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
Applicant’s response, filed 23 December 2025, is acknowledged. No claims are amended.
Claims 1-18 are pending in the instant application.
Response to Arguments
Applicant’s arguments, with respect to 35 USC 102 and 35 USC 103 rejections of claims 1-20, have been considered but are moot because 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.
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, 4-7, 9, 11, 12, 14-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart (US 20050080313 A1).
Regarding claim 1, Stewart discloses a brachytherapy device (Abstract) comprising a biocompatible (Paragraph [0047]) material arranged in a spherical (Figure 1) form having a fixed diameter (Paragraph [0043], the balloon remains inflated); a channel extending from a first location on the brachytherapy device (Figure 2), through the brachytherapy device, to a second location on the brachytherapy device (Figure 2); and one or more active elements positioned within the channel (Paragraph 0044]), wherein the brachytherapy device is configured to be completely enclosed within a tumor bed (Figure 2, the balloon and channel are enclosed in the tumor bed by a silicone ring).
Regarding claim 2, Stewart discloses the one or more active elements include one or more of a radioactive agent (Paragraph [0044]).
Regarding claim 4, Stewart discloses the second location is opposite the first location (Figure 4).
Regarding claim 5, Stewart discloses the channel extends across a maximum diameter of the brachytherapy device (Figure 4).
Regarding claim 6, Stewart discloses the maximum diameter of the brachytherapy device is one of about 5 cm (Paragraph [0060]).
Regarding claim 7, Stewart discloses the biocompatible material is polysiloxane (Paragraph [0047]).
Regarding claim 9, Stewart discloses the device comprising one or more additional channels that extend through the brachytherapy device (Figure 16).
Regarding claim 11, Stewart discloses a brachytherapy device (Abstract) comprising a biocompatible (Paragraph [0047]) material arranged in a spherical (Figure 1) form having a fixed diameter (Paragraph [0043], the balloon remains inflated); a central column extending through a center of the brachytherapy device, the central column including a continuous channel extending at least partially along a length of the central column (Figure 2); and one or more active elements positioned within the central channel (Paragraph 0044]), wherein the brachytherapy device is configured to be completely enclosed within a tumor bed (Figure 2, the balloon and channel are enclosed in the tumor bed by a silicone ring).
Regarding claim 12, Stewart discloses the one or more active elements include one or more of a radioactive agent (Paragraph [0044]).
Regarding claim 14, Stewart discloses the length of the central column is generally equal to a diameter of the brachytherapy device (Figure 2).
Regarding claim 15, Stewart discloses the maximum diameter of the brachytherapy device is one of about 5 cm (Paragraph [0060]).
Regarding claim 16, Stewart discloses the biocompatible material is polysiloxane (Paragraph [0047]).
Regarding claim 18, Stewart discloses 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 the central column terminates at an opposite second pole of the brachytherapy device (Figure 2).
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 3, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20050080313 A1) in view of Weinberger (US 5924973 A).
Regarding claims 3 and 13, Stewart does not disclose the nature of the radiation source. Weinberger discloses an apparatus for radiation therapy (Abstract) wherein the apparatus comprises a balloon (Col 8, lines 45-48) wherein the source is small metallic seed, cited as commonly used in conventional brachytherapy and HDR (Col 8, lines 36-39). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Stewart, with the radioactive agent including one or more of radioactive seeds as taught by Weinberger, since such a modification commonly used in conventional brachytherapy and HDR (Col 8, lines 36-39).
Regarding claim 10, Stewart does not disclose the size of the channel. Weinberger discloses an apparatus for radiation therapy (Abstract) wherein the apparatus comprises a balloon (Col 8, lines 45-48) wherein the source is small metallic seed, cited as commonly used in conventional brachytherapy and HDR (Col 8, lines 36-39), and further wherein the seed has a diameter of ≤ 1mm (Col 8 lines 40-41). The channel has to be larger the seed in order for the seed to fit, but also cannot be so large that the seed can move in any other direction but along the longitudinal axis of the channel. As such, a channel with a diameter of about 0.7 mm to about 1.2 mm would have been obvious with seed of Weinberger. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Stewart, with a channel with a diameter of about 0.7 mm to about 1.2 mm in order to fit the seed as taught by Weinberger, since the channel diameter range would be large enough to fit the largest seed, but not so large to allow to much extraneous movement.
Claim(s) 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20050080313 A1) in view of Drobnik (US 20090312593 A1).
Regarding claims 8 and 17, Stewart discloses an embodiment of a bioabsorbable device wherein the biodegradable material may comprise polyglycolic acid or polylactic acid, but does not disclose the balloon, disclosed in claims 1 and 11, is biodegradable. Drobnik discloses a treatment balloon (Abstract), wherein the balloon and radioactive material are bio-absorbable (Paragraph [0023]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Stewart, with a bio-absorbable balloon as taught by Drobnik comprising the biodegradable materials of polyglycolic acid or polylactic acid, since such a modification would provide the predictable results of eliminating the need to remove the balloon or source.
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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791