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
The Applicant’s arguments with respect to the 35 U.S.C. 101 and 112 rejections are persuasive. The rejections have been withdrawn.
Applicant's arguments filed 1/22/2026 have been fully considered but they are not persuasive.
The Applicant argues that Jafari is not a minimally invasive surgery. The Examiner disagrees and respectfully submits that the ventilation and facial breathing mask of Jafari are indeed “minimally invasive”, especially as broadly claimed.
The Applicant argues that Jafari does not entail a “direct calculation” that is simpler, non-compensated calculation. The Examiner disagrees and respectfully submits, that as claimed, the device and respective processing that takes place in Jafari does not exclude additional equations and calculations, and the limitation “direct calculation” results in no distinguishable difference between the instant claims and the prior art of Jafari.
The rejections are maintained.
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 8-16 are 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 Applicant did not have possession of the limitation “a direct calculation” using volume, pressure increase, according to the equation Cc = V2/Ap. At the time of filing, there was no disclosure regarding a “direct calculation”.
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 8-16 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.
Claims 8-16 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.
The term “direct calculation” in claim 8 is a relative term which renders the claim indefinite. The term “direct calculation” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim any process that uses the equation Cc = V2/Apc.
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) 8-13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100236555 A1 to Jafari et al. (hereinafter, Jafari).
Regarding Claim 8, Jafari discloses a medical device for determining a compliance of a body cavity in minimally invasive surgery, the device comprising inter alia:
at least one fluid reservoir (paragraph [0021] “Compressor 44 or another source(s) of pressurized gas (e.g., air and oxygen) is coupled with inspiratory module 42 to provide a gas source for ventilatory support via inspiratory limb 32.”);
at least one controlled pump (paragraph [0007] “The system includes: a pressure generating system adapted to generate a flow of breathing gas…”);
at least one volumetric flow measuring device (paragraph [0007] “…delivered lung volume module that calculates a leak-compensated delivered lung volume for a first breath based on the leakage during the first breath and the flow of the breathing gas in the ventilation tubing system…”);
at least one pressure sensor (paragraph [0007] “…one or more sensors operatively coupled to the pressure generating system or the ventilation tubing system, in which each sensor is capable of generating an output indicative of a pressure or flow of the breathing gas in the ventilation tubing system…”); and
at least one electronic computing unit communicatively coupled to the at least one controlled pump, the at least one volumetric flow measuring device, and the at least one pressure sensor, the at least one electronic computing unit configured to (paragraph [0063]; Jafari discloses a controller including a module for leak estimation, delivered volume, respiratory calculation, and pressure control., i.e., a computing unit “for providing” the necessary controls) (paragraph [0036] “This desired delivered volume is received by the ventilator and stored in memory for use during PRVC ventilation.”):
a) determine a stationary cavity pressure (pci) in the body cavity via the at least one pressure sensor while the at least one controlled pump is inactive (paragraph [0030] “… it may be desirable to establish a baseline pressure and/or flow trajectory for a given respiratory therapy session…”);
b) control the at least one controlled pump to supply a predefined, pulsed volume flow of a fluid into the body cavity over a defined time period (paragraph [0041] “…duration of the inspiratory and expiratory phases may be determined based on patient effort or based on a preselected inspiratory time…”) (During inspiration, the ventilator applies a target pressure to deliver a set volume, paragraph [0041] “The duration of the inspiratory and expiratory phases may be determined based on patient effort or based on a preselected inspiratory time.”) (paragraph [0041] “When in an inspiratory phase, the ventilator raises the pressure in the ventilator tubing system so that the target inspiratory pressure is applied. During exhalation, the pressure may be dropped to some pre-selected positive end expiratory pressure (PEEP) level or to atmospheric level depending on the desires of the operator.”) with a defined temporal length (paragraph [0041] “The duration of the inspiratory and expiratory phases may be determined based on patient effort or based on a preselected inspiratory time.”);
c) measure, via the at least one volumetric flow measuring device, a volume (V2) of the fluid supplied during the defined time period (paragraph [0006] “The leak-compensated lung compliance may be estimated based on the leak-compensated delivered lung volume and a pressure difference, such as the difference between an end inspiratory pressure of a first breath and an end expiratory pressure of the first breath.”);
d) measure, via the at least one pressure sensor, a pressure increase (Apc) in the body cavity resulting from the supplied volume (V2) (paragraph [0027] “…the circuit compliance may be estimated by pressurizing the ventilator circuit 30 (or circuit 30 and interface 28 combination) when flow to the patient is blocked and measuring the volume of additional gas introduced to cause the pressure change (compliance=volume delivered/pressure difference)…”) (paragraph [0027] “The term circuit compliance is used to refer to the relationship between the pressure in the ventilator circuit 30 (or ventilator circuit 30 and attached patient interface 28, depending on how the compliance is determined) changes based on changes in volume delivered into the circuit.”); and
e) calculate a compliance (Cc) of the body cavity based on a direct calculation using the measured volume (V2) and the measured pressure increase (Δpc) according to the equation Cc = V2/Δpc, wherein the calculated compliance (Cc) provides a characterization of the body cavity to automatically identify an operating parameter for the minimally invasive surgery (paragraph [0026] “The amount the lung expands is proportional to the lung compliance and is defined as a function of gas pressure differential (e.g., lung compliance=volume delivered/pressure difference).”).
Regarding Claim 9, Jafari discloses wherein the at least one electronic computing unit is further configured to: repeat steps (b) through (d) multiple times to generate a plurality of data points, each data point including a volume and a corresponding pressure; and derive a pressure-volume (p-V) diagram for the body cavity based on the plurality of data points (see paragraphs [0050], [0051] and [0061] where it is disclosed that the calculations are repeated).
Regarding Claim 10, Jafari discloses the medical device of claim 8, wherein the identified operating parameter is a maximum allowable fluid flow rate for insufflating the body cavity ([0002] “In one implementation of PRVC, the ventilator estimates the compliance of the patient's lungs and uses the estimated lung compliance to calculate the target pressure that will result in the delivery of the pre-selected volume of gas.”).
Regarding Claim 11, Jafari discloses the medical device of claim 8, wherein the at least one electronic computing unit is further configured to: determine a leakage volumetric flow by measuring a flow of the fluid required to maintain a constant pressure in the body cavity; and adjust the calculated compliance (Cc) to compensate for the determined leakage volumetric flow ([0004] “This disclosure describes systems and methods for compensating for leakage when during delivery of gas to a patient from a medical ventilator in a pressure regulated volume control (PRVC) ventilation mode. The technology described herein includes systems and methods that compensate the delivery of PRVC ventilation for leakage in the patient circuit by using leak-compensated lung flows as well as respiratory mechanics (lung compliance and lung resistance) estimated in a manner that compensates for elastic and inelastic leaks from the ventilation system.”).
Regarding Claim 12, Jafari discloses wherein the fluid is a gas (paragraph [0022] “…pressurized gas (e.g., air and oxygen) …”).
Regarding Claim 13, Jafari discloses wherein the fluid is carbon dioxide (CO2) (paragraph [0022] “…pressurized gas (e.g., air and oxygen) …”).
Regarding Claim 16, Jafari discloses the medical device of claim 8, further comprising a user interface, wherein the at least one electronic computing unit is configured to present the identified operating parameter to a user via the user interface and to proceed with a surgical procedure based on the identified operating parameter only after receiving a confirmation from the user (paragraph [0022] “… an operator interface 52 may be provided to enable an operator to interact with the ventilator (e.g., change ventilator settings, select operational modes, view monitored parameters, etc.).”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jafari in view of US 6872183 B2 to Sampson et al. (hereinafter, Sampson).
Jafari discloses the claimed invention except for expressly disclosing wherein the fluid is a saline solution. However, Sampson teaches a device for delivering a liquid or gas to a body cavity, and monitoring for cavity perforations to determine if pressure in the cavity is substantially sustained during a test period (Abstract), and expressly mentions that saline and/or CO2 can be used interchangeable (col. 7, lines 37-40). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the calculation of determining compliance of Jafari to be used in a saline system of Sampson, as Sampson teaches that this would have also allowed an operator to determine if perforations exist (col. 1, lines 41-45). Both Jafari and Sampson are directed to the same logic of determining if a body cavity is intact, and both frame a mechanism to provide safety of a user using the same fluid dynamic principles. Sampson establishes that whether gas or liquid are used to inflate a cavity, a feedback loop is established to prevent injury.
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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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791