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 .
DETAILED ACTION
Claims 1-22 are pending in the present application file.
Election/Restrictions
Applicant’s election of Invention I (claims 1-13, drawn to a quencher represented by Formula I or II) and a species of Compound 1 traverse in the reply filed January 05, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-2, 4, 6-7 and 9 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 3, 5, 8 and 10-22 do not read on the presently searched and examined subject matter. Therefore, claims 3, 5, 8 and 10-22 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 06/09/2023 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Interpretation
Regarding the limitation of “A quencher”, recited in present claim 1 and “the quencher” recited in dependent claims 2, 4, 6-7 and 9, these limitations are interpreted as an intended use for the compounds of present Formula 1 or 2 and thus not given patentable weight. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Regarding an intended use limitation, MPEP 2111.02(II) notes:
“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. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
In this situation, the limitation does not affect the structure of the compound of formula (I). If the prior art structure is capable of performing the intended use, then it meets the claim. The present claims are interpreted for the purposes of applying prior art as a compound comprising the present Formula 1 or 2 of the present claims.
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.
Claims 1-2, 4, 6-7 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Present claim 1 is directed to a compound represented by Formula 1 or 2, where the variables R1 to R6 and R9 to R14, as well as at least one of R1 of R14, are defined as including many groups which are defined by function rather than structure (various moiety-derived protecting groups, reactive groups enabling a covalent bond), carboxyl derivatives, and any moiety substituted by the moiety or reactive group.
Present claim 2 sets forth a resonance structure of Formula 1, Formula 4. Present claim 4 further limits the compound of claim 1, wherein R1 and R2 are bound with each other to form a substituted or unsubstituted ring. Present claim 6 further limits the compound of claim 1, wherein R3 and R4 are bound with each other to form a substituted or unsubstituted ring.
The present specification discloses further definitions for R1 to R14; however, the specification also details where any one of R1 to R14 comprise any moiety which may be further substituted by a group of moieties or reactive groups. See pages 11-18. The present specification details exemplary compounds of the disclosure on pages 23-27.
The specification provides where the quenchers of the present invention are capable of binding to and labeling a target biomolecule (e.g., nucleic acid) through reactive groups which are functional groups that are able to react with a variety of moieties and may form a covalent bond between a quencher and a target biomolecule. See page 17.
The present specification further details where the compounds of the present invention may be used to label a drug a hormone (including a receptor ligand), a receptor, an enzyme or enzyme substrate, a cell, a cell membrane, a toxin, a microorganism, or a nano biomaterial (polystyrene microsphere or the like), in addition to the biomolecule. See page 28. The specification also discloses where an oligonucleotide including at least one selected from the quenchers represented by Formulas 1 and 2 is provided. See page 28.
The present specification also provides the following on page 31:
Such an oligonucleotide may be used in various ways in chemical and biological fields. Particularly, it may be useful for real time PCR or microassay, but the present invention is not limited thereto.
In addition, according to another aspect of the present invention, a composition for detecting a nucleic acid, including the oligonucleotide, is provided.
The composition for detecting a nucleic acid according to one embodiment of the present invention may further include an enzyme, a solvent (a buffer or the like) and other reagents for a reaction with a target biomolecule, in addition to an oligonucleotide including all of the quencher represented by Formula 1, 2, 4 or 5, MGB, and the fluorophore.
There are no methods or guidance provided which permits the person of ordinary skill in the art to extrapolate from the definition provided for compounds of Formula 1 or 2, all compounds potentially encompassed by the present claims or disclosure.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus of compounds of the present invention are described by the specification to comprise the Compounds 1-22 provided in pages 23-27, the description of compounds of the present invention is not sufficiently detailed to show Applicant was in possession of the full scope of the claimed invention, any compound of Formula 1 or 2 comprising any moiety (or permutations of moieties for R1-R14) where the variables R1 to R6 and R9 to R14, as well as at least one of R1 of R14, are defined as including many groups which are defined by function rather than structure (various moiety-derived protecting groups, reactive groups enabling a covalent bond), carboxyl derivatives, and any moiety substituted by the moiety or reactive group.
Namely, the definitions for the moieties for R1-R14 as provided in the present claims, are not sufficiently detailed in order to stand on their own as being adequately described.
MPEP 2163 goes on to describe what a "representative number of species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus.
Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a).
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 1-2, 4, 6-7 and 9 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.
Claims 1 and 7 recites several alternative options in the definition of a compound of Formula 1 or 2 which are followed by options in parentheses (e.g., “trihalomethyl (-CF3, -CCl3, -CBr3, -CI3), haloformyl (-COCl, -COBr, -COI)”; see page 49, lines 7-8 and last line page 51 to first line page 52). The options following by the groupings in parentheses render the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention.
Dependent claims 2, 4, 6 and 9 do not clarify the indefinite subject matter and are similarly rejected.
Applicant can amend the present claims to delete all instances of alternatives listed in parentheses to overcome this aspect of the indefinite rejection.
Claims 1 and 7 recite the option carboxylate twice as an option for R1 to R6 and R9 to R14 under section (1). See page 48, lines 4 and 12. Claims 1 and 7 also recite fluoro, chloro, bromo, iodo and halogen within the list of alternatives for R1 to R6 and R9 to R14. The claims are indefinite as it is unclear which halogen species are encompassed by the claim.
The term “carboxyl derivative” in present claims 1 and 7 is a relative term which renders the claims indefinite. The term “derivative” or “carboxyl derivative” is not defined by the present claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of molecules or compounds encompassed by the meaning of derivative, which is a relative, ambiguous term in the art, has been rendered indefinite.
Dependent claims 2, 4, 6 and 9 do not clarify the indefinite subject matter and are similarly rejected.
Applicant may amend the present claims to explicitly disclose which specific moieties are encompassed by the claims (i.e. specific carboxyl derivatives) to overcome this aspect of the indefinite rejection.
Claims 1 and 7 include the limitations for a compound of Formula 1 or 2 where R1 to R6 and R9 to R14 as well as at least one of R1 to R14 are a protecting group including various moiety-derived protecting groups (“a protecting group selected from an alcohol-derived protecting group, an amine-derived protecting group, a carbonyl-derived protecting group, a carboxylic acid-derived protecting group, a phosphate-derived protecting group, and an alkyne- derived protecting group”). The term “derived” is not defined by the present claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of molecules or compounds encompassed by the meaning of derived, which is a relative, ambiguous term in the art, has been rendered indefinite.
Dependent claims 2, 4, 6 and 9 do not clarify the indefinite subject matter and are similarly rejected.
Applicant may amend the present claims to explicitly disclose which specific protecting groups are encompassed by the claims (i.e., Boc, Fmoc, PMB, etc.) to overcome this aspect of the indefinite rejection.
Claims 1 and 7 recite the limitations “any moiety substituted with the moiety” and “any moiety substituted with the reactive group” in lines 19-20 of page 48, lines 17-18 and 23 of page 49, and lines 12-13 and 18 of page 52. The claim does not define what is meant by “any moiety” or “the moiety”, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of molecules or compounds encompassed by the meaning of these phrases, has been rendered indefinite. Further there is a lack of antecedent basis for the phrase “the moiety” as it is unclear which moiety is being referred to out of the various possible or permutations of moieties.
Claims 1 and 7 recite the limitation “reactive group enabling a covalent bond with a moiety” in line 21 of page 48, line 19 of page 49, and line 14 of page 52. Claim 1 also recites the limitation “R9 and R10 are not electron-withdrawing groups” in line 5 of page 50.
When claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008). See MPEP 2173.05(g).
In this instance, the claims are unclear because one of ordinary skill would not be appraised of which alternatives, or combination of alternatives, are required to meet the limitation of the claims.
Dependent claims 2, 4, 6 and 9 do not clarify the indefinite subject matter and are similarly rejected.
Applicant may amend the present claims to explicitly disclose which specific moieties are encompassed by the claims to overcome this aspect of the indefinite rejection (“R1 to R6 and R9 to R14 are each independently selected from the group consisting of option A, option B, option C, and option D”; where the various exemplary options A-D are specific species of moieties instead of genera of moieties).
There is no definition for the counter ion A in the definition for Formula 1 or 2 in present claim 1. The claim is indefinite as the scope of products encompassed by the present claims is unclear. Dependent claims 2, 4, 6 and 9 do not clarify the indefinite subject matter and are similarly rejected.
Applicant may amend the claim to provide a definition for the variable A, to overcome this aspect of the rejection.
Claim 1 provides the following chemical structures for Formula 1-3.
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1. Formula 1
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2. Formula 2
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3. Formula 3
Claim 2 provides the following chemical structure for Formula 4.
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4. Formula 4.
The provided structure images are unclear and illegible, especially with regards to the placement of the variables R1 to R6 and R9 to R14. The lack of clarity in the figures render the claims indefinite as it is unclear to one of skill in the art which compounds by the present claims.
Applicant may amend the claim to provide a more legible figure for the structure to overcome this rejection.
Claim 9 recites the limitations "the reactive group" and “a protecting group”. There is insufficient antecedent basis for this limitation in the claim as there are several potential reactive groups or permutations of reactive groups in the definition of Formula 1 or 2. Similarly there are an indefinite amount of protecting groups listed in definition of Formula 1 or 2, which further renders present claim 9 indefinite.
Applicant can amend the claim to specify which variable or reactive group is being protected and by which protecting group to overcome this aspect of the rejection.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4, and 6-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2021/0255191 A1 (Hara et al.; Priority to JP 2020-016297, filed February 3, 2020).
Hara discloses a compound encompassed by present Formula 1 in Example 15 on page 56. See the second compound of paragraph 412 which corresponds to a compound of Formula 1 where wherein R1 and R2 are bound with each other to form an unsubstituted ring, R3 and R4 are bound with each other to form an unsubstituted ring, and the ring is substituted with a halogen, m is 0, n is 0, X is SiR7R8, R7 and R8 form a ring, Q is Formula 3, R9 is carboxylate, R10 is hydrogen, R11 is hydrogen, R12 is carboxylic acid, R13 is hydrogen and R14 is C3 substituted alkyl.
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The compound of Hara is also encompassed by present claims 2, 4 and 6-7.
Claims 1-2, 4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Terazono, Yuichi, et al. "Mimicking the role of the antenna in photosynthetic photoprotection." Journal of the American Chemical Society 133.9 (2011): 2916-2922.
Terazono discloses a synthetic hexad molecule that functionally mimics the role of the antenna in nonphotochemical quenching (NPQ).
One of the compounds disclosed by Terazono includes the following open, protonated form of hexad 4:
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See open form 1o in Fig 1, hexad 4 in Fig 2 and disclosure of the open, protonated form of hexad 4 on pages 2919-2920 and Fig 8.
The compound of Terazono corresponds to a compound of present Formula 1 wherein R1 and R2 are bound with each other to form an unsubstituted ring, R3 and R4 are bound with each other to form an unsubstituted ring, m is 0, n is 0, X is 0, Q is Formula 3, R9 is carboxylate, R10 is hydrogen, R11 is hydrogen, R12 is hydrogen, R13 is anisole, and R14 is substituted C6 aryl.
The compound of Terazono is also encompassed by present claims 2, 4, and 6-7.
Conclusion
Claims 3, 5, 8 and 10-22 are withdrawn.
Claims 1-2, 4, 6-7 and 9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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