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 .
Response to Arguments
This Office Action is in response to the Pre-Appeal Brief Conference Request dated 10 October 2025 and the Pre-Appeal Brief Conference decision dated 13 November 2025. Claims 1 – 11, 13 – 15, 17 – 22, and 24 – 31 are currently pending within the Application wherein Claims 1 – 9 are withdrawn therefrom.
Applicant’s Pre-Appeal Brief Conference arguments, see pages 2 – 4, filed 10 October 2025, with respect to the rejection(s) of independent claim(s) 10 and 13 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Stubbs et al. (US 2005/0015043 A1) modified in view of Levasseur (US 4,593,717 A) and Torisawa et al. (US 2015/0290403 A1) and motivated by Mastri et al. (US 2014/0074015 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19, 20, 24, 26, and 27 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 19 depends upon a cancelled Claim 16
Claim 24 depends upon a cancelled Claim 23.
Claim 27 is dependent upon Claim 24 and would be rejected under 35 U.S.C. 112(b) for the same rationale as the rejection of Claim 24.
Claim 26 depends upon a cancelled Claim 23.
Claims 19, 24, 26, and 27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear what the dependency of Claims 19, 24, 26, and 27 is intended to be because they are dependent upon cancelled claims. For the purpose of examination, the Examiner is interpreting the following dependency:
Claim 19 is interpreted to be dependent upon Claim 13.
Claim 24 is interpreted to be dependent upon Claim 10.
Claim 26 is interpreted to be dependent upon Claim 10
Claim 27 is interpreted to be dependent upon Claim 24.
Claim 20 recites the following (bolded for emphasis):
The system of Claim 17, wherein the logic is further operable, when executed by the processor, to instruct a pressure sensor of the insufflator to take a pressure measurement in response to determine that the insufflation fluid is not being supplied to the patient cavity.
It is unclear to if the recited “a pressure sensor of the insufflator to take a pressure measurement” is referring to the pressure sensor of the insufflator and the pressure measurement recited within Claim 13. Claim 20 is rejected under 35 U.S.C. 112(b) because of this indefiniteness regarding the “pressure sensor of the insufflator” and its respective pressure measurement. For the purpose of examination, Claim 20 will be interpreted to recite the following as it is believed the recited pressure sensor and pressure measurement of Claim 20 is referring to the same pressure sensor and measurement of Claim 13:
The system of Claim 17, wherein the logic is further operable, when executed by the processor, to instruct [[a]] the pressure sensor of the insufflator to take [[a]] ]] the pressure measurement in response to determine that the insufflation fluid is not being supplied to the patient cavity.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19, 24, 26, and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 depends upon a cancelled Claim 16.
Claim 24 depends upon a cancelled Claim 23.
Claim 27 is dependent upon Claim 24 and would be rejected under 35 U.S.C. 112(d) for the same rationale as the rejection of Claim 24.
Claim 26 depends upon a cancelled Claim 23.
Claims 19, 24, 26, and 27 are rejected under 35 U.S.C .112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because these claims are dependent upon rejected claims. Please see the aforementioned dependency interpretations for these claims under the 35 U.S.C. 112(b) section above.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 10 – 11, 13, 15, 22, and 29 – 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stubbs et al. (US 2005/0015043 A1; hereinafter referred to as “Stubbs”) modified in view of Levasseur (US 4,593,717 A) and Torisawa et al. (US 2015/0290403 A1; hereinafter referred to as “Torisawa”) and evidenced/motivated by Mastri et al. (US 2014/0074015 A1; hereinafter referred to as “Mastri”).
Stubbs is cited in the Notice of References Cited form dated January 29, 2025.
Levasseur is cited in the Notice of References Cited form dated August 7, 2024.
Mastri is cited in the Notice of References Cited form dated 28 February 2024.
With regards to claim 10, Stubbs discloses (Figs. 2 and 6) a system (see Fig. 6 and [0047] “Fig. 6 is a schematic representation of an insufflation system for use”) comprising:
a bypass (see Examiner annotated Fig. 6 below; hereinafter referred to as Fig. A) (see [0061] “insufflator 102 is in fluid communication with the insufflation port 58 of each respective trocar assembly 10 utilized in a patient "P" being operated upon.”);
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a first conduit (see Fig. A above) coupled to the bypass (see Fig. A above) is configured to facilitate delivery of the insufflation fluid from an insufflator (102; see [0061]) to the bypass;
a second conduit (see Fig. A above) coupled to the first channel of the bypass (see Fig. A above) is configured to facilitate delivery of the insufflation fluid from the bypass to a patient cavity (P; see [0061]) via a first medical appliance (see the right 10 in Fig. 6; see [0061]) when the first channel is open; and
a third conduit (see Fig. A above) coupled to the second channel of the bypass (see Fig. A above) is configured to facilitate delivery of the insufflation fluid from the bypass to the patient cavity via a second medical appliance (see the left 10 in Fig. 6; see [0061]) when the second channel is open.
However Stubbs is silent with regards to:
a bypass valve comprising at least a handle, a first channel and a second channel, the first channel defining a portion of a first flow path for an insufflation fluid and the second channel defining a first portion of a second flow path for the insufflation fluid, wherein: the bypass valve is configured to block flow of the insufflation fluid along the first flow path when the handle is in a first position such that the second channel is open; the bypass valve is configured to block flow of the insufflation fluid along the second flow path when the handle is in a second position such that the first channel is open; and
the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of the patient cavity based on information delivered via the second flow path.
Nonetheless Levasseur, which is within the analogous art of valves (see abstract), teaches (Figs. 1 – 12) a bypass valve (10; see Col. 2, lines 36 – 56) comprising at least a handle (41; see Col. 2, lines 57 – 68), a first channel (31; see Col. 2, lines 36 – 56) and a second channel (30; see Col. 2, lines 36 – 56), the first channel defining a portion of a first flow path for an insufflation fluid (see at 31 in Fig. 1) and the second channel defining a first portion of a second flow path for the insufflation fluid (see at 30 in Fig. 1), wherein:
the bypass valve is configured to block flow of the insufflation fluid along the first flow path when the handle is in a first position such that the second channel is open (see Fig. 4 where the first flow path, along 31, is blocked while the second channel 30 is open);
the bypass valve is configured to block flow of the insufflation fluid along the second flow path when the handle is in a second position such that the first channel is open (see Fig. 3 where the second flow path, along 30, is blocked while the first channel 31 is open).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the bypass of the system of Stubbs in view of a teaching of Levasseur such that the bypass comprises a bypass valve and the bypass valve comprises at least a handle, a first channel and a second channel, the first channel defining a portion of a first flow path for an insufflation fluid and the second channel defining a first portion of a second flow path for the insufflation fluid, wherein: the bypass valve is configured to block flow of the insufflation fluid along the first flow path when the handle is in a first position such that the second channel is open; the bypass valve is configured to block flow of the insufflation fluid along the second flow path when the handle is in a second position such that the first channel is open.
One of ordinary skill in the art would have been motivated to make this modification because Mastri teaches that it is beneficial to incorporate a bypass valve with a first position blocking pressurized fluid from flowing to a second tube coupled to a second trocar while allowing pressurized fluid to flow to a first tube coupled to a first trocar and a second position allowing pressurized fluid to flow to a first and second tube and their respective trocars (see [0055] – [0062] and Figs. 12 – 13 of Mastri). Mastri teaches that pressurized fluid can be blocked in the first position in order to allow the surgeon to insert the second trocar into the abdomen of the patient while using the first trocar to continually supply pressurized fluid into the abdominal cavity to maintain the desired pressure in the abdominal cavity (see [0055], [0056], and Fig. 12 of Mastri). Once the second trocar is inserted the surgeon can then rotate the handle of the valve to the second position such that pressurized fluid is supplied to the abdomen from both the first and second trocars (see [0059], [0061], and Fig. 13 of Mastri). Mastri teaches that using multiple trocar assemblies in conjunction with the bypass valve allows for better sealing, greater flexibility in the number of surgical instruments which can be utilized simultaneously, and greater efficiency in terms of setup time and operation (see [0061] of Mastri).
A person having ordinary skill in the art would be motivated to incorporate the bypass valve taught by Levasseur into the insufflation system of Stubbs in view of the motivation evidenced by Mastri. Incorporating the bypass valve would allow for the surgeon to insert a second trocar into the abdomen of the patient while continually providing insufflation via a first trocar. Once the second trocar is properly inserted the surgeon could then provide insufflation via both the first and second trocars. The bypass valve allows for the surgeon to remove and insert trocars as needed in order to provide better visualization around the patient’s abdomen while still maintaining the desired pressure within the abdominal cavity from the other trocar. Further a surgeon could remove a trocar and its respective tubing if there was any form of defect, damage, or leak that occurs while still maintaining the desired pressure within the abdominal cavity from the other trocar and without having to completely remove the entire insufflation system from the patient. Finally, the bypass valve having the second position that allows insufflation fluid to flow through both trocars assists with maintaining a stable operating field because it allows for faster insufflation (i.e., if the abdominal cavity becomes deflated having multiple flow sources can restore the working space more quickly) and managing any leakage situations (i.e., if a procedure causes a high amount of leakage then an additional source of insufflation helps maintain the necessary abdominal pressure). Therefore, Mastri provides evidentiary support for a variety of motivations for the bypass valve of Levasseur to be incorporated into the insufflation system of Stubbs.
The system of Stubbs modified in view of Levasseur as motivated by Mastri will hereinafter be referred to as the system of Stubbs, Levasseur, and Mastri.
However, none of Stubbs, Levasseur, or Mastri teaches the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of a pressure of the patient cavity based on information delivered via the second flow path.
Nonetheless Torisawa, which is within the analogous art of insufflation systems (see abstract and title), teaches (see Figs. 1 and 4) the insufflator (66; see [0042] “an insufflation apparatus 66”) comprises a pressure sensor (128; see [0083] “The third pressure sensor 128 and the fourth pressure sensor 129 are pressure detecting devices which detect a pressure inside the gastrointestinal tract through the insufflation conduit”) configured to take a pressure measurement indicative of a pressure of the patient cavity (“gastrointestinal tract”; see [0083]) based on information delivered via the second flow path (“insufflation conduit”; see [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, and Mastri in view of a teaching of Torisawa such that the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of a pressure of the patient cavity based on information delivered via the second flow path. One of ordinary skill in the art would have been motivated to make this modification because Torisawa teaches that incorporating a pressure sensor within the insufflator of the system allows for monitoring of the pressure inside the patient cavity. This monitoring allows the system to prevent the patient cavity from attaining too high of a pressure or too low of a pressure. Too high pressure and the patient’s body suffers the burden while too low causes poor operability for the operator (see Abstract, [0007], and [0008]).
The system of Stubbs, Levasseur, and Mastri modified in view of a teaching of Torisawa will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, and Torisawa.
With regards to claim 11, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10, and Stubbs further teaches (Figs. 2 and 6) wherein the first medical appliance (see the right 10 in Fig. 6; see [0061]) is a trocar (see [0061] “a gas flow trocar assembly 10”).
With regards to claim 13, Stubbs discloses (Figs. 2 and 6) a system (see Fig. 6 and [0047] “Fig. 6 is a schematic representation of an insufflation system for use”) comprising:
an insufflator (102; see [0061]);
a bypass (see Fig. A reiterated below) (see [0061] “insufflator 102 is in fluid communication with the insufflation port 58 of each respective trocar assembly 10 utilized in a patient "P" being operated upon.”);
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a first conduit (see Fig. A reiterated above) coupled to the bypass (see Fig. A reiterated above) and configured to facilitate delivery of the insufflation fluid from the insufflator to the bypass (see [0061]);
a second conduit (see Fig. A reiterated above) coupled to the first channel of the bypass (see Fig. A reiterated above) and configured to facilitate delivery of the insufflation fluid from the bypass to a patient cavity (P; see [0061]) via a first medical appliance (see the right 10 in Fig. 6; see [0061]) when the first channel is open; and
a third conduit (see Fig. A reiterated above) coupled to the second channel of the bypass and configured to facilitate delivery of the insufflation fluid from the bypass to the patient cavity via a second medical appliance (see the left 10 in Fig. 6; see [0061]) when the second channel is open.
However, Stubbs is silent with regards to:
a bypass valve comprising at least a handle, a first channel and a second channel, the first channel defining a portion of a first flow path for an insufflation fluid and the second channel defining a portion of a second flow path for the insufflation fluid, wherein:
the bypass valve is configured to block the insufflation fluid from flowing along the first flow path when the handle is in a first position such that the second channel is open;
the bypass valve is configured to block the insufflation fluid from flowing along the second flow path when the handle is in a second position such that the first channel is open; and
the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of a pressure of the patient cavity based on information delivered via the second flow path.
Nonetheless Levasseur, which is within the analogous art of valves (see abstract), teaches (Figs. 1 – 12) a bypass valve (10; see Col. 2, lines 36 – 56) comprising at least a handle (41; see Col. 2, lines 57 – 68), a first channel (31; see Col. 2, lines 36 – 56) and a second channel (30; see Col. 2, lines 36 – 56), the first channel defining a portion of a first flow path for insufflation fluid (see at 31 in Fig. 1) and the second channel defining a portion of a second flow path for the insufflation fluid (see at 30 in Fig. 1), wherein:
the bypass valve is configured to block the insufflation fluid from flowing along the first flow path when the handle is in a first position such that the second channel is open (see Fig. 4 where the first flow path, along 31, is blocked while the second channel 30 is open);
the bypass valve is configured to block the insufflation fluid from flowing along the second flow path when the handle is in a second position such that the first channel is open (see Fig. 3 where the second flow path, along 30, is blocked while the first channel 31 is open).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the bypass of the system of Stubbs in view of a teaching of Levasseur such that the bypass comprises a bypass valve and the bypass valve comprises at least a handle, a first channel and a second channel, the first channel defining a portion of a first flow path for an insufflation fluid and the second channel defining a first portion of a second flow path for the insufflation fluid, wherein: the bypass valve is configured to block the insufflation fluid from flowing along the first flow path when the handle is in a first position such that the second channel is open; the bypass valve is configured to block the insufflation fluid from flowing along the second flow path when the handle is in a second position such that the first channel is open.
One of ordinary skill in the art would have been motivated to make this modification because Mastri teaches that it is beneficial to incorporate a bypass valve with a first position blocking pressurized fluid from flowing to a second tube coupled to a second trocar while allowing pressurized fluid to flow to a first tube coupled to a first trocar and a second position allowing pressurized fluid to flow to a first and second tube and their respective trocars (see [0055] – [0062] and Figs. 12 – 13 of Mastri). Mastri teaches that pressurized fluid can be blocked in the first position in order to allow the surgeon to insert the second trocar into the abdomen of the patient while using the first trocar to continually supply pressurized fluid into the abdominal cavity to maintain the desired pressure in the abdominal cavity (see [0055], [0056], and Fig. 12 of Mastri). Once the second trocar is inserted the surgeon can then rotate the handle of the valve to the second position such that pressurized fluid is supplied to the abdomen from both the first and second trocars (see [0059], [0061], and Fig. 13 of Mastri). Mastri teaches the use of multiple trocar assemblies in conjunction with the bypass valve allows for better sealing, greater flexibility in the number of surgical instruments which can be utilized simultaneously, and greater efficiency in terms of setup time and operation (see [0061] of Mastri).
A person having ordinary skill in the art would be motivated to incorporate the bypass valve taught by Levasseur into the insufflation system of Stubbs in view of the motivation evidenced by Mastri. Incorporating the bypass valve would allow for the surgeon to insert a second trocar into the abdomen of the patient while continually providing insufflation via a first trocar. Once the second trocar is properly inserted the surgeon could then provide insufflation via both the first and second trocars. The bypass valve allows for the surgeon to remove and insert trocars as needed in order to provide better visualization around the patient’s abdomen while still maintaining the desired pressure within the abdominal cavity from the other trocar. Further a surgeon could remove a trocar and its respective tubing if there was any form of defect, damage, or leak that occurs while still maintaining the desired pressure within the abdominal cavity from the other trocar. Finally, the bypass valve having the second position that allows insufflation fluid to flow through both trocars assists with maintaining a stable operating field because it allows for faster insufflation (i.e., if the abdominal cavity becomes deflated having multiple flow sources can restore the working space more quickly) and managing any leakage situations (i.e., if a procedure causes a high amount of leakage then an additional source of insufflation helps maintain the necessary abdominal pressure). Therefore, Mastri provides evidentiary support for a variety of motivations for the bypass valve of Levasseur to be incorporated into the insufflation system of Stubbs.
The system of Stubbs modified in view of Levasseur and motivated by Mastri will hereinafter be referred to as the system of Stubbs, Levasseur, and Mastri.
However, none of Stubbs, Levasseur, nor Mastri teaches the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of a pressure of the patient cavity based on information delivered via the second flow path.
Nonetheless Torisawa, which is within the analogous art of insufflation systems (see abstract and title), teaches the insufflator (66; see [0042] “an insufflation apparatus 66”) comprises a pressure sensor (128; see [0083] “The third pressure sensor 128 and the fourth pressure sensor 129 are pressure detecting devices which detect a pressure inside the gastrointestinal tract through the insufflation conduit”) configured to take a pressure measurement indicative of a pressure of the patient cavity (“gastrointestinal tract”; see [0083]) based on information delivered via the second flow path (“insufflation conduit”; see [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, and Mastri in view of a teaching of Torisawa such that the insufflator comprises a pressure sensor configured to take a pressure measurement indicative of a pressure of the patient cavity based on information delivered via the second flow path. One of ordinary skill in the art would have been motivated to make this modification because Torisawa teaches that incorporating a pressure sensor within the insufflator of the system allows for monitoring of the pressure inside the patient cavity. This monitoring allows the system to prevent the patient cavity from attaining too high of a pressure or too low of a pressure. Too high pressure and the patient’s body suffers the burden while too low causes poor operability for the operator (see Abstract, [0007], and [0008]).
The system of Stubbs, Levasseur, and Mastri modified in view of a teaching of Torisawa will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, and Torisawa.
With regards to claim 15, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13, and Stubbs further teaches (Figs. 2 and 6) wherein the second medical appliance (see the left 10 in Fig. 6; see [0061]) is one from the set comprising:
an insufflation needle; and
a trocar (see [0061] “a gas flow trocar assembly 10”).
With regards to claim 22, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10, and Stubbs further teaches (Figs. 2 and 6) wherein the second medical appliance (see the left 10 in Fig. 6; see [0061]) is one from the set comprising:
an insufflation needle; and
a trocar (see [0061] “a gas flow trocar assembly 10”).
With regards to claim 29, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10, however, Stubbs is silent with regards to wherein the bypass valve is a three-way valve and is configured to include a position wherein the first channel and the second channel are closed.
Nonetheless Levasseur, which is within the analogous art of valves (see abstract), further teaches (Figs. 1 – 12) wherein the bypass valve (10; see Col. 2, lines 36 – 56) is a three-way valve (the bypass valve 10 is a three way valve as there are three inlets/outlets 30, 31, 32) and is configured to include a position wherein the first channel (31; see Col. 2, lines 36 – 56) and the second channel (30; see Col. 2, lines 36 – 56) are closed (see Col. 2, lines 31 – 32 “FIGS. 8-12 show the five possible positions which effectively close all three ports simultaneously.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a further teaching of Levasseur such that the bypass valve is a three-way valve and is configured to include a position wherein the first channel and the second channel are closed. One of ordinary skill in the art would have been motivated to make this modification because Levasseur teaches that this bypass valve provides a valve which clearly identifies not only the port closed to fluid movement but which also simultaneously indicates the conduit which is open (see Col. 1, lines 65 – 68 of Levasseur).
With regards to claim 30, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13, however, Stubbs is silent with regards to wherein the bypass valve is a three-way valve and is configured to include a position wherein the first channel and the second channel are closed.
Nonetheless Levasseur, which is within the analogous art of valves (see abstract), further teaches (Figs. 1 – 12) wherein the bypass valve (10; see Col. 2, lines 36 – 56) is a three-way valve (the bypass valve 10 is a three way valve as there are three inlets/outlets 30, 31, 32) and is configured to include a position wherein the first channel (31; see Col. 2, lines 36 – 56) and the second channel (30; see Col. 2, lines 36 – 56) are closed (see Col. 2, lines 31 – 32 “FIGS. 8-12 show the five possible positions which effectively close all three ports simultaneously.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a further teaching of Levasseur such that the bypass valve is a three-way valve and is configured to include a position wherein the first channel and the second channel are closed. One of ordinary skill in the art would have been motivated to make this modification because Levasseur teaches that this bypass valve provides a valve which clearly identifies not only the port closed to fluid movement but which also simultaneously indicates the conduit which is open (see Col. 1, lines 65 – 68 of Levasseur).
With regards to claim 31, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13, and Stubbs further teaches (Figs. 2 and 6) the system (see Fig. 6 and [0047] “Fig. 6 is a schematic representation of an insufflation system for use”) further comprising:
the first medical appliance (see the right 10 in Fig. 6; see [0061]) is one from the set comprising: an insufflation needle and a trocar (see [0061] “a gas flow trocar assembly 10”); and
the second medical appliance (see the left 10 in Fig. 6; see [0061]) is one from the set comprising: an insufflation needle and a trocar (see [0061] “a gas flow trocar assembly 10”).
Claim(s) 14, 17 – 21, 24 – 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stubbs, Levasseur, Mastri, and Torisawa as applied to claims 10, 11, and 13 above and in further view of Geisz et al. (US 2018/0103977 A1; hereinafter referred to as “Geisz”).
Geisz is previously cited within the Notice of References Cited dated February 28, 2024.
With regards to claim 14, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13, and Stubbs further teaches (Figs. 2 and 6) the first medical appliance (see the right 10 in Fig. 6; see [0061]) is a trocar (see [0061] “a gas flow trocar assembly 10”).
However, Stubbs is silent with regards to the trocar comprises a pressure sensor configured to determine a pressure measurement indicative of a pressure of the patient cavity.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), teaches (Fig. 1) the trocar (14; see [0019] “Trocar 14”) comprises a pressure sensor (see [0019] “pressure sensor 22 on or associated with the trocar 14. The location can be anywhere in or on trocar 14 or associated with trocar 14”) configured to determine a pressure measurement indicative of a pressure of the patient cavity (see [0019] “pressure sensor 22 is an absolute pressure sensor that can measure pressure in patient cavity 20 (if disposed within patient cavity 20)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the trocar of the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a teaching of Geisz such that the trocar comprises a pressure sensor configured to determine a pressure measurement indicative of a pressure of the patient cavity. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that including a pressure sensor assists the surgeon in determining the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
The system of Stubbs, Levasseur, Mastri, and Torisawa modified in view of a teaching of Geisz will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz.
With regards to claim 17, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13, however, Stubbs is silent with regards to wherein the insufflator comprises:
a processor; and
a computer readable medium having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to the patient cavity based on a pressure measurement.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022] “Insufflator may include appropriate hardware and/or software for processing signals indicative of pressures measured by pressure sensor 22”) comprises:
a processor (42; see [0030] “processor 42”); and
a computer readable medium (40; see [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”) having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to a patient cavity based on a pressure measurement (see [0022] and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, and Torisawa with a teaching of Geisz such that the insufflator comprises: a processor; and a computer readable medium having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to a patient cavity based on a pressure measurement. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
The system of Stubbs, Levasseur, Mastri, and Torisawa modified in view of Geisz will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz.
With regards to claim 18, the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz teaches the claimed invention of claim 14, however, Stubbs is silent with regards to wherein the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022]) is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor (22; see [0019]) of the trocar (14; see [0019]) in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path (see [0022] “Insufflator may include appropriate hardware and/or software for processing signals indicative of pressures measured by pressure sensor 22 and processing such signals to convert them into useful information, such as converting them into pressures, heights, and/or other data that can be used control the flow of insufflation gas to patient cavity 20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz in view of an additional teaching of Geisz such that the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 19, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 13 (see the 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above wherein Claim 19 is interpreted as being dependent upon Claim 13), however, Stubbs is silent with regards to wherein the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the insufflator in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022]) is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor (44; see [0030] “a pressure application 44, which may include logic for effecting pressure and altitude determination”) of the insufflator in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path (see [0022] and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a teaching of Geisz such that insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the insufflator in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 20, the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz teaches the claimed invention of claim 17, however, Stubbs is silent with regards to wherein the logic is further operable, when executed by the processor, to instruct a pressure sensor of the insufflator to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the logic (40; see [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to the other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”) is further operable, when executed by the processor (42; see [0030] “processor 42”), to instruct a pressure sensor (44; see [0030] “a pressure application 44, which may include logic for effecting pressure and altitude determination”) of the insufflator (10; see [0030] “insufflator 10” and see Fig. 3A which shows the pressure sensor being located on the insufflator) to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity (see [0022] and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the logic of the computer readable medium of the insufflator of the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz in view of an additional teaching of Geisz such that the logic is further operable, when executed by the processor, to instruct a pressure sensor of the insufflator to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 21, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 11, however, Stubbs is silent with regards to wherein the trocar comprises a pressure sensor configured to determine a pressure measurement indicative of a pressure of the patient cavity.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), teaches (Fig. 1) the trocar (14; see [0019] “Trocar 14”) comprises a pressure sensor (see [0019] “pressure sensor 22 on or associated with the trocar 14. The location can be anywhere in or on trocar 14 or associated with trocar 14”) configured to determine a pressure measurement indicative of a pressure of the patient cavity (see [0019] “pressure sensor 22 is an absolute pressure sensor that can measure pressure in patient cavity 20 (if disposed within patient cavity 20)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the trocar of the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a teaching of Geisz such that the trocar comprises a pressure sensor configured to determine a pressure measurement indicative of a pressure of the patient cavity. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that including a pressure sensor assists the surgeon in determining the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
The system of Stubbs, Levasseur, Mastri, and Torisawa modified in view of a teaching of Geisz will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz.
With regards to claim 24, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10 (see the 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above wherein Claim 24 is interpreted to depend upon Claim 10), however, Stubbs is silent with regards to wherein the insufflator comprises:
a processor; and
a computer readable medium having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to the patient cavity based on the pressure measurement.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022] “Insufflator may include appropriate hardware and/or software for processing signals indicative of pressures measured by pressure sensor 22”) comprises:
a processor (42; see [0030] “processor 42”); and
a computer readable medium (40; see [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”) having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to a patient cavity based on a pressure measurement (see [0022] and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, and Torisawa with a teaching of Geisz such that the insufflator comprises: a processor; and a computer readable medium having logic stored thereon, the logic operable, when executed by the processor, to supply the insufflation fluid to a patient cavity based on a pressure measurement. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
The system of Stubbs, Levasseur, Mastri, and Torisawa modified in view of Geisz will hereinafter be referred to as the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz.
With regards to claim 25, the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz teaches the claimed invention of claim 21, however Stubbs is silent with regards to wherein the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022]) is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path (see [0022] “Insufflator may include appropriate hardware and/or software for processing signals indicative of pressures measured by pressure sensor 22 and processing such signals to convert them into useful information, such as converting them into pressures, heights, and/or other data that can be used control the flow of insufflation gas to patient cavity 20” and [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to the other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz in view of an additional teaching of Geisz such that the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the first flow path. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 26, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10 (see the 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above wherein Claim 24 is interpreted to depend upon Claim 10), however Stubbs is silent with regards to wherein the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the insufflator in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the insufflator (10; see [0018] “an insufflator 10” and [0022]) is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor (22; see [0019]) of the trocar (14; see [0019]) in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path (see [0022] “Insufflator may include appropriate hardware and/or software for processing signals indicative of pressures measured by pressure sensor 22 and processing such signals to convert them into useful information, such as converting them into pressures, heights, and/or other data that can be used control the flow of insufflation gas to patient cavity 20” and [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to the other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the insufflator of the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a teaching of Geisz such that the insufflator is configured to supply the insufflation fluid to the patient cavity based on the pressure measurement determined by the pressure sensor of the trocar in response to determining that the insufflation fluid is being delivered to the patient cavity along the second flow path. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 27, the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz teaches the claimed invention of claim 24, however, Stubbs is silent with regards to wherein the logic is further operable, when executed by the processor, to instruct the pressure sensor of the insufflator to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the logic (40; see [0030] “Memory 40 stores a pressure application 44, which may include logic for effecting pressure and altitude determination as described with respect to the other FIGURES as well as control of the supply of insufflation gas to patient cavity 20”) is further operable, when executed by the processor (42; see [0030] “processor 42”), to instruct a pressure sensor (44; see [0030] “a pressure application 44, which may include logic for effecting pressure and altitude determination”) of the insufflator (10; see [0030] “insufflator 10” and see Fig. 3A which shows the pressure sensor being located on the insufflator) to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity (see [0022] and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the logic of the computer readable medium of the insufflator of the system of Stubbs, Levasseur, Mastri, Torisawa, and Geisz in view of an additional teaching of Geisz such that the logic is further operable, when executed by the processor, to instruct a pressure sensor of the insufflator to take a pressure measurement in response to determining that the insufflation fluid is not being supplied to the patient cavity. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that the insufflator comprising this structure assists the surgeon in determining and supplying the optimized gas pressure to gain access to a target surgical site in the cavity without over pressurizing the cavity (see [0015 – 0016] of Geisz).
With regards to claim 28, the system of Stubbs, Levasseur, Mastri, and Torisawa teaches the claimed invention of claim 10, however, Stubbs is silent with regards to the system further comprising: determining, by the insufflator, a change in height of the first medical appliance or the second medical appliance relative to a change in pressure in the patient cavity.
Nonetheless Geisz, which is within the analogous art of methods and systems for controlling pressurization of a patient cavity using cavity distension measured by a pressure sensor of a trocar (see abstract), further teaches (Figs. 1 and 3A) the system further comprises determining, by the insufflator, a change in height of the first medical appliance or the second medical appliance relative to a change in pressure in the patient cavity (see [0020] “Pressure sensor 22 is coupled to insufflator 10 through any suitable technique, including a wired connection 25 or a wireless connection. Pressure sensor supplies pressure data to insufflator 10. Insufflator 10 uses this pressure data to determine the change in height of trocar 14 relative to changes in cavity pressure and thus the resulting change in height of patient cavity 20, as described in greater detail below in conjunction with FIGS. 2A through 4”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Stubbs, Levasseur, Mastri, and Torisawa in view of a teaching of Geisz such that the system further comprises determining, by the insufflator, a change in height of the first medical appliance or the second medical appliance relative to a change in pressure in the patient cavity. One of ordinary skill in the art would have been motivated to make this modification because Geisz teaches that using the pressure data provided by the pressure sensor the insufflator can determine the optimum, or a close approximation thereof, of the best pressure for the laparoscopic surgery and as a result control the pressure within patient cavity by controlling the pressure of the insufflation gas supplied by insufflator through the conduit (see [0020] of Geisz).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mastri et al. (US 9,017,281 B2)
Mastri et al. (US 9,616,185 B2)
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/ROBERT F ALLEN/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783