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
Claim 26 is objected to because of the following informalities: In claim 26, line 1, the ‘underscore’ should be removed from between “lumen” and “wherein”. 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 17 and 25 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 17 recites the limitation "the lumen" in line 6. The antecedent basis for this limitation is confusing, since it’s unclear which “lumen” is being referred to. Appropriate correction is required.
Claim 25 recites the limitation "a second lumen in fluid communication with an interior of the one or more heated compartments" in lines 1-2. The antecedent basis for this limitation is confusing, since a ‘first lumen in fluid communication with an interior of the one or more heated compartments’ is no longer recited. Appropriate correction is required.
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, 7, 9-10, 12, 14, 16-17, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini, U.S. 2012/0283716 (hereinafter Bencini) in view of Buckley, U.S. 2012/0136418 (hereinafter Buckley), Ingle, U.S. 2011/0190751 (hereinafter Ingle), and Fischell, U.S. 2006/0224153 (hereinafter Fischell).
Regarding claim 1 and 25, Bencini discloses (as best understood by Examiner) a system for ablation of a target tissue (Fig. 4b; abstract) comprising: a balloon (20) having an outer surface (outer surface of ‘20’) configured to be placed against the target tissue (abstract; paragraph 46) and a directly opposing inner surface surrounding an interior of the balloon (Fig. 4b displays inner surface of ‘20’), the balloon having a proximal end opposite a distal end; a divider (50) within the interior of the balloon (Fig. 4b) configured to separate the interior of the balloon into (i) one or more treatment compartments (26) designed to accommodate a fluid such that fluid accommodated therein directly contacts the inner surface of the balloon and the divider (Fig. 4b displays the fluid accommodated within ‘26’ as directly contacting the inner surface of balloon ‘20’ and the divider ‘50’; paragraph 43); and (ii) one or more insulating compartments (28) designed to accommodate an insulating fluid (paragraphs 29-31), wherein an insulating compartment (28) of the one or more insulating compartments defines a distalmost end of the balloon (see Fig. 4b) and is arranged at the proximal end of the balloon (see Fig. 4b), and wherein the one or more treatment compartments extends radially outward between the edges of the one or more insulating compartments (Fig. 4b), such that the one or more treatment compartments and the one or more insulating compartments are aligned along a longitudinal axis; and a lumen in fluid communication with an interior of the one or more insulating compartments for inflating the one or more insulating compartments with the insulating fluid (paragraph 24; i.e. volume displacement fluid lumen), the one or more insulating compartments necessarily defined by a volumetric heat capacity and thermal conductivity lower than that of surrounding tissues and the fluid, wherein the fluid and the insulating fluid are configured such that energy transfer is permitted through the one or more treatment compartments (paragraph 48) and inhibited through the one or more insulating compartments (paragraphs 29-31). While Bencini discloses a system comprising one treatment compartment and one insulating compartment (along with a variety of other configurations – figs. 2-6; paragraph 47), wherein each of these compartments is in fluid communication with a lumen (note paragraph 28), Bencini fails to explicitly disclose a system comprising a balloon with at least two insulating compartments, wherein the one or more treatment compartments extends radially outward between the at least two insulating compartments such that the compartments are aligned along a longitudinal axis, and further comprising a plurality of lumens wherein the plurality of lumens are collectively in bidirectional fluid communication with interiors of the insulating compartments. Buckley teaches a similar system comprising a variety of configurations, including a system (note figs. 39A-C, paragraph 237) comprising two ‘first-temperature’ compartments (‘3914a’ and ‘3914d’) and two ‘second-temperature’ compartments (3914b-c), wherein the two ‘second-temperature’ compartments (3914b-c) extend radially outward between the two ‘first-temperature’ compartments such that the compartments are aligned along a longitudinal axis, and wherein each of these compartments has a lumen (3908a-d), these lumens being collectively in fluid communication with interiors of the compartments. It is well known in the art that these different ‘expandable energy delivery’ configurations are widely considered to be interchangeable (as can be seen by the wide range of embodiments depicted in Bencini and Buckley). 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 apparatus of Bencini (in view of Buckley) to comprise a balloon with two treatment compartments and two insulating compartments, wherein each of these compartments has a lumen (these lumens being collectively in fluid communication with interiors of the compartments), and wherein the two treatment compartments extend radially outward between the two insulating compartments such that the compartments are aligned along a longitudinal axis. This is because this modification would have merely comprised a simple substitution of interchangeable ‘expandable energy delivery’ configurations in order to produce a predictable result (see MPEP 2143). While this combination of references fails to expressly teach that the lumens in fluid communication with the insulating compartments are bidirectional, Ingle teaches (note figs. 1-3) a similar system comprising a bidirectional lumen (‘122’ – note paragraphs 31 and 37) in fluid communication with an insulating compartment (118). It is well known in the art (as can be seen by the different configurations in Ingle) that these different ‘fluid delivery’ configurations (i.e., one bidirectional lumen vs separate inflow and outflow lumens) 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 apparatus of Bencini to comprise bidirectional lumens in fluid communication with the insulating compartments. This is because this modification would have merely comprised a simple substitution of interchangeable ‘fluid delivery’ configurations in order to produce a similar result (see MPEP 2143). Although Bencini in view of Buckley teaches a balloon comprising treatment compartments (see above), this combination of references fails to expressly teach that these compartments comprise heated compartments containing a heated fluid. However, Fischell teaches a balloon ablation system (abstract) that ablates the target tissue utilizing known methods such as cryogenic cooling or heating with a high temperature fluid (paragraph 20). Thus cryotherapy and heating with a high temperature fluid were art-recognized equivalents for ablating tissue at the time the invention was made. 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 Bencini (in view of Fischell) to comprise heated compartments. This is because this modification would have merely comprised a simple substitution of interchangeable ablation configurations in order to produce a predictable result (see MPEP 2143). It should be noted that this modified device would necessarily teach (as best understood by Examiner; note especially figs. 39A-C in Buckley) a first lumen and a second lumen of the plurality of lumens (in fluid communication with the insulating compartments) that are ‘spatially positioned’ relative to one another (e.g., separate from each other while in close proximity to a central axis of the device) so as to ‘manage’ (i.e., inhibit) thermal transfer (i) between the first lumen of the plurality of lumens and the second lumen of the plurality of lumens and (ii) between the plurality of lumens and the target tissue.
Regarding claim 7, Bencini in view of Buckley, Ingle, and Fischell teaches (see above) a system wherein the divider necessarily includes a plurality of ‘septae’ (after the above modifications).
Regarding claim 9, Bencini in view of Buckley, Ingle, and Fischell teaches (see above) a system wherein the balloon comprises one heated compartment (it should be noted that this is not a negative limitation, so it is not limited to one, and therefore it is necessarily met) and the at least two insulating compartments, and wherein the at least two insulating compartments are designed such that the insulating fluid accommodated therein directly contacts the inner surface of the balloon (see above).
Regarding claim 10, Bencini in view of Buckley, Ingle, and Fischell teaches (see above) a system wherein the one heated compartment necessarily extends ‘about’ (i.e., partially around) a circumference of the balloon, and wherein the at least two insulating compartments are designed such that the insulating fluid accommodated therein directly contacts the inner surface of the balloon (see above).
Regarding claim 12, Bencini in view of Buckley, Ingle, and Fischell teaches (see above) a system wherein the balloon comprises one heated compartment (it should be noted that this is not a negative limitation, so it is not limited to one, and therefore it is necessarily met) situated between the at least two insulating compartments (see above).
Regarding claim 14, Bencini in view of Buckley, Ingle, and Fischell teaches (see above) a system wherein the one or more heated compartments necessarily includes a plurality of heated compartments distributed among the at least two insulating compartments (after the above modifications).
Regarding claims 16 and 17, Bencini in view of Buckley, Ingle, and Fischell teaches (see above, as best understood by Examiner) a balloon having treatment compartments and insulating compartments, wherein each of these compartments is in fluid communication with a lumen (note figs. 39A-C in Buckley). While this combination of references fails to expressly teach a lumen in fluid communication with both insulating compartments (as well as a different lumen in fluid communication with both treatment compartments), a different embodiment of Buckley teaches (note fig. 22A) a similar system comprising a lumen in fluid communication with both insulating compartments. It is well known in the art that these different ‘fluid delivery’ configurations (i.e., one split lumen vs two separate lumens) are widely considered to be interchangeable (also see fig. 21A of Buckley). 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 apparatus of Bencini to comprise a first lumen in fluid communication with both insulating compartments, as well as a second lumen in fluid communication with both treatment compartments. This is because this modification would have merely comprised a simple substitution of interchangeable ‘fluid delivery’ configurations in order to produce a similar result (see MPEP 2143). It should be noted that this modified device would necessarily teach heated compartments that are in fluid communication with one another, as well as insulating compartments that are in fluid communication with one another (via the inlets).
Regarding claim 26, Bencini discloses (see above) a system wherein the lumens (including the inflow lumen) are arranged within a catheter (‘22’ – note paragraph 24). However, Bencini fails to explicitly disclose that the catheter extends distally relative to the distalmost end of the balloon. Buckley teaches (note figs. 38A-B) a similar system comprising a catheter (composed of shaft ‘3806’ and guide member ‘3808’) and a balloon (3814), wherein the catheter (see ‘3808’) extends distally relative to the distalmost end of the balloon. It is well known in the art that the inclusion of a guide member facilitates catheter placement, thereby resulting in increased safety. 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 catheter of Bencini to comprise a guide member as taught by Buckley (which extends distally relative to the distalmost end of the balloon) in order to increase safety.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bencini in view of Buckley, Ingle, and Fischell as applied to claims 1, 7, 9-10, 12, 14, 16-17, 25, and 26 above, and further in view of Dunham, U.S. 5,797,948 (hereinafter Dunham).
Regarding claim 11, Bencini in view of Buckley, Ingle, and Fischell fails to expressly teach (see above) a system wherein the heated compartment follows a spiral shaped pathway about the circumference of the balloon and a portion of the inner surface of the balloon not forming the heated compartment forms or contacts the at least two insulating compartments. However, Dunham discloses a balloon catheter (Figs. 1-2; ‘2’) comprising an outer balloon (20) and an inner balloon (30), wherein the inner balloon follows a spiral shaped pathway about the circumference of the balloon (Fig. 1-2; Col. 4, Lines 2-3, and lines 23-24; which display the inner balloon forming a spiral shaped portion of the surface of the balloon) and a portion of the inner surface of the balloon not forming the heated compartment forms or contacts the one insulating compartment (See Fig. 2). It is well known in the art that these different ‘expandable energy delivery’ configurations 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 balloon of Bencini so that the heated compartment follows a spiral shaped pathway about the circumference of the balloon and that portion of the inner surface of the balloon not forming the heated compartment forms or contacts the insulating compartments (as taught by Dunham). This is because this modification would have merely comprised a simple substitution of interchangeable ‘expandable energy delivery’ configurations in order to produce a predictable result (see MPEP 2143).
Claims 18 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ingle in view of Buckley and Fischell.
Regarding claim 18, Ingle discloses (note figs. 1-3; abstract; paragraph 29) a system for ablation of a target tissue comprising: an outer balloon (106); an elongate structure (110/111) extending through the outer balloon (Fig. 1) defining at least two lumens (120, 122, 126; paragraph 31) extending through proximately a distal end of the outer balloon (Fig. 1) and through which a fluid is directed towards and away from the outer balloon, in opposite directions (paragraph 31); and an inner balloon (104) attached to the elongate structure and disposed within the outer balloon (Figs. 1-3), wherein the inner balloon is bonded or fused to the outer balloon (note paragraph 44) at one or more discrete area(s) of contact (‘202’ – note paragraphs 30 and 44), and wherein, when the inner balloon is inflated with the fluid from one of the at least two lumens (paragraph 31), the inner balloon expands outwards from the elongate structure (Fig. 1-3) and wherein heat transfer from within the inner balloon to the target tissue occurs at the area(s) of contact between the inner balloon and the inner wall of the outer balloon (paragraphs 30 and 40). While Ingle discloses a system comprising inner and outer balloons that are bonded/fused together (note paragraph 44) at area(s) of contact (and can have a variety of shapes – paragraph 56), Ingle fails to explicitly disclose an inner balloon that expands in fewer than all radial directions such that the area(s) of contact are located within an area comprising less than an entire circumference of the inner wall of the outer balloon. Buckley teaches (note figs. 21A-B) a similar system comprising an outer balloon (2110) and an inner component (2118) having a temperature differential therebetween, wherein the inner component is radially offset from a longitudinal axis of the outer balloon such that area(s) of contact (therebetween) are located within an area comprising less than an entire circumference of the inner wall of the outer balloon. It is well known in the art that these different ‘expandable energy delivery’ configurations (i.e., a configuration for targeting tissue via a full balloon circumference vs a configuration for targeting tissue via a partial balloon circumference) 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 apparatus of Ingle to comprise an inner balloon that expands in fewer than all radial directions such that the area(s) of contact are located within an area comprising less than an entire circumference of the inner wall of the outer balloon. This is because this modification would have merely comprised a simple substitution of interchangeable ‘expandable energy delivery’ configurations in order to produce a predictable result (see MPEP 2143). Although Ingle discloses a treatment balloon (see above), Ingle fails to explicitly disclose that it (i.e., the inner balloon) is inflated with a heated fluid. However, Fischell teaches a balloon ablation system (abstract) that ablates the target tissue utilizing known methods such as cryogenic cooling or heating with a high temperature fluid (paragraph 20). Thus cryotherapy and heating with a high temperature fluid were art-recognized equivalents for ablating tissue at the time the invention was made. 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 Ingle to incorporate the heated fluid from Fischell (as opposed to Ingle’s cryotherapy fluid). This is because this modification would have merely comprised a simple substitution of interchangeable ablation configurations in order to produce a predictable result (see MPEP 2143).
Regarding claim 21, Ingle in view of Buckley and Fischell (see above) a system further comprising a lumen in fluid communication with an interior of the outer balloon for inflating the outer balloon with an insulating fluid (paragraph 30 discusses the lumen in fluid communication with the outer balloon for delivering insulation to space ‘118’), such that one or more areas spanning between the area(s) of contact are insulated from the heated fluid within the inner balloon (paragraphs 30 and 44).
Regarding claims 22 and 23, Ingle in view of Buckley and Fischell (see above) a system wherein the one or more areas of contact between the inner balloon and the outer balloon necessarily form a ‘strip’ extending straight along a length of the outer balloon (after the above modifications)
Regarding claim 24, Ingle in view of Buckley and Fischell fails to expressly teach (see above) a system wherein the strip formed by area(s) of contact between the balloons (and which constitutes the treatment area) extends helically along the length of the outer balloon. However, a different embodiment of Buckley teaches (note figs. 16A-B) a similar system comprising an outer balloon (1606) having a helical treatment area (1608). It is well known in the art (as seen by the number of embodiments depicted in Buckley) that any of a wide variety of ‘expandable energy delivery’ configurations could be used interchangeably, and therefore that these specific configurations (i.e., a configuration for targeting tissue via a spiral region on a balloon vs a configuration for targeting tissue via a partial balloon circumference) are also 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 apparatus of Ingle to comprise a strip (which is formed by area(s) of contact between the balloons and which constitutes the treatment area) that extends helically along the length of the outer balloon. This is because this modification would have merely comprised a simple substitution of interchangeable ‘expandable energy delivery’ configurations in order to produce a predictable result (see MPEP 2143).
Response to Arguments
Applicant's arguments filed November 4, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments concerning the ‘lumens that are spatially positioned relative to one another to manage thermal transfer’ (see claim 1), Examiner respectfully disagrees. More specifically, Examiner maintains that Bencini was modified in view of the expandable energy delivery configuration of Buckley (i.e., the cited balloon/lumen configuration), and that this modification merely comprised a simple substitution of interchangeable configurations in order to produce a predictable result. As noted above, Examiner maintains that this interchangeability is shown by the wide range of embodiments depicted in Bencini and Buckley. Furthermore, Examiner asserts that this is not merely a conclusory statement, but an accepted rationale for supporting a conclusion of obviousness (see MPEP 2143).
In response to applicant's 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).
Examiner asserts that the lumens of Bencini were not modified to match the claimed lumens, but rather Bencini was modified in view of the balloon/lumen configuration of Buckley for the cited reasons. Examiner maintains (as stated above) that this modified device, having the lumen configuration seen in Buckley (figs. 39A-C), would necessarily meet the ‘spatially-positioned lumens for managing thermal transfer’ limitation. However, it should also be noted that any lumen configuration would necessarily meet this limitation as it is currently written, due to the breadth of the phrase “manage thermal transfer” (i.e., impact/control/affect thermal transfer).
Regarding Applicant’s arguments that Ingle does not disclose the limitations in claim 18, Examiner respectfully disagrees. More specifically, Examiner maintains that Ingle was modified in view of the expandable energy delivery configuration of Buckley (i.e., the cited inner/outer balloon configuration for targeting a partial circumference), and that this modification merely comprised a simple substitution of interchangeable configurations in order to produce a predictable result. Examiner asserts that this interchangeability (between a configuration for targeting tissue via a full balloon circumference vs a configuration for targeting tissue via a partial balloon circumference) is shown by the wide range of embodiments depicted in Buckley. Furthermore, Examiner asserts that this is not merely a conclusory statement, but an accepted rationale for supporting a conclusion of obviousness (see MPEP 2143).
In response to applicant's 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).
In response to applicant's arguments 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). More specifically, Examiner asserts that Ingle meets most of the claim limitations, but fails to teach a configuration for targeting tissue via a partial balloon circumference. As noted above, Buckley was merely relied upon for its teaching of a similar inner/outer balloon configuration for targeting a partial circumference, in conjunction with its teaching of the interchangeability between a configuration for targeting tissue via a full balloon circumference vs a configuration for targeting tissue via a partial balloon circumference. Therefore, Examiner asserts that the claims are still met by the cited references as they are currently written.
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