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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-2, 7 AND 10 in the reply filed on June 26, 2026 is acknowledged.
Claims 3-6, 8-9 and 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected products, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on June 26, 2026.
Claim Objections
Claim 7 is objected to because of the following informalities: claims 4 and 6 are withdrawn from consideration, the claim should be amended to depend on claim 2 only as this is an elected claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mantri et al. (US 11278293) hereinafter Mantri.
Mantri teaches a device for treatment of proliferative disorders of the prostate gland comprising:
an expandable tubular mesh (811, col. 25, line 59-60) comprising:
a compressed state (Fig. 4A) and an expanded state (Figs. 4B and 26);
a treatment medicament (col. 25, lines 64-65, hemostatic agent to enhance hemostasis);
wherein the expandable tubular mesh is adapted to be inserted into a urethra;
a urinary catheter (delivery catheter inserted through the urethra/penis shown in figures 4a-b and 26) adapted to be inserted into a urethra via a penis; wherein the expandable tubular mesh is attached to a portion of the urinary catheter (See figures 4a-b);
an angioplasty balloon (806) adapted to be inserted into the urinary catheter to the treatment site; wherein the expandable tubular mesh is adapted to expand from the compressed state to the expanded state upon inflation of the angioplasty balloon (See Figures 4a-b).
and the length of the expandable mesh is adapted to extend axially from a treatment site in the urethra to a locking site external to the penis (See Figure 26, where balloon 806 and thereby mesh 811 is locked external to the penis).
Regarding claim 10,
Mantri teaches a method of treatment of proliferative disorders of the prostate gland comprising the steps:
placing an expandable, tubular mesh (811) into a urethra in the prostate gland to a treatment site (see Figure 26), wherein the expandable tubular mesh comprises a compressed state and an expanded state (Refer to col.26, lines 2-8),
wherein the expandable tubular mesh comprises a treatment medicant (Refer to col. 68 lines 23-40);
placing an angioplasty balloon (proximal balloon 806) inside the expandable tubular mesh;
inflating the angioplasty balloon (806) to change the state of the expandable tubular mesh from the compressed state to the expanded state (Refer to col.25. Lines 60-61),
wherein the expanded tubular mesh presses against the inside of the urethra;
removing the angioplasty balloon (in order to remove the catheter and balloon from the urethra); wherein the expandable tubular mesh remains in the urethra at the treatment site after the removal of the angioplasty balloon (refer to col. 26, lines 2-4), wherein urine may flow unimpeded from a bladder through the urethra after the removal of the angioplasty balloon;
waiting a treatment time (col. 26, lines 15-17 and 23-25);
wherein the treatment medicament diffuses into the prostate gland (900) during the treatment time (Figure 4b);
and removing the expandable tubular mesh from the urethra (refer to col. 26, lines 2-4 “until removed”).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mantri et al. (US 11278293) hereinafter Matri in view of Scott et al. (US 7517342).
Regarding claim 2, Mantri fails to explicitly teach an electrical wire attached to the expandable tubular mesh; wherein the expandable tubular mesh is at least partially electrically conductive; wherein a proximal end of the electrical wire extends outside the penis when at least a portion of the expandable tubular mesh is at the treatment site.
Scott teaches a catheter (11), a polymer coated expandable mesh (36), an electrical wire (45) attached to the expandable tubular mesh; wherein the expandable tubular mesh is at least partially electrically conductive (col 8, lines 50-55).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to electrically deliver the medicament on the mesh of Mantri, as taught by Scott, resulting in a proximal end of the electrical wire extending outside the penis when at least a portion of the expandable tubular mesh is at the treatment site, to enhance drug delivery in the area of treatment.
Alternate rejection of claim 1
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hillstead (US 4921484) in view of Mantri et al. (US 11278293) hereinafter Mantri.
Regarding claim 1, Hillstead teaches a device for treatment of proliferative disorders of the prostate gland comprising: an expandable tubular mesh (16) comprising:
a compressed state (Fig. 2) and an expanded state (Fig. 3);
wherein the expandable tubular mesh is adapted to be inserted into a urethra;
a urinary catheter (col. 5, lines 30-31) adapted to be inserted into a urethra via a penis; wherein the expandable tubular mesh is attached to a portion of the urinary catheter (See figure 1);
an angioplasty balloon (20, see col. 5, lines 47-52) adapted to be inserted into the urinary catheter to the treatment site; wherein the expandable tubular mesh is adapted to expand from the compressed state to the expanded state upon inflation of the angioplasty balloon (See Figures 2-3).
Hillstead fails to explicitly teach a treatment medicament; and the length of the expandable mesh is adapted to extend axially from a treatment site in the urethra to a locking site external to the penis.
Mantri teaches a urinary catheter, and an expandable tubular mesh (811, Fig. 4A), expanded by inflation of balloon 806, and a treatment medicament (“a mesh disposed over one or more balloons, inflatable balloon assemblies, or expandable members. Expansion of the mesh-covered member(s) may comprise pressing the mesh against the tissue as described herein. The mesh may remain in the tissue space for a time after the member(s) have been removed or may be removed with the member(s). For example, expanding a distal balloon may comprise pressing a mesh disposed over the distal balloon against the tissue. The distal balloon may be collapsed and retracted from the tissue space along with the catheter while the mesh is left in the tissue space. The mesh may then be later removed or may comprise a material that is at least partially bioabsorbable or resorbable such that it is degraded or absorbed by the tissue over time. The mesh may alternatively be permanently implantable. The mesh may be coated with a hemostatic agent, for example a clot promoting agent like fibrin or thrombin”, Refer to col. 68 lines23-40), and the length of the expandable mesh is adapted to extend axially from a treatment site in the urethra to a locking site external to the penis (see Figure 26).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to coat the mesh of Hillstead with a drug delivery agent, as taught by Mantri to further provide treatment to the target area.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The subject matter found in the independent claims that was not found or suggested in the prior art, was “ a garment adapted to be worn by a patient comprising an electrically conductive portion adapted to make electrical contact with the patient's skin; wherein the garment, when worn by the patient, is adapted to be a first electrode for iontophoresis or electroporation, or both, and wherein a second electrode for the iontophoresis or electroporation, or both, comprises at least a portion of the expandable tubular mesh” in combination with the rest of the elements in clams 1-2.
The closest prior art found, Mantri in view of Scott do not teach or suggest a garment with a conductive portion for making electrical contact with the skin, the garment adapted to be a first electrode.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Huang (US 11497637) teaches a urinary catheter, an expandable mesh coated with an agent to treat BPH.
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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