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 .
Acknowledgments
This office action is in response to the reply filed 06,05,2026
In the reply, Applicant amended claims 1 and 10
Response to Arguments
Applicant’s arguments, see [ applicant marks and arguments ], filed [ 06/05/2026 ], with respect to the rejection(s) of claim(s) [ 1-11 ] under [ 35 USC 103 ] have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of [ Tsukamoto NPL; Inside the body light delivery system using endovascular therapy-based light illumination technology and Chen,Shirata,Hirano ]
Applicant argument that the references cited on the non-final rejection dated 04/28/2026 is fully considered and persuasive. The three references do not teach explicitly transarterial fiber-optic. However, upon further consideration, the examiner relies additionally on Toshihiko Tsukamoto (ET-BLIT,2022) in combination with the previously cited references
Tsukamoto discloses introducing a catheter through the femoral or radial artery and positioning the device within hepatic vasculature. A PHOSITA would have understood such intravascular access through the arterial system to constitute a transarterial approach.
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.
3. 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 non-obviousness.
Claims 1-11 are rejected under 35 U.S.C 103 as being unpatentable over Tsukamoto (ET_BLIT,2022) in view of Chen (US 2002/0087205A10-hereinafter Chen) and further in view of Shirata (Scientific Reports October 24,2017 7:13958-hereinafter Shirata) and Hirano (US005976175A-hereinafter Hirano).
4. Regarding claims 1 and 10, Tsukamoto teaches an endovascular optical-fiber catheter system in which catheter ins introduced through the femoral or radial artery and advanced within hepatic vasculature to deliver light through an optical fiber. Chen teaches a method for treating tumor tissue, including liver tumors using photodynamic therapy (PDT), comprising administering a photosensitizing agent such indocyanine green (ICG), wherein the agent is activated by light to destroy target cells. Chen also teaches applying a light to treatment side, including internal light delivery using implanted light probes. (Chen Para 28,75,150 and FIG9). In addition, Shirata discloses a method of treating hepatocellular carcinoma comprising, administering ICG to a patient, wherein HCC cells take up the ICG and are sensitized to near infrared laser to the liver, wherein the light causes release of reactive oxygen species from ICG induces apoptosis of cancer cells. ICG administered 24 hours prior to irradiation. (Shirata Abstract Near-infrared photothermal/photodynamic therapy with indocyanine green induces apoptosis of hepatocellular carcinoma cells through oxidative stress - PMC)
5. Chen and Shirata do not expressly disclose a transarterial fiber optic catheter for delivering PDT light. Hirano teaches a fiber optics laser conducting probe used specifically for photodynamic therapy, where a laser beam is conducted through an optical fiber and irradiated at the affected part. (US5976175A Abstract: A fiber optic laser conducting probe is used for photodynamic therapy. In this fiber optic laser conducting probe, an optical fiber has an end used for conducting a pulse laser beam. The laser beam is conducted through the optical fiber and irradiated from the end. A end tip is made of polyamide resin. The end tip has a hollow portion, and is attached to the end of the optical fiber such that the pulse laser beam can be irradiated through the end of the optical fiber, through the hollow portion and through the end tip.)
Therefore, it would be obvious to a person of ordinary skill in the art at the time on the invention to modify the PDT treatment methods of Chen and Shirata with the endovascular optical-fiber catheter system of Tsukamoto and the optical-fiber laser probe of Hirano. A PHOSITA would have recognized that employing arterial catheter-based optical fiber delivery would provide a predictable means of delivering therapeutic light to deep liver lesions while utilizing the known ICG-PDT techniques for HCC.
Chen (US2002/0087205A1)
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148: liver tissue
140: light
144 implanted light source
142 surface of liver
18: patient body underneath the skin layer
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Shrirata
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6. Regarding claims 2 and 3, the modified Tsukamoto/Chen combination teaches ICG can be combined with any other photosensitizing agents to enhance PDT efficacy (Fig,12 of Chen). Shirata also teaches intravenous administration of ICG as the standard delivery route for the photosensitizing composition.
7. Regarding claim 4, Hirano teaches fiber optic laser conducting probes used to deliver the laser light for PDT.
8. Regarding claim 5-8 and 11, the modified Tsukamoto/Chen combination as taught by Shirata teaches ICG (5 mg/kg) was intravenously administered for coupe days (0-7days) with irradiation NIR laser irradiation at 823 nm. (Shirata :
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9. Regarding claim 9, the modified Tsukamoto/Chen combination teaches liver tumor as a targeted tissue and Shirita teaches HCC is treated with ICG and PIT. (Shirata Abstract).
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.
Applicant ‘s arguments have been fully considered. The examiner further notes that OTSU et al. (US 2021/0379396 A1); paragraphs (0051 and 0052) describe optical fiber placement within hepatic vasculature and irradiation of tumor tissues relative to the blood vessel into which the optical fiber is inserted. Although OTSU is not applied in the present rejection, the refence is cited to show that optical-fiber delivery within hepatic vasculature was known in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMAD HASSAN KANAAN whose telephone number is (571)270-0363. The examiner can normally be reached I work from 8am:5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMAD HASSAN KANAAN/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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