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 .
This Office Action is in response to the applicant’s response to election filing on 10/07/2025.
Applicant’s cancelation of claims 1-10 and 23-29 is acknowledged and require no further examining. Claims 11-22 are pending and examined below.
Power of Attorney
It is noted that no accepted power of attorney has been filed in the present application.
It appears applicant has legal representation but a valid power of attorney has not been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 et seq.
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 10/07/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/2024, 11/11/2024, 02/12/2025, 05/23/2025, 10/07/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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 11-22 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 pre-AIA the applicant regards as the invention.
Regarding claim 11, the phrase “fixed to the support frame” renders claim 11 vague and indefinite because there is insufficient antecedent basis for this limitation. Prior to the quoted phrase, claim 11 discloses a support plate and a syringe support frame. Prior to the quoted phrase, claim 11 does not recite a support frame. For examining purposes, the phrase is interpreted as “fixed to the syringe support frame”.
Claims 12-15 and 17-22 are dependent of claim 11 and include all the same limitations.
Regarding claim 16, the phrase “between about 5:1 and about 1.2:1” renders claim 16 vague and indefinite because the feature appears to have a narrow range within a broader range. A broad range or limitations together with a narrow range or limitation that falls within the broad range or limitations (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The term “about” refers to a value close to the indicated. This renders the metes and bounds of the range to be unclear. For examining purposes, the phrase is interpreted as “between 5:1 and 1.2:1”.
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 11, 13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over reference Yanke et al. (8,069,886) in view of reference Tartaglia (7,750,328).
Regarding claim 11, Yanke et al. disclose a capsule filling system (10) for transferring a dose of radioactive material from a source container (vial) into a capsule (28), wherein the capsule filling system (10) comprises:
a support plate (14);
a needle assembly (12) coupled to the support plate (14),
wherein the needle assembly (12) is configured to remove a dose of radioactive material from the source container (vial),
wherein the needle assembly (12) includes:
a syringe support frame (110) translationally coupled to the support plate (14);
a syringe (26) having:
a syringe barrel (26B);
a syringe plunger (26A); and
a first needle (26D),
wherein the syringe barrel (26B) is translationally fixed to the syringe support frame (110); and
a syringe actuator (142) translatable relative to the syringe support frame (110) and transitionally fixed to the syringe plunger (26A) to move the syringe plunger (26A) relative to the syringe barrel (26B); and
a controller (285) configured to:
translate the support plate (14) toward the source container (vial);
translate the syringe support frame (110) toward source container (vial);
actuate the syringe actuator (142) to translate the syringe plunger (26A) relative to the syringe barrel (26B) to draw the dose of the radioactive material into the first needle (26D) and/or the syringe barrel (26B).
(Figure 1A, 3B, 5 and Column 3 lines 23-26, Column 5 lines 29-36, Column 6 lines 48-51, 57-60, Column 8 lines 41-45)
However, Yanke et al. does not disclose a needle housing and a second needle.
Tartaglia disclose system comprising: a needle housing (96) having a passage extending therethrough sized and shaped to slidably receive a first needle (100); and a second needle (98) extending from the needle housing (96) and aligned with the needle passage, wherein the second needle (98) has an inner diameter that is greater than the outer diameter of the first needle. (Figure 4 and Column 6 lines 5-14)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Yanke et al. by incorporating the needle housing and second needle as taught by Tartaglia, since column 6 lines 5-14 of Tartaglia states such a modification would help guide the first needle into the source container.
Regarding claim 13, Yanke et al. modified by Tartaglia disclose the syringe support frame (Yanke et al. – 110) is translationally coupled to the support plate (Yanke et al. – 14) via one or more vertical shafts (Yanke et al. – 118), wherein the needle assembly (Yanke et al. – 12) includes a support frame motor (Yanke et al. – servo motor) for translationally moving the syringe support frame (Yanke et al. – 110) along the one or more vertical shafts (Yanke et al. – 118). (Yanke et al. – Figure and Column 5 lines 42-45, 57-59)
Regarding claim 16, Tartaglia disclose the gauge of the second needle (98) is sufficiently large to allow the first needle (100) to pass through. (Column 6 lines 10-14)
However, Yanke et al. modified by Tartaglia do not explicitly disclose the ratio of the inner diameter of the second needle to the outer diameter of the first needle is between 5:1 and 1.2:1.
It would have been obvious to the person of ordinary skill in the art to have the made the ratio between the needle diameters to be between 5:1 and 1.2:1, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges only involves routine skill in the art. [MPEP 2144.05 (II-A)]
On page 9 paragraph 32 of the Specification, the ratio of the inner diameter of the second needle to the outer diameter of the first needle is between 5:1 and 1.2:1, between 3:1 to 1.5:1, or about 2:1. The Specification as originally filed does not disclose any criticality for the claimed feature. Therefore, it would have been prima facie obvious to modify Yanke et al. and Tartaglia to obtain the invention as specified in claim 16 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Regarding claim 17, Yanke et al. modified by Tartaglia disclose the first needle (Yanke et al. – 26D) and the second needle (Tartaglia – 98) form an annular channel when the first needle (Yanke et al. – 26D) advances concentrically within the second needle (Tartaglia – 98), wherein the needle assembly (Yanke et al. – 12) comprises a filter (Yanke et al. – 222) fluidly coupled to the annular channel for capturing radioactive particles traveling through the annular channel. (Yanke et al. – Column 9 lines 49-61)
Regarding claim 18, Yanke et al. modified by Tartaglia disclose a passage that extends between the annular channel and the filter, wherein the passage includes a material (charcoal filter) configured to capture and retain the radioactive particles. (Yanke et al. – Column 9 lines 49-61)
Regarding claim 19, Yanke et al. modified by Tartaglia disclose a pig assembly (Yanke et al. – 16) configured to hold the source container (Yanke et al. – vial) of the radioactive material. (Yanke et al. – Column 8 lines 45-51)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over reference Yanke et al. (8,069,886) in view of reference Tartaglia (7,750,328) as applied to claim 11 above, and further in view of reference Carrez et al. (9,492,649).
Regarding claim 12, Yanke et al. modified by Tartaglia disclose the claimed invention as stated above but do not disclose a needle guide.
Carrez et al. discloses a needle guide (130) comprising: a compression spring (131) and having a slot (133) sized and shaped to receive a distal tip portion of a second needle (122). (Figure 2, 7 and Column 5 lines 29-32, 40-41)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the needle assembly of Tartaglia by incorporating the needle guide as taught by Carrez et al., since column 5 lines 42-49 of Carrez et al. states such a modification would help prevent any loss of pressurized fluid in the syringe.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over reference Yanke et al. (8,069,886) in view of reference Tartaglia (7,750,328) as applied to claim 11 above, and further in view of reference Yigal et al. (2020/0405949).
Regarding claim 14, Yanke et al. modified by Tartaglia disclose the claimed invention as stated above but do not disclose an optical sensor.
Yigal et al. disclose a system comprising: a needle (31); an optical sensor (13); and a controller (19) configured to determine the position of the needle (31) based the optical sensor (13). (Page 3 paragraph 34, 37)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Yanke et al. by incorporating the optical sensor as taught by Yigal et al., since page 1 paragraph 6 of Yigal et al. states such a modification helps improve the accuracy of the needle position.
Regarding claim 15, Yanke et al. modified by Tartaglia and Yigal et al. disclose the controller (Yanke et al. – 285) is configured to control operation of the needle assembly (Yanke et al. – 12) based at least in part on feedback from the optical sensor (Yigal et al. – 13). (Yanke et al. – Column 12 lines 64-67) (Yigal et al. – Page 1 paragraph 7)
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over reference Yanke et al. (8,069,886) in view of reference Tartaglia (7,750,328) as applied to claim 19 above, and further in view of reference Liu et al. (11,318,068).
Regarding claim 20, Yanke et al. modified by Tartaglia disclose the claimed invention as stated above but do not disclose a first pig and second pig.
Liu et al. disclose a system comprising: a needle (38); a first source container (47); a second source container (45); a support plate (7); and a positioning plate (2), wherein the first source container (47) and the second source container (45) are positioned on the support plate (7), wherein the support plate (7) is positioned relative to the positioning plate (2), wherein the first source container (47) and the second source container (45) are positioned relative to the needle (38) so that the needle (38) is able to withdraw dosage from the first source container (47) or the second source container (45). (Figure 1, 4, 6 and Column 4 lines 33-37, Column 5 lines 1-17, column 6 lines 14-15)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Yanke et al. by incorporating the plurality of source containers and alignment system as taught by Liu et al., since column 1 lines 24-30 of Liu et al. states such a modification would allow automatic mixing of source materials.
Regarding claim 21, Yanke et al. modified by Tartaglia and Liu et al. disclose a pig support plate (Liu et al. – 7) and a pig positioning plate (Liu et al. – 2), wherein the first pig and the second pig are positioned on the pig support plate (Liu et al. – 7) in predetermined positions defined by the pig positioning plate (Liu et al. – 2). (Liu et al. – Column 5 lines 1-17)
Regarding claim 22, Yanke et al. modified by Tartaglia and Liu et al. disclose a rail system (Liu et al. – 23, 24) for moving the first pig and/or the second pig relative to the needle assembly (Yanke et al. – 12). (Liu et al. – Figure 3 and Column 5 lines 42-48)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK B FRY whose telephone number is (571)272-0396. The examiner can normally be reached on Mon-Thur 7am-4pm.
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/PATRICK B FRY/Examiner, Art Unit 3731 October 31, 2025
/STEPHEN F. GERRITY/Primary Examiner, Art Unit 3731 3 November 2025