DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 12/30/2025 with regards to the amended limitations of claim 1 reciting “the distal nodal flange including a cylindraceous central region” have been fully considered but they are not persuasive. While Hunter may not disclose the other amended limitations pertaining to a plurality of recessed disposed along the surface of the distal nodal flange, the Examiner contends that Hunter does expressly show, in Figs. 30-31, that the distal nodal flange (316) comprises a cylindraceous shape.
Applicant’s arguments with respect to claim(s) 1, previously rejected under 35 USC 102(a)(1) in view of Hunter (US 2021/0059708 A1)(previously of record) regarding the amended limitations of “the distal nodal flange including a cylindraceous central region and a plurality of recesses, wherein each recess of the plurality of recesses is defined at least in part by a first recessed surface on the cylindraceous central region and a second recessed surface on the cylidnraceous central region” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, while Hunter does expressly disclose wherein the distal nodal flange portion (316) comprises a cylindraceous shape (see Figs. 30-31), Hunter is not relied upon to disclose or teach the amended limitations of a first and second recessed surface along the cylindraceous central region of the distal nodal flange.
Applicant's arguments filed 12/30/2025 with regards to the amended limitations of claim 19 reciting “a distal sleeve crimped radially inwardly against the distal nodal flange such that the distal sleeve is secured against the distal nodal flange, the distal sleeve engaging with the distal nodal flange to prevent rotational movement of the distal nodal flange relative to the distal sleeve and prevent longitudinal movement of the distal nodal flange relative to the distal sleeve” have been fully considered but they are not persuasive. While Hunter may not disclose the other amended limitations pertaining to a plurality of recessed disposed along the surface of the distal nodal flange and accompanying engagement with the distal sleeve, the Examiner contends that Hunter does expressly show, in Figs. 30-31 and Para. [0123], that the distal sleeve (318) is compressed against the distal nodal flange and secured thereto via a waveguide pin that prevent rotational and longitudinal movement of the distal nodal flange relative to the distal sleeve.
Applicant’s arguments with respect to claim(s) 19, previously rejected under 35 USC 103 in view of Hunter (US 2021/0059708 A1)(previously of record) and Farley (US 5632754 A)(previously of record) regarding the amended limitations of “a distal sleeve crimped radially inwardly against the distal nodal flange such that the distal sleeve is secured 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” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, while Hunter does disclose wherein the distal sleeve (i.e., compression sleeve 318) is compressed against the distal nodal flange to prevent rotational and longitudinal movement of the distal nodal flange relative to the distal sleeve (see Figs. 30-31 and Para. [0123]) neither Hunter nor Farley expressly disclose or suggest the presence of the required recessed surfaces along the surface of the distal nodal flange which receive and engage with the distal sleeve upon crimping thereto and are thus not relied upon to disclose these amended limitations.
Applicant's arguments filed 12/30/2025 with regards to the amended limitations of claim 20 reciting “compressing the malleable sleeve radially inwardly to thereby crimp the malleable sleeve against the distal nodal flange and to thereby compress the elastomeric feature against the distal nodal flange, the malleable properties of the sleeve being configured to maintain the crimp and compression, thereby fixedly securing the malleable sleeve relative to the distal nodal flange” have been fully considered but they are not persuasive. While Hunter may not disclose the other amended limitations pertaining to a plurality of recessed disposed along the surface of the distal nodal flange and accompanying engagement with the elastomeric member, the Examiner contends that Hunter does expressly show, in Figs. 30-31 and Para. [0123], that the malleable sleeve (318) is compressed against the distal nodal flange such that the malleable sleeve is fixedly secured thereto (via a waveguide pin as recited in Para. [0123]). As the compression sleeve of Hunter is recited to be “compressed” against the distal nodal flange, the compression sleeve is understood to maintained the compression against the distal nodal flange unless otherwise stated.
Applicant’s arguments with respect to claim(s) 20, previously rejected under 35 USC 103 in view of Hunter (US 2021/0059708 A1)(previously of record) and Farley (US 5632754 A)(previously of record) regarding the amended limitations of “compressing a malleable sleeve radially inwardly to crimp 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 transition surfaces” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, while Hunter does disclose wherein the malleable sleeve (i.e., compression sleeve 318) is compressed against the distal nodal flange (see Figs. 30-31 and Para. [0123]) to cause the elastomeric features (overmold rings 314) to press against the distal nodal flange, neither Hunter nor Farley expressly disclose or suggest the presences of the required recessed surfaces along the surface of the distal nodal flange which receive the elastomeric member via crimping of the malleable sleeve against the distal nodal flange and are therefore not relied upon to disclose these amended limitations.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 12/30/2025, with respect to the objections to claims 2-18 (now claims 3-18 due to cancellation of claim 2) pertaining to a missing linking phrase between the introductory recitation of claim dependency and further modifying limitations have been fully considered and are persuasive. While the inclusion of a linking phrase (e.g., “wherein” or “further comprising”) would place the claim language in better grammatical form, no such inclusion is required to meet the standards defined within the MPEP. The remaining previous objections of claims 3-18 have been withdrawn.
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 and 15-18 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) comprising:
(i) an acoustic waveguide (waveguide 310, see Figs. 30-31 which may be incorporated into the instrument shown in Figs. 1-8, see 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 includes a cylindraceous central region (see Figs. 30-31 showing wherein distal flange portion 316 has a cylindrical shape); and
(ii) a distal portion of the shaft bearing radially inwardly against the distal nodal flange (portion of the shaft in which compression sleeve 318 is disposed bears radially inward against the flange portion 316, see Figs. 30-31 and Para. [0123]), the distal portion of the shaft cooperating with the cylindraceous surface 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 (see Para. [0123] mentioning wherein a waveguide pin is disposed through the node position at the compression sleeve to be utilized as disclosed above, particularly in regards to preventing relative rotation and translation with regards to the outer sheath as per 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; 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]).
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; and
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 (see Fig. 1 showing an elongate shaft assembly 30) comprising an acoustic waveguide (31, see Fig. 7 and Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7, see 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 and 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 node of the waveguide about overmold rings (see Fig. 29 and 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 compressive 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 node 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 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, especially since the nodal structure is a monolithic and integral portion of the shaft body as shown in Fig. 31.
Regarding claim 3, the combination of Hunter and Yang disclose the invention of claim 1, Hunter, as modified by Yang, further disclose wherein the recesses extending longitudinally across a middle of a central region along a length of the distal nodal flange (plurality of notches or grooves of Yang, as incorporated into the device of Hunter, have a length that extends across a central portion of the distal node so as to have a thickness to receive the overmold rings and would thus extend across a “central” portion of the distal node, 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 recesses including a distal set of recesses (recess of Yang, as incorporated into the device of Hunter, that receive the distal overmold ring) and a proximal set of recesses (recess of Yang, as incorporated into the device of Hunter, that receive the proximal overmold ring), 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 pairs of overmold rings along the central portion of the distal node), the proximal set of recesses being positioned proximally in relation to the longitudinally intermediate portion of the central region (notches or grooves 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 (compression sleeve 318, see Figs. 30-31 and Para. [0123]).
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 16, the combination of Hunter and Yang discloses the invention of claim 15, Hunter further discloses wherein the acoustic waveguide further comprising a flexible region (flexible portion 58, see Fig. 7B) extending along the articulation section (see Fig. 7B).
Regarding claim 17, the combination of Hunter and Yang discloses the invention of claim 16, Hunter further discloses wherein the acoustic waveguide further comprising a flexible region extending along the articulation section (see Fig. 7B).
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 outer distal portion of the shaft assembly and the distal node flange), 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] and 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 each recess 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] and 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] and 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 having a having a curved surface defining the concave shape (see Divincenzo Para. [0073] and 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 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 be compressed against the distal nodal flange), 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 distal node 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 compression sleeve is compressible).
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 (310, see Figs. 30-31 which may be incorporated into the instrument shown in Figs. 1-8, see 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 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 and 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] mentioning wherein a waveguide pin is disposed through the node position at the compression sleeve to be utilized as disclosed above, particularly in regards to preventing relative rotation and translation with regards to the outer sheath as per 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; 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 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 be compressed against the distal nodal flange), 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 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 distal node 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 (see Fig. 1 showing an elongate shaft assembly 30) comprising an acoustic waveguide (31, see Fig. 7 and Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7, see 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 and 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 node of the waveguide about overmold rings (see Fig. 29 and 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 compressive 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 node 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 distal portion of the shaft is understood to “cooperate/engage” with the newly-includes recesses within the nodal structure to prevent rotational and longitudinal motion of said nodal flange relative to the shaft, especially since the nodal structure is a monolithic and integral portion of the shaft body as shown in Fig. 31.
Regarding claim 20, Hunter discloses:
A method, comprising:
(a) positioning an elastomeric feature (overmold rings 314, see Figs. 30-31 and Para. [0123]) about a distal nodal flange of an acoustic waveguide (see Figs. 30-31 and Para. [0123]);
(b) positioning a malleable sleeve (compression sleeve 318, see Figs. 30-31 and 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 and 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]), the 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 frame sleeve has a compressible section configured to bear inwardly against the distal nodal flange and elastomeric features (see Hunter Para. [0123] mentioning wherein the compressible sleeve is configured to be compressed against the distal nodal flange and overmold rings), 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 the 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 node 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 (see Fig. 1 showing an elongate shaft assembly 30) comprising an acoustic waveguide (31, see Fig. 7 and Para. [0063]) having a distal nodal flange (located at element “39” shown in Fig. 7, see 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 and 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 node of the waveguide about overmold rings (see Fig. 29 and 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 compressive 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 node 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 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, especially since the nodal structure is a monolithic and integral portion of the shaft body as shown in Fig. 31. 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.
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 20150245850 A1 to Hibner, US 2014/0114334 A1 to Olson and US 8623027 B2 to Price disclose deflectable cutting assemblies comprising a plurality of overlapping tubular segments over one or more node position.
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.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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