Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 23 June 2025.
CLAIMS UNDER EXAMINATION
Claims 1-22 are pending and have been examined on their merits.
PRIORITY
Provisional Application 60/793,472, filed on 19 April 2006, is acknowledged.
It does not support the amounts of gas flowing through the tracheal interface recited in claims 3 and 14-18. The Provisional Application does not provide support for the limitations recited in claims 19-21. Support is found in Application 11/788865, filed on 19 April 2007.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-18 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
Based on the claims as a whole, claims 12-18 and 22 are determined to be directed to a law of nature/natural principle. The rationale for the determination is explained below.
Claims 12 and 22 further limit the method of lung perfusion recited in claim 1.
Question 1: Are the claims directed to a process, machine manufacture or composition of matter? Yes, claims 12 and 22 are directed to a process.
Question 2A Prong 1: Are the claims directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, claims 12 and 22 are abstract ideas.
(a) The limitations in the claims that set forth the law of nature are:
The 2019 PEG explains that the abstract idea exception includes the following groupings of subject matter:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 12 recites comparing a plurality pulmonary artery and pulmonary vein oxygen saturation levels to determine comparative differences; and identifying a maximum comparative difference. The specification does not define “comparing” or “identifying”. Given its broadest reasonable interpretation, the claim limitation comprises a mental evaluation of data. The claim recites a step of determining comparative differences at a plurality of times and identifying a maximum difference. The determination and identification steps are mental processes (judicial exceptions).
Regarding claim 22: A comparison of measurements is a mental process (a judicial exception). Making an evaluation based on a comparison is a metal process (a judicial exception).
Question 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No.
Claim 12 recites measuring oxygen saturation at a plurality of times. The measurements are interpreted to be necessary data gathering steps that are required to perform the mental evaluation. Claim 12 encompasses the limitations directed to lung perfusion and measurement steps recited in claim 1. The steps are interpreted to be necessary data gathering steps that are required to perform mental evaluations (judicial exceptions) recited in claim 12.
While claim 22 recites a step of adjusting a composition of a flow of gas and measuring the gas, this is interpreted to be an extra-solution activity required to perform the mental evaluation (judicial exception). Claim 22 encompasses the limitations directed to lung perfusion and measurement steps recited in claim 1. The steps are interpreted to be necessary data gathering steps that are required to perform the mental evaluations (judicial exceptions) recited in claim 22.
Question 2B: Do the claims recite any additional elements? Yes.
With respect to Step 2B, limitations that were found to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2B, limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Does the additional element result in the claim amounting to significantly more?
No.
Regarding claims 13-18: The claims are directed to the gas flowed through the tracheal interface. Ventilation of the lung is an extra-solution activity required to perform the comparing and identifying steps (the judicial exceptions) recited in claim 12/
Therefore claims 12-18 and 22 are not eligible subject matter under 35 USC 101.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-2, 4-5, 8 and 11-12 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by DeCampos et al. (Use of a hypoxic lung as a deoxygenator to provide extended assessment of pulmonary function in rats. American Physiological Society 1835-1840).
DeCampos teaches isolated lungs in a perfusion circuit (Abstract). Therefore the art teaches an ex vivo perfusion circuit. A double lung block is ventilated with a hypoxic gas mixture to provide blood with gases that are similar to mixed venous values (Abstract; Figure 1). DeCampos teaches the hypoxic lung is used as a “deoxygenator” (Abstract). DeCampos teaches the deoxygenator provides blood (a perfusion fluid) to perfuse a study lung (Abstract). The deoxygenator taught by DeCampos is broadly interpreted to read on a gas exchange device that deoxygenates perfusion fluid (blood) by applying a gas.
Hypoxic blood from the deoxygenator is pumped into the study lung using a pulmonary artery (see page 1836, right column, first paragraph; Figure 1). The specification does not define a pulmonary artery interface. Therefore the tube connecting to the study lung in Figure 1 is interpreted to be a pulmonary artery interface.
Figure 1 illustrates blood moving (flowing) from the study lung to the deoxygenator lungs through a line. The specification does not define a pulmonary vein interface. Therefore fluid moves away through a pulmonary venous (vein) interface.
The study lung is ventilated with room air (a ventilation gas) using a mechanical ventilator (page 1836, right column, first paragraph). The art teaches the lungs have tracheal cannulas (see page 1837, left column, second paragraph). Therefore the mechanically ventilated study lung has a tracheal interface. Venous blood, which flows into the study lung, “was monitored and kept between 36 and 38° C” (see page 1836, right column, first paragraph). Therefore the blood (perfusion fluid) is at a physiological temperature.
DeCampos teaches the oxygen (a gas) content of blood that enters and leaves the study lung is measured (page 1836, right column, last paragraph).
Therefore claim 1 is anticipated.
DeCampos teaches the gas supplied to the deoxygenator contains oxygen and carbon dioxide (see text below Figure 1). Therefore claim 2 is included in this rejection.
Ventilation with “room air” is interpreted to read on ambient air. Therefore claim 4 is included in this rejection.
DeCampos measures an inspired O2 (oxygen) fraction (see text of Figure 1. Therefore claim 5 is included in this rejection.
DeCampos measures a tidal volume (page 1836, left column, first paragraph). Therefore claim 8 is included in this rejection.
DeCampos measures PEEP (“3cm H2O PEEP”; see 1837 right column, first paragraph). Therefore claim 11 is included in this rejection.
DeCampos teaches blood gases are measured with samples withdrawn with a capillary the from both the deoxy and study lung (see page 1836, right column, last paragraph). DeCampos measures oxygen saturation (page 1836, right column, last paragraph). The art takes hourly measurements (Table 2). The data in Tale 2 illustrates comparison of differences. Therefore claim 12 is included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3, 6-7, 9-10, 13-18 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeCampos in view of Rees et al. (previously cited; Automatic lung parameter estimator. US7008380 with benefit of PCT WO00/45702 2000).
Claim 1 is rejected on the grounds set forth above. The teachings of DeCampos are reiterated. The art teaches mechanical ventilation of the study lung with “room air”. The art does not teach the oxygen composition of the air.
Rees et al. teach a method for determining one or more respiratory parameters (Abstract). The art teaches flowing inspiratory gas into a respiratory system and flowing expiratory gas out of a respiratory system (column 3, lines 50-55). The art teaches gas is delivered via trachea (Figure 4). Rees teaches detecting levels of oxygen in the gas passing into or out of the respiratory system (column 4, lines 5-6). Rees teaches measurement of arterial or venous blood gas (column 9, line 49). Rees teaches the level of oxygen in the arterial and venous blood can be measured (column 6, lines 33-39).
Rees teaches disorders of oxygen transport from the inspired air into the blood can result in a low oxygen saturation of the blood. These disorders in oxygen uptake include abnormal ventilation of the lung and abnormal oxygen diffusion in the lung, and abnormal perfusion (i.e. blood flow) through the lung. Estimation of parameters describing these oxygenation problems is important for diagnosis, monitoring and assessing appropriate therapeutic intervention. See Column 1, lines 34-43.
Rees teaches the system can assess the change in oxygen level in inspired gas (FIO2; inspired oxygen fraction) (column 5, lines 43). The art teaches it is preferred that one gas is atmospheric air and that another of the gases is more or less pure oxygen, i.e. has an 15 25 35 40 45 50 55 60 65 oxygen fraction higher than that of atmospheric air, preferably in the range 0.85 to 1.00. Alternatively or additionally, another gas may be supplied which has an oxygen fraction below that of atmospheric air, i.e. in the range of 0.00 to 0.21, preferably of 0.00 to 0.05. The oxygen level of the inspired gas may be varied not only to level above that of atmospheric air but also below that level, thus providing a wide range of possible levels for performing measurements of the individual (see column 6, lines 10-20).
It would have been obvious to flow gas comprising about 100% oxygen through the tracheal interface taught by DeCampos. One would have been motivated to do so to analyze lung function using pure oxygen. One would have had a reasonable expectation of success since Rees teaches pure oxygen can successfully be used for analysis. One would have expected similar results since both references are directed to methods of testing lung function. Therefore claim 3 is included in this rejection.
DeCampos does not teach measuring an arterial-venous oxygen gradient. A gradient is interpreted to be a difference. Rees teaches measurement of arterial or venous blood gas (column 9, line 49). Rees teaches measuring the level of oxygen in the arterial and venous blood can be measured (column 6, lines 33-39).
It would have been obvious to measure arterial-venous oxygen gradient. One would have been motivated to do so since DeCampos analyzes lung function by measuring oxygen levels and Rees teaches the oxygen in arterial and venous blood can be used to assess lung function. One would have had a reasonable expectation of success since Rees teaches these metrics can successfully be used to analyzing oxygen in a respiratory system. One would have expected similar results since both references are directed to methods of analyzing lung function. Therefore claim 6 is included in this rejection.
DeCampos does not teach measuring a alveolar-arterial oxygen pressure gradient.
Rees teaches alveolar-arterial oxygen pressure gradient is a known quantitative method used to assess oxygenation problems (column 1, lines 55-56).
It would have been obvious to measure the alveolar arterial oxygen gradient. One would have been motivated to do so since DeCampos teaches a method of testing lung function and Rees teaches alveolar-arterial oxygen pressure gradient is a known quantitative method used to assess oxygenation problems. One would have had a reasonable expectation of success since Rees teaches this metric can successfully be used to analyzing oxygen in a respiratory system. One would have expected similar results since both references are directed to methods of evaluating a lung. Therefore claim 7 is included in this rejection.
DeCampos does not teach measuring partial pressure of oxygen in the perfusion fluid flowing into the lung (claim 9) or out of the lung (claim 10). Rees teaches measurement of arterial or venous blood gas (column 9, line 49). Rees teaches the pressure can be measured (e.g. PaO2, PE’O2) in blood circulation can be measured (column 7, lines 43-50).
It would have been obvious to measure the pressure of the perfusion fluid moving into the lung. One would have been motivated to do so since DeCampos teaches a method of testing lung function and Rees teaches both arterial and venous blood gas can be analyzed. One would analyze pressure since Rees identifies this as a metric than can be analyzed. One would have had a reasonable expectation of success since Rees teaches this metric can successfully be used to analyzing oxygen in a respiratory system. One would have expected similar results since both references are directed to methods of evaluating a lung. Therefore claims 9 and 10 are included in this rejection.
It would have been obvious to flow gas comprising about 100% oxygen through the tracheal interface taught by DeCampos. One would have been motivated to do so to analyze lung function using pure oxygen. One would have had a reasonable expectation of success since Rees teaches pure oxygen can successfully be used for analysis. One would have expected similar results since both references are directed to methods of testing lung function. Therefore claim 13 is rendered obvious.
Regarding claims 14-18: A gas containing no oxygen reads on claims 14-18.
It would have been obvious to flow gas comprising less than about no oxygen through the tracheal interface. One would have been motivated to do so since Rees teaches a gas with an oxygen fraction of zero can be used to analyze lung function. Therefore claims 14-18 are rendered obvious.
Regarding claim 22. Rees teaches detecting the level of oxygen in the gas flow passing into or out of the respiratory system (column 4, lines 5-6). Rees teaches the fraction of oxygen in the inspired gas flow can be adjusted (column 4, lines 65-66). The art teaches doing so to achieve a given desired target oxygen level in the blood (column 6, lines 45-50). Therefore claim 22 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeCampos in view of EMS World (previously cited; Clearing the Airway 2004 pages 1-6).
Claim 1 is rejected on the grounds set forth above. The teaching of the prior art are reiterated. DeCampos ventilates a lung. The art teaches the use of tracheal cannula (see page 1837, left column, second paragraph). The art does not teach applying suction through the tracheal interface to clear the alveoli of debris.
EMS teaches suction to remove secretions from the trachea (first paragraph of page 1).
It would have been obvious to use suction to clear the trachea taught DeCampos. One would have been motivated to do so since EMS teaches doing so to remove secretions. The skilled artisan would do so to allow prior ventilation of the trachea. One would have had a reasonable expectation of success since EMS teaches suction can be used to clear the trachea. One would have expected similar results since both references are directed to methods of providing lung ventilation. Therefore claim 19 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious as claimed.
Claim 20-21 are ejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DeCampos in view of Bradley et al. (previously cited; Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: An overview of five Cochrane systematic reviews. Respiratory Medicine (2006) 100, 191–201).
Claim 1 is rejected on the grounds set forth above. The teaching of the prior art are reiterated. DeCampos ventilates a trachea with air (supra). The art does not teach clearing lung debris using variable volumes of oxygen.
Bradley teaches techniques than can be used for airway clearance (see Table 1). The art teaches autogenic drainage. The art teaches it is a breathing three-level breathing sequence comprising difference lung volumes.
It would have been obvious to use the technique taught by Bradley to clear debris from the lung taught by DeCampos. DeCampos analyzes lung function and Bradley teaches using breaths with variable volumes to clear a lung. The skilled artisan would do so to allow proper ventilation of the trachea. One would have had a reasonable expectation of success since Bradley teaches this method of breathing can be used to clear the lungs. One would have expected similar results since both references are directed to methods of ventilating a lung. Therefore claim 20 is rendered obvious. Bradley teaches autogenic drainage comprises beginning at low lung volumes, followed by breathing at mid-lung volumes, followed by deep breathing, huff and coughing. Deep breathing, followed by a huff and a cough is interpreted to read on claim 21.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 19 August 2025 are acknowledged. New grounds of rejection have been necessitated by claim amendment.
CONCLUSION
No Claims Are Allowed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653