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 .
This Office action is responsive to an amendment filed January 21, 2026. Claims 19-39 is/are pending. Claims 19-23, 25 & 37-39 have been canceled. Claims 1-18 have been canceled.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. The numbering of claims should include ALL claims including those that are canceled. The Office suggests that Applicant amend the claim to recite: --claims 1-19 (canceled)--.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim requires the limitations “an access component configured to provide percutaneous fluidic access inside said body cavity, adjacent said hollow organ” at lines 3-4 thereof; however, claim 19 from which the claim depends already requires “an access element configured to be introduced percutaneously in the body cavity to access a zone adjacent the hollow organ.” While the original specification describes a single access element 8 configured to provide percutaneous fluidic access inside said body cavity, adjacent said hollow organ (see fig. 1 thereof), the original specification fails to teach two access elements or components configured to do so. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The limitations “wherein the housing and the separate housing integrating respectively the injection module and the detection module are separate from a housing incorporating the computational module, each of the housings being configured for wireless communication, said user interface comprising a control and a display” render the claim indefinite because the terms “the housing” and “the separate housing” lack sufficient antecedent basis in light of the newly presented amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-20, 25-28, 33 & 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diemunsch et al. (US 2007/0000300) (“Diemunsch” hereinafter).
In regards to claim 19, Diemusch discloses a system for detecting the likelihood of a medially relevant leak in a hollow organ (i.e., intestine) of a human or animal subject, comprising:
an injection module 12 capable of injecting a test gas 16 from a source external to human or animal subject in a controlled manner into a body cavity 18 in which the hollow organ (i.e., intestine) is located, wherein said test gas 16 is not a gas that is present within said body cavity 18 in which the hollow organ (i.e., intestine) is located (see at least par 0030-0032, 0036, 0075, 0082-0083 & 0089-0090),
a detection module 152, said detection module 152 comprising a sensor 70 and an access element 168 capable of being introduced percutaneously in the body cavity to access a zone adjacent the hollow organ (i.e., intestine), said sensor 70 capable of sensing the fluid within the body cavity (i.e., abdominal cavity 18) surrounding said hollow organ (i.e., intestine) (see at least par 0073-0075); and
a user interface (94, 96) (see par 0079 & 0090) that communicates with the computational module 98 (see at least figs. 1 & 4), said user interface (94, 96) having a display element 96 capable of providing an indication of presence or absence of said test gas in said body cavity (i.e., by virtue of being a display) (see at least par 0079);
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wherein said detection module 152 and said computational module 98 are capable of cooperating, simultaneously with or after the injection module 12 starts operating, in a manner, to determine whether the test gas 16 is present in a body cavity 18 in which the hollow organ is located and monitoring a concentration variation of the injected test gas 16 in the body cavity (i.e., “the determined measuring values can also be used to control and monitor the delivery of the insufflation gas 16 to the body cavity 18,” see par 0075), and thereby indicating, after computing, whether the organ is leak-free (see at least par 0036, 0075 & 0089-0090);
wherein the injection and detection modules (12, 152) operate in a synchronized manner under the operative management of the computational module 98, which communicates with said injection and detection modules (12, 152) (see at least par 0079 & 0089-0090).
The Office notes that the limitations “wherein said test gas is injected into the hollow organ to be checked, or into a tightly isolated section of the hollow organ, which is sealed from the body cavity surrounding the hollow organ during and after the injection phase” and “to monitor a concentration variation of the injected test gas in the body cavity, as a parameter indicative of the presence of a leak or perforation in the hollow organ and thereby indicate, after computing, whether the hollow organ is leak-free, wherein absence of the injected test gas in the body cavity is indicative of integrity of the organ, or possibly the closure after a medical procedure, and detection of the injected test gas in the body cavity is indicative of a leak or perforation in the hollow organ” pertain to functional language, which does not structurally distinguish the instantly claimed system from that of Diemunsch since the insufflation cannula 162 (see at least par 0092-0093) of Diemunsch shown in fig. 4 thereof can be inserted percutaneously into the intestine to insufflate the intestine with the insufflation gas 16 while the withdrawal cannula 168 is maintained in the abdominal cavity to withdraw the measuring gas 20 such that the sensor 70, which may be a gas sensor, a gas chromatograph and/or a mass spectrometer (see par 0074), reads a concentration of the withdrawn gas 20 as claimed without otherwise changing the structure of the device of Diemunsch, see MPEP § 2114.
In regards to claim 20, Diemunsch discloses the system according to claim 19, further comprising a transfer tubing 158 configured to be fluidly coupled to said access element 168, and wherein the transfer tubing 168 is configured to convey a gas 20 from the zone (i.e., abdominal cavity) adjacent the hollow organ (i.e., intestine) to the detection module 152 for analysis (see at least fig. 4 and par 0079 & 0089-0090).
In regards to claim 25, Diemunsch discloses the system according to claim 19, wherein said user interface (94, 96) comprising a control 94 that receives information entered by a user of the system (see at least par 0079).
In regards to claim 26, Diemunsch discloses the system according to claim 19, wherein: said injection module 12 is configured to control injection of the test gas 16 and measure or standardize at least one of a volume, concentration, detected test gas pressure in the hollow organ, or rate of injection of the test gas 16 delivered from a corresponding source 28; and said injection module 12 comprises a pressure gauge 74 (see at least par 0036-0042 & 0082-0083).
In regards to claim 27, Diemunsch discloses the system according to claim 26, wherein said pressure gauge determines a pressure within at least one of an injection tubing of said injection module 12 or inside said hollow organ (i.e., intestine) (see least par 0030-0032, 0036 & 0075).
In regards to claim 28, Diemunsch discloses the system according to claim 19, wherein said detection module 152 further comprises: an access component 168, capable of providing percutaneous fluidic access inside said body3Application No.: 16/160,395 Attorney Docket No.: 12470177USResponse to Office Action of July 26, 2021cavity 18, adjacent said hollow organ; and a transferring component 158 that transfers at least one of a sample of gas or gas mixture inside the body cavity to an external analyzing module that makes a real time presence of the test gas within the at least one sample (see at least fig. 4 and par 0092-0093).
In regards to claim 33, Diemunsch discloses the system according to claim 19, wherein said injection module 12 comprises a handheld instrument 158 (see at least fig. 4 and par 0092-0093).
In regards to claim 37, Diemusch discloses a system for detecting the likelihood of a medially relevant leak in a hollow organ (i.e., intestine) of a human or animal subject, comprising:
an injection module 12 capable of injecting a test gas 16 from a source external to human or animal subject in a controlled manner into a body cavity 18 in which the hollow organ (i.e., intestine) is located, wherein said test gas 16 is not a gas that is present within said body cavity 18 (see at least par 0030-0032, 0036, 0075, 0082-0083 & 0089-0090),
a detection module 152 comprising a sensor 70 and an access element 168 capable of being introduced percutaneously in the body cavity to access a zone adjacent the hollow organ (i.e., intestine) and to convey a fluid within the body cavity to the sensor 70 (see at least par 0073-0075); and
a computational module 98 (see at least figs. 1 & 4);
a transfer tubing 158 configured to be fluidly coupled to said access element 168 (see at least fig. 4);
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wherein said detection module 152 and said computational module 98 are configured to cooperate, simultaneously with or after the injection module 12 starts operating, in a synchronized manner, to determine whether the test gas 16 is present in a body cavity 18 in which the hollow organ is located, and thereby indicate, after computing, whether the organ is leak-free (see at least par 0036, 0075 & 0089-0090);
wherein the injection and detection modules (12, 152) operate in a synchronized manner under the operative management of the computational module 98, which communicates with said injection and detection modules (12, 152) (see at least par 0079 & 0089-0090).
The Office notes that the limitations “to monitor a concentration variation of the injected test gas in the body cavity, as a parameter indicative of the presence of a leak or perforation in the hollow organ and thereby indicate, after computing, whether the hollow organ is leak-free, wherein absence of the injected test gas in the body cavity is indicative of integrity of the organ, or possibly the closure after a medical procedure, and detection of the injected test gas in the body cavity is indicative of a leak or perforation in the hollow organ” pertain to functional language, which does not structurally distinguish the instantly claimed system from that of Diemunsch since the insufflation cannula 162 (see at least par 0092-0093) of Diemunsch shown in fig. 4 thereof can be inserted percutaneously into the intestine to insufflate the intestine with the insufflation gas 16 while the withdrawal cannula 168 is maintained in the abdominal cavity to withdraw the measuring gas 20 such that the sensor 70, which may be a gas sensor, a gas chromatograph and/or a mass spectrometer (see par 0074), reads a concentration of the withdrawn gas 20 as claimed without otherwise changing the structure of the device of Diemunsch, see MPEP § 2114.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21-24, 29, 32 & 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch (‘300) in view of Scalici et al. (US 2013/0096399) (“Scalici” hereinafter).
In regards to claim 21, Diemunsch discloses a system according to claim 20, that fails to explicitly teach a system wherein the access element is a trocar. However, Scalici teaches that it is known to provide a system wherein the access element is a trocar (see at least figs. 3 & 5-8 and par 0006, 0060, 0064, 0074-0075, 0081, 0104, 0124 & 0130-0131). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the access element is a trocar as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as transporting the sample through the sample delivery unit using a tubing having a luer adapted for connection to a device for obtaining an aspirate sample, for example, a trocar or Veress needle for blind placement into the body cavity (see at least par 0074 & 0124 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, Diemunsch discloses a system according to claim 20, that fails to explicitly teach a system wherein the tubing is a Veress needle. However, Scalici teaches that it is known to provide a system wherein the tubing is a Veress needle (see at least figs. 3 & 5-8 and par 0006, 0060, 0064, 0074-0075, 0081, 0104, 0124 & 0130-0131). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the tubing is a Veress needle as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as transporting the sample through the sample delivery unit using a tubing having a luer adapted for connection to a device for obtaining an aspirate sample, for example, a trocar or Veress needle for blind placement into the body cavity (see at least par 0074 & 0124 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 23, Diemunsch discloses a system according to claim 19, that fails to explicitly teach a system wherein the sensor is arranged in the access element. However, Scalici teaches that it is known to provide a system wherein the sensor is arranged in the access element (see at least figs. 3 & 5-8 and par 0006, 0060, 0064, 0074-0075, 0081, 0104, 0124 & 0130-0131). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the sensor is arranged in the access element as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as transporting the sample through the sample delivery unit using a tubing having a luer adapted for connection to a device for obtaining an aspirate sample, for example, a trocar or Veress needle for blind placement into the body cavity (see at least par 0074 & 0124 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 24, Diemunsch discloses a system, as described above, that fails to explicitly teach a system wherein said detection module determines a concentration of said test gas in said body cavity. However, Scalici teaches that it is known to provide a system wherein said detection module determines a concentration of said test gas in said body cavity (see at least figs. 1A-B, 3-8 & 28-30, and par 0011-0012, 0047-0049, 0054, 0062 & 0068-0069). Therefore, it would have been obvious to one of ordinary skill in the art at the Applicant’s invention was filed to provide the system of Diemunsch wherein said detection module determines a concentration of said test gas in said body cavity as taught by Scalici et al. since such a modification would amount to applying a known technique (i.e. as taught Scalici) to improve similar devices (i.e. as taught by Diemunsch) in the same way such as determining the composition of the gas contained in the abdominal or pelvic cavity (see at least par 0012 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 29, Diemunsch discloses the system according to claim 25, that fails to explicitly teach a system wherein said computational module: stores and treats data provided by said injection module, said detection module, and said user interface communicates with and operatively manages said injection module and said detection module, retrieves information from said user interface and from a local or remote data storage, and sends information to a user interface. However, Scalici teaches that it is known to provide a system wherein said computational module (i.e., display unit): stores and treats data provided by a sample delivery unit, said detection module (i.e., sample sensing unit), and said user interface (i.e., display unit) communicates with and operatively manages said sample delivery unit and said detection module (i.e., sample sensing unit), retrieves information from said user interface and from a local data storage (i.e., baseline levels of gases), and sends information to a user interface (i.e., display unit) (see at least figs. 5-8 and par 0058-0059, 0068-0071 & 0108-0122). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein said computational module: stores and treats data, as taught by Scalici, provided by said injection module thereof, said detection module, and said user interface communicates with and operatively manages, as taught by Scalici, said injection module and said detection module thereof, retrieves information from said user interface and from a local data storage, and sends information to a user interface as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as designing devices that reusable sections, for example, a reusable sensing unit or display unit for use across patients and procedures (see at least par 0059 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 32, Diemunsch discloses the system according to claim 25, that fails to explicitly teach a system wherein said injection module, said detection module and said computational module are configured for mutual wireless communication or for mutual communication through a physical link. However, Scalici teaches that it is known to provide a system wherein said sample delivery unit, said detection module and said computational module are configured for mutual wireless communication or for mutual communication through a physical link (see at least figs. 5-8 and par 0054 & 0071). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein said injection module, said detection module and said computational module are configured for mutual wireless communication or for mutual communication through a physical link as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as designing devices that reusable sections, for example, a reusable sensing unit or display unit for use across patients and procedures (see at least par 0059 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 38, Diemunsch discloses a system according to claim 20, that fails to explicitly teach a system wherein the access element is a trocar. However, Scalici teaches that it is known to provide a system wherein the access element is a trocar (see at least figs. 3 & 5-8 and par 0006, 0060, 0064, 0074-0075, 0081, 0104, 0124 & 0130-0131). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the access element is a trocar as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as transporting the sample through the sample delivery unit using a tubing having a luer adapted for connection to a device for obtaining an aspirate sample, for example, a trocar or Veress needle for blind placement into the body cavity (see at least par 0074 & 0124 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 39, Diemunsch discloses a system according to claim 20, that fails to explicitly teach a system wherein the tubing is a Veress needle. However, Scalici teaches that it is known to provide a system wherein the tubing is a Veress needle (see at least figs. 3 & 5-8 and par 0006, 0060, 0064, 0074-0075, 0081, 0104, 0124 & 0130-0131). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the tubing is a Veress needle as taught by Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as transporting the sample through the sample delivery unit using a tubing having a luer adapted for connection to a device for obtaining an aspirate sample, for example, a trocar or Veress needle for blind placement into the body cavity (see at least par 0074 & 0124 of Scalici)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claims 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch et al. (US 2007/0000300) (“Diemunsch” hereinafter) in view of Landherr et al. (US 2008/0183127) (“Landherr” hereinafter).
Diemunsch discloses the system according to claim 19, that fails to explicitly teach a system wherein said injection module, said detection module, and said computational module are part of a pre-existing medical system.
However, Landherr teaches that it is known to provide a system wherein said injection module (20, 30), said detection module 100a, and said computational module 100b are part of a pre-existing medical system (i.e., pre-existing peritoneal APD or CAPD treatment systems) (see at least figs. 7A-B and par 0095-0098, 0102, 0112 & 0114).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein said injection module, said detection module, and said computational module are part of a pre-existing medical system as taught by Landherr since such a modification would amount to applying a known technique (i.e., as taught by Landherr) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as providing a separate housing integrating a detection module so that said detection module can be used as a stand-alone test apparatus, used alone or in combination in laboratory, doctor’s office, hospital or home test equipment (see at least par 0095 of Landherr)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch (‘300) in view of Landherr (‘127) further in view of Koninckx et al. (US 5,139,478) (“Koninckx” hereinafter).
Diemunsch as modified by Landherr discloses the system according to claim 30, that fails to explicity teach a system wherein said pre-existing medical system is an anaesthesia apparatus.
However, Koninckx teaches that it is known to provide a system wherein said pre-existing medical system is an anaesthesia -apparatus (see at least col. 4, lines 47-49).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch as modified by Landherr wherein said pre-existing medical system is an anaesthesia apparatus as taught by Koninckx since Landherr teaches a system that can be used as a stand-alone test apparatus, used alone or in combination in laboratory, doctor’s office, hospital or home test equipment (see at least par 0095 of Landherr).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch (‘300) in view of Koninckx et al. (US 5,139,478) (“Koninckx” hereinafter).
Diemunsch discloses a system according to claim 33, that fails to explicitly teach a system wherein said handheld instrument is a flexible endoscope.
However, Koninckx teaches that it is known to provide a system wherein said handheld instrument is a flexible endoscope 25 (see at least abstract, fig. 1 and col. 3, lines 42-49).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein said handheld instrument is a flexible endoscope as taught by Koninckx since such a modification would amount to a simple substitution of one known element (i.e., the cannula of Diemunsch) for another (i.e., the endoscope of Koninckx) to obtain predictable results such as providing gas injection through an insufflation system of a standard or known endoscope--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claims 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch et al. (US 2007/0000300) (“Diemunsch” hereinafter) in view of Landherr et al. (US 2008/0183127) (“Landherr” hereinafter) further in view of in view of Scalici et al. (US 2013/0096399) (“Scalici” hereinafter).
Diemunsch discloses the system according to claim 32, that fails to explicitly teach a system wherein the housing and the separate housing integrating respectively the injection module and the detection module are separate from a housing incorporating the computational module, each of the housings being configured for wireless communication, said user interface comprising a control and a display.
However, Landherr teaches that it is known to provide a system comprising a housing integrating an injection module (20, 30) (see at least figs. 7A-B and par 0053)
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and a separate housing 100a integrating a detection module 46, said separate housing 100a being separate from the housing integrating the injection module 12, said separate
housing 100a being configured to be handheld (see at least figs. 7A-B and par 0095-
0098, 0102, 0112 & 0114) and Scalici teaches that it is known to provide a system with each of the housings being configured for wireless communication (see at least par 0053 & 0071).
Therefore, since Landherr teaches that it is known to provide a system wherein the housing and the separate housing integrating respectively the injection module (20, 30) and the detection module 100a are separate from a housing incorporating the computational module 100b (see at least figs. 7A-B and par 0095 & 0113-0115), said user interface comprising a control and a display (see at least par 0035), with the detection module 100a and computational module 100b being configured for wireless communication (see at least par 0113-0115) and Scalici teaches that it is known to provide a system with the delivery unit and computational module (i.e., display unit) being configured for wireless communication (see at least figs. 5-8 and par 0058-0059, 0068-0071 & 0108-0122), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch with each of the housings being configured for wireless communication as taught by the combined teachings of Landherr and Scalici since such a modification would amount to applying a known technique (i.e., as taught by Scalici) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as designing devices that reusable sections, for example, a reusable sensing unit or display unit for use across patients and procedures (see at least par 0059 of Scalici) so that at least said detection module can be used as a stand-alone test apparatus, used alone or in combination in laboratory, doctor’s office, hospital or home test equipment (see at least par 0095 of Landherr)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diemunsch (‘300) in view of Pradhan (US 2016/0029921).
Diemunsch discloses a system according to claim 25, that fails to explicitly teach a system wherein the user interface is a smartphone with a corresponding software application that communicates at least with the computational module.
However, Pradhan teaches that it is known to provide a system wherein the user interface is a smartphone with a corresponding software application that communicates at least with the computational module (see at least abstract, fig. 1 and par 0024 & 0032, 0034 & 0043).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Diemunsch wherein the user interface is a smartphone with a corresponding software application that communicates at least with the computational module as taught by Pradhan since such a modification would amount to applying a known technique (i.e., as taught by Pradhan) to a known device (i.e., as taught by Diemunsch) ready for improvement to achieve a predictable result such as generating an electronic notification or message such as an alarm to remotely notify the user of the detection of the gases (see at least par 0034 of Pradhan)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed January 21, 2026 have been fully considered but they are not persuasive. Applicant’s newly presented claim language includes new limitations such as “wherein said test gas is injected into the hollow organ to be checked, or into a tightly isolated section of the hollow organ, which is sealed from the body cavity surrounding the hollow organ during and after the injection phase” and “to monitor a concentration variation of the injected test gas in the body cavity, as a parameter indicative of the presence of a leak or perforation in the hollow organ and thereby indicate, after computing, whether the hollow organ is leak-free, wherein absence of the injected test gas in the body cavity is indicative of integrity of the organ, or possibly the closure after a medical procedure, and detection of the injected test gas in the body cavity is indicative of a leak or perforation in the hollow organ” in claim 1; however such limitations pertain to functional language, which does not structurally distinguish the instantly claimed system from that of Diemunsch since the insufflation cannula 162 (see at least par 0092-0093) of Diemunsch shown in fig. 4 thereof can be inserted percutaneously into the intestine to insufflate the intestine with the insufflation gas 16 while the withdrawal cannula 168 is maintained in the abdominal cavity to withdraw the measuring gas 20 such that the sensor 70, which may be a gas sensor, a gas chromatograph and/or a mass spectrometer (see par 0074), reads a concentration of the withdrawn gas 20 as claimed without otherwise changing the structure of the device of Diemunsch, see MPEP § 2114.
In view of the foregoing, the rejections over at least Diemunsch are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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