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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/20/23;8/1/24;6/16/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The distal aspiration while a proximal portion of the drug-coated balloon is sealingly engaged with a distal opening of an interior lumen of the outer guide catheter is not taught or obvious in the prior art. Claims 4-10 are further objected to based on dependency.
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
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.
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 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fulton, III, US 2015/0313732, (“Fulton”). Fulton discloses:
(claim 1) A method of vascular treatment, comprising: advancing a treatment system near a desired treatment site within a patient (see Fig. 11); wherein the treatment system comprises a drug-coated balloon catheter 104,102 [0089] within an outer guide catheter 116; inflating a drug-coated balloon 102 connected near a distal end of the balloon catheter 104; and, aspirating near the drug-coated balloon with the outer guide catheter (see Fig. 11 downward arrows between balloons 121 and 102, [0089-0090]).
Claim 2: the drug-coated balloon catheter 104 further comprises an enlarged tubular portion 124 connected at a distal region of the drug-coated catheter. See Fig. 11
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 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 11-14, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fulton in view of Cox et al. (US 2006/0135985) (“Cox”).
Fulton discloses the invention as substantially claimed but does not directly disclose the drug coating is disposed on the proximal portion and wherein the drug-coated balloon is configured to first inflate a distal portion and then inflate a proximal portion. Fulton does disclose also that the device may be used to place a stent [0019]. Similarly, Cox, in the analogous art, teaches a balloon catheter device with a balloon placing a drug coated stent (on proximal portion) (Figs. 14-16). The distal portion 1450A is configured to inflate prior to the proximal portion 1450B by a reinforcing band (stent [0094]) or different expansion characteristics of the balloon [0150]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug coated balloon of Fulton with the balloon 1450, 3950 as taught by Cox in order to better control the therapeutic environment of the vessel.
According to claims 12-14, the distal portion of the drug-coated balloon inflates prior to the proximal portion of the drug-coated balloon by comprising the distal portion of a first material and comprising the proximal portion of a second material, different than the first material; by comprising the distal portion of a first material thickness and comprising the proximal portion of a second material thickness, different than the first material thickness; by comprising a band over the distal portion of the drug-coated balloon. [0094-0095,0150]
Claims 15-16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fulton in view of Cox further in view of Gaiser et al. (US 5,002,532) (“Gaiser”).
Fulton in view of Cox discloses the invention as substantially claimed but does not directly disclose inflating the distal portion of the drug-coated balloon with a larger distal inflation port and inflating the proximal portion of the drug-coated balloon with a smaller inflation port; inflating the distal portion of the drug-coated balloon with a distal valve and inflating the proximal portion of the drug-coated balloon with a proximal valve, wherein the distal valve and the proximal valve open different amounts. These claims represent additional ways to inflate the balloons at different times. Gaiser, in the analogous art, teaches two inflation lumens 63,64 and proximal and distal valves 73,74, C5L46-C6L2. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Fulton/Cox with the separate inflation lumens or valves to control the individual inflation of the balloon as required by the procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783
Prosecution Insights