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 Amendments filed May 06, 2026 have been entered. Applicant’s amendments have overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed on 02/06/2026. Currently, claims 1, 7, and 20 have been amended and claims 1-20 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (W.O. Application No. 2017044129 A1), in view of Davies (U.S. Application No. 20130046305 A1), and further in view of Appling (U.S. Application No. 20050096642 A1).
Regarding independent claim 1, Lim discloses a catheter (100) comprising:
an elongate shaft (106) extending longitudinally between a proximal portion (120, 130) defining a proximal end (106a) and a distal portion (150) defining a distal end (106b) (pa. 0014 & Figs. 1A-1B); and
a lumen (103) extending through the shaft from the proximal end to the distal end (pa. 0015);
wherein the shaft in the distal portion comprises a heat-shielding layer (114) and an outer layer (116) radially adjacent the heat-shielding layer (pa. 0024), both of which extend to the distal end (pa. 0020, 0024). Examiner will be interpreting the term ‘radially adjacent’ as a relationship where two structures are directly/indirectly next to each other, but specifically in a way that suggests a structure extends outwards from a central point. In this case the outer layer extends radially outwards from the heath-shielding layer.
Lim further discloses wherein the heat-shielding layer comprises an inner liner layer (112) adjacent the lumen, and an intermediate layer (113) adjacent the inner liner layer (pa. 0022);
wherein the outer layer comprises a polymer (e.g., polyethylene or a polymer/metal composite/mixture/blend) (pa. 0025), and
wherein in the distal portion, at least a section of the outer layer is radiopaque (via a combination of markers 117 and coils 170) (pa. 0015, 0036), the polymer in the radiopaque section encapsulating the radiopaque marker (see Fig. 1B), the radiopaque section radially adjacent to the heat-shielding layer (see Fig. 1B).; and
wherein the heat-shielding layer is configured to shield the radiopaque section from heat generated by a medical device received within the lumen (pa. 0015).
Examiner notes that the inner liner layer and the intermediate layer which comprise the heat-shielding layer are made of polymer materials such as polytetrafluoroethylene (PTFE) and Polyether Block Amide (PEBA), respectively (pa. 0022). The Examiner is of the position that the PEBA and PTFE materials relied upon in Lim are known to those of ordinary skill in the art to have thermal insulating properties. The Examiner further notes that Applicant’s own disclosure (see [0034]-[0035]) establishes that such materials are suitable for the layers of the heat-shielding layer. Furthermore, while the Lim reference is silent on a heat-generating radiofrequency electrode received within the lumen, the ability of the heat-shielding layer to shield the radiopaque section from heat is regarded as a functional recitation of the intended use of the heat-shielding layer. 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-shielding layer of Lim readily provides for such functionality given it is made with the specific heat shielding materials.
However, Lim does not disclose a heat-generating radiofrequency electrode. Davies, in the same field of endeavor, teaches a perforation device (100, 200) comprising an elongate body (102) receivable in the catheter (pa. 0043, 0060 & Figs. 1A, 2A-2B) and having a heat-generating radiofrequency electrode (112) positionable proximate the distal end of the catheter (pa. 0047, 0062 & Fig. 1E).
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 substituted the medical device received within the lumen of Lim with the puncture device, including the heat-generating radiofrequency electrode, taught by Lim for the purpose of performing ablation and mapping procedures on tissue in order to treat cardiac conditions (Davies, pa. 0004).
However, Lim/Davies combination do not disclose the polymer in the radiopaque section being filled with a radiopaque filler.
Appling, in the same field of endeavor, teaches a catheter (1) comprising a sheath (3) with a distal sheath tip (5), wherein the tip contains a fluoroscopically visible tip core (9) encapsulated within a thin layer of the translucent material (16) (such polyethylene, pa. 0035); this configuration is analogous to the polymer in the radiopaque section encapsulating the radiopaque marker, as disclosed by Lim. Alternatively, the core may be made of a polymer with radiopaque filler such as tungsten or barium sulfate (pa. 0033 & Figs. 1-2).
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 substituted the method of manufacturing the section of the outer layer that is radiopaque of Lim which included the polymer encapsulating the radiopaque marker, to the alternative method of manufacturing of Appling which involves the polymer being filled with a radiopaque filler since they are both known equivalents in the art and they would yield the same predictable results of providing enhanced visualization techniques to a surgeon during a procedure.
Regarding claim 2, Lim/Davies/Appling combination discloses wherein the liner layer comprises a first polymer (Lim, pa. 0022).
Regarding claim 3, Lim/Davies/Appling combination discloses wherein the first polymer comprises polytetrafluoroethylene (PTFE) (Lim, pa. 0022).
Regarding claim 4, Lim/Davies/Appling combination discloses wherein the intermediate layer comprises a second polymer, wherein the second polymer is melt processable and flexible (i.e., PEBA) (Lim, pa. 0022).
Regarding claim 5, Lim/Davies/Appling combination discloses wherein the second polymer comprises at least one of a polyether block amide (PEBA), an aliphatic polyether-based thermoplastic polyurethane (TPU), a nylon, a polyurethane, and a polyethylene (Lim, pa. 0022).
Regarding claim 6, Lim/Davies/Appling combination discloses wherein the second polymer comprises polyether block amide (Lim, pa. 0022).
Regarding claim 7, Lim/Davies/Appling combination discloses wherein the polymer of the outer layer comprises a third polymer (e.g., polyethylene or a polymer/metal composite/mixture/blend) (Lim, pa. 0025).
Regarding claim 8, Lim/Davies/Appling combination discloses wherein the third polymer comprises at least one of a polyether block amide (PEBA), an aliphatic polyether-based thermoplastic polyurethane (TPU), a nylon, a polyurethane, and a polyethylene (Lim, pa. 0025).
Regarding claim 9, Lim/Davies/Appling combination discloses wherein the third polymer comprises polyether block amide (PEBA) (Lim, pa. 0025).
Regarding claims 10-12, Lim/Davies combination discloses the radiopaque section extends to the distal end and is radially adjacent to the heat-shielding layer (Lim, see Fig. 1B).
However, they do not disclose the wherein in the section that is radiopaque, the third polymer is filled with the radiopaque filler to form a radiopaque composite material, wherein the radiopaque filler comprises at least one of tungsten, barium sulphate, and bismuth
Appling, in the same field of endeavor, teaches a catheter (1) comprising a sheath (3) with a distal sheath tip (5), wherein the tip contains a fluoroscopically visible tip core (9) encapsulated within a thin layer of the translucent material (16) (such polyethylene, pa. 0035); this configuration is analogous to the polymer in the radiopaque section encapsulating the radiopaque marker, as disclosed by Lim. Alternatively, the core may be made of a polymer with radiopaque filler such as tungsten or barium sulfate to form a radiopaque composite material (pa. 0033 & Figs. 1-2).
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 substituted the method of manufacturing the section of the outer layer that is radiopaque of Lim which included the polymer encapsulating the radiopaque marker, to the alternative method of manufacturing of Appling which involves the polymer being filled with a radiopaque filler since they are both known equivalents in the art and they would yield the same predictable results of providing enhanced visualization techniques to a surgeon during a procedure.
Regarding claim 13, Lim/Davies/Appling combination discloses wherein the section that is radiopaque extends along an entirety of the distal portion (Lim, see coils 170 on Fig. 1B).
Regarding claim 14, Lim/Davies/Appling combination discloses wherein the section that is radiopaque comprises a radiopaque band (117) in the distal portion (Lim, pa. 0015).
Regarding claim 15, Lim/Davies/Appling combination discloses wherein the radiopaque band is at the distal end (Lim, see Fig. 1B).
Regarding claim 16, Lim/Davies/Appling combination discloses wherein the distal portion (421) has a length of between about 1 mm and about 5 mm (Lim, pa. 0051 & Fig. 4).
Regarding claim 17, Lim/Davies/Appling combination discloses wherein the liner layer, intermediate layer, and outer layer are of a constant thickness between the proximal end and the distal end (Lim, pa. 0017).
Regarding claim 18, Lim/Davies/Appling combination discloses wherein the proximal portion comprises at least a first tapered section (192) adjacent the distal portion, and the outer layer tapers in thickness in the tapered section (Lim, pa. 0027 & Fig. 1A).
Regarding claim 19, Lim/Davies/Appling combination discloses wherein the distal portion is tapered (Lim, pa. 0028).
Regarding independent claim 20, Lim discloses a perforation system comprising:
a catheter (100) comprising i) an elongate shaft (106) extending longitudinally between a proximal portion (120, 130) defining a proximal end (106a) and a distal portion (150) defining a distal end (106b) (pa. 0014 & Figs. 1A-1B), and ii) a lumen (103) extending through the shaft from the proximal end to the distal end (pa. 0015), wherein the shaft in the distal portion comprises a heat-shielding layer (114) and an outer layer (116) radially adjacent the heat-shielding layer (pa. 0024), both of which extend to the distal end (pa. 0020, 0024) (Examiner will be interpreting the term ‘radially adjacent’ as a relationship where two structures are directly/indirectly next to each other, but specifically in a way that suggests a structure extends outwards from a central point. In this case the outer layer extends radially outwards from the heath-shielding layer), wherein the heat-shielding layer comprises an inner liner layer (112) adjacent the lumen and an intermediate layer (113) adjacent the inner liner layer (pa. 0022), wherein in the distal portion, at least a section (i.e., area of the distal end which includes markers 317) of the outer layer is radiopaque (via markers 317) (pa. 0015), the radiopaque section radially adjacent to the heat-shielding layer (see Figs. 1B and 3); and wherein the heat-shielding layer is configured to shield the radiopaque section from heat generated by a medical device received within the lumen (pa. 0015).
Examiner notes that the inner liner layer and the intermediate layer which comprise the heat-shielding layer are made of polymer materials such as polytetrafluoroethylene (PTFE) and Polyether Block Amide (PEBA), respectively (pa. 0022). The Examiner is of the position that the PEBA and PTFE materials relied upon in Lim are known to those of ordinary skill in the art to have thermal insulating properties. The Examiner further notes that Applicant’s own disclosure (see [0034]-[0035]) establishes that such materials are suitable for the layers of the heat-shielding layer. Furthermore, while the Lim reference is silent on a heat-generating radiofrequency electrode received within the lumen, the ability of the heat-shielding layer to shield the radiopaque section from heat is regarded as a functional recitation of the intended use of the heat-shielding layer. 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-shielding layer of Lim readily provides for such functionality given it is made with the specific heat shielding materials.
Lastly, Lim discloses wherein the radiopaque section comprises a third polymer (e.g., polyethylene or a polymer/metal composite/mixture/blend) (pa. 0025), the polymer in the radiopaque section encapsulating the radiopaque marker (see Fig. 1B), and the radiopaque marker extending continuously along at least a portion of the distal portion (see Figs. 1B and 3).
However, Lim does not disclose a perforation device comprising an elongate body receivable in the catheter and having the heat-generating radiofrequency electrode positionable proximate the distal end of the catheter, nor a radiofrequency generator.
Davies, in the same field of endeavor, teaches a perforation device (100, 200) comprising an elongate body (102) receivable in the catheter (pa. 0043, 0060 & Figs. 1A, 2A-2B) and having a heat-generating radiofrequency electrode (112) positionable proximate the distal end of the catheter (pa. 0047, 0062 & Fig. 1E); and
a radiofrequency generator (not shown) connectable to the perforation device to supply radiofrequency energy to the radiofrequency electrode (pa. 0044, 0062).
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 incorporated the radiofrequency generator of Davies and to have substituted the medical device received within the lumen of Lim with the puncture device, including the heat-generating radiofrequency electrode, taught by Lim for the purpose of performing ablation and mapping procedures on tissue in order to treat cardiac conditions (Davies, pa. 0004).
However, Lim/Davies combination do not teach wherein the radiopaque section comprises the third polymer filled with radiopaque filler.
Appling, in the same field of endeavor, teaches a catheter (1) comprising a sheath (3) with a distal sheath tip (5), wherein the tip contains a fluoroscopically visible tip core (9) encapsulated within a thin layer of the translucent material (16) (such polyethylene, pa. 0035); this configuration is analogous to the polymer in the radiopaque section encapsulating the radiopaque marker, as disclosed by Lim. Alternatively, the core may be made of a polymer with radiopaque filler such as tungsten or barium sulfate (pa. 0033 & Figs. 1-2).
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 substituted the method of manufacturing the section of the outer layer that is radiopaque of Lim which included the polymer encapsulating the radiopaque marker, to the alternative method of manufacturing of Appling which involves the polymer being filled with a radiopaque filler since they are both known equivalents in the art and they would yield the same predictable results of providing enhanced visualization techniques to a surgeon during a procedure.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 05/06/2026, with respect to the 103
rejection of independent claim 1 under Lim and Appling and the 103 rejection of independent claim 20 under Lim, Davies, and Appling have been fully considered and are partially persuasive.
With regards to the newly amended language of independent claim 1, Applicant argues that none of the references cited disclose wherein the heat-shielding layer is configured to shield the radiopaque section from heat generated by a heat-generating radiofrequency electrode received within the lumen. Examiner partially agrees.
While Examiner concedes that the Lim reference is silent on a heat-generating radiofrequency electrode received within the lumen, given that the lumen (103) of Lim is only described as being configured to slidably receive and facilitate the passage of one or more medical devices, the Lim reference does disclose the heat-shielding layer being configured to shield the radiopaque section from heat. As described above, the inner liner layer and the intermediate layer, which comprise the heat-shielding layer, are made of polymer materials such as polytetrafluoroethylene (PTFE) and Polyether Block Amide (PEBA), respectively (pa. 0022). The Examiner is of the position that the PEBA and PTFE materials relied upon in Lim are known to those of ordinary skill in the art to have thermal insulating properties. The Examiner further notes that Applicant’s own disclosure (see [0034]-[0035]) establishes that such materials are suitable for the layers of the heat-shielding layer. While the Lim reference is silent on a heat-generating radiofrequency electrode received within the lumen, the ability of the heat-shielding layer, as claimed, to shield the radiopaque section from some degree of heat produced by a medical device inserted in the lumen is regarded as a functional recitation of the intended use of the heat-shielding layer. 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 this instant case, the heat-shielding layer of Lim readily provides for such functionality given it is made with the specific heat shielding materials such as PEBA and PTFE materials. The Examiner notes that Applicant’s own disclosure (see [0034]-[0035]) establishes that such same materials are suitable for the layers of the heat-shielding layer. In regards to the claim limitation of a heat-generating radiofrequency electrode received within the lumen, Examiner has updated the rejection to include the Davies reference to overcome such shortcomings. Therefore, the rejection using the references cited above are reasonable given the reasonings set-forth above.
With regards to newly amended claim 20, Applicant argues that while the Davies reference teaches a perforation device having a heat-generating radiofrequency electrode, Davies does not suggest the claimed catheter structure, including the heat-shielding layer configured to shield a radiopaque section of an outer layer from heat generated by a radiofrequency electrode received within the lumen. However, Examiner, respectfully, disagrees.
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). In this case, Examiner relied on the Lim reference to disclose the claimed catheter structure including the heat-shielding layer configured to shield a radiopaque section of an outer layer from heat generated by a medical device received within the lumen. As explained above, the ability of the heat-shielding layer to be configured to shield a radiopaque section of an outer layer from heat is regarded as a functional limitation, and since the materials of the heat-shielding layer are capable of providing such properties, then the prior art meets the claim limitations. Additionally, the Davies reference was not relied to teach such catheter structures, given that Lim already teaches that, and was only utilized to teach a specific type of medical device such as a puncturing device comprising a heat-generating radiofrequency electrode. Therefore, the rejection is maintained.
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
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