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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not persuasive. Applicant argues that concrete evidence should not be needed where the steps and materials of the claimed processes are clearly chemically different on the faces of the cited references. This argument is unpersuasive since the rejection is to a product based on product by process. Here, the Office maintains that Evans teaches products with identical chemical composition and structure are produced as a final product. Furthermore, after the process of dissolving the metal molybdenum in acid, the molybdenum prior to precipitation is in the form of molybdate ions in order to form the metal molybdate. Evans also requires the formation of molybdate ions to precipitate metal molybdate. Therefore, the Office maintains that there as a reasonable conclusion that the final products are identical absent evidence to the contrary.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 15, 17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al (US 4,280,053 submitted in the IDS filed 8/4/2022) and in further view of El-Absy et al (“Preparation of 99Mo/99mTc generator based on alumina 99Mo-molybdate (VI) gel”, J Radioanal Nucl Chem (2014) 299:1859-1864 submitted in the IDS filed 8/4/2022 citing from the copy in the parent application 15/902,140).
Regarding claims 1 and 20, Evans discloses a 99mTc elution generator filled with precipitated zirconium molybdates where the molybdates where the particles are sized 150-500 µm (i.e., metal molybdate particulates) (see Col 5, LN 12-25). Evans further discloses alternative molybdates such as titanium molybdate, ceric molybdate, ferric molybdate, stannic molybdate, ammonium molybdosilicate, zirconium molybdosilicate, barium molybdate and any other molybdenum compounds and mixtures (see Col 3, LN 45-57). Evans discloses that these alternative molybdenum compounds may be used because they have very low solubility to eluants which may be used for generators of the present type and have suitable elution characteristics (see Col 3, LN 48-56).
Regarding the metal of the metal molybdenum material is selected from the group consisting of titanium, aluminum, silicon, tin, germanium, hafnium, vanadium, chromium, manganese, cobalt, nickel, iron, copper, niobium, rhodium, gadolinium, thorium, cerium, uranium, praseodymium, terbium, and a combination thereof. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare a 99nTc elution generator where the metal in the metal molybdate comprises titanium, cerium, iron, or tin as disclosed by Evans since Evans expressly suggests that using titanium, cerium, iron and tin molybdates is suitable for 99mTc elution generator because of low solubility to eluants and suitable elution characteristics.
Evans does not disclose that the metal molybdate particulates are prepared by a process comprising reacting a metal molybdenum material in a liquid medium with a first acid to provide a Mo composition; combining the Mo composition with a metal source to provide a metal-Mo composition and pH adjusting the metal-Mo composition with a base to precipitate a plurality of metal-Mo particulates. Evans also does not disclose a metal-molybdate where an average size of particulates is in a range of from at least 550 µm.
Regarding reacting a metal molybdenum material in a liquid medium with a first acid to provide a Mo composition; combining the Mo composition with a metal source to provide a metal-Mo composition and pH adjusting the metal-Mo composition with a base to precipitate a plurality of metal-Mo particulates, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As a practical matter, the Patent Office is not equipped to manufacture products by the myriads of processes put before it and then obtain prior art products and make physical comparisons therewith. A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their particular nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972); In re Fessmann, 180 USPQ 324 (CCPA 1974).
Here, the prior art Evans discloses metal molybdates as gels and in particles. The instant claim implies the chemical composition comprising a metal molybdate where the structure is in the form of particulates. Therefore, Evans discloses a product having the same chemical composition and structure. In the event any slight differences can be shown between the two metal molybdates the burden is on Applicant to provide concrete evidence that the difference exhibits unexpected properties compared to the prior art Evans. See Ex parte Gray, 10 USPQ2d 1922.
Regarding the average size of the plurality of metal-Mo particulates is a range of from at least 550 microns, El-Absy discloses a AlMo gel produced by complete dissolution of MoO3 powder wrapped in Al foil with 5M of NaOH, adding H2O2 and concentrated HNO3 acid to form a precipitate. El-Absy discloses the formed AlMo gel precipitate drying and crushed to obtain 0.15-0.8 mm particle size (i.e., 150 to 800 µm) (see Page 1860, Preparation of alumina 99Mo-molybdate (VI) gel matrices). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990). Here, El-Absy teaches that a particle size range of 150 µm to 800 µm is suitable for packing in the form of a chromatographic column for preparing a 99Tc generator. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans where the particle size is any range overlapping with 150 µm to 800 µm including where the average particle size is greater than 550 µm since El-Absy discloses that particles in a range of 550 to 800 micron are suitable for forming 99Tc generator columns.
Regarding Claims 2 and 21, Evans discloses a 99mTc elution generator filled with precipitated zirconium molybdate particles (i.e., metal molybdate particulates). Evans does not disclose that the metal molybdate particulates are prepared by a process comprising oxidizing a metal molybdenum material in a liquid medium with a first acid to provide a Mo composition; combining the Mo composition with a metal source to provide a metal-Mo composition and pH adjusting the metal-Mo composition with a base to precipitate a plurality of metal-Mo particulates.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As a practical matter, the Patent Office is not equipped to manufacture products by the myriads of processes put before it and then obtain prior art products and make physical comparisons therewith. A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their particular nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972); In re Fessmann, 180 USPQ 324 (CCPA 1974).
Here, the prior art Evans discloses zirconium molybdate particles (i.e., a metal molybdate) with particle structure. The instant claim implies the chemical composition comprising a metal molybdate where the structure is in the form of particulates. Therefore, Evans discloses a product having the same chemical composition and structure. In the event any slight differences can be shown between the two metal molybdates the burden is on Applicant to provide concrete evidence that the difference exhibits unexpected properties compared to the prior art Evans. See Ex parte Gray, 10 USPQ2d 1922.
Regarding claim 15 and 17, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans where the particle size is any range overlapping with 150 µm to 800 µm including where the average particle size is greater than 600 µm since El-Absy discloses that particles in that range are suitable for forming 99Tc generator columns.
Claim(s) 3-10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans and in further view of Clearfield et al (The preparation and crystal structure of a basic zirconium molybdate and its relationship to ion exchange gels, J Inorganic and Nuclear Chem. Vol 34, 8 (1972) pp 2643-2663), and in further view of El-Absy.
Evans discloses metal molybdate in gel-like form with some degree of fine crystallinity (see Col 3, Ln 60-62). Evans further discloses metal molybdates such as zirconium molybdate, titanium molybdate, ceric molybdate, ferric molybdate, stannic molybdate, ammonium molybdosilicate, zirconium molybdosilicate, barium molybdate and any other molybdenum compounds and mixtures produced (see Col 3, LN 45-57). Evans further discloses the alternative molybdates to zirconium molybdate made using similar techniques to producing the zirconium molybdate gel (see Col 3, LN 28-30). Evans discloses that these alternative molybdenum compounds may be used because they have very low solubility to eluants which may be used for generators of the present type and have suitable elution characteristics (see Col 3, LN 48-56).
Regarding the metal of the metal molybdenum material is selected from the group consisting of titanium, aluminum, silicon, tin, germanium, hafnium, vanadium, chromium, manganese, cobalt, nickel, iron, copper, niobium, rhodium, gadolinium, thorium, cerium, uranium, praseodymium, terbium, and a combination thereof. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare a 99nTc elution generator where the metal in the metal molybdate comprises titanium, cerium, iron, or tin as disclosed by Evans since Evans expressly suggests that using titanium, cerium, iron and tin molybdates is suitable for 99mTc elution generator because of low solubility to eluants and suitable elution characteristics.
Regarding, bonds between metal, metalate, or metallic salt and a molybdate in the form of oxo-bridge, hydroxo-bridge, or a combination thereof, Clearfield discloses that zirconium molybdate as an amorphous, precipitated-gel has a structure held together by [Zr-O (and OH)-Mo]-bridges (i.e., Oxo bridges and hydroxo bridges) (see Abstract). As provided above Evans discloses amorphous, precipitated metal molybdate gels including zirconium molybdate and titanium, ceric, ferric, and stannic molybdate gels made using the same techniques as the zirconium molybdate gel. One of ordinary skill in the art would reasonably expect that the metal molybdates as disclosed by Evans which comprise amorphous, precipitated gels has a structure held together by [Metal-O (and OH)-Mo]-bridges (i.e., Oxo bridges and hydroxo bridges) like Clearfield which is a composition that has the same structure as an amorphous molybdate gel and which is produced by the same process of precipitation.
Evans does not disclose a metal-molybdate where an average size of particulates is in a range of from at least 550 µm.
Regarding the average size of the plurality of metal-Mo particulates is a range of from at least 550 microns, El-Absy discloses a AlMo gel produced by complete dissolution of MoO3 powder wrapped in Al foil with 5M of NaOH, adding H2O2 and concentrated HNO3 acid to form a precipitate. El-Absy discloses the formed AlMo gel precipitate drying and crushed to obtain 0.15-0.8 mm particle size (i.e., 150 to 800 µm) (see Page 1860, Preparation of alumina 99Mo-molybdate (VI) gel matrices). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990). Here, El-Absy teaches that a particle size range of 150 µm to 800 µm is suitable for packing in the form of a chromatographic column for preparing a 99Tc generator. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans where the particle size is any range overlapping with 150 µm to 800 µm including where the average particle size is greater than 550 µm since El-Absy discloses that particles in a range of 550 to 800 micron are suitable for forming 99Tc generator columns.
Regarding Claims 4, as applied above, Evans, Clearfield, and El-Absy suggest that a particle size range of 550 µm to 800 µm would be obvious for preparing packing material for a 99Tc generator. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans, Clearfield, and El-Absy with the metal-molybdate gel particles in any range overlapping with the prior art range of 550 µm to 800 µm including the claimed range to 1275 µm.
Regarding claim 5, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans, Clearfield, and El-Absy where the metal-molybdate gel particles is in any range overlapping with the prior art range of 550 µm to 800 µm including the claimed range to 1075 µm.
Regarding Claims 6-8, Evans discloses a zirconium molybdate with elution efficiency of 90% (See Col 6, Ln 13).
Regarding Claim 9, Evans discloses the zirconium molybdate disposed in an elution column and having an elution efficiency of 90% (see Col 5, Ln 23 and 47 and Col 6, LN 13). Evans also discloses the eluant comprising saline (i.e., an aqueous liquid) (Col 5, Ln 45).
Regarding Claim 10, Evans also discloses the eluant comprising saline (i.e., an aqueous liquid) (Col 5, Ln 45). Evans also discloses the eluant comprising water (See Col 4, LN 43).
Regarding claim 19, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare the metal-molybdate gel particles as disclosed by Evans where the particle size is any range overlapping with 150 µm to 800 µm including where the average particle size is greater than 600 µm since El-Absy discloses that particles in that range are suitable for forming 99Tc generator columns.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans, Clearfield, and El-Absy as applied to Claim 3 and in further view of Bloomquist (US 2011/0051875 submitted in the IDS filed 8/4/2022).
As applied to Claim 3, Evans, Clearfield, and El-Absy disclose a metal molybdate comprising a plurality of metal-Mo particulates comprising [Metal-O (and OH)-Mo]-bridges (i.e., Oxo bridges and hydroxo bridges) where the metal in the metal molybdate is a titanium, tin, iron, or cerium and where the average size of the particulates is at least 550 µm.
Evans further discloses the metal-Mo particulate comprising 99Mo (i.e., irradiated molybdenum).
Bloomquist discloses an isotope delivery system comprising titanium molybdate for generating technetium-99m ions where the irradiated titanium molybdate is placed into a transfer cask made of lead, tungsten and or depleted uranium to properly shield the irradiated titanium molybdate from humans (see [0005], [0008], and [0063]). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to place the zirconium-molybdate material as disclosed by Evans and Clearfield into a transfer cask as disclosed by Bloomquist in order to shield users from radiation as suggested by Bloomquist.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Evans, Clearfield, and El-Absy as applied to Claim 3 and in further view of Monroy-Guzman et al (“Titanium Molybdate Gels as Matrix of 99Mo 99MTc Generators” submitted in the IDS filed 8/4/2022).
As applied to Claim 3, Evans, Clearfield, and El-Absy disclose a metal molybdate comprising a plurality of metal-Mo particulates comprising [Metal-O (and OH)-Mo]-bridges (i.e., Oxo bridges and hydroxo bridges) where the metal in the metal molybdate is a titanium, tin, iron, or cerium and where the average size of the particulates is at least 550 µm.
Evans further discloses the metal molybdate packed to form a column in a generator (see Col 5, Ln 23).
Evans does not disclose the elution column having a volume of at least 3 ml.
Monroy-Guzman discloses titanium-molybdate gel disposed in a glass column for the preparation of a 99Mo/99mTc generator where 99mTc elution efficiency of greater than 90% by saline (see Page 13, 2.2 and 2.3 and Table 2). Monroy-Guzman further discloses a 12mm x 70 mm column (i.e., columns having volume of 7.92). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to prepare elution column comprising metal molybdate gel as disclosed by Evans, Clearfield, and El-Absy where the volume of the elution column is 7.92 ml as disclosed by Monroy-Guzman since Monroy-Guzman suggests that the column volume is suitable for generating technetium at high elution efficiency from molybdate gel.
Conclusion
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/MICHAEL FORREST/Primary Examiner, Art Unit 1738