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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 7/25/2025, 8/21/2025 and 4/30/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-20 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.
Regarding claim 1, the claim recites the limitation “a radially outer side to a radially inner side” in lines 2-3 and it is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 1, the claim recites the limitation “a distal end side and a proximal end side” in line 6. It is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 1, the claim recites the limitations of “an upstream side to a downstream side” in lines 15-16 and 19 and it is unclear as to whether this is defining an upstream proximal side of the image diagnosis catheter flowing to a downstream distal side of the catheter or whether it is referring to some other element of the catheter. This renders the scope of the claim unclear and rejected for indefiniteness.
Claim 8 recites the limitation "the second outer facing surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the first outer facing surface and the third outer facing surface" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the second outer facing surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the claim recites the limitation “a predetermined transverse plane” and it is unclear as to how the claimed transverse plane is “predetermined” and how this limitation narrows any other claimed transverse plane that otherwise meets the rotationally symmetric claimed limitation. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 10, the claim recites the limitation “the radially inner side with respect to the outer tube and on the radially outer side with respect to the drive shaft” and it is unclear as to what inner and outer sides the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 10, the claim recites the limitation “the distal end side” in lines 6 and 9. It is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 11, the claim recites the limitation “the radially inner side” in lines 3-4 and it is unclear as to what inner side the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 11, the claim recites the limitation “a distal end portion” in line 9 and it is unclear as to what portion the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 12, the claim recites the limitation “the distal end portion” in line 2 and it is unclear as to what portion the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 12, the claim recites the limitations of “the upstream side to the downstream side” in lines 12-13 and it is unclear as to whether this is defining an upstream proximal side of the image diagnosis catheter flowing to a downstream distal side of the catheter or whether it is referring to some other element of the catheter. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 14, the claim recites the limitation “the radially inner side with respect to the inner tube and on the radially outer side with respect to the inner-tube support tube” in lines 2-3 and it is unclear as to what inner and outer sides the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 15, the claim recites the limitation “a radially outer side to a radially inner side” in lines 2-3 and it is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 15, the claim recites the limitation “a distal end side and a proximal end side” in line 6. It is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 16, the claim recites the limitations of “an upstream side to a downstream side” in lines 3-4 and 7 and it is unclear as to whether this is defining an upstream proximal side of the image diagnosis catheter flowing to a downstream distal side of the catheter or whether it is referring to some other element of the catheter. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 17, the claim recites the limitation “the radially outer side” in line 4 and it is unclear as to what inner side the limitation is referring to and whether it is portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 18, the claim recites the limitations of “the upstream side to the downstream side” in lines 8-9 and it is unclear as to whether this is defining an upstream proximal side of the image diagnosis catheter flowing to a downstream distal side of the catheter or whether it is referring to some other element of the catheter. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 20, the claim recites the limitation “a distal end side and a proximal end side” in line 5. It is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 20, the claim recites the limitation “a radially outer side to a radially inner side” in lines 9-10 and it is unclear as to whether these sides are referring to portions of the overall image diagnosis catheter or whether they are referring to portions of other claimed elements. This renders the scope of the claim unclear and rejected for indefiniteness.
Regarding claim 20, the claim recites the limitations of “an upstream side to a downstream side” in lines 16 and 18-19 and it is unclear as to whether this is defining an upstream proximal side of the image diagnosis catheter flowing to a downstream distal side of the catheter or whether it is referring to some other element of the catheter. This renders the scope of the claim unclear and rejected for indefiniteness.
Claims dependent upon rejected claims are also rejected for indefiniteness. Therefore, dependent claims 2-7, 13, and 19 are also rejected.
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 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamashita (U.S. Pub. No. 20170172541) hereinafter Yamashita.
Regarding claim 15, primary reference Yamashita teaches:
An image diagnosis catheter (abstract) comprising:
an outer tube ([0065], figure 12, outer tube 32),
an inner tube ([0065], figure 12, inner tube 34),
an inner-tube support tube ([0065], figure 12, protection tube 67), and
a drive shaft in this order from a radially outer side to a radially inner side ([0065], figure 12, rotary shaft 42);
an inner tube spacer that holds the inner-tube support tube so as to define an inner-tube support tube outer flow path ([0065], figure 12, spacer tube 68 forms an inner tube spacer with respect to the protection tube 67 and wherein “The protection tube 67 is formed of a metal pipe body having a rough-winding coil shape. Therefore, a physiological salt solution can flow through gaps of the coil, and thus, no air remains inside the outer tube 32” forming an inner-tube support tube outer flow path; see also [0062], [0073] physiological salt solution supplied into the outer tub 32, and through into gaps of the coil of [0065]);
a connector hub movable to a distal end side and a proximal end side relative to the outer tube together with the inner tube, the inner-tube support tube, the drive shaft, and the inner tube spacer ([0075]-[0076], hub 31 of the ultrasound catheter 1 is moveable as indicated in figure 2 from a distal to proximal side direction relative to the catheter including the outer, inner support tubes and drive shaft and spacer of figure 12);
an inner flow path and an outer flow path ([0065], figure 12, spacer tube 68 forms an inner tube spacer with respect to the protection tube 67 and wherein “The protection tube 67 is formed of a metal pipe body having a rough-winding coil shape. Therefore, a physiological salt solution can flow through gaps of the coil, and thus, no air remains inside the outer tube 32” forming an inner flow path and outer flow path when all of the gaps of the claimed elements are filled with the salt solution and removing all air within; see also [0062], [0073] physiological salt solution supplied into the outer tub 32, and through into gaps of the coil of [0065]); and
an inner-tube-spacer proximal-side flow path formed on the proximal end side relative to the inner tube spacer, wherein at least the inner tube spacer defines an inner- tube-spacer partition flow path ([0065], figure 12, spacer tube 68 forms an inner tube spacer with respect to the protection tube 67 and wherein “The protection tube 67 is formed of a metal pipe body having a rough-winding coil shape. Therefore, a physiological salt solution can flow through gaps of the coil, and thus, no air remains inside the outer tube 32” forming an inner-tube spacer proximal-side flow path on the proximal side of the inner tube spacer as well as a partition flow path when all of the gaps of the claimed elements are filled with the salt solution and removing all air within; see also [0062], [0073] physiological salt solution supplied into the outer tub 32, and through into gaps of the coil of [0065]).
Allowable Subject Matter
Claims 1-14 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding independent claims 1 and 20, the claims include limitations directed to inner and outer flow paths, defined in such ways relative to the tube elements that form complete flow paths that appear to be nonobvious in light of the closest prior art references of record. The closest prior art references are indicated below. These claims would be allowable if the applicant provides additional amendments to overcome the current 112(b) rejections above.
Claims 16-19 include additional limitations similar to that of independent claims 1 and 20 which would overcome the current prior art rejection of claim 15 above. Claim 15 is also rejected under 112(b) above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sakaguchi (U.S. Pub. No. 20210338199) teaches to a diagnostic imaging catheter that includes a drive shaft and proximal end hub portion for supporting the device. The reference further teaches to inner and outer tube elements across the device, but fails to teach to the flow channels as provided in independent claims 1 and 20.
Sakaguchi (U.S. Pub. No. 20170333001) teaches to a diagnostic imaging catheter that includes a drive shaft and proximal end hub portion for supporting the device. The reference further teaches to inner and outer tube elements across the device, but fails to teach to the flow channels as provided in independent claims 1 and 20.
Okubo et al. (U.S. Pub. No. 20160143616) teaches to a catheter device with a hub that moves the drive shaft and inner and outer tubes for providing connection across the device for imaging of a region of interest.
Sakaguchi (U.S. Pub. No. 20190021694) teaches to catheter with an ultrasound imaging device that includes a motor unit that transits throughout the device for operation. The device further includes operational lumens and passageways for fluid flow during use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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