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 .
Status of the Application
Claims 1-30 in the claim set filed on 7/31/2024 are under examination.
Drawings
The drawings are objected to because of the following reasons:
Figure 1A shows a carbon instead of nitrogen on an amide of the modified tyrosine moiety.
Figures 41 (A-B), 44 (B-D), 45 (A-D), and 49 (A-D) show "X" instead of number values.
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.
Specification
The disclosure is objected to because of the following informalities: Figure 12 is missing from the list of figures in the "Brief Description of the Figures".
Appropriate correction is required.
Applicant is warned against the addition of new matter.
The disclosure is objected to because of the following informalities: mislabeled figures: the specification mislabeled figures 13-51. These do not correspond to the described figures in the drawings sheet filed on 11/26/2024.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: The “Brief Description of the Figures refers to Figure 49 . The figure is in grayscale.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: figures on pages 3 and 4 are blurry and difficult to read..
Appropriate correction is required.
Claim Objections
Claims 27 and 30 are objected to because of the following informalities: "an. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
The term “below the detectable limit” in claims 13-16 is a relative term which renders the claim indefinite. The term “below the detectable limit” is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Particularly, .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 1-10 and 13-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann, J. (US 11,129,912 B1; cited in the IDS filed on 10/14/2024) and Lehenberger, S.; et al. (Lehenberger, S.; Barkhausen, C.; Cohrs, S.; Fischer, E.; Grunberg, J.; Hohn, A.; Koster, U.; Schibli, R.; Turler, A.; Zhernosekov, K. The low-energy β- and electron emitter 161Tb as an alternative to 177Lu for targeted radionuclide therapy. 2011, 38, 917-924).
McCann, J. (hereafter referred to as McCann) is drawn to 177Lu-PSMA I&T
radiopharmaceuticals (title; abstract). McCann teaches a 177Lu-PSMA I&T radiopharmaceutical
in high purity possesses extended shelf life and teaches various synthetic methods,
compositions, and treatments comprising 177Lu-PSMA I&T (abstract, lines 3-5).
As to claim 1, McCann teaches a composition comprising 177Lu-PSMA I&T (abstract; col 2, lines 10-12) suitable for administration to a human patient in need thereof for at least 72 hours after formulation (col 10, lines 1-3; col 21, lines 3-5).
McCann does not expressly teach the molar ratio of PSMA I&T to 177Lu.
Lehenberger, S.; et al. (hereafter referred to as Lehenberger) is drawn to targeted radionuclide therapies included 177Lu-DOTATATE (title; abstract; pg 917, col 2, para 2; Table 1) and methods of preparation and affect of molar ratios on radiochemical purity (pg 920; col 2, para 1; pg 922, col 1, Fig 5).
Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 11.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known methods described in McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
As to claim 2, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 3, McCann teaches the composition is suitable for administration to a human patient in need thereof for at least 120 hours after formulation (col 23, lines 31-39; col 23, lines 58-62).
As to claim 4, McCann teaches a radiochemical purity of 95% or greater at administration (col 10, lines 1-3; col 21, lines 3-5).
As to claim 5, McCann teaches a pH range of 4.5-7.0 (col 26, line 52). The claimed range of 3.5-6.0 overlaps with the prior art range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 6, McCann teaches a pH range of 4.5-7.0 (col 26, line 52). The claimed range of 3.5-5.0 overlaps with the prior art range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 7, McCann teaches a pH range of 4.5-7.0 (col 26, line 52). The claimed range of 3.5-4.5 overlaps with the prior art range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 8, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range from 10.0:1.0 to 11.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 9, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range from 9.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 10, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range from 8.0:1.0 to 9.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 13, McCann teaches the composition is free of not more than 0.5% radiochemical impurities (col 30, lines 43-44; col 30, lines 45-48). This means the composition has impurities in the range of 0-0.5%. The claimed range of Fe metal content of less than or equal to 0.05 µg/GBq fully lies within this range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 14, McCann teaches the composition is free of not more than 0.5% radiochemical impurities (col 30, lines 43-44; col 30, lines 45-48). This means the composition has impurities in the range of 0-0.5%. The claimed range of Cu metal content of less than or equal to 0.05 µg/GBq fully lies within this range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 15, McCann teaches the composition is free of not more than 0.5% radiochemical impurities (col 30, lines 43-44; col 30, lines 45-48). This means the composition has impurities in the range of 0-0.5%. The claimed range of Zn metal content of less than or equal to 0.05 µg/GBq fully lies within this range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 16, McCann teaches the composition is free of not more than 0.5% radiochemical impurities (col 30, lines 43-44; col 30, lines 45-48). This means the composition has impurities in the range of 0-0.5%. The claimed range of Pb metal content of less than or equal to 0.05 µg/GBq fully lies within this range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 17, McCann teaches a radiochemical purity of 97.5% or greater up to at least 72 hours after production (col 10, lines 1-3; col 21, lines 3-5).
As to claim 18, McCann teaches a radiochemical purity of 98% or greater up to at least 72 hours after production (col 10, lines 1-3; col 21, lines 3-5).
As to claim 19, McCann teaches 7 or more cycles of treatment (col 24, lines 22-29).
As to claim 20, McCann teaches a solution comprising about 5-120 mg/mL of ascorbic acid (col 9, lines 9-15; col 9, lines 16-42). The claimed range of 10-50 mg/mL of ascorbic acid lies within the prior art range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 21, McCann teaches a solution comprising about 5-120 mg/mL of ascorbic acid (col 9, lines 9-15; col 9, lines 16-42). The claimed range of at least 28 mg/mL of ascorbic acid overlaps with the prior art range. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
As to claim 22, McCann teaches a composition further comprising DTPA (col 23, lines 6-14).
As to claim 23, McCann teaches a radiopharmaceutical kit comprising the composition (col 25, lines 37-57).
As to claim 24, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7).
As to claim 25, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7).
As to claim 26, McCann teaches a composition comprising 177Lu-PSMA I&T (abstract; col 2, lines 10-12) suitable for administration to a human patient in need thereof for at least 72 hours after formulation (col 10, lines 1-3; col 21, lines 3-5).
McCann does not expressly teach the molar ratio of PSMA I&T to 177Lu.
Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.5:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known methods described in McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
As to claim 27, McCann teaches a method of treating a cancer using a radiochemical composition (col 23, lines 24-62) with the method comprising administering a radiochemical composition into a human patient in need thereof (col 23, lines 31-39), where the radiochemical composition comprises 177Lu-PSMA I&T in a solution having a pH of 4.5-7.0 (col 26, line 52). The claimed range for the pH is 3.5 to 6.0 which overlaps with the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Additionally, McCann teaches a radiochemical purity of more than 95% when administered (col 10, lines 1-3; col 21, lines 3-5) and wherein the composition is suitable for administration to a human patient in need thereof for at least 72 hours after formulation (col 10, lines 1-3; col 21, lines 3-5).
McCann does not expressly teach the molar ratio of PSMA I&T to 177Lu.
Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 11.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known methods described in McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
As to claim 28, McCann teaches the cancer is prostate cancer (col 23, lines 24-30).
As to claim 29, McCann teaches the cancer is metastatic castration-resistant prostate cancer (col 23, lines 53-57).
As to claim 30, McCann teaches a method of treating a cancer using a radiochemical composition (col 23, lines 24-62) with a method comprising administering a radiochemical composition into a human patient in need thereof (col 23, lines 31-39) where the 177Lu-PSMA I&T solution has a pH of 4.5-7.0 (col 26, line 52). The claimed pH range of 3.5-6.0 overlaps with the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Additionally, McCann teaches a radiochemical purity of more than 95% when administered (col 10, lines 1-3; col 21, lines 3-5) and wherein the composition is suitable for administration to a human patient in need thereof for at least 72 hours after formulation (col 10, lines 1-3; col 21, lines 3-5).
McCann does not expressly teach the molar ratio of PSMA I&T to 177Lu.
Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known methods described in McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCann and Lehenberger as applied to claims 1-10 and 13-30 above, and further in view of Weineisen, M.; et al. (Weineisen, M.; et al. 68Ga- and 177Lu-Labeled PSMA I&T: Optimization of a PSMA-Targeted Theranostic Concept and First Proof-of-Concept Human Studies. Supplementary Information. J. Nucl. Med., 2015, 56, 1169-1176; cited in the IDS filed on 10/14/2024). The teachings of McCann and Lehenberger as applied in the previous rejections are incorporated in this rejection.
Weineisen, M.; et al (hereafter referred to as Weineisen) is drawn to the materials and methods of making the materials and tabulations of results (title; body of document; supplementary figure 1; supplementary table 1; supplementary table 2).
As to claim 11, McCann teaches a PSMA I&T content (col 29, lines 30-34).
McCann does not expressly teach a PSMA I&T content in terms of weight per dose.
Weineisen teaches 150-200 ug PSMA I&T for a 6-8 GBq formulation (pg 2, para 3, lines 1-2). This gives a ug/GBq range of 18.75-33.3 ug/GBq for dose ranges of McCann suitable for use in human from 1 GBq to 30 GBq, this range gives a ug/dose range of 18.75-999 ug/dose. The claimed range of 30-110 ug/dose PSMA I&T lies fully within this range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods of Weineisen with McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
As to claim 12, McCann teaches a PSMA I&T content (col 29, lines 30-34).
McCann does not expressly teach a PSMA I&T content in terms of weight per dose.
Weineisen teaches 150-200 ug PSMA I&T for a 6-8 GBq formulation (pg 2, para 3, lines 1-2). This gives a ug/GBq range of 18.75-33.3 ug/GBq for dose ranges of McCann suitable for use in human from 1 GBq to 30 GBq, this range gives a ug/dose range of 18.75-999 ug/dose. The claimed range of 40-95 ug/dose PSMA I&T lies fully within this range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods of Weineisen with McCann and Lehenberger, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable.
Nonstatutory 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.
Copending Application No. 18/681,264 and Copending Application No. 18/798,723
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1 and 20 of copending Application No. 18/681,264 in view of
McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Claims 1-30 provisionally rejected on the ground of nonstatutory double patenting as being
unpatentable over claim 1 of copending Application No. 18/798,723 in view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition of 177Lu-PSMA I&T with a molar ratio between 8.0:1.0 to
11.0:1.0 of PSMA I&T to 177Lu, suitable for use in humans, and stable for at least 72 hours and in some
Cases, stability of up to 120 hours, and a pH range between 3.5 and 6.0, and trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, ascorbic acid, DTPA, and method of treating cancers.
Conflicting claims of copending application no. 18/681,264 (hereafter referred to as ‘264) and
copending application no. 18/798,723 (hereafter referred to as ‘723) teach a lanthanide metal chelated to PSMA I&T.
Conflicting claims of ‘264 and ‘723 do not teach stability with a radiochemical purity of 95-99%
or higher up to 120hrs after formulation.
Conflicting claims of ‘264 and ‘723 do not teach molar ratios of 8.0:1.0 to 11.0:1.0 of PSMA I&T to 177Lu.
Conflicting claims of ‘264 and ‘723 do not teach pH ranges 3.5-6.0.
Conflicting claims of ‘264 and ‘723 do not teach trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq.
Conflicting claims of ‘264 and ‘723 do not teach ascorbic acid from 10-50 mg/mL.
Conflicting claims of ‘264 and ‘723 do not teach DTPA.
Confliciting claims of ‘264 and ‘723 do not teach a method of treating cancers.
McCann is drawn to 177Lu-PSMA I&T radiopharmaceuticals (title; abstract). McCann
teaches a 177Lu-PSMA I&T radiopharmaceutical in high purity possesses extended shelf life and
teaches various synthetic methods, compositions, and treatments comprising 177Lu-PSMA I&T
(abstract, lines 3-5).
Regarding stability with a radiochemical purity of 95-99% or higher up to 120hrs after
formulation, McCann teaches a radiochemical purity of 99% or greater for at least 120 hours after
formulation (col 10, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding molar ratios of 1.0:1.0 to 8.0:1.0, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding pH ranges of 3.5-6.0, McCann teaches the composition with a pH from 4.5-7.0 (col
26, lines 52-67). This range overlaps with the claimed range of 3.5-6.0. In such cases where the
claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness
exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05
ug/GBq, McCann teaches the composition is free of not more than 0.5% radiochemical
impurities (col 10, lines 18-22). This means the composition has impurities in the range of 0-
0.5%. The claimed range of 0.05 ug/GBq fully lies within this range. In such cases, where the
claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of
obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding ascorbic acid from 10-50mg/mL, McCann teaches the composition further
comprises about 5-120 mg/mL ascorbic acid (col 9, lines 23-29). The claimed range of 10-
50mg/mL lies fully within this range. In such cases where the claimed ranges "overlap or lie
inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP
2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding DTPA, McCann teaches a composition further comprising DTPA (col 23, lines
10-14).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding prostate cancer, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7) wherein that cancer is a type of prostate cancer is prostate cancer (col 23, lines 24-30).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Copending Application No. 18/791,256 and Copending Application No. 18/791,270
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1, 15, 23-27 of copending Application No. 18/791,256 in view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 1, 15-18, 25-29 of copending Application No. 18/791,270 in view of
McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition of 177Lu-PSMA I&T with a molar ratio between 8.0:1.0 to
11.0:1.0 of PSMA I&T to 177Lu, suitable for use in humans, and stable for at least 72 hours and in some
Cases, stability of up to 120 hours, and a pH range between 3.5 and 6.0, and trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, ascorbic acid, DTPA, and method of treating prostate cancers.
Conflicting claims of copending application no. 18/791,256 (hereafter referred to as ‘256) and
copending application no. 18/791,270 (hereafter referred to as ‘270) teach the composition of 177Lu-
PSMA I&T. And ‘256 teaches a molar ratio of 8.0:1.0 to 11.0:1.0. In this case, the molar ratio ranges overlap. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). And ‘270 teaches a molar ratio of 3.0:1
to 8.0:1.0. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). And ‘256 and ‘270 teach a radiochemical purity of at least 95% for at least 72 hours post production.
The claims of ‘256 and ‘270 do not teach stability up to 120 hours.
The claims of ‘256 and ‘270 do not teach a pH range between 3.5 and 6.0.
The claims of ‘256 and ‘270 do not teach do not teach trace metal impurities of Fe, Cu, Zn, and,
Pb less than or equal to 0.05 ug/GBq.
The claims of ‘256 and ‘270 do not teach ascorbic acid in a range of 10-50mg/mL.
The claims of ‘256 and ‘270 do not teach DTPA.
The claims of ‘256 and ‘270 do not teach a method of treating prostate cancer.
Regarding stability with a radiochemical purity of 95-99% or higher up to 120hrs after
formulation, McCann teaches a radiochemical purity of 99% or greater for at least 120 hours after formulation (col 10, lines 1-3).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding pH ranges of 3.5-6.0, McCann teaches the composition with a pH from 4.5-7.0 (col
26, lines 52-67). This range overlaps with the claimed range of 3.5-6.0. In such cases, where the
claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness
exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, McCann teaches the composition is free of not more than 0.5% radiochemical impurities (col 10, lines 18-22). This means the composition has impurities in the range of 0-0.5%. The claimed range of 0.05 ug/GBq fully lies within this range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding ascorbic acid from 10-50mg/mL, McCann teaches the composition further comprises about 5-120 mg/mL ascorbic acid (col 9, lines 23-29). The claimed range of 10-50mg/mL lies fully within this range. In such cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding DTPA, McCann teaches a composition further comprising DTPA (col 23, lines
10-14).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding prostate cancer, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7) wherein that cancer is a type of prostate cancer is prostate cancer (col 23, lines 24-30).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Copending Application No. 18/228,510 and Copending Application No. 18/354,581
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claim 1, 7, 35, 39, 44, and 45 of copending Application No. 18/228,510 in
view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10-11, 13, 17-22, 28-30 of copending Application No. 18/354,581 in view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition of 177Lu-PSMA I&T with a molar ratio between 8.0:1.0 to
11.0:1.0 of PSMA I&T to 177Lu, suitable for use in humans, and stable for at least 72 hours and in some
Cases, stability of up to 120 hours, and a pH range between 3.5 and 6.0, and trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, ascorbic acid, DTPA, and method of treating prostate cancers.
Conflicting claims of copending application no. 18/228,510 (hereafter referred to as ‘510) and
copending application no. 18/354,581 (hereafter referred to as ‘581) teach lanthanide PSMA I&T
compositions for use in humans with pH ranges for ‘510 from 3.5-4.2 and for ‘581 from 5.5-7.5. In the
case of ‘510, a prima facie case of obviousness exists where the claimed ranges or amounts do not
overlap with the prior art but are merely close. See MPEP 2144.05(I). In the case of ‘581, the
claimed ranges "overlap or lie inside ranges disclosed by the prior art", so a prima facie case of
obviousness exists. See MPEP 2144.05(I). ‘510 and ‘581 teach ascorbic acid. ‘510 teaches a
radiochemical purity of at least 95% for at least 90 hours and ‘581 teaches a radiochemical purity of at
least 96%.
The conflicting claims of ‘510 and ‘581 do not teach molar ratios of 1.0:1.0 to 8.0:1.0 of PSMA
I&T to 177Lu.
The conflicting claims of ‘510 and ‘581 do not teach trace metal impurities.
The conflicting claims of ‘510 and ‘581 do not teach ascorbic acid.
The conflicting claims of ‘510 and ‘581 do not teach DTPA.
Regarding molar ratios of 8.0:1.0 to 11.0:1.0, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05
ug/GBq, McCann teaches the composition is free of not more than 0.5% radiochemical
impurities (col 10, lines 18-22). This means the composition has impurities in the range of 0-0.5%. The claimed range of 0.05 ug/GBq fully lies within this range. In such cases where the
claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of
obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding ascorbic acid from 10-50mg/mL, McCann teaches the composition further
comprises about 5-120 mg/mL ascorbic acid (col 9, lines 23-29). The claimed range of 10-
50mg/mL lies fully within this range. In such cases where the claimed ranges "overlap or lie
inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP
2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding DTPA, McCann teaches a composition further comprising DTPA (col 23, lines
10-14).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding prostate cancer, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7) wherein that cancer is a type of prostate cancer is prostate cancer (col 23, lines 24-30).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Copending Application No. 19/251,254
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-2 and 5-6 of copending Application No. 19/251,254 in view of
McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection.
Instant claims require a composition of 177Lu-PSMA I&T with a molar ratio between 8.0:1.0 to
11.0:1.0 of PSMA I&T to 177Lu, suitable for use in humans, and stable for at least 72 hours and in some
Cases, stability of up to 120 hours, and a pH range between 3.5 and 6.0, and trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, ascorbic acid, DTPA, and method of treating prostate cancers.
Conflicting claims of copending application no. 19/251,254 (hereafter referred to as ‘254)
teaches a 177Lu composition with ascorbic acid, a radiochemical purity of 95% or higher up to 7 days
after formulation, and DTPA.
Conflicting claims of ‘254 do not teach PSMA I&T.
Conflicting claims of ‘254 do not teach molar ranges of PSMA I&T to 177Lu.
Conflicting claims of ‘254 do not teach pH ranges.
Conflicting claims of ‘254 do not teach trace metal impurities.
Conflicting claims of ‘254 do not teach ascorbic acid.
Conflicting claims of ‘254 do not teach a method of treating prostate cancer.
Regarding the composition of 177Lu PSMA I&T, McCann teaches the composition (col 2, line 2).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding molar ratios of 8.0:1.0 to 11.0:1.0, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Regarding pH ranges of 3.5-6.0, McCann teaches the composition with a pH from 4.5-7.0 (col
26, lines 52-67). This range overlaps with the claimed range of 3.5-6.0. In such cases where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness
exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05
ug/GBq, McCann teaches the composition is free of not more than 0.5% radiochemical
impurities (col 10, lines 18-22). This means the composition has impurities in the range of 0-
0.5%. The claimed range of 0.05 ug/GBq fully lies within this range. In such cases where the
claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of
obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding ascorbic acid from 10-50mg/mL, McCann teaches the composition further
comprises about 5-120 mg/mL ascorbic acid (col 9, lines 23-29). The claimed range of 10-
50mg/mL lies fully within this range. In such cases where the claimed ranges "overlap or lie
inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP
2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Regarding prostate cancer, McCann teaches a method of treating cancer in a human patient in need thereof by administering the composition to the human patient (col 11, lines 22-39; col 23, lines 24-62; col 30, lines 4-7) wherein that cancer is a type of prostate cancer is prostate cancer (col 23, lines 24-30).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the
combination were predictable. See MPEP 2143(I)(A).
Copending Application No. 19/204,235 and 19/063,049
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 9, 11-14, 16-20 of copending Application No. 19/204,235 in view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct
claims have not in fact been patented.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-24 of copending Application No. 19/063,049 in view of McCann, Lehenberger, and Weineisen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct
claims have not in fact been patented.
Instant claims are drawn to a composition of 177Lu-PSMA I&T with a molar ratio between 8.0:1.0 to 11.0:1.0 of PSMA I&T to 177Lu, suitable for use in humans, and stable for at least 72 hours and in some cases, stability of up to 120 hours, and a pH range between 3.5 and 6.0, and trace metal impurities of Fe, Cu, Zn, and, Pb less than or equal to 0.05 ug/GBq, ascorbic acid, DTPA, and method of treating prostate cancers.
Conflicting claims teach the composition of 177Lu-PSMA I&T with a radiochemical purity
of 95% for up to 120 hours after formulation and a molar ratio range of PSMA I&T to 177Lu for ‘235 from 1.0:1.0 to 5.0:1.0 and for ‘049 from 1.0:1.0 to 8.0:1.0 a pH range from 3.5 to 6.0, DTPA, ascorbic acid, 7 or more cycles of administration in a human, and trace metal impurities of Fe, Cu, Zn, and Pb at or below 0.05 ug/GBq. With respect to pH ranges, in cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP
2144.05(I).
The conflicting claims of ‘235 and ‘049 do not expressly teach the molar ratio range of greater than 8.0:1.0 to 11.0:1.0.
Regarding molar ratios of 8.0:1.0 to 11.0:1.0, Lehenberger teaches a molar ratio of 4:1 to 19:1 of the chelating ligand to 177Lu (pg 922, col 1, Fig 5). The claimed range of greater than 8.0:1.0 to 10.0:1.0 lies fully within the prior art range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
A person of ordinary skill in the art could have combined the elements as claimed by known
methods, and that in combination, each element merely performs the same function as it does
separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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