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 .
Status of the Claims
By amendment filed February 01, 2026, claim 1 has been amended. Claims 1 through 20 are currently pending.
Response to Arguments
Applicant’s arguments, filed February 01, 2026, with respect to the rejections of the claims 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 Therefore, the rejection has been withdrawn.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 the previously cited prior art and new prior art necessitated by the amendments to the claims. As will be discussed further within this Office Action, Helmus (U.S. Patent # 5,569,463) taught that it was known in the art to form pockets/islands of active material on the surface of a catheter comprising a polymer coating. Therefore, the claims are still obvious in view of the known prior art.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the polysaccharide comprising layer of Rubben formed and outer layer, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant’s argument that the active substances forming “islands or pockets” produced an unexpected result of increased adhesion of polysaccharides to the substrate surface is not persuasive because applicant has not provided any objective evidence that the claimed process produced unexpected results over the prior art. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). See MPEP section 716.02(b). Furthermore, the citation of Heinrich is not persuasive because this document has not been filed with the Office nor has applicant provided any explanation on how the document showed unexpected results of the claimed process over the prior art. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). See MPEP section 716.02(b).
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lennox (U.S. Patent # 6,280,411) in view of Rubben (U.S. Patent Publication No. 2015/0258311) and Helmus et al (U.S. Patent # 5,569,463).
In the case of claims 1 and 18-20, Lennox teaches a medical device including a substrate that was expandable used of the localized delivery of drug agents and a method of forming the medical device (Abstract and Column 1 Lines 5-7). Lennox teaches that the medical device was a balloon/expandable catheter comprising a balloon/expandable portion 120 which was at least partially wetted/coated with a first solution in the form of a polymer solution to form a polymer coating 130 on the surface of the balloon/expandable portion 120 (Column 2 Line 42 through Column 3 Line 6). Lennox further teaches that the polymer was a polysaccharide (Column 3 Lines 7-15). Lennox further teaches that after wetting/coating the surface with the polymer the polymer was wetted with a second solution containing an active substance in the form of a solution comprising a drug agent (Column 5 Lines 37-52).
Though Lennox teaches having applied the active substance/drug agent multiple times (Column 5 Lines 59-62) Lennox does not teach having applied the active substance as a primary solution to the surface of the balloon prior to application of the first/polymer solution.
Rubben teaches a method for coating the balloon of a balloon catheter with an active ingredient from a solution wherein the solution comprising the active ingredient was applied to the surface of the balloon prior to applying the solution of polysaccharide (Abstract). Furthermore, Rubben teaches having applied the solution of the active agent multiple times in order to increase the active agent load on the balloon surface (Page 3 Paragraph 0031).
Based on the teachings or Rubben, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have applied/wetted the surface of the balloon of Lennox with a primary solution containing an active substance/drug agent before applying the first/polymer solution in order to increase the load/amount of drug agent/active substance on the surface of the balloon.
Though Lennox in view of Rubben teach having wetted a part of the surface of the balloon with a solution containing an active substance neither reference teaches that the active substance formed islands on the surface of the balloon surface.
Helmus teaches a medical device including a catheter comprising a polymer layer overlaying a polymer reservoir incorporating an active agent (Abstract, Column 1 Lines 10-12 and Column 2 Line 57). Helmus teaches that the medical device was coated with a reservoir polymer layer comprising an active agent on which was coated a polymeric surface layer comprising an elutable component in the form of polysaccharides (Column 3 Lines 24-65). Helmus taches that the active agent in the reservoir was in the form of pockets/islands (Column 5 Lines 16-22).
Based on the teachings of Helmus, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have formed the active substance of Lennox in view of Rubbin as islands on the surface of the balloon because this was a known configuration in the art for active substances on the surface of catheters.
As for claim 2, Lennox does not tach having further wetted the balloon surface with a water and/or at least one alcohol and/or at least one ketone containing liquid after wetting the surface with the active substance.
Rubben teaches a method for coating the balloon of a balloon catheter with an active ingredient from a solution, wetting the surface with a polysaccharide solution and having wetted the surface with a liquid containing water and/or at least one alcohol (Abstract). Rubben teaches that wetting the surface of the balloon coated with an active agent coating embrittled the coating allowing for the active substance to be homogeneously distributed within the polysaccharide coating/matrix (Page 2 Paragraph 0014).
Based on the teachings of Rubben, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have further applied a liquid containing water and/or at least one alcohol to the balloon surface of Lennox coated with the polymer/polysaccharide coating and drug agent/active substance coating in order to embrittle the coating allowing for the homogenous distribution of the drug agent/active substance within the polymer/polysaccharide coating.
As for claims 3 and 7, Rubben teaches that the liquid containing water and/or at least one alcohol contained ketone and/or alcohols including ethanol, methanol, acetone and/or isopropanol which were present in the range of about 10 to 70% (v/v) (Page 2 Paragraph 0017).
As for claims 4-6, Lennox teaches that the polymer coating was loaded/wetted with the drug agent/active agent solution multiple times wherein the drug agent/active agent was the same or different from previous applications (Column 5 Lines 59-62). Furthermore, as was discussed previously these solutions contained water and/or alcohol in the range of 10 to 70% (v/v).
As for claims 8-11, Lennox does not teach that the first/polymer solution and/or the second/drug agent solution contained one or several alcohols. However, as was discussed previously, the polymer solution of Lennox comprised polysaccharides.
Rubben teaches that the polysaccharide was applied as an aqueous solution comprising one or several alcohols including ethanol, methanol and/or isopropanol wherein the alcohol was present in the amount of 10% to 70% (v/v) or 30 to 65% (v/v) (Page 2 Paragraph 0021).
Based on the teachings of Rubben, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have applied the polymer/polysaccharide solution of Lennox as an aqueous alcohol containing solution wherein the alcohol was ethanol, methanol and/or isopropanol in the amount of 10 to 70% (v/v) because this was a known method in the art for forming a polymer/polysaccharide coating on the surface of a catheter balloon.
As for claims 12-14, Lennox does not teach that the polysaccharide of the first/polymer solution had any of the properties of claims 12-14. However, Rubben teaches that the polysaccharide used was a dextran polysaccharide soluble in water having an average molar mass of approximately 40,000 Da (Page 2 Paragraphs 0021-0024).
Based on the teachings of Rubben, at the time the present invention was effectively filed it would have been obvious to one of ordinary skill in the art to have used a water-soluble dextran polysaccharide with an average molar mass of 40,000 Da as the polysaccharide of Lennox because this was a known polysaccharide in the art for forming a polymer coating on the surface of a balloon catheter.
As for claims 15 and 16, Lennox teaches that the active substance/drug agent included hydrophobic agents including substances that modifying cell proliferation, corticosterone/corticosteroid and paclitaxel (Column 4 Lines 22-39).
As for claim 17, Lennox teaches that the fist solution/polymer solution did not contain an active substance (Column 2 Line 57 through Column 3 Line 6).
Conclusion
Claims 1 through 20 have been rejected. No claims were allowed.
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 MICHAEL P WIECZOREK whose telephone number is (571)270-5341. The examiner can normally be reached Monday - Friday, 6:00 AM - 3:30 PM.
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/MICHAEL P WIECZOREK/Primary Examiner, Art Unit 1712