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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/01/2025 has been entered.
Response to Amendment
The Amendments filed December 01, 2025 have been entered. Applicant’s amendments have overcome the 112(b) rejection previously set forth in the Final Office Action mailed on 09/11/2025. Currently, claims 1, 10, and 20 have been amended and claims 1-20 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 7-11, and 20 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 7 recites the limitation "a third polymer" in line 1. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the third polymer of the outer layer is different from the polymer that comprises the outer layer as cited in independent claim 1, or if they are the same material. For examination purposes, Examiner will treat both polymers as the same material of the outer layer. Claims 8-11 are also rejected because they are dependent on claim 7.
Claim 20 recites the limitation "the third polymer" in line 16. There is insufficient antecedent basis for this limitation in the 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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (W.O. Application No. 2017044129 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), 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).
However, Lim does 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/Appling combination discloses wherein the liner layer comprises a first polymer (Lim, pa. 0022).
Regarding claim 3, Lim/Appling combination discloses wherein the first polymer comprises polytetrafluoroethylene (PTFE) (Lim, pa. 0022).
Regarding claim 4, Lim/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/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/Appling combination discloses wherein the second polymer comprises polyether block amide (Lim, pa. 0022).
Regarding claim 7, as best understood, Lim/Appling combination discloses wherein the outer layer comprises a third polymer (e.g., polyethylene or a polymer/metal composite/mixture/blend) (pa. 0025).
Regarding claim 8, Lim/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/Appling combination discloses wherein the third polymer comprises polyether block amide (PEBA) (Lim, pa. 0025).
Regarding claims 10-12, Lim/Appling 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/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/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/Appling combination discloses wherein the radiopaque band is at the distal end (Lim, see Fig. 1B).
Regarding claim 16, Lim/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/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/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/Appling combination discloses wherein the distal portion is tapered (Lim, pa. 0028).
Claim 20 is 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 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), and 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 radiopaque section comprises the 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 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 a puncture device and an RF generator for the purpose of performing ablation and mapping procedures on tissue in order to treat certain 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 5-7, filed 12/01/2025, with respect to the 102
rejection of claim 1 under Lim and the 103 rejection of claim 20 under Lim in view of Davies have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1 and 20 to further require the polymer in the radiopaque section of the outer layer being filled with a radiopaque filler is defined
over Lim 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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (W.O. Application No. 2017044129 A1), and further in view of Appling (U.S. Application No. 20050096642 A1).
Claim 20 is 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).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794