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 § 102
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.
Claim(s) 1-6, 9, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richter 7,052,510.
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The current claims are article claims. Richter discloses a system (see fig. 1) for dilation within a patient's body of a surface, the system comprising: an inflatable device having: an interior inflatable body (e.g. 6) configured to inflate in response to receiving fluid (Fig. 2); and an exterior inflatable body (8) at least partially surrounding the interior inflatable body and configured to inflate when the interior inflatable body inflates and apply an expansion force to the surface to dilate the surface (this is functional language nevertheless see 2:5-15), the exterior inflatable body having a distal portion, a proximal portion, and one or more openings at the distal portion (see mark-up supra which indicates openings) configured to allow the fluid within the interior inflatable body to escape the exterior inflatable body when the interior inflatable body is punctured or bursts (function language. See MPEP 2114 below).
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
4. Regarding claims 2-6, e.g. “…wherein the inflatable device has a first expansion rate when the interior inflatable body is below a threshold inflation pressure and the inflatable device has a second expansion rate when the interior inflatable body is above the threshold inflation pressure, the second expansion rate being lower than the first expansion rate; claim 3 “..wherein the exterior inflatable body expands beyond a resting state when the interior inflatable body is inflated to the threshold inflation pressure; claim 4 “..wherein the first expansion rate is based on compliance of the interior
inflatable body and the second expansion rate is based on compliance of the exterior inflatable body and the compliance of the interior inflatable body”; claim 5 “wherein the exterior inflatable body shields the interior inflatable body from puncture.”; claim 6 “… wherein the exterior inflatable body is configured to retain one or more portions of the interior inflatable body when the interior inflatable body is punctured or bursts.” These are all functional limitations. The claims are article claims and not method claims. See MPEP 2114 supra.
5. Regarding claim 9, see element (14);
6. Regarding claim 12 Richter has been disclosed above and further discloses a delivery apparatus configured to deliver an expandable implant to a location in a patient’s body (stent 14) and including an elongate shaft (see catheter shaft 2) and an inflatable device (see rejection of claim 1 for details) coupled to the elongate shaft (Fig. 1.)
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 13-16 is rejected under 35 U.S.C. 103 as being unpatentable over Richter 7,052,510 in view of Madrid et al. 9,707,078.
Richter has been disclosed above and includes a catheter shaft (2) however Richter does not specify that the catheter shaft includes a handle and that the inflatable body is located at the distal end portion (see 1:66-67 and 2:23 which states “..The details of the catheter have not been included here, as they are well known to those skilled in the art…”.
Madrid et al. teaches an elongated catheter with a handle (20, see figures 1 and 2) where an inflatable body is located at the distal end. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Richter and provide a delivery catheter with a handle because the catheter of Richter is a cross sectional view and by providing a handle would aid in guiding/navigating the inflatable device to the implantation location.
9. Regarding claim 14 see nose cone (32) of Madrid et al.
10. Regarding claim 15 “inflation lumen” see 2:2 of Richter et al.
11. Regarding claim 16, Richter et al. states that the outer balloon may be non-compliant therefore it meets the limitation and is obvious that the outer inflatable balloon has a lower compliance than the inner inflatable balloon.
12. Regarding claims 17-19 these limitations are functional in nature (see MPEP 214 as discussed supra).
Allowable Subject Matter
13. Claims 7-8, 10-11, 20 are 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.
14. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is considered to be Richter 7,052,510 and Madrid et al. 9,707,078 and have been disclosed above.
The prior art fails to teach or disclose that the exterior inflatable body is coupled to a shaft of a delivery apparatus at the proximal portion of the exterior inflatable body and the exterior inflatable body is disconnected to the shaft of the delivery apparatus at the distal portion of the exterior inflatable body; wherein the interior inflatable body has a first length and the exterior inflatable body has a second length that is less than the first length. The prior art further fails to teach or disclose a diameter of the interior inflatable body at a distal portion of the interior inflatable body is greater than a diameter of the exterior inflatable body at the proximal portion of the exterior inflatable body, and
wherein the surface comprises an interior surface of an expandable implant being wider
at a distal end of the expandable implant than at a proximal end of the expandable implant and wherein the exterior inflatable body has a thickness at the proximal
portion that is greater than a thickness of the exterior inflatable body at the distal portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 February 26, 2026
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