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 Arguments
Applicant’s arguments, filed 11 June 2026, with respect to 35 USC 102 rejections of claim 1, 2, 4-7, 9, 11, 12, 14-16 and 18 and the 35 USC 103 rejections of claims 3, 8, 10, 13 and 17 have been fully considered and are persuasive. The 35 USC 102 rejections of claim 1, 2, 4-7, 9, 11, 12, 14-16 and 18, and the 35 USC 103 rejections of claims 3, 8, 10, 13 and 17 have been withdrawn. Stewart (US 20050080313 A1) fails to disclose that the brachytherapy device is configured to be completely enclosed in the tumor bed. However, upon further consideration, a new ground(s) of rejection is made in view of Kaplan (US 6746661 B2).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan (US 6746661 B2).
Regarding claim 1, Kaplan discloses a brachytherapy device (Abstract) comprising a biocompatible material (Figures 4A and 4B, “12”) arranged in a spherical or ellipsoid form having a fixed diameter (Col 7, lines 10-15); a channel extending from a first location on the brachytherapy device (Figures 4A and 4B, “40”), through the brachytherapy device, to a second location on the brachytherapy device (Figures 4A and 4B, “40”); and one or more active elements positioned within the channel (Figures 4A and 4B, radioisotope, “42”), wherein the brachytherapy device is configured to be completely enclosed within a tumor bed (Col 1, lines 23-27, Col 6, lines 20-67).
Regarding claim 2, Kaplan discloses the one or more active elements is a radioactive agent (Figures 4A and 4B, radioisotope, “42”).
Regarding claim 4, Kaplan discloses the second location is opposite the first location (Figures 4A and 4B, “40”).
Regarding claim 5, Kaplan discloses the channel extends across a maximum diameter of the brachytherapy device (Figure 4A, “40”).
Regarding claim 6, Kaplan discloses the maximum diameter of the brachytherapy device is one of about 2 cm, 3 cm, 5 cm, or 7 cm (Col 6, lines 10-15).
Regarding claims 7 and 8, Kaplan discloses the biocompatible material is polysiloxane, polydimethylsiloxane, polyether ether ketones, polyglycolic acid, L polylactic acid, D polylactic acid, or mixtures of L polylactic acid and D polylactic acid (Col 3, lines 58-67).
Regarding claim 9, Kaplan discloses one or more additional channels that extend through the brachytherapy device (Col 14, lines 13-17).
Regarding claim 10, Kaplan discloses a diameter of the channel is from about 0.7 mm 0.8 mm (Col 14, Lines 10-12).
Regarding claim 11, Kaplan discloses a brachytherapy device (Abstract) comprising a biocompatible material (Figures 4A and 4B, “12”) arranged in a spherical or ellipsoid form having a fixed diameter (Col 7, lines 10-15); a central column extending through a center of the brachytherapy device (Figures 4A and 4B, “40”), the central column including a continuous channel extending at least partially along a length of the central column (Figures 4A and 4B, “40”).; and one or more active elements positioned within the central column (Figures 4A and 4B, radioisotope, “42”), wherein the brachytherapy device is configured to be completely enclosed within a tumor bed (Col 1, lines 23-27).
Regarding claim 12, Kaplan discloses the one or more active elements is a radioactive agent (Figures 4A and 4B, radioisotope, “42”).
Regarding claim 14, Kaplan discloses the length of the central column is generally equal to a diameter of the brachytherapy device (Figure 4A, “40”).
Regarding claim 15, Kaplan discloses the diameter of the brachytherapy device is one of about 2 cm, 3 cm, 5 cm, or 7 cm (Col 6, lines 10-15).
Regarding claims 16 and 17, Kaplan discloses the biocompatible material is polysiloxane, polydimethylsiloxane, polyether ether ketones, polyglycolic acid, L polylactic acid, D polylactic acid, or mixtures of L polylactic acid and D polylactic acid (Col 3, lines 58-67).
Regarding claim 18, Kaplan discloses a first end of the central column terminates at a first pole of the brachytherapy device, and wherein a second end of the central column terminates at an opposite second pole of the brachytherapy device (Figure 4A, “40”, if the shape was circular, the channel extending through each side of the biocompatible material would define the poles).
Allowable Subject Matter
Claims 3 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 3 and 13 incorporate the limitations of claims 1 and 11 respectively. Kaplan discloses the device is a radioactive seed and therefore it would not be obvious to a POSITA to include one or more of radioactive seeds or radioactive strands in the channel. Although Kaplan discloses the radioisotope can be configured into microspheres (Col 14, lines 58-61), a POSITA would recognize that microspheres hold a different meaning in the art than a radioactive seed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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