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
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.
Claim(s) 14-16, 20-23, 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz US2012/0078050 and further in view of Mathieu US2012/0302835.
Schwartz discloses for claim 14, “A method, comprising:
connecting (“stylet assembly 11 is adapted to connect with a hand grip 20” 0078) a housing of a reusable hand-piece (housing of hand grip 20; fig 2; 0078) to a housing of a first disposable shaft assembly (housing of detachable stylet assembly 11; fig 3a, 3b; 0078), wherein said reusable hand-piece has articulation controls (trigger 21 with handle 22) and an electronics module (electrical components connected to electrical connection 26 including electrical mating connector mounted inside hand grip 20 described at 0090 and display means 23; fig 9 shows electrical connection 26 with dashed outline for corresponding the mating connector and display 23; 0090) and said first disposable shaft assembly has an articulation wire actuating assembly (actuation assembly 15; fig 9; 0079) and a connector (electrical connection 26 of stylet 11; fig 9; 0090);
wherein said connecting connects the articulation controls to the articulation wire actuating assembly (0080-0081 describes the details of the connecting of the articulation controls to the articulation assembly, also shown in figs 9, 10, 12, 13) and the electronics module to the connector of the first disposable shaft assembly (0090 describes the corresponding electrical connection via the connector)”.
Schwartz does not disclose “wherein the articulation controls of the reusable hand-piece includes a first articulation control knob and a second articulation control knob”. Mathieu teaches in the same field of endeavor, articulation control comprised of two knobs (control levers 90, 91 considered to read on the claimed knob since the levers define a projection which rotates about an axis; 0057). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Mathieu into the invention of Schwartz in order to configure the method e.g. as claimed because it provides additional axes of articulation).
Schwartz discloses for claim 15, “The method of claim 14, comprising: separating the housing of the reusable hand-piece from the housing of the first disposable shaft assembly so as to separate the articulation controls from the articulation wire actuating assembly and the electronics module from the connector of the first disposable shaft assembly (0079 describes the stylet assembly and hand grip 20 as detachable)”.
Schwartz discloses for claim 16, “The method of claim 15, comprising: connecting the housing of the reusable hand-piece to a housing of a second disposable shaft assembly (0018 describes as an object of the device as to provide a device having a detachable stylet whereby any number of other like stylets are therefore attachable), wherein said second disposable shaft assembly has an articulation wire actuating assembly (actuation assembly 15; fig 9; 0079) and a connector (electrical mating connector mounted inside hand grip 20 connecting to electrical connection 26 of stylet 11; fig 9; 0090); and wherein said connecting connects the articulation controls to the articulation wire actuating assembly and the electronics module to the connector of the second disposable shaft assembly (0080-0081 describes the details of the connecting of the articulation controls to the articulation assembly, also shown in figs 9, 10, 12, 13; and 0090 describes the corresponding electrical connection via the connector)”.
Modified Schwartz discloses for claim 20, “The method of claim 19, wherein the first articulation control knob has a first drive shaft and the second articulation control knob has a second drive shaft, and wherein the first and second drive shafts are concentric (Mathieu: fig 9; 0056 describes the articulation axes with concentric drive shafts)”.
Schwartz discloses for claim 21, “The method of claim 14, wherein the housing of the reusable hand-piece is arranged for connection to and disconnection from the housing of the first disposable shaft assembly without hand tools (0078-0079 describes the connection of the stylet assembly 11 to hand grip 20 whereby no mention of hand tools is made; additionally, and object of the device is disclosed as providing “a detachable stylet that is easily connectable with a hand grip” 0018)”.
Schwartz discloses for claim 22, “The method of claim 14, wherein the reusable hand-piece is absent a fluid connector that communicates with a lumen of the first disposable shaft assembly (the description of the device includes no mention of a fluid connector or fluid providing capability)”.
Schwartz does not disclose for claim 23, “The method of claim 14, wherein the housing of the first disposable shaft assembly includes a port in fluid communication with a lumen of a shaft of the first disposable shaft assembly”.
Mathieu teaches in the same field of endeavor, a fluid connector fitting 18 for providing fluid through the device (fig 2; 0042 describes connecting to a suction device or a fluid feed source). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Mathieu into the invention of Schwartz in order to configure the method e.g. as claimed because it provides the added advantage of suction and/or fluid supply.
Schwartz discloses for claim 26,
“A method, comprising:
attaching a housing of a reusable hand-piece (housing of hand grip 20; fig 2; 0078) to a housing of a first disposable shaft assembly (housing of detachable stylet assembly 11; fig 3a, 3b; 0078), wherein said reusable hand-piece has an articulation control (trigger 21 with handle 22) mounted to the housing of the reusable hand-piece and said first disposable shaft assembly has an articulation wire actuating assembly mounted to the housing of the first disposable shaft assembly, the articulation wire actuating assembly (actuation assembly 15; fig 9; 0079) attached to an articulation wire (control wire 18; fig 9; 0080) extending along a first direction and along a length of the first disposable shaft assembly (the control wire extends along the longitudinal axis of the tube 12; fig 9);
wherein said reusable hand-piece has an electronics module (electrical components connected to electrical connection 26 including electrical mating connector mounted inside hand grip 20 described at 0090 and display means 23; fig 9 shows electrical connection 26 with dashed outline for corresponding the mating connector and display 23; 0090) and said first disposable shaft assembly has a connector (electrical connection 26 of stylet 11; fig 9; 0090);
wherein said attaching connects the articulation control to the articulation wire actuating assembly of the first disposable shaft assembly along a second direction (0080-0081 describes the details of the connecting of the articulation controls to the articulation assembly, also shown in figs 9, 10, 12, 13; this connection is made perpendicular to the direction of control wire, i.e. is made for example in fig 9 into and out of the page, while the control wire runs vertically up and down the page);
wherein the electronics module has a connector (electrical mating connector mounted inside hand grip 20 described at 0090) that engages the connector of the first disposable shaft assembly when the housing of the reusable hand-piece assembly is connected to the housing of the first disposable shaft assembly (0090 describes the corresponding electrical connection via the connector); and
wherein said second direction is different than said first direction (the second direction, i.e. connection direction is made perpendicular to the direction of control wire, i.e. is made for example in fig 9 into and out of the page, while the control wire runs vertically up and down the page);
wherein the electronics module of the reusable hand-piece includes an image controller for image capture and/or recording video (display means 23; 0099 describes any monitor having a screen which includes an image processor taking as input the image signal from the connector and processes the signal for display considered as image capture)”
Schwartz does not disclose for claim “wherein the reusable handpiece includes controls for controlling irrigation, suction, insufflation, and/or irrigation”.
Mathieu teaches in the same field of endeavor, a fluid connector fitting 18 for providing fluid through the device (fig 2; 0042 describes connecting to a suction device or a fluid feed source). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Mathieu into the invention of Schwartz in order to configure the method e.g. as claimed because it provides the added advantage of suction and/or fluid supply.
Schwartz discloses for claim 27, “The method of claim 26, comprising: separating the housing of the reusable hand-piece from the housing of the first disposable shaft assembly so as to separate the articulation control from the articulation wire actuating assembly of the first disposable shaft assembly (0079 describes the stylet assembly and hand grip 20 as detachable)”.
Schwartz discloses for claim 28, “The method of claim 27, comprising:
connecting the housing of the reusable hand-piece to a housing of a second disposable shaft assembly (0018 describes as an object of the device as to provide a device having a detachable stylet whereby any number of other like stylets are therefore attachable), wherein said second disposable shaft assembly has an articulation wire actuating assembly (actuation assembly 15; fig 9; 0079); and
wherein said connecting connects the articulation control to the articulation wire actuating assembly of the second disposable shaft assembly (0080-0081 describes the details of the connecting of the articulation controls to the articulation assembly, also shown in figs 9, 10, 12, 13; and 0090 describes the corresponding electrical connection via the connector)”.
Schwartz does not disclose for claim 29, “The method of claim 26, wherein the articulation control of the reusable hand-piece includes a first articulation control knob and a second articulation control knob”.
Mathieu teaches in the same field of endeavor, articulation control comprised of two knobs (control levers 90, 91 considered to read on the claimed knob since the levers define a projection which rotates about an axis; 0057). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Mathieu into the invention of Schwartz in order to configure the method e.g. as claimed because it provides additional axes of articulation).
Modified Schwartz discloses for claim 30, “The method of claim 29, wherein the first articulation control knob has a first drive shaft and the second articulation control knob has a second drive shaft, and wherein the first and second drive shafts are concentric and extend along the second direction (Mathieu: fig 9; 0056 describes the articulation axes with concentric drive shafts)”.
Schwartz discloses for claim 31, “The method of claim 26, wherein the housing of the reusable hand-piece is arranged for connection to and disconnection from the housing of the first disposable shaft assembly without hand tools (0078-0079 describes the connection of the stylet assembly 11 to hand grip 20 whereby no mention of hand tools is made; additionally, and object of the device is disclosed as providing “a detachable stylet that is easily connectable with a hand grip” 0018)”.
Schwartz discloses for claim 32, “The method of claim 26, wherein the reusable hand- piece is absent a fluid connector that communicates with a lumen of the first disposable shaft assembly (the description of the device includes no mention of a fluid connector or fluid providing capability)”.
Schwartz does not disclose for claim 33, “The method of claim 26, wherein the housing of the first disposable shaft assembly includes a port in fluid communication with a lumen of a shaft of the first disposable shaft assembly”.
Mathieu teaches in the same field of endeavor, a fluid connector fitting 18 for providing fluid through the device (fig 2; 0042 describes connecting to a suction device or a fluid feed source). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Mathieu into the invention of Schwartz in order to configure the method e.g. as claimed because it provides the added advantage of suction and/or fluid supply.
Claim(s) 24, 25, 34, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz and Mathieu as applied to claim 14 or 26 respectively above, and further in view of Fan US2015/0351610.
Schwartz does not disclose for claim 24, “The method of claim 14, wherein the articulation wire actuating assembly comprises a rack and pinion assembly; wherein the rack and pinion assembly includes a first gear rack coupled to a first articulation control knob through a first gear and a second gear rack coupled to a second articulation control knob through a second gear; wherein the articulation wire extending along a length of the first disposable shaft assembly is a first articulation wire coupled to the first gear rack such that rotation of the first articulation control knob translates the first gear rack; and wherein a second articulation wire is coupled to the second gear rack such that rotation of the second articulation control knob translates the second gear rack”.
Fan teaches in the same field of endeavor, providing a steering mechanism for a bendable endoscope using a rack and pinion system in the same manner as claimed (fig 1-8; “Horizontal-Direction Rotation Operating Part” is fully described in 0055-0064, see specifically fig 4 and 0057, where comparable gear racks 21a-d and gears 22a-b connected to four wires 18a-d to articulate the insertion shaft) along with a locking mechanism (24; 0056). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Fan into the invention of Mathieu in order to configure the method e.g. as claimed because it provides technical advantages including but not limited to reducing the number of components to reduce a manufacturing cost and achieve weight reduction while providing additional degrees of freedom (0010).
Modified Schwartz discloses for claim 25, “The method of claim 24, wherein the rack and pinion assembly, comprises: a third gear rack associated with the first articulation control knob and a fourth gear rack associated with the second articulation control knob; wherein rotation of the first articulation control knob translates the third gear rack in a direction opposite that of the first gear rack; and wherein rotation of the second articulation control knob translates the fourth gear rack in a direction opposite that of the second gear rack (Fan: fig 1-8; “Horizontal-Direction Rotation Operating Part” is fully described in 0055-0064, see specifically fig 4 and 0057, where comparable gear racks 21a-d and gears 22a-b connected to four wires 18a-d to articulate the insertion shaft).
Schwartz does not disclose for claim 34, “The method of claim 26, wherein the articulation wire actuating assembly comprises a rack and pinion assembly; wherein the rack and pinion assembly includes a first gear rack coupled to a first articulation control knob through a first gear and a second gear rack coupled to a second articulation control knob through a second gear; wherein the articulation wire extending along a length of the first disposable shaft assembly is a first articulation wire coupled to the first gear rack such that rotation of the first articulation control knob translates the first gear rack; and wherein a second articulation wire is coupled to the second gear rack such that rotation of the second articulation control knob translates the second gear rack”.
Fan teaches in the same field of endeavor, providing a steering mechanism for a bendable endoscope using a rack and pinion system in the same manner as claimed (fig 1-8; “Horizontal-Direction Rotation Operating Part” is fully described in 0055-0064, see specifically fig 4 and 0057, where comparable gear racks 21a-d and gears 22a-b connected to four wires 18a-d to articulate the insertion shaft) along with a locking mechanism (24; 0056). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Fan into the invention of Mathieu in order to configure the method e.g. as claimed because it provides technical advantages including but not limited to reducing the number of components to reduce a manufacturing cost and achieve weight reduction while providing additional degrees of freedom (0010).
Modified Schwartz discloses for claim 35, “The method of claim 34, wherein the rack and pinion assembly, comprises: a third gear rack associated with the first articulation control knob and a fourth gear rack associated with the second articulation control knob; wherein rotation of the first articulation control knob translates the third gear rack in a direction opposite that of the first gear rack; and wherein rotation of the second articulation control knob translates the fourth gear rack in a direction opposite that of the second gear rack (Fan: fig 1-8; “Horizontal-Direction Rotation Operating Part” is fully described in 0055-0064, see specifically fig 4 and 0057, where comparable gear racks 21a-d and gears 22a-b connected to four wires 18a-d to articulate the insertion shaft)”.
Response to Arguments
Applicant's arguments filed 1/2/2026 have been fully considered but they are not persuasive.
Applicant’s argument (page 7) asserts the Schwartz and Mathieu combination is improper because it “would require a substantial reconstruction and redesign of Schwartz and change the basic principle under which Schwartz was designed to operate”. Regarding the change of the basic principle, Applicant specifically isolates the hand grip and trigger of Schwartz as the sole “basic principle” of the reference, but the reference discloses more than the hand grip and trigger as the innovative and advantageous features of their invention. Another critical basic principle of Schwartz is the modular replaceable nature of their device which is not compromised or altered in the proposed modification with Mathieu. This principle is maintained in lieu of another (hand grip) in order to replace the bending mechanism with well-known knobs providing the advantage of multiple axes of bending. This is a classic example of trading one advantageous effect for another. Applicant’s insinuation that an invention can have only one basic principle is in error. An invention can definitely have more than a single advantageous feature leading to “basic principles” as Schwartz has demonstrated. Therefore, applicant’s argument amounts to too narrowly defining the Schwartz reference and is therefore considered not persuasive.
With respect to the “substantial reconstruction and redesign of Schwartz”, based on the prior art that Schwartz cites, including but not limited to US2975785 (0004), such endoscopes are well-known to have multiple knobs for manipulation. Since Swartz itself cites these previously known designs in their reference as “Description of Related Art” ostensibly as a starting point, converting the device of Schwartz back to a well-known knob system is not considered a substantial reconstruction and redesign that is prohibitive of a modification since it would simply required replacing one known bending mechanism with another.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
4/14/26
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