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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 10/8/2024 wherein claims 1, 3, 6-8, 10-13, 16, 19-22, 26, 32, and 34-39 were amended and claims 2, 4, 5, 10, 14, 15, 17, 18, 23-25, 27-31, 33, 40, and 41 were canceled.
Note(s): Claims 1, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 34-39 are pending.
Priority
This application is a CON of PCT/US22/80572 filed 11/29/2022 and PCT/US22/80572 claims benefit to PRO 63/283,999 filed 11/29/2021.
Note(s): The earliest effective filing date is 11/29/2021 because the pending invention is fully supported therein.
Claim Interpretation
Independent claim 1 is directed to a method of treating a subject suffering from prostate cancer wherein the subject (i) has exhibited prostate cancer progression during or after treatment with one or more androgen receptor inhibitor agents and (ii) is chemotherapy-naive before treatment with the one or more androgen receptor inhibitor agents; said method comprising administering to the subject an amount of a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA providing from a 4 to 10 Gbq dose at least four times, at four week or longer intervals between doses.
Independent claim 26 is directed to a kit comprising a pharmaceutical preparation of a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and instructions.
Information Disclosure Statement
The information disclosure statements filed 10/8/2024; 11/13/2024; 7/15/2025; and 9/19/2025 were considered.
Double Patenting Rejections
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 26, 32, and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-12 of U.S. Patent No. 11,491,246. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA, one or more ascorbate compounds, one or more gentisate compounds, overlapping dosages. The claims differ in that those of the pending application may optionally have an inhibitor coadministered. Thus, the skilled artisan would recognize that the pending invention encompasses the patented invention.
Claims 26, 32, and 35-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,129,912. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and one or more ascorbate compounds. The claims differ in that those of the pending application may optionally have an inhibitor coadministered. Thus, the skilled artisan would recognize that the pending invention encompasses the patented invention.
Claims 26, 32, and 35-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,558,440. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and one or more ascorbate compounds. The claims differ in that those of the pending application may optionally have an inhibitor coadministered. Thus, the skilled artisan would recognize that the pending invention encompasses the patented invention.
Claims 26, 32, and 35-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64 and 65 of copending Application No. 17/934,450 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and one or more ascorbate compounds. The claims differ in that those of the pending application may optionally have an inhibitor coadministered. Thus, the skilled artisan would recognize that the pending invention encompasses the patented invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 6-9, 16, 19, 20, 22, 26, 32, and 35-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54-60 of copending Application No. 18/934,324 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA. The claims differ in that those of the pending application may optionally have an inhibitor coadministered. Thus, the skilled artisan would recognize that the pending invention encompasses the patented invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 34-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates to inhibitors other than abiraterone, enzalutamide, apalutamide, darolutamide, cimetidine, orteronel, galeterone, seviteronel, tipilutamide, bicalutamide, fluamide, and nilutamide. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 34-39 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, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 34-39: Independent claim 1 and 26 are ambiguous because it is unclear what androgen receptor inhibitor agents (see independent claim 1) and what treatment agents are being referenced in independent claim 26. Thus, one cannot determine the metes and bounds of the pending invention. Furthermore, since claims 3, 6-9, 11-13, 16, 19-22, 32, and 34-39 depend upon independent claims 1 or 26, those claims are also vague and indefinite.
Note(s): The phrase, ‘one or more androgen receptor inhibitor agents’ appears in claims 1, 6, 7, and 16.
Claims 1, 3, 6-9, 11-13, 16, 19-22: Independent claim 1 is ambiguous because it is unclear what limitations are being applied to ascertain whether or not a subject exhibits prostate cancer progression. In addition, it is unclear whether or not the amount administered to the subject in line 8 of claim 1 is an “effective” amount or not. In addition, the claim is ambiguous because it is unclear if the phrase ‘suffering from’ in line 1 of claim 1 should be ‘has’. The phrase ‘suffering from’ may be interpreted as (1) a subject that has prostate cancer or (b) a subject that has prostate cancer that is not displaying symptoms or progression of the disease. Applicant is respectfully requested to amend the claim to clearly set forth what is the claimed invention.
In line 11, the phrase ‘longer intervals’ is confusing. Specifically, the phrase “longer intervals” is a relative phrase which renders the claim indefinite. The phrase “longer intervals” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, since 6-9, 11-13, 16, and 19-22, depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claims 1, 3, 6-9, 11-13, 16, and 19-22: Independent claim 1 is ambiguous because it is unclear if both (i) and (ii) are required or if it is (i) or (ii). In claim 1, line 3, should ‘and’ be ‘or’? Since claims 3, 6-9, 11-13, 16, and 19-22 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claim 3: The claim is ambiguous because of ‘and/or’ in line 3. The use of ‘and/or’ is not proper Markush terminology. Applicant’s attention is respectfully directed to MPEP 803.02.III for how one may write a Markush containing claim. In addition, it is noted that line 2 of the claim has the phrase ‘one or more’ before the listing of inhibitors; thus, ‘and/or’ in claim 4 is confusing.
Claims 3 and 6: The claims are ambiguous because of the phrase ‘exhibited cancer progression’. Specifically, the claims lacks limitations/parameters that must be met in order to determine whether or not the cancer has progressed or not. Without a standard of determining if a subject exhibits cancer progression or not, individuals reading the claim will independently apply different standards.
Claim 13: The claim is ambiguous because of the phrase ‘exhibits elevated PSA levels’. Specifically, the phrase is a relative term which renders the claim indefinite. The phrase is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 19 and 20: The claims are ambiguous because it is unclear if the phrase ‘suffering from’ in line 2 of the claims should be ‘has’. The phrase ‘suffering from’ may be interpreted as (1) a subject that has prostate cancer or (b) a subject that has prostate cancer that is not displaying symptoms or progression of the disease. Applicant is respectfully requested to amend the claims to clearly set forth what is the claimed invention.
Claim 21: The claim is ambiguous because of the phrase ‘one or more distinct chemotherapeutic agents’. In particular, it is unclear if Applicant is indicating that the agents are those that are different from lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA or if Applicant is referring to a particular grouping of chemotherapeutic agents and stating the agent may be one or more from a listing.
Claim 22: The claim is confusing because the structure in the claim is the same substance administered in claim 1 from which claim 22 depends. However, in claim 1, the complex is actually lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA, not “comprises” lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA. The use of ‘comprises’ in the claim results in the scope of claim 22 being broader than that of claim 1.
Claims 26, 32, and 34-39: Independent claim 26 is ambiguous because it is a product claim (kit) that incorporates active steps generally reserved for method/process claims therein. For example the complex must be suitable for administration to yield a desired dosage and assist subjects treated previously to yield certain results.
According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (kit), the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has the product or when the complex is used for intravenous administration and given to the subject in an amount that results in a dosage of 4-10 Gbq or when the treatment process is given to subjects having mCRPC that were previously treated with androgen receptor pathway inhibition.
Since claims 32 and 34-39 depend upon independent claim 26 for clarity, those claims are also vague and indefinite.
Claim 32: The claim is ambiguous because the dosage range is unclear. Specifically, the phrase ‘± 10% within shelf-life’ does not identify a specific endpoint for the dosage range because the claim does not set forth information that provides information on what is the shelf-life and the standard dosage present when the complex reaches shelf-life.
Claim 34: Did Applicant intend to replace ‘includes’ with ‘further comprises’? Specifically, in claim 26, it is not set forth that any other product components, except lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA is present. Thus, sodium ascorbate and sodium gentisate are additional components of the composition.
Claim 35: The phrase, ‘at end of synthesis and formulation of the pharmaceutical preparation’ are active steps generally reserved for process/method claims. Claim 35 is directed to a kit comprising the complex and instructions. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (kit), the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs.
Claim 38 and 39: The phrases ‘for handheld infusion administration’ and ‘the pharmaceutical preparation is transported’, respectively are directed to active steps of the kit components. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (kit), the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs.
103 Rejection
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over Chatalic et al (Theranostics, 2016, Vol. 6, No. 6, pages 849-861).
Independent claim 1 is directed to a method of treating a subject suffering from prostate cancer wherein the subject (i) has exhibited prostate cancer progression during or after treatment with one or more androgen receptor inhibitor agents and (ii) is chemotherapy-naive before treatment with the one or more androgen receptor inhibitor agents; said method comprising administering to the subject an amount of a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA providing from a 4 to 10 Gbq dose at least four times, at four week or longer intervals between doses.
Claim 3 is directed to the method of claim 1 wherein the subject has exhibited cancer progression during treatment with one or more of abiraterone, enzalutamide, apalutamide, darolutamide, cimetidine, orteronel, galeterone, seviteronel, topilutamide, bicalutamide, fluamide and nilutamide.
Claim 6 is directed to the method of claim 1 wherein the subject has exhibited cancer progression following at least two months of treatment with one or more androgen receptor inhibitor agents.
Claim 7 is directed to the method of any one of claim 1 wherein treatment with one or more androgen receptor inhibitor agents is the only chemotherapy administered to the subject before administering the lutetium-177 labeled PSMA-targeted radioligand.
Claim 8 is directed to the method of claim 1 wherein the subject is taxane chemotherapy-naive and/or taxane chemotherapy adverse.
Claim 9 is directed to the method of claim 1 wherein the identified subject exhibits elevated PSMA expression relative to a healthy subject.
Claim 13 is directed to the method of claim 1 wherein the identified subject exhibits elevated PSA levels.
Claim 16 is directed to the method of claim 1 wherein administration of one or more androgen receptor inhibitor agents is terminated before administering the complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA.
Claim 19 is directed to the method of claim 1 wherein the subject is suffering from metastatic castration-resistant prostate cancer (mCRPC).
Claim 20 is directed to the method of claim 19 wherein the subject is suffering from metastatic castration-resistant prostate cancer (mCRPC) with prostate- specific membrane antigen (PSMA)-avid lesions.
Claim 21 is directed to the method of claim 1 wherein the complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA is administered in combination with one or more distinct chemotherapeutic agents.
Claim 22 is directed to the method of claim 1 wherein the complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA comprises the structure therein.
Chatalic et al disclose the treatment of prostate cancer using a preclinical application of 177Lu-PSMA I&T, a DOTAGA chelated urea based PSMA inhibitor. The inhibitor is optionally coadministered with 2-PMPA (2-(phosphonomethyl)pentane-1,5-dioic acid). 177Lu-PSMA I&T alone showed signs of nephrotoxicity after 3 months of therapy (see entire document, especially, abstract).
Chatalic et al disclose that prostate cancer (PCa) is a major health problem in men and prognosis is dependent on stage of the disease and the five-year survival rated for advance disseminated PCa is only 29%. In addition, it is disclosed that metastatic castration resistant PCa (mCRPC) is associated with poor prognosis and diminished quality of life (page 849, ‘Introduction’). Treatment options for mCRPC subjects include taxane based therapies (e.g., docetaxel and cabazitaxel) and hormonal therapies (e.g., enzalutamide and abiterone). However, the therapies are only temporarily effective and development of treatment resistance is observed. Furthermore, Chatalic et al disclose that there is an urgent need to develop specific therapies that target PCa visceral lesions (page 850, left column, first paragraph. On page 850 (left and right columns, bridging paragraph), the results of various inhibitors are disclosed from various studies.
On page 850, Figure 1 discloses the structure of PSMA I&T which is identical to Applicant’s complex absent lutetium-177 attached thereto. PSMA I&T is radiolabeled with 177Lu (page 851, right column, first complete paragraph) and the labeling efficiency is determined by ITLC and radiochemical purity. The 177Lu labeled PSMA I&T is identical to Applicant’s claimed compound appearing in pending independent claims 1 and 26.
Dose escalation studies were conducted to optimize and evaluate dosing (page 852, left and right columns, bridging paragraph). Biodistributions date was also evaluated for 177Lu PSMA I&T (page 853, left column, first complete paragraph). 177Lu PSMA I&T was administered intravenously with and without 2-PMPA (an inhibitor) and results evaluated (page 853, left and right columns, bridging paragraph; page 853, right column, first complete paragraph; pages 854-855, bridging paragraph).
The therapeutic efficacy of 177Lu PSMA I&T alone and with 2-PMPA was evaluated as it relates to tumor growth (page 856, right column, first and second complete paragraphs). According to Chatalic et al, 177Lu PSMA I&T involved follow up of at least 6-months. The median dosage per cycle was 5.76 GBq (3.6-8.7 GBq) (page 857, left and right columns, bridging paragraph).
Thus, based on the disclosure of Chatalic et al, the limitations of claims 3, 6-9, 13, 16, and 19-22 are met.
Claim 11 is directed to the method of claim 1 wherein the identified subject exhibits PSMA expression standard uptake value (SUV)max >15 at one site of disease and/or SUVmax >10 at all measurable disease sites.
Claim 12 is directed to the method of claim 1 wherein the identified subject exhibits at least 1 positive lesion SUVmax >10.
In regards to claims 11 and 12, it would have been obvious to a skilled artisan prior to the effective date of the invention to optimize the disease data as both inventions disclose the administering of an identical complex and Chatalic et al disclose evaluating the date to obtain maximum results. In particular, according to MPEP 2112.01.II, it is disclosed that if the composition (complex) is identical between the pending invention and cited prior art , then products of identical chemical composition cannot have mutually exclusive properties. Thus, the (SUV)max variables would be identical as the same complex is administered alone and with an inhibitor.
Also, according to MPEP 2144.05.II, where 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. Thus, the optimum (SUV)max values are obvious modifications.
Independent claim 26 is directed to a kit comprising a pharmaceutical preparation of a complex of lutetium-177 and EuK-Sub-kf-iodo-y-DOTAGA and instructions.
Claim 32 is directed to the kit of claim 26 wherein the lutetium-177 EuK-Sub-kf- iodo-y-DOTAGA complex is provided in a single dose form sufficient to provide 6.8 GBq +/- 10% within shelf-life.
Claim 35 is directed to the kit of claim 26 wherein the pharmaceutical preparation has a radioactive concentration (RAC) of 0.5 to 1.2 GBq/mL.
Claim 36 is directed to the kit of claim 26 wherein the pharmaceutical preparation has a total peptide content of less than or equal to 250 pg, sum of EuK-Sub-kf-iodo-y-DOTAGA and lutetium-177 EuK-Sub-kf-iodo-y-DOTAGA complex.
In regards to independent claim 26 and claims depending thereupon, Chatalic et al disclose the preparation of EuK-Sub-kf-iodo-y-DOTAGA and radiolabeling it with 177Lu. Thus, providing both the complex and instructions to generate the complex. It would have been obvious to the skilled artisan that the approximate components are packaged until the need to generate the radiolabeled complex is needed. Hence, one inherently has a kit and kit components present. Thus, the limitations of claim 26 are met.
In regards to the specific properties of the complex disclosed in claims 32, 35, and 36, according to MPEP 2112.01.II, it is disclosed that if the composition (complex) is identical between the pending invention and cited prior art , then products of identical chemical composition cannot have mutually exclusive properties. Thus, the effective dosage, RAC, and total peptide would be identical as the same complex is administered alone and with an inhibitor to yield a desired result.
Thus, the limitations of claims 32, 35, and 36 are rendered obvious.
Claim 37 is directed to the kit of claim 26 wherein the pharmaceutical preparation is in a single dosage vial.
Claim 38 is directed to the kit of claim 26 wherein the pharmaceutical preparation is provided in a disposable syringe with syringe shield.
Claim 39 is directed to the kit of claim 26 wherein the kit includes a radiation shielded pig.
In regards to the limitations of claims 37, 38, and 39, it is duly noted that according to Chatalic et al, it is disclosed that the complex was administered by intravenous injection. The complex may be administered alone or in combination with an inhibitor (Chatalic et al, page 853, right column, first complete paragraph). Thus, the skilled artisan would recognize that the use a syringe is a common mode of administering compositions intravenously to a subject, like Applicant discloses intravenous administration in claim 26 from which claims 37-39 depend).
Thus, the limitations of claims 37-39 are rendered obvious by the cited prior art.
For the reasons set forth herein, the pending claims are rendered obvious by the teachings of Chatalic et al.
Comments/Notes
In claim 1, line 10, ‘week’ should be ‘weeks’?
For clarity of claim 36, it is respectfully requested that the claim be written as follows: “The kit of claim 26 wherein the EuK-Sub-kf-iodo-y-DOTAGA and lutetium-177 EuK-Sub-kf-iodo-y-DOTAGA complex has a total peptide content of less than or equal to 250 pg.
The Examiner is aware of numerous applications with similar subject matter. However, while every effort has been made to review all applications containing overlapping subject matter, some applications may have been missed. Thus, Applicant is respectfully requested to submit all serial numbers of applications containing overlapping subject matter for review by the Examiner.
Conclusion
Claims 1, 3, 6-9, 11-13, 16, 19-22, 26, 32, and 34-39 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
July 25, 2026
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