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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----5/27/2022, which is a national stage application of PCT/EP2020/083976 filed 11/30/2020, which claims foreign priority to EP19306540.6 filed 11/29/2019.
As filed, claims 1-21 are pending, wherein claim 1 is an independent claim.
Election/Restrictions
Applicant's election with traverse of Group I – Claims 1-15 and 17-21 in the reply filed on 2/5/2026 is acknowledged.
Regarding the restriction requirement, the traversal, in summary, is on the ground(s) that the subject matter of all claims and species is sufficiently related that a thorough search for the subject matter of any one Group of claims and species would encompass a search for the subject matter of the remaining claims. Thus, it is respectfully submitted that the search and examination of the entire application could be made without serious burden. MPEP 803 stated that “if the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or indistinct inventions” (emphasis added). It is respectfully submitted that this policy should be applied in the present application in order to avoid unnecessary delay and expense to Applicants and duplicative examination by the Patent Office.
This is not found persuasive because the Examiner, as stated in the previous office action, found compound of instant formula (I) of Group I and compound of instant formula (II) of Group II are patentably distinct from one another. Therefore, claims 1-21 are not so linked as to form a single general inventive concept and lack of unity of invention. The vastness of the claimed subject matter and the complications in understanding the claim subject matter impose a serious burden on the search and examination of the claimed subject matter.
Regarding the election of species requirement, the Applicant made their election, which is shown below, with traverse. The traversal is shown above.
This is not found persuasive because the Examiner, as stated in the previous office action, found that the instant compounds are drawn to different structural cores and are drawn to a host of distinct species between the different structural cores. The only portion of the instant compounds shared by all species is the azetidine ring. The azetidine ring is not a special technical feature that results in a contribution over the prior art. As such, the instant compounds lack unity of invention.
The restriction and election of species requirement is still deemed proper and is therefore made FINAL.
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
Regarding the election of species requirement, Applicant elected the species of
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, which is compound 15 on pg. 44 of the instant specification. The Examiner finds that the claims, which read on the elected species, are instant claims 1, 2, 4-9, 11-15, 17, and 21.
Claims 3, 10, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/5/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species . Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does makes a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Because the Markush-type claim (i.e. claim 1) is determined to be free of prior art, claims 3, 10, and 18-20 are rejoined and examined herein. Accordingly, the election of species requirement is hereby withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/27/2022 and 11/15/2024 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the following limitation for instant variable R1:
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The abovementioned limitation recites that HWR1 belong to the class of fluorophores after the cleavage of -C(O)-WR1 bond, but never recites what R1 pertains to. Accordingly, without knowing what R1 pertains to, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
In addition, the claim recites the phrase, “the class of fluorophores”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” class of fluorophores. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 4, the claim recites the phrase:
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wherein the transitional phrase, “comprises” or “comprising”, is an open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The term, “compound”, contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means (see Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148). By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a “compound" is singular and requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, “comprising”, used in conjunction with “compound” fails to articular exactly what subject matter is excluded from the claim scope of compounds, thereby rendering the scope of claim 4 indefinite.
Regarding claim 5, the claim recites the phrases:
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The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, the claim recites the phrase:
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wherein the transitional phrase, “comprising”, is an open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The term, “compound”, contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means (see Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148). By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a “compound" is singular and requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, “comprising”, used in conjunction with “compound” fails to articular exactly what subject matter is excluded from the claim scope of compounds, thereby rendering the scope of claim 5 indefinite.
Regarding claim 5, the claim recites the phrase:
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The use of the phrase, “possibly interrupted”, introduced ambiguity into the scope of the abovementioned variables, and it is unclear to the Examiner whether the abovementioned variables contains hetero-atoms chosen from N, S, and O. Accordingly, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claim 5, the claim recites the phrase, “Rg is a hydrogen, Br, Cl, I, or F atom”, but instant formula (A2) failed to recite instant variable Rg. Accordingly, the abovementioned phrase introduced ambiguity into the metes and bounds of this claim, which rendered the claim indefinite.
Regarding claim 6, the claim recites the phrase:
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The term, “including”, and the parenthesis, rendered the claim indefinite because it is unclear whether the limitations following the term and within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 11 and 12, the claims recites the phrase, “the formation of a fluorescent precipitate”, wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” formation of a fluorescent precipitate. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 15, the claim is drawn to a method of in vivo detection, and recites the phrase, “using a compound (I) according to claim 1”. It is unclear to the Examiner what active step applicant is intending to encompass with the word, “using”. According, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claim 17, the claim is drawn to a method of making a compound of instant formula (I), and recites the phrases, “implementation of a compound (II)” and “implementation of a compound (III)”. It is unclear to the Examiner what active step applicant is intending to encompass with the word, “implementation”. According, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claim 18, the claim is drawn to a method of making a compound of instant formula (I), and recites the phrases, “implementation of a compound (VII)” and “implementation of a compound (VIII)”. It is unclear to the Examiner what active step applicant is intending to encompass with the word, “implementation”. According, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claim 19, the claim is drawn to a method of making a compound of instant formula (I), and recites the phrases, “implementation of a compound (VII)” and “implementation of a compound (IX)”. It is unclear to the Examiner what active step applicant is intending to encompass with the word, “implementation”. According, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claim 20, the claim is drawn to a method of making a compound of instant formula (I), and recites the phrases, “implementation of a compound (VII)” and “implementation of a compound (X)”. It is unclear to the Examiner what active step applicant is intending to encompass with the word, “implementation”. According, the metes and bounds of this claim are unclear, which rendered the claim indefinite.
Regarding claims 2-4, 7-15, and 17-20, the claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
Claim Rejections - 35 USC § 112 fourth paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
Subject to the following paragraph [concerning multiple dependent claims], 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 (emphasis added).
Claims 8-10 are rejected under the fourth paragraph of 35 U.S.C. § 112 and under 37 CFR § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Regarding claims 8-10, the claim is dependent upon claim 1. The subject matter in claim 1 is drawn to a compound of instant formula (I). The subject matter in claims 8-10 is drawn to a limited embodiment of instant formula (I).
The scope of claims 8-10 is broader than scope of claim 1 because claims 8-10 include species that is outside of instant variable Y (e.g. Y is -CH2 -). Because the scope of claims 8-10 is broader than claim 1, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 8-10 is commensurate with the scope of claim 1.
Claim Objections
Claims 2-12, 15, and 17-21 are objected to because of the following informalities:
Regarding claim 2, the claim recites the phrase, “Compound (I) according to claim 1 of formula (Ia)”.
Such expression can be clarified by reciting – The compound , which has the structure of formula (Ia) --.
Regarding claim 3, the claim recites the phrase, “Compound (I) according to claim 1 of formula (Ib)”.
Such expression can be clarified by reciting – The compound , which has the structure of formula (Ib) --.
Regarding claims 4-7 and 21, the claims recite the phrase, “, “Compound (I) according to claim 1”.
Such expression can be clarified by reciting -- The compound
Regarding claim 5, the claim recites the phrase, “wherein WR1 is an aromatic group –OR1 according to formula (A1)”.
Such expression can be clarified by reciting -- wherein WR1 is
Regarding claim 5, the claim recites the phrase, “or, --OR1 is of the aryloxy type and corresponds to one of the following structure (A2), (A3) or (A4)”.
Such expression can be clarified by reciting -- OR1 is
Regarding claim 8, the claim recites the phrase, “Compound (I) according to claim 1 of formula (Ic)”.
Such expression can be clarified by reciting – The compound , which has the structure of formula (Ic) --.
Regarding claim 9, the claim recites the phrase, “Compound (I) according to claim 1 of formula (Id)”.
Such expression can be clarified by reciting – The compound , which has the structure of formula (Id) --.
Regarding claim 10, the claim recites the phrase, “Compound (I) according to claim 1 of formula (Ie)”.
Such expression can be clarified by reciting – The compound , which has the structure of formula (Ie) --.
Regarding claims 11 and 12, the claims recite the phrase, “Method for the in vitro or ex vivo detection”.
Such expression can be clarified by reciting – A method for in vitro or ex vivo detection --.
Regarding claims 11 and 12, the claims recite the phrase, “into contact with a compound (I) according to claim 1”.
Such expression can be clarified by reciting -- into contact with the compound
Regarding claims 11 and 12, the claims recite the phrase, “leading to the release of HWR1”.
Such expression can be clarified by reciting -- leading to1 --.
Regarding claim 15, the claim recites the phrase, “A method for the in vivo detection”.
Such expression can be clarified by reciting -- A method for
Regarding claims 17-20, the claims recite the phrase, “Process for the preparation of a compound of formula (I)”.
Such expression can be clarified by reciting – A process for a preparation of the compound of formula (I) –
Regarding claim 17, the claim recites the phrase, “implementation of a compound (III) of formula”.
For consistency, such expression can be clarified by reciting -- implementation of a compound (III)
Regarding claim 18, the claim recites the phrase, “implementation of a compound (VII) of the following formula” and “implementation of a compound (VIII) of formula”.
For consistency, such expressions can be clarified by reciting -- implementation of a compound (VII)
Regarding claim 19, the claim recites the phrase, “implementation of a compound (VII) of the following formula” and “implementation of a compound (X) of formula”.
For consistency, such expressions can be clarified by reciting -- implementation of a compound (VII) IX)
Regarding claim 20, the claim recites the phrase, “implementation of a compound (VII) of the following formula” and “implementation of a compound (X) of formula”.
For consistency, such expressions can be clarified by reciting -- implementation of a compound (VII) --.
Appropriate correction is required.
Conclusion
Claims 1-15 and 17-20 are rejected.
Claims 2-12, 15, and 17-21 are objected.
Claim 16 is withdrawn.
The instant claims are drawn to drawn to a compound of instant formula (I), a method of detection via the compound thereof, or a method of making the compound thereof; and the presence of instant variable R4 does not appear to have been disclosed previously in the prior arts. For at least this reason, the instant claims are substantially differentiated from any prior art reference, such as U.S. Patent Application Publication No. 2006/0247295, hereinafter Gangwar (see IDS filed 5/27/2022). Furthermore, the prior art provide insufficient guidance or motivation that would have led a person having ordinary skill in the art to arrive at the instantly claimed process.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621