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 Arguments
Applicant’s arguments, see pages 5-7, filed 2/13/2026, with respect to the rejection(s) of Claims 1-2, 4, 8-12, 16-19, and 22 under 35 U.S.C. § 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Krite and Van Kesteren.
Claim Objections
Claim 1 is objected to because of the following informalities:
In Claim 1, “wherein said control unit is configured to detect a physiological status of said pulmonary system by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said determined concentration and or distribution of said free gas, over said time period” should read “wherein said control unit is configured to detect a physiological status of said pulmonary system by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said determined concentration and/or distribution of said free gas, over said time period”.
Appropriate correction is required.
Claim Interpretation
The Examiner makes note of the following interpretations:
Claims 2, 9, and 17 all recite instances of one element being “associated with” another element, and Claim 3 recites wherein an element is “not associated with” another element. If the word “associated” is considered an active verb that is supposed to be performed, these claims would be rejected under 35 U.S.C. § 112(b) as method steps in an apparatus-type claim. Instead, all instances of one element A being “associated with” another element B are being interpreted in this application as simply a further description of the inherent properties of element A, which also means element B is at least indirectly connected, linked, and related to element A. As an example, in Claim 1, “wherein said change over time in an intensity of said detected light signal transmitted through said cavity is associated with a variation of a volume of said cavity” is interpreted to mean the varying intensity of said detected light signal is partly due to variation in a volume of the cavity—not that a mathematical calculation is done regarding this association. Therefore, prior art references do not need to recite an active “associating” in order to read on the respective claims.
Claim Interpretation- 35 USC § 112(f)
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 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: “optical member” and “a detector unit” in Claim 1.
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.
Claim 1 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “optical member” in line 3 for the apparatus performing the specified function
“optical member” is liked with the transitional word “for” modified by the functional language “emitting a light signal through a cavity of said pulmonary system of said subject”
“optical member” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on pages 19-20 as an optical fibre arrangement connected to a light source, a laser, a waveguide, an LED, and equivalents thereof.
Claim 1 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “unit” in line 5 for the apparatus performing the specified function
“unit” is modified by the functional language “detector”
“unit” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on page 20 as photodiodes, photomultiplier tubes, avalanche photodiodes, charge-coupled devices, CCD or CMOS light sensitive devices, and equivalents thereof.
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 1-4,6-12,14 and 16-22 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.
Claim 1 recites “wherein said control unit is configured to detect a physiological status of said pulmonary system by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said determined concentration and or distribution of said free gas, over said time period”. There was no previously recited determined concentration and/or distribution of said free gas—only “wherein said control unit is configured to further obtain a concentration and/or distribution of a free gas from said detected light signal transmitted through said cavity over said time period”. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein said control unit is configured to detect a physiological status of said pulmonary system by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said obtained concentration and or distribution of said free gas, over said time period”.
Claims 2-4,6-12,14 and 16-22 are rejected by virtue of dependence on Claim 1.
Claim Rejections - 35 USC § 103
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.
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.
(Examiner’s Note: In the following rejection, references made to “Column/page X, lines a-n” will be abbreviated to “X:a-n”).
Claims 1-2, 4, 8-12, 16-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Krite et al (WO 2017029344 A1, cited in applicant’s IDS, hereinafter Krite) in view of Van Kesteren et al (US 20150011852 A1, hereinafter Van Kesteren).
Regarding Claim 1, Krite discloses a device (See Fig. 1) for monitoring a pulmonary system of a subject (“Accordingly, embodiments of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device, system or method according to the description for measuring free gas in a cavity, such as a lung or in the digestive system”, 3:27-33), said device comprising:
an optical member ( Elements 5-6 and 11-12, Fig. 1; “The light sources, 6, such as lasers…”, 18:10) for emitting a light signal through a cavity of said pulmonary system of said subject (“The main part of the individually frequency marked light is led through optical fibre 11 down through the, in this example used, endotracheal tube 3”, 15:22-24), wherein said light signal comprises at least one wavelength (“The device, system and method include a light source for emitting light with a wavelength associated with an absorption band of the free gas”, Abstract);
a detector unit (Elements 14, Fig. 1);
wherein said optical member and said detector unit are configured to be positioned (See Fig. 3) so that said light signal is transmitted from said optical member through said cavity to be detected by said detector unit (“The detector or detectors 14 is/are adapted to be arranged against the skin. The detector should have a surface sized to detect the light transmitted through the tissue…”, 16:34-17:2); and
a control unit (Element 8, Fig. 1) configured to obtain a change over a time period in an intensity of said detected light signal transmitted through said cavity (“wherein the control unit evaluates line profile changes in an absorption spectrum for determining the free gas, or the distribution of the free gas, or the concentration of the free gas”, Claim 17);
wherein said control unit is configured to further obtain a concentration and/or distribution of a free gas from said detected light signal transmitted through said cavity over said time period (“wherein the control unit evaluates line profile changes in an absorption spectrum for determining the free gas, or the distribution of the free gas, or the concentration of the free gas”, Claim 17; See all of 11:18-12:7, which describes determination of a gas concentration by determining the intensity of a detected light signal, described in 11:4-6); and
Krite discloses the claimed invention except for expressly disclosing wherein said control unit is configured to detect a physiological status of said pulmonary system by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said determined concentration and or distribution of said free gas, over said time period. However, Van Kesteren teaches wherein said control unit (Element 20, Fig. 7) is configured to detect a physiological status (“ the ventilation device may be controlled on the basis of the measured/determined concentration of gas”, [0014]; “the display means of the ventilation device 30 may be adapted to display a gas concentration determined by the monitoring device 20 and may further store gas concentration information over a predetermined time period for instance for later evaluation by a physician or for close loop adaptation of the ventilation settings”, [0076]; to control the ventilator based on different gas concentration measurements, the control unit must equate different gas concentration measurements with different physiological statuses that require different ventilator settings) by evaluating a temporal correlation between said intensity of said detected light signal transmitted through said cavity and said determined concentration and or distribution of said free gas (“The sensing layer, which is irradiated for instance with visible light, infrared light and/or ultraviolet light may generate luminescent light (optical response), the intensity as a function of time of which depends on the concentration of the gas being currently present in the sensing layer”, [0015]), over said time period (“The monitoring device or ventilation device may include means for storing monitored data as a function of time”, [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the steps of Van Kesteren to the control unit configuration of Krite, because both devices are directed to the same pertinent problem of using detected gas concentrations as feedback to change the settings of a medial ventilator (see 4:32-35 of Krite, and [0033] of Van Kesteren), and all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art .
Regarding Claim 2, modified Krite discloses the device of claim 1, wherein said detected light signal is associated with the same wavelength over time, such that said at least one wavelength of said emitted light signal is a single wavelength (“The device, system and method include a light source for emitting light with a wavelength associated with an absorption band of the free gas”, Abstract).
Regarding Claim 4, modified Krite discloses the device of claim 1, wherein said physiological status relates to detecting a pulmonary complication and/or an aeration problem (“Oxygen in the lungs is of special interest as it is a prerequisite for vital functions of a human. Monitoring oxygen in the lungs is of interest, particularly, for premature new-born infants. In connection with the diseases in the cavities of the head, for example, sinusitis or otitis media, the gas filled cavity may be filled with liquids and the gas signal will decrease or disappear”, 1:22-29; “In this way, the results of changes in the settings of the medical ventilator or medications may be directly observed, and the information from the observation may be used to optimize the treatment of the patient using a feedback system”, 10:29-33).
Regarding Claim 8, modified Krite discloses the device of claim 1, wherein said at least one wavelength of said emitted light signal is within an optical window of tissue (“When monitoring gases using narrow-band light, such as laser light, the light has been transmitted towards the skin over the cavity containing the free gas, such as the lungs or intestines. The light that has penetrated enough tissue to reach the cavity is scattered and transmitted to a detector positioned against the skin a few centimetres laterally the light source.”, 8:29-35).
Regarding Claim 9, modified Krite discloses the device of claim 1, wherein said at least one wavelength of said emitted light signal is associated with an absorption band of the free gas in the pulmonary system (“The device, system and method include a light source for emitting light with a wavelength associated with an absorption band of the free gas”, Abstract).
Regarding Claim 10, modified Krite discloses the device of claim 1, wherein said optical member is adapted to be inserted internally in the subject using an introducing member (“an optical fibre connected to the light source and adapted to be inserted internally in the subject using an introducing member”, 4:2-4).
Regarding Claim 11, modified Krite discloses the device of claim 1, wherein said optical member is adapted to be arranged on a skin surface of the subject for emitting said light signal towards said cavity (“It may be observed that the same equipment, with some modification, may be used for external injection of light into the human body in those cases wherein a medical ventilator with a tracheal tube, or a bronchoscope is not used, for example through a feeding tube through the oesophagus. In these cases the light may be expanded and made diffused by a scattering medium with a large enough surface, for example a few cm2, made in contact with the skin”, 17:27-18:1).
Regarding Claim 12, modified Krite discloses the device of claim 1, wherein said detector is configured to be positioned on a skin surface for detecting said light signal transmitted through said cavity of said subject (“a detector unit adapted to be positioned on a skin surface for detecting light transmitted through tissue of the subject”, 6:1-3).
Regarding Claim 16, modified Krite discloses the device of claim 1, wherein the light signal comprises at least two different wavelengths (“two light sources 5, 6 are used for measuring a gas, for example oxygen at about 760 nm, and water vapour at about 820 nm”, 13:31-33).
Regarding Claim 17, modified Krite discloses the device of claim 16, wherein at least one of said wavelengths is associated with an absorption band of a reference gas (“two light sources 5, 6 are used for measuring a gas, for example oxygen at about 760 nm, and water vapour at about 820 nm”, 13:31-33).
Regarding Claim 18, modified Krite discloses the device of claim 9, wherein the free gas is a physiological gas or a mixture of gases, including at least one of oxygen, nitric oxide (NO), carbon dioxide, anaesthesia gases and water vapour (“two light sources 5, 6 are used for measuring a gas, for example oxygen at about 760 nm, and water vapour at about 820 nm”, 13:31-33).
Regarding Claim 19, modified Krite discloses the device of claim 1, wherein the control unit is configured for controlling a medical ventilator (“the control unit 8 may be connected to the controller 9 of the medical ventilator 2 for controlling the settings of the medical ventilator 2”, 14:21-24) based on said detected physiological status of said pulmonary system (“In some examples the measured value of the free gas in the lungs may be used for affecting the controller 9 for controlling the setting of the medical ventilator 2”, 18:27-29).
Regarding Claim 22, modified Krite discloses the device of claim 1, wherein an optical filter with a transmission at said wavelength of said emitted light signal is arranged in front of said detector unit (Examiner’s note: As this claim limitation is presented as part of an alternative list, only one of the elements must be anticipated for the entire claim limitation to be anticipated); and/or wherein said emitted light signal is pulsed with gated detection (Examiner’s note: As this claim limitation is presented as part of an alternative list, only one of the elements must be anticipated for the entire claim limitation to be anticipated); and/or wherein said emitted light signal is amplitude modulated with a modulation frequency (“In some examples, the detection is made frequency- and phase-sensitively. The light, such as laser light, from the light source may be wavelength modulated at a selected frequency…”, 10:34-11:2) and a frequency spectrum of the detected signal is analysed at said modulation frequency (“…and synchronous intensity variations may be detected when the modulation is conducted around a gas absorption wavelength”, 11:2-11:4); and/or wherein said emitted light signal is amplitude modulated with a varied modulation frequency (“Additionally, in some examples, the lasers may be wavelength modulated by modulating the drive current on two separate frequencies”, 14:27-29) and a frequency spectrum of the detected signal is analysed at the varying modulation frequency (“The frequencies may typically be in the region around 10kHz to allow noise reduced phase- sensitive detection ( lock-in-detection)”, 14:29-31).
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krite in view of Van Kesteren, as evidenced by the Non-Patent Literature (NPL) to Svanberg et al (“Diode laser Spectroscopy for noninvasive monitoring of oxygen in the lungs of newborn infants”, cited in applicant’s IDS, hereinafter Svanberg).
Regarding Claim 14, modified Krite discloses the device of claim 1, wherein said light signal is provided using Tunable Diode Laser Absorption Spectroscopy (“Another option is to perform the GASMAS measurements both for the gas concentration to be determined and for water vapour”, 12:31-33; Svanberg provides extrinsic evidence that the GASMAS technique relies on Tunable Diode Laser Absorption Spectroscopy (page 627); see MPEP 2131.01).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Krite in view of Van Kesteren, and further in view of the Non-Patent Literature (NPL) to Lewander et al ("Nonintrusive gas monitoring in neonatal lungs using diode laser spectroscopy: feasibility study", cited in the applicant’s IDS, hereinafter Lewander).
Regarding Claim 3, modified Krite discloses the device of claim 1. Modified Krite discloses the claimed invention except for expressly disclosing wherein said wavelength is not associated with an absorption band of the free gas. However, Lewander teaches wherein said wavelength is not associated with an absorption band of a free gas (“While discussing optimal interrogation wavelengths we note that the very interesting respiratory gas carbon dioxide cannot be measured nonintrusively by the present technique, since the relevant absorption wavelengths for this molecule fall in a spectral region of heavy absorption by the tissue surrounding the gas volume”, page 4; the Examiner notes that carbon dioxide is named as a free gas on page 5, lines 7-10 of the applicant’s written description). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the wavelength of modified Krite with the wavelength of Lewander, such that said wavelength is not associated with an absorption band of a free gas, for the diagnostic advantages taught by Lewander (page 5).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Krite in view of Van Kesteren, and further in view of Svanberg.
Regarding Claim 6, modified Krite discloses the device of claim 1. Modified Krite discloses the claimed invention except for expressly disclosing wherein a variation of a volume is a qualitative measure. However, Svanberg teaches wherein a variation of a volume is a qualitative measure ("Since the concentration of fully saturated water vapor at 37 C is known, signals of water vapor can be used to calibrate oxygen signals and to estimate sizes of gas-filled cavities…Each measurement resulted in a data set of four arrays with 80,000 intensity readings each. The first array comprised average raw readings, as a function of time (0–0.2 s) of the sample detector. The second array enclosed corresponding readings of the reference detector. Oxygen and water vapor signals, demodulated by the analogue lock-in amplifiers, were stored in the third and fourth arrays, respectively", page 627; if water vapor signals are associated with volume, then both qualitative and quantitative variations of the water signals is associated with qualitative and quantitative variations in volume). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Krite, with qualitative variations in volume measurements as taught by Svanberg, because this is another way to track oxygen in the lungs and therefore track physiological statuses.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Krite in view of Van Kesteren, and further in view of Hunter et al (US 20150305612 A1, hereinafter Hunter).
Regarding Claim 7, modified Krite discloses the device of claim 1. Modified Krite discloses the claimed invention except for expressly disclosing wherein said control unit is configured to detect a variation in volume by obtaining a first transmission signal transmitted through a first cavity, and a second transmission signal transmitted through a second cavity, and compare the first and second transmission signals to detect a changing in a volume of one of said cavities in relation to the other. (The Examiner notes Krite does disclose a system configured to obtain a first transmission signal transmitted through a first cavity and a second transmission signal transmitted through a second cavity in Fig. 1). However, Hunter teaches wherein said control unit is configured to detect a variation in volume by obtaining a first transmission signal transmitted through a first cavity (“Generate a population of images of patient 10 at both inspiration and expiration using imaging device 40”, [0099]; the images are disclosed to include lobes of the left lung in [0105]-[0106]), and a second transmission signal transmitted through a second cavity (“Generate a population of images of patient 10 at both inspiration and expiration using imaging device 40”, [0099]; the images are disclosed to include lobes of the right lung in [0107]-[0109]), and compare the first and second transmission signals (“Segment the lung lobes in both the inspiration and expiration images”, [0101]) to detect a changing in a volume of one of said cavities in relation to the other (“Determine a volume difference for each lung lobe between inspiration and expiration”, [0102]; by knowing a volume difference for each lung, the volume difference of one of the lungs in relation to the other is also known). It would have been obvious to further modify the device of Krite as suggested by Hunter such that said control unit is configured to detect a variation in volume by obtaining a first transmission signal transmitted through a first cavity, and a second transmission signal transmitted through a second cavity, and compare the first and second transmission signals to detect a changing in a volume of one of said cavities in relation to the other, because knowing the relative volume of one lung in relation to the other provides a more robust data set for medical diagnostics and therapeutic decision making.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Krite in view of Van Kesteren and Lewander, and further in view of Choncholas et al (US 20080185009 A1, hereinafter Choncholas).
Regarding Claim 20, modified Krite discloses the device of claim 19. Modified Krite discloses the claimed invention except for expressly disclosing wherein the control unit is configured to send a signal to increase the pressure of said medical ventilator when an atelectasis is detected. However, Chocholas, which also discloses a medical ventilator (Abstract), teaches increasing the pressure of said medical ventilator when an atelectasis is detected (“the patient may be suffering from atelectasis, or the collapsing of the lung...The clinician counteracts this by applying large sustained or distending pressures to recruit the atelatatic lung and keeping the patient's lungs open at the end of each breath by applying positive end expiratory pressure (PEEP) to prevent derecruitment”, [0052]). 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 control unit configuration of modified Krite by increasing the pressure of said medical ventilator when an atelectasis is detected, as suggested by Choncholas, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 21, modified Krite discloses the device of claim 19. Modified Krite discloses the claimed invention except for expressly disclosing wherein the control unit is configured to send a signal to reduce the pressure of said medical ventilator when an atelectasis is reduced. However, Choncholas, which also discloses a medical ventilator (Abstract) teaches wherein excessive ventilator pressure applied to the patient's respiratory system can cause undesirable side effects to the patient such as impeding venous return and reducing cardiac output (“However, the PEEP, as with any ventilatory pressure, must be carefully controlled because excessive pressure applied to the patient's respiratory system can cause undesirable side effects to the patient such as impeding venous return and reducing cardiac output. Other adverse side effects include excessive peak pressure that may lead to lung over distention or even rupture of alveolar sacs within the lung”, [0052]). 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 control unit configuration of Krite to reduce the pressure of said medical ventilator when an atelectasis is reduced, in order to avoid negative side effects of high medical ventilator pressures.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791