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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 November 2025 has been entered.
Claim Objections
Claim 1 is objected to because of lack of antecedent basis for the recited limitation "the diaphragmatic pressure" in line 31. Appropriate correction is required.
Claim 1 is objected to because of lack of antecedent basis for the recited limitation "the parameters" in line 31. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-19 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. In particular, Claim 1 now recites “based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between one of the parameters measured at step c), being indicative of movement of one or more parts of the diaphragm, and diaphragmatic pressure”; however, the instant specification fails to show possession of the diaphragmatic pressure being determined based on a linear relationship because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically, the instant specification discloses linear relationship of transdiaphragmatic pressure (Pei) and not diaphragmatic pressure as claimed. The instant specification also makes a point to distinguish between transdiaphragmatic pressure and diaphragmatic pressure such that the diaphragmatic pressure is discloses as a functional parameter (see ¶ [0029, 0099, 0136, 0188]). Nowhere in the instant specification is it disclosed that the functional parameter diaphragmatic pressure is determined based on a linear relationship of one or more of the measurements of step c).
Furthermore, ¶ [0079] discloses that Pdi is determined based on:
“the determination of the transdiaphragmatic pressure is based on the variation of the propagation velocity of the shear wave. The linear relation between the transdiaphragmatic pressure and the propagation velocity of the shear wave, generated by the stimulation, may be used to determine the transdiaphragmatic pressure based on the sole value of the propagation velocity of the shear wave” (emphasis added).
Similarly, ¶ [0178-0180] discloses various linear relationships between Pdi and SMdi such as “mean Pdi swing and mean SMdi”, “Pdi swing and maximal SMdi”, and “max SMdi and Pdi swing.” However, the instant specification fails to disclose that the Pdi is determined based on a linear relationship of one or more of the measurements of step c). The instant specification only discloses a linear relationship between Pdi and propagation velocity of the shear wave or a species of SMdi.
Accordingly, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of “based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between one of the parameters measured at step c), being indicative of movement of one or more parts of the diaphragm, and diaphragmatic pressure.” Therefore, Claim 1 fails to meet the written description requirement of 35 U.S.C. 112(a).
Claims 16-17 recite similar limitations and are rejected under the same rationale as Claim 1. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 5-12, & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chino et al. ("Diaphragmatic shear modulus at various submaximal inspiratory mouth pressure levels," (19 March 2018), Respiratory Physiology & Neurobiology 252–253 (2018) 52–57; hereinafter "Chino") in view of previously presented Goligher et al. ("Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity," (19 February 2015), Intensive Care Med (2015) 41:642-649; hereinafter " Goligher").
With regards to Claim 1, Chino discloses the method for measuring, the method comprising the following steps of:
a) a stimulation step by which a stimulation of the diaphragm is provided to generate a movement of one or more parts of the diaphragm (ultrasound shear wave elastography of the diaphragm; see Chino Abstract; it should be appreciated that relies on measuring shear wave pulse {i.e. acoustic/mechanical stimulation} velocity propagating in a target tissue; see Chino pg. 52, ¶ 1);
b) during the movement of said one or more parts of the diaphragm (ultrasound transducer was finely adjusted so as to obtain clear echoes from pleural and peritoneal membranes {i.e. one or more parts of the diaphragm}; see Chino pg. 53, ¶ 9), imaging one or more parts of the diaphragm over time through an imaging step (shear wave elastography images were continuously acquired at a sampling rate of 1 Hz; see Chino pg. 53, ¶ 9) comprising the steps of:
emitting at least 100 unfocused ultrasound waves per second towards a region of the human or the animal comprising the one or more parts of the diaphragm to be imaged during the imaging step (Shear wave elastography images were continuously acquired at a sampling rate of 1 Hz; see Chino pg. 53, ¶ 9);
detecting ultrasound waves reflected and/or scattered by organic tissues of the human or the animal located in the region (Shear wave elastography images {i.e. images reconstructed from returned echoes} were continuously acquired at a sampling rate of 1 Hz; see Chino pg. 53, ¶ 9);
processing the reflected and/or scattered ultrasound waves over time to generate images (shear wave elastography images {i.e. images reconstructed from returned echoes} were continuously acquired at a sampling rate of 1 Hz; see Chino pg. 53, ¶ 9);
c) processing images previously acquired during the imaging step to measure:
(claimed in the alternative)
a propagation of a movement from said one or more parts of the diaphragm to one or more adjacent parts over time (average shear wave velocity (V) of the diaphragm within the ROI was measured using built-in software of the ultrasound system (Q-Box trace) and then converted into shear modulus (μ) using the equation μ = ρV2 , where ρ is the density of soft tissues (1000 kg/m3); see Chino pg. 53, ¶ 9; it should be appreciated that averaging and velocity measurements are time dependent); and/or
a propagation speed of a movement from said one or more parts of the diaphragm to one or more adjacent parts over time (average shear wave velocity (V) of the diaphragm within the ROI was measured using built-in software of the ultrasound system (Q-Box trace) and then converted into shear modulus (μ) using the equation μ = ρV2 , where ρ is the density of soft tissues (1000 kg/m3); see Chino pg. 53, ¶ 9; it should be appreciated that averaging and velocity measurements are time dependent); and/or
(claimed in the alternative)
(claimed in the alternative)
d)
While Chino discloses fitting the submaximal inspiratory mouth pressure and the diaphragmatic shear modulus to a simple linear equation (see Chino pg. 56, ¶ 2 & FIG. 2), it appears that Chino may be silent to determining the diaphragmatic pressure from a linear relation between one of the parameters measured at step c), being indicative of movement of one or more parts of the diaphragm, and the diaphragmatic pressure. However, Chino cites De Bruin et al. which teaches of diaphragm thickness and inspiratory strength and Goligher teaches of measuring diaphragm thickness with ultrasound. In particular, Goligher teaches of measuring one or more movements of different parts of the diaphragm over time (measuring diaphragm thickness (Tdi) and thickening (TFdi)) via ultrasound; see Goligher Abstract). Goligher also teaches of based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between one of the parameters measured at step c), being indicative of movement of one or more parts of the diaphragm, and the diaphragmatic pressure (FIG. 2 of Goligher clearly illustrates a fitted line that establishes a linear relationship ship between TFdi and ∆Pdi).
Chino and Goligher are both considered to be analogous to the claimed invention because they are in the same field of ultrasound assessment of the diaphragm during mechanical ventilation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chino to incorporate the above teachings of Goligher to provide at least measuring one or more movements of different parts of the diaphragm over time and based on one or more measurements of the processing step, determining the diaphragmatic pressure from a linear relation between one of the parameters measured at step c), being indicative of movement of one or more parts of the diaphragm, and the diaphragmatic pressure. Doing so would aid in aid in assess and monitor for diaphragm atrophy and inactivity during mechanical ventilation (see Goligher pg. 647, ¶ 2).
It should be appreciated that the same logic pattern and rationale are applied to Claims 16-17 as applied to Claim 1.
With regards to Claim 51, modified Chino teaches of wherein, based on a propagation speed of a movement through the diaphragm, the determining step d) comprises a determination of:
a contractility of the diaphragm (Shear modulus assessed by ultrasound shear wave elastography can be used as an index of change in active muscle force {i.e. contractility} produced by an individual muscle; see Chino pg. 55, ¶ 6); and/or
(claimed in the alternative).
With regards to claim 61, Chino discloses wherein:
the stimulation step a) further comprises a mechanical stimulation and/or an acoustic stimulation of one or more parts of the diaphragm generating a mechanical wave and/or an acoustic wave at said given part, the mechanical wave and/or the acoustic wave propagating towards adjacent parts of said given part (ultrasound shear wave elastography of the diaphragm; see Chino Abstract; it should be appreciated that relies on measuring shear wave pulse {i.e. acoustic/mechanical stimulation} velocity propagating in a target tissue; see Chino pg. 52, ¶ 1);
the imaging step b) further comprises imaging said given part and said adjacent parts through which the mechanical wave and/or the acoustic wave propagate(s) (see Chino elastograms of FIG. 1).
With regards to Claim 76, modified Chino teaches of wherein the mechanical wave and/or the acoustic stimulation is an ultrasonic stimulation, said ultrasonic stimulation comprising an emission of one or more focused ultrasound waves per second towards a given part of the diaphragm, said one or more focused ultrasound waves generating an elastic shear wave at said given part, the elastic shear wave propagating towards adjacent parts of said given part (ultrasound shear wave elastography of the diaphragm; see Chino Abstract; it should be appreciated that relies on measuring shear wave pulse {i.e. acoustic/mechanical stimulation} velocity propagating in a target tissue; see Chino pg. 52, ¶ 1; ultrasound transducer was finely adjusted so as to obtain clear echoes from pleural and peritoneal membranes of the diaphragm (i.e., to align the ultrasound imaging plane along the direction of the diaphragm in the zone of apposition), and to place a region of interest (ROI) for shear wave elastography image acquisition at 0.5–2.0 cm below the costophrenic sinus; see Chino pg. 53, ¶ 9; it should be appreciated that a finely adjusted ROI having a depth between 0.5-2.0cm indicated to one of ordinary skill in the art of focused ultrasound transmission).
With regards to Claim 86, modified Chino teaches of wherein the processing step c) further comprises a measure of a propagation velocity of the shear wave (measurement of the shear wave velocity {i.e. propagation velocity of the shear wave} and shear modulus; see Chino pg. 53, ¶ 9).
With regards to Claim 96, modified Chino teaches of wherein the determining step d) further comprises a determination of a contractility of the diaphragm based on the propagation velocity of the shear wave (Shear modulus assessed by ultrasound shear wave elastography can be used as an index of change in active muscle force {i.e. contractility} produced by an individual muscle; see Chino pg. 55, ¶ 6).
With regards to Claim 106, modified Chino teaches of wherein the stimulation step a) is performed during ventilation of the human or the animal (the diaphragmatic shear moduli during submaximal inspiration tasks at 15, 30, 45, 60, and 75% of the MIP {i.e. ventilation} were assessed by shear wave elastography; see Chino pg. 53, ¶ 10).
With regards to Claim 116, modified Chino teaches of wherein the determining step d) further comprises a determination of a diaphragm work (shear modulus assessed by ultrasound shear wave elastography can be used as an index of change in active muscle force {i.e. work} produced by an individual muscle; see Chino pg. 55, ¶ 6).
With regards to Claim 126, modified Chino teaches of wherein the determining step d) further comprises a determination of a diaphragm activity based on the propagation velocity of the shear wave (shear modulus measurements {i.e. activity determination} based on shear wave velocity; see Chino pg. 53, ¶ 9).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chino in view of Goligher, as applied to Claim 1 above, and in further view of Sarwal et al. ("Neuromuscular Ultrasound for Evaluation of the Diaphragm," (March 2013), Muscle Nerve. 2013 March ; 47(3): 319–329; hereinafter "Sarwal").
With regards to Claim 2, while modified Chino discloses all of the limitations of intervening claim 1 as shown above, it appears that Chino may be silent to wherein the stimulation of the diaphragm is an electrical and/or a magnetic stimulation. However, Sarwal teaches of ultrasound inspection of the diaphragm during phrenic nerve stimulation {i.e. electrical stimulation} (see Sarwal pg. 3, ¶ 1).
Sarwal also teaches of evaluating response to phrenic nerve stimulation over time and detecting diaphragm motion by ultrasound in response to phrenic nerve stimulation (see Sarwal pg. 3, ¶ 1 & pg. 7, ¶ 2, respectively).
Modified Chino and Sarwal are both considered to be analogous to the claimed invention because they are in the same field of ultrasonic inspection of the diaphragm. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chino to incorporate the above teachings of Sarwal to provide at least wherein the stimulation of the diaphragm is an electrical. Doing so would aid in distinguishing central nervous system pathology from lower motor neuron disease (see Sarwal pg. 7, ¶ 2).
With regards to Claim 32, wherein the processing step c) further comprises a measure of the amplitude of the movement of the diaphragm based on an intensity of the stimulation (average shear wave velocity (V) {i.e. amplitude of movement} of the diaphragm within the ROI was measured using built-in software of the ultrasound system (Q-Box trace) and then converted into shear modulus (μ) using the equation μ = ρV2 , where ρ is the density of soft tissues (1000 kg/m3); see Chino pg. 53, ¶ 9).
Claims 4 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chino in view of Goligher, as applied to Claim 1 above, and in further view of McKenzie et al. (“Phrenic nerve conduction times and twitch pressures of the human diaphragm,” (01 May 1985), J Appl Physiol, 58(5):1496-504; hereinafter "McKenzie").
With regards to Claim 41, while modified Chino discloses all of the limitations of intervening claim 1 as shown above, it appears that modified Chino may be silent to wherein the determining step d) further comprises a determination of a nerve conduction velocity. However, McKenzie teaches of Phrenic nerve conduction times and twitch pressures of the human diaphragm via phrenic nerve stimulation (see McKenzie Abstract).
Modified Chino and McKenzie are both considered to be analogous to the claimed invention because they are in the same field of assessment of diaphragmatic dysfunction. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chino to incorporate the above teachings of McKenzie to provide at least a determination of a nerve conduction velocity. Doing so would aid in understanding the role of inspiratory muscle fatigue in development of respiratory failure (see McKenzie pg. 1496, ¶ 1).
With regards to Claim 151, further comprising a step of determining a nerve conduction velocity from a time separating the stimulation of the diaphragm from the occurrence of a movement of the diaphragm associated to said stimulation (phrenic nerve conduction times and twitch pressures of the human diaphragm via phrenic nerve stimulation; see McKenzie Abstract; it should be appreciated that one of ordinary skill in the art would recognize that nerve conduction velocity assessed by phrenic nerve stimulation latency amounts to determining a time separating the stimulation of the diaphragm from the occurrence of a movement of the diaphragm associated to said stimulation; see also McKenzie pg. 1496, ¶ 1).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chino in view of Goligher as applied to Claim 6 above.
With regards to Claim 136, while Chino discloses all of the limitations of intervening claim 6 as shown above, it appears that Chino may be silent to wherein the determining step d) further comprises a determination of a transdiaphragmatic pressure based on the variation of the propagation velocity of the shear wave. However, Chino does teach that “[S]ince trans-diaphragmatic pressure is thought to be the best available index of diaphragmatic force at the moment (Moxham et al., 1981), the association between trans-diaphragmatic pressure and diaphragmatic shear modulus assessed by shear wave elastography should be investigated in future studies,” (see Chino pg. 57, ¶ 1).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chino to incorporate a determination of a transdiaphragmatic pressure based on the variation of the propagation velocity of the shear wave. Doing so would amount to combining prior art elements according to known methods to yield predictable results as indicated by Chino.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chino in view of Goligher, as applied to Claim 6 above, and in further view of Nguyen et al. (US PGPUB 20210338204; hereinafter "Nguyen")
With regards to Claim 146, Chino discloses wherein the stimulation step a) further comprises successive emissions of focused ultrasound waves towards the region of interest, each of said successive emissions being performed:
according to a different axis, and/or (ultrasound transducer was finely adjusted so as to obtain clear echoes from pleural and peritoneal membranes of the diaphragm {i.e. successive emissions at different axes} (i.e., to align the ultrasound imaging plane along the direction of the diaphragm in the zone of apposition), and to place a region of interest (ROI) for shear wave elastography image acquisition at 0.5–2.0 cm below the costophrenic sinus; see Chino pg. 53, ¶ 9)
according to a different focal length (ultrasound transducer was finely adjusted so as to obtain clear echoes from pleural and peritoneal membranes of the diaphragm (i.e., to align the ultrasound imaging plane along the direction of the diaphragm in the zone of apposition), and to place a region of interest (ROI) for shear wave elastography image acquisition at 0.5–2.0 cm {i.e. different focal lengths} below the costophrenic sinus; see Chino pg. 53, ¶ 9),
It appears that modified Chino may be silent to the method further comprises a determination of a spatial organization of muscles fascicles based on three-dimensional velocity fields reconstruction. However, Nguyen teaches of ultrasound systems and methods for smart shear wave elastography in anisotropic tissue (see Nguyen Abstract). In particular, Nguyen teaches of a determination of a spatial organization of muscles fascicles based on three-dimensional velocity fields reconstruction (identifying muscle fiber structures from 3D shear wave elastography dataset; see Nguyen Claim 1).
Modified Chino and Nguyen are both considered to be analogous to the claimed invention because they are in the same field of ultrasonic shear wave elastography. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chino to incorporate the above teachings of Nguyen to provide at least a determination of a spatial organization of muscles fascicles based on three-dimensional velocity fields reconstruction. Doing so would aid determining the location and orientation of the fibers relative to the transducer and adjust an angle of the ultrasound pulses accordingly for shear wave elastography (see Nguyen ¶ [0003]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Chino in view Goligher and Sarwal, as applied to Claim 2, and in further view of Journee et al. (“Ultrasound myography: Application in nerve conduction velocity assessment and muscle cooling,” (29 March 1993), Ultrasound in Medicine & Biology, Vol 19, Issue 7, 1993, Pages 561-566; hereinafter "Journee")
With regards to Claim 191, modified Chino teaches of further comprising the step of determining a nerve conduction (evaluating response to phrenic nerve stimulation over time and detecting diaphragm motion by ultrasound in response to phrenic nerve stimulation; see Sarwal pg. 3, ¶ 1 & pg. 7, ¶ 2, respectively).
It appears that modified Chino may be silent to determining a nerve conduction velocity. However, Journee teaches of ultrasound myography (UMG) which is studying muscle twitch induced by electrical stimulation (see Journee Abstract). In particular, Journee teaches of calculating nerve conduction velocities with UMG (see Journee Abstract).
Modified Chino and Journee are both considered to be analogous to the claimed invention because they are in the same field of ultrasound detected electrical stimulation. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chino to incorporate the above teachings of Journee to provide at least nerve conduction velocity. Doing so would aid in the assessment of nerve conduction velocities and noninvasive analysis of deep biomechanical processes (see Journee Abstract).
Allowable Subject Matter
Claims 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to Claim 18, none of the cited prior art discloses or teaches of a relationship between propagation velocity of the shear wave and/or shear modulus and diaphragmatic paralysis outside of Applicants own publications. The closest prior art (Gottesman et al., Sarwal et al., & Goligher) all relate ultrasonically measured diaphragmatic thickness to diaphragmatic paralysis and not propagation velocity of the shear wave.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 & 16-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In particular, Applicant argues that “Chino, nor any of the other cited documents, disclose the feature herein referred to as feature A of amended claim I that is "a method to determine the diaphragmatic pressure from ultrasound images." Moreover, Chino, and the other cited documents do not disclose or suggest the feature referred to as feature B of amended claim I that is "determining the diaphragmatic pressure from a linear relation between one of the parameters measured in step c) and the diaphragmatic pressure."” Without conceding to the Applicant’s arguments, it should be appreciated that the amended claims do no recite “feature A” and, thus, said argument is not persuasive. Regarding “feature B”, the Office relies on Goligher which determines an ultrasound measurement of thickening fraction TFdi {I.e. an amplitude of a movement of one or different parts of the diaphragm over time OR one or more movements of different parts of the diaphragm over time} which is linearly correlated to transdiaphragmatic pressure Pdi in FIG. 2 via a fitted line.
With regards to dependent claims, Applicant relies on the virtue of their dependency upon abovementioned independent claims to argue novelty. Accordingly, said argument is not persuasive for at least the same reasons as Claims 1, 16, & 17 as detailed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
McCool et al. (“Diaphragm Ultrasound in the Intensive Care Unit,” (2015), In: Jankowich, M., Gartman, E. (eds) Ultrasound in the Intensive Care Unit. Respiratory Medicine, p235-247).
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 ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798