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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/16/25 has been entered.
Response to Arguments
Applicant’s arguments, see page 2 of remarks (pg 7 response), filed 9/16/25, with respect to the rejection(s) of claim(s) 1,47,51 under 35 U.S.C. 103 over Weeks and Yassour and Mikulich 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 Therefore, the rejection has been withdrawn.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 Bessler (5855601). The amendment removed the limitation of diameter difference for the second member of which Mikulich was used as a teaching to address this limitation. The amendment introduced a new limitation of protruding anchors extend in both proximal and distal directions along the scaffold is taught in the new teaching of Bessler and rejections follow.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,6,7,14,47,51 are rejected under 35 U.S.C. 103 as being unpatentable over Weeks et al. (CA 2043601) in view of Yassour et al. (WO 99/65417) and Bessler et al. (5855601). Weeks et al. disclose a method comprising: inserting an apparatus into a prostatic urethra of a patient (page 3 of specification, lines 1-3). Fig. 1 shows the apparatus 10 comprises a first member 11 and a second member 16 on the first member. It is noted that Weeks et al. show (Fig. 5) an embodiment where the first member 10 can include openings 19 that can be construed to define a “scaffold” structure. Fig. 4 shows the first member 11 comprises an inner lumen 15 that extends from an open proximal end toa distal end along a length of the first member. Weeks et al. disclose (page 6 of specification, lines 16,17) the first member comprises a bioresorbable material. Fig. 4 also shows the second member 17 surrounds at least a portion of the first member. Fig. 1 shows the second member 16 is compressible on the first member via dehydration, page 4 of specification, lines 10-15. Fig. 3 shows the second member 16 is configured to resiliently expand on the first member from a compressed configuration relative to the first member to an expanded configuration relative to the first member, where the second member is in the compressed configuration when the apparatus is inserted into the prostatic urethra of the patient; and allowing the second member to expand relative to the second member after the apparatus is inserted into the prostatic urethra of the patient, where an outer surface of the second member presses against an inner surface of the prostatic urethra as the second member expands. It is noted that Weeks does disclose (page 1, line 25) the first member is a stent (commonly known in the art as scaffolds). Fig. 3 shows the first member forming an inner lumen that extends from an open end to a partially occluded distal end (narrowed tip) along a length of the first member, with the partially occluded distal end defined as tapered tip with structure configured to maintain a fluid passage. However, Weeks et al. did not explicitly define a stent scaffold or that it being a lattice or grille so that a partially occluded distal end is configured for prevention of particles from clogging the lumen. Yassour et al. teach (Fig. 5A) a scaffold structure 90 forming an inner lumen that extends from an open end to a partially occluded distal end 92 along a length of the first member, with the partially occluded distal end formed as a lattice or grille configured to maintain a fluid passage while preventing particles from clogging the lumen, page 12, lines 25,26. It would have been obvious to one of ordinary skill in the art to utilize scaffold structure defining a lattice with a partially occluded distal tip configured to prevent particles as taught by Yassour et al. in the method of placement of apparatus in a urethra by Weeks et al. such that the ability to capture particles (page 12 Yassour) within the vessel are not enabled to pass through the lumen and cause the patient trauma. However, Weeks also did not disclose the scaffold structure including protruding anchors that point in both proximal and distal directions along the scaffold structure. Bessler et al. teach (Fig. 7) a scaffold structure 50 including protruding anchors 64 that point in both proximal and distal directions along the scaffold structure. It would have been obvious to one of ordinary skill in the art to provide a scaffold structure with protruding anchors that point in both proximal and distal directions along the scaffold structure as taught by Bessler et al. for stent apparatus used in the method of treating a prostatic urethra by Weeks as modified with Yassour such that it holds structure together when assembled and implanted, see Bessler col. 6, lines 1-2. With respect to claim 6, as mentioned above Bessler teaches protruding anchors on the scaffold, which are fully capable of being a size and shape that fixes the scaffold structure to tissue of a patient after the second layer is resorbed or dissolved inside the patient. Regarding claim 7, Yassour et al. teach (page 9, lines 12,13) that a scaffold is configured to expand from a collapsed configuration to an expanded configuration inside a patient. Regarding claim 14, the apparatus is configured to be inserted into a prostatic urethra of a patient (page 3 of Weeks), where the second layer is configured to expand relative to the first layer (due to the expandable scaffold taught by Yassour) after the apparatus is inserted into the prostatic urethra of the patient, and where an outer surface of the second layer is configured to press against an inner surface of the prostatic urethra as the second member expands.
Claim(s) 2,12 are rejected under 35 U.S.C. 103 as being unpatentable over Weeks et al. (CA 2043601) in view of Yassour et al. (WO 99/65417) and Bessler et al. (5855601) as applied to claim 1 above, and further in view of Gellman et al. (2003/019993). Weeks as modified by Yassour and Bessler is explained supra. However, Weeks and Yassour and Bessler did not disclose the hydrogel layer is Chitosan. Gellman teaches (paragraph 28) the second layer or cover on a stent structure can be Chitosan. It would have been obvious to one of ordinary skill in the art to select the appropriate material, such as Chitosan as taught by Gellman for the cover or second layer on the first member of the apparatus of Weeks et al. as modified with Yassour et al. and Bessler such it provides an acceptable biocompatible material that is resorbable and can be crosslinked, see Gellman. With respect to claim 12, Weeks et al. as modified by Yassour et al. and Bessler did not disclose the first layer has a first degradation rate which is different than a second degradation rate of the second layer. Gellman teaches (paragraphs 36,49,52) that the different layers can have different degradation rates. It would have been obvious to one of ordinary skill in the art to optimize the degradation of the layers as taught by Gellman et al. with the stent of Weeks et al. as modified with Yassour et al. and Bessler such that the appropriate characteristics are provided for the layers to meet the desired result of its use, release profile for the second layer and structural stability for the first layer.
Claim(s) 8,9 are rejected under 35 U.S.C. 103 as being unpatentable over Weeks et al. (CA 2043601) in view of Yassour et al. (WO 99/65417) and Bessler et al. (5855601) as applied to claim 1 above, and further in view of Behan et al. (WO 2012/059906). Weeks et al. in view of Yassour et al. and Bessler et al. is explained supra. However, Weeks as modified by Yassour et al. and Bessler et al. did not disclose the second layer is configured to hydroscopicly swell into a shape having an enlarged distal end configured to be located against a bladder neck of a patient. Behan teaches (Fig. 72) an implant 810 that expands (page 30, line 2) with an enlarged distal end 811 configured to be located against a bladder neck of a patient, see Fig. 74. It would have been obvious to one of ordinary skill in the art to provide the second layer on the stent of Weeks as modified with Yassour et al. and Bessler et al. to be configured to hydroscopicly swell into a shape having an enlarged distal end configured to be located against a bladder neck of a patient per the teaching of Behan such that it matches the anatomy. With respect to claim 9, it can be seen (Figs. 74-79) Behan teaches the outer shape of the implant is an outer conical shape extending from the enlarged distal end in a direction towards a proximal end of the structure.
Claim(s) 10,13 are rejected under 35 U.S.C. 103 as being unpatentable over Weeks et al. (CA 2043601) in view of Yassour et al. (WO 99/65417) and Bessler et al. (5855601) as applied to claim 1 above, and further in view of Long et al. (2008/0039954). Weeks et al. in view of Yassour et al. and Bessler et al. is explained supra. However, Weeks as modified by Yassour et al. and Bessler et al. did not explicitly state that at least one portion of the second layer has an outer diameter which is configured to hydroscopicly swell between about 200-500 percent from a non- swelled first configuration to a hydroscopicly swelled second configuration. Long et al. teach (paragraph 26) that an implantable material can swell (paragraph 53) to a configuration within the range of about 200-500 percent its non-swell configuration. It would have been obvious to one of ordinary skill in the art to provide the second layer to swell within the range of about 200-500 percent its non-swell configuration per the teaching of Long et al. on the stent of Weeks as modified by Yassour et al. and Bessler et al. such that it matches the anatomical site, see Long paragraph 59. With respect to claim 13, Weeks as modified with Yassour et al. and Bessler et al. was silent as to the second member is compressible such that it is configured to resiliently expand on the first member from a compressed configuration relative to the first member to an expanded configuration relative to the first member. Long et al. teach (paragraph 51) that a swellable material can be compressible such that it is configured to resiliently expand from a compressed configuration to an expanded configuration. It would have been obvious to one of ordinary skill in the art to provide the second layer to be configured with a compressible first configuration and then expand from the compressed configuration as taught by Long et al. on the stent of Weeks et al. as modified by Yassour et al. and Bessler et al. such that the engagement in the site provides a good “press-fit” type of interlock at the vessel site, see Long paragraph 21.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Weeks et al. (CA 2043601) in view of Yassour et al. (WO 99/65417) and Bessler et al. (5855601) as applied to claim 1 above, and further in view of Dardi (2012/0089218). Weeks et al. in view of Yassour et al. and Bessler et al. is explained supra. However, Weeks as modified by Yassour et al. and Bessler et al. did not explicitly state that there is a protective cover on the second layer to limit moisture entering the second layer, where the protective cover is configured to be slid off the second layer after the apparatus is inserted into a patient. Dardi teaches (paragraph 49) there can be a protective cover on the second layer of a stent to limit moisture entering the second layer, where the protective cover is configured to be slid off of the second layer after the apparatus is inserted in the patient. It would have been obvious to one of ordinary skill in the art to incorporate a protective cover as taught by Dardi with the stent of Weeks et al. as modified by Yassour et al. and Bessler et al. such that it prevents early or premature expansion via swelling if contacting body fluids of the lumen prior to insertion at the precise site.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799