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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/15/2026 has been entered.
Response to Amendment
The Amendment filed June 15, 2026 has been entered. Applicant’s amendments have overcome the Double Patenting rejection previously set-forth in the Final Rejection mailed on 03/13/2026. Currently, claims 1, 15, and 20-23 have been amended, claim 9 has been cancelled, claim 24 has been newly added, and claims 1-8, and 10-24 are pending in the application.
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 1-5, 7-8, 12-14, and 24 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 1 recites the limitation “at least one electrical contact configured to deliver electrical current, generated by the therapeutic medical device, to a metallic support structure positioned in the wall of the vessel to deliver the energy to the metallic support structure,” (emphasis added by Examiner) found in lines 15-17. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner how the metallic support structure is configured to deliver the energy to the metallic support structure. For examination purposes, Examiner will treat the claim language as, “at least one electrical contact configured to deliver electrical current, generated by the therapeutic medical device, to a metallic support structure positioned in the wall of the vessel to deliver the energy to the vessel”. Claims 2-5, 7-8, 12-14, and 24 are also rejected because they are dependent on claim 1.
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, 7-8, and 24 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 and claim 24, Habib discloses a system, comprising:
an intravascular medical device (10) (pa. 0014, 0060 & Figs. 2(b), 3(b)) comprising:
a heat therapy assembly (i.e., combination of balloons 18 and 22, distal electrodes/heating element 15, proximal electrodes/heating element 17, arms/spokes 16 and 19, and tip portion 12) (pa. 0053-0054, 0060-0061) configured to:
expand a vessel (1) beyond an initial diameter of the vessel (pa. 0031, 0067). Examiner notes that although the device deploys and exerts an expansion force on the occluding material 20 of the vessel, the combination of the mechanical force and the application of RF energy/current via the electrode causes partial degeneration of muscle fibers so that the vessel wall can be deformed, as noted by figures 5(a) and 5(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 to a wall of the vessel to heat the wall of the vessel (pa. 0027, 0087, 0101); and
an elongated member coupled to the heat therapy assembly (see Fig. 2(b)); and
a therapeutic medical device (e.g., an RF radiation source) communicatively coupled to the heat therapy assembly and configured to control the heat therapy assembly to deliver the energy (pa. 0060, 0101) to:
ablate smooth muscle cells of the wall of the vessel (pa. 0058); and
substantially apply heat/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, 22) configured to radially expand to expand the wall of the vessel (pa. 0057, 0067). Examiner highlights paragraph 0059 of Habib which describes how the vessel is fixed at a final diameter greater than the initial. The application of heat 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.
Finally, Habib discloses wherein the heat therapy assembly comprises at least one electrical contact (e.g., the distal electrodes/heating element 15) configured to deliver electrical current, generated by the therapeutic medical device (pa. 0014, 0101), to a metallic support structure, comprising a stent, and positioned in the wall of the vessel, causing the metallic support structure to generate radiant energy to heat the wall of the vessel (pa. 0011, 0057-0058). Examiner notes that an electrical current must be inherently present in the invention of Habib given that radiant energy is delivered/transmitted from the RF radiation source and is received by the electrodes on the heat therapy assembly. Furthermore, Examiner notes that the claim language of the metallic support structure being positioned in the wall of the vessel to deliver the energy to the metallic support structure is regarded as a functional recitation of the intended use of the heat therapy assembly. It has been held that a functional 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. In the instant case, heat therapy assembly, including the distal electrode, of Habib readily provides for such functionality of receiving and delivering electrical current, generated by the therapeutic medical device to a metallic support structure positioned in the wall of the vessel. Therefore, the prior art meets the functional claim limitation.
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 (e.g., proximal electrode 17) configured to deliver the energy to the wall of the vessel (Habib, pa. 0067).
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. 5(a)-5(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. 0067).
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).
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 06/15/2026, with respect to the 103
rejection of independent claim 1 under Habib and Baker has been fully considered but are not persuasive.
With regards to newly amended independent claim 1, Applicant argues that neither Habib nor Baker describe "at least one electrical contact configured to deliver electrical current, generated by the therapeutic medical device, to a metallic support structure positioned in the wall of the vessel. Specifically, Applicant contends that none of Habib, Baker, or Hastings suggests utilizing a pre-existing metallic support structure to act as an antenna to generate radiant energy. However, Examiner, respectfully, disagrees.
As mentioned above, the newly added language of independent claim 1 is regarded to the Examiner as a functional recitation of the intended use of the heat therapy assembly. It has been held that a functional 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. In the instant case, heat therapy assembly, including the distal electrode, of Habib readily provides for such functionality of receiving and delivering electrical current, generated by the therapeutic medical device to a metallic support structure/stent positioned in the wall of the vessel. Therefore, the prior art meets the functional claim limitation. Examiner suggests further amending the claim to positively recite the metallic support structure as a structural component of the heat therapy assembly, and not merely as a functional limitation of the claim language. Therefore, for all the reasonings set-forth above, the rejection using the combination of references is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Favreau (U.S. Application No. 20200188017 A1) teaches a bipolar ablation device for treatment of a stenosis within an implanted metallic stent.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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