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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on November 10, 2025 is acknowledged.
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 1-12 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.
In re claim 1, it is unclear what the metes and bounds of limitation “an ultrasound transducer device configured to send and receive ultrasound pulses for measuring fluid velocity and fluid flow direction in a head of a patient” are. Is “measuring fluid velocity and fluid flow direction in a head of a patient” a necessary function of this ultrasound transducer or just a function that a transducer is capable of doing? If it is a necessary function, the limitation should be: an ultrasound transducer device configured to send and receive ultrasound pulses to measure fluid velocity and fluid flow direction in a head of a patient. For the purpose of the Examination, the Examiner will interpret as: an ultrasound transducer device configured to send and receive ultrasound pulses to measure fluid velocity and fluid flow direction in a head of a patient.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kliot et al. (US 2006/0100530, hereinafter Kliot ‘530).
In re claim 1, Kliot ‘530 teaches a system of evaluating cerebrovascular function in a patient, the system comprising: a respiratory monitoring device (0047-0049, devices for acquisition of respiration); a vascular monitoring device (0047-0049, ECG); an ultrasound transducer device configured to send and receive ultrasound pulses for measuring fluid velocity and fluid flow direction in a head of a patient (0046, 0058); and a computing device in data communication with the respiratory monitoring device, vascular monitoring device, and the ultrasound transducer device (fig. 2, 0049, 0051, 0057, 0058).
In re claim 2, Kliot ‘530 teaches wherein the ultrasound transducer device is positioned to direct ultrasound toward the head of the patient (fig. 1, 10, 0034, 0046).
In re claim 3, Kliot ‘530 teaches wherein the ultrasound transducer device is configured to measure fluid velocity and flow direction via transcranial doppler ultrasound (TDC) (0007, 0008, 0033, 0046, 0084).
In re claim 5, Kliot ‘530 teaches wherein the ultrasound transducer device is a head-mounted transducer that rests upon the head of the patient (fig. 1, 10, 0034, 0046).
In re claim 6, Kliot ‘530 teaches wherein the ultrasound transducer device is configured to measure a middle cerebral artery blood flow velocity (MCA.sub.V) of the patient (0060, 0070, etc.).
In re claim 11, Kliot ‘530 teaches wherein the vascular monitoring device includes an electrocardiogram for measuring a heart rate of the patient (0020, 0047, 0048).
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 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.
Claim(s) 4, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530 in view of Schaafsma; Arjen (US 2007/0293760, hereinafter Schaafsma ‘760).
In re claim 4, Kliot ‘530 fails to teach wherein the ultrasound is an ultrasound pulse with a frequency of about 2 MHz and a depth of about 46-65 mm.
Schaafsma ‘760 teaches wherein the ultrasound is an ultrasound pulse with a frequency of about 2 MHz and a depth of about 46-65 mm (0105).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Kliot ‘530 to include the features of Schaafsma ‘760 in order to obtain optimal diagnoses at the desired location.
In re claim 10, Schaafsma ‘760 teaches wherein the vascular monitoring device includes a finger pressure cuff or an arm pressure cuff for measuring arterial blood pressure (MAP) of the patient (0106).
Claim(s) 7, 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530 in view of Calkins et al. (US 6,402,697, hereinafter Calkins ‘697).
In re claim 7, Kliot ‘530 fails to teach wherein the respiratory monitoring device is a differential oxygen/carbon dioxide analyzer for measuring a relative amount of oxygen and carbon dioxide in a patient environment.
Calkins ‘697 teaches wherein the respiratory monitoring device is a differential oxygen/carbon dioxide analyzer for measuring a relative amount of oxygen and carbon dioxide in a patient environment (col. 11, lines 25-48; col. 26, lines 20-35; col. 27, lines 29-47).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Kliot ‘530 to include the features of Calkins ‘697 in order to provide a cardiac output monitoring device that measures attributes of respired gasses on a breath-by-breath basis.
In re claim 8, Calkins ‘697 also teaches wherein patient's environment is a closed respiratory environment including a facemask, or a closed environment chamber (col. 11, lines 49-65).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530 in view of Hemnes et al. (US 2012/0302908, hereinafter Hemnes ‘908).
In re claim 8, Kliot ‘530 fails to teach wherein patient's environment is a closed respiratory environment including a facemask, or a closed environment chamber.
Hemnes ‘908 teaches wherein patient's environment is a closed respiratory environment including a facemask, or a closed environment chamber (0096).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Kliot ‘530 to include the features of Hemnes ‘908 in order to better distinguish pulmonary arterial hypertension (PAH) from other forms of pulmonary hypertension (PH) such as pulmonary venous hypertension (PVH).
In re claim 9, Hemnes ‘908 also teaches wherein the respiratory monitoring device is a nasal cannula for measuring an end-tidal carbon dioxide (P.sub.ETCO.sub.2) at a nasal cavity of the patient (0051, 0055, 0058).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530 in view of Hornick; Ofer (US 2012/0238834, hereinafter Hornick ‘834).
In re claim 12, Kliot ‘530 fails to teach wherein the vascular monitoring device is configured to monitor a blood composition of the patient by measuring an oxygen and carbon dioxide transport of the blood of the patient.
Hornick ‘834 teaches wherein the vascular monitoring device is configured to monitor a blood composition of the patient by measuring an oxygen and carbon dioxide transport of the blood of the patient (0091, 0123, 0160-0163, 0168, 0309-0315).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Kliot ‘530 to include the features of Hornick ‘834 in order to monitor the patient's medical status, provide treatment, verify that the treatment works and that respiration improves or further deteriorates; and make critical decisions regarding additional measures, such as the need for artificial ventilation or its removal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M RAYMOND can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3798