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 August 19, 2026 has been entered. Applicant’s amendments have overcome the Drawing Specification objections and the 112(a) and 112(b) rejections previously set-forth in the Final Office Action mailed on 06/22/26, Currently, claims 1, 23-24 have been amended, and claims 1-3, 5, 7-10, 14-21, and 23-24 are pending in the application.
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 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, the Examiner highlights that Gruba discloses the use of a textile material for one of more of the components of its disclosed system. Gruba specifically provides 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 modified the balloon of Gruba (in view of the biocompatible PET material which may be incorporated in the balloon in a nonspecific manner) to have a mesh overlying an external/outer surface of the balloon, as taught by Beetel, in order to provide a flexible and conformable biocompatible structure for providing contact between the electrodes mounted on the mesh and the surrounding tissue. Beetel itself contemplates the use of the mesh to provide additional contact area with the tissue, as well as greater surface area for mounting energy delivery elements (see [0098].
Moreover, it would have been obvious to provide the electrodes of Gruba to be disposed on the mesh overlying the balloon 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 of the wire extending entirely between the mesh and the balloon, and then through a bore in a side surface of the catheter.
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). Additionally, Figs. 13C-1 - 13C-2 of Vrba teach an embodiment of the ablation device which includes a shaft (1305) with one or more openings (1348) through which electrode wires (1302) can extend and run along the annular space between the inner and outer balloons to a respective electrode (1303) (Col. 66, lines 10-13).
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).
Furthermore, it would have been obvious to have added the one or more openings on the shaft of Vrba to the side surface of the catheter of Gruba for the purpose of allowing efficient routing techniques of the intermediate portion of the wire of the heart treatment device; additionally, either variant/configuration (i.e., the wire extending directly to the lumen of the catheter vs. the wire extending through a bore in the side surface of the catheter and then through a lumen of the catheter) would yield to the same predictable results of routing a remaining portion of the wire to a proximal portion of the heart treatment device in order to connect to an energy source.
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 the 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 retention members disposed on the occluder for holding the occluder in place in the left atrial appendage, wherein the ablation electrode is separated from the retention members.
Jayaraman, in the same field of endeavor, teaches retention members (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 the retention members taught by Jayaraman to the occluder of Gruba for the purpose of providing an additional safeguard against the occluder accidentally becoming dislodged from the target tissue.
Examiner emphasizes that since the retention members 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 of references would lead to the configuration/arrangement wherein at least one of the ablation electrodes is separated from the retention members, 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 retention members.
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 circumscribing a longitudinal axis, a proximal end relatively close to the disc and a distal end relatively distant from the disc, a first flat surface traverse to the longitudinal axis and enclosing the proximal end and a second flat surface traverse to the longitudinal axis and 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 the bulb having a cylindrical shape circumscribing a longitudinal axis (see annotated Fig. 13 below), with a proximal end (lower portion of the bulb) relatively close to the disc and a distal end (upper portion of the bulb) relatively distant from the disc (see Fig. 13), a first flat surface (see annotated Fig. 13 below) traverse to the longitudinal axis and enclosing, or encircling, the proximal end and a second flat surface (see annotated Fig. 13 below) traverse to the longitudinal axis and enclosing, or encircling, the distal end, and the connective element connects the disc to the first flat surface of the bulb (Col. 5, lines 65-67).
PNG
media_image1.png
426
555
media_image1.png
Greyscale
Examiner notes that on the agenda submitted by Applicant for the interview held on 08/18/2026, Applicant remarks and stablishes on the record how the proximal end of the bulb 372 is shown as a straight line on the left side of the bulb (Fig. 3 of the filed Drawings), with connecting element 375 having one end connected to the straight line and the other end connected to disc 370. As a straight line depicts the edge of a plane, and as a plane constitutes a flat surface, with a similar analysis for the distal end of the bulb. Therefore, in the same manner, Examiner is interpreting the first flat surface and the second flat surface of the device of Jayaraman as being flat/straight edges of a plane that traverses the longitudinal axis, with the connecting element indirectly connecting the disc to the first flat surface of the bulb.
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 and shape 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 08/19/2026 have been fully considered but they are not persuasive.
With regards to independent claim 1, Applicant argues that while Gruba teaches that any of the components of the disclosed systems may include a textile material, Gruba provides no additional information on what material may be used for the balloon or how it may be used. Specifically, Applicant contends the materials listed by Gruba could form the balloon itself; they could be imbedded within a polymer to reinforce the balloon; or they could form a reinforcing layer in the interior of the balloon, and that absolutely nothing in Gruba remotely suggests that the material could or should be included "on the balloon”. However, Examiner, respectfully, disagrees.
Examiner highlights paragraph 0114 of Gruba stating “the systems 100, 200 (and variations, systems or components thereof disclosed herein) may include a textile material” (emphasis added by Examiner). The textile described in paragraph 0114 is biocompatible; biocompatibility is a desirable property given that the occlusive implant is an implantable component of the system. The important aspect of this portion of the prior art is that any component, including the expandable member 130, may include a textile material.
Now, Examiner concedes that this section of Gruba is at most vague/broad and does not specify whether the textile material is a type of reinforcing inner or outer layer on the balloon or makes up the balloon itself. Paragraph 0114 is only highlighted in the Office Action in order to provide important background information of the invention of Gruba, and provide a strong motivation as to why someone of ordinary skill in the art would look to the Beetle reference, which more clearly depicts a biocompatible textile material overlying an exterior surface of a balloon, in order to modify the biocompatible textile of Gruba to be incorporated on the exterior surface of the balloon. Therefore, for at least the reasoning set-forth above, the Examiner finds that this newly proffered rationale in the rejection of claim 1 above is tenable.
With regards to independent claim 1, Applicant argues that nothing in the Gruba reference suggests how electrodes could be placed on a textile material overlying the exterior of the balloon. However, Examiner disagrees.
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. 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) can 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 shows how a textile material can overlie 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. Therefore, based on the reasonings set-forth above, claim 1 is rejected.
In regard to independent claim 1, Applicant argues that nothing in the Gruba reference suggests securing the electrodes to the balloon surface. Specifically, Applicant contends that since the wire hoop electrodes of Gruba are not explicitly described as being secured to the balloon, then it is not clear that a secure attachment of the electrodes to the balloon is necessary or even desired. However, Examiner disagrees.
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 not 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 gap 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 to the surface of the mesh. Therefore, claim 1 remains rejected.
In regard to the newly amended language of claim 1, Examiner agrees that the Gruba reference does not disclose such limitation, but relies on the Vrba reference to ameliorate such shortcomings.
In regard to claim 23, Applicant argues that Gruba simply teaches "electrode structures 140, 142 and/or the occlusive implant 134 may deliver ablation energy (and/or complete the circuit) to the LAA" [0064]. That is different from teaching an ablation electrode on the occluder. Even if the entire occlusive implant is an electrode delivering ablation energy, it would be impossible to separate the electrode from the anchors of Jayaraman as required by claim 23. However, Examiner disagrees.
While paragraph 0064 of Gruba teaches an embodiment where the occlusive implant itself is formed from a conductive material, the last sentence of the paragraph teaches a separate embodiment where the occlusive implant instead includes conductive regions (which Examiner interprets such conductive regions as being the electrodes on the occluder). Therefore, in view of the combination using the Jayaraman reference, Examiner emphasizes that since the retention members 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 various conductive regions surrounding the occluder device, this combination would lead to the configuration/arrangement wherein at least one of the ablation electrodes is separated from the retention members, 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 retention members.
Lastly, in regard to claim 24, Applicant has amended the claim to include the flat surfaces are traverse to the longitudinal axis of the bulb. Examiner has utilized a new interpretation of the Jayaraman reference to reject the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mazzocchi (US 6506204 B2) teaches an anchor which is sized to engage the lumen of a vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
