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 .
Priority
The Application Date Sheet makes note of two Foreign Priority documents. However, it appears that a certified copy of only one document has been provided.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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 7 and 13-21 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.
As to claim 7, the claim uses “preferably”. This is similar to wording such as “optionally” and “for example” described in MPEP 3173.05(d), and is indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 13 recites the limitation "the commencement of delivery…" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-21 are rejected as they depend from or require all the limitations of a rejected claim.
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) 1, 5, 13, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterke et al. (US 2022/0054772 A1), hereafter “Sterke”, in view of Williams JR. (US 2007/0106209 A1), hereafter “Williams”.
As to claim 1, Sterke discloses an insufflator (1; see Fig. 1) selectively operable in an insufflating mode (mode after overdistension pressure determined) for insufflating a cavity in the body of a human or animal subject and in a set-up mode (mode where forced oscillations are performed) for determining a working pressure range for the cavity (see para 0057, 0103), the insufflator comprising:
a flow control means (1I and relative parts of 1A which control/adapt flow of gas) adapted for controlling flow of insufflating gas for insufflating the cavity (abstract, para 0012, 0048, 0081),
a pressure sensor adapted to monitor pressure in the cavity (cavity pressure) and to produce a signal indicative of the cavity pressure (para 0035, 0082, 0132),
a flow sensor adapted to monitor flow of insufflating gas to the cavity and to produce a signal indicative of flow of insufflating gas to the cavity (para 0035, 0131, 0155),
a signal processor (1M and rest of 1A),
an electronic storing means accessible to the signal processor (see para 0167; it is noted that there must also necessarily be some form of electronic storage means for remembering/maintaining an optimal pressure),
the signal processor being programmed
to read the signals from the pressure sensor and from the flow sensor at predefined time intervals during insufflating of the cavity in the set-up mode (see para 0016, 0048, 0057, 0083, 0088),
to determine a pressure/volume relationship between cavity pressure and the volume of the cavity from the signals read from the pressure sensor and the flow sensor (abstract, para 0048, 0081, 0082, 0103),
to determine an optimum maximum pressure value of the working pressure range above which the cavity pressure should not exceed from the pressure/volume relationship between the cavity pressure and the volume of the cavity (see para 0017, 0055, 0088, 0097, 0103, 0105).
store the optimum maximum pressure value in the storing means (see para 0088, 0096, 0100, 0167; it is noted that there must also necessarily be some form of electronic storage means for remembering/maintaining an optimal pressure)
Sterke does not expressly recite the signal processor being configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value in the storing means.
Williams discloses an electronic storing means (memory device 108) accessible by a signal processor (controller 101), the signal processor being configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value and the optimum maximum pressure value in the storing means (see para 0039, 0044, 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 Sterke in view of Williams to modify the insufflator such that the signal processor was configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value in the storing means. One would have been motivated to do so as part of an automated control system that uses past/stored values to keep a pressure within a cavity within a certain range (see para 0039, 0044, 0059 of Williams).
As to claim 5, Sterke in view of Williams teaches an insufflator as claimed in Claim 1 in which the signal processor is programmed to determine the optimum maximum pressure value as the cavity pressure at which the increase in the volume of the cavity per unit increase in cavity pressure commences to decrease or is minimal, or as the cavity pressure at a second point of inflection of a graph representative of the pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke).
As to claim 13, Sterke discloses a method for determining an optimum maximum pressure value of a working pressure range for insufflating a cavity (3) in the body of a human or animal subject, the method comprising:
delivering insufflating gas to the cavity (3) (abstract, para 0012, 0048, 0081),
monitoring cavity pressure values (para 0035, 0082, 0132) and corresponding values of cumulative volume of insufflating gas delivered to the cavity at predefined time intervals from the commencement of delivery of insufflating gas to the cavity (see para 0016, 0035, 0048, 0057, 0083, 0088; Sterke measures flow, volume of the cavity, and pressure during forced oscillations to determine a response of the patient’s body),
determining a pressure/volume relationship between the cavity pressure and the volume of the cavity from the monitored cavity pressure values and the monitored cumulative volume values (abstract, para 0048, 0081, 0082, 0103), and
determining the optimum maximum pressure value of the working pressure range from the pressure/volume relationship (see para 0017, 0055, 0057, 0088, 0089, 0097, 0103, 0105).
Sterke is silent to the method being for determining a minimum working pressure value and determining the minimum working pressure value of the working pressure range from the pressure/volume relationship.
Williams discloses an electronic storing means (memory device 108) accessible by a signal processor (controller 101), the signal processor being configured to determine a minimum working pressure value of a working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value and the optimum maximum pressure value in the storing means (see para 0039, 0044, 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 Sterke in view of Williams to modify the method for determining a minimum working pressure value and to include determining the minimum working pressure value of the working pressure range from the pressure/volume relationship. One would have been motivated to do so as part of an automated control system that uses past/stored values to keep a pressure within a cavity within a certain range (see para 0039, 0044, 0059 of Williams).
As to claim 17, Sterke in view of Williams teaches a method as claimed in Claim 13 in which the optimum maximum pressure value is determined as the cavity pressure at which the increase in the volume of the cavity per unit increase in cavity pressure commences to decrease or is minimal, or as the cavity pressure at a second point of inflection of a graph representative of the pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke).
As to claim 19, Sterke in view of Williams teaches a method as claimed in Claim 13 in which the insufflating gas is delivered to the cavity at a substantially constant rate during the determining of the working pressure range (see para 0014, 0095, 0129 of Sterke; also see para 0038, 0059 of Williams).
Claim(s) 1-6, 8, 9 and 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterke et al. (US 2022/0054772 A1), hereafter “Sterke”, in view of Diaz Cambronero et al. (WO 2021/048429 A1, provided by applicant on 7/12/24), hereafter “Diaz Cambronero”
As to claim 1, Sterke discloses an insufflator (1; see Fig. 1) selectively operable in an insufflating mode (mode after overdistension pressure determined) for insufflating a cavity in the body of a human or animal subject and in a set-up mode (mode where forced oscillations are performed) for determining a working pressure range for the cavity (see para 0057, 0103), the insufflator comprising:
a flow control means (1I and relative parts of 1A which control/adapt flow of gas) adapted for controlling flow of insufflating gas for insufflating the cavity (abstract, para 0012, 0048, 0081),
a pressure sensor adapted to monitor pressure in the cavity (cavity pressure) and to produce a signal indicative of the cavity pressure (para 0035, 0082, 0132),
a flow sensor adapted to monitor flow of insufflating gas to the cavity and to produce a signal indicative of flow of insufflating gas to the cavity (para 0035, 0131, 0155),
a signal processor (1M and rest of 1A),
an electronic storing means accessible to the signal processor (see para 0167; it is noted that there must also necessarily be some form of electronic storage means for remembering/maintaining an optimal pressure),
the signal processor being programmed
to read the signals from the pressure sensor and from the flow sensor at predefined time intervals during insufflating of the cavity in the set-up mode (see para 0016, 0048, 0057, 0083, 0088),
to determine a pressure/volume relationship between cavity pressure and the volume of the cavity from the signals read from the pressure sensor and the flow sensor (abstract, para 0048, 0081, 0082, 0103),
to determine an optimum maximum pressure value of the working pressure range above which the cavity pressure should not exceed from the pressure/volume relationship between the cavity pressure and the volume of the cavity (see para 0017, 0055, 0088, 0097, 0103, 0105),
store the optimum maximum pressure value in the storing means (see para 0088, 0096, 0100, 0167; it is noted that there must also necessarily be some form of electronic storage means for remembering/maintaining an optimal pressure)
Sterke does not expressly recite, the signal processor being configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value and the optimum maximum pressure value in the storing means.
Diaz Cambronero discloses a signal processor (6) being configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall (see at least pages 12, 21, & 34), and to store the minimum working pressure value and an optimum maximum pressure value in the storing means (see at least pages 8, 12, 34; there must necessarily be some form of electronic storage so that pressure can be maintained within a range).
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 such that the signal processor was configured to determine a minimum working pressure value of the working pressure range below which cavity pressure should not fall, and to store the minimum working pressure value and the optimum maximum pressure value in the storing means. One would have been motivated to do so as part of a means for maintaining insufflation between a minimum pressure necessary to maintain tension in walls of the cavity and the optimum maximum pressure value (see at least pages 12, 21, & 34 of Diaz Cambronero).
As to claim 2, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 as described above. Sterke is silent to the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at which the cavity pressure commences to increase after commencement of insufflating of the cavity in the set-up mode. However, Diaz Cambronero teaches “The minimum value of the range of optimal volumes, as explained above, may be a predefined value as a function of the type of surgery. For example, the minimum pressure is usually 6 ~ 8 mmHg in laparoscopic surgery, and the minimum value of the range of optimal volumes could be the volume corresponding to that minimum pressure” (page 21) and “The determination (33) of the range of optimal volumes is enabled as a range of volumes proximal to the point of inflection of the distensibility curve, and generally below that point. For example, the range of optimal volume could be a range with a maximum or upper limit value defined as the volume beyond which the increment of pressure is disproportionate, in other words, the volume at the point of inflection of the distensibility curve, and with a minimum value or lower limit value determined as the volume which generates a minimum pressure necessary to maintain the tension of the walls of the expanded cavity, which depends on the cavity and the endoscopic procedure, and which could be a predefined value as a function of the type of surgery. By way of an example, the minimum volume in laparoscopy is that which corresponds to approximately 6 8 mmHg” (page 34). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Sterke such that the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at which the cavity pressure commences to increase after commencement of insufflating of the cavity in the set-up mode. One would have been motivated to do so as such a value may be representative of when the tension in the walls of the cavity begins (see above-cited portions of Diaz Cambronero).
As to claim 3, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 as described above. Sterke is silent to the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at a first point of inflection of a graph representative of the pressure/volume relationship between the cavity pressure and the volume of the cavity. However, Diaz Cambronero teaches the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at a first point of inflection of a graph representative of the pressure/volume relationship between the cavity pressure and the volume of the cavity (see pages 21, 33-34). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Sterke such that the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at a first point of inflection of a graph representative of the pressure/volume relationship between the cavity pressure and the volume of the cavity. One would have been motivated to do so as Diaz Cambronero teaches that doing so is optimal for establishing the range of optimal pressures during a surgery (see pages 21, 33-34).
As to claim 4, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 as described above. Sterke is silent to the specifics of claim 4 however Diaz Cambronero teaches the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at which an initial pressure/volume relationship of the pressure/volume relationship between the cavity pressure and the volume of the cavity during which the cavity pressure remains substantially constant transitions to a first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant (see pages 21, 33-34, Fig. 7 of Diaz Cambronero). 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 such that the signal processor is programmed to determine the minimum working pressure value as the cavity pressure at which an initial pressure/volume relationship of the pressure/volume relationship between the cavity pressure and the volume of the cavity during which the cavity pressure remains substantially constant transitions to a first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant. One would have been motivated to do so as Diaz Cambronero teaches that doing so is optimal for establishing the range of optimal pressures during a surgery (see pages 21, 33-34).
As to claim 5, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 as described above, and further wherein the signal processor is programmed to determine the optimum maximum pressure value as the cavity pressure at which the increase in the volume of the cavity per unit increase in cavity pressure commences to decrease or is minimal, or as the cavity pressure at a second point of inflection of a graph representative of the pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke; see pages 21, 33-34, Fig. 7 of Diaz Cambronero).
As to claim 6, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 4 as described above, and further teaches the signal processor is programmed to determine the optimum maximum pressure value as the cavity pressure at which the pressure/volume relationship between the cavity pressure and the volume of the cavity transitions from the first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant to a second pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant, but is greater than the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity during the first pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke; also see pages 21, 33-34, Fig. 7 of Diaz Cambronero).
As to claim 8, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 above. Sterko is silent to the specifics of claim 8 however Diaz Cambronero teaches the signal processor is programmed to determine a plurality of intervening pressure values between the minimum working pressure value and the optimum maximum pressure value of the working pressure range, and to output a signal indicative of the working pressure range to an interface means configured to enable selection of a working pressure value from the working pressure range through the interface means (see page 13, Fig. 4 of Diaz Cambronero). 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 such that the signal processor is programmed to determine a plurality of intervening pressure values between the minimum working pressure value and the optimum maximum pressure value of the working pressure range, and to output a signal indicative of the working pressure range to an interface means configured to enable selection of a working pressure value from the working pressure range through the interface means. One would have been motivated to do so as a way to allow a user to select a desired working pressure (see pages 13, 35, Fig. 4 of Diaz Cambronero).
As to claim 9, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 8 above, in which the interface means comprises a visual display screen and an input means configured to input a signal indicative of a selected working pressure value (see pages 13, 35 of Diaz Cambronero).
As to claim 13, Sterke discloses a method for determining an optimum maximum pressure value of a working pressure range for insufflating a cavity (3) in the body of a human or animal subject, the method comprising:
delivering insufflating gas to the cavity (3) (abstract, para 0012, 0048, 0081),
monitoring cavity pressure values (para 0035, 0082, 0132) and corresponding values of cumulative volume of insufflating gas delivered to the cavity at predefined time intervals from the commencement of delivery of insufflating gas to the cavity (see para 0016, 0035, 0048, 0057, 0083, 0088; Sterke measures flow, volume of the cavity, and pressure during forced oscillations to determine a response of the patient’s body),
determining a pressure/volume relationship between the cavity pressure and the volume of the cavity from the monitored cavity pressure values and the monitored cumulative volume values (abstract, para 0048, 0081, 0082, 0103), and
determining the optimum maximum pressure value of the working pressure range from the pressure/volume relationship (see para 0017, 0055, 0057, 0088, 0089, 0097, 0103, 0105).
Sterke is silent to the method being for determining a minimum working pressure value and determining the minimum working pressure value of the working pressure range from the pressure/volume relationship.
Diaz Cambronero discloses determining a minimum working pressure value and determining the minimum working pressure value of the working pressure range from the pressure/volume relationship (see at least pages 12, 21, & 34).
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 such that the method includes determining a minimum working pressure value and includes a step of determining the minimum working pressure value of the working pressure range from the pressure/volume relationship. One would have been motivated to do so as part of a means for maintaining insufflation between a minimum pressure necessary to maintain tension in walls of the cavity and the optimum maximum pressure value (see at least pages 12, 21, & 34 of Diaz Cambronero).
As to claim 14, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 13 as described above. Sterke does not expressly recite the limitations of claim 14, however Diaz Cambronero further teaches the minimum working pressure value is determined as the cavity pressure at which the cavity pressure commences to rise after commencement of insufflating of the cavity (see at least pages 12, 21, & 34 of Diaz Cambronero). It therefore would have been obvious to having ordinary skill in the art to have further modified Sterke such that the minimum working pressure value is determined as the cavity pressure at which the cavity pressure commences to rise after commencement of insufflating of the cavity. One would have been motivated to do so as Diaz Cambronero teaches that doing so is optimal for establishing the range of optimal pressures during a surgery (see pages 21, 33-34 of Diaz Cambronero).
As to claim 15, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 13 as described above. Sterke does not expressly recite the limitations of claim 15, however Diaz Cambronero further teaches the minimum working pressure value is determined as the cavity pressure at a first point of inflection of a graph representative of the pressure/volume relationship between the cavity pressure and the volume of the cavity (see at least pages 12, 21, & 34). It therefore would have been obvious to having ordinary skill in the art to have further modified Sterke such that the minimum working pressure value is determined as the cavity pressure at a first point of inflection of a graph representative of the pressure/volume relationship between the cavity pressure and the volume of the cavity. One would have been motivated to do so as Diaz Cambronero teaches that doing so is optimal for establishing the range of optimal pressures during a surgery (see pages 12, 21, 33-34 of Diaz Cambronero).
As to claim 16, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 13 as described above. Sterke does not expressly recite the limitations of claim 16, however Diaz Cambronero further teaches the minimum working pressure value is determined as the cavity pressure at which an initial pressure/volume relationship of the pressure/volume relationship between the cavity pressure and the volume of the cavity during which the cavity pressure remains substantially constant transitions to a first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant (see pages 21, 33-34, Fig. 7 of Diaz Cambronero). It therefore would have been further obvious to one having ordinary skill in the art to have modified Sterke such that the minimum working pressure value is determined as the cavity pressure at which an initial pressure/volume relationship of the pressure/volume relationship between the cavity pressure and the volume of the cavity during which the cavity pressure remains substantially constant transitions to a first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant One would have been motivated to do so as Diaz Cambronero teaches that doing so is optimal for establishing the range of optimal pressures during a surgery (see pages 21, 33-34, Fig. 7 of Diaz Cambronero).
As to claim 17, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 13 in which the optimum maximum pressure value is determined as the cavity pressure at which the increase in the volume of the cavity per unit increase in cavity pressure commences to decrease or is minimal, or as the cavity pressure at a second point of inflection of a graph representative of the pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke; also see pages 21, 33-34, Fig. 7 of Diaz Cambronero).
As to claim 18, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 16 in which the optimum maximum pressure value is determined as the cavity pressure at which the pressure/volume relationship between the cavity pressure and the volume of the cavity transitions from the first pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant to a second pressure/volume relationship during which the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity is substantially constant, but is greater than the increase in cavity pressure per unit volume of insufflating gas delivered to the cavity during the first pressure/volume relationship (see Fig. 4, para 0035, 0017, 0055, 0088, 0097, 0103, 0105 of Sterke; also see pages 21, 33-34, Fig. 7 of Diaz Cambronero).
As to claim 19, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 13 in which the insufflating gas is delivered to the cavity at a substantially constant rate during the determining of the working pressure range (see para 0014, 0095, 0129 of Sterke; also see page 11 of Diaz Cambronero).
As to claim 20, Sterke in view of Diaz Cambronero discloses a method for insufflating a cavity in the body of a human or animal subject at a selectable working pressure value within the working pressure range determined in accordance with the method as claimed in Claim 13 (see rejection of claim 13 above, as well as para 0017, 0055, 0103 of Sterke), the method comprising:
delivering insufflating gas to the cavity (para 0081 of Sterke),
monitoring the cavity pressure (para 0035, 0082, 0132),
controlling the delivery of insufflating gas to and from the cavity for maintaining the cavity pressure at the selectable working pressure value in response to the cavity pressure (para 0012, 0017, 0055, 0081, 0103 of Sterke).
Sterke does not expressly recite comparing the cavity pressure with the minimum working pressure value, and increasing the delivery of insufflating gas to the cavity in the event of the cavity pressure falling below the minimum working pressure value to return the cavity pressure to or above the minimum working pressure value.
However, Diaz Cambronero teaches “The determination (33) of the range of optimal volumes is enabled as a range of volumes proximal to the point of inflection of the distensibility curve… For example, the range of optimal volume could be a range with a maximum or upper limit value defined as the volume beyond which the increment of pressure is disproportionate, in other words, the volume at the point of inflection of the distensibility curve, and with a minimum value or lower limit value determined as the volume which generates a minimum pressure necessary to maintain the tension of the walls of the expanded cavity, which depends on the cavity and the endoscopic procedure, and which could be a predefined value as a function of the type of surgery. By way of an example, the minimum volume in laparoscopy is that which corresponds to approximately 6 - 8 mmHg” (see para beginning line 5 on page 34) as well as use of a processing unit (6) to read sensor values from a sensor module (3) and homeostatsis module (4) and issue commands, including maintaining pressure within a range (see at least the paragraph beginning line 22 col. 18, the paragraph beginning line 8 page 27, and the paragraph beginning line 11 page 36).
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 further to include comparing the cavity pressure with the minimum working pressure value, and increasing the delivery of insufflating gas to the cavity in the event of the cavity pressure falling below the minimum working pressure value to return the cavity pressure to or above the minimum working pressure value. One would have been motivated to do so to ensure pressure in the cavity is maintained above a level necessary to maintain tension of the wall of the cavity.
As to claim 21, Sterke in view of Diaz Cambronero teaches a method as claimed in Claim 20 as described above. Sterke does not expressly recite in which the cavity pressure is compared with the optimum maximum pressure value, and insufflating gas is drawn from the cavity in the event of the cavity pressure exceeding the optimum maximum pressure value to reduce the cavity pressure to or below the optimum maximum cavity pressure value. However, Diaz Cambronero further teaches “The fluid insufflation module may additionally comprise at least one suction pump, which is preferably of variable flow synchronized with the impeller pump. In this manner, adaptive control of the fluid volume in the cavity is enabled in a manner which, if the generated volume is excessive, the suction pump can extract the fluid necessary” (page 15; also see page 31). It therefore would have been obvious to one having ordinary skill in the art, when modifying Sterke, to further do so such that the cavity pressure is compared with the optimum maximum pressure value, and insufflating gas is drawn from the cavity in the event of the cavity pressure exceeding the optimum maximum pressure value to reduce the cavity pressure to or below the optimum maximum cavity pressure value. One would have been motivated to do so as part of a closed loop design for maintaining optimum volume/pressure within the cavity (see pages 15 and 31 of Diaz Cambronero).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterke in view of Diaz Cambronero as applied to claim 1 above, and further in view of Sekino et al. (US 5,328,458), hereafter “Sekino”.
As to claim 7, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 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 the signal processor being programmed in the set-up mode to cease insufflating of the cavity in response to the cavity pressure reaching a maximum safe pressure value, and preferably, the maximum safe pressure value is greater than the optimum maximum pressure value.
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 being programmed in the set-up mode to cease insufflating of the cavity in response to the cavity pressure reaching a maximum safe pressure value, and preferably, the maximum safe pressure value is greater than the optimum maximum pressure value. One would have been motivated to do so to avoid causing damage to a patient (see para beginning line 11 col. 22 of Sekino).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sterke in view of Diaz Cambronero as applied to claim 1, and further in view of DieMunsch et al. (US 2007/0000300 A1, hereafter “DieMunsch”).
As to claim 10, Sterke in view of Diaz Cambronero teaches an insufflator as claimed in Claim 1 in which the flow control means is adapted for delivering insufflating gas to the cavity (para 0081 of Sterke).
Sterke does not expressly recite wherein the flow control means is adapted for drawing insufflating gas from the cavity.
DieMunsch discloses attachment of a measuring device 14 to an insufflation device 12 wherein the measuring device 14 withdraws gas through a combined withdrawal device 22 (see Fig. 1, para 0063, 0074).
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 by configuring the control means to include a means for drawing insufflating gas from the cavity, such as by adding a measuring device similar to that disclosed by DieMunsch. One would have been motivated to do so in order to analyze gas from the cavity (see para 0064, 0069-0071, 0074 of DieMunsch).
As to claim 11, Sterke in view of Diaz Cambronero and DieMunsch teaches an insufflator as claimed in Claim 10 in which the flow control means comprises a flow controller operable under the control of the signal processor in the set-up mode and in the insufflating mode for delivering insufflating gas to the cavity (abstract, para 0081, Claim 1 of Sterke).
As to claim 12, Sterke in view of Diaz Cambronero and DieMunsch teaches an insufflator as claimed in Claim 10 as described above.
Sterke does not expressly recite the flow control means comprises a vacuum applying means operable under the control of the signal processor for applying a vacuum to the cavity for drawing insufflating gas or smoke from the cavity.
DieMunsch teaches a vacuum applying means (68) operable under the control of a signal processor (90) for applying a vacuum to the cavity for drawing insufflating gas from the cavity (para 0071, 0072, 0083).
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 further such that the flow control means comprises a vacuum applying means operable under the control of the signal processor for applying a vacuum to the cavity for drawing insufflating gas from the cavity. One would have been motivated to do so in order to provide a way of controlling flow of insufflating gas (see para 0071, 0072, 0083 of DieMunsch).
Conclusion
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/James D Ponton/Primary Examiner, Art Unit 3783
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