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 IDS filed on 03/10/2023, 08/15/2023, 01/25/2024, 01/29/2024, 02/12/2024, 02/15/2024, and 11/15/2024.
Claims 1-20 are pending.
Claims 12-19 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/08/2025 is acknowledged.
Claim Rejections - 35 USC § 112
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 4, 6, 7, 8 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.
Claim 1, recites that “the chemical reaction does not result in the formation of a new bond on the radionuclide”, however claim 4 recites “attaching a biological moiety to the deprotected radioactive compound” which would be the formation of a new bond. This goes against the limitation set forth in claim 1. For compact prosecution purposes, the limitation of “the chemical reaction does not result in the formation of a new bond on the radionuclide” only applies for steps (a) and (b) listed in claim 1 and not the steps following the steps (a) and (b).
The dependent claims fall therewith.
Claims 2-11 and 20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “comprises the use of an acid selected from the group consisting of phosphoric acid, hydrochloric acid, sulfuric acid, trifluoroacetic acid, and aqueous mixtures thereof”, and the claim also recites "optionally wherein said acid is 80 wt% phosphoric acid" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
This type of indefiniteness is also present in claims 4, 5, 7-9.
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.
Claims 1-4, 6, 9 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHI (US 9,550,704 B2).
Regarding claim 1, CHI teaches a method of performing a chemical a chemical reaction of a radioactive compound comprised in a mixture, wherein said method comprises the following steps:
A radioactive solution is passed through a non-soluble polymer-filled cartridge, the polymer includes silica, which reads on a solid phase (claim 1), this step reads on (a) contacting said mixture with a solid phase.
The cartridge is heated to 120° C (column 26, paragraph 3), which reads on (b) heating said mixture to a temperature selected in the range from 30°C up to 150°C.
No alkaline solution is listed in the experiment, which reads on wherein steps (a) and (b) do not involve contacting said solid phase with an alkaline solution,
The silica gel used is C-18 (column 19, paragraph 2), which is used by Applicant (instant claim 20). This type of silica does not form new bonds, but simply traps the radioisotope, which reads on wherein said chemical reaction does not result in the formation of a new bond on a radionuclide comprised in said radioactive compound. Furthermore, radioisotope-labeled compound is deprotected from the cartridge (claim 8 and 9) which means it does not result in the formation of a new bond on the radionuclide.
The radioisotope can be chosen from a list which includes iodine-131 (claim 1), which reads on wherein said radioactive compound does not comprise fluorine-18.
Regarding claim 2, CHI teaches the solid phase within the cartridge traps the radioisotope (claim 1). The radioisotope is eluted from the cartridge using a solution (claim 1 and column 26, paragraph 3).
Regarding claims 3 and 4, CHI teaches an acid can be used, such as hydrochloric acid to deprotect the radioisotope (claim 8 and 9). The chemical reaction are promoted using hearing (column 14, paragraph 7).
Regarding claim 6, CHI teaches the deprotected radioisotope can be further conjugated to a disease targeting compound (claim 15). The disease targeting compound comprises a biological compound (column 13, paragraph 3).
Regarding claim 9, CHI teaches the radioisotope can be chosen from a list which includes iodine-131 (claim 1).
Regarding claim 20, CHI teaches the solid phase polymer includes silica (claim 1).
Additional disclosures: the resultant radioactive compound is used to specifically target and image diseases (column 1, paragraph 2).
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.
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 1-6, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CHI (US 9,550,704 B2).
CHI teaches Applicant’s invention as discussed above including: Regarding claim 5, CHI teaches the reaction is heated for 15 minutes (column 26, paragraph 3) to facilitate the reaction.
CHI does not specifically teach using the temperature claimed by Applicant.
The reference does not specifically teach the temperature used as claimed by the Applicant. The temperature 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 the ordinary skill to determine the optimal temperature in order to best achieve desired results, such as heating the reaction to a proper temperature to facilitate the reaction to run to completion as it is well known in the art that heat is a catalyst for many reactions. Furthermore if the temperature is too high it can destroy the precursors and the reaction as a whole and if it is too low then the reaction can take a long time. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the temperature would have been obvious at the time of Applicant’s invention.
Claims 1-9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CHI (US 9,550,704 B2) in view of D’HUYVETTER (131I-labeled Anti-HER2 Camelid sdAb as a Theranostic Tool in Cancer Treatment. Clin Cancer Res. 2017.).
CHI teaches Applicant’s invention as discussed above.
CHI does not teach conjugating the compound to an antibody.
Regarding claims 7 and 8, D’HUYVETTER teaches attaching 131-I to a Camelid single-domain antibody-fragments (sdAbs) that targets HER2, which is used to target and image cancer (abstract), which is a disease. The antibody fragment is derived from heavy-chain-antibodies, also known as a VHH (page 2, paragraph 4) and is considered a disease targeting biological compound. This targeting compound has high stability and exceptionally specific targeting properties (page 2, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate attaching the radioisotope to an antibody fragment. The person of ordinary skill in the art would have been motivated to make those modifications, because it has high stability and exceptionally specific targeting properties, and reasonably would have expected success because the resultant radioactive compound made in CHI is used to specifically target and image diseases and is conjugated to a disease targeting biological compound.
Claims 1-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CHI (US 9,550,704 B2) and D’HUYVETTER (131I-labeled Anti-HER2 Camelid sdAb as a Theranostic Tool in Cancer Treatment. Clin Cancer Res. 2017.) in view of VAIDYANATHAN (A Polar Substituent-Containing Acylation Agent for the Radioiodination of Internalizing Monoclonal Antibodies: N-Succinimidyl 4-Guanidinomethyl-3-[131I]iodobenzoate ([131I]SGMIB. Bioconjugate Chem. 2001.).
CHI and D’HUYVETTER teach Applicant’s invention as discussed above.
CHI and D’HUYVETTER do not teach converting N-succinimidyl-4-(1,2- bis(tert-butoxycarbonyl)guanidino)methyl-3-[(131)I]iodobenzoate (Boc2-[1311]SGMIB) to N-succinimidyl-4-guanidinomethyl- 3-[(131)I]iodobenzoate 11]SGMIB.
Regarding claims 10 and 11, CHOI teaches converting N-succinimidyl-4-(1,2- bis(tert-butoxycarbonyl)guanidino)methyl-3-[(131)I]iodobenzoate (Boc2-[1311]SGMIB) to N-succinimidyl-4-guanidinomethyl- 3-[(131)I]iodobenzoate 11]SGMIB) in a yield of 60-65% (abstract). This reaction is done through deprotection of the precursor to achieve the product. The resultant product was then labeled with antibodies (abstract). The compound showed enhanced retention in tumor cells (page 437, paragraph 3).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using Boc2-[1311]SGMIB and converting it to N-succinimidyl-4-guanidinomethyl- 3-[(131)I]iodobenzoate 11]SGMIB). The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success, because the radioisotope Boc2-[1311]SGMIB and the 131-I used in CHI are functional equivalents of 131-I radioisotopes that are deprotected and then further labeled to target diseases. Furthermore, using this reactant/product combination resulted in a good yield and showed enhanced retention in tumor cells.
The reference does not specifically teach the amount of time the compound is heated used as claimed by the Applicant. The amount of time the compound is heated 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 the ordinary skill to determine the optimal amount of time the compound is heated in order to best achieve desired results, such as heating the reaction long enough to facilitate the reaction to run to completion as it is well known in the art that heat is a catalyst for many reactions. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the amount of time the compound is heated would have been obvious at the time of Applicant’s invention.
Conclusion
No claims are allowable.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618