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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 202110029677.8, filed on 1/8/2021.
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).
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.
Claim Rejections - 35 USC § 112
Enablement
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 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites “a monoclonal antibody A1M5 inhibiting an SMIM15, being secreted by a hybridoma cell strain 1M5 with deposit number CCTCC NO: C2020247”; claim 7 recites “a hybridoma cell secreting the monoclonal antibody A1M5 inhibiting SMIM15 according to claim 1 is the hybridoma cell stain 1M5 with deposit number of CCTCC NO:C2020247”.
It is apparent that the 1M5 hybridoma is required to produce the claimed invention. As a required element, the 1M5 hybridoma must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the cell lines/hybridomas which produce the SP34, 10G, and LOGE. See 37 CFR 1.1801-1.1809.
If the deposit has been made under the terms of the Budapest Treaty, an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the 1M5 hybridomas have been deposited under the Budapest Treaty and that the 1M5 hybridomas will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. See 37 CFR 1.808.
Further, the record must be clear that the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for a sample or for the enforceable life of the patent whichever is longer. See 37 CFR 1.806.
If the deposit has not been made under the Budapest treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who Is in a position to make such assurances, or a statement by an attorney of record over his or her signature must be made, stating that the deposit has been made at an acceptable depository and that the criteria set forth in 37 CFR 1.801-1.809, have been met.
If the deposit was made after the effective filing date of the application for a patent in the United States, a verified statement is required from a person in a position to corroborate the fact, and should state, that the 15M hybridoma, which are deposited, are biological material specifically identified in the application as filed, except if the person is an attorney or agent registered to practice before the Office, in which case the statement need not be verified. See MPEP 1.804(b). Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Further, amendment of the specification to disclose the date of deposit and the complete name and address of the depository (ATCC.10801 University Boulevard, Manassas, VA 20110-2209) is required as set forth in 37 C.F.R. 1.809(d). As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
It is apparent that the 1M5 is required to practice the claimed invention. It is noted that the Applicant has provided the method for producing the claimed invention in the specification in regards to artificial synthetic peptide fragment (2019-348 polypeptide-KLH) utilized for immunizing SPF BALB/c female mice and the IgG subtype produced from immunization. The Applicant does not disclose that the deposited hybridoma will be made available to the public upon issuance of a patent, does not identify the deposit as being made under the Budapest Treaty, and does not disclose the monoclonal antibody sequence information.
It is noted that these elements satisfy the enablement requirements under 35 USC 112, first paragraph as well. Applicant is invited to make the record clear whether satisfaction of the requirements under 35 USC 112, first paragraph, enablement for biological materials has been satisfied in a current U.S. Patent for hybridoma 1M5 in order to make the record of the instant application complete.
Claims 2-6 are rejected based on their dependency to independent claim 1.
Regarding claim 6, the specification discloses a deposited monoclonal antibody (hybridoma deposit number: C2020247) and provides Western blot and IHC data demonstrating that this antibody can bind and detect SMIM15, this disclosure only enables the antibody for the specific assays shown.
The specification lacks any functional data supporting therapeutic use of the antibody. There is no teaching regarding SMIM15’s mechanism of action in diseases or if it is directly implicated in disease processes and prior art does not teach a direct correlation of SMIM15’s role in disease processes. The Human Protein Atlas project does teach SMIM15 as an unfavorable prognostic marker in three cancer subtypes (cervical, lung, and renal cancer) in Kaplan-Meier survival plots based on the correlation of SMIM15 RNA expression and patient outcomes; however, this is not sufficient to establish that SMIM15 is a therapeutically actionable target, nor that binding SMIM15 with the claimed monoclonal antibody produces a therapeutic effect (see references cited). Additionally, the SMIM15 gene is located on 5q12 and large deletions of 5q12 that includes SMIM15 gene locus has been linked to developmental delays, intellectual disabilities, and a rare condition 5212 deletion syndrome taught by Cetin et al, Jaillard et al, and Rood et al (see references cited). However, a direct causal or correlative link between SMIM15 and these diseases has not been established. Accordingly, a person of ordinary skill in the art would be unable to make and use the claimed antibody therapeutically without undue experimentation.
Additionally, for diagnostic applications beyond the demonstrated Western Blot and IHC assays, the specification provides no guidance on how to use the antibody in other diagnostic or clinical contexts. Extending the disclosed methods to such uses would require substantial experimentation and optimization for a person of ordinary skill in the art and therefore is not enabled.
Claim Rejections - 35 USC § 101/35 USC § 112
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.
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 5 and 6 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. The claim(s) recite(s) “is utilized”. It is not clear whether the claims are a process claim or product claims. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness.
Improper Dependent Claims
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.
Claims 2-3 and 5-7 are 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. Claims 2-7 depend from claim 1 but does not further limit the subject matter of claim 1. Claims 2 defines an inherent property of the claimed monoclonal antibody and therefore does not limit the scope of independent claim 1. Claim 3 defines the way in which the monoclonal antibody is made which does not further limit the scope of claimed monoclonal antibody of independent claim 1. Claim 5 and 6 merely recite intended use of the claimed invention and does not impose any additional structural or functional limitation of the claimed invention. The specification also does not provide additional details on how the monoclonal antibody is materially modified to perform detecting SMIM15 or how it is used as a therapeutic drug and diagnostic reagent. Claim 7 merely restates the limitations already present in claim 1 and does not further limit the scope of 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH ELIZABETH STEIN whose telephone number is (571)272-0093. The examiner can normally be reached M-F 8-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641