DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. This action is responsive to the Preliminary Amendment filed on August 28, 2023. Claims 21-40 are pending, and have been examined on the merits.
Specification
3. The disclosure is objected to because of the following informalities:
¶[0001] of the Specification, titled “PRIORTY,” should be amended to include the Patent Number (U.S. 11,786,296) of the Parent Application (U.S. 16/783,626).
Appropriate correction is required.
Claim Objections
4. Claims 22, 27, 28, 34, 36, & 38 are objected to because of the following informalities:
a. In claim 22, line 2, the recitation of “to tissue” should instead recite --to the tissue--.
b. In claim 27, line 2, the recitation of “the elongate shaft” should instead recite --the elongate shaft of the surgical instrument--.
c. In claim 28, line 1, the recitation of “the elongate shaft” should instead recite --the elongate shaft of the surgical instrument--.
d. In claim 34, line 4, the recitation of “a longitudinal axis” should instead recite --the longitudinal axis--.
e. In claim 36, line 2, the recitation of “to tissue” should instead recite --to the tissue--.
f. In claim 38, line 8, the recitation of “a patient” should recite --the patient--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 23 & 39 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
7. Claim 23 recites the limitation “the ablation head defining a distal end of an ablation instrument” in lines 1-2. This recitation renders the claim indefinite, as it is not clear whether the recited “ablation instrument” is intended to be the “surgical instrument” of claim 21 (from which claim 23 depends), or a separate/additional instrument. As such, the structure required by the claim is not clear. Clarification is required.
8. Claim 39 recites the limitation “the ablation head including first and second electrodes” in lines 1-2. This recitation renders the claim indefinite, as it is not clear whether the “an electrode” of claim 38 (from which claim 39 depends) is intended to be one of the “first and second electrodes” of claim 39, or whether the “first and second electrodes” of claim 39 are provided in addition to the “electrode” of claim 38. As such, the structure required by the claim is not clear. Clarification is required.
Claim Rejections - 35 USC § 103
9. 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.
10. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. Claims 21, 23, 24, 30-32, 34, & 35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0265094 to Goldfarb et al. ("Goldfarb") in view of U.S. Patent Application Publication No. 2012/0116158 to Hale et al. ("Hale").
12. Regarding claim 21, Goldfarb teaches a surgical instrument assembly comprising:
(a) an endoscope [endoscope (30) - ¶[0104]; FIGS. 1, 3D], the endoscope [(30)] including an elongate shaft [e.g., ¶[0108]; FIGS. 3D-3E] defining a longitudinal axis [longitudinal axis of flexible shaft of endoscope (30)] and having a distal end [distal tip (30d) of endoscope (30), having a lens/lens barrel (30e) - ¶’s [0108], [0109]; FIG. 3H], the endoscope [(30)] having a window [broadly, lens/lens barrel (30e) - ¶’s [0108], [0109]; FIG. 3H; note also FIGS. 3E-3G]] with a field of view [¶[0108]],…; and
(b) a surgical instrument comprising:
(i) an elongate shaft [tube (44) - ¶[0103]; FIGS. 3A, 3I] having a malleable distal portion [see ¶[0103] (“In the embodiment shown, a distal portion of tube 44 extends out of and beyond the distal end of outer tube 42. This protruding distal portion of tube 44 may be straight or curved. Also, it may be pre-formed at the time of manufacture or malleable to a desired shape at the time of use”)], a proximal region of the malleable distal portion being fixed against longitudinal movement relative to the endoscope [see ¶[0104] (“In FIG. 3I, heat shrink tube or overlamination 40 surrounds the tubes 44,28 over a majority of the length of the straight portions of the tubes. Optionally, all or a portion of the curved distal end portions of tubes 44,28 may be surrounded by heat shrink tubing or overlamination 40d”); FIG. 3I; NOTE: as broadly as currently claimed, tube (44) is fixed against movement relative to endoscope (30), even though endoscope 30 is ultimately slidable relative to tube (44) through endoscope channel (28) (¶[0104)]]; and
(ii) an ablation head [energy delivery electrode - ¶[0134]] coupled to the malleable distal portion [broadly, a tool inserted through the malleable distal portion is “coupled to” the malleable distal portion - ¶[0134]], the ablation head including at least one electrode operable to deliver energy to tissue for ablating the tissue [see ¶[0134] (“A variety of tools, instruments or devices may be inserted through tube 44, including, but not limited to: graspers, cutters, punches, flexible microdebriders, dissectors, electrodes for energy delivery (RF, heat, cryotherapy, ultrasound, or microwave), lasers, suction catheters, irrigation catheters, balloon catheters, etc.”)].
Field of View
While Goldfarb teaches that the endoscope may have a lens with a minimum field of view of about seventy degrees [e.g., ¶[0108], as well as directional control of the visual field provided by the endoscope [¶[0109]], Goldfarb does not explicitly teach:
the field of view including a region proximal to the distal end [of the endoscope].
Hale, in a similar field of endeavor, teaches a wide-angle flexible endoscope [Abstract] comprising, inter alia, a viewing window (70), a wide-angle lens system (165) with and optical center (160) [¶[0046]]. Hale teaches that the optical center (160) is angularly offset from the longitudinal axis (60) of the endoscope and covers a viewing range 130 of 160 degrees from -45 to +115 degrees relative to the longitudinal axis, which allows for an endoscopic image field (130) that spans the longitudinal axis and an angle greater than ninety degrees to the longitudinal axis, such that the simultaneous image field gathered by the endoscope provides both forward and retrograde imaging [¶[0047]]. Hale teaches that providing a variable view endoscope that spans this range is beneficial because it enables a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes. This improves the ability of a user to safely operate and handle the device in the body cavity [¶[0047]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Goldfarb to utilize an endoscope having a field of view including a region proximal to the distal end, since such a modification would provide the benefit/advantage of enabling a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes, which would improve the ability of a user to safely operate and handle the device in the body cavity, as explicitly taught by Hale [¶[0047]].
13. Regarding claim 23, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches the ablation head defining a distal end of an ablation instrument [¶[0134]].
14. Regarding claim 24, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches the ablation head [device head] extending distally [¶[0134]] from the malleable distal portion along a head axis [axis of device extending through tube (44) - ¶[0134]], the malleable distal portion being configured to bend relative to the longitudinal shaft axis [¶[0103] (“This protruding distal portion of tube 44 may be straight or curved. Also, it may be pre-formed at the time of manufacture or malleable to a desired shape at the time of use”)] to orient the ablation head in a position in which the head axis is offset from and parallel to the longitudinal shaft axis [e.g., FIGS. 3A, 3I].
15. Regarding claim 30, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches the ablation head [device head - ¶[0134]] being configured to be positioned within the field of view [e.g., ¶[0113]].
16. Regarding claim 31, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches a proximal portion of the elongate shaft [(44)] of the surgical instrument extending parallel to the elongate shaft of the endoscope [(30) [FIGS. 3A, 3I].
17. Regarding claim 32, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches a proximal portion of the elongate shaft [(44)] of the surgical instrument being in contact with the elongate shaft of the endoscope [(30)] [via contact with endoscope channel (28) - ¶[0103]; FIGS. 3A, 3I], the ablation head [device head] being configured to assume a position in which the ablation head is spaced apart from the elongate shaft of the endoscope [device extending through tube (44) (¶[0134]) will be spaced apart from the elongate shaft of the endoscope - FIGS. 3A, 3I].
18. Regarding claim 34, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Goldfarb further teaches the endoscope further comprising a handle [handle (60)] from which the elongate shaft of the endoscope extends distally, the elongate shaft of the endoscope and the surgical instrument being rotatable together relative to the handle about a longitudinal axis defined by the elongate shaft of the endoscope [¶[0103]].
19. Regarding claim 35, Goldfarb teaches a surgical instrument assembly comprising:
(a) an endoscope [endoscope (30) - ¶[0104]; FIGS. 1, 3D], the endoscope [(30)] including an elongate shaft [e.g., ¶[0108]; FIGS. 3D-3E] having a longitudinal axis [longitudinal axis of flexible shaft of endoscope (30)] and a distal shaft end [distal tip (30d) of endoscope (30), having a lens/lens barrel (30e) - ¶’s [0108], [0109]; FIG. 3H] through which the endoscope is configured with a field of view [via lens/lens barrel (30e) - ¶’s [0108], [0109]; FIG. 3H; note also FIGS. 3E-3G]] with a field of view [¶[0108]],…; and
(b) an ablation instrument [¶[0134]] fixedly secured relative to the elongate shaft of the endoscope [¶[0103]], the ablation instrument comprising:
(i) a malleable shaft portion [tube (44) - ¶[0103]; FIGS. 3A, 3I] having a malleable distal portion [see ¶[0103] (“In the embodiment shown, a distal portion of tube 44 extends out of and beyond the distal end of outer tube 42. This protruding distal portion of tube 44 may be straight or curved. Also, it may be pre-formed at the time of manufacture or malleable to a desired shape at the time of use”)]; ¶[0104] (“In FIG. 3I, heat shrink tube or overlamination 40 surrounds the tubes 44,28 over a majority of the length of the straight portions of the tubes. Optionally, all or a portion of the curved distal end portions of tubes 44,28 may be surrounded by heat shrink tubing or overlamination 40d”); FIG. 3I; NOTE: as broadly as currently claimed, tube (44) is fixed against movement relative to endoscope (30), even though endoscope 30 is ultimately slidable relative to tube (44) through endoscope channel (28) (¶[0104)], and
(ii) an ablation head [energy delivery electrode - ¶[0134]] secured to the malleable shaft portion [broadly, a tool inserted through the malleable distal portion is “secured to” the malleable distal portion - ¶[0134]], the ablation head including at least one electrode operable to ablate patient tissue [¶[0134]].
Field of View
While Goldfarb teaches that the endoscope may have a lens with a minimum field of view of about seventy degrees [e.g., ¶[0108], as well as directional control of the visual field provided by the endoscope [¶[0109]], Goldfarb does not explicitly teach:
the field of view encompassing a region proximal to the distal shaft end [of the endoscope].
Hale, in a similar field of endeavor, teaches a wide-angle flexible endoscope [Abstract] comprising, inter alia, a viewing window (70), a wide-angle lens system (165) with and optical center (160) [¶[0046]]. Hale teaches that the optical center (160) is angularly offset from the longitudinal axis (60) of the endoscope and covers a viewing range 130 of 160 degrees from -45 to +115 degrees relative to the longitudinal axis, which allows for an endoscopic image field (130) that spans the longitudinal axis and an angle greater than ninety degrees to the longitudinal axis, such that the simultaneous image field gathered by the endoscope provides both forward and retrograde imaging [¶[0047]]. Hale teaches that providing a variable view endoscope that spans this range is beneficial because it enables a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes. This improves the ability of a user to safely operate and handle the device in the body cavity [¶[0047]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Goldfarb to utilize an endoscope having the field of view encompassing a region proximal to the distal shaft end, since such a modification would provide the benefit/advantage of enabling a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes, which would improve the ability of a user to safely operate and handle the device in the body cavity, as explicitly taught by Hale [¶[0047]].
20. Claims 22, 25-29, 33, & 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Goldfarb and Hale, and further in view of U.S. Patent Application Publication No. 2015/0164571 to Saadat ("Saadat").
21. Regarding claims 22, 25-29, & 33, the combination of Goldfarb and Hale teaches all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
While Goldfarb teaches that a number of devices may be utilized including, e.g., RF energy delivery devices [see ¶[0134]], the combination of Goldfarb and Hale does not explicitly teach the following particulars of the RF energy device:
[claim 22] the at least one electrode comprising first and second electrodes operable to deliver bipolar RF energy to tissue;
[claim 25] the ablation head comprising a planar surface, the at least one electrode being disposed on the planar surface;
[claim 26] the ablation head being rectangular;
[claim 27] an electrical conductor housed within the elongate shaft, the electrical conductor being configured to electrically couple the at least one electrode of the ablation head with an energy source;
[claim 28] the elongate shaft comprising an electrically conductive material configured to electrically couple the at least one electrode of the ablation head with an energy source;
[claim 29] further comprising an electrical connector coupled with a proximal portion of the elongate shaft of the surgical instrument, the electrical connector being configured to releasably couple with an energy source to place the at least one electrode in electric communication with the energy source; and
[claim 33] the ablation head including a first surface that faces toward the elongate shaft of the endoscope and an opposed second surface that faces away from the elongate shaft of the endoscope, the at least one electrode being disposed on the second surface.
Saadat, in a similar field of endeavor, teaches devices and methods for ablating regions of tissue [¶[0002], including the posterior nasal nerves [e.g., ¶’s [0011], [0018], [0054]]. More particularly, Saadat teaches that probes may be introduced and advanced through the nasal cavity, including under visualization via an endoscope, for the purposes of contacting and ablating at least one posterior nasal nerve [e.g., claims 1, 17, 20, 21].
With reference to FIGS. 22A-22C of Saadat (with FIG. 22B of Saadat reproduced below), Saadat teaches an ablation probe (362) having a rectangular ablation head [FIG. 22B] with a planar surface having an array of RF electrodes (379) disposed thereon operable to deliver bipolar RF energy to tissue [see ¶[0187] which also references the prior embodiment of FIG. 21A (and ¶[0186])].
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FIG. 22B of SAADAT
Sadaat further teaches an electrical conductor [electrical cable (386)] housed within an elongate shaft [(384)], the electrical conductor [(386)] being configured to electrically couple the electrodes [(379)] of the ablation head with an energy source [RF energy generator - ¶[0185]].
Sadaat additionally teaches that the elongate shaft [(384)] comprises an electrically conductive material [broadly, electrical cable (386) is an electrically conductive material included in shaft (384)] configured to electrically couple the electrodes [(379)] of the ablation head with an energy source [RF energy generator - ¶[0185]].
Saadat further teaches an electrical connector [electrical connector (343) - ¶’s [0185]-[0187]] coupled with a proximal portion of the elongate shaft of the surgical instrument [FIG. 22A], the electrical connector [(343)] being configured to releasably couple with the energy source [RF energy generator - ¶[0185]] to place the electrodes [(379)] in electric communication with the energy source ¶’s [0185]-[0187]].
Given Goldfarb’s explicit teaching that a number of devices may be utilized including, e.g., RF energy delivery devices [see ¶[0134]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Goldfarb and Hale to utilize a known, art-recognized RF ablation device, including one wherein the at least one electrode comprises first and second electrodes operable to deliver bipolar RF energy to tissue, the ablation head comprises a planar surface, the at least one electrode being disposed on the planar surface, the ablation head being rectangular, an electrical conductor housed within the elongate shaft, the electrical conductor being configured to electrically couple the at least one electrode of the ablation head with an energy source, the elongate shaft comprising an electrically conductive material configured to electrically couple the at least one electrode of the ablation head with an energy source, and further comprising an electrical connector coupled with a proximal portion of the elongate shaft of the surgical instrument, the electrical connector being configured to releasably couple with an energy source to place the at least one electrode in electric communication with the energy source, all as taught by Saadat, since such a modification amounts merely to the simple substitution of one known ablation probe for another, yielding predictable results [ablation of target tissue within a nasal cavity] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
As modified, the surface of the planar ablation head of Goldfarb/Hale/Saadat facing the tissue to be treated (second surface) would have the electrodes disposed thereon (in order to contact the tissue), and would be facing away from the endoscope, while the opposed surface (first surface) would face the endoscope [see, e.g., FIG. 13B of Goldfarb for context].
22. Regarding claims 36 & 37, the combination of Goldfarb and Hale teaches all of the limitations of claim 35 for the reasons set forth in detail (above) in the Office Action.
While Goldfarb teaches that a number of devices may be utilized including, e.g., RF energy delivery devices [see ¶[0134]], the combination of Goldfarb and Hale does not explicitly teach the following particulars of the RF energy device:
[claim 36] the at least one electrode comprising first and second electrodes operable to deliver bipolar RF energy to tissue.
[claim 37] a proximal end of the ablation instrument including an electrical connector configured to releasably couple with an energy source operable to deliver energy to the at least one electrode.
Saadat, in a similar field of endeavor, teaches devices and methods for ablating regions of tissue [¶[0002], including the posterior nasal nerves [e.g., ¶’s [0011], [0018], [0054]]. More particularly, Saadat teaches that probes may be introduced and advanced through the nasal cavity, including under visualization via an endoscope, for the purposes of contacting and ablating at least one posterior nasal nerve [e.g., claims 1, 17, 20, 21].
With reference to FIGS. 22A-22C of Saadat (with FIG. 22B of Saadat reproduced below), Saadat teaches an ablation probe (362) having an array of RF electrodes (379) disposed thereon operable to deliver bipolar RF energy to tissue [see ¶[0187] which also references the prior embodiment of FIG. 21A (and ¶[0186])].
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FIG. 22B of SAADAT
Sadaat further teaches an electrical conductor [electrical cable (386)] housed within an elongate shaft [(384)], the electrical conductor [(386)] being configured to electrically couple the electrodes [(379)] of the ablation head with an energy source [RF energy generator - ¶[0185]].
More particularly, Saadat additionally teaches an electrical connector [electrical connector (343) - ¶’s [0185]-[0187]] coupled with a proximal portion of the elongate shaft of the surgical instrument [FIG. 22A], the electrical connector [(343)] being configured to releasably couple with the energy source [RF energy generator - ¶[0185]] to place the electrodes [(379)] in electric communication with the energy source ¶’s [0185]-[0187]].
Given Goldfarb’s explicit teaching that a number of devices may be utilized including, e.g., RF energy delivery devices [see ¶[0134]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Goldfarb and Hale to utilize a known, art-recognized RF ablation device, including one wherein the at least one electrode comprises first and second electrodes operable to deliver bipolar RF energy to tissue, and wherein a proximal end of the ablation instrument includes an electrical connector configured to releasably couple with an energy source operable to deliver energy to the at least one electrode, all as taught by Saadat, since such a modification amounts merely to the simple substitution of one known ablation probe for another, yielding predictable results [ablation of target tissue within a nasal cavity] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
23. Regarding claim 38, Goldfarb teaches a method of ablating tissue of a patient with a surgical instrument assembly comprising an endoscope [endoscope (30) - ¶[0104]; FIGS. 1, 3D] and an ablation instrument [comprising tube (44) and the device inserted there-through, including RF energy delivery electrode - ¶[0134]], the endoscope [(30)] defining a longitudinal axis [longitudinal axis of flexible shaft of endoscope (30)] and including a distal end configured to capture an image of patient anatomy [distal tip (30d) of endoscope (30), having a lens/lens barrel (30e) - ¶’s [0108], [0109]; FIG. 3H] within a field of view…[¶[0108]], the ablation instrument being fixedly secured to the endoscope [via contact with endoscope channel (28) - ¶[0103]; FIGS. 3A, 3I] and including a malleable shaft portion [see ¶[0103] (“In the embodiment shown, a distal portion of tube 44 extends out of and beyond the distal end of outer tube 42. This protruding distal portion of tube 44 may be straight or curved. Also, it may be pre-formed at the time of manufacture or malleable to a desired shape at the time of use”)] and an ablation head having an electrode [RF energy delivery electrode - ¶[0134]], the method comprising:
(a) inserting the distal end of the endoscope [(30)] and the ablation head [energy delivery electrode - ¶[0134]] into a cavity [nasal cavity - e.g., Abstract; ¶’s [0103], [0112]] of a patient; [and]
(b) under visualization provided by the endoscope via the field of view, positioning the electrode of the ablation head [e.g., ¶’s [0011], [0012], [0134]]…;
A. Field of View
While Goldfarb teaches that the endoscope may have a lens with a minimum field of view of about seventy degrees [e.g., ¶[0108], as well as directional control of the visual field provided by the endoscope [¶[0109]], Goldfarb does not explicitly teach:
a field of view that includes a region that is proximal to the distal end [of the endoscope].
Hale, in a similar field of endeavor, teaches a wide-angle flexible endoscope [Abstract] comprising, inter alia, a viewing window (70), a wide-angle lens system (165) with and optical center (160) [¶[0046]]. Hale teaches that the optical center (160) is angularly offset from the longitudinal axis (60) of the endoscope and covers a viewing range 130 of 160 degrees from -45 to +115 degrees relative to the longitudinal axis, which allows for an endoscopic image field (130) that spans the longitudinal axis and an angle greater than ninety degrees to the longitudinal axis, such that the simultaneous image field gathered by the endoscope provides both forward and retrograde imaging [¶[0047]]. Hale teaches that providing a variable view endoscope that spans this range is beneficial because it enables a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes. This improves the ability of a user to safely operate and handle the device in the body cavity [¶[0047]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Goldfarb to utilize an endoscope having a field of view that includes a region that is proximal to the distal end, since such a modification would provide the benefit/advantage of enabling a user to view objects that reside in front of the endoscope and behind the standard fields of view for endoscopes, which would improve the ability of a user to safely operate and handle the device in the body cavity, as explicitly taught by Hale [¶[0047]].
B. Contacting Tissue
Finally, while Goldfarb teaches that a number of devices may be utilized including, e.g., RF energy delivery devices [see ¶[0134]], the combination of Goldfarb and Hale does not explicitly teach the following particulars of ablation using the RF energy device:
(b) under visualization provided by the endoscope via the field of view, positioning the electrode of the ablation head in electrical contact with the tissue; and
(c) energizing the electrode to thereby ablate the tissue.
Saadat, in a similar field of endeavor, teaches devices and methods for ablating regions of tissue [¶[0002], including the posterior nasal nerves [e.g., ¶’s [0011], [0018], [0054]]. More particularly, Saadat teaches that probes may be introduced and advanced through the nasal cavity, including under visualization via an endoscope, for the purposes of contacting and ablating at least one posterior nasal nerve [e.g., claims 1, 17, 20, 21].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Goldfarb and Hale to include the steps of, under visualization provided by the endoscope via the field of view, positioning the electrode of the ablation head in electrical contact with the tissue, and energizing the electrode to thereby ablate the tissue, as taught by Sadaat, since such a particular positioning and ablation technique for ablating the posterior nasal nerves was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Saadat, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Goldfarb/Hale, and the results [identifying, contacting, and ablating the posterior nasal nerves] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
24. Regarding claim 39, the combination of Goldfarb, Hale, & Saadat teaches all of the limitations of claim 38 for the reasons set forth in detail (above) in the Office Action.
Saadat further teaches an exemplary probe (362) (e.g., shown in FIG. 22B of Saadat reproduced below) having an ablation head including first and second electrodes [any two of the electrodes of the array of RF electrodes (379)], ablating the tissue comprising delivering bipolar RF energy to the tissue [¶’s [0186]-[0187]].
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FIG. 22B of SAADAT
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Goldfarb, Hale, and Saadat to utilize a known, art-recognized RF ablation device, including one having an ablation head including first and second electrodes [any two of the electrodes of the array of RF electrodes (379)], [and] ablating the tissue comprising delivering bipolar RF energy to the tissue, as taught by Saadat, since such a modification amounts merely to the simple substitution of one known ablation probe for another, yielding predictable results [ablation of target tissue within a nasal cavity] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
25. Regarding claim 40, the combination of Goldfarb, Hale, & Saadat teaches all of the limitations of claim 38 for the reasons set forth in detail (above) in the Office Action.
Goldfarb (as modified above in the rejection of claim 38) further teaches bending the malleable shaft portion to position the ablation head at a first location relative to the distal end of the endoscope, inserting the distal end of the endoscope and positioning the electrode of the ablation head each being performed while maintaining the ablation head at the first location relative to the distal end of the endoscope [e.g., ¶’s [0011], [0012], [0134]].
Double Patenting
26. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321I or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) – 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
27. Claims 21-40 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,786,296.
Although the claims at issue are not identical, they are not patentably distinct from each other because matters of differing claim scope between the instant claims and the issued claims would be resolved and obvious to one of ordinary skill in the art in view of the various references cited above.
Conclusion
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bradford C. Blaise/Examiner, Art Unit 3794