Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-20 are pending in the Claim Set filed 1/09/2026.
No amendments have been made.
Herein, claims 1-20 are for examination.
Withdrawn Rejections
The provisional rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 19-32 of copending Application No. 17223641 (herein ‘641) in view of Rowland et al (US2004/0039441) is withdrawn because Application No. 17223641 was OFFICIALLY abandoned on 12/20/2024.
Applicant’s arguments on page 10 of the reply filed 1/9/2026 that an Office Action in Application No. 17/223,641 was mailed on April 16, 2024, and no response with an extension of time was filed by the deadline of October 16, 2024. Therefore, the Applicant argument that Application No. 17/223,641 was abandoned as of July 16, 2024 is herein acknowledged.
In response: Application No. 17223641 is abandoned on 12/20/2024.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL-The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention is maintained.
This is a New Matter rejection.
Claim 1 recites (in part) the phrase: ‘wherein the coating layer is homogenized’
However, there is lack of written support in the disclosure for the phrase ‘wherein the coating layer is homogenized”.
A complete search of the disclosure did not provide clear support for the phrase “wherein the coating layer is homogenized” as part of a balloon catheter as currently claimed. The term ‘homogenized’ appears only in para. [0065] of the entire disclosure. However, para. [0065] is discussing preparation of the coating solution, and not the coating on the balloon catheter as currently claimed. Homogenization is a process step of the solution, not the coating on the balloon catheter. Thus, there is insufficient written support for the amendment to claim 1 wherein the balloon catheter comprises a coating and the “wherein the coating layer is homogenized”.
M.P.E.P. §2163 states that amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement.
Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter.
Claims 2-20 are rejected as depending from a rejected claim.
Office suggests amending Instant Claim 1 to recite (in part):
‘wherein the coating layer is a uniform coating on the exterior surface of the balloon catheter.
Support for this proposed amendment is found in the Specification filed 6/01/2022 at paragraph [0073].
[0073] With regard to dispensing the coating solution from the metering dispenser onto an exterior surface 24 of the balloon catheter 10, in one embodiment, the coating solution is dispensed from the metering dispenser while the balloon catheter 10 is rotating and/or linearly moving. During dispensing, the coating solution flows continuously to the exterior surface 24 of the balloon catheter 10 without forming droplets. In one embodiment, the drops of the coating solution move back and forth longitudinally and transversely over the exterior surface 24 of the balloon catheter 10 while the solvent evaporates, resulting in the consistent and uniform deposition of coating solution over the exterior surface 24 of the balloon catheter 10 and resulting in a uniform dry coating layer over the exterior surface 24 of the balloon catheter 10. Without being bound by the theory, it is believed that the rotational and traversal movements allow the flexible tail to break the surface tension between the coating and the expandable balloon 12, forming a uniform coating on the exterior surface 24 of the balloon catheter 10.
Response to Arguments
Applicants argue in the reply filed 1-09-2026 that support for this limitation: ‘wherein the coating layer is homogenized’, as set forth e.g. in para. [0065] of the published version of the instant application, it is clearly set forth that a coating solution can undergo homogenization. The same paragraph also clearly states that the coating solution may be prepared by mixing or stirring until a homogenous solution is obtained, i.e. the contents or that which comprises the coating solution is homogenized.
Mere rephrasing of a passage does not constitute new matter. Accordingly, a rewording of a passage where the same meaning remains intact is permissible. In re Anderson, 471 F.2d 1237, 176 USPQ 331 (CCPA 1973). The mere inclusion of dictionary or art recognized definitions known at the time of filing an application may not be considered new matter. MPEP § 2163.07.
Further, to satisfy the written description requirement under 35 U.S.C. § 112, first paragraph, a specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP § 2163(1). This possession may be shown through express, implicit, or inherent disclosure. Id. To determine whether the specification provides express, implicit, or inherent disclosure, the MPEP dictates that the factual inquiry to be used is whether the specification conveys with reasonable clarity to those skilled in the art that Applicant was in possession of the invention as now claimed.
Applicant argue that the present specification provides express, implicit, and inherent support for all of the presently pending claims. By definition, homogenous mixtures are solutions with a uniform composition, where all components are completely blended and evenly distributed, making it impossible to see the separate parts. This type of solution consists of a single phase and has the same properties throughout. Synonyms include "uniform mixture." In particular, a homogeneous mixture is characterized by uniform dispersion of its constituent substances throughout; the substances exist in equal proportion everywhere within the mixture. Differently put, a homogeneous mixture will be the same no matter from where in the mixture it is sampled. For example, if a solid-liquid solution is divided into two halves of equal volume, the halves will contain equal amounts of both the liquid medium and dissolved solid (solvent and solute). (See, e.g., The Editors of Encyclopaedia Britannica. "homogenization". Encyclopedia Britannica, 20 Apr. 2021 https://www.britannica.com/science /homogenization. Accessed 29 October 2025.)
Further, Applicants are that the specification then clearly sets forth steps in which a coating solution is applied to form a coating layer (see, e.g. para. [0061]). Thus, if the coating layer is of a coating solution and the coating solution is homogenized, it is clear that the specification supports the instance wherein the coating layer is itself homogenized. This is further supported by para. [0073] of the instant application, where the coating solution is applied to the exterior surface of the balloon "resulting in the consistent and uniform deposition of coating solution over the exterior surface." Paragraph [0032] also explicitly states that the "therapeutic agent may also be uniformly distributed in the coating layer."
The Applicant also notes that "the examiner has the initial burden of presenting by a preponderance of the evidence why a person skilled in the art would not recognize in applicant's disclosure a description of the invention defined by the claims." MPEP § 2163.04 (citing In re Wertheim, 541 F.2d. 257,263, 191 USPQ 90, 97 (CCPA 1976)). Here, the Office has not provided any reason on the record why one skilled in the art could not have readily envisioned the invention as presently claimed based on the as-filed application. As such, Applicant asserts that the Office's (this SENTENCE was not completed in reply filed 1-09-2026).
Thus, Applicant submits that the term and synonyms thereof are present throughout the application, and that a person having ordinary skill in the art would recognize the instantly claimed catheters in the description. Therefore, the basis for the rejection is moot. One skilled in the art could readily envision the instant claims based on the disclosure of the original application and could reasonably conclude that the inventor had possession of the currently claimed balloon catheters. MPEP § 2163(1).
Response to Arguments
Applicant’s arguments have been fully considered but they are not persuasive, because the subject matter provided in para. [0065] is discussing preparation of the coating solution, and not the coating on a balloon catheter, i.e., a homogenized coating on a balloon catheter, as instantly claimed.
Instant Specification at page 22, para, [0065]:
[0065] Alternatively, in another embodiment, the coating solution may be prepared by adding the hydrophobic therapeutic agent and the combination of additives sequentially to the solvent. Such technique of sequentially adding components to the solvent may be based upon solubility of such components and/or other parameters known in the art. For example, the coating solution may be prepared by first adding the hydrophobic therapeutic agent to the solvent and then adding the combination of additives. Alternatively, the combination of additives may be added first to the solvent, after which the hydrophobic therapeutic agent may be added. Adding the combination of additives first to the solvent may be beneficial wherein a hydrophobic therapeutic does not sufficiently dissolve in a solvent (when added prior to the combination of additives). Without being bound by the theory, it is believed that the combination of additives will increase the solubility of the hydrophobic therapeutic agent in the solvent. In some embodiments, preparation of the coating solution may also involve homogenization under high shear conditions and optionally under pressure. In some embodiments, the preparation of the coating solution may also involve filtering the coating solution. For example, in one particular embodiment, the coating solution is prepared by: (1) mixing a fixed amount of the hydrophobic therapeutic agent, the combination of additives, and the solvent, (2) stirring the resulting mixture at room temperature, for example, or with slight heating such as to less than 60 °C until a homogenous solution is obtained, and (3) filtering the solution through a 0.45 am filter.
Claim Set filed 1-09-2026:
Instant Claim 1. (Previously Presented) A balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising:
a coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein: the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin,
beta-lapachone, biologically active vitamin D, and combinations thereof; and
the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl
laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof;
wherein the coating layer is homogenized; and
a biocompatible polymer.
Thus, homogenization as explicitly discussed in para. [0065] (Also, [0065] Patent Application Publication US2022/0296863) is a process step of the preparation of the coating solution, i.e., preparation of the coating solution may also involve homogenization under high shear conditions and optionally under pressure, of which is unlike and distinctly different from ‘the balloon catheter comprising a coating layer, wherein the coating layer is homogenized (instant claim 1 in part). Accordingly, para. [0065] fails to provide a link between preparation of the coating solution and a balloon catheter. Therefore para. [0065] provides insufficient support for the limitation: wherein the coating layer is homogenized.
Specification at pages 20-21, para, [0061]:
II Methods for Preparing Balloon Catheters
[0061] Methods for preparing a balloon catheter 10 may include (1) preparing a coating solution including a solvent, a therapeutic agent, and a combination of additives, (2) loading a metering dispenser with the coating solution, (3) inflating the balloon catheter 10 to 0 to 3 atm, and rotating the balloon catheter 10 about the longitudinal axis of the catheter and/or moving the balloon catheter 10 in a linear direction along the longitudinal or transverse axis of the balloon catheter 10, (4) dispensing the coating solution from the metering dispenser onto an exterior surface 24 of the balloon catheter 10 and flowing the coating solution on the surface of the balloon catheter 10 while the balloon catheter 10 is rotating and/or linearly moving, (5) evaporating the solvent, forming a coating layer 30 on the balloon catheter 10, (6) drying, folding, and wrapping the balloon catheter 10, and (7) sterilizing the balloon catheter 10. In one embodiment, the method for preparing the balloon catheter 10 further includes (8) drying the balloon catheter 10 after sterilization.
Thus, para. [0061] is directed to dispensing the coating solution from the metering dispenser onto an exterior surface of the balloon catheter.
Nowhere does the subject matter disclosed in para. [0061] require a coating layer overlying an exterior an exterior surface of a balloon, wherein the coating layer is homogenized. In fact, para, [0061] does not mention that the coating layer is homogenized. At best, para. [0061] discloses evaporating the solvent, forming a coating layer on the balloon catheter, drying, folding, and wrapping the balloon catheter, and sterilizing the balloon catheter. Therefore para. [0061] provides insufficient support for the limitation: wherein the coating layer is homogenized (i.e., the balloon catheter comprising a coating layer, wherein the coating layer is homogenized: instant claim 1 in part).
Specification at pages 24-25, para, [0073]:
D. Dispensing the Coating Solution from the Metering Dispenser onto an Exterior
Surface 24 of the Balloon Catheter 10
[0073] With regard to dispensing the coating solution from the metering dispenser onto an exterior surface 24 of the balloon catheter 10, in one embodiment, the coating solution is dispensed from the metering dispenser while the balloon catheter 10 is rotating and/or linearly moving. During dispensing, the coating solution flows continuously to the exterior surface 24 of the balloon catheter 10 without forming droplets. In one embodiment, the drops of the coating solution move back and forth longitudinally and transversely over the exterior surface 24 of the balloon catheter 10 while the solvent evaporates, resulting in the consistent and uniform deposition of coating solution over the exterior surface 24 of the balloon catheter 10 and resulting in a uniform dry coating layer over the exterior surface 24 of the balloon catheter 10. Without being bound by the theory, it is believed that the rotational and traversal movements allow the flexible tail to break the surface tension between the coating and the expandable balloon 12, forming a uniform coating on the exterior surface 24 of the balloon catheter 10.
Nowhere does the subject matter disclosed in para. [0073] require a coating layer overlying an exterior an exterior surface of a balloon, wherein the coating layer is homogenized. In fact, para, [0073] does not mention that the coating layer is homogenized. At best, para. [0073] discloses forming a uniform coating on the exterior surface 24 of the balloon catheter 10, i.e., uniform coating refers to the distribution of the coating on the balloon catheter. Thus, para. [0073] fails to provide sufficient support for the coating itself is homogenized.
Therefore, the rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION- The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 1-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is maintained.
The term ‘homogenized’ in claim 1 is unclear.
It is unclear if “homogenized” for the coating layer is a process step and it remains unclear what is being done while the coating is on the balloon catheter such that it is ‘homogenized’.
The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its ‘metes and bounds.’
The remaining claims are rejected as depending from a rejected claim.
Response to Arguments
Applicant argue that both the specification and the ordinary definition of the term sufficiently describe "homogenized" such that a person having ordinary skill in the art would understand what is claimed.
The Applicant argues that the specification does sufficiently describe the term homogenized, as discussed supra. Further, with respect to the ordinary meaning of the term, homogenized is, for example, defined in the Merriam Webster dictionary as an adjective for being "uniform in structure or composition" (see, merriam-webster. com/dictionary/homogenized). As set forth in e.g. para. [0065] the contents of the coating solution are mixed or stirred until homogenized, or in other words, the components are uniform throughout the solution. There is therefore no limit for one of skill in the art to consider. Homogenization does not refer to a degree or concentration and to the extent that one skilled in the art reading the claims and understanding the plain meaning of the word, the full scope is immediately appreciated.
Applicant’s arguments have been fully considered but they are not persuasive, because it is unclear as to Applicants intent. Thus, it is unclear if the limitation: ‘wherein the coating layer is homogenized’ is a process step and/or whether the coating requires further treatment, e.g., heating the coating, to provide a coating layer overlying an exterior surface of a balloon, wherein the coating layer is homogenized, i.e., it remains unclear what is being done while the coating is on the balloon catheter such that it is ‘homogenized’.
Instant Specification at page 22, para, [0065]:
[0065] Alternatively, in another embodiment, the coating solution may be prepared by adding the hydrophobic therapeutic agent and the combination of additives sequentially to the solvent. Such technique of sequentially adding components to the solvent may be based upon solubility of such components and/or other parameters known in the art. For example, the coating solution may be prepared by first adding the hydrophobic therapeutic agent to the solvent and then adding the combination of additives. Alternatively, the combination of additives may be added first to the solvent, after which the hydrophobic therapeutic agent may be added. Adding the combination of additives first to the solvent may be beneficial wherein a hydrophobic therapeutic does not sufficiently dissolve in a solvent (when added prior to the combination of additives). Without being bound by the theory, it is believed that the combination of additives will increase the solubility of the hydrophobic therapeutic agent in the solvent. In some embodiments, preparation of the coating solution may also involve homogenization under high shear conditions and optionally under pressure. In some embodiments, the preparation of the coating solution may also involve filtering the coating solution. For example, in one particular embodiment, the coating solution is prepared by: (1) mixing a fixed amount of the hydrophobic therapeutic agent, the combination of additives, and the solvent, (2) stirring the resulting mixture at room temperature, for example, or with slight heating such as to less than 60 °C until a homogenous solution is obtained, and (3) filtering the solution through a 0.45 am filter.
Furthermore, para. [0065] fails to provide a link between preparation of the coating solution and a balloon catheter (emphasis added). Moreover, nowhere does para. [0065] explicitly state that the components are uniform throughout the solution (as is suggested by Applicants). Thus, homogenization as explicitly discussed in para. [0065] (Also, [0065] Patent Application Publication US2022/0296863) is a process step of the preparation of the coating solution, i.e., preparation of the coating solution may also involve homogenization under high shear conditions and optionally under pressure, of which is unlike and distinctly different from ‘the balloon catheter comprising a coating layer, wherein the coating layer is homogenized (instant claim 1 in part). Accordingly, para. [0065] fails to provide a link (nexus) between preparation of the coating solution and a balloon catheter. Therefore para. [0065] provides insufficient support for the limitation: wherein the coating layer is homogenized.
Therefore para. [0065] fails to resolve the indefinite issues directed to the limitation: wherein the coating layer is homogenized.
Double Patenting Rejections are Maintained
(no Terminal Disclaimer filed)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The rejection of claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8414525 (herein ‘525) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘525 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
. ‘525 claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising a coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, and combinations thereof; and the at least one first additive comprises a PEG fatty esters, and an adherent layer between the coating layer and the exterior surface of the balloon, the adherent layer comprising a biocompatible polymer.
Instant Claims and ‘525 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘525 claims.
’525 claims differ from Instant Claims in that the ‘525 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8414909 (herein ‘909) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘452 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘909 claims are directed to a balloon catheter for delivering a therapeutic agent to a target site of a blood vessel, the balloon catheter comprising: wherein: an inflatable polyamide balloon; and a coating layer that adheres to an exterior surface of the inflatable polyamide balloon, the coating layer comprises a hydrophobic therapeutic agent and at least one water-soluble additive; the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, and combinations thereof; the at least one water-soluble additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates; wherein the at least one water-soluble additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate; further comprising an adherent layer between the exterior surface of the inflatable polyamide balloon and the coating layer.
Instant Claims and ‘909 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘909 claims.
’909 claims differ from Instant Claims in that the ‘909 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8414910 (herein ‘910) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘910 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘910 claims are directed to a balloon catheter for delivering a therapeutic agent to a target site of a blood vessel, the balloon catheter comprising: wherein: an inflatable polyamide balloon; and a coating layer that adheres to an exterior surface of the inflatable polyamide balloon, the coating layer comprises a hydrophobic therapeutic agent and at least one water-soluble additive; the hydrophobic therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, and combinations thereof; the at least one water-soluble additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates; wherein the at least one water-soluble additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate; further comprising an adherent layer between the exterior surface of the inflatable polyamide balloon and the coating layer.
Instant Claims and ‘910 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additives wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘910 claims.
’910 claims differ from Instant Claims in that the ‘910 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9023371 (herein ‘371) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘371 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘371 claims are directed to a medical device for delivering a therapeutic agent to a tissue, the medical device comprising a coating layer overlying an exterior surface of the medical device, the coating layer comprising a therapeutic agent and an additive, wherein: the therapeutic agent is chosen from paclitaxel, rapamycin, and mixtures thereof; the additive is chosen from gluconolactone, glucoheptonolactone, glucooctanoic lactone, gulonic acid lactone, mannonic acid lactone, ribonic acid lactone, and combinations thereof; wherein the medical device includes one of is chosen from a balloon catheter, a perfusion balloon catheter, an infusion catheter, a cutting balloon catheter, a scoring balloon catheter, a laser catheter, an atherectomy device, a debulking catheter, a stent, a filter, a stent graft, a covered stent, a patch, a wire, and a valve; further comprising an adherent layer between the exterior surface of the medical device and the coating layer.
Instant Claims and ‘371 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘371 claims.
’371claims differ from Instant Claims in that the ‘371 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9764065 (herein ‘065) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘065 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘065 claims are directed to a medical device for delivering a therapeutic agent to a tissue, the medical device comprising a coating layer overlying an exterior surface of the medical device, the coating layer comprising a therapeutic agent and at least one water soluble additive, wherein the medical device is a stent, a stent graft, or a balloon catheter; the therapeutic agent is a water insoluble drug chosen from paclitaxel, rapamycin, daunorubicin, doxorubicin, lapachone, vitamin D2, vitamin D3, and combinations thereof; the at least one water-soluble additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates; further comprising an adherent layer between the exterior surface of the medical device and the coating layer.
Instant Claims and ‘065 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘065 claims.
’065 claims differ from Instant Claims in that the ‘065 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21) Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9757544 (herein ‘544) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘544 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘544 claims are directed to a medical device for delivering a therapeutic agent to a tissue, the medical device comprising a dried coating layer overlying an exterior surface of the medical device, the dried coating layer comprising a hydrophobic therapeutic agent and a first additive, and a second additive, wherein: the hydrophobic therapeutic agent is a water-insoluble drug chosen from paclitaxel, rapamycin, daunorubicin, doxorubicin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the first additive is selected from the group consisting of PEG sorbitan monolaurates, PEG sorbitan monooleates, and combinations thereof; and the second additive is selected from the group consisting of sorbitol, sorbitan, xylitol, gluconolactone, and combinations thereof.
Instant Claims and ‘544 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘544 claims.
’544 claims differ from Instant Claims in that the ‘544 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9937159 (herein ‘159) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘159 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘159 claims are directed to a balloon catheter comprising a coating layer overlying an exterior surface of the balloon catheter, wherein: the balloon catheter is sized and configured for insertion into a passage of a respiratory system; the coating layer comprises a water insoluble drug and a combination of a first additive and a second additive; the water insoluble drug is chosen from paclitaxel and rapamycin; the first additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or N-octanoyl N-methylglucamine; and the second additive is chosen from sorbitol, glucose, sucrose, lactobionic acid, gluconolactone, meglumine, lactic acid, gentisic acid, or combinations thereof; wherein: the first additive is PEG-20 sorbitan monolaurate; and the second additive is sorbitol or wherein: the first additive is PEG-20 sorbitan monolaurate; and the second additive is sorbitol or gluconolactone; wherein the balloon catheter further comprises an adherent layer between the exterior surface and the coating layer.
Instant Claims and ‘159 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘159 claims.
’159 claims differ from Instant Claims in that the ‘159 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10881644 (herein ‘644) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘644 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘644 claims are directed to a balloon catheter comprising a coating layer overlying an exterior surface of the balloon catheter; and an adherent layer between the exterior surface and the coating layer, wherein: the balloon catheter is sized and configured for insertion into a passage of a respiratory system; the coating layer comprises a water insoluble drug and a combination of a first additive and a second additive the water insoluble drug is chosen from paclitaxel and rapamycin; the first additive is PEG-20 sorbitan monolaurate; and the second additive is gluconolactone; further comprising a top layer over the coating layer. The intended use of the catheter for insertion into a passage of a respiratory system does not create a structural difference, thus the intended use is not limiting.
Instant Claims and ‘644 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additive wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘644 claims.
’644 claims differ from Instant Claims in that the ‘644 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11534430 (herein ‘430) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘430 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘430 claims are directed to a balloon catheter comprising: a coating layer overlying an exterior surface of a balloon of the balloon catheter; and an adherent layer between the exterior surface and the coating layer, wherein: the balloon catheter is sized and configured for insertion into a passage of a respiratory system; the adherent layer adheres the coating layer directly to the exterior surface of the balloon catheter; the coating layer comprises a water insoluble drug and a combination of a first additive and a second additive; the water insoluble drug is chosen from paclitaxel and rapamycin; the first additive is chosen from PEG laurate, PEG oleate, PEG stearate, PEG glyceryl laurate, PEG glyceryl oleate, PEG glyceryl stearate, polyglyceryl laurate, polyglyceryl oleate, polyglyceryl myristate, polyglyceryl palmitate, PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate, PEG sorbitan stearate, or combinations thereof; and the second additive is chosen from sorbitol, glucose, sucrose, lactobionic acid, gluconolactone, meglumine, lactic acid, gentisic acid, or combinations thereof.
The intended use of the catheter for insertion into a passage of a respiratory system does not create a structural difference, thus the intended use is not limiting.
Instant Claims and ‘430 claims are obviously directed to common subject matter. Thus, it would have been prima facie obvious for one of ordinary skill in the art at the time of invention to provide a balloon catheter for delivering a therapeutic agent to target site in a blood vessel having a coating layer comprising a therapeutic agent and an additives wherein an adherent layer is positioned between the coating layer and the exterior surface of the balloon as instantly claimed in view of the ‘430 claims.
’430 claims differ from Instant Claims in that the ‘430 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending U.S. Patent No. 11376404 (herein ‘404) in view of Rowland et al (US2004/0039441) is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because Instant Claims and ‘404 claims are directed to common subject matter.
Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; wherein the coat layer is homogenized, and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
‘404 claims are directed to Instant claims are directed to a balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; and a biocompatible polymer, wherein the biocompatible polymer is present in an adherent layer.
’404 claims differ from Instant Claims in that the ‘404 claims do not recite that the coat layer is homogenized.
However, Rowland cures the deficiency.
Rowland teaches a drug eluting medical device is provided for implanting into vessels or luminal structures within the body of a patient. The coated medical device comprises a coating consisting of a controlled-release matrix of a biocompatible polymer, wherein the coating layer is a single layer of a homogeneous mixture of drugs and matrix. Rowland teaches that the homogeneous coating provides a controlled release of the drug into adjacent tissue device (Abstract; [0043]; [0048]; claim 21). Accordingly, it would have been obvious to one of ordinary skill to modify the balloon catheter as instantly claimed to comprise a homogeneous coating layer that uniformly distributes therapeutic agents slowly from a medical device having a reasonable expectation of success in view of the teachings of Rowland.
Response to Arguments
Applicants argue on page 9 of the reply filed 1-09-2026 that Terminal Disclaimers over U.S. Patent Nos. 8,414,525; 8,414,909; 8,414,910; 9,023,371;
9,764,065; 9,757,544; 9,937,159; 10,881,644; 11,534,430; and 11,376,404 are submitted herein.
Applicants’ arguments have been fully considered but they are not persuasive, because at the time of this Office Action no Terminal Disclaimers over U.S. Patent Nos. 8,414,525; 8,414,909; 8,414,910; 9,023,371; 9,764,065; 9,757,544; 9,937,159; 10,881,644; 11,534,430; and 11,376,404 have been made of Official Record at USPTO.
Therefore, all of the Double Patenting Rejections set forth above are maintained because no Terminal Disclaimers (TDs) over U.S. Patent Nos. 8,414,525; 8,414,909; 8,414,910; 9,023,371; 9,764,065; 9,757,544; 9,937,159; 10,881,644; 11,534,430; and 11,376,404 have been submitted herein.
Further, Applicants did not distinctly and specifically point out the supposed errors in the Double Patenting rejections. Accordingly, the Double Patenting Rejections are maintained for the reasons stated above.
Conclusions
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. The examiner can normally be reached Monday-Friday 10:00am-6:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.W./Examiner, Art Unit 1619 /SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights