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 .
Detailed Action
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/25 has been entered.
Claims 8, 41-44 and 46-60 are pending and under examination. Applicant has amended claims 8 and 41-44 and added new claims 46-60.
Claim Rejections – 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 103 (or as subject to pre-AIA 35 U.S.C. 103) is incorrect, any correction of the statutory basis 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148
USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 1 03(a) are summarized as follows:
Applicant Claims
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.
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 8, 41-44 and 46-60 are rejected under 35 U.S.C. 103(a) as being unpatentable over Jain et al. (US 20150250906, pub date Sep. 10, 2015), as evidenced by Rosman et al. (IUPAC Subcommittee for Isotopic Abundance Measurements; Pure Appl.Chem, 1999, 71, 1593).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Jain et al. teaches forming compositions of labelled substrates with a carrier (paragraphs 54-61 and claim 25).
One of Jain et al.’s labelled substrates is the fluorine-18 (labeled) derivative of p-aminobenzoic acid (PABA), 2-Fluoro-PABA, along with mixtures containing both with a carrier (Figure 2; examples; paragraph 42-43, 108; claims 19, 20, 25).
Jain et al. teaches the equivalency of 18F and 19F labelled isotopes (paragraph 42).
To further clarify Jain et al.’s teaching:
Jain et al. teaches “labeled substrate is labeled with a radionuclide” and “labeled substrate is in the form of a pharmaceutical composition comprising the labeled substrate and a pharmaceutically acceptable carrier” (claims 20 and 25). Jain et al. teaches “addition of excess unlabelled tracer blocked accumulation of M. tuberculosis-associated activity, indicating that PABA uptake was saturable and specific” and “to further assess the specificity of uptake, E. coli cultures were co-incubated with [.sup.18F]FDS and increasing concentrations of unlabeled sorbitol” (examples 2 and 4).
Jain et al. teaches ”By "detectable label(s) or moieties" is meant a composition that when linked to a molecule of interest renders the latter detectable, via spectroscopic, photochemical, biochemical, immunochemical, chemical means or other imaging means. For example, useful labels include radioactive isotopes, magnetic beads, metallic beads, colloidal particles, fluorescent dyes, electron-dense reagents, enzymes (for example, as commonly used in an ELISA), biotin, digoxigenin, or haptens. Specific radioactive labels include most common commercially available isotopes including, for example, .sup.3H, .sup.11C, .sup.13C, .sup.15N, .sup.18F, .sup.19F, .sup.123I, .sup.124I, .sup.125I, .sup.131I, .sup.86Y, .sup.89Zr, .sup.111In, .sup.94mTc, .sup.99mTc, .sup.64Cu and .sup.68Ga.” (paragraph 42)
Jain et al. also teaches “In accordance with an embodiment, the labeled substrates of the present invention include .sup.18F labeled substrates. Examples of such substrates include, but are not limited to, 2 -fluoro-PABA, 3 -fluoro-PABA, and 2-fluoro-mannitol. Other fluorinated substrates identified here are also within the scope of the present invention.” (paragraph 43)
Jain et al. teaches radiochemical purities were determined by analytical HPLC. (paragraph 95)
Jain et al. specifically teaches fluorine-18 (labeled) derivative of 2-Fluoro-PABA (paragraph 43) whose structure is as follows:
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131
79
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Jain et al. exemplifies the core PABA structure is as follows and its target pathway (Figure 2, first row; claim 19):
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190
613
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Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Jain et al. is deficient in the sense that it does not exemplify the composition with the 19F isotope, along with the 18F isotope.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
However, it would be prima facie obvious to one of ordinary skill in the art at the time of the invention, to include the 19F isotope with the 18F isotope in Jain et al.’s composition of 4-amino-2-fluorobenzoic acid, since Jain et al. teaches the equivalency of both the 19F and 18F isotopes, and because the 19F isotope is the naturally occurring isotope of fluorine which is usually present at 100% abundance (see row number 9, Fluorine of Rosman et al. evidentiary reference). Thus it would be reasonable to expect both the 18F and 19F isotopes to be present in Jain et al.’s composition of 4-amino-2-fluorobenzoic acid, because Jain et al. teaches the equivalency of the two isotopes and because of the high natural occurrence of the 19F natural isotope of fluorine. Furthermore, since Jain et al. teaches addition of excess unlabeled tracer and using an unlabeled compound (e.g. sorbitol) to assess specificity of uptake into E. coli cultures, it would be reasonable to vary the ratio of fluorine labeled and unlabeled isotope in order to assess the specificity of uptake into E. coli cultures.
With regard to applicant’s claim limitations for the process of forming 2-Fluoro-PABA, since Jain et al.’s 2-Fluoro-PABA compound is the same structure as applicant’s compound, this would still read on applicant’s process for preparing their 2-Fluoro-PABA composition. Thus, the process of making the 2-Fluoro-PABA compound would have no impact on the process for preparing the overall composition as claimed.
Furthermore, since Jain et al. teaches formation of compositions of labelled substrates of 2-Fluoro-PABA with a carrier, it is obvious to prepare these specific compositions of 2-Fluoro-PABA.
With regard to applicant's limitation regarding the ratio of labeled and unlabeled compound and the radiochemical purity of the labeled compound, it is the position of the examiner that one of ordinary skill in the art, at the time of the invention, would through routine and normal experimentation determine the optimization of this limitation to provide the best effective variable depending on the result desired. Because Jain et al. teaches radiochemical purities and using both the labeled and unlabeled compounds in their assays, the examiner asserts that the ratio of labeled and unlabeled compound and the radiochemical purity are art recognized result-effective variables. Thus it would be obvious in the optimization process to optimize the ratio of labeled and unlabeled compound and the radiochemical purity. The applicant does not show any unusual and/or unexpected results for the limitations stated. Note that the prior art provides the same effect desired by the Applicant, the formation of compositions of labeled 2-Fluoro-PABA with a carrier.
Response to Arguments
Applicant’s arguments have been considered but are not persuasive for the following reasons:
The examiner acknowledges applicant’s that Jain et al. does not teach the method of preparing 2-Fluoro-PABA.
With regard to applicant’s claim limitations for the process of forming 2-Fluoro-PABA, since Jain et al.’s 2-Fluoro-PABA compound is the same structure as applicant’s compound, this would still read on applicant’s process for preparing their 2-Fluoro-PABA composition. Thus, the process of making the 2-Fluoro-PABA compound would have no impact on the process for preparing the overall composition as claimed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
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Jennifer Cho Sawyer
Patent Examiner
Art Unit: 1691
/RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691