DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicants’ election of the combination of Copper Cu-64 PSMA I&T, gentisic acid and sodium acetate in the reply filed on July 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities: the phrase “Cu-64 PSMA I&T” is used throughout the specification and what the abbreviations in this phrase stand for is not spelled out anywhere in the disclosure as originally filed.
Appropriate correction is required.
Claim Objections
Claims 1 – 10 and 22 – 30 are objected to because of the following informalities: the phrase the phrase “Copper Cu-64 PSMA I&T” is used throughout the claims and what the abbreviations in this phrase stand for is not spelled out the first time it is used in the claims. “Copper Cu-64” also appears duplicative as Cu is the two-letter abbreviation for copper. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the abbreviation "EOS” is used in the claims and what this stands for is never spelled out in the claims.. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The scope of the claimed compositions is not clear since part (a) of claim recites about 1 mCi to about 15 mCi per unit at the time of dose, which reflects the radioactivity present in the claimed composition. The phrasing “per unit” could imply that this applies to only a portion of the composition if the unit does not equal the entire composition but nowhere in the claims or specification is unit or unit dose defined to make this clear as to the meaning of this phrase.
Claim 1 concludes with the limitation “the radioactivity concentration of the radiopharmaceutical composition is from about 1 mCi to about 36 mCi” (emphasis added). Curies or millicuries refer to the number of disintegrations per second which is not a concentration so the use of “radioactivity concentration” is not understood.
The actual numerical values recited have the same units but different numerical values that those recited in part (a) of claim 1. How these two different ranges in the same claim with the same units relate to one another and how the concentration recited at the end of the claim is in fact a concentration is not understood and the scope of the claimed compositions cannot be determined.
The dependent claims fall therewith.
Please clarify.
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 – 10 and 22 -3 0 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) in view of Chen et al. (US 2011/0206606).
Lee et al. discloses PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging through in vitro and in vivo studies (whole document, e.g., abstract). Positron emission tomography (PET) imaging using 64Cu is promising rather than 68Ga because of its relatively long half-life (12.7 h) and economic production by cyclotron (¶ bridging p 417 and 418).
Lee et al. does not disclose the presence of gentisic acid and sodium acetate.
Chen et al. discloses stabilized radiopharmaceutical formulations with stabilizers that improve the radiostability of radiotherapeutic and radiodiagnostic compounds such as targeted compounds such as the gastrin releasing peptide receptor (whole document, e.g., abstract). Many stabilizers have been identified that, alone or in combination, inhibit radiolytic damage to radiolabeled compounds (¶ [0022]). The radionuclide in the stabilized formulations can be 64Cu (e.g., claim 23) and the stabilizer can be gentisic acid or a pharmaceutically acceptable salt thereof (e.g., claim 25) such as sodium gentistate (¶ [0154]). In a preferred embodiment, 2 – 20 mg/mL gentisic acid is used (¶ [0151]). A physiologically acceptable buffer or salt solution at a pH of about 4.5 to about 8.5 with acetate being a preferred buffer at a molarity of 0.02 M to about 0.2 M (¶¶ [0022] and [0023]). When sodium acetate is used for the conversion, this converts to 1.64 – 16.40 mg/mL. The amount of labeled conjugate appropriate for administration is dependent upon the distribution profile of the chosen conjugate in the sense that a rapidly cleared conjugate may need to be administered in higher doses than one that clears less rapidly (¶ [0130]). For the 177Lu complexes, solutions with about 0.01 to about 100 mCi per mL are preferred with the unit dose to be administered having about 0.01 mCi to about 100 mCi although narrower ranges are also disclosed (¶ [0130]). Solutions that contain the radiostabilizers of the invention are expected to have long post-reconstitution stability, so the presence of a bacteriostat is critical in order to maintain sterility (¶ [0023]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and a buffer such as acetate with the 64Cu-PMSA I&T disclosed by Lee et al. to prepare a stabilized formulation of the radiolabeled construct. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Chen et al. discloses that radiostabilizers such gentisic acid or salts such as sodium gentisate can increase the stability of radiolabeled targeting ligands. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of the prior art are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
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 – 10 and 22 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4 and 6 of U.S. Patent No. 11,129,912 in view of Weineisen et al. (J Nucl Med, 2015), Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606).
The claims of US’912 recite a method that results in the production of 177Lu-labeled EuK-Sub-kf-iodo-y-DOTAGA in a process that does not include the presence of a gentisate compounds (claim 1). However, the claims do not exclude the presence of such ingredients after the material is prepared.
That the compound is PSMA I&T labeled with 64Cu is not claimed.
Weineisen et al. discloses that the compound of the claims of US’912 is that of the first generation tracer shown in Figure 1 with PSMA I&T being a third generation tracer. As shown in Table 1, the PSMA I&T exhibited lower IC50 values than the compounds of US’912 and can be labeled with either 68Ga or 177Lu.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use PSMA I&T rather than the compound of US’912 given the lower IC50 values disclosed by Weineisen et al. and to label with 64Cu as taught by Lee et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because of the improved affinity for PSMA I&T compared to that of US’912 and the better kinetics for 64Cu disclosed by Lee et al.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and a buffer such as acetate with the 64Cu-PMSA I&T to prepare a stabilized formulation of the radiolabeled construct. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Chen et al. discloses that radiostabilizers such gentisic acid or salts such as sodium gentisate can increase the stability of radiolabeled targeting ligands. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’912 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Claims 1 – 10 and 22 – 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of U.S. Patent No. 12,324,846 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606).
The claims of US’846 recite administering to a subject 177Lu-PSMA I&T with a particular ratio of the radioisotope to the PSMA I&T and radiochemical purity for at least 72 hours after manufacture and limitations on the absorbed dose to the kidneys (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’846 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’946 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8, 11, 35 – 40 and 44 - 48 of copending Application No. 18/228,510 in view of Lee et al. (Cancer Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’510 recite a composition containing 177Lu-PSMA I&T and ascorbic acid that is suitable for administration to a patient (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’510 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’510 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 28 of copending Application No. 18/791,256 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’256 recite a method in which a composition containing 177Lu-PSMA I&T with a particular ratio of the radioisotope to the PSMA I&T and radiochemical purity for at least 72 hours after manufacture and limitations on the absorbed dose to the kidneys is administered to a subject (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’256 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’256 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 5 – 25 and 31 – 34 of copending Application No. 18/791,288 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’288 recite a composition containing 177Lu-PSMA I&T with a particular molar ratio of ingredients and radiochemical purity suitable for administration to a subject (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’288 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’288 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 25 of copending Application No. 18/791,300 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’300 recite a composition comprising 177Lu-PSMA I&T with a particular molar ratio of ingredients suitable for administration to a subject (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’300 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’300 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 25 of copending Application No. 18/798,723 in view of Chen et al. (US 2011/0206606). The claims of US’723 recite a method of detecting prostate cancer in a subject by administering a composition comprising about 5 mCi to about 9 mCi of a Cu-64 PSMA I&T composition and imaging the patient.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’723 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 19/063,049 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’049 recite a composition of 177Lu-PSMA I&T with a particular molar ratio of ingredients with a particular ratio of the radioisotope to the PSMA I&T, pH and iron metal content suitable for administration to a patient (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’049 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’049 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims1 - 30 of copending Application No. 19/198,962 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’962 recite a composition containing 177Lu-PSMA I&T with a particular molar ratio of ingredients and radiochemical purity suitable for administration to a subject (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’962 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’962 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 30 of copending Application No. 19/208,200 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’200 recite a composition containing 177Lu-PSMA I&T with a particular molar ratio of ingredients, radiochemical purity and amount of radioactivity for injection to a human patient (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’200 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’200 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 10 and 22 – 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7 and 13 - 30 of copending Application No. 19/209,267 in view of Lee et al. (Can Biother Radiopharm, 2002; article published online January 12, 2021) and Chen et al. (US 2011/0206606). The claims of US’267 recite a method in which a composition containing 177Lu-PSMA I&T with a particular molar ratio of ingredients and radiochemical purity is administered to a subject with a range of mean absorbed radiation per gram of salivary gland occurs (claim 1).
That the radioisotope is 64Cu is not claimed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to replace that 177Lu of US’267 with 64Cu as in Lee et al. given the different energies and half-lives of the different radioisotopes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that PSMA I&T labeled with 64Cu showed the feasibility of the PSMA specific PET imaging.
The presence of gentisic acid and sodium acetate is not claimed.
Chen et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate radiostabilizers such as gentisic acid and use a buffer such as acetate to prepare the radioisotope containing composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because ingredients such as gentisic acid are known in the art to inhibit radiolytic damage to radiolabeled compounds and acetate can be used as a buffer to resist changes in the pH of the claimed compositions. The selection of the radiostabilizers such as gentisic acid and buffers such as acetate from those that are taught in the prior art as suitable is within the skill of one of ordinary skill in the art. When sodium is also present in the solution such as from sodium gentisate and/or other sodium containing reagents such as those used to adjust the pH of the buffer, sodium acetate will be present. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of sufficient buffering capacity for the buffer and sufficient stabilization from the radiostabilizers and sufficient radioactivity in the solution and a unit dose for administration to a subject to carry out the desired use such as PET imaging. Ranges that overlap are prima facie obvious absent evidence of criticality (see MPEP 2144.05). Maintaining the sterility of the compositions is explicitly taught by Chen et al. and is important when the compositions will be administered to a subject so the preparation of a sterile composition would be obvious to one of ordinary skill in the art.
The recitation “for use in the diagnosis of prostate cancer in a human subject” in claims 22 is a recitation of the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The materials of US’267 are capable of being used in this manner and therefore this limitation recited in the preamble of claim 22 is met by the applied prior art.
The radiochemical purity as recited in claims 10, 29 and 30 arises from the initial purity of the material, the decay of the radioisotope and the materials present in the compositions. One of ordinary skill in the art would be motivated to start with the highest possible level of radiopurity. As compositions as required by the instant claims are rendered obvious by the applied prior art, the same results, such as radiochemical purity must necessarily occur. “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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