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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/26/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25-26 and 28-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Figures depict the proximal transition portion decreasing as it transitions to the flexible member, and the distal transition portion increasing as it transitions to the flexible member to the distal transition portion. However, the text of the specification, as originally filed, appears to fail to disclose either of linear increases/decreases and/or logarithmic increases/decreases to the proximal and/or distal transition portion. Further, it is hard to distinguish differing levels of transition that include both specific linear and/or logarithmic transitions from the Figures, as originally filed. If the Examiner has inadvertently overlooked any support for this claimed subject matter, Applicant is request to provide direct citations for such support and reconsideration will be provided.
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.
Regarding claims 28-29, the phrase "the distal portion decreases … along the longitudinal axis from the flexible portion to the distal portion" (emphasis added) renders the claim(s) indefinite because claim 27 already requires the cross-sectional area of the distal transition portion to increase along the longitudinal axis from the flexible portion to the distal portion, thereby rendering the scope of the claim(s) unascertainable due to the contradicting claim requirement. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 40 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fagan et al. (US 2021/0353325) as supported by Provisional Application No. 63/026,377.
Fagan discloses (see Figs. 2-5B) an ultrasonic surgical instrument comprising the following claim limitations:
(claim 40) (claim 40) A method of deflecting an end effector (200, Fig. 2) of an ultrasonic surgical instrument (20, Fig. 2), wherein the ultrasonic surgical instrument (20) has a shaft assembly (214, Fig. 2) including (a) a proximal shaft portion (216) defining a longitudinal axis (i.e., longitudinal axis of 214); (b) a distal shaft portion (218) (as shown in Fig. 2); and (c) an articulation section (i.e., shaft portion extending from 210 to 230, Fig. 2 and extending from 410 to 430 in Figs. 4A-5B) extending between the proximal and distal shaft portions (as shown in Figs. 2 and 5A-5B), the method comprising:(a) articulating the articulation section (at 210/410) in a first direction to thereby deflect the distal shaft portion (218) relative to the longitudinal axis and through a first plane (i.e., active deflection step as shown at 210/410 in Figs. 2, 4B and 5B along the Y-axis; [0087]); and (b) articulating the articulation section (at 230/430) in a second direction different from the first direction to thereby deflect the distal shaft portion (218) relative to the longitudinal axis and through a second plane different from the first plane (i.e., active deflection step as shown at 230/430 in Figs. 2, 4A and 5A along the Z-axis; [0087]), wherein the first plane forms a first angle with the longitudinal axis (i.e., along the Y-axis, as shown in Figs. 2, 4B and 5B; [0087]) and the second plane forms a second angle with the longitudinal axis (i.e., along the Z-axis, as shown in Figs. 2 and 4A and 5A; [0087]), the first angle being proximal to the second angle (as shown in Figs. 2 and 5A-5B), and the first plane being perpendicular to the second plane (as shown in Figs. 2 and 5A-5B, end effector 200 is deflectable in along both the Y and Z axes that are perpendicular to each other).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-25, 27-28, 30-33 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Fagan et al. (US 2021/0353325) as supported by Provisional Application No. 63/026,377 in view of Olsen et al. (US 9,095,367).
Fagan discloses (see Figs. 2-5B) an ultrasonic surgical instrument comprising the following claim limitations:
(claim 21) An ultrasonic surgical instrument (20, Fig. 2), comprising:(a) a shaft assembly (214, Fig. 2), wherein the shaft assembly (20) comprises: (i) a proximal shaft portion (216) extending along a longitudinal axis (i.e., longitudinal axis of 214), and (ii) an articulation section (i.e., shaft portion extending from 210 to 230, Fig. 2 and extending from 410 to 430 in Figs. 5A-5B) extending distally from the proximal shaft portion (as shown in Figs. 2 and 5A-5B); (b) a waveguide (401, Figs. 4A-5B) including a proximal portion (i.e., portion disposed proximal to region 410, as shown in Figs. 5A-5B), a proximal transition portion (i.e., proximal/rightmost tapered portion adjacent to region 410, as shown in Fig. 5B), a distal transition portion (i.e., distal/leftmost tapered portion adjacent to region 430, as shown in Fig. 5A), a distal portion (i.e., portion disposed distal to region 430, as shown in Figs. 5A-5B), and a flexible portion (i.e., extending from region 410 to region 430, as shown in Figs. 5A-5B; [0082]), wherein the flexible portion is directly coupled to both the proximal transition portion and the distal transition portion (as expressly shown in Figs. 5A-5B), a cross-sectional area of the flexible portion (i.e., at 410/430 in Figs. 5A-5B) is less than a cross-sectional area of the proximal portion (i.e., portions 410/430 are reduced in cross-sectional area as compared to the full thickness proximal portion) and less than a cross-sectional area of the distal portion (i.e., portions 410/430 are reduced in cross-sectional area as compared to the full thickness distal portion), the proximal transition portion having a cross-sectional area greater than the cross-sectional area of the flexible portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a greater cross-sectional area than flexible portion 410, as shown in Fig. 5B) and less than the cross-sectional area of the proximal portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a lesser cross-sectional area than the full thickness proximal portion, as shown in Fig. 5B), the distal transition portion having a cross-sectional area greater than the cross-sectional area of the flexible portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a greater cross-sectional area than flexible portion 430, as shown in Fig. 5A) and less than the cross-sectional area of the distal portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a lesser cross-sectional area than the full thickness distal portion, as shown in Fig. 5A), and the flexible portion extends at least partially through the articulation section (as shown in Figs. 2 and 4A-5B; [0082]); and (c) an end effector (200, Fig. 2) arranged at a distal end of the shaft assembly (214) (as shown in Fig. 2), wherein the end effector (200) includes an ultrasonic blade (202, Fig. 2) acoustically coupled with the waveguide (401) and configured to be driven by the waveguide with ultrasonic energy ([0087]), wherein the articulation section is configured to selectively bend the flexible portion to thereby deflect the end effector relative to the longitudinal axis and through a first plane (i.e., deflection as shown at 210/410 in Figs. 2 and 5B along the Y-axis), wherein the articulation section is further configured to selectively bend the flexible portion to thereby deflect the end effector relative to the longitudinal axis and through a second plane (i.e., deflection as shown at 230/430 in Figs. 2 and 5A along the Z-axis), and wherein the second plane (Z-axis, as shown in Fig. 5A) is perpendicular to the first plane (Y-axis, as shown in Fig. 5B) for multiplanar deflection of the end effector relative to the longitudinal axis (as shown in Figs. 5A-5B, end effector 200 is deflectable in along both the Y and Z axes that are perpendicular to each other);
(claim 22) wherein the cross-sectional area of the proximal transition portion, in its entirety, is greater than the cross-sectional area of the flexible portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a greater cross-sectional area than flexible portion 410, as shown in Fig. 5B);
(claim 23) wherein the cross-sectional area of the distal transition portion, in its entirety, is greater than the cross-sectional area of the flexible portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a greater cross-sectional area than flexible portion 430, as shown in Fig. 5A);
(claim 24) wherein the cross-sectional area of the proximal transition portion decreases along the longitudinal axis from the proximal portion to the flexible portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a distally tapering cross-sectional area, as shown in Fig. 5B);
(claim 25) wherein the cross-sectional area of the proximal transition portion decreases linearly along the longitudinal axis from the proximal portion to the flexible portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a distally, linearly tapering cross-sectional area, as shown in Fig. 5B);
(claim 27) wherein the cross-sectional area of the distal transition portion increases along the longitudinal axis from the flexible portion to the distal portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a distally increasing cross-sectional area, as shown in Fig. 5A);
(claim 28) wherein the cross-sectional area of the distal transition portion decreases linearly along the longitudinal axis from the flexible portion to the distal portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a distally, linearly increasing cross-sectional area, as shown in Fig. 5A);
(claim 30) An ultrasonic surgical instrument (20, Fig. 2), comprising:(a) an end effector (200, Fig. 2) including an ultrasonic blade (202, Fig. 2); and (b) a shaft assembly (214, Fig. 2), including: (i) a proximal shaft portion (216) defining a longitudinal axis (i.e., longitudinal axis of 214), (ii) a distal shaft portion (218, Fig. 2), (iii) an articulation section (i.e., shaft portion extending from 210 to 230, Fig. 2 and extending from 410 to 430 in Figs. 5A-5B) extending between the proximal (216) and distal (218) shaft portions (as shown in Figs. 2-5B), and (c) a waveguide (401, Figs. 4A-5B) including a proximal portion (i.e., portion disposed proximal to region 410, as shown in Figs. 5A-5B), a proximal transition portion (i.e., proximal/rightmost tapered portion adjacent to region 410, as shown in Fig. 5B), a distal transition portion (i.e., distal/leftmost tapered portion adjacent to region 430, as shown in Fig. 5A), a distal portion (i.e., portion disposed distal to region 430, as shown in Figs. 5A-5B), and a flexible portion (i.e., extending from region 410 to region 430, as shown in Figs. 5A-5B; [0082]; [0087]), wherein the flexible portion is directly coupled to both the proximal transition portion and the distal transition portion (as expressly shown in Figs. 5A-5B), a cross-sectional area of the flexible portion (i.e., at 410/430 in Figs. 5A-5B) is less than a cross-sectional area of the proximal portion (i.e., portions 410/430 are reduced in cross-sectional area as compared to the full thickness proximal portion) and less than a cross-sectional area of the distal portion (i.e., portions 410/430 are reduced in cross-sectional area as compared to the full thickness distal portion), the proximal transition portion having a cross-sectional area greater than the cross-sectional area of the flexible portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a greater cross-sectional area than flexible portion 410, as shown in Fig. 5B) and less than the cross-sectional area of the proximal portion (i.e., proximal/rightmost tapered portion adjacent to region 410 has a lesser cross-sectional area than the full thickness proximal portion, as shown in Fig. 5B), the distal transition portion having a cross-sectional area greater than the cross-sectional area of the flexible portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a greater cross-sectional area than flexible portion 430, as shown in Fig. 5A) and less than the cross-sectional area of the distal portion (i.e., distal/leftmost tapered portion adjacent to region 430 has a lesser cross-sectional area than the full thickness distal portion, as shown in Fig. 5A), and the flexible portion extends at least partially through the articulation section (as shown in Figs. 2 and 4A-5B; [0082]; [0087]), wherein the articulation section is configured to articulate in a first direction to thereby deflect the ultrasonic blade relative to the longitudinal axis and through a first plane (i.e., deflection as shown at 210/410 in Figs. 2 and 5B along the Y-axis), wherein the articulation section is further configured to articulate in a second direction to thereby deflect the ultrasonic blade relative to the longitudinal axis and through a second plane (i.e., deflection as shown at 230/430 in Figs. 2 and 5A along the Z-axis), wherein the second direction (Z-axis, as shown in Fig. 5A) is perpendicular to the first direction (Y-axis, as shown in Fig. 5B) such that the second plane is perpendicular to the first plane for multiplanar deflection of the ultrasonic blade relative to the longitudinal axis (as shown in Figs. 5A-5B, end effector 200 with blade 202 is deflectable in along both the Y and Z axes that are perpendicular to each other);
(claim 31) wherein the articulation section (210/230;410/430) of the shaft assembly (214) defines an articulation section lumen (i.e., lumen through 214) configured to provide clearance between the flexible portion of the waveguide and the articulation section throughout deflection of the end effector relative to the longitudinal axis through the first and second planes (as expressly shown in Figs. 2 and 4A-4B; [0082]; [0087]);
(claim 32) wherein the articulation section (210/230;410/430) defines a plurality of rotational axes (i.e., both Y-axis and Z-axis), wherein the articulation section is configured to selectively rotate the end effector about the rotational axes during deflection of the end effector relative to the longitudinal axis through at least one of the first or second planes (as expressly shown in Figs. 2-5B; [0082]; [0087]);
(claim 33) wherein the plurality of rotational axes includes at least one pitch axis (i.e., along the Z-axis) and at least one yaw axis (i.e., along the Y-axis) (as shown in Figs. 2-5B; [0082]; [0087]);
(claim 37) wherein the articulation section (210/230;410/430) of the shaft assembly (214) is configured to limit the flexible portion of the waveguide (401) to a predetermined maximum bend radius ([0081]; range expressly limited from about 1 degree to about 45 degrees); and
(claim 38) wherein the articulation section (210/230;410/430) of the shaft assembly (214) defines an articulation section lumen (i.e., lumen through 214) configured to provide clearance between the flexible portion of the waveguide and the articulation section when the flexible portion of the waveguide is bent to the predetermined maximum bend radius (as expressly shown in Figs. 2 and 4A-4B; [0082]; [0087]).
Fagan, as applied above, discloses an ultrasonic surgical instrument and method comprising all the limitations of the claim except for the entirety of the flexible portion comprising a reduced cross-sectional area. Instead, the reduced cross-sections (210/230;410/430) are reduced only along the x-z plane or the x-y plane and not entirely between the proximal and distal portions (as shown in Figs. 5A-5B).
However, Olson teaches (see Figs. 43-50) an ultrasonic surgical instrument (e.g., 538, Fig. 44) with a waveguide (802) having a proximal portion (804), a distal portion (808), and a flexible portion (806), wherein the flexible portion is directly coupled to both the proximal portion and the distal portion (as shown in Fig. 47), in which the waveguide (802) is reduced only along a single plane (as shown in Fig. 47), similar to the waveguide of Fagan, or alternatively, Olson further teaches a waveguide (1102, Fig. 50) including a proximal portion (1104), a distal portion (1108), and a flexible portion (1106) directly coupled to both the proximal portion and the distal portion (as shown in Fig. 50), wherein the flexible portion, in its entirety, comprises a reduced cross-sectional area compared to both the proximal portion and the distal portion (as shown in Fig. 50) to allow for an equal flex bias in all directions/axes (col. 39, lines 4-8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the flexible portion of the waveguide of Fagan for the flexible portion of the waveguide of Olson, such that the flexible portion has a reduced cross-sectional area in its entirety as taught by Olson. The claim would have been obvious because the substitution of one known element (ribbon shaped flexible portion of waveguide) for another (cylindrical shaped flexible portion of waveguide) would have yielded the predictable result of allowing the waveguide to bend with the articulation section. Additionally, or alternatively, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of allowing the articulation section to bend in two different planes as the reduced cross-sectional area of the flexible portion in its entirety would allow for an equal flex bias in all directions between the proximal and distal portions of the waveguide.
Claim(s) 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Fagan in view of Olsen as applied to claims 24 and 27 above, and further in view of Stulen et al. (US 2016/0302819).
Fagan in view of Olsen, as applied above, discloses an ultrasonic surgical instrument and method comprising all the limitations of the claim except for wherein the cross-sectional area of the proximal transition portion decreases logarithmically along the longitudinal axis from the proximal portion to the flexible portion, and wherein the cross-sectional area of the distal transition portion increases logarithmically along the longitudinal axis from the flexible portion to the distal portion.
Stulen teaches (see Figs. 3-4, 6A-6B, 12-13 and 33A-33B) a similar ultrasonic surgical instrument and method comprising logarithmically transitions (e.g., see logarithmic/curved proximal and distal transitions of the flexible portion 266 of waveguide 280) from proximal and distal portions of the waveguide (280) to the flexible portion (266) (as shown in Figs. 12-13). Accordingly, Stulen teaches that it is known that logarithmic waveguide transitions and linear waveguide transitions are elements that are functional equivalents for providing the transfer of ultrasonic vibrations through the flexible portion of a waveguide to an ultrasonic blade ([0084]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the logarithmic waveguide transitions taught by Stulen for the linear waveguide transitions of Fagan because both elements were known equivalents for providing the transfer of ultrasonic vibrations through the flexible portion of a waveguide to an ultrasonic blade within the ultrasonic surgical instrument art. The substitution would have resulted in the predictable results of providing the transfer of ultrasonic vibrations through the flexible portion of a waveguide to an ultrasonic blade to the device of Fagan in view of Olsen.
Claim(s) 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Fagan in view of Olsen as applied to claim 32 above, and further in view of Schuh et al. (US 2020/0093554).
Fagan in view of Olsen, as applied above, discloses an ultrasonic surgical instrument and method comprising all the limitations of the claim except for the plurality of rotational axes including a proximal pitch axis and a distal pitch axis and/or a proximal yaw axis and a distal yaw axis, and a plurality of articulation cable segments grounded to at least a portion of the articulation section of the shaft assembly, wherein selective manipulation of the articulation cable segments causes deflection of the end effector relative to the longitudinal axis through the first and second planes.
However, regarding claims 34-35, Schuh teaches (see Figs. 23A-24B) a similar articulating surgical instrument (i.e., with an articulating portion at 212) comprising a plurality of rotational axes including a proximal pitch axis (along joint 252A, pitch axis; [0154]) and a distal pitch axis (along joint 252C) and/or a proximal yaw axis (along joint 252B, yaw axis; [0154]) and a distal yaw axis (along joint 252D) in order to beneficially including more than one joint in the articulation portion to thereby allow for both an increased range of motion in at least two degrees of freedom and a further cumulative increase in articulation range within each respective degree of freedom for improved access and articulation at a treatment site ([0154]-[0155]).
Regarding claim 36, Fagan in view of Olsen discloses the invention as claimed, and Fagan further teaches embodiments with articulation cables (see for example, Fig. 8) but fails to explicitly disclose a plurality of articulation cable segments grounded to at least a portion of the articulation section of the shaft assembly, wherein selective manipulation of the articulation cable segments causes deflection of the end effector relative to the longitudinal axis through the first and second planes.
However, Schuh teaches (see Figs. 23A-24B) a surgical instrument comprising a shaft assembly (202, Figs. 23A-23B) comprising a plurality of articulation cable segments (pull wires 236A1-A4, 236B1-B4) grounded to at least a portion of the articulation section of the shaft assembly (via holes 260 in the links 250), wherein selective manipulation of the articulation cable segments causes deflection of the distal end (248, 24B) relative to the longitudinal axis through the first and second planes (([0154]-[0155]; [0161]-[0163]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the articulation section of Fagan in view of Olsen the articulation section of Schuh as claimed. The claims would have been obvious because the substitution of one known element (articulation section) for another would have yielded the predictable result of articulating the end effector in two different planes with respect to the longitudinal axis. Further, the articulation section of Schuh would increase the range of motion of the articulation section for the users benefit in advancement to desired treatment sites (([0154]-[0155]; [0161]-[0163]).
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figs. 2-5B of Fagan in view of Olsen as applied to claims 30 above, and further in view of the embodiment of Figs. 17-19 of Fagan.
The embodiment of Figs. 2-5B of Fagan discloses an ultrasonic surgical instrument comprising the following claim limitations:
(claim 39) wherein the end effector (200, Fig. 2) further includes a clamp arm (201, Fig. 2) movably secured relative to the ultrasonic blade (202, Fig. 2) and configured to move from an open position configured to receive a tissue (open position shown in Fig. 2) toward a closed position configured to clamp the tissue against the ultrasonic blade (202) ([0081]; jaw 201 is expressly pivotable relative to ultrasonic blade 202).
The embodiment of Figs. 2-5B of Fagan in view of Olsen, as applied above, discloses an ultrasonic surgical instrument and method comprising all the limitations of the claim except for at least one closure cable extending distally through the articulation section to the clamp arm and configured to actuate the clamp arm from one of the open or closed positions toward the other of the open or closed positions.
However, the embodiment of Figs. 17-19 of Fagan teaches a similar ultrasonic surgical instrument and method comprising at least one closure cable (1761, Fig. 17) extending distally through the articulation section (1747, Fig. 17) to the clamp arm (1701, Fig. 17) and configured to actuate the clamp arm (1704) from one of the open (Figs. 17-18) or closed (Fig. 19) positions toward the other of the open or closed positions ([0107]-[0109]) in order to beneficially provide the ability to open and close the clamp arm to thereby enable the selective capture and treatment of target tissue ([0107]-[0109]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of embodiment of Figs. 2-5B of Fagan to have at least one closure cable extending distally through the articulation section to the clamp arm and configured to actuate the clamp arm from one of the open or closed positions toward the other of the open or closed positions in order to beneficially provide the ability to open and close the clamp arm to thereby enable the selective capture and treatment of target tissue, as taught by the embodiment of Figs. 17-19 of Fagan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771