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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
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) 49-55, 58-60, 62, 64-68, 71, 72 and 77-80 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walsh (US 2011/0124951).
Regarding claim 49, Walsh discloses a treatment or assistance device for operating in or with a tubular or sac wall of a vessel in a human or animal body, comprising: a changeable volume portion 1101 adapted to interact with said vessel 1100 so as to modify a volume of the vessel (¶98); a mechanical or electronic-mechanical energy storage device 1103/1125 functioning with said changeable volume portion such that, in use, a decrease in the volume of said changeable volume portion creates a pressure or energy charge in said energy storage means, said pressure or energy charge being able to be subsequently released to cause said changeable volume portion to increase in volume (¶113 and ¶114; internal blood pressure rise results in fluid being pushed from the cuff, which is a decrease in said changeable volume portion, thus increasing the pressure in the windkessel/energy storage means. The charge then being subsequently released to transfer the pressure pack to the cuff/changeable volume portion, increasing the volume of the changeable volume portion); wherein the changeable volume portion is flexible and compressible such that the changeable volume portion is at least partially rollable across its width and insertable into an endoscopic deployment tube along a length of the device, 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 (device may be implanted thorascopically - ¶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 at least partially rolled across its width and insertable into an endoscopic deployment tube along a length of the device, 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 50, wherein the changeable volume portion is constructed at least in part from an elastomeric material, the elastomeric material being the energy storage device (¶38).
Regarding claim 51, wherein the changeable volume portion is a graft or a stent graft, or a part thereof and the energy storage device is an elastomeric material or deformable stent member which forms the graft, the stent graft part or the part thereof (¶37, ¶38).
Regarding claim 52, wherein the changeable volume portion and the energy storage device are adjusted to a threshold or reference position, volume, or pressure, the device being adjustable via an attached port 1102 at time of implantation and during use (¶40, ¶108).
Regarding claim 53, wherein media with which the changeable volume portion is primed comprises with one or more of the following media: air, helium or a gas (among others - ¶103, ¶116, ¶41).
Regarding claim 54, wherein media with which the energy storage device is primed is one or more of the following compressible media: air, helium or a gas (among others - ¶103, ¶116, ¶41).
Regarding claim 55, where the performance of the device is monitored by electronic sensors mounted in one or more of an attached port, the changeable volume portion or the energy storage device (¶118, ¶203).
Regarding claim 58, further comprising load sensors attached to an electronic circuit and a data logger to quantitate the device tension and vessel coupling, allowing adjustment of the device ends to balance the load at each side on the device at time of implanting and for monitoring device status and performance (¶128 and ¶202 are adjustment of the cuff, which includes the cuff ends, to balance the load at each side of the device since the balloon is cuff is one big balloon the pressure will balance as pressure flows from higher to lower pressure zones until all pressure is equal; ¶203 discloses internal pressure sensors which are used to adjust the pressure of the cuff electronically).
Regarding claim 59, wherein the changeable volume portion is a cuff member comprising an inflatable portion, the cuff member and the inflatable portion being able to be positioned around or in the vessel (¶98, ¶101).
Regarding claim 60, wherein the device contains an adjustable attachment tensioner (¶100 – diameter is adjusted on implantation and utilizes temporary adjustable, temporary tensioners such as pegs).
Regarding claim 62, wherein the port is attached to a syringe piston where the piston is incrementally stepped with a stepper motor to increase or decrease the device position, volume, or pressure threshold or reference to an adjusted operational level (¶128).
Regarding claim 64, Walsh discloses a cuff, comprising: a changeable volume portion 1101 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); a mechanical or electronic-mechanical energy storage device 1103 adapted to function with the changeable volume portion such that, in use, the changeable volume portion decreases the vessel volume when applied, allowing the volume of the vessel to increase during systole and dampen pressure by the changeable volume portion and energy storage device absorbing energy, subsequently releasing the absorbed energy during diastole to cause the changeable volume portion to decrease the vessel volume (¶113); wherein the changeable volume portion is flexible and compressible such that the changeable volume portion is at least partially rollable across its width and insertable into an endoscopic deployment tube along a length of the device, 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 (device may be implanted thorascopically - ¶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 at least partially rolled across its width and insertable into an endoscopic deployment tube along a length of the device, 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 65, wherein the cuff being of an elongated and thin form having a first portion which is convergent then divergent in a longitudinal direction of the cuff, the cuff comprising a second portion adjacent, near to, or in the vicinity of, the first portion, the second portion having at least one aperture 1102 (fig 3, ¶99).
Regarding claim 66, wherein the cuff has at least one aperture cut out for shaping the cuff around the inner radius of a curved vessel, the aperture being convergent and divergent in at least one section of the cuff (fig 3, ¶99).
Regarding claim 67, that uses at least two end flap cuff configurations for independent tensioning of cuff to vessel (¶97, opposite ends of cuff).
Regarding claim 68, that uses a cuff with a cut out window 1102 to improve the range of the changeable volume (fig 3).
Regarding claim 71, wherein the cuff is attached by using side flaps connected to the sides of the changeable volume portion for independent tensioning of the cuff to the changeable volume portion (¶97-100, fig 3, each end/side flap can be independently tensioned during the diameter adjustment of ¶100).
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; a single, continuous, inflatable changeable-volume chamber 1110 (¶95, ¶96) permanently secured to the cuff along a longitudinal length of the cuff, the 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 containing a compressible fluid selected from air, carbon dioxide, or nitrogen (¶103); wherein the elastomeric material of the changeable-volume chamber and the compressible fluid together define a passive mechanical energy storage system configured such that radial expansion of the ascending aorta during systole compresses the changeable-volume chamber and stores mechanical energy solely by elastic deformation and fluid compression, without active pumping, electrical actuation, or electronic control; wherein elastic recoil of the elastomeric material during diastole releases the stored mechanical energy to cause inward radial contraction of the changeable-volume chamber and application of a counter-pulsatile compressive force to the outer wall of the ascending aorta (¶104 and ¶106); wherein the cuff includes a flexible but substantially inextensible outer layer that limits outward radial expansion of the changeable-volume chamber such that volumetric deformation of the chamber is directed predominantly toward the vessel wall (¶96); wherein 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 at least partially rolled across the circumferential width of the cuff and inserted longitudinally into a tubular endoscopic deployment tool; wherein the deployment tool is dimensioned for passage through a surgical trocar port for minimally invasive thoracoscopic implantation; and wherein the device is configured to be unloaded from the deployment tool within a chest cavity and positioned around the ascending aorta using an endoscopic instrument without the use of sutures, staples, or penetrating fasteners through the vessel wall (device may be implanted thorascopically - ¶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 at least partially rolled across its width and insertable into an endoscopic deployment tube along a length of the device, 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 78, wherein the changeable volume portion comprises a single sealed inflatable chamber formed entirely from an elastomeric polymer (fig 1; ¶102) and containing only a compressible gas as an internal medium (¶103).
Regarding claim 79, wherein the device is entirely passive in operation, such that the changeable volume portion stores and releases mechanical energy solely through elastic deformation and gas compression, and does not include any pump, motor, valve actuator, electronic controller, or external power source (¶103 and ¶105; fig 1 without the external system as per ¶103-¶107).
Regarding claim 80, wherein the device is configured for minimally invasive thoracoscopic implantation, the changeable volume portion and an associated cuff being rollable across a width of the device and insertable into a tubular deployment tool sized for passage through a surgical trocar port, and further configured to be unloaded and positioned around the vessel using an endoscopic instrument (device may be implanted thorascopically - ¶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 at least partially rolled across its width and insertable into an endoscopic deployment tube along a length of the device, 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).
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.
Claim(s) 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2011/0124951) in view of Forsell (US 2010/0211092).
Regarding claim 56, while Walsh substantially discloses the invention as claimed, it does not disclose wherein the electronic device and sensor components are electrically powered by an attached implanted battery, an attached electronic energy harvesting circuit, an attached implanted induction coil charged via inductive power delivered by an external coil, or via electrical power connected with an electrical subcutaneous port and electrical power needle, wherein the electronic device and sensor components are connected to an electronic communications circuit via analogue to digital conversion or via a digital connection, using an electronic communication circuit that can send data electronically via RF, wi-fi, blue tooth, or an electrical subcutaneous port to an external receiver to log and record data.
Walsh discloses use of a battery including an implanted battery (¶119 and ¶132).
Forsell discloses a similar device wherein the electronic device and sensor components are electrically powered by an attached implanted battery (battery 111 is inside 105 which is implanted as per fig 1) and charged via external source 112, wherein the electronic device and sensor components are connected to an electronic communications circuit (¶235, external communications device 106 communicates with an electronic communications circuit in 105) via analogue to digital conversion or via a digital connection (¶271), using an electronic communication circuit that can send data electronically via RF (¶272 – electromagnetic signal for carrying digital signals; the electromagnetic spectrum is made of 7 different types of radiation such that one of ordinary skill in the art reading Forsell as a whole, including ¶263 of Forsell, would appreciate that choosing radio frequency as the particular frequency is a matter of design choice based on its intended use of communication/transmitting data).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Walsh such that the electronic device and sensor components are electrically powered by an attached implanted battery, wherein the electronic device and sensor components are connected to an electronic communications circuit via analogue to digital conversion or via a digital connection, using an electronic communication circuit that can send data electronically via RF as taught by Walsh in order to allow the device to be recharged without removing the device and operation of the device to be controlled remotely.
Claim(s) 57, 61 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walsh (US 2011/0124951) in view of Peters et al (US 2007/0167898).
Regarding claim 57, while Walsh substantially discloses the invention as claimed, it does not disclose the device has an attached tag or tape for deploying and positioning the changeable volume portion around the vessel, said changeable volume portion and said tag or tape being flexible and compressible to fit into a deployment tool to fit into a standard endoscopy port, allowing for a surgical instrument to access said tag or tape via an additional endoscopy port to unload the device, said endoscopy ports being inserted in the intercostal spaces or tissues in proximity to the vessel.
Walsh discloses the device is flexible and compressible to fit into a deployment tool (¶168) to fit in a standard endoscopy port (intended use, a balloon deployment catheter is capable of fitting into a standard endoscopy trocar port).
Peters discloses an implantable cuff which has tags 30a/30b at opposing ends of the cuff which are used for deploying and positioning the device around the vessel (figs 2-4 and/or figs 6-9).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Walsh such that the changeable volume has an attached tag or tape for deploying and positioning the device around the vessel, said changeable volume portion and said tag or tape being flexible and compressible to fit into a deployment tool to fit into a standard endoscopy port as taught by Peters as it is a known, alternative means by which to affix the cuff to the vessel and thus is simple substitution of one means of attaching for another.
The combination allows for a surgical instrument to access the device tag via an additional endoscopy port to unload the device (intended use, an additional endoscopy port is capable of being used as claimed) and the endoscopy ports capable of being inserted in the intercostal spaces or tissues in proximity to the vessel (the endoscopy ports are only claimed as intended use, as is this intended use of a trocar port, which the device is capable of being use with).
Regarding claim 61, while Walsh substantially discloses the invention as claimed, it does not disclose the device contains an adjustable outer cushion to protect surrounding vessels and tissues.
Peters discloses an implantable cuff which has tags 30a/30b (said tags also being capable of being used as cushions if they are looped back around or overlap portions of the cuff) at opposing ends of the cuff which are used for deploying and positioning the device around the vessel (figs 2-4 and/or figs 6-9).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Walsh such that the device has an attached tag or tape (which is also a cushion) for deploying and positioning the device around the vessel as taught by Peters as it is a known, alternative means by which to affix the cuff to the vessel and thus is simple substitution of one means of attaching for another.
Regarding claim 70, while Walsh substantially discloses the invention as claimed, it does not disclose the cuff is attached using a double bar cuff attachment, a single bar cuff attachment, or a split cuff bar attachment.
Peters discloses an implantable cuff which has cuff attachment bars 30a/30b at opposing ends of the cuff which are used for deploying and positioning the device around the vessel (figs 2-4 and/or figs 6-9).
It would have been obvious to one of ordinary skill in the art, at the time of the effective filing date of the instant application, to modify Walsh such that the cuff is attached using a double bar cuff attachment or a single bar cuff attachment as taught by Peters as it is a known, alternative means by which to affix the cuff to the vessel and thus is simple substitution of one means of attaching for another.
Allowable Subject Matter
Claim 63 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.
Claim 69 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.
On pages 13-15 Applicant introduces the argument that Walsh does not disclose “the changeable volume portion is flexible and compressible such that the changeable volume portion is at least partially rollable across its width and insertable into an endoscopic deployment tube along a length of the device, 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.” More specifically:
On page 16, Applicant argues the claimed feature requires structural and functional capability that Walsh does not have as they differ greatly from being “flexible enough to follow the shape of the outer wall of the vessel” as described in Walsh. The examiner disagrees, Applicant introduces the claim does not requires a specific sized trocar, only “an endoscopy trocar port”. There is no set size for such a port that would preclude using Walsh. The examiner also wishes to stress that Applicant uses the term “rolled”, but claim only requires “partially rollable along its width”, such that only a slight bending of opposite ends of the uninflated device is considered to meet such a limitation. Being flexible enough to follow the shape of the outer wall of the vessel is seen as being enough to anticipate “partially rollable along its width” (especially when read alongside ¶96 – flexible along the width) and is such is considered enough to allow for insertion via an endoscopic deployment tube adapted to fit into an endoscopy trocar port (which are only claimed as part of intended use, one is capable of providing a large endoscopic deployment tube and trocar to accommodate the claimed device).
On page 16, Applicant argues Walsh does not teach or enable partial rolling or loading into an endoscopic deployment tube. Applicant argues Walsh includes multiple rigid or semi-rigid structural elements that would preclude smooth rolling or compression into a trocar-sized device as they would inherently restrict compressibility and would likely cause mechanical interference or damage if loaded into an endoscopic deployment tube. Applicant again uses language not in the claims “smooth rolling or compression” are vastly different from “partially rollable”. The reenforcing means of ¶97 are optional “The cuff 1101 can include reinforcing fibres or wires struts...”, even if they are added, they are longitudinal (see figs 4 and 5 for examples) and will still allow for partial rolling. The elements in ¶100 are also optional, and while they may not all allow for as tight of a role as if they weren’t present, they still allow for the claimed “partial rolling”.
On page 17, the examiner does not dispute Walsh does not mention rolling, insertion into a tube or unloading through an endoscopy port, but does take issue that the reliance on “flexibility” language conflates compliance for vessel coupling with structural compressibility for minimally invasive deployment as the are not considered different properties at all. Without flexibility, Applicant’s own device could not operate. Compressibility isn’t required by the claim, only the device’s capability to be partially rolled and usage with a device that doesn’t have an inherent size limitation.
On page 18, Applicant argues ¶139 relates to a different device (stent 1400) and does not remedy the deficiency. The examiner disagrees, ¶139 describes a very similar device which has reinforcing members 1403 but is still capable of being used into a reduced diameter and length, which is considered evidence against Applicant’s argument that the other embodiments are not capable of being rolled due to reinforcing structures.
On page 18, Applicant argues the physical construction of Walsh’s device precludes partial rolling and endoscopic tube deployment. More specifically, that a person of ordinary skill in the art would recognize that attempting to insert the structure into a standard trocar port (typically 12-13 mm) would risk damaging the component or prevent deployment altogether. Applicant is introduce artificial limitations in the argument that are not present in the claims. Even if such sizes were required, the minimum embodiment of Walsh is described in ¶96, a cuff flexible along its width with a thicker outer that is inflatable. ¶97 describes reinforcing member that CAN be used, but don’t have to be. ¶100 describes pegs and holes that can be used, but don’t have to be, and the pegs themselves appear to be provided separately from the cuff. The examiner does not dispute that some of the options of the cuff of Walsh can prevent a full rolling of the device, but the examiner believes one of ordinary skill in the art looking at the disclosure of Walsh would appreciate that it is capable of being at least partially rolled into an endoscope (and then inserted via a trocar port).
Regarding the affidavit:
In point 10 Applicant argues the Walsh prototype (the Walsh reference) is not capable of fitting into a standard trocar port (small-diameter 12-13 mm). The examiner can only again respond that this size limitation cannot be read into the claim.
In point 13, while the flexibility was intended solely to allow the device to conform to the vessel’s outer curvature, it does not change that the materials and structure appear to allow for further flexibility capability.
In point 14, Applicant argues various features of Walsh render it unsuitable for partial rolling or compression into an endoscopic deployment tube that fits a standard trocar port. Similar to the previous point, Applicant makes the statement but utilizes an unclaimed limitation (specific size). Further, based on the examiner’s understanding of the specification, some to all of the features disclosed are not always present in every embodiment of Walsh (see minimum embodiment in paragraph 45e above).
The examiner does not dispute point 15, but Walsh does not have to disclose how the device could be loaded, only that it have the structure for the capability for such, as the examiner has established.
Point 16 addresses ¶139 of a stent not being related to the claimed device (and assumedly the embodiment used by the examiner in the rejection). Yet the stent has many similar structural properties to that of the embodiment used by the examiner and distinctly discloses being introduced as claimed. Thus the examiner sees it as evidence refuting that the other embodiment could be at least partially rolled and introduced as claimed.
Conclusion
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.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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