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 .
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.
Claim(s) 1-2, 6-9, 14-16, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Slessarev et al (Pub. No.: US 2009/0120435) in view of Klein et al (Pub. No.: US 2014/0311491)
Regarding claims 1, 8, 15, Slessarev et al disclose a method of determining a perfusion metric (CVR/CVF, 0050 and claim 114) in a subject comprising:
pre-determining an arterial input function comprising a square input function, the square input function corresponding to a first end tidal partial pressure of oxygen (PeTO2) [see 0046, claim 118], a second PetO2 [see 0047, claim 118] and an end tidal partial pressure of carbon dioxide (PetCO2);
inducing an increase in arterial partial pressure of oxygen in a subject [see claims 118, 120] by:
targeting the first PetO2 with a sequential gas delivery (SGO) device [see 0015, claims 118, 120];
targeting the second PetO2 with the sequential gas delivery device [see 0015, claims 118, 120];
controlling the PetCO2 with the sequential gas delivery device [see 0015, 0062-0063, 0096];
measuring a magnetic signal (via Bold, emphasis added) in a selected voxel in the subject responsive to the increase in arterial partial pressure of oxygen [see 0050];
outputting a perfusion metric (cerebral blood flow) for the selected voxel at a display, the perfusion metric computed based on the pre-determined arterial input function and the magnetic signal [see 0050] by disclosing controlling the end tidal CO.sub.2 and O.sub.2 levels of a subject using one of the aforementioned methods and monitoring cerebral blood flow or oxygenation via some method such as a blood oxygen level dependent (BOLD) with functional Magnetic Resonance Imaging signal intensity [see 0050].
Slessarev et al may not explicitly mention wherein the first PetO2 is less than the second PetO2.
However, Slessarev et al disclose end tidal partial pressure of oxygen between two known levels (30-50 mmHg) [see 0015] which means the first one could be 30 mmhg and the second one 50 mmhg; therefore, the end tidal partial pressure of oxygen of 30 mmhg is less than the second end tidal partial pressure of oxygen of 50 mmhg (emphasis added).
Nonetheless, Klein et al disclose selecting different end tidal partial pressures of oxygen in the range of 30 mmhg up to 100 mmhg to attain a target response [see 0102-0106]
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Slessarev et al and Klein et al by selecting an end tidal partial pressures of oxygen of 30 mmhg and an end tidal partial pressures of oxygen of 95 mmhg; so that a level of oxygen can be attained and the success of a given tuning sequence can be judged accordingly [see 0102, Klein et al].
Regarding claims 2, 9, 16, Slessarev et al disclose wherein the sequential gas delivery device is configured to induce the increase in arterial partial pressure of oxygen within one second (by disclosing no greater than 30 second which means less than 1 second is within that range, emphasis added) [see claim 113].
Regarding claims 6, 13, 20, Slessarev et al disclose wherein the perfusion metric is selected from the group consisting of cerebral blood flow [see 0003], mean transit time [see claim 113], and cerebral blood volume [see 0050, claim 114] by disclosing controlling the end tidal CO.sub.2 and O.sub.2 levels of a subject using one of the aforementioned methods and monitoring cerebral blood flow or oxygenation via some method such as a blood oxygen level dependent (BOLD) with functional Magnetic Resonance Imaging signal intensity [see 0050].
Regarding claims 7, 14, 21, Slessarev et al disclose wherein the magnetic signal is measured using blood oxygen level dependent (BOLD) magnetic resonance imaging [see 0138] by disclosing physiological variable is CVR as measured by MRI [see claim 114].
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.
Claim(s) 3-5, 10-12, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Slessarev et al (Pub. No.: US 2009/0120435) in view of Klein et al (Pub. No.: US 2014/0311491) as applied to claims 1, 8, 15 above and further in view Friedrich et al (Pub. No.: US 2017/0325784).
Regarding claims 3, 10, 17, Slessarev et al disclose the second PetO2 corresponds to normoxia in the subject [see fig 4].
Slessarev et al don’t disclose wherein the first PetO2 corresponds to hypoxia in the
subject.
Nonetheless, Friedrich et al disclose wherein the first PetO2 corresponds to hypoxia in the
subject [see 0216, figs 5, 8]
Therefore, it is obvious to one skilled in the art at time the invention was filed and would have been motivated to combine Slessarev et al Klein et al and Friedrich et al by monitoring hypoxia; in order to determine a condition characterized by insufficient oxygen supply to the body's tissues, which can lead to serious health complications.
Regarding claim 4, 11, 18, Slessarev et al may not explicitly mention wherein the first PetO2 is about 40 mmHg and the second PetO2 is about 95 mmHg.
However, Slessarev et al disclose end tidal partial pressure of oxygen between two known levels (30-50 mmHg) [see 0015] which means the first one could be 30 mmhg and the second one 50 mmhg; therefore, the end tidal partial pressure of oxygen of 30 mmhg is less than the second end tidal partial pressure of oxygen of 50 mmhg (emphasis added).
Nonetheless, Klein et al disclose selecting different end tidal partial pressures of oxygen in the range of 30 mmhg up to 100 mmhg to attain a target response [see 0102-0106]
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Slessarev et al Friedrich et al and Klein et al by selecting an end tidal partial pressures of oxygen of 30 mmhg and an end tidal partial pressures of oxygen of 95 mmhg; so that a level of oxygen can be attained and the success of a given tuning sequence can be judged accordingly [see 0102, Klein et al].
Regarding claims 5, 12, 19, Slessarev et al disclose controlling PetCO2 comprises maintaining
normocapnia while targeting the first and second PetO2 [see fig 4].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOEL F BRUTUS/Primary Examiner, Art Unit 3798
Prosecution Insights