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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 85-93, and 96-104 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 85 recites the limitation "the cumulative volume of insufflating gas delivered …" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 85 recites the limitation "from the commencement of delivery of the insufflating gas …" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Each of Claims 86-102 and 104 use the term “preferably” (sometimes in multiple instances). The word “preferably” implies that the limitations that follow are not required. However, it is unclear if this is what applicant intends.
Each of claims 87-93, 96, 98-100, 102 and 104 use the term “advantageously” (sometimes in multiple instances). The word “advantageously” implies that the limitations that follow are not required. However, it is unclear if this is what applicant intends.
Claim 89 recites the limitation "the second pressure value" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 91 recites the limitation "the second pressure value" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 92 recites the limitation "the second pressure value" in the penultimate line. There is insufficient antecedent basis for this limitation in the claim.
Claim 98 recites the limitation "the second pressure value" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 100 recites the limitation "the second pressure value" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 101 recites the limitation "the second pressure value" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the deficiencies of the claims from which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
Claim(s) 85-90, and 93-99 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sterke et al. (US 2022/0054772 A1, hereafter “Sterke”).
As to claim 85, Sterke discloses an insufflator (1; see Fig. 1) adapted to be selectively operated in a normal insufflating mode (mode after overdistension pressure determined) and in a set-up mode (mode where forced oscillations are performed), the insufflator being configured in the set-up mode for determining the value of an optimum maximum pressure for insufflating a cavity in the body of a human or animal subject (optimum maximum pressure is the pressure that is selected based on feedback about the oscillation mechanics; see para 0017, 0055, 0088, 0097, 0103, 0105), the insufflator comprising:
a delivery means (1I) for delivering insufflating gas to the cavity (para 0081),
a pressure sensor for producing a signal indicative of the pressure in the cavity (para 0035, 0082, 0132),
a flow sensor for monitoring flow of insufflating gas being delivered to the cavity and for producing a signal indicative of the cumulative volume of insufflating gas delivered to the cavity from the commencement of delivery of the insufflating gas thereto or a signal indicative of the rate at which the insufflating gas is being delivered to the cavity (para 0035, 0131, 0155), and
a signal processor (1A) adapted to read the signal produced by the pressure sensor, and to read the signal produced by the flow sensor during insufflating of the cavity, and in the set-up mode (abstract, para 0048, 0081, 0082):
to determine a pressure/volume relationship between the pressure in the cavity and insufflating gas delivered to the cavity as the insufflating gas is being delivered to the cavity from values of the signals read from the pressure sensor and the flow sensor (abstract, para 0048, 0081, 0082, 0103), and
to determine the value of the optimum maximum pressure as the value of a transition pressure at which the pressure/volume relationship transitions from a first pressure/volume relationship to a second pressure/volume relationship, the second pressure/volume relationship being different to the first pressure/volume relationship (the point at which the pressure/volume relationship transitions corresponds to the point at which it is determined damage to surrounding tissue occurs; in other words the optimum maximum pressure is the pressure that is selected based on feedback about the oscillation mechanics; see para 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 86, Sterke discloses an insufflator as claimed in Claim 85 in which the pressure/volume relationship determined by the signal processor comprises the value of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity (see para 0035; Sterke measures pressure within the cavity and measures insufflator flow to the cavity, and both can be used to select/adjust optimal insufflation – see para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and preferably, the first pressure/volume relationship comprises either a substantially linear relationship or a non-linear relationship (these are the only two possibilities, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and preferably, the first pressure/volume relationship comprises a substantially linear relationship during which the pressure in the cavity increases linearly with respect to the delivery of insufflating gas to the cavity (“preferably” limitations not required, though this appears to merely describe one possible option for the first pressure/volume relationship, Sterke would operate in such a manner based off at least para 0017, 0055, 0088, 0097, at least during certain timeframes).
As to claim 87, Sterke discloses an insufflator as claimed in Claim 85 in which the second pressure/volume relationship comprises either a substantially linear relationship or a non-linear relationship (these are the only two possibilities, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and preferably, the second pressure/volume relationship comprises a substantially linear relationship during which the pressure in the cavity increases linearly with respect to the delivery of insufflating gas to the cavity (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and advantageously, the value of the increase of the pressure in the cavity per unit volume of insufflating gas delivered to the cavity in the second pressure/volume relationship, is greater than the value of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity in the first pressure/volume relationship (“preferably” limitations not required).
As to claim 88, Sterke discloses an insufflator as claimed in Claim 85 in which the first pressure/volume relationship transitions to the second pressure/volume relationship through an intermediate pressure/volume relationship (see annotated Fig. 4 below), and preferably, the intermediate pressure/volume relationship comprises a non-linear relationship (“preferably” limitations not required, however see annotated Fig. 4 below), and advantageously, the signal processor is programmed to determine the transition pressure value as a pressure value lying in a range between a first pressure value and a second pressure value, and the signal processor is programmed to determine the first pressure value as the pressure at which the first pressure/volume relationship transitions to the intermediate pressure/volume relationship, and the signal processor is programmed to determine the second pressure value as the pressure at which the intermediate pressure/volume relationship transitions to the second pressure/volume relationship, and preferably, the signal processor is programmed to determine the transition pressure value as the average value of the first and the second pressure values (“preferably” limitations not required).
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As to claim 89, Sterke discloses an insufflator as claimed in Claim 85 in which the signal processor is programmed to determine the transition pressure value as a point of inflection on a line representative of a graph of the pressure/volume relationship during insufflating of the cavity (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105) as the first pressure/volume relationship transitions to the second pressure/volume relationship, and preferably, in the graph of the pressure/volume relationship, volume is plotted on the abscissa, and pressure is plotted on the ordinate of the graph, and advantageously, the signal processor is programmed to determine the point of inflection by interpolating the point of intersection of a portion of the line representative of the first pressure/volume relationship and a portion of the line representative of the second pressure/volume relationship, and preferably, the signal processor is programmed to determine the point of inflection on the line of the graph representative of the pressure/volume relationship during insufflating of the cavity by extrapolating the portion of the line representing the first pressure/volume relationship beyond the first pressure value, and extrapolating the line representing the second pressure/volume relationship beyond the second pressure value, and to determine the value of the transition pressure at the point of intersection of the extrapolated parts of the lines representing the first and second pressure/volume relationship (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105)..
As to claim 90, Sterke discloses an insufflator as claimed in Claim 85 in which the signal processor is programmed to read the values of the signals produced by the pressure sensor and the flow sensor either continuously or at predefined time intervals (see para 0016, 0057, 0088), and preferably, the signal processor is programmed to time-stamp, cross-reference and store in memory each pair of the values of the signals read from the pressure sensor and the flow sensor, and advantageously, the signal processor is programmed to determine the value of the transition pressure from the stored, time- stamped and cross-referenced values of the pairs of values of the signals read from the pressure sensor and the flow sensor, and preferably, the signal processor is programmed to determine the value of the cumulative volume of insufflating gas delivered to the cavity and the corresponding value of the pressure in the cavity, each time the values of the signals are read from the flow sensor and the pressure sensor, and to time-stamp, cross-reference and store in memory each pair of the determined value of the cumulative volume of the insufflating gas delivered to the cavity and the corresponding value of the pressure in the cavity, and advantageously, the signal processor is programmed to determine the value of the transition pressure from the stored, cross- referenced and time-stamped pairs of values of the cumulative volume of insufflating gas delivered to the cavity and the corresponding pressure in the cavity, and preferably, the signal processor is programmed to compute the value of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity each time the values of the signals are read by the signal processor from the pressure sensor and the flow sensor, and advantageously, the signal processor is programmed to apply a smoothing algorithm to the computation of each value of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 93, Sterke discloses an insufflator as claimed in Claim 85 in which the signal processor is programmed to limit the supply of insufflating gas to the cavity in response to the pressure in the cavity reaching the optimum maximum pressure value when the insufflator is operating in the normal insufflating mode (see para 0017, 0048, 0055, 0081, 0088, 0097, 0103, 0105), and preferably, the signal processor is programmed to terminate the supply of insufflating gas to the cavity in response to the pressure in the cavity exceeding the optimum maximum pressure when the insufflator is operating in the normal insufflating mode, and advantageously, the signal processor is programmed to terminate the supply of insufflating gas to the cavity in response to the pressure in the cavity reaching the optimum maximum pressure value when the insufflator is operating in the normal insufflating mode, and preferably, the signal processor is programmed to reinstate the supply of insufflating gas to the cavity in response to the pressure in the cavity falling below the optimum maximum pressure value when the insufflator is operating in the normal insufflating mode (“preferably” limitations not required).
As to claim 94, Sterke discloses a method for determining an optimum maximum pressure value for insufflating a cavity in the body of a human or animal subject, the method comprising: delivering insufflating gas to the cavity (see Fig. 1, abstract, para 0012, 0082), determining a pressure/volume relationship between the pressure in the cavity and insufflating gas delivered to the cavity as the insufflating gas is being delivered to the cavity (see Fig. 4, para 0017, 0055, 0088, 0097, 0103, 0105), determining the optimum maximum pressure value as the value of a transition pressure at which the pressure/volume relationship transitions from a first pressure/volume relationship to a second pressure/volume relationship, the second pressure/volume relationship being different to the first pressure/volume relationship (the point at which the pressure/volume relationship transitions corresponds to the point at which it is determined damage to surrounding tissue occurs; in other words the optimum maximum pressure is the pressure that is selected based on feedback about the oscillation mechanics; see para 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 95, Sterke discloses a method as claimed in Claim 94 in which the determined pressure/volume relationship comprises the value of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity (see Fig. 4, para 0017, 0055, 0088, 0097, 0103, 0105; although not explicitly referred to, value of the increase in pressure in the cavity per unit volume of insufflating gas directly related to/resulting from the pressure/flow measurements taken), and preferably, the first pressure/volume relationship comprises either a substantially linear relationship or a non-linear relationship, and preferably, the first pressure/volume relationship comprises a substantially linear relationship during which the pressure in the cavity increases with respect to the delivery of insufflating gas to the cavity (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 96, Sterke discloses the method as claimed in Claim 94 in which the second pressure/volume relationship comprises either a substantially linear relationship or a non-linear relationship (these are the only two possibilities; however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and preferably, the second pressure/volume relationship comprises a substantially linear relationship during which the pressure in the cavity increases with respect to the delivery of insufflating gas to the cavity, and advantageously, the value of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity in the second pressure/volume relationship is greater than the value of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity in the first pressure/volume relationship, and preferably, the first pressure/volume relationship transitions to the second pressure/volume relationship through an intermediate pressure/volume relationship, and preferably, the intermediate pressure/volume relationship comprises a non-linear relationship (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 97, Sterke discloses a method as claimed in Claim 96 in which the transition pressure value is determined as a pressure value lying in a range between a first pressure value and a second pressure value, the first pressure value being determined as the pressure at which the first pressure/volume relationship transitions to the intermediate pressure/volume relationship, and the second pressure value being determined as the pressure at which the intermediate pressure/volume relationship transitions to the second pressure/volume relationship (see annotated Fig. 4 above), and preferably, the transition pressure value is determined as the average value of the first and second pressure values (“preferably” limitations not required).
As to claim 98, Sterke discloses a method as claimed in Claim 94 in which the transition pressure value is determined as a point of inflection on a line of a graph representative of the pressure/volume relationship during insufflating of the cavity as the first pressure/volume relationship transitions to the second pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105), and preferably, in the graph representative of the pressure/volume relationship, volume is plotted on the abscissa, and pressure is plotted on the ordinate, and advantageously, the point of inflection is determined by interpolating the point of intersection of a portion of the line representative of the first pressure/volume relationship and a portion of the line representative of the second pressure/volume relationship, and preferably, the portion of the line representative of the first pressure/volume relationship is extrapolated beyond the first pressure value, and the portion of the line representative of the second pressure/volume relationship is extrapolated beyond the second pressure value, and the point of inflection is determined as the point of intersection of the extrapolated portion of the line representative of the first pressure/volume relationship and the extrapolated portion of the line representative of the second pressure/volume relationship (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105).
As to claim 99, Sterke discloses the method as claimed in Claim 94 in which the value of the pressure in the cavity and the corresponding value of either the rate at which insufflating gas is being delivered to the cavity or the cumulative volume of insufflating gas delivered to the cavity are determined either continuously or at predefined time intervals (see para 0016, 0057, 0088), and preferably, each pair of the determined values of either the pressure in the cavity and the corresponding rate at which the insufflating gas is being delivered to the cavity, or the pressure in the cavity and the corresponding cumulative volume of insufflating gas delivered to the cavity are time-stamped, cross-referenced and stored, and advantageously, the value of the transition pressure is determined from the pairs of the values of the pressure in the cavity and the corresponding rate at which insufflating gas is being delivered to the cavity, and preferably, the value of the transition pressure is determined from the stored, cross-referenced and time-stamped pairs of values of the pressure in the cavity and the corresponding cumulative volume of insufflating gas delivered to the cavity, and advantageously, the value of the increase in the pressure of the cavity per unit volume of insufflating gas delivered to the cavity is computed from each pair of the determined values of the pressure in the cavity and the corresponding rate of delivery of insufflating gas to the cavity, or from each pair of the determined values of the pressure in the cavity and the corresponding cumulative volume of insufflating gas delivered to the cavity, and preferably, a smoothing algorithm is applied to each computation of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity (“preferably” limitations not required, however see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105).
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 of this title, 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.
Claim(s) 92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterke in view of Sekino et al. (US 5,328,458), hereafter “Sekino”.
As to claim 92, Sterke discloses an insufflator as claimed in Claim 85 as described above. Sterke does note in para 0107 that “A pressure release valve may be connected to the manifold 13 for medical safety” but does not expressly recite wherein the signal processor is programmed to terminate delivery of insufflating gas to the cavity in the set-up mode in response to the pressure in the cavity reaching a pressure beyond which the cavity can no longer be safely insufflated.
Sekino, directed to an insufflation apparatus, includes “an insufflation unit 203 which serves to control the pressure of gas insufflated” (para beginning line 3 col. 18), the insufflation unit 203 receiving signals from sensor(s) (see at least the paragraph beginning line 39 col. 18 and paragraph beginning line 5 col. 19), and teaches “The control of keeping the pressure in the body cavity at the value set is usually conducted in the insufflation unit 203… When the pressure in the body cavity becomes abnormally high as described above, therefore, the relief valve 300 is automatically opened so that any state dangerous to the patient can be instantly avoided” (see para beginning line 11 col. 22).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sterke (if not already configured to do so) such that the signal processor is programmed to terminate delivery of insufflating gas to the cavity in the set-up mode in response to the pressure in the cavity reaching a pressure beyond which the cavity can no longer be safely insufflated. One would have been motivated to do so in order to prevent unwanted injury to a patient (see above-cited portions of Sekino).
The remaining limitations of claim 92 not discussed are claimed as “preferable” and thus not considered to be required.
Claim(s) 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterkin.
As to claim 101, Sterkin discloses a method as claimed in claim 94 as described above. While Sterkin does not expressly recite delivery of insufflating gas to the cavity is terminated in response to the value of the transition pressure being determined, and preferably, delivery of insufflating gas to the cavity is terminated in response to the second pressure value being determined, and preferably, the insufflating gas is delivered to the cavity at a relatively slow rate, while the value of the optimum maximum pressure is being determined, Sterkin discloses determining the value of the transition pressure (para 0017, 0055, 0088, 0097, 0103, 0105), and that control of insufflation pressure can be controlled automatically (para 0017, 0030, 0097, 0103, 0155). Sterkin also teaches that forced osciallation for determining optimal pressure values can occur continuously or non-continuously (see para 0059, 0088).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have configured Sterkin such that delivery of insufflating gas to the cavity is terminated in response to the value of the transition pressure being determined. This could be fulfilled by either a) Sterkin terminating the delivery as part of an automated control method or b) Sterkin terminating delivery as part of a pre-planned oscillation that is used for determining optimum pressure. One would have been motivated to do so for a) optimizing delivery of pressure to the cavity or b) determining the optimum pressure to the cavity (see above-cited portions of Sterkin). The examiner notes that the limitations of “preferably, delivery of insufflating gas to the cavity is terminated in response to the second pressure value being determined, and preferably, the insufflating gas is delivered to the cavity at a relatively slow rate, while the value of the optimum maximum pressure is being determined” are claimed as preferable and therefore interpreted as optional/not required.
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterkin in view of Hochman (US 2008/0154188 A1).
As to claim 102, Sterkin discloses a method as claimed in claim 94 as described above, but does not expressly recite a signal indicative of the value of the optimum maximum pressure is produced, and preferably, the signal indicative of the value of the optimum maximum pressure comprises a human sensory perceptible signal, and advantageously, the signal indicative of the value of the optimum maximum pressure is adapted for applying to a visual display screen, for display thereon, and preferably, the signal indicative of the value of the optimum maximum pressure is adapted for storing in an electronic memory of an insufflator.
Hochman discloses “The perceptible signal may be audible, or visual, or both. For example, the audible signal may have a pitch and/or a volume that increases with pressure, to a set point or to a point when a different audible sound is generated that indicates the desired minimum, desired or optimum pressure has been reached…” (see para 0017).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sterkin to include a signal indicative of the value of the optimum maximum pressure is produced. One would have been motivated to do so in order to inform a user that the optimum maximum pressure value is reached (see para 0017 of Hochman). The remaining limitations of “preferably, the signal indicative of the value of the optimum maximum pressure comprises a human sensory perceptible signal, and advantageously, the signal indicative of the value of the optimum maximum pressure is adapted for applying to a visual display screen, for display thereon, and preferably, the signal indicative of the value of the optimum maximum pressure is adapted for storing in an electronic memory of an insufflator” are interpreted to be optional/not required.
Claim(s) 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterkin in view of Williams JR. et al. (US 2007/0106209 A1), hereafter “Williams”.
As to claim 103, Sterkin a method for operating an insufflator (1; see Fig. 1) for insufflating a cavity (3) in the body of a human or animal subject, the insufflator comprising a delivery means (1I) for delivering insufflating gas to the cavity (para 0081), and a signal processor (1A, 1M) for controlling the operation of the delivery means (abstract, para 0012, 0024, 0048, 0081), determining an optimum maximum pressure value by using the method as claimed in Claim 94 (see rejection of claim 94 above), and programming the signal processor to control the delivery means to limit the delivery of insufflating gas to the cavity, in response to the pressure in the cavity reaching the optimum maximum pressure value (see at least the abstract, para 0017, 0055, 0088, 0097, 0103, 0105).
Sterkin does not expressly disclose storing the value of the optimum maximum pressure value determined by the method as claimed in Claim 94 in an electronic memory of the insufflator.
Williams discloses an insufflator (100) and storing values related to pressure in an electronic memory (108) of the insufflator (see para 0012, 0043, 0044, 0047, 0049, 0059).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sterkin to include storing the value of the optimum maximum pressure value determined by the method as claimed in Claim 94 in an electronic memory of the insufflator. One would have been motivated to do so in order to store data and optimize delivery of insufflation to a patient (see para 0012, 0043, 0044, 0047, 0049, 0059 of Williams).
As to claim 104, Sterkin in view of Williams teaches the method as claimed in claim 103 as described above, and Sterkin further discloses the signal processor is programmed to terminate delivery of insufflating gas to the cavity in response to the pressure in the cavity reaching the optimum maximum pressure value (see para 0017, 0048, 0055, 0081, 0088, 0097, 0103, 0105). The remaining limitations of “preferably, the delivery of insufflating gas to the cavity is reinstated on the pressure in the cavity falling below the optimum maximum pressure value, and advantageously, the insufflator comprises a pressure sensor for monitoring the pressure in the cavity, the pressure sensor being configured to produce a signal indicative of the pressure in the cavity, and the signal processor is programmed to control the delivery means to maintain the pressure in the cavity substantially at a selectable desired working pressure in response to the value of the signal indictive of the pressure in the cavity read from the pressure sensor” are considered to be optional/not required.
Allowable Subject Matter
Claims 91, 100 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 91, while Sterke discloses an insufflator as claimed in Claim 90 as described above, Sterke is silent to wherein the signal processor is programmed to time-stamp, cross-reference and store in memory each computed value of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and advantageously, the signal processor is programmed to determine the value of the transition pressure from the computed values of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and preferably, the signal processor is programmed to determine the first pressure value from the computed values of the increase in the pressure in the cavity per unit volume of the insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and advantageously, the signal processor is programmed to determine the second pressure value from the computed values of the increase in the pressure in the cavity per unit volume of the insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and preferably, the signal processor is programmed to store the value of the optimum maximum pressure in memory, and advantageously, the signal processor is programmed to produce a signal indicative of the value of the optimum maximum pressure, and preferably, the signal produced by the signal processor indicative of the value of the optimum maximum pressure is adapted for conversion to a human sensory perceptible signal, and advantageously, the signal indicative of the value of the optimum maximum pressure produced by the signal processor is adapted for applying to a visual display screen for displaying the value of the optimum maximum pressure thereon in combination with the limitations of claims 85 and 90.
As to claim 100, while Sterke discloses a method as claimed in Claim 99 as described above, Sterke is silent to wherein each computed value of the increase in pressure in the cavity per unit increase in the volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity are time-stamped, cross-referenced and stored, and preferably, the value of the transition pressure is determined from the computed values of the increase in pressure in the cavity per unit volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and advantageously, the first pressure value is determined from the computed values of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and preferably, the second pressure value is determined from the computed values of the increase in the pressure in the cavity per unit volume of insufflating gas delivered to the cavity and the corresponding values of the pressure in the cavity, and advantageously, the pressure/volume relationship is determined each time the value of the pressure in the cavity and the corresponding value of either the rate at which the insufflating gas is being delivered to the cavity or the cumulative volume of insufflating gas delivered to the cavity are determined, and preferably, delivery of insufflating gas to the cavity is terminated in the set-up mode in response to the pressure in the cavity reaching a maximum set-up safe pressure value beyond which the cavity can no longer be safely insufflated, and advantageously, the maximum set-up safe pressure value is selectable or predefined, and preferably, the maximum set-up safe pressure value lies in the range of 20mmHg to 25mmHg, and advantageously, the maximum set-up safe pressure value lies in the range of 1OmmHg to 15mmHg, and preferably, the maximum set-up safe pressure value is approximately 15mmHg in combination with the limitations of claims 99 and 94.
Conclusion
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/James D Ponton/ Primary Examiner, Art Unit 3783
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