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 .
The current application has the effective filing date of 12/16/2022 according to the priority chain on the record.
Claim Status
Claims 1-20 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“cradle assembly” (claim 1),
“gear assembly” (claim 1),
“rail assembly” (claim 3),
“actuator assembly” (claims 4 and 15),
“elevator actuator assembly” (claim 17).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-10 and 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gu et al. US 2022/0362518 A1 (hereinafter “Gu”).
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Regarding claim 1, Gu discloses a motorized control system (Fig.1: endoscopic system 100; see [0054]) for a medical device (endoscope 110), comprising:
a control assembly (motor control assembly 140), comprising:
a first body (motor control housing 142) including a cradle assembly (as shown in [0054] and Figs. 1-6: contents and/or assembly within 142; Note: 142 is interpreted to encompass both “first body” and “cradle assembly” in this office action), wherein the cradle assembly (142) is configured to removably couple to the medical device (110; see [0054: 1st sentence] “motor control assembly 140 including a motor control housing 142 configured to detachably interface with the handle 112 of the endoscope 110”), the first body (142) including:
a gear assembly (Fig.3: gear assemblies 150 and 160; [0073]),
a first motor (first motor 144) configured to drive a first gear (first gear assembly 150) of the gear assembly (as shown in Figs. 3-4 and [0073: 2nd sentence] “the first gear assembly 150 may include a first worm gear 154 and a first worm gear shaft 152 configured to engage the first worm gear 154.”), and
a second motor (second motor 146) configured to drive a second gear (second gear assembly 160) of the gear assembly (as shown in Figs. 3-4 and [0074:3rd to last sentence] “the second gear assembly 160 may include a second worm gear 164 and a second worm gear shaft (not visible) configured to engage the second worm gear 164”);
wherein the gear assembly (150 and 160) is configured to receive a plurality of knobs (first drive axel 170 and second drive axle 180) of the medical device (110; as shown in Fig. 7 and [0074-0075, 0080] the first drive axle 170 may be slidably received by the first gear assembly 150 and the second drive axle 180 may be slidably received by the second gear assembly 160);
wherein the first motor (144) is configured to drive the first gear (154) to rotate a first knob (170) of the plurality of knobs (see [0073, 0076] first axel 170 is configured to engage with the first worm gear 154); and
wherein the second motor (146) is configured to drive the second gear (164) to rotate a second knob (180) of the plurality of knobs (see [0073, 0077] second drive axle 180 may be configured to engage with the second worm gear 164).
Regarding claim 5, Gu discloses the motorized control system of claim 1, wherein the cradle assembly (142) further comprises: a first worm gear (154) coupled to the first motor (144) and engaged with the first gear (150; see [0073] “the first gear assembly 150 may include a first worm gear 154 and a first worm gear shaft 152 configured to engage the first worm gear 154.”); and a second worm gear (164) coupled to the second motor (152) and engaged with the second gear (160; see [0073] “the second gear assembly 160 may include a second worm gear 164 and a second worm gear shaft (not visible) configured to engage the second worm gear 164.”).
Regarding claim 6, Gu discloses the motorized control system of claim 5, wherein: the first motor (144), the first worm gear (154), and the first gear (150) are longitudinally aligned (as shown in Fig.4: 150, 154, 156, 144 ); the second motor (146), the second worm gear (164), and the second gear (160) are longitudinally aligned (as shown in Fig.4: 160,164, 166, 146); and the first gear (1150) is adjacent to the second gear (160; as shown in Fig. 4).
Regarding claim 7, Gu discloses the motorized control system of claim 1, wherein the first gear (150) includes a series of recesses configured to align with prongs of the first knob (as shown in Fig. 5: area surrounding 150 adapted to receive the drive axel 170); and wherein the second gear (160) includes a series of recesses configured to align with prongs of the second knob. (as shown in Fig. 5: area surrounding 160 is taken to encompass “recess” adapted to receive the drive axel 170)
Regarding claim 8, Gu discloses the motorized control system of claim 1, wherein the control assembly (140 of endoscope 110) is controlled by a control unit ([0023-0024] controller; see [0069] endoscope connected to a workstation or com with display; alternatively, also see [0088] “…the at least one motor may be controller by a central processing unit (CPU), a microprocessor, and/or a combination thereof.”) including an electronic display ([0069] display screen, touch panel computer).
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Regarding claim 9, Gu discloses the motorized control system of claim 1, wherein the first body (142) includes a first frame (removable cover 141), a base frame (see annotated Fig. 3 above), and a mounting plate (internal removable cover 143; as shown in Fig. 2 and [0054]).
Regarding claim 10, Gu discloses the motorized control system of claim 9, wherein the mounting plate (143) extends longitudinally in a proximal-distal direction (see Fig. 2), and wherein the first motor (144) and the second motor (146) are coupled to the mounting plate (143; as shown in Fig. 2).
Regarding claim 12, Gu discloses the motorized control system of claim 9, wherein the first frame (141) includes a first distal lumen (second maximum inner extent 165) and the base frame (see annotated Fig. 3 above) includes a second distal lumen (second maximum inner extent 165), and wherein each of the first distal lumen and the second distal lumen are configured to receive a portion of the medical device (110; see Fig. 6 and [0079]).
Regarding claim 13, Gu discloses the motorized control system of claim 1, further comprising a remote control ([0069] remote workstation and/or touch panel computer via wired or wireless communication) configured to communicate with the control assembly to operate the first motor and the second motor. ([0069] remote work station and/or touch panel computer controls operations of control assembly 140)
Regarding claim 14, Gu discloses motorized control system of claim 1, wherein the medical device is an endoscope. ([0052] endoscope 110)
Regarding claim 15, Gu discloses the motorized control system of claim 1, further comprising an actuator assembly ([0084-0085]) including a first circular member (deflection mechanism 120) and a second circular member (deflection mechanism 122), wherein the actuator assembly is configured to receive a shaft (shaft 180) of the medical device. (see Figs. 4-5 and [0074-0085])
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Gu as applied to claim 1 above, and further in view of Hu et al. CN 101708129 A1 (Foreign reference submitted by the Applicant, Google English translation is applied in the following rejection, said translation is attached).
Regarding claim 2, Gu discloses the motorized control system of claim 1, but does not disclose a rotary drive. However, Hu, another prior art reference in the analogous art of motorized control systems for endoscopes (Figs. 1, 3, 4 and 6: remote control device for gastrointestinal endoscope) discloses a motorized system comprising a rotary drive (rotating shaft 38) coupled to a proximal end of the control assembly (40), wherein the rotary drive (38) is configured to rotate the control assembly (40) and the medical device (endoscope) about a longitudinal axis of the medical device. (See Figs.3-6, and pg.3-4/6 “the top of the nose 3 is provided with a rotating shaft 38, and the steering driven gear 37 is fixed on the rotating shaft 38, and the rotating shaft 38 is also provided with a bearing 39, and the machine head 3 is rotatably suspended on the machine head seat 40 by the bearing 39 and the bearing 39 seats in the machine head seat 40 inner cavity, turning to the driving gear 36 is driven by a flexible shaft so that the machine head 3 has an increased degree of freedom of its own rotation…) It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gu, to further include the rotary drive so as to rotate control assembly (140) and the endoscope (110) in view of Hu, the motivation for doing so is to enable motorized rotational movements of an endoscope, as this would provide the advantage of steady movements, instead of erratic movements controlled by hand.
With regarding claim 3, Gu in view of Hu discloses the motorized control system of claim 2, but does not disclose a base assembly and a rail assembly. Hu further discloses a base assembly (horizontal nut 25) coupled to the first body (vertical screw mandrel frame 30); and a rail assembly (horizontal screw mandrel frame 27 and horizontal screw mandrel 26) coupled to the base assembly (27), wherein the rail assembly (26, 27) includes at least one motor (micro-motor) and is configured to move the control assembly (40) in proximal and distal directions. (See Figs.2-4, also see pg. 3/6 “…one end of the horizontal screw mandrel 26 … is connected to the motor drive through a flexible shaft…certainly also can all be provided with micro-motor drive at one end of horizontal screw mandrel 26 and vertical screw mandrel 29 upper ends, be connected with control line between console 1 and micro-motor…). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gu, to further include the base assembly and rail assembly so as to move the first body (motor control assembly 140 and first body 142) for coupling with the endoscope (110) in view of Hu, the motivation for doing so is to enable motorized relative proximal and distal movements between first body and the endoscope controlled by a motor, as this would provide the advantage of steady and leveled movements, instead of erratic movements controlled by hand.
Regarding claim 4, Gu in view of Hu discloses the motorized control system of claim 3, Gu further discloses wherein the control assembly (140) further comprises: an actuator assembly (implicit in view of elevator feature, see [0071: last 4 sentences]) comprising: an elevator actuator (elevator control 12 ) configured to align with an elevator lever (elongate shaft 114) of the medical device (endoscope 110); an elevator motor (elevator motor); wherein the actuator assembly is configured to move an elevator lever of the medical device (see [0071: last 4 sentences]). Gu does not explicitly disclose a third gear coupled to the elevator motor. However, because Gu explicitly states “the distal tip 116 may include an elevator configured to manipulate a guidewire, a tool, a medical instrument, etc. extending through the elongate shaft 114”; it would have been an obvious design choice at the time of invention to modify Gu to replace the recited ‘guidewire, tool’ with a gear. This is because gear is a known mechanical means for facilitating motorized movements, and various gears are already used in for motorizing movements of the endoscope in Gu (as discussed in claim 1 and shown Figs. 2-3).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gu as applied to claim 1 above, and further in view of Black et al. US 2003/0009086 A1 (hereinafter “Black”).
Regarding claim 11, Gu teaches the motorized control system of claim 1 for controlling the endoscope 110, but does not disclose a telescopic support assembly. However, telescopic scopes are well known in the field of endoscopes, accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gu to implement telescopic support assembly in order to stabilize a telescopic endoscope during use. Alternatively, Black discloses a telescoping endoscope comprising a telescopic shaft, in which the telescope is controlled by a motor control device or means alike (see [0032]). It would have been obvious to a person of ordinary skill in the art at the time to modify Gu’s endoscopic 110 such that it has a telescopic shaft and motor control in view of Black, because telescopic endoscopes are well known as it is able reach different and/or farther targets. Based on this modification, it would have been further obvious to implement a telescope support assembly, which would provide stability so the telescopic components are secured and stabilized during use of said device.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over of Gu in view of Hu (CN 101708129 A1, English translation, cited above).
Regarding claim 16, Gu discloses a motorized control system (Fig.1: endoscopic system 100; see [0054]) for a medical device (endoscope 110), comprising:
a control assembly (motor control assembly 140), comprising:
a first body (motor control housing 142) including a cradle assembly (as shown in [0054] and Figs. 1-6: contents and/or assembly within 142; Note: 142 is interpreted to encompass both “first body” and “cradle assembly” in this office action), wherein the cradle assembly (142) is configured to removably couple to the medical device (110; see [0054: 1st sentence] “motor control assembly 140 including a motor control housing 142 configured to detachably interface with the handle 112 of the endoscope 110”), the first body (142) comprising:
a gear assembly (Fig.3: gear assemblies 150 and 160; [0073]), and
a first motor (first motor 144) configured to drive a first gear (first gear assembly 150) of the gear assembly (as shown in Figs. 3-4 and [0073: 2nd sentence] “the first gear assembly 150 may include a first worm gear 154 and a first worm gear shaft 152 configured to engage the first worm gear 154.”); and
wherein the gear assembly (150 and 160) is configured to receive a first knob (first axel 170) of the medical device (110; as shown in Fig. 7 and [0074-0075, 0080] the first drive axle 170 may be slidably received by the first gear assembly 150 and the second drive axle 180 may be slidably received by the second gear assembly 160); and
wherein the first motor (144) is configured to drive the first gear (154) to rotate the first knob (170) of the plurality of knobs (see [0073, 0076] first axel 170 is configured to engage with the first worm gear 154).
Gu does not disclose a rotary drive. However, Hu, another prior art reference in the analogous art of motorized control systems for endoscopes (Figs. 1, 3, 4 and 6: remote control device for gastrointestinal endoscope) discloses a motorized system comprising a rotary drive (rotating shaft 38) coupled to a proximal end of the control assembly (40), wherein the rotary drive (38) is configured to rotate the control assembly (40) and the medical device (endoscope) about a longitudinal axis of the medical device. (See Figs.3-6, and pg.3-4/6 “the top of the nose 3 is provided with a rotating shaft 38, and the steering driven gear 37 is fixed on the rotating shaft 38, and the rotating shaft 38 is also provided with a bearing 39, and the machine head 3 is rotatably suspended on the machine head seat 40 by the bearing 39 and the bearing 39 seats in the machine head seat 40 inner cavity, turning to the driving gear 36 is driven by a flexible shaft so that the machine head 3 has an increased degree of freedom of its own rotation…) It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gu, to further include the rotary drive so as to rotate control assembly (140) and the endoscope (110) in view of Hu, the motivation for doing so is to enable motorized rotational movements of an endoscope, as this would provide the advantage of steady movements, instead of erratic movements controlled by hand.
Regarding claim 17, Gu in view of Hu discloses the motorized control system of claim 16, Gu further teaches wherein the control assembly further comprises: an elevator actuator assembly (implicit in view of elevator feature, see [0071: last 4 sentences]) comprising: an elevator actuator (elevator control 12) configured to align with an elevator lever (elongate shaft 114) of the medical device (endoscope 110); an elevator motor (elevator motor); wherein the actuator assembly is configured to move an elevator lever of the medical device (see [0071: last 4 sentences]). Gu does not explicitly disclose a third gear coupled to the elevator motor. However, because Gu explicitly states “the distal tip 116 may include an elevator configured to manipulate a guidewire, a tool, a medical instrument, etc. extending through the elongate shaft 114”; it would have been an obvious design choice at the time of invention to modify Gu to replace the recited ‘guidewire, tool’ with a gear. This is because gear is a known mechanical means for facilitating motorized movements, and various gears are already used in for motorizing movements of the endoscope in Gu (as discussed in claim 1 and shown Figs. 2-3).
Regarding claim 18, Gu further teaches wherein the motorized control system of claim 16, wherein the first gear (150) includes a series of recesses configured to align with prongs of the first knob. (As shown in Fig. 5: area surrounding 150 adapted to receive the drive axel 170.)
Regarding claim 19, Gu teaches a motorized control system (Fig.1: endoscopic system 100; see [0054]) for a medical device (endoscope 110), comprising:
a control assembly (motor control assembly 140) comprising:
a first body (motor control housing 142 and contents within) configured to removably couple to the medical device (110; see [0054: 1st sentence] “motor control assembly 140 including a motor control housing 142 configured to detachably interface with the handle 112 of the endoscope 110”), the first body (142) including:
a gear assembly (Fig.3: gear assemblies 150 and 160; [0073]),
a first frame (removable cover 141);
a first motor (first motor 144) configured to drive a first gear (first gear assembly 150) of the gear assembly (as shown in Figs. 3-4 and [0073: 2nd sentence] “the first gear assembly 150 may include a first worm gear 154 and a first worm gear shaft 152 configured to engage the first worm gear 154.”); and
an actuator assembly (implicit in view of elevator feature, see [0071: last 4 sentences]) configured to move an elevator lever (elongate shaft 114) of the medical device (112), comprising:
an elevator actuator (elevator control 12) configured to align with an elevator lever (elongate shaft 114) of the medical device (see [0071: last 4 sentences]);
an elevator motor (elevator motor); and
wherein the gear assembly (150 and 160) is coupled to the first frame (removable cover 141; see [0054] “the one or more internal covers 143 may provide structural support for selected internal components”; the internal components include gears 150 and 160 as shown in Figs. 1-3) and is configured to receive a first knob (first axel 170) of the medical device (see [0073, 0076] first axel 170 is configured to engage with the first worm gear 154); and
wherein the first motor (144) is configured to drive the first gear (154) to rotate the first knob. (170; see [0073, 0076] first axel 170 is configured to engage with the first worm gear 154.)
Gu does not teach the control assembly comprising the first frame (141) and a base frame (see annotated Fig. 3 above), but dos not teach wherein the first frame is rotatably coupled to the base frame. Hu, another prior art reference in the analogous art of motorized control systems for endoscopes (Figs. 1, 3, 4 and 6: remote control device for gastrointestinal endoscope) discloses a motorized system comprising a first frame (machine head seat 40) rotatably coupled to a base frame (rotating shaft 38); see Figs.3-6, and pg.3-4/6 “the top of the nose 3 is provided with a rotating shaft 38, and the steering driven gear 37 is fixed on the rotating shaft 38, and the rotating shaft 38 is also provided with a bearing 39, and the machine head 3 is rotatably suspended on the machine head seat 40 by the bearing 39 and the bearing 39 seats in the machine head seat 40 inner cavity, turning to the driving gear 36 is driven by a flexible shaft so that the machine head 3 has an increased degree of freedom of its own rotation…” It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Gu, to further include rotating coupling between the control assembly (140) and the endoscope (110) in view of Hu, the motivation for doing so is to enable motorized rotational movements of an endoscope, as this would provide the advantage of steady movements, instead of erratic movements controlled by hand.
Gu also does not disclose wherein the actuator assembly comprises a third gear coupled to the elevator motor. However, because Gu explicitly states “the distal tip 116 may include an elevator configured to manipulate a guidewire, a tool, a medical instrument, etc. extending through the elongate shaft 114”; it would have been an obvious design choice at the time of invention to modify Gu to replace the recited ‘guidewire, tool’ with a gear. This is because gear is a known mechanical means for facilitating motorized movements, and various gears are already used in for motorizing movements of the endoscope in Gu (as discussed in claim 1 and shown Figs. 2-3).
Regarding claim 20, Gu The motorized control system of claim 19, wherein the first frame includes a first lumen and the base frame includes a second lumen longitudinally aligned with the first lumen; and wherein each of the first lumen and the second lumen is configured to receive a portion of the medical device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
December 11, 2025