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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-19, 22-25 and 38-47, in the reply filed on 02 July 2026 is acknowledged.
The nonelected claims have been canceled.
Claim Objections
Claims 6, 7 and 24 are objected to because of the following informalities:
Claims 6, 7 and 24 employ the language “selected from … or …” which is not traditional Markush claim format. The examiner suggests “selected from the group consisting of … and …,” or “is … or ….”
Appropriate correction is required.
Claim is 47 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim must depend from previous claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 47 has not been further treated on the merits.
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.
Claims 4, 10-12 and 17. are rejected under 35 U.S.C. 112(b) paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 4 initially states the inert metal oxide substrate “has a porosity” which requires the presence of some amount of porosity. The claim subsequently recites a range for the porosity of “less than about 10.” This range has zero as a lower limit, which suggests that porosity need not be present. Thus, the claim is indefinite as to whether the inert metal oxide contains porosity or not.
Claim 10 recites, “as one or more solid compound, crystalline, or amorphous phases of the radioisotope bound…” The claim could mean the parent radioisotope is in the form of a solid compound, and the solid compound has a crystalline or amorphous phase. The claim could also mean the radioisotope surface layer is a solid compound, or an amorphous phase, or a crystalline phase.
In claims 11 and 12, line 2, “the solid compound phases” lacks antecedent basis. Only “one or more solid compound phases” are referred to in claim 10.
In claim 17, each item in the list, “the … heat-treated radioisotope surface layer, radioisotope-doped layer, solid compound, crystalline or amorphous phases” lacks antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 38-45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 38-45 recite “the chamber configured to house an inert ceramic substrate of claim 1….” This claim language does not require the presence of the inert ceramic substrate of claim 1 in the radioisotope generator. Rather, it needs only be capable of housing the inert metal oxide substrate.
MPEP 608.01(n) states:
[The] test as to whether a claim is a proper dependent claim is that it shall include every limitation of the claim from which it depends and specify a further limitation of the subject matter claimed.
Claims 38 to 45 do not include every limitation of claim 1.
Applicants may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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.
Claims 1-3, 5-15, 18, 22, 25, 38-41 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norman et al. (US 5,038,046)(Norman).
As to claims 1, 6, 9 and 18, Norman discloses a radioisotope generator comprising a mixture of a 228Th compound in a matrix of powdered graphite or alumina (i.e., a metal oxide) and compacted into a disk. See col. 3, lines 53-56 and col. 48-56. The result is a substrate disk having 228Th immobilized throughout the disk including a portion (i.e., surface layer) that is necessarily bound near a surface of the disk.
The 228Th emanates a gaseous intermediate 220Rn. See the abstract.
Claim 2 is a product-by-process claim. For purposes of examination, product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. See MPEP 2113. In the present case, the recited step of heat treated does not appear to imply a structure that is not present in Norman.
As to claim 3, Norman discloses the presence of membrane (14) which permits the transmission of the intermediate isotope and blocks the transmission of the parent isotope (i.e., 228Th). Therefore, the device of Norman is expected to have a transmission of parent radioisotope of essentially zero in use.
As to claim 5, Norman discloses the parent radioisotope is 228Th (abstract) which is alpha emitting.
As to claim 7, Norman discloses the parent radioisotope is 228Th (abstract) which has 212Pb as a daughter isotope. See col. 4, lines 65-68.
As to claim 8, Norman disclose a disc having the same structure as presently claimed. Therefore, the claim 8 activity is presumed inherent to article of Norman.
As to claims 10-12 and 14, Norman discloses incorporating a thorium compound into the matrix and the compound is amorphous or microcrystalline. See col. 3, 40-42.
As to claim 13, Norman discloses the 228Th are added in the form of particles to the alumina/inert ceramic matrix. See col. 7, lines 47-50.
As to claim 15, Norman disclose the 228Th is added in the form of thorium nitrate, which contains oxygen and is therefore considered and oxide. See col. 6, line 59.
As to claim 17, any portion of the surface of the disc of Norman can be considered a surface layer and be subdivided into layers between 0.1 and 1000 nm.
As to claim 22, Norman discloses the metal oxide is alumina, i.e., an oxide of aluminum. See col. 3, line 56, and col. 7, lines 63-64.
Claim 25 is a product-by-process claim. For purposes of examination, product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. See MPEP 2113. In the present case, the recited step of oxidatively pretreating a metal substrate does not appear to imply a structure associated with the resultant oxide that is not present in Norman. The claim does not require the presence of the metal substrate after oxidation.
As to claim 38, Norman discloses a radioisotope generator comprising a housing having chambers 10 and 12 which are configured to house the source (40) of the gaseous radioisotope. See the Figure 2 and col. 7, line 48 to col. 8, line 23.
As to claim 39, Norman discloses the collection chamber (12) may be made of stainless steel and includes walls. See Figure 2, and col. 8, line 20. The instant specification indicate a collection surface may be the surface of the collection chamber which is made of stainless steel. See paragraphs [0074] and [0263] of the published application. The surface of the disc (40) of Norman containing the parent radioisotope faces downward towards the collection container. See Figure 1.
As to claim 40, the instant specification (paragraph [0174] of the published application) defines “line-of-site” as follows:
[0174] … It will be understood that “line-of-sight” communication refers to a configuration where the collection surface and radioisotope surface layer are at some point in time in view of each other within the chamber without any obstacle (such as a closed valve or retractable seal) in between, to allow for the efficient transport of emanated gaseous intermediate radioisotope. In some embodiments, the chamber may be configured with one or more valves, seals and/or closures configured to temporarily physically isolate/separate the inert ceramic substrate from the collection surface, such as when the daughter radioisotope is extracted from the collection surface. While such physical separation of the inert ceramic substrate from the collection surface temporarily disrupts the line-of-sight communication, it will be understood that when collection of emanated radioisotope is occurring, the chamber is configured at some point to provide line-of-sight communication between the radioisotope surface layer and the collection surface. In other words, such line-of-sight configuration does not preclude the presence of one or more closures, seals and/or valves being present in the chamber to temporarily physically isolate/separate the inert ceramic substrate from the collection surface, such as when daughter radioisotope is being extracted from the collection surface.
Norman meets this definition. Although there is a membrane 14 in between the emanation source 40 and the collection surface 12, the porous membrane does not present an obstacle to the flow of the radioisotope.
As to claim 41, Figure 2 of Norman shows the collection chamber beneath the emanation source which enables gravity assisted collection.
As to claim 47, Norman discloses a radioisotope generator comprising a housing having chambers 10 and 12 which are configured to house the source (40) of the gaseous radioisotope. See the Figure 2 and col. 7, line 48 to col. 8, line 23.
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 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (US 5,038,046)(Norman) as applied to claim 1 above.
Norman anticipates claim 1 for the reasons recited above. Norman fails to disclose the radioisotope disc has a porosity of less than about 10 vol.% as recited in claim 4.
However, Norman discloses the incorporating a source of 228Th into a porous matrix and pressing the mixture into a disc. See col. 7, lines 48-57. As is known to one of ordinary skill in the art, merely compacting a mixture such as alumina and a 228Th source will not achieve a disc without some amount of porosity. A disc that is very dense will require the daughter radioisotopes to escape via solid state diffusion. Norman discloses the disc is formed in the order to achieve ease of handling. Id.
Thus, a highly dense disc will slow diffusion and make the disc physically robust and easy to handle, whereas larger amounts of porosity in the disc will enhance radioisotope emanation while reducing handling strength. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to have optimized the porosity of the disc of Norman to optimize radioisotope emanation and handling strength.
As to claim 19, Norman does not disclose the size of the formed disk. However, it has been held to have been within he level of ordinary skill in the art to have changed the size of a prior art product. See MPEP 2144.04 IV A.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (US 5,038,046)(Norman) as applied to claim 1 above, and further in view of Jernstrom et al. (US 2019/0066860 A1).
Norman anticipates claims 1 and 22 for the reasons recited above. Norman teaches the matrix may be aluminum oxide or an inert ceramic. Norman fails to teach Ta2O5 or ZrO2 as the matrix material.
Jernstrom teaches vanadium, niobium or tantalum oxides (i.e., oxide ceramics) are employed as inorganic supports for radioisotope generators. See the abstract.
It would have been obvious to one of ordinary skill in the art at the time of filing to have employed Ta2O5 as the inert powder ceramic of Norman. The rationale for doing to is the selection of a known material (i.e., Ta2O5) based on its suitability for its intended purpose (radionuclide absorbent). See MPEP 2144.07.
Claims 38-46 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hara (US 2018/0047474 A1)(O’Hara) in view of Norman et al. (US 5,038,046)(Norman).
As to claims 38 and 46, O’Hara teaches a gas radioisotope emanation apparatus. See the abstract. The apparatus includes a housing 8 which houses a porous disc 4 emanation source. See Figure 1 and paragraph [0016] and [0022].
O’Hara fails to disclose the particulars of the porous disc 4 emanation source, i.e., the structure recited in claim 1 and incorporated by reference into claims 38 and 46.
Norman discloses a radioisotope generator comprising a mixture of a 228Th compound in a matrix of powdered graphite or alumina (i.e., a metal oxide) and compacted into a disk. See col. 3, lines 53-56 and col. 48-56. The result is a substrate disk having 228Th immobilized throughout the disk including a portion (i.e., surface layer) that is necessarily bound near a surface of the disk. The 228Th emanates a gaseous intermediate 220Rn. See the abstract.
It would have been obvious to one of ordinary skill in the art at the time of filing to have employed the radioisotope generating disk of Norman as the isotope source 4 of O’Hara. The rationale for doing so is the simple substitution of one known element (disc source 4 of O’Hara) with the another (i.e., the disc of Norman) to achieve predictable results. See MPEP 2143 1.B.
As to claim 39, the apparatus includes the holder 12 and collection stage, which collectively form a “collection chamber” and collection surface. See Figure 1.
As to claim 40, the instant specification (paragraph [0174] of the published application) defines “line-of-site” as follows:
[0174] … It will be understood that “line-of-sight” communication refers to a configuration where the collection surface and radioisotope surface layer are at some point in time in view of each other within the chamber without any obstacle (such as a closed valve or retractable seal) in between, to allow for the efficient transport of emanated gaseous intermediate radioisotope. In some embodiments, the chamber may be configured with one or more valves, seals and/or closures configured to temporarily physically isolate/separate the inert ceramic substrate from the collection surface, such as when the daughter radioisotope is extracted from the collection surface. While such physical separation of the inert ceramic substrate from the collection surface temporarily disrupts the line-of-sight communication, it will be understood that when collection of emanated radioisotope is occurring, the chamber is configured at some point to provide line-of-sight communication between the radioisotope surface layer and the collection surface. In other words, such line-of-sight configuration does not preclude the presence of one or more closures, seals and/or valves being present in the chamber to temporarily physically isolate/separate the inert ceramic substrate from the collection surface, such as when daughter radioisotope is being extracted from the collection surface.
O’Hara meets this definition. O’Hara shows a valve 16 in between the emanation source and collection surface, however, at a point in time, this valve is opened to allow the emanated radioisotope to flow into the collection stage 14. See Figure 1.
As to claim 41, it would have been obvious to one of ordinary skill in the art to have placed the source above the collection surface in order to enhance migration by gravity because it was known that 220Rn is a heavy element and will sink in the presence of lighter gases such as air or nitrogen.
As to claims 42-45, Norman discloses the apparatus includes an inlet port 14 for delivery of a carrier gas (i.e., fluid) into holder 12 which facilitates transfer of the gas out of the port 18 (i.e., fluid outlet port) and into the collection stage. The collection stage is connected to a vacuum pump 20 to facilitate removal of the selected isotope.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4-9, 18-19, 22, 23, 38 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12, 573,519 (‘519). Although the claims at issue are not identical, they are not patentably distinct from each other.
As to claim 1, claims 1-15 of the ‘519 patent completely encompass all of the limitations of instant claim 1. Claims 1-15 of the ‘519 patent teach a metal oxide substrate having a radioisotope bound on or near the surface of the substrate.
The claims of the ‘519 patent do not teach the limitation wherein the radioisotope is “in an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….” Claim 6 of the ‘519 patent teaches the radioisotope is contained “in an amount effective to provide an activity of 10 MBq/cm2 and 1000 MBq/cm2 and instant claim 8 recites the immobilized parent metal provides an activity of 1 to about 1500 MBq/cm2. Based upon the overlap in these ranges, 10 MBq/cm2 to 1000 MBq/cm2 appears to be “an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….”
Claim 2 is a product-by-process, and no difference can be discerned between the product of the claims of the ‘519 patent and the product that results from heat treating as recited in claim 2.
As to claim 4, claim 1 of the ’519 patent teaches the substrate is porous. One of ordinary skill in the art interprets this limitation to suggest that the metal oxide has a porosity of greater than zero, which overlaps the range recited in claim 4. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05.
As to claim 5, claim 1 of the ‘519 teaches the radioisotope is thorium-228, which is alpha emitting.
As to claim 6, claim 1 of the ‘519 patent teaches the radioisotope is thorium-228.
The limitations of instant claim 7 can be found in claim 13 of the ‘519 patent.
The limitations of instant claim 8 can be found in claim 6 of the ‘519 patent.
As to claim 9, claim 1 of the ‘519 teaches some of the radioisotope is bound on or near the surface.
The limitations of instant claim 18 can be found in claim 8 of the ‘519 patent.
As to claim 19, the claims of the ‘519 patent do not teach the thickness of the metal oxide substrate. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04.
As to claims 22-23, claims 7 and 10 of the ‘519 patent teach tantalum oxide or zirconium oxide as the substrate.
As to claims 38 and 46, claim 1 of the ‘519 patent teaches a “substrate for a radioisotope generator.” It would have been obvious to one of ordinary skill in the art to have incorporated such a substrate into a chamber.
Claims 1-10, 14-19, 22-23, 38 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,340,916 (‘916). Although the claims at issue are not identical, they are not patentably distinct from each other.
As to claim 1, claims 1-22 of the ‘916 patent completely encompass all of the limitations of instant claim 1. Claims 1-15 of the ‘916 patent teach a tantalum oxide (i.e., metal oxide) substrate having a 228Th layer on the surface of the substrate.
The claims of the ‘916 patent do not teach the limitation wherein the radioisotope is “in an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….” Claim 9 of the ‘916 patent teaches the radioisotope is contained to provide at least 100 MBq/cm2, and instant claim 8 recites the immobilized parent metal provides an activity of 1 to about 1500 MBq/cm2. Based upon the overlap in these ranges, at least 100 MBq/cm2 MBq/cm2 appears to be “an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….”
The limitations of claim 2 can be found in claim 11 of the ‘916 patent.
The limitations of claim 3 can be found in claim 14 of the ‘916 patent.
The limitations of claim 4 can be found in claim 6 of the ‘916 patent.
As to claim 5, claim 1 of the ‘916 teaches the radioisotope is thorium-228, which is alpha emitting.
As to claim 6, claim 1 of the ‘916 patent teaches the radioisotope is thorium-228.
As to claim 7, claim 1 of the ‘916 teaches the radioisotope is thorium-228 which emanates 220Rn. 220Rn inherently decays to lead 212.
The limitations of instant claim 8 can be found in claims 8 and 9 of the ‘916 patent.
The limitations of claim 9 can be found in claim 10 of the ‘916 patent.
As to claim 10, claim 10 of the ‘916 patent teaches a 228Th oxide layer. 228Th oxide is a compound. The solid material must inherently be either crystalline, amorphous, or a mixture.
The limitations of instant claims 14-15 can be found in claim 1 of the ‘916 patent.
As to claim 16, claim 1 of the ’916 patent teaches the layer comprises thorium oxide, which one of ordinary skill in the art would interpret to mean ThO2.
As to claim 17, the claims of the ‘916 patent do not teach the thickness of the thorium oxide layer. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04 IV.
As to claim 18, the claims of the ‘916 patent do not teach the shape of the substrate. However, it has been held to be within the level of ordinary skill in the art to change the shape of a prior art product. See MPEP 2144.04 IV.
As to claim 19, the claims of the ‘916 patent do not teach the thickness of the metal oxide substrate. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04.
As to claims 22-23, claim 1 of the ‘916 patent teaches tantalum oxide as the substrate.
As to claims 38 and 46, claim 1 of the ‘916 patent teaches a 220Rn emanating tantalum oxide substrate. It would have been obvious to one of ordinary skill in the art to have incorporated such a substrate into a chamber.
Claims 1-10, 14-15, 17-19, 22-23, 38 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,249,439 (‘439). Although the claims at issue are not identical, they are not patentably distinct from each other.
As to claim 1, claims 1-16 of the ‘439 patent completely encompass all of the limitations of instant claim 1. Claims 1-16 of the ‘439 patent teach a tantalum oxide (i.e., metal oxide) substrate having a 228Th layer on the surface of the substrate.
The claims of the ‘439 patent do not teach the limitation wherein the radioisotope is “in an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….” Claim 5 of the ‘439 patent teaches the radioisotope is contained to provide at least 100 MBq/cm2, and instant claim 8 recites the immobilized parent metal provides an activity of 1 to about 1500 MBq/cm2. Based upon the overlap in these ranges, at least 100 MBq/cm2 appears to be “an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….”
The limitations of claim 2 can be found in claim 8 of the ‘439 patent.
The limitations of claim 3 can be found in claim 6 of the ‘439 patent.
The limitations of claim 4 can be found in claim 2 of the ‘439 patent.
As to claim 5, claim 1 of the ‘439 teaches the radioisotope is thorium-228, which is alpha emitting.
As to claim 6, claim 1 of the ‘439 patent teaches the radioisotope is thorium-228.
As to claim 7, claim 1 of the ‘439 teaches the radioisotope is thorium-228 which emanates 220Rn. 220Rn inherently decays to lead-212.
The limitations of instant claim 8 can be found in claim 5 of the ‘439 patent.
The limitations of claim 9 can be found in claim 1 of the ‘439 patent.
As to claim 10, claim 1 of the ‘439 patent teaches a 228Th layer. The 228Th substitutes for the tantalum in the oxide substrate and the results is a portion that is 228Th oxide. 228 Th oxide is a compound. The solid material must inherently be either crystalline, amorphous, or a mixture.
The limitations of instant claims 14-15 can be found in claim 1 of the ‘439 patent.
As to claim 17, the claims of the ‘439 patent do not teach the thickness of the thorium layer. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04 IV.
As to claim 18, the claims of the ‘439 patent do not teach the shape of the substrate. However, it has been held to be within the level of ordinary skill in the art to change the shape of a prior art product. See MPEP 2144.04 IV.
As to claim 19, the claims of the ‘439 patent do not teach the thickness of the metal oxide substrate. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04.
As to claims 22-23, claim 1 of the ‘439 patent teaches tantalum oxide as the substrate.
As to claims 38 and 46, claim 1 of the ‘439 patent teaches a chamber housing the 228 Th based generator.
Claims 1-9, 17-19, 38 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/618,309 (‘309). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As to claim 1, claims 1-11 of the ‘309 application completely encompass all of the limitations of instant claim 1. Claims 1-16 of the ‘309 application teach an inert oxide substrate having a 228Th layer on the surface of the substrate.
The claims of the ‘309 application do not teach the limitation wherein the radioisotope is “in an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….” Claim 3 of the ‘309 application teaches the radiosisotope is contained to provide 100 to 1500 MBq/cm2, and instant claim 8 recites the immobilized parent metal provides an activity of 1 to about 1500 MBq/cm2. Based upon the overlap in these ranges, 100 -1500 MBq/cm2 appears to be “an amount effective to generate a medically useful dose of daughter radioisotope through a chain of spontaneous decay from the parent radioisotope via a gaseous intermediate radioisotope….”
Claim 2 is a product-by-process, and no difference can be discerned between the product of the claims of the ‘309 application and the product that results from heat treating as recited in claim 2.
The limitations of claim 3 can be found in claim 1 of the ‘309 application.
The limitations of claim 4 can be found in claim 1 of the ‘309 application.
As to claim 5, claim 1 of the ‘309 application teaches the radioisotope is thorium-228, which is alpha emitting.
As to claim 6, claim 1 of the ‘309 application teaches the radioisotope is thorium-228.
As to claim 7, claim 1 of the ‘309 application teaches the radioisotope is thorium-228 which emanates 220Rn. 220Rn inherently decays to lead-212.
The limitations of instant claim 8 can be found in claim 3 of the ‘309 application.
The limitations of claim 9 can be found in claim 1 of the ‘309 application.
As to claim 17, the claims of the ‘309 application do not teach the thickness of the thorium layer. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04 IV.
As to claim 18, the claims of the ‘309 application do not teach the shape of the substrate. However, it has been held to be within the level of ordinary skill in the art to change the shape of a prior art product. See MPEP 2144.04 IV.
As to claim 19, the claims of the ‘309 application do not teach the thickness of the metal oxide substrate. However, it has been held to have been obvious to one of ordinary skill in the art at the time of filing to have changed the size of a prior art product. See MPEP 2144.04.
As to claims 38 and 46, claim 1 of the ‘309 application teaches a chamber housing the 228 Th based generator.
Allowable Subject Matter
Claim 24 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Sample whose telephone number is (571)272-1376. The examiner can normally be reached Monday to Friday 7AM to 3:30 PM.
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/David Sample/Primary Examiner, Art Unit 1784
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