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 .
35 USC § 112(f) or 112 (pre-AIA ), Sixth Paragraph
CLAIM INTERPRETATION
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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.
Claim limitation:
“a respiratory monitoring device” recited in claim 1 and dependent claims thereafter has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “device” coupled with functional language “measure” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
“a vascular monitoring device” recited in claim 1 and dependent claims thereafter has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “device” coupled with functional language “measure” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) above has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
For “a respiratory monitoring device” recited in claim 1 and dependent claims thereafter, the specification (0038) discloses the following:
[0038] In some embodiments, the respiratory monitoring device 216 may be an atmospheric sampling device, such as a differential oxygen/carbon dioxide analyzer, that allows for the measurement of the relative amount of oxygen and carbon dioxide in the patient's environment.
[0039] In other embodiments, the respiratory monitoring device 216 is a nasal cannula that is positioned in the patient's nasal cavity to measure the P.sub.ETCO.sub.2 of the patient directly during rest and the exercise.
Therefore, “a respiratory monitoring device” recited in claim 1 and dependent claims thereafter have been interpreted as being atmospheric sampling device or any equivalent structures in light of the specification for the purpose of examination.
For “a vascular monitoring device” recited in claim 1 and dependent claims thereafter, the specification (0040) discloses the following:
[0040] In addition to the respiratory monitoring device 216, the system includes a vascular monitoring device 217 to measure the user's heart rate, blood pressure, or other vascular information during rest and the exercise. For example, the vascular monitoring device 217 may include a finger pressure cuff to measure MAP. In other examples, the vascular monitoring device 217 may include an arm pressure cuff to measure MAP. In yet other examples, the vascular monitor device may include an electrocardiogram to measure heart rate.
Therefore, “a vascular monitoring device” recited in claim 1 and dependent claims thereafter have been interpreted as a pressure cuff device, or ECG device or any equivalent structures in light of the specification for the purpose of examination.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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) 1-3, 5, 7, 8, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot et al. (US 2006/0100530, hereinafter Kliot ‘530) in view of Calkins et al. (US 6,402,697, hereinafter Calkins ‘697) and Billinger et al. (Dynamics of middle cerebral artery blood flow velocity during moderate-intensity exercise, J Appl Physiol 122: 1125–1133, March 09, 2017, hereinafter Billinger ‘2017).
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) 0070); 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),
Calkins ‘697 teaches a respiratory monitoring device configured to measure respiratory information including measuring one or more of oxygen consumption, carbon dioxide production, or end-tidal carbon dioxide of the patient (fig. 6, fig. 9; col. 11, line 1-15, line 42-48; col. 16, lines 18-40).
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.
Billinger ‘2017 teaches the computing device programmed to correlate the MCAv with a physical activity load of the patient during the exercise activity based on one or more of the respiratory information or the vascular information, to generate a correlated cerebrovascular curve (fig. 1, it’s label, page 1128).
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, and to include the features of Billinger ‘2017 in order to unveil novel aspects of cerebrovascular function in health and disease.
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 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).
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(s) 4, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530, Calkins ‘697 and Billinger ‘2017 in view of Schaafsma; Arjen (US 2007/0293760, hereinafter Schaafsma ‘760).
In re claim 4, Kliot ‘530, Calkins ‘697 and Billinger ‘2017 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, Calkins ‘697 and Billinger ‘2017 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) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kliot ‘530, Calkins ‘697 and Billinger ‘2017 in view of Hemnes et al. (US 2012/0302908, hereinafter Hemnes ‘908).
In re claim 8, Kliot ‘530, Calkins ‘697 and Billinger ‘2017 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, Calkins ‘697 and Billinger ‘2017 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, Calkins ‘697 and Billinger ‘2017 in view of Hornick; Ofer (US 2012/0238834, hereinafter Hornick ‘834).
In re claim 12, Kliot ‘530, Calkins ‘697 and Billinger ‘2017 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, Calkins ‘697 and Billinger ‘2017 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-12 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.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. 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 3797
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