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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites “further comprising maintaining the inflation of the reduced-diameter central portion through plural inflation and deflation cycles.” However, in view of Applicant’s disclosure, it is unclear to the examiner how the inflation of the reduced-diameter central portion is maintained “through plural inflation and deflation cycles”. There is no mention of a “cycle” or “plural” cycles in Applicant disclosure. In [0020] of Applicant disclosure, Applicant discloses “sequential” inflation, but it is unclear if this is what is intended by Applicant when reciting “plural” inflation and deflation cycles. Theretofore, examiner interprets any balloon device capable of inflation and deflation would meet the limitation.
Claims 1-15 are 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.
Claim 1 recites “distal and proximal balloon end portions”, Examiner recommends amending the claim to recite “a” or “an” when introducing limitations/structural features to establish a primary antecedent basis. Similarly with claims 10 and 15.
Claim 2 recites “said balloon portions”. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “in a range about 1.5 mm to about 7.0 mm” rendering the claim indefinite because it is unclear whether it is “about” 1.5 mm to 7.0 mm which is one range or “1.5 mm to 7.0 mm” which is another range.
Claim 9 recites “the balloon end portions”. There is insufficient antecedent basis for this limitation in the claim.
Claims 10 and 15 recite “said balloon”, “the vascular wall” and “the treatment site”. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites “the treatment site”. There is insufficient antecedent basis for this limitation in the claim.
Appropriate action is required.
All remaining claims are rejected by virtue of dependency from the rejected
independent claims.
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 1-5 and 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley (US 2017/0173302 A1, herein, Beasley), in view of Crocker et al. (US 5470313 A, herein, Crocker).
Regarding claim 1, Beasley discloses a profiled drug-coated balloon (balloon 12 – Fig.6), comprising:
distal and proximal balloon end portions (end sections 18, 20) having a first nominal full inflation diameter (diameter of ends when balloon is inflated – Fig.6);
a central balloon portion (16) between said end portions,
a drug carrying nanoparticle coating (“a portion coated with such a drug G, such as one designed for achieving a desired therapeutic effect when applied to the interior of the vessel… materials may be used in the form of gels, powders, dust, particles, nano-particles, liquids, stains, adhesives and the like”, see para [0077]- [0078]) on said central balloon portion.
Beasly does not expressly disclose a central balloon portion between said end portions, the central balloon portion having a second, lesser nominal full inflation diameter
Crocker teaches a central balloon (central focal segment 30 – Fig.2) portion between said end portions, the central balloon portion having a second, lesser nominal full inflation diameter (see annotated Fig.2).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Beasley to include a central balloon portion has a second, lesser nominal full inflation diameter as taught by Crocker to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
PNG
media_image1.png
352
617
media_image1.png
Greyscale
Regarding claim 2, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 1, further comprising at least one inflation lumen communicating with said balloon portions (“allow the inflation of the balloon 12 via one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12”, see para [0052]).
Regarding claim 3, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 2, further comprising separate inflation lumens for the balloon end portions and central balloon portion ("allow the inflation of the balloon 12 via one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12”, see para [0052]).
Regarding claim 4, Beasly discloses the profiled drug-coated balloon of claim 1, as recited above.
Beasley does not appear to expressly disclose wherein the first nominal full inflation diameter of the balloon end portions is in a range of about 1.5 mm to about 7.0 mm, and the second, lesser nominal full inflation diameter of the central balloon portion is about 0.05 mm to about 0.50 mm less than the first nominal full inflation diameter.
Crocker teaches wherein the first nominal full inflation diameter of the balloon end portions (proximal end 26 and distal end 28 – Figs.2-3) is in a range of about 1.5 mm to about 7.0 mm (“typically, coronary angioplasty dilatation balloons will have a first diameter within the range of from about 1.5 mm to about 4.0 mm”, see Col.7 lines 55-58), and the second, lesser nominal full inflation diameter of the central balloon portion (central segment 30 – Figs.2-3) is about 0.05 mm to about 0.50 mm less than the first nominal full inflation diameter (“balloons can be readily constructed having a difference between the first inflation diameter and second inflation diameter anywhere within the range of from about 0.1 mm up to 1.0 mm or more”, see Col.7 lines 50-53).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the teachings of Crocker with the disclosure of Beasley so that first nominal full inflation diameter of the balloon end portions is in a range of about 1.5 mm to about 7.0 mm, and the second, lesser nominal full inflation diameter of the central balloon portion is about 0.05 mm to about 0.50 mm less than the first nominal full inflation diameter to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
Regarding claim 5, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 1, wherein said drug carrying nanoparticle coating comprises one or more of sirolimus, sirolimus derivative, paclitaxel or combinations thereof, cytostatic/cytotoxic drug combinations in amorphous, non-crystalline form, contained within PLGA nanoparticles (“treatment balloon 112 may include a working surface W2 including a treatment, such as for example a therapeutic agent (e.g., a drug, such as “paclitaxel”), see para [0075]).
Regarding claim 7, Beasly discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 2, as recited above.
Beasley does not appear to expressly disclose wherein the distal and proximal balloon end portions are configured to expand more rapidly than the central balloon portion.
Crocker teaches wherein the distal and proximal balloon end portions are configured to expand more rapidly than the central balloon portion (under broadest reasonable interpretation, examiner interprets the full inflation of the end portions before the gradual full inflation of central portion as more rapidly (“a proximal segment and a distal segment of the balloon are inflatable to a first diameter”, see Col.1 lines 61-64)).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Beasley so that the distal and proximal balloon end portions are configured to expand more rapidly than the central balloon portion as taught by Crocker to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
Regarding claim 8, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 2, further comprising a catheter body defining said at least one inflation lumen and a central guidewire lumen (“shaft S may be an elongated, tubular shaft 24 forming a guidewire lumen 23 that directs the guidewire 26 through the catheter 10”, see para [0053]).
Regarding claim 9, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 8, wherein the catheter body further defines separate inflation lumens for the balloon end portions and the balloon central portion (“one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12”, see para [0052]).
Regarding claim 10, Beasly discloses a method of intravascular drug delivering using a drug-coated balloon (balloon 12 – Fig.6), comprising:
providing a profiled balloon with enlarged distal and proximal end portions (end sections 18,20 – Fig.6) and a reduced- diameter central portion, wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion (“coated with such a drug G, such as one designed for achieving a desired therapeutic effect when applied to the interior of the vessel”, see para [0077]);
positioning the profiled balloon at an intravascular treatment site with said balloon in a deflated state (“in clinical practice, an angioplasty balloon 12 may be expanded from a deflated, folded state... within a vessel at a treatment area T”, see para [0004]);
inflating the enlarged distal and proximal end portions to contact the vascular wall bounding the treatment site (“balloon 12 may be expanded from a deflated, folded state (FIG. 1) to an inflated, expanded state (FIG. 2) within a vessel at a treatment area T, such as a portion of the circumferential inner wall of a blood vessel V”, see para [0004]), as recited above.
Beasley does not appear to expressly disclose providing a profiled balloon with enlarged distal and proximal end portions and a reduced- diameter central portion, wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion;
inflating the reduced-diameter central portion after the enlarged distal and proximal end portions contact the vascular wall.
Crocker teaches providing a profiled balloon with enlarged distal and proximal end portions and a reduced- diameter central portion (see annotated Fig.2), wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion;
inflating the reduced-diameter central portion after the enlarged distal and proximal end portions contact the vascular wall (“a central segment of the balloon is inflatable to a second greater diameter”, see Col.1 lines 64-65).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Beasley to include a reduced-diameter central portion that inflates as taught by Crocker to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
Regarding claim 11, Beasley discloses the method of claim 10, further comprising maintaining the inflation of the reduced- diameter central portion through plural inflation and deflation cycles ("balloon 12 in such case also has a pre-determined surface area that remains substantially constant during and after inflation, also has a pre-determined length and pre-determined diameter that each, or together, remain substantially constant during and after inflation", see para [0055]).
Regarding claim 12, Beasley discloses the method of claim 11, further comprising applying cycling pressure to the reduced- diameter central portion to create undulating pressure waves across the treatment site bounded by the enlarged distal and proximal balloon portions (examiner interprets the change in pressure as the balloon inflates and deflates pushing against the narrowing site as creating undulating pressure waves “the balloon 12 may be inflated at the treatment area T so as to dilate the vessel V and compress the lesion L”, see para [0073]).
Regarding claim 13, Beasly discloses the method of claim 10, as recited above.
Beasley does not appear to expressly disclose further comprising overinflating the reduced-diameter central portion to form a convex wall section.
Crocker teaches overinflating the reduced-diameter central portion to form a convex wall section (“a central segment of the balloon is inflatable to a second greater diameter”, see Col.1 lines 64-65, annotated Fig.3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Beasley so that central segment overinflates as taught by Crocker to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
PNG
media_image2.png
410
769
media_image2.png
Greyscale
Regarding claim 14, Beasley discloses the method of claim 10, further comprising deflating and removing the balloon without first removing any excess drug compositions surrounding the balloon (“the balloon 12 may be deflated and removed after use”, see para [0073]).
Regarding claim 15, Beasly discloses a method of intravascular drug delivering using a drug-coated balloon (balloon 12 – Fig.6), comprising:
providing a profiled balloon with enlarged distal and proximal end portions (end sections 18,20 – Fig.6) and a reduced- diameter central portion wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion (“coated with such a drug G, such as one designed for achieving a desired therapeutic effect when applied to the interior of the vessel”, see para [0077]);
positioning the profiled balloon at an intravascular treatment site with said balloon in a deflated state (“in clinical practice, an angioplasty balloon 12 may be expanded from a deflated, folded state... within a vessel at a treatment area T”, see para [0004]);
inflating the enlarged distal and proximal end portions to contact the vascular wall bounding the treatment site (“balloon 12 may be expanded from a deflated, folded state (FIG. 1) to an inflated, expanded state (FIG. 2) within a vessel at a treatment area T, such as a portion of the circumferential inner wall of a blood vessel V”, see para [0004]);
applying cycling pressure to the reduced- diameter central portion to create undulating pressure waves across the treatment site bounded by the enlarged distal and proximal balloon portions (examiner interprets the change in pressure as the ballon inflates and deflates pushing against the narrowing site as creating undulating pressure waves “the balloon 12 may be inflated at the treatment area T so as to dilate the vessel V and compress the lesion L”, see para [0073]); and
deflating and removing the balloon without first removing any excess drug compositions surrounding the balloon (“the balloon 12 may be deflated and removed after use”, see para [0073]), as recited above.
Beasley does not appear to expressly disclose providing a profiled balloon with enlarged distal and proximal end portions and a reduced- diameter central portion, wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion;
inflating the reduced-diameter central portion after the enlarged distal and proximal end portions contact the vascular wall;
overinflating the reduced-diameter central portion to form a convex wall section.
Crocker teaches providing a profiled balloon with enlarged distal and proximal end portions and a reduced- diameter central portion, wherein a drug carrying nanoparticle coating is provided on said reduced-diameter central portion;
inflating the reduced-diameter central portion after the enlarged distal and proximal end portions contact the vascular wall (“a central segment of the balloon is inflatable to a second greater diameter”, see Col.1 lines 64-65);
overinflating the reduced-diameter central portion to form a convex wall section (see annotated Fig.3).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Beasley to include a reduced-diameter central portion that inflates and overinflates as taught by Crocker to further provide a balloon “which expands in a predictable inflation profile while minimizing any damage to the native vessel” (Crocker Col.1 lines 34-35).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Beasley, in view of Herweck et al. (US 20050113687 A1, herein, Herweck).
Regarding claim 6, Beasley discloses the profiled drug-coated balloon (balloon 12 – Fig.6) of claim 5, as recited above.
Beasley does not appear to expressly disclose wherein the drug carrying nanoparticle coating consists of PLGA nanoparticles with a combination of sirolimus and paclitaxel.
Herweck teaches wherein the drug carrying nanoparticle coating consists of PLGA nanoparticles with a combination of sirolimus and paclitaxel.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the disclosure of Beasley so that the drug carrying nanoparticle coating consists of PLGA nanoparticles with a combination of sirolimus and paclitaxel as taught by Herweck to further provide a balloon “able to be atraumatically transferred from the medical device to targeted tissue locations within the body without causing an inflammatory response and while delivering a therapeutic agent” (Herweck para [0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights