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 .
Status of the Claims
Claims 1-20 are pending and examined herein.
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 1-20 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.
Claims 1 and 11 recite a microscopy probe comprising a luminescent metal binding protein, which chelates a luminescent metal.
Claims 3 and 15 recite the luminescent metal binding protein comprises more than 20% N and Q amino acids.
Claims 4 and 18 recite the luminescent metal binding protein comprises an amino acid sequence that is at least 80% identical to SEQ ID NO: 1 or 2.
Claims 6 and 13 recite the luminescent metal is a lanthanide.
Claim 9 recites a polynucleotide encoding the microscopy probe of claim 1 and claim 10 recites a vector comprising the polynucleotide.
Claim 16 recites the luminescent metal binding protein is an ortholog, paralog, or analog of calsequestrin.
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc) (MPEP §2163.03.V).
“[T]he disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." (MPEP § 2163.II.A).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.") (MPEP § 2163).
Claims 1 and 11 are broadly drawn to any protein capable of binding any luminescent metal.
The specification fails to disclose a luminescent metal binding protein other than mouse and human calsequestrin.
The specification fails to disclose a broad genus of all possible metals with luminescent properties. Instead, it only discloses specific metals recited in claim 14: Ce3+, Pr3+, Nd3+, Pm3+, Sm3+, Eu3+, Gd3+, Tb3+, Dy3+, Ho3+, Er3+, Tm3+, Yb3+, U3+, U4+, U5+, and U6+.
Claims 3 and 15 are broadly drawn to any protein capable of binding a luminescent metal and comprising more than 20% N and Q amino acids. The specification fails to disclose a representative number of species of such broad genus of proteins by their structure. No proteins other than those with SEQ ID NO: 1 or 2 are disclosed. An amino acid composition is insufficient to define a protein by structure.
Claims 4 and 18 are broadly drawn to any protein comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 1 or 2. The specification fails to disclose representative number of species of such broad genus of proteins by their structure. No proteins other than those with exact SEQ ID NO: 1 or 2 are disclosed.
Claims 6 and 13 recite the luminescent metal is a lanthanide. Table 1 excludes La3+ and Lu3+; therefore, the broad genus of lanthanides as recited in the claims is not supported by the specification.
Claim 9 recites a polynucleotide encoding the microscopy probe of claim 1 and claim 10 recites a vector comprising the polynucleotide. The claims are broadly drawn to any polynucleotide and any vector. The specification fails to disclose a representative number of species of such broad genus of polynucleotides or vectors by their structure or name. No polynucleotides or vectors are disclosed.
Claim 16 broadly drawn to any ortholog, paralog, or analog of calsequestrin. The specification fails to disclose a representative number of species of such broad genus of calsequestrin variants by their structure or name. No orthologs, paralogs, or analogs of mouse and human calsequestrins are disclosed.
Therefore, claims 1-20 are rejected under 35 U.S.C. 112(a) for failure to describe a sufficient number of proteins capable of binding any luminescent metal; proteins comprising more than 20% N and Q amino acids; proteins comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 1 or 2; the broad genus of all lanthanides suitable for use in instant invention; and a broad genus of calsequestrin ortholog, paralog, or analog variants.
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 1-11 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.
Claim 1 recites “the microscopy probe is configured to be detected using a light microscope and an electron microscope; and the luminescent metal binding protein is configured to chelate a luminescent metal”. It is unclear why it is the microscopy probe that is configured to be detected using a light microscope and an electron microscope but not the luminescent metal binding protein, because it is the luminescent metal binding protein that binds the luminescent metal, which in turn provides detection during microscopy.
Claims 1 and 11 recite “to chelate” a luminescent metal, while claim 5 dependent from claim 1 recites “to bind” luminescent metals. It is unclear if chelation or binding is actually claimed. Chelation is a distinct subset of binding. Chelation requires a specific configuration of amino acid side chains, while binding relies on charges alone. The distinction between chelation and binding is important regarding claimed calsequestrin, which does not chelate metal ions but binds them (see Marabelli et al. Biomolecules. 2023 Nov 23;13(12):1693 – “Abundant quantities of Ca2+ cooperatively bind to CASQ with low affinity” (pg. 1, last par.)). All claims will be interpreted as reciting “binding”.
Claims 2-10 are rejected because they depend from rejected claim 1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 1 and 8 recite “the microscopy probe is configured to be detected”, claims 1, 5, and 11 recite “protein is configured to chelate” and “protein is configured to bind”.
The specification fails to disclose any specific process or method for configuring the microscopy probe and the luminescent metal binding proteins. For the purposes of this examination the “configuring” of the probe and the protein will be interpreted as treatments of the probe and the protein with luminescent metals.
Please note that the claims do not recite any steps or structures for making the probe and/or protein specific toward a particular target. Therefore, the microscopy probe is interpreted as a luminescent metal binding protein without any specific affinity.
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 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.
Claims 1, 2, 6-14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by Zambrano et al. (IDS; PGPub 2014/0322744).
Regarding claims 1, 6, 8, 11 and 13, Zambrano teaches a probe suitable for correlative electron and light microscopy by using lanthanides in combination with mutated metallothionein-tags ([0010]) and “lanthanides present interesting electron dense and fluorescence properties. These two characteristics allow lanthanides to be tracked by electron microscopy and light microscopy” ([0011]). Therefore, the probe of Zambrano is naturally configured to be detected using a light microscope and an electron microscope.
Metallothionein-tags is the luminescent metal binding protein and lanthanides is the luminescent metal of instant disclosure.
Regarding claims 2, 7, 12, and 14, Zambrano teaches luminescent metal europium, which has an atomic number of 63, meeting the limitations reciting an atomic number of at least 57 (claim 2), an atomic number greater than 57 (claim 12), and luminescent metal Er3+ (claims 7 and 14).
Regarding claims 9 and 10, Zambrano teaches “The present invention relates to a nucleic acid, expression construct or expression vector encoding a metallothionein tag according to the present invention” ([0018]). The nucleic acid is the polynucleotide encoding the microscopy probe of claim 1.
Regarding claim 19, Zambrano teaches “The present invention relates to a recombinant cell comprising the nucleic acid, expression construct or expression vector of the invention” ([0019]).
Regarding claim 20, Zambrano teaches “the fusion protein is present in a cell” and “the sample is prepared for being suitable for microscopy analysis prior to the analyzing step” ([0026]).
Double patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/163,834. The claims are identical in both applications.
Subject Matter Free of the Prior Art
Claims 3-5 and 15-18 are free of the prior art.
Prior art is silent on a microscopy method and a luminescent metal binding protein: comprising more than 20% N and Q amino acid (claim 3); comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 1 or 2 (claims 4 and 18); configured to bind to more than 10 luminescent metals (claim 5); ortholog, paralog, or analog of calsequestrin (claim 16); is a mouse or human calsequestrin (claim 17).
The closest prior art is Zambrano et al. (IDS; PGPub 2014/0322744). The reference teaches a probe and a microscopy method using such probe, wherein the probe is based on metallothionein, which is unrelated to calsequestrin by amino acid sequence.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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