DETAILED ACTION
Status of Claims
The amendments, and arguments, filed November 21, 2025, are acknowledged and have been fully considered. Claims 1-14 and 16-21 are pending and currently under consideration. Claims 1, 11 and 21 have been amended; and claim 15 was previously cancelled. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Final
Maintained Claim Objections
The following claims are objected to because of the following informalities:
A. Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
B. Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
C. Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
D. Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Appropriate correction is required.
Maintained Claim Rejections – 35 U.S.C. § 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 11-14, 17-18 and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over WANG (WO 2009/051614 A1, Publ. Apr. 23, 2009; on 10/12/2023 IDS; hereinafter, “Wang”), in view of ROSENBLUTH (US 5,312,430, Issued May 17, 1994; on 10/12/2023 IDS; hereinafter, “Rosenbluth”).
Wang is directed to
Title: DRUG RELEASING COATINGS FOR MEDICAL DEVICES
Abstract: The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups. In a preferred embodiment, the additive comprises ascorbyl palmitate, polyglycerol-10 oleate, octoxynol-9, p-isononylphenoxypolyglycidol, tyloxapol, niacinamide, thiamine hydrochloride, nicotinic acid, 2-pyrrolidone-5-carboxylic acid or albumin.
Wang, title & abstract. In this regard, Wang discloses:
[0230] It is contemplated that the medical devices of embodiments of the present invention have applicability for treating blockages and occlusions of any body passageways, including, among others, the vasculature, including coronary, peripheral, and cerebral vasculature, the gastrointestinal tract, including the esophagus, stomach, small intestine, and colon, the pulmonary airways, including the trachea, bronchi, bronchioles, the sinus, the biliary tract, the urinary tract, prostate and brain passages. They are especially suited for treating tissue of the vasculature with, for example, a balloon catheter or a stent.
[0231] Yet another embodiment of the present invention relates to a method of treating a blood vessel. The method includes inserting a medical device comprising a coating into a blood vessel. The coating layer comprises a therapeutic agent and an additive. In this embodiment, the medical device can be configured as having at least an expandable portion. Some examples of such devices include balloon catheters, perfusion balloon catheters, an infusion catheter such as distal perforated drug infusion catheters, a perforated balloon, spaced double balloon, porous balloon, and weeping balloon, cutting balloon catheters, scoring balloon catheters, self-expanded and balloon expanded-stents, guide catheters, guide wires, embolic protection devices, and various imaging devices.
[0232] As mentioned above, one example of a medical device that is particularly useful in the present invention is a coated balloon catheter. A balloon catheter typically has a long, narrow, hollow tube tabbed with a miniature, deflated balloon. In embodiments of the present invention, the balloon is coated with a drug solution. Then, the balloon is maneuvered through the cardiovascular system to the site of a blockage, occlusion, or other tissue requiring a therapeutic agent. Once in the proper position, the balloon is inflated and contacts the walls of the blood vessel and/or a blockage or occlusion. It is an object of embodiments of the present invention to rapidly deliver drug to and facilitate absorption by target tissue. It is advantageous to efficiently deliver drug to tissue in as brief a period of time as possible while the device is deployed at the target site. The therapeutic agent is released into such tissue, for example the vessel walls, in about 0.1 to 30 minutes, for example, or preferably about 0.1 to 10 minutes, or more preferably about 0.2 to 2 minutes, or most preferably, about 0.1 to 1 minutes, of balloon inflation time pressing the drug coating into contact with diseased vascular tissue.
Wang, par. [0230]-[0232]. Further in this respect, Wang teaches exemplary balloon coating compositions:
[0241] EXAMPLES
[0242] The following examples include embodiments of medical devices and coating layers within the scope of the present invention. While the following examples are considered to embody the present invention, the examples should not be interpreted as limitations upon the present invention.
[...]
[0262] Formulation 18-50-100 mg (0.06-0.12 mmmole) paclitaxel, 1-1 .6 ml acetone, 1-1.6 ml ethanol, 0.4-1.0 ml water, and 50-200 mg gluconolactone were mixed.
[0263] Formulation 19-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.5-1 .0 ml acetone, 0.5-1.0 ml ethanol, 35-70 mg Tween 20, and 35-70 mg N-octanoyl N-methylglucamine were mixed.
[0264] Formulation 20-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.4-1.0 ml acetone, 0.4-1.0 ml ethanol, 0.2-0.4 ml water, 35-70 mg Tween 20, and 35-70 mg sorbitol were mixed.
[0265] Formulation 21-40-80 mg (0.048-0.096 mmmole) paclitaxel, 0.5-1.0 ml acetone, 0.5-1.0 ml ethanol, 40-80 mg meglumine, and 32-64 mg gensitic acid (equal molar ratio with meglumine) were mixed.
[0266] Formulation 22-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.4-0.8 ml acetone, 0.4-0.8 ml ethanol, 0.25-0.50 ml water, 35-70 mg lactobionic acid, and 10-20 mg diethanolamine (equal molar ratio with lactobionic acid) were mixed.
[0267] Formulation 23-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.5-1 .0 ml acetone, 0.5-1 .0 ml ethanol, and 70-140 mg N-octanoyl N-methylglucamine were mixed.
[0268] Formulation 24-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.4-0.8 ml acetone, 0.4-0.8 ml ethanol, 0.2-0.4 ml water, 35-70 mg meglumine, and 18-36 mg lactic acid (equal molar ratio with meglumine) were mixed.
[0269] Formulation 25-50-100 mg (0.06-0.12 mmole) paclitaxel, 0.8-1 .6 ml acetone, 0.8-1 .6 ml ethanol, 0.4-1 .0 ml water, 50-100 mg gensitic acid, and 30-60 mg diethanolamine (equal molar ratio with gensitic acid) were mixed.
[0270] Formulation 26-Comparison solution-50 mg (0.06 mmole) paclitaxel, 1 ml ethanol, 0.2 ml acetone, 0.042 ml Ultravist 370 were mixed.
[0271] Formulation 27-Comparison solution-40 mg (0.048 mmole) paclitaxel, 0.5 ml ethanol, 0.5 ml acetone were mixed.
[0272] Formulation 28-35-70 mg (0.042-0.084 mmmole) paclitaxel, 0.5-1 .0 ml acetone, 0.5-1 .0 ml ethanol, 35-70 mg Triton X-100, and 35-70 mg N-heptanoyl N-methylglucamine were mixed.
(Wang, par. [0241]-[0242] & [0262]-[0272], Ex. 1, formulation 18-28), which are suitable for coating an exemplary percutaneous transluminal coronary angioplasty (PTCA) balloon catheter:
[0299] Example 15
[0300] 6 PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length) were inflated at 1-3 atm. The inflated balloon was loaded with a formulation 18-28 in example 1. A sufficient amount of drug on the balloon (3 microgram per square mm) was obtained. The inflated balloon was folded, and then dried. The coated folded balloon was then rewrapped and sterilized for animal testing.
[0301] The coated PTCA balloon catheter was inserted into a target site in the coronary vasculature (LAD, LCX and RCA) of a 25-45 pound pig. The balloon was inflated to about 12 atm. The overstretch ratio (the ratio of balloon diameter to vessel diameter) was about 1. 15 - 1.20. The drug delivered into the target tissue during 30-60 seconds of inflation. The balloon catheter was then deflated and was withdrawn from animal body. The target blood vessel was harvested 0.25 -24 hours after the procedure. The drug content in the target tissue and the residual drug remaining on the balloon were analyzed by tissue extraction and HPLC.
[0302] In some of these animal studies, a stent was crimped on the drug coated balloon catheters prior to deployment. In chronic animal tests, angiography was performed before and after all interventions and at 28-35 days after the procedure. Luminal diameters were measured and late lumen loss was calculated. Late lumen loss is the difference between the minimal lumen diameter measured after a period of follow-up time (usually weeks to months after an intervention, such as angioplasty and stent placement in the case of this example) and the minimal lumen diameter measured immediately after the intervention . Restenosis may be quantified by the diameter stenosis, which is the difference between the mean lumen diameters at follow-up and immediately after the procedure divided by the mean lumen diameter immediately after the procedure. The animal test results for Formulations 18-28 are reported below. All data is an average of five or six experimental data points.
(Wang, par. [0299]-[0302], Ex. 15).
Regarding independent claims 1, 11 and 21 and the requirements:
1. ([…]) A system comprising:
a balloon catheter in a stricture or stenosis of a body lumen, the balloon catheter comprising
an elongated balloon; and
a coating layer overlying external surfaces of the balloon, the coating layer comprising at least one additive and a therapeutic agent,
wherein the balloon catheter is free of an adherent layer between the external surfaces of the balloon and the coating layer that protects integrity of the coating layer, and wherein the balloon catheter is free of a top layer on the coating layer that reduces loss of the coating layer before it is brought into contact with target tissues;
wherein the balloon is being inflated to contact the coating layer with the stricture or stenosis; and
a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope, and wherein the stricture or stenosis of the body lumen is free of continuous irrigation;
wherein the inflation of the balloon to contact the coating layer with the stricture or stenosis is visualizable via the scope.
[...]
11. ([…]) A system comprising:
a balloon catheter in a stricture or stenosis of a body lumen, the balloon catheter comprising an elongated balloon, wherein the balloon is in a deflated state after inflation to contact a coating layer overlaying external surfaces of the inflated balloon with the stricture or stenosis, the coating layer on the inflated balloon comprising at least one additive and an initial drug load of a therapeutic agent, wherein the balloon catheter is free of an adherent layer between the external surfaces of the balloon and the coating layer that protects integrity of the coating layer, and wherein the balloon catheter is free of a top layer on the coating layer that reduces loss of the coating layer before it is brought into contact with target tissues; and
a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope, and wherein the stricture or stenosis of the body lumen is free of continuous irrigation;
wherein the therapeutic agent that deposited during the inflation of the balloon from the external surfaces of the balloon onto the stricture or stenosis during the inflating is visualizable via the scope.
[…]
21. ([…]) A system comprising:
a balloon catheter in a stricture or stenosis of a body lumen, the balloon catheter comprising
an elongated balloon attached to a catheter shaft; and
a coating layer overlying external surfaces of the balloon, the coating layer comprising at least one additive and a therapeutic agent;
a scope in the body lumen, wherein the catheter shaft of the balloon catheter is loaded into a working channel of the scope, and wherein the stricture or stenosis of the body lumen is free of continuous irrigation;
wherein
the balloon is being inflated to contact the coating layer with the stricture or stenosis, and the inflation of the balloon to contact the coating layer with the stricture or stenosis is visualizable via the scope, or
the balloon is in a deflated state after inflation to contact the coating layer with the stricture or stenosis and the therapeutic agent that deposited during the inflation of the balloon from the external surfaces of the balloon onto the stricture or stenosis during the inflating is visualizable via the scope.
Wang clearly teaches “6 PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length)” that are “loaded with a formulation 18-28 in example 1” (Wang, par. [0300], Ex. 15) in order to obtain a “coated PTCA balloon catheter was inserted into a target site in the coronary vasculature” (Wang, par. [0301], Ex. 15), whereby it is noted that:
the “6 PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length)” (Wang, par. [0300], Ex. 15) encompasses:
a “balloon catheter” of claims 1, 11 and 21, and
an “elongated balloon” of claims 1, 11 and 21; and
the coating of the “coated PTCA balloon catheter” (Wang, par. [0301], Ex. 15) is obtained from “a formulation 18-28 in example 1” (Wang, par. [0300], Ex. 15), which contains:
“paclitaxel” (Wang, par. [0262]-[0272], Ex. 1, formulation 18-28), which is:
“paclitaxel” of claims 8 and 17:
8. ([…]) The system of claim 1, wherein the therapeutic agent comprises paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, sirolimus, a sirolimus analogue, everolimus, an everolimus analogue, tacrolimus, a tacrolimus analogue, mammalian target of rapamycin (mTOR) inhibitors, an mTOR inhibitor analogue, or a combination thereof.
[…]
17. ([…]) The system of claim 11, wherein the therapeutic agent comprises paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, sirolimus, a sirolimus analogue, everolimus, an everolimus analogue, tacrolimus, a tacrolimus analogue, mammalian target of rapamycin (mTOR) inhibitors, an mTOR inhibitor analogue, or a combination thereof.
a “therapeutic agent” of claims 1, 11 and 21; and
an “initial drug load of a therapeutic agent” of claim 11; and
additives such as gluconolactone (Wang, par. [0262], Ex. 1, formulation 18), which is encompassed by “at least one additive” of claims 1, 11 and 21;
thereby meeting the requirements of:
claims 1 and 11 for a “coating layer on the inflated balloon comprising at least one additive and an initial drug load of a therapeutic agent,” and
claim 21 for “a coating layer overlying external surfaces of the balloon, the coating layer comprising at least one additive and a therapeutic agent”
Regarding claims 1 and 11 and the requirements:
“wherein the balloon catheter is free of an adherent layer between the external surfaces of the balloon and the coating layer that protects integrity of the coating layer, and wherein the balloon catheter is free of a top layer on the coating layer that reduces loss of the coating layer before it is brought into contact with target tissues” (claim 1), and
“wherein the balloon catheter is free of an adherent layer between the external surfaces of the balloon and the coating layer that protects integrity of the coating layer, and wherein the balloon catheter is free of a top layer on the coating layer that reduces loss of the coating layer before it is brought into contact with target tissues” (claim 11),
Wang teaches a coating configured with an “adherent layer,” which “is a separate layer underlying the drug coating layer, improves the adherence of the drug coating layer to the exterior surface of the medical device and protects coating integrity” and a “top layer” to “reduce loss of the drug layer before it is brought into contact with target tissues” (Wang, par. [0094]), and a “top layer” configured to “prevent loss of drug during transit through tortuous anatomy to the target site or during the initial expansion of the device before the coating makes direct contact with target tissue” (Wang, par. [0210]-[0211]). However, Wang teaches that “[i]n some embodiments, the device may optionally include an adherent layer” and “may include a top layer” (Wang, par. [094]), whereby both an “adherent layer” and “top layer” are optional for Wang’s device, and therefore not required, thereby meeting the above noted requirements of claims 1 and 11. For being free of an “adherent layer” and “top layer.” See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
It is further noted that the requirements of:
claim 1 for “wherein the balloon is being inflated to contact the coating layer with the stricture or stenosis,”
claims 1, 11 and 21 for “wherein the stricture or stenosis of the body lumen is free of continuous irrigation,”
claims 5 and 14 for:
5. ([…]) The system of claim 1, wherein the stricture or stenosis is in the esophagus, airways, sinus, trachea, colon, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, rectum, large intestine, urinary tract, prostatic urethra, urethra, or ureter.
[…]
14. ([…]) The system of claim 11, wherein the stricture or stenosis comprises is in the esophagus, airways, sinus, trachea, colon, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, rectum, large intestine, urinary tract, prostatic urethra, urethra, or ureter.
claim 11 for “wherein the balloon is in a deflated state after inflation to contact a coating layer overlaying external surfaces of the inflated balloon with the stricture or stenosis,” and
claim 21 for “the balloon is being inflated to contact the coating layer with the stricture or stenosis” and “the balloon is in a deflated state after inflation to contact the coating layer with the stricture or stenosis and the therapeutic agent that deposited during the inflation of the balloon from the external surfaces of the balloon onto the stricture or stenosis during the inflating,”
are recitations of intended use. In this regard, recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim, see MPEP § 2103 (I)(C). In this respect, Wang broadly discloses:
[0230] It is contemplated that the medical devices of embodiments of the present invention have applicability for treating blockages and occlusions of any body passageways, including, among others, the vasculature, including coronary, peripheral, and cerebral vasculature, the gastrointestinal tract, including the esophagus, stomach, small intestine, and colon, the pulmonary airways, including the trachea, bronchi, bronchioles, the sinus, the biliary tract, the urinary tract, prostate and brain passages. They are especially suited for treating tissue of the vasculature with, for example, a balloon catheter or a stent.
(Wang, par. [0230]), whereby the structure of Wang’s device appears to be suited for the intended uses recited in claims 1, 5, 11, 14 and 21. However it is noted that although Wang teaches an embodiment, wherein “[t]he drug coated balloon catheters and uncoated balloon catheters (as control) were inserted via a bronchoscope into the pulmonary airway in pigs” (Wang, par. [0294]) Wang DOES NOT TEACH a particular structure of a “scope” in order to meet the instant requirements of:
claim 1 for “a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope” for the intended use, “wherein the inflation of the balloon to contact the coating layer with the stricture or stenosis is visualizable via the scope”; or
claims 2-3 and 12-13 for:
2. ([…]) The system of claim 1, wherein the balloon catheter and the scope are positioned side-by-side.
3. ([…]) The system of claim 1, wherein the balloon catheter is loaded into the scope.
[…]
12. ([…]) The system of claim 11, wherein the balloon catheter and the scope are positioned side-by-side.
13. ([…]) The system of claim 11, wherein the balloon catheter is loaded into the scope.
claim 4 for and endoscope or cytoscope:
4. The system of claim 1, wherein the scope comprises an endoscope, enteroscope, colonoscope, sigmoidoscope, rectoscope, anoscope, rhinoscope, bronchoscope, or a cystoscope.
claim 11 for “a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or wherein the balloon catheter is loaded into the scope” for the intended use, “wherein the therapeutic agent that deposited during the inflation of the balloon from the external surfaces of the balloon onto the stricture or stenosis during the inflating is visualizable via the scope,” and
claim 21 for “a scope in the body lumen, wherein the catheter shaft of the balloon catheter is loaded into a working channel of the scope.”
Based on the state of the art, an artisan or ordinarily skill would have found this feature obvious.
Rosenbluth, for instance, is directed to:
BALLOON DILATION CATHETER
ABSTRACT
Disclosed is an apparatus and method for the treatment of the symptoms of obstructive prostatism. The apparatus comprises an expandable dilation catheter and preferably an axially elongate sheath, adapted for transurethral insertion via the external opening of the urethra. The sheath is ellipsoid in cross-section, and provides an initial path through which the catheter and a standard cystoscope lens is guided. The dilation catheter or the sheath are provided with a non-radiological locating means for positioning the dilation portion of the catheter with respect to an anatomical landmark. Once the catheter has been properly positioned with respect to both the bladder neck and the sphincter, the dilation balloon may be inflated to force open the affected prostatic urethra and eliminate the obstruction.
(Rosenbluth, title & abstract), which is suitable for treating “hyperplasia of the prostate gland” (Rosenbluth, col. 1, ln. 32-33). In this regard, Rosenbluth’s device features a cystoscope and balloon in a sheath assembly:
Referring now to the drawings in detail, wherein like reference numerals designate like elements throughout the several views thereof, there is shown generally at 10 in FIG. 1, a dilation catheter and sheath assembly embodying the present invention in a preferred form. The sheath 12 is advantageously a substantially rigid, axially elongate hollow shaft throughout most of its length, but having a flexible distal tip 14. The sheath 12 exhibits an inner surface 16 which is substantially ellipsoid in cross-section, and is adapted to receive and guide an axially elongate catheter 18 and an endoscope 20 longitudinally therethrough. Advantageously, the particular endoscope used is known as a cystoscope. Alternatively, a variety of other means for locating anatomical landmarks within the body lumen may be used, as discussed infra.
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(Rosenbluth, col 4, ln. 53-68 & Fig. 1), wherein the cystoscope is used to visualize positioning of the balloon prior to inflation:
Referring to FIGS. 11 and 16, near the proximal end of the dilation balloon 62, and encircling the proximal shoulder 64 thereof, is a heavy black line 106 for use with the cystoscope embodiment of the present invention. Prior to inflating the dilation balloon 62, care should be taken to ensure that the black line 106 does not extend onto any portion of the external urethral sphincter muscle 108. This is vitally important as accidental dilation of the sphincter 108 may cause the patient to lose voluntary control over micturition, especially if the sphincter experiences plastic deformation, i.e., the inability to return to its original shape.
(Rosenbluth, col 8, ln. 37-48). In this regard, it is noted that “endoscope 20,” wherein “the particular endoscope used is known as a cystoscope” (Rosenbluth, col 4, ln. 63-65, Fig. 1) for visualizing the positioning of the balloon prior to inflation (Rosenbluth, col 8, ln. 37-48) is a “scope” loaded with a balloon catheter, positioned side-by-side, for visualizing the medical device comprising the coating in the body lumen stricture with a scope during the contacting of claims 1-4, 11-13 and 21.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to use Wang’s PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length)” (e.g., Wang, par. [0300], Ex. 15) to treat “the urinary tract, prostate” (Wang, par. [0230]), and to have incorporated a cytosope, as taught by Rosenbluth (Rosenbluth, col 8, ln. 37-48). One would have been motivated to do so with a reasonable expectation of success since both Wang and Rosenbluth are concerned with similar problems in the art, namely the use of a balloon catheter (Wang, par. [0232]; Rosenbluth, abstract) for treating blockages of the urinary tract and prostate (Wang, par. [0230]; Rosenbluth, col 1, ln. 18-44). Further, it is well within the skill of the ordinary artisan to select suitable balloon structure and configuration for “treating blockages and occlusions of any body passageways, including, among others, [...], the urinary tract, prostate.” Wang, par. [0230]. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely using a cytosope to “ensure that the black line 106 does not extend onto any portion of the external urethral sphincter muscle 108” prior to inflation (Rosenbluth, col 8, ln. 37-48) in a “sheath assembly” (Rosenbluth, col 5, ln. 26-51) in order to obtain the advantage of a device to visualize positioning of the balloon prior to inflation (Rosenbluth, col 8, ln. 37-48) for treating “hyperplasia of the prostate gland” (Rosenbluth, col. 1, ln. 32-33).
Thus, the prior art renders claims 1-5, 8, 11-14, 17 and 21 obvious.
Regarding claim 6 and the requirements:
6. ([…]) The system of claim 1, wherein the one or more additives in the coating layer comprise N-acetylglucosamine, N-octyl-D-gluconamide, N-nonanoyl-N-methylglycamine, N-octanoyl-N-methyl glutamine, C6-ceramide, dihydro-C6-ceramide, cerabroside, sphingomyelin, galaclocerebrosides, lactocerebrosides, N-acetyl-D-sphingosine, N-hexanoyl-D-sphingosine, N-octonoyl-D-sphingosine, N-lauroyl-D-sphingosine, N-palmitoyl-D-sphingosine, N-oleoyl-D-sphingosine, PEG caprylic/capric diglycerides, PEG8 caprylic/capric glycerides, PEG caprylate, PEG8 caprylate, PEG caprate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, monolaurin, monocaprin, monocaprylin, monomyristin, monopalmitolein, monoolein, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthosine, xanthosine monophosphate, caffeine, allantoin, (2-hydroxyethyl)urea, N,N′-bis(hydroxymethyl)urea, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, or combinations thereof.
Wang teaches suitable additives (Wang, par. [0113]-[0173]), inter alia, pentaerythritol (Wang, par. [0125]), which is “one or more additives” of claim 6.
Thus, the prior art renders claim 6 obvious.
Regarding claim 18, it is noted that the requirements:
18. ([…]) The system of claim 11, wherein the contacting of the coating layer and the stricture or stenosis is sufficient to release 37% to 97% of the initial drug load
Are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 11, which achieve the resulting release effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended release effect of a composition that meets the structural requirements of claim 11. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 11 will achieve the intended result of the functional limitations and fall within the boundaries of the claims.
Thus, the prior art renders claim 18 obvious.
Claims 7 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over WANG (WO 2009/051614 A1, Publ. Apr. 23, 2009; on 10/12/2023 IDS; hereinafter, “Wang”), in view of ROSENBLUTH (US 5,312,430, Issued May 17, 1994; on 10/12/2023 IDS; hereinafter, “Rosenbluth”), as applied to claims 1-6, 8, 11-14 and 17-18, above, and further in view of SLAGER (US 2012/0296274 A1, Publ. Nov. 22, 2012; on 10/12/2023 IDS; hereinafter, “Slager”).
The teachings of Wang and Rosenbluth, as set forth above, are hereby incorporated. However, Wang DOES NOT TEACH the additives of claims 7 and 16:
7. The system of claim 1, wherein the one or more additives in the coating layer comprises pentaerythritol ethoxylate (15/4), pentaerythritol ethoxylate (3/4), or a combination thereof.
[…]
16. ([…] The system of claim 11, wherein the one or more additives in the coating layer comprises pentaerythritol ethoxylate (15/4), pentaerythritol ethoxylate (3/4), or a combination thereof.
since the incorporation of suitable coating materials is well within the purview of the ordinarily skilled artisan.
Slager, for instance, is directed to:
DELIVERY OF COATED HYDROPHOBIC ACTIVE AGENT PARTICLES
ABSTRACT
Embodiments of the invention include devices and coatings for devices including coated hydrophobic active agent particles. In an embodiment, the invention includes a drug delivery device including a substrate; and coated therapeutic agent particles disposed on the substrate, the coated therapeutic agent particles comprising a particulate hydrophobic therapeutic agent; and a cationic agent in contact with the particulate hydrophobic therapeutic agent. Other embodiments are also included herein.
(Slager, title & abstract), which are suitable for “urethral balloons and urethral stents for urological treatments.” (Slager, par. [0071]). In this regard, Slager discloses suitable coating materials, inter alia, “Pentaerythritol ethoxylate 15/4 EO/OH” for paclitaxel. Slager, par. [0226]. It is noted that “Pentaerythritol ethoxylate 15/4 EO/OH,” which is disclosed by Slager as a suitable coating material for paclitaxel (Slager, par. [0226]), is “pentaerythritol ethoxylate (15/4)” of claims 7 and 16.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to take Wang’s exemplary “6 PTCA balloon catheters (3.5 and 3.0 mm in diameter and 20 mm in length)” (Wang, par. [0300], Ex. 15), and to have incorporated a coating material such as “Pentaerythritol ethoxylate 15/4 EO/OH” per Slager (Slager, par. [0226]). One would have been motivated to do so with a reasonable expectation of success since both Wang and Slager are concerned with similar problems in the art, namely drug release coatings for medical devices (Wang, abstract; Slager, abstract), e.g., catheters for use in the urinary tract or urethra (Wang, par. [0230]; Slager, par. [0071]). Further, it is well within the skill of the ordinary artisan to select suitable additives. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the manufacture of a balloon catheter (Wang, par. [0300], Ex. 15) with “Pentaerythritol ethoxylate 15/4 EO/OH” per Slager (Slager, par. [0226]) in order to obtain the advantage of a suitable coating material for a hydrophobic active agent such as paclitaxel (Wang, par. [0262]-[0272], Ex. 1; Slager, par. [0226]).
Thus, the prior art renders claims 7 and 16 obvious.
Response to Arguments
Applicants’ arguments, filed on November 21, 2025 (hereinafter, referred to as “Remarks”), have been fully considered, but they are not persuasive, and have been addressed previously.
With regard to applicant’s arguments at pp. 8-11, as summarized by:
A person of ordinary skill in the art would recognize that modifying or eliminating Rosenbluth's continuous irrigation would compromise the safety and efficacy of Rosenbluth's visualization system. The continuous nature of Rosenbluth's irrigation is not merely preferred but is essential to achieving the clear visualization required for safe device positioning and deployment. However, due to Wang's above-discussed requirements for transit protection, controlled release, and rapid tissue transfer, a person of ordinary skill in the art would believe that combining Rosenbluth's continuously irrigated visualization with Wang would render Wang's device unsuitable for its intended purpose. Further, a person of ordinary skill in the art would not have undertaken a hypothetical substantial redesign of Wang's device to achieve transit protection, controlled release, and rapid tissue transfer in the presence of Rosenbluth's continuous irrigation, because Wang emphasizes that its coating formulation achieves “surprising” and unexpected benefits, including that “additives according to embodiments of the present invention which include a hydrophilic part and a drug affinity part, in combination with a therapeutic agent, form an effective drug delivery coating on a medical device without the use of oils and lipids" (¶[0019]). Modifying Wang's carefully balanced formulation to hypothetically accommodate Rosenbluth's continuous irrigation would sacrifice these unexpected advantages, thereby making Wang unsuitable for its intended purpose, and would not have been performed. As such, a person of ordinary skill in the art would not have combined Rosenbluth with Wang as alleged, and independent claims l, 11, and 21 are patentable over Wang in view of Rosenbluth for this additional reason.
(Remarks, p. 10, par. 1, cont. on p. 11), the requirements of claims 1, 11 and 21 for “wherein the stricture or stenosis of the body lumen is free of continuous irrigation,” are recitations of intended use. In this regard, recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim, see MPEP § 2103 (I)(C). In the instant case, the claims are drawn to a system, not a method of using, and therefore, the claims should be amended to structurally exclude the capability of continuous irrigation from the system (e.g., from the scope itself, not the location of intended use, namely the body lumen) in order to distinguish from the prior art per applicant’s arguments
Summary/Conclusion
Claims 1-14 and 16-21 are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611