DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Formal Matters
Claims 1 and 2 are pending and under examination.
Benefit
The application claims benefit as a Continuation of 17/981151 (11/4/2022) issued as US 12,156,675, which claims benefit as a Continuation to 16/694,930 (11/25/2019) issued as US 11,490,922, which claims benefit as a Continuation to 15/625,868 (6/16/2017) issued as US 10,485,569, which claims benefit as a Continuation to 14/629,367 (2/23/2015) issued as US 9,707,007, which claims benefit as a Continuation to 13/750,689 (1/25/2013) issued as US 8,961,550, which claims benefit to US Provisional 61/663,517 (6/22/2012) and US Provisional 61/625,503 (4/17/2012).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8 January 2025 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1, line 2 reads “an outer tube characterized by a proximal end a distal end,”. There appears to be language or punctuation missing between “proximal end” and “a distal end”, such as “proximal end and a distal end” or alternatively “proximal end, distal end, …”. Compare claim 2, line 7. Appropriate correction is required.
Non-Statutory Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,159,675 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘675 patent is obvious over claim 1 of the application in view of Werneth. A comparison of the claim language between claim 1 of the application and claim 1 of the ‘675 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 12,156,675
1. A transseptal punch comprising: an outer tube characterized by a proximal end a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating in a distal tip disposed distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube.
1. A transseptal punch comprising: an outer tube characterized by a proximal end a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube; wherein the flexible region of the outer tube comprises a segment of the outer tube which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and the flexible region of the inner tube comprises a segment of the inner tube with a longitudinally oriented slot.
Claim 1 of the ‘675 patent teaches as set forth in the table, above.
Claim 1 of the ‘675 patent does not teach a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘675 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘675 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claim 1 of the ‘675 patent discloses the claimed base transseptal punch device, the claims of the ‘675 patent do not disclose a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip. Werneth specifically addresses this, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claim 1 of the ‘675 patent includes the base device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘675 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘675 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claim 1 of the ‘675 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10,485,569 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of the ‘569 patent is obvious over claim 1 of the application in view of Werneth. A comparison of the claim language between claim 1 of the application and claim 11 of the ‘569 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 10,485,569
1. A transseptal punch comprising: an outer tube characterized by a proximal end a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end,
said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating in a distal tip disposed distally beyond the distal end of the outer tube,
said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube.
11. A transseptal punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue, said inner tube having slotted portion near the distal end of the thereof, said slotted portion having a longitudinally oriented slot disposed in the inner tube; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube.
Claim 11 of the ‘569 patent teaches as set forth in the table, above.
Claim 11 of the ‘569 patent does not teach a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘569 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘569 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claim 11 of the ‘569 patent discloses the claimed base transseptal punch device, the claims of the ‘569 patent do not disclose a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip. Werneth specifically addresses this, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claim 11 of the ‘569 patent includes the base device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘569 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘569 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claim 11 of the ‘569 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,961,550 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘550 patent is obvious over claim 1 of the application in view of Werneth. A comparison of the claim language between claim 1 of the application and claim 1 of the ‘550 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 8,961,550
1. A transseptal punch comprising: an outer tube characterized by a proximal end a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating in a distal tip disposed distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube.
1. A transseptal punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube, wherein the flexible region of the outer tube comprises a segment of the outer tube which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and the flexible region of the inner tube comprises a segment of the inner tube with a longitudinally oriented slot and an angled slot extending from an end of the longitudinally oriented slot.
Claim 1 of the ‘550 patent teaches as set forth in the table, above.
Claim 1 of the ‘550 patent does not teach a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘550 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘550 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claim 1 of the ‘550 patent discloses the claimed base transseptal punch device, the claims of the ‘550 patent do not disclose a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip. Werneth specifically addresses this, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claim 1 of the ‘550 patent includes the base device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘550 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘550 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claim 1 of the ‘550 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,490,922 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 of the ‘922 patent is obvious over claim 2 of the application in view of Werneth. A comparison of the claim language between claim 2 of the application and claims 1 and 7 of the ‘922 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 11,490,922
2. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, with the distal tip disposed distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube;
navigating the punch through a guide catheter until the distal tip of the inner tube is in contact with the fossa ovalis;
1. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end, wherein said flexible region of the outer tube is provided in a form in which the outer tube comprises a segment which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue, wherein said flexible region of the inner tube is provided in a form in which the inner tube comprises a segment of the inner tube with a longitudinally oriented slot; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube; navigating a guide catheter until a distal end of the guide catheter is in the right atrium and proximate the fossa ovalis; pushing the punch through the guide catheter until the distal tip of the inner tube is within the distal end of the guide catheter; bending the distal end of the punch by tensioning the inner tube relative to the outer tube, to place the distal tip of the inner tube and the distal end of the guide catheter in apposition to the fossa ovalis; pushing the punch distally, relative to the guide catheter, to force the distal tip out of the distal end of the guide catheter and through the fossa ovalis to create a puncture in the fossa ovalis; pushing distal end of the guide catheter through the puncture created by the punch, so that the distal tip of the guide catheter is disposed within the left atrium; and withdrawing the punch from the guide catheter.
7. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end, wherein said flexible region of the outer tube is provided in a form in which the outer tube comprises a segment which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue, wherein said flexible region of the inner tube is provided in a form in which the inner tube comprises a half pipe; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube; navigating a guide catheter until a distal end of the guide catheter is in the right atrium and proximate the fossa ovalis; pushing the punch through the guide catheter until the distal tip of the inner tube is within the distal end of the guide catheter; bending the distal end of the punch by tensioning the inner tube relative to the outer tube, to place the distal tip of the inner tube and the distal end of the guide catheter in apposition to the fossa ovalis; pushing the punch distally, relative to the guide catheter, to force the distal tip out of the distal end of the guide catheter and through the fossa ovalis to create a puncture in the fossa ovalis; pushing distal end of the guide catheter through the puncture created by the punch, so that the distal tip of the guide catheter is disposed within the left atrium; and withdrawing the punch from the guide catheter.
Claims 1 and 7 of the ‘922 patent teaches as set forth in the table, above.
Claims 1 and 7 of the ‘922 patent do not teach connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘992 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘922 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claims 1 and 7 of the ‘922 patent disclose the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device, the claims of the ‘922 patent do not disclose connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip. Werneth specifically addresses this in FIGs 1 and 2, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claims 1 and 7 of the ‘922 patent includes the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘922 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘922 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claims 1 and 7 of the ‘922 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,485,569 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘569 patent is obvious over claim 2 of the application in view of Werneth. A comparison of the claim language between claim 2 of the application and claim 1 of the ‘569 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 10,485,569
2. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue;
said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, with the distal tip disposed distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube;
navigating the punch through a guide catheter until the distal tip of the inner tube is in contact with the fossa ovalis;
1. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube;
navigating a guide catheter until a distal end of the guide catheter is in the right atrium and proximate the fossa ovalis; pushing the punch through the guide catheter until the distal tip of the inner tube is within the distal end of the guide catheter; bending the distal end of the punch by tensioning the inner tube relative to the outer tube, to place the distal tip of the inner tube and the distal end of the guide catheter in apposition to the fossa ovalis; pushing the punch distally, relative to the guide catheter, to force the distal tip out of the distal end of the guide catheter and through the fossa ovalis to create a puncture in the fossa ovalis; pushing distal end of the guide catheter through the puncture created by the punch, so that the distal tip of the guide catheter is disposed within the left atrium; and withdrawing the punch from the guide catheter.
Claim 1 of the ‘569 patent teaches as set forth in the table, above.
Claim 1 of the ‘569 patent does not teach connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘569 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘569 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claim 1 of the ‘569 patent discloses the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device, the claims of the ‘569 patent do not disclose connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip. Werneth specifically addresses this in FIGs 1 and 2, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claim 1 of the ‘569 patent includes the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘569 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘569 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claim 1 of the ‘569 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 9,707,007 in view of Werneth et al., US 20060089637 (27 April 2006).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 8 of the ‘007 patent are obvious over claim 2 of the application in view of Werneth. A comparison of the claim language between claim 2 of the application and claims 1 and 8 of the ‘007 patent is provided in the chart below, followed by the applicable teachings of Werneth and the rationale for combining the references. Accordingly, a terminal disclaimer or amendments are required to overcome the rejection.
Application 18/967,428
US Patent 9,707,007
2. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, with the distal tip disposed distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube;
navigating the punch through a guide catheter until the distal tip of the inner tube is in contact with the fossa ovalis;
1. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end, wherein said flexible region is provided in a form in which the outer tube comprises a segment which is snake-cut with a plurality of radially oriented slots in the wall of the outer tube, said radially oriented slots being substantially radially aligned along one side of the outer tube; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube;
navigating a guide catheter until a distal end of the guide catheter is in the right atrium and proximate the fossa ovalis; pushing the punch through the guide catheter until the distal tip of the inner tube is within the distal end of the guide catheter; bending the distal end of the punch by tensioning the inner tube relative to the outer tube, to place the distal tip of the inner tube and the distal end of the guide catheter in apposition to the fossa ovalis; pushing the punch distally, relative to the guide catheter, to force the distal tip out of the distal end of the guide catheter and through the fossa ovalis to create a puncture in the fossa ovalis; pushing distal end of the guide catheter through the puncture created by the punch, so that the distal tip of the guide catheter is disposed within the left atrium; and withdrawing the punch from the guide catheter.
8. A method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart, said method comprising the steps of: providing a punch for punching a hole in the fossa ovalis, said punch characterized by a distal end and a proximal end, said punch comprising: an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal and a distal end; and an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof and a distal tip adapted to pierce body tissue, wherein said flexible region is provided in a form in which the inner tube comprises a half pipe; said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally beyond the distal end of the outer tube, said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube; navigating a guide catheter until a distal end of the guide catheter is in the right atrium and proximate the fossa ovalis; pushing the punch through the guide catheter until the distal tip of the inner tube is within the distal end of the guide catheter; bending the distal end of the punch by tensioning the inner tube relative to the outer tube, to place the distal tip of the inner tube and the distal end of the guide catheter in apposition to the fossa ovalis; pushing the punch distally, relative to the guide catheter, to force the distal tip out of the distal end of the guide catheter and through the fossa ovalis to create a puncture in the fossa ovalis; pushing distal end of the guide catheter through the puncture created by the punch, so that the distal tip of the guide catheter is disposed within the left atrium; and withdrawing the punch from the guide catheter.
Claims 1 and 8 of the ‘007 patent teaches as set forth in the table, above.
Claims 1 and 8 of the ‘007 patent do not teach connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the ‘007 patent with Werneth because the prior art included each element claimed, although not necessarily in a single reference. The ‘922 patent and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, claims 1 and 8 of the ‘007 patent disclose the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device, the claims of the ‘007 patent do not disclose connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip. Werneth specifically addresses this in FIGs 1 and 2, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claims 1 and 8 of the ‘007 patent includes the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of the ‘007 patent architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside the ‘007 patent’s transseptal puncture device of claim 1 (within the same inner lumen) using known assembly methods without redesigning the core delivery path of claims 1 and 8 of the ‘007 patent. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gurusamy et al., US 7,635,353 (22 December 2009) in view of Werneth et al., US 20060089637 (27 April 2006).
Regarding independent claim 1, Gurusamy teaches a transseptal punch (FIG 1, 10) comprising:
an outer tube characterized by a proximal end a distal end (FIG 1, outer needle tube 28; col 5, line 56), and
a flexible region at the distal end, said flexible region characterized by a proximal and a distal end (FIG 1; col 1, line 50); and
an inner tube characterized by a proximal and a distal end (FIG 1, inner needle tube 26),
said inner tube having a flexible region near the distal end thereof (FIG 1; col 1, line 50; col 5, lines ) and a distal tip adapted to pierce body tissue (col 4, lines 42-49);
said inner tube being disposed within the outer tube (FIG 1), extending from the proximal end of the outer tube to the distal end of the outer tube (FIG 1), and
terminating in a distal tip disposed distally beyond the distal end of the outer tube (FIG 1),
said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube (FIG 4, conjoined inner and outer tubes 88, col 5, lines 54-59).
Gurusamy does not teach a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip.
Werneth teaches catheter 100 (FIG 1) comprising an integral sheath comprising a tip where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Gurusamy with Werneth because the prior art included each element claimed, although not necessarily in a single reference. Gurusamy and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, Gurusamy discloses the claimed base transseptal punch device, the Gurusamy does not disclose a source of radiofrequency energy operably connected to the inner tube to apply RF energy to the distal tip. Werneth specifically addresses this, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because Gurusamy includes the base device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using the device architecture of Gurusamy would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside Gurusamy’s transseptal puncture device (within the same lumen) using known assembly methods without redesigning the core delivery path of Gurusamy. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success in combining these teachings.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gurusamy et al., US 7,635,353 (22 December 2009) in view of Werneth et al., US 20060089637 (27 April 2006).
Regarding independent claim 2, Gurusamy teaches a method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart (column 1, lines 14-39) comprising:
providing a punch for punching a hole in the fossa ovalis (FIG 1, 10), said punch characterized by a distal end and a proximal end (FIG 1; col 1, line 50);, said punch comprising:
an outer tube characterized by a proximal end, a distal end, and a flexible region at the distal end, said flexible region characterized by a proximal end and a distal end (FIG 1, outer needle tube 28; col 5, line 56); and
an inner tube characterized by a proximal end and a distal end, said inner tube having a flexible region near the distal end thereof (FIG 1, inner needle tube 26; col 1, line 50) and a distal tip adapted to pierce body tissue (col 4, lines 42-49);
said inner tube being disposed within the outer tube (FIG 1), extending from the proximal end of the outer tube to the distal end of the outer tube (FIG 1), and
terminating in a distal tip disposed distally beyond the distal end of the outer tube (FIG 1),
said inner tube fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube (FIG 4, conjoined inner and outer tubes 88, col 5, lines 54-59).
Gurusamy does not expressly teach connecting a source of radiofrequency energy to the inner tube and applying radiofrequency to the distal tip.
Werneth teaches a method of accessing the left atrium of the heart of a patient, from the right atrium and through the fossa ovalis of the heart (FIG 2, ¶47) using a catheter 100 (FIG 1) comprising an integral sheath comprising a tip (FIG 2) where the catheter passes through or penetrates the fossa ovalis 7 over a guide wire placed by a trans-septal puncture device (¶47). Catheter 100 carries a structure carrying RF electrodes 130 at the distal tip (FIG 2) to deliver RF energy (¶47). FIG 2 of Werneth shows control shaft 150 extending from the proximal end to the distal end 102 of catheter shaft 101 and resides in a lumen therebetween (¶50). FIG 2 also shows the RF source (130) extending from the distal tip of the inner tube (150) of Werneth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified Gurusamy with Werneth because the prior art included each element claimed, although not necessarily in a single reference. Gurusamy and Werneth teach in the same field of endeavor of surgical cardiac endoluminal devices. Although, Gurusamy patent discloses the method of accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device, Gurusamy does not disclose connecting a source of radiofrequency energy to the inner tube and applying RF energy to the distal tip. Werneth specifically addresses this in FIGs 1 and 2, stating that the catheter device penetrates the fossa ovalis over a guide wire placed by a trans-septal puncture device, as shown in FIG 1 (¶47). Werneth also specifically addressed that the RF electrodes 130 are delivered from control shaft 160 as the inner tube of catheter shaft 101 (FIG 2, ¶50) to deliver the radiofrequency (RF) energy from the distal tip. Because claims Werneth’s FIG 2 includes accessing the left atrium of the heart from the right and through the fossa ovalis of the heart using the claimed base transseptal punch device comprising a catheter configured to penetrate the fossa ovalis, a person of ordinary skill in the art, seeking to provide additional therapeutic benefit to the patient using Gurusamy’s device architecture would reasonably consult Werneth’s RF ablation energy solution. Werneth’s control shaft comprising a source of RF energy to be applied to the distal tip can be incorporated alongside Gurusamy’s transseptal puncture device (within the same inner lumen) using known assembly methods without redesigning the core delivery path of Gurusamy. Because the references address the same engineering problem (transseptal puncture devices to deliver therapeutic benefits through a penetrated fossa ovalis) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a source of RF energy operably connected to the inner tube of a transseptal puncture device), a person of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Konstorum et al., US 6,749,560 (15 June 2004) teaches an endoscope shaft with a slotted tube.
Mark et al., US 6,419,641 (16 July 2002) teaches flexible tip medical instruments.
Lesh et al., US 6,650,923 (18 November 2003) teaches a method for accessing the left atrium of the heart by locating the fossa ovalis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771