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 .
Receipt is acknowledged of Applicant’s IDS filed on 11/21/2024.
Claims 1-20 are pending in the instant application.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/228,510; 19/208,200; 19/198,982; 18/791,288; 18/791,300; 19/063,049 (reference application) over HOOIJMAN et al (Development of [225Ac]Ac-PSMA-I&T for Targeted Alpha Therapy According to GMP Guidelines for Treatment of mCRPC. Pharmaceutics 2021, 13, 715, pg. 1-15).
The co-applications recite a radiopharmaceutical composition comprising .sup.177Lu-PSMA I&T and ascorbic acid (see claim 1), about 42.5 mg/ml ascorbic acid (see claim 7), which is 4.25% when the volume is 1mL, wherein the composition comprises about 40 μL ethanol per mL of solution (see claim 4), which is 4% when the volume is 1 mL, in sufficient amounts of radioactivity for intended use (see claim 36).
The co-applications do not recite 225Actinum.
HOOIJMAN teaches the prior art had known of treating prostate cancer patients with 177Lu-labeled PSMA-ligands. Radionuclide therapy efficacy may even be improved by using the alpha emitter Ac-225. Higher efficacy is claimed due to high linear energy transfer specifically towards PSMA positive cells, causing more double-strand breaks (see abstract), wherein ascorbate and ethanol were added (see pg. 3; and 6) as a quencher (see pg. 8) to reduce the formation of radiolysis (see pg. 8-9) and optimized the stability of [225Ac]Ac-PSMA-I&T (see pg. 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate 225Actinum. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success, because 177-Lu and Ac-225 are functional equivalent compounds used for treating prostate cancer, wherein Ac-225 appears to have more therapeutic effect.
The references do not specifically teach adding the ingredients in the specific range of concentration amounts claimed by Applicant. The concentration/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 concentration/amount of each ingredient to add in order to best achieve the desired results, such as treatment of prostate cancer, reduce the formation of radiolysis and optimized the stability of: [225Ac]Ac-PSMA-I&T. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient concentration/amount would have been obvious at the time of Applicant's invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-20 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.
Claims 1, 11, 12 and 20 contain the terms "PSMA" and “I&T”, which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 1, at the very least, should define "PSMA" and “I&T” by its formal name; once "PSMA" and “I&T” are defined, the term "PSMA" and “I&T” may be subsequently recited.
The dependent claims fall therewith.
Regarding claims 1-10 and 20, the exact formulation is not clear. As the radioactivity concentration is given in “MBq per ml”, but the amount of ascorbic acid and ethanol is given “mg” rather than “mg per ml”.
Regarding claims 11-19, the exact formulation is not clear. As the radioactivity concentration is given in “ug per ml”, but the amount of ascorbic acid and ethanol is given “mg” rather than “mg per ml”.
The dependent claims fall therewith.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HOOIJMAN et al (Development of [225Ac]Ac-PSMA-I&T for Targeted Alpha Therapy According to GMP Guidelines for Treatment of mCRPC. Pharmaceutics 2021, 13, 715, pg. 1-15).
HOOIJMAN teaches a composition comprised of: [225Ac]Ac-PSMA-I&T (see title and abstract); ascorbate and ethanol were added (see pg. 3; and 6) as a quencher (see pg. 8) to reduce the formation of radiolysis (see pg. 8-9) and optimized the stability of [225Ac]Ac-PSMA-I&T (see pg. 4), wherein the quenchers’ concentrations were optimized (see abstract; and pg. 9) and the pH is >5.5 (see abstract), such as 5.5-9 (see pg. 10, see Table 5).
HOOIJMAN further teaches requested dosages for patients include: 8-12 MBq in a volume of 3-8mL (see pg. 6), wherein 8-12 MBq in 8mL has a concentration of 1-1.5 MBq/mL; 0.5M of ascorbate final concentration (see pg. 6), which is about 8.81% and reads on 88.1 mg in a volume of 1mL; and 5% of ethanol (see pg. 6), which reads on 50 mg in volume of 1 mL.
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over HOOIJMAN et al (Development of [225Ac]Ac-PSMA-I&T for Targeted Alpha Therapy According to GMP Guidelines for Treatment of mCRPC. Pharmaceutics 2021, 13, 715, pg. 1-15).
As discussed above, HOOIJMAN teaches treating prostate cancer with a composition comprised of: [225Ac]Ac-PSMA-I&T (see title and abstract); ascorbate and ethanol were added (see pg. 3; and 6) as a quencher (see pg. 8) to reduce the formation of radiolysis (see pg. 8-9) and optimized the stability of [225Ac]Ac-PSMA-I&T (see pg. 4), wherein the quenchers’ concentrations were optimized (see abstract; and pg. 9) and the pH is >5.5 (see abstract), such as 5.5-9 (see pg. 10, see Table 5).
HOOIJMAN further teaches requested dosages for patients include: 8-12 MBq in a volume of 3-8mL (see pg. 6), wherein 8-12 MBq in 8mL has a concentration of 1-1.5 MBq/mL; 0.5M of ascorbate final concentration (see pg. 6), which is about 8.81% and reads on 88.1 mg in a volume of 1mL; and 5% of ethanol (see pg. 6), which reads on 50 mg in volume of 1 mL.
The reference does not specifically teach adding the ingredients in the specific range of concentration amounts claimed by Applicant. The concentration/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 concentration/amount of each ingredient to add in order to best achieve the desired results, such as treatment of prostate cancer, reduce the formation of radiolysis and optimized the stability of [225Ac]Ac-PSMA-I&T. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient concentration/amount would have been obvious at the time of Applicant's invention.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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