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 .
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 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 Dycus (US PGPub 2003/0018331).
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); 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).
PNG
media_image1.png
388
573
media_image1.png
Greyscale
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 the 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 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.
Dycus teaches a vessel sealing surgical instrument comprising a housing (20), elongated shaft (12), an end effector comprising a pair of jaws (100; Figure 1A), and a knife assembly (200; Figure 12; Paragraph 0101) comprising a knife (206) which is configured to attach to a knife carrier (220; Figure 12; Paragraph 0103), wherein the knife (206) comprises a proximal end having an engagement feature including at least one detent (212a and 212b) disposed on the proximal end of the knife (Figure 12) and the knife drive rod (220) includes at least one complementary aperture (230a) defined therein configured to engage the at least one detent (212a and 212b) to secure the knife (206) to the knife drive rod (220; Figure 12; Paragraph 0096).
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 Dycus 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 Dycus would be sufficient to provide consistent and accurate distal translation of the knife through tissue (Paragraph 0096; Dycus).
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 Dycus teaches the engagement feature includes a plurality of detents (212a and 212b) disposed on the proximal end of the knife (206; Figure 12) and the knife drive rod (220) includes a plurality of complementary apertures (230a) defined therein configured to engage the at least one detent (212a/212b) to secure the knife (200) to the knife drive rod (34; Paragraph 0096; Dycus).
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).
PNG
media_image1.png
388
573
media_image1.png
Greyscale
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 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.
Dycus teaches a vessel sealing surgical instrument comprising a housing (20), elongated shaft (12), an end effector comprising a pair of jaws (100; Figure 1A), and a knife assembly (200; Figure 12; Paragraph 0101) comprising a knife (206) which is configured to attach to a knife carrier (220; Figure 12; Paragraph 0103), wherein the knife (206) comprises a proximal end having an engagement feature including at least one detent (212a and 212b) disposed on the proximal end of the knife (Figure 12) and the knife drive rod (220) includes at least one complementary aperture (230a) defined therein configured to engage the at least one detent (212a and 212b) to secure the knife (206) to the knife drive rod (220; Figure 12; Paragraph 0096).
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 Dycus 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 Dycus would be sufficient to provide consistent and accurate distal translation of the knife through tissue (Paragraph 0096; Dycus).
Regarding Claim 9, the combination of references disclosed above teaches the surgical instrument according to claim 8, wherein Dycus teaches the at least one detent (212a and 212b) is disposed on the proximal end portion of the knife (See Figure 12).
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 Dycus teaches the engagement feature includes a plurality of detents (212a and 212b) disposed on the proximal end of the knife (206; Figure 12) and the knife drive rod (220) includes a plurality of complementary apertures (230a) defined therein configured to engage the at least one detent (212a/212b) to secure the knife (200) to the knife drive rod (34; Paragraph 0096; Dycus).
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 Dycus (US PGPub 2003/0018331) 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
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMED G GABR/Primary Examiner, Art Unit 3771