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 .
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Application and Claims
Application 14/979,566 was filed on 12/28/15. On 9/26/17, US Patent 9,771,582 issued from the ’566 application with claims 1-35. On 9/19/19, reissue application 16/576,102 was filed to correct the ’582 patent. On 1/11/22, US Reissue Patent 48,887 issued from the ’102 application with claims 1-35. On 7/19/24, this reissue application was filed as a reissue of the RE’887 patent with claims 1-35. No claims have been amended, canceled, or added. Claims 1-35 are pending and under examination.
Claim Objections
Claim 6 has been amended relative to the version in the RE’887 patent; it depends from itself rather than from claim 5. All changes to claims in the patent under reissue must be identified according to the provisions of 37 CFR 1.173(b) and (d).
Certificate of Correction in Parent Application
On 9/13/22, a certificate of correction was issued in the underlying RE’887 patent amending the specification and claims. Applicant has neither provided a copy of the certificate of correction in this application nor included the amendments made by that certificate without brackets or italics. See 37 CFR 1.173(a)(1); MPEP 1411.01; MPEP 1453(VI)(C).
Nucleotide and/or Amino Acid Sequence Disclosures
This application is governed by ST.26 rules. Sequence listings submitted in either non-provisional applications filed under 35 U.S.C. 111(a) or provisional applications filed under 111(b) that have a filing date on or after 7/1/22, including reissue applications, must be in XML format and comply with WIPO Standard ST.26 and 37 CFR 1.831 through 1.835. See MPEP 1410, 2415.01.
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. In particular, the specification has not been amended to refer to the sequence listing filed with this application. A specification amendment in compliance with 37 CFR 1.173(b)(1) and (d) is required.
Assignee’s Consent to Reissue
The 7/8/22 consent to reissue signed by Toyohiro Hamasaki is defective because it was neither signed by a person with apparent authority as defined in MPEP 325(V) nor signed by a person authorized to act on behalf of the assignee at the time of signing. MPEP 325(V) recognizes that persons with “apparent authority” to sign on behalf of an organization include officers of that organization, e.g., its chief executive officer, president, vice-president, secretary, or treasurer. Consenter Hamasaki is none of these, being designated only as Director of the Technology and IP Strategy Division of the Corporate Technology Sector of the Nitto Denko Corporation. There is also nothing in the record to indicate that consenter Hamasaki was authorized to act on behalf of the assignee; compare assignment document and power-of-attorney documents, identifying Robert Hilton and Ise Hirofumi, respectively, as so authorized.
This matter would be resolved by submission of a replacement consent of the assignee signed by either a person authorized to act on behalf of the assignee; an officer of the assignee; or a patent practitioner already appointed power of attorney at the time of signing.
Claim Rejections—35 U.S.C. 251
Claims 1-35 are also rejected under 35 U.S.C. 251 because the reissue is not correcting an error in the original patent. Claims 1-35 of US Patent 10,047,111 have been superseded by the previous reissue US RE49,431. Once a claim in the patent has been reissued, it does not exist in the original patent; thus, it cannot be reissued from the original patent in another reissue application. Applicant should cancel claims 1-35. The subject matter recited in claims 1-35 may be presented as additional new claims. See MPEP 1451.
Claim Rejections - 35 USC § 112
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 1-35 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.
Claims 1-35 are indefinite because the invention is not particularly pointed out and distinctly claimed. Claims 1-35 present one coverage in previous reissue US RE49,431 and another in the present reissue application. This is inconsistent. Once a claim in the patent has been reissued, it does not exist in the original patent; thus, it cannot be reissued from the original patent in another reissue application. See MPEP 1451(I).
Furthermore, claim 1 requires that each of the RNAi molecules targeted to GST-p “has an antisense strand SEQ ID NO: 131 and a sense strand SEQ ID NO: 157.” This is confusing because it is unclear whether the RNA molecules comprise the enumerated sequences or consist of the enumerated sequences, for example. Similar issues are also present in claims 1-4. Clarification is required.
Claims 2-35 depend from claim 1 and do not rectify the indefiniteness, so they must also be rejected under 35 U.S.C. 112(b).
Claims 2-4, like claim 1, lack the transitional phrase “comprising” or “consisting of” before each SEQ ID NO: designator, so it is unclear whether they are open to the inclusion of additional nucleotides or not. Clarification is required.
Claim 6 depends from itself and is therefore indefinite. See MPEP 2173.05 (clear antecedent basis required; see claim objection above).
Claim 17 is indefinite because it recites a list of alternatives that is not clearly closed. See MPEP 2173.05(h). Claim 17 refers to a lipid “selected from the group of [species].” The word “consisting” may be missing after the word “group” at line 2.
Double Patenting
Claim Interpretation
Consistent with US Patent RE48,887, claim 6 is interpreted for these rejections as depending from claim 5.
Rejections
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.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 2, and 5-35 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2, and 5-35, respectively, of prior U.S. Patent No. 9,771,582. This is a statutory double patenting rejection. SEQ ID NOs: 131, 157, 341, and 355 have not been updated relative to the ’582 patent, so the claims reciting those sequences have identical scope.
Claims 1-35 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-35, respectively, of prior U.S. Patent No. RE48,887. This is a statutory double patenting rejection. SEQ ID NOs: 131, 157, 341, 355, 156, 182, 343, and 357 have not been updated relative to the RE’887 patent, so the claims reciting those sequences have identical scope.
Conclusion
No claims are allowed.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. RE48,887 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORA E BARNHART DRISCOLL, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
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, Patricia Engle, can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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