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 .
Specification
The abstract of the disclosure is objected to because it is greater than 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-13 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 claim 1, the limitation “the balloon catheter makes it possible to” renders the claim indefinite, it is unclear if the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 6, the limitation renders the claim indefinite:
“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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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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+ 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].”
In claim 6, it is unclear what is meant by the balloon catheter “defines a function”. The language “described below” renders the claim indefinite. It is unclear what is meant by the balloon catheter “performs fitting”, it is unclear what structural feature this corresponds with. Notably, the claimed balloon catheter does not include a processor/controller for performing the claimed calculations. An arithmetic part unit is recited in 3, however, claim 6 does not depend from claim 3, and it is unclear if this arithmetic part or another processor part is intended to perform the claimed calculations.
Similarly, it is unclear what structural feature performs “estimates a balloon diameter” and “calculates a blood layer thickness”.
Furthermore, it is unclear how a balloon diameter is estimated “from the obtained time after the inflation start”, no equation is set forth relating balloon diameter to inflation start time.
Furthermore, the language calculates a blood layer thickness “according to an expression described below” renders the claim indefinite.
Furthermore, the equation which describes parameters of “blood vessel diameter (inner diameter)” renders the claim indefinite. No “blood vessel diameter” has been previously calculated. Furthermore, it is unclear what is meant by the term (inner diameter) in parentheses, the scope and bounds of the claim are unclear.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claims 9 and 10, the limitation “two kinds of green light…and red light…” renders the claim indefinite. The term “two kinds” is unclear as to whether there are two kinds of green light, and two kinds of red light, for a total of four different kinds of light. In claim 10, the claim refers to specific wavelengths of 560 nm corresponding with green light and 650 nm corresponding with red light.
The examiner would suggest amending the language in claims 9 and 10 to refer to “two kinds of light including green light and red light”.
In claim 11, it is unclear what is meant by the phrase “in back”. It is unclear what the term “back” relates to, it is unclear if this refers to a structural feature of the balloon catheter.
In claims 12 and 13, the limitation “the catheter” lacks antecedent basis. It is suggested to refer to “the balloon catheter” as recited in other dependent claims.
Claim Rejections - 35 USC § 102
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 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlin et al. (US 2008/0077225; hereinafter Carlin).
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).
Carlin also shows an arithmetic operation part that determines presence or absence of a blood flow based on the intensity of the scattered light ([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]).
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) 4-10 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 the invention substantially as described in the 102 rejection above.
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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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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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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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.
Conclusion
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