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 .
Claims and Previous Objections/Rejections Status
Claims 21,24,26-29 and 31-40 are pending in the application. Claims 22,23,25 and 30 are cancelled in the amendment filed 7/29/26.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
New Grounds of Rejection
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) 21,24,26-29 and 31-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over
NCT02820454 (6/28/2016) in view of Berbeco et al. (WO2018/107057A1) and Verry et al. (Nanomed, 2016, 11 (18), pp.2405-2417) and in further view of Mignot et al. (Chem. Eur. J. 2013, 19, 6122-6136).
NCT02820454 (6/28/2016) discloses the method of treating brain metastases using nano-sized AGuIX polysiloxane gadolinium-chelate nanoparticles via radiosensitization (p2, Study Identification, Brief title; p4, Conditions; p5, Arms and Interventions, Drug:AGuIX Other names).
The method of treating brain metastases comprises a single intravenous injection of AGuIX to a patient and subsequent whole brain radiation therapy starting 4 hours after AGuIX injection, up to 2 weeks (p3, Study Description, Detailed Description) that encompasses the method of treating brain metastases and intravenous injection of the instant claim 21.
The whole brain radiation therapy encompasses the whole brain radiation therapy of the instant claim 33.
The radiation therapy comprises 30Gy 10 sessions of 3 Gy (p3, Study Description, Detailed
Description; p5, Arms and Interventions, Radiation: whole brain radiation therapy) that encompasses the total dose of ionizing radiation and about 3 Gy per fraction in a maximum of 10 fraction of the instant claims 34-36.
The secondary brain metastases are from histologically confirmed solid tumor (p6, Eligibility, Criteria) that encompasses the solid tumor of instant claim 21.
An MRI scan (T1 contrast enhancement) is performed 2 hours after injection to visualize the distribution of AGuIX in brain metastases and surrounding healthy tissue (p3, Study Description, Detailed Description; p5, Secondary Outcome Measures) that encompasses imaging the brain metastases via T1 MRI of the instant claim 40.
NCT02820454 does not explicitly disclose an injectable solution at a concentration between 50 and 150 mg/mL, 80 and 120 mg/mL or about 100 mg/mL.
NCT02820454 further discloses five dose escalation cohorts include 15 mg/kg, 30 mg/kg, 50
mg/kg, 75 mg/kg and 100 mg/kg (p5, Arms and Interventions). The patients are treated at
sequentially rising dose levels of AGuIX (p4, Study Description, Detailed Description).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an injectable solution having concentration between 50 and 150 mg/mL, 80 and 120 mg/mL or about 100 mg/mL by varying and/or optimizing the AGuIX nanoparticles injectable solution concentration to provide the therapeutically effective doses for administration, according to the guidance provided by NCT02820454, to determine the dose limiting toxicities and maximum tolerated dose that advantageously yields the greatest radioenhancing effect at the site of the tumor. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
NCT02820454 does not disclose a.) a second therapeutically effective amount between 50 and 150 mg/kg, between 80 mg/kg and 120 mg/kg, about 100 mg/kg; b.) injecting the first AGuIX within a period of between 2 and 7 days prior to first irradiation; c.) injecting a second therapeutically effective amount within period of 1 hour to 12 hours or d.) injecting a third therapeutically effective amount between 50 and 150 mg/kg.
NCT02820454 discloses five dose escalation cohorts include 15 mg/kg, 30 mg/kg, 50 mg/kg, 75 mg/kg and 100 mg/kg as well as that stated above.
Berbeco et al. (WO2018/107057A1) discloses the method of treating cancer (e.g.
radiosensitizing a cancer in a subject) with high atomic number containing nanoparticles in combination with ionizing radiation (abstract; p13, lines 10-11 and 22; claims 19,21,22).
The nanoparticles of size from about 3 nm to about 6 nm comprise Bi/Gd-NODAGA covalently bound to a polysiloxane core (p2; p4, lines 1-3; p14; p16, lines 8-10 and 12-13; p19, lines 20-28; claims
3,5,9; Figure 1B).
The method of treating a tumor involves administering (i.e. intravenous) to the subject a
therapeutically effective amount of the nanoparticles and waiting a sufficient time to allow the
nanoparticles to accumulate in a cell or tissue associated with the cancer (p4, lines 4-5; p27, lines 21-30; p30, lines 20-21). The time sufficient to allow the nanoparticles to accumulate in a cell or tissue is from about 30 seconds to about 24 hours (p28, lines 1-13).
The method of treating a tumor involves administering one or more doses of radiation to the subject (p4, lines 4-10; p20, lines 1-5; p25, lines 14-18; claim 19) after the accumulation of the nanoparticles in a cell or tissue associated with the cancer. The cells are irradiated with a 6MV Varian
Truebeam® machine (p34, lines 22-23; p36, lines 7-9).
The individual steps of administering a therapeutically effective amount of the nanoparticles and administering one or more doses of radiation may be repeated multiple times (e.g. two times, three times, etc.) (p26, lines 9-13).
Verry et al. (Nanomed, 2016, 11 (18), pp.2405-2417) discloses the intravenous injection of AGuIX NPs into rats for image-guided radiation therapy and radiosensitization of brain tumors on days 0 and 6 after tumor implantation for pharmacokinetic and toxicology study (abstract; p2406, Pharmacokinetics & regulatory toxicology study; p2408, Radiotherapy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to allow the first injection of AGuIX nanoparticles to accumulate in a cell or tissue from about 2 days to 6 days as taught by Berbeco et al. and Verry et al., respectively, to provide sufficient time to allow the nanoparticles to accumulate in a cell or tissue. It would have been predictable to one of ordinary skill in the art to examine the extended incubation of the first injection of AGuIX nanoparticles for at least 2 days to determine the greatest accumulation of the radiosensitizer in the tumor cells or tissue prior to irradiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to allow the second injection of AGuIX nanoparticles to accumulate in a cell or tissue between 1 hour to 12 hours as Berbeco et al. teaches multiple administrations of the nanoparticles prior to irradiation and to allow a sufficient amount of time to allow the nanoparticles to accumulate in a cell or tissue is from about 30 seconds to about 24 hours and therefore, it would have been predictable to one of ordinary skill in the art to examine the incubation of the second injection of AGuIX nanoparticles for between 1-12 hours for determining the greatest accumulation of the radiosensitizer in the tumor cells or tissue prior to irradiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to examine the doses of NCT02820454 for the second injection of the AGuIX nanoparticle to determine the dose limiting toxicities and maximum tolerated dose that advantageously yields the greatest radioenhancing effect at the site of the tumor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to provide a third injection of AGuIX nanoparticles as Berbeco et al. teaches multiple administrations of the nanoparticles prior to irradiation and to allow a sufficient amount of time to allow the nanoparticles to accumulate in a cell or tissue prior to irradiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to examine the doses of NCT02820454 for the third injection of the AGuIX nanoparticle to determine the dose limiting toxicities and maximum tolerated dose that advantageously yields the greatest radioenhancing effect at the site of the tumor.
NCT02820454 does not explicitly disclose that the solid primary cancer comprises melanoma, lung, breast or colon cancer.
Verry et al. further discloses the strong efficacy of the combination of AGuIX NPs and radiation
exposure in tumor treatment, such as brain melanoma metastases (p2406, left column, first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the brain metastases of NCT02820454 originates from a melanoma solid primary tumor as Verry et al. teaches that brain metastases originate from melanoma and both disclosures disclose the treatment of brain metastases originating from solid primary tumors using AGuIX NPs and radiation.
NCT02820454 does not explicitly disclose that AGuIX nanoparticles comprise a polysiloxane shell bound to Gd-DOTAGA chelating agents (n between 5 and 50) having a hydrodynamic diameter between 2 and 6 nm or lyophilized AGuIX nanoparticles contained in a pre-filled vial.
Verry et al. further discloses that the AGuIX nanoparticles are Gd chelates (DOTAGA) covalently linked to a polysiloxane network core having a size of 3 ± 1 nm (p2407, Gd-based NPs).
Mignot et al. (Chem. Eur. J. 2013, 19, 6122-6136) discloses 5 nm particles comprising polysiloxane matrix with DOTAGA-Gd3+ chelates on the surface (abstract).
The particles are freeze-dried for storage and can be dispersed again in water before use (p6125, right column, first full paragraph; p6134, Purification) that encompass the lyophilized powder gadolinium-chelated polysiloxane nanoparticles in a pre-filled vial to be reconstituted in an aqueous solution of the instant claim 26.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the AGuIX NPs of NCT02820454 comprise the same structure as the polysiloxane shell bound Gd-DOTAGA chelating agents of Verry et al. and Mignot et al. having a size of 3 ± 1 nm and 5 nm, respectively wherein the AGuIX of NCT02820454 is analogous to the AGuIX of Verry et al. and Mignot et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to store the lyophilized AGuIX powder in a pre-filled vial for the advantage of storage and for further reconstitution in water to chelate Gd3+ prior to administration as the standard taught by Mignot et al.
Mignot et al. further discloses
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176
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(Figure 1) wherein the polysiloxane
core is surrounded by five individual Gd atoms (p6127, left column, first paragraph). The particles
contain around 1.5 DOTAGA per Gd (Table 2; p6128, left column, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the AGuIX of NCT02820454 comprises at least 5 Gd-NODAGA moieties as Mignot et al. envisioned at least 5 Gd atoms surround the polysiloxane core and 1.5 DOTAGA per Gd in the particles to yield particles with very low toxicity and efficiency as MRI agents and sensitizing agents for image-guided radiotherapy.
Response to Arguments
The Applicant’s assertions with regards to Luchette et al. are moot as the reference is not used in the instant rejection.
Applicant asserts that the surprising finding, by the present inventors, that the gadolinium-chelated polysiloxane nanoparticles exhibit long persistence in brain metastases from solid primary cancers (melanoma, lung, breast and colon cancers). Examples section of the Specification shows that for patients administered with the largest dose tested (100 mg/kg body weight), persistence of the MRI enhancement was observed in brain metastases at day 8, i.e. up to one week after administration of AGuIX nanoparticles. The long persistence in metastases provides a wide therapeutic window that can benefit fractionated radiotherapy. The method comprises two injections of the nanoparticles prior to irradiation.
The reference of Verry et al. was used to teach of the strong efficacy of the combination of AGuIX NPs and radiation exposure in tumor treatment, such as brain melanoma metastases.
The reference of Verry et al. further discloses that the imaging and radiotherapy experimental protocol comprises MRI sequence, AGuIX injection, MRI sequence and radiotherapy (RT) on D10 after implantation followed by subsequent MRI sequences, AGuIX injection, MRI sequences and RT on D17
(Figure 1) and therefore, Verry et al. envisioned MRI imaging of AGuIX at 7 days post administration.
The reference of NCT02820454 discloses the method of treating brain metastases using nano-sized AGuIX.
The AGuIX of NCT02820454 encompasses the AGuIX of the instant claims, has the same
properties and is capable of the same functions, such as persistence in brain metastases and of the MRI enhancement observed in brain metastases at day 8.
The reference of Berbeco et al. teaches that the individual steps of administering a therapeutically effective amount of the Gd-NODAGA covalently bound to a polysiloxane core nanoparticles and administering one or more doses of radiation may be repeated multiple times (e.g. two times, three times, etc.). Therefore, Berbeco et al. envisioned a fractionated radiotherapy and method comprising multiple injections of the nanoparticles prior to irradiation.
Also, 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 Mignot et al. describes a top-down synthesis route to ultrasmall
multifunctional Gd-based silica nanoparticles but does not provide any information regarding the
persistence of the nanoparticles in tumor tissues.
The reference of Mignot et al. was not used to teach of persistence of the nanoparticles in tumor tissues but was used to teach of 5 nm particles comprising polysiloxane matrix with DOTAGA-Gd3+ chelates on the surface that are freeze-dried for storage and can be dispersed again in water before use that encompasses the lyophilized compound is stored in a vial prior to reconstitution.
Applicant asserts that Berbeco et al. discloses an extremely large number of Gd3+/Bi3+ nanoparticles. The structure of the nanoparticles of Berbeco et al. are different from the gadolinium-chelated polysiloxane nanoparticles of the claimed method. The only in vivo experiments were performed in a fast-growing subcutaneous xenograft solid tumor model (A549 lung adenocarcinoma). Nothing in Berbeco et al. teaches, or even suggests, the persistence of gadolinium-chelated polysiloxane nanoparticles in a brain metastasis more than a week after injection. Berbeco teaches away from using
Gd3+-chelated nanoparticles but demonstrates the higher efficacy of SiBiGdNP over SiGdNP.
The reference of Berbeco et al. was not used to teach of the persistence of gadolinium-chelated polysiloxane nanoparticles in a brain metastasis more than a week after injection or explicitly used to teach of AGuIX but was used to teach that the individual steps of administering a therapeutically effective amount of the Gd-NODAGA polysiloxane core nanoparticles and administering one or more doses of radiation may be repeated multiple times (e.g. two times, three times, etc.). Therefore, envisioning a fractionated radiotherapy and method comprising multiple injections of the nanoparticles prior to irradiation.
The Applicant concedes that Berbeco et al. teaches that waiting a sufficient time to allow the nanoparticles to accumulate at a cell or tissue site associated with cancer prior to irradiation is a well-known practice in the art and that specifically the sufficient time is from about 30 seconds to about 24 hours is nothing more than the time classically used in the art.
Applicant asserts that NCT02820454 discloses a single intravenous injection of AGuIX and the
first radiotherapy session will be performed 4 hours after AGuIX injection. Applicant asserts that NCT02820454 is mute regarding studying persistence of the AGuIX in a brain metastases and about performing two injections of AGuIX nanoparticles prior to the first irradiation.
The reference of NCT02820454 was not used to teach of the persistence of the AGuIX in a brain metastases and two injections of AGuIX nanoparticles prior to the first irradiation. The reference of NCT02820454 was used to teach of the treatment of brain metastases from a solid tumor examined in five dose escalation cohorts include 15 mg/kg, 30 mg/kg, 50 mg/kg, 75 mg/kg and 100 mg/kg and the radiation therapy protocol.
The reference of Berbeco et al. teaches of administering a therapeutically effective amount of the Gd-NODAGA polysiloxane core nanoparticles and administering one or more doses of radiation may be repeated multiple times (e.g. two times, three times, etc.). Therefore, envisioning a fractionated radiotherapy and method comprising multiple injections of the nanoparticles prior to irradiation.
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 21,24,26-29,31-36 and 40 are rejected on the ground of nonstatutory double patenting
as being unpatentable over claims 1-4 and 9-13 of U.S. Patent No. 11,497,818B2 in view of NCT02820454 (6/28/2016), Berbeco et al. (WO2018/107057A1) and in further view of Verry et al. (Nanomed, 2016, 11 (18), pp.2405-2417).
The nanoparticles of U.S. Patent No. 11,497,818B2 comprise a polyorganosiloxane matrix, Gd and a chelating moiety wherein the polyorganosiloxane matrix is functionalized with the chelating moiety that encompass the gadolinium-chelated polysiloxane nanoparticles of the instant claims.
The nanoparticles of U.S. Patent No. 11,497,818B2 have a diameter from 1 to 5 nm that encompasses the hydrodynamic diameter of between 2 and 6 nm of the instant claims.
The nanoparticles of U.S. Patent No. 11,497,818B2 comprise 10-60 Gd that encompasses the 5-50 and 5-20 Gd of the instant claims.
The nanoparticles of U.S. Patent No. 11,497,818B2 are lyophilized that encompasses the lyophilized nanoparticles of the instant claims.
U.S. Patent No. 11,497,818B2 does not disclose the method of treating a brain metastases from a primary melanoma or imaging via MRI.
NCT02820454 discloses that stated above.
Verry et al. (Nanomed, 2016, 11 (18), pp.2405-2417) discloses that stated above.
It would have been obvious to one of ordinary skill in the art to utilize the nanoparticles of U.S. Patent No. 11,497,818B2 for the method of treating a brain metastases from a primary melanoma solid tumor as NCT02820454 teaches that the AGuIX nanoparticles in doses of 15 mg/kg, 30 mg/kg, 50 mg/kg, 75 mg/kg and 100 mg/kg are advantageously used for treating brain metastases in combination with whole brain radiation therapy and imaging via MRI for the advantage of visualizing the distribution of AGuIX in brain metastases and surrounding healthy tissue while Verry et al. teaches that brain metastases originate from melanoma and both disclosures disclose the treatment of brain metastases originating from solid primary tumors using AGuIX NPs and radiation.
It would have been obvious to vary and/or optimize the AGuIX nanoparticle injectable solution
concentration to provide the therapeutically effective doses for administration, according to the guidance provided by NCT02820454, to provide a composition having the desired concentration of therapeutically effective injected doses to determine the dose limiting toxicities and maximum tolerated dose that advantageously yields the greatest radioenhancing effect at the site of the tumor. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The AGuIX NPs of NCT02820454 and Verry et al. comprise an analogous structure to the nanoparticles of U.S. Patent No. 11,497,818B2. The composition of U.S. Patent No. 11,497,818B2 has the same properties and is capable of the same functions, such as being used for the method of treating a brain metastases.
U.S. Patent No. 11,497,818B2 does not disclose the method steps of injecting a first, second and third therapeutically effective amount prior to irradiation.
Berbeco et al. (WO2018/107057A1) discloses that stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer multiple injections of AGuIX nanoparticles as Berbeco et al. teaches multiple administrations of the nanoparticles prior to irradiation and to allow a sufficient amount of time to allow the nanoparticles to accumulate in a cell or tissue prior to irradiation for determining the greatest accumulation of the radiosensitizer in the tumor cells or tissue prior to irradiation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to examine the doses of NCT02820454 for the second and/or third injection of the AGuIX nanoparticle to determine the dose limiting toxicities and maximum tolerated dose that
advantageously yields the greatest radioenhancing effect at the site of the tumor.
Response to Arguments
Applicant asserts that the independent claim 21 was amended to introduce a feature regarding the solid primary cancer (“wherein the solid primary cancer is a primary melanoma, a primary lung cancer, a primary breast cancer or a primary colon cancer”).
The reference of Verry et al. was used to teach AGuIX nanoparticles having a size of 3 ± 1 nm that are used to treat brain melanoma metastases via the combination of AGuIX NPs and radiation.
The reference of NCT02820454 was used to teach of AGuIX that is used for the method of treating brain metastases resulting from a solid tumor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the brain metastases originates from a melanoma solid primary tumor as Verry et al. teaches that brain metastases originate from melanoma and discloses the treatment of brain metastases originating from solid primary tumors using AGuIX NPs and radiation.
The AGuIX NPs of NCT02820454 and Verry et al. comprise an analogous structure to the nanoparticles of U.S. Patent No. 11,497,818B2. The composition of U.S. Patent No. 11,497,818B2 has the same properties and is capable of the same functions, such as being used for the method of treating a brain metastases for a solid melanoma tumor.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
