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 12/01/2025 has been entered.
Claims 1, 11, 26 and 28 have thereby been amended.
Claims 6-8 and 10 have been canceled and claims 18-25 have been withdrawn from consideration.
Claim 29 has been added.
Claims 1-5, 9, 11-17, and 26-29 are being examined in this office action.
Claim Interpretation
The phrase “having a random ORIENTATION and an absence of uniformity” recited in claims 1, 11, 26 and 28 is interpreted as describing a random placement and/or orientation of the microcrystals.
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.
Claims 1-5, 9, 11-17, 26-27 and 29 are under 35 U.S.C. 103 as being unpatentable over Alston (US 20170367705) in view of Kangas (US 20110015664).
Regarding claim 1, Alston discloses a drug coated balloon, comprising: a balloon (Fig. 7A: 700) having an outer surface comprised of expanded polytetrafluoroethylene (745; page 7, para. [0097], sentence 1); and a drug coating layer on the outer surface of the balloon (Fig. 7B: 750; page 7, para. [0096], sentence 1), the drug coating layer containing at least one therapeutic agent (page 8, para. [0104], sentence 1), and wherein the drug coating layer comprises microcrystals in a haystack orientation having a random orientation and an absence of uniformity in placement on the outer surface of the balloon (page 7, para. [0093], sentences 1-2; Fig. 7B: 750 being on the outer surface; para. [0096], sentence 1, 750 being the drug coating), wherein about 80% of the drug coating layer releases from the balloon in about 100 minutes following implantation (page 3, para. [0034]). However, Alston discloses the drug coating layer as containing an excipient in addition to a therapeutic agent, and fails to disclose the drug coating layer only consisting of therapeutic agent(s).
Kangas teaches an analogous drug boated balloon with a crystal haystack formation (Figs. 3a-b; para. [0072]) which is formed with a therapeutic agent and without an excipient (para. [0025], sentences 3-4; claim 31). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Alston drug coating by incorporating the method of forming the drug coating without excipients, as taught by Kangas, such that the result is the same type of crystalline consisting of at least one therapeutic agent (the drug coating comprising paclitaxel and free from an excipient: para. [0074], sentences 11-12), with the benefit of not requiring the extra materials and steps of using an excipient.
Regarding claim 2, Alston in view of Kangas teaches the drug coated balloon of claim 1, as described above, the balloon being comprised of a composite of expanded polytetrafluoroethylene (Alston: Fig. 7B: 745; page 7, para. [0097], sentence 1) and nylon (Alston: Fig. 7B: 740; page 8, para. [0099], sentence 1 and last sentence).
Regarding claim 3, Alston in view of Kangas teaches the drug coated balloon of claim 1, as described above, wherein the at least one therapeutic agent comprises paclitaxel (Alston: page 9, para. [0105], sentence 1).
Regarding claim 4, Alston in view of Kangas teaches the drug coated balloon of claim 3, as described above, wherein the balloon is configured to deliver the paclitaxel to a tissue to reduce a cellular proliferative response associated with restenosis (Alston: page 9, para. [0105], sentences 1-2).
Regarding claim 5, Alston in view of Kangas teaches the drug coated balloon of claim 3, as described above, wherein the drug coating layer further comprises a therapeutic agent (Alston: pages 8-9, para. [0104], last two sentences) selected from docetaxel, protaxel, arsenic trioxide, thalidomide, atorvastatin, cerivastatin, Fluvastatin, betam ethasone diproprionate, dexamethasone 21 -palmitate, sirolimus, everolimus, zotarolimus, biolimus, or temsirolimus (Alston: page 9, para. [0105]).
Regarding claim 9, Alston in view of Kangas teaches the drug coated balloon of claim 1, as described above, wherein the drug coating layer penetrates the outer surface of the balloon by an average penetration depth of 2 µm to 10 µm (Alston: page 7, para. [0097], sentence 1).
Regarding claim 11, Alston discloses a drug coated balloon comprising: a balloon (Fig. 7A: 700) having an outer surface (Fig. 7B: 740 and 745); and a drug coating layer on the outer surface of the balloon (750; page 7, para. [0096], sentence 1), the drug coating layer containing at least one therapeutic agent (page 8, para. [0104], sentence 1; wherein the drug coating layer comprises microcrystals in a haystack orientation having a random orientation and an absence of uniformity in placement on the outer surface of the balloon (page 7, para. [0093], sentences 1-2; Fig. 7B: 750 being on the outer surface; para. [0096], sentence 1, 750 being the drug coating), wherein about 80% of the drug coating layer releases from the balloon in about 100 minutes following implantation (page 3, para. [0034]).
Regarding claim 12, Alston in view of Kangas teaches the drug coated balloon of claim 1, as described above, the outer surface further comprising nylon (Alston: Fig. 7B: 740; page 8, para. [0099], sentence 1 and last sentence). However, Alston discloses the drug coating layer as containing an excipient in addition to a therapeutic agent, and fails to disclose the drug coating layer only consisting of therapeutic agent(s).
Kangas teaches an analogous drug boated balloon with a crystal haystack formation (Figs. 3a-b; para. [0072]) which is formed with a therapeutic agent and without an excipient (para. [0025], sentences 3-4; claim 31). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Alston drug coating by incorporating the method of forming the drug coating without excipients, as taught by Kangas, such that the result is the same type of crystalline consisting of at least one therapeutic agent (the drug coating comprising paclitaxel and free from an excipient: para. [0074], sentences 11-12), with the benefit of not requiring the extra materials and steps of using an excipient.
Regarding claim 13, Alston in view of Kangas teaches the drug coated balloon of claim 8, as described above, wherein a majority of the microcrystals each have a major dimension length that is at least 10 times greater than a major dimension width (Alston: page 2, para. [0017], sentence 2).
Regarding claim 14, Alston in view of Kangas teaches the drug coated balloon of claim 13, as described above, wherein the major dimension length of the majority of the microcrystals is at least 13 times or at least 15 times greater than the major dimension length (Alston: page 2, para. [0017], sentence 2).
Regarding claim 15, Alston in view of Kangas teaches the drug coated balloon of claim 13, as described above, wherein the major dimension width of the majority of the microcrystals is between 0.5 µm and 2 µm (Alston: page 2, para. [0017], last sentence).
Regarding claim 16, Alston in view of Kangas teaches the drug coated balloon of claim 8, as described above, wherein the microcrystals have a random and substantial absence of uniformity in angles from the outer surface, and a majority of the microcrystals project from the outer surface at an angle of 50 degrees to 15 degrees (Alston: page 2, para. [0015]; page 10, para. [0114], sentence 2).
Regarding claim 17, Alston in view of Kangas teaches the drug coated balloon of claim 1, as described above, the outer surface comprised of expanded polytetrafluoroethylene (Alston: 745; page 7, para. [0097], sentence 1).
Regarding claim 26, Alston discloses a drug coated balloon, comprising: a balloon (Fig. 7A: 700) having an outer surface comprised of expanded polytetrafluoroethylene (745; page 7, para. [0097], sentence 1); and a drug coating layer on the outer surface of the balloon (750; page 7, para. [0096], sentence 1), the drug coating layer containing at least one therapeutic agent (page 8, para. [0104], sentence 1), and wherein the drug coating layer comprises microcrystals in a haystack orientation having a random orientation and an absence of uniformity in placement on the outer surface of the balloon (page 7, para. [0093], sentences 1-2; Fig. 7B: 750 being on the outer surface; para. [0096], sentence 1, 750 being the drug coating), wherein about 80% of the drug coating layer releases from the balloon in about 100 minutes following implantation (page 3, para. [0034]). However, Alston discloses the drug coating layer as containing an excipient in addition to a therapeutic agent, and fails to disclose the drug coating layer only consisting of therapeutic agent(s).
Kangas teaches an analogous drug boated balloon with a crystal haystack formation (Figs. 3a-b; para. [0072]) which is formed with a therapeutic agent and without an excipient (para. [0025], sentences 3-4; claim 31). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Alston drug coating by incorporating the method of forming the drug coating without excipients, as taught by Kangas, such that the result is the same type of crystalline consisting of at least one therapeutic agent (the drug coating comprising paclitaxel and free from an excipient: para. [0074], sentences 11-12), with the benefit of not requiring the extra materials and steps of using an excipient.
Regarding claim 27, Alston in view of Kangas teaches the balloon of claim 26, as described above, wherein the fatty acids and their derivatives are selected from monocarboxylic acids (Alston: page 10, para. [0112], sentence 2), polysorbates, and shellac.
Regarding claim 29, Alston discloses a drug coated balloon, comprising: a balloon (Fig. 7A: 700) having an outer surface including an expanded polymer (745; page 7, para. [0097], sentence 1); and a therapeutic agent on the outer surface of the balloon (750; page 7, para. [0096], sentence 1), the therapeutic agent included in microcrystals arranged in a random, haystack orientation with an absence of uniformity in placement on the outer surface of the balloon (page 7, para. [0093], sentences 1-2; Fig. 7B: 750 being on the outer surface; para. [0096], sentence 1, 750 being the drug coating), the therapeutic agent configured to release from the balloon such that by 100 min under vascular physiologic conditions at least 80% of the drug coating layer is released from the balloon (page 3, para. [0034]). However, Alston discloses the drug coating layer as containing an excipient in addition to a therapeutic agent, and fails to disclose the drug coating layer only consisting of therapeutic agent(s).
Kangas teaches an analogous drug boated balloon with a crystal haystack formation (Figs. 3a-b; para. [0072]) which is formed with a therapeutic agent and without an excipient (para. [0025], sentences 3-4; claim 31). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Alston drug coating by incorporating the method of forming the drug coating without excipients, as taught by Kangas, such that the result is the same type of crystalline consisting of at least one therapeutic agent (the drug coating comprising paclitaxel and free from an excipient: para. [0074], sentences 11-12), with the benefit of not requiring the extra materials and steps of using an excipient.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 20170367705) in view of Cleek (US 20140271775).
Regarding claim 28, Alston discloses a drug coated balloon, comprising: a balloon (Fig. 7A: 700) having an outer surface comprised of expanded polytetrafluoroethylene (745; page 7, para. [0097], sentence 1); and a drug coating layer on the outer surface of the balloon (750; page 7, para. [0096], sentence 1), the drug coating layer comprising at least one therapeutic agent (page 8, para. [0104], sentence 1) and substantially free of an excipient (page 10, para. [0112], sentences 1-2: 0.5mg/mL of excipient with 15-35mg/mL of therapeutic agent equates to less than 3.33-1.43% excipient by weight), and wherein the drug coating layer comprises microcrystals in a haystack orientation having a random and an absence of uniformity in placement on the outer surface of the balloon (page 7, para. [0093], sentences 1-2; Fig. 7B: 750 being on the outer surface; para. [0096], sentence 1, 750 being the drug coating), wherein about 80% of the drug coating layer releases from the balloon in about 100 minutes following implantation (page 3, para. [0034]). However, Alston fails to specifically disclose the excipient as urea.
Cleek teaches an analogous composite expanded polytetrafluoroethylene paclitaxel drug delivery balloon, with a crystalline drug eluding coating. The Cleek device teaches the excipient used with the paclitaxel as urea (page 14, para. [0173], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Alston device by incorporating urea as the excipient as taught by Cleek in order to provide a cost-effective excipient that increases the solubility of paclitaxel for treatment (page 1, para. [0008], sentences 2-3). It directly follows that incorporating the specific excipient for Alston as the urea as taught by Cleek would result in the drug coating layer comprising from 0% to 4.75% by weight, as disclosed by Alston, of urea.
Response to Arguments
Applicant’s Arguments, filed 12/01/2025, regarding the prior art rejections of independent claims 1, 11 and 26, have been fully considered and are persuasive. However, in light of the amendments made to independent claims 1, 11 and 26, the claims stand rejected as recited above in view of Kangas. Kangas teaches that the same type of random crystalline structure of a drug coating layer can be formed without the excipient and with the drug agent only. Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this teaching my Kangas into the Alston device and method, reducing the number of materials and steps required, thereby meeting all limitations of the amended independent claims 1, 11 and 26.
Regarding Applicant’s argument that Alston fails to teach “80% of the drug coating layer releases from the ballon in about 100 minutes,” Examiner maintains this limitation is met by Alston. As the claims are currently written, given their broadest reasonable interpretation, 80% of the drug bust be released “within” 100 minutes, or even “by” 100 minutes, which does occur by the cited Alston teachings of that release occurring within 60 seconds.
Applicant’s Arguments, regarding the prior art rejections of independent claim 28, has been fully considered and is not persuasive, as the excipient of urea is still claimed, contrary to Applicant’s Arguments.
Furthermore, the now incorporated Kangas reference does teach a haystack crystal formation formed without an excipient.
For these reasons, claims 1-5, 9, 11-17, and 26-29, as they are currently written, stand rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783