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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “164” has been used to designate both a seal (Fig. 9) and a tip (Fig. 10).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 7 (Fig. 3), 62 (Fig. 3), 92 (Fig. 4 and 6), 108 (Fig. 5), 102b (Fig. 5), 102c (Fig. 5), 112 (Fig. 7), 136 (Fig. 8C), 138 (Fig. 8C), 168 (Fig. 10E), 214 (Fig. 11), 192 (Fig. 11), and 198 (Fig. 11).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The disclosure is objected to because of the following informalities:
Incorrect numbering of elements. In paragraph 082 of the specification, “male component 152 and female component 150” should read “male component 150 and female component 152.”
Appropriate correction is required.
Claim Objections
Claims 1, 4-17, and 19-20 are objected to because of the following informalities:
In claim 1, line 1, “the endoscope” should read “the portable endoscope”
In claim 1, line 8, claim 19, line 9, and claim 20, line 8, “the powered suction system including,” should read “the powered suction system including:”
In claims 4-17, “the portable endoscope as in claim 1” should read “the portable endoscope of claim 1”
In claim 5, line 1, “wherein suction control system” should read “wherein the suction control system”
In claim 19, line 1, “the bronchoscope” should read “the portable bronchoscope”
In claim 20, line 13, “configured modulate” should read “configured to modulate”
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 limitations are:
“a suction control system configured to use a sensed pressure to manipulate the negative pressure applied to the working channel” in claims 1 and 20 as described in Para. [062] of Applicant’s specification.
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 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 1-20 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.
Claims 1, 19, and 20 recite the limitation "the internal working channel of the proximal component" in l. 7 of claim 1, l. 8 of claim 19, and l. 7 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the internal working channel of the proximal component” is being interpreted as “an internal working channel of the proximal component.”
Claims 1, 19, and 20 recite the limitation "the insertion tube" in l. 4 of claim 1, l. 5 of claim 19, and l. 4 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the insertion tube” is being interpreted as “the flexible insertion tube.”
Claims 1, 4-6, 14, 17, and 19-20 recite the limitation "the working channel" in l. 14 of claim 1, l. 3 of claim 4, l. 2 of claim 5, l. 2 of claim 6, l. 2-3 of claim 14, l. 2 of claim 17, l. 18, 25, and 17 of claim 19, and l. 13 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the working channel” is being interpreted as “the internal working channel.”
Claim 2 recites the limitation "the trap" in l. 2 of claim 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the trap” is being interpreted as “the liquid trap.”
Claims 4 and 10 recite the limitation "the electrical processing unit " in l. 4 of claim 4 and l. 2 of claim 10. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the electrical processing unit” is being interpreted as “an electrical processing unit.”
Claim 12 recites the limitation "the pressure sensor" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the pressure sensor” is being interpreted as “a pressure sensor.”
Claim 12 recites the limitation "the fluid trap" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the fluid trap” is being interpreted as “the liquid trap.”
Claims 12 and 16 recite the limitation "the negative pressure pump" in l. 4 of claim 12 and l. 2 of claim 16. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the negative pressure pump” is being interpreted as “the pump.”
Claim 14 recites the limitation "the proximal end" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the proximal end” is being interpreted as “the proximal component.”
Claim 14 recites the limitation "the port" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the port” is being interpreted as “the fluid trap port.”
Claim 15 recites the limitation "the inlet connector" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 15 is being interpreted as dependent upon claim 14 such that “the inlet connector” is “an inlet connector” established in claim 14.
Claims 15-16 recite the limitation "the outlet connector" in lines l. 1-2 of claim 15 and l. 2 of claim 16. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claims 15 and 16 are being interpreted as dependent upon claim 14 such that “the outlet connector” is “an outlet connector” established in claim 14.
Claims 18-19 recite the limitation "the flexible tubing" in l. 3 of claim 18 and l. 21-22 of claim 19. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the flexible tubing” is being interpreted as “the flexible insertion tube.”
Claims 19-20 recite the limitation "the pump" in l. 27 of claim 19 and l. 11 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the pump” is being interpreted as “the negative pressure pump.”
Claims 3, 7-11, and 13 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 7, 9, 17, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Appl. Publ. No. 2024/0057848 A1 to Fukatsu et al. (“Fukatsu”).
Regarding claim 1, Fukatsu discloses a portable endoscope with controlled suction (endoscope 10; Fig. 10, paragraph 0125), the endoscope comprising:
a proximal component and a distal component (the boundaries of the proximal component and the distal component are defined by the solid outline as seen in annotated Fig. 10 below; Fig. 10), the proximal component including a handle (the operation section 12 is a device for allowing the user to operate the endoscope 10, and includes, for example, a grip section; Fig. 10 and 15, paragraphs 0129 and 0161) and the distal component comprising a flexible insertion tube extending from the proximal component to a distal end (the insertion section 14 has a flexible, elongated shape; Fig. 10, paragraph 0126 and 0160), the insertion tube including an internal working channel extending from the distal end to the proximal component (the suction tube 52 is provided in the insertion section 14, one end of which is connected to the suction port 51 provided at the distal end of the insertion section 14, while the other end is connected to port 53; Fig. 10, paragraph 0127);
a powered suction system including a fluid circuit in fluid communication with the internal working channel of the proximal component (the suction tube 52 branches near the port 53, and the branched suction tube 52 is connected to the suction device 30; Fig. 10, paragraph 0127), the powered suction system providing suction to the distal end (the suction device 30 is connected to the suction tube, and provides suction when the suction ON control signal CNT is input; Fig. 10, paragraph 0037), the powered suction system including,
a source of negative pressure from a pump (the suction device 30 includes … a suction pump 32; Fig. 10, paragraph 0130);
a liquid trap in the fluid circuit (the suction device 30 includes … a suction tank 34; Fig. 10, paragraph 0130), the liquid trap in fluid communication with the source of negative pressure (the suction tube 52, which branches near the port 53, is connected to the suction pump 32 via the suction amount measurement section 37, the solenoid valve 35, and the suction tank 34; Fig. 10, paragraph 0131); and
a suction control system comprising at least one user input element (the suction operation detection sensor 55 detects the pressing of the suction operation button 54, and outputs a detection signal to the control determination section 162; Fig. 10, paragraph 0129), the suction control system configured to use a sensed pressure to manipulate the negative pressure applied to the working channel (the suction control circuit 31 includes a drive circuit for the suction pump 32 and a drive circuit for the solenoid valve 35, and controls ON/OFF of the suction as well as the suction strength by driving the suction pump 32 and the solenoid valve 35 according to the control signal CNT output from the control section 170; Fig. 10, paragraph 0131)(the pressure sensor 36 is connected to the suction tube 52, which branches near the port 53. The pressure sensor 36 measures the pressure in the suction tube 52, and outputs the measurement valve to the inspection status determination status 161; Fig. 10, paragraph 0132).
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Regarding claim 9, Fukatsu discloses the portable endoscope according to claim 1. Fukatsu further discloses wherein the pump is located in an external component in fluid communication with the proximal component (the suction device 30 includes … a suction pump 32; Fig. 10, paragraph 0130).
Regarding claim 17, Fukatsu discloses the portable endoscope according to claim 1. Fukatsu further discloses comprising an accessory port for inserting fluid in the working channel (the port 53 is provided for allowing treatment tools such as forceps to be inserted into the body cavity from the suction port 51 via the suction tube 52, or for dispersing chemical liquids and the like into the body cavity from the suction port 51 via the suction tube 52 using a syringe; Fig. 10, paragraph 0127), the fluid circuit including a fluid valve configured to prevent backflow of liquids from the accessory port toward the source of negative pressure (solenoid valve 35; Fig. 10, paragraph 0131).
Regarding claim 20, Fukatsu discloses a portable endoscope (endoscope 10; Fig. 10, paragraph 0125), comprising:
a proximal component and a distal component (the boundaries of the proximal component and the distal component are defined by the solid outline as seen in annotated Fig. 10 below; Fig. 10), the proximal component including a handle (the operation section 12 is a device for allowing the user to operate the endoscope 10, and includes, for example, a grip section; Fig. 10 and 15, paragraphs 0129 and 0161) and the distal component comprising a flexible insertion tube extending from the proximal component to a distal end (the insertion section 14 has a flexible, elongated shape; Fig. 10, paragraph 0126 and 0160), the insertion tube including an internal working channel extending from the distal end to the proximal component (the suction tube 52 is provided in the insertion section 14, one end of which is connected to the suction port 51 provided at the distal end of the insertion section 14, while the other end is connected to port 53; Fig. 10, paragraph 0127);
a powered suction system including a fluid circuit in fluid communication with the internal working channel of the proximal component (the suction tube 52 branches near the port 53, and the branched suction tube 52 is connected to the suction device 30; Fig. 10, paragraph 0127), the powered suction system providing suction to the distal end (the suction device 30 is connected to the suction tube, and provides suction when the suction ON control signal CNT is input; Fig. 10, paragraph 0037), the powered suction system including,
a negative pressure pump positioned in the proximal component (the suction device 30 includes … a suction pump 32; Fig. 10, paragraph 0130);
a liquid trap in the fluid circuit (the suction device 30 includes … a suction tank 34; Fig. 10, paragraph 0130), the liquid trap in fluid communication with the pump (the suction tube 52, which branches near the port 53, is connected to the suction pump 32 via the suction amount measurement section 37, the solenoid valve 35, and the suction tank 34; Fig. 10, paragraph 0131); and
a suction control system comprising at least one user input element (the suction operation detection sensor 55 detects the pressing of the suction operation button 54, and outputs a detection signal to the control determination section 162; Fig. 10, paragraph 0129), the suction control system configured to modulate the negative pressure applied to the working channel (the suction control circuit 31 includes a drive circuit for the suction pump 32 and a drive circuit for the solenoid valve 35, and controls ON/OFF of the suction as well as the suction strength by driving the suction pump 32 and the solenoid valve 35 according to the control signal CNT output from the control section 170; Fig. 10, paragraph 0131).
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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.
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.
Claims 2-3, 6, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2025/0134357 A1 to Li et al. (“Li”).
Regarding claim 2, Fukatsu discloses the portable endoscope according to claim 1. Fakatsu further teaches a pressure sensor configured to sense the pressure in the working channel (the pressure sensor 36 measures the pressure in the suction tube 52; Fig. 10, paragraph 0132). However, Fukatsu does not explicitly disclose wherein the powered suction system includes a pressure sensor configured to sense the negative air pressure applied to the trap and the suction control system includes an electrical processing unit electrically coupled to the pressure sensor and providing the sensed pressure.
Li teaches wherein the powered suction system includes a pressure sensor configured to sense the negative air pressure applied to the trap (the pressure sensor is used for detecting the intracavity pressure in the suction container 93; Fig. 10, paragraph 0084) and the suction control system includes an electrical processing unit electrically coupled to the pressure sensor and providing the sensed pressure (converted into a pressure value by a conversion circuit for output; paragraphs 0063-0068). Li teaches that the sensed pressure in the suction container is useful information when adjusting the suction flow rate for achieving a dynamic balance between perfusion and suction (paragraph 0093).
Li is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Li by adding a pressure sensor to sense the negative air pressure applied to the trap and an electrical processing unit for providing the sensed pressure. Doing so is useful when adjusting the suction flow rate for achieving a dynamic balance between perfusion and suction, as recognized by Li.
Regarding claim 3, Fukatsu discloses the portable endoscope according to claim 1. Fakatsu further teaches wherein the suction control system includes a valve (solenoid valve 35; Fig. 10, paragraph 0131). However, Fukatsu does not explicitly disclose wherein the suction control system includes a mechanically actuated negative pressure release valve.
Li teaches wherein the suction control system includes a mechanically actuated negative pressure release valve (the suction container 93 is provided with a relief valve; Fig. 10, paragraph 0084). Li teaches the use of the relief valve for quickly regulating the intracavity pressure in the suction container (paragraph 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Li by adding a mechanically actuated negative pressure release valve. Doing so helps to quickly regulate the intracavity pressure in the suction container, as recognized by Li.
Regarding claim 6, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the suction control system regulates the pressure applied to the working channel by releasing pressure in the fluid circuit.
Li teaches wherein the suction control system regulates the pressure applied to the working channel by releasing pressure in the fluid circuit (when the intracavity pressure is not at the “pressure control value ±8mmHg”, it indicates that the pressure is higher or lower than the “pressure control value” at this time, and the pressure difference is too large. At this time, it is necessary to adjust the pressure in a wide range by coarse tuning, such as tuning the perfusion gear and tuning the relief valve to quickly regulate the intracavity pressure close to or reach the pressure control value; Fig. 10, paragraph 0094-0095 and 0101 and 0087). Li teaches that regulating the pressure applied to the working channel through use of a relief valve helps to avoid tissue damage caused by excessive pressure fluctuations in the body (paragraph 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Li by regulating the pressure applied to the working channel by releasing pressure in the fluid circuit. Doing so helps to avoid tissue damage caused by excessive pressure fluctuations in the body, as recognized by Li.
Regarding claim 10, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the fluid circuit includes an over-pressure valve, wherein the electrical processing unit actuates the over-pressure valve in response to a sensed pressure in the fluid circuit that is greater than a user selected pressure.
Li teaches wherein the fluid circuit includes an over-pressure valve (the suction container 93 is provided with a relief valve; Fig. 10, paragraph 0084), wherein the electrical processing unit actuates the over-pressure valve in response to a sensed pressure in the fluid circuit that is greater than a user selected pressure (when the intracavity pressure is not at the “pressure control value ±8mmHg”, it indicates that the pressure is higher or lower than the “pressure control value” at this time, and the pressure difference is too large. At this time, it is necessary to adjust the pressure in a wide range by coarse tuning, such as tuning the perfusion gear and tuning the relief valve to quickly regulate the intracavity pressure close to or reach the pressure control value; Fig. 10, paragraph 0094-0095 and 0101 and 0087). Li teaches the use of the relief valve for quickly regulating the intracavity pressure in the suction container (paragraph 0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Li by adding a mechanically actuated negative pressure release valve. Doing so helps to quickly regulate the intracavity pressure in the suction container, as recognized by Li.
Regarding claim 11, Fukatsu, as previously modified by Li, discloses the portable endoscope according to claims 1 and 10. Fukatsu further discloses wherein the over-pressure valve is a solenoid valve (solenoid valve 35; Fig. 10, paragraph 0131).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2024/0269367 A1 to Tsuruta et al. (“Tsuruta”).
Regarding claim 4, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the proximal component includes one or more user input elements that provide input to the suction control system to selectively adjust the regulated negative pressure applied to the working channel of the distal component, wherein the electrical processing unit is responsive to the user input for regulating suction pressure.
Tsuruta teaches wherein the proximal component includes one or more user input elements that provide input to the suction control system to selectively adjust the regulated negative pressure applied to the working channel of the distal component (the flow rate in the suction conduit can be set by a user such as an operator using an input apparatus which is not shown; paragraphs 0053 and 0099), wherein the electrical processing unit is responsive to the user input for regulating suction pressure (the control circuit 11 performs feedback control, such as PID (proportional-integral-derivative) control, to change the drive output to the suction pump 12b based on the measurement result from the flow meter 13 for maintaining the set flow rate; Fig. 2, paragraph 0054).
Tsuruta is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated user inputs in the endoscopic system of Fukatsu, as taught by Tsuruta, to increase the functionality of the endoscope of Fukatsu by enabling the user to adjust the negative pressure applied to the working channel.
Regarding claim 5, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein suction control system regulates the pressure applied to the working channel by changing the pump pressure.
Tsuruta teaches wherein suction control system regulates the pressure applied to the working channel by changing the pump pressure (the control circuit 11 generates drive output to drive the suction pump 12b to be outputted to the suction pump 12b. The suction pump 12b operated based on the drive output, thereby generating a predetermined suction pressure inside the suction conduit with the suction channel 27 and the suction tube 62; Fig. 2, paragraph 0052-0054). Tsuruta teaches that regulation of the pressure applied to the working channel allows for perfusion to be performed with a constant pressure inside the organ (paragraph 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Tsuruta by regulating the pressure applied to the working channel by changing the pump pressure. Doing so allows for perfusion to be performed with a constant pressure inside the organ, as recognized by Tsuruta.
Claims 7-8 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2020/0214543 A1 to Ben-arye (“Ben-arye”).
Regarding claim 7, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the pump is located in the proximal component.
Ben-arye teaches wherein the pump is located in a handle portion of the proximal component (a separate liquid withdrawal pump 71 is shown for withdrawing liquid from an anatomical region through an orifice in the catheter and into the cell collection reservoir 73 located in the handle 15 of the device; Fig. 7, paragraph 0077). Ben-arye teaches that by placing the pump in the handle portion, the endoscope can be completely self-contained, thereby enabling higher maneuverability and flexibility for the user (paragraph 0019).
Ben-arye is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Ben-arye by adding the pump to the handle portion of the proximal component. Doing so would help make the endoscope completely self-contained, thereby enabling higher maneuverability and flexibility for the user, as recognized by Ben-arye.
Regarding claim 8, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the pump is located in a handle portion of the proximal component.
Ben-arye teaches wherein the pump is located in a handle portion of the proximal component (a separate liquid withdrawal pump 71 is shown for withdrawing liquid from an anatomical region through an orifice in the catheter and into the cell collection reservoir 73 located in the handle 15 of the device; Fig. 7, paragraph 0077). Ben-arye teaches that by placing the pump in the handle portion, the endoscope can be completely self-contained, thereby enabling higher maneuverability and flexibility for the user (paragraph 0019).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Ben-arye by adding the pump to the handle portion of the proximal component. Doing so would help make the endoscope completely self-contained, thereby enabling higher maneuverability and flexibility for the user, as recognized by Ben-arye.
Claims 14 and 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2023/0255456 A1 to Limberg et al. (“Limberg”).
Regarding claim 14, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the proximal end includes a fluid trap port, the port including an inlet connector that is in fluid communication with the working channel and receives liquids and air from the working channel, and an outlet connector that is in fluid communication with the source of negative pressure.
Limberg teaches wherein the proximal end includes a fluid trap port (port 582”; Fig. 4A-B, paragraph 0056), the port including an inlet connector that is in fluid communication with the working channel and receives liquids and air from the working channel (the suction path may travel from scope 10 to trap 930 (via second portion 1537”, connector 1640, and first lumen 932); Fig. 4B, paragraph 0060), and an outlet connector that is in fluid communication with the source of negative pressure (from trap 930 to tower 20 (via second lumen 934 and first portion 1535”); Fig. 4B, paragraph 0060).
Limberg is considered to be analogous to the claimed invention because it is in the same field of medical device with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Limberg by including a port with inlet and outlet connectors. Fukatsu does not disclose any limitations regarding the structure for how the working channel of the endoscope, the fluid trap, and the pump connect in the fluid circuit. As known to one of ordinary skill in the art, ports and tubing connectors are a conventional connection means used in endoscopes for maintaining fluid flow between a pump, a fluid trap, and a working channel of an endoscope.
Regarding claim 15, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the inlet connector and the outlet connector are tubing connectors.
Limberg teaches wherein the inlet connector and the outlet connector are tubing connectors (first lumen 932 and second lumen 934; Fig. 4B, paragraph 0060).
Limberg is considered to be analogous to the claimed invention because it is in the same field of medical device with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Limberg by including tubing connectors. Fukatsu does not disclose any limitations regarding the structure for how the working channel of the endoscope, the fluid trap, and the pump connect in the fluid circuit. As known to one of ordinary skill in the art, tubing and tubing connectors are a conventional connection means used in endoscopes for maintaining fluid flow between a pump, a fluid trap, and a working channel of an endoscope.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2007/0191711 A1 to Bush et al. (“Bush”) and U.S. Patent Appl. Publ. No. 2024/0358938 A1 to O’Dea et al. (“O’Dea”).
Regarding claim 16, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose comprising a hydrophobic filter in the fluid circuit between the outlet connector and the negative pressure pump.
Bush teaches a hydrophobic filter in the fluid circuit before the negative pressure pump (a hydrophobic filter 14 may be installed to prevent liquid transport to vacuum pump 5 in the event of a degasser unit failure; Fig. 4, paragraph 0046).
Bush is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Bush by adding a hydrophobic filter before the negative pressure pump. Doing so would help protect the pump, as recognized by Bush.
O’Dea teaches a filter in the fluid circuit between the outlet connector of the water trap and the negative pressure pump (water trap 243 and a filter 244; Fig. 12, paragraph 0379-0380). O’Dea teaches that by placing the water trap before the filter, the filter can be protected (paragraph 0380).
O’Dea is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of O’Dea by adding a filter between the outlet connector and the negative pressure pump. Doing so would protect the filter, as recognized by O’Dea.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of U.S. Patent Appl. Publ. No. 2024/0156334 A1 to Nakamura et al. (“Nakamura”).
Regarding claim 18, Fukatsu discloses the portable endoscope according to claim 1. Fukatsu further discloses comprising a flexion control system including a flexion wheel (angle operating dial; Fig. 15, paragraph 0161), the flexion control system providing user control of the flexible tubing of the distal component (by the user’s operation of the angle operating dial, the curving section 15 of the insertion section 14 bends up, down, left, and right. This action is called an angle operation; Fig. 15, paragraph 0161). However, Fukatsu does not explicitly disclose comprising a flexion control system including a thumb lever and a plurality of steering wires.
Nakamura teaches comprising a flexion control system including a thumb lever (a raising base operation lever 24; Fig. 1, paragraph 0066), a flexion wheel (an left-right bending operation knob 23; Fig. 1, paragraph 0066), and a plurality of steering wires (the bending operation mechanism 35 pulls or loosens the up-down bending operation wires 37 and the left-right bending operation wires 38 according to the amounts of operation on the up-down bending operation knob 22 and the left-right bending operation knob 23; Fig. 3, paragraph 0073), the flexion control system providing user control of the flexible tubing of the distal component (the bending operation mechanism 35 is this able to bend the bending portion 11 in every direction including up-down and left-right directions; Fig. 3, paragraph 0073).
Nakamura is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a thumb lever in the endoscopic system of Fukatsu, as taught by Nakamura, to increase the functionality of the endoscope of Fukatsu by enabling the user to raise the raising base.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu in view of Ben-yare, Li, Nakamura, and Tsuruta.
Regarding claim 19, Fukatsu discloses a portable bronchoscope with controlled suction of the airway (endoscope 10; Fig. 10, paragraph 0125), the bronchoscope comprising:
a proximal component and a distal component (the boundaries of the proximal component and the distal component are defined by the solid outline as seen in annotated Fig. 10 below; Fig. 10), the proximal component including a handle (the operation section 12 is a device for allowing the user to operate the endoscope 10, and includes, for example, a grip section; Fig. 10 and 15, paragraphs 0129 and 0161) and the distal component comprising a flexible insertion tube extending from the proximal component to a distal end (the insertion section 14 has a flexible, elongated shape; Fig. 10, paragraph 0126 and 0160), the insertion tube including an internal working channel extending from the distal end to the proximal component (the suction tube 52 is provided in the insertion section 14, one end of which is connected to the suction port 51 provided at the distal end of the insertion section 14, while the other end is connected to port 53; Fig. 10, paragraph 0127);
a powered suction system including a fluid circuit in fluid communication with the internal working channel of the proximal component (the suction tube 52 branches near the port 53, and the branched suction tube 52 is connected to the suction device 30; Fig. 10, paragraph 0127), the powered suction system providing suction to the distal end (the suction device 30 is connected to the suction tube, and provides suction when the suction ON control signal CNT is input; Fig. 10, paragraph 0037), the powered suction system including:
a negative pressure pump (the suction device 30 includes … a suction pump 32; Fig. 10, paragraph 0130);
a liquid trap in the fluid circuit (the suction device 30 includes … a suction tank 34; Fig. 10, paragraph 0130), the liquid trap in fluid communication with the source of negative pressure (the suction tube 52, which branches near the port 53, is connected to the suction pump 32 via the suction amount measurement section 37, the solenoid valve 35, and the suction tank 34; Fig. 10, paragraph 0131);
a pressure sensor (the pressure sensor 36 measures the pressure in the suction tube 52; Fig. 10, paragraph 0132);
a suction control system including an electrical processing unit electrically coupled to the pressure sensor and responsive to user input for regulating suction pressure, the suction control system configured to use the sensed pressure to regulate the negative pressure applied to the working channel (the suction control circuit 31 includes a drive circuit for the suction pump 32 and a drive circuit for the solenoid valve 35, and controls ON/OFF of the suction as well as the suction strength by driving the suction pump 32 and the solenoid valve 35 according to the control signal CNT output from the control section 170; Fig. 10, paragraph 0131);
wherein the proximal component includes:
a flexion control system including a flexion wheel (angle operating dial; Fig. 15, paragraph 0161), the flexion control system providing user control of the flexible tubing of the distal component (by the user’s operation of the angle operating dial, the curving section 15 of the insertion section 14 bends up, down, left, and right. This action is called an angle operation; Fig. 15, paragraph 0161).
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However, Fukatsu does not explicitly teach wherein the powered suction system including, a negative pressure pump positioned in a handle portion of the proximal component;
a pressure sensor configured to sense the negative air pressure applied to the liquid trap;
wherein the proximal component includes,
a flexion control system including a thumb lever, a flexion wheel, and a plurality of steering wires,
one or more user input elements that provide input to the suction control system to selectively adjust the regulated negative pressure applied to the working channel of the distal component; and
wherein the suction control system regulates the pressure applied to the working channel by (i) changing the negative pressure generated by the pump and/or (ii) releasing pressure in the fluid circuit.
Ben-arye teaches wherein the pump is located in a handle portion of the proximal component (a separate liquid withdrawal pump 71 is shown for withdrawing liquid from an anatomical region through an orifice in the catheter and into the cell collection reservoir 73 located in the handle 15 of the device; Fig. 7, paragraph 0077). Ben-arye teaches that by placing the pump in the handle portion, the endoscope can be completely self-contained, thereby enabling higher maneuverability and flexibility for the user (paragraph 0019).
Ben-arye is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Ben-arye by adding the pump to the handle portion of the proximal component. Doing so would help make the endoscope completely self-contained, thereby enabling higher maneuverability and flexibility for the user, as recognized by Ben-arye.
Li teaches wherein the powered suction system includes a pressure sensor configured to sense the negative air pressure applied to the trap (the pressure sensor is used for detecting the intracavity pressure in the suction container 93; Fig. 10, paragraph 0084). Li teaches that the sensed pressure in the suction container is useful information when adjusting the suction flow rate for achieving a dynamic balance between perfusion and suction (paragraph 0093).
Li is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscopic system of Fukatsu to incorporate the teachings of Li by adding a pressure sensor to sense the negative air pressure applied to the trap and an electrical processing unit for providing the sensed pressure. Doing so is useful when adjusting the suction flow rate for achieving a dynamic balance between perfusion and suction, as recognized by Li.
Nakamura teaches comprising a flexion control system including a thumb lever (a raising base operation lever 24; Fig. 1, paragraph 0066), a flexion wheel (an left-right bending operation knob 23; Fig. 1, paragraph 0066), and a plurality of steering wires (the bending operation mechanism 35 pulls or loosens the up-down bending operation wires 37 and the left-right bending operation wires 38 according to the amounts of operation on the up-down bending operation knob 22 and the left-right bending operation knob 23; Fig. 3, paragraph 0073), the flexion control system providing user control of the flexible tubing of the distal component (the bending operation mechanism 35 is this able to bend the bending portion 11 in every direction including up-down and left-right directions; Fig. 3, paragraph 0073).
Nakamura is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a thumb lever in the endoscopic system of Fukatsu, as taught by Nakamura, to increase the functionality of the endoscope of Fukatsu by enabling the user to raise the raising base.
Tsuruta teaches wherein the proximal component includes one or more user input elements that provide input to the suction control system to selectively adjust the regulated negative pressure applied to the working channel of the distal component (the flow rate in the suction conduit can be set by a user such as an operator using an input apparatus which is not shown; paragraphs 0053 and 0099), wherein the electrical processing unit is responsive to the user input for regulating suction pressure (the control circuit 11 performs feedback control, such as PID (proportional-integral-derivative) control, to change the drive output to the suction pump 12b based on the measurement result from the flow meter 13 for maintaining the set flow rate; Fig. 2, paragraph 0054).
Tsuruta is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a suction system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated user inputs in the endoscopic system of Fukatsu, as taught by Tsuruta, to increase the functionality of the endoscope of Fukatsu by enabling the user to adjust the negative pressure applied to the working channel.
Allowable Subject Matter
Claims 12-13 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, Fukatsu discloses the portable endoscope according to claim 1. However, Fukatsu does not explicitly disclose wherein the suction control system includes the pressure sensor on a circuit board and a manifold mounted to the circuit board over the pressure sensor, the manifold providing fluid communication with an air outlet of the fluid trap and the air inlet to the negative pressure pump.
U.S. Patent Appl. Publ. No. 2016/0310210 A1 to Harshmann et al. teaches wherein a pressure sensor on a circuit board and a manifold mounted to the circuit board over the pressure sensor (manifold 1008 can further comprise a recessed seat 113 formed in a surface thereof for receiving and securing one or more printed circuit boards thereto, such as by soldering or additive printing directly thereon, and one or more liquid pressure sensors and gauges; Fig. 9 and 11, paragraph 0068), the manifold providing fluid communication with an outlet and an inlet (manifold 1008 distributes or redirects the inflow, outflow, and/or electrical flows between shaft 102 and with the system console; Fig. 9 and 11, paragraph 0062).
However, Harshmann does not explicitly teach wherein the suction control system includes the pressure sensor on a circuit board and a manifold mounted to the circuit board over the pressure sensor, the manifold providing fluid communication with an air outlet of the fluid trap and the air inlet to the negative pressure pump.
Additionally, there is no reason, teaching, or suggestion provided with any prior art of record to modify the above endoscopic system to include the manifold and circuit board structure between the fluid trap and the pressure pump.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2009/0062611 A1 to Toyama teaches a control circuit for controlling a suction pump so that the pressure of the fluid in the lumen in the vicinity of the suction opening portion falls within an appropriate pressure range based on the pressure detected by the pressure/flow-rate sensor as described in the abstract and following descriptive text.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795