Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/23/26 has been entered.
Claims and Previous Objections/Rejections Status
Claims 30-42 are pending in the application.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
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.
Claim(s) 30-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jalomӓki et al. (US 2025/0121103A1) in view of Meyrick et al. (Target. Oncol. (2021) 16:369-380).
Jalomӓki et al. (US 2025/0121103A1) discloses a method of treating cancer and improved radiographic progression-free survival of a patient via administration of 177Lu-PSMA RLT to chemo naïve patients (abstract; FIG. 17; p33, [0363],[0365]; p34, [0387]).
The primary objective of the study is to prospectively assess the efficacy of 177Lu-PSMA I&T on the improvement of radiographic progression free survival (rPFS) compared to standard of care hormone therapy (p49, [0455]; p50, [0464]; p51, [0486]; p93, [1053]). The rPFS after administration of 177Lu-PSMA RLT is at least 6-12 months (p34, [0387]).
The improvement of rPFS encompasses the method of reducing the risk of radiographic progression in a subject of the instant claims.
The patients are determined to be mCRPC with PSMA positive metastatic disease based upon imaging prior to administration of 177Lu-PSMA I&T (p31, [0357-0358]; p33, [0365],[0368]). The prior positive mCRPC determination encompasses the positive mCRPC of the instant claims.
The patients are determined to be positive via PSMA-PET scans (e.g. [68Ga]Ga-PSMA-11 or
[18F]DCFPyL) (p31, [0357]; p51, [0497]; p55, [0563]) that encompasses the PSMA-positivity of the mCRPC is determined by PET with [68Ga]Ga-PSMA-11 or [18F]DCFPyL of the instant claims.
The patients may be treatment naïve (chemo naïve) or not treatment naïve (Figure 17; p33, [0363],[0369]; p91, [0996-0097]). The exclusion criteria include prior chemotherapy (docetaxel or cabazitaxel) (p51, [0505]) that encompasses the taxane-naïve patients of the instant claims.
The patients had previous ARAT therapy and progressed on ARAT therapy (FIG. 17; p51, [0493-0496]).
The ARAT therapy comprises abiraterone or enzalutamide that encompasses the ARPI, such as abiraterone or enzalutamide of the instant claims.
The 177Lu-PSMA RLT comprises both 177Lu-PSMA I&T and 177Lu-PSMA-617 (p49, [0445]) that encompasses the 177Lu-labeled RLT, such as 177Lu-PSMA I&T and 177Lu-PSMA-617 of the instant claims.
The 177Lu-PSMA I&T is labelled with non-carrier added 177Lu (p11, [0151]; p35, [0402]) that encompasses the no carrier added 177Lu of the instant claims.
The 177Lu-PSMA I&T is administered in a single dose of 7.4 GBq ± 10%, a single dose of 7.4 GBq ± 5%, etc. (p31, [0352]; p52, [0534]).
The administration of 177Lu-PSMA I&T encompasses the administration of a PSMA-binding radioligand therapeutic (RLT) agent to a subject of the instant claims.
The single dose of 7.4 GBq ± 10% or 7.4 GBq ± 5% of 177Lu-PSMA I&T encompasses the dose of 7.4 GBq ± 10% and 7.4 GBq ± 5% of the instant claims.
The method comprises a six week treatment cycle of injections of 177Lu-PSMA I&T for 6
treatment cycles or until radiographic progression of disease is determined (p26, [0304]; p27, [0323];
p52, [0537]; p55, [0575]; p93, 1037]).
The six week treatment cycle encompasses the administered dose one every 6 (±1) weeks of the instant claims.
The 6 treatment cycles encompasses the up to 6 cycles of the instant claims.
The rPFS is defined as the time from randomization to radiographic progression (using PCWG3 and RECIST 1.1 criteria) (p34, [0387]; p49, [0455]).
Jalomӓki et al. does not explicitly disclose the reduction in risk is of at least 50%, is of at least 55% or is of at least 57%.
Meyrick et al. (Target. Oncol. (2021) 16:369-380) discloses 177Lu-PSMA radioligand therapy (RLT)
(177Lu-PSMA I&T and 177Lu-PSMA-617) for determining PET/CT progression free survival. Chemotherapy-
naïve status was a significant pre-therapy factor associated with longer survival of patients wherein survival analysis confirmed better outcomes in individuals who had demonstrated therapy response (abstract; p370, Key Points; p372, right column, first paragraph and 3.2 Analysis of Therapy Outcomes; p375, 4 Discussion).
Baseline PSA was significantly linked to survival outcome: lower levels predicted a lower risk of death and disease progression (abstract). Patients with a ≥50% prostate-specific antigen decline had an improved overall survival twice that of patients with no change in PSA after 177Lu-PSMA targeted therapy (p370, Key Points).
The PSA decline after RLT yielded a hazard ratio (HR) for death of 0.33 (p373, 3.3. Survival Analysis).
Jalomӓki et al. further discloses that upon administration of the 177Lu-PSMA RLT to a patient, the
PSA decline is more than about 40%, more than about 45%, more than about 50% and all the way up to
more than about 80% (p31, [0356]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Jalomӓki et al. provides an at least 50%, at least 55% or at least 57% reduced risk of radiographic progression or death as Meyrick et al. teaches that chemotherapy-naïve status for patients is a significant pre-therapy factor associated with longer survival, that lower levels of PSA predict a lower risk of death and disease progression for patients with a ≥50% prostate-specific antigen decline and an improved overall survival twice that of patients with no change in PSA after 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617) while Jalomӓki et al. teaches of a PSA decline of more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80% and rPFS is of at least 6-12 months.
Therefore, it would have been predictable to one of ordinary skill in the art that the method of Jalomӓki et al. improves the radiographic progression free survival (rPFS) of taxane-naïve patients with at least 50%, at least 55% or at least 57% reduced risk of radiographic progression as Meyrick et al. teaches that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617) and Jalomӓki et al. teaches that the PSA of the chemotherapy-naïve subjects decline is of more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80%.
Also, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Jalomӓki et al. provides an at least 50%, at least 55% or at least 57% reduced risk of radiographic progression as the method comprises the administration of 177Lu-PSMA RLT to an ARPI treated and taxane-naïve patient population and the method of the instant claims does not provide for any addition compounds, conditions or techniques over the method of Jalomӓki et al.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The 177Lu-PSMA I&T and 177Lu-PSMA-617 of Jalomӓki et al. and/or Meyrick et al. administered in a single dose of 7.4 GBq ± 10% in a six week treatment cycle for 6 cycles encompasses the 177Lu-PSMA I&T and 177Lu-PSMA-617 of the instant claims administered in a single dose of 7.4 GBq ± 10% in a six week treatment cycle for 6 cycles, have the same properties and is capable of the same functions, such as characterized by providing at least 50%, at least 55% or at least 57% reduction of risk of radiographic progression or death.
Response to Arguments
The Applicant’s assertions with regards to the references of von Eyben and Sartor are moot as they are not used in the instant rejection.
Applicant asserts that Jalomӓki’s target hazard ratio of 0.60, corresponding to a risk reduction of
40%, the anticipated effect, is less than the at least 50% that the claims require. The Office relies on Jalomӓki’s statement in paragraph that a target hazard ratio under the alternative hypothesis of 0.60 for rPFS is reasonable to expect. Jalomӓki’s target hazard ratio reflects the effect size that investigators considered reasonable to anticipate for purposes of designing and powering a prospective clinical trial. Taken at face value as the level of benefit the art anticipated, that assumption corresponds to a 40% reduction in the risk of radiographic progression or death, which is below the "at least 50%", the "at
least 55%", and the "at least 57%.” Jalomӓki discloses no result at all, much less the reductions.
The reference of Meyrick et al. was used to teach that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617).
The reference of Jalomӓki et al. was used to teach of the method for improving the radiographic progression free survival (rPFS) of taxane-naïve patients as well as that stated above.
Jalomӓki et al. further discloses that upon administration of the 177Lu-PSMA RLT to a patient, the
PSA decline is more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80%.
It would have been predictable to one of ordinary skill in the art that the method of Jalomӓki et al. improves the radiographic progression free survival (rPFS) of taxane-naïve patients with at least 50%, at least 55% or at least 57% reduced risk of radiographic progression as Meyrick et al. teaches that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617) and Jalomӓki et al. teaches that the PSA of the chemotherapy-naïve subjects with 177Lu-PSMA I&T and 177Lu-PSMA-617 decline is of more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80%.
Therefore, the administration of 177Lu-PSMA I&T and 177Lu-PSMA-617 of Jalomӓki et al. will provide for a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration with a reasonable expectation of success.
Applicant asserts that the claimed result is not inherent. To the extent the rejection rests on the theory that the at least 50% reduction is an inherent property of administering the same agent to the same population, inherency requires that the result necessarily flow from the disclosed method, not merely that it might occur. In re Oelrich, 666 F.2d 578; MPEP § 2112. Jalomӓki discloses only a planning assumption (HR 0.60) for a prospective trial; it does not disclose performance of the method and attainment of a >50% reduction. A design assumption corresponding to approximately 40% risk reduction does not make a >50% result a necessary consequence. If anything, it points below the claimed threshold. The burden-shifting rationale of In re Best, 562 F.2d 1252 (CCPA 1977), is therefore not triggered, because the reference does not disclose a process that necessarily possesses the claimed characteristic.
The reference of Meyrick et al. was used to teach that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617).
The reference of Jalomӓki et al. was used to teach of the method for improving the radiographic
progression free survival (rPFS) of taxane-naïve patients as well as that stated above.
Jalomӓki et al. further discloses that upon administration of the 177Lu-PSMA RLT to a patient, the
PSA decline is more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80%.
It would have been predictable to one of ordinary skill in the art that the method of Jalomӓki et al. improves the radiographic progression free survival (rPFS) of taxane-naïve patients with at least 50%, at least 55% or at least 57% reduced risk of radiographic progression as Meyrick et al. teaches that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617) and Jalomӓki et al. teaches that the PSA of the chemotherapy-naïve subjects with 177Lu-PSMA I&T and 177Lu-PSMA-617 decline is of more than about 40%, more than about 45%, more than about 50% and all the way up to more than about 80%.
Also, products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The 177Lu-PSMA I&T and 177Lu-PSMA-617 of Jalomӓki et al. and/or Meyrick et al. administered in a single dose of 7.4 GBq ± 10% in a six week treatment cycle for 6 cycles encompasses the 177Lu-PSMA I&T and 177Lu-PSMA-617 of the instant claims administered in a single dose of 7.4 GBq ± 10% in a six week treatment cycle for 6 cycles, have the same properties and is capable of the same functions, such as characterized by providing at least 50%, at least 55% or at least 57% reduction of risk of radiographic progression or death.
Applicant asserts that the claimed result is unexpected relative to the closes prior art. The observed rPFS hazard ratio of 0.41 (approximately a 59% reduction) materially exceeds every effect size that the art identified as reasonable to expect: Jalomӓki’s 0.6 planning assumption is approximately 40%. A treatment effect substantially greater than the pre-specified assumptions of the closest prior art is evidence of unexpected results probative of nonobviousness. The observed primary rPFS hazard ratio of 0.41 (approximately a 59% reduction) demonstrates a materially greater result than anticipated.
The reference of Meyrick et al. was used to teach that chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617).
Therefore, the observed rPFS HR of 0.33 of Meyrick et al. shows that an approximately a 59% reduction is not unexpected after the administration of 177Lu-PSMA I&T and 177Lu-PSMA-617 to a taxane-naïve subject that has completed ARPI.
The arguments of counsel cannot take the place of evidence in the record. Examples of attorney statements are not evidence and must be supported by an appropriate affidavit or declaration include statements regarding unexpected results. MPEP § 716.01 (c).
Applicant asserts that objective evidence confirms that the claimed result was not regarded by those of ordinary skill in the art as a predictable consequence of the cited references. 177Lu-PSMA- 617 had been approved and recommended since 2022 for patients with PSMA-positive metastatic castration-resistant prostate cancer who had received both a prior ARPI and taxane-based chemotherapy. The agent was thus available to clinicians, and its activity in metastatic castration-resistant prostate cancer was known. Notwithstanding that availability, it was not recommended for the earlier, taxane-naive line of therapy recited in the claims. Only following the reported PSMAfore primary result (rPFS HR 0.41; approximately a 59% reduction) was that limitation lifted. On March 28, 2025, the U.S. Food and Drug Administration expanded the approved indication for 177Lu-PSMA-617 to include patients with PSMA-positive mCRPC who have been treated with an ARPI and are considered appropriate to delay taxane-based chemotherapy. The label expansion was literally practice-changing, as reflected in the 2026 ESMO Clinical Practice Guideline for advanced and metastatic prostate cancer, which for the first time extended its recommendation to the same taxane-naive, post-ARPI population, whereas the prior ESMO guidance recommended 177Lu-PSMA-617 only for patients previously treated with both an ARPO and a taxane.
That the agent was already in clinical use in a later line of therapy, yet the field nonetheless undertook a dedicated Phase 3 randomized controlled trial before extending its use to the expanded population, and revised clinical practice only upon that trial's reported outcome, is objective evidence that skilled artisans did not consider the claimed magnitude of benefit predictable from the design assumptions of Jalomӓki (HR 0.60). Had the claimed result been an expected consequence of those references, a dedicated, pivotal trial and a corresponding revision to clinical-practice guidelines would not have been required. This recognition is tied directly to the demonstrated rPFS benefit that defines the claimed invention, establishing the requisite nexus between the objective evidence and the claimed subject matter. See MPEP § 716.01.
This evidence also confirms that the difference between the anticipated and observed effects is not a mere difference in degree arrived at through routine optimization. The magnitude of benefit demonstrated for the claimed method altered the recommended course of treatment for the very patient population recited in the claims-taxane-naive patients who have received a prior ARPI, for whom effective options are limited. A result that changes what clinicians are advised to do is qualitatively different in kind from the incremental effect the cited references anticipated.
The reference of Meyrick et al. (March 2021) teaches that chemotherapy-naïve subjects that have completed ARPI having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617).
Therefore, the prior art of Meyrick et al. (March 2021) did teach of the use of 177Lu-PSMA I&T
and 177Lu-PSMA-617 earlier than 2022 for a taxane-naive line of therapy and demonstrated rPFS benefits wherein chemotherapy-naïve subjects having lower levels of PSA provides for the advantage of a lower risk of death and disease progression with a hazard ratio (HR) of 0.33 which corresponds to a risk reduction of 67% lower after administration of 177Lu-PSMA radioligand therapy (RLT) (177Lu-PSMA I&T and 177Lu-PSMA-617).
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 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2,4,5 and 23-30 of copending Application No. 19/136,066 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of reducing the risk of radiographic progression or death and the method of prolonging the time period of radiographic progression-free survival (rPFS) of copending Application No. 19/136,066 comprise the administration of 177Lu-PSMA radioligand therapy (RLT), such as 177Lu-PSMA I&T and 177Lu-PSMA-617 to taxane-naïve patients provides an at least 50% reduction in risk of rPFS compared to ARPI treatment that encompasses the method of reducing the risk of radiographic progression of or death of the instant claims via the administration of 177Lu-PSMA radioligand therapy (RLT), such as 177Lu-PSMA I&T and 177Lu-PSMA-617 to taxane-naïve patients to provide an at least 50%, at least 55%, or of at least 57% reduction in risk of rPFS compared to ARPI treatment.
The method of copending Application No. 19/136,066 comprises a dose of 7.4 (±10%) GBq once every 6 (±1) weeks for up to 6 cycles encompasses the dose of 7.4 (±10%) GBq once every 6 (±1) weeks for up to 6 cycles of the instant claims.
The ARPI treatment of copending Application No. 19/136,066 comprises abiraterone,
enzlutamide, etc. that encompasses the ARPI treatment comprising abiraterone, enzlutamide, etc. of the instant claims.
The taxane-naïve patients of copending Application No. 19/136,066 has PSMA positive metastatic castration prostate cancer (mCRPC) that encompasses the taxane-naïve patients comprising PSMA positive metastatic castration prostate cancer of the instant claims.
The mCRPC is determined via [68Ga]Ga-PSMA-11, 18F-DCPyL, etc. for copending Application No. 19/136,066 that encompasses the mCRPC is determined via [68Ga]Ga-PSMA-11, 18F-DCPyL, etc. of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
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