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 .
Status of Claims
Claims 1-8 are pending in the instant application.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the objection to the abstract for minor informalities. This objection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the objection to Claim 1 for minor informalities. This objection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1 and 5 under 35 U.S.C. 112(b). Further, Applicant’s clarification of the attachment point of variable Q in the remarks filed December 2nd, 2025 as
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is noted, and provides sufficient clarity to overcome this rejection. This rejection is hereby withdrawn.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
The rejection of Claims 1-8 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is maintained. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant traverses the rejection beginning at Page 13 of the remarks filed December 2nd, 2025 on the basis that the rejection is based “only on an assertion that example compounds (Compounds 1-4) contain variable attachment points and that characterization data allegedly do not show which of the possible positional isomers was synthesized. The rejection does not analyze the invention in light of the remaining Wands factors nor establish that any undue experimentation would be required.”
The Examiner does not find this argument persuasive.
Breadth of the claims:
At Page 14, First Two Paragraphs of the remarks filed December 2nd, 2025, Applicant notes “breadth alone does not render a claim non-enabled” and states positional isomerism does not expand claim breadth.
The Examiner clarifies that the assertion of claim breadth is not considered in isolation to determine enablement of the instant claims, but rather to clarify the record as to the scope of the compounds instantly claimed. Claim 1 is drawn to a compound of Chemical Formula 1, which includes 8 variables in the core structure, with the substituent Q introducing 4 additional variables and the option for positional isomers. Therefore, the scope of the claim is broad, as it encompasses myriad distinct compounds.
Nature of the invention:
At Page 14, Third Paragraph of the remarks filed December 2nd, 2025, Applicant states, “Fluorescent probe synthesis and positional isomer formation are predictable chemical processes that a skilled artisan routinely performs.”
Per MPEP 608.01(p), “At least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims.”
While generation of positional isomers may be a routine for a person having ordinary skill in the art, for the specification to be sufficiently enabling, a specific operative embodiment or example of the invention must be provided. In the instant case, no specific example has been provided. Rather, a Markush structure representing multiple isomers, which are distinct compounds, has been provided without guidance as to which specific positional isomers are obtainable via the methods disclosed in the specification.
State of the prior art:
As noted in the non-final rejection mailed September 2nd, 2025, with respect to notation used o represent the structures of chemical compounds, Brecher (“Graphical Representation Standards for Chemical Structure Diagrams”, Pure Appl. Chem., Vol. 80, No. 2, 277-410, 2008; cited in non-final office action mailed September 2nd, 2025; hereinafter referred to as Brecher) represents the state of the prior art. Particularly of note to the instantly claimed compounds, at Page 395, Brecher teaches under GR-9.4 Variable attachment location, that “In addition to allowing the type of attachment to vary, it may also be convenient to indicate that the attachment’s location is variable as well. This type of notation should be restricted to substituents that are known to be bonded to a specific ring, but at an unspecified or unknown atom of that ring … Unless explicitly specified otherwise, such diagrams imply that the substituent may be bonded to any ring atom that has an attached hydrogen atom.” Becher provides, as example, the following diagram:
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Beginning at Page 14, Fourth Paragraph, of the remarks filed December 2nd, 2025, Applicant states, “Applicant has found that the linkage can be connected to the 4- or 5- position, and it can be reciprocal anytime.
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”
The Examiner construes this as the Applicant suggesting that what has been synthesized instantly is the position isomer resulting in the amide linkage being at the 4 or 5 position, above, or a mixture of compounds thereof. In view of Brecher, above, the claims are not limited to two position isomers, but rather 4 position isomers based on the presentation of the structures, for example:
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as recited in instant Claim 2 represents four distinct isomeric compounds, not two.
Based on this, the Applicant acknowledges that all four isomers represented by the above structure have not been generated. Further, Applicant’s reliance on ambiguity of the amide linkage placement seems to bely the notion that generation of specific positional isomers is routine in the art.
Level of ordinary skill in the art:
Applicant states at Page 15, Second Paragraph, of the remarks filed December 2nd, 2025, that synthesis of aromatic amide compounds in the art is routine. The Examiner is in agreement that synthesis of such compounds is routine in the art. Enabling disclosure of such synthesis, however, requires, as noted above, that specific embodiments are disclosed. The Markush structures representing multiple compounds do not satisfy this requirement.
Predictability in the art:
Applicant states in the remarks at Page 15, Third Paragraph, “The predictability of synthesizing small-molecule fluorescent compounds is high, and the Examiner has not shown otherwise.” Applicant’s earlier statement of the ambiguity of the 4- and 5-attached amide linkage coupled with a lack of evidence of the other two positional isomers claimed demonstrates a lack of predictability as it relates to the instant invention. Applicant has not provided evidence of each of the four isomers claimed.
Amount of direction provided and working examples:
Beginning at Page 15, Fourth Paragraph, of the remarks filed December 2nd, 2025, Applicant notes four working examples in Compounds 1-4, and states, “The structural diagrams clearly teach that the amide linkage resides at the 4- or 5-position.”
At Page 17 of the instant specification, Compound 1 is provided:
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In view of Brecher, as noted above, this diagram represents four compounds, and does not clearly teach an amide linkage at the 4- or 5-position. Further, the claims are drawn to a compound of Chemical Formula 1. In the remarks, Applicant seems to suggest what has been made is a mixture of compounds resulting from an amide linkage at the 4- or 5- position. In this case, Applicant has not sufficiently demonstrated enablement for each of the four compounds, for example, represented by the structure of Compound 1, above. Applicant suggests synthetic routes to each of the isomers represented by the structural diagram is routine, but has failed to provide any direction or guidance that would readily enable a person having ordinary skill in the art to be able to obtain a specific position isomer of the compounds claimed.
In view of the foregoing, Applicant is not enabled for a compound of Chemical Formula 1. Per MPEP § 2164.01(a), “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The rejection of Claims 4 and 8 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is maintained.
Applicant did not address the rejection of Claims 4 and 8 under 35 U.S.C. 112(d) in the remarks filed December 2nd, 2025. For clarity of the record, the rationale for these rejections is reproduced here:
Claim 4 fails to further limit the subject matter of Claim 1. Claim 1 is drawn to a fluorescent compound for detecting a biomaterial having the Chemical Formula 1. Claim 4 recites biomaterials for which the compound may be used to detect. “Detecting a biomaterial”, however, does not provide a structural limitation to the subject matter for which Claim 1 is drawn, but is a statement of the intended use of the invention. Per MPEP 2111.02, II., “The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim” as drafted without importing “’extraneous’ limitations from the specification.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
As Claim 1 is drawn to a fluorescent compound of the Chemical Formula 1, the intended use of detecting a biomaterial does not provide a structural limitation. Therefore, Claim 4’s recitation of biomaterials does not further limit the scope of Claim 1, as it does not further limit the structure of a compound of Chemical Formula 1.
Similarly, Claim 8 depends from Claim 5, which is drawn to a composition for detecting a biomaterial comprising a fluorescent compound by the Chemical Formula 1. The recitation of the intended use of detecting a biomaterial does not introduce a structural limitation to the composition by which Claim 5 is drawn. Therefore, Claim 8, by reciting biomaterials, does not further limit Claim 5, as it does not introduce any further structural limitations to the composition by which Claim 5 is drawn.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claims 1-8 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624