DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-36 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “and said connection end” in at the end of line 12 and beginning of line 13. However, it is unclear what this limitation is intended to be interpreted as since there are no defining elements to this phrase.
Claims 22-36 are rejected as being dependent upon a rejected base claim.
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.
The factual inquiries 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.
Claim(s) 21-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman, Jr. et al., (US 10,136,943; hereinafter Cosman) in view of Gould et al., (US 4552554; hereinafter Gould).
Regarding claim 21, a first embodiment of Cosman (Figures 1A-1B and 2) discloses a radiofrequency cannula assembly for thermal ablation, comprising: a radiofrequency electrode (180); a radiofrequency cannula (100) for insertion into a body tissue, comprising: a metal made tubular cannula shaft (127) having: a bevel tip (121) which has a distal end opening, a connection end (non-tissue-penetrating end) which has a proximal end opening (connected to hub 110), an inner electrode passage (105) extending from said proximal end opening (connected to hub 110) to said distal end opening along a longitudinal axis of said cannula shaft (127), a curved portion (106) formed between said bevel tip (121) and said connection end (non-tissue-penetrating end), an elongated and straight shaft body defined between said curved portion (106), where said cannula shaft (127) is bent between said bevel tip (121) and said connection end (non-tissue-penetrating end), a slant active tip portion (101), extended between said curved portion (106) and said bevel tip (121), defining a predetermined included angle with respect to said elongated and straight shaft body, and a radial electrode outlet opening (226) provided on a short side of said active tip portion (101) in form of an elongated longitudinal hole adjacent to said curved portion (106), having a proximal end and a distal end, communicating said inner electrode passage (105) with outside, wherein said bevel tip (121) is in form of slant surface extending from said short side to a long side of said active tip portion (101), said curved portion (106) is a portion of said cannular shaft (127) where said long side of said active tip portion (101) bends for the predetermined included angle towards said shaft body such that said electrode outlet opening (226) is formed in said short side of said active top portion (101) adjacent to said curved portion (106); and a luer-lock connection member (112) connected to said connection end (non-tissue-penetrating end) of said cannula shaft (127); and a mandrel (140) configured to be inserted into said inner electrode passage (105) of said radiofrequency cannula (100) and extended from said proximate end opening (connected to hub 110) to the opening (226) while inserting said radiofrequency cannula (100) in the body tissue and to be withdrawn from said inner electrode passage (105) of said radiofrequency cannula (100) after said slant active tip portion (301) of said radiofrequency cannula (100) reaching a desired tissue part, such that said mandrel (140) inserted in said radiofrequency cannula (100) closes said electrode outlet opening (226) and strengthens said cannula shaft while inserting and penetrating the body tissue (Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45).
The first embodiment of Cosman fails to disclose an electrode guiding arrangement, which is provided at said electrode outlet opening of said cannula shaft comprising an electrode guiding lobe, having a free proximal end and a lobe distal end, integrally extended from said distal end of said electrode outlet opening inwardly for a predetermined length and a predetermined slant angle with respect to said shaft body to form a an inclined stopper between said distal end opening and said electrode outlet opening and defining a guiding surface facing said inner electrode passage, wherein said electrode guiding lobe is integrally formed from a portion of a cannula side wall at said active tip portion of said cannula shaft to inclinedly bend inwardly until said free proximal end in contact with an opposing inner surface of said inner electrode passage; wherein the mandrel is configured to extend to said electrode guiding lobe, wherein said predetermined slant angle is formed between said short side of said slant active tip portion and said guiding surface of said electrode guiding lobe, wherein a distal tip portion of said radiofrequency electrode forms a straight active electrode tip of said radiofrequency electrode, having a length generally equal to a length of said slant active tip portion of said cannula shaft, being inserted in said inner electrode passage is guided by said electrode guiding lobe to penetrate out of said inner electrode passage through said electrode outlet opening such that said straight active electrode tip of said radiofrequency electrode and said slant active tip portion of said radiofrequency cannula have a predetermined distance and define a predetermined angle therebetween, wherein the predetermined distance between said straight active electrode tip of said radiofrequency electrode and said bevel tip of said slant active tip portion of said radiofrequency cannular is controlled by the predetermined included angle, a location of said electrode outlet opening in said slant active tip portion of said radiofrequency cannular, a length of said slant active tip portion of said radiofrequency cannula, and a shape of said straight active electrode tip of said radiofrequency electrode.
However, Cosman (Figure 5A) teaches a second embodiment including an electrode guiding arrangement, which is provided at the electrode outlet opening (526) of said cannula shaft comprising an electrode guiding lobe (520A), having a free proximal end and a lobe distal end, integrally extended from a distal end of the electrode outlet opening (526) inwardly for a predetermined length and a predetermined slant angle with respect to the shaft body to form an inclined stopper (flap) between the distal end opening (of bevel tip 521) and the electrode outlet opening (526) and defining a guiding surface facing said inner electrode passage (105), wherein said electrode guiding lobe (520A) is integrally formed from a portion of a cannula side wall (520) at said active tip portion (521) of said cannula shaft to inclinedly bend inwardly until said free proximal end of said electrode guiding lobe (520A) is in contact with an opposing inner surface of said inner electrode passage (105); wherein the mandrel (140) is configured to extend to said electrode guiding lobe (520A), (Col. 26, lines 11-46). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment (Figure 2) of Cosman to include an electrode guiding lobe, as taught by the second embodiment (Figure 5A) of Cosman, because the modification would ensure that the electrode exits the side electrode opening, rather than the distal opening, irrespective of the rotational alignment of the electrode shaft within the cannula lumen (Cosman; Col. 26, lines 27-30). Furthermore, the modification would provide for consistent extension of the electrode tip from the cannula side outlet and a fluid injection both distal to and to the side of the cannula active tip since the lobe 520A does not create a fluid-tight seal (Cosman; Col. 26, lines 31-40). Accordingly, the modified device would include the base curved tip of Figure 2 of Cosman with an inclined electrode guiding lobe as taught by Figure 5A of Cosman included in the opening of the Figure 2 base design. Therefore, the combination would include wherein said predetermined slant angle is formed between said short side of said slant active tip portion and said guiding surface of said electrode guiding lobe, wherein a distal tip portion of said radiofrequency electrode forms a straight active electrode tip of said radiofrequency electrode, having a length generally equal to a length of said slant active tip portion of said cannula shaft, being inserted in said inner electrode passage is guided by said electrode guiding lobe to penetrate out of said inner electrode passage through said electrode outlet opening such that said straight active electrode tip of said radiofrequency electrode and said slant active tip portion of said radiofrequency cannula have a predetermined distance and define a predetermined angle therebetween, wherein the predetermined distance between said straight active electrode tip of said radiofrequency electrode and said bevel tip of said slant active tip portion of said radiofrequency cannular is controlled by the predetermined included angle, a location of said electrode outlet opening in said slant active tip portion of said radiofrequency cannular, a length of said slant active tip portion of said radiofrequency cannula, and a shape of said straight active electrode tip of said radiofrequency electrode.
Cosman fails to teach that said electrode guiding lobe gradually reduces a width from said lobe distal end to said free proximal end to facilitate a bending of said electrode guiding lobe about said distal end thereof and define a U-shape hole of said electrode outlet opening formed in said short side of said slant active tip portion of said cannula shaft of said radiofrequency cannula surrounding said electrode guiding lobe, wherein the predetermined length of said electrode guiding lobe is larger than an inner diameter of said inner electrode passage and shorter than a longitudinal length of said electrode outlet opening, wherein said electrode guiding lobe has two lobe sides and a lobe end which are surrounded by said U-shape hole of said electrode outlet opening to form an inclined stopper for said distal end opening of said radiofrequency cannula, so as for preventing the body tissue entered through said distal end portion from blocking said electrode outlet opening and entering a portion of said inner electrode passage extending between said electrode guiding lobe and said proximal end opening of said inner electrode passage. However, Gould (Figures 3b-4a) teaches a cannula introducer assembly comprising a guiding lobe (26), wherein said guiding lobe (26) gradually reduces a width from a lobe distal end (distal end of element 26) to a free proximal end (free proximal end of element 26) to facilitate a bending of said guiding lobe (26) about said distal end thereof and define a U-shape hole of said opening (20) formed (as shown in Figure 3e) in a top side of said cannula shaft (12) surrounding said guiding lobe (26), wherein the predetermined length of said guiding lobe (26) is larger than an inner diameter of the inner passage of the tube and shorter than a longitudinal length of said opening (20), wherein said guiding lobe (26) has two lobe sides (two longitudinal sides) and a lobe end (curved end) which are surrounded by said U-shape hole of said opening (20) to form an inclined stopper for said distal end opening of said cannula (12), so as for preventing the body tissue entered through said distal end portion from blocking said opening (20) and entering a portion of said inner passage extending between said guiding lobe (26) and a proximal end opening of said inner passage (Col. 4, lines 17-62). Therefore, it would have been an obvious matter of design choice to modify Cosman to include said electrode guiding lobe gradually reducing a width from said lobe distal end to said free proximal end to facilitate a bending of said electrode guiding lobe about said distal end thereof and define a U-shape hole of said electrode outlet opening formed in said short side of said slant active tip portion of said cannula shaft of said radiofrequency cannula surrounding said electrode guiding lobe, wherein the predetermined length of said electrode guiding lobe is larger than an inner diameter of said inner electrode passage and shorter than a longitudinal length of said electrode outlet opening, wherein said electrode guiding lobe is defined to have two lobe sides and a lobe end which are surrounded by said U-shape hole of said electrode outlet opening to form an inclined stopper for said distal end opening of said radiofrequency cannula, so as for preventing the body tissue entered through said distal end portion from blocking said electrode outlet opening and entering a portion of said inner electrode passage extending between said electrode guiding lobe and said proximal end opening of said inner electrode passage, since applicant has not disclosed that having a U-shaped elongated longitudinal hole and correspondingly shaped guiding lobe, solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a U-shaped elongated longitudinal hole and correspondingly shaped electrode guiding lobe, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 22, Cosman/Gould fails to teach wherein said predetermined included angle between said active electrode tip of said radiofrequency electrode and said slant active tip portion of said radiofrequency cannula is 12.39°. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cosman/Gould to include said predetermined included angle between said active electrode tip of said radiofrequency electrode and said slant active tip portion of said radiofrequency cannula at 12.39° since the predetermined included angle is simply a result-effective variable which would determine the deflection of the electrode out of the opening and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Regarding claim 23, Cosman/Gould fails to teach wherein said predetermined slant angle formed between said short side of said slant active tip portion and said electrode guiding surface of said electrode guiding tube is 28°. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cosman/Gould to include said predetermined slant angle formed between said short side of said slant active tip portion and said electrode guiding surface of said electrode guiding tube at 28° since the predetermined included angle is simply a result-effective variable which would determine the deflection of the electrode out of the opening and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Regarding claim 24, Cosman/Gould fails to teach wherein said predetermined slant angle formed between said short side of said slant active tip portion and said electrode guiding surface of said electrode guiding tube is 28°. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cosman/Gould to include said predetermined slant angle formed between said short side of said slant active tip portion and said electrode guiding surface of said electrode guiding tube at 28° since the predetermined included angle is simply a result-effective variable which would determine the deflection of the electrode out of the opening and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)(B).
Regarding claim 25, Cosman (Figures 1A-1B and 3) further discloses wherein said radiofrequency cannula (100) further comprises an insulation covering (130) and extending between said connection end (non-tissue-penetrating end) and said curved portion (306) of said cannula shaft (Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45).
Regarding claim 26, Cosman (Figures 1A-1B and 3) further discloses wherein said radiofrequency cannula (100) further comprises an insulation covering (130) extending between said connection end (non-tissue-penetrating end) and said curved portion (306) of said cannula shaft (Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45).
Regarding claim 27, Cosman (Figures 1A-1B and 3) further discloses wherein said radiofrequency cannula (100) further comprises an insulation covering (130) extending between said connection end (non-tissue-penetrating end) and said curved portion (306) of said cannula shaft (Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45).
Regarding claim 28, Cosman (Figures 1A-1B and 3) further discloses wherein said radiofrequency cannula (100) further comprises an insulation covering (130) extending between said connection end (non-tissue-penetrating end) and said curved portion (306) of said cannula shaft (Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45).
Regarding claim 29, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 30, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 31, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 32, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 33, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 34, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 35, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Regarding claim 36, Cosman/Gould further teaches wherein said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) is formed by: forming said elongated longitudinal hole in the form of said U-shape in said short side of said slant active tip portion (101) of said cannula shaft (127) of said radiofrequency cannula and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) which is defined to have two lobe sides (two longitudinal sides of lobe 26 taught by Gould) and a lobe end (curved proximal end side of lobe 26 taught by Gould), wherein said two lobe sides and said lobe end are surrounded by said elongated longitudinal hole (of said opening 226); bending said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) into said inner electrode passage (105) of said radiofrequency cannula (100) about a root end thereof (to formed the inclined proximal end of the lobe) until said lobe end (curved proximal end side of lobe 26 taught by Gould) is in contact with said opposing inner surface of said inner electrode passage (105), such that said elongated longitudinal hole forms said electrode outlet opening (226) of said radiofrequency cannula (100) to communicate said inner electrode passage (105) with outside and said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) forms said inclined stopper (flap) for said distal end opening (opening at the bevel 121) of said radiofrequency cannula (100) configured to prevent any tissue entered through said distal end opening from blocking said electrode outlet opening (226) and entering a portion of said inner electrode passage (105) extending between said electrode guiding lobe (lobe 520A of Cosman formed with U-shaped opening taught by Gould) and said proximal end opening of said inner electrode passage (105); and forming said curved portion (106) between said electrode outlet opening (226) and said proximal end opening of said cannula shaft (127) to define said slant active tip portion (101), extending between said distal end opening and said curved portion (106), which has said predetermined slant angle with respect to said longitudinal axis of said cannula shaft (100), (Cosman: Col. 18, line 38 – Col. 19, line 60; Col. 24, lines 11-45; Gould: Col. 4, lines 17-62).
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
With regard to Applicant’s first and second arguments that that Examiner must identify explicit reason to combine references and conclusory statements are insufficient, Examiner respectfully disagrees. Examiner notes that each modification has a clearly articulated motivation to combine references, as explained in the rejections above. Examiner requests Applicant to specify which, if any, modifications lack explicit reason in any of the rejections outlined above. Referring specifically to the rejection of independent claim 21 above, the explicit reason to combine the first embodiment of Cosman with the second embodiment of Cosman is that the modification would ensure that the electrode exits the side electrode opening, rather than the distal opening, irrespective of the rotational alignment of the electrode shaft within the cannula lumen (Cosman; Col. 26, lines 27-30). Furthermore, the modification would provide for consistent extension of the electrode tip from the cannula side outlet and a fluid injection both distal to and to the side of the cannula active tip since the lobe 520A does not create a fluid-tight seal (Cosman; Col. 26, lines 31-40). Finally, there is no teaching in the Cosman reference that the two embodiments cannot be combined to include features of different embodiments. Rather, Cosman clearly discloses that a number of embodiments of the invention have been described, but various modifications may be made without departing from the spirit and scope of the invention; therefore, other embodiments are within the scope of the disclosed claims (Col. 47, lines 1-5).
With regard to applicant's third argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With regard to Applicant’s fourth argument that absence of motivation shows non-obviousness, Examiner respectfully disagrees. There is a clear motivation, as explained above, to provide each combination/modification in the cited combination of references. Furthermore, Examiner again notes that Cosman clearly discloses that a number of embodiments of the invention have been described, but various modifications may be made without departing from the spirit and scope of the invention; therefore, other embodiments are within the scope of the disclosed claims (Col. 47, lines 1-5).
With regard to Applicant's fifth argument that Examiner must identify and explain each difference, Examiner notes that each difference in limitations between the cited references and the invention as recited in the claims has been articulated in the rejections above. Examiner requests Applicant to specify, if any, which difference has not been articulated in which claim in order to address this issue.
With regard to Applicant’s sixth argument that drawings cannot fill textual silence, Examiner respectfully disagrees. Specifically, Applicant alleges that the Gould reference is silent regarding “unidentified” elements 26a and 26b, Examiner notes that the rejections above do not rely specifically on elements 26a/26b. Rather, the important element to note in Gould is the flap 26, which is bent inwards within a circular cross-section, as shown in Figure 4a of Gould. Since there would be spaces in the sides of the circular cross-section which are not covered by the flap 26 when it is bent into the circular cross-section, there would be a U-shaped hole provided surrounding the flap in this case.
With regard to Applicant's final argument against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, Examiner maintains that the modified device taught by the Cosman/Gould combination provides the invention as recited at least in independent claim 21.
Examiner notes that in a previous interview, Applicant had contemplated other amendments to attempt to differentiate the invention from the cited combination of references. Examiner encourages Applicant to formally submit such amendments for consideration.
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794