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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first drum comprises a third winding port to receive a third pull wire and a fourth winding port to receive a fourth pull wire” as set forth in claim 12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 7-11 are objected to because of the following informalities: Claim 7 states in the final clause “rotation of the drum in a second direction cause the distal tip to bend” where “cause” should presumably be “causes”. Appropriate correction is required. Claims 8-11 are objected to based on their dependency from claim 7.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
While this could be a typographical error, the Examiner notes that claim 12 requires the first drum to comprise third and worth winding ports. The disclosure does not show this. The claim appears as though the third and fourth winding ports were intended to be part of the second drum. With the ports on the second drum, the wires can be operated as disclosed and claimed. With the ports on the first drum, the Examiner does not see where Applicant has provided sufficient direction as to how this would work. Therefore, the Examiner asserts that Applicant was not in possession of the claimed invention at the time of filing. Appropriate clarification or correction is required.
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 1-3, 5, 7-10, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (US 2023/0309801) in view of Okamoto (US 2014/0121462).
Regarding Claim 1, Christensen discloses:
An endoscope having a proximal end and a distal end with a steerable distal tip, the endoscope (see Fig. 1 showing the proximal end 2 and steerable tip 4) comprising:
a drum (15, shown in Fig. 2, applies to both elements 8 and 12);
an anchoring cylinder (flange 14 and element 19, the two are attached to form an anchoring cylinder) affixed to an interior surface of the endoscope (see Fig. 1 showing that the device is integral such that 19 is affixed to the interior surface of the endoscope);
a first pull wire (6) coupled to the drum and affixed to the anchoring cylinder (see Figs. 2, 5, and 7, for example, showing the wire 6 as it extends through the anchoring cylinder and wraps around the drum), such that rotation of the drum in a first direction causes the first pull wire to wind around the drum (see Fig. 2 and Paragraph 0070 indicating that as the handle is turned, the drum is turned such that the wire has a force acting on it to wrap around the drum); and
a second pull wire (7) coupled to the drum and affixed to the anchoring cylinder (see Figs. 2, 5, and 7, for example, showing the wire 6 as it extends through the anchoring cylinder and wraps around the drum), such that rotation of the drum in a second direction causes the second pull wire to wind around the drum (see Fig. 2 and Paragraph 0070 indicating that as the handle is turned, the drum is turned such that the wire has a force acting on it to wrap around the drum).
Christensen does not explicitly disclose a motor positioned within an interior of the endoscope, the motor comprising an axle and wherein the drum is connected to the axle such that rotation of the axle causes rotation of the drum. Okamoto teaches using a motor (12) having an axle (12a) for controlling the movement of a drum having pull wires attached thereto (see Fig. 4). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen’s device to include Okamoto’s motor and axle. Such a modification provides motorized control of the distal tip giving the user with electronic control and precision when articulating the device.
Regarding Claim 2, Christensen as modified further discloses wherein the drum comprises: a first winding port (groove 18a) through which the first pull wire is threaded (see Fig. 6 and Paragraph 0080); and a second winding port (groove 18b) through which the second pull wire is threaded (see Paragraph 0080 describing how there are multiple grooves receiving the steering wires; the claim does not limit the ports in such a way that the first winding port may only receive the first pull wire, the fact that the reference allows for the ports to receive both wires is not precluded by the claim language).
Regarding Claim 3, Christensen as modified further discloses wherein the anchoring cylinder comprises: a first anchoring port (23a) through which the first pull wire is threaded (see Paragraph 0082 indicating that wire 6 is guided through 23a); and a second anchoring port (23b) through which the second pull wire is threaded (see Paragraph 0082 indicating that wire 7 is guided through 23b).
Regarding Claim 5, Christensen does not explicitly disclose wherein the endoscope further comprises an electrical interface positioned proximal from the motor. Okamoto teaches having a universal cord (4) extending proximally of the handle in which the motor is located for transmitting signals to and from the scope to external devices as is known in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen’s device to include Okamoto’s electrical interface. Such a modification provides a means for transmitting signals without being in the way of the handle’s controls. This configuration is common and well-known in the art.
Regarding Claim 7, Christensen discloses:
An endoscope comprising:
a proximal end (2) housing a drive system (controls for the wires including 8 and 12);
a distal end (3) including a steerable distal tip (4);
a first pull wire (6) having a proximal end, coupled to the drive system (see Fig. 2 and Paragraph 0068 discussing the fixation of the wire to the drive system), and a distal end affixed to the steerable distal tip (see Fig. 2 and Paragraph 0068 indicating that the wire is connected to the distal end); and
a second pull wire (7) having a proximal end, coupled to the drive system (see Fig. 2 and Paragraph 0068 discussing the fixation of the wire to the drive system), and a distal end affixed to the steerable distal tip (see Fig. 2 and Paragraph 0068 indicating that the wire is connected to the distal end);
wherein the drive system comprises:
a drum (8 and 12, two drums are disclosed, see Fig. 2), wherein:
the proximal ends of the first pull wire and the second pull wire are coupled to the drum (see Paragraph 0068 indicating that the wires are connected to the drum);
rotation of the drum in a first direction causes the distal tip to bend in a first direction (see Paragraph 0069 indicating that rotating the drum in the counter-clockwise direction causes a corresponding tilt of the distal tip in a particular direction); and
rotation of the drum in a second direction cause the distal tip to bend in a second direction (see Paragraph 0069 indicating that rotating the drum in the clockwise direction causes a corresponding tilt of the distal tip in a different direction).
Christensen does not explicitly disclose a motor positioned within an interior of the endoscope, the motor comprising an axle; and wherein the drum is connected to the axle such that rotation of the axle causes rotation of the drum. Okamoto teaches using a motor (12) having an axle (12a) for controlling the movement of a drum having pull wires attached thereto (see Fig. 4). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen’s device to include Okamoto’s motor and axle. Such a modification provides motorized control of the distal tip giving the user with electronic control and precision when articulating the device.
Regarding Claim 8, Christensen as modified further discloses wherein the drum comprises: a first winding port (groove 18a) through which the first pull wire is threaded (see Fig. 6 and Paragraph 0080); and a second winding port (groove 18b) through which the second pull wire is threaded (see Paragraph 0080 describing how there are multiple grooves receiving the steering wires; the claim does not limit the ports in such a way that the first winding port may only receive the first pull wire, the fact that the reference allows for the ports to receive both wires is not precluded by the claim language).
Regarding Claim 9, Christensen as modified further discloses an anchoring cylinder (flange 14 and element 19, the two are attached to form an anchoring cylinder) affixed to the endoscope (see Fig. 1 showing that the device is integral such that 19 is affixed to the interior surface of the endoscope), wherein the proximal ends of the first pull wire and the second pull wire are affixed to the anchoring cylinder (see Paragraph 0082 indicating that wire 6/7 is guided through 23a/23b), wherein the anchoring cylinder comprises: a first anchoring port (23a) through which the first pull wire is threaded; and a second anchoring port (23b) through which the second pull wire is threaded (see Paragraph 0082 indicating that wire 6/7 is guided through 23a/23b).
Regarding Claim 10, Christensen as modified further discloses wherein a diameter of the drum is less than a diameter of the anchoring cylinder (14 and 19 have a larger diameter than drum 15 as seen in Figs. 3 and 4).
Regarding Claim 12, Christensen discloses:
A drive system housed within an endoscope, the drive system comprising:
a first drum (8), wherein the first drum comprises a first winding port (18a) to receive a first pull wire (6) and a second winding port (18b) to receive a second pull wire (see Paragraph 0080 describing how there are multiple grooves receiving the steering wires; the claim does not limit the ports in such a way that the first winding port may only receive the first pull wire, the fact that the reference allows for the ports to receive both wires is not precluded by the claim language);
a first anchoring cylinder (19) comprising a first anchoring port (23a) to receive the first pull wire and a second anchoring port (23b) to receive the second pull wire (see Paragraph 0082 indicating that wire 6/7 is guided through 23a/23b);
a second drum (12; see Paragraph 0072, drums 8 and 12 are similarly configured), wherein the first drum (the Examiner is treating this as the second drum as that makes sense of the Disclosure and style of the claim; see Written Description discussion above for more details) comprises a third winding port (18a) to receive a third pull wire (10) and a fourth winding port (18b) to receive a fourth pull wire (11); and
a second anchoring cylinder (19; see discussion above in that the drums and related components are found for both drums 8 and 12, which would include a second anchoring cylinder 19) comprising a third anchoring port to receive the third pull wire and a fourth anchoring port to receive the fourth pull wire (see Paragraph 0082 indicating that wire 6/7 is guided through 23a/23b).
Christensen does not explicitly disclose a first motor comprising a first axle, wherein the first drum is connected to the first axle such that rotation of the first axle causes rotation of the first drum; a second motor positioned proximal from the first motor, comprising a second axle; and wherein the second drum is connected to the second axle such that rotation of the second axle causes rotation of the second drum. Okamoto teaches using a motor (12) having an axle (12a) for controlling the movement of a drum having pull wires attached thereto (see Fig. 4). Because Christensen discloses two drums, a person having ordinary skill in the art would understand that to effectively operate each unit separately, a motor would need to be provided for each. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen’s device to include Okamoto’s motor and axle. Such a modification provides motorized control of the distal tip giving the user with electronic control and precision when articulating the device.
Regarding Claim 14, Christensen does not explicitly disclose an electrical interface coupled to electrical connections of the first motor and the second motor. Okamoto teaches having a universal cord (4) extending proximally of the handle in which the motor is located for transmitting signals to and from the scope to external devices as is known in the art. The Examiner also notes that Okamoto’s motors are connected to a power source via cord 4 such that the motors have electrical connections to receive power from the power source. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen’s device to include Okamoto’s electrical interface. Such a modification provides a means for transmitting signals without being in the way of the handle’s controls. This configuration is common and well-known in the art.
Regarding Claim 15, Christensen as modified further discloses wherein: rotation of the first drum in a first direction causes a steerable tip of the endoscope to bend in a first direction (see Paragraphs 0069-0070 describing rotation in one direction causing up motion); rotation of the first drum in a second direction causes the steerable tip to bend in a second direction (see Paragraphs 0069-0070 describing rotation in one direction causing down motion); rotation of the second drum in the first direction causes the steerable tip to bend in a third direction (see Paragraphs 0069-0070 describing rotation in one direction causing right motion); and rotation of the second drum in the second direction causes the steerable tip to bend in a fourth direction (see Paragraphs 0069-0070 describing rotation in one direction causing left motion).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (US 2023/0309801) and Okamoto (US 2014/0121462), as applied to claim 1 above, and further in view of Miyake (US 2005/0054899).
Christensen and Okamoto disclose the invention substantially as claimed as stated above, but they do not explicitly disclose wherein the first pull wire and the second pull wire are affixed to the anchoring cylinder with an adhesive. Miyake teaches using adhesive for attaching wires to a pulley (Paragraph 0134) so that the wires do not slip out of the pulley. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen and Okamoto’s device to use Miyake’s adhesive to attach the wires. Such a modification is a simple substitution of one method of attachment for another to yield predictable results. The adhesive help keep the wires from slipping out of the pulley.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (US 2023/0309801) and Okamoto (US 2014/0121462), as applied to claims 1 and 12 above, and further in view of Hunter et al. (US 2015/0011830).
Regarding Claims 6 and 13, Christensen and Okamoto disclose the invention substantially as claimed as stated above, but they do not explicitly disclose wherein a maximum diameter of the motor is less than 6 mm; wherein the first motor and the second motor have a maximum diameter of less than 6 mm. Hunter teaches using a motor to drive wires with a diameter of approximately 6 mm (Paragraph 0063) meaning plus or minus 6 mm, which keeps the size of the device relatively small. Furthermore, making adjustments to the size of components without changing the function is obvious when there is a reasonable expectation of success. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen and Okamoto’s motor size to have Hunter’s dimensions. Such a modification is the mere change in size without a change in function and helps reduce the overall size of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen et al. (US 2023/0309801) and Okamoto (US 2014/0121462), as applied to claim 7 above, and further in view of Barry et al. (US 2004/0242966).
Christensen and Okamoto disclose the invention substantially as claimed as stated above, but they do not explicitly disclose wherein a maximum outer diameter of the proximal end and the distal end of the endoscope is less than 6 mm. The Examiner notes that making endoscopes as small as 3 mm or less is known in the art. Barry teaches making an endoscope with a diameter of 7.5 French, equivalent to 2.5 mm (Paragraph 0038). Adjusting the size without changing the function is considered obvious when a person having ordinary skill in the art would have a reasonable expectation of success. Here, the size is a known size in the art such that the adjustment would be reasonable. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Christensen and Okamoto’s device to have Barry’s small diameter. Such a modification reduces the size of the scope so that it can reach smaller parts of the body as is known in the art.
Conclusion
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795