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 .
Applicant's election without traverse of Group I in the reply filed on 07/24/25 is
acknowledged.
Claims 10, 12 withdrawn from further consideration pursuant to 37 CFR 1.142(b)
as being drawn to a nonelected Group II, there being no allowable generic or linking
claim. Election was made without traverse in the reply filed on 07/24/25.
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.
Claims 1, 3, and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath Mani et al (U. S. Patent Application: 2016/0121027, here after Mani),
further in view of Lixiao Wang (U. S. Patent Application: 2010/0209472, here after Wang), and Yung-Ming Chen et al (Chinese Patent: 103826757, here after Chen).
Claim 1 is rejected. Mani teaches a method for preparing a drug-coated balloon
controllable in drug metabolism (drug release balloon), wherein the method comprises
the following steps:
coating a balloon with drug-loaded formula comprising polymers (DS) and
therapeutics (PAT) [abstract], comprising step 1: mixing DS, PAT, a drug receptor protein inhibitor (metabolism modulator) [0210, 0211], a drug [0210, 0211], water, and ethanol to prepare a medicinal liquid [0297], applying the coating to the balloon by dipping, and step 5; drying the sprayed balloon to obtain the drug-coated balloon [0298 last line]. Although in this embodiment Mani teaches coating via dipping,
however, Mani also teaches coating can be done with spraying as well [0057].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the
invention was made to have a method of coating the balloon as Mani teaches and apply
the coating with spraying, because it is also a suitable to apply coating to balloons. Mani
teaches;
step 2: loading the medicinal liquid prepared in the step 1 into an ultrasonic spraying
equipment; and setting flow parameters [0298, 0242];
step 3: adjusting a distance between an ultrasonic nozzle of the ultrasonic spraying
equipment and the balloon [0242], spraying is at room temperature therefore the coating
is done in ambient temperature(controlled) at 25-28 °C;
step 4: turning on the ultrasonic spraying equipment and spraying along an axial
direction of the balloon (horizontal translation speed) [table 1A, 1B], and obviously back
and forth as known by ordinary skill in art; and Mani also teaches wetting a surface of
the balloon with ethanol [0298], but not before coating (spraying). However, Mani also
teaches repeating coating/drying steps to form desirable multilayered drug coated
device [0051]. Therefore, it would have been obvious to one of ordinary skill in the art at
the time of the invention was made to have a method of coating the balloon as Mani
teaches where steps of coating (and dehydration in ethanol) and drying, because it
helps to achieve desirable coating thickness layer. Each dehydration step is wetting the
surface with ethanol for next coating step (prior to coating or spraying step). Mani does
not teach rotating the balloon and adjusting the rotation speed of it during coating.
Wang teaches a method of coating a balloon where the balloon is rotating during
coating process, and also teaches adjusting the speed of rotation with sweeping motion
(back and forth) speed of sprayer [0262] to coat the balloon, and form unform coating
[0111 last line]. Therefore, it would have been obvious to one of ordinary skill in the art
at the time of the invention was made to have a method of coating the balloon as Mani
teaches where the balloon is rotated with adjusted speed, because it is important to
form uniform coating to release the drug uniformly to target tissues. Mani teaches in the composition comprising drug is siromilus(rapamycin) [0211]. Claim 4 is rejected. Mani teaches the drug is rapamycin(siromilus) [0211], but does not teach the drug receptor protein inhibitor is FKBP12 (an inhibitor of immunoaffinity protein). Chen teaches coating a balloon for drug release composition and teaches the drug is rapamycin and drug receptor protein inhibitor is FKBP12[0071]. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to have a method of coating the balloon as Mani teaches where the drug and inhibitor are based on Chen teaching, because Chen teaches suitable coating composition for drug released balloons.
Claim 3 is rejected. Mani teaches the drug metabolism modulator comprising the drug receptor protein inhibitor and bosentan (drug metabolism isoenzyme inducer) [0211].
Claim 5 is rejected as Mani teaches in the composition comprising drug
is siromilus(rapamycin), and imatinib (the drug metabolism isoenzyme inhibitor as an inhibitor of CYP3A4) [0211].
Claim 6 is rejected. Mani teaches the drug metabolism modulator comprising the drug receptor protein inhibitor and bosentan (drug metabolism isoenzyme inducer CYP3A4) [0211].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gopinath
Mani et al (U. S. Patent Application: 2016/0121027, here after Mani), Lixiao Wang (U. S.
Patent Application: 2010/0209472, here after Wang), Yung-Ming Chen
et al (Chinese Patent: 103826757, here after Chen), further in view of Idris Edmond Graziani et al (Canadian Patent: 2676613, here after Graziani).
Claim 4 is rejected. Chen does not teach protein inhibitor FKBP12 comprising 3-pyridin-3-ylpropyl-(2S)-1-(3,3-dimethyl-2-oxo-pentanoyl)-pyrrolidine-2-carboxylate (OR GPI1046). Graziani teaches a drug for cardiovascular disorder, where FKBP12 comprising GPI1046[table 2]. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to have a method of coating the balloon as Mani, Wang and Chen teach where the inhibitor FKBP12 comprising GPI1046, because it is suitable for cardiovascular disorder.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over
Gopinath Mani et al (U. S. Patent Application: 2016/0121027, here after Mani), Lixiao
Wang (U. S. Patent Application: 2010/0209472, here after Wang), Yung-Ming Chen et al (Chinese Patent: 103826757, here after Chen), and further in view of
Tetsuya Yasuhiro et al (WO 2006/137510, here after Yasuhiro).
Claims 7-9 are rejected. Neither of Mani nor Wang teach a ratio of the drug
receptor protein inhibitor to the drug is 0.25-4: 1. Yasuhiro teaches a ratio of drug
receptor protein inhibitor to the drug is 0.01-100[0046]. Therefore, it would have been
obvious to one of ordinary skill in the art at the time of the invention was made to have a
method of coating the balloon as Mani and Wang where a ratio of drug receptor protein
inhibitor to the drug is 0.01-100, because it is suitable ratio for making drug treatment
balloons. Although it does not teach a ratio of 0.25-4: 1. However overlapping ranges
are prima facie evidence of obviousness. It would have been obvious to one having
ordinary skill in the art to have selected the portion of [overlapping range] that
corresponds to the claimed range. In re Malagari, 182 USPQ 549 (CCPA 1974).
and a drug metabolism slows down as a function of an increase of an addition
amount of the drug receptor protein inhibitor. Therefore, it would have been obvious to
one of ordinary skill in the art at the time of the invention was made to have a method of
coating the balloon as Mani, Wang, and Chen where a ratio of drug receptor protein inhibitor to the drug is 0.25-4:1, because one having ordinary skill in the art to have selected the portion of the overlapping range that corresponds to the claimed range in absence of criticality. a drug metabolism slows down as a function of an increase of an addition amount of the drug receptor protein (metabolism isoenzyme inhibitor/ or inducer).
Response to Arguments
Applicant's arguments filed 01/06/26 have been fully considered but they are not persuasive. The applicant argues Mani does not teach addition of a drug receptor protein inhibitor, a drug metabolism isoenzyme inhibitor, or an inducer. The examiner disaggregate, Mani teaches therapeutic agent comprising rapamycin, bosentan (drug metabolism isoenzyme inducer), imatinib (the drug metabolism isoenzyme inhibitor as an inhibitor of CYP3A4) [0211], or drug receptor protein inhibitor [0210].
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.
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/TABASSOM TADAYYON ESLAMI/Primary Examiner, Art Unit 1718