DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to the amendment filed on 06/29/2026, No Claims have been cancelled, and Claims 1-15 and newly added Claim 16-20 are pending.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) 1, 8, and 17 under Moua, Drochner, and Dycus have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Moua (US PGPub 2014/0257285) in view of Drochner (US PGPub 2018/0008298) and Kerr (US PGPub 2013/0085516). Applicant’s Argument that the prior art fails to teach the amended claim language has been considered but is moot because the new grounds of rejections relies on a newly discovered prior art reference, Kerr, to teach the newly amended claim language.
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) 1-4 and 8-12 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moua (US PGPub 2014/0257285) in view of Drochner (US PGPub 2018/0008298) and Kerr (US PGPub 2013/0085516).
Regarding Claim 1, Moua teaches a surgical instrument (abstract; Figure 1), comprising:
a housing (112; Figure 1) including at least one actuator (122; Figure 1) disposed thereon (Paragraph 0050);
an elongated shaft (116) extending from a distal portion of the housing (112; Figure 1), the elongated shaft (116) including an end effector assembly (114) engaged at a distal end thereof (Figure 1; Paragraph 0050), the end effector (114) assembly including a pair of opposing jaw members (130 and 132; Figure), at least one of the jaw members (132) including a knife channel (158) defined therein (Figure 2A; Paragraph 0059); and
a knife assembly (Figure 3A; Paragraph 0062) including:
a knife (156) having the proximal end and a distal end (157; Figure 3A) defining a knife length therebetween (Figure 3A), the proximal end including an engagement feature disposed thereon, (see annotated Figure 6 below; Paragraph 0062), wherein the knife (156) includes a first side surface and a second side surface opposite the first side surface (the side surfaces are the long side of element 156), wherein the first side surface and the second side surface are connected at a top and bottom (the top and bottom surface are the short sides of element 156 Figure 6); and
a knife drive rod (102; Figure 3A and Figure 6) configured to operably engage the engagement feature (of the knife 156) to secure the knife drive rod (102) to the knife (156) such that the distal end (157) of the knife (156) extends beyond the engagement feature (as seen in Figure 3A and annotated Figure 6 below).
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Moua fails to disclose:
an articulating section disposed between the housing and the end effector assembly, the articulating section configured to selectively articulate the end effector assembly upon actuation of the at least one actuator, the articulating section and a proximal end of the knife channel defining a first distance therebetween;
wherein the knife length is less than a length of the first distance;
wherein the engagement feature includes at least one detent disposed on the proximal end of the knife and the knife drive rod includes at least one complementary aperture defined therein configured to engage the at least one detent to secure the knife to the knife drive rod.
Drochner teaches cutting mechanisms for surgical end effector assembles (abstract) comprising an articulating section (15; Figure 1A; Paragraph 0037) disposed between the housing (20) and the end effector assembly (100; Figure 1A), the articulating section (15) configured to selectively articulate the end effector assembly (100) upon actuation of the at least one actuator (80; Paragraph 0036; Figure 1A), the articulating section (15) and a proximal end of the knife channel (338) defining a first distance therebetween (wherein the first distance is between the articulating section 15 and the proximal end of the jaws (100 since the knife channel (338) extends within the jaw; see Figures 1B and Figure 4A-4C; Paragraph 0061), wherein the knife length (of knife 334 in Figures 4A-4C) is less than a length of the first distance (the first distance between the articulating section 15 and the jaws (100) and since the knife (334) fits fully within the jaws, the knife has a length smaller than the first length).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Moua to include an articulation section on the elongated shaft, as taught by Droucher, for the advantage of articulating the end effector to manipulate the attack angle of the end effector.
It also would have been obvious to one of ordinary skill in the art to modify the placement of the articulation section, taught by Droucher, along the shaft of Moua such that a first distance defined by the articulation section and the knife channel defined by the jaw is larger than a length defined by the knife of Moua since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402
The combination of references further fails to disclose:
wherein the engagement feature includes at least one detent disposed on the proximal end of the knife, wherein the at least one detent projects from the first side surface or the second side surface, and wherein the knife drive rod includes at least one complementary aperture defined therein configured to engage the at least one detent to secure the knife to the knife drive rod.
Kerr teaches surgical forceps (abstract) comprising a housing (20), elongated shaft (12), an end effector comprising a pair of jaws (100; Figure 1), and a knife assembly (Paragraph 0047 and Paragraph 0089; see the embodiment of Figure 18, of which the Examiner is relying upon; Paragraph 0097) comprising a knife (1844b; Figure 18) which is configured to attach to a knife drive rod (1844a; Figure 18; Paragraph 0095 and 0097), wherein the knife (1844b) comprises a proximal end having an engagement feature including at least one detent (posts 1860) disposed on the proximal end of the knife (Figure 18; Paragraph 0097) and the knife drive rod (1844a) includes at least one complementary aperture (1850; Figure 18; Paragraph 0097) defined therein configured to engage the at least one detent (1860) to secure the knife (1844b) to the knife drive rod (1844a; Figure 18; Paragraph 0097).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the engagement feature taught by Moua with the engagement feature as taught by Kerr since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the engagement feature of Kerr would be sufficient to facilitate the engagement and disengagement of at least a portion of the knife assembly for cleaning and re-engaging the knife assembly, or for replacing the knife assembly (or components thereof) with a new knife assembly in preparation for re-use (Paragraph 0089; Kerr).
Regarding Claim 2, the combination of references disclosed above teaches the surgical instrument according to claim 1, wherein Moua teaches the at least one detent is spot welded within the at least one complementary aperture (Paragraph 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the connection between the detent and the complementary aperture of the combination of references such that they are further welded, as taught by Moua, for the advantage of preventing the knife from disconnected from the knife drive rod.
Regarding Claim 3, the combination of references disclosed above teaches the surgical instrument according to claim 1, wherein Moua teaches the knife drive rod (102) is welded, riveted, or swaged to the knife (156; Paragraph 0062).
Regarding Claim 4, the combination of references disclosed above teaches the surgical instrument according to claim 1, wherein Kerr teaches the at least one detent (1860) is a plurality of detents (1860) disposed on the proximal end of the knife (1844b; Figure 18) and the knife drive rod (1944a) includes a plurality of complementary apertures (1850; Figure 18; Paragraph 0097) defined therein configured to engage the plurality of detents (1860) to secure the knife (1844b) to the knife drive rod (1844a; Paragraph 0096; Kerr).
Regarding Claim 8, Moua teaches a surgical instrument (abstract; Figure 1), comprising:
a housing (112; Figure 1; Paragraph 0050);
an elongated shaft (116) extending from a distal portion of the housing (112; Figure 1), the elongated shaft (116) including an end effector assembly (114) engaged at a distal end thereof (Figure 1; Paragraph 0050), the end effector (114) assembly including a pair of opposing jaw members (130 and 132; Figure), at least one of the jaw members (132) including a knife channel (158) defined therein (Figure 2A; Paragraph 0059); and
a knife assembly (Figure 3A; Paragraph 0062) including:
a knife (156) having the proximal end and a distal end (157; Figure 3A), the proximal end including an engagement feature disposed thereon (see annotated Figure 6 below; Paragraph 0062); and
a knife drive rod (102; Figure 3A and Figure 6) configured to coupled to the engagement feature (of the knife 156) to secure the knife drive rod (102) to the knife (156) such that the distal end (157) of the knife (156) extends beyond the engagement feature (as seen in Figure 3A and annotated Figure 6 below), wherein the knife (156) includes a first side surface and a second side surface opposite the first side surface (the side surfaces are the long side of element 156), wherein the first side surface and the second side surface are connected at a top and bottom (the top and bottom surface are the short sides of element 156 Figure 6)
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Moua fails to disclose:
an articulating section disposed between the housing and the end effector assembly, the articulating section configured to selectively articulate the end effector assembly;
wherein the engagement feature includes at least one detent and the knife drive rod includes at least one complementary aperture defined therein configured to engage the at least one detent to secure the knife to the knife drive rod.
Drochner teaches cutting mechanisms for surgical end effector assembles (abstract) comprising an articulating section (15; Figure 1A; Paragraph 0037) disposed between the housing (20) and the end effector assembly (100; Figure 1A), the articulating section (15) configured to selectively articulate the end effector assembly (100; Paragraph 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Moua to include an articulation section on the elongated shaft, as taught by Droucher, for the advantage of articulating the end effector to manipulate the attack angle of the end effector.
The combination of references further fails to disclose:
wherein the engagement feature includes at least one detent disposed, wherein the at least one detent projects from the first side surface or the second side surface, and wherein the knife drive rod includes at least one complementary aperture defined therein configured to engage the at least one detent to secure the knife to the knife drive rod.
Kerr teaches surgical forceps (abstract) comprising a housing (20), elongated shaft (12), an end effector comprising a pair of jaws (100; Figure 1), and a knife assembly (Paragraph 0047 and Paragraph 0089; see the embodiment of Figure 18, of which the Examiner is relying upon; Paragraph 0097) comprising a knife (1844b; Figure 18) which is configured to attach to a knife drive rod (1844a; Figure 18; Paragraph 0095 and 0097), wherein the knife (1844b) comprises a proximal end having an engagement feature including at least one detent (posts 1860) disposed on the proximal end of the knife (Figure 18; Paragraph 0097) and the knife drive rod (1844a) includes at least one complementary aperture (1850; Figure 18; Paragraph 0097) defined therein configured to engage the at least one detent (1860) to secure the knife (1844b) to the knife drive rod (1844a; Figure 18; Paragraph 0097).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the engagement feature taught by Moua with the engagement feature as taught by Kerr since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the engagement feature of Kerr would be sufficient to facilitate the engagement and disengagement of at least a portion of the knife assembly for cleaning and re-engaging the knife assembly, or for replacing the knife assembly (or components thereof) with a new knife assembly in preparation for re-use (Paragraph 0089; Kerr).
Regarding Claim 9, the combination of references disclosed above teaches the surgical instrument according to claim 8, wherein Kerr teaches the at least one detent (1860) is disposed on the proximal end portion of the knife (1844b) (See Figure 18; Paragraph 0097).
Regarding Claim 10, the combination of references disclosed above teaches the surgical instrument according to claim 8, wherein Moua teaches the at least one detent is spot welded within the at least one complementary aperture (Paragraph 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the connection between the detent and the complementary aperture of the combination of references such that they are further welded, as taught by Moua, for the advantage of preventing the knife from disconnected from the knife drive rod.
Regarding Claim 11, the combination of references disclosed above teaches the surgical instrument according to claim 8, wherein Moua teaches the knife drive rod (102) is welded, riveted, or swaged to the knife (156; Paragraph 0062).
Regarding Claim 12, the combination of references disclosed above teaches the surgical instrument according to claim 8, wherein Kerr teaches the engagement feature (1860) is a plurality of detents (1860) disposed on the knife (1844b; Figure 18; Paragraph 0097) and the knife drive rod (1944a) includes a plurality of complementary apertures (1850; Figure 18; Paragraph 0097) defined therein configured to engage the plurality of detents (1860) to secure the knife (1844b) to the knife drive rod (1844a; Paragraph 0096; Kerr).
Regarding Claim 16, the combination of references disclosed above teaches the surgical instrument of claim 8, Moau teaches the knife (156) includes a knife body that extends from the distal end portion to the proximal end portion, wherein the first side surface of the knife body confronts the knife drive rod (102; see Figure 6) and the second side surface confronts the knife channel (158; Figure 6; Paragraph 0059) and Kerr teaches the knife (1844b) includes a knife body that extends from the distal end portion to the proximal end portion, wherein the first side surface of the knife body (1844b) confronts the knife drive rod (1844a; as best seen in Figure 6) and the second side surface confronts the knife channel (1425; Figure 14a; Paragraph 000091), wherein the at least one detent (1860) extends from the first side surface (Figure 18; Paragraph 0094-0097).
Regarding Claim 17, Moua teaches a surgical instrument (abstract; Figure 1), comprising:
a housing (112; Figure 1) including at least one actuator (122; Figure 1) disposed thereon (Paragraph 0050);
an elongated shaft (116) extending from a distal portion of the housing (112; Figure 1), the elongated shaft (116) including an end effector assembly (114) engaged at a distal end thereof (Figure 1; Paragraph 0050), the end effector (114) assembly including a pair of opposing jaw members (130 and 132; Figure), at least one of the jaw members (132) including a knife channel (158) defined therein (Figure 2A; Paragraph 0059); and
a knife assembly (Figure 3A; Paragraph 0062) including:
a knife (156) having knife body extending from a proximal end and a distal end (157; Figure 3A) having an engagement feature (see annotated Figure 6 below)
a knife drive rod (102; Figure 3A and Figure 6) configured to operably engage the engagement feature (of the knife 156) to secure the knife (156) to the knife rod (102) (as seen in Figure 3A and annotated Figure 6 below).
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Moua fails to disclose:
an articulating section disposed between the housing and the end effector assembly, the articulating section configured to selectively articulate the end effector assembly upon actuation of the at least one actuator, the articulating section and a proximal end of the knife channel defining a first distance therebetween;
wherein the engagement feature of the knife is a first and second detent, spaced apart from one another, and extending from a side of the knife body,
wherein the knife rode has a first and second aperture complementary to the first and second detent, wherein the first and second aperture are configured to engage the first detent and the second detent to sure the knife to the knife drive rod,
wherein the first and second detent extend from the side of the knife body that confronts the knife drive rod.
Drochner teaches cutting mechanisms for surgical end effector assembles (abstract) comprising an articulating section (15; Figure 1A; Paragraph 0037) disposed between the housing (20) and the end effector assembly (100; Figure 1A), the articulating section (15) configured to selectively articulate the end effector assembly (100) upon actuation of the at least one actuator (80; Paragraph 0036; Figure 1A), the articulating section (15) and a proximal end of the knife channel (338) defining a first distance therebetween (wherein the first distance is between the articulating section 15 and the proximal end of the jaws (100 since the knife channel (338) extends within the jaw; see Figures 1B and Figure 4A-4C; Paragraph 0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Moua to include an articulation section on the elongated shaft, as taught by Droucher, for the advantage of articulating the end effector to manipulate the attack angle of the end effector.
The combination of references further fails to disclose:
wherein the engagement feature of the knife is a first and second detent, spaced apart from one another, and extending from a side of the knife body,
wherein the knife rod has a first and second aperture complementary to the first and second detent, wherein the first and second aperture are configured to engage the first detent and the second detent to sure the knife to the knife drive rod,
wherein the first and second detent extend from the side of the knife body that confronts the knife drive rod.
Kerr teaches surgical forceps (abstract) comprising a housing (20), elongated shaft (12), an end effector comprising a pair of jaws (100; Figure 1), and a knife assembly (1840; Paragraph 0047 and Paragraph 0089; see the embodiment of Figure 18, of which the Examiner is relying upon; Paragraph 0097) comprising a knife (1844b; Figure 18) which is configured to attach to a knife drive rod (1844a; Figure 18; Paragraph 0095 and 0097), wherein the knife assembly (1840; Figure 18) includes :
wherein the engagement feature of the knife (1844b) is a first and second detent (1860; Paragraph 0097), spaced apart from one another (Figure 18), and extending from a side of the knife body (Figure 18),
wherein the knife rod (1844a) has a first and second aperture (1850; Figure 18; Paragraph 0097) complementary to the first and second detent (Paragraph 0097), wherein the first and second aperture (1850) are configured to engage the first detent and the second detent (1860) to secure the knife (1844b) to the knife drive rod (1844a; Paragraph 0097),
wherein the first and second detent (1860) extend from the side of the knife body (1844a) that confronts the knife drive rod (1844b).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the engagement feature taught by Moua with the engagement feature as taught by Kerr since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the engagement feature of Kerr would be sufficient to facilitate the engagement and disengagement of at least a portion of the knife assembly for cleaning and re-engaging the knife assembly, or for replacing the knife assembly (or components thereof) with a new knife assembly in preparation for re-use (Paragraph 0089; Kerr).
Regarding Claim 18, the combination of references disclosed above teaches the surgical instrument according to Claim 17, wherein Kerr teaches the first and second detent (1860) extend from the side of the knife body (1844a) that confronts with the knife drive rod (1844a; Figure 18; Paragraph 0097).
Regarding Claim 19, the combination of references disclosed above teaches the surgical instrument according to Claim 17, wherein Moua teaches the at least one detent is spot welded within the at least one complementary aperture (Paragraph 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the connection between the detent and the complementary aperture of the combination of references such that they are further welded, as taught by Moua, for the advantage of preventing the knife from being improperly disconnected from the knife drive rod.
Regarding Claim 20, the combination of references disclosed above teaches the surgical instrument according to claim 1, wherein Moua teaches the top of the knife is a top surface of the knife (See Figure 6 in which the top surface is the short top side of knife 156), wherein the first side surface and the second side surface are connected by the top surface (see Figure 6 in which the first and second side surfaces are the long sides of knife 156)
Claim(s) 5-7 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moua (US PGPub 2014/0257285) in view of Drochner (US PGPub 2018/0008298) and Kerr (US PGPub 2013/0085516) as applied to claim 1 above, and further in view of Manzo (US PGPub 2012/0215220).
Regarding Claims 5-7, the combination of references disclosed above teaches the surgical instrument according to claim 1, but fails to disclose wherein the knife and the knife drive rod are made of different types of materials (Claim 5), wherein the knife is made of metal and the knife drive rod is made of a flexible elastic material (Claim 6), and wherein the knife is made of stainless steel and the knife drive rod is made of Nitinol (Claim 7)
Manzo teaches a surgical cutting instrument comprising a knife assembly (Figure 10) comprising a knife (19) and a knife drive rod (20; Figure 10) wherein the knife (19) and the knife drive rod (20) are made of different types of materials (Paragraph 0091 and 0093), wherein the knife (19) is made of metal (Paragraph 0093) and the knife drive rod is made of a flexible elastic material (Paragraph 0091), and wherein the knife (19) is made of stainless steel (Paragraph 0093) and the knife drive rod (20) is made of Nitinol (Paragraph 0091)
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the materials of the knife and drive rod of the combination of references using the materials as taught by Manzo, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07).
Regarding Claims 13-15, the combination of references disclosed above teaches the surgical instrument according to claim 1, but fails to disclose wherein the knife and the knife drive rod are made of different types of materials (Claim 13), wherein the knife is made of metal and the knife drive rod is made of a flexible elastic material (Claim 14), and wherein the knife is made of stainless steel and the knife drive rod is made of Nitinol (Claim 15)
Manzo teaches a surgical cutting instrument comprising a knife assembly (Figure 10) comprising a knife (19) and a knife drive rod (20; Figure 10) wherein the knife (19) and the knife drive rod (20) are made of different types of materials (Paragraph 0091 and 0093), wherein the knife (19) is made of metal (Paragraph 0093) and the knife drive rod is made of a flexible elastic material (Paragraph 0091), and wherein the knife (19) is made of stainless steel (Paragraph 0093) and the knife drive rod (20) is made of Nitinol (Paragraph 0091)
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the materials of the knife and drive rod of the combination of references using the materials as taught by Manzo, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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