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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/4/2026 has been entered.
Response to Arguments
Applicant's arguments filed 6/4/2026 have been fully considered but they are not persuasive.
Regarding Submitted Arguments Pertaining to Claim 1:
Applicant contends that none of either Hunter (US 2021/0059708 A1)(previously of record) or Yang (WO 2023065118 A1)(previously of record) expressly disclose or adequately suggest the amended limitations of “the first recessed surface and second recessed surface positioned on a plane perpendicular to the waveguide axis such that the first recessed surface is angularly spaced from the second recessed surface about the waveguide axis”. There do not appear to be any arguments directed to how the previously-cited prior art of record fails to disclose or suggest the above-cited limitation.
However, for clarity of the record, the examiner respectfully contends that Hunter, when combined with the teachings of Yang, adequately discloses “the first recessed surface and second recessed surface positioned on a plane perpendicular to the waveguide axis such that the first recessed surface is angularly spaced from the second recessed surface about the waveguide axis”. Hunter, as modified by Yang, has been modified to include a plurality of notches/grooves disposed along the outer periphery of the distal flange portion of Hunter that are configured to receive the overmold rings of Hunter. The plurality of grooves or notches included along the outer peripheral surface of the distal flange portion are reasonably understood to extend around at least a portion of the circumference thereof so as to attach the overmold rings along said circumference. As indicated in Examiner’s Diagram of Hunter Fig. 30 below, portions of each included notch/groove along the periphery of the distal flange portion may be designated as a “surface” which may be identified to be angularly offset from another designated “surface”. As Yang discloses wherein the notches/grooves are positioned around the circumference of the distal nodal flange, portions of each included notch/groove may be identified so as to be angularly offset from one-another while remaining within the scope of the disclosure. The examiner therefore respectfully contends that, Hunter, as modified by Yang, discloses the above-cited amended limitation(s).
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Examiner’s Diagram of Hunter Fig. 30
Applicant additionally contends that none of either Hunter or Yang expressly disclose or adequately suggest the amended limitations of “a shaft having a distal portion bearing radially inwardly against the distal nodal flange, the distal portion of the shaft cooperating with the cylindraceous central region of the distal nodal flange and the first and second recessed surfaces to prevent rotational movement of the distal nodal flange relative to the distal portion of the shaft and to prevent longitudinal movement of the distal nodal flange relative to the distal portion of the shaft along the waveguide axis”. This is on the grounds that the compression sleeve (318) of Hunter is explicitly part of the waveguide and is thus not a part of the shaft assembly (cited Para. [0123]). Applicant contends that the compression sleeve is not configured to prevent translation as Hunter does not provide any express disclosure pertaining to such a feature.
The examiner respectfully disagrees with the proposed interpretation of the prior art. In regard to the amended limitations of “a shaft having a distal portion bearing radially inwardly against the distal nodal flange”, the compression sleeve (318) is interpreted to be analogous to the claimed “shaft” and is configured to apply a compressive force to the overmold rings (314) which themselves apply a radially-inward force against the distal flange portion (316) (see Para. [0123]-[0124]). Additionally, Para. [0123]-[0124] recite wherein a waveguide pin (320) extends through distal flange portion (316) and compression sleeve (318); the waveguide pin (320) prevents longitudinal and rotational movement of the compression sleeve (318) relative to the distal flange portion (316). The examiner therefore contends that, while Hutner may not provide an express disclosure of wherein the compression sleeve “prevents rotation/translation of the distal flange portion”, the disclosure of wherein the compression sleeve applies a compressive force to the distal flange portion (via the overmold rings) and comprises a waveguide pin extending therethrough (i.e., through both the compression sleeve and distal flange portion), the compression sleeve appears to reasonably aid in preventing rotational/translation motion relative to the distal flange portion. The examiner therefore respectfully contends that Hunter provides adequate disclosure of the claimed function.
Regarding Submitted Arguments Pertaining to Claim 19 and 20:
Applicant contends that none of Hunter (US 2021/0059708 A1)(previously of record), Yang (WO 2023065118 A1)(previously of record) or Farley (US 5632754 A)(previously of record) expressly disclose or adequately suggest the limitations of “a distal sleeve crimped radially inwardly against the distal nodal flange such that the distal sleeve is secured against the distal nodal flange and against the recessed surfaces of each of the plurality of recesses”. This is on the grounds that the compression sleeve (318) of Hunter is not crimped radially-inwardly against the distal flange portion but rather appears to be pushed outwardly by overmold rings (314).
The examiner respectfully disagrees with the proposed interpretation. Para. [0123]-[0124] of Hutner provide disclose of wherein the compression sleeve applies a compressive force to the overmold rings against the distal flange portion. While overmold rings lie between the compression sleeve and the distal flange portion, the examiner contends the disclosure of Hunter reasonably suggests the compression sleeve’s primary function is to maintain a compressive, radially-inward force against the overmold rings disposed along an outer peripheral surface of the distal flange portion. Hunter further discloses wherein this compression helps to reduce transverse misalignment, increase clamping stiffness, and minimize ultrasonic impedance (see Para. [0123]). The examiner therefore respectfully contends that Hunter provides adequate disclosure to reasonably suggest the claimed function.
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.
Claim(s) 1, 3-4, 11, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2021/0059708 A1)(previously of record) in view of Yang (WO 2023065118 A1)(previously of record).
Regarding claim 1, Hunter discloses:
An apparatus (see Fig. 1), comprising:
(a) a shaft assembly (shaft portion 60; see Fig. 1) including a distal end (see Fig. 1) and comprising:
(i) an acoustic waveguide (waveguide 310; see Figs. 30-31; waveguide 310 may be incorporated into the instrument shown in Figs. 1-8 per Para. [0123]) defining a waveguide axis and having a distal end (see Figs. 30-31; waveguide 310 defines an axis along the length thereof and comprises a distal end), the acoustic waveguide being configured to transmit ultrasonic vibrations (see Para. [0060]), the acoustic waveguide having a distal nodal flange (distal flange portion 316; see Figs. 30-31), the distal nodal flange includes a cylindraceous central region (see Figs. 30-31 showing wherein distal flange portion 316 has a cylindrical shape); and
(ii) a shaft (compression sleeve 318; see Figs. 30-32) having a distal portion bearing radially inwardly against the distal nodal flange (see Para. [0123]-[0124]; compression sleeve 318 bears radially inward against distal flange portion 316; see also Figs. 30-32), the distal portion of the shaft cooperating with the cylindraceous central region of the distal nodal flange to prevent rotational movement of the distal nodal flange relative to the distal portion of the shaft and to prevent longitudinal movement of the distal nodal flange relative to the distal portion of the shaft along the waveguide axis (see Para. [0123]-[0124]; waveguide pin 320 extends through distal flange portion 316 and compression sleeve 318; waveguide pin 320 prevents longitudinal and rotational movement of the compression sleeve 318 relative to the distal flange portion 316);
(b) an end effector (end effector 16; see Fig. 1) at the distal end of the shaft assembly (see Fig. 1), the end effector including:
(i) an ultrasonic blade (blade 46; see Figs 1-2; blade 46 is interchangeable with blade 312 as shown in Figs. 30-31 and recited in Para. [0123]), the ultrasonic blade being positioned at the distal end of the acoustic waveguide (see Figs. 7A and 31); and
(ii) a clamp arm (clamp arm 44; see Figs 1 and 7A) operable to pivot toward and away from the ultrasonic blade (see Para. [0058]-[0059]).
However, Hunter does not expressly disclose:
wherein the cylindraceous central region of the distal flange portion includes a plurality of recesses, wherein each recess of the plurality of recesses is defined at least in part by a first recesses surface on the cylindraceous central region and a second recessed surface on the cylindraceous region;
wherein the first recessed surface and the second recessed surface are positioned on a plane perpendicular to the waveguide axis such that the first recessed surface is angularly spaced from the second recessed surface about the waveguide axis;
wherein the distal portion of the shaft cooperates with the first and second recessed surfaces in preventing rotational movement of the distal nodal flange relative to the distal portion of the shaft and to prevent longitudinal movement of the distal nodal flange relative to the distal portion of the shaft.
In the same field of endeavor, namely ultrasonic cutting instruments, Yang teaches an ultrasonic device (see Fig. 1) comprising a shaft assembly (shaft assembly 30; see Fig. 1) comprising an acoustic waveguide (central rod 31; see Fig. 7; see also Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7; see also Para. [0075] indicating this is the “node” that support portion 39 is located at) and a distal portion of said shaft assembly (portion of the inner sleeve 32 housing sealing support 39) bearing radially inward against the nodal distal flange (portion of the inner sleeve 32 of the shaft assembly comprising “at least one” sealing support 39 bears radially inwardly against the distal nodal flange via the sealing support positioned between the two components; see Fig. 7; see also Para. [0075]) that is secured thereto within a “plurality” of notches or grooves formed in the central portion of the outer perimeter of the waveguide (see Para. [0075]) which would prevent the sealing support from sliding along the length of the node during either installation or use due to being placed within the grooves of the nodal flange (see Para. [0075]).
While Hunter discloses wherein the compression sleeve is secured to the distal flange portion of the waveguide about overmold rings (see Fig. 29; Para. [0122]), Hunter does disclose an express manner in which the overmold rings are secured at a set location along the distal flange portion during installation. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal flange portion and overmold rings of Hunter to have each of the two overmold rings disposed within a plurality of respective notches or grooves disposed about the circumference of the distal flange portion as taught and suggested by Yang to, in this case, provide a plurality of apertures in which to seat the overmold rings about the circumference of the distal flange portion (see Yang Para. [0075]). Such a modification would also aid in preventing the overmold rings from sliding along the length of the distal flange portion during either installation or use. The compression sleeve is understood to “cooperate” with the newly-included recesses within the distal flange to prevent rotational and longitudinal motion of said distal flange portion relative to the compression sleeve. In the resulting combination, the plurality of grooves or notches included along the outer peripheral surface of the distal flange portion are reasonably understood to extend around at least a portion of the circumference thereof so as to attach the overmold rings along said circumference. As indicated in Examiner’s Diagram of Hunter Fig. 30 below, portions of each included notch/groove along the periphery of the distal flange portion may be designated as a “surface” which may be identified to be angularly offset from another designated “surface”. As Yang discloses wherein the notches/grooves are positioned around the circumference of the distal nodal flange, portions of each included notch/groove may be identified so as to be angularly offset from one-another while remaining within the scope of the disclosure.
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Examiner’s Diagram of Hunter Fig. 30
Regarding claim 3, the combination of Hunter and Yang disclose the invention of claim 1, Hunter, as modified by Yang, further disclose wherein at least one recess of the plurality of recesses extending longitudinally across a middle of a central region along a length of the distal nodal flange (plurality of notches or grooves along the periphery of the distal nodal flange of Yang, as incorporated into the distal flange portion of Hunter, have a length that extends across a central portion of the distal nodal flange/distal flange portion so as to have a thickness to receive the overmold rings and would thus extend across a “central” portion of the distal flange portion, defined as any point immediately adjacent the terminal end portions thereof).
Regarding claim 4, the combination of Hunter and Yang disclose the invention of claim 1, Hunter, as modified by Yang, further discloses wherein the plurality of recesses including a distal set of recesses (grooves/notches of along the periphery of the distal nodal flange of Yang, as incorporated into the distal flange portion of Hunter, that receive the distal overmold ring as shown in Hunter Fig. 30) and a proximal set of recesses (grooves/notches of along the periphery of the distal nodal flange of Yang, as incorporated into the distal flange portion of Hunter, that receive the proximal overmold ring as shown in Hunter Fig. 30), the distal set of recesses being positioned distally in relation to a longitudinally intermediate portion of a central region along a length of the distal nodal flange (see Hunter Fig. 30 showing a space between the pair of overmold rings along the central portion of the distal flange portion), the proximal set of recesses being positioned proximally in relation to the longitudinally intermediate portion of the central region (notches/grooves along the periphery of the distal nodal flange of Yang, as incorporated into the distal flange portion of Hunter, receiving the proximal overmold ring would be positioned proximally to the space between the two overmold rings), the longitudinally intermediate portion of the central region providing a structural interruption between the distal set of recesses and the proximal set of recesses (see Hunter Figs. 30-31 showing this space between the overmold rings that would create a gap between the sets of notches or grooves receiving their respective overmold ring).
Regarding claim 11, the combination of Hunter and Yang discloses the invention of claim 1, Hunter further discloses wherein the distal portion of the shaft including a frame sleeve positioned coaxially about the distal nodal flange (overmold rings 314; see Fig. 30-31).
Regarding claim 15, the combination of Hunter and Yang discloses the invention of claim 1, Hunter further discloses wherein the shaft assembly further including an articulation section (articulation section 64; see Fig. 3A), the articulation section being operable to deflect the end effector laterally away from a central longitudinal axis of the shaft assembly (see Para. [0064] and [0066]).
Regarding claim 18, the combination of Hunter and Yang discloses the invention of claim 1, Hunter further discloses wherein the shaft assembly further comprising an elastomeric member (overmold rings 314; see Figs. 30-31) interposed between the distal nodal flange and the distal portion of the shaft (see Figs. 30-31 showing wherein the overmold rings are disposed between the compression sleeve and the distal flange portion), the elastomeric member being compressed against the distal nodal flange by the distal portion of the shaft (see Para. [0123]).
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2021/0059708 A1)(previously of record) in view of Yang (WO 2023065118 A1)(previously of record), further in view of Divincenzo (US 2020/0038072 A1)(previously of record).
Regarding claim 5, the combination of Hunter and Yang disclose all of the limitations of the invention of claim 1.
However, none of either Hunter or Yang provide substantial detail about the structure of the mating notches or grooves and thus do not expressly disclose wherein the second recessed surface providing a transition to the first recessed surface from other portions of the distal nodal flange.
In the field of endeavor of surgical device comprising mating engagement features between two adjacent components via notches or grooves, Divincenzo teaches wherein two components (projections 464 of locking collar 400 and grooves 344/346 of the handle 300; see Para. [0073]; see also Figs. 3D and 4C) that mate accomplish such a connection by incorporating a set of protrusions (464; see Fig. 4C) that mate with a set of grooves (344; see Fig. 3D) to lock the components together (see Para. [0073]), wherein the grooves comprise a first recessed surface (see Examiner’s Diagram of Divincenzo Fig. 3E below illustrating a “first recessed surface “ of the mating groove) and a second recessed surface (see Examiner’s Diagram of Divincenzo Fig. 3E below illustrating a “second recessed surface” of the mating groove), the second recessed surface providing a transition to the first recessed surface from the other portions of the groove (see Examiner’s Diagram of Divincenzo Fig. 3E below).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the overmold rings and notches/grooves of Hunter, as modified by Yang, to have the overmold rings comprise convex protrusions that mate with the concave groove structure as disclosed by Divincenzo to provide a known configuration of grooves within the art to satisfy the mating groove description of Yang. As Yang does not provide an express teaching pertaining to the structure of the grooves, one of ordinary skill in the art would have looked to known alternative to provide an accompanying structure to ensure the grooves function as intended per the teachings of Yang.
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Examiner’s Diagram of Divincenzo Fig. 3E
Regarding claim 6, the combination of Hunter, Yang and Divincenzo disclose the invention of claim 5, Hunter, as modified by Yang and Divincenzo further discloses wherein the first recessed surface being flat (see Examiner’s Diagram of Divincenzo Fig. 3E above showing wherein the “first recessed surface” is flat and free from protrusions, indents, grooves, divots or any other anomalous structure).
Regarding claim 7, the combination of Hunter, Yang and Divincenzo disclose the invention of claim 5, Hunter, as modified by Yang and Divincenzo further discloses wherein the second recessed surface being curved (see Examiner’s Diagram of Divincenzo Fig. 3E above showing wherein the “second recessed portion” is curved with respect to the surrounding planar structure of the interior of the handle within which the groove is disposed).
Regarding claim 8, the combination of Hunter and Yang disclose all of the limitations of the invention of claim 1.
However, none of either Hunter or Yang provide ample detail about the structure of the mating notches or grooves and thus do not expressly disclose wherein each recess of the plurality of recesses having a concave shape.
In the field of endeavor of surgical device comprising mating engagement features between two adjacent components via notches or grooves, Divincenzo teaches wherein two components (projections 464 of locking collar 400 and grooves 344/346 of the handle 300; see Para. [0073]; see also Figs. 3D and 4C) that mate accomplish such a connection by incorporating a set of convex protrusions (464; see Fig. 4C) that mate with a set of concave grooves (344; see Fig. 3D) to lock the components together (see Para. [0073]; see also Examiner’s Diagram of Divincenzo Fig. 3E above).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the overmold rings and notches/grooves of Hunter, as modified by Yang, to have the overmold rings comprise convex protrusions that mate with the concave groove structure as disclosed by Divincenzo to provide a known configuration of grooves within the art to satisfy the mating groove description of Yang. As Yang does not provide an express teaching pertaining to the structure of the grooves, one of ordinary skill in the art would have looked to known alternative to provide an accompanying structure to ensure the grooves function as intended per the teachings of Yang.
Regarding claim 9, the combination of Hunter, Yang and Divincenzo disclose the invention of claim 8, Hunter, as modified by Yang and Divincenzo, further discloses wherein each recess of the plurality of recesses having a having a curved surface defining the concave shape (see Divincenzo Para. [0073]; see also Examiner’s Diagram of Divincenzo Fig. 3E above).
Regarding claim 10, the combination of Hunter, Yang and Divincenzo disclose the invention of claim 8, Hunter, as modified by Yang and Divincenzo, further discloses wherein each recess of the plurality of recesses having a negative conical surface defining the concave shape (see Divincenzo Para. [0073] and Examiner’s Diagram of Divincenzo Fig. 3E above).
Claim(s) 12-14 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2021/0059708 A1)(previously of record) in view of Yang (WO 2023065118 A1)(previously of record), further in view of Farley (US 5632754 A)(previously of record).
Regarding claim 12, the combination of Hunter and Yang discloses all of the limitations of the invention of claim 11.
However, while Hunter discloses wherein the frame sleeve has a compressible section configured to bear inwardly against the distal nodal flange (see Hunter Para. [0123] mentioning wherein the compressible sleeve is configured to compress overmold rings against distal flange portion), Hunter does not expressly disclose wherein this compression is achieve through a crimping action.
In the field of endeavor of surgical devices comprising one component compressed over another component to provide an affixation securement, Farley teaches wherein a slip ring is designed to compress the distal end of a catheter body against the exterior of a surgical housing, wherein said compression is achieve by crimping, heat shrinking or any other means known to those skilled in the art (see Col. 7, Lines 55-68).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve of Hunter to be compressed against the overmold rings by a crimping action as disclosed by Farley since Farley provides a teaching wherein crimping is a known process in the art and may be utilized, along with any other known compression means, to secure components together (see Farley Col. 7, Lines 55-68).
Regarding claim 13, the combination of Hunter, Yang and Farley disclose the invention of claim 12, Hunter further discloses wherein the crimping section is malleable (see Hunter Para. [0123] mentioning wherein the overmold rings are formed from silicone, a compressible material).
Regarding claim 14, the combination of Hunter, Yang and Farley disclose the invention of claim 12, Hunter further discloses wherein the clamp arm being pivotally coupled with the frame sleeve (see Para. [0058]-[0059] and [0123]).
Regarding claim 19, Hunter discloses:
An apparatus (see Fig. 1), comprising:
(a) a shaft assembly (shaft portion 60; see Fig. 1) comprising:
(i) an acoustic waveguide (waveguide 310; see Figs. 30-31; waveguide 310 may be incorporated into the instrument shown in Figs. 1-8 per Para. [0123]), the acoustic waveguide being configured to transmit ultrasonic vibrations (see Para. [0060]), the acoustic waveguide having a distal nodal flange (distal flange portion 316; see Figs. 30-31), the distal nodal flange being a solid cylindraceous shape (see Figs. 30-31 showing wherein distal flange portion 316 has a solid cylindrical shape); and
(ii) an articulation section (articulation section 64; see Fig. 3A), the distal nodal flange being positioned distally in relation to the articulation section (see Fig. 7B); and
(iii) a distal sleeve (compression sleeve 318; see Figs. 30-31) compressed radially inwardly against the distal nodal flange (see Para. [0123]), such that the distal sleeve is secured against the distal nodal flange (see Figs. 30-31; see also Para. [0123]), the distal sleeve engaging with the distal nodal flange to prevent rotational movement of the distal nodal flange relative to the distal sleeve and to prevent longitudinal movement of the distal nodal flange relative to the distal sleeve (see Para. [0123]-[0124]; waveguide pin 320 extends through the distal flange portion and compression sleeve which would prevent/restrict longitudinal and rotational movement of the compression sleeve relative to the distal flange portion; see also Para. [0090])
(b) an end effector (end effector 16; see Fig. 1) at a distal end of the shaft assembly (see Fig. 1), the end effector including:
(i) an ultrasonic blade (blade 46; see Figs 1-2; blade 46 is interchangeable with blade 312 as shown in Figs. 30-31 and recited in Para. [0123]), the ultrasonic blade being positioned at a distal end of the acoustic waveguide (see Figs. 7A and 31); and
(ii) a clamp arm (clamp arm 44; see Figs 1 and 7A) operable to pivot toward and away from the ultrasonic blade (see Para. [0058]-[0059]), the articulation section being operable to deflect the end effector laterally away from a central longitudinal axis of the shaft assembly (see Para. [0064] and [0066]).
However, while Hunter discloses wherein the distal sleeve has a compressible section configured to bear inwardly against the distal nodal flange (see Hunter Para. [0123]-[0124]; compression sleeve configured to compress overmold rings 314 against the distal flange portion) Hunter does not expressly disclose:
wherein this compression is achieve through a crimping action;
wherein the distal nodal flange being includes a plurality of recesses thereon, each recess defining a recessed surface on the solid cylindraceous shape; and
wherein the distal sleeve is compressed radially inwardly against the recessed surfaces of each of the plurality of recesses, the distal sleeve engaging with the recessed surfaces to prevent rotational movement of the distal nodal flange relative to the distal sleeve and to prevent longitudinal movement of the distal nodal flange relative to the distal sleeve.
In the field of endeavor of surgical devices comprising one component compressed over another component to provide an affixation securement, Farley teaches wherein a slip ring is designed to compress the distal end of a catheter body against the exterior of a surgical housing, wherein said compression is achieve by crimping, heat shrinking or any other means known to those skilled in the art (see Col. 7, Lines 55-68).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve of Hunter to be compressed against the overmold rings by a crimping action as disclosed by Farley since Farley provides a teaching wherein crimping is a known process in the art and may be utilized, along with any other known compression means, to secure components together (see Farley Col. 7, Lines 55-68).
In the same field of endeavor, namely ultrasonic cutting instruments, Yang teaches an ultrasonic device (see Fig. 1) comprising a shaft assembly (shaft assembly 30; see Fig. 1) comprising an acoustic waveguide (central rod 31; see Fig. 7; see also Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7; see also Para. [0075] indicating this is the “node” that support portion 39 is located at) and a distal portion of said shaft assembly (portion of the inner sleeve 32 housing sealing support 39) bearing radially inward against the nodal distal flange (portion of the inner sleeve 32 of the shaft assembly comprising “at least one” sealing support 39 bears radially inwardly against the distal nodal flange via the sealing support positioned between the two components; see Fig. 7; see also Para. [0075]) that is secured thereto within a “plurality” of notches or grooves formed in the central portion of the outer perimeter of the waveguide (see Para. [0075]) which would prevent the sealing support from sliding along the length of the node during either installation or use due to being placed within the grooves of the nodal flange (see Para. [0075]).
While Hunter discloses wherein the compression sleeve is secured to the distal flange portion of the waveguide about overmold rings (see Fig. 29; Para. [0122]), Hunter does disclose an express manner in which the overmold rings are secured at a set location along the distal flange portion during installation. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal flange portion and overmold rings of Hunter to have each of the two overmold rings disposed within a plurality of respective notches or grooves disposed about the circumference of the distal flange portion as taught and suggested by Yang to, in this case, provide a plurality of apertures in which to seat the overmold rings about the circumference of the distal flange portion (see Yang Para. [0075]). Such a modification would also aid in preventing the overmold rings from sliding along the length of the distal flange portion during either installation or use. The compression sleeve is understood to “cooperate” with the newly-included recesses within the distal flange to prevent rotational and longitudinal motion of said distal flange portion relative to the compression sleeve. In the resulting combination, the plurality of grooves or notches included along the outer peripheral surface of the distal flange portion are reasonably understood to extend around at least a portion of the circumference thereof so as to attach the overmold rings along said circumference. As indicated in Examiner’s Diagram of Hunter Fig. 30 below, portions of each included notch/groove along the periphery of the distal flange portion may be designated as a “surface” which may be identified to be angularly offset from another designated “surface”. As Yang discloses wherein the notches/grooves are positioned around the circumference of the distal nodal flange, portions of each included notch/groove may be identified so as to be angularly offset from one-another while remaining within the scope of the disclosure.
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Examiner’s Diagram of Hunter Fig. 30
Regarding claim 20, Hunter discloses:
A method, comprising:
(a) positioning an elastomeric feature (overmold rings 314; see Figs. 30-31; see also Para. [0123]) about a distal nodal flange (distal flange portion 316; see Figs. 30-31) of an acoustic waveguide (see Figs. 30-31 and Para. [0123]-[0124]);
(b) positioning a malleable sleeve (compression sleeve 318; see Figs. 30-31; see also Para. [0123]) about the distal nodal flange such that the elastomeric feature is radially interposed between the malleable sleeve and the distal nodal flange (see Figs. 30-31; see also Para. [0123]); and
(c) compressing the malleable sleeve radially inwardly to thereby compress the malleable sleeve against the distal nodal flange and to thereby compress the elastomeric feature against the distal nodal flange (see Para. [0123]), malleable properties of the sleeve being configured to maintain the compression, thereby fixedly securing the malleable sleeve relative to the distal nodal flange (see Para. [0123]).
However, while Hunter discloses wherein the compression sleeve is configured to bear inwardly against the distal flange portion and overmold rings (see Hunter Para. [0123]), Hunter does not expressly disclose:
wherein this compression is achieve through a crimping action;
wherein the distal nodal flange including a plurality of recesses positioned longitudinally around the distal nodal flange, each recess of the plurality of recesses defining a recessed surface and at least one transition surface between a body of the distal nodal flange and the recessed surface; and
compressing the malleable sleeve radially inwardly to thereby compress the malleable sleeve against the distal nodal flange and to thereby compress the elastomeric feature against the distal nodal flange such that the elastomeric feature is received within the plurality of recesses and engages with the recessed surfaces and the transition surfaces.
In the field of endeavor of surgical devices comprising one component compressed over another component to provide an affixation securement, Farley teaches wherein a slip ring is designed to compress the distal end of a catheter body against the exterior of a surgical housing, wherein said compression is achieve by crimping, heat shrinking or any other means known to those skilled in the art (see Col. 7, Lines 55-68).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve of Hunter to be compressed against the distal flange portion and overmold rings by a crimping action as disclosed by Farley since Farley provides a teaching wherein crimping is a known process in the art and may be utilized, along with any other known compression means, to secure components together (see Farley Col. 7, Lines 55-68).
In the same field of endeavor, namely ultrasonic cutting instruments, Yang teaches an ultrasonic device (see Fig. 1) comprising a shaft assembly (shaft assembly 30; see Fig. 1) comprising an acoustic waveguide (central rod 31; see Fig. 7; see also Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7; see also Para. [0075] indicating this is the “node” that support portion 39 is located at) and a distal portion of said shaft assembly (portion of the inner sleeve 32 housing sealing support 39) bearing radially inward against the nodal distal flange (portion of the inner sleeve 32 of the shaft assembly comprising “at least one” sealing support 39 bears radially inwardly against the distal nodal flange via the sealing support positioned between the two components; see Fig. 7; see also Para. [0075]) that is secured thereto within a “plurality” of notches or grooves formed in the central portion of the outer perimeter of the waveguide (see Para. [0075]) which would prevent the sealing support from sliding along the length of the node during either installation or use due to being placed within the grooves of the nodal flange (see Para. [0075]).
While Hunter disclosed wherein the compression sleeve is secured to the distal flange portion of the waveguide about overmold rings (see Fig. 29; see also Para. [0122]), Hunter does disclose an express manner in which the overmold rings are secured at a set location along the distal node during installation. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve and attaching overmold rings of Hunter to have each of the two overmold rings disposed within a plurality of respective notches or grooves disposed about the central portion of the circumference of the distal flange portion as taught and suggested by Yang to, in this case, provide an aperture in which to seat the overmold rings about the circumference of the distal node (see Yang Para. [0075]) which would also aid in preventing the overmold rings from sliding along the length of the distal node during either installation or use. The portion of the distal flange portion of Hunter between the “plurality of” newly included recesses constitutes a “transition surface”. The distal portion of the shaft is understood to “cooperate” with the newly-includes recesses within the nodal structure to prevent rotational and longitudinal motion of said nodal flange relative to the shaft. The Examiner notes that as elastomeric feature (i.e., the overmold rings) of Hunter are received within the plurality of the newly-included recesses, the overmold rings are understood to engage with said recessed surfaces and transition surfaces positioned between adjacent recessed surfaces.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 2021/0059708 A1)(previously of record) in view of Yang (WO 2023065118 A1)(previously of record), further in view of Farley (US 5632754 A)(previously of record), further in view of Worrell (US 2023/0115451 A1).
Regarding claim 21, the combination of Hunter, Yang and Farley disclose all of the limitations of the invention of claim 19, Hunter further discloses wherein the distal sleeve is configured to compress the overmold rings and maintain a relative position between the distal sleeve and the distal nodal flange (see Para. [0123]-[0124]).
However, Hunter does not expressly disclose a material used to form the compression sleeve and thus does not expressly disclose wherein the distal sleeve comprises a malleable material such that the distal sleeve is thereby configured to bent inwardly towards an axis of the distal sleeve.
In the field of endeavor of surgical compression sleeves, Worrell teaches a compression sleeve (compression tube 202; see Fig. 2) may be formed from shape memory material such a Nitinol that may be “trained” to naturally compress to a predetermined inner diameter so as to maintain compression to an acceptable degree (see Para. [0052]).
Since Hunter discloses wherein the compression sleeve is configured to apply a compressive force against the overmold rings and underlying distal flange portion but does not disclose an material used to form the compression sleeve, one of ordinary skill in the art would have looked to relevant prior art for known materials used to form similar compression sleeves. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve of Hunter to be made from a shape memory material, such as Nitinol, as disclosed by Worrell since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. See In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 22, the combination of Hunter, Yang and Farley disclose all of the limitations of the method of claim 20, Hunter further discloses the step of compressing the malleable sleeve toward an axis defined by the malleable sleeve to thereby maintain a relative position of the malleable sleeve to the distal nodal flange (see Para. [0123]-[0124]).
However, Hunter does not expressly disclose a material used to form the compression sleeve and thus does not expressly disclose wherein malleable sleeve is formed from a malleable material.
In the field of endeavor of surgical compression sleeves, Worrell teaches a compression sleeve (compression tube 202; see Fig. 2) may be formed from shape memory material such a Nitinol that may be “trained” to naturally compress to a predetermined inner diameter so as to maintain compression to an acceptable degree (see Para. [0052]).
Since Hunter discloses wherein the compression sleeve is configured to apply a compressive force against the overmold rings and underlying distal flange portion but does not disclose a material used to form the compression sleeve, one of ordinary skill in the art would have looked to relevant prior art for known materials used to form similar compression sleeves. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the compression sleeve of Hunter to be made from a shape memory material, such as Nitinol, as disclosed by Worrell since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art. See In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 12004769 B2 to Cowles, US 2017/0304655 A1 to Cotter, US 2022/0225983 A1 to Souls and US 2022/0125438 A1 to Lakkireddy disclose materials used to form surgical compressible devices consistent with the newly amended limitations of claims 21-22.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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