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 .
Response to Arguments
Applicant’s arguments, see pages 2-3, filed 01/30/2026, with respect to the 103 rejection(s) of claim(s) 1 and 12 over Sakurai in view of Mastel (claim 1) and Mastel and Houser (claim 12) have been fully considered and are persuasive. The examiner agrees that Sakurai fails to disclose “the constant diameter of the cylindrical envelope being substantially equal to an external diameter of the probe body at a distal portion of the probe body” as required by claims 1 and 12. However, upon further consideration, a new ground(s) of rejection is made in over Boyd (US 3433226) in view of Mastel (claim 1) and Boyd (US 3433226) in view of Mastel and Houser.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a locking feature” in claim 13. The limitation in claim 13 fails to include sufficient structure to perform the recited function of “locking". In the specification, para. 0038 recites “a coupler on the probe tip 114 can include one or more toolless attachments and/or interlocks that are user-manipulatable with respect to the probe body 112 for engagement, attachment, and/or locking thereto, and for disengagement or detachment therefrom. The attachment feature 222 can include threads or other protrusions or grooves or shapes to engage corresponding complementary features of the probe body 112, such as to lock or otherwise help mechanically secure the probe tip 114 to the probe body 112”. Therefore, the limitation will be interpreted as any of the structures defined above or any structural equivalent thereof capable of securing the first probe tip to the probe body.
“one or more attachment mechanisms” in claim 16. The limitation in claim 16 fails to include sufficient structure to perform the recited function of “attaching". In the specification, para. 0038 recites “a coupler on the probe tip 114 can include one or more toolless attachments and/or interlocks that are user-manipulatable with respect to the probe body 112 for engagement, attachment, and/or locking thereto, and for disengagement or detachment therefrom. The attachment feature 222 can include threads or other protrusions or grooves or shapes to engage corresponding complementary features of the probe body 112, such as to lock or otherwise help mechanically secure the probe tip 114 to the probe body 112”. Therefore, the limitation will be interpreted as any of the structures defined above or any structural equivalent thereof capable of securing the first probe tip to the probe body.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them 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 1, 3-5, 12-16, and 22-25 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.
Claim 1 recites the limitation “an external surface of the probe tip defining a cylindrical envelope, the external grooves extending inward from the cylindrical envelope, the cylindrical envelope having a constant diameter from a proximal end of the probe tip to the distal end of the probe tip, the constant diameter of the cylindrical envelope being substantially equal to an external diameter of the probe body at a distal portion of the probe body” and claim 12 includes a limitation with similar language. First, the term “cylindrical envelope” is not used or found in the specification. The term “envelope” is something that envelops or wraps around something. However, the specification fails to provide support for the probe tip comprising any form of envelope, wrapper or cover as defined under broadest reasonable interpretation of the term “envelope”.
Second, if the external surface of the probe tip is intended to be the cylindrical body, the probe tip does not have the constant diameter from the proximal to distal end of the probe tip as claimed due to the external grooves provided on the distal end of the probe tip. While the thick lines drawn around the distal end of the probe tip in the annotated version of Fig. 2A that applicant provides to show the “cylindrical envelope” in remarks filed 01/30/2026 do make a cylinder, this is not what is disclosed in the specification/drawings. The distal face of the probe tip is not circular as depicted by applicant’s annotation, it is star-shaped. Therefore, “a cylindrical envelope having a constant diameter” is not supported as defined by the claims.
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, 12-16, and 22-25 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.
Claims 1 (line 11) and 12 (line 10) recite the limitation “an external surface” of the probe tip/first probe tip. However, the claims introduce “an exterior surface” of the probe tip/first probe tip in lines 7-8 (claim 1) and line 7 (claim 12). Although the language is not exact, the two terms are synonymous with each other. Therefore, it is unclear if the “external surface” is meant to further define the “exterior surface” or if it is meant to further claim a new, additional element. For interpretation purposes, “the external surface” will be interpreted the same as “the exterior surface”.
Claim 1 recites the limitation "a distal portion of the probe body" in the last line of the claim. It is unclear to the examiner if the “distal portion” is meant to further define the previous introduced distal portion recited in line 2 of the claim. For interpretation purposes, “a distal portion of the probe body” is interpreted as “the distal portion of the probe body”.
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.
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, 3-4, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 3433226) in view of Mastel (US 20200129330).
Regarding claim 1, Boyd discloses a device 10 for acoustic calculi fracture (Fig. 1, abstract: “Vibratory catheterization apparatus and method of using the same for medicinal purposes such as decimation of atheromatous placques”), the device 10 comprising:
a probe body 18 being elongate and extending between a distal portion and a proximal portion, the probe body 18 having a lumen longitudinally therethrough (Fig. 1, col 2, lines 70-71 and col. 3, line 1: “Member 18 is hollow and metallurgically joined to member 14 in line with passageway 22”); and
a probe tip 20 being user-attachable to the probe body 18 and user-detachable from the probe body 18 (Fig. 1 illustrates tip 20 threadedly connected to the probe body 18, col. 4 lines 10-12: “If desired, the member 18 may be provided with removable tips which can be disposable” and col. 4 lines 67-68: “the geometry of the removable tip 20 is a square edge”), the probe tip 20 being configured to transmit acoustic energy from the probe body 18 to a distal end of the probe tip 20 (col. 4 lines 42-62: “The operable usage of the ultrasonic endarterectomy catheter requires that a reliable source of vibratory energy be coupled to the working tip 20…The vibrational energy generated by the transducer can be coupled to the members 16 and 18…This results in an excursion of the tip 20 parallel to the plane of the end face thereof…by which the placques of the calcified atheromata, are destroyed”),
an external surface of the probe tip 20 defining a cylindrical envelope (see Fig. 1 which illustrates the probe tip 20 defining a cylindrical body, thereby also defining a cylindrical envelope),
the cylindrical envelope having a constant diameter from a proximal end of the probe tip 20 to the distal end of the probe tip 20, the constant diameter of the cylindrical envelope being substantially equal to an external diameter of the probe body 18 at a distal portion of the probe body 18 (see Fig. 1 which illustrates the cylindrical body of the probe tip 20 having a constant diameter substantially equal to an external diameter of the probe body 18).
Boyd further discloses that the probe tip can vibrate in a plurality of modes including longitudinal, torsional, and radial vibration and that the mechanism by which the plaque of calcified atheromata is destroyed is dependent on the physical characteristics of the vibrating tip (col. 4 lines 48-65).
However, Boyd fails to disclose the probe tip including a plurality of external grooves extending axially along an exterior surface of the probe tip, the external grooves having a maximum depth at the distal end of the probe tip and decreasing in depth with increasing distance away from the distal end of the probe tip, and the external grooves extending inward from the cylindrical envelope.
Mastel in the same field of endeavor of ultrasonic devices (para. 0008, 0010) teaches that it is known in the art for a probe tip 522 to comprise a plurality of external grooves 524 extending axially along an exterior surface of the probe tip 522 (see Fig. 19, para. 0229: “FIG. 19 illustrates head 522 that includes at least one external recess 524 situated at the distal end of head 522 and extending along at least a portion of the length of the needle”), the external grooves 524 having a maximum depth at a distal end of the probe tip and decreasing in depth with increasing distance away from the distal end of the probe tip (see Fig. 21A for example which best illustrates external grooves having a maximum depth at a distal end of the probe tip and decreasing in depth with increasing distance away from the distal end of the probe tip; The examiner notes that both embodiments of Figs. 19 and 21A illustrate “external longitudinal recesses” or grooves as discussed in para. 0064, 0066, and 0231), and the external grooves extending inward from a cylindrical envelope (see Fig. 19 which illustrates the grooves 524 extending inward from a cylindrical body of the probe tip 422) for the purpose assisting in and improving material fracturing during use (para. 0224: “FIGS. 17A-25B and FIGS. 30-39 illustrate various features that can be implemented in a phacoemulsification needle head to assist in and improve lens grooving and cracking and/or engagement of target lenticular material during phacoemulsification”).
In light of this teaching, 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 probe tip in Boyd to include the plurality of external grooves, as taught by Mastel, since Mastel explicitly teaches that a probe tip having a smooth, circular exterior can be disadvantageous during surgery, particularly during torsional movement (para. 0010) because the smooth surface is unable to engage and grip the target material during use (para. 0010-0011). The inclusion of the external grooves, as taught by Mastel, would be advantageous because the grooves would allow for better engagement of the plaque during use, thereby improving the fracturing of plaque and reduce the need to increase the ultrasonic energy needed for fracturing during use, thereby making surrounding tissues less susceptible to trauma during surgery (para. 0010-0011 and 0224 of Mastel).
Regarding claim 3, modified Boyd discloses further comprising an acoustic energy source 12 actuatable for providing the acoustic energy to the probe body 18 such that the probe tip 20 is actuated for acoustic fracture of one or more calculi via the probe tip 20 (Fig. 1, col. 4 lines 48-57 of Boyd: “The vibrational energy generated by the transducer can be coupled to the members 16 and 18 in several different modes. The first and simplest mode is that of longitudinal vibration, as shown, wherein the particle displacements occur in a direction parallel to the axis of members 16 and 18. A second mode of vibration is that of lateral or b5transverse vibration wherein particle displacements occur in a direction normal to the axis of members 16 and 18…this results in an excursion of the tip 20”).
Regarding claim 4, modified Boyd discloses wherein the probe tip 20 includes a toolless interlock user-manipulatable with respect to the probe body 18 to interchange the probe tip with the probe body (see Fig. 1 of Boyd, best shown in Figs. 2-3 of Boyd, of the probe tip being threadedly connected to the probe body 18; col. 4 lines 65-75 of Boyd: “In FIGURE 1, the geometry of the removable tip 20 is a square edge. As shown more clearly in FIGURE 2, the tip 201 removably mounted on a coupling member 18' may have a chisel edge defined by an internal beveled surface 26. In FIGURE 2, the beveled surface 26 provides a sharp cutting edge at the periphery. A third type of tip is illustrated in FIGURE 3. Tip 20' removably mounted on coupling member 18"… The tips of FIGURES 2 and 3 may be substituted for the tip 20 in FIGURE 1”).
Regarding claim 24, modified Boyd discloses wherein the probe body is a multi- frequency device (col. 3 lines 42-48 of Boyd: “The aforesaid power supply system, in a typical ex-ample, is capable of producing electrical signals in the range of between about 60 cycles per second and about 300,000 cycles per second. This frequency range is suitable for purposes of the present invention, including as it does frequencies in both the audible range (such as up to about 15,000 cycles per second) and the ultrasonic range (generally above about 15,000 cycles per second)”).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 3433226) in view of Mastel (US 20200129330), as applied to claim 1 above, further in view of Idemoto et al. (US 5180363) [hereinafter Idemoto].
Regarding claim 5, modified Boyd discloses all of the limitations set forth above in claim 1. However, Modified Boyd fails to disclose wherein the probe tip comprises a ceramic or a composite ceramic material.
Idemoto in the same field of endeavor teaches an ultrasonic device (Fig. 6, abstract) used for cutting, crushing, or severing hard material in the body (col. 3 lines 51-62) comprising a probe tip (interpreted as an operation section) formed of a ceramic or a composite ceramic material (col. 8 lines 33-52), wherein ceramic material is a known material in the art for cutting, crushing, or severing hard material in the body (col. 3 lines 51-62, col. 8 lines 45-52).
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 probe tip in modified Boyd to include the ceramic material, as taught by Idemoto, since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 3433226) in view of Mastel (US 20200129330), as applied to claim 1 above, and further in view of Rockley (US 20130018383).
Regarding claim 22, modified Boyd discloses all of the limitations set forth above in claim 1. Modified Boyd further discloses the probe tip 20 has a lumen extending longitudinally through the probe tip 20 for the purpose of passing irrigation fluid during use (col. 3 lines 74-75 and col. 4 lines 1-2: “A coolant fluid may be introduced through conduit 24 and passageway 22 to cool the member 18, to irrigate tis4 sue in the vicinity to the tip 20, and flush away any micron sized particles resulting from decimation of placques”). However, modified Boyd fails to disclose the probe tip comprises a plurality of axial grooves disposed within the lumen of the probe.
Rockley in the same field of endeavor of ultrasonic devices (Figs. 13-15, para. 0002, 0069) teaches a probe tip 512 comprising a plurality of axial grooves 560 disposed within a lumen of the probe tip 512 (Figs. 13-14, para. 0073).
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 lumen of the probe tip in modified Boyd to include the plurality of axial grooves, as taught by Rockley, in order to help tear or emulsify clot material passing through the lumen during the procedure (para. 0073 of Rockley).
Claim(s) 12-16, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 3433226) in view of in view of Mastel (US 20200129330) and Houser et al. (US 20080234708) [hereinafter Houser].
Regarding claim 12, Boyd discloses a calculi fracture device 10 (Fig. 1, abstract: “Vibratory catheterization apparatus and method of using the same for medicinal purposes such as decimation of atheromatous placques”), the device comprising:
a plurality of probe tips 20, 20’, 20” that are different from one another and are each selectively user- interchangeable with a probe body 18 of a lithotripsy device without requiring a separate tool (Figs. 1-3, best shown in Figs. 2-3 of the probe tip being threadedly connected to the probe body 18; col. 4 lines 10-11: “the member 18 may be provided with removable tips” and col. 4 lines 65-75: “In FIGURE 1, the geometry of the removable tip 20 is a square edge. As shown more clearly in FIGURE 2, the tip 201 removably mounted on a coupling member 18' may have a chisel edge defined by an internal beveled surface 26. In FIGURE 2, the beveled surface 26 provides a sharp cutting edge at the periphery. A third type of tip is illustrated in FIGURE 3. Tip 20' removably mounted on coupling member 18"…The tips of FIGURES 2 and 3 may be substituted for the tip 20 in FIGURE 1”), and
a first probe tip 20 of the plurality of probe tips 20, 20’, 20” being configured to transmit acoustic energy from the probe body 18 to a distal end of the first probe tip 20 (col. 4 lines 42-62: “The operable usage of the ultrasonic endarterectomy catheter requires that a reliable source of vibratory energy be coupled to the working tip 20…The vibrational energy generated by the transducer can be coupled to the members 16 and 18…This results in an excursion of the tip 20 parallel to the plane of the end face thereof…by which the placques of the calcified atheromata, are destroyed”),
an external surface of the first probe tip 20 defining a cylindrical envelope (see Fig. 1 which illustrates the first probe tip 20 defining a cylindrical body, thereby also defining a cylindrical envelope),
the cylindrical envelope having a constant diameter from a proximal end of the first probe tip 20 to the distal end of the first probe tip 20, the constant diameter of the cylindrical envelope being substantially equal to an external diameter of the probe body 18 at a distal portion of the probe body 18 (see Fig. 1 which illustrates the cylindrical body of the first probe tip 20 having a constant diameter substantially equal to an external diameter of the probe body 18).
Boyd further discloses that the plurality of probe tips can vibrate in a plurality of modes including longitudinal, torsional, and radial vibration and that the mechanism by which the plaque of calcified atheromata is destroyed is dependent on the physical characteristics of the vibrating tip (col. 4 lines 48-65).
However, Boyd fails to disclose the first probe tip including a plurality of external grooves extending axially along an exterior surface of the first probe tip, the external grooves having a maximum depth at the distal end of the first probe tip and decreasing in depth with increasing distance away from the distal end of the first probe tip, and the external grooves extending inward from the cylindrical envelope.
Mastel in the same field of endeavor of ultrasonic devices (para. 0008, 0010) teaches that it is known in the art for a probe tip 522 to comprise a plurality of external grooves 524 extending axially along an exterior surface of the probe tip 522 (see Fig. 19, para. 0229: “FIG. 19 illustrates head 522 that includes at least one external recess 524 situated at the distal end of head 522 and extending along at least a portion of the length of the needle”), the external grooves 524 having a maximum depth at a distal end of the probe tip and decreasing in depth with increasing distance away from the distal end of the probe tip (see Fig. 21A for example which best illustrates external grooves having a maximum depth at a distal end of the probe tip and decreasing in depth with increasing distance away from the distal end of the probe tip; The examiner notes that both embodiments of Figs. 19 and 21A illustrate “external longitudinal recesses” or grooves as discussed in para. 0064, 0066, and 0231), and the external grooves extending inward from a cylindrical envelope (see Fig. 19 which illustrates the grooves 524 extending inward from a cylindrical body of the probe tip 422) for the purpose assisting in and improving material fracturing during use (para. 0224: “FIGS. 17A-25B and FIGS. 30-39 illustrate various features that can be implemented in a phacoemulsification needle head to assist in and improve lens grooving and cracking and/or engagement of target lenticular material during phacoemulsification”).
In light of this teaching, 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 first probe tip in Boyd to include the plurality of external grooves, as taught by Mastel, since Mastel explicitly teaches that a probe tip having a smooth, circular exterior can be disadvantageous during surgery, particularly during torsional movement (para. 0010) because the smooth surface is unable to engage and grip the target material during use (para. 0010-0011). The inclusion of the external grooves, as taught by Mastel, would be advantageous because the grooves would allow for better engagement of the plaque during use, thereby improving the fracturing of plaque and reduce the need to increase the ultrasonic energy needed for fracturing during use, thereby making surrounding tissues less susceptible to trauma during surgery (para. 0010-0011 and 0224 of Mastel).
However, modified Boyd fails to disclose a kit.
Houser in the same field of endeavor teaches kit comprising multiple, interchanging, end effectors 754 having different characteristics (Fig. 31, para. 0090).
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 in modified Boyd to include the plurality of probe tips together in a kit, as taught by Houser, since Houser expressly discloses that it is known in the art to store a device comprising interchanging tool heads in a kit (Fig. 31, para. 0090 of Houser). The modification would yield the predictable result of a way for the user to store various probe tips; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 13, modified Boyd discloses wherein the first probe tip 20 further comprises a locking feature for securing the first probe tip 20 to the probe body 18 (Fig. 1 of Boyd illustrates tip 20 threadedly connected to the probe body 18, col. 4 lines 10-12 of Boyd: “If desired, the member 18 may be provided with removable tips which can be disposable” and col. 4 lines 67-68: “the geometry of the removable tip 20 is a square edge”).
Regarding claim 14, modified Boyd discloses further comprising an acoustic energy source 12 attached to the probe body 18 for providing acoustic energy to the probe body 18 (Fig. 1, col. 4 lines 48-57 of Boyd: “The vibrational energy generated by the transducer can be coupled to the members 16 and 18 in several different modes. The first and simplest mode is that of longitudinal vibration, as shown, wherein the particle displacements occur in a direction parallel to the axis of members 16 and 18. A second mode of vibration is that of lateral or b5transverse vibration wherein particle displacements occur in a direction normal to the axis of members 16 and 18…this results in an excursion of the tip 20”).
Regarding claim 15, modified Boyd discloses wherein the different probe tips of the plurality of probe tips 20, 20’ 20” are different in at least one of the following characteristics: tip morphology (Figs. 1-3, col. 4 lines 65-75 of Boyd: “In FIGURE 1, the geometry of the removable tip 20 is a square edge. As shown more clearly in FIGURE 2, the tip 201 removably mounted on a coupling member 18' may have a chisel edge defined by an internal beveled surface 26. In FIGURE 2, the beveled surface 26 provides a sharp cutting edge at the periphery”).
Regarding claim 16, modified Boyd discloses wherein the first probe tip 20 is user-attachable to the probe body with one or more attachment mechanisms (Fig. 1 of Boyd illustrates tip 20 threadedly connected to the probe body 18, col. 4 lines 10-12 of Boyd: “If desired, the member 18 may be provided with removable tips which can be disposable” and col. 4 lines 67-68: “the geometry of the removable tip 20 is a square edge”).
Regarding claim 25, modified Boyd discloses wherein the probe body of a lithotripsy device is a multi- frequency device (col. 3 lines 42-48 of Boyd: “The aforesaid power supply system, in a typical ex-ample, is capable of producing electrical signals in the range of between about 60 cycles per second and about 300,000 cycles per second. This frequency range is suitable for purposes of the present invention, including as it does frequencies in both the audible range (such as up to about 15,000 cycles per second) and the ultrasonic range (generally above about 15,000 cycles per second)”).
Claim(s) 23 are rejected under 35 U.S.C. 103 as being unpatentable over Boyd (US 3433226) in view of Mastel (US 20200129330) and Houser et al. (US 20080234708) [hereinafter Houser], as applied to claim 12, Rockley (US 20130018383).
Regarding claim 23, modified Boyd discloses all of the limitations set forth above in claim 12. Modified Boyd further discloses the plurality of probe tips 20, 20’, 20” have a lumen extending longitudinally through the probe tips for the purpose of passing irrigation fluid during use (Figs. 1-3, col. 3 lines 74-75 and col. 4 lines 1-2 of Boyd: “A coolant fluid may be introduced through conduit 24 and passageway 22 to cool the member 18, to irrigate tis4 sue in the vicinity to the tip 20, and flush away any micron sized particles resulting from decimation of placques”). However, modified Boyd fails to disclose each probe tip of the plurality of the probe tips comprises a plurality of axial grooves disposed within the lumen of the respective probe tips.
Rockley in the same field of endeavor of ultrasonic devices (Figs. 13-15, para. 0002, 0069) teaches a probe tip 512 comprising a plurality of axial grooves 560 disposed within a lumen of the probe tip 512 (Figs. 13-14, para. 0073).
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 lumens of the probe tips in modified Boyd to include the plurality of axial grooves, as taught by Rockley, in order to help tear or emulsify clot material passing through the lumen during the procedure (para. 0073 of Rockley).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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