DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 18 February 2026 has been entered.
Status of Claims
Claim(s) 1, 3-6, 21-24, 28 and 31-33 is/are currently amended. New claim(s) 35-36 has/have been added. Claim(s) 1-36 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the prior Office action(s), the pending claims contain at least one limitation that has been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) (e.g., expandable element, mechanical device, anchor element, etc.).
Claim Objections
Claim(s) 32 is/are objected to because of the following informalities: "said plural anchors" should be amended/corrected to "said plural anchor elements" for consistency with the limitations of claim 28.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 22, 35-36 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 22 and claims dependent thereon, the limitation "wherein said plural anchors are attached to the sensor between a first and second end of the sensor" of claim 22 is indefinite. Specifically, it is unclear if "between" is inclusive of the first and second ends, or refers only to the portion(s) of the sensor in the space separating said ends. If the former, claim 24 only appears to require two anchors. If the latter, the limitations of claims 23-24 appear to contradict the limitations of claim 22 (i.e., requiring anchors at the first and second ends, while the plural anchors are required to be "between" said ends), but potentially could be intended to require three anchors (a first anchor between the first and second ends, a second anchor at the first end, and a third anchor at the third end). For the purpose of this Office action, claim 22-24 will be discussed with the understanding said claims require at least a first of the plural anchors to be attached to the sensor between a first and second end of the sensor, at least a second of the plural anchors to be attached to the first end of the sensor, and at least a third of the plural anchors to be attached to the second end of the sensor.
Regarding claims 35-36 and claims dependent thereon, the limitation "wherein said radially expandable and collapsible sensor coil is non-self-expanding and configured to exert insufficient outward radial force to limit natural expansion and contraction of the vessel wall" is indefinite. It is unclear how, or in what manner, the limitations further limit the limitations of the respective parent claims. Each of claims 33 and 1, on which claims 35 and 36 respectively depend, recite the coil is non-resilient and permits natural physiologic expansion and contraction of the blood vessel wall. As noted in the prior Office action and below, the claim term "non-resilient," in view of Applicant's specification (¶ [0011], ¶ [0072], etc.) appears to be commensurate in scope with being non-self-expanding, as opposed to lacking any resiliency whatsoever. Indeed, Applicant indicates this interpretation of non-resilient is relied on as the basis for such amendments (e.g., Remarks, pg. 11). Accordingly, it is unclear how, if at all, the limitations of new claims 35-36 further limit the scope of claims 33 and 1, respectively.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 35-36 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As discussed above with respect to rejections under 35 U.S.C. 112(b) above, it is unclear how, if at all, the limitations of claims 35-36 further limit the scope of claims 33 and 1, respectively. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 7-8, 21-28, 30-31 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/102435 A1 (previously cited, Sweeney) in view of WO 2016/131020 A1 (previously cited, Gifford) and US 2010/0324665 A1 (previously cited, Shaw).
Regarding claims 1, 4, 7-8, 21, 26-27 and 36, Sweeney discloses and/or suggests a system for deployment of a sensor in a blood vessel having a blood vessel wall, such as an interior vena cava (IVC) (throughout document, e.g., ¶ [0001]), the system comprising:
a radially expandable and collapsible sensor configured to permit natural physiologic expansion and contraction of the blood vessel wall while maintained in contact with the blood vessel wall as the vessel wall moves through cycles of distention and collapse (i.e., exerting insufficient outward radial force to limit natural expansion and contraction of the vessel wall) to produce a wireless signal correlated with the vessel diameter or area, the sensor comprising a coil configured as an L-C circuit having an open center that produces a resonant frequency varying with changes in shape or dimension of the vessel (¶ [0005] sensor comprising a coil configured to engage at least two opposed points on a vascular lumen wall and configured to dimensionally expand and contract with natural movement of the lumen wall, wherein the coil comprises a resonant circuit having a resonant frequency that varies with the variable inductance correlated to its dimensional expansion and contraction; ¶ [0021], e.g., Fig. 2, implant 12a, or coil thereof (¶ [0023]); Fig. 2a, implant 12b, or coil thereof (¶¶ [0027]-[0028]); etc.); and
anchors, such as barbs, disposed around the sensor and configured to maintain the sensor in contact with the vessel wall during both natural physiologic expansion and contraction thereof, wherein the sensor is held in place by said anchors embedded in the vessel wall (Fig. 2, anchors 48, including barbs 50, to help prevent migration of the implant after placement in the IVC by engaging the IVC wall; ¶ [0028]; etc.), wherein the anchors are selectively moveable from a first position where said anchors are non-engageable with the vessel wall (e.g., within a delivery catheter) to a second position wherein said anchors are engageable with the vessel wall (e.g., pushed outside the delivery catheter) (¶¶ [0052]-[0053]).
Sweeney neither expressly discloses the above-noted sensor is non-resilient, nor the system comprises an expandable element configured within the sensor such that, in use, the expandable element is positioned within the open center during deployment, expansion of the expandable element causes the sensor to expand to radially fix the anchors in the wall of the blood vessel, and the expandable element is removable from within the coil after fixation. The examiner notes the term "non-resilient" has been interpreted to mean not sufficiently radially resilient to rely on self-expansion for anchoring (i.e., non-self-expanding), as opposed to lacking any resiliency whatsoever, consistent with the specification (¶ [0011], ¶ [0072], etc., as published). However, Sweeney discloses the vessel wall is relatively compliant compared to other vessels and thus can be more easily distorted by forces applied by resilient implants to maintain their position within the vessel (¶ [0003]), disclosing providing a sensor that is highly compliant, or configured to exert insufficient outward radial force (i.e., having a low radial force, or low resilience) minimizes distortion of the vessel's natural expansion and collapse so as to accurately perform the measurement function (¶ [0082]). Sweeney further discloses an implant/sensor may be configured to maintain its position and orientation through biasing between resilient elements, or by placing anchors, surface textures, barbs, scales, pin-like spikes, etc., on the structure to securely engage the vessel wall (¶ [0069]).
Gifford discloses a comparable system for deployment of a sensor in a blood vessel having a blood vessel wall, the system comprising a radially expandable and collapsible sensor configured to permit natural physiological expansion and contraction of the blood vessel wall while maintained in contact with the blood wall as the vessel wall moves through cycles of distension and collapse (e.g., Fig. 26, stent 2603 including marker element(s) 2606 that expands and contracts with the IVC). Similar to Sweeney, Gifford discloses implants allowing the IVC to be more flexible allow the IVC to more naturally collapse or expand, and further discloses non-resilient sensor or anchor materials (i.e., having less springiness than Nitinol, and/or lacking the resilience to sufficiently self-expand) may be implanted using an expandable element configured within the sensor to expand said sensor/anchor (e.g., ¶ [00137] balloon to actively expand a stent against the IVC).
Shaw discloses a system for deployment of a medical device in a blood vessel comprising: a non-resilient radially-expandable medical device having an open center (200, 300); anchors, such as barbs, disposed around the medical device and configured to maintain the device in contact with the vessel wall during both natural physiologic expansion and contraction thereof (barb portion(s) 210; ¶¶ [0005]-[0006] anchors or barbs provide and/or facilitate fixation or anchoring to a targeted site), wherein the anchors are moveable from a first position in which the anchor is non-engageable with the vessel wall (e.g., Fig. 2A) to a second position in which the anchor is engageable with the vessel wall (e.g., Fig. 2B); and an expandable element (¶ [0026] means to expand), such as a balloon (throughout document, e.g., balloon 108, 202) or mechanical device (¶ [0026] mechanical bow-arms, expandable "Chinese lanterns," expandable baskets, or other expanding devices or materials), wherein the expandable element is configured such that, in use, the expandable element is positioned within the open center of the medical device during deployment (e.g., Figs. 2-3; ¶ [0023]; ¶ [0025] expandable medical device surrounds balloon), and expansion of the expandable element causes radial expansion the medical device to fix the anchors in a wall of the blood vessel (e.g., Figs. 2B, 3, etc.; ¶ [0006]; etc.). While Shaw does not expressly disclose the the expandable element is removable from within the medical device after fixation, Shaw discloses the catheter and/or expandable element thereof is used only for anchoring and/or implantation of a medical device, such that one of ordinary skill in the art would at once envisage the delivery catheter and expandable element are subsequently removed from the medical device and the patient after anchoring/fixation of the expandable medical device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the sensor being non-resilient (i.e., non-self-expanding), the anchors being moveable from a first position in which the anchor is non-engageable with the vessel wall to a second position in which the anchor is engageable with the vessel wall, and to further comprise an expandable element, such as a balloon or mechanical device, configured within the sensor such that, in use, the expandable element is positioned within the open center during deployment, expansion of the expandable element causes the radial expansion of the coil/sensor to fix the anchors in a wall of the blood vessel, and the expandable element is removeable from within the coil after fixation as taught/suggested by Shaw in order to facilitate implanting and/or fixing a sensor at a desired location within the IVC that is highly compliant and minimizes distortion of the vessel's natural expansion and collapse so as to more accurately perform the measurement function (Sweeney, ¶ [0082]; Gifford, ¶ [00137]) in a manner that eliminates a need for aggressive over-expansion, provides anchoring if over-expansion is minimal, does not interfere with the delivery of the sensor, etc. (Shaw, ¶ [0006]).
Regarding claims 22-24, Sweeney as modified teaches/suggests at least one anchor of the plural anchors is attached to the sensor between a first and second end of the sensor, at least one anchor of the plural anchors is attached to the first end of the sensor, and at least a second anchor of the plural anchors is attached to the second end of the sensor, opposite the first (e.g., ¶ [0005] coil is configured to engage at least two opposed points on the vascular lumen wall, e.g., Figs. 2, 2a; two anchors on opposed ends of the implant around its circumference, with at least one anchor between said anchors).
Regarding claim 25, Sweeney as modified discloses/suggests the sensor is configured to obtain an area measurement of the blood vessel (e.g., ¶ [0058]).
Regarding claims 28 and 30-31, Sweeney discloses/suggests a method for deployment of a sensor in a blood vessel having a vessel wall, such as the IVC (throughout document, e.g., ¶ [0001]) to determine a diameter of cross-sectional area of the vessel (e.g., ¶ [0058]), the method comprising:
inserting a radially expandable and collapsible sensor into the blood vessel using a delivery system (e.g., ¶¶ [0052]-[0053]), the sensor comprising a coil having an open center configured as a variable inductance L-C circuit with a resonant frequency that changes based on changes in the shape or diameter of the coil, wherein the coil exerts insufficient outward radial force to limit natural expansion and contraction of the vessel wall (¶ [0005] sensor comprising a coil configured to engage at least two opposed points on a vascular lumen wall and configured to dimensionally expand and contract with natural movement of the lumen wall, wherein the coil comprises a resonant circuit having a resonant frequency that varies with the variable inductance correlated to its dimensional expansion and contraction; ¶ [0021], e.g., Fig. 2, implant 12a, or coil thereof (¶ [0023]); Fig. 2a, implant 12b, or coil thereof (¶¶ [0027]-[0028]); etc.), and anchor elements disposed around the coil (Fig. 2, anchors 48, including barbs 50, to help prevent migration of the implant after placement in the IVC; ¶ [0028]; etc.) (e.g., ¶ [0053] may be inserted from a peripheral vein such as the femoral or iliac vein into the IVC);
fixing the sensor against the vessel wall with the anchor elements embedded in the wall of the blood vessel, such that the sensor remains in contact with the vessel wall during repeated expansion and collapse of the sensor during natural physiologic expansion and contraction of the vessel (e.g., ¶ [0053] fully deploying the implant; ¶ [0068] implant 12 is maintained in contact against the IVC wall without undue radial pressure that may cause distortion thereof);
removing the delivery system (¶ [0053]); and
when energized by an external electrical field, receiving a wireless signal correlated with diameter or cross-sectional area of the blood vessel produced by the sensor as the sensor coil expands and contracts with the blood vessel as the vessel wall moves through cycles of distension and collapse during natural physiologic expansion and contraction of the vessel (e.g., ¶ [0021] when remotely energized by an electric field delivered by one or more transmit coils within the antenna module positioned external to the patient, the L-C circuit produces a resonant frequency dependent upon the inductance of the variable inductor, which is then detected by one or more receive coils of the antenna module to determine the change in the vessel geometry or dimension).
Sweeney neither expressly discloses the above-noted sensor is non-resilient (i.e., non-self-expanding), nor discloses the method comprises expanding an expandable element configured within the open center of the coil during deployment such that expansion of the expandable element causes the sensor to expand radially to contact the vessel wall, and forces the anchor elements to embed in the vessel wall so as to fix the sensor against the vessel wall, or removing the expandable element from within the sensor. However, Sweeney discloses the IVC is relatively compliant compared to other vessels and thus can be more easily distorted by forces applied by implants to maintain their position within the vessel (¶ [0003]), disclosing providing a sensor that is highly compliant (i.e., having a low radial force, or low resilience) minimizes distortion of the vessel's natural expansion and collapse so as to accurately perform the measurement function (¶ [0082]). Sweeney further discloses an implant/sensor may be configured to maintain its position and orientation through biasing between resilient elements, or by placing anchors, surface textures, barbs, scales, pin-like spikes, etc., on the structure to securely engage the vessel wall (¶ [0069]).
Gifford discloses a comparable system for deployment of a sensor in a blood vessel having a blood vessel wall, the system comprising a radially expandable and collapsible sensor configured to permit natural physiological expansion and contraction of the blood vessel wall while maintained in contact with the blood wall as the vessel wall moves through cycles of distension and collapse (e.g., Fig. 26, stent 2603 including marker element(s) 2606 that expands and contracts with the IVC). Similar to Sweeney, Gifford discloses implants allowing the IVC to be more flexible allow the IVC to more naturally collapse or expand, and further discloses non-resilient sensor or anchor materials (i.e., having less springiness than Nitinol, and/or lacking the resilience to sufficiently self-expand) may be implanted using an expandable element configured within the sensor to expand said sensor/anchor (e.g., ¶ [00137] balloon to actively expand a stent against the IVC).
Shaw discloses a system for deployment of a medical device in a blood vessel comprising: a radially-expandable medical device (200, 300, e.g., stent); anchor elements, such as barb, disposed around the medical device and configured to maintain the medical device in contact with the vessel wall during physiologic expansion and contraction thereof (barb portions 210; ¶¶ [0005]-[0006] anchors or barbs provide and/or facilitate fixation or anchoring to a targeted site), the anchor elements being moveable from a first position in which the anchor is non-engageable with the vessel wall (e.g., Fig. 2A) to a second position in which the anchor is engageable with the vessel wall (e.g., Fig. 2B); and an expandable element (e.g., ¶ [0026] means to expand), such as a balloon (throughout document, e.g., balloon 108, 202) or mechanical device(¶ [0026] mechanical bow-arms, expandable "Chinese lanterns," expandable baskets, or other expanding devices or materials), configured within an open center of the medical device such that, in use, expansion of the expandable element causes the device to expand to radially fix the at least one anchor element in a wall of the blood vessel (e.g., Fig. 3; ¶ [0006]; etc.). While Shaw does not expressly disclose the expandable element is removable from within the sensor, Shaw discloses the catheter and/or expandable element thereof is used only for anchoring and/or implantation of the device, such that one of ordinary skill in the art would at once envisage the catheter and expandable element are subsequently removed from the device and patient after the medical device is fixed/anchored.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sweeney with the sensor being non-resilient (i.e., non-self-expanding) and to further comprise expanding an expandable element configured within an open center of the coil during deployment, such that expansion of the expandable element causes the coil/sensor to expand radially to contact the vessel wall and embeds the anchor elements in the vessel wall, thereby fixing the sensor/coil against the vessel wall, and thereafter removing the expandable element from within the sensor as taught/suggested by Shaw in order to facilitate implanting and/or fixing a coil/sensor within the IVC that is highly compliant and minimizes distortion of the vessel's natural expansion and collapse so as to more accurately perform the measurement function (Sweeney, ¶ [0082]; Gifford, ¶ [00137]) in a manner that eliminates a need for aggressive over-expansion, provides anchoring if over-expansion is minimal, does not interfere with the delivery of the sensor/coil, etc. (Shaw, ¶ [0006]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford and Shaw as applied to claim(s) 1 above, and further in view of US 2013/0192611 A1 (previously cited, Taepke).
Regarding claim 2, Sweeney as modified discloses/suggests the limitations of claim 1, as discussed above, but does not disclose the anchor comprises an erodible or fracturable element configured such that, upon healing of the sensor into the wall of the blood vessel, erosion or fracture of the element decouples the sensor from the anchor.
Gifford discloses sensors may heal into the IVC wall over time, such that the stent, anchor, or other elements that hold the markers in place may not need to be permanent and may instead be bioerodable (¶ [00137]). Alternatively/Additionally, Taepke discloses an implant comprising a biodegradable fixation mechanism (throughout document), since conventional fixation devices (tines, barbs, etc.) placed in certain vessels can erode through vessel walls (¶ [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the anchors comprising an erodible element configured such that, upon healing of the sensor into the wall of the blood vessel, erosion of the element decouples the sensor from the anchor as taught/suggested by Gifford and/or Taepke in order to eliminate a foreign body, rendering the IVC more flexible (Gifford, ¶ [00137]); prevent erosion of the IVC wall (Taepke, ¶ [0021]); etc.
Claim(s) 3, 20 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford and Shaw as applied to claim(s) 1 and 28 above, and further in view of US 2009/0005803 A1 (previously cited, Batiste).
Regarding claims 3 and 20, Sweeney as modified discloses/suggests the limitations of claim 1, and further discloses the at least one anchor comprises plural anchors arranged around the sensor (Fig. 2), wherein the anchors comprise barbs (barbs 50), as discussed above. Sweeney further discloses the barbs have a first part extending in a radial direction outward from the sensor (Fig. 2, dimension "E") and a second part including a portion extending transverse with respect to the first part (Fig. 2, dimension "F"). Sweeney does not expressly disclose the second part is "distal," presumably at the terminal end of the first part.
Batiste discloses an anchor(s) having a first part extending in a radial direction outward from a medical device and a second, distal part including a portion extending transverse with respect to the first part (securing barb 600 extending radially outward from each distal end of the primary filter limbs and curves back towards the first element end 302).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with each of the anchors having a first part extending in a radial direction outward from the sensor and a second, distal part including a portion extending transverse with respect to the first part as taught/suggested by Batiste in order to resist and prevent movement of the sensor with respect to the inner surface of the vascular wall while in a deployed state (Batiste, ¶ [0049]) and/or as a simple substitution of one suitable anchor shape for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 32, Sweeney as modified discloses/suggests the limitations of claim 28, as discussed above, and further discloses the anchor elements have a first part extending from the sensor and a second, distal part extending from the first part to retain the anchors within the vessel wall during natural physiologic expansion and contraction of the vessel (Fig. 2, dimensions "E" and "F"; barbs 50 extending outwardly at the end of anchors 48 to engage the IVC wall; ¶ [0068] coil measurement section is maintained in contact with against the IVC wall without undue radial pressure that may cause distortion thereof; etc.). Sweeney does not expressly disclose the first part extends in a radial direction outward from the sensor and the second, distal part extends in a transverse direction with respect to the first part.
Batiste discloses an anchor(s) having a first part extending in a radial direction outward from a medical device and a second, distal part including a portion extending transverse with respect to the first part (securing barb 600 extending radially outward from each distal end of the primary filter limbs and curves back towards the first element end 302).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sweeney with each of the anchor elements having a first part extending in a radial direction outward from the sensor and a second, distal part including a portion extending in a transverse direction with respect to the first part as taught and/or suggested by Batiste in order to resist and prevent movement of the sensor with respect to the inner surface of the vascular wall while in a deployed state (Batiste, ¶ [0049]) and/or as a simple substitution of one suitable anchor shape for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 5-6 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford and Shaw as applied to claim(s) 1 and 28 above, and further in view of US 2003/0216803 A1 (previously cited, Ledergerber); or alternatively, over Sweeney in view of Gifford and Shaw as applied to claim(s) 1 above, and further in view of Ledergerber and US 2018/0008445 A1 (Peña Duque).
Regarding claims 5-6, Sweeney as modified discloses/suggests the limitations of claim 1, but does not expressly disclose the system further comprises a sheath configured at least partially about the sensor, the sheath configured for protecting the expandable element from the anchors, wherein the sheath is removable from about the sensor such that removal of the sheath moves each anchor element from the first position to the second position.
Ledergerber teaches/suggests a system for deployment of a radially-expandable device in a blood vessel (e.g., Abstract, stent-graft secured to a body lumen; stent-graft 100; ¶ [0077]; etc.); at least one anchor element attached to the device and configured to maintain the device in contact with the vessel wall during physiologic expansion and contraction thereof (barbs 136); and a sheath configured at least partially about the device, the sheath configured for protecting an expandable element (¶ [0077] balloon of balloon catheter assembly 25) from the at least one anchor element (protective sheath 105 extending substantially the entire length of stent-graft 100), wherein the sheath is removable from about the device such that removal of the device moves the anchor element from a first position in which the anchor is non-engageable with the vessel wall (e.g., ¶ [0076] protective sheath 105 bends barbs 136 towards the body of the stent-graft 100 such that barbs 136 generally lay parallel along stent-graft 100 and are not extending radially outward) to a second position in which the anchor is engageable with the vessel wall (e.g., ¶ [0079] removal of protective sheath 105 allow barbs 136 to deploy, i.e., to extend radially away from the stent-graft 100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney to further comprise a sheath configured at least partially about the sensor, the sheath configured for protecting the expandable element from the at least one anchor element, wherein the sheath is removable from about the sensor such that removal of the sheath moves the anchor element from the first position to the second position as taught/suggested by Ledergerber in order to prevent damage during the delivery of the sensor to a desired monitoring position (Ledergerber, ¶ [0076]) and/or as a simple substitution of one suitable system arrangement/configuration for ensuring the anchor elements do not interfere with delivery of the sensor for another to yield no more than predictable results. See MPEP 2143(I)(B).
Sweeney as modified discloses and/or suggests the sheath fully surrounds the sensor during deployment, i.e., is "about the sensor," which, consistent with the specification as filed, provides at least some measure of protection for the expandable element from the anchors (e.g., ¶ [0016]).
Alternatively/Additionally, Sweeney discloses, in some embodiments, a sensor/coil may be gradually deployed (e.g., ¶ [0053]). Peña Duque discloses a sheath (removable, non-expandable sheath) configured about an expandable device (¶ [0103] sheath is located between the expandable balloon and a balloon-expandable stent), wherein removal of said sheath permits gradual deployment of the expandable element and expandable device (e.g., ¶ [0102]). One of ordinary skill in the art would additionally readily appreciate the sheath disclosed by Peña Duque provide some measure of protection of the expandable element from the expandable device, or components thereof. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the sheath further comprising a sheath configured at least partially about the sensor (i.e., between the expandable element and the sensor, or anchors thereof) as taught/suggested by Peña Duque, which protects the expandable element, in order to enable gradually deploying/expanding the sensor/coil to ensure the coil is properly positioned (Sweeney, ¶ [0053]).
Regarding claim 29, Sweeney as modified discloses/suggests the limitations of claim 28, as discussed above, but does not disclose the method comprises removing a sheath from the sensor prior to expanding the expandable element.
Ledergerber discloses a method comprising inserting a radially expandable device (stent-graft 100) into a blood vessel (¶ [0077]), the device comprising at least one anchor element (barbs 136); removing a sheath (protective sheath 105) from the device (¶ [0079] protective sheath 105 is removed from stent-graft 100 in order to allow barbs 136 to deploy); and, after removing the sheath, expanding an expandable element configured within the device such that expansion of the expandable element causes the device to expand to radially fix the at least one anchor element in a wall of the blood vessel (e.g., transition from Fig. 5C to 5D; ¶ [0080] stent-graft 100 may be transitioned to the expanded state using balloon catheter 25 or other mechanical tool in which barbs 136 engage arterial walls in order to stabilize the position of stent-graft 100 within artery 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sweeney with removing a sheath from the sensor prior to expanding the expandable element as taught/suggested by Ledergerber in order to prevent damage during the delivery of the sensor to a desired monitoring position (Ledergerber, ¶ [0076]) and/or as a simple substitution of one suitable means/method for ensuring the anchor element(s) does/do not interfere with delivery of the sensor for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 9-15 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford and Shaw as applied to claim(s) 1 above, and further in view of US 2014/0188127 A1 (previously cited, Dubrul).
Regarding claims 9-14, Sweeney as modified discloses/suggests the limitations of claim 1, as discussed above. While Shaw discloses the expandable element is not limited to a balloon (e.g., ¶ [0026]), Shaw (or Sweeney as modified thereby) does not expressly disclose the expandable element comprises a tube.
Dubrul discloses an expandable element comprising a non-rigid tube comprising a first inner tube and a second outer tube, the tube comprising a plurality of straight incisions through the surface of the tube along its length (¶ [0091] malecot type of expandable element, i.e., tube having a number of longitudinally extending slits, e.g., Figs. 86-91, outer tube 414 having slits 412 and inner tube 417), wherein a region of the tube about the incisions is expandable upon applying a longitudinal pulling force to an internal surface of the tube (e.g., ¶ [0195] to place the device in a radially expanded state, inner tube 417 is pulled).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the expandable element comprising a non-rigid tube comprising a first inner tube and a second outer tube, the tube comprising a plurality of straight incisions through the surface of the tube along its length, wherein a region of the tube about the incisions is expandable upon applying a longitudinal pulling force to an internal surface of the tube, as taught and/or suggested by Dubrul as a simple substitution of one suitable expandable means/mechanism for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 15 and 18-19, Sweeney as modified discloses/suggests the limitations of claim 13, and further discloses the tube comprises a first inner tube and a second outer tube, as discussed above, but does not expressly disclose application of a force to the tube comprises applying a longitudinal pushing force to an external surface of the tube and/or the longitudinal pushing force is applied to the second outer tube. Rather, as discussed above with respect to claim 14, Dubrul (or Sweeney as modified thereby) discloses applying a longitudinal pulling force to an internal surface of the tube and/or to the inner tube. However, one of ordinary skill in the art would readily appreciate pushing the outer tube while maintaining the inner tube at a given, fixed position achieves the same relative movement and/or force between the inner and outer tubes as pulling the inner tube while maintaining the outer tube at a given, fixed position. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with application of a force to the tube comprising applying a longitudinal pushing force to an external surface of the tube and/or to the outer tube as a simple substitution of one suitable means/method for achieving relative movement/force between inner and outer tubes, thereby controlling radial expansion of the expandable element, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Sweeney with application of a force to the tube comprising applying a longitudinal pushing force to an external surface of the tube and/or to the outer tube because Applicant has not disclosed that pushing the external surface of the tube and/or pushing the outer tube provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant appears to disclose pulling the internal surface of the tube and/or an inner tube as a suitable alternative to the above-noted arrangement (e.g., ¶¶ [0080]-[0081]). Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art, would have expected Applicant's invention to perform equally well with the method/means for expanding the expandable element disclosed by Dubrul (e.g., pulling an internal surface of the tube and/or inner tube) because either arrangement enables providing the necessary relative movement/force to facilitate radial expansion of the tube.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford, Shaw and Dubrul as applied to claim(s) 14 above, and further in view of US 5,782,239 A (Webster, Jr.).
Regarding claims 16-17, Sweeney as modified discloses/suggests the limitations of claim 14, as discussed above, but does not expressly disclose the system further comprises a tether element fixed to an internal surface of the tube.
Webster Jr. discloses/suggests a tube (inner catheter) comprising a region of expandable arms (plurality of arms forming a three-dimensional shape), wherein said region is expandable upon applying a longitudinal pulling force to an external surface of the tube (Abstract); and a tether element fixed to an internal surface of the tube, wherein the longitudinal pulling force is applied to the tether (Abstract, a proximally directed force to a puller wire causes the three-dimensional shape to expand outwardly, e.g., Fig. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney to further or alternatively comprise a tether element fixed to an internal surface of the tube, wherein the longitudinal pulling force is applied to the tether, as taught/suggested by Webster, Jr. as a simple substitution of one suitable means/method for controlling radial expansion of the expandable element for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney in view of Gifford and Shaw; or alternatively, over Sweeney in view of Gifford, Shaw and Taepke or Batiste.
Regarding claims 33-35, Sweeney discloses/suggests a system for deployment of an implantable sensor in a blood vessel having a blood vessel wall, comprising:
a radially expandable and collapsible sensor coil configured as an L-C circuit to permit natural physiologic expansion and contraction of the blood vessel wall (i.e., exerting insufficient outward radial force to limit natural expansion and contraction) while maintained in contact with the blood vessel wall as the vessel wall moves through cycles of distension and collapse to produce a wireless variable resonant frequency signal correlated with the vessel diameter or area (¶ [0005] sensor comprising a coil configured to engage at least two opposed points on a vascular lumen wall and configured to dimensionally expand and contract with natural movement of the lumen wall, wherein the coil comprises a resonant circuit having a resonant frequency that varies with the variable inductance correlated to its dimensional expansion and contraction; ¶ [0021], e.g., Fig. 2, implant 12a, or coil thereof (¶ [0023]); Fig. 2a, implant 12b, or coil thereof (¶¶ [0027]-[0028]); etc.); and
plural anchors attached around the sensor (Fig. 2, anchors 48, including barbs 50, to help prevent migration of the implant after placement in the IVC; ¶ [0028]; etc.), said anchors having a first part extending in a radial direction outward from the sensor (Fig. 2, dimension "F") and a second part including a portion extending in a transverse direction with respect to the first part to retain the anchors within the vessel wall and maintain the sensor in contact with the vessel wall during both natural physiologic expansion and natural physiologic contraction thereof (Fig. 2, barb 50 extending outwardly at the end of anchors 48 to engage the IVC wall, dimension "E"; ¶ [0068] coil measurement section is maintained in contact with against the IVC wall without undue radial pressure that may cause distortion thereof; etc.).
Sweeney neither expressly discloses the above-noted sensor is non-resilient (i.e., non-self-expanding), nor the system comprises an expandable element configured to be received within the sensor such that, in use, expansion of the expandable element causes the sensor to expand to radially fix the anchors in the vessel wall. However, Sweeney discloses the IVC wall is relatively compliant compared to other vessels and thus can be more easily distorted by forces applied by implants to maintain their position within the vessel (¶ [0003]), disclosing providing a sensor that is highly compliant (i.e., having a low radial force, or low resilience) minimizes distortion of the vessel's natural expansion and collapse so as to accurately perform the measurement function (¶ [0082]). Sweeney further discloses an implant/sensor may be configured to maintain its position and orientation through biasing between resilient elements, or by placing anchors, surface textures, barbs, scales, pin-like spikes, etc., on the structure to securely engage the vessel wall (¶ [0069]).
Gifford discloses a comparable system for deployment of a sensor in a blood vessel having a blood vessel wall, the system comprising a radially expandable and collapsible sensor configured to permit natural physiological expansion and contraction of the blood vessel wall while maintained in contact with the blood wall as the vessel wall moves through cycles of distension and collapse (e.g., Fig. 26, stent 2603 including marker element(s) 2606 that expands and contracts with the IVC). Similar to Sweeney, Gifford discloses implants allowing the IVC to be more flexible allow the IVC to more naturally collapse or expand, and further discloses non-resilient sensor or anchor materials (i.e., having less springiness than Nitinol, and/or lacking the resilience to sufficiently self-expand) may be implanted using an expandable element configured within the sensor to expand said sensor/anchor (e.g., ¶ [00137] balloon to actively expand a stent against the IVC).
Shaw discloses a system for deployment of a medical device in a blood vessel comprising: a non-resilient radially-expandable medical device (200, 300); at least one anchor, such as a barb(s), attached to the device and configured to maintain the device in contact with the vessel wall during both natural physiologic expansion and contraction thereof (barb portion(s) 210; ¶¶ [0005]-[0006] anchors or barbs provide and/or facilitate fixation or anchoring to a targeted site) and moveable from a first position wherein the anchor is non-engageable with the vessel wall (e.g., Fig. 2A) to a second position wherein the anchor is engageable with the vessel wall (e.g., Fig. 2B); and an expandable element (e.g., ¶ [0026] means to expand), such as a balloon (throughout document, e.g., balloon 108, 202) or mechanical device (¶ [0026] mechanical bow-arms, expandable "Chinese lanterns," expandable baskets, or other expanding devices or materials), configured within the device such that, in use, expansion of the expandable element causes the device to expand to radially fix the at least one anchor element in a wall of the blood vessel (e.g., Fig. 3; ¶ [0006]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the sensor coil being non-resilient (i.e., non-self-expanding), and to further comprise an expandable element configured to be received within the sensor such that, in use, expansion of the expandable element causes the sensor to expand to radially fix the anchors in vessel wall as taught/suggested by Shaw in order to facilitate implanting and/or fixing a sensor within the IVC that is highly compliant and minimizes distortion of the vessel's natural expansion and collapse so as to more accurately perform the measurement function (Sweeney, ¶ [0082]; Gifford, ¶ [00137]) in a manner that eliminates a need for aggressive over-expansion, provides anchoring if the over-expansion is minimal, and does not interfere with the delivery of the device (Shaw, ¶ [0006]).
Sweeney as modified discloses the anchors have a first part extending from the sensor and a second, distal part extending from the first part to retain the anchors within the vessel wall during natural physiologic expansion and contraction of the vessel (Fig. 2, dimensions "E" and "F"; barb 50 extending outwardly at the end of anchors 48 to engage the IVC wall; ¶ [0068] coil measurement section is maintained in contact with against the IVC wall without undue radial pressure that may cause distortion thereof; etc.). Sweeney does not expressly disclose the first part extends in a radial direction outward from the sensor and the second, distal part extends in a transverse direction with respect to the first part.
Batiste discloses an anchor(s) having a first part extending in a radial direction outward from a medical device and a second, distal part including a portion extending transverse with respect to the first part (securing barb 600 extending radially outward from each distal end of the primary filter limbs and curves back towards the first element end 302).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Sweeney with the anchors having a first part extending in a radial direction outward from the sensor and a second, distal part including a portion extending in a transverse direction with respect to the first part as taught and/or suggested by Batiste in order to resist and prevent movement of the sensor with respect to the inner surface of the vascular wall while in a deployed state (Batiste, ¶ [0049]) and/or as a simple substitution of one suitable anchor shape for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant contends, "Sweeney does not disclose a non-resilient L-C coil that exerts insufficient radial force to self-anchor and that is held in place by plural anchors embedded around the coil. This fact is specifically acknowledged in the Office Action, which states that Sweeney does not 'expressly' disclose a non-resilient sensor in the analyses for the system and method claims, and in the analysis of claim 33 (Office Action, ¶10; ¶17). This fact is not disproved by the later, contradictory statements in the 'Response to Arguments,' which characterizes Sweeney in a completely opposite manner as 'expressly' disclosing a non-resilient coil by equating 'non-resilient' with 'highly compliant (low radial force)' (Office Action, iJ18, citing Sweeney ¶ [0069], ¶ [0082]).
The examiner respectfully disagrees the statements in the prior Office action are contradictory. It was acknowledged in the rejections of record that Sweeney does not expressly disclose that a particular L-C coil embodiment(s) described therein (e.g., 12a, 12b) is "non-resilient," or lacks sufficient radial resilience to rely on self-expansion for anchoring. However, Sweeney does make other explicit statements disclosing/suggesting that sensors that are highly compliant, or configured to exert insufficient outward radial force (i.e., having a low radial force, or low resilience), minimize distortion of the vessel's natural expansion and collapse so as to accurately perform the measurement function (e.g., ¶ [0082]).
Applicant further contends the cited portions of Sweeney do "not reach the limitation now present in claim 1 that the coil has insufficient radial force to self-anchor and therefore must be held by plural anchors embedded in the wall. In contrast, the present Application expressly states that the coil is 'not sufficiently radially resilient to rely on self-expansion for anchoring' and 'does not rely on resilience or outward bias to provide anchoring'" (Remarks, pgs. 8-9).
The examiner respectfully disagrees. Sweeney discloses the sensors/coils are configured to have a compliance/resilience to permit it to move with changes in the IVC wall geometry or dimension while maintaining its position with minimal distortion of the natural movement of the IVC wall (¶ [0028]), and discloses a coil that is highly compliant (i.e., having a low radial force, or low resilience) minimizes distortion of the vessel's natural expansion and collapse so as to accurately perform the measurement function (¶ [0082]). Sweeney further discloses, "Each structure is configured based on size, shape and materials to maintain its position and orientation through biasing between resilient elements of the implant to ensure contact with the vessel walls. Additionally or alternatively, anchors, surface textures, barbs, scales, pin-like spikes or other securement means may be placed on the structure to more securely engage the vessel wall" (¶ [0069] emphasis added). Accordingly, Sweeney discloses anchors may be used as an alternative to resiliency to ensure contact with the vessel walls and maintaining the sensor/coil position and orientation. Therefore, Sweeney at least suggests a sensor/coil (e.g., 12a), rather than being sufficiently resilient to self-expand, may be highly-compliant and/or non-resilient and instead securely engaged with the vessel wall via the anchors, thereby minimizing vessel distortion and providing accurate measurements.
Applicant further contends, "The anchoring mechanisms discussed in Sweeney include biasing and external anchors and surface features (¶ [0069]); there is no teaching to place an expander inside the coil's open center, to protect that expander with a sheath during anchor deployment, or to remove the expander after anchor fixation while preserving the coil's resonance and open lumen" (Remarks, pg. 9); and "Neither [Shaw nor Gifford] describes an expander positioned within the open center of a resonant L-C coil during deployment and then removed, and neither reference addresses preservation of the coil's inductance and open lumen when such an expander is used. The amended claim therefore recites structural and operational relationships that are not present in Sweeney, Shaw, or Gifford" (Remarks, pg. 9).
The rejection of record does not rely on Sweeney alone for disclosure of an expander or expandable element. However, as noted above, Sweeney does at least suggest (or provide some motivation for) making the coil highly compliant or non-resilient to minimize vessel distortion and provide accurate measurements. The rejection of record does not propose to further expand the open center as illustrated in, e.g., Fig. 2 of Sweeney, but rather to use an active expandable element (e.g., balloon) to transition a highly compliant, non-resilient sensor from a collapsed delivery configuration to an expanded measurement configuration (e.g., Sweeney, Figs. 9B-C), rather than relying on its resiliency for such expansion. Gifford discloses comparable compliant/non-resilient (i.e., lacking the resiliency or springiness to self-expand) expandable devices, such as stents, may be implanted using an expandable element configured within the stent to expand said stent (e.g., ¶ [00137] balloon to actively expand a stent against the IVC). Shaw provides additional structural details of such an expandable element and/or its cooperation with an expandable medical device (or anchors thereof) to be implanted, including that the expandable element is positioned within an open center of the device in a collapsed configuration during deployment of the medical device (e.g., Fig. 1A, 2A, etc.), is used to expand the medical device radially so that anchors thereof embed in a tissue wall to anchor/fix the medical device in place (Fig. 2B, 3, etc.), and subsequently withdrawn leaving the device implanted (as the delivery system is used only for deployment of the device, as discussed above).
Applicant further contends, "There is also a technical incompatibility that undercuts any reasonable expectation of success of the proposed combination. The L-C coil in Sweeney is configured to move with the IVC wall and to maintain an open center and stable inductive path so that, when excited externally, the circuit produces a detectable resonant signal correlated with vessel dimension (¶ [0016], ¶ [0021]-[0023]). Positioning and inflating a balloon inside that open center to force anchors into the wall would occupy the lumen during deployment and risk detuning or shorting the coil windings, which directly conflicts with the described need to minimize distortion and to maintain high-Q behavior. The Office Action does not provide an articulated rationale showing how Shaw's balloon could be used 'within the open center' of a coil in a manner that preserves coil operability and is removable after fixation, as now required by claim 1. The present Application, by contrast, sets out a deployment sequence in which the expander is placed only temporarily within the open center, a sheath shields it from anchors, anchors are embedded to hold the low-force coil in place, and the expander is then withdrawn (Spec., ¶ [0076]-[0086]; FIGS. 6-7; FIGS. 14A-16B)" (Remarks, pgs. 9-10).
The examiner respectfully disagrees. The examiner first notes claim 1 does not require a sheath. In the proposed modification(s), as noted above, the expandable element is utilized only for deployment or anchoring of the sensor/coil (i.e., transitioning the sensor/coil from a collapsed delivery configuration to a deployed/anchored measurement configuration) and subsequently removed from the sensor and patient comparable to other expandable medical devices (e.g., stents) as disclosed and/or suggested by Gifford and Shaw. Accordingly, comparable to deployment of a balloon-expandable stent, the center of the sensor/coil is occupied during deployment, but open during subsequent use of the device (i.e., diameter/area measurements) as required by Sweeney. Further, Applicant has provided no logical basis or reasoning for the conclusory statement that "positioning and inflating a balloon inside that open center to force anchors into the wall would…risk detuning or shorting the coil windings." The examiner is unable to locate either any disclosure in Sweeney relating to detuning or shorting coil windings during device deployment, or any reasonable basis as to why expanding the sensor with an expandable element (e.g., balloon) rather than self-expanding using the sensor's/coil's own resiliency would lead to such a risk(s).
Applicant further contends, "To the extent the Office Action characterizes anchor geometry or the placement of an expander within a coil as 'design choice,' that reasoning does not address the claim's core distinctions" (Remarks, pg. 10).
No such characterization has been made with respect to the placement of an expander within a coil, either in the rejection of record or in the prior Office action.
With respect to claim 4, Applicant contends Sweeney does not disclose anchors that are selectively movable, Shaw is only taught in the context of balloon expandable "medical devices," and the rejection does not supply a reasoned basis for importing the movable-anchor mechanism of Shaw into the Sweeney coil sensor while preserving the coil sensor's intended compliant behavior (Remarks, pgs. 10-11).
The examiner respectfully disagrees. As noted in the rejections above, Sweeney discloses the delivery system enables selectively moving the anchors between a first position in which the anchors are non-engageable with the vessel wall and a second position in which the anchors are engageable with the vessel wall (e.g., through movement of a pusher and/or delivery catheter). Said system relies on resiliency of sensor/coil to ultimately embed the anchors in the vessel wall. Shaw discloses/suggests a means for selectively transitioning anchors from the first position to the second position using an expandable element suitable for non-resilient (i.e., non-self-expanding) expandable medical devices. Since the sensor/coil of Sweeney as modified is similarly non-resilient, Shaw reasonably suggests an alternative means for selectively moving the anchors for engagement with the vessel wall when at a desired location within the blood vessel.
With respect to claim 28, Applicant contends, "Neither Shaw nor Gifford addresses implementing such a within-coil expansion/removal sequence for a resonant, open-center coil sensor, or how to do so while preserving the measurement operation of the coil and without interfering with natural distension/collapse cycles that the claim expressly requires the sensor to follow" (Remarks, pgs. 12); and further contends, "The Office Action relies on the premise that the combination would 'facilitate implanting and/or fixing a sensor within the IVC' while minimizing distortion (Office Action, ¶10, method discussion), but it does not explain why a skilled artisan would place a balloon expander within an open-center resonant coil and actively expand the coil to force anchors into the wall, given that Sweeney is relied upon by the Office Action for emphasizing low radial force and minimizing distortion of natural vessel expansion/collapse and does not require an expander device (Office Action, iJl0 citing Sweeney [0082] as discussed by the examiner).
The examiner respectfully disagrees. The combination of Sweeney, Gifford and Shaw addresses the expansion and removal sequence as required by claim 28 for at least the reasons noted above. Additionally, Applicant mischaracterizes the premise of the proposed modification as "facilitat[ing] implanting and/or fixing a sensor within the IVC while minimizing distortion," while the rejection(s) actually states said modification facilitates "implanting and/or fixing a coil/sensor within the IVC that is highly compliant and minimizes distortion of the vessel's natural expansion and collapse so as to more accurately perform the measurement function." The rejection(s) of record does not contend that the act of implanting or fixing the sensor in the manner claimed/suggested by the cited art "minimizes distortion," but that an implanted highly compliant or non-resilient sensor/coil minimizes distortion relative to a resilient coil during area/diameter measurements as taught/suggested by Sweeney. Giffords and Shaw are relied upon as disclosing a means/method to implant/fix such a highly compliant sensor (i.e., that lacks the springiness or resiliency for self-expansion) at a desired location within the blood vessel. As discussed above with respect to claim 1, Sweeney discloses an open-center coil is delivered to a target location in a collapsed configuration and expanded at the target location. Sweeney discloses the coil is configured to permit natural distension/collapse cycles in the expanded configuration. The delivery system/method expressly disclosed by Sweeney relies on the resiliency of the coil to self-expand for implantation. However, in other portions of the disclosure, Sweeney expressly discloses a highly compliant coil is beneficial to minimize vessel distortions during diameter/area measurements. Gifford discloses comparable highly compliant (i.e., not sufficiently resilient to self-expand) devices may be similarly delivered in a collapsed configuration and actively expanded with an expandable element, e.g., balloon. Shaw illustrates/suggests how such expansion is achieved, i.e., the expandable element is positioned with the open center of an expandable device to be implanted and delivered to a desired location within the vasculature, the expandable element is then used to expand said device at the desired located, and lastly, since the device is a chronically implanted device (e.g., a stent) and the expandable element (and remainder of the delivery system) utilized only for deployment or implantation of the device, the expandable element is removed from the expanded device and patient, consistent with state of the art device deployment systems. There is neither any evidence in the cited art, nor provided by Applicant as to why or how this alternative means/method of securing the implant at a desired location in the combination as proposed would in any way affect measurement operation of the coil or interfere with natural distension/collapse cycles during said measurements. To the contrary, the disclosure of Sweeney indicates the more compliant nature of such a sensor, once deployed, minimizes any interference with natural movement of the blood vessel, thereby leading to more accurate measurements, as noted above.
With respect to claim 2, Applicant contends, "[Even] if Gifford and/or Taepke suggests that some fixation components may be biodegradable in certain contexts, the cited combination does not teach or suggest the specific configuration required by claim 2 in which a dedicated erodible or fracturable element is arranged so that, upon healing of the sensor into the vessel wall, erosion or fracture of that element decouples the sensor from the anchor" (Remarks, pgs. 13-14).
The examiner respectfully disagrees. Giffords discloses anchors may be made of a bioerodable material, therefore having an erodible element, wherein said material is configured to last until a device is healed into the wall of the blood vessel (e.g., ¶ [0051]). This is comparable to the disclosure of Taepke, which requires that the temporary biodegradable fixation mechanism is designed to degrade in a period of time that is sufficient to allow healing of a sensor into the wall of a blood vessel (e.g., ¶ [0057] temporary fixation mechanism is designed to degrade in a period of time that is sufficient to allow enough tissue growth to chronic fixation mechanism 103 to secure sensor 38). The cited prior art indicates erodible/degradable anchors are designed to ensure they erode/degrade upon sufficient healing of the sensor into the wall of the blood vessel to secure the sensor without the anchors, and therefore meets the limitations of claim 2. This interpretation is consistent with Applicant's own disclosure, which states, "This is advantageous as it provides the ability for the sensor to be mechanically decoupled from the anchor at a time post deployment, potentially when the sensor and anchors have healed into the vessel. As such, the decoupling could be achieved via a biodegradable portion that is designed to erode over time in vivo…" (¶ [0013]).
With respect to claims 3 and 20, Applicant contends, "The purpose of the anchors in Sweeney and Batiste is merely to prevent migration of the device along the vessel" (Remarks, pg. 14); and the Office action "does not establish a reasoned basis, with a reasonable expectation of success, for applying those specific anchor forms [of claim 20] in the claimed coil-sensor deployment system" (Remarks, pgs. 14-15)
The examiner respectfully disagrees. As discussed above, Sweeney discloses anchors, which may include barbs, may be used as an alternative to resiliency to ensure contact with the vessel walls and maintaining the sensor/coil position and orientation (¶ [0069]). Batiste discloses securing barbs that "resist and prevent movement of the filter assembly with respect to the inner surface of the vascular wall while in a deployed state" (¶ [0049]). Accordingly, Batiste similarly discloses barbs having the geometry as claimed ensure contact with the vessel wall (i.e., prevent movement with respect to said wall) while deployed, and therefore would have been an obvious geometry to employ in Sweeney as modified.
With respect to claims 5-6, Applicant contends the sheath of Ledergerber is not configured to protect the expandable element from the anchors but consistently describes the sheath in terms of controlling barb orientation to avoid damage to the body during advancement and then allowing barb deployment upon sheath removal (Remarks, pgs. 16-17).
The examiner respectfully disagrees. The above-noted argument is inconsistent with Applicant's own disclosure, which states, "The system may further comprise a sheath configured at least partially about the sensor, the sheath and anchor element configured for protecting the expandable element from the at least one anchor element. In this manner, the sheath may fully surround the sensor and the expandable element and aids in the delivery of the expandable element and sensor into a vessel" (¶ [0016]). Accordingly, Applicant discloses a sheath "configured for protecting the expandable element from said anchors" encompasses a sheath that fully surrounds expandable device and its anchors, comparable to the sheath disclosed by Ledergerber. Further, one of ordinary skill in the art would readily appreciate such a sheath provides at least some measure of protection of an expandable element from the anchors, e.g., by preventing the anchors from being pushed into said expandable element. Additionally, the only sheath Applicant discloses with any specificity that is used to move the anchors is an outer sheath, wherein removal of said sheath permits biased anchors to move into an engageable position (¶ [0064]). While Applicant discloses a sheath may be positioned between the sensor and the expandable element (¶ [0016]), Applicant fails to sufficiently describe how removal a sheath between the sensor and the expandable element would/could change a position of the anchors as required by the limitations of claim 6. Accordingly, based on the application as filed, the scope of claim 5 appears to reasonably encompass a sheath positioned about (i.e., around) the sensor or comparable expandable element, and the expandable element, as taught/suggested by Ledergerber.
With respect to claims 9-15 and 18-19, Applicant contends, "Dubrul does not describe use of the slitted-tube mechanism as an expandable element positioned within an implantable sensor for the specific purpose of expanding a non-resilient, open-center, resonant coil and fixing vessel-wall anchors while preserving long-term physiologic expansion/contraction measurement functionality" (Remarks, pgs. 17-18); and "Shaw already provides multiple types of expandable elements (balloons and mechanical expanders) for balloon-expandable devices (Office Action iJl0 citing Shaw ¶[0026]), yet the rejection does not explain why a skilled artisan would depart from those known expansion modalities and import the more specialized malecot/slitted-tube mechanism from Dubrul into an implantable resonant sensor deployment system" (Remarks, pg. 18).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As noted by Applicant, Shaw expressly discloses mechanical expanders can be utilized as an alternative to a balloon. While Shaw discloses generic types of mechanical expanders, Shaw does not describe these mechanical expanders in any detail and/or to the specific level of detail required by the present claims. Dubrul, however, does disclose said detail(s) of how a particular mechanical expander may operate. Since Shaw discloses such mechanical expanders are a suitable and predictable alternative to the expandable element being a balloon, the mechanical expandable element/system of Dubrul would have been an obvious modification (e.g., suitable, predictable mechanical expander).
Applicant further contends, "The Office Action's equivalence assertion does not cite any disclosure in Dubrul showing that the claimed pushing actuation is implemented, desirable, or predictably achieves the same controlled radial expansion, and it does not address that a compression-driven push approach can introduce different mechanical behavior and stability concerns compared to a pull actuation" (Remarks, pg. 18-19).
The examiner respectfully disagrees. As noted in rejection of record above, one of ordinary skill in the art would readily appreciate pushing the outer tube while maintaining the inner tube at a given, fixed position achieves the same relative movement and/or force between the inner and outer tubes as pulling the inner tube while maintaining the outer tube at a given, fixed position. Additionally, Applicant's remarks fail to address pushing as opposed to pulling being any more than a mere matter of design choice, particularly as Applicant expressly discloses these are suitable alternatives and are each "simple methods of method of applying a sufficient force to the tube to cause to region of the tube comprising the incisions to expand" (¶¶ [0080]-[0081]).
Applicant's remarks with respect to claim 32 appear to be essentially the same as presented with respect to claims 3 and/or 20. Applicant's remarks with respect to claims 33-34 appear to be substantially the same arguments as provided with respect to claim 1 and claims 3 and/or 20. These arguments have been addressed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: US 6,174,316 B1 to Tuckey discloses a system for delivering a medical device comprising a sheath configured to protect an expandable element from the medical device (e.g., stent) (col. 3, line 48 - col. 4, line 9, elastomeric sheath 55 between balloon 35 and stent 10 that reduces possibility of damage to the balloon).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791