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 .
Status of Claims
The present office action is in response to the Remarks and Amendment filed 08/15/2024. As directed by the amendment, claim 1 has been cancelled, and claims 2-21 have been newly added. Thus, claims 2-21 are presented pending in this application.
Claim Objections
Claims 9, and 13-14 are objected to because of the following informalities:
Claim 9 recites, “expiratory volume” in ln 2 which Examiner suggest amending to read --expiratory volume.-- as it is missing a ‘.’ at the end of the claim.
Claim 13 recites, “when flow rate” in ln 2 which Examiner suggest amending to read --when the flow rate--
Claim 14 recites, “when flow rate” in ln 2 which Examiner suggest amending to read --when the flow rate--
Appropriate correction is required.
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.
The following limitation is interpreted under 35 U.S.C. 112(f) in accordance with the above presumptions:
A processing arrangement in claim 2
The following is considered the corresponding structure for the above limitation:
An integrated circuit, microprocessor, controller, external processor, or a computer, such as a laptop, or PC or a remote processor or mobile processing device such as a server, tablet, or mobile device as described in ¶0081,0099.
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-6, 10-17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe et al. (US 20090118633 A1; cited in IDS filed on 08/15/2024) in view of Levitsky et al. (US 20110009763 A1; cited in IDS filed on 08/15/2024).
Regarding claim 2, Jaffe et al. discloses, a method for estimating an exhaled gas measurement during flow respiratory therapy where a flow of respiratory gases dilutes exhaled gases(Fig 7; ¶0052-0056, implies a method for estimating an exhaled gas measurement using a gas measurement 110 of Fig 7 and a ventilation measurement component 120 of Fig 7 where a flow of respiratory gases dilutes exhaled gases as described in ¶0058), the method comprising:
providing a flow respiratory therapy to a patient (¶0033, “ mechanical ventilation of the patient”);
receiving an exhaled gas measurement (110, Fig 7; ¶0052, “The gas concentration or partial pressure values…to gas sensor 14 and CO.sub.2 signal unit 18”);
receiving flow data (120, Fig 7; ¶0053, “Ventilation values measured at the airway or via other technologies…to flow, volume, pressure, temperature, and humidity or any combination thereof”); and
determining a compensated exhaled gas measurement (¶0054-0055, “ The gas concentration values from gas measurement component 110 and ventilation measurement component 120 are received by the end-tidal gas measurement component 130…Characteristics of the received ventilation values are used by the end-tidal gas measurement component 130 to derive a more robust end-tidal gas value from the gas concentration values) using a processing arrangement (an end-tidal measurement component 130, Fig 7; ¶0054, “…implementing end-tidal gas measurement component 130 via processing unit 20 of FIG. 1”) based on the exhaled gas measurement and the flow data.
While Jeff et al. discloses that the method using the flow and/or pressure waveform to better delineate the end of expiration (¶0038) and a simulation shown with a flow, a volume and an alveolar CO2 as shown in Figs 8A and 8B, Jeff et al. does not specifically discloses, the flow respiratory therapy providing a flow of gases with a varying flow parameter.
However, Levitsky et al. which is analogous art to the claimed invention for a system for sampling exhaled breath and for supply of a gas (abstract), teaches the flow respiratory therapy providing a flow of gases with a varying flow parameter (¶0069--0078, implies varying flow parameter having reduced flow during a predetermined period of time, so thus reducing substantial dilution during the measurement; Figs 8A-8B represents a gas flow at a predetermined duty cycles as described in ¶0085-0088) in purpose of enhancing the reliability of the measurement of sampled exhaled breath (¶0034,0047).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jeff et al. to include the flow respiratory therapy providing a flow of gases with a varying flow parameter as taught by Levitsky et al. in purpose of enhancing the reliability of the measurement of sampled exhaled breath (¶0034,0047).
Regarding claim 3, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, wherein the flow respiratory therapy is provided via a non-sealing patient interface (displaced “nasal cannula” in Table 1).
Regarding claim 4, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, wherein receiving the exhaled gas measurement comprises receiving an exhaled gas measurement from a capnometer (¶0035, “gas sensor 14 capable of measuring carbon dioxide content in a patient's exhaled breath… CAPNOSTAT.RTM.”; ¶0067, implies the method of Jeffe et al. uses the capnometer).
Regarding claim 5, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, wherein the flow respiratory therapy is nasal high flow respiratory therapy (see “high flow oxygen” and displaced nasal cannula” in Table 1).
Regarding claim 6, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, wherein determining the compensated exhaled gas measurement comprises determining an estimate of flow rate dilution (Examiner notes that Table 1 of Jeffe et al. discusses the effects on PetCO2 during high oxygen flow therapy or nasal cannula as the CO2 concentration is diluted by the ambient air or the incoming oxygen as noted in ¶0058-0059 which implies identifying the estimate of flow rate dilution in order to achieve the reliable/viable estimate of arterial CO2 via different methods/approach as described in ¶0049-0051 and further using the ventilation parameters as described in ¶0054).
Regarding claim 10, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Jeffe et al. further discloses, wherein the varying flow parameter is a flow rate (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 11, Jaffe et al. in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Jeffe et al. further discloses, wherein the flow rate is varied during expiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 12, Jaffe et al. in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Jeffe et al. further discloses, wherein the flow rate is reduced during expiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 13, Jaffe et al. in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Jeffe et al. further discloses, wherein the exhaled gas measurement is obtained when flow rate is altered (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 14, Jaffe et al. in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Jeffe et al. further discloses, wherein the exhaled gas measurement is taken when flow rate is reduced (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 15, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Jeffe et al. further discloses, wherein the flow of gases is pulsed at a transition between expiration and inspiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation while the flow is increased during inhalation).
Regarding claim 16, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Jeffe et al. further discloses, wherein the flow of gases is breath dependent (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 17, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Jeffe et al. further discloses, wherein the flow of gases is oscillatory (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation while the flow is increased during inhalation).
Regarding claim 20, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, displaying the compensated exhaled gas measurement (¶0033, “a gas measurement system…a data display”; ¶0056, “The reliability may be based simply on a threshold of ventilatory stability and may be indicated on the display of the host system numerically or graphically”).
Regarding claim 21, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Jeffe et al. further discloses, wherein the method is performed during anesthesia (¶0032, “respiratory gases, such as oxygen, nitrous oxide, nitric oxide, and other gases, such as anesthetic agents”; ¶0057, “during… patient controlled anesthesia”).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe et al. (US 20090118633 A1; cited in IDS filed on 08/15/2024) in view of Levitsky et al. (US 20110009763 A1; cited in IDS filed on 08/15/2024) as applied to claim 2 above, and further in view of Lewis et al. (US 20070175473 A1).
Regarding claim 18, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
While Jeffe et al. discloses a filtering rules to account for dilatation of the gas sample during the high oxygen flow therapy (Table 1; ¶0058-0067), Jeffe et al. is silent on a flow rate of gases.
However, Lewis et al. which is analogous art to the claimed invention for a high flow therapy system (abstract) and measuring gas data such as a gas flow rate and a carbon dioxide content (¶0068), teaches a flow rate between 10-100 L/min (¶0104, “a gas flow rate of up to about 60 liters per minute… about to 40 liters per minute”) in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jaffe et al. to include wherein the flow of gases is provided to the patient with a flow rate between 10 -100 L/min as taught by Lewis et al. in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Regarding claim 19, Jaffe et al. in view of Levitsky et al. discloses the method of claim 2 as discussed above.
While Jeffe et al. discloses a filtering rules to account for dilatation of the gas sample during the high oxygen flow therapy (Table 1; ¶0058-0067), Jeffe et al. is silent on a flow rate of gases.
However, Lewis et al. which is analogous art to the claimed invention for a high flow therapy system (abstract) and measuring gas data such as a gas flow rate and a carbon dioxide content (¶0068), teaches a flow rate between 10-100 L/min (¶0104, “a gas flow rate of up to about 60 liters per minute… about to 40 liters per minute”) in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jaffe et al. to include wherein the flow of gases is provided to the patient with a flow rate between 40-80 L/min as taught by Lewis et al. in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 10, and 17 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent 10,722,143.
Although the claims at issue are not identical, they are not patentably distinct from each other as per the following mapping because the cited patent anticipate and/or make obvious the claimed invention.
Regarding claim 2, Patent ‘143 discloses a method for estimating an exhaled gas measurement during flow respiratory therapy where a flow of respiratory gases dilutes exhaled gases, the method comprising (claim 1, ln 1-2):
providing a flow respiratory therapy to a patient (claim 1, ln 1-4 implies providing high flow therapy to a patient), the flow respiratory therapy providing a flow of gases with a varying flow parameter (claim 7, ln 1-3; claim 9, ln 1-2);
receiving an exhaled gas measurement (claim 1, ln 6-7);
receiving flow data (claim 1, ln 8-9); and
determining a compensated exhaled gas measurement using a processing arrangement based on the exhaled gas measurement and the flow data (claim 1, ln 9-11).
Regarding claim 10, Patent ‘143 discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein the varying flow parameter is a flow rate (claim 7, ln 1-3; claim 9, ln 1-2).
Regarding claim 17, Patent ‘143 discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein the flow of gases is oscillatory (claim 7, ln 1-3; claim 9, ln 1-2).
Claims 2-3, 10, 17 and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,048,527.
Although the claims at issue are not identical, they are not patentably distinct from each other as per the following mapping because the cited patent anticipate and/or make obvious the claimed invention.
Regarding claim 2, Patent ‘527 discloses a method for estimating an exhaled gas measurement during flow respiratory therapy where a flow of respiratory gases dilutes exhaled gases, the method comprising (claim 1, ln 1-2):
providing a flow respiratory therapy to a patient (claim 1, ln 28-35, implies providing a flow respiratory therapy to a patient via a cannula), the flow respiratory therapy providing a flow of gases with a varying flow parameter (claim 12, ln 1-2; claim 14, ln 1-2);
receiving an exhaled gas measurement (claim 1, ln 3-4);
receiving flow data (claim 1, ln 28-30); and
determining a compensated exhaled gas measurement using a processing arrangement based on the exhaled gas measurement and the flow data (claim 1, ln 9-14, ln 24-27, ln 31-35).
Regarding claim 3, Patent ‘527 discloses the method of claim 2 as discussed above.
Patent ‘527 further discloses, wherein the flow respiratory therapy is provided via a non-sealing patient interface (claim 1, ln 28-35, implies providing a flow respiratory therapy to a patient via a cannula).
Regarding claim 10, Patent ‘527 discloses the method of claim 2 as discussed above.
Patent ‘527 further discloses, wherein the varying flow parameter is a flow rate (claim 12, ln 1-2; claim 14, ln 1-2).
Regarding claim 17, Patent ‘527 discloses the method of claim 2 as discussed above.
Patent ‘527 further discloses, wherein the flow of gases is oscillatory (claim 12, ln 1-2; claim 14, ln 1-2).
Regarding claim 20, Patent ‘527 discloses the method of claim 2 as discussed above.
Patent ‘527 further discloses, displaying the compensated exhaled gas measurement (claim 1, ln 9-15).
Claims 2-6, 8, 10-17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 13-17, and 20 of U.S. Patent No. 10722143 in view of Levitsky et al. (US 20110009763 A1; cited in IDS filed on 08/15/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other as per the following mapping because the cited patent anticipate and/or make obvious the claimed invention.
Regarding claim 2, Patent ‘143 discloses a method for estimating an exhaled gas measurement during flow respiratory therapy where a flow of respiratory gases dilutes exhaled gases, the method comprising (claim 1, ln 1-2; claim 13, ln 1-2):
providing a flow respiratory therapy to a patient (claim 1, ln 1-4 implies providing high flow therapy to a patient; claim 13, ln 10-12),
receiving an exhaled gas measurement (claim 1, ln 6-7; claim 13, ln 3);
receiving flow data (claim 1, ln 8-9; claim 13, ln 4); and
determining a compensated exhaled gas measurement using a processing arrangement based on the exhaled gas measurement and the flow data (claim 1, ln 9-11; claim 13, ln 5-9).
Patent ‘143 does not discloses, the flow respiratory therapy providing a flow of gases with a varying flow parameter.
However, Levitsky et al. which is analogous art to the claimed invention for a system for sampling exhaled breath and for supply of a gas (abstract), teaches the flow respiratory therapy providing a flow of gases with a varying flow parameter (¶0069--0078, implies varying flow parameter having reduced flow during a predetermined period of time, so thus reducing substantial dilution during the measurement; Figs 8A-8B represents a gas flow at a predetermined duty cycles as described in ¶0085-0088) in purpose of enhancing the reliability of the measurement of sampled exhaled breath (¶0034,0047).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Patent ‘143 to include the flow respiratory therapy providing a flow of gases with a varying flow parameter as taught by Levitsky et al. in purpose of enhancing the reliability of the measurement of sampled exhaled breath (¶0034,0047).
Regarding claim 3, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein the flow respiratory therapy is provided via a non-sealing patient interface (claim 1, ln 4; claim 13, ln 10-12).
Regarding claim 4, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein receiving the exhaled gas measurement comprises receiving an exhaled gas measurement from a capnograph or capnometer (claim 3, ln 1-2; claim 4, ln 1-2; claim 14, ln 1-3; claim 15, ln 1-3).
Regarding claim 5, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein the flow respiratory therapy is nasal high flow respiratory therapy (claim 16, ln 1-2).
Regarding claim 6, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein determining the compensated exhaled gas measurement comprises determining an estimate of flow rate dilution (claim 13, ln 5-9).
Regarding claim 8, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, wherein determining the compensated exhaled gas measurement comprises determining an estimate of expiratory volume dilution (claim 6, ln 1-3; claim 17, ln 1-3).
Regarding claim 10, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Patent ‘143 further discloses, wherein the varying flow parameter is a flow rate (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 11, Patent ‘143 in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Patent ‘143 further discloses, wherein the flow rate is varied during expiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 12, Patent ‘143 in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Patent ‘143 further discloses, wherein the flow rate is reduced during expiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 13, Patent ‘143 in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Patent ‘143 further discloses, wherein the exhaled gas measurement is obtained when flow rate is altered (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 14, Patent ‘143 in view of Levitsky et al. discloses the method of claim 10 as discussed above.
Modified Patent ‘143 further discloses, wherein the exhaled gas measurement is taken when flow rate is reduced (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation).
Regarding claim 15, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Patent ‘143 further discloses, wherein the flow of gases is pulsed at a transition between expiration and inspiration (Levitsky et al.: ¶0069-0078,0085-0088; Figs 8A-8B; Examiner notes Levitsky et al. teaches the reduced flow during the exhalation while the flow is increased during inhalation).
Regarding claim 16, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Patent ‘143 further discloses, wherein the flow of gases is breath dependent.
Regarding claim 17, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Modified Patent ‘143 further discloses, wherein the flow of gases is oscillatory.
Regarding claim 20, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
Patent ‘143 further discloses, displaying the compensated exhaled gas measurement (claim 5, ln 1-4).
Claims 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 13 of U.S. Patent No. 10,722,143 in view of Levitsky et al. (US 20110009763 A1; cited in IDS filed on 08/15/2024) as applied to claim 2 above, and further in view of Lewis et al. (US 20070175473 A1).
Regarding claim 18, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
While Patent ‘143 discloses high flow respiratory therapy (claim 1, ln 1-2), Patent ‘143 does not specifically discloses, wherein the flow of gases is provided to the patient with a flow rate between 10 -100 L/min.
However, Lewis et al. which is analogous art to the claimed invention for a high flow therapy system (abstract) and measuring gas data such as a gas flow rate and a carbon dioxide content (¶0068), teaches a flow rate between 10-100 L/min (¶0104, “a gas flow rate of up to about 60 liters per minute… about to 40 liters per minute”) in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Patent ‘143 to include wherein the flow of gases is provided to the patient with a flow rate between 10 -100 L/min as taught by Lewis et al. in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Regarding claim 19, Patent ‘143 in view of Levitsky et al. discloses the method of claim 2 as discussed above.
While Patent ‘143 discloses high flow respiratory therapy (claim 1, ln 1-2), Patent ‘143 does not specifically discloses, wherein the flow of gases is provided to the patient with a flow rate between 40-80 L/min.
However, Lewis et al. which is analogous art to the claimed invention for a high flow therapy system (abstract) and measuring gas data such as a gas flow rate and a carbon dioxide content (¶0068), teaches a flow rate between 10-100 L/min (¶0104, “a gas flow rate of up to about 60 liters per minute… about to 40 liters per minute”) in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Patent ‘143 to include wherein the flow of gases is provided to the patient with a flow rate between 40-80 L/min as taught by Lewis et al. in order to provide the high flow therapy and minimize or eliminate the entrainment of ambient air (¶0104-0107).
Allowable Subject Matter
Claims 7 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 8 would be allowable if rewritten to overcome the rejection(s) under double patenting, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: the closest identified prior art of record are Jaffe et al. (US 20090118633 A1; cited in IDS filed on 08/15/2024) and Colman et al. (US 20110066061 A1).
Jaff et al. identifies the source of etCO2 error due to dilation of the gas sample (Table 1; ¶0058-0059) and various approaches of determining reliable/viable estimate of arterial CO2 (¶0048-0051), but the prior art does not specifically teach or suggest determining a compensate exhaled gas measurement based on the flow data including total patient expiratory volume, or is used in the determination of total patient expiratory volume and/or wherein determining the compensated exhaled gas measurement comprises determining an estimate of expiratory volume dilution.
Colman et al. also identifies the supply of oxygen interfering with the accuracy of the CO2 measurements in exhaled breath of the patient (¶0061), but the prior art does not suggest or teach the determination involving the use of the total patient expiratory volume or determining an estimate of expiratory volume dilution.
No other prior art is found which alternately would obviously satisfy the overall requirements of the instant claim. It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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