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 Amendment
The Amendment filed 12/18/2025 has been entered. Claims 1 and 3-17 remain pending in the application.
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.
Claim(s) 1, 5, 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531).
Regarding claim 1, Weber discloses a drug-loaded implantable medical device 2 (figure 1A), comprising a device body 10, a porous membrane 20 (figure 1B, paragraph 0082, “SIBS coating applied on the balloon surface is construed as a part of the membrane and since SIBS coating is porous, membrane is construed as porous membrane) fixed on the device body 10, and a nanocrystalline drug (paragraph 0082, “methylcyclohexane-based paclitaxel”) loaded on a surface of the porous membrane.
Weber is silent regarding wherein the surface of the microporous membrane and the nanocrystalline drug are electrically charged, and an electrical charge on the surface of the microporous membrane is of the same polarity as an electrical charge on the nanocrystalline drug.
However, Leone teaches a design of an infusion balloon catheter wherein the surface (column 2, lines 30-33, surface of “microporous membrane”) of the device and the drug are electrically charged (column 2, lines 30-33, “hydrophilic”), and an electrical charge on the surface of the device is of the same type as an electrical charge on the drug for the purpose of improving penetrability of medications through the micropores of the microporous membrane (column 2, lines 30-33).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the charge of the microporous membrane and the nanocrystalline drug of Weber to incorporate a charge wherein a charge on the surface of the microporous membrane is of the same type as a charge on the nanocrystalline drug as taught by Leone for the purpose of rapidly delivering the drug to a tissue and delivering the drug while reducing premature loss the drug from the device (paragraph 0123).
Regarding claim 5, Weber discloses the microporous membrane 20 (figure 1B, paragraph 0082, “SIBS coating applied on the balloon surface is construed as a part of the membrane and since SIBS coating is porous, membrane is construed as porous membrane) has a pore size (porous membrane would have a pores of certain size).
However, Weber does not expressly disclose the pore size in the range from 0.2µm to 0.8µm as required by claim.
Weber discloses (paragraph 0054) that the pores of certain size is necessary for optimally filling the pore structures with the active agents. As explained in paragraph 0054, the optimized filling of the pore structure with the active agents is disclosed to be a result effective variable in that changing the pore size would affect the filling of the pore structure with the active agents. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Weber device to have the pore size within the claimed range, as it involves only adjusting the pore size. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing of the claimed invention to modify the device of Weber by making the pore size in the range from 0.2µm to 0.8µm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, Weber discloses wherein the microporous membrane has a thickness in a range from 1µm to 200µm (paragraph 0040).
Regarding claim 13, Weber discloses wherein the device body is a balloon (paragraph 0030, lines 2-6).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531) and further in view of Claude et al. (US 2002/0146557 A1).
Regarding claim 3, Weber/Leone (hereinafter referred as “modified Weber”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the microporous membrane is formed from at least one of nylon, polyvinylidene fluoride, mixed cellulose, polytetrafluoroethylene, polypropylene, polyethersulfone, or glass fibers.
However, Claude teaches a design of a medical device wherein the microporous membrane is formed from at least one of nylon, polyvinylidene fluoride, mixed cellulose, polytetrafluoroethylene (paragraph 0007, lines 16-22), polypropylene, polyethersulfone, or glass fibers for the purpose of using a biocompatible material that enables drug adsorption using appropriate manufacturing approach (paragraphs 0007, 0009, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the porous membrane (20) of modified Weber to incorporate wherein the microporous membrane is formed from at least one of nylon, polyvinylidene fluoride, mixed cellulose, polytetrafluoroethylene, polypropylene, polyethersulfone, or glass fibers as taught by Claude for the purpose of using a biocompatible material that enables drug adsorption using appropriate manufacturing approach (paragraphs 0007, 0009, lines 1-4).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531) and further in view of Blankenship (US 2004/0267197 A1).
Regarding claim 4, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the microporous membrane has a porosity in a range from 40% to 90%.
However, Blankenship teaches a design of a balloon (figure 1) wherein the microporous membrane has a porosity in a range from 40% to 90% (paragraph 0008, lines 1-6) for the purpose of designing a balloon that has a relatively high strength, low profile design (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the microporous membrane of modified Weber to incorporate wherein the microporous membrane has a porosity in a range from 40% to 90% as taught by Blankenship for the purpose of designing a balloon that has a relatively high strength, low profile design (abstract).
Claims 7, 8, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531) and further in view of Jenkins et al. (US 2008/0317843 A1).
Regarding claim 7, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber discloses the use of stabilizer (paragraph 0082 “stabilized with 50% by weight lecithin”) but is silent regarding further comprising a stabilizer adsorbed on a surface of the nanocrystalline drug, wherein the mass of the stabilizer is in a range from 0.2% to 20% of a total mass of the nanocrystalline drug.
However, Jenkins teaches a design of a nanoparticle formulation comprising a stabilizer (paragraph 0104) adsorbed on a surface of the nanocrystalline drug, wherein the mass of the stabilizer is in a range from 0.2% to 20% of a total mass of the nanocrystalline drug (paragraph 0105, lines 14-20) for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4) and providing a stabilized drug composition (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the stabilizer of modified Weber to incorporate comprising a stabilizer adsorbed on a surface of the nanocrystalline drug, wherein the mass of the stabilizer is in a range from 0.2% to 20% of a total mass of the nanocrystalline drug as taught by Jenkins for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4) and providing a stabilized drug composition (paragraph 0042).
Regarding claim 8, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the stabilizer is selected from at least one of poloxamer, polyvinylpyrrolidone (PVP), tween, hydroxypropyl methyl cellulose (HPMC), dextran, sodium dodecyl sulfate (SDS), sodium carboxymethylcellulose and polyvinyl alcohol (PVA).
However, Jenkins teaches wherein the stabilizer is selected from at least one of poloxamer, polyvinylpyrrolidone (PVP), tween, hydroxypropyl methyl cellulose (HPMC), dextran, sodium dodecyl sulfate (SDS), sodium carboxymethylcellulose and polyvinyl alcohol (PVA) (paragraph 0108) for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4) and providing a stabilized drug composition (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the stabilizer of modified Weber to incorporate wherein the stabilizer is selected from at least one of poloxamer, polyvinylpyrrolidone (PVP), tween, hydroxypropyl methyl cellulose (HPMC), dextran, sodium dodecyl sulfate (SDS), sodium carboxymethylcellulose and polyvinyl alcohol (PVA) as taught by Jenkins for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4) and providing a stabilized drug composition (paragraph 0042).
Regarding claim 10, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the nanocrystalline drug has a particle size in a range from 20nm to 300nm.
However, Jenkins teaches wherein the nanocrystalline drug has a particle size in a range from 20nm to 300nm (paragraph 0002, lines 8-10) for the purpose of using an appropriate particle size to deliver the agent into the patient’s body (paragraph 0002).
While Jenkins does not explicitly disclose the particle size in a range from 20nm to 300nm.
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 particle size in a range from 20nm to 300nm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0053] indicating the particle size “may” be within the claimed range).
Regarding claim 12, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the nanocrystalline drug, a mass percentage of crystalline drugs is in a range from 70% to 100%.
However, Jenkins teaches wherein the nanocrystalline drug, a mass percentage of crystalline drugs is in a range from 70% to 100% (paragraph 0105, lines 8-14, paragraph 0247, Modafinil is crystalline drug) for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the nanocrystalline drug to incorporate a mass percentage of crystalline drugs is in a range from 70% to 100% as taught by Jenkins for the purpose of achieving a desirable formulation (paragraph 0106, lines 1-4).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531) in view of Jenkins et al. (US 2008/0317843 A1) and further in view of Karpf (US 2011/0117179 A1).
Regarding claim 9, modified Weber/Jenkins (hereinafter referred as “modified Weber ‘42”) discloses the claimed invention substantially as claimed, as set forth above in claim 7. Modified Weber ‘42 is silent regarding the nanocrystalline drug is anti-hyperplasia drug.
However, Karpf teaches a design of a composition wherein the drug is anti-hyperplasia drug (paragraph 0114, lines 1-10) for the purpose of treating the patient suffering from hyperplasia condition (paragraph 0114, lines 1-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the nanocrystalline drug of modified Weber ’42 to incorporate anti-hyperplasia drug as taught by Karpf for the purpose of treating the patient suffering from hyperplasia condition (paragraph 0114, lines 1-10).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Weber et al. (US 2012/0150142 A1) in view of Leone (US 5,318,531) and further in view of Farokhzad et al. (US 2012/0156135 A1).
Regarding claim 11, modified Weber discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Weber is silent regarding wherein the nanocrystalline drug has a spherical, rod-like, worm-like or disk-like morphology.
However, Farokhzad teaches a design of nanoparticles wherein the nanocrystalline drug has a spherical, rod-like, worm-like or disk-like morphology (paragraph 0076, lines 4-7) for the purpose of using a well-known shape for designing nanocrystalline drug (paragraph 0076, lines 4-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shape of the nanocrystalline drug to incorporate a spherical, rod-like, worm-like or disk-like morphology as taught by Farokhzad for the purpose of using a well-known shape for designing nanocrystalline drug (paragraph 0076, lines 4-7).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM 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, CHELSEA STINSON can be reached at 571-270-1744. 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.
/NILAY J SHAH/Primary Examiner, Art Unit 3783