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 1-18 were originally filed June 7, 2023.
The preliminary amendment received June 7, 2023 amended claims 3-6, 11-14, 17, and 18.
The amendment received June 16, 2026 amended claims 1 and 6.
Claims 1-18 are currently pending.
Claims 1-14 are currently under consideration.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-14) in the reply filed on February 5, 2026 is acknowledged. The traversal is on the grounds that Groups I and II share a single general inventive concept and that Omura et al. do not teach polypeptide variants with increased water solubility and moesin binding relative to SEQ ID NO: 1. This is not found persuasive because the least common denominator may be utilized to break Unity of Invention. The present method does not even require the polypeptide of claim 1, but refers to a generic “polypeptide, fragment, or fusion polypeptide or fragment thereof” without any additional structure or any relationship to SEQ ID NO: 1. Therefore, Groups I and II are not linked by a general inventive concept. In addition, independent claim 1 is much broader in scope than applicants’ representative has characterized the polypeptide. Independent claim 1 comprises a variant of SEQ ID NO: 1 or a fragment thereof and potentially a fusion polypeptide. There is a disconnect between the preamble and the body of the claim (i.e. preamble - variant of SEQ ID NO: 1, fragment thereof, or fusion polypeptide; body of claim – variant of SEQ ID NO: 1, or a fragment thereof). Furthermore, it is unclear from present independent claim 1 if the fragment or fusion polypeptide are fragments or fusions of SEQ ID NO: 1 or fragments or fusions of a variant SEQ ID NO: 1. In addition, while functional limitations may be utilized in the claims, the structure required for the function should be clear.
Please note: elections are definitive and NOT conditional (see page 4, second paragraph of the response received February 5, 2026).
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 5, 2026.
Applicant's election with traverse of variants of SEQ ID NO: 1 having increased water solubility and moesin binding activity and comprising an affinity tag in the reply filed on February 5, 2026 is acknowledged. The traversal is on the grounds that the “alleged species differ only in routine and predictable modifications such as deletions, affinity tags, and orientation, which do not render them patentably distinct” and a “search of any one species would reasonably encompass the others, and no materially different patentability issues arise among the disclosed embodiments”. This is not found persuasive because applicants neglected to traverse the prior art of record utilized to break Unity of Invention. In addition, a search for one sequence or affinity tag may not be coextensive with a search for another seqeucne or affinity tag.
Please note: the examiner of record thanks the attorney of record for clearly stating on the record that the species are not patently distinct and have no materially different patentability issues (see page 3, last paragraph of the response received February 5, 2026). Thus, the species are all obvious variants of each other by applicants’ assertion.
Please note: elections are definitive and NOT conditional (see page 4, second paragraph of the response received February 5, 2026).
Please note: applicants’ representative elected subgenuses (i.e. variants of SEQ ID NO: 1 having increased water solubility and moesin binding activity and an affinity tag) instead of single, specific species, therefore, the subgenuses were searched.
The requirement is still deemed proper and is therefore made FINAL.
Due to the amendments received June 16, 2026, claims 2-5 and 7-14 have been rejoined.
Potential Rejoinder
Applicants elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim (i.e. claims 15-18 do not require the limitations of present independent claim 1 and will not be rejoined) will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/US2021/062280 filed December 7, 2021 which claims the benefit of 63/281,132 filed November 19, 2021 and 63/122,451 filed December 7, 2020.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
See claims 1, 2, 6, and 10. See paragraphs 11, 86, 102, 111, 127, and 133. See 6xHis and hexahistidine.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
See Figures 4, 9A, and 9B.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Objections
The objection to claim 1 regarding the preamble should be clarified (e.g. A polypeptide comprising, A variant polypeptide, etc.) is withdrawn in view of the amendment received June 16, 2026.
The objection to claim 1 regarding the commas in the claim should be reviewed in order to clarify the claim (e.g. a variant of SEQ ID NO: 1 or a fragment thereof; a variant of SEQ ID NO: 1, a fragment of SEQ ID NO: 1, or a fusion polypeptide of SEQ ID NO: 1) is withdrawn in view of the amendment received June 16, 2026.
The objection to claim 1 regarding articles are missing from the claim (e.g. a fragment thereof, a fusion polypeptide) is withdrawn in view of the amendment received June 16, 2026.
The objection to claim 6 regarding the following is suggested the “polypeptide of claim 1 comprising a sequence with more than 90% identity to SEQ ID NO: 1” is withdrawn in view of the amendment received June 16, 2026.
New Objections Necessitated by Amendment
Claim Objections
Claim 4 is objected to because of the following informalities: “O198” or “0198” should read “D198” (see line 3, two recitations). Appropriate correction is required. Please note: applicants are respectfully requested to carefully review SEQ ID NO: 1 to determine which residue is at position 198 (e.g. D/Asp or other).
Claim 7 is objected to because of the following informalities: “O198” or “0198” should read “D198” (see line 3). Appropriate correction is required. Please note: applicants are respectfully requested to carefully review SEQ ID NO: 1 to determine which residue is at position 198 (e.g. D/Asp or other).
Claim 12 is objected to because of the following informalities: “ofclaim” should read “of claim”. Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Withdrawn Rejections
The rejection of claims 1 and 6 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 1 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 1 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 6 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 6 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 6 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 is withdrawn in view of the amendment received June 16, 2026.
The rejection of claim 6 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the amendment received June 16, 2026.
The rejection of claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Clark et al. U.S. Patent Application Publication 2006/0263774 published November 23, 2006 is withdrawn in view of the amendment received June 16, 2026.
New Rejections Necessitated by Amendment
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 1-5 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 new matter rejection.
Support in the originally filed specification was not found for the product by process limitations of independent claim 1, lines 7-10.
For example, a range of 6-8M urea was not found (i.e. 8M urea was found at pages 24, 29, and 32). In addition, while very specific methods of making and methods of determining activity are recited in the examples, the broader methods of making and methods of determining activity in present independent claim 1 are not found in the originally filed specification.
It is applicants’ responsibility to specifically point out support in the originally filed specification for any amendments made during prosecution.
Claim 6 is 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 new matter rejection.
Support in the originally filed specification was not found for the method limitations of independent claim 6.
For example, a range of 6-8M urea was not found (i.e. 8M urea was found at pages 24, 29, and 32). In addition, while very specific methods of making are recited in the examples, the broader methods of making in present independent claim 6 are not found in the originally filed specification.
It is applicants’ responsibility to specifically point out support in the originally filed specification for any amendments made during prosecution.
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 1-5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, independent claim 1 requires the very specific structure of a polypeptide consisting of amino acids 79-197 of SEQ ID NO: 1 with a C-terminal hexahistidine tag. It is unclear how the method of making (i.e. lines 7-8) alters the structure already recited in the claim. Furthermore, if the method of making does not alter the structure recited in the claims, then the method is unnecessary.
Claims 1-5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, independent claim 1 requires the very specific structure of a polypeptide consisting of amino acids 79-197 of SEQ ID NO: 1 with a C-terminal hexahistidine tag. It is unclear how the method of determining activity (i.e. lines 9-10) alters the structure already recited in the claim. If applicants wish to incorporate a function to the structure, the function can be clearly stated without the method of determining activity (i.e. wherein the polypeptide has moesin binding activity).
Claims 1-5 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation polyhistidine, and the claim also recites 6 histidines (6xHis) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “0198”/”O198” is. There is not an amino acid which corresponds to “0” or “O”.
Claim 4 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. One of skill in the art would not be able to determine the scope of “a plurality of deletions…corresponding to amino acid residues M1 to P78, O198 to G361, or M1 to P78 and O198 to G361 using SEQ ID NO: 1”. For example, are residues 79-197 of SEQ ID NO: 1 required by the claim or not. If SEQ ID NO: 1 is simply a reference, then residue 79-197 could be from other aligned sequences (e.g. residues 79-197 of SEQ ID NO: 1 are not required). In addition, the present claim may be considered an improper use claim – see MPEP § 2173.05(q). Moreover, it is unclear if “a plurality of deletions” includes 2, 3, 4, etc. of residues 1-78 or 198-361 or if the plurality of deletions is the entire N-terminus from residues 1-78 and the entire C-terminus from residues 198-361.
Claim 6 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the scope of “expressing a nucleic acid encoding amino acids 79-197 of SEQ ID NO: 1” is. Is the polynucleotide limited to expressing a polypeptide consisting of amino acids 79-197 of SEQ ID NO: 1 with a C-terminal hexahistidine tag or does the polypeptide encompass full length SEQ ID NO: 1?
Claim 6 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the amino acids 97-197 of SEQ ID NO: 1 with a C-terminal hexahistidine tag correlate to the last method step of “recovering a water-soluble moesin-binding polypeptide”.
Claim 6 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 6 recites the limitation "the expressed polypeptide" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 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. One of skill in the art would not be able to determine the scope of the present claims. For example, the present claim includes an improper “use” (see line 7; two recitations). See MPEP § 2173.05(q).
Claim 6 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 6 recites the limitation "the solubilized polypeptide" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claims 7-14 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “0198”/”O198” is. There is not an amino acid which corresponds to “0” or “O”.
Claims 7-14 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. One of skill in the art would not be able to determine the scope of “a plurality of deletions…corresponding to amino acid residues M1 to P78 and O198 to G361 using SEQ ID NO: 1”. For example, are residues 79-197 of SEQ ID NO: 1 required by the claim or not. If SEQ ID NO: 1 is simply a reference, then residue 79-197 could be from other aligned sequences (e.g. residues 79-197 of SEQ ID NO: 1 are not required). In addition, the present claim may be considered an improper use claim – see MPEP § 2173.05(q). Moreover, it is unclear if “a plurality of deletions” includes 2, 3, 4, etc. of residues 1-78 or 198-361 or if the plurality of deletions is the entire N-terminus from residues 1-78 and the entire C-terminus from residues 198-361.
Claims 7-14 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how biotin is related to the variant.
Claims 7-14 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the “parent HYMKR polypeptide” is.
Claim 11 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how histidine can be added (e.g. including substitution) at residues which have been deleted. It is suggested that applicants indicate that a polyhistidine tag is added to the N- or C-terminus of residues 79-197 of SEQ ID NO: 1. In addition, the present claim may be considered an improper use claim – see MPEP § 2173.05(q).
Claim 11 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the “parent HYMKR polypeptide” is.
Claim 14 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what additional structure is required for the function other than the structure recited in independent claim 7.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 depends on independent claim 1. Independent claim 1 requires a C-terminal polyhistidine tag which is a hexahistidine tag. Dependent claim 2 requires a polyhistidine or hexahistidine tag. Therefore, claim 2 is redundant and fails to further limit the structure of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends on independent claim 1. Independent claim 1 requires a C-terminal hexahistidine tag. Dependent claim 3 requires an affinity tag at the amino (N-) or carboxy (C-) terminal end. Therefore, claim 3 is broader in scope than independent claim 1 (i.e. N-terminal addition of an affinity tag, C-terminal addition of an affinity tag, an affinity tag) and fails to further limit the structure of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 depends on independent claim 1. Independent claim 1 requires a polypeptide consisting of amino acids 79-197 of SEQ ID NO: 1. Dependent claim 4 requires a plurality of deletions of M1-P78, D198-G361, or M1-P78 and D198-G361 of SEQ ID NO: 1. Therefore, dependent claim 4 fails to further limit the structure of independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 depends from independent claim 7. Independent claim 7 refers to a function related to a HYMKR polypeptide fragment of SEQ ID NO: 1. Dependent claim 12 refers to HYMKR polypeptide from Homo sapiens. SEQ ID NO: 1 is HYMKR polypeptide from Homo sapiens. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 depends from independent claim 7. Independent claim 7 refers to a function related to a HYMKR polypeptide fragment of SEQ ID NO: 1. Dependent claim 12 refers to HYMKR polypeptide of SEQ ID NO: 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 101
Please note: the rejection of claim 1 was withdrawn due to the structural change of a C-terminal hexahistidine. “Recombinant” and “isolated” (i.e. “hand of man”) are not sufficient to withdraw a 35 USC 101 rejection. In addition, the product-by-process limitations do not alter the structure in such a way as to negate the 35 USC 101 rejection.
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.
Claims 7-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to fragments of haymaker/tom40 (SEQ ID NO: 1) without significantly more. The claims recite the following structure a variant of a parent HYMKR polypeptide comprising a plurality of deletions of amino acid residues corresponding to amino acid residues M1 to P78 and D198 to G361 of SEQ ID NO: 1 wherein the variant comprises biotin. This judicial exception is not integrated into a practical application because the present claims are drawn to a product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is unclear how biotin is associated with SEQ ID NO: 1.
SEQ ID NO: 1
RESULT 1
TOM40_HUMAN
ID TOM40_HUMAN Reviewed; 361 AA.
AC O96008; A0A024R0P9; Q86VW4; Q8WY09; Q8WY10; Q8WY11; Q9BR95;
DT 11-JAN-2001, integrated into UniProtKB/Swiss-Prot.
DT 01-MAY-1999, sequence version 1.
DT 18-JUN-2025, entry version 196.
DE RecName: Full=Mitochondrial import receptor subunit TOM40 homolog;
DE AltName: Full=Protein Haymaker;
DE AltName: Full=Translocase of outer membrane 40 kDa subunit homolog;
DE AltName: Full=p38.5;
GN Name=TOMM40; Synonyms=C19orf1, PEREC1, TOM40;
OS Homo sapiens (Human).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Euarchontoglires; Primates; Haplorrhini; Catarrhini; Hominidae;
OC Homo.
OX NCBI_TaxID=9606;
RN [1]
RP NUCLEOTIDE SEQUENCE [GENOMIC DNA].
RX PubMed=10520737; DOI=10.3109/10425179809086433;
RA Freitas E.M., Zhang W.J., Lalonde J.P., Tay G.K., Gaudieri S.,
RA Ashworth L.K., Van Bockxmeer F.M., Dawkins R.L.;
RT "Sequencing of 42kb of the APO E-C2 gene cluster reveals a new gene:
RT PEREC1.";
RL DNA Seq. 9:89-100(1998).
RN [2]
RP NUCLEOTIDE SEQUENCE [GENOMIC DNA / MRNA] (ISOFORM 1).
RA Yoshiura K., Murray J.C.;
RT "A transcriptional map in the region of 19q13 derived using direct
RT sequencing and exon trapping.";
RL Submitted (JAN-1998) to the EMBL/GenBank/DDBJ databases.
RN [3]
RP NUCLEOTIDE SEQUENCE [MRNA] (ISOFORM 1).
RC TISSUE=Lymphocyte;
RX PubMed=11745481; DOI=10.1002/ijc.1555;
RA Das B., Tao S.-Z., Mushnitsky R., Norin A.J.;
RT "Genetic identity and differential expression of p38.5 (Haymaker) in human
RT malignant and non-malignant cells.";
RL Int. J. Cancer 94:800-806(2001).
RN [4]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RA Mural R.J., Istrail S., Sutton G.G., Florea L., Halpern A.L., Mobarry C.M.,
RA Lippert R., Walenz B., Shatkay H., Dew I., Miller J.R., Flanigan M.J.,
RA Edwards N.J., Bolanos R., Fasulo D., Halldorsson B.V., Hannenhalli S.,
RA Turner R., Yooseph S., Lu F., Nusskern D.R., Shue B.C., Zheng X.H.,
RA Zhong F., Delcher A.L., Huson D.H., Kravitz S.A., Mouchard L., Reinert K.,
RA Remington K.A., Clark A.G., Waterman M.S., Eichler E.E., Adams M.D.,
RA Hunkapiller M.W., Myers E.W., Venter J.C.;
RL Submitted (JUL-2005) to the EMBL/GenBank/DDBJ databases.
RN [5]
RP NUCLEOTIDE SEQUENCE [LARGE SCALE MRNA] (ISOFORMS 1 AND 2).
RC TISSUE=Eye, Lung, Skin, Testis, and Uterus;
RX PubMed=15489334; DOI=10.1101/gr.2596504;
RG The MGC Project Team;
RT "The status, quality, and expansion of the NIH full-length cDNA project:
RT the Mammalian Gene Collection (MGC).";
RL Genome Res. 14:2121-2127(2004).
RN [6]
RP PROTEIN SEQUENCE OF 185-195 AND 332-348, AND IDENTIFICATION BY MASS
RP SPECTROMETRY.
RC TISSUE=Brain, and Cajal-Retzius cell;
RA Lubec G., Vishwanath V.;
RL Submitted (MAR-2007) to UniProtKB.
RN [7]
RP IDENTIFICATION IN THE TOM COMPLEX WITH TOMM7; TOMM20 AND TOMM22.
RX PubMed=12198123; DOI=10.1074/jbc.m205613200;
RA Johnston A.J., Hoogenraad J., Dougan D.A., Truscott K.N., Yano M., Mori M.,
RA Hoogenraad N.J., Ryan M.T.;
RT "Insertion and assembly of human tom7 into the preprotein translocase
RT complex of the outer mitochondrial membrane.";
RL J. Biol. Chem. 277:42197-42204(2002).
RN [8]
RP FUNCTION, SUBCELLULAR LOCATION, AND IDENTIFICATION IN THE TOM COMPLEX WITH
RP TOMM20; TOMM22 AND TOMM70.
RX PubMed=15644312; DOI=10.1074/jbc.m413816200;
RA Humphries A.D., Streimann I.C., Stojanovski D., Johnston A.J., Yano M.,
RA Hoogenraad N.J., Ryan M.T.;
RT "Dissection of the mitochondrial import and assembly pathway for human
RT Tom40.";
RL J. Biol. Chem. 280:11535-11543(2005).
RN [9]
RP IDENTIFICATION IN THE TOM COMPLEX.
RX PubMed=18331822; DOI=10.1016/j.bbrc.2008.02.150;
RA Kato H., Mihara K.;
RT "Identification of Tom5 and Tom6 in the preprotein translocase complex of
RT human mitochondrial outer membrane.";
RL Biochem. Biophys. Res. Commun. 369:958-963(2008).
RN [10]
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RX PubMed=21269460; DOI=10.1186/1752-0509-5-17;
RA Burkard T.R., Planyavsky M., Kaupe I., Breitwieser F.P., Buerckstuemmer T.,
RA Bennett K.L., Superti-Furga G., Colinge J.;
RT "Initial characterization of the human central proteome.";
RL BMC Syst. Biol. 5:17-17(2011).
RN [11]
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RC TISSUE=Liver;
RX PubMed=24275569; DOI=10.1016/j.jprot.2013.11.014;
RA Bian Y., Song C., Cheng K., Dong M., Wang F., Huang J., Sun D., Wang L.,
RA Ye M., Zou H.;
RT "An enzyme assisted RP-RPLC approach for in-depth analysis of human liver
RT phosphoproteome.";
RL J. Proteomics 96:253-262(2014).
RN [12]
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RX PubMed=25944712; DOI=10.1002/pmic.201400617;
RA Vaca Jacome A.S., Rabilloud T., Schaeffer-Reiss C., Rompais M., Ayoub D.,
RA Lane L., Bairoch A., Van Dorsselaer A., Carapito C.;
RT "N-terminome analysis of the human mitochondrial proteome.";
RL Proteomics 15:2519-2524(2015).
RN [13]
RP INTERACTION WITH TIMM29.
RX PubMed=27554484; DOI=10.7554/elife.17463;
RA Kang Y., Baker M.J., Liem M., Louber J., McKenzie M., Atukorala I.,
RA Ang C.S., Keerthikumar S., Mathivanan S., Stojanovski D.;
RT "Tim29 is a novel subunit of the human TIM22 translocase and is involved in
RT complex assembly and stability.";
RL Elife 5:0-0(2016).
RN [14]
RP FUNCTION, INTERACTION WITH BCAP31 AND NDUFS4, AND SUBCELLULAR LOCATION.
RX PubMed=31206022; DOI=10.1126/sciadv.aaw1386;
RA Namba T.;
RT "BAP31 regulates mitochondrial function via interaction with Tom40 within
RT ER-mitochondria contact sites.";
RL Sci. Adv. 5:eaaw1386-eaaw1386(2019).
CC -!- FUNCTION: Channel-forming protein essential for import of protein
CC precursors into mitochondria (PubMed:15644312, PubMed:31206022). Plays
CC a role in the assembly of the mitochondrial membrane respiratory chain
CC NADH dehydrogenase (Complex I) by forming a complex with BCAP31 and
CC mediating the translocation of Complex I components from the cytosol to
CC the mitochondria (PubMed:31206022). {ECO:0000269|PubMed:15644312,
CC ECO:0000269|PubMed:31206022}.
CC -!- SUBUNIT: Forms part of the preprotein translocase complex of the outer
CC mitochondrial membrane (TOM complex) which consists of at least 7
CC different proteins (TOMM5, TOMM6, TOMM7, TOMM20, TOMM22, TOMM40 and
CC TOMM70). Interacts with mitochondrial targeting sequences
CC (PubMed:12198123, PubMed:15644312, PubMed:18331822). Interacts with
CC TIMM29; linking the TIM22 complex to the TOM complex (PubMed:27554484).
CC Forms a complex with BCAP31 (via C-terminus) which mediates the
CC translocation of components of the mitochondrial membrane respiratory
CC chain NADH dehydrogenase (Complex I) from the cytosol to the
CC mitochondria (PubMed:31206022). Interacts (via N-terminus) with CYP1A1
CC (via mitochondrial targeting signal); this interaction is required for
CC CYP1A1 translocation across the mitochondrial outer membrane (By
CC similarity). {ECO:0000250|UniProtKB:Q75Q40,
CC ECO:0000269|PubMed:12198123, ECO:0000269|PubMed:15644312,
CC ECO:0000269|PubMed:18331822, ECO:0000269|PubMed:27554484,
CC ECO:0000269|PubMed:31206022}.
CC -!- INTERACTION:
CC O96008; Q2TAZ0: ATG2A; NbExp=7; IntAct=EBI-1057581, EBI-2514077;
CC -!- SUBCELLULAR LOCATION: Mitochondrion outer membrane
CC {ECO:0000269|PubMed:15644312, ECO:0000269|PubMed:31206022}; Multi-pass
CC membrane protein {ECO:0000255}. Note=Associates with the mitochondria-
CC associated ER membrane via interaction with BCAP31.
CC {ECO:0000269|PubMed:31206022}.
CC -!- ALTERNATIVE PRODUCTS:
CC Event=Alternative splicing; Named isoforms=2;
CC Name=1;
CC IsoId=O96008-1; Sequence=Displayed;
CC Name=2;
CC IsoId=O96008-2; Sequence=VSP_008589, VSP_008590;
CC -!- SIMILARITY: Belongs to the Tom40 family. {ECO:0000305}.
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DR EMBL; AF050154; AAD02504.1; -; Genomic_DNA.
DR EMBL; AF043250; AAC82342.1; -; mRNA.
DR EMBL; AF043253; AAC82343.1; -; Genomic_DNA.
DR EMBL; AF043251; AAC82343.1; JOINED; Genomic_DNA.
DR EMBL; AF043252; AAC82343.1; JOINED; Genomic_DNA.
DR EMBL; AF316398; AAL46624.1; -; mRNA.
DR EMBL; AF316399; AAL46625.1; -; mRNA.
DR EMBL; AF316401; AAL46626.1; -; mRNA.
DR EMBL; AF316402; AAL46627.1; -; mRNA.
DR EMBL; CH471126; EAW57302.1; -; Genomic_DNA.
DR EMBL; CH471126; EAW57304.1; -; Genomic_DNA.
DR EMBL; CH471126; EAW57305.1; -; Genomic_DNA.
DR EMBL; BC001779; AAH01779.1; -; mRNA.
DR EMBL; BC006413; AAH06413.1; -; mRNA.
DR EMBL; BC012134; AAH12134.1; -; mRNA.
DR EMBL; BC017224; AAH17224.1; -; mRNA.
DR EMBL; BC047528; AAH47528.1; -; mRNA.
DR CCDS; CCDS12646.1; -. [O96008-1]
DR RefSeq; NP_001122388.1; NM_001128916.2. [O96008-1]
DR RefSeq; NP_001122389.1; NM_001128917.2. [O96008-1]
DR RefSeq; NP_006105.1; NM_006114.3. [O96008-1]
DR PDB; 7CK6; EM; 3.40 A; A/B=1-361.
DR PDB; 7CP9; EM; 3.00 A; I/J=1-361.
DR PDB; 7VBY; EM; 2.54 A; B/I=1-361.
DR PDB; 7VC4; EM; 3.74 A; B/I=1-361.
DR PDB; 7VD2; EM; 2.53 A; B/I=1-361.
DR PDB; 7VDD; EM; 3.74 A; B/I=1-361.
DR PDB; 8XVA; EM; 5.92 A; B/I=1-361.
DR PDB; 9EIH; EM; 3.10 A; G/H/I/J=1-361.
DR PDB; 9EII; EM; 2.75 A; I/J=1-361.
DR PDB; 9EIJ; EM; 3.30 A; I/J=1-361.
DR PDBsum; 7CK6; -.
DR PDBsum; 7CP9; -.
DR PDBsum; 7VBY; -.
DR PDBsum; 7VC4; -.
DR PDBsum; 7VD2; -.
Query Match 100.0%; Score 1907; Length 361;
Best Local Similarity 100.0%;
Matches 361; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
Qy 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
Qy 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
Qy 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
Qy 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
Qy 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
Qy 361 G 361
|
Db 361 G 361
SEQ ID NO: 2
RESULT 1
K7EJ57_HUMAN
ID K7EJ57_HUMAN Unreviewed; 214 AA.
AC K7EJ57;
DT 09-JAN-2013, integrated into UniProtKB/TrEMBL.
DT 05-OCT-2016, sequence version 8.
DT 08-OCT-2025, entry version 80.
DE SubName: Full=Translocase of outer mitochondrial membrane 40 {ECO:0000313|Ensembl:ENSP00000465032.1};
DE Flags: Fragment;
GN Name=TOMM40 {ECO:0000313|Ensembl:ENSP00000465032.1};
OS Homo sapiens (Human).
OC Eukaryota; Metazoa; Chordata; Craniata; Vertebrata; Euteleostomi; Mammalia;
OC Eutheria; Euarchontoglires; Primates; Haplorrhini; Catarrhini; Hominidae;
OC Homo.
OX NCBI_TaxID=9606 {ECO:0000313|Ensembl:ENSP00000465032.1, ECO:0000313|Proteomes:UP000005640};
RN [1] {ECO:0000313|Ensembl:ENSP00000465032.1}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RX PubMed=11237011; DOI=10.1038/35057062;
RG International Human Genome Sequencing Consortium;
RA Lander E.S., Linton L.M., Birren B., Nusbaum C., Zody M.C., Baldwin J.,
RA Devon K., Dewar K., Doyle M., FitzHugh W., Funke R., Gage D., Harris K.,
RA Heaford A., Howland J., Kann L., Lehoczky J., LeVine R., McEwan P.,
RA McKernan K., Meldrim J., Mesirov J.P., Miranda C., Morris W., Naylor J.,
RA Raymond C., Rosetti M., Santos R., Sheridan A., Sougnez C.,
RA Stange-Thomann N., Stojanovic N., Subramanian A., Wyman D., Rogers J.,
RA Sulston J., Ainscough R., Beck S., Bentley D., Burton J., Clee C.,
RA Carter N., Coulson A., Deadman R., Deloukas P., Dunham A., Dunham I.,
RA Durbin R., French L., Grafham D., Gregory S., Hubbard T., Humphray S.,
RA Hunt A., Jones M., Lloyd C., McMurray A., Matthews L., Mercer S., Milne S.,
RA Mullikin J.C., Mungall A., Plumb R., Ross M., Shownkeen R., Sims S.,
RA Waterston R.H., Wilson R.K., Hillier L.W., McPherson J.D., Marra M.A.,
RA Mardis E.R., Fulton L.A., Chinwalla A.T., Pepin K.H., Gish W.R.,
RA Chissoe S.L., Wendl M.C., Delehaunty K.D., Miner T.L., Delehaunty A.,
RA Kramer J.B., Cook L.L., Fulton R.S., Johnson D.L., Minx P.J., Clifton S.W.,
RA Hawkins T., Branscomb E., Predki P., Richardson P., Wenning S., Slezak T.,
RA Doggett N., Cheng J.F., Olsen A., Lucas S., Elkin C., Uberbacher E.,
RA Frazier M., Gibbs R.A., Muzny D.M., Scherer S.E., Bouck J.B.,
RA Sodergren E.J., Worley K.C., Rives C.M., Gorrell J.H., Metzker M.L.,
RA Naylor S.L., Kucherlapati R.S., Nelson D.L., Weinstock G.M., Sakaki Y.,
RA Fujiyama A., Hattori M., Yada T., Toyoda A., Itoh T., Kawagoe C.,
RA Watanabe H., Totoki Y., Taylor T., Weissenbach J., Heilig R., Saurin W.,
RA Artiguenave F., Brottier P., Bruls T., Pelletier E., Robert C., Wincker P.,
RA Smith D.R., Doucette-Stamm L., Rubenfield M., Weinstock K., Lee H.M.,
RA Dubois J., Rosenthal A., Platzer M., Nyakatura G., Taudien S., Rump A.,
RA Yang H., Yu J., Wang J., Huang G., Gu J., Hood L., Rowen L., Madan A.,
RA Qin S., Davis R.W., Federspiel N.A., Abola A.P., Proctor M.J., Myers R.M.,
RA Schmutz J., Dickson M., Grimwood J., Cox D.R., Olson M.V., Kaul R.,
RA Raymond C., Shimizu N., Kawasaki K., Minoshima S., Evans G.A.,
RA Athanasiou M., Schultz R., Roe B.A., Chen F., Pan H., Ramser J.,
RA Lehrach H., Reinhardt R., McCombie W.R., de la Bastide M., Dedhia N.,
RA Blocker H., Hornischer K., Nordsiek G., Agarwala R., Aravind L.,
RA Bailey J.A., Bateman A., Batzoglou S., Birney E., Bork P., Brown D.G.,
RA Burge C.B., Cerutti L., Chen H.C., Church D., Clamp M., Copley R.R.,
RA Doerks T., Eddy S.R., Eichler E.E., Furey T.S., Galagan J., Gilbert J.G.,
RA Harmon C., Hayashizaki Y., Haussler D., Hermjakob H., Hokamp K., Jang W.,
RA Johnson L.S., Jones T.A., Kasif S., Kaspryzk A., Kennedy S., Kent W.J.,
RA Kitts P., Koonin E.V., Korf I., Kulp D., Lancet D., Lowe T.M.,
RA McLysaght A., Mikkelsen T., Moran J.V., Mulder N., Pollara V.J.,
RA Ponting C.P., Schuler G., Schultz J., Slater G., Smit A.F., Stupka E.,
RA Szustakowski J., Thierry-Mieg D., Thierry-Mieg J., Wagner L., Wallis J.,
RA Wheeler R., Williams A., Wolf Y.I., Wolfe K.H., Yang S.P., Yeh R.F.,
RA Collins F., Guyer M.S., Peterson J., Felsenfeld A., Wetterstrand K.A.,
RA Patrinos A., Morgan M.J., de Jong P., Catanese J.J., Osoegawa K.,
RA Shizuya H., Choi S., Chen Y.J.;
RT "Initial sequencing and analysis of the human genome.";
RL Nature 409:860-921(2001).
RN [2] {ECO:0000313|Ensembl:ENSP00000465032.1, ECO:0000313|Proteomes:UP000005640}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RX PubMed=15057824; DOI=10.1038/nature02399;
RA Grimwood J., Gordon L.A., Olsen A., Terry A., Schmutz J., Lamerdin J.,
RA Hellsten U., Goodstein D., Couronne O., Tran-Gyamfi M., Aerts A.,
RA Altherr M., Ashworth L., Bajorek E., Black S., Branscomb E., Caenepeel S.,
RA Carrano A., Caoile C., Chan Y.M., Christensen M., Cleland C.A.,
RA Copeland A., Dalin E., Dehal P., Denys M., Detter J.C., Escobar J.,
RA Flowers D., Fotopulos D., Garcia C., Georgescu A.M., Glavina T., Gomez M.,
RA Gonzales E., Groza M., Hammon N., Hawkins T., Haydu L., Ho I., Huang W.,
RA Israni S., Jett J., Kadner K., Kimball H., Kobayashi A., Larionov V.,
RA Leem S.H., Lopez F., Lou Y., Lowry S., Malfatti S., Martinez D.,
RA McCready P., Medina C., Morgan J., Nelson K., Nolan M., Ovcharenko I.,
RA Pitluck S., Pollard M., Popkie A.P., Predki P., Quan G., Ramirez L.,
RA Rash S., Retterer J., Rodriguez A., Rogers S., Salamov A., Salazar A.,
RA She X., Smith D., Slezak T., Solovyev V., Thayer N., Tice H., Tsai M.,
RA Ustaszewska A., Vo N., Wagner M., Wheeler J., Wu K., Xie G., Yang J.,
RA Dubchak I., Furey T.S., DeJong P., Dickson M., Gordon D., Eichler E.E.,
RA Pennacchio L.A., Richardson P., Stubbs L., Rokhsar D.S., Myers R.M.,
RA Rubin E.M., Lucas S.M.;
RT "The DNA sequence and biology of human chromosome 19.";
RL Nature 428:529-535(2004).
RN [3] {ECO:0000313|Ensembl:ENSP00000465032.1}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RX PubMed=15496913; DOI=10.1038/nature03001;
RG International Human Genome Sequencing Consortium;
RT "Finishing the euchromatic sequence of the human genome.";
RL Nature 431:931-945(2004).
RN [4] {ECO:0007829|PubMed:21269460}
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RX PubMed=21269460; DOI=10.1186/1752-0509-5-17;
RA Burkard T.R., Planyavsky M., Kaupe I., Breitwieser F.P., Burckstummer T.,
RA Bennett K.L., Superti-Furga G., Colinge J.;
RT "Initial characterization of the human central proteome.";
RL BMC Syst. Biol. 5:17-17(2011).
RN [5] {ECO:0007829|PubMed:24275569}
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RX PubMed=24275569; DOI=10.1016/j.jprot.2013.11.014;
RA Bian Y., Song C., Cheng K., Dong M., Wang F., Huang J., Sun D., Wang L.,
RA Ye M., Zou H.;
RT "An enzyme assisted RP-RPLC approach for in-depth analysis of human liver
RT phosphoproteome.";
RL J. Proteomics 96:253-262(2014).
RN [6] {ECO:0007829|PubMed:25944712}
RP IDENTIFICATION BY MASS SPECTROMETRY [LARGE SCALE ANALYSIS].
RX PubMed=25944712;
RA Vaca Jacome A.S., Rabilloud T., Schaeffer-Reiss C., Rompais M., Ayoub D.,
RA Lane L., Bairoch A., Van Dorsselaer A., Carapito C.;
RT "N-terminome analysis of the human mitochondrial proteome.";
RL Proteomics 15:2519-2524(2015).
RN [7] {ECO:0000313|Ensembl:ENSP00000465032.1}
RP IDENTIFICATION.
RG Ensembl;
RL Submitted (MAY-2025) to UniProtKB.
CC -!- SUBCELLULAR LOCATION: Membrane {ECO:0000256|ARBA:ARBA00004141}; Multi-
CC pass membrane protein {ECO:0000256|ARBA:ARBA00004141}. Mitochondrion
CC outer membrane {ECO:0000256|ARBA:ARBA00004294}.
CC ---------------------------------------------------------------------------
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DR EMBL; AC011481; -; NOT_ANNOTATED_CDS; Genomic_DNA.
DR AlphaFoldDB; K7EJ57; -.
DR SMR; K7EJ57; -.
DR MassIVE; K7EJ57; -.
DR Antibodypedia; 3972; 177 antibodies from 35 providers.
DR Ensembl; ENST00000589649.1; ENSP00000465032.1; ENSG00000130204.13.
DR UCSC; uc060zuc.1; human.
DR HGNC; HGNC:18001; TOMM40.
DR OpenTargets; ENSG00000130204; -.
DR VEuPathDB; HostDB:ENSG00000130204; -.
DR GeneTree; ENSGT00390000003308; -.
DR HOGENOM; CLU_054399_1_0_1; -.
DR OMA; TRFNYRW; -.
DR OrthoDB; 19656at2759; -.
DR ChiTaRS; TOMM40; human.
DR Proteomes; UP000005640; Chromosome 19.
DR Bgee; ENSG00000130204; Expressed in olfactory bulb and 210 other cell types or tissues.
DR ExpressionAtlas; K7EJ57; baseline and differential.
DR GO; GO:0005829; C:cytosol; IDA:HPA.
DR GO; GO:0005741; C:mitochondrial outer membrane; IEA:UniProtKB-SubCell.
DR GO; GO:0005739; C:mitochondrion; IDA:HPA.
DR GO; GO:0008320; F:protein transmembrane transporter activity; IEA:InterPro.
DR GO; GO:0030150; P:protein import into mitochondrial matrix; IEA:InterPro.
DR InterPro; IPR027246; Porin_Euk/Tom40.
DR InterPro; IPR037930; Tom40.
DR PANTHER; PTHR10802; MITOCHONDRIAL IMPORT RECEPTOR SUBUNIT TOM40; 1.
DR Pfam; PF01459; Porin_3; 1.
PE 1: Evidence at protein level;
KW Membrane {ECO:0000256|ARBA:ARBA00023136};
KW Mitochondrion {ECO:0000256|ARBA:ARBA00022787};
KW Mitochondrion outer membrane {ECO:0000256|ARBA:ARBA00022787};
KW Proteomics identification {ECO:0007829|PeptideAtlas:K7EJ57,
KW ECO:0007829|ProteomicsDB:K7EJ57};
KW Reference proteome {ECO:0000313|Proteomes:UP000005640};
KW Transmembrane {ECO:0000256|ARBA:ARBA00022692};
KW Transmembrane beta strand {ECO:0000256|ARBA:ARBA00022452};
KW Transport {ECO:0000256|ARBA:ARBA00022448}.
FT REGION 1..71
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 1..10
FT /note="Low complexity"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 11..36
FT /note="Pro residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 37..52
FT /note="Low complexity"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 59..71
FT /note="Low complexity"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT NON_TER 214
FT /evidence="ECO:0000313|Ensembl:ENSP00000465032.1"
SQ SEQUENCE 214 AA; 21915 MW; 7403E3F17827F592 CRC64;
Query Match 100.0%; Score 632; Length 214;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVALSTIGESNYHFGVTYVGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 NPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVALSTIGESNYHFGVTYVGT
Qy 61 KQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQTQQSKFVNWQVDGEYRGS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 139 KQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQTQQSKFVNWQVDGEYRGS 197
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 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. WO 2004/030615 published April 15, 2004 (please note: due to the large size of the application, only pages 1-9 and 230-301 are attached to the present Office Action).
For present claims 7-14, Wu et al. teach SEQ ID NO: 5514 which has 100% identity and the same length as present SEQ ID NO: 1, fragments, variants, fusion proteins, substitutions, and affinity tags including biotin or poly-His (please refer to the entire specification particularly pages 1-9 and 230-301).
Therefore, the teachings of Wu et al. anticipate the presently claimed polypeptide.
RESULT 1
ABM82134
(NOTE: this sequence has 30 duplicates in the database searched.
See complete list at the end of this report)
ID ABM82134 standard; protein; 361 AA.
XX
AC ABM82134;
XX
DT 15-JUN-2007 (revised)
DT 18-NOV-2004 (first entry)
XX
DE Tumour-associated antigenic target (TAT) polypeptide PRO51565, SEQ:5514.
XX
KW Tumour-associated antigenic target; TAT; human; overexpression; cancer;
KW tumour; diagnosis; cell proliferative disorder; breast cancer;
KW colorectal cancer; lung cancer; ovarian cancer; liver cancer;
KW central nervous system cancer; bladder cancer; pancreatic cancer;
KW cervical cancer; melanoma; leukaemia; hybridisation probe;
KW chromosome identification; chromosome mapping; gene mapping;
KW gene therapy; cytostatic; BOND_PC;
KW mitochondrial outer membrane protein TOM40;
KW mitochondrial outer membrane protein;
KW mitochondrial outer membrane protein TOM40 [Homo sapiens]; TOMM40; TOM40;
KW PEREC1; C19orf1; PER-EC1; D19S1177E;
KW mitochondrial outer membrane protein [Homo sapiens]; TOMM40 protein;
KW TOMM40 protein [Homo sapiens];
KW translocase of outer mitochondrial membrane 40 homolog (yeast);
KW D19S1177E [Homo sapiens]; haymaker protein;
KW haymaker protein [Homo sapiens]; GO3674; GO5739; GO5741; GO6626; GO6820;
KW GO8308; GO15031; GO16020; GO16021; GO19867.
XX
OS Homo sapiens.
XX
CC PN WO2004030615-A2.
XX
CC PD 15-APR-2004.
XX
CC PF 29-SEP-2003; 2003WO-US028547.
XX
PR 02-OCT-2002; 2002US-0414971P.
XX
CC PA (GETH ) GENENTECH INC.
XX
CC PI Wu TD, Zhang Z, Zhou Y;
XX
DR WPI; 2004-347921/32.
DR N-PSDB; ACN40623.
DR PC:NCBI; gi5174723.
DR PC:SWISSPROT; O96008.
XX
CC PT New tumor-associated antigenic target polypeptides and nucleic acids,
CC PT useful in preparing a medicament for treating or detecting a
CC PT proliferative disorder, e.g. breast, lung, colorectal, ovarian or
CC PT prostate cancer or tumor.
XX
CC PS Claim 12; SEQ ID NO 5514; 7273pp; English.
XX
CC The invention relates to human tumour-associated antigenic target (TAT)
CC polypeptides, and their related nucleic acids. The TAT polypeptides are
CC overexpressed in cancer tissues compared to normal tissues, and may thus
CC serve as effective targets for the diagnosis and treatment of cancer in
CC mammals. The invention also relates to nucleic acid and polypeptide
CC sequences at least 80\% identical to the TAT nucleic acids and
CC polypeptides; expression vectors and host cells comprising a TAT nucleic
CC acid; an antibody specific for a TAT polypeptide; a peptide or organic
CC molecule which binds to a TAT polypeptide; fusion proteins comprising a
CC TAT polypeptide; and methods and compositions for the treatment or
CC diagnosis of cancer in mammals. TAT polypeptides, nucleic acids,
CC antibodies, antagonists, binding molecules and compositions are useful
CC for diagnosing or treating a cell proliferative disorder associated with
CC increased TAT expression, particularly cancers such as breast cancer,
CC colorectal cancer, lung cancer, ovarian cancer, liver cancer, bladder
CC cancer, pancreatic cancer, cervical cancer, cancers of the central
CC nervous system, melanoma and leukaemia. TAT nucleic acids may further be
CC used as hybridisation probes, in chromosome and gene mapping, in
CC chromosome identification and in gene therapy. The present sequence
CC represents a TAT polypeptide of the invention
CC
CC Revised record issued on 15-JUN-2007 : Enhanced with precomputed
CC information from BOND.
XX
SQ Sequence 361 AA;
Query Match 100.0%; Score 1907; Length 361;
Best Local Similarity 100.0%;
Matches 361; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
Qy 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
Qy 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
Qy 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
Qy 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
Qy 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
Qy 361 G 361
|
Db 361 G 361
Claims 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mintz et al. U.S. Patent Application Publication 2007/0083334 published April 12, 2007.
For present claims 7-14, Mintz et al. teach SEQ ID NO: 904047 which has 100% identity and the same length as present SEQ ID NO: 1, fusion proteins, affinity tags including biotin and hexa-histidine, fragments, mutants, and variants (please refer to the entire specification particularly paragraphs 291-293, 318-323, 340, 450, 451).
Therefore, the teachings of Mintz et al. anticipate the presently claimed polypeptide.
RESULT 1
US-11-443-428A-904047
(NOTE: this sequence has 22 duplicates in the database searched.
See complete list at the end of this report)
Sequence 904047, US/11443428A
Patent No. 7745391
2007/0083334
GENERAL INFORMATION
APPLICANT: Mintz, Liat
APPLICANT: Xie, Hanqing
APPLICANT: Dahari, Dvir
APPLICANT: Levanon, Erez
APPLICANT: Freilich, Shiri
APPLICANT: Beck, Nili
APPLICANT: Zhu, Wei-Yong
APPLICANT: Wasserman, Alon
APPLICANT: Hermesh, Chen
APPLICANT: Azar, Idit
APPLICANT: Bernstein, Jeanne
TITLE OF INVENTION: METHODS AND SYSTEMS USEFUL FOR ANNOTATING BIOMOLECULAR SEQUENCES
FILE REFERENCE: 02/23929
CURRENT APPLICATION NUMBER: US/11/443,428A
CURRENT FILING DATE: 2006-05-31
NUMBER OF SEQ ID NOS: 1034312
SEQ ID NO 904047
LENGTH: 361
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 1907; Length 361;
Best Local Similarity 100.0%;
Matches 361; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGNVLAASSPPAGPPPPPAPALVGLPPPPPSPPGFTLPPLGGSLGAGTSTSRSSERTPGA 60
Qy 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATASASGAAEDGACGCLPNPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVA
Qy 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LSTIGESNYHFGVTYVGTKQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQT
Qy 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QQSKFVNWQVDGEYRGSDFTAAVTLGNPDVLVGSGILVAHYLQSITPCLALGGELVYHRR
Qy 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PGEEGTVMSLAGKYTLNNWLATVTLGQAGMHATYYHKASDQLQVGVEFEASTRMQDTSVS
Qy 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 FGYQLDLPKANLLFKGSVDSNWIVGATLEKKLPPLPLTLALGAFLNHRKNKFQCGFGLTI
Qy 361 G 361
|
Db 361 G 361
Claims 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barrett et al. WO 2017/180587 published October 19, 2017 (due to the large size of the documents only pages 1-917 have been provided).
For present claims 7-14, Barrett et al. teach SEQ ID NO: 90526 (214mer; 100% identity to present SEQ ID NO: 2 – residues 79-197 of present SEQ ID NO: 1), fusions, fragments, deletions, substitutions, variants, biotin (i.e. affinity tag), and polyhistidine (please refer to the entire specification particularly paragraphs 9, 11, 13, 16, 30, 53, 54, 102, 104, and 107-122).
RESULT 1
US-16-092-829B-90526
Sequence 90526, US/16092829B
Patent No. 11446398
WO 2017/180587
GENERAL INFORMATION
APPLICANT: BARRETT, PETER
APPLICANT: GLADSTONE, MICHAEL N.
APPLICANT: KASSUM, TARIQ A.
APPLICANT: SURI, VIPIN
APPLICANT: LI, DAN JUN
APPLICANT: SUN, DEXUE
APPLICANT: DOLINSKI, BRIAN
TITLE OF INVENTION: REGULATED BIOCIRCUIT SYSTEMS
FILE REFERENCE: 2095.1300US371
CURRENT APPLICATION NUMBER: US/16/092,829B
CURRENT FILING DATE: 2018-10-11
PRIOR APPLICATION NUMBER: PCT/US2017/026950
PRIOR FILING DATE: 2017-04-11
PRIOR APPLICATION NUMBER: 62/320,864
PRIOR FILING DATE: 2016-04-11
PRIOR APPLICATION NUMBER: 62/466,596
PRIOR FILING DATE: 2017-03-03
NUMBER OF SEQ ID NOS: 213456
SEQ ID NO 90526
LENGTH: 214
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
OTHER INFORMATION: Payload ID: 18097
FEATURE:
OTHER INFORMATION: Gene Name: translocase of outer mitochondrial membrane 40 homolog (yeast)
FEATURE:
OTHER INFORMATION: ENSP ID: ENSP00000465032
Query Match 100.0%; Score 632; Length 214;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 NPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVALSTIGESNYHFGVTYVGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 NPGTFEECHRKCKELFPIQMEGVKLTVNKGLSNHFQVNHTVALSTIGESNYHFGVTYVGT
Qy 61 KQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQTQQSKFVNWQVDGEYRGS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 139 KQLSPTEAFPVLVGDMDNSGSLNAQVIHQLGPGLRSKMAIQTQQSKFVNWQVDGEYRGS 197
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 7-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,771,971 in view of Barrett et al. WO 2017/180587 published October 19, 2017 (due to the large size of the documents only pages 1-917 have been provided).
U.S. Patent 8,771,971 claims haymaker (i.e. present SEQ ID NO: 1).
Barrett et al. teach SEQ ID NO: 90526 (214mer; 100% identity to present SEQ ID NO: 2 – residues 79-197 of present SEQ ID NO: 1), fusions, fragments, deletions, substitutions, variants, biotin (i.e. affinity tag), and polyhistidine (please refer to the entire specification particularly paragraphs 9, 11, 13, 16, 30, 53, 54, 102, 104, and 107-122).
All the claimed elements (i.e. haymaker, polyhistidine affinity tags, biotin) were known in the prior art and one skilled in the art could have combined the elements (i.e. fusion polypeptides) as claimed by known methods with no change in the respective functions (i.e. individual components retain individual functions) and the combination would have yielded predictable results (i.e. utilizing an affinity tag to purify, capture, track, etc. polypeptide which the affinity tag is fused to) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. making fusion polypeptides comprising affinity tags) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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