DETAILED ACTION
Applicant has elected Invention I with traverse in the reply filed 02/26/2026.
Claims 1-19 are pending.
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/Restrictions
Applicant's election with traverse of Invention I in the reply filed on 02/26/2026 is acknowledged. The traversal is on the ground(s) that a thorough search for the subject matter of any one group of claims would encompass a search for the subject matter of the remaining claims. This is not found fully persuasive.
Invention II (claims 10-17) requires a first and second pump and a first and second flowmeter. Invention I (claims 1-9) and Invention IV (claim 19) do not require the structure to be present. Similarly, Invention III (claim 18) requires a pump, pressure gauge, liquid feed passage, flowmeter, and a processor for estimating a value of pressure at the distal end of the liquid feed passage. The method of calculating the pressure only relies on a pressure drop corresponding to a liquid feed flow rate in the liquid feed passage, rather than performing a regression analysis based on pressure and flow rate measurements during a first and second operation, as required in Inventions I and IV. Thus, the restriction between Inventions I and II, I and III, II and IV, and III and IV is proper.
However, Examiner has reconsidered the restriction between Inventions I and IV. Inventions I and IV are directed to related methods, wherein a first and second operation of feeding liquid into a target is performed and pressure is estimated based on a regression formula. Examiner agrees with Applicant that a search of the subject matter of Invention I would encompass a search for the subject matter of Invention IV.
The restriction requirement is still deemed proper between Inventions I, IV and Inventions II, III and is therefore made FINAL.
Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Inventions II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/26/2026.
Claims 1-9 and 19 are the current claims hereby under examination.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 should refer to a “first liquid feed flow rate” in line 4 and a “second liquid feed flow rate” as two flow rates are acquired – one in the first operation and another in the second operation.
Claim 2, line 6, it should read “based on” or “using” the regression formula.
Claim 2, line 8, it should read “based on the regression curve and the estimation value”.
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.
Claim 7 is 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.
Regarding claim 7, it is unclear what the “not-smaller value of the estimation value” is. Is the display displaying the estimation value or another value? For examination purposes, the claim will be interpreted such that the estimation value is displayed alongside the pressure in the suction passage acquired from the pressure gauge.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 19:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1 and 19 are directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 19 recite an abstract idea. In particular, the claims generally recite
the following:
subtracting the suction flow rate from the liquid feed flow rate to acquire a flow rate difference (claim 1);
acquiring, based on a regression formula of the liquid feed flow rate and the pressure in the suction passage at the time of the first operation, an estimation value of an internal pressure of the perfusion target at the time of the second operation from the flow rate difference (claim 1); and
acquiring, based on a regression formula of a liquid feed flow rate of the liquid feed passage and pressure in the suction passage at a time of the first operation, an estimation value of an internal pressure of the living body at a time of the second operation from a flow rate difference obtained by subtracting a suction flow rate of the suction passage from a liquid feed flow rate of the liquid feed passage at the time of the second operation (claim 19).
These elements recited in claims 1 and 19 are drawn to an abstract idea since they are directed towards mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I) and mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“subtracting the suction flow rate from the liquid feed flow rate to acquire a flow rate difference” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably subtract two flow rates to obtain a flow rate difference. There is nothing to suggest an undue level of complexity in “subtracting the suction flow rate from the liquid feed flow rate to acquire a flow rate difference”.
“acquiring, based on a regression formula of the liquid feed flow rate and the pressure in the suction passage at the time of the first operation, an estimation value of an internal pressure of the perfusion target at the time of the second operation from the flow rate difference” is drawn to a mathematical concept. A regression formula for fitting a best fit line or curve to a data set is a routine mathematical formula used to extrapolate a data and determine similarities in data.
“acquiring, based on a regression formula of a liquid feed flow rate of the liquid feed passage and pressure in the suction passage at a time of the first operation, an estimation value of an internal pressure of the living body at a time of the second operation from a flow rate difference obtained by subtracting a suction flow rate of the suction passage from a liquid feed flow rate of the liquid feed passage at the time of the second operation” is drawn to a mathematical concept. A regression formula for fitting a best fit line or curve to a data set is a routine mathematical formula used to extrapolate a data and determine similarities in data.
Prong Two: Claims 1 and 19 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Recite the words "apply it" or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a.” (claim ), "b" (claim ), etc.) and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "at a time of a first operation for feeding liquid to a perfusion target with a liquid feed passage and not suctioning the liquid from the perfusion target with a suction passage, acquiring a liquid feed flow rate in the liquid feed passage and pressure in the suction passage" (claim 1), "at a time of a second operation for feeding the liquid to the perfusion target with the liquid feed passage and suctioning the liquid from the perfusion target with the suction passage, acquiring a liquid feed flow rate in the liquid feed passage and a suction flow rate in the suction passage" (claim 1), “disposing a distal end of a liquid feed passage and a distal end of a suction passage in a living body” (claim 19), "performing a first operation for feeding liquid to the living body with the liquid feed passage and not suctioning the liquid from the living body with the suction passage” (claim 19), and “performing a second operation for feeding the liquid to the living body with the liquid feed passage and suctioning the liquid from the living body with the suction passage” (claim 19))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 19 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a liquid feed passage” and “a suction passage as disclosed in the Applicant’s specification in paragraph 0036, “The perfusion system 1 further includes a liquid feed passage 15 including a liquid feed port 15a at a distal end and a suction passage 16 including a suction port 16a at a distal end”, paragraph 0039, “the liquid feed passage 15 includes the liquid feed tube 53 and the liquid feed channel 34. The channel opening 34a functions as the liquid feed port 1Sa at a distal end of the liquid feed passage 15”, and paragraph 0044, “the suction passage 16 includes the suction channel 35, the first suction tube 54, and the second suction tube 57. The channel opening 35a functions as the suction port 16a at a distal end of the suction passage 16”.
These elements do not qualify as significantly more because this limitation is simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-9 depend from the independent claims. Dependent claims 2-9 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“calculating, based on acquired two or more sets of the liquid feed flow rates and the pressures in the suction passage, as the regression formula, a regression curve for giving pressure in the suction passage for any liquid feed flow rate; and acquiring, based on the regression curve, as the estimation value, pressure in the suction passage corresponding to the liquid feed flow rate having a same value as the flow rate difference” (claim 2), “at the time of the first operation, when pressure in the suction passage acquired at a first liquid feed flow rate XI is represented as P1, pressure in the suction passage acquired at a second liquid feed flow rate X2 is represented as P2, x represents any liquid feed flow rate, and y represents pressure in the suction passage corresponding to x, representing the regression curve as a regression line based on following relational expressions: … substituting the flow rate difference in x to acquire the estimation value” (claim 3), and “when the liquid feed flow rate and the suction flow rate do not change and the pressure in the suction passage changes by a predetermined pressure difference or more, performing the first operation and recalculating the regression formula” (claim 4)),
Further describe the pre-solution activity (“at the time of the first operation, acquiring two or more pressures respectively in the suction passage at two or more liquid feed flow rates having different values” (claim 2), “at the time of the second operation, detecting and acquiring pressure in the suction passage with a pressure gauge provided on the suction passage” (claim 4), “wherein the liquid feed flow rate is acquired by a first flowmeter provided on the liquid feed passage or is estimated and acquired based on an operation amount of a first pump that feeds the liquid to the liquid feed passage, and the suction flow rate is acquired by a second flowmeter provided on the suction passage or is estimated and acquired based on an operation amount of a second pump that suctions the liquid from the suction passage” (claim 6), “detecting and acquiring pressure in the suction passage with a pressure gauge provided on the suction passage” (claim 7), and “directly measuring a pressure value in the perfusion target with a pressure gauge disposed in the perfusion target” (claim 9)), and
Further describe the post-solution activity (“when the estimation value is larger than the target value, adjusting at least one of the liquid feed flow rate or the suction flow rate such that the flow rate difference decreases; and when the estimation value is smaller than the target value, adjusting at least one of the liquid feed flow rate or the suction flow rate such that the flow rate difference increases” (claim 5), “at the time of the first operation, displaying, on a display apparatus, a not- smaller value of the estimation value and the pressure in the suction passage acquired from the pressure gauge” (claim 7), “when the estimation value is larger than a predetermined threshold, performing warning indicating that the internal pressure of the perfusion target is abnormal” (claim 8), and “when a difference between the estimation value and the directly measured pressure value is larger than a predetermined threshold, performing warning indicating that there is an abnormality in the pressure gauge or the acquisition of the estimation value” (claim 9)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform different.
Therefore, claims 1-9 and 19 are rejected as being directed to non-statutory subject matter.
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 1-5, 7-8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20200187761) and Storz (US 5556378).
Regarding claims 1-4, Shelton discloses a perfusion target internal pressure estimation method comprising:
at a time of a first operation for feeding liquid to a perfusion target with a liquid feed passage and not suctioning the liquid from the perfusion target with a suction passage, acquiring a liquid feed flow rate in the liquid feed passage and pressure in the suction passage (Fig. 6A, box 612 and paragraph 0088, “The irrigation flow can produce a positive pressure change at the anatomical environment, which can be sensed at 612 using a pressure sensor”; Paragraph 0057, “In an example, the pressure sensor may be attached to or integrated into a distal portion of the medical device 110, such as a distal tip of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with the anatomical environment 101. In an example, the pressure sensor may be positioned at a more proximal location inside the tubular portion of the endoscope away from the anatomical environment 101”; Fig. 4, pressure sensor 352; Shelton does not explicitly state perform “acquiring a flow rate”; however, the irrigation and suction flow rates are controlled by the control module (Fig 1, control module 160). As such, the flow rates would be known and read on the limitation of “acquired”);
at a time of a second operation for feeding the liquid to the perfusion target with the liquid feed passage and suctioning the liquid from the perfusion target with the suction passage, acquiring a liquid feed flow rate in the liquid feed passage and a suction flow rate in the suction passage (Fig. 6A, boxes 613-614 and paragraphs 0088-0089, wherein suction is applied to produce a negative pressure change; Shelton does not explicitly perform “acquiring a flow rate”; however, the irrigation and suction flow rates are controlled by the control module (Fig 1, control module 160). As such, the flow rates are known and read on the limitation of “acquired”);
subtracting the suction flow rate from the liquid feed flow rate to acquire a flow rate difference (Fig. 6A, boxes 613-614 and paragraphs 0088-0089, wherein the pressure difference is measured caused by the difference between the irrigation flow rate in and the suction flow rate out); and
acquiring an estimation value of an internal pressure of the perfusion target at the time of the second operation from the flow rate difference (Paragraph 0089, determining the pressure based off of the pressure caused by the difference in flow rates between irrigation and suction).
Shelton fails to disclose estimating the value of an internal pressure of the perfusion target based on a regression formula.
Regarding the limitations of claims 2-4, Shelton discloses acquiring two or more pressures at two or more liquid feed flow rates having different values (Paragraphs 0076-0077, wherein the adjustments to irrigation and suction continue until pressure reaches the desired pressure; Examiner interprets this to mean more than one pressure is being measured at different flow rates since the flow rate(s) would necessarily change until the desired pressure is reached). Shelton further discloses acquiring a pressure (Fig. 6A, box 612 and paragraph 0088, “The irrigation flow can produce a positive pressure change at the anatomical environment, which can be sensed at 612 using a pressure sensor”; Paragraph 0057, “In an example, the pressure sensor may be attached to or integrated into a distal portion of the medical device 110, such as a distal tip of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with the anatomical environment 101. In an example, the pressure sensor may be positioned at a more proximal location inside the tubular portion of the endoscope away from the anatomical environment 101”; Fig. 4, pressure sensor 352) in the suction passage corresponding to the liquid feed flow rate have a same value as the flow rate difference (Examiner points out that in the first operation, only the irrigation channel is flowing; thus, the flow rate difference is the same as the liquid feed flow rate). Shelton further discloses at the time of the second operation, detecting and acquiring pressure in the suction passage with a pressure gauge provided on the suction passage (Fig. 6A, boxes 613-614 and paragraphs 0088-0089, wherein suction is applied to produce a negative pressure change; Paragraph 0057, “In an example, the pressure sensor may be attached to or integrated into a distal portion of the medical device 110, such as a distal tip of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with the anatomical environment 101. In an example, the pressure sensor may be positioned at a more proximal location inside the tubular portion of the endoscope away from the anatomical environment 101”).
Shelton fails to disclose calculating a regression curve for acquiring the pressure in the suction passage and wherein the regression curve is calculated using y = ax + b. Shelton also fails to disclose when the liquid feed and suction flow rates don’t change in the second operation, but the pressure in the suction passage changes by a predetermined pressure difference, recalculating the regression formula.
Shelton and Storz are in the same field of pressure determination. Storz teaches a device for irrigation and suction drainage of body cavities during a surgery. A pressure within the patient is determined through an equation accounting for the irrigation and suction pressures and the flow rates/fluxes of irrigation and suction (Col 4, lines 2-25). The equation at line 22 takes on the form of y = ax + b, wherein P0 is equal to y or the pressure within the patient to be determined,
P
1
-
P
2
R
1
-
R
2
is equal to a (the slope of the graph seen in Fig. 3), R1 is equal to x, and P2 is equal to b. As P2 equates to the point where the line intersects the y-axis, the value is equivalent to ‘b’ as defined by the Applicant in claim 3. As R1 is known and can be changed, equating to ‘x’ in Applicant’s equation, the corresponding pressure can be determined. The pressure inside the patient can be determined based on any input of the flow rate (Col 4, lines 26-52, wherein the doctor can change the pressure in the patient by changing the flow or pressure values at the irrigation/suction lines). Further, Storz discusses that the curve may change when pressure change but the effective flow remains unchanged (Col 5, lines 10-50; Examiner interprets this curve change as recalculating the curve).
As Shelton discloses the pressure and flow rate relationship to achieve a desired pressure within the patient, Storz illustrates the relationship on a graph using a regression formula to determine the pressure in the patient. A regression formula is made part of the ordinary capabilities of one skilled in the art based upon the teaching of Storz. One of ordinary skill would be motivated in applying this known technique to the known method disclosed by Shelton, and the result of determining pressure in a patient would have been predictable to one of ordinary skill in the art. Therefore, 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 Shelton to incorporate the regression formula technique taught by Storz, and the result of determining pressure in a patient would have been predictable to one of ordinary skill in the art.
Regarding claim 5, Shelton as modified further discloses bringing the estimation value close to a target value by:
when the estimation value is larger than the target value, adjusting at least one of the liquid feed flow rate or the suction flow rate such that the flow rate difference decreases; and when the estimation value is smaller than the target value, adjusting at least one of the liquid feed flow rate or the suction flow rate such that the flow rate difference increases (Fig. 6A, box 614 and paragraph 0089, wherein when the sensed tissue pressure is checked against the desired pressure, the suction flow rate can be adjusted until the desired pressure is reached. If the sensed pressure is higher, the suction flow rate would be increased, and if the sensed pressure is lower, the suction flow rate would be decreased; Paragraph 0057, “The control module 160 can compare the sensed environmental pressure to the desired environmental pressure, and adjust one or more of an irrigation flow rate or a suction flow rate to drive the environmental pressure towards a level of the desired environmental pressure”).
Regarding claim 7, Shelton as modified further discloses detecting and acquiring pressure in the suction passage with a pressure gauge provided on the suction passage (Paragraph 0057, “Examples of the pressure sensor can include resistive, capacitive, piezoelectric, optical, or Micro Electro-Mechanical System (MEMS) pressure sensors. In an example, the pressure sensor may be attached to or integrated into a distal portion of the medical device 110, such as a distal tip of an insertable tubular portion of an endoscope, such that the pressure sensor is in contact with the anatomical environment 101. In an example, the pressure sensor may be positioned at a more proximal location inside the tubular portion of the endoscope away from the anatomical environment 101”; Paragraph 0090, “The application of suction pressure can produce a negative pressure change at the anatomical environment, which can be sensed by a pressure sensor at 622”; As Shelton discusses the sensor may be within the tubular portion of the endoscope and also measures the suction pressure, Examiner interprets this configuration to read on the pressure gauge being “provided” on the suction passage); and
at the time of the first operation, displaying, on a display apparatus (Fig. 1, user interface 140), a not-smaller value of the estimation value and the pressure in the suction passage acquired from the pressure gauge (Paragraph 0058, “The user interface 140 may include an output unit, such as a display, to present information collected during the endoscopic procedures including, for example, images (including live video) of the surgical field, operating status of the medical device 110 including status of the working channel 111, information about channel state such as a clogged channel or successful unclogging, and environmental pressure as sensed by the sensor circuit 150, among others”).
Regarding claim 8, Shelton as modified further discloses when the estimation value is larger than a predetermined threshold, performing warning indicating that the internal pressure of the perfusion target is abnormal (Paragraph 0078, “In an example, a warning can be issued (e.g., from the user interface 140) if the desired positive pressure received from a user exceeds the upper bound of positive pressure, or if desired negative pressure is lower than the safety bound of negative pressure. With such a safety mechanism, the control module 160 can maintain the environmental pressure at a user-specified level, while at the same time preventing or minimizing excess positive or negative pressures imposed on the anatomical environment during the procedure”).
Regarding claim 19, Shelton discloses a living body internal pressure estimation method comprising:
disposing a distal end of a liquid feed passage and a distal end of a suction passage in a living body (Fig. 4, distal ends of suction channel 112 and irrigation channel 114 at anatomical environment 101 in anatomical site);
performing a first operation for feeding liquid to the living body with the liquid feed passage and not suctioning the liquid from the living body with a suction passage, acquiring a liquid feed flow rate in the liquid feed passage and pressure in the suction passage (Fig. 6A, boxes 611-612 and paragraph 0088, “The irrigation flow can produce a positive pressure change at the anatomical environment, which can be sensed at 612 using a pressure sensor”, wherein irrigation flow starts without activation of suction);
performing a second operation for feeding the liquid to the living body with the liquid feed passage and suctioning the liquid from the living body with the suction passage (Fig. 6A, boxes 613-614 and paragraphs 0088-0089, wherein suction is applied while irrigation is being applied to produce a negative pressure change); and
acquiring an estimation value of an internal pressure of the living body at the time of the second operation from a flow rate difference obtained by subtracting a suction flow rate of the suction passage from a liquid feed flow rate of the liquid feed passage at the time of the second operation (Fig. 6A, boxes 613-614 and paragraphs 0088-0089, wherein the pressure difference is measured caused by the difference between the irrigation flow rate in and the suction flow rate out; Paragraph 0089, determining the pressure based off of the pressure caused by the difference in flow rates between irrigation and suction).
Shelton fails to disclose estimating the value of an internal pressure of the perfusion target based on a regression formula.
Shelton and Storz are in the same field of pressure determination. Storz teaches a device for irrigation and suction drainage of body cavities during a surgery. A pressure within the patient is determined through an equation accounting for the irrigation and suction pressures and the flow rates/fluxes of irrigation and suction (Col 4, lines 2-25). The pressure inside the patient can be determined based on any input of the flow rate (Col 4, lines 26-52, wherein the doctor can change the pressure in the patient by changing the flow or pressure values at the irrigation/suction lines). As Shelton discloses the pressure and flow rate relationship to achieve a desired pressure within the patient, Storz illustrates the relationship on a graph using a regression formula to determine the pressure in the patient. A regression formula is made part of the ordinary capabilities of one skilled in the art based upon the teaching of Storz. One of ordinary skill would be motivated in applying this known technique to the known method disclosed by Shelton, and the result of determining pressure in a patient would have been predictable to one of ordinary skill in the art. Therefore, 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 Shelton to incorporate the regression formula technique taught by Storz, and the result of determining pressure in a patient would have been predictable to one of ordinary skill in the art.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20200187761) and Storz (US 5556378) as applied to claim 1 above, and further in view of Shelton (US 20200187768), hereinafter “Shelton 768”.
Regarding claims 6 and 9, while Shelton as modified discloses setting flow rates, Shelton fails to disclose acquiring the feed flow rate and the suction flow rate by two flowmeters.
Regarding the limitation of claim 9, Shelton as modified discloses directly measuring a pressure value in the perfusion target with a pressure gauge disposed in the perfusion target (Fig. 4, wherein the pressure sensor 352 may monitor the pressure at the anatomical environment 101). While Shelton discloses giving a warning when the measured pressure exceeds the desired pressure by an upper/lower bound (paragraph 0078), Shelton fails to explicitly disclose giving a warning when there is a difference in pressure between the estimated value and the measured value.
Shelton and Shelton 768 are in the same field of measuring anatomical pressure. Shelton 768 teaches an analogous device of irrigating an anatomical site, wherein the irrigation and suction channels monitor flow parameters (i.e., flow rate) measured by a flow sensor disposed in the channels (Paragraphs 0076 and 0078). Shelton 768 discusses that clogging during the procedure in one of the channels may alter the pressure balance between the anatomical site and the channels (Paragraphs 0050-0051). When the balance is too high, the device undergoes an unclogging routine to restore the pressure balance between the channels and the anatomical site to continue the procedure (Fig. 4B).
As Shelton is concerned with irrigating an anatomical site, Shelton 768 improves upon the design by adding flow sensors to aid in detection of clogged channels and detecting when there is a pressure imbalance between the channels and the anatomical site. The system can adjust the flow rates to maintain pressure despite a clog (Paragraph 0055) when the pressure imbalance is too high. Therefore, 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 apparatus of Shelton to incorporate the flow sensors as taught by Shelton 768 in order to maintain pressure at the anatomical site despite any clogging of one of the channels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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