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 1-14, 23-32) and Species 3 (claims 6-9, 27-29) in the reply filed on 4/15/2026 is acknowledged.
Claims 4-5, 10-22, 25-26 and 30-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/15/2026.
Claims 1-3, 6-9, 23-24 and 27-29 are examined in this office action.
Claim Objections
Applicant is advised that should claims 6, 7 and 8 be found allowable, claims 27, 28 and 29 respectively will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 8 and 29 are rejected under 35 U.S.C. 112(b) 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.
Recitation of “Ra+2” in line 1 of claims 8 and 29 lacks a positive antecedent basis. For examination purpose, claims 8 and 29 are assumed to be dependent on claim 7 which recites “Ra+2”.
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.
(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.
Claims 1-3, 6-9, 23-24 and 27-29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2024/0239686 A1 to Harvey et al. (hereinafter “Harvey”).
As per claim 1, Harvey discloses a method for eluting a desired activity concentration of radionuclide activity of a desired daughter radionuclide-containing aqueous eluate that comprises the steps of:
contacting separation particles with an aqueous solution that comprises a mixture of a mother radionuclide and a desired daughter radionuclide, and wherein the desired daughter radionuclide has a high affinity for and binds to the separation particles and the mother radionuclide has a low affinity for and does not bind to the separation particles to form a dispersion containing at least water, the separation particles, the desired daughter radionuclide, the separation particles bound to the desired daughter radionuclide, and a unbound mother radionuclide;
maintaining that contact for a time period sufficient for unbound desired daughter radionuclide to bind to the separation particles;
separating the unbound mother radionuclide from the desired daughter radionuclide-bound separation particles using a washing solution;
stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity; and
retaining a second fractional amount of the desired daughter radionuclide in the separation particles (see paragraphs [0022], [0032]).
As per claim 2, Harvey discloses the method according to claim 1, and Harvey further discloses wherein the desired daughter radionuclide is Tc99m present as TcO4 −1 or Re188 present as ReO4 −1 (see paragraphs [0023], [0033]).
As per claim 3, Harvey discloses the method according to claim 2, and Harvey further discloses wherein the separation particles comprise particles having a plurality of covalently bonded —X—(CH2CH2O)n—CH2CH2R groups, wherein X is O, S, NH or N—(CH2CH2O)m—R3, where m is a number having an average value of zero to about 225, n is a number having an average value of about 15 to about 225, R3 is hydrogen, C1-C2 alkyl, 2-hydroxyethyl or CH2CH2R, and R is selected from the group consisting of −OH, C1-C10 hydrocarbyl ether having a molecular weight up to about one-tenth that of the —(CH2CH2O)n-portion, carboxylate, sulfonate, phosphonate and —NR1R2 groups where each of R1 and R2 is independently hydrogen, C2-C3 hydroxyalkyl or C1-C6 alkyl, or —NR1R2 together form a 5- or 6-membered cyclic amine having zero or one oxygen atom or zero or one additional nitrogen atom in the ring, said separation particles having a percent CH2O/mm2 of particle surface area of greater than about 8,000 and less than about 1,000,000 (see paragraph [0024]).
As per claims 6 and 27, Harvey discloses the method according to claim 1, and Harvey further discloses wherein the desired daughter radionuclide is Ac225 present as Ac+3 (see paragraphs [0025], [0036]).
As per claims 7 and 28, Harvey discloses the method according to claim 6, and Harvey further discloses wherein the mother radionuclide for the desired daughter radionuclide Ac225 is present as Ra+2 (see paragraphs [0026], [0037]).
As per claims 8 and 29, Harvey discloses the method according to claim 6, and Harvey further discloses wherein the Ra+2 is one or both of Ra225 and Ra226 (see paragraphs [0027], [0038]).
As per claim 9, Harvey discloses the method according to claim 6, and Harvey further discloses wherein the separation particles comprise a diglycolamide extractant corresponding in structure to Formula I, below:
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dispersed onto a porous inert resin or silica support, and wherein R1, R2, R3 and R4 are the same or different and are hydro or hydrocarbyl groups such that the sum of carbon atoms of R1+R2+R3+R4 is about 14 to about 56 (see paragraphs [0028]-[0029]).
As per claim 23, Harvey discloses a method for enhancing the radionuclide activity of a desired daughter radionuclide-containing aqueous eluate separated from an aqueous composition containing a mother radionuclide and a daughter radionuclide in which said aqueous composition is 1) contacted with a separation medium in which said desired daughter radionuclide has a high affinity for and binds to said separation medium and said mother radionuclide has a low affinity for and does not bind to said separation medium to form a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide 2) that contact is maintained for a time period sufficient for unbound desired daughter radionuclide to bind to the separation medium, 3) the unbound mother radionuclide is separated from the desired daughter radionuclide-bound separation medium formed in step 2) using a washing solution, and 4) the bound desired daughter radionuclide is stripped from the separation medium using a volume of stripping solution to form an aqueous eluate;
wherein the improvement comprises stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity, such that a second fractional amount of the desired daughter radionuclide is retained in the separation particles, thereby enhancing the desired daughter radionuclide activity in subsequent elutions than if a fractional amount of the desired daughter radionuclide was not retained in the separation particles (see paragraphs [0022], [0032]).
As per claim 24, Harvey discloses the method according to claim 23, and Harvey further discloses wherein the desired daughter radionuclide is Tc99m present as TcO4 −1 or Re188 present as ReO4 −1 (see paragraphs [0023], [0033]).
Claims 1-3 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,603,834 to Rogers, et al. (hereinafter "Rogers").
As per claim 1, Rogers discloses a method for eluting a desired activity concentration of radionuclide activity of a desired daughter radionuclide-containing aqueous eluate (the precursor for the preferred technetium isotope Tc99m or TcO4 −1, i.e., the daughter isotope, is Mo4 −2, i.e., the parent isotope, a process of recovery of TcO4 −1 ions from an aqueous solution containing TcO4 −1 and Mo4 −2ions, as shown in figure 4, different weight distribution ratios of TcO4 −1 ions were achieved using different salts at different concentrations, the applicants do not disclose specific value of the desired activity of the radionuclide; figure 4; column 7, lines 10-67; column 13, lines 55-60; column 21, lines 1-15) that comprises the steps of:
contacting separation particles with an aqueous solution that comprises a mixture of a mother radionuclide and a desired daughter radionuclide, and wherein the desired daughter radionuclide has a high affinity for and binds to the separation particles and the mother radionuclide has a low affinity for and does not bind to the separation particles (the precursor for the preferred technetium isotope Tc99m, i.e., the daughter isotope, is Mo4 −2, i.e., the parent or mother isotope, the process comprises contacting separation particles with "an aqueous solution containing TcO4 −1 ions and Mo4 −2 ions and a dissolved salt, the contact is maintained for a time period sufficient to form TcO4 −1 ion-bound separation particles and an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., where the separation particles that bind TcO4 −1 ions and do not bind Mo4 −2 ions are expected to have higher affinity for daughter TcO4 −1 ions and low affinity for the parent Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60) to form a dispersion containing at least water, the separation particles, the desired daughter radionuclide, the separation particles bound to the desired daughter radionuclide, and a unbound mother radionuclide (contacting separation particles with an aqueous solution containing TcO4 −1 ions and Mo4 −2 ions to form TcO4 −1 ion-bound separation particles and an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., dispersion of the particles and aqueous or water solution comprising daughter TcO4 −1 ion-bound particles and aqueous solution of unbound Mo4 −2; column 7, lines 10-67; column 13, lines 55-60);
maintaining that contact for a time period sufficient for unbound desired daughter radionuclide to bind to the separation particles (the contact is maintained for a time period sufficient to form TcO4 −1 ion-bound separation particles and an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., where the separation particles that bind TcO4 −1 ions and do not bind Mo4 −2 ions are expected to have higher affinity for daughter TcO4 −1 ions and low affinity for the parent Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60);
separating the unbound mother radionuclide from the desired daughter radionuclide-bound separation particles using a washing solution (the TcO4 −1 ion-bound separation particles are then preferably separated from the aqueous solution containing Mo4 −2 ions in the presence of an aqueous solution, i.e., the washing solution; column 7, lines 10-67; column 13, lines 55-60);
stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity (the TcO4 −1 ion-bound separation particles are contacted with a second aqueous solution, i.e., the stripping solution, to free the TcO4 −1 ions from the separation particles and form an aqueous solution containing free TcO4 −1 ions, as shown in figure 4, different weight distribution ratios of TcO4 −1 ions were achieved using different salts at different concentrations, the applicants do not disclose specific value of the desired activity of the radionuclide; figure 4; column 7, lines 10-67; column 13, lines 55-60; column 21, lines 1-15); and
retaining a second fractional amount of the desired daughter radionuclide in the separation particles (the TcO4 −1 ion-bound particles are contacted with a second solution to free the TcO4 −1 ions from the particles, and further, 33 free column volumes (fcv) of water were passed into the column over the resin to remove the Na99mTcO4, find 91 percent of the Tc99m was recovered in five fcv, i.e., where about 9 percent of Tc99m retained on the particles after washing with 5 fcv, and was later recovered by washing with additional 28 volumes, the applicants do not disclose the value of the desired amount of radionuclide to be retained on the particles; column 7, lines 10-67; column 26, lines 40-55).
As per claim 2, Rogers discloses the method according to claim 1, and Rogers further discloses wherein the desired daughter radionuclide is Tc99m present as TcO4 −1 (the precursor for the preferred technetium isotope 99mTc, i.e., the daughter isotope, is 99Mo, i.e., the parent isotope, a process of recovery of TcO4 −1 ions from an aqueous solution containing TcO4 −1 and Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60; column 21, lines 1-15).
As per claim 3, Rogers discloses the method according to claim 1, and Rogers further discloses wherein the separation particles comprise particles having a plurality of covalently bonded —X—(CH2CH2O)n—CH2CH2R groups, wherein X is O, S, NH or N—(CH2CH2O)m—R3, where m is a number having an average value of zero to about 225, n is a number having an average value of about 15 to about 225, R3 is hydrogen, C1-C2 alkyl, 2-hydroxyethyl or CH2CH2R, and R is selected from the group consisting of -OH, C1-C10 hydrocarbyl ether having a molecular weight up to about one-tenth that of the —(CH2CH2O)n-portion, carboxylate, sulfonate, phosphonate and —NR1R2 groups where each of R1 and R2 is independently hydrogen, C2-C3 hydroxyalkyl or C1-C6 alkyl, or —NR1R2 together form a 5- or 6-membered cyclic amine having zero or one oxygen atom or zero or one additional nitrogen atom in the ring, said separation particles having a percent CH2O/mm2 of particle surface area of greater than about 8,000 and less than about 1,000,000 (see column 7, lines 25-42)
As per claim 23, Rogers discloses a method for enhancing the radionuclide activity of a desired daughter radionuclide-containing aqueous eluate separated from an aqueous composition containing a mother radionuclide and a daughter radionuclide (the precursor for the preferred technetium isotope Tc99m, i.e., the daughter isotope, is Mo4 −2, i.e., the parent isotope, and further, in solution a relatively large quantity of non-radioactive molybdenum 98Mo and relatively low concentration of radionuclides Tc99m is present, a process of recovery of TcO4 −1 ions from an aqueous solution containing TcO4 −1 and Mo4 −2 ions, i.e., enrichment or enhancement of the solution with radioactive 99mTc, the applicants do not disclose specific value of enrichment or enhancement of the radionuclide; figure 4; column 7, lines 10-67; column 13, lines 55-60; column 14, lines 1-10; column 21, lines 1-15) in which said aqueous composition is
1) contacted with a separation medium in which said desired daughter radionuclide has a high affinity for and binds to said separation medium and said mother radionuclide has a low affinity for and does not bind to said separation medium (the precursor for the preferred technetium isotope Tc99m i.e., the daughter isotope, is Mo4 −2, i.e., the parent or mother isotope, the process comprises contacting separation particles with an aqueous solution containing TcO4 −1 ions and Mo4 −2 ions and a dissolved salt, the contact is maintained for a time period sufficient to form TcO4 −1 ion-bound separation particles and an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., where the separation particles that bind TcO4 −1 ions and do not bind Mo4 −2 ions are expected to have higher affinity for daughter TcO4 −1 ions and low affinity for the parent Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60) to form a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide (contacting separation particles with an aqueous solution containing TcO4 −1 ions and Mo4 −2 ions to form TcO4 −1 ion-bound separation particles and an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., dispersion of the particles and aqueous or water solution comprising daughter TcO4 −1 ion-bound particles and aqueous solution of unbound Mo4 −2; column 7, lines 10-67; column 13, lines 55-60)
2) that contact is maintained for a time period sufficient for unbound desired daughter radionuclide to bind to the separation medium (the contact is maintained for a time period sufficient to form TcO4 −1 ion-bound separation particles anti an aqueous solution containing Mo4 −2 ions or unbound parent radionuclide, i.e., where the separation particles that bind TcO4 −1 ions and do not bind Mo4 −2 ions are expected to have higher affinity for daughter TcO4 −1 ions and low affinity for the parent Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60),
3) the unbound mother radionuclide is separated from the desired daughter radionuclide-bound separation medium formed in step 2) using a washing solution (the TcO4 −1 ion-bound separation particles are then preferably separated from the aqueous solution containing Mo4 −2 ions in the presence of an aqueous solution, i.e., the washing solution; column 7, lines 10-67; column 13, lines 55-60), and
4) the bound desired daughter radionuclide is stripped from the separation medium using a volume of stripping solution to form an aqueous eluate (the TcO4 −1 ion-bound separation particles are contacted with a second aqueous solution, i.e., the stripping solution, to free the TcO4 −1 ions from the separation particles and form an aqueous solution containing free TcO4 −1 ions, as shown in figure 4, different weight distribution ratios of TcO4 −1 ions were achieved using different salts at different concentrations, the applicants do not disclose specific value of the desired activity of the radionuclide; figure 4; column 7, lines 10-67; column 13, lines 55-60; column 21, lines 1-15);
wherein the improvement comprises stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity, such that a second fractional amount of the desired daughter radionuclide is retained in the separation particles (the TcO4 −1 ion-bound particles are contacted with a second solution to free the TcO4 −1 ions from the particles, and further, 33 free column volumes (fcv) of water were passed into the column over the resin to remove the Na99mTcO4, and 91 percent of the Tc99m was recovered in five fcv, i.e., the first fractional amount of the daughter radionuclide, and where about 9 percent of Tc99m retained on the particles after washing with 5 fcv, and was recovered in additional 28 volumes, i.e., the second fractional amount of the daughter radionuclide, the applicants do not disclose the value of the desired amount of radionuclide to be retained on the particles; column 7, lines 10-67; column 26, lines 40-55), thereby enhancing the desired daughter radionuclide activity (in solution a relatively large quantity of non-radioactive molybdenum 98Mo arid relatively low concentration of radionuclides Tc99m is present; a process of recovery of TcO4 −1 ions from an aqueous solution containing TcO4 −1 and Mo4 −2 ions, i.e., enrichment or enhancement of the solution with radioactive Tc99m, the applicants do not disclose specific value of enrichment or enhancement of the radionuclide; column 13, lines 55-60; column 14, lines 1-10) in subsequent elutions than if a fractional amount of the desired daughter radionuclide was not retained in the separation particles (33 free column volumes (fcv) of water were passed into the column over the resin to remove the Na99mTcO4, and 91 percent of the Tc99m was recovered in five fcv, i.e., where about 9 percent of Tc99m retained on the particles after washing with 5 fcv was recovered in additional 28 volumes, and was not retained in the separation particles; column 7, lines 10-67; column 26, lines 40-55).
As per claim 24, Rogers discloses the method according to claim 23, and Rogers further discloses wherein the desired daughter radionuclide is Tc99m present as TcO4 −1 (the precursor for the preferred technetium isotope 99mTc, i.e., the daughter isotope, is Mo4 −2, i.e., the parent isotope, a process of recovery of TcO4 −1 ions from an aqueous solution containing TcO4 −1 and Mo4 −2 ions; column 7, lines 10-67; column 13, lines 55-60; column 21, lines 1-15).
Claims 1, 6-9, 23 and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 7,157,022 B2 to Horwitz et al. (hereinafter “Horwitz”).
As per claim 1, Horwitz discloses a method for eluting a desired activity concentration of radionuclide activity of a desired daughter radionuclide-containing aqueous eluate that comprises the steps of:
contacting separation particles with an aqueous solution that comprises a mixture of a mother radionuclide and a desired daughter radionuclide, and wherein the desired daughter radionuclide has a high affinity for and binds to the separation particles and the mother radionuclide has a low affinity for and does not bind to the separation particles to form a dispersion containing at least water, the separation particles, the desired daughter radionuclide, the separation particles bound to the desired daughter radionuclide, and a unbound mother radionuclide (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9);
maintaining that contact for a time period sufficient for unbound desired daughter radionuclide to bind to the separation particles (see col. 3, line 58 – col. 4, line 48; col. 6, lines 9-14; col. 12, lines 22-28);
separating the unbound mother radionuclide from the desired daughter radionuclide-bound separation particles using a washing solution (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “Over 90% of the Ra(II) is eluted through the first bed volume of rinse”);
stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “Stripping the N,N,N’,N’-tetra-n-octyl-DGA resin with 0.10 M HCl removes 96% of the Ac(III) in just five volumes); and
retaining a second fractional amount of the desired daughter radionuclide in the separation particles (EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “The stripping peak in FIG. 11 shows a maximum decontamination factor (DF) of Ac(III) from Ra(II) of more than 102, although more extensive rinsing is likely to increase the DF to more than 104” ).
As per claims 6 and 27, Horwitz discloses the method according to claim 1, and Horwitz further discloses wherein the desired daughter radionuclide is Ac225 present as Ac+3 (see col. 12, lines 22-23).
As per claims 7 and 28, Horwitz discloses the method according to claim 6, and Horwitz further discloses wherein the mother radionuclide for the desired daughter radionuclide Ac225 is present as Ra+2 (see col. 12, lines 22-28).
As per claims 8 and 29, Horwitz discloses the method according to claim 6, and Horwitz further discloses wherein the Ra+2 is one or both of Ra225 and Ra226 (see col. 12, lines 22-28).
As per claim 9, Horwitz discloses the method according to claim 6, and Horwitz further discloses wherein the separation particles comprise a diglycolamide extractant corresponding in structure to Formula I, below:
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dispersed onto a porous inert resin or silica support, and wherein R1, R2, R3 and R4 are the same or different and are hydro or hydrocarbyl groups such that the sum of carbon atoms of R1+R2+R3+R4 is about 14 to about 56 (see col. 6, lines 44-67; col. 7, lines 17-32).
As per claim 23, Horwitz discloses a method for enhancing the radionuclide activity of a desired daughter radionuclide-containing aqueous eluate separated from an aqueous composition containing a mother radionuclide and a daughter radionuclide in which said aqueous composition is
1) contacted with a separation medium in which said desired daughter radionuclide has a high affinity for and binds to said separation medium and said mother radionuclide has a low affinity for and does not bind to said separation medium to form a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9);
2) that contact is maintained for a time period sufficient for unbound desired daughter radionuclide to bind to the separation medium (see col. 3, line 58 – col. 4, line 48; col. 6, lines 9-14; col. 12, lines 22-28);
3) the unbound mother radionuclide is separated from the desired daughter radionuclide-bound separation medium formed in step 2) using a washing solution (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “Over 90% of the Ra(II) is eluted through the first bed volume of rinse”); and
4) the bound desired daughter radionuclide is stripped from the separation medium using a volume of stripping solution to form an aqueous eluate (see EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “Stripping the N,N,N’,N’-tetra-n-octyl-DGA resin with 0.10 M HCl removes 96% of the Ac(III) in just five volumes);
wherein the improvement comprises stripping a first fractional amount of the bound desired daughter radionuclide from the separation particles using a volume of stripping solution to form the aqueous eluate solution having a desired daughter radionuclide activity, such that a second fractional amount of the desired daughter radionuclide is retained in the separation particles, thereby enhancing the desired daughter radionuclide activity in subsequent elutions than if a fractional amount of the desired daughter radionuclide was not retained in the separation particles (EXAMPLE 6: Separation of Ac(III) and Ra(II) in col. 9: “The stripping peak in FIG. 11 shows a maximum decontamination factor (DF) of Ac(III) from Ra(II) of more than 102, although more extensive rinsing is likely to increase the DF to more than 104” ).
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 1-3, 6-9, 23-24 and 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-9 and 13-14 of copending Application No. 18/513381. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 6-9 and 13-14 of copending Application No. 18/513381 anticipate claims 1-3, 6-9, 23-24 and 27-29 of the instant application.
See claim comparison table below.
Claims of
Application No. 18/513220
Claims of
Application No. 18/513381
Comparison
1
1
Narrow claim 1 anticipates broad instant claim 1 and contains all the limitation of claim 1.
2
2/1
Narrow claim 2/1 anticipates broad instant claim 2 and contains all the limitation of claim 2.
3
3/1
Narrow claim 3/1 anticipates broad instant claim 3 and contains all the limitation of claim 3.
6
6/1
Narrow claim 6/1 anticipates broad instant claim 6 and contains all the limitation of claim 6.
7
7/1
Narrow claim 7/1 anticipates broad instant claim 7 and contains all the limitation of claim 7.
8
8/1
Narrow claim 8/1 anticipates broad instant claim 8 and contains all the limitation of claim 8.
9
9/1
Narrow claim 9/1 anticipates broad instant claim 9 and contains all the limitation of claim 9.
23
13
Narrow claim 13 anticipates broad instant claim 23 and contains all the limitation of claim 23.
24
14/13
Narrow claim 14/13 anticipates broad instant claim 24 and contains all the limitation of claim 24.
27
6/1
Narrow claim 6/1 anticipates broad instant claim 27 and contains all the limitation of claim 27.
28
7/1
Narrow claim 7/1 anticipates broad instant claim 28 and contains all the limitation of claim 28.
29
8/1
Narrow claim 8/1 anticipates broad instant claim 29 and contains all the limitation of claim 29.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
5/20/26
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