The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group I, claims 1-11, to peptide sequence AgOR1, in the reply filed on November 17, 2025 is acknowledged. The traversal is on the ground(s) that the examiner has not provided any indication that the content of the claims interpreted in light of the description was considered in making the assertion of a lack of unity and therefore has not met the burden necessary to support the assertion. This is not found persuasive because the claims, when interpreted in light of the instant specification, still all relate to an amino acid sequence represented by formula (1) (specification p. 2). As noted in the text of the restriction requirement, Lee et al. (WO 03020913; IDS 12.11.24) teach variant olfactory receptor polypeptides comprising an amino acid sequence represented by formula (1) and having the amino acid residues and conditions recited. Therefore, the special technical feature linking the inventions of Groups I-IV does not constitute a special technical feature as defined by PCT 13.2, as it does not define a contribution over the prior art. See also the reasons noted on at least p. 4-5 of the restriction requirement. Regarding Applicants’ remarks that search of all the claims would not impose a serious burden on the office, the remarks are not persuasive. As noted in the text of the restriction requirement, search of patentably distinct inventions require a different field of search in different classes/subclasses/definitions and/or utilizing various electronic sources and/or employing different and distinct search strategies and search queries, thereby imposing a serious search and examination burden on the office. Further, amino acid sequences comprising formula (1) encompass an enormous number of distinct amino acid sequences having different amino acid residues and therefore properties, and would further impose an undue burden on the office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-14 have been withdrawn from further consideration by the examiner because they are drawn to non-elected inventions. Claims 1-11, to peptide sequence AgOR1, are under consideration.
Priority: This application is a 371 of PCT/JP2021/027265, filed July 21, 2021, which claims benefit to foreign application JP 2020-126684, filed July 27, 2020. A copy of the foreign priority document has been received in the instant application on January 27, 2023, and is not in the English language.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraphs 0061, 0064 (of the application publication). 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.
Failure to Comply with Sequence Rules
Where the description of a patent application discusses a sequence of 4 or more amino acids or a sequence of 10 or more nucleic acids, reference must be made to the sequence by use of the sequence identifier preceded by “SEQ ID NO:” in the text of the description even if the sequence is also embedded in the text of the description of the patent application (see 37 CFR 1.821, especially paragraphs (a)-(d)). The sequence identifier may be used in either the drawing or the Brief Description of Drawings (see MPEP 2422).
Objection to the Specification:
The drawings are objected to because: at least Figs. 1, 2, 3, 4 describe and/or disclose amino acid sequences without identifiers. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The sequences must be in computer readable form (CRF) for search. See also MPEP
2422 for sequence compliance requirements. 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 1-11 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.
In analyzing the claims for compliance with the written description requirements of 35 U.S.C. 112(a), a determination is made as to whether the specification contains a written description sufficient to show they had possession of the full scope of their claimed invention at the time the application was filed. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
Claims 1-11 are drawn to a mutant-insect olfactory receptor protein, comprising amino acid sequence B composed of amino acid sequence A containing a mutation, wherein the amino acid sequence A is in a corresponding wild-type insect olfactory receptor protein and represented by formula (1): ɸ7X1X2Z1X3X4Z2Z3ɸ6Uɸ5ɸ4ɸ3ɸ2ɸ1X5X6 wherein X1 to X6 and Z1 to Z3 represent amino acids derived from the amino acid sequence of the wild-type insect olfactory receptor, ɸ1 represents a hydrophobic amino acid, ɸ2 to ɸ7 each independently represent an uncharged polar amino acid or a hydrophobic amino acid, and U represents an uncharged polar amino acid, and the mutant insect olfactory receptor satisfies at least one condition selected from the group consisting of the conditions (1) to (3), etc., nucleic acid molecules encoding the mutant-insect olfactory receptor protein, and a cell comprising the nucleic acid molecules.
Accordingly, the claims encompass a significantly large genus of mutant insect olfactory receptor proteins, nucleic molecules encoding the mutant insect olfactory receptor proteins, and cells comprising the nucleic acid molecules. The recited genus of mutant insect olfactory receptor proteins are defined through their activity only and do not require any particular structure and comprise any combination of amino acid residues and/or mutations (including substitutions, deletions, additions) since the amino acid residues recited in the claims are merely representative of an amino acid sequence of the mutant insect olfactory receptor proteins. The recited genus of eukaryotic cells comprising the biomolecules having the activities and having no particular structure, comprises any prokaryotic, microorganism, eukaryotic or mammalian cell. As such, the described genera are biomolecules defined solely by their functional characteristics and any type of cell comprising said biomolecules defined solely by their functional characteristics, which is not sufficient characteristic for written description purposes. MPEP 2163.
However, the specification teaches specific mutant insect olfactory receptor proteins, including mutant Anopheles gambiae olfactory receptor 1 (AgOR1) proteins comprising SEQ ID NO: 3 and having substitutions M401L+K402S, M401L+K402N, or M401L+K402S+additional mutations (SEQ ID NOS: 45, 51 and 55).
The specification does not disclose any mutant insect olfactory receptor proteins comprising any amino acid sequence representative of formula 1 of unknown amino acid residues.
Thereby, the specification has described in terms of its complete structure only the wild type polypeptide with activity and specific mutations therein (as discussed above).
The specification does not describe by other relevant identifying characteristics a representative number of additional species within the broadly claimed genus.
It is noted that the specification also teaches the general methodology for performing mutagenesis to obtain mutant insect olfactory receptor proteins and methods for measuring or detecting activity. However, possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
This finding is also emphasized in Ex Parte Kubin (No. 2007-0819, Bd. Pat. Ann. & Int. May 31. 2007), wherein it is stated that:
“Although there is often significant overlap” between the enablement and written description requirements, “they are nonetheless independent of each other.” University of Rochester, 358 F.3d at 921, 69 USPQ2d at 1891. An “invention may be enabled even though it has not been described.” Id. Such is the situation here. While we conclude one skilled in the art would have been able to make and use the full scope of claim 73 through routine experimentation, we find Appellants did not describe the invention of claim 73 sufficiently to show they had possession of the claimed genus of nucleic acids. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 1348, 69 USPQ2d 1508, 1513 (Fed. Cir. 2004) (“invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed”).
Thereby, a showing of how to potentially identify and make other nucleic acids/polypeptides is not sufficient to establish that Applicants were in possession of the invention as broadly claimed.
The skilled artisan cannot necessarily envision the detailed structures of ALL variants of any insect olfactory receptor protein comprising any amino acid sequence representative of formula 1 of unknown amino acid residues and having at least one condition selected from the group consisting of the conditions (1) to (3) because the specification provides minimal guidance as to which substitutions and/or deletions and/or additions and which amino acids are essential and critical for which insect olfactory receptor protein to have a changed property or activity, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the methods of making the claimed invention. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating or making it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for mutant AgOR1 proteins comprising the amino acid sequence of SEQ ID NO: 45, 51 or 55, does not reasonably provide enablement for any and all mutant insect olfactory receptor proteins comprising any amino acid sequence representative of formula 1 of unknown amino acid residues and having at least one condition selected from the group consisting of the conditions (1) to (3). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The scope of the instant claims is not commensurate with the enablement of the instant disclosure, because practice of the claimed invention would require undue experimentation by an artisan of ordinary skill in the art to ascertain which mutant insect olfactory receptor proteins comprising any amino acid sequence representative of formula 1 of unknown amino acid residues will have at least one condition selected from the group consisting of the conditions (1) to (3), and in which cells. Claims 1-11 are drawn to a mutant-insect olfactory receptor protein, comprising amino acid sequence B composed of amino acid sequence A containing a mutation, wherein the amino acid sequence A is in a corresponding wild-type insect olfactory receptor protein and represented by formula (1): ɸ7X1X2Z1X3X4Z2Z3ɸ6Uɸ5ɸ4ɸ3ɸ2ɸ1X5X6 wherein X1 to X6 and Z1 to Z3 represent amino acids derived from the amino acid sequence of the wild-type insect olfactory receptor, ɸ1 represents a hydrophobic amino acid, ɸ2 to ɸ7 each independently represent an uncharged polar amino acid or a hydrophobic amino acid, and U represents an uncharged polar amino acid, and the mutant insect olfactory receptor satisfies at least one condition selected from the group consisting of the conditions (1) to (3), etc., nucleic acid molecules encoding the mutant-insect olfactory receptor protein, and a cell comprising the nucleic acid molecules.
Accordingly, the claims encompass a significantly large genus of mutant insect olfactory receptor proteins, nucleic molecules encoding the mutant insect olfactory receptor proteins, and cells comprising the nucleic acid molecules. The recited genus of mutant insect olfactory receptor proteins are defined through their activity only and do not require any particular structure and comprise any combination of amino acid residues and/or mutations (including substitutions, deletions, additions) since the amino acid residues recited in the claims are merely representative of an amino acid sequence of the mutant insect olfactory receptor proteins. Thus, there could be a myriad and/or countless number of variants wherein the mutant insect olfactory receptor protein may or may not exhibit activity and exhibit property changes. Therefore, for the instant claimed invention, it would require an undue burden of experimentation for a skilled artisan to determine exactly which variants have activity and exhibit property changes.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: “'Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. ''Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
In the instant case, the quantity of experimentation would be large since there are myriad substitutions and/or deletions and/or insertions and/or additions and amino acid residues to choose from to obtain mutant insect olfactory receptor proteins comprising any amino acid sequence representative of formula 1 of unknown amino acid residues exhibiting property changes and/or having at least one condition selected from the group consisting of the conditions (1) to (3). The amount of guidance in the specification is minimal as to which substitutions at which positions in a wildtype insect olfactory receptor protein, i.e. AgOR1 protein, are essential and critical for having at least one condition selected from the group consisting of the conditions (1) to (3). In particular, the specification teaches specific mutant insect olfactory receptor proteins, including mutant Anopheles gambiae olfactory receptor 1 (AgOR1) proteins comprising SEQ ID NO: 3 and having substitutions M401L+K402S, M401L+K402N, or M401L+K402S+additional mutations (SEQ ID NOS: 45, 51 and 55) (see working examples).
The specification does not disclose any mutant insect olfactory receptor proteins comprising any amino acid sequence representative of formula 1 of unknown amino acid residues. The nature of the invention is such that many different polypeptides that are substantially similar to insect olfactory receptor proteins may or may not have activity exhibiting property changes and conditions. The state of the prior art is that even proteins that are highly similar to the wild-type protein are at times not fully active. The relative level of skill in this art is very high. The predictability as to what substantially similar protein will have which activity is zero. When the factors are considered in their entirety, the Wands analysis dictates a finding of undue experimentation and thus, the claims are not enabled.
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 and dependent claims are drawn to a mutant-insect olfactory receptor protein, comprising amino acid sequence B composed of amino acid sequence A containing a mutation, wherein the amino acid sequence A is in a corresponding wild-type insect olfactory receptor protein and represented by formula (1): ɸ7X1X2Z1X3X4Z2Z3ɸ6Uɸ5ɸ4ɸ3ɸ2ɸ1X5X6 wherein X1 to X6 and Z1 to Z3 represent amino acids derived from the amino acid sequence of the wild-type insect olfactory receptor, ɸ1 represents a hydrophobic amino acid, ɸ2 to ɸ7 each independently represent an uncharged polar amino acid or a hydrophobic amino acid, and U represents an uncharged polar amino acid, and the mutant insect olfactory receptor satisfies at least one condition selected from the group consisting of the conditions (1) to (3), etc., nucleic acid molecules encoding the mutant-insect olfactory receptor protein, and a cell comprising the nucleic acid molecules.
Claim 1 is generally confusing and it is not clear what features are being recited in the mutant insect olfactory receptor protein. It is not clear what amino acid sequence(s) are comprised in the mutant insect olfactory receptor protein and which amino acid residues form the amino acid sequence(s) in the mutant insect olfactory receptor protein because the amino acid residues recited in the claim are merely representative of an amino acid sequence of the mutant insect olfactory receptor proteins. Further, it is not clear how amino acid sequence A is different than amino acid B to meet the conditions (1) to (3). Further clarification and/or correction is requested. Therefore, as currently written, the mutant insect olfactory receptor protein can reasonably comprise any amino acid sequence of an insect olfactory receptor polypeptide.
Claims 2-7 are generally confusing for the reasons noted above for claim 1 because the amino acid residues recited in the claims are merely representative of an amino acid sequence of the mutant insect olfactory receptor proteins and it is not clear what the amino acid sequence(s) are. Further clarification and/or correction is requested.
Claim 8 is confusing because it is not clear what is meant by the amino acid sequence A is a sequence “present closer” to the C-terminus of the amino acid sequence of the wild-type insect olfactory receptor protein.
Claims 9-11 are included in this rejection because they are dependent on the above claim(s) and fail to cure its defects.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (WO 03020913; IDS 12.11.24). Since it is not clear what amino acid sequences and/or residues are present in the mutant insect olfactory receptor protein, for prior art purposes, the mutant insect olfactory receptor protein can reasonably comprise any amino acid sequence of an insect olfactory receptor polypeptide.
Lee et al. teach various Anopheles gambiae odorant receptor proteins comprising amino acid sequences represented by instant formula (1) and having representative amino acid residues and therefore, meeting the conditions recited (at least p. 19-21, also Figs. 1, 3-4; instant claims 1-9).
Regarding instant claim 10, Lee et al. teach nucleic acid molecules encoding the Anopheles gambiae odorant receptor proteins (at least p. 21-32).
Regarding instant claim 11, Lee et al. teach a host cell comprising the nucleic acid molecules encoding the Anopheles gambiae odorant receptor proteins (at least p. 32-35).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marsha Tsay whose telephone number is (571)272-2938. The examiner can normally be reached M-F.
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/Marsha Tsay/Primary Examiner, Art Unit 1656