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
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.
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, 6-10, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlin et al. (US 2008/0077225; hereinafter Carlin) in view of Stepp et al. (US 2018/0042482; hereinafter Stepp).
Carlin shows a balloon catheter (abstract) comprising: a balloon catheter including a catheter tube and a balloon provided at a distal end portion of the catheter tube ([0047], [0050]); an optical fiber housed in the catheter tube ([0047]-[0050]); a light irradiation part disposed in the balloon and coupled to the optical fiber and a light detection part that detects radiated light ([0053], [0057], [0079]); and a light source that generates light to be radiated ([0048]), wherein the balloon catheter makes it possible to radiate, from the balloon, light having a wavelength that can be absorbed by a substance present in blood, detect scattered light from an inside of a blood vessel, and monitor a state of a blood flow between the balloon and a blood vessel wall over time from intensity of the detected light ([0065]-[0068], [0081]-[0082]; Fig. 6). Also, calculate a blood layer thickness between the balloon and a blood vessel wall based on the intensity of the detected scattered light, and prevent blockage of blood flow by adjusting a balloon diameter using the determined blood flow (determination of vessel lumen size for accurate selection of appropriate size balloon, [0081]).
Carlin also shows an arithmetic operation part that determines presence or absence of a blood flow based on the intensity of the scattered light from inside of a blood vessel ([0065]-[0068], [0081]-[0082]); a display part for displaying a state of the blood flow analyzed by the arithmetic operation part (Fig. 6); wherein the balloon catheter detects the scattered light in back ([0049], [0058]-[0064]); wherein the catheter is a blood vessel blockage or aortic blockage catheter ([0046], [0052], [0057], [0064], [0081]-[0083]); wherein the catheter is a blood vessel blockage or aortic blockage catheter ([0046], [0052], [0057], [0064], [0081]-[0083]).
Carlin fails to show wherein a wavelength of the light to be radiated is 400 to 500 nm; wherein the balloon catheter radiates, from the balloon, the light having the wavelength that can be absorbed by the substance present in the blood, the light being lights having a plurality of wavelengths with different optical penetration depths, detects scattered lights from the inside of the blood vessel of the lights having the respective wavelengths, and monitors a blood flow rate between the balloon and the blood vessel wall from intensities of the scattered lights of the lights having the respective wavelengths; wherein the balloon catheter defines a function represented by Expression (1) or (2) described below, performs fitting using an elapsed time from a balloon inflation start at a time when backscattered light is detected and data of backscattered light intensity, determines a coefficient,
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103
499
media_image1.png
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T: time
α: value determined for each wavelength
P: any backscattered light intensity
p: actual backscattered light intensity closest to a/2
t: time at a time when P=p
or
T(P) =
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media_image2.png
61
127
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+ C (2)
T(P): time
P: any backscattered light intensity
b: coefficient determined for each wavelength
C: coefficient determined for each wavelength
uses the calculated coefficient and substitutes, in Expression (1) or (2) described above, backscattered light intensity detected by radiating light (green) having a wavelength of 560 nm or light having a wavelength of 650 nm to thereby calculate an elapsed time after the inflation start, estimates a balloon diameter from the obtained time after the inflation start, and calculates a blood layer thickness according to an expression described below [blood layer thickness=blood vessel diameter (inner diameter)-balloon diameter]; wherein the lights with the different optical penetration depths are lights having two kinds, three kinds, four kinds, five kinds, or six kinds of wavelengths among lights having wavelengths such as near infrared light, infrared light, 380 to 430 nm light (violet), 430 nm to 490 nm light (blue), 490 nm to 550 nm light (green), 550 nm to 590 nm light (yellow), 590 nm to 640 nm light (orange), and 640 to 770 nm light (red); wherein the lights with the different optical penetration depths are at least two kinds among light having a wavelength of 475 nm, light having a wavelength of 542 nm, and light having a wavelength of 438 nm; wherein the lights with the different optical penetration depths are two kinds of green light and red light; wherein the lights with the different optical penetration depths are two kinds of green light having a wavelength of 560 nm and red light having a wavelength of 650 nm.
Stepp discloses systems and methods for measurement of blood. Stepp teaches wherein a wavelength of the light to be radiated is 400 to 500 nm ([0011], [0017]); the light being lights having a plurality of wavelengths with different optical penetration depths, detects scattered lights from the inside of the blood vessel of the lights having the respective wavelengths ([0009], [0011], [0015], [0017], [0020]); wherein the lights with the different optical penetration depths are lights having two kinds, three kinds, four kinds, five kinds, or six kinds of wavelengths among lights having wavelengths such as near infrared light, infrared light, 380 to 430 nm light (violet), 430 nm to 490 nm light (blue), 490 nm to 550 nm light (green), 550 nm to 590 nm light (yellow), 590 nm to 640 nm light (orange), and 640 to 770 nm light (red) ([0009], [0011], [0015], [0017], [0020]); wherein the lights with the different optical penetration depths are at least two kinds among light having a wavelength of 475 nm, light having a wavelength of 542 nm, and light having a wavelength of 438 nm ([0009], [0011], [0015], [0017], [0020]); wherein the lights with the different optical penetration depths are two kinds of green light and red light; wherein the lights with the different optical penetration depths are two kinds of green light having a wavelength of 560 nm and red light having a wavelength of 650 nm ([0009], [0011], [0015], [0017], [0020]).
It would have been obvious to one of ordinary skill in the art, to have modified the invention of Carlin to utilize light of various wavelengths as taught by Stepp, in order to more accurately monitor the state of the patient’s blood flow by monitoring for known blood analytes (Stepp, [0003], [0006]). Carlin furthermore notes that while the main embodiment is directed to infrared type measurements, other embodiments may encompass electromagnetic radiation at optical frequencies ([0056]). It would be within the level of one of ordinary skill in the art to modify Carlin to utilize other known wavelengths in order to more accurately monitor the blood flow state within the blood vessel during the balloon expansion.
Regarding the limitation “wherein the balloon catheter defines a function represented by Expression (1) or (2) described below, performs fitting using an elapsed time from a balloon inflation start at a time when backscattered light is detected and data of backscattered light intensity, determines a coefficient,
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media_image1.png
103
499
media_image1.png
Greyscale
T: time
α: value determined for each wavelength
P: any backscattered light intensity
p: actual backscattered light intensity closest to a/2
t: time at a time when P=p
or
T(P) =
PNG
media_image2.png
61
127
media_image2.png
Greyscale
+ C (2)
T(P): time
P: any backscattered light intensity
b: coefficient determined for each wavelength
C: coefficient determined for each wavelength
uses the calculated coefficient and substitutes, in Expression (1) or (2) described above, backscattered light intensity detected by radiating light (green) having a wavelength of 560 nm or light having a wavelength of 650 nm to thereby calculate an elapsed time after the inflation start, estimates a balloon diameter from the obtained time after the inflation start, and calculates a blood layer thickness according to an expression described below [blood layer thickness=blood vessel diameter (inner diameter)-balloon diameter]”
While Carlin does not directly refer to the claimed equation, Carlin describes optically determining vessel lumen size and diameter, lesion size, a shape and size of a balloon stent as it is inflated within the lumen ([0074], [0081]-[0082]; Fig. 6), and it would be an obvious design choice to of one of ordinary skill in the art, to utilize other suitable equivalent equations, such as the claimed equation, to accurately characterize the state of the patient’s blood flow within the vessel as the balloon is inflated. Lacking further criticality or unexpected results, the measurements of Carlin are considered a suitable equivalent to the claimed equation, as they provide the same end result of measuring the state of the blood flow during balloon expansion.
Response to Arguments
In response to applicant’s arguments regarding the combination of Carlin and Stepp, examiner respectfully disagrees. The examiner maintains that such a combination is appropriate and would be within the level of one of ordinary skill in the art. Stepp is within the same field of endeavor which encompasses diagnostic analysis of a patient’s blood. It would be within the level of one of ordinary skill in the art to operate an optical based device to utilize a plurality of known wavelengths, and the selection of particular wavelengths for diagnostic analysis may be accomplished without undue experimentation. Notably, Stepp is not required to teach determining presence of absence of blood flow based on an intensity of scattered light, as this feature is taught by Carlin. In any case, it is noted that Stepp similarly relies upon detecting an intensity of backscattered light ([0044], [0050]).
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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