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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-12 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton Jr. et al. (Hamilton: Pub. No. 2010/0256630) in view of Altmann et al. (Altmann: EP 3 075 311), Edwards et al. (Edwards: Pub. No. 2002/0139379), Kelleher et al. (Kelleher: Pat. No. 6,112,123) and Houser et al. (Houser: Pat. No. 5,313,943).
Regarding claim 1, Hamilton discloses a method of treating Barrett’s esophagus and esophageal cancer by irreversible electroporation (IRE) using pulse waveforms (par. 0011) to ablate diseased portions of the esophagus (pars. 0002, 0010), wherein it is taught that any device capable of applying suitable voltages to the targeted tissue, including electrode arrays, flexible devices or other devices available in electro-medicine, may be used (par. 0013). Altmann discloses related devices useful in electro-medicine, wherein energy is delivered via one or more splines (splines 27) of a set of splines of an ablation device, the ablation device including: a first catheter (catheter 12) defining a longitudinal axis and a lumen therethrough; a second catheter 23 extending from a distal end of the first catheter lumen (see Figs. 3A, 3B and 4A), wherein the set of splines have a proximal portion coupled to a distal end of the first catheter lumen (see for example Fig. 4A) and a distal portion coupled to a distal cap 25, each spline including an intermediate portion between the proximal portion and the distal portion, the intermediate portion including a set of electrodes 240 formed on a surface of each of the splines (see Figs. 4A, 5C), each electrode having an insulated electrical lead associated herewith, the insulated electrical leads disposed in a body of each of the set of splines (see pars. 0018-0020). Edwards further shows the use of substantially similar structure (note for example Figs. 9A, 9B and 10) suitable for placement within the esophagus for specifically treating gastroesophageal disorders.
Given that Hamilton suggests that any flexible, electrode array device known to be useful in electro-medicine may be used to treat Barrett’s esophagus, given that Altmann discloses such a known device and given that Edwards discloses that substantially similar devices have been found to be useful in treating esophageal disorders, those of ordinary skill in the art would have considered use of the Altmann device to treat Barrett’s esophagus by IRE to be obvious, with any necessary modifications to account for usage in the esophagus being minor and amounting to routine experimentation considering the fact that substantially similar devices like Edwards have already been adapted for use in the esophagus.
Regarding the use of a balloon coupled to the first catheter, Kelleher discloses a related device for use in treating Barrett’s esophagus that incorporates the use of a first balloon 90 coupled to a first catheter (see Fig. 5B). Kelleher teaches that by incorporating the balloon, the difficulties associated with prior art ablation techniques may be overcome (see Background of Invention), as it allows one to create an esophageal volume within which a fluid may be introduced, thus effectively bathing the entire surface area of the tissue that is to be ablated, allowing for more consistent energy application.
Regarding the use of a second catheter including a distal cap, as stated above, Altmann discloses a second catheter 23 extending from a distal end of the first catheter lumen (Fig. 4A). Kelleher teaches that in order to form the esophageal volume, a second balloon 22 may be employed which requires the use of a catheter lumen extending to the second balloon in order to selectively inflate the balloon (col. 8, lines 19-30). Given that Altman teaches the need to protectively surround the wire 17 and the advantages to creating more consistent energy application expressed by Kelleher in a related energy application device, those of ordinary skill in the art would have found it obvious to surround the wire 17 within a catheter all the way to the distal cap so as to allow both additional protection and the creation of a fluid communication path to the distal balloon.
Regarding the recited transitioning/configuring steps, the splined/armed ablation device of Altmann/Edwards requires such transitioning in order to controllably expand the splines/arms, resulting in the configuration claimed (Altmann: see expander 17 operation; Edwards: see the discussion of Figs. 9B and 10). Note also the commentary below in the “Response to Arguments” section.
Regarding spline stiffness, Houser discloses a related ablation catheter including a set of splines arranged in a basket-like configuration (Fig. 1, basket 70; Fig. 12, splines 76). Houser teaches that the splines may include regions of varying stiffness along their length so as to allow for a multitude of different prescribed basket shapes (col. 14, lines 18-36). Artisans of ordinary skill in the art would have considered the exact configuration to be dependent upon the desired location of the basket within the body, such that the basket is shaped to readily conform to the topography of the targeted tissue, with routine experimentation determining the final configuration best suited for its location. In the instant case, one can readily see that the tubular geometry of the esophagus might necessitate splines with flexible proximal and distal regions, and a relatively stiff intermediate region so as to allow the bulk of electrodes in the intermediate region to lie against and conform to the tubular shape of the esophagus. As such, artisans of ordinary skill in the art would have considered the claimed spline stiffness to be a matter of obvious design.
Regarding claims 2-4, 6 and 7, Hamilton discloses advancing an ablation device into an inferior portion of the esophagus (see Fig. 6A).
Regarding claim 5, selective inflation of the balloon(s) discussed above necessarily involves the recited balloon transition.
Regarding claim 8, the examiner considers the requisite manipulatable handle portion of the ablation device to collectively form an actuator that, by virtue of the selectable expansion/contraction of both the splines and balloon(s), is configured to allow transition of the set of splines between the first and second configuration (such as through manipulation of wire 17) and the selective inflation of the balloon through requisite inflation/deflation structure.
Regarding claims 9 and 10, Kelleher discloses the use of an opening 54 orientated towards the electrode in order to bathe the electrode in a saline or gel solution so as to create a more even distribution of energy. Kelleher further teaches that the fluid port is not critical to the invention (col. 8, lines 9-18). Lacking any expressed criticality by the applicant, the number of openings would have been considered a matter of obvious design by those of ordinary skill in the art. Clearly any number allowing a sufficient volume of fluid to be communicated to the electrode would have sufficed, with the exact number depending on the type of fluid used, the size of the lumen(s), the volume of fluids required, required pressures, etc., and thus involves routine experimentation.
Regarding claims 11, 12 and 17, note the discussion of the second balloon above.
Regarding claim 14, while the exact range of cross-sectional diameters of the overall spline shape at its largest portion is not recited by the above references, clearly since Hamilton intends to treat the same disease at the same location with the same type of energy (IRE) as in the present invention, those of ordinary skill would have considered the dimension of the deployed spline shape to be a matter of obvious design dependent upon the range of typical esophageal diameters one would expect to encounter when treating the targeted region.
Regarding claims 15 and 16, Edwards teaches that the electrodes can have a variety of shapes and sizes (par. 0080). Clearly the diameter of the electrodes and effectively the diameter of the splines upon which the electrodes are disposed on, would be a matter of routine design. Lacking any expressed criticality, one would expect the treatment of Barrett’s esophagus in the same region of the esophagus and using the same manner of ablation as in the present invention to suggest that similar electrode/spline diameters would also be employed by prior artisans.
Regarding new claim 18, as already argued above, Houser discloses a related ablation catheter including a set of splines arranged in a basket-like configuration (Fig. 1, basket 70; Fig. 12, splines 76). Houser teaches that the splines may include regions of varying stiffness (i.e., regions of varying bending modulus) along their length so as to allow for a multitude of different prescribed basket shapes (col. 14, lines 18-36), but does not cite any specific bending modulus percentage of the intermediate region compared to the distal region. Hamilton teaches that arrays of electrodes made using a variety of materials, sizes and shapes may be used (par. 0026). Artisans of ordinary skill in the art would have considered the exact bending modulus percentage of the intermediate region compared to the distal region, to be dependent upon the intended location of the basket array within the body (e.g., application of the electrode array to a concave body structure would require consistent flexibility throughout the splines in order to conform the electrodes to the curvature, while a longitudinal, tubular region like the esophagus would require more flexibility at the distal and proximal ends of any spline in order to allow the splines to adequately expand and contact the relatively flat, longitudinal wall portion of the esophagus along the spline’s intermediate section), such that the basket is shaped to readily conform to the topography of the targeted tissue, with routine experimentation determining the relative bending modulus best suited for its location. It is further noted that the applicant merely discloses, in an exemplary fashion, a relative percentage of bending modulus at about 50% or larger, further supporting the contention that the exact percentage would depend upon the particular anatomical geometries at hand, and thus a matter of obvious design.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton et al., Altmann et al., Edwards et al., Kelleher et al. and Houser et al. as applied to claims 1-12 and 14-18 above, and further in view of Hall et al. (Hall: Pub. No. 2018/0168511).
Regarding claim 13, while both Altmann and Edwards disclose that ablation devices may operate in bipolar mode to delivery energy as is known in the art, neither specifically discloses that such a mode entails using a set of electrodes on adjacent splines/arms. Hall, however, in a substantially related ablation device, states that bipolar electrode sets/pairs may be formed between two electrodes located on adjacent splines (par. 0066), as well as a variety of other known configurations. Clearly, lacking any unexpected results, the choice as to which electrodes are paired is a matter of obvious design and dependent upon routine experimentation to determine the best configuration for the application at hand.
Response to Arguments
Applicant's arguments filed September 10, 2025 have been fully considered but they are not persuasive.
Regarding the rejection of claims under §103, the applicant argues that the examiner is using impermissible hindsight, as demonstrated by the examiner only introducing the Houser reference after the applicant has amended claim 1 to include specific limitations regarding spline stiffness. It is additionally stated that Houser is directed to a catheter for cardiac diagnosis in contrast to the current invention which is directed to treating the esophagus. The applicant also asserts that the examiner has given no motivation for why one of ordinary skill in the art treating esophageal conditions would look to cardiac catheter technology for guidance on spline stiffness.
The examiner respectfully responds that the examiner cannot be expected to anticipate every possible limitation that the applicant decides to import into the claims in their attempt to overcome applied prior art, nor can the examiner read limitations into the claims that are not present. Contrary to the applicant’s assertion that the examiner provided no motivation for why one of ordinary skill in the art would look to cardiac catheter technology for guidance, the examiner indicated in the previous Office Action that base reference Hamilton suggested that any flexible, electrode array device known to be useful in electro-medicine may be used to treat Barrett’s esophagus. The flexible electrode array catheter of Houser is an electrode array device known to be useful in electro-medicine. Electro-medical devices include those that use electrical energy to diagnose, monitor or treat medical conditions, and are not limited to any particular anatomical location or use. Such flexible electrode array catheters are well-known to allow one to conveniently access body passages with the electrodes in a non-deployed state during introduction, while permitting expansion and contact with bodily tissues at the targeted site. Hamilton further teaches that electro-medicine ablation can be performed with a wide range of variation and that arrays of electrodes made using a variety of materials, sizes and shapes spaced at an array of distances may be employed (par. 0026). As indicated in the rejection, Houser teaches that various shapes may be obtained by varying spline stiffness (col. 14, lines 18-36). Whereas a bulbous shaped organ or body region might dictate consistent flexibility throughout the length of the splines in order to ensure electrode contact along the varying contours of the tissue, deployment within a tubular-walled vessel such as the esophagus, would only require the distal and proximal ends of the splines to bend to the extent necessary to expand the array from its contracted position into its final expanded position, with the electrodes contacting the inner wall in a longitudinally parallel manner along the axis of the esophagus. Clearly, as discussed above in the rejection of this feature, any adaptation necessary to account for the specific geometries of the targeted region in order to effectively contact the electrodes to the desired targeted tissue would have been considered a matter of obvious and routine design to those of ordinary skill.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nagale et al. ‘660 discloses a treatment catheter with an expandable electrode array (see Fig. 1) that may be used within the digestive tract, urinary tract, or any other desired location to measure electrical activity and/or apply electrical pacing. It is taught that the electrode array may include any shaped configuration (par. 0026). Edwards ‘991 discloses an esophageal catheter that includes an expandable/collapsible electrode array, where the array may be in the form of a basket-shaped device (par. 0060).
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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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
December 11, 2025