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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group V, claims 40-44, in the reply filed on 7/8/2025 is acknowledged.
Claims 25-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups I-IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/2025.
Claims 40-44 are examined herein.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2021/071500, filed 07/30/2021. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. GB2011989.7, filed on 7/31/2020 in the United Kingdom.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 1/31/2023, 4/26/2023 and 1/6/2025 are being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph 456. 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.
Claim Objections
Claims 41 and 44 are objected to because of the following informalities:
In claim 41 line 1, "A biosensor according to claim 40" appears to be a typographical error, namely it is suggested that (annotations added) to conform with conventional claim language.
In claim 44 line 1, “A method according to claim 43” appears to be a typographical error, namely it is suggested that, “A method according to claim 43” read as “The .
Appropriate correction is required.
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 40-44 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. This is a written description rejection.
Claims 40-44 require a protein having an amino acid sequence as defined in SEQ ID NO: 6, or a fragment or variant thereof.
The specification does not describe which amino acid residues, or other molecular components are present in the genus of agents encompassed by claims 40-44. The specification fails to disclose the structures common to all members of the genus and fails to provide sufficient specific examples of agents to be used. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described. Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement.
The specification discloses that “[t]he term "variant" or "functional variant" as used herein with reference to any of the sequences described herein refers to a variant polypeptide sequence or part of the polypeptide sequence which retains the biological function of the full non-variant sequence” (para. 391). Although the specification does provide a few examples of sequence alterations to the protein that do not affect the function of the protein, namely “[f]or example, the amino acid alanine, a hydrophobic amino acid, may be substituted by another less hydrophobic residue, such as glycine, or a more hydrophobic residue, such as valine, leucine, or isoleucine. Similarly, changes which result in substitution of one negatively charged residue for another, such as aspartic acid for glutamic acid, or one positively charged residue for another, such as lysine for arginine, can also be expected to produce a functionally equivalent product” (para. 391), these few examples of substitutions are not considered enough written description for the vast genus of variants encompassed by the claim. Indeed, the specification discloses that “[a]s used in any aspect described herein, a "variant" or a "functional variant" has at least 25%...overall sequence identity to the non-variant amino acid sequence” (para. 392). The proteins encompassed by the claims can have up to 75% of SEQ ID NO: 6 being a variant while retaining the original function. These protein variants claimed by function are not properly described in the specification. A person having ordinary skill in the art would question whether Applicant was in possession of the genus of functional variants of SEQ ID NO: 6 encompassed by the claims.
Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
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.
Claim 42 is 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 42 recites “Use of a biosensor according to claim 40, wherein the biosensor is used to identify olfactory ligands; or wherein the biosensor is used in high-throughput screening;
or wherein the biosensor is used to detect field populations of aphids”.
However, the claim is indefinite because it is not clear to what statutory category it belongs. In other words, it is not clear whether the claim is to a product or a method. The claim depends from a product claim (claim 40) but appears to be drawn to a method claim, which is not clear. Furthermore, the claim is indefinite because the claim appears to lack any body and is just a preamble, namely the intended use of the biosensor of claim 40. For these reasons, a person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 42 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim recites "use of a biosensor according to claim 40, wherein the biosensor is used to identify olfactory ligands; or wherein the biosensors is used in high-throughput screening; or wherein the biosensor is used to detect field population of aphids". The claim fails to clearly recite a method of using the biosensor of claim 40, and is also not directed to the biosensor of claim 40. The claim also lacks a body and appears to be mere preamble/intended purpose of the biosensor of claim 40. Therefore, given that the claim is not directed to a process, machine, manufacture, or composition of matter, the claim is rejected under 101 (see MPEP 2173.05(q)).
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.
Claims 40 and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. PLoS ONE 7(3): e32759. doi:10.1371/journal.pone.0032759- Cite No. 3 of IDS 4/26/2023 ("Sun").
Although the Sun reference is cited in the IDS 4/26/2023, it is also presently being cited in a PTO-892 form and a copy is being included with this Office Action because it includes the Supplemental Figure 1 and Supplemental Table 1, which are cited in the rejection below.
Regarding claim 40, Sun teaches a biosensor for detecting an analyte in a sample (“odorant-binding proteins (OBPs)…have been recognised as very important elements in the process of chemodetection and recognition” page 2 col. 1 para. 2, “Now, in the light of the new specific role of OBPs in olfactory perception [14–22] and based on the results here presented, we can identify a level, between odorants and olfactory receptors, where decodification of the chemical message is performed by OBPs” page 9 col. 1 para. 3, “OBPs in insects are responsible for recognising the different semiochemicals” page 9 col. 2 para. 1), the biosensor comprising: a protein having an amino acid sequence as defined in SEQ ID NO: 6, or a fragment or variant thereof (“A. pisum OBP6” Figure 2 page 4 col. 2, see Fig. S1 page 11 showing the amino acid sequence and Figures 4-5). Note that the A. pisum OBP6 amino acid sequence taught by Sun (Fig. S1) is a fragment of SEQ ID NO: 6 claimed, specifically, the last 160 amino acids (of the 215 amino acids of SEQ ID NO:6). Sun further teaches a signal generator, wherein the signal generator is configured to output a signal when the analyte is bound to the protein (“The affinity of other ligands was measured in competitive binding assays, using 1-NPN as the fluorescent reporter at 2 mM concentration and 2–16 mM concentrations of each competitor” page 3 col. 2 para. 4, see Figure 4). Note that although Sun fails to use the language “a signal generator, wherein the signal generator is configured to output a signal when the analyte is bound to the protein” the teaching of the competitive binding assays using the 1-NPN fluorescent probe inherently provides “a signal generator, wherein the signal generator is configured to output a signal when the analyte is bound to the protein” because the fluorescence of the probe would decrease if the competitor is present, i.e. in response to the binding of the protein with the analyte.
Regarding claim 42, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the claim is interpreted as being drawn to a method of using the biosensor according to claim 40. Still, the claim lacks body or method steps and merely recites the intended use of the biosensor. Therefore, Sun inherently addresses claim 42.
Nevertheless, Sun further teaches a method of using the biosensor according to claim 40, wherein the biosensor is used to identify olfactory ligands (page 3 col. 2 para. 4, see Figure 4).
Regarding claim 43, Sun further teaches a method of detecting an analyte in a sample (“All three newly expressed proteins (OBP6, OBP7 and OBP10) bind the fluorescent probe with good affinity (Figure 4, upper left panel), as most of insect OBPs, thus allowing other ligands to be tested in competitive binding assays” page 5 col. 2 para. 4) comprising a. providing a biosensor according to claim 40 (“A. pisum OBP6” Figure 2 page 4 col. 2, see Fig. S1 and Figures 4-5); b. contacting the biosensor with the sample; and c. comparing a magnitude of the signal generated by the biosensor when the sample is present with a reference magnitude of the signal generated by the biosensor when the sample is absent (“Fluorescence binding assays - To measure the affinity of the fluorescent ligand N-phenyl-1-naphthylamine (1-NPN) to each protein, a 2 mM solution of the protein in 50 mM Tris-HCl, pH 7.4, was titrated with aliquots of 1 mM ligand in methanol to final concentrations of 2–16 mM. The probe was excited at 337 nm and emission spectra were recorded between 380 and 450 nm. The affinity of other ligands was measured in competitive binding assays, using 1-NPN as the fluorescent reporter at 2 mM concentration and 2–16 mM concentrations of each competitor” page 3 col. 2 para. 4, “Dissociation constants of the competitors were calculated from the corresponding IC50 values, using the equation: KD = [IC50]/1+[1-NPN]/K1-NPN, [1-NPN] being the free concentration of 1-NPN and K1-NPN being the dissociation constant of the complex Protein/1-NPN” page 4 col. 1 para. 1, see Table S1). Note that although Sun fails to use the language “b. contacting the biosensor with the sample; and c. comparing a magnitude of the signal generated by the biosensor when the sample is present with a reference magnitude of the signal generated by the biosensor when the sample is absent”, the teaching of calculating the dissociation constants of the protein for each competitor inherently provides steps b-c because calculating the dissociation constants involves contacting the biosensor with the sample; and comparing a magnitude of the signal generated by the biosensor when the sample is present with a reference magnitude of the signal generated by the biosensor when the sample is absent (page 4 col. 1 para. 1, see Table S1).
Regarding claim 44, Sun further teaches wherein the biosensor is used to identify olfactory ligands (page 3 col. 2 para. 4, see Figure 4 and Table S1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Sun as applied to claim 40 above, and further in view of Mineo (JP 2002071555 A).
Sun teaches the biosensor according to claim 40 as discussed above.
Sun fails to teach wherein the biosensor further comprises: a flow path for moving the sample; a substrate; and a protein-containing layer immobilised to the substrate and in contact with the flow path, wherein the protein-containing layer comprises the protein.
Mineo teaches a biosensor for detecting an analyte in a sample (“Chemical substance sensor and detection method of chemical substance” Title) the biosensor comprising: an odor-binding protein (“The present inventor paid attention to such an odorant binding protein and diligently studied a method for detecting a chemical substance using the odorant binding protein” page 2 para. 3); and a signal generator, wherein the signal generator is configured to output a signal when the analyte is bound to the protein (“Here, the amount of such an odorant binding protein immobilized on the immobilizing material changes depending on the presence or absence of a chemical substance in the sample. Therefore, in this case, the presence or absence of the chemical substance in the sample can be determined based on the change in the immobilized amount of the odorant binding protein” page 4 para. 2, “In the method of detecting an odorant using the chemical sensor 100 described above, a change in the refractive index of the interface 15 caused when the odorant binding protein is immobilized (adsorbed) on the immobilizing material 4 of the sensor chip 1 is a surface plasmon. It is detected as a change in the resonance angle based on the resonance” page 5 para. 9). Mineo further teaches wherein the biosensor further comprises: a flow path for moving the sample (“The chemical substance sensor according to the present invention comprises a cartridge having a flow passage through which a solution containing a sample and an odorant binding protein can flow” page 2 para. 4); a substrate (“and a cartridge which can contact the solution in the flow passage and is arranged along the flow of the solution” page 2 para. 4, “The sensor chip 1 has a substrate 2 made of a material that transmits light, such as glass” page 5 para. 5); and a protein-containing layer immobilised to the substrate and in contact with the flow path, wherein the protein-containing layer comprises the protein (“As described above, the fixing material 4 is formed on the metal thin film 3 of the sensor chip 1. As shown in FIG. 3, the fixing material 4 is composed of the NTA linker 10” page 6 para. 2, “Here, the odorant binding protein is immobilized by utilizing the binding force between histidine and NTA13. It is also possible to immobilize the odorant binding protein to the linker using a combination of the above or a combination of GST (glutathione S transferase) and glutathione” page 6 para. 7, see Figures). Mineo further suggests that the biosensor comprising: a flow path for moving the sample; a substrate; and a protein-containing layer immobilised to the substrate and in contact with the flow path, wherein the protein-containing layer comprises the protein, enables the detection of a plurality of types of chemical substances with high sensitivity and low cost (“An object of the present invention is to provide a chemical substance sensor and a chemical substance detection method which can be detected with high sensitivity and low cost and which can be applied to a plurality of types of chemical substances having different binding characteristics. Is to provide” page 1 para. 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Sun to include the flow path for moving the sample, the substrate, and the protein-containing layer immobilised to the substrate and in contact with the flow path, wherein the protein-containing layer comprises the protein taught by Mineo because Mineo suggests that this enables the detection of a plurality of types of chemical substances with high sensitivity and low cost and Sun is interested in detecting a plurality of types of olfactory ligands. A person having ordinary skill in the art would have had a reasonable expectation of success because both Sun and Mineo teach a biosensor for detecting an analyte in a sample, the biosensor comprising: an odor-binding protein; and a signal generator, wherein the signal generator is configured to output a signal when the analyte is bound to the protein.
Conclusion
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/Fernando Ivich/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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