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 .
Title Warning
The title of the invention is not sufficiently descriptive. If a satisfactory title is not supplied by the applicant, the examiner may change the title on or after allowance. See MPEP 606.01.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it has fewer than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 4, 10, and 12 are objected to because of the following informalities:
Regarding claims 4, 10, and 12, the claims must not have bullet points. Hyphens (or other symbols representing a bullet point) must not be used to represent a bullet point.
Regarding claim 4, a colon must be added after "a compound of formula V".
Regarding claim 10, comma must be added before and after the limitation "each comprising a metal ion complex".
Appropriate correction is required.
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.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claim 1 recites the limitation "or a salt or solvate thereof" at the end of the claim. It is unclear whether this limitation modifies the immediately preceding limitation "C1-C6alkyl" or whether it modifies "A compound" or "formula I." While the grammar of the claim suggests that the limitation "or a salt or solvate thereof" modifies the immediately preceding noun, the salt of an alkyl group does not make sense. Dependent claims 3 and 20 recite "the compound of claim 1, or a salt or solvate thereof," and dependent claim 10 recites "a compound of formula I according to claim 1, or a salt or solvate thereof." If the limitation "or a salt or solvate thereof" in claim 1 refers to formula I, then the limitations of dependent claims 3, 10, and 20 encompass a salt of a salt and a solvate of a solvate, which is indefinite.
Dependent claims 2-8 and 10-20 are rejected for depending from indefinite claim 1.
Claim 4 recites the limitation "or salts or solvates thereof" at the end of the claim. It is unclear whether this limitation modifies "a compound of formula XIX:" or "the group consisting of."
Claim 8 recites the limitation "the compounds of formulae II-VI." There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitations "the compounds" [plural] and "the combination." There is insufficient antecedent basis for these limitations because the claim previously recites "in combination with one or more fluorogenic compounds."
Claim 10 recites the limitation "detecting fluorescence from the compound of formula I or, if present, the compounds of the combination, wherein the presence of fluorescence indicates the presence of the platinum complex in the test sample." There is not clear antecedent basis for the limitations "the presence of fluorescence," "the presence of the platinum complex," and "the platinum complex." The claim previously introduces the limitation "a platinum complex" twice within the limitations "A method for detecting a platinum complex" and "a test sample suspected of comprising a platinum complex." It is unclear whether the scope of the claim requires that the "test sample suspected of comprising a platinum complex" does in fact comprise a platinum complex, given the limitation "detecting fluorescence from the compound of formula I" appears to require a presence of fluorescence.
Claim 11 recites the limitation "the fluorescence response pattern." There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, the intended meanings of the limitations "as between" and "the fluorescence response pattern as between the test sample and the one or more reference samples" is unclear.
Claims 11 and 12 recite the limitation "the platinum complex in the test sample." There is insufficient antecedent basis for this limitation because claim 10 does not clearly set forth that the test sample must comprise a platinum complex, instead reciting "a test sample suspected of comprising a platinum complex."
Claim 12 recites the limitation "the fluorescence response pattern of the platinum complex in the test sample." There is insufficient antecedent basis for this limitation because claim 11 previously recites "the fluorescence response pattern of the test sample."
Claim 12 recites the limitations "the fluorescence response pattern of the reference sample," "the reference sample" [singular], and "the reference sample having the same concentration." There is insufficient antecedent basis for these limitations in the claim.
Claim 18 recites the limitation "the concentration of a platinum-containing drug in a subject." There is insufficient antecedent basis for this limitation because a subject is not inherently characterized by a single concentration of a substance. Instead, different tissue types may have different concentrations of the substance.
Claim 18 recites the limitation "the determining the concentration of the platinum-containing drug in the biological sample according to the steps of claim 10." There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 3-8, and 10-20 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a portion of the claimed subject matter, does not reasonably provide enablement for the full scope of the claimed subject matter.
Regarding claims 1, 3-8, and 10-20, the specification, while being enabling for Y being O or Se, does not reasonably provide enablement for Y being Si or Ge.
Regarding claims 1, 3-8, and 10-20, the specification, while being enabling for R3 and R4 being independently H or C1-C6alkyl when R1 is N, does not reasonably provide enablement for either of R3 and R4 being absent when R1 is N.
Regarding claims 1, 3-8, and 10-20, the specification, while being enabling for one of R3 and R4 being absent when R1 is O, does not reasonably provide enablement for none or both of R3 and R4 being absent when R1 is O.
Regarding claims 1, 3-8, and 10-20, the specification, while being enabling for R5 and R6 being independently H or C1-C6alkyl when R2 is N, does not reasonably provide enablement for either of R5 and R6 being absent when R2 is N.
Regarding claims 1, 3-8, and 10-20, the specification, while being enabling for one of R5 and R6 being absent when R2 is O, does not reasonably provide enablement for none or both of R5 and R6 being absent when R2 is O.
Regarding claim 5, the specification, while being enabling for the first through fifth and seventh structures of the claim, does not reasonably provide enablement for the sixth structure of claim 5.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use --the invention commensurate in scope with these claims.
Factors to be considered when determining whether the claimed invention would require undue experimentation are given in MPEP 2164.01 (a). In re Wands, 858 F. 2d 731,737; 8 USPQ 2d 1400, 1404 (Fed. Cir. 1988).
(A) The breadth of the claims.
Independent claim 1 recites formula I and the limitations "Y is selected from O, Si, Se and Ge; R1 and R2 are independently N or O; and R3-R6 are independently absent or H or C1-C6alkyl."
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Dependent claim 5 recites a sixth structure, which is reproduced below with annotation of the implicit hydrogen atoms at the saturated carbons of the fused ring.
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(B) The nature of the invention.
The invention is a fluorogenic compound for detecting platinum complexes, including anti-cancer drugs.
(C) The state of the prior art.
The prior art of Wang (CN108218880A) discloses the following derivative of rhodamine B:
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The prior art of Strongin (US 2016/0047830) discloses the following derivatives of rhodamine B, where R11 is N-C(═R13)-NH2 and R13 is S (pages 2-3):
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The prior art of Zhang ("Design and synthesis of a novel rhodamine-based chemosensor and recognition study to Fe3+," Heterocycl. Commun. 2016) discloses the following derivative of rhodamine B (Scheme 1):
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The prior art of Shen ("Fluorescent sensing of monofunctional platinum species," Chem. Commun., 2015,51, 6312-6314; IDS) discloses a fluorescein dithiocarbamic acid probe for sensing a platinum complex (Scheme 1).
The prior art of record does not disclose a compound related to formula I where Y is Si or Ge.
The prior art of record does not disclose a compound related to a compound of formula I where R1 is N and either of R3 and R4 is absent (or where R2 is N and either of R5 and R6 is absent).
The prior art of record does not disclose a compound related to a compound of formula I where R1 is O and none or both of R3 and R4 is absent (or where R2 is O and none or both of R5 and R6 is absent).
The prior art of record does not disclose a compound related to the sixth structure of claim 5 that has a partially saturated fused carbocycle ring system.
(D) The level of one of ordinary skill.
One of ordinary skill in the art would look for guidance in the specification and/or prior art for guidance as to how to prepare a compound of formula I where Y is Si or Ge; where R1 is N and either of R3 and R4 is absent (or where R2 is N and either of R5 and R6 is absent); or where R1 is O and none or both of R3 and R4 is absent (or where R2 is O and none or both of R5 and R6 is absent). One of ordinary skill in the art would understand that such compounds violate ordinary valence rules.
One of ordinary skill in the art would look for guidance in the specification and/or prior art for guidance as to how to prepare the partially saturated fused ring moiety of the sixth structure of claim 5.
(E) The level of predictability in the art.
The level of predictability in organic chemistry depends upon the similarity of the structures being prepared. Predicting valence rules has a high level of predictability.
(F) The amount of direction provided by the inventor.
No guidance is provided by the inventor regarding how to prepare compounds of the rejected scope of formula I or the sixth structure of claim 5.
(G) The existence of working examples.
A working example is provided of a compound of formula Ia (claim 2).
No working examples are provided of a compound of formula I where Y is Si or Ge.
No working examples are provided of a compound of formula I where R1 is N and either of R3 and R4 is absent (or where R2 is N and either of R5 and R6 is absent).
No working examples are provided of a compound of formula I where R1 is O and none or both of R3 and R4 is absent (or where R2 is O and none or both of R5 and R6 is absent).
No working examples are provided of the sixth structure of claim 5.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In view of the lack of direction provided by the inventor and the prior art, it would have required undue experimentation for one of ordinary skill in the art before the time of filing to make and use the rejected scope of the claims.
Allowable Subject Matter
Claim 2 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action. If put in independent form, the rewritten claim 2 must not include broader or redundant limitations recited in claim 1.
The prior art of record, including the closest prior art of Wang (CN108218880A) and Strongin (US 2016/0047830), do not disclose the compound of formula Ia, or a salt or solvate thereof. While this prior art discloses derivatives of rhodamine B, it does not teach or suggest modification of these disclosed derivatives of rhodamine B to provide the compound of formula Ia, or a salt or solvate thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE ADAMS whose telephone number is (571)270-5043. The examiner can normally be reached M, T, Th, and F, 12-4 P.M.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE ADAMS/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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