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 .
Response to Amendment
The Amendment filed December 10, 2025 has been entered. Applicant’s amendments have overcome the claim objection previously set-forth in the Non-Final Rejection mailed on 10/06/2025. Currently, claims 1, 13 have been amended, and claims 1-23 are pending in the application.
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.
Claims 1-5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Habib (U.S. Application No. 20120232326 A1), and further in view of Baker (U.S. Patent No. 5957920 A).
Regarding independent claim 1, Habib discloses a system, comprising:
an intravascular medical device (10) (pa. 0049 & Figs. 2(a), 3(a)) comprising:
a heat therapy assembly (i.e., distal end of the medical device) configured to:
expand a vessel (1) beyond an initial diameter of the vessel (pa. 0031, 0057-0058). Examiner notes that although the device deploys and exerts an expansion force on the occluding material 20, the combination of the mechanical force and the application of RF energy via electrode 14 cause partial degeneration of muscle fibers so that the vessel wall can be deformed, as noted by figures 4(a) and 4(b) which shows not only a restoration in luminal patency but also an increase in the outer diameter of the vessel wall; and
while the vessel is expanded, deliver energy (via electrodes 14) to a wall of the vessel to heat the wall of the vessel (pa. 0057-0058); and
an elongated member coupled to the heat therapy assembly (see Fig. 2(a)); and
a therapeutic medical device (an RF energy source) communicatively coupled to the heat therapy assembly and configured to control the heat therapy assembly to deliver the energy (pa. 0049) to:
ablate smooth muscle cells of the wall of the vessel (pa. 0058); and
substantially apply RF energy to the wall of the vessel to fix the vessel at a final diameter greater than the initial diameter (pa. 0059), wherein the heat therapy assembly comprises an expansion device (18) configured to radially expand to expand the wall of the vessel (pa. 0057). Examiner highlights paragraph 0059 of Habib which describes how the vessel is fixed at a final diameter greater than the initial. The application of RF energy causes the tissue of the wall of the vessel to soften and as it cools it adopts the new widened position to restore effective flow.
However, Habib does not explicitly disclose denaturing one or more structural proteins of the wall of the vessel.
Baker, in the same field of endeavor, teaches a catheter for delivering thermal energy to a target tissue using radio-frequency (RF) electrodes (abstract) for the purpose of modeling the tissue by altering the bio-mechanical characteristics of the targeted tissue volume with the creation of a collagen fiber matrix in the extracellular space (Col. 3, lines 16-20). The extracellular collagen consists of a continuous helical molecule made up of three polypeptide coil chains bonded together by heat labile intermolecular cross-links (or hydrogen cross-links) which may be broken by mild thermal effects thus causing the helical structure of the molecule to be destroyed (or denatured) with the peptide chains separating into individual randomly coiled structures (Col. 5, lines 39-58). During the injury healing process, specifically in the early stages of inflammation, the inflammatory exudate contains fibrinogen which together with enzymes released from blood and tissue cells, cause fibrin to be formed and laid down in the area of the injury. The fibrin serves as a hemostatic barrier and acts as a scaffold for repair of the injury site. Thereafter, fibroblasts migrate and either utilize the fibrin as scaffolding or for contact guidance thus further developing a fiber-like scaffold in the injury area (Col. 4, lines 57-66).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have denatured the one or more structural proteins of the wall of the vessel, as taught by Baker, in order to induce the biological injury healing response which alters the structural support or flexibility characteristics of the target tissue volume (Baker, Col. 6, lines 32-39).
Regarding claim 2, Habib discloses the invention substantially as claimed in claim 1 discussed above.
However, Habib does not disclose wherein the one or more structural proteins comprise elastin and collagen, and wherein after substantial denaturation, the one or more structural proteins cross-link to form a scaffold (pa. 0038).
Baker, in the same field of endeavor, teaches a catheter for delivering thermal energy to a target tissue using radio-frequency (RF) electrodes (abstract) for the purpose of modeling the tissue by altering the bio-mechanical characteristics of the targeted tissue volume with the creation of a collagen fiber matrix in the extracellular space (Col. 3, lines 16-20). The extracellular collagen consists of a continuous helical molecule made up of three polypeptide coil chains bonded together by heat labile intermolecular cross-links (or hydrogen cross-links) which may be broken by mild thermal effects thus causing the helical structure of the molecule to be destroyed (or denatured) with the peptide chains separating into individual randomly coiled structures (Col. 5, lines 39-58). During the injury healing process, specifically in the early stages of inflammation, the inflammatory exudate contains fibrinogen which together with enzymes released from blood and tissue cells, cause fibrin to be formed and laid down in the area of the injury. The fibrin serves as a hemostatic barrier and acts as a scaffold for repair of the injury site. Thereafter, fibroblasts migrate and either utilize the fibrin as scaffolding or for contact guidance thus further developing a fiber-like scaffold in the injury area (Col. 4, lines 57-66).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have denatured the one or more structural proteins cross-link to form a scaffold, as taught by Baker, in order to alter the structural support or flexibility characteristics of the target tissue volume (Baker, Col. 6, lines 32-39).
Regarding claim 3, Habib discloses wherein, to ablate the smooth muscle cells, the therapeutic medical device is configured to control the heat therapy assembly to deliver the energy to maintain a temperature of the smooth muscle cells within a target temperature range (pa. 0058).
However, Habib does not disclose denaturing the one or more structural proteins.
Baker, in the same field of endeavor, teaches a catheter for delivering thermal energy to a target tissue using radio-frequency (RF) electrodes (abstract) for the purpose of modeling the tissue by altering the bio-mechanical characteristics of the targeted tissue volume with the creation of a collagen fiber matrix in the extracellular space (Col. 3, lines 16-20). The extracellular collagen consists of a continuous helical molecule made up of three polypeptide coil chains bonded together by heat labile intermolecular cross-links (or hydrogen cross-links) which may be broken by mild thermal effects thus causing the helical structure of the molecule to be destroyed (or denatured) with the peptide chains separating into individual randomly coiled structures (Col. 5, lines 39-58).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have denatured the one or more structural proteins of the wall of the vessel, as taught by Baker, in order to induce the biological injury healing response which alters the structural support or flexibility characteristics of the target tissue volume (Baker, Col. 6, lines 32-39).
Regarding claim 4, Habib discloses the invention substantially as claimed in claim 1 discussed above.
However, Habib does not disclose the target temperature range is defined by a lower temperature threshold value associated with death of the smooth muscle cells and denaturation of the one or more structural proteins, and wherein the lower temperature threshold value is greater than or equal to about 60 ℃.
Baker, in the same field of endeavor, teaches a target temperature range defined by a lower temperature threshold value associated with death of the smooth muscle cells and denaturation of the one or more structural proteins, and wherein the lower temperature threshold value is greater than or equal to about 60 ℃ (Col. 7, lines 13-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have denatured the one or more structural proteins of the wall of the vessel with the lower temperature threshold range, as taught by Baker, in order to induce the biological injury healing response which alters the structural support or flexibility characteristics of the target tissue volume (Baker, Col. 6, lines 32-39).
Regarding claim 5, Habib discloses the invention substantially as claimed in claim 1 discussed above.
However, Habib does not disclose the target temperature range is defined by an upper temperature threshold value associated with bubble formation of one or more fluids in the wall of the vessel, and wherein the upper temperature threshold is less than about 100 ℃.
Baker, in the same field of endeavor, teaches a target temperature range is defined by an upper temperature threshold value associated with bubble formation of one or more fluids in the wall of the vessel, and wherein the upper temperature threshold is less than about 100 ℃ (Col. 7, lines 13-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have denatured the one or more structural proteins of the wall of the vessel with the upper temperature threshold range, as taught by Baker, in order to induce the biological injury healing response which alters the structural support or flexibility characteristics of the target tissue volume (Baker, Col. 6, lines 32-39).
Regarding claim 7, Habib/Baker combination discloses wherein the heat therapy assembly comprises one or more therapeutic elements (14) configured to deliver the energy to the wall of the vessel (Habib, pa. 0049).
Regarding claim 8, Habib/Baker combination discloses wherein the one or more therapeutic elements include one or more surfaces configured to contact the wall of the vessel (Habib, see Figs. 4(a)-4(b)), and wherein the one or more therapeutic elements are configured to deliver thermal energy to the wall of the vessel to heat the wall of the vessel (Habib, pa. 0056).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Habib and Baker as applied to claims 1 and 7 above, and further in view of Hastings (U.S. Application No. 20110307034 A1).
Regarding claim 9, Habib discloses wherein the one or more therapeutic elements comprise at least one electrical contact (i.e., a surface on the electrodes) configured to deliver electrical current (pa. 0057-0058), wherein the therapeutic medical device is configured to deliver the electrical current to the at least one electrical contact (pa. 0055). Examiner is interpreting the therapeutic medical device (i.e., the remotely controllable device that manipulates the actuation of the wires inside the electrodes) as being configured to deliver electrical current since without the actuation of the wires there is not application of current to the tissue.
However, Habib/Baker combination do not disclose a structure positioned in the wall of the vessel that delivers energy.
Hastings, in the same field of endeavor, teaches an apparatus (80) comprising a set of thermoelectric elements (84) disposed on thermally conductive and/or thermally insulating portions of substrate (87). The several thermoelectric elements that are disposed on thermally conductive portions (i.e., a structure positioned in contact to the target tissue) of the substrate are useful to provide increased thermal energy output and/or an increased surface area for generating thermal energy (pa. 0113, 0145 & Fig. 8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the conductive portions of Hastings adjacent to the electrode surfaces of Habib in order to provide increased thermal energy output and/or an increased surface area to the target vessel.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Habib and Baker as applied to claim 1 above, and further in view of Melder (U.S. Application No. 20140114215 A1).
Regarding claim 12, Habib/Baker combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose one or more needles configured to introduce a chemical agent into the wall of the vessel to denature the one or more structural proteins.
Melder, in the same field of endeavor, teaches a renal neuromodulation catheter that comprises a plurality of needles that can be retracted or otherwise blocked prior to deployment, wherein chemical agents can be delivered via the one or more needles into the wall of the vessel in order to facilitate neuromodulation (pa. 0032, 0050).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of needles of Melder to the medical device of Habib in order to introduce chemical agents that assist in altering, damaging, or disrupting proteins in the vessel (Melder, pa. 0032).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Habib and Baker as applied to claim 1 above, and further in view of Rajagopalan (U.S. Application No. 20170007310 A1).
Regarding claim 13, Habib/Baker combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not explicitly disclose the therapeutic medical device is configured to control the expansion device to expand the wall of the vessel to a predetermined diameter that is greater than or equal to the final diameter.
Rajagopalan, in the same field of endeavor, teaches a system (10) comprising a balloon (136) whose inflow and/or outflow rates of fluid delivered to and/or extracted from are controlled by a controller (250), specifically via an algorithm (251) which receives feedback from a sensor (139) located on the surface of the balloon (pa. 0281), such that the pressure/diameter of the balloon is maintained at varied ranges based on the size of the target tissue (pa. 0125, 0201 & Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sensor of Rajagopalan to the surface of the expansion device of Habib, and the software algorithm to the therapeutic medical device in order to more precisely/accurately adjust the size of the balloon inside the vessel.
Regarding claim 14, Habib/Baker/Rajagopalan combination discloses wherein the expansion device comprises a balloon configured to transform from a deflated delivery configuration to an inflated deployed configuration (Habib, pa. 0037).
Double Patenting
Claims 1-5, 7-8, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 12-14 of U.S. Application No. 20230165633 A1 in view of Habib (U.S. Application No. 20120232326 A1).
Regarding instant claim 1, it is the Examiner’s position that copending independent claim 1 is narrower in some aspects given that the copending claim recites a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 1. These narrower aspects include the claimed intravascular medical device, a heat therapy assembly, an elongated member, a therapeutic medical device, and a heat therapy assembly. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 1 and the copending claim 1 exists in that the copending claim 1 fails to provide that the heat therapy device functions “to expand a vessel beyond an initial diameter of the vessel, and fix the vessel at a final diameter greater than the initial diameter.” Habib, however, provides for a similar system as that of the copending claim and specifically contemplates expanding a vessel (1) beyond an initial diameter of the vessel (pa. 0031, 0057-0058), and fix the vessel at a final diameter greater than the initial diameter (pa. 0058). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the heat therapy assembly functionality of Habib in combination with the system in copending claim 1 to provide for expanding the wall of the vessel beyond its initial diameter.
With respect to dependent claims 2-5, 7-8, and 13, see copending application dependent claims 2-5, 12-14.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 12/10/2025, with respect to the 102
rejection of claim 1 under Mathur has been fully considered and are persuasive. Specifically, Applicant’s amendments to claim 1 to further require the system to fix the vessel at a final diameter greater than the initial diameter, wherein the heat therapy assembly comprises an expansion device configured to radially expand to expand the wall of the vessel is defined over Mathur given that it does not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Habib (U.S. Application No. 20120232326 A1), and further in view of Baker (U.S. Patent No. 5957920 A).
It is the Examiner’s position that the newly filed rejections based on the combination of Habib and Baker are tenable for at least the reasoning set forth in the action 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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794