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 .
Response to Arguments
Applicant’s arguments, see pages 8-10, filed 06/17/2026, with respect to the rejection(s) of claim(s) 1-6, 8-18, 20-21, and 6 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stenzel (US 2005/0112273), Yan et al. (US 2021/0007867) and Stucke (US 2005/0232970).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 9-10, 13, 16-18,21 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Neil et al. (US 2012/0171354) in view of Stenzel (US 2005/0112273), Yan et al. (US 2021/0007867) and Stucke (US 2005/0232970).
As to claim 1, O’Neil et al. discloses a process for coating a substrate with at least one biomolecule in a solution (dissolved in any known solvent, see 0027). The process comprises nebulizing the solution to form a liquid aerosol; combing the aerosol with a non-thermal plasma (see 0019, 0037) to form a coating; and depositing the coating onto the surface of the substrate (see abstract). The biomolecule can be a biopolymer, protein, polysaccharide, etc. (see 0024) as well as bioactive agents or pharmaceutical agents (see 0033). The substrate can be a medical device (see 0032).
O’Neil et al. fails to teach spraying a second solvent in aerosol form on the coating, wherein the spraying of the second solvent increases uniformity of the coating as required by claim 1.
Stenzel teaches spraying a solvent onto a formed coating to reflow the coating and obtain a uniform/consistent surface (see 0028-0030). Stenzel states the solvent can be an alcohol (see 0045). Stenzel teaches the treatment can be applied to devices having a polymeric coating formed thereon where non-uniform coatings which can cause failing drug release or drug nonuniformity (see 0012).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of O’Neil to include the solvent treatment taught by Stenzel in order to reflow the deposited organic/polymeric coating improving its uniformity and consistency. One would have been motivated to do so since both are directed to stents having polymeric/drug coatings formed thereon, while Stenzel teaches that solvent respraying/reflow produces a more uniform coating, which is desired in the stents of O’Neil for consistent drug release.
Yan et al. teaches solvent spraying of polymeric stents and teaches spray flow rates of at least 20 uL/min (see 0197). Yan et al. further teaches movement/rotation during solvent spraying to obtain uniformity of shaping and prevent excess dissolution or redistribution of polymer material (see 0197 and 0205). Yan et al. further identifies ethanol, methanol, and isopropanol as suitable solvents (see 0175).
It would have been further obvious to one having ordinary skill in the art to use the controlled alcohol solvent spray taught by Yan et al. when performing the Stenzel solvent reflow because Yan et al. teaches controlling the spray delivery to achieve uniform polymer shaping while avoiding excessive dissolution or redistribution.
Yan et al. teaches that the quantity/rate of solvent delivered to the polymeric stent affects the degree and uniformity of the polymer shaping and that excess solvent exposure should be avoided. Stucke discloses that the treated surface area of a stent is about 0.8757 cm2 (see 0160). Taking Stucke surface area, the amount of solvent treatment would equate to less than or equal to 87.57 microliters. It would have been obvious to one having ordinary skill in the art using Stenzel’s solvent reflow treatment, to determine the appropriate amount of treatment solvent relative to the known surface area to achieve sufficient reflow while avoiding excessive dissolution through routine experimentation especially since Yan et al. teaches it was known to use solvent flows within the claimed range.
As to claim 2, Stenzel et al. teaches preforming the treatment while the surface is still wet which would mean the coating is treated right after application (see 0029).
As to claim 4, the organic compound comprises a biomolecule (O’Neil 0024) and the coating retains pharmaceutical/bioactivity of the compound (see 0023 of O’Neil).
As to claim 5, O’Neil et al. states the biopolymer can be phosphorylcholine (see 0024).
As to claims 9-10, O’Neil et al. states the substrate can be a stent (see 0032). et al. shows stents can be formed of metallic or polymer substrate materials (see 0009).
As to claim 13, Stenzel et al. solvent treatment is performed after formation of the coating for the purpose of reflowing the previously deposited coating. Stenzel’s post deposition treatment is incorporated into O’Neil et al.’s method, the second solvent would be applied to the already formed coating rather than being introduced into O’Neil et al. non-thermal plasma.
As to claim 16, Stenzel et al. states the process can be performed while the polymer/drug is still wet (see 0029).
As to claim 17, Stenzel et al. further teaches the solvent treatment can take place after the coating is dried (see 0029).
As to claim 18, the solvent removes defects or cracks in the coating (see 0013).
As to claim 21, the aerosol can consist of a biomolecule and a first solvent (see 0052 of O’Neil).
As to claim 27, O’Neil states the biomolecule can be an acetic acid (see 0027).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Neil et al. (US 2012/0171354) in view of Stenzel (US 2005/0112273), Yan et al. (US 2021/0007867) and Stucke (US 2005/0232970) as applied to claim 1 above, and further in view of Whitbourne et al. (US 8287590).
The teachings of O’Neil et al., Stenzel, Yan and Stucke as applied to claim 1 are as stated above.
O’Neil et al., Stenzel, Yan and Stucke fail to teach dissolving the organic compound in the first solvent for at least 48 hours or preparing the solution at least 48 hours before nebulizing to form the aerosol as required by claims 11 and 12.
Whitbourne et al. discloses a process for forming a multi-layered coating on a stent. The process comprises forming solutions containing polymers and drugs where the solutions have a shelf-life up to 18 months when stored at room temperature. The solutions are applied to the stent via spraying. Whitbourne et al. further teaches various polymers can be used in the coating such as biopolymers.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of O’Neil, Stenzel, Yan and Stucke to include using a prepared solution as taught by Whitbourne et al., to have prepared solutions for coatings in the future. One would have been motivated to do so since both are directed coating medical devices with biomolecules and drugs through a form of spraying where Whitbourne further teaches having coating solutions with a long-shelf life which will reduce the time needed to prepare the coatings.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Neil et al. (US 2012/0171354) in view of Stenzel (US 2005/0112273), Yan et al. (US 2021/0007867) and Stucke (US 2005/0232970) as applied to claim 1 above, and further in view Yang et al. (US 6120847).
The teachings of O’Neil et al., Stenzel, Yan and Stucke as applied to claim 1 are as stated above.
O’Neil et al., Stenzel, Yan and Stucke fail to teach the solvent is sprayed for a period of time ranging from 30 seconds to about 5 minutes as required by claim 28.
Yang et al. teaches contacting an already formed polymeric coating with a solvent for a predetermined time to eliminate surface imperfections. Yang et al. teaches a general treatment of about 0.5 seconds to about 2 hours, with a preferred range of 10 seconds to 1 minute. Yang et al. further teaches that the contact time can be adjusted depending upon the degree of coating imperfections to be removed (see col. 5, lines 18-35).
It would have been obvious to one having ordinary skill in the art to select a solvent-treatment time within the claimed range through routine experimentation in order to optimize the degree of defect removal and surface uniformity especially since Yang et a. teaches the treatment time is a result effective variable affecting the degree of coating modification and teaches treatment times that encompass and overlap the claimed range.
The teachings of O’Neil et al., Stenzel, Yan and Stucke as applied to claim 1 are as stated above.
O’Neil et al., Stenzel, Yan and Stucke fail to teach the second solvent is sprayed as an aerosol that comprises the second solvent and a second organic compound as required by claim 15.
Stenzel (‘409) teaches post-treatment of an already deposited coating by applying additional solvent to the coating. Stenzel
Claim(s) 1, 2, 4-5, 8-10, 13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2021/0187545) in view of Stenzel (US 2005/0112273), Yan et al. (US 2021/0007867) and Stucke (US 2005/0232970).
Shah et al. discloses a method for depositing biomolecules, pharmaceutical agents, and other therapeutic agents onto a surface by forming an aerosol of a solution and activating using a non-thermal plasma (see abstract, 0038). Shah et al. states the use of plasma can product coatings that uniform, pin hole fee and well bonded to the substrate (see 0024). Shah et al. further discloses the biomolecule can be a biopolymer (see 0049).
Shah et al. fails to teach spraying a second solvent in aerosol form on the coating, wherein the spraying of the second solvent increases uniformity of the coating as required by claim 1.
Stenzel teaches spraying a solvent onto a formed coating to reflow the coating and obtain a uniform/consistent surface (see 0028-0030). Stenzel states the solvent can be an alcohol (see 0045). Stenzel teaches the treatment can be applied to devices having a polymeric coating formed thereon where non-uniform coatings which can cause failing drug release or drug nonuniformity (see 0012).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Shah et al. to include the solvent treatment taught by Stenzel in order to reflow the deposited organic/polymeric coating improving its uniformity and consistency. One would have been motivated to do so since both are directed to stents having polymeric/drug coatings formed thereon, while Stenzel teaches that solvent respraying/reflow produces a more uniform coating, which is desired in the stents of O’Neil for consistent drug release.
Yan et al. teaches solvent spraying of polymeric stents and teaches spray flow rates of at least 20 uL/min (see 0197). Yan et al. further teaches movement/rotation during solvent spraying to obtain uniformity of shaping and prevent excess dissolution or redistribution of polymer material (see 0197 and 0205). Yan et al. further identifies ethanol, methanol, and isopropanol as suitable solvents (see 0175).
It would have been further obvious to one having ordinary skill in the art to use the controlled alcohol solvent spray taught by Yan et al. when performing the Stenzel solvent reflow because Yan et al. teaches controlling the spray delivery to achieve uniform polymer shaping while avoiding excessive dissolution or redistribution.
Yan et al. teaches that the quantity/rate of solvent delivered to the polymeric stent affects the degree and uniformity of the polymer shaping and that excess solvent exposure should be avoided. Stucke discloses that the treated surface area of a stent is about 0.8757 cm2 (see 0160). Taking Stucke surface area, the amount of solvent treatment would equate to less than or equal to 87.57 microliters. It would have been obvious to one having ordinary skill in the art using Stenzel’s solvent reflow treatment, to determine the appropriate amount of treatment solvent relative to the known surface area to achieve sufficient reflow while avoiding excessive dissolution through routine experimentation especially since Yan et al. teaches it was known to use solvent flows within the claimed range.
As to claim 2, Stenzel et al. teaches preforming the treatment while the surface is still wet which would mean the coating is treated right after application (see 0029).
As to claim 4, the organic compound comprises a biomolecule Shah 0049) and the coating retains pharmaceutical/bioactivity of the compound (see abstract of Shah).
As to claim 5, Shah et al. states the biomolecule can be phosphorylcholine (see 0049).
As to claim 8, the thickness of the layer can be 10-500 nm (see 0015).
As to claims 9-10, Shah et al. the substrate can be a medical device formed of a metal or plastic (see 0067).
As to claim 13, Stenzel et al. solvent treatment is performed after formation of the coating for the purpose of reflowing the previously deposited coating. Stenzel’s post deposition treatment is incorporated into O’Neil et al.’s method, the second solvent would be applied to the already formed coating rather than being introduced into O’Neil et al. non-thermal plasma.
As to claim 15, Stenzel et al. states a first coating can be applied to the stent, a second coating can be sprayed onto the stent (see 0099) where the second coating includes a solvent that absorbs the first coating causing it to reflow. The reflowing of the underlying coating provides a more uniform layer (see 0035, 0096). Shah teaches repeating the process to form multiple layers. It would have been obvious to one having ordinary skill in the art when performing Shah’s subsequent coating pass to apply the second organic material to employ a solvent that is capable of re-flowing the previously deposited layer as taught by Stenzel. In order to obtain the additional benefit of leveling and increasing the uniformity of the previously applied coating.
As to claim 16, Stenzel et al. states the process can be performed while the polymer/drug is still wet (see 0029).
As to claim 17, Stenzel et al. further teaches the solvent treatment can take place after the coating is dried (see 0029).
As to claim 18, the solvent removes defects or cracks in the coating (see 0013 of Stenzel).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2021/0187545) in view of Stenzel (US 2005/0112273).
Shah et al. discloses a method for depositing biomolecules, pharmaceutical agents, and other therapeutic agents onto a surface by forming an aerosol of a solution and activating using a non-thermal plasma (see abstract, 0038). Shah et al. states the use of plasma can product coatings that uniform, pin hole fee and well bonded to the substrate (see 0024). Shah et al. further discloses the biomolecule can be a biopolymer (see 0049).
Shah et al. fails to teach spraying a second solvent in aerosol form on the coating, wherein the spraying of the second solvent with a second organic compound where the second solvent increases uniformity of the coating as required by claim 29.
Stenzel et al. states a first coating can be applied to the stent, a second coating can be sprayed onto the stent (see 0099) where the second coating includes a solvent that absorbs the first coating causing it to reflow. The reflowing of the underlying coating provides a more uniform layer (see 0035, 0096). Shah teaches repeating the process to form multiple layers.
It would have been obvious to one having ordinary skill in the art when performing Shah’s subsequent coating pass to apply the second organic material to employ a solvent that is capable of re-flowing the previously deposited layer as taught by Stenzel. In order to obtain the additional benefit of leveling and increasing the uniformity of the previously applied coating.
Allowable Subject Matter
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the cited prior art fails to teach or suggest using the claimed amount of solvent that is sprayed onto the coating as claimed. The cited prior art teaches values of at least 20 microliters/ cm2.
Conclusion
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/CACHET I. PROCTOR/
Examiner
Art Unit 1712
/CACHET I PROCTOR/Primary Examiner, Art Unit 1712
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