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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
A date of 06/15/2022 was used for priority.
Election/Restrictions
Applicant’s election with traverse of compound 7 in the reply filed on 06/15/2026 is acknowledged. The applicant argues that that the grouping of the species in the restriction requirement are not mutually exclusive and thus instead of selecting species (i) or species (ii) elected one specific compound. The examiner agrees with this selection and has examined the claims based on the election of compound 7. The elected compound 7 corresponds to claims 1-3, 5-7, 9, 11-12, so claims 1-3, 5- 7, 9, 11-12 were examined. In addition, claims 4, 8 and 10 are currently withdrawn. The applicants stated that claim 10 reads on the elected species, however, claim 10 does not read on the elected species due to a lack of a carboxy group for the variables R39 or R43.
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The elected compound 7 was found to be anticipated by the prior art and the search was halted.
Claim Interpretation
For the purposes of examination two R13 are considered adjacent to each other due to definition given in the specification and examples shown:
[0026-0027] In a case of taking a case of n = 3 as an example, preferred examples of the structure having a ring formed by bonding adjacent groups among R¹¹ to R¹³ include the following structures.
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[0026-0027] In a case of taking a case of n = 3 as an example, preferred examples of the structure having a ring formed by bonding adjacent groups among R¹¹ to R¹³ include the following structures.
Additionally, for the purposes of examination as defined by the instant specification any group that is not specified may be substituted or unsubstituted (page 7 and see also claims 6-7). This is clearly the intention of the application because while no substituents are mentioned for the alkyl group of L1 or L2 in claim 1 the dependent claim 6 describes the alkyl groups as having substituents. Additionally, since the specification provides no specific definition of structures that would impair the effect of the present invention, it is assumed that any substituted structures of the instant invention would not impair its function.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Fluorescent Cyanine Dyes For Labeling Biological Substances.
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.
The disclosure is objected to because it contains an embedded hyperlink (page 87: https://www.horiba.com/fileadmin/uploads/Scientific/Documents/Fluorescence/quantumyielde trad.pdf) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informalities: the compounds on pages and the labels for the compounds on pages 53-55, 60, 62-78 are of poor resolution.
Appropriate correction is required.
The use of the terms SNAP Ultra, Sfar C18, Alexa Fluor(page 55 and 88), which are trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
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 1-3, 5-7, 9, 11-12 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.
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The claims 1-3, 5-7, 9, 11-12 are indefinite because of the term “adjacent”, which generally refers to groups that are directly next to each other, however, the examples given in the specification allow for groups that are not directly next to each other to be bonded. For the purposes of examination two R13 are considered adjacent to each other due to definition given in the specification and examples shown: “In a case of taking a case of n = 3 as an example, preferred examples of the structure having a ring formed by bonding adjacent groups among R¹¹ to R¹³ include the following structures” [0026-0027]. However, the scope of the claims are not clear because this structure would require two R13 groups to be bound.
The claims 1-3, 5-7, 9, 11-12 are indefinite because of the terms “Formula I”, “General Formula I” and “General Formulae I” , the scope of the claims are indefinite since there are two General Formula I structures one in claim 1 and one in claim 7. Additionally these claims are indefinite because General Formula I and Formula I are both used in claim 1. It is not clear to one of ordinary skill in the art the scope of these claims because one would not know which structure is being referred to when discussing Formula I.
The claims 1-3, 5-7, 9, 11-12 are indefinite because of the phrase “a ring Z1 and a ring Z2 represent” this is unclear because the phrase seems to indicate by using the word “a” that there is another option for these rings.
To over come this rejection the applicant is recommended to amend the claim to read “Z1 and Z2 are…”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7, 9, and 11-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by SHIROKANE (SHIROKANE et al., WO 2023032995 A1, effective filing date 2021-08-31).
The reference SHIROKANE teaches the elected compound 7 (page 105).
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This anticipates claims 1-3, 5-7, 9.
The reference SHIROKANE teaches “A labeled biological substance obtained by binding the compound according to any one of claims 1 to 16 to a biological substance. The labeled biological material according to claim 17, wherein said biological material is any one of proteins, amino acids, nucleic acids, nucleotides, sugar chains and phospholipids”(reference claims 17-18).
This anticipates claims 11-12
The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1-3, 5-7 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HERMANSON(HERMANSON et. al., US 2016168383 A1, 2016-06-16).
The reference HERMANSON teaches the following compound [0528], wherein R11=H, R12=H, R13=R13 =6-memebered ring, R12=
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, R33=a sulfo group (see claim 7), R31-32=H, R34-35=H, n=3, L2=
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, m=4, R21=methyl, L1==
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, m=4, R21=alkyl substituted with a carboxy group, R1=R4=methyl, R2=R3=
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, m=4, R21=alkyl, Z1=Z2=6-membered rings with substituent. Since General Formula I (claim 7) is defined in the claim as a substituent capable of being bonded to a biological substance. R12 is taken to be a substituent capable of binding to a biological substance.
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This anticipates claims 1-3, 5-7.
The reference HERMANSON teaches “Compounds in any embodiment were used as dyes for optical labelling of organic or inorganic biomolecules, referred to as recognition units. Recognition units are molecules having specificity and/or affinity for a specific group of molecules. Examples include, but are not limited to, antibodies that have affinity for antigens, enzymes that bind and/or react with a specific bond or bonds within a sequence of amino acids in a peptide or react with a substrate, cofactors such as metals that enhance or inhibit specific interactions, lectins that bind specific sugars or sugar sequences (e.g., oligosaccharides, polysaccharides, dextrans, etc.)…”[0681].
This anticipates claims 11-12.
Claim(s) 1-2, 5-7, 9 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wycisk (Wycisk et al., Glycerol-Based Contrast Agents: A Novel Series of Dendronized Pentamethine Dyes, Bioconjugate Chem. 2015, 26, 773−781).
The reference Wycisk teaches the following compound 8c (page 775) as a Glycerol-Modified Dye for the purpose of which then were converted to “Conversion into NHS esters using HSTU yielded active esters 9a−e for conjugation with biomolecules, with the antibody cetuximab(ctx) targeting the epidermal growth factor receptor of the tumor cells”(page 775).
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The compound 8c is a compound of instant General Formula I, wherein n=2, R11=H, R12=H, R13=General Formula IV (see instant claim 7), R41=alkyl substituted with a carboxy group, R39-40=H R42-43=H, R13=H, R1-R4=alkyl group, Z1=Z2=6 membered rings, L1 and L2 = substituted alkyl groups.
This anticipates claims 1-2, 5-7, 9 and 11-12.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7, 9 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12559476 B2 and over claims 1-9 of U.S. Patent No. 12522609 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent ‘476 claims:
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This helps to teach claims 1-2, 7, 9 and 11-12.
The patent ‘609 claims:
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This helps to teach claims 1-2, 7, 9 and 11-12.
The patents ‘476 and ‘609 do not teach a specific compound of the instant claims however instead teach a general formula (all claims).
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘476 or ‘609 to achieve the instant compounds because they are suggested by the general formula of the patent ‘476 and ‘609. One would have reasonable expectation of success because they were suggested and one would be motivated to do so to make labeled biological substances. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Conclusion
Claims 1-3, 5-7, 9 and 11-12 are rejected.
Claims 4, 8 and 10 are currently withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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