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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/25 has been entered.
Acknowledgments
This office action is in response to the reply filed on 10/23/25. Claims 1-2, 4, 11, 13, 17-19 and 21 are pending.
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.
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.
Claims 1, 4, 11, 13, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 5,879,282) (“Fischell”) in view of Hebert et al. (US 2004/0006305) (“Hebert”) further in view of Sorensen et al. (US 6,500,108) (“Sorensen”) further in view of DeLuca (US 4,096,862) further in view of Yarnall et al. (US 10,310,097) (“Yarnall”).
(claims 1, 11) Fischell discloses: a method and system for in vivo location determination of a balloon catheter, the method comprising: inserting into a body of a subject the balloon catheter 10 including a balloon member 20 comprising a radioactive material 13P,D; and detecting the in vivo location of the radioactive material, wherein the balloon catheter further comprises a tube 12 having a hollow portion 19 through which a guide wire 30 passes, wherein the balloon member is provided to be inflatable on the tube which is to be inserted into the body along the guide wire, a first radioactive material 16 of Fischell is formed into an elastic cylinder placed inside the elastic balloon (C2L24-30,C3L48-52) and a second radioactive material is 13P,D is fixedly disposed (Fig. 1) at the tube 12 inside the balloon member 20.
Fischell does not directly disclose filling the elastic cylinder of the radioactive material with a gel phase in which the first radioactive material is mixed. Hebert, in the analogous art, teaches this feature. Hebert teaches the radioactive material of the balloon carried in a gel-like substance [0060]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Fischell with the gel as taught by Hebert to contain the radioactive material within a desired area.
Sorensen, in the analogous art, teaches that the radioactive isotopes on the treatment configuration (balloon catheter) are selected from a group comprising 99mTc, 123I or 131I, C3L20-34, abstract, C9L58-C10L3, Table 3, C10L37-40. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added the radionuclides as listed in Sorensen to the device of Fischell/Hebert to ensure proper dosage and safety to a patient (Sorensen, C5L35-57,C3L20-34)
Fischell/Hebert/Sorensen does not directly disclose detecting the in vivo location of the radioactive material comprising: detecting radiation emitted from the radioactive material through a hand-guided probe positioned at a target site outside the body, and indicating that the radioactive material is adjacent to the target site through an alarm and/or count based on detection signal received from the hand-guided probe. DeLuca, in the analogous art, teaches using an external probe to detect radiation 18 emitted from the radioactive material 16 and indicating that the radioactive material is adjacent to the target site through an alarm or signal based on the detection signal received from the probe 20, wherein as a distance between the hand-guided probe and the first radioactive material or the second radioactive material becomes shorter, the alarm becomes louder and the count increases, the first or second radioactive material includes one or more radioactive isotopes that emit gamma rays or beta particles. Yarnall, in the analogous art also teaches these detection features, see Figs. 4,5, C11L29-C12L29. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added a radiation measuring instrument as taught by DeLuca and Yarnall to the system of Fischell/Hebert/Sorensen to ensure proper location for the procedure.
(claims 4, 19) the first or second radioactive material (marker bands of Fischell—solid) is formed in any one of liquid, gaseous, gel, and solid phases.
(claims 13, 17) The radioactive material of Fischell 13P,D is fixedly located at the guidewire 30 (Fig. 1) or fixedly disposed on one of an inner wall of the balloon member and the tube 12 (Fig. 1)
(claim 18) the balloon member is operated in a deflated state and an inflated state in which an outer surface thereof is inflated from the deflated state to press an inner wall of a blood vessel with an outer surface thereof, and the second radioactive material 13P,D is provided to maintain a same position inside the balloon member, when the balloon member is in the deflated state and the inflated state. See Fig. 1,2, uninflated, Fig. 3,4, inflated
Claims 2 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Hebert in view of Sorensen in view of DeLuca in view of Yarnall further in view of Kramer et al. (US 5,916,167) (“Kramer”).
Fischell/Hebert/Sorensen/DeLuca/Yarnall discloses the radioactive material but does not directly disclose wherein the radioactive isotope is included in an amount in which radiation is emitted at an intensity of 0.001 cps (counts per second) to 99,999 cps. Kramer, in the analogous art, teaches teach the radioactive isotope included in an amount in which radiation is emitted at an intensity of 0.001 cps to 99,999 cps (see column 6; lines 34-40 “A range selection switch is provided at 46. Switch 46 permits the practitioner to select any of four count rate ranges to achieve full scale readouts when the system 10 is employed in tracking radiopharmaceuticals. These ranges may, for example, be 0-1000 counts per second; 0-2500 counts per second; 0-10,000 counts per second; and 0- 30,000 counts per second.” The prior art teaches a detector able to detect ranges from 0 to 30,000 cps which falls within the range of 0.001 cps to 99,999 cps). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Fischell/Hebert/Sorensen/DeLuca/Yarnall so a radioactive isotope can be detected at a range from 0.001 cps to 99,999 cps as taught by Kramer so that the radioactive isotope can be detected and tracked (see column 6; lines 34-37 of Kramer, disclosing “A range selection switch is provided at 46. Switch 46 permits the practitioner to select any of four count rate ranges to achieve full scale readouts when the system 10 is employed in tracking radiopharmaceuticals”).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because of the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument (the radioisotope used).
Conclusion
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/DEANNA K HALL/Primary Examiner, Art Unit 3783