Office Action 1: Non-Final Rejection (2024-10-29)
Rejection types: 101 - Patent-Eligible Subject Matter, 102 - Lack of Novelty, 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
AMENDMENTS TO THE CLAIMS

This listing of claims will replace all prior versions and listings of claims in the application.

Listing of Claims:

This listing of claims will replace all prior versions and listings of claims in the application.

Claims 1-17. (Cancelled).216

Claim 18. (Currently Amended) A method of operating a capnography system, comprising:receiving, at one or more processors, a carbon dioxide (C02) concentration in exhaled breath of a subject from a CO2 sensor of a CO2 sensing system;
determining, by the one or more processors, one or more breath related parameters based on the CO2 concentration;
receiving, at the one or more processors, an indication of a type of a tubing system connected to the CO2 sensing system; and
changing or suggesting a change, by the one or more processors, of an operation mode of the CO2 sensing syste based on the indication of the type of the tubing system.

Claim 19. (Currently Amended) The method of claim \[\[19\]\] 18,further comprising:receiving, at the one or more processors, a second indication regarding a property of the tubing system; and
changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing syste based on the second indication\[\[;\]\],
wherein the property of the tubing system comprises a length of the sampling system, a diameter of the tubing system, a target group of the tubing system, an intended duration of the tubing system, or any combination thereof.

Claim 20. (Currently Amended) The method of claim \[\[19\]\] 18further comprising:receiving, at the one or more processors, a second indication regarding a manufacturing detail of the tubing system; and
changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing system, based on the second indication\[\[;\]\],
wherein the property of the tubing system comprises a production site, a production date, a production station, a lot number, a serial number, an expiration date, or any combination thereof.

Claims 21-24. (Cancelled).2223

Claim 25. (New) The method of claim 18, wherein changing or suggesting the change of the operation mode comprises suggesting the change of the operation mode, the method further comprising, sending, by the one or more processors, the suggested change in the operation mode of the CO2 sensing system to a user interface.

Claim 26. (New) The method of claim 18, wherein the tubing system comprises an intubation tube, and wherein changing the operation mode of the CO2 sensing system comprises enhancing or suggesting an enhancement, by the one or more processors, of an operation of a pump of the CO2 sensing system upon intubation and until a first CO2 signal is obtained by the CO2 sensor, thereby reducing a time required for verification of correct intubation.

Claim 27. (New) The method of claim 18, wherein the tubing system comprises a bite block, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying CO2 concentration peaks resulting from insufflation of the subject, initiating use of an algorithm configured to reduce nuisance alarms during insufflation, or suggesting use of the algorithm configured to reduce nuisance alarms during insufflation.

Claim 28. (New) The method of claim 18, wherein the tubing system comprises an oral nasal cannula, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying a high respiration rate resulting from pain, initiating use of an algorithm configured to reduce nuisance alarms during pain management, or suggesting the use of the algorithm configured to reduce nuisance alarms during pain management.

Claim 29. (New) The method of claim 18, wherein the tubing system comprises an oxygen supply tube, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying aberrations in CO2 measurements resulting from dilution of the exhaled breath with oxygen, initiating use of an algorithm configured to at least one of correct, normalize, or adjust the one or more breath related parameters based on the identified dilution, or suggest use of the algorithm configured to at least one of correct, normalize, or adjust the one or more breath related parameters based on the identified dilution.

Claim 30. (New) The method of claim 18, further comprising:receiving, at the one or more processors, usage data, wherein the usage data comprises a number of occlusion of the tubing system, a duration of use, a number of uses/connections of the tubing system to a CO2 sensing system, or any combination thereof; and
generating, by the one or more processors, a signal terminating the usability of the tubing system, in response to determining, based on the usage data, that the tubing system has run obsolete.

Claim 31. (New) The method of claim 18, wherein changing or suggesting the change of the operation mode of the CO2 sensing system comprises changing or suggesting the change in an operation of the pump based on the indication of the type of the tubing system.

OFFICE ACTION:
DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 30 is/are objected to because of the following informalities:
Claim 30, Ln. 4 recites “a CO2 sensing system” which should read “the CO2 sensing system” following after claim 18
Appropriate correction is required.
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.
Claim(s) 20, 26, and 31 is/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 pre-AIA  the applicant regards as the invention.
Claim 20 recites the limitation “the property of the tubing system” in Ln. 6.  There is insufficient antecedent basis for this limitation in the claim.  For the purposes of limitation be interpreted as reading “the manufacturing detail of the tubing system”.
Claim 26 recites the limitation “enhancing or suggesting an enhancement … of an operation of a pump of the CO2 sensing system upon intubation and until a first CO2 signal is obtained by the CO2 sensor, thereby reducing a time required for verification of correct intubation” which deems the claim indefinite. The claim recites an intended functionality, i.e. enhancing or suggesting an enhancement, without claiming any particular operation which would constitute an enhancement. The claim is thus overly broad in design. For example, how is operation of the pump to be altered to provide the intended enhancement?
Claim 31 recites the limitation “the pump” in Ln. 3.  There is insufficient antecedent basis for this limitation in the claim.  For the purposes of examination the claim will instead be read as dependent on claim 26, which provides the proper antecedent basis.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 18-20, 25-29, and 31 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process without significantly more. The claim(s) recite(s) 1) receiving a carbon dioxide (CO2) concentration in exhaled breath of a subject; 2) determining one or more breath related parameters based on the CO2 concentration; 3) receiving an indication of a type of a tubing system connected; and 4) changing or suggesting a change of an operation mode of the CO2 sensing system based on the indication of the type of the tubing system. This judicial exception is not integrated into a practical application because the only positively recited element of the claim is one or more processors. The courts have held that the mere performing of a mental process with a computer, e.g. the claimed processor(s), fails to extend beyond the judicial exception (see MPEP 2106.04(a)(2)(III). In claim 18 the receiving of sensor data is a mental process, the determining of a parameter from the received data is a mental process, the receiving of type information is a mental process, and the decision to change or suggest a change is a mental process. The CO2 sensor and the CO2 sensing system are merely generic elements in the claim which are conventional in a capnography system and are only recited in regard to the pre-solution activity of data gathering. The tubing system is only incidentally recited in the claim are performs no meaningful function as claimed. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claim only pertain to the processing of data and determining of a decision based upon the data. At a minimum the claim only requires suggestion of a change, which fails to meaningfully integrate the judicial exception of the mental process into a practical application.
Each of claims 19 and 20 further only recite the receiving of additional data and at a minimum a further suggestion based upon that additional data. The claims thus fail to extend beyond the judicial exception.
Claim 25 merely requires the communication of a suggestion, which amounts to insignificant post-solution activity. The claim thus fails to extend beyond the judicial exception.
Each of claims 26-29 further recite, at a minimum, a suggestion based upon a particular type of tubing system recited by each respective claim. Again, the mere recitation of a suggestion fails to extend beyond a mental process. It is noted that while a particular type of tubing system is recited by each respective claim that no active use of the tubing system is recited by the claims. The claims thus fail to extend beyond the judicial exception.
Claim 31 at a minimum only requires a suggestion to be made, which fails to extend beyond a mental process. The claim thus fails to extend beyond the judicial exception.
It is noted that claim 30 is not rejected under 35 U.S.C. 101 because it is found to add significantly more than the judicial exception of a mental process in its active generating of a signal which terminates the usability of the tubing system, in response to determining, based on the usage data, that the tubing system has run obsolete.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18, 26, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiss et al. (U.S. Pub. 2016/0073929).
Regarding claim 18, Weiss discloses a method of operating a capnography system (Figs. 1-2; ¶¶0020-0024), comprising: receiving, at one or more processors (Fig. 2 #24; ¶0025; see also ¶0029 – required for sending/receiving of data by gas sampling device 14), a carbon dioxide (CO2) concentration in exhaled breath of a subject (¶0021 – by capnograph) from a CO2 sensor (¶0021 – capnograph measuring EtCO2) of a CO2 sensing system (Fig. 2 #14; ¶0021); determining, by the one or more processors, one or more breath related parameters based on the CO2 concentration (¶0021 – no specific parameter is required by the claim); receiving, at the one or more processors, an indication of a type of a tubing system connected to the CO2 sensing system (¶¶0029-0031 – determined through identification); and changing or suggesting a change, by the one or more processors, of an operation mode of the CO2 sensing system based on the indication of the type of the tubing system (¶¶0029, 0036 – operation begun if appropriate connector).
Regarding claim 26, Weiss discloses the tubing system comprises an intubation tube (¶0016 – endotracheal tube), and wherein changing the operation mode of the CO2 sensing system comprises enhancing or suggesting an enhancement, by the one or more processors, of an operation of a pump of the CO2 sensing system upon intubation and until a first CO2 signal is obtained by the CO2 sensor, thereby reducing a time required for verification of correct intubation (¶¶0029, 0036 – operation begun if appropriate connector). The claim is written in such a broad manner than merely operating the CO2 sensing system upon intubation may be read as satisfying the claimed operation of enhancing operation to reduce a time required for verification of correct intubation because it would be expected to take longer to verify correct intubation without use of the CO2 sensing system than with use of the CO2 sensing system.
Regarding claim 31, Weiss discloses changing or suggesting the change of the operation mode of the CO2 sensing system comprises changing or suggesting the change in an operation of the pump based on the indication of the type of the tubing system (¶¶0029, 0036 – operation begun if appropriate connector). Triggering of operation may be read as a change in an operation of the pump.
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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.  Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA  35 U.S.C. 103(a) 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) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Colman et al. (U.S. Pub. 2014/0014729).
Regarding claim 19, Weiss discloses receiving, at the one or more processors, a second indication regarding a property of the tubing system (¶¶0030-0031 – many options of stored data), wherein the property of the tubing system comprises a length of the sampling system, a diameter of the tubing system, a target group of the tubing system, an intended duration of the tubing system (¶0031), or any combination thereof. Only one of the recited options is required for reading on the claim.
Weiss fails to explicitly disclose changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing system based on the second indication.
Colman ‘729 teaches a tubing verification system (e.g. ¶0041) and teaches identification details of a tubing connector may be used to change a mode of operation (¶0053). Colman ‘729 teaches various types of connectors may be obviously intended for different uses (e.g. for children or for intubated patients) and thus that an identification of which connector is being used may be obviously used to alter parameters of operation (¶0053).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Weiss changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing system based on the second indication in order to provide the benefit of using identification of what type of tubing system is connected to alter parameters of operation so that operation is best suited toward the type of tubing system is current use in view of Colman ‘729.
Regarding claim 20, Weiss discloses receiving, at the one or more processors, a second indication regarding a manufacturing detail of the tubing system (¶¶0030-0031 – various details regarding manufacture), wherein the manufacturing detail of the tubing system comprises a production site, a production date (¶0030), a production station, a lot number (¶0031), a serial number (¶0031), an expiration date, or any combination thereof. Only one of the recited options is required for reading on the claim.
Weiss fails to explicitly disclose changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing system based on the second indication.
Colman ‘729 teaches a tubing verification system (e.g. ¶0041) and teaches identification details of a tubing connector may be used to change a mode of operation (¶0053). Colman ‘729 teaches various types of connectors may be obviously intended for different uses (e.g. for children or for intubated patients) and thus that an identification of which connector is being used may be obviously used to alter parameters of operation (¶0053).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Weiss changing or suggesting the change, by the one or more processors, of the operation mode of the CO2 sensing system based on the second indication in order to provide the benefit of using identification of what type of tubing system is connected to alter parameters of operation so that operation is best suited toward the type of tubing system is current use in view of Colman ‘729.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Coleman et al. (U.S. Pub. 2017/0325716).
Regarding claim 25, Weiss discloses a user interface (Fig. 1 shown on #14).
Weiss fails to explicitly disclose changing or suggesting the change of the operation mode comprises suggesting the change of the operation mode, the method further comprising, sending, by the one or more processors, the suggested change in the operation mode of the CO2 sensing system to the user interface.
Coleman teaches a capnograph system (Fig. 2) and teaches changes to operation may be either made automatically by a capnograph or may be presented as a recommendation for manual operation (e.g. ¶¶0093-0094). One of ordinary skill in the art would have considered it prima facie obvious for a recommendation to a user to be presented via a user interface.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Weiss changing or suggesting the change of the operation mode comprises suggesting the change of the operation mode, the method further comprising, sending, by the one or more processors, the suggested change in the operation mode of the CO2 sensing system to the user interface in order to provide the benefit of presenting a recommendation of operation to a user instead of simply automating a change of operation in view of Coleman.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Colman et al. (U.S. Pub. 2009/0275851) and further in view of Boyer (U.S. Pub. 2016/0093205).
Regarding claim 27, Weiss fails to disclose the tubing system comprises a bite block, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying CO2 concentration peaks resulting from insufflation of the subject, initiating use of an algorithm configured to reduce nuisance alarms during insufflation, or suggesting use of the algorithm configured to reduce nuisance alarms during insufflation.
Colman ‘851 teaches a capnography system including a bite block (Figs. 4 & 5C-5D; ¶¶0050, 0054-0056), and insufflation of the subject occurring during CO2 sensing (¶0057 – oxygen delivery). Colman ‘851 teaches a bite block as providing the benefit of allowing performance of capnography in conjunction with an endoscopy procedure (¶¶0005, 0059).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Weiss the tubing system comprises a bite block, and insufflation of the subject occurring during CO2 sensing in order to provide the benefit of allowing performance of capnography in conjunction with an endoscopy procedure in view of Colman ‘851.
Boyer teaches a method of reducing nuisance alarms, including those occurring during capnography (¶¶0021-0023, 0060), and teaches evaluating sensed signals against thresholds, such as a threshold variably set in response to another patient parameter, in order to reduce nuisance alarms (¶¶0054-0057). One of ordinary skill in the art would have considered peak CO2 concentration one obvious patient variable to be used in alarms during capnography, and thus one obvious variable to compare against a threshold in order to reduce nuisance alarms.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have further incorporated in Weiss changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying CO2 concentration peaks resulting from insufflation of the subject, initiating use of an algorithm configured to reduce nuisance alarms during insufflation in order to provide the benefit of selecting peak CO2 concentration, as one obvious patient variable to be used in alarms during capnography, for comparison against a threshold variably set in response to another patient parameter in order to reduce nuisance alarms in view of Boyer.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Colman et al. (U.S. Pub. 2010/0317986).
Regarding claim 28, Weiss discloses the tubing system comprises an oral nasal cannula (¶¶0002, 0016).
Weiss fails to disclose changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying a high respiration rate resulting from pain, initiating use of an algorithm configured to reduce nuisance alarms during pain management, or suggesting the use of the algorithm configured to reduce nuisance alarms during pain management.
Colman ‘986 teaches a capnography device and teaches pain and pain management as particular situations which will alter a patient’s respiratory rate (¶¶0053-0054). Colman ‘986 also teaches that alarms tend to become an annoyance during pain management (¶0055).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Weiss changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying a high respiration rate resulting from pain, initiating use of an algorithm configured to reduce nuisance alarms during pain management in order to provide the benefit of reducing the annoyance of alarms during pain management, when the patient’s respiratory rate will be expected to be unusual in view of Colman ‘986.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Colman et al. (U.S. Pub. 2011/0040713).
Regarding claim 29, Weiss fails to disclose the tubing system comprises an oxygen supply tube, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying aberrations in CO2 measurements resulting from dilution of the exhaled breath with oxygen, initiating use of an algorithm configured to at least one of correct, normalize, or adjust the one or more breath related parameters based on the identified dilution, or suggest use of the algorithm configured to at least one of correct, normalize, or adjust the one or more breath related parameters based on the identified dilution.
Colman ‘713 teaches CO2 sensing can be performed in conjunction with oxygen delivery (¶0125). Colman ‘713 further teaches it is known for oxygen supply to result in dilution of the CO2 signal for which correction should be made to the EtCO2 level (¶0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Weiss the tubing system comprises an oxygen supply tube, and wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying aberrations in CO2 measurements resulting from dilution of the exhaled breath with oxygen, initiating use of an algorithm configured to at least one of correct, normalize, or adjust the one or more breath related parameters in order to provide the benefit of applying a correction in response to the known dilution of the CO2 signal caused by oxygen supply in view of Colman ‘713.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiss et al. (U.S. Pub. 2016/0073929) in view of Ben-Oren et al. (U.S. Patent 6656127).
Regarding claim 30, Weiss discloses receiving, at the one or more processors, usage data, wherein the usage data comprises a number of occlusion of the tubing system, a duration of use (¶0031), a number of uses/connections of the tubing system to the CO2 sensing system (¶¶0030-0031), or any combination thereof. Only one of the recited options is required for reading on the claim.
Weiss fails to disclose generating, by the one or more processors, a signal terminating the usability of the tubing system, in response to determining, based on the usage data, that the tubing system has run obsolete.
Ben-Oren teaches a breath test system (e.g. Fig. 3) and teaches once a problem is determined that the instrument may be completely disabled (Col. 27, Ln. 62 – Col. 28, Ln. 22; Col. 29, Ln. 42-47; Col. 41, Ln. 12-16). Ben-Oren teaches disabling the instrument as providing the benefit of preventing use benefit an expiry date and/or preventing generation of false results (Col. 29, Ln. 42-47; Col. 41, Ln. 12-16). One of ordinary skill in the art would have considered it prima facie obvious to have identified the recommended duration of use, number of connections, or life-time after first connection in Weiss (¶0031) as variables suitable to trigger a disabling operation in view of Ben-Oren.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Weiss generating, by the one or more processors, a signal terminating the usability of the tubing system, in response to determining, based on the usage data, that the tubing system has run obsolete in order to provide the benefit of preventing use benefit an expiry date and/or preventing generation of false results in view of Ben-Oren.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Regarding the independent claim further attention is drawn to Colman et al. (U.S. Pub. 2014/0014729; e.g. ¶¶0052-0053) and Peer et al. (U.S. Pub. 2017/0224975; e.g. ¶¶0063-0064).


NEXT OFFICE ACTION: 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 Amendment
The Amendment filed 23 Jan 2025 has been entered.  Claims 18-20 and 25-35 are pending in the application.  Claims 18-20 and 25-31 are currently amended with claims 32-35 newly added.  Applicant’s amendment to the Claims have overcome each and every objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 29 Oct 2024.
The prior 35 U.S.C. 101 rejection is withdrawn as requested (Pg. 2-3) based on the amendment to the claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are: “communication component” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the “communication component” is best understood from the specification as at least: a 1-wire electrically erasable programmable read-only memory (EEPROM) (¶0018).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: Examiner concurs with applicant’s assertion that amended claim 18 patentably distinguishes over the prior art. Of particular note claim 18 recites receiving particular first data and second data and then “changing, by the one or more processors, an operation mode of the CO2 sensing system during operation of the CO2 sensing system based on the second data indicative of the information associated with the tubing system.” Thus, the change in operation mode is required to be “during operation of the CO2 sensing system.” The language “during operation” implies that the CO2 sensing system should be in active usage when the change in operation mode is made. A prior art which changes operation mode when a different connector is attached would not be accurately read as changing operation mode “during operation” as the attaching of a different connector would imply that operation had been interrupted, while the term “during” requires an ongoing, continual process of operation.
Weiss et al. (U.S. Pub. 2016/0073929) teaches a consideration of storing a duration of operation while connected for smart connector 16 (¶0031). However, Weiss does not teach or suggest changing an operation mode of the CO2 sensing system during operation of the CO2 sensing system based on the second data indicative of the information associated with the tubing system.
Ben-Oren et al. (U.S. Patent 6656127) was cited in the 35 U.S.C. 103 rejection of claim 30 in the preceding Office action for its teaching of disabling of operation. However, the disabling particularly taught in Ben-Oren relates to problems detecting during a self-diagnostic calibration (Col. 27-29 “1. Self-diagnostics” discussion). Thus, the disabling taught in Ben-Oren is meaningfully different in concept than the claimed changing of an operation mode of the CO2 sensing system during operation based on the second data received from the communication component associated with the tubing system.
Another notable prior art is Peer et al. (U.S. Pub. 2017/0224975) which has a single sentence discussing that electronic chip 305 can be provided with information that the tube has been used a maximum permitted number of times (¶0068). However, there is no teaching or suggestion that receiving the information that the tube has been used a maximum permitted number of times would then lead to a processor of the system causing a change of operation mode during operation.
It is thus found that the overall requirements of amended claim 18 would not have been prima facie obvious to one having ordinary skill in the art at the time of the effective filing of the invention without improper hindsight reasoning.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”

CITED REFERENCE SUMMARIES: Ref US6656127B1: [content unavailable]
Ref US6935338B1: Claims:
An airway adaptor comprising: (a) a tubular body having a first gas flow passage defined therein and a longitudinal axis extending along the first gas flow passage; and (b) a protrusion extending from an interior wall of the tubular body into the gas flow passage, wherein the protrusion includes: (1) a distal end portion spaced apart from the interior wall of the tubular body, and wherein at least a first portion of the distal end portion is defined in a first plane that is generally parallel to the longitudinal axis, and (2) a second gas flow passage defined through the protrusion having an inlet defined in the first portion of the distal end portion, and an outlet at an exterior portion of the tubular body; and (c) a pair of sidewalls extending from the distal end portion of the protrusion such that each sidewall is defined in a second plane is generally parallel to the longitudinal axis, wherein the inlet of the second gas flow passage is disposed between the pair of sidewalls, and wherein the first plane is generally perpendicular to the second plane.
(a) a tubular body having a first gas flow passage defined therein and a longitudinal axis extending along the first gas flow passage; and
(b) a protrusion extending from an interior wall of the tubular body into the gas flow passage, wherein the protrusion includes: (1) a distal end portion spaced apart from the interior wall of the tubular body, and wherein at least a first portion of the distal end portion is defined in a first plane that is generally parallel to the longitudinal axis, and (2) a second gas flow passage defined through the protrusion having an inlet defined in the first portion of the distal end portion, and an outlet at an exterior portion of the tubular body; and
(1) a distal end portion spaced apart from the interior wall of the tubular body, and wherein at least a first portion of the distal end portion is defined in a first plane that is generally parallel to the longitudinal axis, and
(2) a second gas flow passage defined through the protrusion having an inlet defined in the first portion of the distal end portion, and an outlet at an exterior portion of the tubular body; and
(c) a pair of sidewalls extending from the distal end portion of the protrusion such that each sidewall is defined in a second plane is generally parallel to the longitudinal axis, wherein the inlet of the second gas flow passage is disposed between the pair of sidewalls, and wherein the first plane is generally perpendicular to the second plane.
The airway adaptor of claim 1 , wherein the protrusion is substantially tubular.
The airway adaptor of claim 1 , wherein the protrusion is formed of substantially hydrophobic material.
The airway adaptor of claim 1 , wherein the protrusion is substantially centrally located on the tubular body and extends into the first gas flow passage in a direction that is substantially perpendicular to the longitudinal axis.
The airway adapter of claim 1 , wherein the protrusion is detachable from the tubular body.
The airway adapter of claim 1 , wherein a channel is defined between the sidewalls, with the inlet of the second gas flow passage being located at a bottom of the channel.
The airway adapter of claim 1 , wherein the second gas flow passage through the protrusion is defined by a plurality of bores having different diameters.
The airway adapter of claim 1 , wherein each sidewall in the pair of sidewalls includes a substantially planar surface, and wherein the planar surfaces are oriented such that the planar surfaces face one another.
The airway adapter of claim 8 , wherein the planar surfaces are tapered such that a distance between the planar surfaces decreases as a distance toward the distal end portion decreases.
The airway adapter of claim 1 , wherein a channel is defined at a junction between each sidewall and a surface of the protrusion at the distal end portion.
The airway adapter of claim 1 , wherein the distal end portion includes a first surface generally parallel to the direction of the flow of gas through the first passage and a raised surface extending from the first surface, and wherein the inlet is defined in the raised surface.
The airway adapter of claim 1 , further comprising a coupling portion extending from an exterior wall of the tubular body adapted to be coupled to a conduit, and wherein the coupling portion includes a third gas flow passage in fluid communication with the second gas flow passage.
An airway adaptor comprising: (a) a tubular body having a first gas flow passage defined therein and a longitudinal axis extending along the first gas flow passage; and (b) a protrusion extending from an interior wall of the tubular body into the gas flow passage in a direction generally perpendicular to the longitudinal axis and terminating at a distal end portion that is spaced apart from the interior wall of the tubular body; (c) a second gas flow passage defined in the protrusion having an inlet at the distal end portion and an outlet at an exterior portion of the tubular body; (d) a first sidewall extending from a first side of the distal end portion of the protrusion in a cantilevered fashion, wherein the first sidewall extends from the protrusion in a direction that is generally perpendicular to the longitudinal axis; and (e) a second sidewall extending from a second side of the distal end portion of the protrusion in a cantilevered fashion, wherein the second sidewall extends from the protrusion in a direction that is generally perpendicular to the longitudinal axis, and wherein the inlet of the second gas flow passage is disposed between the pair of sidewalls.
(b) a protrusion extending from an interior wall of the tubular body into the gas flow passage in a direction generally perpendicular to the longitudinal axis and terminating at a distal end portion that is spaced apart from the interior wall of the tubular body;
(c) a second gas flow passage defined in the protrusion having an inlet at the distal end portion and an outlet at an exterior portion of the tubular body;
(d) a first sidewall extending from a first side of the distal end portion of the protrusion in a cantilevered fashion, wherein the first sidewall extends from the protrusion in a direction that is generally perpendicular to the longitudinal axis; and
(e) a second sidewall extending from a second side of the distal end portion of the protrusion in a cantilevered fashion, wherein the second sidewall extends from the protrusion in a direction that is generally perpendicular to the longitudinal axis, and wherein the inlet of the second gas flow passage is disposed between the pair of sidewalls.
The airway adapter of claim 13 , wherein a channel is defined between the first sidewall and the second sidewalls with the inlet of the second gas flow passage being located at a bottom of the channel.
The airway adapter of claim 13 , wherein the second gas flow passage through the protrusion is defined by a plurality of bores having different diameters.
The airway adapter of claim 13 , wherein the first sidewall includes a first substantially planar surface, wherein the second sidewall includes a second substantially planar surface, and wherein the first planar surface and the second planar surface generally face one another.
The airway adapter of claim 16 , wherein the first and the second planar surfaces are tapered such that a distance between the planar surfaces decreases as a distance toward the distal end portion decreases.
The airway adapter of claim 13 , wherein the distal end portion includes a first surface generally parallel to the direction of the flow of gas through the first passage and a raised surface extending from the first surface, and wherein the inlet is defined in the raised surface.
The airway adapter of claim 13 , further comprising: a first channel defined at a first junction between the first sidewall and a surface of the protrusion at the distal end portion; and a second channel defined at a second junction between the second sidewall and the surface of the protrusion at the distal end portion.
a first channel defined at a first junction between the first sidewall and a surface of the protrusion at the distal end portion; and
a second channel defined at a second junction between the second sidewall and the surface of the protrusion at the distal end portion.
Ref US20060278221A1: Claims:
A process for the automatic identification of a type of a breathing tube, the process comprising: providing a respirator with a reading unit; providing a memory element connected to a breathing tube, the memory element having data identifying the breathing tube stored thereon; and reading data from the memory element with the reading unit which is part of the respirator, when the breathing tube is brought into the vicinity of the respirator.
providing a respirator with a reading unit;
providing a memory element connected to a breathing tube, the memory element having data identifying the breathing tube stored thereon; and
reading data from the memory element with the reading unit which is part of the respirator, when the breathing tube is brought into the vicinity of the respirator.
A process for the automatic identification of the type of a breathing tube in accordance with claim 1 , wherein the memory element is read when the breathing tube is operatively connected to the respirator.
A process in accordance with claim 1 , further comprising: identifying when the breathing tube is not suitable for an intended mode of respiration or identifying a mode of respiration that does not fit the breathing tube set at the respirator; and triggering an alarm upon identifying when the breathing tube is not suitable for an intended mode of respiration or upon identifying a mode of respiration that does not fit the breathing tube set at the respirator.
identifying when the breathing tube is not suitable for an intended mode of respiration or identifying a mode of respiration that does not fit the breathing tube set at the respirator; and
triggering an alarm upon identifying when the breathing tube is not suitable for an intended mode of respiration or upon identifying a mode of respiration that does not fit the breathing tube set at the respirator.
A process in accordance with claim 1 , further comprising: performing a check to determine whether the breathing tube is correctly connected to the respirator; and triggering an alarm if the breathing tube is not connected correctly to the respirator.
performing a check to determine whether the breathing tube is correctly connected to the respirator; and
triggering an alarm if the breathing tube is not connected correctly to the respirator.
A process in accordance with claim 1 , wherein the reading unit includes a writing and reading unit and further comprising: writing additional data to the memory unit to store additional data in the memory element connected to the breathing tube while the breathing tube is connected to the respirator.
writing additional data to the memory unit to store additional data in the memory element connected to the breathing tube while the breathing tube is connected to the respirator.
A process in accordance with claim 5 , wherein respiration parameters are stored as additional data.
A process in accordance with claim 5 , wherein at least one or more of patient data, accounting data, therapy data, diagnostic data and data that log the use of the breathing tube are stored as additional data.
A process in accordance with claim 5 , wherein stored respiration parameters are read from the memory unit and these respiration parameters are taken over by the respirator upon connection of the breathing tube to the respirator.
A process in accordance with claim 5 , further comprising: providing a central hospital logistics unit or a patient management system wherein stored data are read from the memory element and these data are processed and passed on to the central system of the hospital logistics unit or to the patient management system.
providing a central hospital logistics unit or a patient management system wherein stored data are read from the memory element and these data are processed and passed on to the central system of the hospital logistics unit or to the patient management system.
A process in accordance with claim 8 , further comprising: providing an additional respiration device; and reading stored respiration parameters from the memory unit and taking these respiration parameters over by the additional respirator upon connection of the breathing tube to the additional respirator.
providing an additional respiration device; and
reading stored respiration parameters from the memory unit and taking these respiration parameters over by the additional respirator upon connection of the breathing tube to the additional respirator.
A respirator system for the automatic recognition of the type of a breathing tube, the system comprising: a respirator; a breathing tube which can be connected to said respirator; a memory element having stored thereon data identifying said breathing tube, said memory element being rigidly connected to said breathing tube; and a memory element reading unit for reading of data from the memory element when the breathing tube is located in the vicinity of the respirator.
a breathing tube which can be connected to said respirator;
a memory element having stored thereon data identifying said breathing tube, said memory element being rigidly connected to said breathing tube; and
a memory element reading unit for reading of data from the memory element when the breathing tube is located in the vicinity of the respirator.
A system in accordance with claim 11 , wherein said memory element reading unit is integrated in a pneumatic interface at the respirator and is designed such that reading takes place when said breathing tube compatible with that interface is connected.
A system in accordance with claim 11 , wherein the breathing tube memory element has data storage means, which can be read and written on in case of a connected said respirator.
A system in accordance with claim 11 , further comprising control means performing an automatic adaptation of the mode of respiration to the type of the breathing tube after the type of the breathing tube has been recognized.
A system in accordance with claim 11 , further comprising alarm means for triggering an alarm when said breathing tube that is not suitable for an intended mode of respiration is identified or a mode of respiration that does not fit the identified breathing tube is set on the respirator.
A system in accordance with claim 11 , further comprising connection means for determining whether the breathing tube is connected correctly to the respirator and which triggers an alarm when the breathing tube is not connected correctly to the respirator.
A system in accordance with claim 11 , further comprising data transmission means associated with a data storage means of said memory element, said data transmission means associated with said data storage means comprising a radio frequency identification (RFID) system.
A system in accordance with claim 17 , wherein said data transmission means and associated said data storage means of said memory element is an RFID tag rigidly connected to the breathing tube.
A system in accordance with claim 13 , wherein said data storage means is for storing respiration parameters.
A system in accordance with claim 13 , wherein said data storage means is for storing patient data, accounting data, therapy data and/or diagnostic data.
A system in accordance with claim 11 , wherein: said respirator has a pneumatic interface between said respirator and said breathing tube; said memory element reading unit and said memory element are associated with contactless transmission means for a contactless transmission of data between said respirator and said breathing tube, said contactless transmission means being integrated in the pneumatic interface between the respirator and the breathing tube.
said respirator has a pneumatic interface between said respirator and said breathing tube;
said memory element reading unit and said memory element are associated with contactless transmission means for a contactless transmission of data between said respirator and said breathing tube, said contactless transmission means being integrated in the pneumatic interface between the respirator and the breathing tube.
A system in accordance with claim 11 , said memory element reading unit and said memory element are associated with means for coding and decoding data transmitted between said memory element reading unit and said memory element and/or stored data.
A system in accordance with claim 11 , further comprising means whereby information stored on said memory element prohibits the further use of the breathing tube.
A system in accordance with claim 11 , further comprising: an additional respirator with an additional respirator memory element reading unit for reading stored respiration parameters from the memory unit and taking these respiration parameters over for operation of the additional respirator upon connection of the breathing tube to the additional respirator.
an additional respirator with an additional respirator memory element reading unit for reading stored respiration parameters from the memory unit and taking these respiration parameters over for operation of the additional respirator upon connection of the breathing tube to the additional respirator.
Ref US20090275851A1: Claims:
A bite block assembly adapted for capnography and oxygen delivery to a subject, said bite block assembly comprising: a first capnography passageway adapted for passage therethrough of exhaled breath from said subject to a capnograph; and a second oxygen delivery passageway, separate from said first passageway, adapted for passage therethrough of oxygen from an oxygen source to the mouth of said subject.
A bite block assembly according to claim 1 , and also including a gas collection cannula having formed therein said first capnography passageway.
A bite block assembly according to claim 2 , and wherein said gas collection cannula also comprises an oxygen delivery cannula adapted to deliver oxygen from said oxygen source to the nostrils of said subject.
A bite block assembly according to claim 3 and wherein said oxygen delivery cannula is connected to said oxygen source by a gas delivery tube.
A bite block assembly according to claim 1 , and also comprising a bite block having formed therein said second oxygen delivery passageway.
A bite block assembly according to claim 3 , and also comprising a tube element adapted to connect said oxygen delivery cannula to said second oxygen delivery passageway.
A bite block assembly according to claim 6 and wherein said tube element comprises a branch of said gas delivery tube, and is adapted to connect to said second oxygen delivery passageway.
A bite block assembly according to claim 7 and wherein said tube element is sealed by a normally closed valve.
A bite block assembly according to claim 8 and wherein said normally closed valve comprises a luer valve.
A bite block assembly according to claim 9 and wherein a mating luer portion of said luer valve is mounted onto said oxygen delivery passageway.
A bite block assembly according to claim 6 and wherein said tube element is permanently mounted onto said bite block and is adapted to connect to said gas delivery tube at a connection point formed therein.
A bite block assembly according to claim 11 and wherein said connection point is sealed by a normally closed valve.
A bite block assembly according to claim 12 and wherein said normally closed valve comprises a luer valve.
A bite block assembly according to claim 13 and wherein a mating luer portion of said 
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