DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 03/10/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Status of Claims
This action is in response to claims filed 06/05/2025. Claims 1-6, 8-14, 16-22 are pending in the application.
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.
Claims 12-14 are rejected 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 depends from claim 13 which depends from itself. Therefore, it is unclear how these claims relate to the independent claims. For the sake of examination, claim 12 will be interpreted as depending from claim 11, and claim 13 will be interpreted as depending from claim 11.
Claim 14 is rejected as depending from rejected claim 13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-6, 8, 10-14, 16, 18, 22 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dea (US 2010/0228202) in view of Broyles (US 2016/0106961) and further in view of Roth (US 2012/0041412).
Regarding claim 1, O’Dea discloses a medical device comprising an intermediate layer (134, Fig 24) overlying an exterior surface (132, Fig 24) of the device, wherein the intermediate layer is parylene (Para 0165).
O’Dea is silent regarding a micropatterned surface and a coating layer overlying the micropatterned surface, wherein: the micropatterned surface comprises a plurality of microstructures, wherein the microstructures increase tissue retention of the therapeutic agent in the diseased lumen compared to an identical treatment of a diseased lumen with an otherwise identical medical device lacking the micropatterning; the type of parylene; and the coating layer comprises a hydrophobic therapeutic agent and at least one additive.
Broyles teaches an analogous balloon catheter (300, Fig 3a) comprising a micropatterned surface (6, Fig 3b) and a coating layer (“paclitaxel/succinic acid coating”) overlying the micropatterned surface (Para 0119), wherein: the micropatterned surface comprises a plurality of microstructures (312,314, Fig 3b), wherein the microstructures increase tissue retention of the therapeutic agent in the diseased lumen compared to an identical treatment of a diseased lumen with an otherwise identical medical device lacking the micropatterning (Para 0071, Para 0119; the pattern can increase drug retention on the balloon which means more drug can be deposited and retained in the diseased lumen); an intermediate layer (5, Fig 3b) and the coating layer comprises a hydrophobic therapeutic agent and at least one additive (Paclitaxel is hydrophobic and succinic acid is the at least one additive).
Roth further teaches an analogous balloon catheter comprising a micropattern surface wherein the micropatterned layer is made of parylene C, parylene N or parylene F (Para 0011, lines 1-13 and lines 84-87).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device to comprise a micropatterned surface and a coating layer and modify the intermediate layer to be made of parylene C, parylene N or parylene F in order to have a device that can deliver a therapeutic agent to a target tissue (Para 0007 -Broyles), that can increase retention of said therapeutic agent on the balloon (Para 0071 -Broyles), and that can have an intermediate layer that is biostable (Para 0011, lines 84-87 -Roth).
Regarding claim 2, the modified invention of O’Dea, Broyles, and Roth discloses the plurality of microstructures (312,314, Fig 3b -Broyles) are formed directly on the intermediate layer (134, Fig 24 – O’Dea as modified by Broyles to have microstructures) overlying the exterior surface of the device.
Regarding claim 3, the modified invention of O’Dea, Broyles, and Roth discloses the microstructures comprise a plurality of recesses (312, Fig 3b -Broyles) and protrusions (314, Fig 3b -Broyles) (Para 0063 -Broyles).
Regarding claim 4, the modified invention of O’Dea, Broyles, and Roth discloses the microstructures comprise depots (recesses 312, Fig 3b -Broyles), and wherein the coating layer fills at least a portion of the depots (Para 0012 -Broyles).
Regarding claim 5, the modified invention of O’Dea, Broyles, and Roth discloses the intermediate layer comprises a micropatterned film (134, Fig 24 -O’Dea as modified by Broyles to have microstructures; “film” is defined in Merriam-Webster as “a thin covering or coating”. As the parylene layer is a coating, it can be interpreted as a film) adhered to an exterior surface (132, Fig 24 -O’Dea) (Para 0064 -Broyles).
Regarding claim 6, the modified invention of O’Dea, Broyles, and Roth discloses the micropatterned surface comprises a micropatterned polymer (134, Fig 24; Para 0165 -O’Dea; Para 0011 -Roth; the micropattern surface comprises the polymer parylene).
Regarding claim 8, the modified invention of O’Dea, Broyles, and Roth discloses the therapeutic agent comprises paclitaxel (Para 0119 -Broyles).
Regarding claim 10, the modified invention of O’Dea, Broyles, and Roth discloses the medical device is a balloon catheter (Para 0165 -O’Dea).
Regarding claim 11, O’Dea discloses a method for preparing a medical device, the method comprising: forming an exterior surface (132, Fig 24), an intermediate layer (134, Fig 24), wherein the intermediate layer is parylene (Para 0165)
O’Dea is silent regarding providing increased tissue retention of a therapeutic agent at a target site of a diseased lumen in vasculature of a patient in need of the therapeutic agent, the method comprising micropatterning an exterior surface, an intermediate layer, or both to form a micropatterned surface layer; and applying a coating layer comprising a hydrophobic therapeutic agent and at least one additive over the micropatterned surface layer; and the type of parylene.
Boyles discloses an analogous method for preparing a balloon catheter that provides increased tissue retention of a therapeutic agent at a target site of a diseased lumen in vasculature of a patient in need of the therapeutic agent (Para 0011; Para 0071), the method comprising: micropatterning an intermediate layer (5, Fig 3b) to form a micropatterned surface layer (Para 0063); and applying a coating layer comprising a hydrophobic therapeutic agent and at least one additive over the micropatterned surface layer (Para 0119; Paclitaxel is hydrophobic and succinic acid is the at least one additive).
Roth further teaches an analogous method of preparing a balloon catheter comprising micropatterning a layer wherein the micropatterned layer is made of parylene C, parylene N or parylene F (Para 0011, lines 1-13 and lines 84-87).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to comprise a micropatterning the intermediate layer and applying a coating layer and modify the intermediate layer to be made of parylene C, parylene N or parylene F in order to have a device that can deliver a therapeutic agent to a target tissue (Para 0007 -Broyles), that can increase retention of said therapeutic agent on the balloon (Para 0071 -Broyles), and that can have an intermediate layer that is biostable (Para 0011, lines 84-87 -Roth).
Regarding Claim 12, the modified invention of O’Dea, Broyles, and Roth discloses micropatterning comprises forming a plurality of recesses (312, Fig 3b -Broyles) and protrusions (314, Fig 3b -Broyles) on the exterior surface of the device (Para 0063 -Broyles; as the intermediate layer of Broyles 5 is formed on the exterior surface of the device, the recesses and protrusions are formed on the exterior surface of the device)
Regarding claim 13, the modified invention of O’Dea, Broyles, and Roth discloses micropatterning comprises forming a plurality of recesses (312, Fig 3b -Broyles) and protrusions (314, Fig 3b -Broyles) on the intermediate layer (Para 0063 -Broyles).
Regarding claim 14, the modified invention of O’Dea, Broyles, and Roth discloses the micropatterning forms depots (recesses 312, Fig 3b -Broyles), and applying the coating layer fills at least a portion of the depots (Para 0012 -Broyles).
Regarding claim 16, the modified invention of O’Dea, Broyles, and Roth discloses the therapeutic agent comprises paclitaxel (Para 0119 -Broyles).
Regarding claim 18, the modified invention of O’Dea, Broyles, and Roth discloses the medical device is a balloon catheter (Para 0165 -O’Dea).
Regarding Claim 22, the modified invention of O’Dea, Broyles, and Roth discloses the intermediate layer (134, Fig 24 -O’Dea as modified by Broyles) is micropatterned (Para 0064 -Boyles)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over O’Dea (US 2010/0228202) in view of Broyles (US 2016/0106961) and further in view of Roth (US 2012/0041412) and further in view of DeVries (US 2014/0276407).
Regarding Claim 12, the modified invention of O’Dea, Broyles, and Roth discloses all of the elements of the invention as discussed above, however, is silent regarding micropatterning comprises forming a plurality of recesses and protrusions on the exterior surface of the device.
DeVries teaches an analogous balloon catheter (100, Fig 43) having a micropatterned surface layer (110, Fig 43) wherein the micropatterning comprises forming a plurality of recesses and protrusions on the exterior surface of the device (Para 0023, 00118-0119; the micropattern can be on an exterior surface of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the micropatterning to be formed on the exterior surface of the device as DeVries teaches that micropatterning formed on an intermediate layer (polymer coating applied to the exterior surface) and an exterior surface of the device could be used to achieve the same result (imparting desired surface characteristics to a device as detailed in Para 0022, 0126) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Claims 9, 17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Dea (US 2010/0228202) in view of Broyles (US 2016/0106961) and further in view of Roth (US 2012/0041412) and further in view of Yamashita (US 2015/0328372) as evidenced by Kantor (US 2019/0224460).
Regarding claim 9, the modified invention of O’Dea, Broyles, and Roth discloses all of the elements of the invention as discussed above, however, is silent regarding the at least one additive comprises a polysorbate and a sugar alcohol.
Yamashita teaches an analogous medical device comprising a balloon with a coating layer that comprises a hydrophobic therapeutic agent (paclitaxel) and at least one additive, wherein the at least one additive comprises a polysorbate and a sugar alcohol (sorbitol) (Para 0164).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating layer to include a polysorbate and a sugar alcohol as taught by Yamashita in order to provide an excipient to facilitate the release of the drug from the drug coating (Para 0074 -Kantor).
Regarding claim 17, the modified invention of O’Dea, Broyles, and Roth discloses all of the elements of the invention as discussed above, however, is silent regarding the at least one additive comprises a polysorbate and a sugar alcohol.
Yamashita teaches an analogous medical device comprising a balloon with a coating layer that comprises a hydrophobic therapeutic agent (paclitaxel) and at least one additive, wherein the at least one additive comprises a polysorbate and a sugar alcohol (sorbitol) (Para 0164).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating layer to include a polysorbate and a sugar alcohol as taught by Yamashita in order to provide an excipient to facilitate the release of the drug from the drug coating (Para 0074 -Kantor).
Claims 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita (2015/0328372) in view of O’Dea (US 2010/0228202) and further in view of Roth (US 2012/0041412) and further in view of Broyles (US 2016/0106961).
Regarding claim 19, Yamashita discloses a method of providing a therapeutic treatment in a subject, the method comprising: inserting a medical device into a diseased lumen of the subject (Para 0085); and expanding the medical device to cause therapeutic agent to be released into walls of the diseased lumen (Para 00085).
Yamashita is silent regarding the medical device comprising an exterior surface, an intermediate layer overlying the exterior surface, and a coating layer overlying the intermediate layer, wherein the intermediate layer comprises micropatterning and is chosen from polymerized alkylcyclohexanes, polymerized toluene, polymerized xylenes, parylene C, parylene N, parylene D, parylene X, parylene AF-4, parylene SF, parylene HT, parylene VT-4 (parylene F), parylene CF, parylene A, and parylene AM, or combinations thereof and the coating layer comprises a hydrophobic therapeutic agent and at least one additive, wherein the micropatterning facilitates results in longer tissue retention of the therapeutic agent in the diseased lumen compared to an identical treatment of a diseased lumen with an otherwise identical medical device lacking the micropatterning.
O’Dea discloses an analogous method of providing a treatment comprising a medical device having an intermediate layer (134, Fig 24) overlying an exterior surface (132, Fig 24) of the device, wherein the intermediate layer is parylene (Para 0165).
Roth further teaches an analogous method of providing a treatment comprising a medical device comprising forming a layer wherein the layer is made of parylene C, parylene N or parylene F (Para 0011, lines 1-13 and lines 84-87).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Boyles to add an intermediate layer made of parylene C, parylene N or parylene F in order to have a low friction coating (Para 0165 -O’Dea) that is bistable (Para 0011, lines 1-13 and lines 84-87 -Roth).
The modified invention of Yamashita, O’Dea, and Roth discloses all of the elements of the invention as discussed above, however, is silent regarding a coating layer overlying the intermediate layer, wherein the intermediate layer comprises micropatterning and the coating layer comprises a hydrophobic therapeutic agent and at least one additive, wherein the micropatterning facilitates results in longer tissue retention of the therapeutic agent in the diseased lumen compared to an identical treatment of a diseased lumen with an otherwise identical medical device lacking the micropatterning.
Broyles discloses a medical device (300, Fig 3a) comprising an exterior surface (4, Fig 3b), an intermediate layer (5, Fig 3b) overlying the exterior surface, and a coating layer (“paclitaxel/succinic acid coating”) overlying the intermediate layer (Para 0119), wherein the intermediate layer comprises micropatterning (Para 0063) and the coating layer comprises a hydrophobic therapeutic agent and at least one additive (Paclitaxel is hydrophobic and succinic acid is the at least one additive), wherein the micropatterning facilitates results in longer tissue retention of the therapeutic agent in the diseased lumen compared to an identical treatment of a diseased lumen with an otherwise identical medical device lacking the micropatterning (Para 0071, Para 0119; the pattern can increase drug retention on the balloon which means more drug can be deposited and retained in the diseased lumen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon to have a coating layer and have the intermediate layer comprise micropatterning as taught by Boyles in order to have a desired amount of loading, retention of therapeutic agent on the balloon, and delivery of the therapeutic agent to the surrounding tissue (Para 0071).
Regarding claim 20, the modified invention of Yamashita, O’Dea, Roth, and Boyles discloses contracting the medical device; and removing the medical device from the diseased lumen (Para 0085 -Yamashita).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over O’Dea (US 2010/0228202) in view of Broyles (US 2016/0106961) and further in view of Roth (US 2012/0041412) and further in view of Wang (US 2016/0250452).
Regarding Claim 21, the modified invention of O’Dea, Broyles, and Roth discloses all of the elements of the invention as discussed above, however, is silent regarding the coating layer further comprises a surfactant.
Wang teaches an analogous medical device comprising a balloon with a coating layer that comprises paclitaxel and at least one additive, wherein the coating layer further comprises a surfactant (Para 0020, 0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating layer to comprise a surfactant as taught by Wang in order to have a coating layer that can protect the hydrophobic therapeutic agents from premature release during the device delivery process while facilitating rapid release and elution of the hydrophobic therapeutic agent (Para 0043).
Response to Arguments
Applicant’s arguments from the Appeal Brief filed 03/10/2026, on page 11 , regarding the modification of O’Dea with Boyles and Roth with additional coatings would increase electrical insulation and destroy the reference have been fully considered but are not persuasive. As detailed in paragraph 0164, lines 16-37 of O’Dea, the electrodes apply a stimulus current signal of known current value to the conductive solution within the balloon and read the resulting voltage signals to determine the transverse cross-sectional area, diameter and volume of a vessel, cavity or lumen within which the balloon 132 of the balloon catheter 130 is located. The outer coatings have no bearing on the conductivity of the conductive solution and the electrodes’ ability to measure its voltage. Therefore, the combination does not destroy the reference.
Applicant’s arguments from the Appeal Brief filed 03/10/2026, on pages 11-12 , regarding Boyles ePTFE balloon is incompatible with the conducting solution needed for O’Dea have been fully considered but are not persuasive. As detailed in the rejection above, the primary reference, O’Dea, teaches a ballon catheter with an exterior surface and intermediate layer of parylene. Broyles is relied on to teach that the micropatterning of the intermediate layer can increase drug retention (Para 0119 -Broyles). O’Dea is not concerned with porosity as they use a parylene intermediate layer. Roth is relied on to teach that the micropatterned layer can specifically be made of parylene C, B, or F as these are known to be biostable (Para 0011 -Roth). As Broyles is only relied upon to teach the micropatterning and the rejection does not import the porous material of the layer, there is no conflict in the combination of the references. Applicant arguments appear to be conflating the previous rejection that relied on Boyles in view of O’Dea and Roth and the current rejection that relies on O’Dea in view of Boyles and Roth. In the previous rejection with Boyles as the primary reference, all of the elements of Boyles must be considered and any modifications can’t prevent the device from performing its intended purpose. Changing the material in view of O’Dea and Roth did just that (changed a porous material to a nonporous material). However, in the current rejection, O’Dea is the primary reference. The material of O’Dea’s balloon already comprises a nonporous layer of parylene. By modifying the parylene layer to be a specific type of parylene as taught by Roth does not prevent O’Dea from functioning as intended. Therefore, the current rejection does not suffer from the same issue.
Applicant’s arguments from the Appeal Brief filed 03/10/2026, on pages 12, regarding the proposed modification would destroy the function of the intermediate layer of O’Dea have been fully considered but are not persuasive. O’Dea’s intermediate layer is a low friction coating as detailed ion Para 0164. The modification, while it would add recesses comprising a drug therewithin (See Para 0012 of Boyles that describes that the therapeutic agent is applied to the recesses on the balloon surface), the protrusions having the low friction coating would still be the primary contact point with the patient’s tissue. Therefore, the coating being made of parylene can still perform its function and would still be advantageous over a balloon that does not have the coating.
Applicant’s arguments from the Appeal Brief filed 03/10/2026, on pages 12-13, regarding Boyles being unable to be modified by O’Dea and Roth to replace the material of the balloon as it would make the device inoperable for its intended purpose have been fully considered and are persuasive. Claims 11 and 12 have been rejected under a new ground, as detailed above, that does not rely on Boyles as a primary teaching. Boyles is now only relied on to teach the micropatterning and not the underlying balloon material.
Applicant’s arguments from the Appeal Brief filed 03/10/2026, on pages 13-17, regarding O’Dea is not analogous art with Broyles or Roth have been fully considered but is not persuasive. According to MPEP 2141.01(a)(I), a prior art reference must be analogous to the claimed invention to be relied upon as a reference under 35 U.S.C. 103. The test for analogous art is as follows: A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor. Examiner points out that all of the relied upon references are directed to balloon catheters. Thus, O’Dea, Broyles, and Roth are all analogous art to the claimed invention at least under prong 1. Applicant’s arguments (that references are non-analogous merely because both relate to the same industry and that O’Dea’s device, directed to electrophysiological testing, is not within the same field of endeavor as the present claims or those of Broyles or Roth, directed to drug delivery) are not convincing as O’Dea, Broyles, and Roth are not just related in that they are in the medical field/industry, they are all directed to balloon catheters and can be found in the same CPC classification (A61M25/10+). One of ordinary skill in the art would look to references in the same classification to modify their device as it is the most likely place to find related art.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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