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 specification and claims filed on 30 October 2025 are acknowledged. Claims 68-72, 74-80, 82-84, 86, 87, 90, 91, 93, 94, 95, and 98-103 are amended, and claims 81, 85, and 97 are newly canceled. Claims 68-80, 82-84, 86-96, and 98-104 are pending; claim 104 is withdrawn; and claims 68-80, 82-84, 86-96, and 98-103 are examined herein on the merits.
In response to the amendments filed on 30 October 2025, the objections to the specification are changed; the objections to the claims are partially withdrawn and modified; the rejections under 35 U.S.C. 112(a) regarding the written description requirement are partially withdrawn; the rejections under 35 U.S.C. 112(a) regarding the enablement requirement are partially withdrawn; and the rejections under 35 U.S.C. 112(d) are partially withdrawn and modified.
Specification
The amendment filed 30 October 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The specification has been amended to remove parts of the original disclosure, and therefore introducing new matter by changing the teachings of the original disclosure.
In paragraph [0010], structures (4) and (5) and a subset of the definitions of the Rn groups have been removed.
In paragraph [0011], a subset of the definition of the R6 group has been removed.
Applicant is required to cancel the new matter in the reply to this Office Action by restoring the indicated subject matter to the specification.
Claim Objections
Claims 68-70 and 94 are objected to because of the following informalities:
Regarding claim 68, hyphens (or other symbols representing bullet points) must not be used.
Regarding claims 68 and 94, the limitation "structure (1), (2), and (3)" must be changed to "structures (1), (2), and (3)" or "structure (1), structure (2), and structure (3)."
Regarding claim 69, in the definition of R7, the final choice should be preceded by "or." In the alternative, standard Markush grouping language should be used ("R7 is selected from a group consisting of A, B, … and Z").
Claim 70 recites the limitation "wherein the sulfonic acid and the salt thereof is selected from group 1 and is a substance according to structure (1)." The limitation "is selected from group 1" is redundant.
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.
Claim 69 and 101-103 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”).
The original disclosure sets forth two distinct embodiments. The first aspect of the invention involves at least one molecular sensor selected from a triarylamine, a biphenyl diamine, a benzene diamine, and/or a diaryl benzamide ([0005] of published application). In a second aspect of the invention, the molecular sensor is a triarylborane dye (ibid.).
All of the pending claims recite that molecular sensor is a triarylborane dye and therefore are drawn to the second aspect. None of the claims recite combination with an additional molecular sensor that drawn to the first aspect.
(A)
Claim 69 has been amended to recite the indefinite limitation "group 1 or an ester, or an amide, or a salt thereof."
The original disclosure teaches "the sulfonic acid is a naphthalenedisulfonic acid according to structure (4) and (5), i.e. one of said acids and/or an ester, an amide or a salt thereof." ([0033] of published application; original claim 44).
The original disclosure does not support an ester or an amide of structure (1), of structure (2), or of structure (3), which are members of group 1. This is new matter.
(B)
Non-original claim 101 recites the limitations "detecting at least one of the analytes qualitatively or quantitatively by measuring an enhancement or a decline of the intensity" and "wherein triacetone triperoxide is detected by at least one of a fluorescence attenuation at the first mixed layer …."
The closest support is the broad specification teaching of "detecting at least one of the analytes qualitatively and/or quantitatively by measuring an enhancement or a decline of the intensity" ([0173] of published application). However, sufficient written description support for measuring a decline or attenuation in fluorescence intensity is limited to the disclosed first aspect. In contrast, the specification teaches that exposure of a first mixed layer comprising a triarylborane causes fluorescence enhancement ([0005], [0098], [0202], [0203] of published application; Figs. 7 and 7A), contrary to the highlighted limitations. The specification teaches the following ([0005] of published application):
Depending on their nature, the selected molecular sensor provided in a mixed layer has a high selectivity and sensitivity to peroxidic explosives and hydrogen peroxide as indicated by means of either fluorescence “dim-down”/fluorescence attenuation (first aspect) or “light-up”/fluorescence amplification (second aspect) upon contact of the mixed layer with the analyte.
Accordingly, the highlighted limitations do not comply with the written description requirement in combination with a sensor according to claim 68.
Dependent claims 102 and 103 are rejected for depending from claim 101.
(C)
Non-original claim 101 recites the limitation "wherein triacetone triperoxide is detected by … a fluorescence enhancement at the second separate layer."
The second separate layer of a sensor according to claim 68 is also identified by the specification as a catalyst layer, as opposed to a sensor layer. The original disclosure does not disclose detection of a peroxide analyte by fluorescence enhancement at the second separate layer (or catalyst layer) for the embodiment of second aspect (the molecular being a triarylborane). This is new matter.
As shown in Fig. 7, the acidic catalyst layer shows no fluorescence enhancement upon reaction with TATP ([0202] of published application).
Dependent claims 102 and 103 are rejected for depending from claim 101.
(D)
Non-original claim 102 recites the limitation "wherein detecting the intensity comprises at least one of measuring an attenuation by absorption of at least a part of an excitation light and by absorption of at least a part of an emission light within or by at least one layer of the at least one sensor."
Verbatim antecedent basis for this stand-alone limitation in the original disclosure is provided in the specification ([0175] of published application). Further explanation is provided by the specification ([0183]-[0185] of published application; bolding added):
In other words: Upon exposure to hydrogen peroxide or TATP, DADP, HMTD, a reaction in the sensor layer is initiated, which leads to a formation of an oxidised triarylamine species, which shows a broad absorption spectrum from 400-550 nm and 600-850 nm. This analyte-specific light absorbing species absorbs the fluorescence of the used dye, such that a decrease in fluorescence can be measured. Absorption spectra of triphenylamine in the sensor layer after exposure to hydrogen peroxide or TATP is shown in FIG. 1.
In yet other words: According to an embodiment the sensor after or while being in contact with the analyte containing gas is exposed to an excitation light (which is emitted, e.g., by a suitable LED). The excitation light is directed through or on the sensor, thus exciting a fluorescent compound whose fluorescence is absorbed by a dye present in or adjacent to a so called “first mixed layer” after reaction with the analyte. Throughout the measurement said fluorescent compound, i.e. the dye, is excited by the excitation light and thus yields a base line with the detector. Said base line serves as a starting line to measure fluorescence quenching (=attenuation=dim-down). If the analyte upon contact with the sensor layer is converted, the fluorescence of the dye is (at least partially) absorbed by the first mixed layer and a decrease of fluorescence intensity can thus be detected. However, the dye itself remains unaffected within the sensor layer or adjacent thereto, as explained above.
Advantageously, the broad absorption of oxidized triarylamines e.g. triphenylamine allows the application of broad range of fluorescent dyes as emission source.
Accordingly, sufficient written description support for the stand-alone limitations of claim 102 are limited to the embodiment of the first aspect. The claimed combination of the embodiment of second aspect (the molecular being a triarylborane) with these limitations does not comply with the written description requirement.
(E)
Non-original claim 103 recites the limitation "wherein the provided at least one sensor comprises a fluorescent dye, which is either homogenously distributed within the first mixed layer or which constitutes a first separate layer on top or beneath the first mixed layer, wherein the fluorescent dye is characterized by an absorption maximum within a range selected from: 340-450 nm…"
Verbatim antecedent basis for a portion of this stand-alone limitation in the original disclosure is provided in the specification ([0178] of published application). However, this teaching regarding the fluorescent dye is directed to the first aspect of the disclosure (aspect 1) with a triarylamine molecular probe ([0005], [0063], [0071]-[0074], [0150], [0159], [0185] of published application; see also original claim 14, which depends from original claim 12). Closest support for the remainder of the limitation is found in the specification ([0071] of published application) and original claim 14 (which depends from original claim 12), which is taught with a different range ("340-550 nm") as well as being directed to the first aspect of the disclosure with a triarylamine molecular probe.
Accordingly, sufficient written description support for the stand-alone limitations of claim 102 highlighted above are limited to the embodiment of the first aspect. The claimed combination of the embodiment of second aspect (the molecular being a triarylborane) with these limitations does not comply with the written description requirement.
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.
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 94-96 and 98-100 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the non-rejected choices of R1-R5, does not reasonably provide enablement for R1-R5 being selected from I(OH)3. 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 94 recites a sulfonic acid selected from structure 1, which is a phenyl ring having substituents that include R1-R5. The scope of R1-R5 includes selection from I(OH)3, which is the basis of this rejection.
The scope of dependent claims 95, 96, and 98-103 permit the choice of a sulfonic acid of structure (1) having at least one substituent selected from I(OH)3.
(B) The nature of the invention.
The invention is a sensor for the detection of peroxide analytes.
(C) The state of the prior art.
A search of the prior art provided no examples of a phenyl group having a I(OH)3 substituent.
(D) The level of one of ordinary skill.
One of ordinary skill in the art would look to the prior art and specification for guidance on how to prepare the claimed sulfonic acid of structure (1) having a I(OH)3 substituent.
(E) The level of predictability in the art.
The level of predictability in the preparation of organic compounds depends upon the structural similarity of the compounds being prepared. Preparing a hypervalent iodine compound having an oxidation state of iodine that differs from known examples is highly unpredictable.
(F) The amount of direction provided by the inventor.
No guidance is provided regarding how to prepare a sulfonic acid of structure (1) having a I(OH)3 substituent.
(G) The existence of working examples.
No working examples are provided of a sulfonic acid of structure (1) having a I(OH)3 substituent.
(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 guidance in the prior art and instant disclosure, it would require undue experimentation by one of ordinary skill in the art to prepare a sulfonic acid of structure (1) having a I(OH)3 substituent.
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 68-80, 82-84, 86-96, and 98-103 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 68 recites the limitation "the compositions of group 1 and group 2" in the penultimate line. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 69-80, 82-84, 86-93, and 101-103 are rejected under 35 U.S.C. 112(b) for inheriting deficiencies from independent claim 68.
Claims 69-71 recite the limitation "the sulfonic acid and the salt thereof." There is insufficient antecedent basis because claim 68 previously introduces both "a sulfonic acid or a salt thereof" and "a second sulfonic acid…and a salt of the second sulfonic acid." It is suggested that the modifier "first" be applied to the first set of limitations introduced in claim 68. (Compare related rejection of claim 90.)
Claim 69 recites the limitation "group 1 or an ester, or an amide, or a salt thereof." The meaning of an ester of group 1, an amide of group 1, or a salt of group 1 is unclear. An ester of group 1 can be interpreted in two different ways: (i) a member of group 1 that is an ester and (ii) an ester of a member of group 1 (i.e., a modification of group 1).
Claim 69 recites the limitation "wherein the sulfonic acid and the salt thereof is selected from group 1 or an ester, or an amide, or a salt thereof." It is unclear whether claim 69 requires all of the limitations of claim 68 under either interpretation (i) or (ii), given the claim 68 limitations "the sulfonic acid and the salt thereof is selected from group 1 and group 2" and "the second sulfonic acid and the salt of the second sulfonic acid are selected from the compositions of group 1 and group 2." Regarding interpretation (i), the scope of structure (1), structure (2), and structure (3) as recited in claim 68 does not comprise an ester or an amide. Regarding interpretation (ii), the scope of claim 68 does not encompass an ester, or an amide, or a salt of a substance according to structure (1), structure (2), or structure (3).
Claim 69 recites the limitation "a cation of the salt." There is insufficient antecedent basis for the limitation "the salt" in the claim.
Claim 69 recites the limitation "wherein R7 = …." There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 75-77, the use of the pronoun "these" is unclear.
Claim 82 recites the limitation "a fluorescence attenuating compound selected from: methylester, ethylester, phenylester, N-methylamide, N-ethylamide, N,N- dimethylamide, N,N-diethylamide, N-phenylamide, and N,N-diphenylamide." The meaning of this limitation is unclear. None of methylester, ethylester, phenylester, N-methylamide, N-ethylamide, N,N- dimethylamide, N,N-diethylamide, N-phenylamide, and N,N-diphenylamide is a substance or a compound. A substance or compound can be "a methyl ester" but not "methyl ester." Claim 100 is indefinite for analogous reasons.
Claim 83 recites the limitation "the additional mixed layer." There is insufficient antecedent basis for this limitation because the claim previously introduces "another mixed layer."
Claim 84 recites the limitation "R52 = a boronic ester of glycol, pinacol, 1,4-butanediol, 1,5-pentanediol, tartaric acid, 2,2-dimethyl-1,3-propanediol, a cyclic boronate of methyliminodiacetic acid (MIDA), a cyclic boronamide of brenzcatechine, 1,8-diaminonaphthalene, o-phenylenediamine, or one or more derivatives thereof." This limitation is unclear for multiple reasons. Are "pinacol, 1,4-butanediol, 1,5-pentanediol, tartaric acid, 2,2-dimethyl-1,3-propanediol" choices of R52, or do these limitations modify "a boronic ester of…" The intended meaning of "brenzcatechine" is completely unclear. The German word for catechol or 1,2-dihydroxybenzene is "Brenzcatechin." However, the meaning of a cyclic boronamide of 1,2-dihydroxybenzene is completely unclear. Are "1,8-diaminonaphthalene, o-phenylenediamine" choices of R52, or do these limitations modify "a cyclic boronamide of"? The intended scope of "one or more derivatives" is unclear. The antecedents of the pronoun "thereof" are unclear because it is unclear whether "thereof" refers to all previous choices of R52 or to only the nearest subset (i.e., referring only to "a cyclic boronamide of …" or only to "o-phenylenediamine").
Regarding claim 87, it is unclear whether the definition provided for "x" is meant to refer instead to "n."
Claim 90 recites the limitation "the sulfonic acid and the salt thereof selected from group 1." There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 93, it is unclear how claim 93 further limits claim 83.
Regarding claim 94, the chemical structure/identity of a sulfonic acid of structure (1) having a R1-R5 substituent selected from I(OH)3 is unclear.
Claim 94 recites the limitation "x = y = 50-150, or x = y = 75-125." 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 94 recites the broad recitation "50-150," and the claim also recite "75-125," 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.
Dependent claims 95, 96, and 98-100 are rejected under 35 U.S.C. 112(b) for inheriting deficiencies from independent claim 94.
Claim 95 recites the limitation "the sulfonic acid." There is insufficient antecedent basis because claim 94 previously introduces both "a sulfonic acid or a salt thereof" and "a second sulfonic acid…and a salt of the second sulfonic acid." Even if the claim 95 limitation "the sulfonic acid" is interpreted as referring to the claim 94 limitation "a sulfonic acid…," it is unclear whether the claim 94 limitation "a sulfonic acid or a salt thereof" is limited to the sulfonic acid (rather than the salt thereof).
Claim 99 recites the limitation "a fluorescence attenuating compound selected from the group consisting of: methylester, ethylester, phenylester and their amides." The meaning of this limitation is completely unclear. None of methylester, ethylester, and phenylester is a compound. A compound can be "a methyl ester" but not "methyl ester." Moreover, it is unclear what is meant by an amide of an ester.
Claim 101 recites the limitation "the analytes" [plural]. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 68, 70-80, 82-84, and 86-93 would be allowable if rewritten to overcome the objection(s) and rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the non-redundant limitations of the base claim and any intervening claims.
The closest prior art is discussed on pages 19-20 of the non-final office action.
Response to Arguments
Applicant's arguments filed on 30 October 2025 have been considered and are not fully persuasive and/or are moot in view of the modified grounds of rejection.
Applicant's arguments do not specifically address the maintained grounds of rejection, including parts (III)-(VI) of the rejections under 35 U.S.C. 112(a) regarding the written description requirement, which are now indicated as parts (B)-(E).
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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