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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 13, 2026 has been entered.
Claim Objections
Claims 13, 15, 22, 25-27, and 38 are objected to because of the following informalities: In claim 13, line 9, -vein- should be inserted after “intercostal”; In claim 15, line 1, -active- should be inserted before “ablation”; In claim 22, line 11, “at” should be replaced with -a-; In claim 25, line 3, “is” should be deleted; In claim 26, line 3, -at least one- should be inserted before “delivery state”; In claim 27, line 2, “a length” should be replaced with -an active ablation length-; In claim 38, line 18, -energy- should be inserted before “delivery”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-33, 35, and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites a “source of irrigation fluid” in line 12. However, there does not appear to be sufficient support for this specific claim limitation in Applicant’s disclosure. Appropriate correction is required.
Claim 23 recites the limitation “the membrane is at least one of: a microporous membrane, an electrically conductive membrane, a capacitive coupling membrane, or a weeping membrane”. However, there does not appear to be sufficient support for this open-ended claim limitation in Applicant’s disclosure (i.e., the disclosure never mentions whether the membrane may be more than one of these things simultaneously). Appropriate correction is required.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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 13 and 15-40 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.
Claims 13, 22, and 38 recite the limitation "the proximal and distal regions" in line 5 (also see lines 7-8). There is insufficient antecedent basis for this limitation in the claim.
Claims 13 (line 18) and 38 (line 12) recite the limitation "an intercostal vein". The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 22 is found to be indefinite because Examiner is unsure of what is meant by the limitation “a fluid delivery port on the flexible distal section and connectable to a source of irrigation fluid… the at least one ablation element configured to receive conductive fluid through said fluid supply lumen”. More specifically, it is unclear how/whether the fluid delivery port is connected to the fluid supply lumen, and how/whether the irrigation fluid is related to the conductive fluid. This renders the scope of the claim unclear.
Claim 27 recites the limitation "an outer diameter" in line 3. The antecedent basis for this limitation is confusing, since it has already been recited.
It should be noted that all other cited claims have been rejected for 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.
Claim(s) 13, 15-17, 20-31, and 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn, U.S. 2014/0058376 (hereinafter Horn) in view of Salahieh, U.S. 2015/0105659 (hereinafter Salahieh), Feiring, U.S. 5,236,413 (hereinafter Feiring) and Levin, U.S. 2014/0371736 (hereinafter Levin).
Regarding claims 13, 15, and 17, Horn discloses (note figs. 1-4) a device for ablation comprising: a flexible shaft (‘12’ - necessarily flexible, see ‘guidewire’ in paragraph 33) having a flexible distal section (includes the portion of ‘12/42’ disposed within ‘30’, and a distal portion of ‘12/42’ extending proximally from ‘30’), a proximal section (i.e., the proximal-most section of ‘12’), and a fluid lumen (50) extending through the flexible shaft, wherein the flexible shaft connects the proximal and distal sections; at least one ablation element disposed at the flexible distal section, and a fluid delivery port (32) on the flexible distal section and configured to discharge a conductive fluid from a source of the conductive fluid (24) external to the patient; wherein the at least one ablation element includes a membrane (30) in fluid communication with the fluid lumen, the membrane having an expanded configuration with a cylindrically shaped active ablation region (surface of ‘30’), as well as a delivery configuration, the active ablation region necessarily having a length and outer diameter, and wherein the cylindrically shaped active ablation region includes a wire (36) coiled in a helix that extends completely around the flexible shaft several times. However, Horn fails to explicitly disclose the specifically-claimed length/diameter ranges of the ablation region in the different configurations. Salahieh teaches a similar device for targeting a similar region of a patient (e.g., a renal artery), wherein the device of Salahieh comprises the specifically-claimed length/diameter ranges of an ablation region in an expanded (note paragraph 99) and delivery configuration (note paragraph 52; in the delivery/deflated configuration, the diameter of the active ablation region would be comparable to that of the catheter shaft). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the device of Horn to comprise the dimensions of Salahieh. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result. Furthermore, such a modification would have involved a mere change in the size of a component, and a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It should be noted that this modified device still fails to expressly teach a helically-coiled wire that extends completely around the flexible shaft at least seven times, wherein the fluid delivery port is between turns of the wire coiled in the helix. However, Feiring teaches (note fig. 3A) a similar device comprising a balloon (14) with a helically-coiled electrode and fluid ports (‘28’ and ‘42’) therein, wherein the helically-coiled wire extends completely around the flexible shaft at least seven times, and wherein one of the fluid ports is between turns of the wire coiled in the helix. This specific helical electrode configuration has been utilized because it “enhances uniform radial distribution of the electrical field” (note col. 4, line 44), thereby resulting in increased safety and efficiency. Although Feiring teaches that a fluid return/outflow port (42) is disposed between turns of the wire coiled in the helix, and that the fluid delivery/inflow port (28) is at the proximal end of the balloon, Levin teaches (note figs. 4A-B) a similar system that can be operated in either configuration (along with a variety of other configurations) interchangeably (note paragraph 137 - either port could function as the fluid delivery port). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have further modified the system of Horn such that the helically-coiled wire extends completely around the flexible shaft at least seven times (in order to increase safety and efficiency), and such that the fluid delivery port is between turns of the wire coiled in the helix (since this modification would have merely comprised a simple substitution of interchangeable fluid delivery configurations in order to produce a similar result – see MPEP 2143). Finally, it should be noted that this modified device would be capable of performing the claimed function (i.e., capable of being used in the claimed manner).
Regarding claim 16, Horn discloses (see above) a device wherein the flexible distal section of the flexible shaft has at least one surface (e.g., distal portion of ‘12/42’ extending proximally from ‘30’) that is capable of being bent at an angle of at least 90 degrees and with a bend radius in a range of 4 mm to 15 mm. 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 20, Horn discloses (see above) a device wherein the membrane at least partially defines an interior volume that is in fluid communication with the fluid lumen (note paragraph 48).
Regarding claims 22, 24, and 27, Horn discloses (note figs. 1-4) a device for ablation comprising: a flexible shaft (‘12’ – necessarily flexible, see ‘guidewire’ in paragraph 33) having a fluid supply lumen (50), a flexible distal section (includes the portion of ‘12/42’ disposed within ‘30’, and a distal portion of ‘12/42’ extending proximally from ‘30’), and a proximal section (i.e., the proximal-most section of ‘12’), wherein the flexible shaft connects the proximal and distal sections; and at least one ablation element mounted at the flexible distal section; a fluid delivery port (32) on the flexible distal section and connectable to a source of irrigation fluid (24); wherein the at least one ablation element comprises a membrane (30) presenting an active ablation length and an outer diameter, the at least one ablation element configured to receive conductive fluid through said fluid supply lumen (note paragraph 48), the membrane having an expanded configuration and a delivery configuration; wherein the at least one ablation element necessarily comprises an active ablation length, an outer diameter, and a wire (36) coiled in a helix that extends completely around the flexible shaft several times. However, Horn fails to explicitly disclose the specifically-claimed length/diameter ranges of the ablation region in the different configurations. Salahieh teaches a similar device for targeting a similar region of a patient (e.g., a renal artery), wherein the device of Salahieh comprises the specifically-claimed length/diameter ranges of an ablation region in an expanded (note paragraph 99) and delivery configuration (note paragraph 52; in the delivery/deflated configuration, the diameter of the active ablation region would be comparable to that of the catheter shaft). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the device of Horn to comprise the dimensions of Salahieh. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result. Furthermore, such a modification would have involved a mere change in the size of a component, and a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It should be noted that this modified device still fails to expressly teach a helically-coiled wire that extends completely around the flexible shaft at least seven times, wherein the fluid delivery port is between turns of the wire coiled in the helix. However, Feiring teaches (note fig. 3A) a similar device comprising a balloon (14) with a helically-coiled electrode and fluid ports (‘28’ and ‘42’) therein, wherein the helically-coiled wire extends completely around the flexible shaft at least seven times, and wherein one of the fluid ports is between turns of the wire coiled in the helix. This specific helical electrode configuration has been utilized because it “enhances uniform radial distribution of the electrical field” (note col. 4, line 44), thereby resulting in increased safety and efficiency. Although Feiring teaches that a fluid return/outflow port (42) is disposed between turns of the wire coiled in the helix, and that the fluid delivery/inflow port (28) is at the proximal end of the balloon, Levin teaches (note figs. 4A-B) a similar system that can be operated in either configuration (along with a variety of other configurations) interchangeably (note paragraph 137 - either port could function as the fluid delivery port). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have further modified the system of Horn such that the helically-coiled wire extends completely around the flexible shaft at least seven times (in order to increase safety and efficiency), and such that the fluid delivery port is between turns of the wire coiled in the helix (since this modification would have merely comprised a simple substitution of interchangeable fluid delivery configurations in order to produce a similar result – see MPEP 2143). Finally, it should be noted that this modified device would be capable of performing the claimed function (i.e., capable of being used in the claimed manner).
Regarding claims 21 and 28, Horn in view of Salahieh, Feiring, and Levin teaches (see above) a device having an ablation element comprising a membrane, wherein the membrane defines an interior volume while in the expanded configuration. However, this combination of references fails to expressly teach the specifically-claimed size range of this interior volume. It would have been an obvious matter of design choice to have further modified the dimensions (i.e., the interior volume) of Horn accordingly, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 23, Horn discloses (see above) a device wherein the membrane is a microporous weeping membrane (see ‘40’ – note paragraph 35).
Regarding claim 25, Horn discloses (see above) a device wherein the flexible distal section (e.g., distal portion of ‘12/42’ extending proximally from ‘30’) of said flexible shaft is capable of being bent at a bend angle of at least 90 degrees and with a bend radius of between 4 mm and 15 mm. 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 26, Horn discloses (see above) a device wherein the at least one ablation element is configurable in at least one delivery (i.e., deflated) state and in at least one deployed (i.e., inflated) state, and while in the delivery state, the at least one ablation element is necessarily radially more contracted than in the deployed state.
Regarding claim 29, Horn discloses (see above) a device wherein the ablation element has one single ‘non-deployable configuration’ (e.g., when it is currently deployed it is no longer ‘deployable’).
Regarding claim 30, Horn discloses (see above) a device further comprising at least one temperature sensor positioned inside said ablation element (note paragraph 32).
Regarding claim 31, Horn discloses (see above) a device wherein the at least one ablation element and the at least one temperature sensor are connectable to an ablation energy source (note paragraph 10).
Regarding claims 36 and 37, Horn discloses (see above) a device wherein the wire is enclosed within the membrane (see figs. 2 and 4).
Regarding claim 38, Horn discloses (note figs. 1-4) a device for treatment comprising: a flexible shaft (‘12’ – necessarily flexible, see ‘guidewire’ in paragraph 33) having a fluid supply lumen (50), a flexible distal section (includes the portion of ‘12/42’ disposed within ‘30’, and a distal portion of ‘12/42’ extending proximally from ‘30’), and a proximal section (i.e., the proximal-most section of ‘12’), wherein the flexible shaft connects the proximal and distal sections; at least one energy delivery element (30) mounted on the flexible distal section; and a fluid outlet (32) in fluid communication with the fluid supply lumen (note paragraph 48); and wherein the at least one energy delivery element necessarily comprises: an active energy delivery length, an outer diameter, and a conductive wire (36) coiled in a helix that extends along the active delivery length and coils completely around the flexible shaft several times, wherein the conductive wire is configured to be electrically connected to an energy source (18) external to the patient and the wire is configured to dispense energy, wherein the fluid outlet is on the flexible distal section. However, Horn fails to explicitly disclose the specifically-claimed length/diameter ranges of the energy delivery element. Salahieh teaches a similar device for targeting a similar region of a patient (e.g., a renal artery), wherein the device of Salahieh comprises the specifically-claimed length/diameter ranges of an energy delivery element (note paragraph 99). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the device of Horn to comprise the dimensions of Salahieh. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result. Furthermore, such a modification would have involved a mere change in the size of a component, and a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It should be noted that this modified device still fails to expressly teach a helically-coiled wire that extends completely around the flexible shaft at least seven times, wherein the fluid delivery port is between turns of the wire coiled in the helix. However, Feiring teaches (note fig. 3A) a similar device comprising a balloon (14) with a helically-coiled electrode and fluid ports (‘28’ and ‘42’) therein, wherein the helically-coiled wire extends completely around the flexible shaft at least seven times, and wherein one of the fluid ports is between turns of the wire coiled in the helix. This specific helical electrode configuration has been utilized because it “enhances uniform radial distribution of the electrical field” (note col. 4, line 44), thereby resulting in increased safety and efficiency. Although Feiring teaches that a fluid return/outflow port (42) is disposed between turns of the wire coiled in the helix, and that the fluid delivery/inflow port (28) is at the proximal end of the balloon, Levin teaches (note figs. 4A-B) a similar system that can be operated in either configuration (along with a variety of other configurations) interchangeably (note paragraph 137 - either port could function as the fluid delivery port). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have further modified the system of Horn such that the helically-coiled wire extends completely around the flexible shaft at least seven times (in order to increase safety and efficiency), and such that the fluid delivery port is between turns of the wire coiled in the helix (since this modification would have merely comprised a simple substitution of interchangeable fluid delivery configurations in order to produce a similar result – see MPEP 2143). Finally, it should be noted that this modified device would be capable of performing the claimed function (i.e., capable of being used in the claimed manner).
Regarding claim 39, Horn discloses (see above) a device wherein the wire is enclosed within a membrane (see figs. 2 and 4).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn in view of Salahieh, Feiring, and Levin as applied to claims 13, 15-17, 20-31, and 36-39 above, and further in view of Koblish, U.S. 9,486,280 (hereinafter Koblish).
Regarding claim 40, Horn discloses a device comprising a flexible shaft having a flexible distal section and a proximal section. However, Horn fails to explicitly disclose that the flexible distal section has a flexibility greater than a flexibility of the flexible shaft proximate to the flexible distal section. Koblish teaches a similar system comprising a flexible shaft having a flexible distal section (66) and a proximal section (64), wherein the flexible distal section has a flexibility greater than a flexibility of the flexible shaft proximate to the flexible distal section (note col. 7, line 16). This configuration is utilized so that a single device can exhibit a blend of flexibility and semi-stiffness to facilitate insertion and steering (thereby resulting 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 system of Horn so that the flexible distal section has a flexibility greater than a flexibility of the flexible shaft proximate to the flexible distal section, in order to increase safety and efficiency.
Allowable Subject Matter
Claims 18, 19, and 32-35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the 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 the criticality behind the specific number of helical turns, Examiner respectfully disagrees. While Examiner acknowledges the role these windings play in field uniformity and flexibility, Examiner maintains that there is no criticality behind the specifically-claimed number of turns since this number is never even mentioned in the specification (i.e., it appears as though a slightly different number of turns would provide the same benefits).
Regarding Applicant’s arguments concerning the usage of the device, Examiner maintains that the modified device would be capable of being used in the claimed manner at the claimed target site. As stated previously, 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. Furthermore, Examiner asserts that the ‘sufficient length’ limitation would necessarily be met by this combination of references, due to its breadth and the wide range of patient dimensions (especially children).
Regarding Applicant’s arguments concerning the flexibility of the shaft disclosed by Horn, Examiner respectfully disagrees. More specifically, Examiner asserts that the entire shaft is flexible since the entire shaft is introduced over a guidewire. Regarding Applicant’s arguments concerning the modification of Horn in view of Salahieh, Examiner respectfully disagrees. More specifically, Examiner maintains that this rejection (as seen above) properly meets the claims, since Horn is merely being modified in view of the size of Salahieh (a similar reference that targets the same renal area). Although neither reference discloses the claimed target site, Examiner asserts (again) that the modified device would be capable of being used in the claimed manner at the claimed target site. It should be noted that Salahieh has merely been used for its teachings on size (as seen above), and that Salahieh’s coil has not been relied upon for the modification of Horn (nor has the coil of Salahieh ben modified, as suggested by Applicant).
Regarding Applicant’s arguments concerning claims 16 and 25, Examiner respectfully disagrees. More specifically, Examiner maintains that these claims have been met as they are currently written, due to the breadth of limitations such as “flexible distal section” and “surface” (see above rejections for updated interpretation). Examiner asserts that the remaining claims have been met by the cited references, as can be seen above.
Conclusion
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794