), and an elongated body between the first anchor end and the second anchor end (110 body of 100 Fig. 4e); insertion into a lumen of a vessel or duct and absorption of fluid (26, 28, ¶077, Fig. 2b); b) a non-swellable drug depot portion (120, ¶047 which has same material such as polyurethanes, hydrocarbon polymers, polyacrylic esters, silicone polymer as in the current application, see ¶0076), the non-swellable drug depot portion being cylindrical in shape (Fig. 3) and having a first depot end (lower end of 120, Fig. 3), a second depot end (upper end of 120, Fig. 3), and an elongated depot body between the first and the second deport ends (Fig. 3), the non-swellable drug depot portion comprising one or more drug depots (120, ¶025), each of the one or more drug depots comprising a non-swellable polymer matrix (Fig. 3, 130, ¶025, ¶0047) including a polymer (¶039, ¶047) and one or more therapeutic agents (¶039), and one or more coating layers (Fig. 3, 140, ¶025) on an outer surface of each of the one or more drug depots that form a drug impermeable membrane (¶051, ¶056): and c) at least one depot channel (150, ¶025,¶058), the at least one depot channel being a tunnel completely traversing the one or more coating layers and the polymer matrix of each of the one or more drug depots (Fig. 3), wherein the self-retaining implantable drug device is removable (¶038), but it fails to disclose that the anchor is swellable and wherein upon insertion into a lumen, the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen but does not dissolve.
However, Silvestrin discloses an implantable drug delivery device (105 Figs. 64-73, ¶0113 which can be removed ¶0006) and wherein the anchors (7205. Fig. 72a-b) are made with an uncoated swellable material (¶00241, ¶0254) and the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen (¶0248, the hydrogel same material as used in the application see ¶0054 of the current application).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the anchor of Goldenberg so that the anchor is swellable and wherein upon insertion into a lumen, the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen but does not dissolve as taught by Silvestrin for the purpose of securing the device in the tissue as known in the art and stay within the tissue’s limits (Silvestrin, ¶0241).
Re claim 5, Goldenberg discloses wherein the one or more drug depot are a controlled-release formulation (¶005, ¶056).
Re claim 6, Goldenberg discloses wherein the controlled-release formulation is a sustained-release formulation or an extended release formulation (¶060).
Re claim 7, Goldenberg discloses wherein the controlled-release formulation exhibits zero-order release kinetics (¶062).
Re claim 9, Goldenberg discloses wherein the self-retaining implantable drug delivery device has 0.5 mm to 0.7 mm outside diameter (110, ¶028).
Re claim 10, Goldenberg discloses wherein the self-retaining implantable drug delivery device has a length of 5 mm to 15 mm (¶030).
Re claim 16, the modified Goldenberg discloses a kit comprising the device as defined in Claim 1 (see the rejection of claim 1).
Re claim 17, Goldenberg discloses further comprises metallic stylets that facilitate insertion and placement of stent (¶008).
Re claim 18, Goldenberg discloses a removable self-retaining implantable drug delivery device (abstract, Figs. 2a-4e, ¶038) comprising: a) an uncoated anchor portion (110 body of 100 Fig. 3 and 180s, Fig. 2b, ¶025) being cylindrical in shape and having a first distal end (top 180, Fig. 2b), a second anchor end (lower 180, Fig. 2b), and an elongated body between the first and the second anchor ends (110 body of 100 Fig. 3), wherein insertion into a lumen of a vessel or duct and absorption of fluid (26, 28, ¶077, Fig. 2b); and b) ) a non-swellable drug depot portion (120, ¶047 which has same material such as polyurethanes, hydrocarbon polymers, polyacrylic esters, silicone polymer as in the current application, see ¶0076), the non-swellable drug depot portion being cylindrical in shape (Fig. 3) and having a first depot end (lower end of 120, Fig. 3), a second depot end (upper end of 120, Fig. 3), and an elongated depot body between the first and the second deport ends (Fig. 3), the non-swellable drug depot portion comprising a non swellable polymer matrix (Fig. 3, 130, ¶025, ¶047) comprising one or more drug depots (Fig. 3, 120, ¶025) having one or more therapeutic drugs (¶039), one or more coating layers on an outer surface of the non-swellable polymer matrix that forms a drug impermeable membrane (140, ¶025, ¶051, ¶056); and c) at least one depot channel (150, ¶025,¶058), the at least one depot channel passing completely through the one or more coating layers and the non-swellable polymer matrix (150, Fig. 3), wherein the first or second anchor end of the anchor portion is secured to the first or second deport end of the non-swellable drug depot portion (Fig. 2b); wherein the self-retaining implantable drug device is removable (¶038), wherein the one or more therapeutic drugs are released over period of time of at least one week (¶066) and wherein the release rate approximates zero order kinetics (¶026), but it fails to disclose that the anchor is swellable and wherein upon insertion into a lumen, the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen but does not dissolve.
However, Silvestrin discloses an implantable drug delivery device (105 Figs. 64-73, ¶0113 which can be removed ¶0006) and wherein the anchors (7205. Fig. 72a-b) are made with an uncoated swellable material (¶00241, ¶0254) and the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen (¶0248, the hydrogel same material as used in the application see ¶0054 of the current application).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the anchor of Goldenberg so that the anchor is swellable and wherein upon insertion into a lumen, the swellable anchor becomes soft and pliable and conforms to the lumen without distorting or deforming the lumen but does not dissolve as taught by Silvestrin for the purpose of securing the device in the tissue as known in the art and stay within the tissue’s limits (Silvestrin, ¶0241).
Re claim 20, the modified Goldenberg discloses kit comprising the device as defined in claim 18 (see the rejection of claim 18).
Re claim 21, the modified Goldenberg discloses wherein the at least one depot channel is at least two depot channels (Goldenberg, Fig. 3, ¶058).
Re claim 22, the modified Goldenberg discloses wherein the at least one depot channel is at least 5 depot channels (Goldenberg, Fig. 3, ¶058).
Re claim 23, the modified Goldenberg discloses wherein at least one of the one or more coating layers is composed of a polymeric material or a metallic material (Goldenberg, ¶051).
Re claim 24, the modified Goldenberg discloses wherein the one or more coating layers is from 1 to 5 coating layers (Goldenberg, ¶051).
Re claim 25, the modified Goldenberg discloses wherein the one or more coating layers is at least two coating layers (Goldenberg, ¶051).
Re claim 26, the modified Goldenberg discloses wherein the at least one depot channel is at least two depot channels (Goldenberg, Fig. 3, ¶058).
Re claim 27, the modified Goldenberg discloses wherein the at least one depot channel is at least 5 depot channels (Goldenberg, Fig. 3, ¶058).
Re claim 28, the modified Goldenberg discloses wherein at least one of the one or more coating layers is composed of a polymeric material or a metallic material (Goldenberg, ¶051).
Re claim 29, the modified Goldenberg discloses wherein the one or more coating layers is from 1 to 5 coating layers (Goldenberg, ¶051).
Re claim 30, the modified Goldenberg discloses wherein the one or more coating layers is at least two coating layers (Goldenberg, ¶051).
Response to Arguments
Applicant’s arguments, see remark, filed 8/15/2025, with respect to the rejection(s) of claim(s) 1 and 18 under 103 using Jarrett have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Goldenberg in view of Silvestrin.
The applicant argues with regards to Goldenberg that its device is not removable. This is found not persuasive as Goldenberg specifically discloses that in ¶003, ¶022, ¶038.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783