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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/2026 has been entered.
Amendment of Claim 1 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 to 9 and 12 to 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1:
The Claim includes the limitation “wherein a part of the cutter frame assembly is disposed in the extension tube and penetrates through the connecting assembly”. There is insufficient antecedent basis for this limitation in the claim, the connecting assembly has not been disclosed in the claim yet. Note that “a connecting assembly”, that the Examiner is considering as the same, is mentioned on line 19.
The Claim also includes the limitation “two or more bendable pull beams are placed in an overlapping manner”. This is unclear and as written not really supported in the Specification. The “overlapping manner” is unclear since it is not indicated if they are overlapped to each other or to something else. Also, the Claim only makes reference to two bendable pull beams, more beams are not disclosed and actually according to the specification the additional pull beams could correspond to an embodiment not shown on any figure where the pull beams are segmented.
Claim Rejections - 35 USC § 103
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.
Claims 1 to 5, 7, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nei (CN 205339036), Nei (US 2018/0289372) will be used for text and figures, and in view of Milliman (US 2006/0049229).
Regarding Claim 1:
Nei discloses a surgical instrument with a pivotable effector, wherein the surgical instrument adopts an integral design and comprises comprising:
an effector at a distal end, a controller at a proximal end, and an extension tube between the effector and the controller, wherein the extension tube is respectively connected to a distal end of the controller and a proximal end of the effector; wherein the extension tube is movably connected to a distal end of the controller (Figure 1, surgical instrument not numbered with actuator 100 that will be considered an end effector, controller 300 and extension tube 200 movably connected to a distal end of the controller);
a cutter frame assembly (Figure 3, operating driving assembly 160, that includes cutter 164 and a flexible cutter bar 166 will be considered a cutter frame assembly);
wherein a distal end of the extension tube is pivotally connected to a proximal end of the effector (Figures 2 shows a pivoting position) and ; wherein the extension tube forms a connection channel for transferring an action of the controller to the effector (Figure 3, magazine sleeve 504, part of extension tube 200, forms a connection channel for transferring an action of the controller to the effector for operating driving assembly 160 and pulling pieces 514a and b);
the controller comprises an articulation control mechanism capable of moving in at least one direction (Figure 1, paragraph 0042, bend control spanner 313 will be considered as part of the articulation control mechanism and indirectly drives bend control rod 508);
the extension tube comprises a first bendable component and a second bendable component, wherein a distal end of the first bendable component and a distal end of the second bendable component respectively penetrate through a connecting assembly, and are connected to left and right sides of the effector; wherein each of the first bendable component and the second bendable component is a bendable pull beam (Figures 3 and 5, paragraph 0046 first flexible pulling piece 514a, and second flexible pulling piece 514b will be considered the first bendable component and a second bendable components, both will be considered bendable pull beams and as indicated on paragraph 0055, penetrate through intermediate connector 518, that will be considered part of a connection assembly, and are connected to left and right sides of the effector at rivet 184) and two or more bendable pull beams are placed in an overlapping manner (Figure 3, this limitation was considered unclear, but on Figure 3, see from the side flexible pulling pieces 514a and 514b can be considered that they overlap each other; also first rack 510a and second rack 510b can be considered “bendable pull beams” and overlap pulling pieces 514a and 514b at the ends).
when the articulation control mechanism moves in at least one direction, the first bendable component and the second bendable component provide a rotation torque for the effector and drive the effector to rotate towards at least one side relative to the distal end of the extension tube (Paragraph 0055, the flexible pulling pieces provide certain rotation torque for the actuator to drive the actuator to rotate), when the first bendable component is tightened, the second bendable component is released, or when the second bendable component is tightened, the first bendable component is released (Paragraph 0057, 0058 and 0060, Figure 8, the first rack 510a pulls the first flexible pulling piece 514a. At the moment, the first rack 510a drives the gear 512 to rotate, the second rack 510b is then driven to move towards the far end of the magazine 500, as indicated by the arrow, and the second flexible pulling piece 514b is released… when bend control rod 508 is moved proximally, the first flexible pulling piece 514a is released. The first rack 510a drives the gear 512 to rotate, the second rack 510b is then driven to move towards the near end of the magazine 500).
Nei discloses a cutter frame assembly but does not disclose if it includes cutter bar protection plates.
Milliman teaches a cutter assembly including cutter bar protection plates (Figure 27, axial drive assembly 212 and blow out plates 255 will be considered the cutter assembly, paragraph 0109, A pair of blow out plates 255 are positioned adjacent the distal end of housing portion 200 adjacent the distal end of axial drive assembly 212 to prevent outward bulging of drive assembly 212 during articulation of tool assembly 17) positioned to inhibit outward bulging of the axial drive assembly 212. Note that the location of blow out plates 255 on Figures 27 to 30 is the same as the one of cutter bar protection plates 4 and 5 on Figure 2 of the Application.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to Nei the teachings of Milliman and include cutter bar protection plates at a connection between the cutter frame assembly and the connecting assembly to inhibit outward bulging of the flexible cutter bar 166 of the driving assembly 160.
Regarding Claim 2:
Nei discloses that the distal end of the extension tube is pivotally connected to the proximal end of the effector via a hinge; the first bendable component does not pass through a center of the hinge (Figures 4 and 5, paragraph 0055, the distal end of the extension tube pivotally connected to the proximal end of the effector via intermediate connector 518, connected to the distal end of the extension tube by hinge 522b, the flexible pulling pieces 514a, 514b do not pass through the center of the hinges), such that the first bendable component takes the hinge as a rotation axis, provides a rotation torque for the effector, and drives the effector to rotate to at least one side relative to the distal end of the extension tube (Figures 6 and 7 show the end effector rotated).
Regarding Claim 3:
Nei discloses that the effector rotates on a plane perpendicular to the hinge rotation axis (Figures 5, 6 and 7 show the effector 100 rotating on a plane perpendicular to the hinge 522b rotation axis).
Regarding Claim 4:
Nei discloses that the articulation control mechanism comprises an operating component, a articulation control gear, and a first articulation control rack (Figure 6, Paragraph 0051, bend control rod 508 will be considered the operating component, gear 512 will be considered the articulation control gear and second rack 510b will be considered the first articulation control rack), wherein the operating component is connected to the articulation control gear, and drives the articulation control gear to rotate (Figure 6, axial movement of bend control rod 508 drives gear 512); the articulation control gear is engaged with the first articulation control rack (Figure 6, gear 512 engages second rack 510b); the rotation of the articulation control gear drives the first articulation control rack to move forward or backward (Figure 6 shows it moving forward); and the first articulation control rack is fixedly connected to a proximal end of the first bendable component (Paragraph 0051, second rack 510b is fixedly connected with the near end of the second flexible pulling piece 514b, considered the first bendable component).
Regarding Claim 5:
Nei discloses that when the articulation control mechanism moves in a first direction, the articulation control mechanism drives the first bendable component to move to a proximal end thereof, drives the second bendable component to move to a distal end thereof, and then drives the effector to rotate to a first side relative to the distal end of the extension tube; and when the articulation control mechanism moves in a second direction, the articulation control mechanism drives the first bendable component to move to the distal end thereof, drives the second bendable component to move to the proximal end thereof, and then drives the effector to rotate to a second side relative to the distal end of the extension tube (Paragraph 0057, 0058 and 0060, Figure 8, the first rack 510a pulls the first flexible pulling piece 514a. distal axial movement of bend control rod 508 makes the first rack 510a drive the gear 512 to rotate, the second rack 510b is then driven to move proximally towards the far end of the magazine 500, as indicated by the arrow, and the second flexible pulling piece 514b is released… when bend control rod 508 is moved proximally, the first flexible pulling piece 514a is released. The first rack 510a drives the gear 512 to rotate, the second rack 510b is then driven to move distally towards the near end of the magazine 500 pivoting the end effector in the opposite direction).
Regarding Claim 7:
Nei discloses that the first flexible component and the second flexible component are segmented flexible components (Figure 4, first flexible pulling piece 514a is fixedly attached to first rack 510a and second rack 510b is fixedly attached to second rack 510b, so they both can be considered segmented flexible components).
Regarding Claim 14:
Nei discloses that the articulation angle of the effector to at least one side relative to the distal end of the extension tube is one of multiple distinct angle values between 0 and 100 degrees (Paragraphs 0057 and 0060, Figures 6 and 8, α and β can be any numerical value from 0° to 180°).
Regarding Claim 15:
Nei discloses that the surgical instrument is an endoscopic stapler (Paragraph 0016).
Claims 6, 8, 9, 12, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nei (CN 205339036), Nei (US 2018/0289372) will be used for text and figures, and in view of Milliman (US 2006/0049229) as applied to claim 4 above, and further in view of Fanelli (US 2014/0243801).
Regarding Claims 6 and 8:
Nei discloses that when the articulation control mechanism moves in a first direction, the articulation control mechanism drives the first bendable component to move to a proximal end thereof, drives the second bendable component to move to a distal end thereof, and then drives the effector to rotate to a first side relative to the distal end of the extension tube; and when the articulation control mechanism moves in a second direction, the articulation control mechanism drives the first bendable component to move to the distal end thereof, drives the second bendable component to move to the proximal end thereof, and then drives the effector to rotate to a second side relative to the distal end of the extension tube (Paragraph 0057, 0058 and 0060, Figure 8, the first rack 510a pulls the first flexible pulling piece 514a. distal axial movement of bend control rod 508 makes the first rack 510a drive the gear 512 to rotate, the second rack 510b is then driven to move proximally towards the far end of the magazine 500, as indicated by the arrow, and the second flexible pulling piece 514b is released… when bend control rod 508 is moved proximally, the first flexible pulling piece 514a is released. The first rack 510a drives the gear 512 to rotate, the second rack 510b is then driven to move distally towards the near end of the magazine 500 pivoting the end effector in the opposite direction):
the articulation control mechanism further comprises a second articulation control rack (Figure 8, paragraph 0042, first rack 510a will be considered a second articulation control rack); the articulation control gear is engaged with the second articulation control rack; and the second articulation control rack is fixedly connected to a proximal end of the second bendable component.
Nei does not disclose that the rotation of the articulation control gear drives the second articulation control rack to move forward or backward, the second articulation control rack, first rack 510a, actually causes the rotation of gear 512, considered the articulation control gear.
Fanelli teaches a similar surgical instrument with a pivotable effector where all the articulation control mechanism is located in the controller, not just the bend control spanner, the articulation control mechanism comprises an operating component, a articulation control gear, and a first articulation control rack (Figures 12 and 14, Paragraph 0061, articulation knob 214, located on articulation knob casing 215 will be considered the operating component, articulation pinion 250 will be considered the articulation control gear, first rack 252 and second rack 256, also located on articulation knob casing 215 will be considered the first articulation and second control racks), wherein the operating component is connected to the articulation control gear, and drives the articulation control gear to rotate (Figure 14, paragraph 0066, when the user turns articulation knob (214), articulation pinion (250) rotates together with articulation knob (214); the articulation control gear is engaged with the first articulation control rack (Figure 6, gear 512 engages second rack 510b); the rotation of the articulation control gear drives the first articulation and the second control racks to move forward or backward (Paragraph 0066, As articulation pinion 250 rotates, articulation pinion 250 translates first rack 252 and second rack 256 accordingly in opposing directions); the first and second articulation control racks are fixedly connected to a proximal end of the first and second bendable components (Figure 14, first rack 252 is fixedly connected with the near end of the first arm 242, considered the first bendable component and second rack 256 is fixedly connected with the near end of the second arm 240) both bendable components can be considered pull beams extend along the extension tube and are connected to opposite sides of the end effector to rotate it around a pivot.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Nei the teachings of Fanelli and have all the all the articulation control mechanism located in the controller, not just the bend control spanner, having a rotating knob as the operating component and directly rotating the articulation control gear, extending the first and second bendable components along the shaft, having rotation of the articulation control gear drive the first and the second articulation control racks to move forward or backward as an alternative way to rotate the end effector in exactly the same way.
Regarding Claim 9:
As discussed for Claim 8 above, the modified invention of Nei discloses the invention as claimed.
Nei does not disclose that the extension tube comprises an outer sleeve tube, an upper inner tube, and a lower inner tube, the upper inner tube, the lower inner tube, and the outer sleeve tube being coaxially arranged, actually Nei does not disclose many details regarding the extension tube.
Fanelli discloses that the extension tube comprises an outer sleeve tube, an upper inner tube, and a lower inner tube the upper inner tube, the lower inner tube, and the outer sleeve tube being coaxially arranged (Figure 12, the extension tube is considered the section of Shaft assembly proximal of the articulation joint 211 and is formed by elongate shaft 232 that will be considered an outer sleeve tube, Rotation control 213 that will be considered an upper inner tube and articulation knob casing 215 that will be considered a lower inner tube, the three coaxially arranged.
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Nei the teachings of Fanelli and have an extension tube as claimed as a well know in the art configuration for an extension tube.
Regarding Claim 12:
As already discussed for Claims 6 and 8, and considering left and right relative positioning correspond to a viewing direction from the end effector facing the handle, i.e. proximally along axis LA, the modified invention of Nei disclose the first bendable component is a left bendable pull beam; the second bendable component is a right bendable pull beam; the first articulation control rack is a left articulation control rack; the second articulation control rack is a right articulation control rack; an upper side of the articulation control gear is connected to the rotation knob, such that the rotation of the rotation knob drives the articulation control gear to rotate, then drives the left articulation control rack and the right articulation control rack to move forward or backward, and correspondingly drives the left bendable pull beam to move forward or backward; and the right articulation control rack drives the right bendable pull beam to move forward or backward.
Also, the modified invention of Nei also discloses the left articulation control rack and the right articulation control rack, 252 and 256 are respectively disposed on the two sides of the articulation knob casing 215, considered the lower inner tube on Claim 9.
Regarding Claim 13:
As discussed for Claim 8 above, the modified invention of Nei discloses the invention as claimed.
The modified invention of Nei does not disclose wherein a rotating head upper-cover and a rotating lower-cover which are connected to each other are disposed at a proximal end of the extension tube; the articulation control mechanism is located between the rotating head upper-cover and the rotating lower-cover; and a rotation knob is rotatably connected to the rotating head upper-cover via a rotation knob pin.
Fanelli teaches a similar surgical instrument with a pivotable effector where all the articulation control mechanism is located in the controller, not just the bend control spanner, the articulation control mechanism comprises an operating component, a articulation control gear, and a first articulation control rack (Figures 12 and 14, Paragraph 0061, articulation knob 214, located on articulation knob casing 215 will be considered the operating component, articulation pinion 250 will be considered the articulation control gear, first rack 252 and second rack 256, also located on articulation knob casing 215, will be considered the first articulation and second control racks), wherein the operating component is connected to the articulation control gear, and drives the articulation control gear to rotate (Figure 14, paragraph 0066, when the user turns articulation knob (214), articulation pinion (250) rotates together with articulation knob (214); the articulation control gear is engaged with the first articulation control rack (Figure 6, gear 512 engages second rack 510b); the rotation of the articulation control gear drives the first articulation and the second control racks to move forward or backward (Paragraph 0066, As articulation pinion 250 rotates, articulation pinion 250 translates first rack 252 and second rack 256 accordingly in opposing directions); the first and second articulation control racks are fixedly connected to a proximal end of the first and second bendable components (Figure 14, first rack 252 is fixedly connected with the near end of the first arm 242, considered the first bendable component and second rack 256 is fixedly connected with the near end of the second arm 240) both bendable components can be considered pull beams extend along the extension tube and are connected to opposite sides of the end effector to rotate it around a pivot. The articulation knob casing 215 that accommodates the whole articulation control mechanism is comprised by an upper half that will be considered a rotating head upper-cover indicated as RHUC in the annotated figure bellow and a lower half that will be considered as a rotating lower-cover, indicated as RLC; and a rotation knob 214 rotatably connected to the rotating head upper-cover via a not numbered shaft holding pinion 250 and will be considered a rotation knob pin.
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Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Nei the teachings of Fanelli and have all the all the articulation control mechanism located in the controller, not just the bend control spanner, having a rotating knob as the operating component and directly rotating the articulation control gear, extending the first and second bendable components along the shaft, having rotation of the articulation control gear drive the first and the second articulation control racks to move forward or backward and having the articulation control mechanism located between a rotating head upper-cover and a rotating lower-cover which are connected to each other are disposed at a proximal end of the extension tube including a rotation knob is rotatably connected to the rotating head upper-cover via a rotation knob pin as an alternative way to rotate the end effector in exactly the same way.
Regarding Claim 16:
As discussed for Claim 8 above, the modified invention of Nei discloses the invention as claimed.
The modified invention of Nei does not disclose if the first bendable component and the second bendable component are segmented bendable components.
Fanelli discloses that the first bendable component and the second bendable component are segmented bendable components (Figure 17 shows that first arm 242 and second arm 240 are made in sections of different shape and cross section, each one can be considered a “segment” short of any additional limitation).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the modified invention of Nei the teachings of Fanelli and have the first bendable component and the second bendable component made as segmented bendable components since the use of parts made in sections of different shape and cross section is well known in the art.
Response to Arguments
Applicant’s arguments with respect to a rejection of the amended claims as being anticipated by Fanelli (US 2014/0243801) 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. The Examiner made a new rejection of Claim 1 over Nei (CN 205339036) in view of Milliman (US 2006/0049229), where Nei shares similar figures and disclosure of the “connecting assembly”; while Milliman is used for the new limitation regarding the “cutter bar protection plates”, that the Examiner notes are mentioned in the Specification without any hint of what their relevance is, as written they look more like a matter of design choice. Milliman actually teaches that the plates are used to prevent bulging of the cutter assembly during operation while pivoting.
Regarding the reference Nei, that was mentioned by the Examiner in the previous action, the Applicant argues that
“Nie fails to disclose at least the above special feature (c). As shown in FIG. 3 of Nei,
reproduced below, each of the first pulling piece 514a and the second pulling piece 514b is in the form of an integral beam instead of two or more bendable pull beams being placed in an overlapping manner”
The Examiner rejected this limitation under 112(b), the claim mentions more than two bendable pull beams while only two are disclosed, not more than two; also, the nature of the overlapping is not clear, the Examiner rejected this limitation in two different ways.
Regarding the reference Fanelli, the Applicant argues that:
That is, Fanelli fails to teach or suggest that the arms 240, 242 penetrate a connecting assembly to connect the effector. Fanelli also fails to teach or suggest that the cutter frame assembly (48, 14) penetrates the same connecting assembly as the arms 240, 242.
The Examiner notes that no structure whatsoever is given to the connecting assembly and that arms 240 and 242 and the firing assembly of Fanelli, comprising firing beam 219, and knife 248 surely penetrate the articulation joint that is considered the connecting assembly. The Examiner used the reference Nei not because the amendment better disclosed the structure of the connecting assembly, but because the connecting assembly of Nei is exactly the same as the one described in the Figures and Specification.
The Examiner considers that a proper rejection can still be made using Fanelli as main reference and adding the teachings of Milliman for the cutter bar protection plates.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular all the new references on the PTO-892, “Notice of Reference Cited” teach the use of “cutter bar protection plates” under different names and cutter assemblies penetrating “connecting assemblies” such as articulation joints of different kinds. Also, proper rejections can be made under the references Hall (US 2009/0206124), Figure 106 in particular, and Morgan (US 2016/01744976) Figure 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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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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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/ROBERT F LONG/Primary Examiner, Art Unit 3731