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 .
Drawings
The drawings are objected to because in figs. 1-2, the rectangular boxes having reference numerals “11” and “29” should be labeled with a descriptive text, since the rectangular box is a generic graphical representation. See 37 CFR 1.83(a) and examiner note to Formed Paragraph 6.22 in MPEP section 608.02(b).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2 and 5-6 are objected to because of the following informalities:
In claim 1, line 11-12, the term “and is inhaled by a user” is suggested to be changed to --and is configured to be inhaled by a user-- in order to make it clear that the user is not being positively claimed.
In claim 2, line 4, the term “the second filer” is suggested to be changed to --the second filter-- in order to fix typographical error.
In claim 5, line 4, the term “the therapeutic gas enters a body of the user” is suggested to be changed to --the therapeutic gas is configured to enter a body of the user-- in order to make it clear that the user is not being positively claimed.
In claim 6, lines 2 and 4, the term “enters the body” is suggested to be changed to --configured to enter the body-- in order to make it clear that the user is not being positively claimed.
In claim 6, line 3, the term “the nebulizer (32), which specifically comprises” is suggested to be changed to --the nebulizer (32) comprises-- in order to clarify the claim.
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.
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: the limitation “carbon dioxide monitoring AI (artificial intelligence) module…the carbon dioxide monitoring AI module predicts the respiratory state of the user (34) on the physiological information based on comprehensive data analysis AI algorithm, determines a ratio of the carbon dioxide and the oxygen according to the respiratory state, and sets the determined ratio of the carbon dioxide and the oxygen to a preset ratio” (claim 10, line 3 and lines 8-12, wherein the term “module” is a generic placeholder and the function is “carbon dioxide monitoring AI” and “predicts the respiratory state of the user (34) on the physiological information based on comprehensive data analysis AI algorithm, determines a ratio of the carbon dioxide and the oxygen according to the respiratory state, and sets the determined ratio of the carbon dioxide and the oxygen to a preset ratio”).
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.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“carbon dioxide monitoring AI module”: carbon dioxide monitoring AI module 40 in pages 16 and 17 of the specification, it is noted 40 is a reference numeral for the carbon dioxide monitoring AI module, however, the corresponding structure(s) is/are missing from the specification, see the 112(a) and 112(b) rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “carbon dioxide monitoring AI (artificial intelligence) module…the carbon dioxide monitoring AI module predicts the respiratory state of the user (34) on the physiological information based on comprehensive data analysis AI algorithm, determines a ratio of the carbon dioxide and the oxygen according to the respiratory state, and sets the determined ratio of the carbon dioxide and the oxygen to a preset ratio” (claim 10, line 3 and lines 8-12) is a term that invokes 112(f), however, the specification fails to provide any corresponding structure for the limitation “carbon dioxide monitoring AI (artificial intelligence) module” is. Pages 14-16 of the specification filed on 4/12/2024 discloses the term “the carbon dioxide monitoring AI module” but fails to disclose the corresponding structure(s) for the module. Therefore, the limitation contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “comprehensive data analysis AI algorithm” (claim 10, lines 9-10) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification discloses the term “AI algorithm” in pages 5, 14 and 16, but provides no written description on what the comprehensive data analysis AI algorithm is.
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.
Claims 1-10 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.
Regarding claim 1, the limitation “set in a ventilator” (line 5) is unclear as to what is the structural relationship between the ventilator and the breathing device, therefore, it is unclear if the ventilator is part of the breathing device or not.
Regarding claim 1, the limitation “all of which” (lines 4-5) is unclear as to what are being included in the term “all of which”, does the term “all of which” include the air source pipeline, the low pressure oxygen source pipeline, the high pressure oxygen source pipeline, the carbon dioxide source pipeline and the gas supply pipeline, or the air source pipeline, the low pressure oxygen source pipeline, the high pressure oxygen source pipeline, the carbon dioxide source pipeline and the gas supply pipeline and the breathing device or a subset of the air source pipeline, the low pressure oxygen source pipeline, the high pressure oxygen source pipeline, the carbon dioxide source pipeline and the gas supply pipeline.
Regarding claim 1, the limitation “a third check valve” (line 10) is unclear if there are a first check valve and a second check valve being claimed or not. To claim a third check valve without claiming a first check valve and a second check valve makes it unclear if the first check valve and the second check valve are being positively claimed or not.
Regarding claim 3, the limitation “a third filter (413)” (line 2) is unclear if there are a first filter and a second filter being claimed or not. To claim a third filter without claiming a first filter and a second filter makes it unclear if the first filter and the second filter are being positively claimed or not. It is noted that claim 3 does not depend on claim 2.
Regarding claim 3, the limitation “a second pressure sensor” (lines 3-4) is unclear if a first pressure sensor is being claimed or not. To claim a second pressure sensor without claiming a first pressure sensor makes it unclear if the first pressure sensor is being positively claimed or not. It is noted that claim 3 does not depend on claim 2.
Regarding claim 3, the limitation “the ratio reaches a preset value” (line 17) is unclear if the preset value is the same as or different from “a preset ratio” being claimed in claim 1, line 20 or not.
Regarding claim 4, the limitation “a fourth pressure sensor” (lines 2-3) is unclear if a first pressure sensor, a second pressure sensor and a third pressure sensor are being claimed or not. To claim a fourth pressure sensor without claiming a first pressure sensor, a second pressure sensor and a third pressure sensor makes it unclear if a first pressure sensor, a second pressure sensor and a third pressure sensor are being claimed or not.
Regarding claim 4, the limitation “the fourth pressure sensor (35) detects a gas concentration in the gas supply pipeline” (lines 6-7) is unclear if the applicant is claiming a pressure sensor or a concentration sensor. It is noted that the claim is claiming “pressure sensor”, however, the claim further claim that the gas sensor is for detecting a gas concentration.
Regarding claim 5, the limitation “a fifth pressure sensor” (line 3) is unclear if a first pressure sensor, a second pressure sensor, a third pressure sensor and a fourth pressure sensor are being claimed or not. To claim a fourth pressure sensor without claiming a first pressure sensor, a second pressure sensor, a third pressure sensor and a fourth pressure sensor makes it unclear if a first pressure sensor, a second pressure sensor, a third pressure sensor and a fourth pressure sensor are being claimed or not.
Regarding claim 9, the limitation “the a flow control valve” (lines 3-4) is unclear if the claim limitation is trying to claim --the flow control valve-- or --a flow control valve--.
Regarding claim 9, the limitation “the third flow control valve (17)” (line 5) lacks proper antecedent basis. Furthermore, it is unclear if the “third flow control valve” is referring to “the a flow control valve” being claimed in claim 9, lines 3-4.
Regarding claim 9, the limitation “a fifth filter” (lines 3) is unclear if a first filter and a second filter are being claimed or not, to claim a fifth filter without claiming a first filter and a second filter makes it unclear if a first filter and a second filter are being claimed or not.
Any remaining claims are rejected for their dependency on a rejected base claim.
Claim limitation “carbon dioxide monitoring AI (artificial intelligence) module…the carbon dioxide monitoring AI module predicts the respiratory state of the user (34) on the physiological information based on comprehensive data analysis AI algorithm, determines a ratio of the carbon dioxide and the oxygen according to the respiratory state, and sets the determined ratio of the carbon dioxide and the oxygen to a preset ratio” (claim 10, line 3 and lines 8-12) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Pages 14-16 of the specification filed on 4/12/2024 discloses the term “the carbon dioxide monitoring AI module” but fails to disclose the corresponding structure(s) for the module. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2022/0241528) in view of Baba (JP-H0984876).
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Regarding claim 1, McCormick discloses a breathing device (entire breathing device shown in fig. 8) with carbon dioxide (see fig. 8 and atmospheric air at 9, paragraph 0078, atmospheric air would have some carbon dioxide), which comprises an air source pipeline (30d, fig. 8, paragraphs 0078), a low pressure oxygen source pipeline (30a, fig. 8, paragraph 0077, pipeline 30a is connected to low pressure oxygen source 8a, paragraph 0075), a high pressure oxygen source pipeline (30b, fig. 8, paragraphs 0076-0077, pipeline 30b is connected to high pressure oxygen source 8b, paragraphs 0074-0077), a gas supply pipeline (see the annotated-McCormick fig. 8 above) all of which are set in a ventilator (the ventilator is 2 or the housing of 2, see fig. 2a and fig. 8 for reference, as shown, all of the pipelines are positioned in 2); a breathing pipeline (14 or 14’, see figs. 3-4B and 8, paragraphs 0038-0040) which is set outside the ventilator (see figs. 3-4B and fig. 8), wherein air from an air source (atmospheric air source in fig. 8 that is connected to 30d, fig. 8, paragraph 0078) enters the ventilator through the air source pipeline (see 30d, fig. 8), low pressure oxygen from a low pressure oxygen source (source 8a, fig. 8, paragraphs 0075 and 0077-0078) is mixed with the air in the air source pipeline through the low pressure oxygen source pipeline (see the annotated-McCormick fig. 8 above, paragraphs 0075-0078); mixed breathing gas enters the gas supply pipeline which is located behind a third check valve (54, see the annotated-McCormick fig. 8 above and paragraph 0079), is transmitted outside the ventilator (as shown the annotated-McCormick fig. 8 above, the gas mixed with the atmospheric air is provided to the patient via 60 and 14, see paragraphs 0074-0080) through the gas supply pipeline, and is inhaled by a user (patient at the receiving end of 14, see figs. 3-4B and 8) through the breathing pipeline (see the annotated-McCormick fig. 8 above); high pressure oxygen from a high pressure oxygen source (8b, fig. 8, paragraphs 0062 and 0065-0066) enters the ventilator through the high pressure oxygen source pipeline (30b), the oxygen from the high pressure oxygen source and the air formed a therapeutic gas, the therapeutic gas enters the gas supply pipeline, is transmitted outside the ventilator through the gas supply pipeline, and is inhaled by the user through the breathing pipeline for treatment (see paragraphs 0074-0080, McCormick discloses that high pressure oxygen and air are provided to the patient through the breathing pipeline, the higher pressure oxygen source and the air formed a therapeutic gas that enters the gas supply pipeline and is transmitted outside the ventilator through the gas supply pipeline and inhaled by the user through the breathing pipeline for treatment), wherein the gas mixed with the high pressure oxygen in a preset ratio so as to adjust a content of oxygen and air in a body of a user (see fig. 8 and paragraphs 0074-0080, the high pressure oxygen is mixed with the atmospheric air at a particular ratio based on the design of the system, therefore, would be a preset ratio and would be used to adjust content of oxygen and air in a body of a user, furthermore, McCormick discloses that the blower module 26 is controllable and discloses in paragraphs 0076 and 0083 a regulator 36), but fails to disclose that the breathing device is with carbon dioxide compensation function, a carbon dioxide source pipeline, carbon dioxide gas from a carbon dioxide source and the high pressure oxygen in the high pressure oxygen source pipeline are mixed through the carbon dioxide source pipeline and form a therapeutic gas; wherein the carbon dioxide gas is mixed with the high pressure oxygen in a preset ratio, so as to adjust a content of carbon dioxide in a body of the user.
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However, Baba teaches a breathing device (1a, fig. 1, paragraphs 0001 and 0012-0019 of the English translation) is with carbon dioxide compensation function (see carbon dioxide being controlled mix in 1d via controlled valve 1b, paragraphs 0014 and 0018), a carbon dioxide source pipeline (see the annotated-Baba fig. 1 above, the pipeline includes 1n, 1b, 1h, 1m and 1d), carbon dioxide gas from a carbon dioxide source (see source of CO2 connected to 1n and 1b) and an oxygen in an oxygen source pipeline are mixed through the carbon dioxide source pipeline and form a therapeutic gas; wherein the carbon dioxide gas is mixed with the oxygen in a preset ratio, so as to adjust a content of carbon dioxide in a body of the user (see paragraphs 0011-0018, 0033 and 0036), Baba further discloses a carbon dioxide sensor positioned on a gas supply pipeline for detecting a carbon dioxide in the gas supply pipeline (see carbon dioxide sensor 1u, paragraphs 0016, 0024 and 0028, the pipeline where 1u is located on is considered as the gas supply pipeline).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the high pressure oxygen pipeline of McCormick to be connected to a carbon dioxide source and a carbon dioxide source pipeline as taught by Baba and to have the carbon dioxide sensor as taught by Baba to be positioned on the gas supply pipeline of the modified McCormick as taught by Baba for the purpose to providing carbon dioxide therapy to the user when needed, thereby, providing comfort to the patient who are in needs of carbon dioxide therapy (see paragraphs 0011-0018, 0033 and 0036 of Baba).
Regarding claim 4, the modified McCormick discloses an oxygen sensor (49, fig. 8, paragraph 0078 of McCormick), a fourth pressure sensor (57, fig. 8 and paragraph 0040 of McCormick) and a gas flow sensor (47, fig. 8, and paragraph 0078 of McCormick) are provided on the gas supply pipeline (see fig. 8 of McCormick); the oxygen sensor (49, fig. 8, paragraph 0078 of McCormick) detects an oxygen concentration in the gas supply pipeline, the fourth pressure sensor (57, fig. 8 and paragraph 0040 of McCormick) detects a gas concentration in the gas supply pipeline, and the gas flow sensor (47, fig. 8, and paragraph 0078 of McCormick) detects a gas flow in the gas supply pipeline, the modified McCormick discloses a carbon dioxide sensor being provided on the gas supply pipeline, the carbon dioxide sensor detects a carbon dioxide concentration in the gas supply pipeline (see carbon dioxide sensor 1u in fig. 1 and paragraphs 0016, 0024 and 0028 of Baba).
Regarding claim 9, the modified McCormick discloses that the breathing device further comprises an auxiliary gas source pipeline (pipe line comprising 79c, 83c, 86c, 82c, 88c, 287, 30c, see fig. 8 and paragraphs 0050-0052, 0082-0092 of McCormick), the auxiliary gas source pipeline is provided with a fifth filter (82c, fig. 8 and paragraph 0087 of McCormick) and a third flow control valve (88c, fig. 8, paragraph 0087, see the valve 88a in fig. 6 and paragraph 0083 of McCormick for reference) and a seventh pressure sensor (85c, fig. 8, paragraph 0087 of McCormick) is located between the fifth filter and the third flow control valve (see fig. 8); auxiliary gas from an auxiliary gas source (gas from 12c in fig. 8 of McCormick) is mixed with the high pressure oxygen and the carbon dioxide gas through the auxiliary gas source pipeline, and mixed gas enters the gas supply pipeline (paragraphs 0050-0052, 0082-0092 of McCormick, see the annotated-McCormick fig. 8 above, the gas from 12c travels to the high pressure oxygen line 30b to be mixed with the high pressure oxygen when the gas from 12c is depleted and is at the same pressure as the regulator 36, furthermore, the gas being within the high pressure oxygen pipeline would be mixed with the carbon dioxide gas after the modification with Baba, the mixed gas would then enter the gas supply pipeline, see the annotated-McCormick fig. 8 above).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2022/0241528) in view of Baba (JP-H0984876) as applied to claim 1 above, and further in view of Chang (2016/0287824) and Liu (CN 113967222).
Regarding claim 2, the modified McCormick discloses a first filter (47, fig. 8, paragraph 0078 of McCormick) is provided on the air source pipeline (30d of McCormick, see the annotated-McCormick fig. 8 above), a second filter (32a, fig. 8 and paragraphs 0075-0077 of McCormick) and a first check valve (34a, fig. 8, paragraphs 0075-0077 of McCormick) are provided on the low pressure oxygen source pipeline (30a, fig. 8 of McCormick), the low pressure oxygen flows through the second filter and first check valve in sequence and enters an oxygen flow sensor (41, fig. 8, paragraphs 0075-0078 of McCormick), the low pressure oxygen and the air from the oxygen flow sensor enter a breathing gas generator (26 comprising 56, fig. 8 and paragraphs 0039, 0049 and 0078 of McCormick) through a line (45, fig. 8 of McCormick, see the line section of 45 that is between the sensor 41 and the blower module 26) between the flow sensor and the breathing gas generator (see the annotated-McCormick fig. 1 above), and are mixed by the breathing gas generator forming a breathing gas (see fig. 8 of McCormick); the breathing gas enters the gas supply pipeline through the third check valve (54, fig. 8 and paragraph 0079 of McCormick), but fails to disclose that the low pressure oxygen and the air from the oxygen flow sensor enter a breathing gas generator through a second check valve and a first pressure sensor is provided on the low pressure oxygen source pipeline and is located between the first check valve and the oxygen flow sensor for measuring a pressure of the low pressure oxygen in the low pressure oxygen source pipeline.
However, Chang teaches a check valve positioned between a flow sensor and a mixing point, wherein the check valve is positioned downstream of the flow sensor (10, fig. 3, paragraph 0247) and upstream of a mixing point (see fig. 3, as shown, the check valve 22 is downstream from the flow sensor 10 and is upstream of the mixing point, the mixing point is mixing chamber 19, paragraphs 0261-0264).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the line between the gas generator and the first flow sensor of the modified McCormick to have the check valve as taught by Chang for the purpose of providing accurate flow measurement of the oxygen being provided to the flow gas generator, by preventing any back flow that could take place throughout the operation of the device.
After the modification, the second check valve is the check valve of Chang placed between the flow sensor (10 of McCormick) and the gas generator (26 of McCormick).
The modified McCormick fails to disclose a first pressure sensor is provided on the low pressure oxygen source pipeline and is located between the first check valve and the oxygen flow sensor for measuring a pressure of the low pressure oxygen in the low pressure oxygen source pipeline.
However, Liu teaches a pressure sensor (3, fig. 1) is provided on an oxygen source pipeline (pipeline where 2, 3, 4, 5 are being positioned on, see fig. 1) and is located upstream of an oxygen flow sensor (6, fig. 1, paragraph 0030) for measuring a pressure of the oxygen in the oxygen source pipeline (paragraphs 0012, 0018, 0030 and 0035).
The modified McCormick fails to disclose a first pressure sensor is provided on the low pressure oxygen source pipeline of the modified McCormick to have the first pressure sensor as taught by Martin to be positioned upstream from the flow sensor (10 of McCormick) of the modified McCormick as taught by Liu for the purpose of monitoring the pressure within the low oxygen pipe line in order to control the pressure and flow within the low oxygen pipe line to the needed level (paragraphs 0012, 0018, 0030 and 0035 of Liu).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2022/0241528) in view of Baba (JP-H0984876) as applied to claim 1 above, and further in view of Anderson (5,237,987), Oldfield (2021/0052844), Boulanger (CA 02849155), Eichelman (3,593,710) and Wang (CN 109498928).
Regarding claim 5, the modified McCormick discloses a breathing pipeline (see the annotated-McCormick fig. 8 above), but fails to disclose a humidifier and a nebulizer are provided on a breathing pipeline, a fifth pressure sensor is located between the humidifier and the nebulizer, the breathing gas or the therapeutic gas enters a body of the user through the nebulizer, atomizing gas of the nebulizer is from the high pressure oxygen in the high pressure oxygen source pipeline, the high pressure oxygen enters an atomizing pipeline through a shut-off valve, and then enters the nebulizer through a first throttle valve for atomizing medication.
However, Anderson teaches a humidifier (40, fig. 1) and a nebulizer (42 and 48, fig, 1) are provided on a breathing pipeline (36, fig. 1, col 6, lines 13-62).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the breathing pipeline of the modified McCormick to have the humidifier and nebulizer as taught by Anderson for the purpose of providing comfort to the patient by providing humidified air and medication that are needed by the patient (see col 6, lines 13-62 of Anderson).
After the modification, the breathing gas or the therapeutic gas enters a body of the user through the nebulizer (see fig. 1 of Anderson). The modified McCormick fails to disclose that the a fifth pressure sensor is located between the humidifier and the nebulizer.
However, Oldfield teaches a pressure sensor (18b, fig. 1, paragraph 0233, Oldfield discloses that the sensor 18b can be a pressure sensor) that is directly downstream from the humidifier (17, fig. 1, paragraphs 0233-0234).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the humidifier of the modified McCormick to have pressure to be positioned directly downstream from the humidifier of the modified McCormick as taught by Oldfield for the purpose of controlling the device to provide the needed gas flow to the patient (see paragraphs 0233-0234 of Oldfield).
After the modification with Oldfield, the pressure sensor 18b of Oldfield would be the fifth pressure sensor that is positioned between the humidifier and nebulizer of Anderson. The modified McCormick fails to disclose atomizing gas of the nebulizer is from the high pressure oxygen in the high pressure oxygen source pipeline, the high pressure oxygen enters an atomizing pipeline through a shut-off valve, and then enters the nebulizer through a first throttle valve for atomizing medication.
However, Boulanger teaches atomizing gas for a nebulizer is from the high pressure oxygen (see the high pressure O2 source (9a) extending to the nebulizer via line 11, fig. 1) in a high pressure oxygen source pipeline (see nebulizer in fig. 1, see page 5, paragraph 3 of the English translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the nebulizer of the modified McCormick to be connected to the high pressure oxygen source pipeline of the modified McCormick as taught by Boulanger for the purpose of providing an alternative high pressure source that is capable of providing atomization to the nebulizer (see page 5, paragraph 3 of the English translation of Boulanger).
After the modification, the atomizing pipeline (11 of Boulanger) would connect the high pressure oxygen source to the nebulizer. The modified McCormick fails to disclose that the high pressure oxygen enters an atomizing pipeline through a shut-off valve, and then enters the nebulizer through a first throttle valve for atomizing medication.
However, Eichelman teaches a shut-ff valve (15, fig. 1) for controlling a pressure line (see line 16, col 6, lines 14-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modify the atomizing pipeline of the modified McCormick to have the shut-off valve as taught by Eichelman for the purpose of providing user control that would allow the user to turn off the nebulizer when needed (see col 6, lines 14-41 of Eichelman).
The modified McCormick fails to disclose that the high pressure oxygen enters an atomizing pipeline to the nebulizer through a first throttle valve for atomizing medication.
However, Wang teaches a first throttle valve for controlling atomizing pressure for an atomizing pipeline (see throttle valve S1 and 1 in fig. 1, see paragraphs 0030-0041).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the atomizing pipeline of the modified McCormick to have the throttle valve as taught by Wang for the purpose of effectively providing needed pressure to effectively control the nebulization of a particular medication (see paragraph 0038 of Wang).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2022/0241528) in view of Baba (JP-H0984876), Anderson (5,237,987), Oldfield (2021/0052844), Boulanger (CA 02849155), Eichelman (3,593,710) and Wang (CN 109498928) as applied to claim 5 above, and further in view of Kruger (2017/0361043).
Regarding claim 7, the modified McCormick discloses a fifth pressure sensor (pressure sensor 18b of Oldfield that is positioned between the humidifier and the nebulizer), but fails to disclose that the fifth pressure sensor is connected with an alarm; when the fifth pressure sensor detects that a pressure exceeds a preset range, an alarm instruction is sent to the alarm, and the alarm sends out an abnormal pressure alarm to remind occurrence of gas path blockage or gas leakage.
However, Kruger teaches a pressure sensor connected with an alarm, when the pressure sensor detects that a pressure exceeds a preset range, an alarm instruction is sent to the alarm, and the alarm sends out an abnormal pressure alarm to remind occurrence of gas path blockage (see paragraphs 0019-0020, 0098, 0101 and 0117-0124, Kruger discloses that pressure measured values 99 and flow measured values 97 are obtained and the pressure alarm event 105 is a pressure alarm event, which occurs if the pressure measured values 99 exceed a predefined pressure threshold value 104 and hence the event 105 is considered to be valid, the preset range is the range of pressures that exceeds the threshold, furthermore, Kruger discloses that alarm cause 111 is related to alarm caused by the patient, while alarm cause 113 can be caused by machine, therefore, the alarm trigger an abnormal pressure alarm related to a blockage, would be to remind occurrence of gas path blockage).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fifth pressure sensor of the modified McCormick to detect that a pressure exceeds a preset range, an alarm instruction is sent to the alarm, and the alarm sends out an abnormal pressure alarm to remind occurrence of gas path blockage as taught by Kruger for the purpose of providing safety to the user by alerting the user of abnormal air pressure (see paragraphs 0019-0020, 0098, 0101 and 0117-0124 of Kruger).
Allowable Subject Matter
Claims 3, 6, 8 and 10 are allowed over the prior art.
Claims 3, 6 and 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li (CN 113413529) is cited to show a device comprising a high pressure oxygen source and a low pressure oxygen source.
Kagan (WO 2016001448) is cited to show a respiratory device comprising oxygen and a gas flow generator.
Lundby (WO 2018/137780) is cited to show a system comprising an oxygen source and a carbon dioxide source.
FR 3098727 is cited to show a ventilator comprising high pressure oxygen and low pressure oxygen.
Heesch (FR 2977163) is cited to sow a respiratory device comprising an oxygen source and a nitrogen source.
Kreb (2002/0185126) is cited to show breathing system comprising an oxygen source and a carbon dioxide source.
Turner (2020/0345914) is cited to show a control system comprises an oxygen source and a carbon dioxide source.
Boulanger (2019/0321576) is cited to show a gas mixer for providing a gas mixture to a mechanical ventilator.
Tector (2016/0346498) is cited to show a respiratory therapy device comprising a ventilator connected to a gas source.
Brunetto Tancredi (2020/0368464) is cited to show an AI module for a respiratory device. Friberg (2013/0239968) is cited to show a breathing circuit.
Davenport (6,378,520) is cited to show a nebulizer connected to a high oxygen pressure line.
Lepel (2007/0049841) is cited to show a medication delivery device.
Martin (2014/0144434) is cited to show an oxygen delivering system comprising an oxygen pressure sensor and an oxygen flow sensor.
Choncholas (2007/0062532) is cited to show a breathing circuit comprising a nebulizer and a humidifier.
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/TU A VO/Primary Examiner, Art Unit 3785