DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1 should read, “A robot system for gastroscopy based on visual-tactile fusion and optical learning, comprising...”
Applicant is reminded of 37 C.F.R. 1.75 and MPEP 608.01(i) which states that “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by line indentation.” Future claim amendments should reflect this as currently, all of the elements are submitted in simple paragraph form. Appropriate correction is required.
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:
“a gastroscope control system” in claim 1 which is given structural recitation in applicant’s specification [0009]
“an identification and positioning module” in claim 1 which has not been given structural recitation in the applicant’s specification
“an integration computation module” in claim 1 which has not been given structural recitation in the applicant’s specification
“a visual-tactile fusion system” in claim 5 which has not been given structural recitation in the applicant’s specification (described as software in [0025])
“a motion control system” in claim 5 which has not been given structural recitation in the applicant’s specification (described as software in [0025]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 § 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 1-7 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. Claims 1 and 5 contain limitations interpreted under 112(f) which have no structural recitation in the applicant’s specification as detailed above. This creates the presumption that the applicant has not provided sufficient written description of the particular structure used to carry out the function performed in each instance.
Claims 2-4 and 6-7 stand as rejected under 112(a) for being dependent upon a rejected base claim.
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 1-7 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.
Claim limitation “an identification and positioning module”, “an integration computation module”, “a visual-tactile fusion system”, and “a motion control system” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification either provides no definitive structure to associate with these limitations that are at least capable of performing the described function, or these limitations have been described as software (see applicant’s specification [0025] for these limitations). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-4 and 6-7 stand as rejected under 112(b) for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2023/0110791 to Shelton (hereinafter “Shelton”) in view of "A novel detection technology for early gastric cancer based on Raman spectroscopy" by Yin, Fumei, et al (hereinafter “Yin”).
In regards to claim 1, Shelton discloses a robot system for endoscopy comprising: a gastroscope control system (Element 120), an identification and positioning module ([0091] [0093] [0113]), and an integration computation module ([0102]), wherein the gastroscope control system acquires gastroscope image data ([0091]); the identification and positioning module receives the gastroscope image data ([0113]), and performs a region of interest (ROT) localization on the gastroscope image data; and the integration computation module conducts a molecular spectral measurement on an ROT to obtain spectral data of a gastric tissue ([0102] [0113] [0120]).
However, Shelton does not disclose that the integration and computation module calculates an integral energy ratio based on the spectral data.
Yin discloses a method for detecting gastric cancer using endoscopes (see Abstract) wherein images from the endoscopy analyzed and an internal energy ratio based on the spectral data in the images is calculated (Fig. 6E, Section 3.2). It would have been obvious before the effective filing date of the claimed invention to modify Yin to disclose calculating an integral energy ratio such as that taught by Yin as “Raman spectroscopy can be used as a powerful tool for detecting EGC while elucidating biomolecular dynamics in tumorigenesis.” (Yin, Abstract)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton and Yin as applied to claim 1 above, and further in view of US Patent Application Publication 2020/0359997 to Caswell (hereinafter “Caswell”).
In regards to claim 2, Shelton discloses further that the gastroscope control system comprises a gastroscope ([0092]), a robotic arm (Element 114), and a main unit (Element 133, [0098] [0111]), wherein the gastroscope is arranged at a distal end of the robotic arm and is linearly connected to the main unit (see Fig. 1), to acquire the gastroscope image data ([0091]); the robotic arm is linearly connected to the main unit (See Fig. 1), and a motion of the robotic arm is controlled by a pre-programmed algorithm within the main unit ([0111] [0209] [0275] [0330]).
However, Shelton does not disclose a miniature force sensor, a knob actuator, or that the miniature force sensor is arranged at a distal end of the gastroscope, and when the distal end of the gastroscope contacts and presses against a gastrointestinal wall, the miniature force sensor generates a force feedback signal and transmits the force feedback signal to the main unit; and the knob actuator controls an angle of a gastroscope image.
Caswell discloses a system for imaging internal body cavities comprising a gastroscope (Abstract) and further comprising a miniature force sensor ([0013]), a knob actuator (Element 125, [0060]), and wherein the miniature force sensor is arranged at a distal end of the gastroscope, and when the distal end of the gastroscope contacts and presses against a gastrointestinal wall, the miniature force sensor generates a force feedback signal and transmits the force feedback signal to the main unit ([0013] [0077]); and the knob actuator controls an angle of a gastroscope image ([0060], knobs can control movement of gastroscope, movement of the scope changes the angle). It would have been obvious before the effective filing date of the claimed invention to modify Shelton and Yin to include the miniature force sensor and the knob actuator such as that taught by Caswell in order to prevent injury to the patient ([0077]) and to control the bending of the gastroscope ([0075]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, Yin, and Caswell as applied to claim 2 above, and further in view of US Patent Application Publication 2007/0260214 to Mikkaichi (hereinafter “Mikkaichi”).
In regards to claim 3, Shelton, Yin, and Caswell do not disclose that the gastroscope comprises an operation section, an insertion section, an optical fiber lens, an objective lens, and an image sensor, wherein the insertion section is a tubular structure equipped with an optical fiber, the operation section is fixedly connected to the insertion section, and an instrument inlet is disposed at a junction between the operation section and the insertion section; an opposite end of the operation section is arranged with a first knob and a second knob, the first knob is larger than the second knob, and the first knob and the second knob are coaxially arranged and connected to a guidewire within the insertion section; a curvature section is arranged near a distal end of the insertion section, the guidewire is arranged at an interior of the insertion section, and the curvature section at the distal end of the insertion section is driven by twisting the guidewire via the first knob and the second knob; the optical fiber lens, an instrument outlet, the objective lens, and the image sensor are arranged at the distal end of the insertion section, wherein the optical fiber lens transmits a light emitted from a light source, the objective lens captures an optical signal reflected from the gastrointestinal wall and performs an imaging, and the gastroscope image data is transmitted to the main unit through the image sensor; and an endoscopic treatment instrument is inserted from the instrument inlet and extends from the instrument outlet.
However, Mikkaichi discloses an endoscope for imaging the gastrointestinal system wherein the gastroscope comprises an operation section (Element 2), an insertion section (Element 3+7), an optical fiber lens (Element 122), an objective lens (Element 55), and an image sensor (Element 57), wherein the insertion section is a tubular structure equipped with an optical fiber ([0052]), the operation section is fixedly connected to the insertion section (see Fig. 8), and an instrument inlet is disposed at a junction between the operation section and the insertion section ([0041], see Fig. 2A); an opposite end of the operation section is arranged with a first knob and a second knob, the first knob is larger than the second knob, and the first knob and the second knob are coaxially arranged and connected to a guidewire within the insertion section ([0039] [0068]); a curvature section is arranged near a distal end of the insertion section (Element 4, [0039]), the guidewire is arranged at an interior of the insertion section, and the curvature section at the distal end of the insertion section is driven by twisting the guidewire via the first knob and the second knob ([0069]); the optical fiber lens, an instrument outlet (Element 10), the objective lens, and the image sensor are arranged at the distal end of the insertion section (see Fig. 8), wherein the optical fiber lens transmits a light emitted from a light source ([0052]), the objective lens captures an optical signal reflected from the gastrointestinal wall and performs an imaging ([0052]), and the gastroscope image data is transmitted to the main unit through the image sensor ([0075]); and an endoscopic treatment instrument is inserted from the instrument inlet and extends from the instrument outlet ([0040]). It would have been obvious before the effective filing date of the claimed invention to modify Shelton, Yin, and Caswell to include the operation section, insertion section, optical fiber lens, objective lens and image sensor such as that taught by Mikkaichi in to successfully guide and image areas of the gastrointestinal system (Abstract).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, Yin, Caswell, and Mikkaichi as applied to claim 3 above, and further in view of US Patent Application Publication 2025/0100154 to Mizohana (hereinafter “Mizohana”).
In regards to claim 3, Shelton, Yin, Caswell, and Mikkaichi do not teach that the robotic arm comprises a position sensor, a force sensor, a motor, a base, two connecting rods, three joints comprising a first joint, a second joint and a third joint, a gripper, and a main unit connection interface, wherein the base is integrated with the first joint, the two connecting rods are arranged alternately with the three joints, and the gripper is arranged at a distal end of the third joint farthest from the base; the motor, the position sensor, and the force sensor are arranged at each of the three joints, the motor is configured to control a rotational motion of each of the three joints, the position sensor is configured to detect the a rotation angle of the motor in real time, and the force sensor is configured to measure a torque output of the motor in real time; and the main unit connection interface is connected to the main unit by a cable.
However, Mizohana discloses a robotic arm wherein the robotic arm (Element 100) comprises a position sensor (Element 250), a force sensor (Element 260, [0051]), a motor (Element 231), a base (Element 209), two connecting rods (Elements 212 and 214), three joints comprising a first joint (J1), a second joint (J3) and a third joint (J5), a gripper (Element 300), and a main unit connection interface (Element 400, see Fig. 2), wherein the base is integrated with the first joint (see Fig. 1), the two connecting rods are arranged alternately with the three joints (See Fig. 1), and the gripper is arranged at a distal end of the third joint farthest from the base (see Fig. 1); the motor, the position sensor, and the force sensor are arranged at each of the three joints ([0051] [0056]), the motor is configured to control a rotational motion of each of the three joints ([0059]), the position sensor is configured to detect the a rotation angle of the motor in real time ([0051] [0059]), and the force sensor is configured to measure a torque output of the motor in real time ([0051]); and the main unit connection interface is connected to the main unit by a cable (400 is connected by cable in Fig. 2). It would have been obvious to modify Shelton, Yin, Caswell, and Mikkaichi to include the position sensor, force sensor, motor, base, connecting rods, joints, and main unit connection interface such as that taught by Mizohana in order to position the robot arm and the target anatomy in an appropriate target positional relationship (Mizohana [0006]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, Yin, Caswell, and Mikkaichi as applied to claim 3 above, and further in view of US Patent Application Publication 2024/0197155 to Fawdry (hereinafter “Fawdry”). Shelton, Yin, Caswell, and Mikkaichi do not disclose:
wherein the knob actuator is internally formed with mating recesses corresponding to the first knob and the second knob and comprises an outer turntable, an inner turntable, a first servo motor, a second servo motor, a central shaft, and a housing, wherein the housing, the outer turntable, and the inner turntable are coaxially arranged, and the central shaft is fixed within the housing; the first servo motor is housed within the outer turntable, and the second servo motor is housed within the inner turntable; both the first servo motor and the second servo motor are engaged with a central shaft gear to enable a coaxial rotation; and the outer turntable drives the first knob to rotate, and the inner turntable drives the second knob to rotate.
wherein the knob actuator is cylindrical
However, Fawdry discloses a motorized control system for a medical device comprising:
wherein the knob actuator is internally formed with mating recesses corresponding to the first knob and the second knob and comprises an outer turntable, an inner turntable, a first servo motor, a second servo motor, a central shaft, and a housing, wherein the housing, the outer turntable, and the inner turntable are coaxially arranged, and the central shaft is fixed within the housing; the first servo motor is housed within the outer turntable, and the second servo motor is housed within the inner turntable; both the first servo motor and the second servo motor are engaged with a central shaft gear to enable a coaxial rotation; and the outer turntable drives the first knob to rotate, and the inner turntable drives the second knob to rotate (Figs. 3-6, [0049]-[0058])
wherein the knob actuator is cylindrical (see Fig. 4)
It would have been obvious before the effective filing date of the claimed invention to modify Shelton, Yin, Caswell, and Mikkaichi to include a knob actuator with a mating recess for the gastroscope knobs such as that taught by Fawdry in order to automize control of the navigation of the scope which reduces human error which more likely leads to patient injury.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Shelton clearly demonstrates a main unit (element 133), a light source (Element 152), a display device (Element 146), a control console (Element 148), an image processor (Element 142). Caswell clearly teaches a force feedback processor ([0013] [0077]). However, the prior art does not disclose “construct[ing] a 3D safety spatial model based on a pre- programmed haptic database; the visual-tactile fusion system integrates the gastroscope image data with the force feedback signal, monitors a real-time position and an orientation tracking of an endoscope within a gastric cavity, and calculates a pressure exerted by the objective lens on the gastrointestinal wall; and the motion control system receives the control signal from the control console, converts the control signal into a motion command using a pre-programmed control algorithm, and transmits the motion command to the knob actuator and the robotic arm.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 571-270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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