DETAILED ACTION
This action is pursuant to claims filed on 5/6/2024. Claims 1-14 are pending. A first action on the merits of claims 1-14 is as follows.
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
Reference JP 2011505194 of the IDS filed 5/6/2024 has not been considered because it fails to comply with 37 CFR 1.98(a)(3)(i) because there is not a concise explanation of relevance as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, nor is there a translation of the reference provided.
Claim Objections
Claim 2 objected to because of the following informalities:
Claim 2 states “toque” in line 2. This appears to be a typographical error and should be corrected to --torque--.
Appropriate corrections are required.
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 3-8 and 13-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 states “the proximal end portion includes a second female screw portion” in line 3. There has not been a first female screw portion introduced in claim 3 or any of the preceding claims. It is unclear whether the proximal end portion is intended to include multiple female screw portions or if there is another female screw portion present on a separate piece. Therefore, the claim is indefinite.
Claims 4-8 are rejected due to their dependance on claim 3.
Claim 13 states “a second female screw portion” in lines 2-3, and “the fastener includes a second fastening portion” in line 5. A first female screw portion and a first fastening portion of the fastener have not been introduced in claims 12 or 13. It is unclear whether the proximal end portion includes two female screw portions or if there is supposed to be another female screw portion present on a separate piece. It is also unclear which part of the fastener the "second fastening portion" is intended to be. Claim 12 already states that the fastener screws into the transducer and the transmission portion so it is unclear if this "second fastening portion" is part of the piece already disclosed, or a new, separate piece that screws into the “second fastening portion.” Therefore, the claim is indefinite.
Claim 14 is rejected due to its dependance on claim 13.
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.
Claims 1-4, 9-10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Houser (US 20090036914 A1) in view of Madan et al. (hereinafter ‘Madan’, US 6278218 B1).
Regarding independent claim 1, Houser discloses an ultrasound treatment tool (ultrasonic treatment tool in Figs. 1 and 4) comprising:
an ultrasound transducer (ultrasound transducer 14 in Fig. 1; [0052]: the transducer includes a transduction portion 18, a first resonator portion 20, and a second resonator portion 22, and ancillary components; [0054]: the fore-bell 22 may be tapered inwardly from its proximal end to its distal end to amplify the ultrasonic vibration amplitude as the velocity transformer 28 – thus fore-bell 22 forms the transformer 28 which in turn means the transformer 28 is part of the transducer) configured to generate ultrasound vibration ([Abstract]: the transducer is configured to produce vibrations at a predetermined frequency);
a vibration transmission portion (transmission waveguide 104 in Fig. 1) configured to transmit the ultrasound vibration ([0004]: vibrations generated by the transducer section are transmitted to the surgical end effector via an ultrasonic waveguide extending from the transducer section to the surgical end effector); and
a fastener (stud 48 in Fig. 1) that includes a first fastening portion screwed with the ultrasound transducer (first fastening portion is the portion inside of the transducer portion 28 as seen in Fig. 1) and a second fastening portion screwed with the vibration transmission portion (second fastening portion is the portion that extends into the ultrasonic waveguide 104 in Fig. 1), the fastener being configure to connect the ultrasound transducer and the vibration transmission portion ([0058]: the distal end of the ultrasonic transducer may be coupled at the surface 30 to the proximal end of the waveguide by a threaded connection such as a cannulated threaded stud 48), wherein
the vibration transmission portion is formed of a material ([0063]: the waveguide 104 may be made from titanium alloy, or any suitable aluminum allow), the proximal end portion being screwed with the second fastening portion (the proximal end portion is screwed with the second fastening portion as seen in Figs. 1 and 2).
However, Houser is silent to the material of the fastener stud.
Madan teaches an ultrasonic transducer and a method of tuning such a transducer by selecting from a plurality of tuning elements ([Abstract]). Similar to Houser, Madan teaches a velocity transformer 64 of an ultrasonic transducer 82 that connects to a waveguide via a threaded stud 50 as seen in Fig. 1 ([Col 1, lines 40-45]; [Col 4, lines 63-67]). The transducer of Houser is a stacked transducer known as a “Langevin stack” ([0072]). The transducer of Houser is tuned by selecting the length of the assembly to be an integral number of one-half wavelengths ([0059}. The transducer of Madan is also a “Langevin stack” type of transducer ([Col 3, lines 43-53]). Madan teaches that typically, these stack up type transducers are individually tuned during the manufacturing process but can still result in “stack-up” issues arising due to the combining of multiple parts where variations due to each part sum together to produce a significant variation ([Col 2, lines 19-29]). Typically, these types of transducers are made longer than necessary and trimmed down to the desired tuning range ([Col 2, lines 30-44]). This trimming process often occurs at attachment surfaces where other acoustic assemblies, such as the end-effector, are to be attached ([Col 2, lines 30-44]). The trimming also modifies the surface finish quality which is an important parameter for efficient acoustic assemblies, and the trimming process can lead to significant manufacturing issues and expense ([Col 2, lines 30-44]). Madan teaches that these “Stack-up” resonant frequency discrepancies of the acoustic assembly can be corrected by proper selection of a tuning element such as stud 50, rather than through trimming the length of the acoustic assembly ([Col 5, lines 16-31]). The stud can be selected from a variety of lengths and materials, such as stainless steel or tungsten, to achieve the desired resonant frequency ([Col 6, lines 4-21]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a stud made of stainless steel or tungsten that is the desired length to achieve the desired tuning frequency as taught by Madan because doing so would eliminate the need to trim the acoustic assembly of Houser during the tuning process thus eliminating “stack-up” issues while preserving the finish on the acoustic assembly. This would in turn result in the claimed invention because utilizing a stainless steel or tungsten stud would mean the stud is made of a stronger material than the aluminum vibration transmission portion.
Regarding claim 2, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 1. Houser further discloses that the assembly may be connected on the stud and torqued to the required level ([0065]). The claimed limitation of “a torque at a time of detachment of the first fastening portion from the ultrasound transducer is set to be smaller than a torque at a time of detachment of the second fastening portion from the vibration transmission portion” is simply a byproduct of the assembly process. Applicant has not claimed any specific structure that sets the torque. In the specification of the instant application, the Applicant discloses that the torque is simply a result of how tight the operator torques each piece together ([0030]-[0032]). The Houser/Madan combination is capable of being torqued to the required levels as it merely depends on how tight and in what order the operator attaches both pieces. The device itself does not torque the pieces together. Therefore, since Houser discloses that the assembly may be torqued to the required level during assembly, Houser is inherently capable of setting a torque at a time of detachment of the first fastening portion from the ultrasound transducer to be smaller than a torque at a time of detachment of the second fastening portion from the vibration transmission portion.
Regarding claim 3, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 2, wherein
the proximal end portion includes a second female screw portion that is recessed toward a distal end of the vibration transmission portion (portion 66 in Figs. 2 and 5 which are recessed female screw portions into the vibration transmission portion), and
the second fastening portion is a male portion that is screwed with the second female screw portion and is set to be in contact with a bottom surface of the second female screw portion (the second fastening portion is a male portion that screws into the second female screw portion as seen in Figs. 1, 2, 4, and 5 and touches the bottom and back surface of the recessed hole as annotated below – bottom is a vague term because it depends on the orientation of the device and the claim is not specific to the orientation of the device; in the case of Fig. 2, there is a small bottom surface in the vertical direction that the screw touches; in Fig. 5 it is unclear if the stud extends all of the way to the back but it is shown to extend all of the way to the back of the slot in Fig. 4).
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Regarding claim 4, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 3, wherein
a first female screw portion that is recessed toward a proximal end of the ultrasound transducer is arranged in a distal end portion of the ultrasound transducer (first female screw portion 69 in Figs. 2 and 5 that are recessed in a distal end portion of the transducer), the distal end portion being screwed with the first fastening portion (the distal end portion is screwed with the first fastening portion as seen in Figs. 1, 2, 4, and 5), and
the first fastening portion is a male screw portion screwed with the first female screw portion and is set to be in no contact with a bottom surface of the first female screw portion (in the case where the device is vertical, there is no contact between the first male portion and the first female portion in Fig. 4).
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While Houser shows no contact in figure 4, the lack of contact is not explicitly explained.
Similarly, Madan teaches that the stud may not contact the back of the recess in the transducer as shown in Fig. 3. The threaded portion does not extend all of the way back into the bore as seen in Fig. 3 ([Col 5, lines 9-15]). The relationship between the stud size and insertion into the bore allows for “stack-up” frequency discrepancies to be corrected ([Col 5, lines 16-31]). Furthermore, varying the length of the stud and the depth of insertion into the bore can vary the location of the center of mass of stud 50 within the distal-end 95 in order to correct resonant frequency variations ([Col 6, lines 56-65]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the stud such that it does not touch the back of the bore in the transducer in order to ensure the center of mass of the stud is in a location that corrects resonant frequency variations.
Regarding claim 9, the Houser/Madan combination discloses the invention according to claim 1 as described above. Houser further discloses that the assembly may be connected on the stud and torqued to the required level ([0065]). The claimed limitation of “fastening torque of the fastener with respect to the vibration transmission portion is set to be equal to or larger than 0.33 times of a fastening torque of the fastener with respect to the ultrasound transducer” is simply a byproduct of the assembly process. Applicant has not claimed any specific structure that sets the torque. In the specification of the instant application, the Applicant discloses that the torque is simply a result of how tight the operator torques each piece together ([0030]-[0032]). The Houser/Madan combination is capable of being torqued to the required levels as it merely depends on how tight and in what order the operator attaches both pieces. The device itself does not torque the pieces together. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to set the torque of the fastener with respect to the vibration transmission portion to be equal to or larger than 0.33 times of a fastening torque of the fastener with respect to the ultrasound transducer, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to set the torque of each piece to the claimed value since it is merely a byproduct of how tight the operator tightens each piece during assembly and finding the optimum torque range involves only routine skill in the art.
Regarding claim 10, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 1, wherein the proximal end portion is made of an aluminum alloy (Houser discloses the waveguide may be aluminum [0063]).
Regarding independent claim 12, Houser discloses a method of manufacturing an ultrasound treatment tool that includes
an ultrasound transducer (ultrasound transducer 14 in Fig. 1; [0052]: the transducer includes a transduction portion 18, a first resonator portion 20, and a second resonator portion 22, and ancillary components; [0054]: the fore-bell 22 may be tapered inwardly from its proximal end to its distal end to amplify the ultrasonic vibration amplitude as the velocity transformer 28 – thus fore-bell 22 forms the transformer 28 which in turn means the transformer 28 is part of the transducer) configured to generate ultrasound vibration ([Abstract]: the transducer is configured to produce vibrations at a predetermined frequency); and
a vibration transmission portion (transmission waveguide 104 in Fig. 1) configured to transmit the ultrasound vibration ([0004]: vibrations generated by the transducer section are transmitted to the surgical end effector via an ultrasonic waveguide extending from the transducer section to the surgical end effector),
the method comprising:
screwing a fastener with the proximal end portion of the vibration transmission portion ([0058]: the waveguide is coupled to the stud 48 via a threaded connection), which is made of aluminum ([0063]: the waveguide is made of aluminum); and
screwing the fastener with the ultrasound transducer ([0058]: the distal end of the transducer is connected to the waveguide through the threaded stud 48; Figs. 1, 2, 4, and 5 show the threads into the transducer), wherein
the fastener is screwed with each of the vibration transmission portion and the ultrasound transducer to set a torque at a time of detachment ([0065]: the assembly is torqued to a required level).
However, Houser does not disclose that the stud is configured with a material that has a higher strength than a proximal end portion of the vibration transmission portion.
Madan teaches an ultrasonic transducer and a method of tuning such a transducer by selecting from a plurality of tuning elements ([Abstract]). Similar to Houser, Madan teaches a velocity transformer 64 of an ultrasonic transducer 82 that connects to a waveguide via a threaded stud 50 as seen in Fig. 1 ([Col 1, lines 40-45]; [Col 4, lines 63-67]). The transducer of Houser is a stacked transducer known as a “Langevin stack” ([0072]). The transducer of Houser is tuned by selecting the length of the assembly to be an integral number of one-half wavelengths ([0059}. The transducer of Madan is also a “Langevin stack” type of transducer ([Col 3, lines 43-53]). Madan teaches that typically, these stack up type transducers are individually tuned during the manufacturing process but can still result in “stack-up” issues arising due to the combining of multiple parts where variations due to each part sum together to produce a significant variation ([Col 2, lines 19-29]). Typically, these types of transducers are made longer than necessary and trimmed down to the desired tuning range ([Col 2, lines 30-44]). This trimming process often occurs at attachment surfaces where other acoustic assemblies, such as the end-effector, are to be attached ([Col 2, lines 30-44]). The trimming also modifies the surface finish quality which is an important parameter for efficient acoustic assemblies, and the trimming process can lead to significant manufacturing issues and expense ([Col 2, lines 30-44]). Madan teaches that these “Stack-up” resonant frequency discrepancies of the acoustic assembly can be corrected by proper selection of a tuning element such as stud 50, rather than through trimming the length of the acoustic assembly ([Col 5, lines 16-31]). The stud can be selected from a variety of lengths and materials, such as stainless steel or tungsten, to achieve the desired resonant frequency ([Col 6, lines 4-21]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a stud made of stainless steel or tungsten that is the desired length to achieve the desired tuning frequency as taught by Madan because doing so would eliminate the need to trim the acoustic assembly of Houser during the tuning process thus eliminating “stack-up” issues while preserving the finish on the acoustic assembly. This would in turn result in the claimed invention because utilizing a stainless steel or tungsten stud would mean the stud is made of a stronger material than the aluminum vibration transmission portion.
However, the Houser/Madan combination is silent to screwing the fastener in such that the torque at the time of detachment of the fastener from the ultrasound transducer is set to be smaller than a torque at a time of detachment of the second fastening portion from the vibration transmission portion.
The claimed limitation of is part of the assembly process. Applicant has not claimed any specific structure that sets the torque. In the specification of the instant application, the Applicant discloses that the torque is simply a result of how tight the operator torques each piece together ([0030]-[0032]). The Houser/Madan combination is capable of being torqued to the required levels as it merely depends on how tight and in what order the operator attaches both pieces, as stated in paragraph [0065]. The device itself does not torque the pieces together. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made screw the fastener and the waveguide together tighter than the fastener and the transducer since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. The torque specifications are simply the optimum or workable ranges of the tightening force and the Houser/Madan combination has disclosed that these can be tightened together to whatever predetermined torque is required. Therefore, since Houser discloses that the assembly may be torqued to the required level during assembly, Houser is inherently capable of screwing the fastener and waveguide together tighter than the fastener and the transducer, and doing so is simply attaching them in the optimum or workable torque range which involves only routine skill in the art.
Regarding claim 13, the Houser/Madan combination discloses the method according to claim 12, wherein
the proximal end portion includes a second female screw portion that is recessed toward a distal end of the vibration transmission portion (portion 66 in Figs. 2 and 5 which are recessed female screw portions into the vibration transmission portion),
the fastener includes a second fastening portion that is a male screw portion screwed with the second female screw portion (the second fastening portion is a male portion that screws into the second female screw portion as seen in Figs. 1, 2, 4, and 5), and
the screwing the fastener with the vibration transmission portion includes inserting the second fastening portion into the second female screw portion to screw the second fastening portion with the second female screw portion and to bring the second fastening portion into contact with a bottom surface of the second female screw portion (the method is inherent from the disclosed structure where the male screw portion touches the bottom and back surface of the recessed hole as annotated below – bottom is a vague term because it depends on the orientation of the device and the claim is not specific to the orientation of the device; in the case of Fig. 2, there is a small bottom surface in the vertical direction that the screw touches; in Fig. 5 it is unclear if the stud extends all of the way to the back but it is shown to extend all of the way to the back of the slot in Fig. 4).
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Regarding claim 14, the Houser/Madan combination discloses the method according to claim 13, wherein
a first female screw portion that is recessed toward a proximal end of the ultrasound transducer is arranged in a distal end portion of the ultrasound transducer (first female screw portion 69 in Figs. 2 and 5 that are recessed in a distal end portion of the transducer),
the fastener includes a first fastening portion that is a male screw portion screwed with the first female screw portion (the fastener has a male screw that is screwed with the first female fastening portion as seen in Figs. 1, 2, 4, and 5), and
the screwing the fastener with the ultrasound transducer includes inserting the first fastening portion into the first female screw portion to screw the first fastening portion with the first female screw portion and to prevent the first fastening portion from coming into contact with a bottom surface of the first female screw portion (in the case where the device is vertical, there is no contact between the first male portion and the first female portion in Fig. 4 when the first fastening portion is inserted into the female screw portion – the method inherently follows from the structure).
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While Houser shows no contact in figure 4, the lack of contact is not explicitly explained.
Similarly, Madan teaches that the stud may not contact the back of the recess in the transducer as shown in Fig. 3. The threaded portion does not extend all of the way back into the bore as seen in Fig. 3 ([Col 5, lines 9-15]). The relationship between the stud size and insertion into the bore allows for “stack-up” frequency discrepancies to be corrected ([Col 5, lines 16-31]). Furthermore, varying the length of the stud and the depth of insertion into the bore can vary the location of the center of mass of stud 50 within the distal-end 95 in order to correct resonant frequency variations ([Col 6, lines 56-65]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the stud such that it does not touch the back of the bore in the transducer in order to ensure the center of mass of the stud is in a location that corrects resonant frequency variations.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Houser/Madan combination in further view of Houser et al. (hereinafter “Houser ‘263”, US 20120116263 A1).
Regarding claim 5, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 4, wherein
a distal end of the ultrasound transducer and a proximal end of the vibration transmission portion are in contact with each other when the ultrasound transducer and the vibration transmission portion are connected to each other by the fastener (the distal end of the transducer and proximal end of the vibration transmission portion are in contact when connected by the fastener as seen in Figs. 1, 2, 4, and 5), and
the distance between an anti-node and its nearest node is one-quarter wavelength ([0056] – thus the location of the nodes and anti-nodes simply depends on the wavelength)
However, the combination is silent to the location of the anti-node and node positions near the stud.
Houser ‘263 teaches a surgical instrument that is separable into a transducer unit and a lower body portion that includes a waveguide ([Abstract]). Houser ‘263 further teaches various connection mechanisms between the transducer unit and the lower body portion, one even being a threaded connection, as seen in Figs. 2-17. Houser ‘263 goes on to further state that the antinode can be placed in any desirable location such as in the most proximal connection face, the most distal connection face, or located anywhere along these locations ([0042]). Houser ‘263 additionally states that the interface may be located anywhere between a node and an antinode ([0042]). Furthermore, as stated by the applicant in paragraph [0069] as well as by Houser ‘263 in paragraph [0042], the antinodes and nodes are parts of the ultrasonic wave produced and not physical structures of the device itself. Additionally, the applicant has not claimed any particular structure or waveform length and/or frequency that results in the claimed antinode and node placement. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to ensure the contact position and the bottom surface of the female screw portion of the vibration transmission portion are between an anti-node and a node as taught by Houser ‘263, since applicant has not disclosed that this node and antinode placement is created by any particular structure, or occurs at any specific wavelength or frequency, or solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any node and antinode placement. Therefore, because Houser ‘263 discloses arranging the connection face to be anywhere between an antinode and node and the Houser/Madan combination has the claimed structure and is capable of forming an ultrasonic wave, it would be an obvious design choice to modify the ultrasonic wave produced such that the connection face and bottom of the female screw portion are between the antinode and nodes of the ultrasonic wave.
Regarding claim 6, the Houser/Madan/Houser ‘263 combination discloses the invention in claim 5 as described above. Houser ‘263 further teaches that the antinode can be placed on the most proximal connection face between the transducer and the waveguide ([0042]). While the connection type is different, in the combination the screw fastener’s most proximal connection face is the location where the screw and base of the transducer recession are close to each other. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to ensure the antinode is located at the most proximal portion of the connection as taught by Houser ‘263, since applicant has not disclosed that this antinode placement is created by any particular structure, occurs at any specific wavelength or frequency, solves any stated problem, or is for any particular purpose and it appears that the invention would perform equally as well with any antinode placement. Therefore, because Houser ‘263 discloses arranging the antinode to be placed on the most proximal portion of the connection and the Houser/Madan combination has the claimed structure and is capable of forming an ultrasonic wave, it would be an obvious design choice to modify the ultrasonic wave produced such that the antinode occurs closer to the bottom of the recess of the transducer than it does to the vibration transmission portion.
Regarding claim 7, the Houser/Madan/Houser ‘263 combination discloses the ultrasound treatment tool according to claim 6, wherein the bottom surface of the female screw portion of the ultrasound transducer is located at the anti-node position among the anti-node position and the node position that are adjacent to each other (in the Houser/Madan/Houser ‘263 combination, the antinode is placed in the most proximal portion of the connection which is the bottom surface of the female screw portion of the ultrasound transducer as described above).
Regarding claim 8, the Houser/Madan/Houser ‘263 combination discloses the ultrasound treatment tool according to claim 5, wherein a connection portion between the ultrasound transducer and the vibration transmission portion by the fastener is set to reduce an acoustic impedance of components from the proximal end side toward the distal end side (the specification of the instant application states in paragraphs [0034] and [0069] that the acoustic impedance is reduced through material selection, specifically that the transducer is titanium, the stud is titanium or stainless steel, and the transmission portion is aluminum; this is the same for the present combination – Houser discloses the waveguide may be aluminum [0063], Madan teaches that the transducer may be titanium [Col 3, lines 54-67], and the stud may be stainless steel [Col 6, lines 14-21]; thus, because the claim is written functionally and the materials disclosed by the combination are the same materials from the instant application, the combination has the claimed reduction in acoustic impedance; the claim language is satisfied because the acoustic impedance is reduced in several connection portions between the transducer and the transmission unit – i.e. between the stainless steel stud and the aluminum waveguide, between the titanium transducer and the aluminum waveguide, and between the titanium transducer and the stainless steel stud).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Houser/Madan combination in further view of Sawada (US 20160263403 A1).
Regarding claim 11, the Houser/Madan combination discloses the ultrasound treatment tool according to claim 1 as described above. Houser seems to further indicate that portions of the stud are threaded opposite of one another as shown in the annotated figure 5 below.
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However, the combination does not discuss the thread directions of the stud.
Sawada teaches an ultrasonic treatment device that includes a connecting unit that connects a vibration generating unit to a probe ([Abstract]). Similar to the Houser/Madan combination, the connecting unit can be a double sided stud as seen in Figs. 11-13. Sawada further states that the first engagement portion of the connection unit is a right-handed screw and the second engagement portion is a left-handed screw ([0078]). This results in the two engagement portions having spirals in the opposite directions ([0078]). Sawada further teaches that utilizing opposite threading can allow for the fastener to be detached from only one side and repositioned to a better angle ([0083]). While Sawada relies on holding the connection unit, the same result would occur by loosening the waveguide of the Houser/Madan combination since the rotation of the waveguide in one direction would tighten the fastener against the waveguide and loosen the faster from the transducer, allowing for repositioning. This would further inherently result in preventing overtightening because when the waveguide is attached it will only be able to tighten a set amount before the connection with the transducer would begin to loosen. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the opposite threading configuration of Sawada with the stud of the Houser/Madan combination in order to allow for easy repositioning and prevent overtightening.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794