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 .
Response to Amendment
The Amendments filed April 24, 2026 has been entered. Applicant’s amendments have overcome the Drawing objection and the claim objection previously set-forth in the Non-Final Office Action mailed on 04/20/26, Currently, claims 1-2 and 23-24 have been amended, and claims 1-3, 5, 7-10, 14-21, and 23-24 are pending in the application.
Drawings
The replacement drawing for figure 3 received on April 24, 2026 is acknowledged. The replacement drawing of Figure 3 is unacceptable because it contains new matter therein. Specifically, Applicant’s updates the figure to include reference number 318 and the appearance of two semi-circular lines are considered new matter by the Examiner because such were not previously illustrated in the figures nor were clearly described in the Specification to support the specific manner in which they are depicted in replacement figure 3. Accordingly, replacement figure 3 will NOT BE ENTERED.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features of a first flat surface enclosing the proximal end and a second flat surface enclosing the distal end, as described in claim 24, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 04/24/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Paragraphs 0037 and 0042 were amended to include retention members 318. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 23, the claim presently recites, “wherein the ablation electrode on the occluder is separated from the anchors”.
The Examiner has reviewed the instant disclosure and has identified a few recitations of the locations of the anchors/retention members and the electrodes on the occluder device. Specifically, paragraph [0037] of the filed Specifications filed 04/24/2026 provides that, “Occluder 320 may be anchored within LAA 160 by retention members 318 disposed around the surface of proximal disc 370 and/or distal bulb 372 that latch onto the tissue of the LAA”, and paragraph [0038] of the filed Specifications filed 09/14/2021 provides that “electrodes 310 may be spaced evenly around the perimeters of proximal disc 370 and distal bulb 372”.
The anchors and the electrodes, as described in the Specification, are characterized as being on the surface of the occluder device but it is not clear on whether or not the anchors and the electrodes are truly separated from each other, given that “disposed around the surface” and “evenly around the perimeters” are not conclusive/definitive statements regarding their specific locations on the surface of the occluder device.
Thus, it is the Examiner’s position that the requirement of claim 23 of the ablation electrode on the occluder being separated from the anchors has no support since thiswas not described in the Specification in such a way as to reasonably convey to oneskilled in the relevant art that the inventor or a joint inventor, or for applications subjectto pre-AIA U.S.C. 112, the inventor(s), at the time the application was filed, had passionof the claimed invention given that the disclosure only specifically provides that the anchors and the electrodes are both located on the surface of the occluder device.
Regarding claim 24, the claim presently recites, “a first flat surface enclosing the proximal end and a second flat surface enclosing the distal end”.
The Examiner has reviewed the instant disclosure and has identified a few recitations of the shape of the occluder, including the distal bulb. Specifically, paragraph [0037] of the Specification filed on 09/14/21 provides that, “the occluder preferably is formed of a shape-memory material that enables it to be compressed within a delivery device and to return to its expanded shape when released from the delivery device … Proximal disc 370 and distal bulb 372 are shaped and sized to fit snugly within LAA 160 when fully expanded”.
The bulb, as described in the Specification, is characterized as being formed of a shape-memory material, having a diameter shaped to fit the LAA, but it is not clear on whether the first surface enclosing the proximal end and the second surface enclosing the distal end are flat, specifically in either the expanded configuration before conforming to the shape of the tissue during contact or in the collapsed configuration.
Thus, it is the Examiner’s position that the requirement of claim 24 of the first surface enclosing the proximal end and the second surface enclosing the distal end to be flat has no support since this was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA U.S.C. 112, the inventor(s), at the time the application was filed, had passion of the claimed invention given that the disclosure specifically only provides that the bulb is flexible and able to contour to the different shapes of the LAA in the expanded state.
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 35 U.S.C. 112 (pre-AIA ), 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 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation "tissue of the left atrial appendage" in lines 2-3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this tissue of the left atrial appendage is different from the tissue of the left atrial appendage already cited in claim 1, or if they are the same tissue. For examination purposes, Examiner will treat both tissues of the left atrial appendage as the same.
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, 3, 5, 7-10, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Gruba (U.S. Application No. 20200008870 A1), in view of Jayaraman (U.S. Patent No. 11253261 B2), in view of Schaer (E.P. Application No. 1790304 A2), in view of Beetel (U.S. Application No. 20120101413 A1), and further in view of Vrba (U.S. Patent No. 10524859 B2).
Regarding independent claim 1, Gruba discloses a heart treatment device
(100), comprising:
a catheter (102) extending from a proximal end (106) to a distal end (104) (pa.
0061 & Fig. 1);
an occluder (134) (pa. 0064) releasably disposed within the catheter and adapted to be deployed within a left atrial appendage of a patient (pa. 0060);
a balloon (130) coupled to the catheter (pa. 0064 & Fig. 1), the balloon including a plurality of holes (the regions 144, 146 located on the balloon are permeable and allow liquid to “exude, elute, or weep” through) (pa. 0070);
a fluid source (254) in communication with the balloon for supplying a fluid to the balloon, the fluid being dispensable through the holes (pa. 0098 & Fig. 7);
an ablation electrode (140) disposed on the balloon (specifically in the alternative embodiment disclosed where the electrode structures are positioned on an exterior surface of the balloon) and configured to deliver ablation energy to tissue of the left atrial appendage (pa. 0064, 0076 & Fig. 2); and
a wire (126) having a distal end portion (i.e., distal region of the wire that is directly attached to the ablation electrode) extending from the ablation electrode, an intermediate portion (i.e., region of the wire that extends proximally from the distal region) extending proximally from the distal end portion, and then through a bore in the wall of the catheter to a lumen of the catheter, and a remaining portion (i.e., proximal region of the wire that is within the catheter lumen and outside device (100) and that is connected to an RF generator) extending through the lumen of the catheter to an energy source (pa. 0064 & Fig. 3).
Lastly, Examiner highlights that the device (any components disclosed herein) may include a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, or textured. Synthetic biocompatible yarns suitable include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters (pa. 0114).
However, Gruba does not disclose the occluder includes a disc and a bulb connected to the disc by a connective element, the disc and the bulb being articulable relative to one another and to the connective element, wherein outer surfaces of the disc and the bulb are at least partially coated with an electrically insulating material.
Jayaraman, in the same field of endeavor, teaches an occluder (100) constructed as a mesh of resilient expandable material such as a wire mesh (Col. 4, lines 46-48), wherein the occluder comprises a disc (160) and a bulb (120) connected to the disc by a connective element (128) (Col. 5, lines 64-67 – Col. 6, lines 1-9 & Figs. 1, 3, 13-15), the disc and the bulb being articulable relative to one another and to the connective element (Col. 8, lines 36-46). Furthermore, Jayaraman teaches the occluder may be coated with a flexible fabric, for example a polymeric fabric such as polyethylene terephthalate (PET), which advantageous if it is desired to filter particles from entering or leaving an anatomical structure which are smaller than the openings in the mesh of occluder (Col. 6, lines 26-31).
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 substituted the occluding member of Gruba with the occluding member of Jayaraman, including the disc and bulb components, for the purpose of allowing the heart treatment device to compress and conform to a wide variety of internal anatomical structures while also completely covering the opening of the given anatomical structure. Furthermore, it would have been obvious to include the PET coating the entire surface of the occluder in order to allow for filtering of particles.
However, Gruba/Jayaraman combination do not explicitly teach the holes on the balloon to be micro-holes.
Schaer, in the same field of endeavor, teaches an ablation device (80) comprising an irrigation mechanism (0065) and a balloon (14) (pa. 0116) made of a porous membrane formed using conventional techniques, such as, for example by blowing the material or by drilling micro holes within the material (pa. 0069).
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 size of the holes of the balloon of Gruba to be in the microscale for the purpose of allowing fluid to pass through by applying relatively low pressure (Schaer, pa. 0069).
However, Gruba/Jayaraman/Schaer combination do not teach a mesh overlying the balloon, the mesh comprising a woven elastic fabric that contours to the shape of the balloon as the balloon inflates, nor the wire having the distal end portion extending from the ablation electrode through the mesh, nor the ablation electrode being disposed on the mesh.
Beetel, in the same field of endeavor, teaches a catheter apparatus (12) having expandable mesh structure (22) (pa. 0092) overlying a balloon (in the embodiment where the mesh structure is expandable via an active mechanism facilitated by an interior ballon, pa. 0097). The mesh comprises a woven elastic fabric (i.e., polyethylene terephthalate (PET)) that contours to the shape of the balloon as the balloon inflates (pa. 0088, 0092 & Figs. 3-7). Moreover, Beetel teaches an electrode (24) disposed on the mesh structure by an adhesive or by threading a fiber (58) through an internal bore (120), wherein the electrode is connected to an energy source via a wire (116), and wherein a distal end portion of the wire (i.e., distal region of the wire directly connected to the electrode) extends from the ablation electrode through the mesh (pa. 0107 & Fig. 14).
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 substituted the biocompatible PET material which may be included on the balloon of Gruba with the woven elastic PET mesh structure taught by Beetel since they are both known variants in the art and they would both yield the same predictable results of providing a comfortable, biocompatible structure overlying a balloon.
Moreover, it would have been obvious to provide the electrode to be disposed on the mesh in order to provide a secure attachment of the electrodes via the threading technique, and to further allow the electrodes to be spaced circumferentially and/or axially along the longitudinal axis of the targeted tissue in order to create lesions having a variety of geometric shapes or patterns (Beetel, pa. 0103). Lastly, it would have been obvious to modify the location of the wire of Gruba for the purpose of preventing twisting or kinking of the leads (Beetel, pa. 0107).
However, Gruba/Jayaraman/Schaer/Beetel combination do not teach the intermediate portion extending entirely between the mesh and the balloon.
Vrba, in the same field of endeavor, teaches a balloon catheter (400) comprising a balloon (401) with a plurality of ablation electrodes (403) mounted on the balloon’s surface and electrically connected to an energy source via wire conductors (402) (Col. 50, lines 44-47; Col. 55, lines 42-45 & Fig. 4), and further comprises a flexible sleeve (414) (analogous to the mesh) made of an elastic fabric material (i.e., polyethylene terephthalate) (Col. 56, lines 29-31) and sized and adapted to extend over a full length of the balloon (Col. 56, lines 38-40). The flexible sleeve is provided to enclose at least a portion of the electrical conductors, so that the intermediate portion of the conductive wires are entirely positioned between the sleeve and the balloon (Col. 57, lines 30-34; Col. 58, lines 44-45 & Fig. 8B).
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 position of the intermediate portion of the wire in order to be entirely positioned between the balloon and mesh layers, as taught by Vrba, for the purpose of protecting from damage during use and protect the patient from injury from unwanted interaction with the wires (Vrba, Col. 56, lines 21-25).
Regarding claim 3, Gruba discloses the electrode being positioned on the exterior surface of the balloon (pa. 0076).
However, Gruba/Jayaraman/Schaer/Vrba combination do not disclose a mesh on the balloon, nor the electrode being coupled to a surface of the mesh by an adhesive.
Beetel, in the same field of endeavor, teaches the catheter apparatus (12) having expandable mesh structure (22) (pa. 0092) overlying a balloon (in the embodiment where the mesh structure is expandable via an active mechanism facilitated by an interior ballon, pa. 0097), wherein the ablation electrode is coupled to a surface of the mesh by an adhesive (pa. 0107).
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 bonded the electrodes using an adhesive because substituting one coupling method (even if its unknown/not specified) with another known equivalent method is routine skill in the art since both would yield the same functional and predictable results of attaching an electrode to a surface/structure.
Regarding claim 5, Gruba discloses the electrode being positioned on the exterior surface of the balloon (pa. 0076).
However, Gruba/Jayaraman/Schaer/Vrba combination do not disclose any specific attachment/coupling mechanism, especially a coupling method that includes a suture.
Beetel, in the same field of endeavor, teaches the electrode (24) is disposed on the mesh structure by threading the fiber (58) through the internal bore (120) (pa. 0107).
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 bonded the electrodes using an suture because substituting one coupling method (even if its unknown/not specified) with another known equivalent method is routine skill in the art since both would yield the same functional and predictable results of attaching an electrode to a surface/structure.
Regarding claim 7, Gruba/Jayaraman/Schaer/Beetel/Vrba combination discloses the wire is soldered or laser welded to the ablation electrode (Gruba, pa. 0064).
Regarding claim 8, Gruba/Jayaraman/Schaer/Beetel/Vrba combination discloses a test electrode (140, 142) coupled to the balloon and configured to measure electrical signals in the tissue of the left atrial appendage (Gruba, pa. 0068).
Regarding claim 9, Gruba/Jayaraman/Schaer/Beetel/Vrba combination discloses the distal end of the catheter including a radiopaque marker (Gruba, pa. 0083).
Regarding claim 10, Gruba/Jayaraman/Schaer/Beetel/Vrba combination discloses ablation energy delivered via an irreversible electroporation pathway (Gruba, pa. 0065).
Regarding claim 23, Gruba discloses an ablation electrode (i.e., conductive regions) disposed on the occluder and configured to deliver ablation to tissue of the left atrial appendage (pa. 0064).
Schaer/Beetel/Vrba combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not teach anchors disposed on the occluder for holding the occluder in place in the left atrial appendage, wherein the ablation electrode is separated from the anchors.
Jayaraman, in the same field of endeavor, teaches anchors (140) disposed on the occluder for holding the occluder in place in the left atrial appendage (Col. 7, lines 7-20 & Figs. 23-24).
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 added at least two anchors taught by Jayaraman to the occluder of Gruba for the purpose of providing an additional safeguard against occluder from accidentally becoming dislodged.
Therefore, since the at least two anchors are positioned on limited external areas of the occluder (as seen in Figs. 25-27 of Jayaraman), and the ablation electrodes located on the occluder of Gruba are composed of multiple conductive regions surrounding the entire occluder device, this combination would lead to the configuration/arrangement where at least one of the ablation electrodes is separated from the at least two anchors, and therefore this meets the claim limitation given that it is still broad and only requires that at least one ablation electrode disposed on the occluder is separated from the anchors.
Regarding claim 24, Gruba/Schaer/Beetel/Vrba combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not teach wherein the bulb has a cylindrical shape with a proximal end relatively close to the disc and a distal end relatively distant from the disc, a first flat surface enclosing the proximal end and a second flat surface enclosing the distal end, and the connective element connects the disc to the first flat surface of the bulb.
Jayaraman, in the same field of endeavor, teaches wherein the bulb has a cylindrical shape with a proximal end (lower wall portion of inner bell-shape 126 within an outer bell-shape 124, Col. 5, lines 56-63 & Figs. 8-9, 13) relatively close to the disc and a distal end (wall portion of the inner bell-shape that is distal to the lower wall portion) relatively distant from the disc (Col. 1, lines 37-41), a first flat surface (surface of the lower wall of the inner bell-shape) enclosing, or encircling, the proximal end and a second flat surface (at least a bottom-most portion of the distal end before it curves into a bell shape) enclosing, or encircling, the distal end, and the connective element connects the disc to the first flat surface of the bulb (Col. 5, lines 66-67).
Examiner notes that the claim language is broad and does not require that the first flat surface nor the second flat surface have to be flat relative to a specific axis. In this case, the wall portions of the inner bell-shape are considered generally flat relative to a longitudinal axis.
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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 substituted the occluding member of Gruba with the occluding member of Jayaraman, including the specific configuration of the bulb, disc, and connective element, for the purpose of providing an occlusive structure that is best fitted to engage with the structure of the left atrial appendage.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gruba, Jayaraman, Schaer, Beetel, and Vrba as applied to claim 1 above, and further in view of Lesh (U.S Patent No. 6152144 A).
Regarding claim 2, Gruba/Jayaraman/Schaer/Beetel/Vrba combination discloses a collar (160) configured to receive a threaded insert (not explicitly shown) such that occluder may be deployed or released from the catheter by twisting the threaded insert. However, other coupling mechanisms may be used as desired (Gruba, pa. 0073).
However, they do not disclose a plunger slidably disposed within the catheter and not connected to the occluder, wherein sliding movement of the plunger toward the distal end of the catheter deploys the occluder from the catheter.
Lesh, in the same field of endeavor, teaches a delivery catheter (85) disposed within the LAA opening (87), wherein a distal end (84) of the delivery catheter contains a plunger (97) which is slidably disposed within an inner lumen (98) of the delivery catheter and serves to apply axial force in a distal direction on the collapsed occluding device (102) disposed within the delivery catheter so as to force the occluding device from the delivery catheter and deploy it (Col. 10, lines 30-44 & Figs. 9-12), wherein the plunger is not connected to the occluder at least in the configuration before making contact and applying the axial force on the occluder.
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 substituted the coupling mechanism that is used to deploy the occluder to the targeted tissue with the plunger device taught by Lesh since they are both known variants in the art and they would both yield the same predictable results of allowing the user to control the deployment of an occluding device into the tissue of a patient.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over
Gruba, Jayaraman, Schaer, Beetel, and Vrba as applied to claim 1 above, in view of Ghaffari (U.S Application No. 20140303452 A1), and further in view of Schaer (U.S. Application No. 20040082859 A1), henceforth referred to as Schaer859.
Regarding claim 21, Gruba/Schaer/Beetel/Vrba combination discloses the invention substantially as claimed in claim 1 and discussed above.
Jayaraman, in the same field of endeavor, teaches wherein the occluder is sized to conformingly engage interior sidewalls of a malformed or anomalous anatomical structure within the body (Col. 4, lines 7-16), specifically, the expanded diameter size of the occluder is determined by the range of diameters of anatomical structures to be occluded (Col. 8, lines 7-12).
However, they do not teach a pressure sensor disposed on the balloon, the pressure sensor being adapted to detect a force applied to the balloon when the balloon is expanded in the left atrial appendage, nor an electrical element adapted to (1) receive force data from the pressure sensor, (2) determine from the force data a point in time at which the balloon contacts the walls of the left atrial appendage.
Ghaffari, in the same field of endeavor, teaches a catheter comprising a plurality of sensors (e.g., contact and pressure sensors) (pa. 0249) coupled to the substrate of a balloon (pa. 0251, 0258) that is deployed in the left atrium (pa. 0286).
Ghaffari further teaches the pressure sensor being adapted to detect a force applied to the balloon when the balloon is expanded (pa. 0248, 0262); and
an electrical element (i.e., processing device 1200, 1200A and connected circuitry) adapted to (1) receive force data from the pressure sensor (pa. 0254, 0259), (2) determine from the force data a point in time at which the balloon contacts the walls of the left atrial appendage (pa. 0275). Ghaffari teaches determining ballon contact using a variety of methods, one method is by using pressure recordings to generate data which may be used to estimate the diameter of the balloon and the lumen and provide feedback to the device operator to end balloon inflation at this point (pa. 0251). Another method is using the same data to generate detailed tactile, thermal and spatial maps to visually the entire region of contact to ensure successful deployment (pa. 0259).
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 added a pressure sensor for the purpose of allowing a user to determine when and whether complete occlusion has occurred.
However, Gruba/Jayaraman/Schaer/Beetel/Vrba/Ghaffari combination do not teach determining the size of the left atrial appendage based upon a volume of the fluid received by the balloon at the point in time.
Schaer859, in the same field of endeavor, teaches, means of detecting and displaying balloon inflation volume and/or pressure using generator (70) (analogous to the electrical element) (pa. 0112 & Fig. 2), and determining the shape and size (i.e., diameter) of the balloon by assessing the fluid volume and pressure (pa. 0196), which intrinsically allows for the visualization/determination of the shape and size of the target tissue.
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 incorporated the generator that functions to determine the shape/size of the target tissue using the volume of the balloon, as taught by Schaer859, for the purpose allowing the user to effectively select the occluder that will most effectively block, seal, or control the flow of blood within the tissue based on definitive data such as the diameter of the tissue.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that while Gruba discloses a biocompatible PET material, the yarn forming the textile material is clearly intended to be part of the occlusive implant given that the textile is “selected in a manner which forms a biocompatible and implantable prosthesis”. However, Examiner, respectfully, disagrees.
Examiner highlights the first sentence of the paragraph 0114 cited in the office action to teach the textile material. Specifically, it states that “the systems 100, 200 (and variations, systems or components thereof disclosed herein) may include a textile material” (emphasis added by Examiner). System 100 clearly includes catheter 102 which further comprises proximal expandable member 130, distal expandable member 132, and occlusive implant 134 (pa. 0064 & Fig. 1). Therefore, while paragraph 0114 provides one specific desirable property of the textile, one which includes biocompatibility that allows it to be implantable if need be (given that the occlusive implant is implantable component of the system 100, and if the occlusive implant were to be made up of such textile, the textile material should be compatible with implantation to avoid eliciting adverse local or systemic effects in the human body), this given desirable property is one of many listed in the Gruba reference which a user may choose upon when manufacturing the system. The important aspect disclosed in this 0114 paragraph of Gruba is that any component, including the expandable member 130, may include a textile material. Therefore, the rejection is maintained.
In regards to independent claim 1, Applicant argues that nothing in the Gruba reference suggests that how a textile material could be included on the balloon while also including the electrodes on the exterior surface. Furthermore, Applicant argues that nothing in Gruba expresses any concern for securing the electrodes on the exterior/interior surface of the balloon and therefore a secure attachment is not necessary. Additionally, Applicant contends that having a mesh around the balloon does not provide any more surface than the surface of the balloon itself.
Examiner agrees that Gruba, at best, only vaguely describes the inclusion of all these different types of components/parts (i.e., the electrodes, the balloon, and the textile) without actually describing/illustrating an embodiment which shows how all of these components could be arranged together. Hence, this is why Examiner utilized the Beetel reference to ameliorate such shortcomings. Examiner highlights that the only reason the textile material of the Gruba reference is highlighted in the last office action was to convey that it would be obvious to substitute in the PET woven mesh fabric taught by the Beetel reference given that Gruba already contemplates using a textile of the same material. The Beetel reference provides a more substantial description and illustrations of how the different parts/components (i.e., an expandable structure covered by a textile fabric with external electrodes) described in the Gruba reference could be arranged properly to function together as described in the language of the independent claim 1. The Beetel reference easily provides a clear arrangement of parts that show how a textile material could cover the exterior surfaces of a balloon/expandable structure without interfering with its expansion upon inflation (given that the mesh of Beetel is made up of a woven polyethylene terephthalate (PET) material which is flexible fiber material that follows the shape of the balloon as it inflates, as seen in Figs. 6-7) and also provides electrodes located on the external surfaces of the woven mesh.
With regards to the concern for not needing a secure attachment mechanism for the electrodes on the exterior surface of the balloon of Gruba, Examiner notes that although Gruba does not place emphasis on describing any attachment mechanism to ensure the electrodes are secured to the surface of the balloon, it is still a necessary/important aspect of the invention in order to function properly. While Gruba does no focus on providing a specific securement mechanism, it does not teach away from this concept given that it would be obvious to one of ordinary skill in the art that electrodes on any catheter should remain in a stable and secure position, unless otherwise specifically described to be detachable in order to provide a specific function. Since the language of claim 1 requires the electrodes to be disposed on the mesh, Examiner utilizes the Beetel reference to teach how the electrode (24) is disposed/secured to the mesh structure via an adhesive or by threading a fiber (58) through an internal bore (120) (pa. 0107). Therefore, since the mesh of Beetel is combined to the surface of the expandable member of Gruba, then there exists a gap for securing the electrodes and the mesh structure. This gab is overcome by the Beetel reference which provides various securing mechanisms used to attach an electrode to the surface of a mesh fiber. Therefore, it would have been obvious to one of ordinary skill in the art to provide a secure attachment of the electrodes via the adhesive or threading technique to allow the electrodes to be permanently attached the surface of the mesh. Therefore, based on the reasonings set-forth above, the rejection using these combination of references is maintained.
With regards to claim 2, Examiner finds arguments persuasive and therefore the rejection has been withdrawn. However, upon further consideration, the following
new grounds of rejection have been set forth in the action above using the Lesh (U.S. Patent No. 6152144 A) reference.
With regards to claim 21, Applicant argues that the Schaer859 reference does not disclose using the volume of fluid received in a balloon to determine the size of an LAA and then determine the size of an occluder based on that measured LAA size. Specifically, Applicant contends that Schaer859 does not disclose an implantable medical device in the body lumen and therefore does not use the inflated diameter to determine the size of such medical device, and it is difficult to see how the diameter of the inflated balloon can be determined given that the balloon has a proximal and a distal section, wherein the distal section does not expand against tissue. However, Examiner disagrees.
The Jayaraman reference teaches wherein the occluder is sized to conformingly engage interior sidewalls of a malformed or anomalous anatomical structure within the body (Col. 4, lines 7-16), and specifically, the expanded diameter size of the occluder is determined by the range of diameters of anatomical structures to be occluded (Col. 8, lines 7-12). The Jayaraman reference already teaches using differently sized occluders based on the need/size of the diameter of the patient’s tissue. However, it is silent on the specific method of determining the size of the tissue based upon a volume of the fluid received by the balloon at the point in time. The Schaer859 is only utilized to teach means of detecting a balloon’s inflation volume and/or pressure using generator (70) (pa. 0112 & Fig. 2), and using that volume information to then determine the shape and size (i.e., diameter) of the balloon (pa. 0196), which inherently allows for the determination of the shape and size of the target tissue. Examiner notes that although the balloon of Schaer859 contains a proximal and distal section, at least the diameter of the proximal section is indicative of the size/diameter of the tissue that it is pressed against. Therefore, at least one diameter measurement is relevant in determining the size of the tissue. Moreover, it is not relevant whether or not the Schaer859 reference teaches an implantable device because at least the Jayaraman teaches an implantable occluding device and the combination of references only includes the addition of the generator of Schaer859, which functions to determine the size of tissue, with the various occluder sizes for occluding the tissue taught by Jayaraman, for the purpose of allowing the user to effectively select the occluder that will most effectively block, seal, or control the flow of blood within the tissue based on definitive data such as the diameter of the tissue. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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