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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/7/2023, 11/14/2023, 5/7/2024, and 8/9/2024 is being considered by the examiner.
Drawings
The drawings are objected to because the text in figures 12A-I, 13A-D, and 16A-B are too small/illegible/blurred. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities:
In claim 6, line 1, “emits a beta radiation” should be –emits beta radiation--.
Appropriate correction is required.
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 6, 12, and 8-22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “a beta radiation” in line 1. It is not clear if this is a new instance or refers to the beta radiation in line 6 of claim 1.
Claim 8 recites the limitation “an RBS” in line 7. It is not clear if this is a new instance or refers the RBS from claim 1.
Claims 9-21 inherit the deficiencies of claim 8 and are likewise rejected.
Claim 12 recites a limitation that is unclear. Wall thickness with the claimed prescription dose passage can vary based on the materials used. Thus, the limitation is indefinite.
Claim 22 has no transition phrase. It is not clear what is actually being claimed as there are no structural components or steps being claimed.
Claim Rejections - 35 USC § 102
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)(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, 8-13, 15, and 22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2018/0358142 (Vose et al., hereinafter Vose).
In regards to claims 1 and 2, Vose discloses a strontium radioactive source (title and abstract; paragraphs 5-6 and 18-31). The device includes the following components:
a capsule (figure 6, element 200; paragraph 18; no specifics are given about the capsule so the medical device can be considered as the capsule due to it being an enclosure that encases the radioactive source) having a distal surface, a proximal surface opposite the distal surface, and a side wall (The surfaces and walls would be a natural part of the instrument that carries the isotope); and
an active beta radioisotope material (strontium-90 radiological insert 318) in an annulus configuration encased in the capsule (radiological insert can be toroidal/annular/donut shape – abstract, paragraphs 6, 24-31), the active beta radioisotope material emits beta radiation through at least a portion of the distal surface of the capsule (paragraph 18 – beta radiation is emitted in a specific direction).
In regards to claim 8, Vose discloses the limitations of claim 1. Vose further shows the presence of a cap system (figures 3 and 5A-F, element 300; paragraphs 24 and 26-32) for housing the radionuclide brachytherapy source (RBS), the cap system comprises an inner cavity formed by a side wall (308) and a bottom surface (302) sealed to a bottom edge of the side wall around its perimeter, the inner cavity (not labeled but is the space that holds the insert (318)) is for accepting the RBS (318 - insert), wherein a flattening filter (304) is disposed on the bottom surface in the inner cavity (140), the flattening filter reduces at least a portion of beta radiation emitted from an RBS thereby controlling an amount of beta radiation emitted from the bottom surface of the cap system (paragraphs 25-31 – element 304 is used to create flat emission profile).
In regards to claims 9-11 and 13, Vose discloses the limitations of claim 8. In addition, it can be seen in figure 3 that the flattening filter can be considered as annular and has an inner diameter, outer diameter, and a thickness. It can be seen in figure 3 that the filter has a combination of at least two different thicknesses, thus meeting the limitation of claim 11. The filter also provides emission of beta radiation through the bottom surface (paragraphs 25-31), which makes it an active surface area.
In regards to claim 12, Vose meets the limitation of claim 8. In addition, due to the 112 issue of claim 12, Vose would meet the limitations of the claim.
In regards to claim 15, Vose discloses the limitations of claim 13. The device naturally provides beta radiation to a treatment volume as it is used to treat patients (paragraph 18). In addition, the limitations of claim 15 appear to be a recitation of intended use or limitations to the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regards to claims 22, Vose discloses a strontium radioactive source (title and abstract; paragraphs 5-6 and 18-31). Due to the 112 issues of the claim, specifically the claim having no actual claimed components, Vose would meet the limitations of the claim.
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.
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.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0138515 (White et al., hereinafter White) in view of US 2016/0375267 (Lutz et al., hereinafter Lutz).
In regards to claims 1-2. White discloses a brachytherapy device (see title and abstract; figures 1, 2A-E, 3, 4A-C, 5, 7, and 12-15; paragraphs 10-98 and 105-131). White shows the following components:
a capsule (holder (38); figures 2A-E, 3, 4A-C, and 5; paragraphs 42-63 and 77, in particular paragraph 44) having a distal surface (cap 38 would contain the distal surface when joined on the capsule), a proximal surface (41) opposite the distal surface, and a side wall (44); and
an active radioisotope material (42) in an annulus configuration encased in the capsule (source is in a form of annular ring (paragraph 44) in the capsule covered by a cap as shown in figure 5 which shows radiation emitted being available on the upper surface (149) of the cap (148)) the active radioisotope material emits radiation through at least a portion of the distal surface of the capsule.
However, White does not give specifics about the radioisotope material. In a related area, Lutz discloses methods and devices for minimally-invasive delivery of radiation to the eye, which in this case is a brachytherapy system (title and abstract; paragraphs 68-137). Of note are paragraphs 106-108 which discloses the use of an annulus source and states that sources used can be Strontium-90, Yttrium 90, Ruthenium-106, Iodine-125, two different Cesium isotopes (131 and 137), thus also meeting the limitation of claim 2. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of White to use beta isotope materials as taught by Lutz because these are several known radioisotopes used in brachytherapy for the treatment of the eye.
In regards to claim 3, White and Lutz disclose the limitations of claim 1. In addition, White states that the capsule dimensions that have an outer diameter from 7-12 mm, which falls within the claimed range.
In regards to claim 4, White and Lutz disclose the limitations of claim 1. In addition, White states that the capsule dimensions that have an outer diameter from 7-12 mm, which falls within the claimed range. While the capsule diameter of 10.8 mm is not explicitly stated, White states that the capsule dimensions can be adapted to provide a treatment area based on a desired size and shape (paragraph 53). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of White and Lutz to have a capsule with 10.8 mm diameter because one of ordinary skill in the art would modify the dimensions of the capsule to the specific diameter based on a desired size and shape.
In regards to claim 6, White and Lutz disclose the limitations of claim 1. The radioisotope naturally emits the beta radiation. The limitations of claim 6, appear to be an intended use of the RBS. Furthermore, the treatment volume is also not being claimed. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use then it meets the claim.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0138515 (White et al., hereinafter White) in view of US 2016/0375267 (Lutz et al., hereinafter Lutz) as applied to claim 1 above, and further in view of US 2007/0055089 (Larsen et al., hereinafter Larsen).
In regards to claim 5, White and Lutz disclose the limitations of claim 1. However, there are no specifics given about the activity of the RBS. In a related area Larsen discloses an apparatus for intraocular brachytherapy (see title and abstract). Of note is paragraph 30 which discloses that the beta emitting material is a Strontium/Yttrium 90 isotope where the source activity is approximately 11 mCi, which is within the claimed range. Larsen states that this are the preferred parameters when delivering radiation for treatment of choroidal neovascularization that occurs in macular degeneration. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device of White and Lutz to use the RBS activity disclosed by Larsen because the chosen activity is preferred when delivering radiation for treatment of choroidal neovascularization that occurs in macular degeneration.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0138515 (White et al., hereinafter White) in view of US 2016/0375267 (Lutz et al., hereinafter Lutz) as applied to claim 1 above, and further in view of US 6,679,824 (Reed et al., hereinafter Reed).
In regards to claim 7, White and Lutz disclose the limitations of claim 1. However, they do not show grips that protrude or are recessed on the surface of proximal surface of the capsule. In a related area, Reed discloses a product used for brachytherapy (see title and abstract). Of note is figure 7, which discloses a radioactive source with several recesses on its surface that allow knobs (6) on the carrier (1) to hold the source in place (column 11, lines 51-54). Note that these recesses can be considered as grips as prongs or forceps would be able to engage with the recesses. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the device of White and Lutz to include grips on the surface of the radiation source as taught by Reed in order to allow for the securement of the source to something and be held in place.
Claim(s) 14 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0358142 (Vose et al., hereinafter Vose), as applied to claims 13 and 15 above, and further in view of US 2010/0004581 (Brigatti et al., hereinafter Brigatti).
In regards to claim 14 and 16-21, Vose discloses the limitations of claim 13 and 15 but does not state the activity of the RBS is 110 mCi. In a related area, Brigatti discloses delivery of radiation to the eye (title and abstract). Of note is paragraph 234 which discloses modification of the RBS depending on desired dose characteristics and treatment depths while giving several ways to modify the RBS. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Vose to obtain the claimed activity for the different treatment volumes as taught by Brigatti in order to customize the treatment based on desired dose and treatment depth characteristics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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