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 .
Election
Applicant's election of Invention I (claims 1-21) in the reply filed on 03/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Non-elected claims 22-30 are withdrawn.
Claim Objections
In Claim 1, it’s highly recommended that the structures of the endoscope be separately recited in either the preamble or a “providing” step to reduce confusion and avoid cluttering the method steps. Two non-limiting examples are provided below:
Example 1: recite a “providing” step, see Provisional Application 63/538,116:
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Example 2: recite the structures of the endoscope in the preamble:
1. A method for pre-cleaning an endoscope, the endoscope comprising a first channel section, a second channel section, and a third channel section connected to each other at a channel connection, the first channel section comprising a first channel opening arranged at an end of the first channel section and at a distal end of the endoscope, the second channel section comprising a second channel opening arranged at an end of the second channel section and formed as a connection port, the third channel section comprising a third channel opening arranged at an end of the third channel section and formed as a connection port . . .
the method comprising:
connecting a liquid source, a suction pump, and a sealing element . . .
In claim 1 line 5-6, “each of the…channel openings are connected to…” should be changed to “each of the…channel openings is connected…”
In claim 9, “the holding element” should be changed to “the intermediate liquid holding element” for consistency with claims 8, 10, 11.
In claim 15 line 3, “first, second and third channel opening” should be “first, second and third channel openings” (plural on “opening”).
In claim 19, “the liquid that is arranged in the liquid source” should be simplified to “the liquid in the liquid source” (delete “that is arranged”).
In claim 20 line 5, the comma after “suction channel” should be deleted.
The preamble of Claim 20 should be changed to “wherein the endoscope comprises one or more of.” As explained below, “first, second and third channels” is interpreted as “a first channel section, a second channel section, and a third channel section,” given the distinction between “channels” and “channel sections.”
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 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the term “pre-cleaning” at line 1. First, it’s unclear if “pre-cleaning” is any different from “cleaning”; if there is a difference, then it’s unclear what that difference is. Second, it’s unclear whether or not the term “pre-cleaning” requires any particular event to occur after cleaning, i.e., (1) pre-cleaning is cleaning before what event? (2) does the claim require that event to occur? Clarification is requested.
For examination purpose, the term “pre-cleaning” is interpreted to mean “cleaning before an unspecified event, which may or may not occur.” It’s also recommended that “pre-cleaning” be changed to “cleaning” for more clarity and simplicity.
Claim 1 recites “first, second and third channels of an endoscope connected to each other at a channel connection” at line 4-5, but subsequently recites “the first channel section” (line 7), “the second channel section” (line 8), and “the third channel section” (line 10). It’s unclear if Applicant intends to recite “first, second and third channel sections” instead of “channels.” The specification distinguishes between “channels” and “channel sections”:
First channel section 11y, second channel section 11x, and third channel section 11b are connected to each other at channel connection 11j, and the three channel sections form suction channel 11 (see Fig. 1, specification at pg. 13), wherein suction channel 11 is separate from air channel 12, water channel 13, and auxiliary water channel 14 (see Fig. 1, specification at 12 line 26-30).
In other words, the specification discloses “channel sections”—not “channels”—connected to each other at the channel connection, and the three channel openings belong to those “channel sections.”
For examination purpose, “first, second and third channels” are interpreted as “a first channel section, a second channel section, and a third channel section,” and it’s recommended that the claim language be amended accordingly.
Claim 1 recites “the first channel section” at line 7. There is insufficient antecedent basis for this limitation in the claim. As explained above, the claim language should be amended to “a first channel section, a second channel section, and a third channel section.”
Claim 1 recites “the second channel section” at line 8. There is insufficient antecedent basis for this limitation in the claim. As explained above, the claim language should be amended to “a first channel section, a second channel section, and a third channel section.”
Claim 1 recites “the third channel section” at line 10. There is insufficient antecedent basis for this limitation in the claim. As explained above, the claim language should be amended to “a first channel section, a second channel section, and a third channel section.”
Claim 1 recites “the environment” at line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the liquid” at line 12. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of “a liquid” in claim 1.
Claim 3 recites: “the sealing element is connected to one or more of the first, second and third channel opening such that the one or more of the first, second and third channel opening is sealed air-tight from the environment that surrounds the one or more of the first, second and third channel opening.” The use of “or more” conflicts with Claim 1, which recites:
connecting a liquid source, a suction pump, and a sealing element each to a different one of a first channel opening, a second channel opening, and a third channel opening (claim 1 at lines 2-4)
the connecting being such that each of the first, second, and third channel openings are connected to either the liquid source, the suction pump, or the sealing element (claim 1 at lines 5-6)
In other words, claim 1 recites that the sealing element is connected to one and only one of the three channel openings, and there is a one-to-one matching between “a liquid source, a suction pump, and a sealing element” and “a first channel opening, a second channel opening, and a third channel opening.” Claim 3 allows the sealing element to be connected to multiple channel openings, in conflict with claim 1.
Claim 3 recites “the environment” at line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “the environment” at line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites “the branched channel section” at line 2-3. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of “a branched channel section” in claims 1, 8, or 11.
Claim 15 requires:
“venting one of the first, second and third channel section to which the suction pump is connected” (as recited in claim 14);
“the other of the first, second and third channel sections are vented” at line 1-2.
Because there are three channel sections and the pump is connected to one of them, it’s unclear whether “the other” refers to one or two of remaining channel sections not connected to the pump. Clarification is requested.
Claim 15 requires:
“venting one of the first, second and third channel section to which the suction pump is connected” (as recited in claim 14);
“the other of the first, second and third channel sections are vented by disconnecting the suction pump from a respective one of the first, second and third channel opening.”
The use of “respective” is vague and confusing: the channel opening, from which the suction pump is disconnected, is respective (i.e., belonging or relating) to what? Claim 15 recites both “one of” three channel sections and “the other of” three channel sections. Clarification is requested; simple and plain language should be adopted.
Claim 21 recites “the suction channel” at line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “the suction channel connection port” at line 2. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected because they depend on a claim rejected herein.
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.
Claims 1-10, 12-13, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over RAMSEY (US PGPUB 20250241526, hereinafter “RAMSEY-526”), in view of RAMSEY (WIPO Publication WO2025003684A1, hereinafter “RAMSEY-684”).
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Regarding Claim 1, RAMSEY-526 teaches a method for pre-cleaning an endoscope (see ¶¶ 0035, 0051, 0091, 0098-99, 0101-03, 0108, applying suction to an inner channel of the endoscope to draw a cleaning liquid through the channel).
RAMSEY-526 teaches the endoscope comprising:
a channel 26 having three channel sections (see annotated Fig. 1 above);
a first channel section (see annotated Fig. 1, a section of channel 26 that’s before the channel connection) comprising a first channel opening (opening of channel 26 at the endoscope’s distal tip 28, see id.) arranged at an end of the first channel section and at a distal end of the endoscope (see id.; see ¶ 0051);
a second channel section (see annotated Fig. 1, a section of channel 26 that’s after the channel connection) comprising a second channel opening (pump connection 22) arranged at an end of the second channel section and formed as a connection port (see annotated Fig. 1; see ¶ 0051);
a third channel section (see annotated Fig. 1, biopsy branch) comprising a third channel opening (biopsy port 32) arranged at an end of the third channel section and formed as a connection port (see annotated Fig. 1; see ¶ 0051);
wherein the three channel sections are connected to each other at a channel connection (see annotated Fig. 1);
wherein the first channel opening is connected to a liquid source (bag 116, see Fig. 3, ¶¶ 0064, 0077-80), the second channel opening is connected to a suction pump (see ¶¶ 0050-51), and the third channel opening is connected to a sealing element (a cover or seal, see ¶¶ 0098, 0109).
RAMSEY-526 teaches wherein the liquid source (bag 116) is configured to provide an enclosure from the environment that surrounds the liquid source (see Figs. 3, 7A-7D; see ¶¶ 0112-13, bag 116 is tightly secured around the endoscope’s distal tip 28; see ¶ 0090, the bag’s neck portion 168 has an elastically deformable ring that must be pressed or stretched in order for the endoscope to enter the bag and the force of the ring grips the endoscope), and wherein the liquid source (bag 116) has a holding chamber with a holding chamber volume for holding the liquid (see Figs. 3, 7A-7D, ¶¶ 0009, 0077, 0081).
RAMSEY-526 teaches or reasonably suggests that the holding chamber volume of the holding chamber is changeable. First, a person of ordinary skill in the art would recognize that bags in general are flexible/changeable. Second, RAMSEY-526 discloses that bag 116 has creases (see Figs. 3, 7A-7D) at the bottom, which means the bag is flexible/changeable. Third, RAMSEY-526 discloses that the top part of the bag is openable by the user (see Figs. 7A-7D, ¶¶ 0080, 0088), which also means the bag is flexible/changeable.
RAMSEY-526 teaches activating the suction pump for drawing liquid from the liquid source towards the suction pump (see ¶¶ 0035, 0051, 0091, 0098-99, 0101-03, 0108). And because the holding chamber volume of the holding chamber is changeable (as explained above), the holding chamber volume of the liquid source reduces (or is reasonably expected to reduce) during said drawing of liquid from the liquid source by the suction pump.
Although RAMSEY-526 does not explicitly teach that the liquid source (bag 116) is configured to provide a “gas-tight sealing” from the environment that surrounds the liquid source, such “gas-tight sealing” is still reasonably suggested for several reasons. First, the bag’s neck portion 168 has a deformable ring that must be pressed or stretched in order for the endoscope to enter the bag, and the force of the ring “grips” the endoscope (¶ 0090), i.e., the ring grips the endoscope with tension or force. Second, other openings of the endoscope are sealed in a gas-tight manner (see ¶¶ 0098, 0108-11, using air-tight seals).
As an alternative ground, if “gas-tight sealing” is not clearly envisaged by the teachings of RAMSEY-526, it still would’ve been obvious before the effective filing date of the claimed invention to modify RAMSEY-526’s liquid source (bag 116) to provide gas-tight sealing, because it’s already known in the prior art that the liquid source—which is connected to the distal tip of the endoscope—may provide gas-tight sealing.
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RAMSEY-684 teaches a liquid source (a flexible pouch 612, see Fig. 17, pg. 25 lines 13 & 20) for connecting with distal tip 922 of endoscope 902 (see Figs. 1 & 17), wherein the liquid source is configured to provide a gas-tight sealing from the environment that surrounds the liquid source (see pg. 26 lines 1-5, pg. 27 lines 29-31, pg. 28 lines 1-9). This gas-tight configuration provides the benefit of keeping the cleaning liquid in contact with the endoscope’s distal tip (see pg. 28 lines 7-9, pg. 27 lines 32-35); this benefit would’ve motivated one of ordinary skill in the art to configure the liquid source (bag 116) in RAMSEY-526 to provide gas-tight sealing.
Regarding Claim 2, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. As explained above, the combination teaches that the liquid source (RAMSEY-526’s bag 116) is changeable/flexible and has gas-tight sealing from the outside environment. This means that the holding chamber volume of the liquid source (bag 116) is reduced by a volume of liquid that is drawn out of the liquid source, because no gas/air is coming into the liquid source from the outside environment.
Regarding Claim 3, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the sealing element is connected to the third channel opening (a cover/seal over RAMSEY-526’s biopsy port 32) such that the third channel opening is sealed air-tight from the environment that surrounds the third channel opening (see RAMSEY-526 at ¶¶ 0098, 0108-11, air-tight seals on biopsy port 32).
Regarding Claim 4, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 3. The combination teaches the sealing clement is connected to the third channel opening (as explained above).
Regarding Claim 5, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the first channel section extends from the first channel opening to the channel connection (see annotated Fig. 1 of RAMSEY-526), the second channel section extends from the second channel opening to the channel connection (see id.), and the third channel section extends from the third channel opening to the channel connection (see id.).
Regarding Claim 6, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the first channel section and the second channel section form a channel (channel 26 of RAMSEY-526) that extends from the first channel opening to the second channel opening (see RAMSEY-526 at annotated Fig. 1, ¶ 0051), and wherein the third channel section forms a branched channel section (see RAMSEY-526 at annotated Fig. 1), which is fluidly connected to the channel at the channel connection (see id.).
Regarding Claim 7, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the liquid source (bag 116 of RAMSEY-526) is connected to the first channel opening and arranged at the distal end of the endoscope (as explained above) such that the liquid source is fluidly connected to the distal end of the endoscope (as explained above) and the liquid source and the distal end of the endoscope are sealed air-tight from the environment that surrounds the distal end of the endoscope and the liquid source (as explained above).
Regarding Claim 8, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the suction pump is connected to the second channel opening (pump connection 22 of RAMSEY-526) via an intermediate liquid holding element with a holding volume (see RAMSEY-526 at ¶ 0050, suction pump is connected to connection 22 by a tube).
Regarding Claim 9, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 8. The combination teaches wherein the holding element is a hose (see RAMSEY-526 at ¶ 0050).
Regarding Claim 10, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 8. The combination teaches wherein the holding volume is formed by a channel of the intermediate liquid holding element (see RAMSEY-526 at ¶ 0050, suction pump is connected to connection 22 by a tube, which has an interior volume).
Regarding Claim 12, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 4. The combination teaches that the third channel section (biopsy branch of RAMSEY-526) is in fluid communication with the suction pump (see RAMSEY-526 at Fig. 1, ¶ 0051, biopsy branch is part of channel 26 that extends to suction pump connection 22), wherein the third channel opening is also sealed (see RAMSEY-526 at ¶¶ 0098, 0108-11). This means that by activating RAMSEY-526’s suction pump—which is connected to suction pump connection 22—air is removed from the third channel section (biopsy branch of RAMSEY-526) in such a way that an underpressure (i.e., negative pressure) builds up in the third channel section.
Regarding Claim 13, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 12. The combination teaches wherein the third channel section is formed as a biopsy branch (as explained above).
Regarding Claim 19, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the liquid that is arranged in the liquid source is a detergent solution (see RAMSEY-526 at ¶ 0064).
Regarding Claim 20, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches a plurality of channels, such as:
an air channel 34 that extends from an air channel connection port 14 or 18 to the distal end of the endoscope (see RAMSEY-526 at Fig. 1, ¶¶ 0052-53);
a suction channel 26 that extends from a suction channel connection port 22 to the distal end 28 of the endoscope (see id. at Fig. 1, ¶ 0051);
a water channel 38 that extends from a water channel connection port 20 to the distal end 28 of the endoscope (see id.at Fig. 1, ¶ 0054);
an auxiliary water channel (unlabeled) that extends from an auxiliary water channel connection port 24 to the distal end of the endoscope (see id. at Fig. 1, ¶ 0050).
Regarding Claim 21, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the suction channel (RAMSEY-526’s channel 26) is formed by the first and second channel sections (see annotated Fig. 1 above), and the suction channel connection port (pump connection 22) is formed by the second channel opening (see RAMSEY-526 at Fig. 1, ¶ 0051).
Claims 1-2, 5-11, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over SASA et al. (German Publication DE3414963A1, as translated by Espacenet), in view of RAMSEY-684 (WIPO Publication WO2025003684A1).
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Regarding Claim 1, SASA teaches a method for cleaning an endoscope (see Figs. 1-10, ¶¶ 0020, 0032-33, 0039, 0062, activate a suction pump to draw cleaning liquid through the endoscope’s interior channels). SASA teaches several embodiments (see Figs. 1-10). Although the embodiment of Fig. 9 has been selected for illustration purposes, the other embodiments are substantially similar to Fig. 9, and SASA’s cleaning method (i.e., drawing cleaning liquid through the channels) is applied to those embodiments in the same/similar manner.
SASA teaches the endoscope (e.g., Fig. 9) comprising:
a channel 15 having three channel sections (see annotated Fig. 9 above);
a first channel section (section 15B) comprising a first channel opening (opening 17) arranged at an end of the first channel section and at a distal end of the endoscope (see annotated Fig. 9; see also ¶¶ 0028, 0060);
a second channel section (see annotated Fig. 9) comprising a second channel opening (opening 13) arranged at an end of the second channel section and formed as a connection port (see annotated Fig. 9; see also ¶¶ 0030-33, 0062);
a third channel section (section 18) comprising a third channel opening (see annotated Fig. 9) arranged at an end of the third channel section and formed as a connection port (see annotated Fig. 9; see also ¶ 0028);
wherein the three channel sections are connected to each other at a channel connection (see annotated Fig. 9);
wherein the first channel opening is connected to a liquid source (cap 80, tube 82, and tank 32, see annotated Fig. 9, ¶ 0062), the second channel opening is connected to a suction pump (suction pump 28, see ¶ 0062), and the third channel opening is connected to a sealing element (removable cover 18A, see ¶ 0028).
SASA teaches that the liquid source (cap 80, tube 82, and tank 32) is configured to provide a gas-tight sealing (see ¶ 0059), the liquid source has a holding chamber (tank 32, see Fig. 9, ¶ 0060) with a holding chamber volume for holding the liquid (liquid L).
SASA teaches activating the suction pump (pump 28) for drawing liquid from the liquid source towards the suction pump (see ¶¶ 0020, 0032-33, 0039, 0062).
SASA does not explicitly teach:
the liquid source is configured to provide a gas-tight sealing “from the environment that surrounds the liquid source”;
“the holding chamber volume of the holding chamber is changeable” and during drawing of liquid from the liquid source, “the holding chamber volume of the liquid source reduces.”
RAMSEY-684 teaches a method of cleaning an endoscope (see, e.g., pg. 7 line 7-10, pg. 9 line 11-12, pg. 22 lines 9-12, pg. 23 lines 16-20, pg. 27 lines 5-13), wherein the endoscope (endoscope 902) has a first channel opening (opening of channel 926 in distal tip 922, see Fig. 1) connected to a liquid source (flexible pouch 612, see Fig. 17, pg. 25 lines 13 & 20).
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RAMSEY-684’s liquid source (pouch 612) is configured to provide a gas-tight sealing from the environment that surrounds the liquid source (see pg. 26 lines 1-5, pg. 27 lines 29-31, pg. 28 lines 1-9), and the liquid source (pouch 612) has a holding chamber with a holding chamber volume for holding the liquid (see Fig. 17). The holding chamber volume of the holding chamber is changeable (see pg. 28 lines 1-9), and the holding chamber volume of the liquid source reduces during drawing of liquid from the liquid source (see id.). The configurations of the liquid source—i.e., flexible pouch with gas-tight sealing—provide the benefit of keeping the cleaning liquid in contact with the endoscope’s distal tip (see pg. 28 lines 7-9, pg. 27 lines 32-35).
Before the effective filing date of the claimed invention, it would’ve been obvious to a person having ordinary skill in the art to replace SASA’s liquid source (cap 80, tube 82, & tank 32) with RAMSEY-684’s liquid source (flexible pouch 612), with reasonable expectation of supplying the cleaning liquid, for several reasons. First, RAMSEY-684’s liquid source (flexible pouch 612) provides the benefit of keeping the cleaning liquid in contact with the endoscope’s distal tip, which would’ve motivated a person of ordinary skill in the art to use RAMSEY-684’s liquid source to holding the cleaning liquid. Second, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421 (2007); MPEP § 2143, B. Here, both SASA’s liquid source (cap 80, tube 82, & tank 32) and RAMSEY-684’s liquid source (flexible pouch 612) serve the same function of holding the cleaning liquid to be supplied into the channels of an endoscope. Thus, their substitution would yield the predictable result of holding and supplying the cleaning liquid.
Regarding Claim 2, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. As explained above, the combination teaches that the liquid source (flexible pouch 612) is changeable/flexible and has gas-tight sealing from the outside environment. This means that the holding chamber volume of the liquid source (pouch 612) is reduced by a volume of liquid that is drawn out of the liquid source, because no gas/air is coming into the liquid source from the outside environment.
Regarding Claim 5, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the first channel section extends from the first channel opening to the channel connection (see annotated Fig. 9 of SASA), the second channel section extends from the second channel opening to the channel connection (see id.), and the third channel section extends from the third channel opening to the channel connection (see id.).
Regarding Claim 6, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the first channel section and the second channel section form a channel (channel 15 of SASA) that extends from the first channel opening to the second channel opening (see SASA at Fig. 9, ¶ 0028), and wherein the third channel section forms a branched channel section (see SASA at annotated Fig. 9), which is fluidly connected to the channel at the channel connection (see id.).
Regarding Claim 7, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the liquid source—i.e., RAMSEY-684’s flexible pouch 612 that replaced SASA’s cap 80, tube 82, and tank 32—is connected to the first channel opening and arranged at the distal end of the endoscope (as explained above) such that the liquid source is fluidly connected to the distal end of the endoscope (as explained above) and the liquid source and the distal end of the endoscope are sealed air-tight from the environment that surrounds the distal end of the endoscope and the liquid source (as explained above).
Regarding Claim 8, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the suction pump (SASA’s pump 28) is connected to the second channel opening (SASA’s opening 13) via an intermediate liquid holding element (SASA’s cylinder 83 and suction pipe 27) with a holding volume (see SASA at Fig. 9, ¶ 0062).
Regarding Claim 9, the combination of SASA and RAMSEY-684 teaches the method according to Claim 8. The combination teaches wherein the holding element is a hose (SASA’s suction pipe 27, as explained above).
Regarding Claim 10, the combination of SASA and RAMSEY-684 teaches the method according to Claim 8. The combination teaches the holding volume is formed by a channel of the intermediate liquid holding element (see SASA at Fig. 9, ¶ 0062, SASA’s cylinder 83 and suction pipe 27 have interior channels that form the holding volume).
Regarding Claim 11, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the holding volume of the intermediate liquid holding element (SASA’s cylinder 83 and suction pipe 27) is larger than a holding volume of the branched channel section (SASA’s biopsy branch 18, see SASA at Fig. 9).
Regarding Claim 19, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the liquid that is arranged in the liquid source is water or a disinfectant solution (see SASA at ¶ 0022).
Regarding Claim 20, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches a plurality of channels, such as:
an air channel 5 that extends from an air channel connection port 10 or 11 to the distal end 2A of the endoscope (see SASA at Fig. 9, ¶¶ 0015, 0062-63);
a suction channel 15 that extends from a suction channel connection port 13 to the distal end 2A of the endoscope (see id. at Fig. 9, ¶¶ 0028, 0062);
a water channel 6 that extends from a water channel connection port 12 to the distal end 2A of the endoscope (see id. at Fig. 9, ¶¶ 0015, 0062-63);
an auxiliary channel 70 that extends from an auxiliary channel connection port 14 to the distal end 2A of the endoscope (see id. at Fig. 9, ¶¶ 0057, 0062-63).
Regarding Claim 21, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches wherein the suction channel (SASA’s channel 15) is formed by the first and second channel sections (see annotated Fig. 9 above), and the suction channel connection port (SASA’s port 13) is formed by the second channel opening (see annotated Fig. 9 above).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of SASA and RAMSEY-684 (as applied to Claim 1), in further view of Applicant’s Admitted Prior Art (AAPA).
Regarding Claim 14, the combination of SASA and RAMSEY-684 teaches the method according to Claim 1. The combination teaches the suction pump (pump 28 of SASA) is connected to the second channel section (see SASA at annotated Fig. 9, ¶ 0062) via the second channel opening (opening 13 of SASA).
Although the combination does not explicitly teach “venting” the second channel section, which is achieved by disconnecting the suction pump from the second channel opening, such disconnection is still reasonably expected because one of ordinary skill in the art would readily understand that the various connection ports of SASA’s endoscope—e.g., air supply connection 10, air supply connection 11, liquid supply connection 12—must be freed up in order to use the endoscope for its intended medical functions. In other words, certain structures useful for the cleaning process—see cylinder 83 in Fig. 9; see pipe 37, pipe 38, cap 31 in Fig. 4; see cap 31 and pipe 27 in Fig. 1; see cap 32 in Fig. 3; see tubes 58 and 59 in Fig. 7—may interfere or obstruct the endoscope’s intended medical functions if those structures are not disconnected after the cleaning process is finished.
Therefore, a person of ordinary skill in the art would reasonably expect the suction pump (SASA’s pump 28, and specifically cylinder 83, see Fig. 9) to be disconnected from the second channel opening (SASA’s opening 13) when cleaning is finished, so that the endoscope may be used for its intended medical functions, wherein said disconnection of the suction pump causes “venting” of the second channel section.
As an alternative ground, if SASA’s disclosures do not clearly envisage disconnecting the suction pump after cleaning is finished, it still would’ve been obvious to do so before the effective filing date of the claimed invention. That’s because Applicant’s Admitted Prior Art (AAPA) discloses that it’s already known in the prior art to disconnect the suction pump when the cleaning is finished (see specification of this application at pg. 2 lines 5-7). All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See KSR, 550 U.S. at 415-421; MPEP § 2143, A.
A statement by an applicant in the specification or made during prosecution identifying the work of another as "prior art" is an admission which can be relied upon for both anticipation and obviousness determinations, regardless of whether the admitted prior art would otherwise qualify as prior art under AIA 35 U.S.C. 102. See MPEP §§ 2152.03, 2129.
In sum, disconnecting the suction pump is either reasonably suggested by SASA or is considered obvious; and when the suction pump (SASA’s pump 28, and specifically cylinder 83) is disconnected from the second channel opening (SASA’s opening 13), the second channel section would be “vented.”
Regarding Claim 15, the combination of SASA, RAMSEY-684, and AAPA teaches the method according to Claim 14. As explained above, the combination teaches that the second channel section is “vented” when the suction pump is disconnected from the second channel opening. Moreover, the combination already teaches that the first channel section, the second channel section, and the third channel section are all connected (i.e., in fluid communication with each other) (see annotated Fig. 9 of SASA); this means that disconnecting the suction pump would vent not only the second channel section, but also vent the first channel section and the third channel section.
Regarding Claim 16, the combination of SASA, RAMSEY-684, and AAPA teaches the method according to Claim 15.
As explained above, the combination teaches activating the suction pump (SASA’s pump 28)—which is connected to the second channel section—to draw liquid from the liquid source towards the suction pump, while the various openings are sealed (see SASA at Fig. 9, caps 80, 25, 22, 76, and 83 are installed over openings). This means that air within the third channel section (biopsy branch 18 of SASA) would’ve been suctioned by the suction pump, i.e., the combination teaches “an underpressure (i.e., negative pressure) that was built up due to the underpressure applied in the third channel section by the suction pump” (see SASA at ¶¶ 0020, 0032-33, 0039-40, 0052, the suction pump generates negative pressure inside the endoscope to draw the cleaning liquid).
As explained above, the combination teaches disconnecting the suction pump after the cleaning is finished, wherein such disconnection causes “venting” in the channel sections. The combination teaches said underpressure (i.e., negative pressure) was built up during the cleaning process (when the suction pump was drawing cleaning liquid), i.e., “before venting.”
The combination does not explicitly teach: after the venting, filling the third channel section with liquid from the second channel section by using the underpressure built up in the third channel section, i.e., there’s cleaning liquid still remaining in the second channel section when cleaning is finished.
But RAMSEY-684 teaches that it’s beneficial to keep the internal channels of the endoscope filled with the cleaning liquid—which is supplied during the cleaning process—until the endoscope undergoes a subsequent sterilization procedure, thereby reducing the formation of biofilm in the channels (see RAMSEY-684 at pg. 3 lines 14-19).
Before the effective filing date of the claimed invention, it would’ve been obvious to a person having ordinary skill in the art to further modify the combination of SASA, RAMSEY-684, and AAPA to keep the internal channels of the endoscope filled with the cleaning liquid —which is drawn from the liquid source by the suction pump during the cleaning process—when the cleaning process is finished, with reasonable expectation of protecting the endoscope.
First, given the benefit of reducing the formation of biofilm in the endoscope’s internal channels, a person of ordinary skill in the art would’ve been motivated to keep those channels filled with the cleaning liquid—which is drawn from the liquid source by the suction pump during the cleaning process—until the endoscope undergoes a subsequent sterilization procedure.
Second, it’s already known in the prior art to draw a cleaning liquid from a liquid source into the internal channels of an endoscope using suction from a suction pump (see SASA), and to keep the internal channels of the endoscope filled with the cleaning liquid until the endoscope undergoes a subsequent sterilization procedure (see RAMSEY-684). All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See KSR, 550 U.S. at 415-421; MPEP § 2143, A.
In the resulting combination of SASA, RAMSEY-684, and AAPA:
During the cleaning process (i.e., before venting), the suction pump (SASA’s pump 28) draws cleaning liquid from the liquid source towards the suction pump, which is connected to the second channel opening (SASA’s opening 13) (as explained above). In other words, the suction pump applies negative pressure (“underpressure”) throughout the endoscope’s internal channels, including the second channel section and the third channel section (see SASA at ¶¶ 0020, 0032-33, 0039-40, 0052; see figure below).
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When cleaning is finished, the internal channels—including the second channel section—of the endoscope would be filled with cleaning liquid, and the suction pump (SASA’s pump 28) would be disconnected from the second channel opening (SASA’s opening 13), thereby causing “venting” of the second channel section (as explained above). “Venting” of the second channel section would cause pressure in the second channel section to normalize (i.e., increase) first, because that’s where the suction pump was previously connected (see figure below).
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Because the second channel section increases pressure first, i.e., before the third channel section does, a pressure difference/gradient is briefly created (see figure above), thereby causing the cleaning liquid in the second channel section to flow towards the third channel section (SASA’s biopsy branch 18).
In other words, the combination of SASA, RAMSEY-684, and AAPA teaches or at least reasonably suggests: after the venting, filling the third channel section with liquid from the second channel section by using the underpressure (i.e., negative pressure) built up in the third channel section.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of RAMSEY-526 and RAMSEY-684 (as applied to Claim 4), in further view of MINER (WIPO Publication WO2012044944A2).
Regarding Claim 17, the combination of RAMSEY-526 and RAMSEY-684 teaches the method according to Claim 4. The combination teaches wherein the connecting of the sealing element (a cover or seal, see RAMSEY-526 at ¶¶ 0098, 0109) to the third channel opening (biopsy port) comprises arranging a sealing element onto the third channel opening (see RAMSEY-526 at Fig. 1, ¶¶ 0098, 0109).
The combination does not explicitly teach that the sealing element is “transparent.” But it’s already known in the prior art to make a structure out of a transparent material (see MINER at ¶ 0032), which allows a human to monitor/observe the cleaning process (see id.).
Before the effective filing date of the claimed invention, it would’ve been obvious to a person having ordinary skill in the art to modify the combination of RAMSEY-526 and RAMSEY-684 to make the sealing element transparent, with reasonable expectation of closing the third channel opening. Given the benefit of allowing humans to monitor/observe the cleaning process within the endoscope, a person of ordinary skill in the art would’ve been motivated to make the sealing element transparent.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of RAMSEY-526, RAMSEY-684, and MINER (as applied to Claim 17), in further view of AKIBA (US Patent 7371211).
Regarding Claim 18, the combination of RAMSEY-526, RAMSEY-684, and MINER teaches the method according to Claim 17. The combination teaches the sealing element—for closing the third channel opening (e.g., a biopsy port)—is a closed element (a cover or seal, see RAMSEY-526 at ¶¶ 0098, 0109). As explained above, the combination already teaches the sealing element is transparent, i.e., it’s a closed transparent element.
The combination does not explicitly teach that the sealing element has the shape of a “tube.” But it’s already known in the prior art that a cover/seal/plug for the biopsy port may have the shape of a tube. See AKIBA at Fig. 3, col. 6 lines 28-52.
Before the effective filing date of the claimed invention, it would’ve been obvious to a person having ordinary skill in the art to modify the combination of RAMSEY-526, RAMSEY-684, and MINER to configure the sealing element in the shape of a tube, with reasonable expectation of closing the third channel opening. First, changes in shape are considered obvious (see MPEP § 2144.04.IV.B.) and the sealing element, changed to a tubular shape, still performs the same function of closing the third channel opening. Second, it’s already known in the prior art that a cover/seal/plug for the biopsy port may have the shape of a tube (see AKIBA). All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See KSR, 550 U.S. at 415-421; MPEP § 2143, A.
Conclusion
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/R.Z.Z./Examiner, Art Unit 1714
/KAJ K OLSEN/Supervisory Patent Examiner, Art Unit 1714
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