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 .
Claim Objections
Claims 12, 15, 31 and 35 are objected to because of the following informalities:
In claim 12, line 7, the phrase “said end portion” should read “said first end portion”.
In claim 12, lines 9-10, the phrase “said snare assembly” should read “said at least one snare assembly”.
In claim 15, the phrase “said snare assembly” should read “said at least one snare assembly”.
In claim 31, lines 7-8, the phrase “said first steerable catheter radially outward through said first lateral opening” appears to be referring to the second steerable catheter extending radially outward through the second lateral opening; it is suggested to amend the claim to recite the second steerable catheter and the second lateral opening.
In claim 35, the phrase “defines a larger open area a than said first working channel” either appears to include an unnecessary ‘a’ term, or should be amended to provide punctuations around ‘a’ to define the symbol for area.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-6, 8-15, 19-21, 23, 28, 31-32, 34-37 and 40 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.
Regarding claim 1, the claim recites “said lateral openings” in line 9. It is unclear whether the phrase is referring to the lateral opening previously introduced, or introducing new, separate lateral openings. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the first lateral opening previously introduced.
Further, the claim recites “said steering portion” in line 10. There is insufficient antecedent basis for this limitation in the claim, since a steering portion has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the steering section previously introduced.
Regarding claim 10, the claim recites “said first longitudinal axis and said second longitudinal axis”. There is insufficient antecedent basis for this limitation in the claim, since a first and second longitudinal axis have not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a first and second longitudinal axis.
Regarding claim 11, the claim recites “said second lateral opening” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, since a second lateral opening has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a second lateral opening.
Regarding claim 40, the claim recites “tether and said central stem is drawn proximally away” in line 9. It is unclear whether the claim is reciting the tether and the central stem collectively drawn proximally away, or is introducing a tether being drawn proximally away, or the central stem being drawn proximally away. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one of the tether and the central stem being drawn proximally away.
Claims 2-3, 5-6, 8-9, 12-15, 19-21, 23, 28, 31-32, 34-37 are indefinite due to their dependencies on indefinite base claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5-6, 8-15, 19-21, 23, 28, 31-32, 34, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank (US 2002/0058885 A1) in view of Davis (US 2020/0405335 A1).
Regarding base claim 1, Burbank discloses (see abstract; paras. [0069]-[0142]; figs. 1-26f) an open loop écraseur (figs. 1 and 4), comprising:
a trocar (includes 30, para. [0071]) that defines and is colinear with a central axis (fig. 1), said trocar including a distal end portion (includes 38, para. [0072]; fig. 4) that defines a sharp distal tip for percutaneous insertion (may include sharp implement, para. [0072]), said distal end portion defining a first lateral opening (51, para. [0077]) proximate said sharp distal tip (fig. 1);
a central stem (56, para. [0074]) dimensioned for a sliding axial translation within said trocar (pulled proximally, figs. 7-9), said central stem including a first lateral side for alignment adjacent said first lateral opening (considered to have a first lateral side adjacent first slot 51, figs. 7-9);
a cutting wire assembly (includes 48 and 88, para. [0086]) at least partially disposed in said trocar (fig. 7); and
means for closing an écraseur loop (includes actuator system, para. [0098]) for at least partial circumscription of a cutting target (tissue specimen 92, para. [0099]; figs. 6-9).
However, Burbank fails to disclose a first steerable catheter disposed in said trocar along said first lateral side of said central stem, said first steerable catheter defining a first working channel and including a distal steering section that is extendible radially outward through said first lateral openings, a distal extremity of said steering portion being steerable radially inward toward said first lateral opening; the means for closing the écraseur loop via said first steerable catheter for at least partial circumscription of the cutting target, wherein said first steerable catheter is retractable within said trocar in a proximal direction to expose said cutting wire assembly for contraction through said cutting target.
Davis teaches (paras. [0048]-[0056]; figs. 2 and 11), in the same field of endeavor, an open loop écraseur (fig. 2) comprising a first steerable catheter (includes 130, para. [0048]; fig. 2) disposed in a sheath (102) along a first lateral side of a central stem (108, disposed laterally of 108, para. [0046]; fig. 6), said first steerable catheter defining a first working channel (defines hollow conduit, para. [0048]) and including a distal steering section (considered to include portion which extends past sheath 102, fig. 2) that is extendible radially outward through an opening (see bend in distal portion of guides 130 and 132 radially outward, figs. 2 and 22-30), a distal extremity of said steering portion being steerable radially inward toward the opening (see distal portion of guides 130 and 132 extending radially inward, figs. 22-30); means for closing the loop via said first steerable catheter for at least partial circumscription of a cutting target (includes actuators 210 and 220, paras. [0056] and [0058]; figs. 22-30), wherein said first steerable catheter is retractable within the sheath in a proximal direction to expose said cutting wire assembly for contraction through said cutting target (extended and retracted with respect to the sheath, para. [0056]), for the purpose of providing a guide for the wires to manipulate the relative shape of the basket (paras. [0056] and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burbank to further include steerable guides for sheath deployment members 48 and cutting member 88, in order to protect the sheath deployment members and cutting member when desired, while also providing the capability of manipulating which portions of the wires contact tissue, based on the suggestions and teachings of Davis (paras. [0056] and [0061]).
Burbank (as modified) further teaches the first steerable catheter disposed in said trocar along said first lateral side of said central stem (combination considered to further teach guides surrounding members 48 and 88 of Burbank and therefore located similarly), the distal steering section is extendible radially outward through said first lateral openings (combination considered to further teach guides of Davis extended similarly around members 48 and 88, which extend through slots 51 of Burbank), the distal extremity of said steering portion being steerable radially inward toward said first lateral opening (combination considered to further teach guides steerable radially inwardly, figs. 22-30 of Davis); wherein said first steerable catheter is retractable within said trocar in a proximal direction to expose said cutting wire assembly for contraction through said cutting target (combination considered to further teach guides extendable and retractable relative to members 48 and 88 of Burbank).
Regarding claim 2, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank further discloses wherein said central stem is retractable within said trocar in said proximal direction (para. [0095]) to expose said cutting wire assembly for contraction through said cutting target (considered to expose different portions of members 48 through proximal retraction, para. [0095]).
Regarding claim 5, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank further discloses wherein said first lateral opening defines a first longitudinal axis in a direction parallel to said central axis (depicted in fig. 4).
Regarding claim 6, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said central stem includes a first steerable catheter deflector portion (54, para. [0081] of Burbank) for tangential alignment with said first lateral opening (figs. 7-9 of Burbank), said first steerable catheter deflector portion extending radially outward and in a distal direction (extends radially outward and in a distal direction relative to rod, fig. 7 of Burbank) for deflection of said first steerable catheter radially outward through said first lateral opening (combination considered to provide deflection of guides radially outward as cap 54 is deployed distally and pulled proximally, changing the position of guides and members 48 and 88, para. [0095] of Burbank).
Regarding claim 8, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said distal steering section of said first steerable catheter includes a steering spine (walls of guides considered to function as a steering spine, figs. 2 and 22-30 of Davis).
Regarding claim 9, Burbank (as modified) teaches the open loop écraseur of claim 8. Burbank (as modified) further teaches wherein said first steerable catheter includes a steering wire (cord 85, para. [0085]; figs. 4-4a of Burbank) for manipulation of said steering spine (combination considered to further teach cord 85 aiding in manipulation of guides of Davis, due to positioning of internal sheath deployment members).
Regarding claim 10, Burbank (as modified) teaches the open loop écraseur of claim 9. Burbank further discloses wherein said first longitudinal axis and said second longitudinal axis are coplanar with a plane that is radially offset from said central axis (considered to be a first and second longitudinal axis of slots 51, which extend circumferentially around shaft 30 and are considered to be coplanar and radially offset relative to the central axis, fig. 4).
Regarding claim 11, Burbank (as modified) teaches the open loop écraseur of claim 9. Burbank further discloses wherein said first lateral opening and said second lateral opening are diametrically opposed on said trocar (considered to be first and second slots 51, depicted as diametrically opposed, figs. 1-9).
Regarding claim 12, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said means for closing said écraseur loop includes at least one snare assembly (14, para. [0082]; fig. 4 of Burbank) that defines a snare axis (fig. 4 of Burbank) and is axially translatable within an internal bypass (lumen of 34 of Burbank) defined within said trocar (fig. 7 of Burbank), each of said at least one snare assembly including a snare portion (46 of Burbank) at a distal end thereof for coupling with a first end portion of said cutting wire assembly (couples with 48, para. [0085] of Burbank), said first end portion being disposed in said first working channel of said first steerable catheter (combination further teaches guides for sheath deployment members 48 of Burbank), said internal bypass being in fluid communication with said distal end portion of said trocar (via distal opening of 34 of Burbank) for translation of said snare portion into said distal end portion of said trocar (via proximal retraction of sheath deployment members 48, figs. 7-9 of Burbank), said end portion being extendible through said first working channel to exit said distal extremity of said distal steering section of said first steerable catheter for coupling with said snare portion (via proximal retraction, considered to be capable of extending distally past distal extremity of guides via proximal and distal movement of guides, figs. 7-9 of Burbank), said snare assembly being retractable in a proximal direction for said at least partial circumscription of said cutting target (via proximal and distal movement of 56, figs. 7-9 of Burbank).
Regarding claim 13, Burbank (as modified) teaches the open loop écraseur of claim 12. Burbank (as modified) further teaches wherein said first end portion of said cutting wire assembly includes a guide wire at a free end thereof (cord 85, para. [0085]) that is attached to a cutting wire (member 88 considered to be cutting wire).
Regarding claim 14, Burbank (as modified) teaches the open loop écraseur of claim 12. Burbank further discloses wherein said first end portion includes a head portion (70, para. [0076]) for secure coupling with said snare portion (figs. 7-9).
Regarding claim 15, Burbank (as modified) teaches the open loop écraseur of claim 12. Burbank further discloses wherein said snare assembly includes a sleeve (sheath is considered to be a sleeve) selectively translatable over said snare axis for closure of said snare portion (para. [0100]; figs. 7-9).
Regarding claim 19, Burbank (as modified) teaches the open loop écraseur of claim 12. Burbank further discloses wherein said snare portion is elastically collapsible (sheath made of elastic material, considered to be collapsible, para. [0102]).
Regarding claim 20, Burbank (as modified) teaches the open loop écraseur of claim 12. Burbank further discloses wherein said snare portion includes a basket portion (considered to be a basket portion, figs. 10a-c).
Regarding claim 21, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said means for closing said écraseur loop includes:
a first snare assembly (14, para. [0082]; fig. 4 of Burbank) that is translatable within said first working channel of said first steerable catheter (combination considered to further teach 14 connected to members 48 extending similarly through guides, figs. 7-9 of Burbank) and includes a first snare portion (46 of Burbank) at a distal end thereof for coupling with a first end portion of said cutting wire assembly (couples with 48, para. [0085] of Burbank), said first snare portion being extendible through said first working channel to exit a distal extremity of said distal steering section of said first steerable catheter for positioning said snare portion adjacent and exterior to said first lateral opening of said trocar (via proximal retraction, considered to be capable of extending distally past distal extremity of guides via proximal and distal movement of guides, figs. 7-9 of Burbank); and
a first exit port (opening of 54, para. [0081] of Burbank) defined at a distal end of said central stem (figs. 7-9 of Burbank), said first exit port being in fluid communication with an internal bypass defined within said trocar that extends axially and proximally from said first exit port (lumen of 34, para. [0071] of Burbank), said first exit port being in fluid communication with said distal end portion of said trocar (figs. 7-9), said first exit port defining an exit port axis that extends radially outward in a distal direction (extends radially outward and in a distal direction relative to rod, fig. 7 of Burbank) for deflection of said first end portion through said first lateral opening of said trocar for coupling with said snare portion (combination considered to provide deflection of guides radially outward as cap 54 is deployed distally and pulled proximally, changing the position of guides and members 48 and 88, para. [0095] of Burbank),
said first end portion of said cutting wire assembly being disposed within said internal bypass and extending through said first exit port (extends through opening of 54 via distal portions of 48, figs. 7-9 of Burbank), said first snare assembly and said central stem being retractable in a proximal direction for said at least partial circumscription of said cutting target (via proximal and distal movement of 56, figs. 7-9 of Burbank).
Regarding claim 23, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said means for closing said écraseur loop includes:
a first snare assembly (14, para. [0082]; fig. 4 of Burbank) that is translatable within said first working channel of said first steerable catheter (combination considered to further teach 14 connected to members 48 extending similarly through guides, figs. 7-9 of Burbank) and includes a first snare portion (46 of Burbank) at a distal end thereof for coupling with a first end portion of said cutting wire assembly (couples with 48, para. [0085] of Burbank), said first snare portion being extendible through said first working channel to exit a distal extremity of said distal steering section of said first steerable catheter for positioning said snare portion adjacent and exterior to said first lateral opening of said trocar (via proximal retraction, considered to be capable of extending distally past distal extremity of guides via proximal and distal movement of guides, figs. 7-9 of Burbank); and
an internal bypass (lumen of 34, para. [0071] of Burbank) defined within said trocar that extends axially and is in fluid communication with said distal end portion of said trocar (figs. 7-9), said first end portion being disposed within said internal bypass (figs. 7-9) and extending into said distal end portion of said trocar (figs. 7-9) and around and proximal to a distal end of said central stem to extend axially and along said first lateral side of said central stem and adjacent said first lateral opening (figs. 7-9 of Burbank, extends proximal of distal end portion of 56),
wherein translation of said first end portion of said cutting wire assembly in a proximal direction within said internal bypass (via proximal and distal movement of 56) causes a distal extremity of said first end portion of said cutting wire assembly to deflect radially outward through said first lateral opening for coupling with said first snare portion (depicted in figs. 7-9).
Regarding claim 28, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said means for closing said écraseur loop includes:
a snare assembly (14, para. [0082]; fig. 4 of Burbank) that is translatable within said first working channel of said first steerable catheter (combination considered to further teach 14 connected to members 48 extending similarly through guides, figs. 7-9 of Burbank) and includes a snare portion (46 of Burbank) at a distal end thereof for coupling with a first end portion of said cutting wire assembly (couples with 48, para. [0085] of Burbank), said snare portion being extendible through said first working channel to exit a distal extremity of said distal steering section of said first steerable catheter for positioning said snare portion adjacent and exterior to said first lateral opening of said trocar (via proximal retraction, considered to be capable of extending distally past distal extremity of guides via proximal and distal movement of guides, figs. 7-9 of Burbank); and
a second steerable catheter (guide 132, para. [0048] of Davis) disposed in said trocar along a second lateral side of said central stem (considered to be on lateral side of stem adjacent second slot 51), said second steerable catheter defining a second working channel (hollow conduit, para. [0048] of Davis) and including a distal steering section (considered to include portion which extends past sheath 102, fig. 2) that is extendible radially outward through a second lateral opening defined at said distal end portion of said trocar proximate said sharp distal tip (combination considered to further teach guides of Davis extended similarly around members 48 and 88, which extend through slots 51 of Burbank), a distal extremity of said second steerable catheter being steerable radially inward toward said second lateral opening (combination considered to further teach guides steerable radially inwardly, figs. 22-30 of Davis), said first end portion of said cutting wire assembly being disposed in said second working channel of said second steerable catheter (combination considered to further teach members 48 and 88 disposed within conduit of guides), a distal extremity of said first end portion being routed through said first lateral opening and said second lateral opening for coupling with said snare portion (figs. 7-9 of Burbank),
wherein said snare portion is coupled to said first end portion of said cutting wire assembly (figs. 7-9 of Burbank) and said snare assembly is retracted to draw said cutting wire assembly into said first working channel for said at least partial circumscription of said cutting target (via proximal and distal movement of 56, figs. 7-9 of Burbank).
Regarding claim 31, Burbank (as modified) teaches the open loop écraseur of claim 28. Burbank (as modified) further teaches wherein said central stem includes a first steerable catheter deflector portion (first access slot 80, para. [0081]; fig. 5) and a second steerable catheter deflector portion (second access slot 80, para. [0081]; fig. 5 of Burbank) proximate a distal end of said central stem (figs. 7-9) for tangential alignment with said first lateral opening and said second lateral opening (figs. 7-9), respectively, said first steerable catheter deflector portion extending radially outward and in a distal direction (considered to extend radially outward and distally relative to rod) for deflection of said first steerable catheter radially outward through said first lateral opening (combination considered to provide deflection of guides radially outward as cap 54 is deployed distally and pulled proximally, changing the position of guides and members 48 and 88, para. [0095]), said second steerable catheter deflector portion extending radially outward and in a distal direction (considered to extend radially outward and distally relative to rod) for deflection of said first steerable catheter radially outward through said first lateral opening (combination considered to provide deflection of guides radially outward as cap 54 is deployed distally and pulled proximally, changing the position of guides and members 48 and 88, para. [0095]).
Regarding claim 32, Burbank (as modified) teaches the open loop écraseur of claim 31. Burbank further discloses wherein the first and second steerable catheter deflector portions are diametrically opposed on said central stem (figs. 5 and 7).
Regarding claim 34, Burbank (as modified) teaches the open loop écraseur of claim 1. Burbank (as modified) further teaches wherein said means for closing said écraseur loop includes:
a first end portion of said cutting wire assembly disposed in said first working channel of said first steerable catheter (combination considered to further teach end portions of members 48 and 88 disposed within guides of Davis);
a second steerable catheter (guide 132, para. [0048] of Davis) disposed in said trocar along a second lateral side of said central stem (considered to be on lateral side of stem adjacent second slot 51), said second steerable catheter defining a second working channel (hollow conduit, para. [0048] of Davis) and including a distal steering section (considered to include portion which extends past sheath 102, fig. 2) that is extendible radially outward through a second lateral opening defined at said distal end portion of said trocar proximate said sharp distal tip (combination considered to further teach guides of Davis extended similarly around members 48 and 88, which extend through slots 51 of Burbank), a distal extremity of said second steerable catheter being steerable radially inward toward said second lateral opening (combination considered to further teach guides steerable radially inwardly, figs. 22-30 of Davis);
wherein said distal steering section of said first steerable catheter is steerable through said first lateral opening and said distal steering section of said second steerable catheter is steerable through said second lateral opening for lateral alignment of the distal extremities of said first steerable catheter and said second steerable catheter within said distal end portion of said trocar (combination considered to further teach guides of Davis steerable through slots 51 of Burbank).
However, Burbank (as modified) fails to specifically teach said first end portion of said cutting wire assembly being extendible from said first working channel into said second working channel to at least partially circumscribe said cutting target with said cutting wire assembly.
Davis teaches (paras. [0050]-[0052]; figs. 1-10), in the same field of endeavor, an open loop écraseur comprising a first end portion of a cutting wire assembly (includes wire 144) being extendible from a first working channel (lumen of guide 130) into a second working channel (lumen of guide 132, forms a loop between guides 130 and 132, para. [0052]; fig. 2) to at least partially circumscribe a cutting target with the cutting wire assembly (figs. 7-10), for the purpose of providing a triangular configuration of repositionable loops that captures objects within its interior region (para. [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burbank (as modified) to include at least one loop of the cutting wire assembly extending between first and second guides, in order to provide a loop that extends across the distal end of the device, providing a triangular configuration of repositionable loops that captures objects within its interior region, based on the suggestions and teachings of Davis (para. [0050]).
Regarding claim 37, Burbank (as modified) teaches the open loop écraseur of claim 34. Burbank (as modified) further teaches comprising a guide stem (54, para. [0074] of Burbank) disposed within and dimensioned for sliding axial translation within said trocar (via proximal and distal movement of 56), said guide stem including a hollow tubular portion (depicted in figs. 7-9) that extends to a distal tip portion (depicted in figs. 7-9), said hollow tubular portion being dimensioned to receive said central stem for sliding axial translation within said hollow tubular portion (56 slides when connected to hollow portion of 54, figs. 7-9), said guide stem defining first and second lateral openings (slots 80, fig. 5) configured for tangential alignment with the first and second lateral openings, respectively, of said trocar (via sheath deployment members, figs. 7-9), said distal tip portion including a proximal face (proximal face of tip which 86 engages) that cooperates with a distal face of said central stem (86) for selective clamping of and said lateral alignment of the distal extremities of said first steerable catheter and said second steerable catheter within said distal end portion of said trocar (combination considered to further teach appropriate alignment of first and second guides and selective clamping via slots 51 of Burbank).
Regarding claim 40, Burbank (as modified) teaches the open loop écraseur of claim 34. Burbank further discloses comprising:
a distal alignment head (54, para. [0074]; figs. 7-9) dimensioned for sliding axial translation through said distal end portion of said trocar (considered to be slidable through proximal and distal movement of 56 to 38) to proximate a distal end of the first and second lateral openings, of said trocar (figs. 7-9); and
coupling means (ring 82, para. [0081]) for drawing said distal alignment head against a distal face of said central stem to define a retracted configuration (positions end cap 54 against a distal face of 56, figs. 5 and 7-9),
wherein said distal alignment head is seated within said distal end portion of said trocar proximate said distal end of the first and second lateral openings and said central stem (considered to be within distal end portion, figs. 7-9),
tether (49, para. [0085]) and said central stem is drawn proximally away from said distal alignment head to define an expanded configuration (ligatures 49 formed by cords 85 considered to be drawn proximally away at least when cap 54 is pushed distally, because balls 70 would be pushed proximally when rod 56 is pushed distally, see figs. 7-9).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burbank in view of Davis as applied to claim 1 above, and further in view of Lippitt (US 5906622).
Regarding claim 3, Burbank (as modified) teaches the open loop écraseur of claim 1.
However, Burbank (as modified) fails to explicitly teach wherein said trocar is metallic.
Lippitt teaches (col. 5 lines 24-37; fig. 1), in the same field of endeavor, an open loop écraseur comprising a metallic outer tubular member (col. 5 lines 24-37).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to form the shaft of Burbank of a metallic material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Burbank in view of Davis as applied to claim 34 above, and further in view of Rafiee (US 2021/0137579 A1).
Regarding claim 35, Burbank (as modified) teaches the open loop écraseur of claim 34.
However, Burbank (as modified) fails to teach wherein said second working channel at said distal extremity of said second steerable catheter defines a larger open area a than said first working channel at said distal extremity of said first steerable catheter.
Rafiee teaches (para. [0027]; figs. 1a-d), an open loop écraseur comprising a second working channel (channel of 10 and 24) at a distal extremity of a second steerable catheter defining a larger open area than a first working channel at a distal extremity of a first steerable catheter (larger compared to 20, figs. 1a-d), for the purpose of spreading applied stress out over a larger area, which can be of particular benefit when contacting delicate anatomical structures (para. [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second working channel of Burbank (as modified) to have a larger open area lumen than the first working channel, in order to provide the capability of spreading applied stress out over a larger area, providing a particular benefit when contacting delicate anatomical structures, based on the teachings of Rafiee (para. [0027]).
Regarding claim 36, Burbank (as modified) teaches the open loop écraseur of claim 35.
Burbank (as modified) further teaches the distal steering section of the second steerable catheter defines a single lumen (conduit of guide 132 of Davis).
However, Burbank (as modified) fails to specifically teach wherein said distal steering section of said first steerable catheter defines at least two lumens.
Rafiee teaches (para. [0031]), in the same field of endeavor, a distal steering section of a first steerable catheter (10) defining at least two lumens (one or more lumens), for the purpose of providing additional lumens for passage of a further medical instrument such as a guidewire or viewing scope (para. [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Burbank (as modified) such that the first guide defines at least two lumens, in order to provide the capability of providing passage of a further medical instrument such as a guidewire or additional sheath deployment member or cutting member by housing multiple instruments with the same guide member when desired, based on the suggestions and teachings of Rafiee (para. [0031]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2003/0163129 A1 to Lee, disclosing a tissue severing and removal device.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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