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 .
Response to Amendment
Amendments to the ADS, abstract and claims filed on 28 May 2026 are acknowledged. Claim 4 has been amended without mark-up to remove the limitation "the group consisting of." Claims 1, 3-5, 8, 10-13, 18, and 20 are amended, and claims 21-24 are newly added. Claims 1-8 and 10-24 are pending and are examined herein on the merits.
In response to the amendments filed on 28 May 2026, the title warning is withdrawn; the objection to the abstract is withdrawn; the objections to the claims are changed; rejections under 35 U.S.C. 112(a) regarding the written description requirement are added; the rejections under 35 U.S.C. 112(b) are partially withdrawn and supplemented; and the rejections under 35 U.S.C. 112(a) regarding scope of enablement are withdrawn. Claim 2 is allowable.
Claim Objections
Claims 10 are objected to because of the following informalities:
Regarding claim 10, the limitation "the one or more compounds" must be changed to "the one or more fluorogenic compounds," if this is the intended meaning.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10-24 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
The examiner respectfully reminds the Applicant that according to MPEP §2163:
"2163.02. Standard for Determining Compliance with Written Description Requirement:
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”).
Independent claim recites formula I and has been amended to recite the limitation
"Y is selected from O, Si(CH3)2, Se and Ge(CH3)2."
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The original disclosure, including original claim 1, states that Y could be Si or Ge, which one of ordinary skill in the art would understand to violate ordinary valence rules.
The original disclosure does not support a compound of Formula I where Y is Si(CH3)2 or Ge(CH3)2. No examples are provided of a compound of formula I that comprises the elements silicon or germanium, let alone the choice of Y being Si(CH3)2 or Ge(CH3)2 in Formula I. Accordingly, the amendment to recite the choice of Y being Si(CH3)2 or Ge(CH3)2 in Formula I is new matter.
In Applicant's arguments filed on 28 May 2026, Applicant argues that written description support for the amendment is provided by the disclosure of silicon rhodamine in paragraph [0041] the specification (reproduced below with added bolding):
As used herein, the term “fluorophore” refers to a chemical moiety that emits light following excitation. Any suitable fluorophore may be used. Suitable fluorophores include, but are not limited to rhodamine and derivatives thereof, such as rhodamine B, rhodamine 6G, rhodamine 123, tetramethylrhodamine and silicon rhodamine, fluorescein and derivatives thereof, and coumarin and derivatives thereof.
None of the fluorophores listed in this paragraph, including silicon rhodamine, are an example of the compound of Formula I. Accordingly, the disclosure of silicon rhodamine does not support a compound of Formula I where Y is Si(CH3)2. Furthermore, the disclosure of silicon rhodamine provides no relevant support for a compound of Formula I where Y is Ge(CH3)2.
None of the fluorophores listed in this paragraph, including silicon rhodamine, are an example of the compound of Formula I. Accordingly, the disclosure of silicon rhodamine does not support a compound of Formula I where Y is Si(CH3)2. Furthermore, the disclosure of silicon rhodamine provides no relevant support for a compound of Formula I where Y is Ge(CH3)2.
Therefore, the Applicants did not show possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention, by description of an actual reduction to practice, or by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention.
Dependent claims 3-8 and 10-24 are rejected for encompassing the full scope of formula I of claim 1, including the rejected choices of Y being Si(CH3)2 or Ge(CH3)2.
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 4-7, 10-19, and 21-24 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.
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:" in the penultimate line of text or "one or more compounds" in the third line of the claim.
Dependent claims 5-7 are rejected for depending from indefinite claim 4.
Claim 10 recites the limitation "the combination" twice. There is insufficient antecedent basis for this limitation because the claim previously recites "in combination with one or more fluorogenic compounds," which uses the word "combination" in a different manner.
Claim 10 recites the limitation "exposing the test sample to a source of light sufficient to excite the compound of formula I or, if present, the one or more compounds of the combination." The claim previously recites "the compound of formula I according to claim 1 optionally in combination with one or more fluorogenic compounds." Accordingly, the limitation "the one or more compounds" is interpreted to have antecedent basis in the limitation "one or more fluorogenic compounds." It is unclear whether the claim means that if the one or more [fluorogenic] compounds are present, the claim requires exposing the test sample to a source of light sufficient to excite the one or more fluorogenic compounds but does not require that the source of light is sufficient to excite the compound of formula I.
Claim 10 recites the limitation "detecting a fluorescence from the compound of formula I or, if present, the one or more compounds of the combination." The claim previously recites "the compound of formula I according to claim 1 optionally in combination with one or more fluorogenic compounds." Accordingly, the limitation "the one or more compounds" is interpreted to have antecedent basis in the limitation "one or more fluorogenic compounds." It is unclear whether the claim means that if the one or more [fluorogenic] compounds are present, the claim requires detecting a fluorescence from the one or more fluorogenic compounds but does not require detecting a fluorescence from the compound of formula I.
Claim 10 recites the limitation "the fluorescence." There is insufficient antecedent basis for this limitation in the claim. The claim previously recites "detecting a fluorescence from the compound of formula I or, if present, [from] the one or more compounds of the combination." Accordingly, the claim previously recites either (i) a fluorescence from the compound of formula I or (ii) a fluorescence from the one or more compounds. It is unclear to which limitation "the fluorescence" refers.
Dependent claims 14-17 are rejected for depending from indefinite claim 10.
Claim 11 recites the limitation "the compounds." There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the fluorescence response pattern of the test sample." There is insufficient antecedent basis for this limitation in the claim. Dependent claim 13 also recites this limitation.
Claim 11 recites the limitation "a difference in the fluorescence response pattern between the test sample and the one or more reference samples." There is insufficient antecedent basis for the limitation "the fluorescence response pattern" because here it refers both to "the test sample" and "the one or more reference samples." In other words, the term "fluorescence response pattern" is being used in a different manner here than earlier in the claim.
Dependent claims 12, 13, 18, and 19 are rejected for depending from indefinite claim 11.
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 in the claim.
Claim 18 recites the limitation "the step of..." There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the biological sample obtained from the subject during the treatment regimen." There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the determining the concentration of the platinum-containing drug in the biological sample according to the method of claim 12." There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites "determining a concentration of the platinum complex in the test sample."
Claim 18 recites the limitation "A method… comprising the step of providing the biological sample … prior to the determining the concentration of the platinum-containing drug in the biological sample according to the method of claim 12." It is unclear whether the scope of claim 18 requires a step of "determining the concentration of the platinum-containing drug in the biological sample according to the method of claim 12." Claim 18 is indefinite because while it depends from claim 12, claim 18 does not clearly require all of the limitations of claim 12.
Claim 21 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:" in the penultimate line of text or "one or more compounds" in the third line of the claim.
Dependent claims 22-24 are rejected for depending from indefinite claim 21.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form without the broader or redundant limitations recited in claim 1.
The prior art of record, including the closest prior art of Wang (CN108218880A; previously cited) and Strongin (US 2016/0047830; previously cited), 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.
Response to Arguments
Applicant's arguments filed on 28 May 2026 have been considered and are not fully persuasive and/or are moot in view of the new grounds of rejection.
Applicant states that " Support for the amendments and the new claims can be found throughout the Application and Figures as originally filed, for example, in paragraphs [0022], [0086]-[0087]." However, these portions of the original disclosure do not support the subject matter that is rejected under 35 U.S.C. 112(a) regarding the written description requirement.
Applicant further argues the following (page 16; bolding added):
Applicant respectfully submits that the skilled person would have readily appreciated that the references to Y = Si and Ge did not satisfy valency rules, and that in related scaffolds for atoms of valency equivalent to Si and Ge, these should be substituted with methyl groups. Consistent with this, at paragraph [0041] the specification refers to silicon rhodamine, which includes a dimethyl silyl group at the corresponding position to Y in formula (I). The skilled person would therefore reasonably infer that the references to Y = Si and Ge throughout the application must refer to Si(CH3)2 or Ge(CH3)2, respectively. It is further submitted that the person skilled in the art is able to access such compounds by known routes.
Relevant guidance to this argument is set forth in MPEP 2163.07, II:
An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971).
While the Examiner agrees that the original references to Y = Si and Ge can be categorized as an obvious error, the Examiner disagrees that the "appropriate correction" would be recognized by one skilled in the art as Y = Si(CH3)2 or Ge(CH3)2, given that many different substituents on Si and Ge are possible that would satisfy valency rules. It is not implicit or inherent that only two methyl substituents can correct the valence error. Given that there is no teaching in the original disclosure that Y of Formula (I) is Si(CH3)2 or Ge(CH3)2, the amendment constitutes new matter.
Applicant's argument that references to Y = Si and Ge throughout the application "must" refer to Si(CH3)2 or Ge(CH3)2 is clearly unpersuasive. In support of this argument, Applicant cites paragraph [0041] the specification, which is reproduced below:
As used herein, the term “fluorophore” refers to a chemical moiety that emits light following excitation. Any suitable fluorophore may be used. Suitable fluorophores include, but are not limited to rhodamine and derivatives thereof, such as rhodamine B, rhodamine 6G, rhodamine 123, tetramethylrhodamine and silicon rhodamine, fluorescein and derivatives thereof, and coumarin and derivatives thereof.
None of the fluorophores listed in this paragraph, including silicon rhodamine, are an example of the compound of Formula I. Accordingly, the disclosure of silicon rhodamine does not support a compound of Formula I where Y is Si(CH3)2. Furthermore, the disclosure of silicon rhodamine provides no relevant support for a compound of Formula I where Y is Ge(CH3)2.
Regarding written description support for the fifth compound of claims 5 and 22, Applicant argues that "there was an obvious mistake in the structure of the compound, which is corrected in the amended claims" (page 16). The examiner agrees that one skilled in the art would not only recognize the existence of the error, but would also recognize the appropriate correction as being found in amended claim 5 and new claim 22. See MPEP 2163.07, II. Accordingly, the amendment to claim 5 and the stand-alone limitations of new claim 22 have sufficient written description support.
Applicant's arguments do not specifically traverse the maintained grounds of rejection under 35 U.S.C. 112(b).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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