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 in response to applicant’s communication of 3/12/2022. Currently claims 1-13 are pending and rejected below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fleeman (US 2003/0109848 A1).
Fleeman discloses an in vivo tube introduction determination device comprising (figures 1-5): a gas detection unit that is connected to a second end of a tube having a first end and said second end, said first end being inserted into a living body; [[and]] a notification (46) unit that provides notification of information based on an output of said gas detection unit[[,]], and wherein said gas detection unit detects a concentration of a first gas component that is carbon dioxide or oxygen and a concentration of a second gas component having a concentration difference between a stomach and an esophagus (see para [0022]).
Concerning claim 2 and said gas detection unit further comprises a first gas detection unit that detects said concentration of said first gas component and a second gas detection unit that detects said concentration of said second gas component (examiner is of the position that the detection of multiple types of gases by the Fleeman detecting unit would be considered a first detection unit and a second detection unit, as different gasses would be considered different “units”).
Concerning claim 3 and said first gas component is carbon dioxide (see para [0022]).
Concerning claim 4 and said second gas component is hydrogen (examiner is of the position that if the tube of Fleeman was in the esophagus or intestinal tract then hydrogen would be the second gas detected as hydrogen is known to be found in the GI tract).
Concerning claim 5 and a display unit, and said display unit that displays a time change of a value corresponding to the concentration of said first gas component and a value corresponding to said concentration of said second gas component (see disclosure of monitor of 46 or machine 20).
Concerning claim 6 and said display unit that displays said time change of said value corresponding to said concentration of said first gas component in a time-series graph (see the use of capnograph para [0021]).
Concerning claim 7 and said display unit that displays said value corresponding to said concentration of said second gas component in real time (see the use of capnograph para [0021]).
Concerning claim 8 and said control unit performs control of determining whether said first end of said tube is positioned in a respiratory tract of said living body or a position other than said respiratory tract on the basis of said concentration of said first gas component (see para [0022]).
Concerning claim 9 and said control unit performs control of determining whether said first end of said tube is positioned in said stomach or said esophagus on the basis of said concentration of said second gas component, in a case where said control unit determines that said first end of said tube is positioned in said position other than said respiratory tract of said living body (again see para [0022]).
Concerning claim 10 and wherein said notification unit provides notification of a determination result as to whether said first end of said tube is positioned in said respiratory tract of said living body or said position other than said respiratory tract and a determination result as to whether said first end of said tube is positioned in said stomach or said esophagus (see the use of capnograph para [0021]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleeman (US 2003/0109848 A1).
Concerning claim 11. and a pump that sucks gas in said living body from said first end of said tube and introduces a sucked gas in said living body into said gas detection unit. Although not expressly disclosed in the handheld capnograph and CO2 gas detector it is well known to a PHOSITA to have a inlet, filter, and intake pump to draw gas into the capnograph as disclosed in Fleeman in order to detect the presence of gas and not introduce harmful substances to a patient in order to detect CO2.
Concerning claim 12 and a filter that prevents an infectious disease. Although not expressly disclosed in the handheld capnograph and CO2 gas detector it is well known to a PHOSITA to have a inlet, filter, and intake pump to draw gas into the capnograph as disclosed in Fleeman in order to detect the presence of gas and not introduce harmful substances to a patient in order to detect CO2.
Concerning claim 13 and an introduction inlet of gas inside said living body to which said second end of said tube is connected and wherein said filter is disposable and is disposed near said introduction inlet. Although not expressly disclosed in the handheld capnograph and CO2 gas detector it is well known to a PHOSITA to have a inlet, filter, and intake pump to draw gas into the capnograph as disclosed in Fleeman in order to detect the presence of gas and not introduce harmful substances to a patient in order to detect CO2.
Response to Arguments
Applicant's arguments filed 9/26/2025 have been fully considered but they are not persuasive. Applicant’s argue that the prior art fails to disclose (Fleeman) detecting Oxygen or detects a second gas component other than CO2. Examiner disagrees.
Examiner is of the position that the claim language is “…detects a concentration of a first gas component that is carbon dioxide or oxygen and a concentration of a second gas component having a concentration difference between a stomach and an esophagus….”. Examiner is of the position that the claim limitations are interpreted to be the first gas component may be “CO2” and the second gas component is “a concentration difference between a stomach and an esophagus”. Examiner is not of the position that the claim specify that the second gas component may not be CO2. Rather the claims specify that the second gas component may be a “concentration difference”. Examiner is of the position that temporal or gas (CO2) concentrations taken as a different time, would satisfy the claim limitations. Examiner is of the position that the Fleeman prior art does compare multiple different CO2 concentrations samples to operate. Examiner is of the position that claim 1 does not require the second gas component to be a different molecular type (O, CO2, H, C, etc.) rather a different concentration. Examiner is of the position that the prior art would have a second gas component of CO2 than the first concentration gas component of CO2.
Concerning applicant’s other arguments concerning the 103 rejections.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Examiner is of the position that the arguments regarding the “dual-detection” is overly narrow regarding claim interpretation than examiner’s broadest reasonable definition and claim interpretation.
Concerning the language of detects a first gas component that is CO2 and a concentration of a second gas component having a concentration difference between a stomach and esophagus; Examiner is of the position that the CO2 of a first gas component may be one first reading by the prior art and a latter reading of CO2 may be a second reading of a second gas component of a different CO2 concentration. Under this broadest reasonable reading the prior art of Fleeman would teach this.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Fleeman anticpates the claims (as interpreted by Examiner above) with their first and second gas components (CO2 based).
Examiner recommends applicant amend the claims to greater define that the second gas concentration is not a temporal or time based future gas concentration reading rather is a molecular/elemental different gas being measured.
It is recommended applicant amend the claims to overcome the prior art rejections.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783