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 “516” has been used to designate both an inlet passage (Fig. 7C) and a guide groove (Fig. 5).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the method for operating a medical system as described in Claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to for the following informalities:
Failure to comply with 37 C.F.R. 1.84(l) & (p)(1): All drawings must be made to have satisfactory reproduction characteristics and all reference characters must be legible (i.e., not blurry). Specifically, Fig. 1 has illegible text and/or reference characters.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Incorrect numbering of elements. In paragraph 0047 of the specification, “barb 115” should read “barb 150.”
The specification should provide further details on the claimed subject matter. Therefore, the method for operating a medical system as disclosed in Claim 20 must be described in the disclosure.
Appropriate correction is required.
Claim Objections
Claims 1-10, 16, and 20 are objected to because of the following informalities:
In claim 1, line 10, claim 10, line 13, and claim 20, line 12, “each guide groove” should read “each of the one or more guide grooves.” This suggested modification would eliminate potential 112(b) rejections arising from a lack of antecedent basis.
In claim 1, lines 19 and 24, and claim 10, lines 22 and 27, “the internal channel of the knob” should read “the internal channel of the knob barrel.” This suggested modification would improve the clarity of the scope of the claim.
In claims 2-9, line 1, “the valve assembly of” should read “the two-way valve assembly of”
In claim 16, line 1, “w\herein” should read “wherein”
Appropriate correction is required.
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 5-6, 8, and 10-20 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 5 and 18 recite the limitation "the angle of rotation" in l. 2 of claim 5 and l. 2 of claim 18. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the angle of rotation” is being interpreted as “an angle of rotation.”
Claims 6 and 19 recite the limitation "the guide grooves" in l. 1 of claim 6 and l. 1 of claim 19. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the guide grooves” is being interpreted as “the one or more guide grooves.”
Claim 8 recites the limitation "the inner wall of the valve body" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the inner wall of the valve body” is being interpreted as “an inner wall of the valve body.”
Claims 10 and 20 recite the limitation "the endoscope fluid channel" in l. 12-13, 21, and 26 of claim 10 and l. 11-12, 20, and 25-26 of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the endoscope fluid channel” is being interpreted as “the fluid channel of the endoscope.”
Claims 12 recites the limitation "the human respiratory system" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the human respiratory system” is being interpreted as “a human respiratory system.”
Claims 14 recites the limitation "the gas" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the gas” is being interpreted as “a gas from the gas source.”
Claims 15-17 recite the limitation "the valve assembly" in l. 1 of claim 15, l. 1 of claim 16, and l. 1 of claim 17. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the valve assembly” is being interpreted as “the two-way valve assembly.”
Claims 16 recites the limitation "the end cap" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the end cap” is being interpreted as “an end cap attached to the valve body.”
Claims 20 recites the limitation "the respiratory system of a patient" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the respiratory system of a patient” is being interpreted as “a respiratory system of a patient.”
Claims 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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1 and 6-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Appl. Publ. No. 2024/0325675 A1 to Dharmadasa et al. (“Dharmadasa”).
Regarding claim 1, Dharmadasa discloses a two-way valve assembly for a medical device (a first example valve 20 suitable for the above purposes is described; Fig. 2A-5, paragraph 0069), comprising:
a knob comprising:
a knob barrel (valve core 27; Fig. 4A-B, paragraph 0069) having a side wall and an internal channel running between inlet and outlet openings in the side wall (the valve core 27 defines a ported chamber 40 having openings 41, 42, 43 respectively at 0, 180 and 90 degree positions relative one another about the valve axis 28; Fig. 4A-B, paragraph 0071), and
one or more guide pins (the undulating outer surface 234 of the valve core 227 includes flatten peaks 234a; Fig. 7B, paragraph 0098);
a valve body comprising:
a valve well encircling the knob barrel (the valve cap 26 and body 25 encloses valve core 27 within the core portion 24 of the body 25; Fig. 4A-B, paragraph 0070),
first and second inlet passages in fluid communication with the valve well (ports 22 and 23; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070),
an outlet passage in fluid communication with the valve well (port 21; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070), and
one or more guide grooves, each guide groove receiving a different one of the one or more guide pins (the undulating surface 232 of the valve body 225 includes flattened peaks 232a and etched valleys 232b that engage with respective etched valleys 234b and flattened peaks 234a on the undulating outer surface 234; Fig. 7C, paragraph 0098); and
a spring applying force to press the side wall of the knob barrel against an inner surface of the valve well (the valve 20 further comprises a biasing element 49, in the form of a spring, positioned between the cap 26 and the valve core 27 … When the valve is assembled, the biasing element 49 exerts a biasing force on the valve core 27 to facilitate engagement of the outer surface 34 of the valve core 27 and the inner surface 32 of the valve body 25; Fig. 4A-B, paragraph 0078);
wherein the knob rotates relative to the valve body between:
a first position in which the inlet opening in the knob barrel forms a seal with the first inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (the tapered profile of the valve core 27 and the valve body 25 can facilitate sealing between the openings 41, 42, 43 and the ports 21, 22, 23 when the valve is in the first and second configurations; 4A-B, paragraph 0079), placing the first inlet passage in fluid communication with the outlet passage through the internal channel of the knob (in a first stable configuration, the ported chamber 40 can provide fluid communication between a first port 21 and a second port 22 via a second opening 43 and a first opening 41; Fig. 3A-B, paragraph 0071), and
a second position in which the inlet opening in the knob barrel forms a seal with the second inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (the tapered profile of the valve core 27 and the valve body 25 can facilitate sealing between the openings 41, 42, 43 and the ports 21, 22, 23 when the valve is in the first and second configurations; 4A-B, paragraph 0079), placing the second inlet passage in fluid communication with the outlet passage through the internal channel of the knob (in a second stable configuration, the ported chamber 40 can provide fluid communication between the first port 21 and a third port 23 via the first opening 41 and a third opening 42; Fig. 3C-D, paragraph 0071); and
wherein each of the one or more guide pins moves from a first seat in a guide groove corresponding to the first position of the knob to a second seat of the guide groove corresponding to the second position of the knob when the knob rotates (as a result, the two undulating surfaces 32, 34 comprise four positions in which they fully engage or mate. Two of these positions define the first and second stable configurations; Fig. 4B-5, paragraph 0076).
The guide pins and guide grooves cited above are disclosed by Dharmadasa in a second embodiment of the valve assembly. It would have been obvious to one of ordinary skill in the art to have modified the valve core and valve body by exchanging the undulating pattern of the first embodiment with the undulating pattern of a second embodiment.
Regarding claim 6, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses wherein the guide grooves are each shaped with a raised portion (the undulating surface 232 of the valve body 225 includes flattened peaks 232a; Fig. 7C, paragraph 0098) between the first seat corresponding to the first position of the knob and the second seat corresponding to the second position of the knob (as a result, the two undulating surfaces 32, 34 comprise four positions in which they fully engage or mate. Two of these positions define the first and second stable configurations; Fig. 4B-5, paragraph 0076 and 0097) such that, when rotating the knob between the first position and the second position, the knob barrel is lifted relative to the valve well to break contact between the knob barrel and the valve well (as the valve core 27 rotates, the undulating surfaces 32, 34 move out of full engagement causing the valve core 27 to axially displace along the valve axis 28 towards the cap 26 and against the biasing force of the biasing element 49…. As the valve core 27 lifts (axially displaces) towards the cap 26, the valve core 27 separates from an inner sidewall surface of the cylindrical portion 24 due to the tapered profiles; Fig. 4A-B, paragraph 0084 and 0101).
Regarding claim 7, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses wherein the one or more guide pins is a plurality of guide pins extending radially from the knob and spaced with radial symmetry about the knob (both undulating surfaces 32, 34 have a 90 degree rotational symmetry about the valve axis 28; Fig. 4-5 and 7, paragraph 0076); and
wherein the one or more guide grooves is a plurality of guide grooves shaped and spaced with radial symmetry about the valve body (both undulating surfaces 32, 34 have a 90 degree rotational symmetry about the valve axis 28; Fig. 4-5 and 7, paragraph 0076).
Regarding claim 8, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses wherein the side wall of the knob barrel and the inner wall of the valve body are cylinders tapered from top to bottom (the valve core 27/ported chamber is tapered such that the second end of the valve core 27 is narrower than the first end of the valve core 27. In this example, the cylindrical portion 24 of the valve body 25 is also tapered; Fig. 2B, paragraph 0079).
Regarding claim 9, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses wherein the knob has a handle sized and shaped to be grasped and rotated by one hand (operating lever 30; Fig. 2A, paragraph 0084). The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987).
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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Dharmadasa.
Regarding claim 2, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses an end cap attached to the valve body (valve cap 26 may be sealed to the valve body 12 via welding or other suitable processes known in the art; Fig. 5, paragraph 0070), wherein the spring is attached to the valve body and the end cap to push the end cap away from the valve body, pressing the knob into the valve body (the biasing element 49 pushes the valve core towards the valve body 25; Fig. 4A-B, paragraph 0078).
While Dharmadasa does not disclose said end cap attached to the valve body opposite the knob, it would have been obvious to one having ordinary skill in the art at the time the invention was made to place an end cap and spring on the side of the valve body opposite the knob, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 3, Dharmadasa, as modified above, discloses a two-way valve assembly according to claims 1 and 2. Dharmadasa further discloses wherein the knob further comprises a pole (first and second portions of the shaft 44, 46; Fig. 2C, paragraph 0077) extending through the valve body (the second portion of the central shaft 46 engages with a corresponding recess or aperture 48 in the surface of the valve body 25; Fig. 4B, paragraph 0077) and into the end cap, the pole having a key fitting at its distal end shaped to engage with a keyhole in the end cap (the first portion of the central shaft 44 extends axially through an aperture 29 in the cap 26; Fig. 4A, paragraph 0073).
Regarding claim 5, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa does not explicitly disclose wherein the outlet opening of the knob barrel subtends an angle of the side wall equal to or greater than the angle of rotation between the first position and the second position.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to optimize the size of the outlet opening of the knob barrel and the angle of rotation between the first position and the second position of modified Dharmadasa, and thus the claimed outlet opening size cannot be considered critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation", where Dharmadasa teaches the general conditions of the claim in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929). See MPEP 2144.05 II.A.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dharmadasa in view of U.S. Patent Appl. Publ. No. 2021/0007586 A1 to Gavalis et al. (“Gavalis”).
Regarding claim 4, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa, in a third embodiment, further discloses raised portions at the inlet and outlet openings to form a seal when the knob barrel is pressed against the valve well (the valve core 127 further comprises a sealing portion 127a for improving the sealing between the ports 121, 122, 123 and the ported chamber 140 when the valve core 127 is in the first and second stable configuration; Fig. 6A-B, paragraph 0090). However, Dharmadasa does not explicitly disclose a tube within the internal channel of the knob barrel.
Gavalis teaches a tube within the internal channel of the knob barrel (the endoscopic valve 300 may include an inner member 340 movably (e.g. slidably, etc) disposable within a valve stem 320; Fig. 3A, paragraph 0036), the tube having raised portions at the inlet and outlet openings to form a seal (an eighth seal 358 may be disposed around an outer surface of the inner member 340 (e.g. a full circumference of the valve stem) distal to the first opening 346 …. a ninth seal 360 may be disposed around an outer surface of the inner member 340 (e.g., a full circumference of the valve stem) distal to the second opening 348; Fig. 3A, paragraph 0038). Gavalis teaches that the inner member enables the valve to switch to a third configuration for pre-cleaning. (paragraph 0036).
Gavalis is considered to be analogous to the claimed invention because it is in the same field of valves used in endoscopic systems. 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 knob barrel of Dharmadasa to incorporate the teachings of Gavalis by adding a tube within the internal channel of the knob barrel. Doing so would enable the valve to switch to a third configuration for pre-cleaning, as recognized by Gavalis.
Claims 10-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dharmadasa in view of U.S. Patent Appl. Publ. No. 2018/0344142 A1 to Abouzgheib (“Abouzgheib”).
Regarding claim 10, Dharmadasa discloses a two-way valve assembly according to claim 1. Dharmadasa further discloses a medical system, comprising:
a two-way valve assembly (a first example valve 20 suitable for the above purposes is described; Fig. 2A-5, paragraph 0069) comprising:
a knob comprising a knob barrel (valve core 27; Fig. 4A-B, paragraph 0069) having a side wall and an internal channel running between inlet and outlet openings in the side wall (the valve core 27 defines a ported chamber 40 having openings 41, 42, 43 respectively at 0, 180 and 90 degree positions relative one another about the valve axis 28; Fig. 4A-B, paragraph 0071) and one or more guide pins (the undulating outer surface 234 of the valve core 227 includes flatten peaks 234a; Fig. 7B, paragraph 0098);
a valve body comprising a valve well encircling the knob barrel (the valve cap 26 and body 25 encloses valve core 27 within the core portion 24 of the body 25; Fig. 4A-B, paragraph 0070), first and second inlet passages in fluid communication with the valve well (ports 22 and 23; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070), an outlet passage in fluid communication with the valve well (port 21; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070) and the valve well, and one or more guide grooves, each guide groove receiving a different one of the one or more guide pins (the undulating surface 232 of the valve body 225 includes flattened peaks 232a and etched valleys 232b that engage with respective etched valleys 234b and flattened peaks 234a on the undulating outer surface 234; Fig. 7C, paragraph 0098); and
a spring applying force to press the side wall of the knob barrel against an inner surface of the valve well (the valve 20 further comprises a biasing element 49, in the form of a spring, positioned between the cap 26 and the valve core 27 … When the valve is assembled, the biasing element 49 exerts a biasing force on the valve core 27 to facilitate engagement of the outer surface 34 of the valve core 27 and the inner surface 32 of the valve body 25; Fig. 4A-B, paragraph 0078);
wherein the knob rotates relative to the valve body between:
a first position in which the inlet opening in the knob barrel forms a seal with the first inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (the tapered profile of the valve core 27 and the valve body 25 can facilitate sealing between the openings 41, 42, 43 and the ports 21, 22, 23 when the valve is in the first and second configurations; 4A-B, paragraph 0079), placing the first inlet passage in fluid communication with the outlet passage through the internal channel of the knob (in a first stable configuration, the ported chamber 40 can provide fluid communication between a first port 21 and a second port 22 via a second opening 43 and a first opening 41; Fig. 3A-B, paragraph 0071), and
a second position in which the inlet opening in the knob barrel forms a seal with the second inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (the tapered profile of the valve core 27 and the valve body 25 can facilitate sealing between the openings 41, 42, 43 and the ports 21, 22, 23 when the valve is in the first and second configurations; 4A-B, paragraph 0079), placing the second inlet passage in fluid communication with the outlet passage through the internal channel of the knob (in a second stable configuration, the ported chamber 40 can provide fluid communication between the first port 21 and a third port 23 via the first opening 41 and a third opening 42; Fig. 3C-D, paragraph 0071).
The guide pins and guide grooves cited above are disclosed by Dharmadasa in a second embodiment of the valve assembly. It would have been obvious to one of ordinary skill in the art to have modified the valve core and valve body by exchanging the undulating pattern of the first embodiment with the undulating pattern of a second embodiment.
However, Dharmadasa does not explicitly disclose a medical system for bronchoscopy, comprising:
an endoscope having a fluid channel therein;
a source of suction;
a gas source; and
a valve body comprising a first inlet passage in fluid communication with the source of suction and the valve well, a second inlet passage in fluid communication with the gas source and the valve well, and an outlet passage in fluid communication with the endoscope fluid channel.
Abouzgheib teaches a medical system for bronchoscopy (a system for performing a bronchoscopy 1000; Fig. 1, paragraph 0043), comprising:
an endoscope (bronchoscope 100; Fig. 1, paragraph 0044) having a fluid channel therein (working channel 140; Fig. 2, paragraph 0044);
a source of suction (vacuum source 201; Fig. 1, paragraph 0048);
a gas source (oxygen source 202; Fig. 1, paragraph 0052); and
a valve (valve apparatus 310; Fig. 1, paragraph 0067) configured to switch between:
a first position placing the source of suction in fluid communication with the endoscope fluid channel (the actuator apparatus 340 is configured to alter the valve apparatus 310 between: (1) a suction supply state in which the vacuum source 201 is in fluid communication with the third conduit section 230 and the oxygen source 202 is cut off from fluid communication with the third conduit section 230; Fig. 1, paragraph 0067), and
a second position placing the gas source in fluid communication with the endoscope fluid channel (the actuator apparatus 340 is configured to alter the valve apparatus 310 between: … (2) an oxygen supply state in which the oxygen source 202 is in fluid communication with the third conduit section 230 and the vacuum source 201 is cut off from fluid communication with the third conduit section 230; Fig. 1, paragraph 0067). The valve assembly enables the operator to selectively couple the working channel of the bronchoscope to an oxygen source so that an operator can force oxygen back into the patient’s lungs easily and without requiring the operator to remove the bronchoscope from the patient’s airways (paragraph 0042).
Abouzgheib is considered to be analogous to the claimed invention because it is in the same field of endoscope systems used for bronchoscopy. 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 medical system of Dharmadasa to incorporate the teachings of Abouzgheib by connecting the two-way valve to an endoscope, a source of suction, and a gas source. Doing so would enable the operator to selectively couple the working channel of the bronchoscope to an oxygen source so that an operator can force oxygen back into the patient’s lungs easily and without requiring the operator to remove the bronchoscope from the patient’s airways, as recognized by Abouzgheib.
Regarding claim 11, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Dharmadasa further discloses wherein each of the one or more guide pins moves from a first seat in a guide groove corresponding to the first position of the knob to a second seat of the guide groove corresponding to the second position of the knob when the knob rotates (as a result, the two undulating surfaces 32, 34 comprise four positions in which they fully engage or mate. Two of these positions define the first and second stable configurations; Fig. 4B-5, paragraph 0076).
Regarding claim 12, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Abouzgheib further teaches wherein the endoscope is a bronchoscope suitable for diagnostic and/or surgical deployment in the human respiratory system (bronchoscope 100; Fig. 1, paragraph 0041-0044).
Regarding claim 13, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Abouzgheib further teaches the gas source is a source of gas suitable for insufflation during bronchoscopy (using the system 1000, described herein, vacuum/suction may be applied to the patient’s airways or, alternatively, gases suction as oxygen and/or liquids such as saline can be insufflated into the patient’s airways via the fluid port 111 and the working channel140; Fig. 1, paragraph 0044).
Regarding claim 14, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Abouzgheib further teaches wherein the gas is room air, contained air, or oxygen (using the system 1000, described herein, vacuum/suction may be applied to the patient’s airways or, alternatively, gases suction as oxygen and/or liquids such as saline can be insufflated into the patient’s airways via the fluid port 111 and the working channel140; Fig. 1, paragraph 0044).
Regarding claim 15, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Dharmadasa further discloses an end cap attached to the valve body (valve cap 26 may be sealed to the valve body 12 via welding or other suitable processes known in the art; Fig. 5, paragraph 0070), wherein the spring is attached to the valve body and the end cap to push the end cap away from the valve body, pressing the knob into the valve body (the biasing element 49 pushes the valve core towards the valve body 25; Fig. 4A-B, paragraph 0078).
While Dharmadasa does not disclose said end cap attached to the valve body opposite the knob, it would have been obvious to one having ordinary skill in the art at the time the invention was made to place an end cap and spring on the side of the valve body opposite the knob, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 16, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Dharmadasa, as modified, further discloses wherein the knob further comprises a pole (first and second portions of the shaft 44, 46; Fig. 2C, paragraph 0077) extending through the valve body (the second portion of the central shaft 46 engages with a corresponding recess or aperture 48 in the surface of the valve body 25; Fig. 4B, paragraph 0077) and into the end cap, the pole having a key fitting at its distal end shaped to engage with a keyhole in the end cap (the first portion of the central shaft 44 extends axially through an aperture 29 in the cap 26; Fig. 4A, paragraph 0073).
Regarding claim 18, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claim 10. Dharmadasa does not explicitly disclose wherein the outlet opening of the knob barrel subtends an angle of the side wall equal to or greater than the angle of rotation between the first position and the second position.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to optimize the size of the outlet opening of the knob barrel and the angle of rotation between the first position and the second position of modified Dharmadasa, and thus the claimed outlet opening size cannot be considered critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation", where Dharmadasa teaches the general conditions of the claim in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929). See MPEP 2144.05 II.A.
Regarding claim 19, Dharmadasa, as previously modified by Abouzgheib, discloses the medical system according to claims 10-11. Dharmadasa further discloses wherein the guide grooves are each shaped with a raised portion (the undulating surface 232 of the valve body 225 includes flattened peaks 232a; Fig. 7C, paragraph 0098) between the first seat corresponding to the first position of the knob and the second seat corresponding to the second position of the knob (as a result, the two undulating surfaces 32, 34 comprise four positions in which they fully engage or mate. Two of these positions define the first and second stable configurations; Fig. 4B-5, paragraph 0076 and 0097) such that, when rotating the knob between the first position and the second position, the knob barrel is lifted relative to the valve well to break contact between the knob barrel and the valve well (as the valve core 27 rotates, the undulating surfaces 32, 34 move out of full engagement causing the valve core 27 to axially displace along the valve axis 28 towards the cap 26 and against the biasing force of the biasing element 49…. As the valve core 27 lifts (axially displaces) towards the cap 26, the valve core 27 separates from an inner sidewall surface of the cylindrical portion 24 due to the tapered profiles; Fig. 4A-B, paragraph 0084 and 0101).
Regarding claim 20, Dharmadasa discloses a method for operating a medical system, comprising:
deploying a two-way valve assembly, wherein the two-way valve assembly (a first example valve 20 suitable for the above purposes is described; Fig. 2A-5, paragraph 0069) comprises:
a knob comprising a knob barrel (valve core 27; Fig. 4A-B, paragraph 0069) having a side wall and an internal channel running between inlet and outlet openings in the side wall (the valve core 27 defines a ported chamber 40 having openings 41, 42, 43 respectively at 0, 180 and 90 degree positions relative one another about the valve axis 28; Fig. 4A-B, paragraph 0071) and one or more guide pins (the undulating outer surface 234 of the valve core 227 includes flatten peaks 234a; Fig. 7B, paragraph 0098);
a valve body comprising a valve well encircling the knob barrel (the valve cap 26 and body 25 encloses valve core 27 within the core portion 24 of the body 25; Fig. 4A-B, paragraph 0070), first and second inlet passages in fluid communication with the valve well (ports 22 and 23; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070), and an outlet passage in fluid communication with the valve well (port 21; the valve body 25 defines three ports 21, 22, 23 extending radially outward from a cylindrical core portion 24 of the valve body 25; Fig. 3A-E, paragraph 0070), and one or more guide grooves, each guide groove receiving a different one of the one or more guide pins (the undulating surface 232 of the valve body 225 includes flattened peaks 232a and etched valleys 232b that engage with respective etched valleys 234b and flattened peaks 234a on the undulating outer surface 234; Fig. 7C, paragraph 0098); and
a spring applying force to press the side wall of the knob barrel against an inner surface of the valve well (the valve 20 further comprises a biasing element 49, in the form of a spring, positioned between the cap 26 and the valve core 27 … When the valve is assembled, the biasing element 49 exerts a biasing force on the valve core 27 to facilitate engagement of the outer surface 34 of the valve core 27 and the inner surface 32 of the valve body 25; Fig. 4A-B, paragraph 0078);
while the knob of the two-way valve assembly is in a first position in which the inlet opening in the knob barrel forms a seal with the first inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (in a first stable configuration, the ported chamber 40 can provide fluid communication between a first port 21 and a second port 22 via a second opening 43 and a first opening 41; Fig. 3A-B, paragraph 0071);
and rotating the knob of the two-way valve assembly from the first position to a second position in which the inlet opening in the knob barrel forms a seal with the second inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body (in a second stable configuration, the ported chamber 40 can provide fluid communication between the first port 21 and a third port 23 via the first opening 41 and a third opening 42; Fig. 3C-D, paragraph 0071).
The guide pins and guide grooves cited above are disclosed by Dharmadasa in a second embodiment of the valve assembly. It would have been obvious to one of ordinary skill in the art to have modified the valve core and valve body by exchanging the undulating pattern of the first embodiment with the undulating pattern of a second embodiment.
However, Dharmadasa does not explicitly disclose a method for operating a medical system, comprising:
deploying an endoscope into the respiratory system of a patient, the endoscope having a fluid channel therein connected to a two-way valve assembly,
clearing fluid from the respiratory system of the patient via suction through the endoscope fluid channel; and
insufflating the patient with air or oxygen deployed through the endoscope fluid channel.
Abouzgheib teaches deploying an endoscope into the respiratory system of a patient (during a bronchoscopy an insertion tube of a bronchoscope is inserted into a patient’s airways via the patient’s mouth; Fig. 1, paragraph 0041), the endoscope having a fluid channel (the bronchoscope 100 generally comprises … a working channel 140; Fig. 2, paragraph 0044) therein connected to a two-way valve assembly (valve apparatus 310; Fig. 1, paragraph 0067), wherein the two-way valve assembly comprises:
while the knob of the two-way valve assembly is in a first position in which the inlet opening in the knob barrel forms a seal with the first inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body, clearing fluid from the respiratory system of the patient via suction through the endoscope fluid channel (the actuator apparatus 340 is configured to alter the valve apparatus 310 between: (1) a suction supply state in which the vacuum source 201 is in fluid communication with the third conduit section 230 and the oxygen source 202 is cut off from fluid communication with the third conduit section 230; Fig. 1, paragraph 0067);
rotating the knob of the two-way valve assembly from the first position to a second position in which the inlet opening in the knob barrel forms a seal with the second inlet passage in the valve body and the outlet opening in the knob barrel forms a seal with the outlet passage in the valve body, and insufflating the patient with air or oxygen deployed through the endoscope fluid channel (the actuator apparatus 340 is configured to alter the valve apparatus 310 between: … (2) an oxygen supply state in which the oxygen source 202 is in fluid communication with the third conduit section 230 and the vacuum source 201 is cut off from fluid communication with the third conduit section 230; Fig. 1, paragraph 0067).
The valve assembly enables the operator to selectively couple the working channel of the bronchoscope to an oxygen source so that an operator can force oxygen back into the patient’s lungs easily and without requiring the operator to remove the bronchoscope from the patient’s airways (paragraph 0042).
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 method of Dharmadasa to incorporate the teachings of Abouzgheib by connecting the two-way valve to an endoscope, a source of suction, and a gas source and performing a bronchoscopy. Doing so would enable the operator to selectively couple the working channel of the bronchoscope to an oxygen source so that an operator can force oxygen back into the patient’s lungs easily and without requiring the operator to remove the bronchoscope from the patient’s airways, as recognized by Abouzgheib.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dharmadasa in view of Abouzgheib as applied to claim 10 above, and further in view of Gavalis.
Regarding claim 17, Dharmadasa, as previously modified by Abouzgheib, discloses a medical system according to claim 10. Dharmadasa, in a third embodiment, further discloses raised portions at the inlet and outlet openings to form a seal when the knob barrel is pressed against the valve well (the valve core 127 further comprises a sealing portion 127a for improving the sealing between the ports 121, 122, 123 and the ported chamber 140 when the valve core 127 is in the first and second stable configuration; Fig. 6A-B, paragraph 0090). However, Dharmadasa does not explicitly disclose a tube within the internal channel of the knob barrel.
Gavalis teaches a tube within the internal channel of the knob barrel (the endoscopic valve 300 may include an inner member 340 movably (e.g. slidably, etc) disposable within a valve stem 320; Fig. 3A, paragraph 0036), the tube having raised portions at the inlet and outlet openings to form a seal (an eighth seal 358 may be disposed around an outer surface of the inner member 340 (e.g. a full circumference of the valve stem) distal to the first opening 346 …. a ninth seal 360 may be disposed around an outer surface of the inner member 340 (e.g., a full circumference of the valve stem) distal to the second opening 348; Fig. 3A, paragraph 0038). Gavalis teaches that the inner member enables the valve to switch to a third configuration for pre-cleaning. (paragraph 0036).
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 knob barrel of Dharmadasa, as modified by Abouzgheib, to incorporate the teachings of Gavalis by adding a tube within the internal channel of the knob barrel. Doing so would enable the valve to switch to a third configuration for pre-cleaning, as recognized by Gavalis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2022/0133131 A1 to Busch teaches a suction valve in an endoscope system 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