DETAILED ACTION
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) 77, 81 and 82 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walsh (US 2011/0124951).
Regarding claim 77, Walsh discloses a vessel treatment device for implantation on an exterior wall of a cardiovascular vessel of a human patient, the device comprising: an elongated, flexible extraluminal cuff 1101 (fig 1) having a proximal end and a distal end and configured to circumferentially surround an ascending aorta (¶99) without penetrating the vessel wall; an inflatable changeable-volume portion 1110 (¶95, ¶96) comprising a single, double or multiple sealed inflatable chambers (fig 2) formed entirely from an elastomeric polymer (such as flexible polyurethane or silicone - ¶102); said changeable-volume chambers permanently secured to the cuff along a longitudinal length of the cuff (fig 1), with at least one changeable-volume chamber being positioned, when implanted, between an inner surface of the cuff and an outer adventitial surface of the ascending aorta (fig 1), wherein the changeable-volume chamber is formed entirely from an elastomeric polymeric material (¶102) and defines a sealed internal chamber inflated with a compressible fluid (¶103); the elastomeric material of the changeable-volume chambers and the compressible fluid together define a passive mechanical energy storage system configured such that radial expansion of the ascending aorta during systole compresses and reduces the volume of at least one of the changeable-volume chambers and stores mechanical energy solely by elastic deformation and fluid compression, and fluid volume reduction by the transfer of fluid within the chambers, without active pumping, electrical actuation, or electronic control; elastic recoil of the elastomeric material during diastole releases the stored mechanical energy to cause inward radial expansion of the changeable-volume chamber and application of a counter-pulsatile force to the outer wall of the ascending aorta (¶104 and ¶106); the cuff and the changeable-volume chamber together define a unitary structure that is flexible and compressible along a circumferential width of the cuff; wherein the device is configured to be deflated and collapsed and inserted longitudinally into a tubular endoscopic deployment tool; the deployment tool is dimensioned for passage through a surgical trocar port for minimally invasive thoracoscopic implantation; and the device is configured to be unloaded from the deployment tool within a chest cavity, unfolded and extended, and positioned around the ascending aorta using an endoscopic instrument and inflated to an operational mechanical energy level (device may be implanted thorascopically and inflated to an operational mechanical energy level via port 1102 - ¶95; the changeable volume portion 1101 is flexible along its length and width - ¶96; and is flexible enough to follow the shape of the outer wall of the vessel it is applied to - ¶97; further it may be made of the same flexible materials as the balloon 1110, such as polyurethane and silicone - ¶102. Taken together, the cuff is capable of being deflated and collapsed and insertable longitudinally into an endoscopic deployment tube, the deployment tube adapted to fit into an endoscopy TROCAR port, enabling the changeable volume portion to be subsequently unloaded in a chest and attached to the vessel).
Regarding claim 81, Walsh discloses a cuff, comprising: a changeable volume portion 1110 configured to operate with a wall of a vessel in a human or animal body, the cuff is adapted for attachment to the vessel and for modifying the volume of the vessel (¶98; fig 1); a mechanical or electromechanical energy storage device 1103 operatively coupled to the the changeable volume portion such that, in use, application of the cuff causes the changeable volume portion to decrease the vessel volume, thereby permitting the vessel volume to increase during systole while the changeable volume portion and the energy storage device absorb mechanical energy, the absorbed mechanical energy being subsequently released during diastole to cause the changeable volume portion to decrease the vessel volume (¶113); wherein the cuff is supported by a collapsible support member 1101 comprising one of a single support member (fig 1, in the event there is no reinforcing), a double/split support member (in the event of reinforcing fibres/struts 1115) or any combination thereof, the cuff is configured to be collapsed, compressed and deflated for longitudinal insertion into a tubular endoscopic deployment tool; the tubular endoscopic deployment tool is dimensioned for insertion through a surgical trocar port to facilitate minimally invasive thorascopic implantation; and following passage through the trocar port, the cuff is configured to: be unloaded from the deployment tool within a chest cavity; unfold and expand; be positioned around the ascending aorta using an endoscopic instrument; be attached to the vessel; and be inflated to an operational mechanical energy level (device may be implanted thorascopically and inflated to an operational mechanical energy level via port 1102 - ¶95; the changeable volume portion 1101 is flexible along its length and width - ¶96; and is flexible enough to follow the shape of the outer wall of the vessel it is applied to - ¶97; further it may be made of the same flexible materials as the balloon 1110, such as polyurethane and silicone - ¶102. Taken together, the cuff is capable of being deflated and collapsed and insertable longitudinally into an endoscopic deployment tube, the deployment tube adapted to fit into an endoscopy TROCAR port, enabling the changeable volume portion to be subsequently unloaded in a chest and attached to the vessel).
Regarding claim 82, wherein the changeable volume portion comprises one or more sealed inflatable chambers, including a single chamber, two chambers, or a plurality of chambers (figs 1 and 2), each chamber being formed entirely from an elastomeric polymer (such as flexible polyurethane or silicone - ¶102) and containing only a compressible gas as an internal medium (¶103).
Allowable Subject Matter
Claims 49-59 and 62 are allowed.
Claim 84 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.
While the closest prior art (Walsh) teaches most limitations of claim 76, it does not teach the connected tubing having the ability of independently adjusting the position, volume, media or pressure of: the changeable volume portion, an attachment tensioner, an outer protection cushion; and the position of (an) attached syringe piston. While Walsh (and other refences used in the various rejections) teach all of these structures, it would require a substantial rework based on impermissible hindsight to add each of the missing structures and then make them independently adjustable via the connected tubing.
Claims 64-67, 70, 71 and 78 are allowed.
Claim 83 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 examiner did not find a teaching or suggestion for modifying closest art Walsh such that the cuff has a cut out window with an attached deformable sheet, especially as Walsh disclose the outer surfaces of the cuff should be relatively inextensible (¶98) and such a window would interfere with the reinforcing wires’/fibres’ 1115 ability to function (¶97).
Response to Arguments
Applicant’s arguments are not persuasive.
Applicant argues the rejection of claim 70 under Peters is based on an improper interpretation of Peters. While claim 70 is indicated allowable as its parent claim is allowable, Applicant has also stated they moved the limitations into new claim 81. The examiner maintains that Peters taught the limitations of previous claim 70, but agrees it does not teach newly amended claim 70. However, with respect to claim 81, Applicant has simultaneously narrowed the claim (requiring the support member structure to be collapsible) and broadened the claim (no requirement of any type of bar attachment) such that Walsh is seen as teaching claim 81 as rejected above.
Applicant argues that claim 77 is likewise patentable as it does not teach that includes a list of multiple structures, but does not point to any one structure in particular. The examiner believes Walsh teaches all the limitations as addressed in the rejection above.
Conclusion
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 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, Michael Tsai can be reached on (571)270-5246. 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.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
Prosecution Insights