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
This Office Action is in response to a preliminary amendment filed on 3/5/2024. As directed by the preliminary amendment, no claims were canceled, claims 1-20 were amended, and no new claims were added. Thus, claims 1-20 are pending for this application.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10 lines 4-5, “said membrane tube assembly (2) being providing a first flow” should be changed to --said membrane tube assembly (2) providing a first flow-- in order to correct the typographical error.
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 use the word “means,” and are 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:
“means for controlling a flow rate of said retentate gas hypoxic mixture exiting said second outlet” in claim 1
“means for controlling pressure of the pressurized air fed to said inlet” in claim 1
“valve means (21, 22) for regulating said permeate and retentate gas mixtures flowing from said outlets” in claim 1
“means for monitoring at least one body parameter” in claim 7
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. Specifically, the corresponding structure of the “means for controlling flow rate” as recited in paragraph [0046] of the original specification include: a back pressure regulator and/or a feed pressure regulator; the corresponding structure of the “means for controlling pressure” as recited in paragraph [0050] of the original specification include: a feed pressure regulator; and the corresponding structure of the “valve means” as recited in paragraphs [0115], [0120] and [0124] of the specification include: a single valve having two paths, a five way valve, and a three way valve; and the corresponding structures of the “means for monitoring at least one body parameter” as recited in claim 8 includes: a pulse oximeter.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 16, the phrase “a method for operating a device according to claim 1 comprising a dispensing device and comprising means for monitoring at least one body parameter (VPm), for performing intermittent hyperoxic/hypoxic training (IHHT), the method comprising” in lines 1-4 is unclear which limitation of the claim “for performing intermittent hyperoxic/hypoxic training (IHHT)” is directed to (the method? The means for monitoring?). For the purpose of examination, examiner has interpreted the limitation to be directed to the method.
Regarding claim 19, the phrase “with a device for providing hyperoxic/hypoxic breathable gas mixtures” in lines 2-3 is unclear whether the “device” is the same as or different from the device of claim 1 (from which claim 19 depends on via claim 10).
Furthermore, the preamble of the claim 19 recites “a breathable mixture”, but the claim limitations that follow are directed to structures of a system (i.e. unclear how “a breathable mixture” can include a “control unit”), therefore the claim is unclear as to what is being claimed by applicant.
The remaining claims are rejected due to dependence on a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 19 does not further limit the subject matter of the claim upon which it depends (claims 10 and 1) because the limitations in the body of the claim are already recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-14, 16 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kostin (US 2009/0183738).
Regarding claim 1, Kostin discloses (Fig. 1) a device for providing hyperoxic/hypoxic breathable gas mixtures (paragraph [0018]) comprising
at least one membrane tube assembly (gas separation module 4 that includes hollow and spiral membranes, paragraph [0018]) for separating air into a permeate gas mixture and a retentate gas mixture, said membrane tube assembly comprising a pressurized air inlet (input, paragraph [0021]), a first gas mixture outlet for permeate hyperoxic gas mixture (outlet connected to ejector 6, paragraph [0027]), and a second gas mixture outlet for retentate hypoxic gas mixture (outlet connected to valve 5, paragraph [0027]);
a source of pressurized air (compressor 1) for feeding pressurized air to said air inlet (paragraph [0018]),
means for controlling a flow rate (valve 5) of said retentate gas hypoxic mixture exiting said second outlet and means for controlling pressure (pressure regulator 3) of the pressurized air fed to said inlet,
a control unit (control unit 12) connected at least to said means for controlling the flow rate of said retentate hypoxic gas mixture exiting said second outlet (paragraph [0019]) and to the means for controlling the pressure of the pressurized air fed to said inlet (paragraph [0033]), and
valve means (distributor 7) for regulating said permeate and retentate gas mixtures flowing from said outlets (paragraph [0019] and [0027] and Fig. 1)).
Regarding claim 2, Kostin discloses a dispensing device (patient respiration node 20) for alternatively dispensing said first or second gas mixture (paragraph [0027]), wherein said valve means is connected to said dispensing device operated for alternatively providing said permeate gas mixture or said retentate gas mixture flowing from said outlets to said dispensing device (paragraph [0026]-[0027]).
Regarding claim 3, Kostin discloses wherein said permeate hyperoxic gas mixture comprises an oxygen percentage of at least 35% (paragraph [0018]) and said retentate hypoxic gas mixture comprises an oxygen percentage less than 15% (paragraph [0018]).
Regarding claim 4, Kostin discloses said means for controlling the flow rate of the retentate gas mixture at said second outlet comprise a back pressure regulator (valve positioned downstream of compressor 1 and thus regulates, at least indirectly, back pressure. See Fig. 1 and paragraphs [0026] and [0033]).
Regarding claim 5, Kostin discloses wherein said means for controlling the pressure (pressure regulator 3) of the pressurized air fed to said inlet comprises a feed pressure regulator (paragraphs [0021] and [0025]).
Regarding claim 7, Kostin discloses said control unit is an electronic control unit (microcontroller, paragraph [0015]) connected to means for monitoring at least one body parameter (blood hemoglobin oxygen saturation sensor 28, paragraph [0019]).
Regarding claim 8, Kostin discloses said means for monitoring at least one body parameter comprises at least a pulse oximeter (blood hemoglobin oxygen saturation sensor, paragraph [0019]).
Regarding claim 9, Kostin discloses at least one filtration unit (moisture trap filter 2) for purifying said pressurized air before feeding it to said inlet (paragraphs [0011] and [0021]).
Regarding claim 10, Kostin discloses (Fig. 1) a method of producing hypoxic and hyperoxic breathable gas mixtures with a device according to claim 1 (see rejection of claim 1 above) comprising the steps of
feeding pressurized air to the membrane tube assembly containing at least one hollow fiber (paragraph [0018]), said membrane tube assembly providing a first flow of a hyperoxic gas mixture and a second flow of hypoxic gas mixture (paragraph [0018]), wherein the hypoxic gas mixture is a retentate gas mixture exiting said membrane tube assembly (paragraph [0018]),
further comprising the step of regulating an oxygen content of said hyperoxic gas mixture and of said hypoxic gas mixture by controlling pressure and/or flow rate of said hypoxic gas mixture exiting from said membrane tube assembly through said second retentate outlet (paragraphs [0031]-[0033]).
Regarding claim 11, Kostin discloses wherein each gas mixture exiting said membrane tube assembly is fed to a dispensing device (patient respiration node 20) without being mixed with ambient air or with the other said gas mixture exiting the membrane tube assembly (see paragraph [0027] and Fig. 1).
Regarding claim 12, Kostin discloses wherein the oxygen content in said hyperoxic/hypoxic gas mixtures is a function of the flow rate of the retentate gas mixture defined at the second outlet of said membrane tube assembly (paragraph [0033]).
Regarding claim 13, Kostin discloses wherein the oxygen content in said hypoxic and hyperoxic mixtures is controlled by at least said means for controlling the flow rate of the retentate gas mixture at said second outlet (paragraphs [0026] and [0033]).
Regarding claim 14, Kostin discloses the oxygen percentage in said hyperoxic/hypoxic mixtures is controlled by at least said means for controlling the pressure of the pressurized air fed at said inlet (paragraph [0033]), which comprise a feed pressure regulator (paragraphs [0021] and [0025]).
Regarding claim 16, as best understood, Kostin discloses a method for operating a device according to claim 1 (see rejection of claim 1 above) comprising a dispensing device (patient respiration node 20) and comprising means for monitoring at least one body parameter (blood hemoglobin oxygen saturation sensor 28, paragraph [0019]), for performing intermittent hyperoxic/hypoxic training (IHHT) (while not disclosed by Kostin, this limitation is provided in preamble and thus interpreted as intended use. Invention of Kostin would be capable of performing IHHT and thus satisfies this limitation), the method comprising the steps of:
continuously feeding pressurized air to said air inlet of said tube membrane (paragraph [0021])
detecting at least one body parameter with said means for monitoring at least one body parameter (paragraph [0019]),
directly or indirectly calculating an oxygen saturation level from said at least one detected body parameter (paragraphs [0031]-[0032]) and
comparing it with a maximum reference level and with minimum reference level stored in said control unit (maximum and minimum reference levels pre-stored and current level compared and concentration of output gas adjusted accordingly, paragraphs [0032]-[0033]),
switching said valve means for alternatively providing to said dispensing device said hyperoxic gas mixture in case said oxygen saturation level is lower than said minimum reference level, or said hypoxic gas mixture in case said oxygen saturation level is higher than said maximum reference level (valve is operated based on comparison to increase or decrease level depending on the comparison, see paragraphs [0041]-[0043]),
wherein said step of switching said valve means results in alternatively providing a hypoxic or a hyperoxic gas mixture to said dispensing device (paragraphs [0040]-[0043]).
Regarding claim 18, Kostin discloses wherein said at least one body parameter comprises oxygen saturation level and/or a heart rate (oxygen saturation level, paragraph [0019])..
Regarding claim 19, as best understood, Kostin discloses a breathable mixture as obtained by a method according to
at least one membrane tube assembly (gas separation module 4 that includes hollow and spiral membranes, paragraph [0018]) for separating air into a permeate gas mixture and a retentate gas mixture, said membrane tube assembly comprising a pressurized air inlet (input, paragraph [0021]), a first gas mixture outlet for permeate hyperoxic gas mixture (outlet connected to ejector 6, paragraph [0027]), and a second gas mixture outlet for retentate hypoxic gas mixture (outlet connected to valve 5, paragraph [0027]);
a source of pressurized air (compressor 1) for feeding pressurized air to said air inlet (paragraph [0018]),
means for controlling a flow rate (valve 5) of said retentate gas hypoxic mixture exiting said second outlet and means for controlling pressure (pressure regulator 3) of the pressurized air fed to said inlet,
a control unit (control unit 12) connected at least to said means for controlling the flow rate of said retentate hypoxic gas mixture exiting said second outlet (paragraph [0019]) and to the means for controlling the pressure of the pressurized air fed to said inlet (paragraph [0033]), and
valve means (distributor 7) for regulating said permeate and retentate gas mixtures flowing from said outlets (paragraph [0019] and [0027] and Fig. 1).
Regarding claim 20, Kostin discloses a method of treating stress-related and metabolic disorders (Abstract) that comprises administering an effective amount of an hypoxic and/or hyperoxic gas mixture as obtainable by a method according to claim 10 (see rejection of claim 10 above).
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.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kostin (US 2009/0183738) in view of Ratto (US 20120017904).
Regarding claim 6, Kostin discloses pressurized air is fed into the inlet of the tube membrane, but does not disclose an air cooler for controlling the temperature of the pressurized air fed to said inlet of said tube membrane.
However, Ratto teaches (Fig. 1) a respiratory gas supply system comprising an air cooler (“cooler”, paragraph [0029]) for controlling the temperature of the pressurized air fed to an inlet of a delivery component 106 (paragraphs [0021] and [0029]).
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 device of Kostin to include an air cooler for controlling the temperature of the pressurized air fed to said inlet of said tube membrane, as taught by Ratto, for the purpose of regulating the temperature of the respiratory gas to within a desired temperature range (paragraph [0029] Ratto).
Regarding claim 15, Kostin discloses the oxygen percentage in said hyperoxic/hypoxic mixtures is controlled, but does not disclose it is controlled at least by means for controlling the temperature of the pressurized air fed at said inlet.
However, Ratto teaches (Fig. 1-2) oxygen percentage in a respiratory gas mixture is controlled at least by means for controlling the temperature of the pressurized air fed at said inlet (oxygen level in gas control step is downstream of and dependent on result of temperature control step, and thus oxygen percentage is controlled at least indirectly by control of temperature, paragraphs [0029] and [0038] and Fig. 2).
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 method of Kostin such that oxygen percentage in said hyperoxic/hypoxic mixtures is controlled at least by means for controlling the temperature of the pressurized air fed at said inlet, as taught by Ratto, for the purpose of ensuring the air is at correct temperature level before mixing occurs in order to prevent waste of oxygen gas in case temperature needs to be adjusted.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kostin (US 2009/0183738).
Regarding claim 17, Kostin discloses maximum and minimum reference levels of oxygen saturation, but does not disclose wherein said maximum reference level of oxygen saturation is a percentage value comprised between 98% and 100%, and wherein said minimum reference level of oxygen saturation is a percentage value comprised between 84% and 86%. However, outside evidence of criticality, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to try to wherein said maximum reference level of oxygen saturation is a percentage value comprised between 98% and 100%, and wherein said minimum reference level of oxygen saturation is a percentage value comprised between 84% and 86% for the purpose of ensuring optimal oxygen transmission to user, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Seefeldt (US 2022/0111330) discloses a gas separation system having a membrane and splitter.
Mailova (US 2012/0330224) discloses a gas conditioning system that supplies hypoxic and hyperoxic air and has a cooling means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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