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 .
Drawings
The drawings were received on 11/26/2025. These drawings are acceptable and approved.
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.
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, 4-5, 11-15, are rejected under 35 U.S.C. 103 as being unpatentable over Root et al (US 20160066932 A1) in view of Shturman (US 5181911 A) and Fox et al (US 20180093079 A1).
Regarding claims 1 and 11, Root discloses a method and a perfusion catheter assembly comprising:
passing a perfusion catheter assembly (300), including a balloon (328) comprising a series of helical windings 342 and an elongate shaft (326) that is operably attached to the balloon (fig. 3), into a blood vessel until the balloon is positioned adjacent a lesion or abnormality in a wall of the blood vessel ([(0031] advanced and directed through vasculature for treatment at the vessel wall injury),
inflating the balloon ([0036] figure 4 is enlarged view of figure 3), including urging fluid into the series of helical windings to move the balloon from a deflated configuration to an inflated configuration (abstract, [0007]), at which an outer surface of the balloon engages the wall of the blood vessel (balloon is introduced and advanced in deflated state, [0037] fig. 5 is also view of fig. 3, once at the treatment site, balloon is inflated; balloon impinges or engages vessel wall) and an inner surface of the balloon defines a passage (544) for bodily fluid to flow ([0037] blood can flow through inner passage defined by balloons windings, see fig. 5); and
maintaining the balloon in the inflated configuration at the lesion or abnormality ([(0038] prolonged inflation for temporary hemostasis in perforations or dissections).
However, Root fails to disclose:
wherein an outer surface of the balloon comprises a bioactive layer overlaid upon a base layer, the bioactive layer including one or more drugs, therapeutic agents, or combinations thereof formulated to treat a tissue at or near the wall of the blood vessel, and the base layer lacking any drugs and therapeutic agents and instead configured to provide a smooth foundation over the series of helical windings for the bioactive layer, and configured to fill the valley between adjacent helical windings, thereby allowing release of the one or more substances into the tissue at or near the wall of the blood vessel.
Shturman teaches a catheter (fig 16; col. 5 lines 39-54) comprising a helical balloon 32 with an outer base layer 93 on the outer surface (flexible thin or thick layer/skin; claim 3) configured to provide a smooth foundation over the series of helical windings to treat tissue at a wall of a blood vessel; wherein maintaining the balloon in the inflated configuration at the lesion or abnormality during release of the one or more substances into the wall of the blood vessel (col 3, lines 30-40).
Fox teaches a catheter including a balloon having a coating (hydrophilic lubricious coating to enhance lubricity and decrease friction) with a layer of a bioactive drug [0005, 0007, 0045, 0095-0096,0100, 0136].
Given the teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Root’s helical balloon with the teachings of Shturman and Fox by incorporating smooth outer base layer (from both references) on the helical balloon and a bioactive drug (taught by Fox) to improve the retention on the helical balloon and release of the bioactive drug. Furthermore, one of ordinary skill in the art would recognize another art advantage in having the agent on a balloon (with or without a base layer including a bioactive layer) instead of as a separate device delivered after inflation, as producing reduced time of the procedure. The agent can be delivered as soon as the balloon in inflated instead of waiting fora separate device, thus reducing procedure time and enhancing effectiveness of the agent delivered.
Regarding claims 4- 5 and 12-15, Root/Shturman/Fox discloses the invention substantially as claimed. However, they fail to disclose the bioactive layer further comprises one or more diagnostics or excipients (claim 4); and the one or more excipients consisting of an antioxidant, urea, propyl gallate, a hydrophilic additive, or combinations thereof (claim 5); (claim 12) the base layer comprises one or more excipients; ( claim 14) the one or more substances consist of one or more drugs, therapeutic agents, diagnostic agents, or combinations thereof, and (claim 15) the bioactive layer further comprises one or more excipients.
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 bioactive layer composition by including one or more diagnostic or excipients into the bioactive layer since such modification an obvious design choice well within the ordinary skill artisan through routine experimentation in optimizing the drug delivery results and/or treatment.
Claims 6-10, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Root et al in view of Shturman and Fox et al as applied to claim 1 above, and further in view of Ehrenreich et al. (US 8049061 B2).
Regarding claims 6-10, Root discloses the perfusion catheter assembly further comprising a containment structure ([0034] sheath (not shown) that can be disposed around the balloon 328 in figure 3 so that it can be more easily be inserted or removed from a patient and therefore surround at least a portion of the bioactive layer.
However, modified Root fails to disclose the containment structure surrounding at least a portion of the bioactive layer (claim 6); further comprising removing the containment structure before release of the bioactive layer into the tissue at or near the wall of the blood vessel (claim 7); wherein removing the containment structure comprises degradation of the containment structure (claim 8); wherein removing the containment structure comprises extraction of the containment structure from the blood vessel in a distal-to-proximal direction. (claim 9); and the containment structure comprises a protective sheath (claim 10).
Ehrenreich teaches a containment structure (120 in figure 5; col. 6, lines 25-54 or 126 in figure 6) where the containment structure 120 can be dissolvable, biodegradable or disintegrable upon expansion or inflation of the expandable member therefore removing the containment structure 120 from the bioactive layer after it has been protected from premature elution of the therapeutic agent into vasculature by the combination of the bioactive layer and base layer. Also, (claim 9), Root discloses removing the containment structure (sheath) comprises extraction of the containment structure from the blood vessel in a distal-to-proximal direction [0034]. (Claim 10), Ehrenreich also discloses the containment structure is a protective sheath (120,126).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Root containment structure (sheath) by providing it with the teachings of Ehrenreich containment structure and bioactive material/base layer dissolvable, biodegradable or disintegrable upon expansion or inflation of the expandable member allowing rapid release of the therapeutic material.
Regarding claims 16 and 20, Root discloses a perfusion catheter assembly, comprising:
a balloon 328 including a series of helical windings 342, wherein, when in an inflated configuration, an inner surface of the balloon defines a passage for bodily fluid to flow (figs 4-5);
a containment structure (sheath not shown [0034]) surrounding at least a portion of the balloon; and
an elongate shaft 326 operably attached to the balloon and including a lumen 330 in fluid communication with the series of helical windings, the lumen configured to allow a flow of fluid into the series of helical windings to move the balloon from a deflated configuration to the inflated configuration [0032].
However, Root fails to disclose 1) a bioactive layer including one or more substances formulated to treat a tissue at or near a wall of a blood vessel; 2) a base layer positioned between an outer surface of the balloon and the bioactive layer, the base layer lacking any drugs and therapeutic agents and configured to provide a smooth foundation over the series of helical windings of the balloon, and 3) the containment structure shielding the bioactive layer from insertion shear forces or bodily liquid solvents.
Shturman teaches a catheter (fig 16; col. 5 lines 39-54) comprising a helical balloon 32 wherein, when in an inflated configuration, an inner surface of the balloon defines a passage for bodily fluid to flow, with an outer base layer 93 on the outer surface (flexible thin or thick layer/skin; claim 3); the base layer lacking any drugs and therapeutic agents and configured to provide a smooth foundation over the series of helical windings to treat tissue at a wall of a blood vessel; wherein maintaining the balloon in the inflated configuration at the lesion or abnormality during release of the one or more substances into the wall of the blood vessel (col 3, lines 30-40). Fox teaches a catheter including a balloon having a coating (hydrophilic lubricious coating to enhance lubricity and decrease friction) with a layer of bioactive drug [0005, 0007, 0045, 0095-0096,0100, 0136]. Given the teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Root’s helical balloon with the teachings of Shturman and Fox by incorporating smooth outer base layer (from both references) on the helical balloon and a bioactive drug (taught by Fox) to improve the retention on the helical balloon and release of the bioactive drug. Furthermore, one of ordinary skill in the art would recognize another art advantage in having the agent on a balloon (with or without a base layer including a bioactive layer) instead of as a separate device delivered after inflation, as producing reduced time of the procedure. The agent can be delivered as soon as the balloon in inflated instead of waiting for a separate device, thus reducing procedure time and enhancing effectiveness of the agent delivered.
Ehrenreich discloses a containment structure (120 in figure 5; col. 6, lines 25-54 or 126 in figure 6) surrounding at least a portion of the bioactive layer, where the containment structure 120 can be dissolvable, biodegradable or disintegrable upon expansion or inflation of the expandable member therefore removing the containment structure 120 from the bioactive layer after it has been protected from premature elution of the therapeutic agent into vasculature by the combination of the bioactive layer and base layer. In regards to claim 20, the containment structure 120(second coating) and 126 are a protective sheath once it is cracked comprises a plurality of perforations allowing under expansion and will therefore allow the therapeutic agent to contact the vessel wall (col. 3 lines 1-24).
Furthermore, Root discloses the perfusion catheter assembly further comprising a containment structure ([0034] sheath (not shown) that can be disposed around the balloon 328 to reduce the collapsed profile of the deflated balloon so that it can be more easily be inserted or removed from a patient and surround at least a portion of the bioactive layer, thereby shielding the bioactive layer from insertion shear forces or bodily liquid solvents.
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 Root/Shturman/Fox’s balloon, with the teachings of Ehrenreich to have the containment structure surround at least a portion of the bioactive layer to prevent the untimely release of the bioactive layer within the blood vessel.
Regarding claim 18, Root fails to disclose the containment structure is integrally formed with the bioactive layer.
Ehrenreich teaches a containment structure (120 or 126) that can be integrally formed with the bioactive layer (col. 6, lines 25-65). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Root’s containment structure (sheath not shown [0034]) with the teaching of Ehrenreich providing integrity on both the containment structure and bioactive layer preventing premature elution or damage of the therapeutic material.
Regarding claims 17 and 19, Root fails to disclose the containment structure comprises a degradable structure (claim 17), and a time-release structure formulated to degrade (claim 19).
Ehrenreich teaches a containment structure (120; col. 6, lines 25-54) where the containment structure 120 can be dissolvable, biodegradable or disintegrable upon expansion or inflation of the expandable member after it has been protected from premature elution of the therapeutic agent into vasculature by the combination of the bioactive layer and base layer.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Roots’ containment structure (sheath) by providing it with the teachings of Ehrenreich containment structure and bioactive material/base layer to form a time-release structure formulated to eventually degrade after balloon inflation.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Root in view of Shturman and Fox et al. as applied to claim 1 above, and further in view of Mueller, Jr. et al (US 4,790,315).
Root/ Shturman/Fox discloses the method substantially as claimed. Root recognizes that most people can withstand non-perfusion dilation of 30-60 seconds.
However, Root/ Shturman/Fox fail to disclose (claim 2) wherein the steps of maintaining the balloon in the inflated configuration comprises maintaining the balloon in the inflated configuration for greater than 60 seconds, and (claim 3) wherein maintaining the balloon in the inflated configuration comprises maintaining the balloon in the inflated configuration for between 60 seconds and 15 minutes.
Mueller, Jr. discloses a perfusion dilatation catheter, including openings (21) on the proximal and distal sides of the balloon (12) to allow for blood to flow past the balloon when the balloon is inflated (column 2 lines 41-45). Mueller, Jr. “when the balloon is inflated, blood can flow past the balloons through openings 21 and lumen 14. This permits the balloon to remain inflated for substantially longer than when is possible with other dilatation catheters where the blood flow is cutoff.” (Column 3 lines 13-17). Mueller discloses a longer inflation time would be desirable since it would increase the probability that the vessel would remain open after the catheter is removed (column 1 lines 29-35). Mueller teaches a prior art catheter might allow for inflation for 30-50 seconds, while Mueller’s improved catheter can remain inflated for 2-15 minutes, thus greatly increasing the chance the vessel will remain open when the catheter is removed (column 3 lines 25- 31).
Before the effective filing date of applicant’s invention, it would have been obvious to one of ordinary skill in the art to maintain the balloon in the inflated configuration for greater than 60 seconds, or between 60 seconds and 15 minutes, in order to greatly increase the chance, the vessel will remain open when the catheter is removed, thus ensuring a more successful procedure.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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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.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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