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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06 April 2026 has been entered.
Response to Amendment
Receipt is acknowledged of an amendment, filed 09 March 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 1-7 and 9-20 are pending.
Claims 1, 3-6, 9, and 15-20 are amended.
Claim 8 is cancelled.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 09 March 2026.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kostrzewski et al. (US Patent Publ. No. 2020/0315622), cited by applicant.
With respect to claim 20, Kostrzewski et al. disclose a surgical device (fig. 1) comprising: an elongate body defining a first longitudinal axis and having a proximal portion and a distal portion (adapter assembly 14, body portion 20, fig. 1); a tool assembly defining a second longitudinal axis (tool assembly 16, figs. 1, 2), the tool assembly supported on the distal portion of the elongate body for pivotal movement about an articulation axis between a non-articulated position and articulated position, the articulation axis being transverse to the first and second longitudinal axes (tool assembly 16 supported on body 20 and pivotable about an articulation axis, figs. 3, 4); a drive assembly including a flexible drive beam and a clamp member (flexible body 68 and working member 66, fig. 5), the flexible drive beam having a proximal portion and a distal portion (fig. 5), the clamp member supported on the distal portion of the flexible drive beam and received within the tool assembly (working member 66 supported on flexible body 68 moves through tool assembly 16, fig. 5, [0054]), the drive assembly movable between a retracted position and an advanced position to move the clamp member through the tool assembly (the flexible body 68 advances and moves the working member through the tool assembly 16, fig. 5, [0054]); and an articulation mechanism (fig. 5) including a drive link (first active articulation link 52) and a driven link (first passive articulation link 56), the drive link having a distal portion (fig. 5), a proximal portion (fig. 5), and a planar inner surface extending between the proximal and distal portions (cam surface 106 includes a planar portion, figs. 6, 20), the distal portion pivotally coupled to the tool assembly (first active articulation link 52 is pivotally coupled to the mounting assembly 50 via the second active articulation link 54 and 112, 116, figs. 20, 21, [0060], [0061]), the driven link having a proximal portion (fig. 5), a distal portion (fig. 5), and a planar inner surface extending between the proximal and distal portions of the driven link (cam surface 126 includes a planar portion, figs. 6, 20), the planar inner surfaces of the drive link and the driven link define a linear channel through which the flexible drive beam moves when the drive assembly is moved between the retracted and advanced positions (channel formed between cam surfaces 106, 156 through which flexible body 68 advances and retracts, figs. 20, 21, 24), with one of the drive link or the driven link supporting the flexible drive beam when the tool assembly is in the at least one articulated position, and (cam surfaces 106, 126 “provide added support to the outer surface of the flexible body 68 of the drive assembly 60 to prevent buckling”, [0059], [0073], figs. 21, 24) wherein the drive link is movable from an intermediate position to an advanced position to articulate the tool assembly about the articulation axis in a first direction (figs. 20, 21) and movable from the intermediate position to a retracted position to articulate the tool assembly about the articulation axis in a second direction (figs. 20, 24).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Kostrzewski et al. (US Patent Publ. No. 2020/0315622), cited by applicant.
With respect to claim 1, Kostrzewski et al. disclose a surgical device (fig. 1) comprising: an elongate body defining a first longitudinal axis and having a proximal portion and a distal portion (adapter assembly 14, body portion 20, fig. 1); a tool assembly defining a second longitudinal axis (tool assembly 16, figs. 1, 2), the tool assembly supported on the distal portion of the elongate body for pivotal movement about an articulation axis between a non-articulated position and at least one articulated position (“tool assembly 16 is pivotal between a non-articulated position in which the tool assembly 16 is aligned with the longitudinal axis “X” and articulated positions in which the tool assembly 16 defines an acute angle with the longitudinal axis “X””, “the radius of curvature changes as the tool assembly 16 is articulated about the pivot axis”, [0051], [0070]), the articulation axis being transverse to the first and second longitudinal axes (tool assembly 16 supported on body 20 and pivotable about an articulation axis, figs. 3, 4); a drive assembly including a flexible drive beam and a clamp member (flexible body 68 and working member 66, fig. 5), the flexible drive beam having a proximal portion and a distal portion (fig. 5), the clamp member supported on the distal portion of the flexible drive beam and received within the tool assembly (working member 66 supported on flexible body 68 moves through tool assembly 16, fig. 5, [0054]), the drive assembly movable between a retracted position and an advanced position to move the clamp member through the tool assembly (the flexible body 68 advances and moves the working member through the tool assembly 16, fig. 5, [0054]); flexible stabilizing members positioned on each side of the flexible drive beam (blowout plates 184. fig. 8, [0070]); and an articulation mechanism (fig. 5) including a proximal drive link (first active articulation link 52), a distal drive link (second active articulation link 54), a proximal driven link (first passive articulation link 56), and a distal driven link (second passive articulation link 58), the proximal drive link having a planar inner surface (cam surface 106 includes a planar portion, figs. 6, 20), a proximal portion (fig. 5), and a distal portion (fig. 5), the distal drive link having a proximal portion pivotally coupled to the distal portion of the proximal drive link and a distal portion pivotally coupled to the tool assembly (second active articulation link 54 is pivotally coupled to the first active articulation link 52 at 112, and pivotally coupled to mounting assembly 50 at 116, figs. 20, 21, [0060], [0061]), the proximal driven link having a planar inner surface (cam surface 126 includes a planar portion, figs. 6, 20), a proximal portion (fig. 5), and a distal portion (fig. 5), the distal driven link having a proximal portion pivotally coupled to the proximal portion of the proximal driven link and a distal portion pivotally coupled to the tool assembly (second passive articulation link 58 is pivotally coupled to the first passive articulation link 56 at 132, and pivotally coupled to mounting assembly 50 at 136, figs. 20, 21, [0063], [0064]), wherein the proximal drive link is movable from an intermediate position to an advanced position to articulate the tool assembly about the articulation axis in a first direction (figs. 20, 21) and movable from the intermediate position to a retracted position to articulate the tool assembly about the articulation axis in a second direction (figs. 20, 24), wherein the planar inner surfaces of the proximal drive link and the proximal driven link define a channel through which the flexible drive beam moves when the drive assembly is moved between the retracted and advanced positions (channel formed between cam surfaces 106, 156 through which flexible body 68 advances and retracts, figs. 20, 21, 24).
To the extent that Kostrzewski et al. can be considered not to expressly disclose at least one of the flexible stabilizing members abutting a corresponding at least one of the planar surfaces of the proximal drive link or the proximal driven link when the tool assembly is in the articulated position, this configuration of the stabilizing members and the planar surfaces of the proximal links is implicit in the disclosure of Kostrzewski et al. at least because Kostrzewski et al. expressly disclose that the stabilizing members abut the planar surfaces of the proximal links in the non-articulated position, and that the proximal links move from the non-articulated position to abutting curved surfaces of the proximal links in an articulated position. Thus, one of ordinary skill in the art would reasonably draw the inference that the stabilizing members would abut the planar surfaces of the proximal links when the tool assembly is in articulated positions between the non-articulated position of figure 20 and the articulated positions of figures 21 and 24, in order for the device to operate as disclosed so that the tool assembly moves from the articulated position of figure 20 to the articulated positions of figures 21 and 24.
Accordingly, it 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 to modify the surgical device of Kostrzewski et al. to include at least one of the flexible stabilizing members abutting a corresponding at least one of the planar surfaces of the proximal drive link or the proximal driven link when the tool assembly is in the articulated position, since Kostrzewski et al. disclose that the stabilizing members abut the planar surfaces of the proximal links in the non-articulated position, and that the proximal links move from the non-articulated position to abutting curved surfaces of the proximal links in an articulated position, and one of ordinary skill in the art would reasonably draw the inference that the stabilizing members would be so configured to operate as disclosed. ("[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)). MPEP 2144.01.
With respect to claim 2, Kostrzewski et al. disclose the proximal drive link and the proximal driven link are confined to linear movement within the elongate body (first active articulation link 52 and first passive articulation link 56 move linearly, figs. 20, 21, 24).
With respect to claim 3, Kostrzewski et al. disclose the planar inner surface of the proximal drive link is positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction (flexible body 68 is urged toward the cam surface 106, the proximal drive link 52 is positioned to engage the flexible body 68 via the blowout plates 184, fig. 21, [0070], [0073]).
With respect to claim 4, Kostrzewski et al. disclose the planar inner surface of the proximal driven link is positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction (flexible body 68 is urged toward the cam surface 126, the proximal driven link 56 is positioned to engage the flexible body 68 via the blowout plates 184, fig. 24, [0070], [0073]).
With respect to claim 9, Kostrzewski et al. disclose each of the flexible stabilizing members has a distal end coupled to the tool assembly and a proximal end received within the elongate body (blowout plates 184 are secured in a slot in the mounting assembly 50 and in the housing 70, [0070]).
With respect to claim 10, Kostrzewski et al. disclose a handle assembly coupled to the proximal portion of the elongate body (handle, fig. 1).
With respect to claim 11, Kostrzewski et al. disclose a mounting assembly fixedly coupled to the tool assembly and pivotally coupled to the elongate body (mounting assembly 50, fig. 19, [0055]).
With respect to claim 12, Kostrzewski et al. disclose the distal portions of the distal drive link and the distal driven link are pivotally coupled to the mounting assembly (second active articulation link 54 is pivotally coupled to mounting assembly 50 at 116, figs. 20, 21, [0060], [0061], the second passive articulation link 58 is pivotally coupled to mounting assembly 50 at 136, figs. 20, 21, [0063], [0064]).
With respect to claim 13, Kostrzewski et al. disclose the mounting assembly defines a channel, and the flexible drive beam extends through the channel of the mounting assembly (mounting assembly 50 defines a channel receiving the flexible body 68, figs. 5, 19).
With respect to claim 14, Kostrzewski et al. disclose the proximal drive link and the proximal driven link define slots, and the distal drive link and the distal driven link are at least partly received within the slots (pivot member 112 is received in opening 110, pivot member 132 is received in opening 130, fig. 6, [0060], [0061]).
With respect to claim 15, Kostrzewski et al. disclose a reload (reload 18, fig. 1) comprising: a proximal body portion defining a first longitudinal axis and having a proximal portion and a distal portion (body portion 20, fig. 1), the proximal body portion configured to releasably engage a surgical device (body portion 20 releasably engages adapter assembly 14 of surgical device 10, [0051], fig. 1); a tool assembly defining a second longitudinal axis (tool assembly 16, figs. 1, 2), the tool assembly supported on the distal portion of the proximal body portion for pivotal movement about an articulation axis between a non-articulated position and at least one articulated position (“tool assembly 16 is pivotal between a non-articulated position in which the tool assembly 16 is aligned with the longitudinal axis “X” and articulated positions in which the tool assembly 16 defines an acute angle with the longitudinal axis “X””, “the radius of curvature changes as the tool assembly 16 is articulated about the pivot axis”, [0051], [0070]), the articulation axis being transverse to the first and second longitudinal axes (tool assembly 16 supported on body 20 and pivotable about an articulation axis, figs. 3, 4); a drive assembly including a flexible drive beam and an I-beam (flexible body 68 and working member 66, fig. 5), the flexible drive beam having a proximal portion and a distal portion (fig. 5), the I-beam supported on the distal portion of the flexible drive beam and received within the tool assembly (working member 66 supported on flexible body 68 moves through tool assembly 16, fig. 5, [0054]), the drive assembly movable between a retracted position and an advanced position to move the I-beam through the tool assembly (the flexible body 68 advances and moves the working member through the tool assembly 16, fig. 5, [0054]); flexible stabilizing members positioned on each side of the flexible drive beam (blowout plates 184. fig. 8, [0070]), and an articulation mechanism (fig. 5) including a proximal drive link (first active articulation link 52), a distal drive link (second active articulation link 54), a proximal driven link (first passive articulation link 56), and a distal driven link (second passive articulation link 58), the proximal drive link having a planar inner surface (cam surface 106 includes a planar portion, figs. 6, 20), a proximal portion (fig. 5), and a distal portion (fig. 5), the distal drive link having a proximal portion pivotally coupled to the distal portion of the proximal drive link and a distal portion pivotally coupled to the tool assembly (second active articulation link 54 is pivotally coupled to the first active articulation link 52 at 112, and pivotally coupled to mounting assembly 50 at 116, figs. 20, 21, [0060], [0061]), the proximal driven link having a planar inner surface (cam surface 126 includes a planar portion, figs. 6, 20), a proximal portion (fig. 5), and a distal portion (fig. 5), the distal driven link having a proximal portion pivotally coupled to the proximal portion of the proximal driven link and a distal portion pivotally coupled to the tool assembly (second passive articulation link 58 is pivotally coupled to the first passive articulation link 56 at 132, and pivotally coupled to mounting assembly 50 at 136, figs. 20, 21, [0063], [0064]), wherein the proximal drive link is movable from an intermediate position to an advanced position to articulate the tool assembly about the articulation axis in a first direction (figs. 20, 21) and movable from the intermediate position to a retracted position to articulate the tool assembly about the articulation axis in a second direction (figs. 20, 24), wherein the planar inner surfaces of the proximal drive link and the proximal driven link define a channel through which the flexible drive beam moves when the drive assembly is moved between the retracted and advanced positions (channel formed between cam surfaces 106, 156 through which flexible body 68 advances and retracts, figs. 20, 21, 24).
To the extent that Kostrzewski et al. can be considered not to expressly disclose at least one of the flexible stabilizing members abutting a corresponding at least one of the planar inner surfaces of the proximal drive link or the proximal driven link when the tool assembly is in the articulated position, this configuration of the stabilizing members and the planar surfaces of the proximal links is implicit in the disclosure of Kostrzewski et al. at least because Kostrzewski et al. expressly disclose that the stabilizing members abut the planar surfaces of the proximal links in the non-articulated position, and that the proximal links move from the non-articulated position to abutting curved surfaces of the proximal links in an articulated position. Thus, one of ordinary skill in the art would reasonably draw the inference that the stabilizing members would abut the planar surfaces of the proximal links when the tool assembly is in articulated positions between the non-articulated position of figure 20 and the articulated positions of figures 21 and 24, in order for the device to operate as disclosed so that the tool assembly moves from the articulated position of figure 20 to the articulated positions of figures 21 and 24.
Accordingly, it 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 to modify the surgical device of Kostrzewski et al. to include at least one of the flexible stabilizing members abutting a corresponding at least one of the planar surfaces of the proximal drive link or the proximal driven link when the tool assembly is in the articulated position, since Kostrzewski et al. disclose that the stabilizing members abut the planar surfaces of the proximal links in the non-articulated position, and that the proximal links move from the non-articulated position to abutting curved surfaces of the proximal links in an articulated position, and one of ordinary skill in the art would reasonably draw the inference that the stabilizing members would be so configured to operate as disclosed. ("[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)). MPEP 2144.01.
With respect to claim 16, Kostrzewski et al. disclose the planar inner surface of the proximal drive link is positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction (flexible body 68 is urged toward the cam surface 106, the proximal drive link 52 is positioned to engage the flexible body 68 via the blowout plates 184, fig. 21, [0070], [0073]).
With respect to claim 17, Kostrzewski et al. disclose the planar inner surface of the proximal driven link is positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction (flexible body 68 is urged toward the cam surface 126, the proximal driven link 56 is positioned to engage the flexible body 68 via the blowout plates 184, fig. 24, [0070], [0073]).
Claims 5-6 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski et al. in view of Beardsley et al. (US Patent Publ. No. 2020/0330095).
With respect to claim 5, Kostrzewski et al. disclose the distal drive link and the distal driven link have inner surfaces (second drive articulation link 54 and second driven articulation link 58 include inner surfaces, fig. 20).
Kostrzewski et al. fail to disclose an inner guide surface of the distal drive link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction.
Beardsley et al. disclose a surgical device including an articulation mechanism including proximal links 74b, 76b, and distal links 86, 88, in which an inner guide surface 90c of the distal link is positioned to engage the flexible drive beam 104 adjacent the articulation axis when the tool assembly is articulated (fig. 11, [0062]), to guide and support blowout plates ([0062]).
It 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 to modify the Kostrzewski et al. device to include an inner guide surface of the distal drive link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction, as taught by Beardsley et al, to guide and support the blowout plates.
With respect to claim 6, Kostrzewski et al. disclose the distal drive link and the distal driven link have inner surfaces (second drive articulation link 54 and second driven articulation link 58 include inner surfaces, fig. 20).
Kostrzewski et al. fail to disclose an inner guide surface of the distal driven link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction.
Beardsley et al. disclose a surgical device including an articulation mechanism including proximal links 74b, 76b, and distal links 86, 88, in which an inner guide surface 90c of the distal link is positioned to engage the flexible drive beam 104 adjacent the articulation axis when the tool assembly is articulated (fig. 11, [0062]), to guide and support blowout plates ([0062]).
It 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 to modify the Kostrzewski et al. device to include an inner guide surface of the distal driven link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction, as taught by Beardsley et al, to guide and support the blowout plates.
With respect to claim 18, Kostrzewski et al. disclose the distal drive link and the distal driven link have inner surfaces (second drive articulation link 54 and second driven articulation link 58 include inner surfaces, fig. 20).
Kostrzewski et al. fail to disclose an inner guide surface of the distal drive link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction.
Beardsley et al. disclose a surgical device including an articulation mechanism including proximal links 74b, 76b, and distal links 86, 88, in which an inner guide surface 90c of the distal link is positioned to engage the flexible drive beam 104 adjacent the articulation axis when the tool assembly is articulated (fig. 11, [0062]), to guide and support blowout plates ([0062]).
It 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 to modify the Kostrzewski et al. device to include an inner guide surface of the distal drive link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the first direction, as taught by Beardsley et al, to guide and support the blowout plates.
With respect to claim 19, Kostrzewski et al. disclose the distal drive link and the distal driven link have inner surfaces (second drive articulation link 54 and second driven articulation link 58 include inner surfaces, fig. 20).
Kostrzewski et al. fail to disclose an inner guide surface of the distal driven link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction.
Beardsley et al. disclose a surgical device including an articulation mechanism including proximal links 74b, 76b, and distal links 86, 88, in which an inner guide surface 90c of the distal link is positioned to engage the flexible drive beam 104 adjacent the articulation axis when the tool assembly is articulated (fig. 11, [0062]), to guide and support blowout plates ([0062]).
It 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 to modify the Kostrzewski et al. device to include an inner guide surface of the distal driven link positioned to engage the flexible drive beam adjacent the articulation axis when the tool assembly is articulated in the second direction, as taught by Beardsley et al, to guide and support the blowout plates.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski et al. in view of Huang et al. (US Patent Publ. No. 2017/0224339).
With respect to claim 7, Kostrzewski et al. fail to disclose the distal drive link and the proximal drive link are formed from a rigid material.
Huang et al. disclose a surgical device in which the end effector 1306 (fig. 124) is comprised of rigid material to minimize deflection in the device and reduce variation in operation.
It 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 to modify the Kostrzewski et al. device to form the distal drive link and the proximal drive link from a rigid material, as taught by Huang et al., to minimize deflection in the device and reduce variation in operation.
Response to Arguments
With respect to the rejection of claims 1-20 under 35 U.S.C. 112(a), the claim amendments and applicant’s arguments have been fully considered and are persuasive. The rejection is hereby withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Beardsley (U.S. Patent No. 10,603,035) disclose a surgical device including an articulation mechanism and a driven link that may be linear (fig. 5, col. 8. L. 4-17).
Kostrzewski (US Patent Publ. No. 2014/0284372) disclose a surgical device including an articulation mechanism and a planar link (fig. 13).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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