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
Information Disclosure Statement (IDS) submitted on 08/02/2024 has been entered and fully considered by the examiner.
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.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over (U.S. Publication No. 2023/0201529) hereinafter “Yamamoto” in view of Smith et al. (U.S. Publication No. 2019/0350672) hereinafter “Smith”.
Regarding claim 1, Yamamoto discloses a catheter assembly [see abstract of Yamamoto] comprising:
a tubular catheter shaft; [see FIGs. 1-2 and [0021]; catheter shaft 20] and
an inner needle inserted into a lumen of the catheter shaft, [see FIGs. 1-2 and [0021]; puncture needle 16] the inner needle comprising an insertion distal end surrounded by a catheter distal end which is a distal end of the catheter shaft in an initial state of the catheter assembly in which the inner needle is inserted into the lumen of the catheter shaft [see FIG. 3 and [0023] of Yamamoto], wherein:
a wavelength conversion member [light emitting portion 24 can be a fluorescent material; inherently a fluorescence material converts the wavelength received into another wavelength; see FIG. 1 and [0033]] is included in at least one of the catheter distal end or the insertion distal end [see FIG. 1 and [0033] of Yamamoto],
Yamamoto does not expressly disclose that that the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light.
Smith, directed towards visualizing grafts and insertable devices using upconverting material [see abstract of Smith] further discloses that the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light. [see [0012] and [0081] of Smith disclosing use of NIR absorbing up conversion fluorescing markings which emit in the visible range located on the insertable device to track it]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Yamamoto further such the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light according to the teachings of Smith in order to replace a two section conversion device comprising of an IR camera and an IR coating with a single step IR conversion material applied to the tip of the needle and reduce the cost of device fabrication. Doing so would have been substituting one conversion device with another equivalent conversion device resulting in predictable and improved results which would have been obvious to try by an ordinarily skilled in the art. (KSR Rationale B)
Regarding claim 2, Yamamoto further discloses that the wavelength conversion member is included in the catheter distal end, [see FIG 1 and [0033]; the fluorescence material is in the location of the light emitting portion 24 at the distal end of the catheter] and the catheter shaft comprises a catheter body that is located on a proximal end side with respect to the catheter distal end and is not capable of converting the near-infrared light into the visible light. [see FIG.1 and [0033]; the conversion member is only at the distal end of the device]
Regarding claim 3, Yamamoto further discloses that the wavelength conversion member constitutes a wall portion of at least a part of the catheter distal end. [see FIGs. 8A and 8B; and [0068] of Yamamoto]
Regarding claim 4, Yamamoto further discloses that the catheter distal end comprises a non-wavelength conversion member that does not include the wavelength conversion material. [see FIG. 1, 8A and 8B and [0033] and [0068]; the rest of the distal end of the needle is not part of the light emitting section 24 and does not include fluorescent material]
Regarding claim 5, Yamamoto further discloses that the wavelength conversion member and the non-wavelength conversion member are adjacent to each other in a circumferential direction or a radial direction of the catheter shaft. [see FIG. 8A-8B; and [0068]-[0069]; the light emitting portion 24 and non-light emitting portion 26 are next to each other
Regarding claim 6, Yamamoto further discloses that the wavelength conversion member is coated on at least one of an outer circumferential surface or an inner circumferential surface of the catheter distal end. [see FIG. 8A-8B; and [0068]-[0069]]
Regarding claim 7, Yamamoto in view of Smith discloses all the limitations of claim 1 [see rejection of claim 1]
Smith further discloses that the wavelength conversion material converts the near-infrared light having a wavelength of more than 700 nm into the visible light having a wavelength ranging from 360 nm to 700 nm. [see [0012] and [0081] of Smith; the excitation wavelength is between 700-1300 nm and the emitted wavelength by an up-conversion material is in the visible range which is between 400-700nm]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Yamamoto as modified by Smith further such that the wavelength conversion material converts the near-infrared light having a wavelength of more than 700 nm into the visible light having a wavelength ranging from 360 nm to 700 nm according to the teachings of Smith since NIR wavelength is absorbed by the fluorescing material in order to replace a two section conversion device comprising of an IR camera and an IR coating with a single step IR conversion material applied to the tip of the needle and reduce the cost of device fabrication. Doing so would have been substituting one conversion device with another equivalent conversion device resulting in predictable and improved results which would have been obvious to try by an ordinarily skilled in the art. (KSR Rationale B)
Regarding claim 8, Yamamto further discloses that the wavelength conversion member is included only in the catheter distal end or only on the insertion distal end. [see FIG. 1, 8A and 8B and [0033] and [0068]; the rest of the distal end of the needle is not part of the light emitting section 24 and does not include fluorescent material]
Regarding claim 9, Yamamoto discloses a catheter system [see abstract of Yamamoto] comprising: a catheter assembly [catheter assembly of FIG. 1] comprising:
a tubular catheter shaft [see FIGs. 1-2 and [0021]; catheter shaft 20] and
an inner needle inserted into a lumen of the catheter shaft, [see FIGs. 1-2 and [0021]; puncture needle 16] the inner needle comprising an insertion distal end surrounded by a catheter distal end which is a distal end of the catheter shaft in an initial state of the catheter assembly in which the inner needle is inserted into the lumen of the catheter shaft [see FIG. 3 and [0023] of Yamamoto], wherein:
a wavelength conversion member [light emitting portion 24; see FIG. 1 and [0033]] is included in at least one of the catheter distal end or the insertion distal end [see FIG. 1 and [0033] of Yamamoto],
Yamamoto does not expressly disclose that that the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light.
Smith, directed towards visualizing grafts and insertable devices using upconverting material [see abstract of Smith] further discloses that the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light. [see [0012] and [0081] of Smith disclosing use of NIR absorbing up conversion fluorescing markings which emit in the visible range located on the insertable device to track it]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Yamamoto further such the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light according to the teachings of Smith in order to replace a two section conversion device comprising of an IR camera and an IR coating with a single step IR conversion material applied to the tip of the needle and reduce the cost of device fabrication. Doing so would have been substituting one conversion device with another equivalent conversion device resulting in predictable and improved results which would have been obvious to try by an ordinarily skilled in the art. (KSR Rationale B)
Regarding claim 10, Yamamoto discloses a method for puncturing a blood vessel [see abstract of Yamamoto], the method comprising:
providing a catheter assembly [catheter assembly of FIG. 1] comprising:
[see FIGs. 1-2 and [0021]; catheter shaft 20] and
an inner needle inserted into a lumen of the catheter shaft, [see FIGs. 1-2 and [0021]; puncture needle 16] the inner needle comprising an insertion distal end surrounded by a catheter distal end which is a distal end of the catheter shaft in an initial state of the catheter assembly in which the inner needle is inserted into the lumen of the catheter shaft [see FIG. 3 and [0023] of Yamamoto],
a wavelength conversion member [light emitting portion 24; see FIG. 1 and [0033]] is included in at least one of the catheter distal end or the insertion distal end [see FIG. 1 and [0033] of Yamamoto],
puncturing a target site with the catheter assembly in the initial state; [see [0024] of Yamamoto]
irradiating the target site with NIR light such that the wavelength conversion member emits light [see [0032]-[0033] of Yamamoto]
and determining that the catheter is not located in the blood vessel by visually recognizing the visible light generated from the wavelength conversion member; [see [0046]; the infrared data received is presented in a visual display unit and locates the catheter]
and determining that the catheter distal end is located in the blood vessel by visually recognizing that the visible light generated from the wavelength conversion member disappears. [see [0046]-[0048] of Yamamoto]
Yamamoto does not disclose the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light and that that the wavelength conversion member emits the visible light;
Smith, directed towards visualizing grafts and insertable devices using upconverting material [see abstract of Smith] further discloses that the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light. [see [0012] and [0081] of Smith disclosing use of NIR absorbing up conversion fluorescing markings which emit in the visible range located on the insertable device to track it]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Yamamoto further such the wavelength conversion member comprising a wavelength conversion material that converts near-infrared light into visible light according to the teachings of Smith in order to replace a two section conversion device comprising of an IR camera and an IR coating with a single step IR conversion material applied to the tip of the needle and reduce the cost of device fabrication. Doing so would have been substituting one conversion device with another equivalent conversion device resulting in predictable and improved results which would have been obvious to try by an ordinarily skilled in the art. (KSR Rationale B)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zemel (U.S. Publication No. 2011/0009738) hereinafter “Zemel”: discloses a needle for vein puncturing during medical procedures which uses infrared scattering coating on the needle tip to track the position of the needle using a camera.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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