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 .
Applicant' s arguments, filed 8/10/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 8/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-17 and 19-20 are the currently pending claims hereby under examination. Claim 18 has been canceled. Claims 1, 8, and 19 have been amended.
Claim Interpretations
In claims 8 and 19, the recited “engagement feature” is interpreted as encompassing a portion or structure of a support arm configured to mechanically engage an aperture or opening of the sensor device. The Specification describes a hook, clasp, clip, or other locking/engagement feature configured to engage an aperture or other opening and does not limit an engagement feature to a particular geometry (Instant Application, [0166], [0169], [0178]).
Objections
Claim 8 is objected to. In claim 8, lines 4 and 7: “the first support arm” and “the second support arm” lack explicit antecedent basis, although based on the prior recitations of “a first support arm segment” and “a second support arm segment,” the Examiner understands “the first support arm” and “the second support arm” to refer respectively to the first support arm segment and the second support arm segment, and Applicant is requested to provide proper antecedent basis by revising the terminology for consistency;
In claim 19, lines 7 and 10 have this same issue as claim 8 above; and
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 2012/0029598 A1), hereinafter Zhao, in view of Chouinard et al. (US 2007/0106370 A1), hereinafter Chouinard.
Regarding claim 1, Zhao teaches a sensor implant device comprising an implantable sensor 20 having housing 22 and fixation mechanism 24, wherein housing 22 encloses components of implantable sensor 20 and fixation mechanism 24 affixes implantable sensor 20 to a target location (Zhao, ¶¶[0026]-[0027]).
Zhao further teaches a first arm structure connected to the stent anchor and extending axially beyond an axial end of the stent anchor (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”; FIG. 3, showing strut 38K extending axially from ring 39 to housing 22 positioned beyond the axial end of ring 39). (The term “arm structure” does not require a member structurally separate from the stent anchor or anchor frame. The Specification states that the support arms may be integrated with the frames or forms of the respective anchors and may be integrally formed with the anchor frame. See Instant Application ¶¶[0163]-[0164].)
Zhao further teaches a sensor device secured to the first arm structure (Zhao, ¶[0026]: “housing 22 may include a pressure sensing device”, wherein housing 22 including the pressure sensing device corresponds to the sensor device; ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”, thereby securing the sensor device to strut 38K).
Zhao further teaches a second arm structure connected to the stent anchor and secured to the sensor device (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”, wherein strut 38L provides a second structural member extending between ring 39 and the sensor-containing housing 22).
Zhao further teaches wherein the first arm structure and the second arm structure are connected to opposite circumferential portions of the stent anchor (Zhao, FIG. 3, showing struts 38K and 38L extending from circumferentially opposite portions of ring 39 and connecting those portions to housing 22).
Also, regarding claim 1, Zhao does not fully teach a single stent anchor comprising a plurality of circumferentially extending rows of cells, each cell having a hexagonal shape. Rather, Zhao teaches a single stent-like anchor structure formed by ring 39, and expressly teaches that fixation mechanism 24 may comprise “a plurality of rings joined in series to form the cylindrical tubular body” when additional anchor length is desired (Zhao, ¶¶[0034], [0036]). The serially joined rings collectively form one cylindrical tubular fixation mechanism 24 and therefore constitute a single stent anchor, rather than multiple separate anchors. Zhao further teaches that the illustrated zig-zag shape is not required and that the struts may instead be arranged to form a ring having a different shape (Zhao, ¶[0034]). However, Zhao does not teach configuring the cylindrical stent anchor to comprise circumferential rows of hexagonal cells.
Chouinard teaches a tubular endoluminal stent having a polygonal-cell architecture and specifically teaches that wound section 12 “comprises three rows 31 of hexagonal cells 30” and terminates in a zig-zag end winding 42 (Chouinard, ¶[0059]; FIG. 3). Chouinard explains that FIG. 3 represents the tubular stent cut parallel to its axis and flattened, such that rows 31 extend circumferentially when the stent is in its tubular configuration (Chouinard, ¶¶[0023], [0044]). Chouinard further teaches that geometric configuration is a component of stent architecture and identifies a filamentary, wound, polygonal-cell architecture having hexagonal cells as one such configuration (Chouinard, ¶¶[0050]-[0051]). Chouinard teaches that wound sections generally have greater radial strength and lesser flexibility than braided sections, that polygonal cells may comprise hexagonal cells, and that the length and architecture of the wound section can be tailored according to the application to provide the desired radial strength (Chouinard, ¶¶[0062]-[0063]). Chouinard further teaches that the radial strength and flexibility required depend primarily on the characteristics of the body lumen in which the stent is deployed and identifies “secure anchoring force and stent-end patency” as characteristics provided by wound stent architectures (Chouinard, ¶¶[0048], [0078]). (The rejection relies on the wound end-section architecture of ¶¶[0059] and [0062]-[0063], not on importing the braided middle section.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cylindrical stent anchor of Zhao by configuring its multi-ring vessel-engaging portion according to the hexagonal polygonal-cell architecture taught by Chouinard, while retaining Zhao's struts 38K and 38L extending from the anchor to housing 22. Zhao expressly teaches that its illustrated ring geometry may be varied, that a plurality of rings may be joined in series to form a cylindrical tubular fixation mechanism of a desired length, and that the fixation mechanism is radially compressed for delivery and expanded in situ such that its struts securely engage the vessel wall (Zhao, ¶¶[0034]-[0036]). Chouinard teaches a known wound stent architecture comprising circumferential rows of hexagonal cells, teaches that the radial characteristics of a stent are selected according to the requirements of the target lumen, and identifies secure anchoring force and stent-end patency as characteristics provided by wound stent architectures (Chouinard, ¶¶[0048], [0051], [0059], [0062]-[0063], [0078]). A person of ordinary skill therefore would have been motivated to use Chouinard's hexagonal-cell architecture for Zhao's expressly variable stent anchor as a known wound stent architecture capable of providing radial characteristics and secure anchoring appropriate to the target vessel. The modification would have constituted the application of a known stent architecture according to the mechanical requirements of the implantation application to a similar expandable vascular stent structure. Zhao further teaches that its antenna techniques are not limited to the illustrated fixation-mechanism structure and may be used with fixation mechanisms having different mechanical structures provided sufficient magnetic coupling is maintained (Zhao, ¶[0044]), such that the change in stent architecture would not require abandoning Zhao's antenna function. The resulting stent anchor would comprise a plurality of circumferentially extending rows of hexagonal cells.
Regarding claim 2, the modified Zhao does not fully teach wherein the stent anchor is dimensioned to anchor within a pulmonary vein in an expanded deployment configuration. Rather, Zhao teaches that implantable sensor 20 may be placed within “veins, vessels, arteries or other vasculature of heart 21” and that fixation mechanism 24 is a generally tubular or cylindrical stent-like structure configured to lodge against a vessel wall when implanted (Zhao, ¶¶[0025]-[0027]). Zhao further teaches that fixation mechanism 24 may be radially compressed for delivery and expanded in situ such that at least a portion of its struts securely engage the vessel wall (Zhao, ¶[0035]). However, Zhao does not specifically identify a pulmonary vein as the target vein or expressly teach dimensioning the stent anchor for anchoring within a pulmonary vein.
Chouinard teaches that stents are deployed endovascularly in blood vessels and that its wound stent architectures provide secure anchoring force (Chouinard, ¶[0078]). Chouinard further teaches that a shape-memory expandable or resiliently compressible stent has a fully expanded diameter and a constrained diameter when deployed within a lumen, with the constrained stent exerting an outward radial force against the lumen (Chouinard, ¶[0048]). Chouinard teaches that the wound section may comprise polygonal cells, including hexagonal cells, and that the length and architecture of the wound section can be tailored to each application to provide the desired radial strength (Chouinard, ¶¶[0062]-[0063]). Chouinard additionally demonstrates application of its stent structures across a broad range of blood-vessel dimensions, including approximately 6 mm femoral applications, 8 mm iliac applications, 34 mm aortic trunk applications, and 45 mm thoracic applications (Chouinard, ¶[0078]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao by selecting a pulmonary vein as the cardiac vein in which the sensor is implanted and dimensioning the Chouinard-derived hexagonal-cell stent anchor so that, in its expanded deployment configuration, it engages the wall of the pulmonary vein. Zhao expressly contemplates placement of its sensor in cardiac veins and teaches that the pressure measurements obtained by the sensor may depend on the location of implantation (Zhao, ¶¶[0025]-[0026]). A person of ordinary skill therefore would have been motivated to select a particular cardiac vein, including a pulmonary vein, when sensing at that cardiac venous location was desired. Chouinard provides the known means for adapting the modified stent anchor to the selected vascular location by teaching that stent architecture and radial strength are tailored to the particular application and by demonstrating expandable stents configured over a broad range of blood-vessel dimensions (Chouinard, ¶¶[0063], [0078]-[0079]). The modification would have constituted the application and routine adaptation of a known expandable vascular stent architecture to one of the cardiac venous implantation locations contemplated by Zhao, with the stent dimensions and radial characteristics selected according to the target vessel. Because Chouinard expressly teaches that its stents expand to a predetermined diameter at the deployment location and are adaptable across substantially different blood-vessel dimensions, a person of ordinary skill would have had a reasonable expectation that the Chouinard-modified anchor could be dimensioned to expand against and securely anchor within the selected pulmonary vein (Chouinard, ¶[0004], [0078]-[0079]).
Regarding claim 3, the modified Zhao does not fully teach wherein the stent anchor is dimensioned to anchor within a coronary sinus in an expanded deployment configuration. Rather, Zhao teaches that implantable sensor 20 may be placed within “veins, vessels, arteries or other vasculature of heart 21” and teaches a generally tubular or cylindrical stent-like fixation mechanism 24 configured to lodge against a vessel wall when implanted (Zhao, ¶¶[0025], [0027]). Zhao further teaches that the sensor may obtain pressure measurements at different locations of the heart depending on the location of implantation (Zhao, ¶[0026]). Chouinard, as incorporated into the modified Zhao regarding claim 1, teaches a radially compressible and expandable stent architecture having a fully expanded diameter and a constrained diameter within a lumen, wherein the constrained stent exerts outward radial force against the lumen. Chouinard further teaches that the radial strength and flexibility required are selected based primarily on the characteristics of the body lumen in which the stent is to be deployed (Chouinard, ¶[0048]). However, the modified Zhao does not expressly identify the coronary sinus as the particular cardiac vein in which the stent anchor is dimensioned to anchor.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao by selecting the coronary sinus as one of Zhao's contemplated cardiac venous implantation locations and dimensioning the Chouinard-derived hexagonal-cell stent anchor such that, in its expanded deployment configuration, it exerts sufficient outward radial force to lodge against the wall of the coronary sinus. Zhao expressly contemplates implantation of its sensor in veins and other vasculature of the heart and teaches that the physiological measurements obtained by the sensor depend on the location of implantation (Zhao, ¶¶[0025]-[0026]). A person of ordinary skill therefore would have had reason to select a particular cardiac venous location, including the coronary sinus, when sensing at that venous location was desired. Chouinard provides the known means for adapting the modified anchor to the selected vessel by teaching that the expanded diameter, radial strength, and flexibility of an expandable stent are selected according to the characteristics of the body lumen in which the stent is deployed (Chouinard, ¶[0048]). The modification would have constituted the application and routine dimensional adaptation of Zhao's vascular sensor anchor, having the Chouinard stent architecture incorporated regarding claim 1, to another cardiac venous implantation location expressly encompassed by Zhao's disclosure. Because Chouinard teaches selection of the expanded configuration and radial characteristics according to the target lumen, a person of ordinary skill would have had a reasonable expectation that the modified anchor could be dimensioned to lodge securely within the selected coronary sinus.
Regarding claim 4, Zhao further teaches wherein the stent anchor is dimensioned to anchor within at least one of a superior vena cava or an inferior vena cava in an expanded deployment configuration (Zhao, ¶[0025]: “implantable sensor 20 may be placed within or near other portions of heart 21 ... such as the aorta, renal arteries, or inferior or superior vena cava”, thereby expressly identifying the inferior and superior vena cava as implantation locations; ¶[0027], teaching that fixation mechanism 24 affixes implantable sensor 20 to the target location and is a generally tubular or cylindrical stent-like structure configured to lodge against a vessel wall when implanted; ¶[0035], teaching that fixation mechanism 24 is expanded in situ at the target location such that at least a portion of struts 38 securely engage the vessel wall).
Regarding claim 5, Zhao teaches that the first arm structure and the second arm structure are configured to hold the sensor device over a central axis of the stent anchor (Zhao, FIG. 2-3; ¶[0027]: “fixation mechanism 24 is mechanically coupled to housing 22 such that implantable sensor 20 is substantially radially centered within vasculature when implanted", teaches that the sensor device is positioned over the central axis of the stent anchor via the connecting structures).
Regarding claim 6, Zhao teaches that the sensor device is configured to generate a signal indicative of a physiological parameter (Zhao, ¶[0004]: "the techniques described in this disclosure are applicable to any implantable medical device that measure any of a variety of parameters of the patient", disclosing that the implantable medical device is configured to measure physiological parameters of a patient; ¶[0026]: "housing 22 may include a pressure sensing device", disclosing a sensor that measures a physiological parameter; ¶[0028]: "telemetry module 42 may transmit signals representative of the sensed parameter", teaching generation and transmission of a signal indicative of the physiological parameter).
Regarding claim 7, Zhao teaches that the physiological parameter is fluid pressure (Zhao, ¶[0004]: "...continuously monitoring a pressure within a vasculature of the patient...", teaching a physiological parameter of fluid pressure; ¶[0026]: "housing 22 may include a pressure sensing device", disclosing a sensor configured to measure pressure; ¶[0017]: "...IMD 14 being an implantable pressure sensor implanted within a heart of patient 12... intravascular pressure, blood pressure...", teaching measurement of fluid pressure within a vessel).
Claims 8-11 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 2012/0029598 A1), hereinafter Zhao, in view of Bitzer et al. (US 2017/0095163 A1), hereinafter Bitzer.
Regarding claim 8, Zhao teaches a sensor implant assembly comprising an anchor frame (Zhao, ¶¶[0027], [0034], teaching fixation mechanism 24 having struts 38A-38J arranged to form ring 39 having lumen 40, wherein the generally tubular or cylindrical stent-like fixation mechanism is configured to lodge against a vessel wall).
Zhao further teaches a first support arm segment projecting from a first circumferential portion of an axial end of the anchor frame (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”; FIG. 3, showing strut 38K projecting from a circumferential portion of an axial end of ring 39 toward housing 22). (The term “support arm segment” does not require a member structurally separate from the stent anchor or anchor frame. The Specification states that the support arms may be integrated with the frames or forms of the respective anchors and may be integrally formed with the anchor frame. See Instant Application ¶¶[0163]-[0164].)
Zhao further teaches a second support arm segment projecting from a second circumferential portion of the axial end of the anchor frame (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”; FIG. 3, showing strut 38L projecting from a different circumferential portion of the axial end of ring 39 toward housing 22).
Zhao further teaches a sensor device positioned over an opening of the axial end of the anchor frame (Zhao, ¶[0026], teaching housing 22 including a pressure sensing device; ¶[0040], teaching that header portion 28 of housing 22 is located within the portion of lumen 40 defined by struts 38K and 38L; FIG. 3, showing housing 22 supported by struts 38K and 38L over the axial opening defined by lumen 40 of ring 39).
Also, regarding claim 8, Zhao does not fully teach the first support arm including a distal portion comprising a first engagement feature; the second support arm including a distal portion comprising a second engagement feature; and the sensor device comprising a first aperture secured to the first engagement feature of the first support arm segment and a second aperture secured to the second engagement feature of the second support arm segment. Rather, Zhao teaches that struts 38K and 38L mechanically couple at one end to ring 39 and at their opposite ends to housing 22, and teaches that fixation mechanism 24 may be mechanically coupled to housing 22 using spot welding, adhesive, or another coupling mechanism. However, Zhao does not teach respective engagement features at the housing-facing portions of struts 38K and 38L secured to respective apertures in housing 22 (Zhao, ¶[0034]).
Bitzer teaches an implantable pressure sensor structure 5000 having wire arms 6003 used to stabilize or anchor the structure at an implantation site. Bitzer teaches that “wire arms 6003 are fastened to the structure 5000 (e.g., at openings formed on the housing of the pressure sensor)” and that the wire arms are preferably resilient (Bitzer, ¶[0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanical connections between Zhao’s struts 38K and 38L and housing 22 by fastening the housing-facing portion of each strut at a respective opening formed in header portion 28 of housing 22 in the manner taught by Bitzer. Zhao already requires each of struts 38K and 38L to be mechanically coupled to the sensor housing and expressly permits coupling mechanisms other than spot welding or adhesive, while Bitzer teaches fastening wire support arms at openings formed on the housing of an implantable pressure sensor. A person of ordinary skill would therefore have had reason to use Bitzer’s known arm-at-opening mechanical attachment as one of Zhao’s expressly contemplated alternative coupling mechanisms for connecting the existing struts to the pressure sensor housing (Zhao, ¶[0034]; Bitzer, ¶[0038]). The modification would require changing only the manner in which the housing-facing ends of Zhao’s existing struts are mechanically connected to housing 22 and would retain Zhao’s ring 39, the circumferential locations from which struts 38K and 38L project, and the position of housing 22 relative to lumen 40. Although Zhao teaches that housing 22 hermetically encloses the components of implantable sensor 20, Zhao further teaches that housing 22 may include a separate header portion 28 formed of a non-conductive, biocompatible material and mechanically affixed against a mating sidewall surface of housing 22. Zhao locates header portion 28 within the portion of lumen 40 defined by struts 38K and 38L. A person of ordinary skill therefore could have formed Bitzer’s attachment openings in header portion 28, which is part of housing 22 and thus part of the sensor device, without forming the attachment openings through the portion of housing 22 that hermetically encloses the sensor components (Zhao, ¶¶[0026], [0038], [0040]). Applying Bitzer’s attachment arrangement at each of Zhao’s two existing strut-to-housing connections would provide a housing-facing portion of each respective strut that mechanically engages a respective opening in header portion 28, thereby providing the first and second engagement features secured to respective first and second apertures as claimed. The modification would have constituted use of a known mechanical attachment technique for the same support-member-to-pressure-sensor-housing coupling function. A person of ordinary skill would have had a reasonable expectation of success because Bitzer expressly employs that attachment arrangement to fasten wire arms to an implantable pressure sensor housing, while Zhao provides a separate biocompatible header portion in the region of the existing strut-to-housing connections in which the respective attachment openings could be formed.
Regarding claim 9, the modified Zhao teaches that the first support arm segment and the second support arm segment are separate arm structures (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”, disclosing two distinct structural members, strut 38K and strut 38L, each independently extending from the anchor frame to the sensor housing, thereby teaching that the first support arm segment and the second support arm segment are separate arm structures; Fig. 3, showing struts 38K and 38L as distinct, separate members originating from different circumferential locations of ring 39).
Regarding claim 10, the modified Zhao teaches that the first support arm segment and the second support arm segment have curved side profiles (Zhao, Fig. 3, showing struts 38K and 38L as outwardly bowed, non-linear members extending between ring 39 and housing 22, thereby teaching that the first support arm segment and the second support arm segment have curved side profiles).
Regarding claim 11, the modified Zhao teaches that the first support arm segment and the second support arm segment partially define a shape of a circle, the sensor device being positioned at a distal apex of the circle (Zhao, Fig. 3, showing struts 38K and 38L as curved members extending from opposite sides of ring 39 and converging toward housing 22, wherein distal end portions of struts 38K and 38L adjacent the housing include inwardly curved segments that together define portions of an arc, such that the two support arm segments partially define a circular shape at the distal region, with housing 22 positioned at the distal apex where the curved segments meet).
Regarding claim 13, the modified Zhao further teaches wherein the first and second support arm segments are shaped and dimensioned to hold the sensor device in alignment with an axis of the anchor frame a distance axially beyond the axial end of the anchor frame (Zhao, ¶[0027], teaching that fixation mechanism 24 is a generally tubular or cylindrical stent-like structure mechanically coupled to housing 22 such that implantable sensor 20 is “substantially radially centered within vasculature when implanted”, thereby teaching alignment of the sensor-containing housing with the longitudinal axis of the tubular anchor frame; ¶[0034], teaching that struts 38K and 38L mechanically couple ring 39 to housing 22; ¶[0040], teaching that header portion 28 is located within the portion of lumen 40 defined by struts 38K and 38L; Figs. 2-3, showing struts 38K and 38L extending axially from ring 39 and holding housing 22 in the axially aligned position beyond the axial end of ring 39).
Regarding claim 14, the modified Zhao further teaches wherein the first and second support arm segments are shaped and dimensioned to hold the sensor device within a radial boundary defined by a barrel of the anchor frame (Zhao, ¶[0027], teaching that fixation mechanism 24 is a generally tubular or cylindrical stent-like structure and is mechanically coupled to housing 22 such that implantable sensor 20 is "substantially radially centered within vasculature when implanted"; ¶[0034], teaching that struts 38K and 38L mechanically couple ring 39 to housing 22; Fig. 3, showing struts 38K and 38L supporting housing 22 at a radial position within the radial envelope defined by the tubular fixation mechanism, thereby holding the sensor device within the radial boundary defined by the barrel of the anchor frame).
Regarding claim 15, the modified Zhao does not fully teach wherein the first and second support arm segments are shaped and dimensioned to hold the sensor device within an axial length of the anchor frame. Rather, Zhao teaches struts 38K and 38L mechanically coupling ring 39 to housing 22, but the configuration illustrated in Fig. 3 positions housing 22 axially beyond ring 39 (Zhao, ¶[0034]; Fig. 3). However, Zhao separately teaches that the position of housing 22 relative to fixation mechanism 24 may be varied, including locating more of housing 22 within lumen 40 and locating header portion 28 within the portion of the lumen defined by ring 39 or additional rings connected in series with ring 39 (Zhao, ¶[0040]). Zhao explains that positioning more of housing 22 within lumen 40 increases magnetic coupling and reduces the overall length of implantable sensor 20, particularly for implantation sites having relatively short landing zones.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied Zhao's expressly disclosed alternative housing position to the arm-supported sensor arrangement by shaping and dimensioning struts 38K and 38L to position housing 22 farther within the lumen defined by the anchor frame. A person of ordinary skill would have been motivated to make the modification because Zhao expressly teaches that such positioning increases magnetic coupling and reduces the overall device length, particularly at implantation sites having relatively short landing zones (Zhao, ¶[0040]). The modification changes the axial position established by Zhao's existing housing-supporting struts while retaining their mechanical coupling function, and the Bitzer attachment incorporated regarding claim 8 does not require a particular axial position of housing 22. Positioning the sensor-containing housing within the axial extent of the anchor frame would provide the claimed support-arm configuration.
Regarding claim 16, the modified Zhao further teaches wherein the sensor device includes a pressure sensor transducer that faces axially inward toward the anchor frame (Zhao, [0026]: "housing 22 may include a pressure sensing device" teaches a pressure sensor transducer; Zhao, [0031]: "Housing 22 is formed to have an opening 27 that exposes pressure sensing device 26 to the environment at the target location. In the example illustrated in FIG. 3, opening 27 of housing 22 is located along a length of housing 22. However, in other embodiments, opening 27 of housing 22 may be located on either end of housing 22. In any case, pressure sensing device 26 is exposed to the surrounding environment to obtain pressure measurements of the surrounding environment" teaches that the sensing face may be positioned at an end of the housing; Zhao, [0040]: "header portion 28 is located within the portion of lumen 40 defined by struts 38K and 38L" and Fig. 3 teach that the housing is positioned along the longitudinal axis relative to the anchor frame, such that when the opening is located at an end of the housing, the pressure sensing device faces along the axis toward the anchor opening, thereby teaching a pressure sensor transducer that faces axially inward toward the anchor frame).
Regarding claim 17, the modified Zhao further teaches wherein the sensor device includes a pressure sensor transducer that faces axially outward away from the anchor frame (Zhao, [0026]: "housing 22 may include a pressure sensing device" teaches a pressure sensor transducer; Zhao, [0031]: "Housing 22 is formed to have an opening 27 that exposes pressure sensing device 26 to the environment at the target location. In the example illustrated in FIG. 3, opening 27 of housing 22 is located along a length of housing 22. However, in other embodiments, opening 27 of housing 22 may be located on either end of housing 22. In any case, pressure sensing device 26 is exposed to the surrounding environment to obtain pressure measurements of the surrounding environment" teaches that the sensing face may be positioned at an end of the housing; Zhao, Fig. 3, showing housing 22 positioned axially beyond the anchor frame, such that when the opening is located at the distal end of the housing facing away from the anchor frame, the pressure sensing device faces axially outward away from the anchor frame, thereby teaching a pressure sensor transducer that faces axially outward away from the anchor frame).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 2012/0029598 A1), hereinafter Zhao, in view of Bitzer et al. (US 2017/0095163 A1), hereinafter Bitzer, and further in view of Greenland et al. (US 2008/0071178 A1), hereinafter Greenland.
The modified Zhao teaches the limitations of claim 8 as discussed above.
Regarding claim 12, the modified Zhao does not fully teach wherein the sensor implant assembly is adapted to assume a delivery configuration in which the first and second support arm segments are at least partially straightened to hold the sensor device a distance away from the axial end of the anchor frame that is greater than in a deployed configuration of the sensor implant assembly. Rather, Zhao teaches endoluminal delivery of implantable sensor 20 and teaches struts 38K and 38L extending between ring 39 and sensor housing 22 (Zhao, ¶¶[0025], [0034]). Zhao further teaches that the material forming struts 38A-38L may be manipulated such that fixation mechanism 24 is radially compressed or otherwise manipulated for delivery and subsequently expanded in situ at the target location (Zhao, ¶[0035]). However, the modified Zhao does not teach configuring struts 38K and 38L to assume an at least partially straightened delivery configuration that holds housing 22 a greater axial distance from the axial end of ring 39 than in the deployed configuration.
Greenland teaches an implantable sensor assembly 110 having sensor 150 coupled through proximal hub portion 168 and intermediate portion 172 to a distal, generally tubular stent-like anchor portion 176. The intermediate portion includes a plurality of struts 182 extending distally and radially from hub portion 168 (Greenland, ¶¶[0032]-[0033]). In the expanded configuration, struts 182 radiate distally and outwardly such that intermediate portion 172 forms an oblique angle relative to longitudinal axis A110, and Greenland expressly teaches that this sloped orientation facilitates retraction of anchor 154 within a delivery sheath after deployment (Greenland, ¶[0034]). Greenland further teaches that sensor assembly 110 is initially retained within delivery catheter 300 with anchor 154 in a collapsed configuration, that anchor 154 self-expands when advanced beyond the catheter, and that the anchor can subsequently re-assume its collapsed configuration and be retracted into the catheter (Greenland, ¶¶[0042]-[0045]; Figs. 5A-5D). Greenland FIGS. 5A-5D depict the intermediate members in a more axially aligned and linear configuration while constrained in the delivery catheter than when deployed, with a corresponding change in the axial positioning of the sensor relative to the anchor.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao by configuring struts 38K and 38L to move from their deployed curved configuration toward a more axial, at least partially straightened configuration when the sensor implant assembly is constrained for catheter delivery, in accordance with the collapsible sensor-to-anchor support arrangement taught by Greenland. Zhao already teaches deformation of the struts of fixation mechanism 24 to facilitate endoluminal delivery, while Greenland teaches an implantable vascular sensor anchor having an intermediate strut portion that extends obliquely between the sensor and stent-like anchor when deployed and is configured to permit the assembly to collapse within a delivery catheter. A person of ordinary skill would have been motivated to apply Greenland's collapsible support arrangement to Zhao because Greenland expressly identifies accurate sensor placement as important and teaches that its intermediate-strut configuration permits an initially deployed sensor anchor to be retracted, repositioned, re-deployed, or removed (Greenland, ¶¶[0004]-[0006], [0034]). The modification would have been compatible with Zhao because Zhao already contemplates manipulation of struts 38A-38L between delivery and deployed states, and the Bitzer modification regarding claim 8 changes the mechanical attachment between the housing-facing portions of struts 38K and 38L and the sensor housing without requiring the intermediate lengths of the struts to remain rigid. For support arms of substantially fixed length extending between the axial end of the anchor frame and the sensor device, moving the arms from a radially bowed deployed configuration toward the longitudinal axis partially straightens the arms and increases their axial projection. The modified support arms therefore hold the sensor device a greater distance from the axial end of the anchor frame in the delivery configuration than in the deployed configuration.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (US 2012/0029598 A1), hereinafter Zhao, in view of Greenland et al. (US 2008/0071178 A1), hereinafter Greenland, in view of Chouinard et al. (US 2007/0106370 A1), hereinafter Chouinard, in view of Bitzer et al. (US 2017/0095163 A1), hereinafter Bitzer, in view of Bodecker et al. (US 2007/0118038 A1), hereinafter Bodecker, and in view of Amirana (US 2004/0215310 A1), hereinafter Amirana.
Regarding claim 19, Zhao teaches a method of sensing a physiological parameter within a patient (Zhao, ¶[0026]: “housing 22 may include a pressure sensing device that obtains pressure measurements in an environment surrounding housing 22,” thereby teaching sensing a physiological parameter within the patient).
Zhao further teaches providing a sensor implant device (Zhao, ¶[0026]: “Implantable sensor 20 includes a housing 22 and a fixation mechanism 24,” wherein housing 22 may include the pressure sensing device).
Zhao further teaches a stent frame (Zhao, ¶[0027], teaching that fixation mechanism 24 is a generally tubular or cylindrical stent-like structure configured to lodge against a vessel wall when implanted; ¶[0034], teaching struts 38A-38J arranged to form ring 39 having lumen 40).
Zhao further teaches a first support arm segment projecting from a first circumferential portion of an axial end of the stent frame (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”; FIG. 3, showing strut 38K projecting from a circumferential portion of the axial end of ring 39 toward housing 22).
Zhao further teaches a second support arm segment projecting from a second circumferential portion of the axial end of the stent frame (Zhao, ¶[0034]: “Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22”; FIG. 3, showing strut 38L projecting from a different circumferential portion of the axial end of ring 39 toward housing 22). Zhao expressly distinguishes struts 38K and 38L from struts 38A-38J forming ring 39.
Zhao further teaches a sensor device (Zhao, ¶[0026], teaching housing 22 including a pressure sensing device; ¶[0034], teaching struts 38K and 38L mechanically coupled to housing 22).
Zhao further teaches deploying the stent frame at least partially within the target blood vessel (Zhao, ¶[0027], teaching fixation mechanism 24 configured to lodge against a vessel wall; ¶[0035], teaching radial compression of fixation mechanism 24 for delivery and subsequent expansion in situ such that at least a portion of struts 38 securely engage the vessel wall).
Also, regarding claim 19, Zhao does not fully teach providing a sensor implant device in a delivery sheath and advancing a sensor implant device within the delivery sheath to a target blood vessel. Rather, Zhao teaches that implantable sensor 20 may be delivered endoluminally using a delivery system tracked through the vasculature from a percutaneous entry site and teaches radial compression of fixation mechanism 24 to aid delivery. However, Zhao does not expressly teach retaining the sensor implant device within a surrounding delivery sheath during advancement (Zhao, ¶¶[0025], [0035]).
Greenland teaches that “the sensor assembly 110 is initially retained within the delivery catheter 300 with the anchor 154 in a collapsed configuration” and teaches advancing the anchor beyond the distal end of catheter 300 for deployment. Greenland further teaches that the sensor assembly may be preloaded in a guide catheter or advanced through the catheter lumen to a location proximate the distal opening before deployment at the target vascular location (Greenland, ¶¶[0042]-[0043], [0060]-[0061]; FIGS. 5A-5D).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhao in view of Greenland by retaining Zhao’s implantable sensor 20 and compressed fixation mechanism 24 within a surrounding delivery catheter or sheath during advancement through the vasculature to the target blood vessel. Zhao already teaches endoluminal vascular advancement and compression of fixation mechanism 24 to aid delivery, while Greenland teaches the known structural means of retaining a collapsed implantable sensor anchor within a delivery catheter during vascular advancement and releasing the anchor at the implantation site. A person of ordinary skill would have been motivated to employ Greenland’s surrounding catheter containment with Zhao to maintain Zhao’s compressible fixation mechanism in its reduced delivery configuration during advancement and to permit controlled deployment at the target location (Greenland, ¶¶[0042]-[0043], [0060]-[0061]). The modification would have constituted application of a known catheter-containment technique to a similar vascular implant having a compressible anchor and would have had a reasonable expectation of success because both Zhao and Greenland contemplate vascular delivery of expandable implantable sensor anchors.
Also, regarding claim 19, the modified Zhao does not fully teach the stent frame comprising a plurality of circumferentially extending rows of cells, each cell having a hexagonal shape. Rather, Zhao teaches that the illustrated zig-zag ring geometry may be changed and that fixation mechanism 24 may comprise a plurality of rings joined in series to form a cylindrical tubular body of a desired length. However, the modified Zhao does not teach configuring the cylindrical stent frame as circumferentially extending rows of hexagonal cells (Zhao, ¶¶[0034]-[0036]).
Chouinard teaches a tubular endoluminal stent having a polygonal-cell architecture and specifically teaches that wound section 12 “comprises three rows 31 of hexagonal cells 30” (Chouinard, ¶[0059]; FIG. 3). Chouinard explains that FIG. 3 depicts the tubular stent cut parallel to its axis and flattened for illustration, such that rows 31 extend circumferentially when the stent is in its tubular configuration (Chouinard, ¶[0044]). Chouinard further teaches that geometric configuration is a component of stent architecture and identifies a filamentary, wound, polygonal-cell architecture having hexagonal cells as one such configuration (Chouinard, ¶¶[0050]-[0051]). Chouinard teaches that wound sections generally have greater radial strength and lesser flexibility than braided sections, that polygonal cells may comprise hexagonal cells, and that the length and architecture of the wound section can be tailored according to the application to provide the desired radial strength (Chouinard, ¶¶[0062]-[0063]). Chouinard further teaches that the radial strength and flexibility required depend primarily on the characteristics of the body lumen in which the stent is deployed and identifies “secure anchoring force and stent-end patency” as characteristics provided by wound stent architectures (Chouinard, ¶¶[0048], [0078]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao by configuring the cylindrical vessel-engaging portion of fixation mechanism 24 according to the hexagonal polygonal-cell architecture of Chouinard’s wound section 12, while retaining Zhao’s struts 38K and 38L extending from the stent frame to housing 22. Zhao expressly teaches that its illustrated ring geometry may be varied, that a plurality of rings may be joined in series to form a cylindrical tubular fixation mechanism of a desired length, and that the fixation mechanism is radially compressed for delivery and expanded in situ to securely engage the vessel wall (Zhao, ¶¶[0034]-[0036]). Chouinard teaches a known wound stent architecture comprising circumferential rows of hexagonal cells, teaches that the radial characteristics of a stent are selected according to the requirements of the target lumen, and identifies secure anchoring force and stent-end patency as characteristics provided by wound stent architectures (Chouinard, ¶¶[0048], [0051], [0059], [0062]-[0063], [0078]). A person of ordinary skill therefore would have been motivated to use Chouinard’s hexagonal-cell architecture for Zhao’s expressly variable stent frame as a known wound architecture capable of providing radial characteristics and secure anchoring appropriate to the target vessel. The modification relies on Chouinard’s wound-section architecture and does not require incorporating Chouinard’s braided middle section. Zhao further teaches that its antenna techniques may be used with fixation mechanisms having different mechanical structures provided sufficient magnetic coupling is maintained, such that changing the vessel-engaging architecture would not require abandoning Zhao’s antenna function. The resulting stent frame would comprise a plurality of circumferentially extending rows of cells, each cell having a hexagonal shape.
Also, regarding claim 19, the modified Zhao does not fully teach the first support arm including a distal portion comprising a first engagement feature; the second support arm including a distal portion comprising a second engagement feature; and the sensor device comprising a first aperture secured to the engagement feature and a second aperture secured to the second engagement feature. Rather, Zhao teaches that struts 38K and 38L mechanically couple at one end to ring 39 and at their opposite ends to housing 22 and expressly teaches that fixation mechanism 24 may be mechanically coupled to housing 22 by spot welding, adhesive, or another coupling mechanism. However, the modified Zhao does not teach respective engagement features at the housing-facing portions of struts 38K and 38L secured to respective apertures in housing 22 (Zhao, ¶[0034]).
Bitzer teaches an implantable pressure sensor structure 5000 having wire arms 6003 used to stabilize or anchor the structure at an implantation site. Bitzer teaches that “wire arms 6003 are fastened to the structure 5000 (e.g., at openings formed on the housing of the pressure sensor)” and teaches that the wire arms are preferably resilient (Bitzer, ¶[0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao by fastening the housing-facing portion of each of Zhao’s existing struts 38K and 38L at a respective opening formed in header portion 28 of housing 22 in the manner taught by Bitzer. Zhao already requires struts 38K and 38L to be mechanically coupled to the sensor housing and expressly permits coupling mechanisms other than spot welding or adhesive, while Bitzer teaches fastening wire support arms at openings formed on the housing of an implantable pressure sensor. A person of ordinary skill would therefore have had reason to use Bitzer’s known arm-at-opening mechanical attachment as one of Zhao’s expressly contemplated alternative coupling mechanisms for connecting the existing struts to the pressure sensor housing (Zhao, ¶[0034]; Bitzer, ¶[0038]). Although Zhao teaches that housing 22 hermetically encloses the components of implantable sensor 20, Zhao further teaches that housing 22 may include a separate header portion 28 formed of a non-conductive, biocompatible material and mechanically affixed against a mating sidewall surface of housing 22. Zhao locates header portion 28 within the portion of lumen 40 defined by struts 38K and 38L. A person of ordinary skill therefore could have formed Bitzer’s attachment openings in header portion 28, which is part of housing 22 and thus part of the sensor device, without forming the attachment openings through the portion of housing 22 that hermetically encloses the sensor components (Zhao, ¶¶[0026], [0038], [0040]). Applying Bitzer’s attachment arrangement at each of Zhao’s two existing strut-to-housing connections would provide a housing-facing portion of each respective strut that mechanically engages a respective opening in header portion 28, thereby providing the first and second engagement features secured to respective first and second apertures. The modification would have constituted use of a known mechanical attachment technique for the same support-member-to-pressure-sensor-housing coupling function. A person of ordinary skill would have had a reasonable expectation of success because Bitzer expressly employs that attachment arrangement to fasten wire arms to an implantable pressure sensor housing, while Zhao provides a separate biocompatible header portion in the region of the existing strut-to-housing connections in which the respective attachment openings could be formed.
Also, regarding claim 19, the modified Zhao does not fully teach deploying the stent frame at least partially within the target blood vessel in a position such that the first and second support arm segments extend beyond an ostium of the target blood vessel to hold the sensor device outside of the target blood vessel; and measuring a physiological parameter in a chamber outside of the target blood vessel using the sensor device. Rather, Zhao teaches a generally tubular or cylindrical stent-like fixation mechanism configured to lodge against a vessel wall, struts 38K and 38L extending axially from ring 39 to housing 22, placement of implantable sensors in cardiac vessels and chambers, and a pressure sensing device configured to obtain pressure measurements in the environment surrounding housing 22. The modified Zhao further includes the multi-row hexagonal vessel-engaging stent architecture incorporated from Chouinard. However, the modified Zhao does not teach selecting a deployment position at a vessel ostium such that the stent frame remains at least partially within the target vessel while struts 38K and 38L extend beyond the ostium and position housing 22 within the adjacent chamber (Zhao, ¶¶[0025]-[0027], [0034]).
Bodecker teaches that it may be advantageous to locate or anchor implantable sensor device 20 at septum 36 separating right atrium 32 and left atrium 34 “such that a portion of the sensor 20 extends into the chamber to be sensed, e.g., the left atrium 34” (Bodecker, ¶[0066]). Bodecker thereby expressly identifies an advantage in positioning at least a portion of an implantable sensor within the cardiac chamber whose physiological parameter is to be sensed. Bodecker does not, however, teach anchoring a stent frame within a target blood vessel or deploying support arms across the ostium of that vessel.
Amirana teaches positioning an expandable stent at the boundary between a pulmonary vein and the left atrium. Amirana teaches that “the distal end of the stent lies within the pulmonary vein, while the proximal end of the stent is provided to rest in the left atrium, outside of the pulmonary vein” and that the proximal end is positioned against the left atrial wall circumjacent the pulmonary-vein ostium (Amirana, ¶[0013]). Amirana further teaches deploying the distal end approximately 0.2 cm to 6 cm into the pulmonary vein and selecting the expanded radial force to anchor the stent against the pulmonary-vein wall (Amirana, ¶¶[0032]-[0034]). After the distal and middle portions are anchored or deep seated within the pulmonary vein, Amirana deploys the proximal end from the catheter in the left atrium, outside of the pulmonary vein, where it remains adjacent the pulmonary-vein ostium (Amirana, ¶[0035]). Amirana thereby teaches a catheter-delivered stent deployment in which a vessel-engaging portion remains anchored within the pulmonary vein while another portion extends beyond the pulmonary-vein ostium into the left atrium.
Amirana is analogous art to the claimed invention. Amirana is in the same field of endeavor of catheter-delivered expandable implants positioned in cardiac vasculature. Even if Amirana were considered outside the more specific field of implantable sensors, Amirana is reasonably pertinent to the particular problem addressed by the claimed deployment step because it teaches how to deploy an implant so that a vessel-engaging portion remains anchored within a cardiac vein while another portion resides beyond the vessel ostium in the adjacent cardiac chamber. See MPEP §2141.01(a); Amirana, ¶¶[0003], [0012]-[0013], [0030]-[0035].
Bodecker is relied upon for the reason to position the sensor within the chamber being sensed, not for anchoring within a blood vessel or for the deployment structure. Amirana is relied upon for the deployment position and depth at the pulmonary-vein ostium, not for the stent-frame geometry, the support-arm structure, or the sensor function.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Zhao in view of Bodecker and Amirana by selecting a pulmonary vein as the target blood vessel and deploying the vessel-engaging portion of the modified stent frame within the pulmonary vein at a depth that permits Zhao’s existing struts 38K and 38L to extend beyond the pulmonary-vein ostium and position housing 22 within the left atrium. Zhao contemplates implantation of sensor 20 in cardiac veins and chambers, teaches that the pressure measurement obtained depends on the implantation location, and provides struts 38K and 38L that position housing 22 axially relative to the vessel-engaging fixation mechanism (Zhao, ¶¶[0025]-[0026], [0034]). Bodecker expressly teaches that it is advantageous to position a portion of an implantable sensor within the chamber to be sensed, including the left atrium, thereby providing a reason to position Zhao’s pressure-sensing housing within the left atrial chamber when left atrial pressure is the desired physiological measurement (Bodecker, ¶[0066]). Amirana supplies the known pulmonary-vein deployment position and depth for obtaining stable vessel-wall anchoring while positioning an axially extending portion of the implant beyond the ostium in the left atrium (Amirana, ¶¶[0013], [0032]-[0035]). A person of ordinary skill therefore would have been motivated to apply Amirana’s pulmonary-vein deployment arrangement to Zhao so that Zhao’s pressure sensing device could obtain the physiological measurement associated with the left atrial chamber, as expressly contemplated by Bodecker, while the modified stent frame remained securely anchored in the adjoining pulmonary vein. The previously incorporated Greenland delivery sheath remains capable of retaining and delivering the resulting compressible implant. Applying the known deployment location and depth would not require changing the operation of Zhao’s stent frame, support arms, or pressure sensing device. A person of ordinary skill would have had a reasonable expectation of success because Amirana demonstrates catheter deployment and stable anchoring of an expandable implant with portions positioned respectively within the pulmonary vein and beyond its ostium in the left atrium, Zhao already provides axially extending struts that offset the sensor housing from the vessel-engaging fixation mechanism, Bodecker demonstrates intracardiac sensing with a portion of the sensor extending into the left atrium, and Greenland provides catheter containment and deployment of a collapsed implantable sensor anchor. With the stent frame anchored at least partially within the pulmonary vein, struts 38K and 38L extending beyond the ostium, and housing 22 positioned in the left atrium, Zhao’s pressure sensing device would measure the physiological parameter in the chamber environment surrounding housing 22.
Regarding claim 20, the modified Zhao further teaches the sensor device is oriented toward the stent frame (Zhao, [0031]: "Housing 22 is formed to have an opening 27 that exposes pressure sensing device 26 to the environment... opening 27... may be located on either end of housing 22... pressure sensing device 26 is exposed to the surrounding environment to obtain pressure measurements", teaches that the sensing opening is located at an end of the housing and is therefore directionally oriented relative to surrounding structures; Zhao, [0034]: "Struts 38K and 38L mechanically couple on one end to ring 39 and on the opposite end to housing 22" and [0040]: "header portion 28 is located within the portion of lumen 40 defined by struts 38K and 38L", teach that the housing is positioned relative to the stent frame such that an end of the housing faces toward the lumen region of the stent frame; Fig. 3, showing housing 22 positioned adjacent the stent lumen defined by ring 39, thereby illustrating that an end-opening of the housing is oriented toward the stent frame).
The modified Zhao further teaches the method further comprises measuring the physiological parameter with respect to fluid flowing through the stent frame and out of the target blood vessel (Zhao, [0027]: "Fixation mechanism 24... is a generally tubular or cylindrical stent-like structure that is configured to lodge against a vessel wall when implanted" and [0034]: "struts 38A-38) are arranged to form a ring 39 having a lumen 40", teach a stent-like structure defining a lumen through which blood flows; Zhao, [0031]: "pressure sensing device 26 is exposed to the surrounding environment to obtain pressure measurements", teaches that the sensing device measures pressure of the surrounding fluid; Figs. 2-3, showing the sensor housing positioned relative to the lumen of the stent structure, thereby illustrating that the exposed sensing device measures pressure of fluid flowing through the stent frame and along the vessel path, including fluid exiting the stent region of the vessel). When the modified device is deployed as discussed regarding claim 19, with the stent frame anchored in the pulmonary vein and housing 22 positioned in the left atrium, blood flowing out of the pulmonary vein necessarily passes through lumen 40 of the stent frame and into the chamber environment surrounding housing 22, where pressure sensing device 26 obtains the physiological measurement.
Response to Arguments
Information Disclosure Statement
The deficiency identified in the previous Office Action concerning the information disclosure statement filed January 27, 2026 has been resolved. Applicant has provided an English translation of foreign patent document citation number 003, EP 2338420 A1. The reference and the submitted English translation have been considered.
35 U.S.C. §102
Applicant's arguments filed 8/10/2026, pages 6-7, regarding the previous 102 Rejections of claims 1, 4-11, and 13-17 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Applicant's Argument: Applicant argues that Zhao does not anticipate amended claim 1 because Zhao does not teach a stent anchor comprising a plurality of circumferentially extending rows of cells, each cell having a hexagonal shape. Applicant further argues that Zhao does not anticipate amended claim 8 because Zhao does not teach the recited first and second apertures secured to respective engagement features of the first and second support arms. Applicant relies on these amendments as also overcoming the previous anticipation rejections of the dependent claims.
Examiner's Response: Applicant's arguments are moot because the previous rejections under 35 U.S.C. 102 are not maintained in the present action. The present action does not rely on Zhao alone for the limitations added by amendment. Claims 1-7 are presently rejected under 35 U.S.C. 103 over Zhao in view of Chouinard, and claims 8-11 and 13-17 are presently rejected under 35 U.S.C. 103 over Zhao in view of Bitzer, as set forth above.
Applicant's Argument: Applicant argues that claims 4-7, 9-11, and 13-17 are allowable in view of each dependent claim's novel and non-obvious combination of features.
Examiner's Response: The previous rejections of claims 4-7, 9-11, and 13-17 under 35 U.S.C. 102 are not maintained in the present action. To the extent Applicant separately alleges that these dependent claims are allowable based on their own novel and non-obvious combination of features, Applicant has not specifically pointed out how the language of the claims patentably distinguishes over the references relied upon in the present rejections. A general allegation that the claims define a patentable invention, without specifically pointing out how the language of the claims distinguishes over the references, is not persuasive. See 37 CFR 1.111(b); MPEP § 2145.
35 U.S.C. §103
Applicant's arguments filed 8/10/2026, pages 7-9, regarding the previous 103 Rejections of claims 1-3, 8, 12, and 19-20 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Applicant's Argument: Applicant argues that claims 2 and 3 are patentable because they depend from amended claim 1 and the previous rejection does not account for the limitations newly added to claim 1.
Examiner's Response: Applicant's argument is moot because the previous rejection of claims 2 and 3 is not maintained in its prior form. Claims 2 and 3 are presently rejected as part of the rejection of claims 1-7 over Zhao in view of Chouinard, as set forth above.
Applicant's Argument: Applicant argues that the previous rejection of claims 1, 8, and 12 over Zhao in view of Greenland does not cure the deficiencies identified with respect to Zhao, including the limitations newly added to claims 1 and 8.
Examiner's Response: Applicant's arguments are moot because the previous rejection over Zhao in view of Greenland is not maintained in the present action. Claim 1 is presently rejected over Zhao in view of Chouinard. Claim 8 is presently rejected over Zhao in view of Bitzer. Claim 12 is presently rejected over Zhao in view of Bitzer and further in view of Greenland. The present grounds are set forth above.
Applicant's Argument: Applicant argues that the rejection of claim 18 over Zhao in view of Allan is moot because claim 18 has been canceled.
Examiner's Response: Claim 18 has been canceled. Accordingly, the previous rejection of claim 18 is moot.
Applicant's Argument: Applicant argues that amended claim 19 includes limitations not accounted for by the previous rejection over Zhao in view of Greenland and Bodecker, including the recited plurality of circumferentially extending rows of cells having a hexagonal shape and the recited aperture and engagement-feature attachment arrangement.
Examiner's Response: Applicant's arguments are moot because the previous rejection of claims 19-20 over Zhao in view of Greenland and Bodecker is not maintained in the present action. Claims 19-20 are presently rejected under 35 U.S.C. 103 over Zhao in view of Greenland, Chouinard, Bitzer, and Amirana, as set forth 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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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