DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 March 2026 has been entered.
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 .
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
-Claim 1 recites “the body” in line 3. Examiner recommends amending to –the radially symmetrical body—
-Claim 14 recites “the body” in line 5. Examiner recommends amending to –the radially symmetrical body—
Appropriate correction is required.
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.
Claim(s) 1, 3, 4, 5, 8, 10, 13, 14, 15, 16, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view of Diederich (U.S. 7476235).
Regarding Claim 1, Abdalla teaches a radioactive seed carrier [Abstract]—reference to “anchorable brachytherapy device”, comprising: a radially symmetrical body having an axis [Fig. 9C, element 950 (brachytherapy device)]—depicts a symmetrically circular body, extending from a proximal end to a distal end [Fig, 9C, element 957 (central column) and 952 (tubes)]—wherein the central column is considered the proximal end and the tubes are considered the distal ends, wherein a cross-sectional diameter of the body at the proximal end is in the range of about one to seven centimeters [044]—reference to the diameter of the device being 2, 3, 5 or 7 centimeters; and a plurality of radioactive seeds positioned within the body between the proximal end and the distal end [0089]—discloses positioning one or more radioactive seeds in the body of the device, the plurality of radioactive seeds comprising radioactive material configured to emit radiation to kill living cells [abstract]—discussion on providing radiation to the tumor bed through seed positioning; wherein the radioactive seed carrier is capable of deformation [0091]—discloses the device may exhibit degrees of deformation.
Abdalla is silent on wherein the body comprises a tapered portion extending along the axis between the proximal end and the distal end, wherein the cross-sectional diameter of the body at the proximal end is greater than a cross-sectional diameter of the body at the tapered portion. Diederich teaches wherein the body comprises a tapered portion extending along the axis between the proximal end and the distal end [Fig. 1, elements 10 (body), 20 (tapered portion), 14 (proximal end), 16 (axis), 26 (distal end)], wherein the cross- sectional diameter of the body at the proximal end is greater than a cross-sectional diameter of the body at the tapered portion [Fig. 2]—depicts cross sectional diameters of the distal end represented by element 16 and the diameter of element 12 representing the proximal end of the device.
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 structure to include a tapered portion at the edge of the device as taught by Diederich to allow for deformation to as suggested by Abdalla as Abdalla discusses the device having elastic deformability to adjust to external pressures with Diederich because Diederich teaches the use of a deployable balloon to inflate the device to deploy it within a lumen [Col 4, lines 42-54].
Regarding Claim 3, Abdalla further teaches wherein the body comprises a substantially spherical portion [Fig. 9C, element 952] and a substantially cylindrical portion [Fig. 9C, element 957] between the proximal end and the distal end, since elements 952 make up the structure and comprise the proximal and distal ends they are interpreted to be between the proximal and distal ends.
Regarding Claim 4, Abdalla further teaches wherein the body comprises a substantially spherical portion connected to the tapered portion [Fig. 9C, elements 952 (tubes), 959 (protrusions), 962 (grooves) and 958 (first planar hub)]—where the spherical portion or tubes including the grooves are connected to the protrusions or tapered portion via the first planar hub.
Regarding Claim 5, Abdalla further teaches wherein at least one of the plurality of radioactive seeds are embedded in the tapered portion [0040]—describes the radioactive seeds being positioned within the grooves.
Regarding Claim 8, Abdalla further teaches further comprising: a channel extending through the body [0040]—reference to elements 910 (tubes) having continuous central channels extending along the length of the tubes.
Regarding Claim 10, Abdalla further teaches wherein an outer surface of the body comprises a sinusoidal surface [0048]—reference to outer protrusions arranged in sinusoidal rows and patterns.
Regarding Claim 13, Abdalla further teaches wherein the radially symmetrical body consists essentially of a material configured for permanent implantation in a tumor bed [0050]—discloses the tubes of the radially symmetrical body made of bioabsorbable material.
Regarding Claim 14, Abdalla teaches a radioactive seed carrier [Abstract]—reference to “anchorable brachytherapy device”, comprising: a radially symmetrical body having an axis [Fig. 9C, element 950 (brachytherapy device)]—depicts a symmetrically circular body, extending from a proximal end to a distal end [Fig, 9C, element 957 (central column) and 952 (tubes)]—wherein the central column is considered the proximal end and the tubes are considered the distal ends, and a plurality of radioactive seeds positioned within the body between the proximal end and the distal end [0089]—discloses positioning one or more radioactive seeds in the body of the device, the plurality of radioactive seeds comprising radioactive material emitting radiation configured to kill living cells [abstract]—discussion on providing radiation to the tumor bed through seed positioning.
Abdalla is silent on wherein the body comprises a tapered portion extending along the axis between the proximal end and the distal end, wherein a cross-sectional diameter of the body at the proximal end is greater than a cross-sectional diameter of the body at the tapered portion. Diederich teaches wherein the body comprises a tapered portion extending along the axis between the proximal end and the distal end [Fig. 1, elements 10 (body), 20 (tapered portion), 14 (proximal end), 16 (axis), 26 (distal end)], wherein a cross-sectional diameter of the body at the proximal end is greater than a cross-sectional diameter of the body at the tapered portion [Fig. 2]—depicts cross sectional diameters of the distal end represented by element 16 and the diameter of element 12 representing the proximal end of the device;
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 structure to include a tapered portion at the edge of the device as taught by Diederich to allow for deformation to as suggested by Abdalla as Abdalla discusses the device having elastic deformability to adjust to external pressures with Diederich because Diederich teaches the use of a deployable balloon to inflate the device to deploy it within a lumen [Col 4, lines 42-54].
Regarding Claim 15, Abdalla further teaches wherein the body comprises a substantially spherical portion [Fig. 9C, element 952] and a substantially cylindrical portion [Fig. 9C, element 957] between the proximal end and the distal end, since elements 952 make up the structure and comprise the proximal and distal ends they are interpreted to be between the proximal and distal ends.
Regarding Claim 16, Abdalla further teaches wherein the body comprises a substantially spherical portion connected to the tapered portion [Fig. 9C, elements 952 (tubes), 959 (protrusions), 962 (grooves) and 958 (first planar hub)]—where the spherical portion or tubes including the grooves are connected to the protrusions or tapered portion via the first planar hub.
Regarding Claim 17, Abdalla further teaches wherein at least one of the plurality of radioactive seeds are embedded in the tapered portion [0040]—describes the radioactive seeds being positioned within the grooves.
Regarding Claim 19, Abdalla further teaches further comprising: a channel extending through the body [0040]—reference to elements 910 (tubes) having continuous central channels extending along the length of the tubes.
Claim(s) 6, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view of Diederich (U.S. 7476235) and in further view of Brachman (WO 2015142316).
Regarding Claim 6, Abdalla and Diederich are silent on further comprising: one or more trim lines indicating locations where the radioactive seed carrier is configured to be separated. Brachman teaches further comprising: one or more trim lines indicating locations where the radioactive seed carrier is configured to be separated [0154]—discusses the carrier including cut lines indicating where the operator would trim the carrier.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include trim lines on the implantable device as taught by Brachman to aid the surgeon in placement of the apparatus as suggested by Abdalla and Diederich, as Abdalla discusses the device being cut to shape or formed to shape at the time of intra-operative placement [0057] and Diederich which discloses placement considerations to protect sensitive non-targeted tissues [Col 3, lines 25-28] with Brachman because Brachman teaches the use of this indicator line to prevent accidental release or damage of/to the radioactive seed [0154].
Regarding Claim 18, Abdalla and Diederich are silent on further comprising: one or more trim lines indicating locations where the radioactive seed carrier is configured to be separated. Brachman teaches further comprising: one or more trim lines indicating locations where the radioactive seed carrier is configured to be separated. [0154]—discusses the carrier including cut lines indicating where the operator would trim the carrier.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include trim lines on the implantable device as taught by Brachman to aid the surgeon in placement of the apparatus as suggested by Abdalla and Diederich, as Abdalla discusses the device being cut to shape or formed to shape at the time of intra-operative placement [0057] and Diederich which discloses placement considerations to protect sensitive non-targeted tissues [Col 3, lines 25-28] with Brachman because Brachman teaches the use of this indicator line to prevent accidental release or damage of/to the radioactive seed [0154].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view of Diederich (U.S. 7476235) and in further view of Brachman (WO 2015142316) and in even further view of Brachman (U.S. 9526463) herein referred to as “Brachman ‘463”.
Regarding Claim 7, Abdalla, Diederich, and Brachman are silent on wherein the one or more trim lines are separated by about five to twenty millimeters. Brachman ‘463 teaches wherein the one or more trim lines are separated by about five to twenty millimeters [Col 12, lines 46-48]—discloses trim lines spaced apart at one centimeter or 10-millimeter intervals.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include trim lines spaced apart in the dimensions specified on the implantable device as taught by Brachman 463’ to accommodate tumors with irregular shapes as suggested by Abdalla, Diedrich, and Brachman, as Abdalla discusses pre-forming the device to various sizes and shapes [0057] and Diederich which discloses placement considerations for the device to protect sensitive non-targeted tissues [Col 3, lines 25-28] and Brachman which discloses proportions of the device being set to maintain ideal implant geometries [0164] with Brachman 463’ because Bachman 463’ teaches cutting and trimming the surface of the radioactive seed to create different sizes of the multiple isolation sheets cut to calculated isolation sheet size to achieve maximum therapeutic index [Cols 12-13, lines 60-12].
Claim(s) 9, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view of Diederich (U.S. 7476235) and in further view of Amols’ (U.S. 20020123660).
Regarding Claim 9, Abdalla and Diederich are silent on wherein an outer surface of the body comprises one or more flutes. Amols’ teaches wherein an outer surface of the body comprises one or more flutes [Abstract; “A low attenuation radioactive seed utilizing a core having a fluted or non-circular cross section.”] and [0008]—describing the core having an outer surface with the same structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include flutes in the outer surface of the body as taught by Amols’ to enhance radiation delivery as suggested by Abdalla and Diederich as Abdalla includes surface structures on the body to interface with the patient’s body to enable accurate radiation deliver [0006] and Diederich which shows depressions and textures of the balloons [Fig. 1, element 20 possesses surface texture] with Amols’ because Amols’ teaches these surface features contributing to increased dose rate, decreased dwelling time, and improved dose consistency in the treatment zone [Abstract].
Regarding Claim 20, Abdalla and Diederich are silent on wherein an outer surface of the body comprises one or more flutes. Amols’ teaches wherein an outer surface of the body comprises one or more flutes [Abstract; “A low attenuation radioactive seed utilizing a core having a fluted or non-circular cross section.”] and [0008]—describing the core having an outer surface with the same structure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include flutes in the outer surface of the body as taught by Amols’ to enhance radiation delivery as suggested by Abdalla and Diederich as Abdalla includes surface structures on the body to interface with the patient’s body to enable accurate radiation deliver [0006] and Diederich which shows depressions and textures of the balloons [Fig. 1, element 20 possesses surface texture] with Amols’ because Amols’ teaches these surface features contributing to increased dose rate, decreased dwelling time, and improved dose consistency in the treatment zone [Abstract].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view of Diederich (U.S. 7476235) and in further view of Kelson (U.S. 8834837).
Regarding Claim 11, Abdalla and Diederich are silent on wherein the radioactive seed carrier is configured for implantation into mammalian tissue via an endoscope. Kelson teaches wherein the radioactive seed carrier is configured for implantation into mammalian tissue via an endoscope [Col 10, lines 42-46]—details introduction into the body via tip of an endoscope while including the reference to radiation ranges in human tissue [Col 8, lines 51-53].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to enable the device to be delivered via endoscope as taught by Kelson to deliver a radioactive source to a tumor site as suggested by Abdalla and Diederich as Abdalla includes reference to the device being delivered via catheter [0003] and Diederich which discloses insertion into the body via catheter [Fig. 10, element 102] with Kelson because Kelson teaches the objective of providing target zone delivery of radiation to avoid irradiation of healthy tissue [Col 2, lines 9-13].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdalla (U.S. 20190224498) in view Diederich (U.S. 7476235) and in further view of Degany (U.S. 6193669).
Regarding Claim 12, Abdalla and Diederich are silent on wherein the radioactive seed carrier is capable of compression, wherein the cross-sectional diameter of the body at the proximal end when compressed is less than about two-thirds of an original size of between one to seven centimeters. Degany teaches wherein the radioactive seed carrier is capable of compression, wherein the cross-sectional diameter of the body at the proximal end when compressed is less than about two-thirds of an original size of between one to seven centimeters [Col 22, lines 11-17]—Discusses a lumen diameter reducing to 2/3 of the original diameter in reference to post dilatation process such as stent deployment [Col 2, lines 29-33].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the device into the body as taught by Degany to deliver a radioactive source to a tumor site utilizing shape change features as suggested by Abdalla and Diederich as Abdalla includes reference to the elastic deformability of the device [0045] and Diederich which teaches a deployable device [Fig. 10, element 106] with Degany because Degany teaches preventing wall recoil and restenosis [Col 2, lines 29-30].
Response to Arguments
Applicant's arguments filed 19 March 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive.
Applicant’s arguments filed 19 March 2026 with respect to the rejection of
claims 1, 3, 4, 5, 8, 10, 13, 14, 15, 16, 17 and 19 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive, however, new rejections are presented above in light of the amendments for claims 1, 3, 4, 5, 8, 10, 13, 14, 15, 16, 17 and 19 under 35 U.S.C. 103 over Abdalla in view of Diederich.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Benson (U.S. 20090143634)-depicts a brachytherapy treatment device with a tapered side including a greater cross-sectional diameter.
-Lamoureux (U.S. 8771162)-includes a device with tapered sides and fins
-Bricote (JP 2002-529160)-shows devices with tapered structures
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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