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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/20/2025. As directed by the amendment: Claims 6-9, 11-14, and 30-32 have been amended, claims 1-5, 10, 15, and 19-29 have been cancelled, and no claims have been added. Thus, claims 6-9, 11-14, 16-18, and 30-32 are presently pending in the application wherein claims 16-18 are withdrawn.
Applicant’s amendments to the claims have overcome the previous objections, 112 rejections, and 101 rejections previously set forth in the Non-Final Office Action mailed 03/19/2025.
Response to Arguments
Applicant’s arguments, see page 9, filed 06/20/2025, with respect to claim 6 have been fully considered and are persuasive. Applicant states (page 9, line 13) that the examiner acknowledges that Claim 9 is novel over Sasaki. Applicant argues (page 9, lines 13-17) that claim 9 recites a specific internal volume of the bolus conduit of 0.1 – 50 ml; there is no disclosure or suggestion in Sasaki for a specific internal volume of 0.1 – 50 ml or the internal range of 1 – 10 ml. Amended claim 6 recites a specific internal volume of the bolus conduit of 1 – 10 ml and must therefore be considered novel over Sasaki. Examiner agrees that Sasaki does not disclose the amendments to claim 6. However, examiner uses Kalafut to teach the specific internal volume is 5 ml wherein the 5 ml is within the range 1-10 ml.
Applicant's arguments, see page 10, filed 06/20/2025, have been fully considered but they are not persuasive.
Applicant argues (page 9, lines 24-27) that Kalafut does nothing to remedy the deficiencies of Sasaki as discussed; the combination of Sasaki and Kalafut neither teaches nor suggests an infusion system where the radioactive solution comprises a radiopharmaceutical having a radioactive half-life of less than 3 minutes and where the specific internal volume of the bolus conduit is 1-10 ml. Examiner disagrees, Sasaki discloses a radioactive drug having a half-life of 2 minutes (less than 3 minutes) (Take, for example, the case where such an injection system is used to administer a radioactive drug (e.g., 18F-FDG (fluorodeoxyglucose), 13N-ammonia, 11C-methionine, or the like) labeled with a nuclide of short half-life (e.g., positron emitting nuclides of 15O, 13N, 11C, and 18F having half-lives of 2, 10, 20, and 110 minutes, respectively) to a subject; parag. [0006], first sentence). Examiner uses Kalafut to disclose the specific internal volume of the bolus conduit is 5 ml (within the claimed range 1-10 ml) (discussed more below).
Applicant further argues (page 10, lines 1-3) that a person of skill in the art would recognize that the teachings of Sasaki and Kalafut are directed towards long-lived radiopharmaceuticals and these teachings are not suitable for radiopharmaceuticals having a radioactive half-life of less than 3 minutes. Applicant states (page 10, lines 3-5) that Kalafut is concerned with longer lived species i.e. FDG which has a half-life of 110 minutes (see e.g. [0011], [0014], and [0069] of Kalafut. Applicant argues (page 10, lines 5-7) that the apparatus of Sasaki is intended for species such as FDG that have half-lives longer than 3 minutes; the radiopharmaceutical solution 72 is held in dose bottle 70 within shielded container 71 (see Fig.1). Applicant argues (page 10, lines 7-11) that the half-life of FDG allows the radiopharmaceutical to be put into dose bottle 70 in shielded container 71 sufficiently long before dispensation without significant decay; Sasaki’s apparatus would not be suitable for radiopharmaceuticals having a half-life of less than 3 minutes. Neither Sasaki nor Kalafut provide any suggestion for the claimed invention. Examiner disagrees, Sasaki discloses having the radioactive drug with a short half-life of 2 minutes (parag. [0006], first sentence). Kalafut discloses the FDG with a short half-life of 110 minutes (column 5, lines 62-64). Both Sasaki and Kalafut disclose a radioactive drug with short half-life. Even if Kalafut discloses that the half-life is 110 minutes (more than 3 minutes), examiner uses Sasaki to teach the radioactive drug with half-life of 2 minutes (less than 3 minutes).
Applicant further argues (page 10, lines 12-14) that a person of skill in the art would not have looked to either Sasaki or Kalafut as suggesting the use of low volumes of radiopharmaceutical having a half-life of less than 3 minutes. Applicant argues (page 10, lines 14-15) that the examiner states that Kalafut discloses delivering 5 ml of a radiopharmaceutical; for the sake of arguments only, 5 ml of a long-lived radiopharmaceutical such as FDG may be appropriate. Applicant states (page 10, lines 16-17) those of ordinary skill would not have recognized that such a small volume could be used for a radiopharmaceutical having a half-life of less than 3 minutes. Examiner disagrees, the amendments to the claim recite “wherein the radioactive solution comprises a radiopharmaceutical having a radioactive half-life of less than 3 minutes, and wherein the specific internal volume of the bolus conduit is 1-10 ml”. The specific volume (5 ml) disclosed in Kalafut is within the claimed range (1-10 ml), and Kalafut discloses that the radioactive drug is FDG with short half-life of 110 minutes (column 5, lines 62-64). Examiner uses Sasaki to teach the radioactive drug with short half-life of 2 minutes (parag. [0006], first sentence), and Kalafut to teach the bolus conduit with the specific volume of 5 ml (within the claimed range 1-10 ml) (column 25, lines 37-43).
Applicant argues (page 10, lines 18-20) that either alone or in combination, Sasaki and Kalafut fail to teach or suggest a system or method for delivery of a radiopharmaceutical having a radioactive half-life of less than 3 minutes and a bolus conduit having a specific volume of 1-10 ml. Applicant states (page 10, lines 20-23) if the skilled person nevertheless decided to use such a radiopharmaceutical, they would not apply the teachings of these references in view of the practical impact using such a short-lived species compared to FDG. Therefore, the combination of Sasaki and Kalafut cannot reach the claimed system. Examiner disagrees, examiner uses Sasaki to disclose a radioactive drug with short half-life of 2 minutes (parag. [0006], first sentence). Examiner uses Kalafut to teach the bolus conduit specific volume of 5 ml (within the claimed range) (column 25, lines 37-43) (discussed more below).
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.
Claims 6-9, 11-14, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki (US 2005/0085682); in view of Kalafut (US 9750953).
Regarding Claim 6, Sasaki discloses an infusion system (Fig.1) for delivering a liquid radioactive solution from a source (radioactive drug solution (72)) to a recipient, said system comprising: - a radiation detector (radiation meter/second detector (40)), - a first valve (three-way cock (44)) having a waste position (when the three-way cock (44) is switched to discard the radioactive drug solution into the waste bottle (62)) (parags. [0028] and [0030]) and a recipient position (when the three-way cock (44) is switched to inject the radioactive drug solution into the patient) (parags. [0028]-[0029]), - a bolus conduit (buffer loop (36A) and tube (36)), a waste conduit (tube (60)) and a recipient conduit (tube (46)), each conduit having a valve end being connected to said first valve (each of the tubes (36, 46, and 60) have a valve end connected to the three-way cock (44) as seen in Fig.1), so that the first valve (44) can establish a waste flow path in the waste position and a recipient flow path in the recipient position (The three-way cock 44 switches the radioactive drug solution that is measured for the amount of radioactivity by the radiation meter 40 between being injected into a patient and being discarded; parag. [0028]) (parags. [0029]-[0030]), the recipient flow path being different from said waste flow path (the recipient flow path is the path from the radioactive drug solution (72) towards the patient via the three way-cock (44) and tubes (46 and 36) (parags. [0027]-[0029] and [0041]), and the waste flow path is the path from the radioactive drug solution (72) towards the waste bottle (62) via three-way cock (44) and tubes (60 and 36)) (parags. [0028]-[0030] and [0041]-[0042]), wherein the waste flow path is defined by the bolus conduit (36) and the waste conduit (60) (the waste flow path is the path from the radioactive drug solution (72) towards the waste bottle (62) via three-way cock (44) and tubes (60 and 36)) (parags. [0028]-[0030] and [0040]-[0041]), and the recipient flow path is defined by the bolus conduit (36) and the recipient conduit (46) (the recipient flow path is the path from the radioactive drug solution (72) towards the patient via the three way-cock (44) and tubes (46 and 36)) (parags. [0027]-[0029] and [0041])) wherein the bolus conduit (36) comprises a bolus inlet (tube (36)) adapted to receive the radioactive solution from the source (72) (the three-way cock 34 injects the radioactive liquid into a tube 36; parag. [0026], last sentence), the waste conduit comprises a waste outlet (outlet at the end of tube (60) where the radioactive drug solution is disposed into the waste bottle (62)) adapted for flow out of said waste conduit (Meanwhile, the radioactive drug solution used in (3) is discharged to the waste bottle 62; parag. [0042], lines 3-4) and the recipient conduit (46) comprises a recipient outlet (final filter (50)) adapted for flow out of said recipient conduit (46) to the recipient (The tube 46 injects the drug branched from the three-way cock 44 into the body of the patient through a final filter 50 and a winged needle 52 which are replaceable patient by patient; parag. [0029], first sentence), wherein the bolus conduit (36A and 36) comprises a measuring section (loop 36A) (the radiation meter (40) measures the amount of radioactivity of the radioactive drug solution held in the buffer loop (36A)) (parag. [0027]) and a specific internal volume (volume within the buffer loop (36A); the entire amount of radioactive drug solution can be held within the buffer loop (36A) before injection) (parag. [0027]), the radiation detector (40) being operable to determine a reference level of radioactivity (amount of radioactivity) of the solution present in said measuring section (36A) (parag. [0027]), in that the waste flow path establishes liquid communication between said bolus inlet (36) and said waste outlet (outlet at the end of tube (60) where the radioactive drug solution is disposed into the waste bottle (62)) (the waste flow path is the path from the radioactive drug solution (72) towards the waste bottle (62) via three-way cock (44) and tubes (60 and 36)) (parags. [0028]-[0030] and [0040]-[0041]), and the recipient flow path establishes liquid communication between the bolus inlet (36) and the recipient outlet (50) (the recipient flow path is the path from the radioactive drug solution (72) towards the patient via the three way-cock (44), tubes (46 and 36), and final filter (50)) (parags. [0027]-[0029] and [0041]), wherein the radioactive solution comprises a radiopharmaceutical having a radioactive half-life of less than 3 minutes (Take, for example, the case where such an injection system is used to administer a radioactive drug (e.g., 18F-FDG (fluorodeoxyglucose), 13N-ammonia, 11C-methionine, or the like) labeled with a nuclide of short half-life (e.g., positron emitting nuclides of 15O, 13N, 11C, and 18F having half-lives of 2, 10, 20, and 110 minutes, respectively) to a subject; parag. [0006], first sentence).
Sasaki does not appear to disclose the specific internal volume of the bolus conduit is 1-10 ml.
Kalafut teaches it was known in the art to have a fluid path element (1160; Fig.10A) for delivering 5 ml of radiopharmaceutical into fluid path element (1160) (column 25, lines 37-43).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sasaki to incorporate the teachings of Kalafut to have a specific internal volume of the bolus conduit 1-10 ml in order to inject a standard infusion volume (column 25, lines 37-43).
Regarding Claim 7, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution from a source to a recipient according to claim 6, and further discloses said system comprising: - a second valve (three-way cock (34)) having an inlet position (when the three-way cock (34) injects the radioactive drug solution into tube (36)) (parags. [0026] and [0033]) and a flushing position (when the three-way cock (34) injects the physiological saline into tube (36)) (parags. [0026] and [0042]), - a flushing conduit (tube (32)) and a source conduit (tube (80)), each conduit having a valve end being connected to said second valve (each of the tubes (32 and 80) have a valve end connected to the three-way cock (34) as seen in Fig.1), the source conduit (80) being adapted for transporting the radioactive solution from the source (72) into the bolus conduit (36/36A), when the second valve (34) is in the inlet position (parags. [0026], [0032]-[0033], and [0041]), - a flushing liquid reservoir (physiological saline bag (10)) comprising a flushing liquid (physiological saline), said flushing liquid reservoir (10) being connected to said flushing conduit (32) (parags. [0024]-[0025]), - a flushing device (physiological saline syringe (28)) being adapted for transporting the flushing liquid (physiological saline) from the flushing liquid reservoir (10) through said flushing conduit (32) and into the bolus conduit (36), when the second valve (34) is in the flushing position (parags. [0024]-[0025] and [0042]).
Regarding Claim 8, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution according to claim 6, and further discloses wherein a second radiation detector (radiation pass sensor/third detectors (94)) and/or a bubble detector is arranged adjacent to the recipient conduit (46) (the radiation pass sensor/third detectors (94) is located on tube (46) as seen in Fig.1).
Regarding Claim 9, Sasaki as modified discloses all the limitations of claim 6 above.
Sasaki does not appear to disclose a specific internal volume of the bolus conduit is approximately 2 ml.
It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to have the specific internal volume in modified Sasaki to have the specific internal volume of the bolus conduit is approximately 2 ml, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the infusion system of Sasaki would not operate differently with the claimed volume. Further applicant places no criticality on the range claimed, indicating simply that the specific internal volume “preferred” has the claimed volume (specification; page 14 (lines 14-15) and page 30 (line 31) and page 31 (lines 1-2)).
Regarding Claim 11, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution according to claim 6, and further discloses wherein said recipient is a device configured for intravenous (IV) administration (winged needle (52)) of said liquid radioactive solution in said bolus conduit (36/36A) into a human (patient) or animal body (parag. [0029]).
Regarding Claim 12, Sasaki as modified discloses all the limitations of claim 6 above.
Sasaki does not appear to disclose an injection speed of the radioactive solution to the recipient is approximately 0.05 - 7 ml/second.
Kalafut teaches it was known in the art to have a flow rate of a radiopharmaceutical of 4 ml/s (This is desirably accomplished by connecting pump unit 1410 through control valve 1420 and ports a-c of control valve 1420 and delivering 10 to 40 ml of saline at a programmed flow rate, for example, 4 ml/s. Then, control valve 1420 rapidly operates to connect ports a-b and the saline is again pumped into the patient P preferably at the same flow rate, this time flushing the radiopharmaceutical from fluid path element 1160, through fluid path element 1150, and into the patient P; column 17, lines 25-34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sasaki to incorporate the teachings of Kalafut to have an injection speed of the radioactive solution to the recipient is approximately 0.05 - 7 ml/second in order to reduce the effects of injecting bolus in the veins to prevent delaying the delivery of the drug (column 17, lines 17-34).
Regarding Claim 13, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution according to claim 6, and further discloses wherein the measuring section (36A) is spiral-shaped or helically shaped or coil shaped (The radiation meter 40 measures the amount of radioactivity of the radioactive drug solution that is held, for example, in a buffer loop 36A of coil shape, for example; parag. [0027], first sentence).
Regarding Claim 14, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution according to claim 13, and further discloses wherein a part of the radiation detector (40) is arranged within the measuring section (36A) (Fig.) (parag. [0027]), so that said measuring section (36A) wreathes said part of the radiation detector (40) (the buffer loop (36A) covers portion of the radiation meter (40) as seen in Fig.1), the radiation detector (40) being operable to determine a level of radioactivity of the solution in the measuring section (The radiation meter 40 measures the amount of radioactivity of the radioactive drug solution that is held, for example, in a buffer loop 36A of coil shape, for example; parag. [0027], first sentence).
Regarding Claim 30, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution from a source to a recipient according to claim 6, and further discloses wherein said radioactive solution is a bolus having a substantially cylindrical body (the radioactive solution is injected into tube (36) (parag. [0026], last sentence) wherein the tube (36) is a cylindrical tube as seen in Fig.1) or delimitation and an unvarying homogeneous radioactivity profile (constant radioactivity profile, since the entire amount of solution is administered at constant speed) throughout the volume of the bolus (The desired amount of radioactive drug solution dispensed is all fed into the radiation meter 40 for accurate measurement of the amount of radioactivity. Then, the entire amount of solution can be administered at constant speed (desired speed); parag. [0037], lines 1-5).
Regarding Claim 31, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution from a source to a recipient according to claim 6, and further discloses wherein the recipient is a device, such as a receptacle, an IV bag or a catheter (winged needle (52)) (parag. [0029]).
Regarding Claim 32, Sasaki as modified discloses the infusion system for delivering a liquid radioactive solution from a source to a recipient according to claim 6, and further discloses wherein the recipient is configured to be in fluid communication with a human patient (patient), so that the radioactive solution may be transferred directly to the patient (The tube 46 injects the drug branched from the three-way cock 44 into the body of the patient through a final filter 50 and a winged needle 52 which are replaceable patient by patient; parag. [0029], first sentence).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 pm.
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783