Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
US Patent 9,303,083 issued on 4/5/16 with claims 1-11. On 1/17/24, applicant filed this reissue application amending claim 1 and canceling claims 2 and 3. Claims 1 and 4-11 are pending and under examination.
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.
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 - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with single 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
This matter will not be held in abeyance.
Claim Rejections—35 U.S.C. 251
Claims 1 and 4-11 are rejected under 35 U.S.C. 251 as being broadened in a reissue application filed outside the two-year statutory period. The amendments to claim 1 have changed the scope of the claims such that they are broadened relative to the patent claims. The ’083 patent issued on 4/5/16, which is more than two years before this reissue application was filed on 1/17/24.
Issued claim 1 refers to SEQ ID NOs: 56 and 54 and identifies certain subsequences within it that correspond to the six complementarity-determining regions (CDRs) of the claimed antibody. In this reissue, applicant has shifted the locations of all six CDRs within SEQ ID NOs: 56 and 54, as evidenced by an examination of the sequences.1 In this depiction, the residues identified as CDRs in the underlying ’083 patent are in bold type, while those identified as CDRs in this reissue application are underlined:
<210> SEQ ID NO: 56
<211> 171 amino acids
<212> PRT
<213> Mus musculus – IgG heavy chain
<400> SEQ ID NO: 56
Met Arg Val Leu Thr Leu Leu Trp Leu Phe Thr Ala Phe Pro Gly Ile
1 5 10 15
Leu Ser Asp Val Gln Leu Gln Glu Ser Gly Pro Gly Leu Val Lys Pro
20 25 30
Ser Gln Ser Leu Ser Leu Thr Cys Thr Val Thr Gly Tyr Ser Ile Asn
35 40 45
Asp Tyr Ala Trp Asn Trp Ile Arg Gln Phe Pro Gly Asn Lys Leu Glu
50 55 60
Trp Met Gly Tyr Ile Ser Tyr Asn Asp Phe Thr Tyr Tyr Asn Pro Ser
65 70 75 80
Leu Lys Ser Arg Ile Ser Ile Thr Arg Asp Thr Ser Lys Asn Gln Phe
85 90 95
Phe Leu Gln Leu Asn Ser Val Thr Ala Glu Asp Thr Ala Thr Tyr Tyr
100 105 110
Cys Val Ser Glu Arg Leu Arg Leu Val Asn His Val Met Asp Tyr Trp
115 120 125
Gly Gln Gly Thr Ser Val Ile Val Ser Ser Ala Lys Thr Thr Pro Pro
130 135 140
Ser Val Tyr Pro Leu Ala Pro Gly Ser Ala Ala Gln Thr Asn Ser Met
145 150 155 160
Val Thr Leu Gly Cys Leu Val Lys Gly Tyr Phe
165 170
<210> SEQ ID NO: 54
<211> 173 amino acids
<212> PRT
<213> Mus musculus – IgG light chain
<400> SEQ ID NO: 54
Met Asp Phe Gln Val Gln Ile Phe Ser Phe Leu Leu Ile Ser Ala Ser
1 5 10 15
Val Lys Ile Ser Arg Gly Gln Ile Val Leu Thr Gln Ser Pro Pro Ile
20 25 30
Met Ser Ala Ser Pro Gly Glu Lys Val Thr Met Thr Cys Ser Ala Ser
35 40 45
Ser Ser Val Asn Met His Trp His Gln Gln Lys Ser Gly Thr Ser Pro
50 55 60
Lys Lys Trp Ile Tyr Asp Thr Ser Lys Leu Ile Ser Gly Val Pro Ala
65 70 75 80
Arg Phe Ser Gly Ser Gly Ser Gly Thr Ser Tyr Ser Leu Thr Ile Ser
85 90 95
Ser Val Glu Ala Glu Asp Ala Ala Thr Tyr Tyr Cys Gln Gln Trp Ser
100 105 110
Ser Tyr Pro Phe Thr Phe Gly Ser Gly Thr Lys Leu Glu Ile Lys Arg
115 120 125
Ala Asp Ala Ala Pro Thr Val Ser Ile Phe Pro Pro Ser Ser Glu Gln
130 135 140
Leu Thr Ser Gly Gly Ala Ser Val Val Cys Phe Leu Asn Asn Phe Tyr
145 150 155 160
Pro Lys Asp Ile Asn Val Lys Trp Lys Ile Asp Gly Ser
165 170
A claim is broader in scope than the original claims if it contains within its scope any conceivable product or process which would not have infringed the original patent. A claim is broadened if it is broader in any one respect even though it may be narrower in other respects.
In this case, an antibody meeting the sequence requirements supplied with the reissue application would not have infringed the underlying ’083 patent because some residues are no longer required to be within the CDRs, while other new residues have been added. For example, an antibody having a heavy-chain CDR2 of Leu Asn Ser Val Thr Ala Glu Asp Thr (reissue claim) would not have infringed an antibody having a heavy-chain CDR2 of Arg Leu Val Asn His Val Met Asp Tyr Trp (patented claim). The same rationale applies to the other five CDRs. As such, because more than two years elapsed between the grant of the patent and the filing of this reissue application, the amendment to the claims constitutes improper broadening, even though the reissue declaration fails to designate this application as a broadening reissue.
Claims 1 and 4-11 are rejected under 35 U.S.C. 251 as failing to satisfy the reissue standard of 35 U.S.C. § 251, specifically the requirement that the reissued patent claim the invention disclosed in the original patent.
Under the original patent requirement, “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.” U.S. Indus. Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668, 676 (1942). “Rather, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1362 (Fed. Cir. 2014) (citing Industrial Chemicals, 315 U.S. at 676). Furthermore:
The ‘original patent’ standard and the written description requirement are not the same. Where the written description requirement is based on what the skilled artisan would have understood was within the possession of the inventor, recent Federal Circuit case law indicates that the original patent requirement under § 251 requires something more.
MPEP 1412.01(I) (quoting Ex parte Sandwick, Appeal No. 2018-008369, op. at 22 (PTAB July 23, 2019)).
As discussed below in the rejection under 35 U.S.C. 112, first paragraph, the invention under examination is not clearly and unequivocally disclosed in the underlying patent as a separate invention, so the original patent requirement has not been met.
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 and 4-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended from requiring that the light-chain CDRs are at positions 49-54, 69-84, and 117-128 of SEQ ID NO: 54 (as the underlying ’083 patent disclosed and claimed) to requiring that they be at positions 46-55, 71-77, and 110-118 of SEQ ID NO: 54. It has also been amended from requiring that the heavy-chain CDRs are at positions 46-55, 71-77, and 100-108 of SEQ ID NO: 56 (as the ’308 patent disclosed and claimed) to requiring that they be at positions 49-54, 69-84, and 117-128 of SEQ ID NO: 56. (See sequence analysis above in improper-broadening rejection under 35 U.S.C. 251.) The underlying ’038 patent repeatedly and unequivocally discloses that the CDRs were at positions 49-54, 69-84, and 117-128 of SEQ ID NO: 54 (light chain) and 46-55, 71-77, and 100-108 of SEQ ID NO: 56 (heavy chain). See abstract; column 2, lines 24-36; column 6, lines 1-19; column 20, lines 11-21.
MPEP 2163.07(II) instructs, “An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of error in the specification, but also the appropriate correction.” The ’038 patent identified the CDRs consistently as being present at positions 49-54, 69-84, and 117-128 of SEQ ID NO: 54 (light chain) and 46-55, 71-77, and 100-108 of SEQ ID NO: 56 (heavy chain). It appears multiple errors are involved (the SEQ ID NOs: being reversed and the residue numbers being incorrectly entered). The error does not seem to be a simple translation error because a cursory review of parent PCT publication WO 2012046745 at the WIPO website2 reveals that this document also identified the CDRs at positions 49-54, 69-84, and 117-128 of SEQ ID NO: 54 (light chain) and 46-55, 71-77, and 100-108 of SEQ ID NO: 56 (heavy chain). (See paragraph 0007.) It is not apparent that the skilled artisan considering the underlying application or its benefit or priority documents would have recognized either that there was an error or what its appropriate correction was. The ’803 patent nowhere discloses or suggests the currently claimed combination of SEQ ID NOs: and positions. The reissue application’s claim 1 is therefore not supported by the ’803 patent. Claims 4-11 depend from claim 1 and do not rectify the issue, so they must also be rejected under 35 U.S.C. 112, first paragraph for inadequate written description.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 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 9 refers to a therapeutic agent comprising the antibody of claim 1 as an active ingredient, “wherein the therapeutic agent is suitable for the malignant tumor expressing the MHC class II protein.” It is unclear for what purpose the therapeutic agent is suitable: recognizing, treating, or something else. Clarification is required.
Conclusion
No claims are allowed. Because the application is not in sequence compliance, no search of patent literature for the claimed sequences could be performed. The examiner accordingly takes no position on whether the claims are novel or non-obvious.
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. 9,303,083 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
1 For this analysis, the examiner obtained the sequences claimed in the ’083 patent by referencing application no. 13/877,844. The presence of SEQ ID NOs: 56 and 54 in the underlying ’844 application does not obviate applicant’s obligation to bring this reissue application into sequence compliance.
2 An untranslated version of foreign-priority document JP 2010-224632 was present in underlying application 13/877,844. The version of JP ’632 in the ’844 application does not disclose any CDR sites within any SEQ ID NOs, so it does not appear to provide written-description support for the antibodies being claimed in the underlying ’803 patent.