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 . 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 Objections
Claims 1, 21, and 22 are objected to because of the following informalities: In claims 1, 21, and 22 (line 2), it appears as though “comprising” should be replaced with -comprises-; In claim 1, line 6, it appears as though “is configured” should be replaced with -being configured-; In claim 21, line 11, it appears as though “communicated” should be replaced with -communicating-; In claim 21, line 11, it appears as though -and- should be inserted after “needle,”; In claim 21, line 14, it appears as though “is located” should be replaced with -being located-; In claim 22, line 11, it appears as though -wherein- should be inserted before “the sleeve”; The semicolon at the end of claim 22 should be replaced with a period. Appropriate correction is required.
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 6-8 and 14-15 are 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 6 recites the limitation "the axis" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "a center axis" in line 3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “axis”.
Claim 14 recites the limitation "the sealing mechanism" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the cooling channel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the interior" in line 2. There is insufficient antecedent basis for this limitation in the claim.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 9, 11, 12, 16, 17, 20, and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, U.S. 2005/0165329 (hereinafter Taylor).
Regarding claim 1, Taylor discloses (note figs. 1-2; abstract) an integrated ablation needle, comprising a sleeve (108) and an electrode needle (112 – note paragraph 44) movably inserted in the sleeve, wherein the electrode needle comprising a needle tip (portions of ‘112’ and ‘114’ defined by ‘102’ – note paragraph 46) at a distal end thereof and a needle bar (remainder of ‘112’) connected with a proximal end of the needle tip, and wherein a sampling slot (130) is opened at least ‘at’ a portion of the needle bar adjacent to the needle tip, and wherein a cutting portion is provided at a distal end of the sleeve (note paragraph 28), the needle tip located outside the sleeve being capable of performing ablation (note paragraphs 44 and 46); and wherein the sleeve is movable axially relative to the needle bar to adjust a length of the distal end of the electrode needle extending out of the sleeve thereby necessarily changing an effective ablation length of the integrated ablation needle (note paragraph 28); wherein the sleeve is movable axially relative to the needle bar to expose or cover the sampling slot (note paragraph 28), and wherein when the sampling slot is exposed, tissue around the needle bar is capable of entering the sampling slot, and when the sampling slot is covered, the cutting portion is configured for cutting the tissue inside the sampling slot off from the tissue outside the sampling slot, thereby obtaining the tissue in the sampling slot as a biopsy sample. It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Taylor discloses (see above) an integrated ablation needle wherein the sleeve is at least partially ‘insulated’ (note paragraph 42).
Regarding claim 9, Taylor discloses (see above) an integrated ablation needle wherein the sleeve is provided with a first ‘positioning portion’ (portion of distal tip of ‘108’), the electrode needle is provided with a second ‘positioning portion’ (portion of proximal face of ‘114’), wherein the first positioning portion and the second positioning portion are ‘engageable’ to each other to achieve ‘axial positioning’ between the electrode needle and the sleeve (see fig. 1).
Regarding claim 11, Taylor discloses (see above) an integrated ablation needle wherein the electrode needle is provided with a ‘cooling channel’ (i.e., a channel capable of cooling – interior of ‘110’) extending axially from a proximal ‘end face’ (see ‘120’) thereof to an ‘interior’ of the needle tip (see ‘134’ at distal-most portion of ‘112’; note paragraph 27).
Regarding claim 12, Taylor discloses (see above) an integrated ablation needle wherein the cooling channel communicates with the sampling slot (note paragraph 27), and an outer diameter of the needle bar is smaller than an inner diameter of the sleeve (see fig. 2).
Regarding claim 16, Taylor discloses (see above) an integrated ablation needle wherein a proximal end of the sleeve and a proximal end of the electrode needle are both (indirectly) connected to a vacuum device (note paragraph 27).
Regarding claim 17, Taylor discloses (see above) an integrated ablation needle further comprising a ‘handle’ (formed by proximal finger loops) connected to a proximal end of the sleeve and a proximal end of the electrode needle, the handle is used to drive the sleeve to move axially relative to the needle bar.
Regarding claim 20, Taylor discloses (see above) a system comprising the integrated ablation needle discussed above and (necessarily) an energy generating device electrically connected to the electrode needle of the integrated ablation needle (note paragraph 44).
Regarding claim 22, Taylor discloses (note figs. 1-2; abstract) an integrated ablation needle, comprising a sleeve (108) and an electrode needle (112 – note paragraphs 44 and 46) movably inserted in the sleeve, wherein the electrode needle comprising a needle tip (114) at a distal end thereof and a needle bar connected with a proximal end of the needle tip, and wherein a sampling slot (130) is opened at least at a portion of the needle bar adjacent to the needle tip, and wherein a cutting portion is provided at a distal end of the sleeve (note paragraph 28); and wherein the sleeve is movable axially relative to the needle bar to expose or cover the sampling slot (note paragraph 28); and wherein when the sampling slot is exposed, tissue around the needle bar is capable of entering the sampling slot, and when the sampling slot is covered, the cutting portion is configured for cutting the tissue inside the sampling slot off from the tissue outside the sampling slot, thereby obtaining the tissue in the sampling slot as a biopsy sample; the sleeve is provided with a first ‘positioning portion’ (portion of distal tip of ‘108’), the electrode needle is provided with a second ‘positioning portion’ (portion of proximal face of ‘114’), wherein the first positioning portion and the second positioning portion are ‘engageable’ to each other to achieve ‘axial positioning’ between the electrode needle and the sleeve (see fig. 1); along a direction parallel to an axis of the sleeve, the second positioning portion is necessarily disposed between the sampling slot and a distal end of the needle tip (see fig. 1).
Regarding claim 23, Taylor discloses (see above) an integrated ablation needle wherein the sleeve has a circular receiving groove in a distal inner wall thereof (formed by inner facing barbs), and a first ‘annular step’ is formed at a junction between a lumen of the sleeve and the receiving groove as the first positioning portion (see portion of ‘108’ between distal tip and barbs); a diameter of the proximal end of the needle tip is larger than a diameter of the needle bar (see fig. 2), and a second ‘annular step’ is formed at a junction between the proximal end of the needle tip and the needle bar as the second positioning portion (see junction between ‘114’ and ‘112’); and when the first annular step ‘abuts’ the second annular step, the electrode needle and the sleeve are axially positioned, and a ‘proximal portion’ of the needle tip (distal-most portion of ‘112’ in contact with ‘114’) is received in (i.e., enclosed by) the receiving groove.
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.
Claim(s) 1, 2, 9, 10, 14, 16, 17, and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank, U.S. 6,497,706 (hereinafter Burbank) in view of Taylor.
Regarding claim 1, Burbank discloses (note figs. 1, 2, 4, and 5) an integrated ablation device, comprising a sleeve (14) and an inner electrode component (11) movably inserted in the sleeve, wherein the inner electrode component comprising a cutting tip (‘21’ – note col. 4, line 24) at a distal end thereof and a bar connected with a proximal end of the cutting tip, and wherein a sampling slot (on either side of ‘11’) is opened at least at a portion of the bar adjacent to the cutting tip, and wherein a ‘cutting portion’ is provided at a distal end of the sleeve (note col. 4, line 24), the cutting tip located outside the sleeve being capable of performing ablation (note col. 4, line 24); and wherein the sleeve is movable axially relative to the bar to necessarily adjust a length of the distal end of the inner electrode component extending out of the sleeve (note col. 4, line 49); wherein the sleeve is movable axially relative to the bar to expose or cover the sampling slot (note col. 4, line 49); and wherein when the sampling slot is exposed, tissue around the bar is capable of entering the sampling slot, and when the sampling slot is covered, the cutting portion is configured for cutting the tissue inside the sampling slot off from the tissue outside the sampling slot, thereby obtaining the tissue in the sampling slot as a biopsy sample. While Burbank discloses a device having an inner electrode component comprising a cutting tip (21) for piercing tissue (using ‘13’), it fails to explicitly disclose that the inner electrode component comprises an electrode needle and the cutting tip comprises a needle tip. Taylor teaches (note fig. 1) a similar device comprising an electrode needle (112 – note paragraphs 44 and 46) having a needle tip (‘114’ and the distal-most portion of ‘112’ extending proximally therefrom) for piercing tissue. It is well known in the art that these different tissue-piercing configurations (i.e., sharp vs. energized) are widely considered to be interchangeable, and that a configuration that is both sharp and energized (see Taylor) would be more efficient. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the device of Burbank to comprise an electrode needle with a needle tip (as taught by Taylor). This is because this modification would have merely comprised a simple substitution of interchangeable tissue-piercing configurations in order to predictably increase efficiency (see MPEP 2143). It should be noted that this modified device (which now comprises the needle tip of Taylor, including the energizable distal-most portion of ‘112’) would teach a sleeve that is movable axially relative to the bar, to adjust a length of the distal end of the electrode needle extending out of the sleeve, thereby necessarily changing an effective ablation length of the integrated ablation device/needle. It should also be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Burbank discloses (see above) an integrated ablation device wherein the sleeve is at least partially ‘insulated’ (note col. 5, line 37).
Regarding claim 9, Burbank in view of Taylor teaches (see above) an integrated ablation device wherein the sleeve is provided with a first ‘positioning portion’ (portion of distal tip of ‘14’), the electrode needle is provided with a second ‘positioning portion’ (portion of proximal face of ‘21’), wherein the first positioning portion and the second positioning portion are ‘engageable’ to each other to achieve ‘axial positioning’ between the electrode needle and the sleeve.
Regarding claim 10, Burbank in view of Taylor teaches (see above) an integrated ablation device wherein the sleeve has a circular receiving groove in a distal inner wall thereof (formed by ‘12’), and a first ‘annular step’ is formed at a junction between a lumen of the sleeve and the receiving groove as the first positioning portion; a diameter of the proximal end of the needle tip (see proximal-most portion of ‘21’) is larger than a diameter of the needle bar (see figs. 4 and 11), and a second ‘annular step’ is formed at a junction between the proximal end of the needle tip and the needle bar as the second positioning portion (see junction between ‘11’ and proximal-most portion of ‘21’ in fig. 11; near reference number ‘18’); and when the first annular step ‘abuts’ the second annular step, the electrode needle and the sleeve are axially positioned, and a ‘proximal portion’ of the needle tip (proximal-most portion of ‘21’) is received in (i.e., enclosed by) the receiving groove.
Regarding claim 14, Burbank in view of Taylor teaches (see above) an integrated ablation device wherein the needle bar is provided with at least one circular ‘sealing groove’ (see junction between ‘11’ and proximal-most portion of ‘21’ in fig. 11; near reference number ‘18’) adjacent to the needle tip, the sealing groove is located between the sampling slot and the needle tip, and a ‘sealing ring’ (12) is received in the sealing groove, wherein the sealing groove and the sealing ring forms a ‘sealing mechanism’.
Regarding claim 16, Burbank in view of Taylor teaches (see above) an integrated ablation device wherein a proximal end of the sleeve and a proximal end of the electrode needle are both (indirectly) connected to a vacuum device (note col. 6, line 20).
Regarding claim 17, Burbank discloses (see above) an integrated ablation device further comprising a handle (note fig. 1) connected to a proximal end of the sleeve and a proximal end of the electrode needle, the handle is used to drive the sleeve to move axially relative to the needle bar.
Regarding claim 20, Burbank in view of Taylor teaches (see above) a system comprising the integrated ablation device discussed above and (necessarily) an energy generating device electrically connected to the electrode needle of the integrated ablation needle.
Regarding claim 21, Burbank discloses (note figs. 1, 2, 4, and 5) an integrated ablation device, comprising a sleeve (14) and an inner electrode component (11) movably inserted in the sleeve, wherein the inner electrode component comprising a cutting tip (‘21’ – note col. 4, line 24) at a distal end thereof and a bar connected with a proximal end of the cutting tip, and wherein a sampling slot (on either side of ‘11’) is opened at least at a portion of the bar adjacent to the cutting tip, and wherein a ‘cutting portion’ is provided at a distal end of the sleeve (note col. 4, line 24); and wherein the sleeve is movable axially relative to the bar to expose or cover the sampling slot (note col. 4, line 49); and wherein when the sampling slot is exposed, tissue around the bar is capable of entering the sampling slot, and when the sampling slot is covered, the cutting portion is configured for cutting the tissue inside the sampling slot off from the tissue outside the sampling slot, thereby obtaining the tissue in the sampling slot as a biopsy sample; wherein a ‘cooling channel’ (i.e., a channel capable of cooling – interior of ‘11’) communicating with the sampling slot (note col. 6, line 20) is defined in the inner electrode component, and a ‘sealing mechanism’ (composed of ‘12’ and junction between ‘11’ and proximal-most portion of ‘21’ in fig. 11 [near reference number ‘18’]) is provided on the sleeve and/or the bar to ‘seal’ (indirectly) a radial gap between the sleeve and the bar (e.g., when ‘12’ is near the junction between ‘11’ and the proximal-most portion of ‘21’ in fig. 11; i.e., near reference number ‘18’), and along a direction parallel to an axis of the sleeve, the sealing mechanism is located between the sampling slot and the cutting tip when the sampling slot is covered by the sleeve. While Burbank discloses a device having an inner electrode component comprising a cutting tip (21) for piercing tissue (using ‘13’), it fails to explicitly disclose that the inner electrode component comprises an electrode needle and the cutting tip comprises a needle tip. Taylor teaches (note fig. 1) a similar device comprising an electrode needle (112 – note paragraphs 44 and 46) having a needle tip (‘114’ and the distal-most portion of ‘112’ extending proximally therefrom) for piercing tissue. It is well known in the art that these different tissue-piercing configurations (i.e., sharp vs. energized) are widely considered to be interchangeable, and that a configuration that is both sharp and energized (see Taylor) would be more efficient. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the device of Burbank to comprise an electrode needle with a needle tip (as taught by Taylor). This is because this modification would have merely comprised a simple substitution of interchangeable tissue-piercing configurations in order to predictably increase efficiency (see MPEP 2143). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 22, Burbank discloses (note figs. 1, 2, 4, and 5) an integrated ablation device, comprising a sleeve (14) and an inner electrode component (11) movably inserted in the sleeve, wherein the inner electrode component comprising a cutting tip (‘21’ – note col. 4, line 24) at a distal end thereof and a bar connected with a proximal end of the cutting tip, and wherein a sampling slot (on either side of ‘11’) is opened at least at a portion of the bar adjacent to the cutting tip, and wherein a ‘cutting portion’ is provided at a distal end of the sleeve (note col. 4, line 24); and wherein the sleeve is movable axially relative to the bar to expose or cover the sampling slot (note col. 4, line 49); and wherein when the sampling slot is exposed, tissue around the bar is capable of entering the sampling slot, and when the sampling slot is covered, the cutting portion is configured for cutting the tissue inside the sampling slot off from the tissue outside the sampling slot, thereby obtaining the tissue in the sampling slot as a biopsy sample; wherein the sleeve is provided with a first ‘positioning portion’ (portion of distal tip of ‘14’), the inner electrode component is provided with a second ‘positioning portion’ (see junction between ‘11’ and proximal-most portion of ‘21’ in fig. 11; near reference number ‘18’), wherein the first positioning portion and the second positioning portion are ‘engageable’ to each other to achieve ‘axial positioning’ between the inner electrode component and the sleeve; along a direction parallel to an axis of the sleeve, the second positioning portion is disposed between the sampling slot and a distal end of the cutting tip. While Burbank discloses a device having an inner electrode component comprising a cutting tip (21) for piercing tissue (using ‘13’), it fails to explicitly disclose that the inner electrode component comprises an electrode needle and the cutting tip comprises a needle tip. Taylor teaches (note fig. 1) a similar device comprising an electrode needle (112 – note paragraphs 44 and 46) having a needle tip (‘114’ and the distal-most portion of ‘112’ extending proximally therefrom) for piercing tissue. It is well known in the art that these different tissue-piercing configurations (i.e., sharp vs. energized) are widely considered to be interchangeable, and that a configuration that is both sharp and energized (see Taylor) would be more efficient. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the device of Burbank to comprise an electrode needle with a needle tip (as taught by Taylor). This is because this modification would have merely comprised a simple substitution of interchangeable tissue-piercing configurations in order to predictably increase efficiency (see MPEP 2143). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 23, Burbank in view of Taylor teaches (see above) an integrated ablation device wherein the sleeve has a circular receiving groove in a distal inner wall thereof (formed by ‘12’), and a first ‘annular step’ is formed at a junction between a lumen of the sleeve and the receiving groove as the first positioning portion; a diameter of the proximal end of the needle tip (see proximal-most portion of ‘21’) is larger than a diameter of the needle bar (see figs. 4 and 11), and a second ‘annular step’ is formed at a junction between the proximal end of the needle tip and the needle bar as the second positioning portion (see junction between ‘11’ and proximal-most portion of ‘21’ in fig. 11; near reference number ‘18’); and when the first annular step ‘abuts’ the second annular step, the electrode needle and the sleeve are axially positioned, and a ‘proximal portion’ of the needle tip (proximal-most portion of ‘21’) is received in (i.e., enclosed by) the receiving groove.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor.
Regarding claims 6-7, Taylor discloses (see above) an integrated ablation needle wherein the cutting portion comprises a cutting surface (122) inclined with respect to the axis of the sleeve, the cutting surface gradually approaches a center axis of the sleeve from a proximal end to a distal end thereof, a first angle is formed between a tangent line of the cutting surface and the axis of the sleeve, wherein a plane where the distal end of the cutting surface is located is perpendicular to the axis of the sleeve (see fig. 2). While Taylor fails to explicitly disclose the specifically-claimed first angle range, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Taylor accordingly since 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. Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor as applied to claims 6-7 above, and further in view of Halter, U.S. 2016/0081585 (hereinafter Halter).
Regarding claim 8, Taylor discloses (see above) an integrated ablation needle wherein a plane where the distal end of the cutting surface is located is angled relative to the axis of the sleeve (see fig. 2). However, Taylor discloses that this plane and axis are perpendicular relative to each other, not that they are angled in the specifically-claimed manner. Halter teaches (note fig. 2) a similar device comprising a sleeve (108) having a distal face that is acutely angled relative to a central axis. It is well known in the art that these different sleeve configurations are widely considered to be interchangeable (as can be seen in the different embodiments of Halter – see figs. 1-2). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Taylor to comprise a sleeve having a distal face that is acutely angled relative to the axis of the sleeve. This is because this modification would have merely comprised a simple substitution of interchangeable sleeve configurations in order to produce a predictable result (see MPEP 2143). While this modified device still fails to explicitly disclose the specifically-claimed angle range between the cutting surface and the axis, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have further modified Taylor accordingly since 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. Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank in view of Taylor as applied to claims 1, 2, 9, 10, 14, 16, 17, and 20-23 above, and further in view of DeLonzor, U.S. 2007/0055173 (hereinafter DeLonzor).
Regarding claim 15, Burbank in view of Taylor teaches (see above) an integrated ablation device comprising a channel for facilitating tissue sampling. However, Burbank fails to explicitly disclose a channel provided with a temperature measuring element extending into the interior of the needle tip. DeLonzor teaches (note fig. 8) a similar device comprising a channel for facilitating tissue sampling (using cooling instead of suction), wherein the channel is provided with a temperature measuring element (necessarily) extending into the interior of the needle tip (note paragraphs 38 and 52). It is well known in the art that these different tissue-anchoring configurations (i.e., cooling vs. suction) are widely considered to be interchangeable, and that the inclusion of a temperature measuring element would result in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Burbank to comprise a channel provided with a temperature measuring element extending into the interior of the needle tip. This is because this modification would have merely comprised a simple substitution of interchangeable tissue-anchoring configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Ko, U.S. 2019/0321012 (hereinafter Ko).
Regarding claims 18-19, Taylor discloses (see above) an integrated ablation needle wherein the proximal end of the needle tip is provided with an ‘avoidance groove’ around a circumference thereof (see junction between ‘112’ and ‘114’), and when the sleeve is axially ‘positioned relative’ to the electrode needle, the cutting portion of the sleeve is ‘received’ in the avoidance groove (note fig. 1), and an outer diameter of the sleeve is equal to or smaller than a diameter of the proximal end of the needle tip (note fig. 1). However, Taylor fails to explicitly disclose an outer tube surrounding the sleeve, wherein the electrode needle and the sleeve are axially movable relative to the outer tube. Ko teaches (note fig. 7) a similar device comprising an outer tube (1310) surrounding a sleeve (1220), wherein an inner needle (1210) and the sleeve are axially movable relative to the outer tube (note paragraphs 107 and 110). It is well known in the art that these different introducer configurations (having a different number of sleeves) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the device of Taylor to comprise an outer tube surrounding the sleeve, wherein the electrode needle and the sleeve are axially movable relative to the outer tube. This is because this modification would have merely comprised a simple substitution of interchangeable introducer configurations in order to produce a similar result (see MPEP 2143).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank in view of Taylor as applied to claims 1, 2, 9, 10, 14, 16, 17, and 20-23 above, and further in view of Ko.
Regarding claims 18-19, Burbank in view of Taylor teaches (see above) an integrated ablation needle wherein the proximal end of the needle tip is provided with an ‘avoidance groove’ around a circumference thereof (see junction between ‘11’ and ‘21’), and when the sleeve is axially ‘positioned relative’ to the electrode needle, the cutting portion of the sleeve is ‘received’ in the avoidance groove (note figs. 5 and 12), and an outer diameter of the sleeve is equal to or smaller than a diameter of the proximal end of the needle tip (note fig. 12). However, Burbank fails to explicitly disclose an outer tube surrounding the sleeve, wherein the electrode needle and the sleeve are axially movable relative to the outer tube. Ko teaches (note fig. 7) a similar device comprising an outer tube (1310) surrounding a sleeve (1220), wherein an inner needle (1210) and the sleeve are axially movable relative to the outer tube (note paragraphs 107 and 110). It is well known in the art that these different introducer configurations (having a different number of sleeves) are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the device of Burbank to comprise an outer tube surrounding the sleeve, wherein the electrode needle and the sleeve are axially movable relative to the outer tube. This is because this modification would have merely comprised a simple substitution of interchangeable introducer configurations in order to produce a similar result (see MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Regarding Applicant’s arguments concerning Taylor, Examiner respectfully disagrees. More specifically, Examiner maintains that Taylor would be capable of performing a biopsy and ablation (in the claimed manner), since Taylor discloses that the portion of ‘112’ delineated by ‘102’ (see fig. 1) could be provided with an electrical current (note paragraphs 44 and 46). As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Applicant’s arguments concerning Burbank, Examiner respectfully disagrees. More specifically, Examiner maintains that newly-rejected Burbank in view of Taylor would be capable of performing a biopsy and ablation (in the claimed manner), since this modified device would contain all of the required structural limitations (as can be seen above). Once again, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Applicant’s argument that claim 11 is not met by Taylor, Examiner respectfully disagrees. More specifically, Examiner maintains that this claim has been met as it is currently written, due to the breadth of limitations such as “proximal end face” and “needle tip” (see above rejection for updated interpretation). Once again, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Applicant’s arguments that claims 21 and 22 are no longer met, Examiner respectfully disagrees. More specifically, Examiner maintains that this claims have been met as they are currently written, due to the breadth of limitations such as “seal,” “sealing mechanism,” and “positioning portion” (see above rejections for specific interpretations). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ‘the seal prevents leakage’ and ‘the sleeve extends beyond the sampling slot’) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, Examiner asserts that all of the claims are (still) met by the cited references, as can be seen above.
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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794