DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 8 is objected to because of the following informalities: line 2 should be amended to - wherein the balloon of the balloon catheter can be inflated to more than 15 bar, -. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: line 2 should be amended to - wherein the balloon of the balloon catheter can be inflated to more than 15 bar, -. Appropriate correction is required.
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.
Claim 16 is 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.
Regarding claim 16:
The claim is unclear because of the limitation “The medical device as claimed in claim 7,” in line 1. The limitation is unclear since the claim depends on a claim that has been canceled. For the sake of examination, the office has assumed that the claim depends on claim 1. Further, the applicant should note making this claim dependent on claim 1 would make it identical to claim 8.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 9, 11-15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011119159 A1 by Wang.
Wang discloses:
Regarding claim 1:
A medical device (figure 1) for at least periodical contact with diseased vessels, comprising: an elongated hollow body (12) with an outer surface (see the outer surface of 12 as shown in figure 1),
wherein the outer surface comprises a non-stretchable, pressure-resistant membrane (see the balloon 12 which is consistent with the applicant’s disclosure which indicates the “non-elastic compression resistant membrane, wherein the membrane is preferably the balloon of a balloon catheter” page 8, lines 10-15; further, the balloon is a folding balloon catheter (non-stretchable) as indicated in ¶081) wherein the pressure-resistant membrane comprises a polyamide (reference indicates the balloons can be made of polyamide; ¶0219), polyether block amide, polyethylene, polyethylene terephthalate or their copolymers and/or blends,
wherein an active substance or active substance mixture comprising a restenosis inhibitor (see the active substance paclitaxel disclosed below) which is specific for delivery onto a vessel wall is disposed on the outer surface (layer on the surface as indicated in ¶0109),
wherein the active substance or the active substance mixture comprises or consists of paclitaxel (see ¶0109 which indicates paclitaxel is used as a therapeutic agent and ¶0107 which indicates the therapeutic agent is used as a layer on the balloon) as the restenosis inhibitor and is present on the outer surface, at least in regions, in a proportion of > 6 µg/mm2 (see ¶0108 which indicates the therapeutic agent (paclitaxel) portion can be 1 to 20 µg/mm2),
wherein the medical device is a balloon catheter (see “balloon catheter” in ¶0106),
wherein, auxiliary substances are disposed on the outer surface, and wherein said auxiliary substances are selected from a group consisting of organically bound iodine (see ¶0213), urea (¶032), magnesium salts, dexpanthenol (¶041), iopamidol, iopromide (¶0213), iomeprol, iohexol, and magnesium stearate (¶0170) and combinations thereof.
Regarding claim 4:
The medical device as claimed in claim 1, wherein, in addition to the auxiliary substances, lipophilic antioxidants (¶0234), are disposed on the outer surface of the medical device.
Regarding claim 5:
The medical device as claimed in claim 1, additionallv comprising an organically bound iodine is disposed on the outer surface at least in regions in a loading density in the range from 0.1 µg/mm2 to 0.5 µg/mm2 (the reference teaches that the drug content (active substance and auxiliary substance) can be 2.88 µg/mm2 or 6.29 µg/mm2 which when multiplied by the weight percentage for the auxiliary substance/iodine would be (1 to 45% as indicated in ¶0252) could be .0288 to 1.296 µg/mm2 which reads on the claim).
Regarding claim 9:
A method for coating a medical device for the treatment of diseased vessels, comprising:
coating the medical device (see ¶022) with a solution comprising a solvent (see ¶0249), a restenosis- inhibiting active substance (see ¶018 and ¶0109 which indicates paclitaxel is used as a therapeutic agent and ¶0107 which indicates the therapeutic agent is used as a layer on the balloon) and an auxiliary substance comprising organically bound iodine forming a matrix for the active substance (¶0213 where iodine can be an auxiliary/contract agent or iopromide as indicated in ¶0131/¶0213),
wherein the auxiliary substance contains the organically bound iodine in a concentration in the range from 1.2% to 12.5% by weight, with respect to the active substance in the solution (see ¶0131/0213 which indicates the auxiliary substance/contracting agent/additive can be iopromide and ¶0253 which indicates the additive in the coating solution can be between 1-45% by weight), and
wherein the organically bound iodine is present as iopromide, iopamidol and/or iomeprol (see ¶0131/0213 which indicates the auxiliary substance/contracting agent/additive can be iopromide and ¶0253 which indicates the additive in the coating solution can be between 1-45% by weight).
Regarding claim 11:
The method as claimed in claim 9, wherein the solution contains paclitaxel in a concentration in the range from 100 mg to 200 mg in 5 mL of solution (¶0328 indicates paclitaxel can include 50-150 mg in 2-6 mL acetone solution).
Regarding claim 12:
The method as claimed in claim 9, wherein the solution contains acetone (¶0250), water (¶0250) and/or ethanol (¶0250) as the solvent, and wherein the solvent contains 3% to 25% by volume of water (see ¶0252 which indicates solvents can be between 0.1-80% by weight).
Regarding claim 13:
A method for coating a medical device (see ¶022) for the treatment of diseased vessels, comprising the following steps in the given order:
(a) preparing a solution comprising a solvent (see ¶0249), a restenosis-inhibiting active substance (see ¶018 and ¶0109 which indicates paclitaxel is used as a therapeutic agent and ¶0107 which indicates the therapeutic agent is used as a layer on the balloon) and an auxiliary substance comprising organically bound iodine forming a matrix for the active substance (¶0213 where iodine can be an auxiliary/contract agent or iopromide as indicated in ¶0131/¶0213), wherein the auxiliary substance contains the organically bound iodine in a concentration in the range from 1.2% to 12.5% by weight with respect to the active substance in the solution, and wherein the organically bound iodine is present as iopromide, iopamidol and/or iomeprol (see ¶0131/0213 which indicates the auxiliary substance/contracting agent/additive can be iopromide and ¶0253 which indicates the additive in the coating solution can be between 1-45% by weight);
(b) applying the solution to at least regions of an outer surface of the medical device, by dipping, spraying or wetting (¶0256) with a volumetric measuring device (tools for spraying and dipping are volumetric measuring devices since they control the amount of substance applied as indicated in ¶0256 by line “each layer is usually deposited on the medical device in multiple application steps in order to control the uniformity and the amount of therapeutic substance and additive applied to the medical device”); and
(c) drying the medical device (see ¶0261 “The balloon is repeatedly sprayed with the coating solution, followed by drying, until an effective amount of the drug is deposited on the balloon”).
Regarding claim 14:
The method as claimed in claim 13, wherein the device comprises an inflatable balloon in an inflated state in step (b), the outer surface of the balloon is coated in the inflated state. at least in the regions of the outer surface of the medical device (¶0260 -¶0262 indicates the balloon can be inflated or partially inflated prior to and during spraying).
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 5 by Wang.
Regarding claim 17:
The method as claimed in claim 11, wherein the solution contains acetone, water and/or ethanol as the solvent, and wherein the solvent contains 3% to 25% by volume of water (¶0252 indicates the drug and additives can be 0.1-80% by weight indicating the solvent can be 20 - 99.9 % by weight and assuming the solvent is water then dividing the wt% by specific gravity of water (1) then the volume percent would be 20-99.9% which would overlap with the claimed range).
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.
Claim(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2011119159 A1 by Wang as applied to claims 6 and 7 above, and further in view of US 20080157444 A1 to Melsheimer.
Regarding claim 8:
Wang fails to disclose:
The medical device as claimed in claim 1, wherein the balloon can be inflated to more than 15 bar.
Melsheimer teaches:
A balloon catheter (see figure 3) where the balloon is constructed to withstand pressures of up to 30 bar (see ¶0036). This increase in pressure prevents the balloon from rupturing when in use in a patient (¶0036).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to make the balloon catheter in Wang from the same methods (and therefore allowing it to inflate to pressure of 30 bar) as taught by Melsheimer in order to prevent a rupturing of the balloon in the user at higher pressures (Melsheimer, ¶0036).
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 8 by Wang and Melsheimer.
Response to Arguments
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 of claims 1, 9 and 13:
The applicant provides several arguments as to why the above rejections are improper and should be withdrawn. However, the office is not persuaded by these arguments.
First, the applicant argues that the Wang reference fails to disclose the specific combinations claim of high-dose Ptx with organically bound iodine in the appropriate loading quantity and a balloon with the appropriate membrane properties (se page 7 of the remarks). The office would point out that nothing in the claims indicate high-dose Ptx and by extension the substances required by the claim are disclosed as indicated above. The applicant further argues that the substances required by the claim are recited in a laundry list and there is no disclosure of the combination as recited by the claim. While it is true that many substances are indicated in several lists, the claiming of these substances is not broad and therefore similar to the instance outlined in MPEP 2144.05(I) since the particular substances are explicitly stated in the list. The specification does not broadly claim an active substance or active substance mixture, restenosis inhibitor or auxiliary substances. The reference mentions the specific substances are required by the claim including polyamide, paclitaxel and organically bound iodine, urea, dexpanthenol and magnesium stearate as indicated above.
Second, the applicant indicates that the balloon catheter in Wang is a general balloon catheter and therefore applies to every balloon catheter in the world (see page 7 of the remarks). However, as indicated above the Wang reference refers to a folding balloon catheter as required by the new amendments to the claim and as indicated in the applicant’s disclosure. For this reason, the reference is interpreted to read on the claim.
Third the applicant argues that range for the active substance is encompassed by the range disclosed in the Wang reference but that the range is so broad that it could not read on the applicants disclosed reference (see page 7 of the remarks). However, as indicated by the applicant, the range is twice the amount required by the claim which is not broad simply double the amount required by the claim. Further, there is not argument that the range is not disclosed only that the range is two broad to read on the range required by the claim. The office is not persuaded by this argument since it is not a broad statement of possible ranges (like any amount greater than 1 µg/mm2 for example) but simply a range that overlaps with the range required by the claim.
Regarding the 35 USC 103 rejection of claims 8 and 16:
The applicant has argued that the Wang reference does not disclose that the combination of paclitaxel and iopromide is novel and non-obvious and further includes unexpected results (see page 8 of the remarks). However, as indicated above, the reference does teach using this combination and the claimed ratios. Since reference teaches the required amounts and combination, it is interpreted to read on the claims and the rejections are maintained even if the benefits of the combination of materials is not disclosed by the reference. For this reason, the above rejections are maintained.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn. However, the new rejections are made based on the applicant’s amendments to the claims.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn. However, a new set of objections have been made above.
Regarding the drawing objections:
The applicant’s amendments to the drawings have addressed the drawing objections and for this reason they are withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783