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 12, 2026 have been entered. Currently, claims 66, 69, 71, 74, 86, 91 and 94 have been amended, and claims 66-75, 86-96 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 66-72, 74-75, and 86-96 are rejected under 35 U.S.C. 103 as being unpatentable over Utley (U.S. Application No. 20110270249 A1), and further in view of Rajagopalan (W.O. Application No. 2012099974 A2).
Regarding independent claim 66, Utley discloses an apparatus for delivering energy to a tissue (3) (pa. 0066-0067 & Fig. 19), the apparatus comprising:
an elongate applicator tool (100) comprising:
an elongate shaft (164) (pa. 0066);
a distal tip region (110) at a distal end of the elongate shaft (pa. 0066);
a plurality of electrodes (101) (pa. 0068) arranged along a surface (upper surface of housing 107, pa. 0072) of the distal tip region at a radial position relative to a longitudinal axis of the distal tip region;
one or more contact projections (combination of deflection mechanism 105 and two sets of expandable member 156) configured to extend outward from the radial position on either side of the plurality of electrodes to frame a region of the tissue to be treated so that the region of the tissue is held taut (pa. 0128 & Figs. 16-17), while the plurality of electrodes remains at the radial position (by applying a substantially uniform apposition force, pa. 0114, which results in direct and sustainable contact between the plurality of electrodes and the tissue surface, pa. 0075), wherein the one or more contact projections comprises a mechanical structure (a thin, flexible, bladder made of a material such as polymer, pa. 0076) configured to expand tissue to prepare for treatment with the plurality of electrodes (pa. 0075); and
a suction port configured to apply suction to draw the region of the tissue that is held taut against the plurality of electrodes (pa. 0075).
Furthermore, while the first embodiment seen in Figures 16-17 includes the deflection mechanism 105, wherein the deflection mechanism comprises an inflation member such as a balloon (pa. 0084), an alternative/second embodiment utilizes a deflection mechanism comprising an expandable stent, frame or cage device (pa. 0085). Therefore, 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 only substituted the inflation member that comprises the deflection mechanism of the first embodiment with the expandable stent of the second embodiment since both deflection mechanisms are known variants in the art and they would both yield the same predictable results of extending outward from the radial position of the plurality of electrodes to frame the region of the tissue to be treated so that the region of the tissue is held taut. To further clarify, Examiner is still utilizing all the disclosed structure of the first embodiment, including the two sets of expandable members 156, and is only substituting the inflation member component with the expandable stent, wherein the expandable stent will be attached to the housing 107 in order to allow the expandable stent to extend outward from the radial position of the plurality of electrodes to frame the region of the tissue to be treated so that the region of the tissue is held taut.
However, Utley does not explicitly disclose to that the apposition force applied by the one or more contact projections results in the removal or decrease in wrinkles from the tissue.
Rajagopalan, in the same field of endeavor, teaches an elongate applicator tool (301) comprising a tissue manipulating device including an expandable element such as inflatable balloons, expandable cages, radially deployable arms (pa. 0207), wherein the tissue manipulating device is capable of applying tissue manipulation techniques such as axial straightening, radial tensioning, applying a radial force to tissue, expanding the tissue such as to reduce protrusions due to folding, or any combination of these (pa. 0045).
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 deployed the functionality (i.e., tissue manipulation techniques which reduce or remove wrinkles, or protrusions, of the tissue) of the expandable element of Rajagopalan into the one or more projections of Utley for the purpose of preventing or reducing the change of under treating the targeted tissue (Rajagopalan, pa. 045).
Regarding claim 67, Utley/Rajagopalan combination discloses wherein the suction port comprises one or more openings adjacent to or underneath of the plurality of electrodes (Utley, pa. 0075).
Regarding claim 68, Utley/Rajagopalan combination discloses wherein the one or more contact projections comprises a pair of arms (Utley, pa. 0085).
Regarding claim 69, Utley/Rajagopalan combination discloses wherein the one or more contact projections are configured to move around circumference of the distal tip region closer or further apart from the plurality of electrodes to hold the region of tissue taut (Utley, pa. 0075).
Regarding claim 70, Utley/Rajagopalan combination discloses further comprising a control (152) for actuating the one or more contact projections (pa. 0125).
Regarding independent claim 71, Utley discloses a method comprising:
placing a distal end region (110) of an applicator tool (100) adjacent (e.g., on a) to a wall of a body lumen (pa. 0066-0067 & Figs. 19-21), wherein the applicator tool comprises an electrode assembly (101) at the distal end region having one or more electrodes at a radial position relative to a longitudinal axis of the distal end region (pa. 0068 & Figs. 16-17);
moving one or more contact projections (combination of deflection mechanism 105 and two sets of expandable member 156) outward from the radial position on either side of the electrode assembly, while the one or more electrodes of the electrode assembly remain at the radial position (by applying a substantially uniform apposition force, pa. 0114, which results in direct and sustainable contact between the plurality of electrodes and the tissue surface, pa. 0075) to hold a region of the wall taut (pa. 0128);
applying suction to secure the one or more electrodes to the region of the wall of the body lumen while the region is held taut (pa. 0075); and
applying energy from the one or more electrodes to treat the wall of the body lumen (pa. 0078).
Furthermore, while the first embodiment seen in Figures 16-17 includes the deflection mechanism 105, wherein the deflection mechanism comprises an inflation member such as a balloon (pa. 0084), an alternative/second embodiment utilizes a deflection mechanism comprising an expandable stent, frame or cage device (pa. 0085). Therefore, 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 only substituted the inflation member that comprises the deflection mechanism of the first embodiment with the expandable stent of the second embodiment since both deflection mechanisms are known variants in the art and they would both yield the same predictable results of extending outward from the radial position of the plurality of electrodes and holding the region of the tissue taut. To further clarify, Examiner is still utilizing all the disclosed structure of the first embodiment, including the two sets of expandable members 156, and is only substituting the inflation member component with the expandable stent, wherein the expandable stent will be attached to the housing 107 in order to allow the expandable stent to extend outward from the radial position of the plurality of electrodes to hold the region of the tissue taut.
However, Utley does not explicitly disclose to that the apposition forced applied by the one or more contact projections results in the removal or decrease in wrinkles from the tissue.
Rajagopalan, in the same field of endeavor, teaches an elongate applicator tool (301) comprising a tissue manipulating device including an expandable element such as inflatable balloons, expandable cages, radially deployable arms (pa. 0207), wherein the tissue manipulating device is capable of applying tissue manipulation techniques such as axial straightening, radial tensioning, applying a radial force to tissue, expanding the tissue such as to reduce protrusions due to folding, or any combination of these (pa. 0045).
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 deployed the functionality (i.e., tissue manipulation techniques which reduce or remove wrinkles, or protrusions, of the tissue) of the expandable element of Rajagopalan into the expandable stent of Utley for the purpose of preventing or reducing the change of under treating the targeted tissue (Rajagopalan, pa. 045).
Regarding claim 72, Utley/Rajagopalan combination discloses wherein applying energy comprises applying RF energy, microsecond pulsed energy, or sub-microsecond pulsed energy (Utley, pa. 0070).
Regarding claim 74, Utley/Rajagopalan combination discloses wherein moving the one or more contact projections outward from the radial position comprises moving a pair of contact projections closer or further apart while holding a target tissue of the wall taut (Utley, pa. 0075, 0128).
Regarding claim 75, Utley/Rajagopalan combination discloses wherein applying energy comprises applying energy to an ear, nasal cavity, mouth, tongue, turbinate, tonsils, soft palate, submucosal glands, parotid glands, esophagus, stomach, small intestine, large intestine, duodenum, pancreas and pancreatic duct, colon or fallopian tubes, uterus, urethra, cervix, trachea, pharynx, larynx, bronchi, or a mucosal epithelium of anatomical structures (Utley, pa. 0068).
Regarding claim 86, Utley discloses holding the region of the wall taut (pa. 0075, 0114).
However, Utley does not explicitly disclose flattening, stretching out or holding in tension a target tissue of the wall of the body lumen.
Rajagopalan, in the same field of endeavor, teaches moving the expansion element outward comprises flattening, stretching out or holding in tension a target tissue of the wall of the body lumen (pa. 045).
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 deployed the functionality (i.e., tissue manipulation techniques which reduce or remove wrinkles, or protrusions, of the tissue) of the expandable element of Rajagopalan into the expandable stent of Utley for the purpose of preventing or reducing the change of under treating the targeted tissue (Rajagopalan, pa. 045).
Regarding claim 87 Utley/Rajagopalan combination discloses the method comprising moving the one or more projections outward prior to applying the suction (Utley, pa. 0075).
Examiner notes that although Utley does not explicitly recite that the suction occurs prior to the expansion of the one or more projections, it does not teach away from doing so, and therefore, the suction is functionally capable of operating at any desired time of the procedure, including before the expansion of the projections.
Regarding claim 88, Utley/Rajagopalan combination discloses the method further comprising viewing, through the applicator tool (via endoscope 111), a target region of the wall of the body lumen (Utley, pa. 0066).
Regarding claim 89, Utley/Rajagopalan combination discloses the method further comprising connecting the applicator tool to a pulse generator (159) via a high voltage connector (165) (Utley, pa. 0112 & Fig. 19).
Regarding claim 90, Utley/Rajagopalan combination discloses wherein the mechanical structure comprises one or more of:
a balloon, a plate, a post, an arm, a frame, or other mechanical structure or mechanism configured to project from the distal tip region of the apparatus (Utley, pa. 0085).
In view of the combination of the embodiments described above, the expandable stent of the second embodiment of Utley includes a frame or cage device, which is interpreted as the mechanical structure.
Regarding claim 91, Utley/Rajagopalan combination discloses wherein the one or more contact projections flank the plurality of electrodes on opposite sides of the plurality of electrodes (Utley, see Figs. 16-17).
Due to a lack of description of the term ‘flank’ in the filed Specification, Examiner is interpreting the term ‘flank’ by the Merriam-Webster definition of “to be situated at the side of; to place something on each side of”. Specifically, this definition is broad and does not specify the side to be a lateral side, nor does the definition exclude/limit the side to be interpreted as an opposing side. In this case, Utley discloses an embodiment, seen in Figures 16-17, where the one or more contact projections are located on both the lateral sides and on the opposing side of the of the electrodes; thereby, meeting the claim limitation.
Regarding claim 92, Utley/Rajagopalan combination discloses the apparatus further comprising at least one of or both:
a camera and illumination source (Utley, pa. 0066).
Regarding claim 93, Utley/Rajagopalan combination discloses wherein the apparatus is configured to be operably coupled to an endoscope (Utley, pa. 0066).
Regarding independent claim 94, Rajagopalan discloses an apparatus for delivering energy to a tissue (3) (pa. 0066-0067 & Fig. 19), the apparatus comprising:
an elongate applicator tool (100) comprising:
an elongate shaft (164) (pa. 0066);
a distal tip region (110) at a distal end of the elongate shaft (pa. 0066);
a plurality of electrodes (101) (pa. 0068) arranged along a surface (upper surface of housing 107, pa. 0072) of a portion of a circumference of the distal tip region at a radial position relative to a longitudinal axis of the distal tip region (see Figs. 16-17);
one or more contact projections (combination of deflection mechanism 105 and two sets of expandable member 156) extending along at least a portion of a remaining circumference (i.e., lower surface and lateral surfaces of the housing 107) of the distal tip region flanking the plurality of electrodes on either side of the plurality of electrodes (see Figs. 16-17), the one or more contact projections comprising a mechanical structure (a thin, flexible, bladder made of a material such as polymer, pa. 0076) configured to extend outward from the radial position to frame a region of the tissue to be treated so that the region of tissue is held taut, while the plurality of electrodes remains at the radial position (pa. 0075) (by applying a substantially uniform apposition force, pa. 0114, which results in direct and sustainable contact between the plurality of electrodes and the tissue surface, pa. 0075), wherein the mechanical structure comprises one or more of: a balloon, a plate, a post, an arm or a frame (see Fig. 1); and
a suction port configured to apply suction to draw the region of the tissue that is held taut against the plurality of electrodes (pa. 0075).
Due to a lack of description of the term ‘flank’ in the filed Specification, Examiner is interpreting the term ‘flank’ by the Merriam-Webster definition of “to be situated at the side of; to place something on each side of”. Specifically, this definition is broad and does not specify the side to be a lateral side, nor does the definition exclude/limit the side to be interpreted as an opposing side. In this case, Utley discloses an embodiment, seen in Figures 16-17, where the one or more contact projections are located on both the lateral sides and on the opposing side of the of the electrodes; thereby, meeting the claim limitation.
However, Utley does not explicitly disclose to that the apposition forced applied by the one or more contact projections results in the removal or decrease in wrinkles from the tissue.
Rajagopalan, in the same field of endeavor, teaches an elongate applicator tool (301) comprising a tissue manipulating device including an expandable element such as inflatable balloons, expandable cages, radially deployable arms (pa. 0207), wherein the tissue manipulating device is capable of applying tissue manipulation techniques such as axial straightening, radial tensioning, applying a radial force to tissue, expanding the tissue such as to reduce protrusions due to folding, or any combination of these (pa. 0045).
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 deployed the functionality (i.e., tissue manipulation techniques which reduce or remove wrinkles, or protrusions, of the tissue) of the expandable element of Rajagopalan into the one or more contact projections of Utley for the purpose of preventing or reducing the change of under treating the targeted tissue (Rajagopalan, pa. 045).
Regarding claim 95, Utley/Rajagopalan combination discloses wherein the apparatus is configured for delivering RF energy, microsecond pulsed energy, or sub-microsecond pulsed energy (Utley, pa. 0068).
Regarding claim 96, Utley/Rajagopalan combination discloses wherein the plurality of electrodes comprises one or more of:
spring electrodes, plate electrodes, tubular electrodes, bar electrodes, coil electrodes or wire electrodes (Utley, pa. 0071).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Utley and Rajagopalan as applied to claim 71 above, and further in view of Vrba (W.O. Application No. 2016090175 A1).
Regarding claim 73, Utley/Rajagopalan combination discloses the invention substantially as claimed in claim 71 discussed above.
However, they do not explicitly disclose each pulse of the plurality of electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds.
Vrba, in the same field of endeavor, teaches an electrosurgical ablation device comprising a plurality of electrodes being able to deliver a plurality of radio frequency pulses (pa. 0461) with an amplitude between about 1 volt (0.001 kV) and 1000 volts (1 kV) (pa. 0462) with a pulse duration of less the 10 microseconds (10000 nanoseconds) (pa. 0466.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pulse amplitude and pulse duration of the radio frequency energy disclosed in Utley to be in ranges taught by Vrba, in order to reduce treatment time as well as protecting the tissue from unwanted heat damage (Vrba, pa. 0466); moreover, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed 08/12/1016 have been fully considered but they are not persuasive.
With regards to newly amended independent claim 66, Applicant argues that neither Utley nor Rajagopalan, alone or in combination, suggests the claim limitation of one or more contact projections configured to extend outward from the radial position on either side of the plurality of electrodes to frame a region of the tissue to be treated so that the region of the tissue is held taut to remove or reduce wrinkles from the tissue, while the plurality of electrodes remains at the radial position, .. and a suction port configured to apply suction to draw the region of the tissue that is held taut against the plurality of electrodes. Specifically, Applicant contends that Utley's alleged contact projection (e.g., inflatable member 105) is positioned on the side of the device opposite the electrode(s) (ablation structure 101) (i.e., does not flank the electrodes) and merely pushes the electrodes toward the tissue wall to obtain contact. Furthermore, Rajagopalan teaches the opposite architecture from the presently claimed arrangement and does not cure Utley's failure to disclose contact projections flanking the electrodes and holding the tissue taut. However, Examiner, respectfully, disagrees.
In a new interpretation of the Utley reference, Figures 16-17 disclose an embodiment where the plurality of electrodes (101) (pa. 0068) are arranged along a surface (upper surface of housing 107, pa. 0072) of the distal tip region at a radial position relative to a longitudinal axis of the distal tip region, one or more contact projections (combination of deflection mechanism 105 and two sets of expandable member 156) are configured to extend outward from the radial position on either side of the plurality of electrodes to frame a region of the tissue to be treated so that the region of the tissue is held taut (pa. 0128 & Figs. 16-17), while the plurality of electrodes remains at the radial position (by applying a substantially uniform apposition force, pa. 0114, which results in direct and sustainable contact between the plurality of electrodes and the tissue surface, pa. 0075), and a suction port configured to apply suction to draw the region of the tissue that is held taut against the plurality of electrodes (pa. 0075). The Rajagopalan reference is then brought in to teach a tissue manipulating device capable of applying tissue manipulation techniques such as axial straightening, radial tensioning, applying a radial force to tissue, expanding the tissue such as to reduce protrusions due to folding, or any combination of these for the purpose of preventing or reducing the change of under treating the targeted tissue (pa. 0045). Therefore, the architecture described in the Rajagopalan reference is moot given that only the functionality aspect of a device is of interest to Examiner.
In regard to the claim limitation of the one or more contact projections flanking the electrodes, due to a lack of description of the term ‘flank’ in the filed Specification, Examiner is interpreting the term ‘flank’ by the Merriam-Webster definition of “to be situated at the side of; to place something on each side of”. Specifically, this definition is broad and does not specify the side to be a lateral side, nor does the definition exclude/limit the side to be interpreted as an opposing side. In this case, Utley discloses an embodiment, seen in Figures 16-17, where the one or more contact projections are located on both the lateral sides and on the opposing side of the of the electrodes; thereby, meeting the claim limitation. Examiner further notes that other embodiments used in the previous Office Action, such as the embodiment seen in Figures 1-3, where the one or more contact projections is only located on an opposite side of the electrode would still meet the claim limitation of the one or more contact projections flanking the plurality of electrodes given the definition described above. Therefore, for all the reasonings set-forth above, the rejection using the combination of references is maintained under a new interpretation of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
