Office Action 2: Notice of Allowance (2025-02-26)

CLAIMS:
AMENDMENTS TO THE CLAIMS

A listing of all claims and their current status in accordance with 37 C.F.R. § 1.121(c) is provided below.

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1-17. (Cancelled).216

18\. (Currently Amended) A method of operating a capnography system, comprising:receiving, at one or more processors, first data indicative of a carbon dioxide (C02) concentration in exhaled breath of a subject from a CO2 sensor of a CO2 sensing system and second data indicative of information associated with a tubing system in response to the tubing system being coupled to the CO2 sensing system, wherein the second data is received from a communication component associated with the tubing system;
  and
changing , by the one or more processors, \[\[of\]\] an operation mode of the C02 sensing system during operation of the C02 sensing system based on the second data indicative of the information associated with the tubing system .

19\. (Currently Amended) The method of claim 18, wherein the second data comprises an indication of a property of the tubing system, the method further comprising:
changing , by the one or more processors, \[\[of\]\] the operation mode of the C02 sensing system based on the indication,
wherein the property of the tubing system comprises a length of the ubing 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.

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20\. (Currently Amended) The method of claim 18, wherein the second data comprises an indication of a manufacturing detail of the tubing system, the method further comprising:
changing , by the one or more processors, \[\[of\]\] the operation mode of the C02 sensing system\[\[,\]\] based on the indication,
wherein the manufacturing detail 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.

21-24. (Cancelled).2223

25\. (Currently Amended) The method of claim 18, further comprising\[\[,\]\]:determining, by the one or more processors, a change of the operation mode based on the second data indicative of the information associated with tubing system;
sending, by the one or more processors, the change in the operation mode of the CO2 sensing system to a user interface associated with the C02 sensing system; and
causing display, by the one or more processors, of the change of the operation mode on the user interface associated with the C02 sensing system.

26\. (Currently Amended) The method of claim 18, wherein the tubing system comprises an intubation tube, and wherein changing the operation mode of the C02 sensing system comprises causing, by the one or more processors, an increase in a speed of a pump of the CO2 sensing system upon intubation of the subject and until a first CO2 signal is obtained by the C02 sensor.

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27\. (Currently Amended) 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, andinitiating use of an algorithm configured to reduce nuisance alarms during insufflation.

28\. (Currently Amended) 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.

29\. (Currently Amended) The method of claim 18,further comprising, determining, by the one or more processors, one or more breath related parameters based on the first data indicative of the CO2 concentration, wherein changing the operation mode of the CO2 sensing system comprises, by the one or more processors, at least one of identifying aberrations in C02 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 ilution.

30\. (Currently Amended) The method of claim 18, further comprising:receiving, at the one or more processors, usage data based on the second data indicative of the information associated with the tubing system, 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 \[\[a\]\]the CO2 sensing system, a number of uses/connections of the tubing system to an additional C02 sensing system, or any combination thereof; \[\[and\]\]

Page 5 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; and
causing, by the one or more processors, transmission of the signal to the communication component associated with the tubing system.

31\. (Currently Amended) The method of claim 18, wherein changing he operation mode of the CO2 sensing system comprises changing an operation of \[\[the\]\]a pump associated with the CO2 sensing system based on the second data indicative of the information associated with the tubing system .

32\. (New) The method of claim 18, wherein the second data comprises an indication of operational data associated with the tubing system and a manufacturing detail of the tubing system, the method further comprising transferring, by the one or more processors, the second data to a remote computational unit communicatively coupled to the capnography system.

33\. (New) The method of claim 32, wherein the remote computational unit is configured to integrate the operational data with the manufacturing detail, thereby enabling identification of a defective tubing system prior to use or distribution of the defective tubing system.

34\. (New) The method of claim 18, wherein the communication component comprise a 1-wire electrically erasable programmable read-only memory (EEPROM).

35\. (New) The method of claim 30, wherein the signal terminating the usability of the tubing system is configured to adjust a status associated with the tubing system, the method further comprising:receiving, at the one or more processors, an indication of the adjusted status associated with the tubing system;
inactivate, by the one or more processors, the CO2 sensing system; and

Amendment, Interview Summary, and Response to Office Action mailed on October 29, 2024 Page 6 cause, by the one or more processors, display of a notification indicating the adjusted status associated with the tubing system.

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.”

APPLICANT REBUTTAL: REMARKS
In the Office Action, the Examiner rejected claims 18-20, and 25-31. By the present response, the Applicant amends claims 18-20, and 25-31, and adds new claims 32-35. The amendments and new claims do not add any new matter, and support can be found in at least paragraphs 35-42, 44, 46-49, 56, and 57 of the originally filed application. Upon entry of these amendments and new claims, claims 18-20, and 25-35 will be pending in the present application and are believed to be in condition for allowance. In view of the foregoing amendments and the following interview summary and remarks, the Applicant respectfully requests reconsideration and allowance of all pending claims.
Interview Summary
A telephonic interview with the Examiner and the Applicant's representative, Madison West (Reg. No. 78,838), was conducted on December 23, 2024. During the interview, the partiesdiscussed proposed claim amendments to overcome the rejection of claims 20, 26, and 31 under 35 U.S.C. § 112(b), the rejection of claims 18-20, 25-29, and 31 under 35 U.S.C. § 101, and the rejection of independent claim 18 under 35 U.S.C. § 102. With regards to the rejection under 35 U.S.C. §§ 112(b) and 101, the Examiner agreed that the proposed amendments appear to overcome the current rejections. With regards to the rejection under 35 U.S.C. § 102, the Examiner agreed that the proposed amendments appear to overcome the current rejection though further search and consideration may be required. The amendments to claims 18, 20, 26, and 31 presented herein generally correspond to the proposed amendments that were discussed during the interview. The Applicant welcomes the Examiner to contact the Applicant's representatives with any further suggested amendments to move the application toward allowance. The Applicant thanks the Examiner for their courtesy in granting and conducting the interview.
Objection to Claim 30
In the Office Action, the Examiner objected to claim 30 for minor informalities. See Office Action, page 2. The Applicant respectfully submits that claim 30 has been amended to recite, "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 the C02 sensing system, a number of uses/connections of
the tubing system to an additional CO2 sensing system, or any combination thereof." The Applicant submits that the amendments to claim 30 correct the minor informalities noted by the Examiner. In view of these amendments, the Applicant respectfully requests withdrawal of the objection to claim 30.
Rej
ections under 35 U.S.C.
&
112(b)
In the Office Action, the Examiner rejected claims 20, 26, and 31 under 35 U.S.C. § 112(b) as being allegedly indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. See Office Action, page 2. The Applicant respectfully submits that amended claims 20, 26, and 31 are definite and distinctly claim the subject matter regarded as the invention. Indeed, as mentioned in the Interview Summary above, the Examiner indicated that the amendments presented in amended claims 20, 26, and 31 appear to overcome the current rejection. Thus, Applicant respectfully requests withdrawal of the rejection of claims 20, 26, and 31 under 35 U.S.C. § 112(b).
Rej
ections under 35 U.S.C.
&
In the Office Action, the Examiner rejected claims 18-20, 25-29, and 31 under 35 U.S.C. § 101 as allegedly being directed to an abstract idea of a mental process without significantly more. See Office Action, page 3. The Applicant respectfully traverses this rejection.
Legal Precedent and Guidelines
The Patent Office has articulated a multi-step test for evaluating the eligibility of claims under 35 U.S.C. § 101. See IPEP 2106(III). Step 1 asks whether the claim is directed to a process, a machine, an article of manufacture, or a composition of matter. See id. If not, the claim is not eligible; if so, the claim is analyzed under Step 2A. See id. Step 2A, Prong 1 asks whether the claim recites a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea). See id. at page 15. If not, the claim is patent eligible; if so, further analysis is required under Step 2A, Prong 2. See id. Step 2A, Prong 2 asks whether the claim recites additional elements that integrate the exception into a practical application of the exception. See id. at page 16. If so, the claim is eligible; if not, further analysis under step 2B is required. See id. Step 2B asks whether
the claim recites additional elements that amount to "significantly more" (e.g., an inventive concept) than the abstract idea. See id. at pages 22 and 23. If yes, the claim is eligible; if not, the claim is not eligible. See id.
Independent claim 18 is patent eligible.
Although the Applicant does not necessarily agree with the rejection of independent claim 18, the Applicant presently amends claim 18 to expedite prosecution. As amended, claim 18 recites, inter alia,
receiving, at one or more processors, first data indicative of a carbon dioxide (CO2) concentration in exhaled breath of a subject from a CO2 sensor of a CO2 sensing system and second data indicative of information associated with a tubing system in response to the tubing system being coupled to the CO2 sensing system, wherein the second data is received from a communication
component associated with the tubing system; and
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.
The Applicant respectfully submits that amended independent claim 18 is patent eligible. Indeed, as mentioned in the Interview Summary above, the Examiner indicated that the amendments presented in amended claim   18 appear to overcome the current rejection. Accordingly, the Applicant respectfully requests reconsideration and withdrawal of the rejection of claims 18-20, 25-29, and 31 under 35 U.S.C. § 101.
Rej
ections under 35 U.S.C.
&
In the Office Action, the Examiner rejected claims 18, 26, and 31 under 35 U.S.C. § 102 as allegedly anticipated by Weiss et al. (U.S. Publication No. 2016/0073929; hereinafter "Weiss"). The Applicant respectfully traverses this rejection.
Legal Precedent
Anticipation under section 102 can be found only if a single reference shows exactly what is claimed. Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 U.S.P.Q. 773 (Fed. Cir. 1985).
For a prior art reference to anticipate under section 102, every element of the claimed invention must be identically shown in a single reference. In re Bond, 910 F.2d 831, 15 U.S.P.Q.2d 1566 (Fed. Cir. 1990). To maintain a proper rejection under section 102, a single reference must teach each and every limitation of the rejected claim. Atlas Powder v. E.I. du Pont, 750 F.2d 1569 (Fed. Cir. 1984). Accordingly, the Applicant needs only point to a single element not found in the cited reference to demonstrate that the cited reference fails to anticipate the claimed subject matter. The prior art reference also must show the identical invention "in as complete detail as contained in the... claim" to support a prima facie case of anticipation. Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 U.S.P.Q. 2d 1913, 1920 (Fed. Cir. 1989).
Weiss does not anticipate independent claim 18.
Although the Applicant does not necessarily agree with the rejection of independent claims 18, the Applicant presently amends claims 18 to expedite prosecution. As amended, claim 18 recites, inter alia,
receiving, at one or more processors, first data indicative of a carbon dioxide (CO2) concentration in exhaled breath of a subject from a CO2 sensor of a CO2 sensing system and second data indicative of information associated with a tubing system in response to the tubing system being coupled to the CO2 sensing system, wherein the second data is received from a communication
component associated with the tubing system; and
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.
The Applicant respectfully submits that Weiss is silent as to at least these features of amended claim 18, and thus cannot anticipate amended claim 18. Indeed, as mentioned in the Interview Summary above, the Examiner indicated that the amendments presented in amended
claim 18 appear to overcome the current rejection. Accordingly, the Applicant submits that Weiss does not disclose all elements of amended claim 18, and thus cannot anticipate amended claim 18. Additionally, the Applicant submits that Weiss does not disclose all elements of dependent claims 26 and 31, at least because of their dependency on independent claim 18, and thus cannot anticipate these dependent claims. Accordingly, the Applicant respectfully requests reconsideration and withdrawal of the rejection of claims 18, 26, and 31 under 35 U.S.C. § 102.
Rej
ections under 35 U.S.C.
&
In the Office Action, the Examiner rejected claims 19 and 20 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Colman et al. (U.S. Publication No. 2014/0014729; hereinafter "Colman '729"); claim 25 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Coleman et al. (U.S. Publication No. 2017/0325716; hereinafter "Coleman '716"); claim 27 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Colman et al. (U.S. Publication No. 2009/0275851; hereinafter "Colman '851") and Boyer (U.S. Publication No. 2016/0093205; hereinafter "Boyer"); claim 28 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Colman et al. (U.S. Publication No. 2010/0317986; hereinafter "Colman '986"); claim 29 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Colman et al. (U.S. Publication No. 2011/0040713; hereinafter "Colman '713"); and claim 30 under 35 U.S.C. § 103 as allegedly obvious over Weiss in view of Ben-Oren et al. (U.S. Patent No. 6,656,127; hereinafter "Ben-Oren"). The Applicant respectfully traverses these rejections.
Legal Precedent
The burden of establishing a prima facie case of obviousness falls on the Examiner. Ex parte Wolters and Kuypers, 214 U.S.P.Q. 735 (B.P.A.I. 1979). To establish prima facie obviousness of a claimed invention, all the claim limitations must be taught or suggested by the prior art. In re Royka, 180 U.S.P.Q. 580 (C.C.P.A. 1974). However, a claimed invention composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art. KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 1741 (2007). The KSR court stated that "it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in
the way the claimed new invention does ... because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known." Id. Specifically, there must be some articulated reasoning with a rational underpinning to support a conclusion of obviousness; a conclusory statement will not suffice. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Indeed, the factual inquiry determining whether to combine references must be thorough and searching, and it must be based on
objective evidence of record.
In re Lee, 61 U.S.P.Q.2d 1430, 1436 (Fed. Cir. 2002).
Dependent claims 19, 20, 25, and 27-30.
Claims 19, 20, 25, and 27-30 depend from amended independent claim 18. As mentioned above, claim 18 is allowable over Weiss. In addition, the Applicant respectfully submits that Colman '729, Coleman '716, Colman '851, Boyer, Colman '986, Colman '713, and Ben-Oren do not cure the deficiencies of Weiss with respect to claim 18, and thus cannot support aprimafacie case of obviousness for claims 19, 20, 25, and 27-30. Accordingly, the Applicant respectfully requests reconsideration and withdrawal of the rejections of claims 19, 20, 25, and 27-30 under 35 U.S.C. § 103.
New claims 32-35
As noted above, the Applicant adds new claims 32-35, which recite additional features not disclosed by the cited references. Support for the new claims may be found in at least paragraphs 46-49, 56, and 57 of the originally filed specification. The Applicant notes that no excess claims fees are due for the new claims. The Applicant respectfully requests allowance of the new claims based at least on their respective dependencies from independent claim 18, as well as the separate elements therein.
Authorization for Extensions of Time and Payment of Fees
In accordance with 37 C.F.R. § 1.136, the Applicant hereby provides a general authorization to treat this and any future reply requiring an extension of time as incorporating a request thereof. The Applicant submits that no fees are currently due in association with the present response. However, if any additional fees are required at this or any other time, then the Applicant authorizes the Commissioner to charge such fees to Deposit Account No. 06-1315; Order No. C00016861USO1DIV/1215-248.
Conclusion


CITED REFERENCE SUMMARIES: Ref US6656127: Claims:
1. A method of performing a breath test, comprising the steps of:
using a predetermined criterion for determining when a change in a measurement of an isotopic ratio of at least one breath sample of a subject is clinically significant; and allowing said criterion to change during said breath test.
2. The method according to claim 1 and wherein said change in said measurement comprises the deviation of said isotopic ratio from a measurement of at least one previous sample of said subject.
3. The method according to claim 2 and wherein said measurement of at least one previous sample of said subject is a baseline measurement.
4. The method according to claim 1 and wherein said change in said measurement comprises the rate of change of said isotopic ratio.
5. The method according to claim 1 and wherein said criterion is a function of the elapsed time of the test.
6. The method according to claim 1 and wherein said criterion is a function of the noise level of the instrument performing said test.
7. The method according to claim 1 and wherein said criterion is a function of the physiological results of said test.
8. A breath test method, comprising the steps of:
performing a first measurement of the isotopic ratio of at least a first breath sample of a subject;
performing a second measurement of the isotopic ratio of at least a second breath sample of said subject; and
determining when said second measurement shows sufficient deviation from said first measurement that a clinically significant result of the breath test may be concluded;
wherein the level of said sufficient deviation is allowed to undergo variation during said breath test.
9. The method according to claim 8 and wherein said first measurement of the isotopic ratio of at least a first breath sample of said subject is a baseline measurement.
10. The method according to claim 8 and wherein said level of sufficient deviation is at least a function of the elapsed time from ingestion of an identifying substrate by a subject.
11. The method according to claim 8 and wherein said level of sufficient deviation is at least a function of the physiological results of the analysis of at least one of said samples.
12. The method according to claim 8 and wherein said level of sufficient deviation is at least a function of the nature of the results obtained in said breath test.
13. The method according to claim 12 and wherein said nature of the results is at least a function of the standard deviation of the spread of results in said breath test.
14. The method according to claim 12 and wherein said nature of the results is at least a function of the noise level present in said results.
15. The method according to claim 12 and wherein said nature of the results is at least a function of the instrumental drift present in said results.
16. The method according to claim 8 and wherein said level of sufficient deviation covers a range of values between an upper threshold and a lower threshold.
17. The method according to claim 16 and wherein said upper threshold and said lower threshold converge as the test proceeds.
18. The method according to claim 8 and wherein said first measurement of the isotopic ratio of at least a first breath sample of a subject is performed only after significant subsidence of oral activity.
19. The method according to claim 16 and wherein the presence of at least two measurements above said upper threshold within a predetermined time is indicative of a positive result of said breath test.
20. The method according to claim 16 and wherein the presence of at least two successive measurements above said upper threshold is indicative of a positive result of said breath test.
21. The method according to claim 16 and wherein the presence of at least two measurements above said upper threshold in combination with the absence of measurements below said lower threshold is indicative of a positive result of said breath test.
22. The method according to claim 16 and wherein the presence of at least two measurements below said lower threshold within a predetermined time is indicative of a negative result of said breath test.
23. The method according to claim 16 and wherein the presence of at least two successive measurements below said lower threshold is indicative of a negative result of said breath test.
24. The method according to claim 16 and wherein the presence of at least two measurements below said lower threshold in combination with the absence of any measurements above said upper threshold is indicative of a negative result of said breath test.
25. The method according to claim 16 and wherein the presence of at least two successive measurements falling below the upper threshold, with less than a predetermined difference in the value of delta between said three measurements, and with less than a predetermined average slope between them, is indicative of a negative result of said breath test.
26. The method according to claim 16 and wherein the presence of at least two successive measurements falling below the lower threshold, with less than a predetermined average slope between them, is indicative of a negative result of said breath test.
27. A breath test method for determining the presence of a clinically significant state in a subject, comprising the steps of:
performing measurements of the changes from a baseline of an isotopic ratio in a plurality of samples of exhaled breath of said subject, following the effective cessation of oral activity; determining a polynomial which approximates the functional plot of said measurements with time;
calculating a weighted standard deviation of said measurements from said polynomial, wherein for measurements over said baseline by more than a predetermined amount, a predefined fractional part of the measurement is taken, while for measurements not over said baseline by more than said predetermined amount, the measurement is taken in its entirety; and determining whether said weighted standard deviation exceeds a predetermined level.
28. A breath test method comprising the steps of:
performing a measurement of the isotopic ratio of at least a first breath sample of a subject; and
determining when said measurement shows sufficient deviation from a baseline measurement that a clinically significant result of the breath test may be concluded;
wherein said deviation comprises an upper and a lower threshold band of uncertainty, and wherein the extent of this band is dependent on at least one of the parameters selected from the group consisting of the elapsed time of said breath test, the standard deviation of the physiological spread of results, the dynamics of the physiological change in isotopic ratio, the number of points measured in the breath test, the environmental conditions present during the breath test, and the noise and/or drift levels of the instrument executing the breath test.
29. A method for determining the reliability of a breath test, comprising the steps of:
obtaining results from said breath test;
defining a reliability parameter by combining at least one of the criteria selected from the group consisting of the instrument noise and/or drift level, the standard deviation of the physiological spread of results, the dynamics of the physiological change in isotopic ratio, and the time elapsed since ingestion of a labeled substrate; and
using said reliability parameter to assess the results of said breath test according to a predetermined reliability criterion.
30. The method according to claim 29 and wherein said reliability parameter is taken into account in determining when a clinically significant result has been obtained in said breath test, in order to terminate said test.
31. The method according to claim 29 and wherein said reliability parameter is output with the result of the breath test.
32. A breath test instrument comprising:
tubing for collecting breath from a subject; and
a gas analyzer for determining isotopic ratio in said gas;
wherein said gas analyzer monitors changes in an isotopic ratio of a gas in exhaled breath samples of said subject virtually continuously, and determines that said test has a clinically significant outcome in accordance with the ongoing results of said test.
33. A breath test instrument according to claim 32, further comprising a signal for indication that a clinically significant outcome of a breath test has been determined.
34. A breath test instrument according to claim 33, and wherein said signal is a visible signal.
35. A breath rest instrument according to claim 33, and wherein said signal is an audible signal.
36. A breath test instrument according to claim 35, and wherein said signal also indicates the nature of the clinically significant outcome of said breath test.
37. A breath test instrument according to claim 32, such that the outcome of said test is substantially independent of dynamic physiological effects occurring in said subject as a result of background conditions.
38. A breath test instrument according to claim 37, and wherein said background conditions are the result of treatment with a drug therapy.
39. A breath test instrument according to claim 37, and wherein said background conditions are the result of food intake in a period prior to the performance of the breath test.
40. A breath instrument according to claim 39, and wherein the need for a pre-test fast by the subject is obviated.
41. A breath test instrument according to claim 32, and wherein the outcome of said test on said subject undergoing treatment with a gastro-intestinal drug therapy, is obtained more reliably than using corresponding breath tests which do not monitor said changes in an isotopic ratio substantially continuously.
42. A breath test instrument according to claim 32, and wherein the outcome of said test is obtained more reliably than would be obtained by corresponding breath test instruments which do not monitor said changes in an isotopic ratio substantially continuously.
43. A breath test instrument according to claim 32, and in which said outcome of said test is obtained sooner than would be obtained by corresponding breath test instruments which do not monitor said changes in an isotopic ratio substantially continuously.
44. A breath test instrument according to claim 32, and in which said ongoing results of said test enable a positive result to be determined even when said isotopic ratio does not clearly exceed a predetermined threshold level.
45. A breath test instrument according to claim 32, and in which said ongoing results of said test enable a negative result to be determined even when said isotopic ratio exceeds a predetermined threshold level.
46. A breath test instrument according to claim 45, and in which said negative result is determined even when said isotopic ratio exceeds said predetermined threshold level because of instrumental drift.
47. A breath test instrument according to claim 32, and in which said ongoing results of said test enable a negative result to be determine by the detection of correlation between said isotopic ratio and instrumental drift.
Ref US20160073929: Claims:
What is claimed is: 1. A connector, comprising: a memory configured to store data; a first portion configured to connect to a ground connection in a gas sampling device; a second portion configured to connect to a positive connection in the gas sampling device, the second portion further configured to transfer data to and from the memory; and an end configured to be connected with a sampling tube configured to transmit gas to the gas sampling device. 2. The connector of claim 1, wherein the connector comprises a modified luer connector. 3. The connector of claim 1, wherein the first portion comprises a filter. 4. The connector of claim 1, wherein the first portion comprises a ring. 5. The connector of claim 1, wherein the memory stores a unique ID and lot number. 6. The connector of claim 1, wherein the memory stores a recommended duration of use. 7. The connector of claim 1, wherein the memory stores a recommended number of connections. 8. The connector of claim 1, wherein the memory stores a recommended life-time after first connection. 9. The connector of claim 1, wherein the memory stores a duration of operation while connected. 10. The connector of claim 1, wherein the memory stores a date and time of first connection. 11. The connector of claim 1, wherein the memory stores a number of connections made to the connector. 12. A method, comprising: inserting a connector into a gas sampling device, the connector comprising: a memory configured to store data; a first portion configured to connect to a ground connection in a gas sampling device; a second portion configured to connect to a positive connection in the gas sampling device, the second portion further configured to transfer data to and from the memory; and an end configured to be connected with a sampling tube configured to transmit gas to the gas sampling device; and engaging the connector with the gas sampling device and closing an electrical bridge by connecting the first portion and the second portion of the smart connector with the gas sampling device. 13. The method of claim 12, wherein the connector comprises a modified luer connector. 14. The method of claim 12, wherein the first portion comprises a filter. 15. The method of claim 12, wherein the first portion comprises a ring. 16. The method of claim 12, wherein the memory stores a unique ID and lot number. 17. The method of claim 12, wherein the memory stores a recommended duration of use. 18. The method of claim 12, wherein the memory stores a recommended number of connections. 19. The method of claim 12, wherein the memory stores a recommended life-time after first connection. 20. The method of claim 12, wherein the memory stores a duration of operation while connected.
A connector, comprising: a memory configured to store data; a first portion configured to connect to a ground connection in a gas sampling device; a second portion configured to connect to a positive connection in the gas sampling device, the second portion further configured to transfer data to and from the memory; and an end configured to be connected with a sampling tube configured to transmit gas to the gas sampling device.
The connector of claim 1, wherein the connector comprises a modified luer connector.
The connector of claim 1, wherein the first portion comprises a filter.
The connector of claim 1, wherein the first portion comprises a ring.
The connector of claim 1, wherein the memory stores a unique ID and lot number.
The connector of claim 1, wherein the memory stores a recommended duration of use.
The connector of claim 1, wherein the memory stores a recommended number of connections.
The connector of claim 1, wherein the memory stores a recommended life-time after first connection.
The connector of claim 1, wherein the memory stores a duration of operation while connected.
The connector of claim 1, wherein the memory stores a date and time of first connection.
The connector of claim 1, wherein the memory stores a number of connections made to the connector.
A method, comprising: inserting a connector into a gas sampling device, the connector comprising: a memory configured to store data; a first portion configured to connect to a ground connection in a gas sampling device; a second portion configured to connect to a positive connection in the gas sampling device, the second portion further configured to transfer data to and from the memory; and an end configured to be connected with a sampling tube configured to transmit gas to the gas sampling device; and engaging the connector with the gas sampling device and closing an electrical bridge by connecting the first portion and the second portion of the smart connector with the gas sampling device.
The method of claim 12, wherein the connector comprises a modified luer connector.
The method of claim 12, wherein the first portion comprises a filter.
The method of claim 12, wherein the first portion comprises a ring.
The method of claim 12, wherein the memory stores a unique ID and lot number.
The method of claim 12, wherein the memory stores a recommended duration of use.
The method of claim 12, wherein the memory stores a recommended number of connections.
The method of claim 12, wherein the memory stores a recommended life-time after first connection.
The method of claim 12, wherein the memory stores a duration of operation while connected.
Ref US20170224975: Claims:
A Luer connector system comprising: a Luer male connector for a Luer female connector, the Luer male connector comprising: a connector base, said connector base having a base void; a primary male member extending distally, in a first direction, from the connector base, said primary male member including a concentric secondary female member having a female void; a first elongated electrical terminal and a second elongated electrical terminal, the first and second elongated electrical terminals extending along a length of the Luer male connector; and a connection indicator, wherein the first and second elongated electrical terminals are configured to electrically attach to a conductive element that is mounted on a secondary male member of a Luer female connector in order to power up the connection indicator to indicate when the Luer male connector and the Luer female connector mate properly. 2. The Luer connector system as in claim 1, wherein the Luer male connector comprises the connection indicator, said connection indicator comprises a device selected from the group consisting of: a light source, a sound making device and an electromechanical vibrator. 3. The Luer connector system as in claim 2, wherein the light source is optically coupled to an optical fiber. 4. The Luer connector system as in claim 2, wherein the Luer male connector further comprises an optical window through which light originating from the light source is visible. 5. The Luer connector system as in claim 1, wherein the connection indicator resides in said base void. 6. The Luer connector system as in claim 1, wherein the base void comprises a circuit board, wherein the first elongated electrical terminal, second elongated electrical terminal and the connection indicator are mounted on said circuit board. 7. The Luer male connector as in claim 6, wherein each of the first and second electrical terminals has a proximal end and a distal end, each proximal end is mounted on the circuit board and each distal end extends in the first direction into the female void of the secondary female member, wherein the connection indicator is configured to be powered up via the circuit board, via the first and second electrical terminals, and via the conductive element mounted on the secondary male member of the Luer female connector when the Luer male connector and the Luer female connector mate properly. 8. The Luer connector system as in claim 6, wherein the circuit board is ring shaped to enable passage there through of a tube. 9. The Luer connector system as in claim 1, wherein the first and second electrical terminals are pre-conditioned to flex by the conductive element mounted on the secondary male member of the Luer female connector when the Luer male connector and the Luer female connector mate properly. 10. The Luer connector system as in claim 1, wherein the conductive element mounted on the secondary male member comprises two axially spaced apart conductive rings. 11. The Luer connector system as in claim 10, wherein each of the first and second electrical terminals is configured to flexibly contact one of the two conductive rings when the Luer male connector and the Luer female connector mate properly. 12. The Luer connector system as in claim 10, wherein the connection indicator is or resides in an electrical circuit, said electrical circuit interposed between
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