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 .
Claim Objections
Claims 3 and 12 are objected to because of the following informalities:
In claim 3, line 3, “of being locking” should read “of locking”
In claim 12, line 1, “wherein fixating the customized template” should read “wherein fixating the customized template further comprises”
Appropriate correction is required.
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.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kustra et al. (US 2016/0354112).
Regarding claim 1, Kustra et al. teaches a device (Abstract; Fig. 2), comprising:
a rectangular brachytherapy template (Fig. 2, needle guide 20) being made of a piece of material having a rectangular array of holes (Fig. 2, orifices 12) through which a radioactive source needle is capable of passing (paras. 0010 and 0020; Fig. 2, needle 14);
a predetermined number of holes being open according to a treatment plan (para. 0030, “an intervention plan, e.g. an HDR/LDR brachy treatment plan”; para. 0036) for a particular patient and each hole that is not one of the predetermined number of holes being closed (Figs. 2-3; paras. 0011, 0019-0020, and 0030-0032, wherein the restriction means 33 opens and closes the orifices 12); and
wherein the brachytherapy template is customized to the treatment plan for the particular patient (paras. 0029-0030, 0035-0036, and 0040).
Regarding claim 7, Kustra et al. teaches a method (paras. 0017-0020), comprising:
performing treatment planning for a brachytherapy treatment for a particular patient, the treatment planning including determining a placement of each radioactive source in the patient (para. 0030, “based on a prescribed dose distribution an intervention plan e.g. an HDR/LDR brachy treatment plan can be calculated, which plan provides needle insertion positions required to deliver a dose distribution that matches the prescribed dose distribution within an acceptable range”; paras. 0020 and 0029);
creating a customized template based on the treatment plan, the customized template having a predetermined number of holes being open according to the treatment plan for the particular patient and each hole that is not one of the predetermined number of holes being closed (paras. 0019-0020, 0022, and 0030-0032); and using the customized template to perform a brachytherapy treatment for the particular patient (paras. 0029-0030 and 0035-0036).
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.
Claim(s) 2 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kustra et al. in view of Schwartz (US 2014/0296612).
Regarding claim 2, Kustra et al. teaches the device according to claim 1 as stated above. Kustra et al. fails to teach a cover that covers each hole that is not one of the predetermined number of holes and leaves open the predetermined number of holes to create the customized template.
Schwartz teaches an analogous device further comprising a cover (Fig. 1, overlay plate 10) that covers each hole that is not one of the predetermined number of holes and leaves open the predetermined number of holes to create the customized template (para. 0024; Fig. 2, apertures 15).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Kustra et al. with the cover of Schwartz. Doing so creates a shield that protects the patient and physician from radiation during the insertion and positioning of the radioactive seeds (Schwartz, para. 0026).
Regarding claim 8, Kustra et al. teaches the method according to claim 7 as stated above. Kustra et al. fails to teach wherein creating the customized template further comprises creating a cover that closes each hole that is not one of the predetermined number of holes and leaves open the predetermined number of holes to create the customized template.
Schwartz teaches an analogous method wherein creating the customized template further comprises creating a cover (Fig. 1, overlay plate 10) that closes each hole that is not one of the predetermined number of holes and leaves open the predetermined number of holes to create the customized template (para. 0024; Fig. 2, apertures 15).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Kustra et al. with the cover of Schwartz. Doing so creates a shield that protects the patient and physician from radiation during the insertion and positioning of the radioactive seeds (Schwartz, para. 0026).
Regarding claim 9, Kustra et al. in view of Schwartz teaches the method according to claim 8 as stated above further comprising placing the cover over the template (Schwartz, Fig. 1; paras. 0015, 0020, and 0028).
Claim(s) 3 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kustra et al. in view of Pitman (US 2017/0319871).
Regarding claim 3, Kustra et al. teaches the device according to claim 1 as stated above. Kustra et al. fails to specifically teach a set of holes along a centerline of the customized template through which fiducial needles are inserted, each hole in the centerline set of holes capable of locking the inserted fiducial needle to fixate the customized template relative to the patient.
Pitman teaches an analogous device further comprising a set of holes along a centerline of the customized template through which fiducial needles are inserted (Claim 4; Fig. 8, one or more fiducial needle locations 108), each hole in the centerline set of holes capable of locking the inserted fiducial needle to fixate the customized template relative to the patient (paras. 0035-0041).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Kustra et al. with the centerline set of holes capable of locking a fiducial needle of Pitman. Securing the fiducial needles in place enables accurate placement of radioactive source needles into designated breast tissue sites according to a treatment plan (Pitman, para. 0037).
Regarding claim 10, Kustra et al. teaches the method according to claim 7 as stated above. Kustra et al. fails to teach fixating the customized template to a surgical table on which the particular patient is lying.
Pitman teaches an analogous method further comprising fixating the customized template to a surgical table on which the particular patient is lying (Fig. 1A, table 52; paras. 0027-0028 and 0035).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Kustra et al. with the fixating step of Pitman. Doing so creates a mechanism for adjuvant partial breast irradiation, wherein the patient lies on their back and the fiducial needle fixation assembly is pressed against their breast tissue (Pitman, paras. 0027-0028)
Regarding claim 11, Kustra et al. in view of Pitman teaches the method according to claim 10 as stated above. Kustra et al. fails to teach performing breast brachytherapy to insert radioactive sources into breast tissue on a patient.
Pitman further teaches performing breast brachytherapy to insert radioactive sources into breast tissue on a patient (Fig. 2; paras. 0027-0029 and 0043).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Kustra et al. in view of Pitman with the brachytherapy targeting breasts of Pitman. Brachytherapy is a technique used for accelerated partial breast irradiation. Implementing brachytherapy to treat breast cancer generally offers a shorter treatment duration and fewer radiation-induced acute skin reactions compared to typical adjuvant breast radiation (Pitman, paras. 0003-0004).
Regarding claim 12, Kustra et al. in view of Pitman teaches the method according to claim 11 as stated above. Kustra et al. fails to specifically teach wherein fixating the customized template further comprises inserting one or more fiducial needles through a set of holes along a centerline of the customized template into the breast tissue and locking each fiducial needle into a hole in the set of holes along the centerline of the customized template to fixate the customized template to the surgical table.
Pitman further teaches wherein fixating the customized template further comprises inserting one or more fiducial needles through a set of holes along a centerline of the customized template into the breast tissue and locking each fiducial needle into a hole in the set of holes along the centerline of the customized template to fixate the customized template to the surgical table (Fig. 1A; paras. 0035-0041 and 0043; Fig. 8, one or more fiducial needle locations 108); .
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Kustra et al. in view of Pitman with the needle insertion step of Pitman. Securing the fiducial needles in place enables accurate placement of radioactive source needles into designated breast tissue sites according to a treatment plan (Pitman, para. 0037).
Regarding claim 13, Kustra et al. in view of Pitman teaches the method according to claim 11 as stated above further comprising inserting a source needle having at least one radioactive source into one of the open holes in the customized template and depositing the at least one radioactive source (Kustra et al., paras. 0019-0020 and 0030-0032; Fig. 2) in the breast tissue (Pitman, para. 0029; Fig. 2).
Regarding claim 14, Kustra et al. in view of Pitman teaches the method according to claim 13 as stated above. Kustra et al. fails to teach wherein the at least one radioactive source is palladium.
Pitman further teaches wherein the at least one radioactive source is palladium (para. 0028).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Kustra et al. in view of Pitman with the palladium of Pitman. Radioactive sources, such as palladium seeds may kill any remaining tumor cells left in the breast tissue after breast conservation surgery (Pitman, paras. 0028-0029).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kustra et al. in view of Fidel et al. (US 2007/0043291).
Regarding claim 4, Kustra et al. teaches the device according to claim 1 as stated above. Kustra et al. fails to teach one or more indicators that indicate a correct hole in the customized template to insert a source needle.
Fidel et al. teaches an analogous device further comprising one or more indicators that indicate a correct hole in the customized template to insert a source needle (Figs. 2A-3; paras. 0029-0030, 0038, and 0041).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Kustra et al. with the one or more indicators of Fidel et al. Incorporating indicators helps physicians identify specific locations on the template where the needles must be inserted in order to treat a diseased tissue (Fidel et al., paras. 0029-0030, 0038, and 0040-0041).
Regarding claim 5, Kustra et al. in view of Fidel et al. teaches the device according to claim 4 as stated above wherein the one or more indicators are lights (Fidel et al., para. 0030; Fig. 2A).
Regarding claim 6, Kustra et al. in view of Fidel et al. teaches the device according to claim 4 as stated above wherein the one or more indicators are colors (Fidel et al., paras. 0029 and 0041; Fig. 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baltas et al. (2004/0059177) teaches a template assembly comprising a protective layer and needle guiding component provided with a plurality of guiding apertures for guiding hollow implant needles towards a desired location.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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