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 Claims
Claims 1-7 and 17-27 are pending.
Claims 1-7, 17-23 and 26-27 have been amended.
Claims 1-7 and 17-27 are currently under examination on the merits
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The U.S. effective filing date of all claims under examination is set at 06/22/2021 based on the PCTCN2021101417 application (filed on 06/22/2021).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2023 is being considered by the examiner.
Drawings
The drawings are objected to because:
Figure 9 is not fully legible in particular it contains figure legends that are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code on Pg. 49 and 50:
https://www.ncbi.nlm.nih.gov/igblast/ (in paragraph [00192]); and
http://www.imgt.org (six occurrences in paragraph [00192])
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 is objected to because of an apparent typographical error. It appears amino acid sequences” is awkwardly missing from the end of the claim. The following amendment is suggested to obviate this objection: “The antibody or antigen-binding fragment thereof of any one ofclaims1-2, wherein the antibody or antigen-binding fragment thereof comprises murine, human- mouse chimeric, humanized or fully human amino acid sequences.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-7 and 17-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 12 (pre-AlA), 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-AlA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation " the heavy chain variable region comprises the heavy chain complementary determining regions CDR1, CDR2 and CDR3, and the light chain variable region comprises the light chain complementary determining regions CDR1, CDR2 and CDR3”. There is insufficient antecedent basis for "the heavy chain variable region”, “the heavy chain complementary determining regions CDR1, CDR2 and CDR3”, “the light chain variable region” and “the light chain complementary determining regions CDR1, CDR2 and CDR3” in the claim. All claims depend on claim 1 and therefore claims 2-7 and 17-27 are also included in this rejection. This rejection can be obviated if claim 1 is amended to recite “An antibody or antigen-binding fragment thereof capable of specifically binding to human tumor necrosis factor receptor 2 (TNFR2), wherein the antibody or antigen-binding fragment comprises a heavy chainvariable region and a light chainvariable region,
Claim 18 contains the trademark/trade name “nanobody”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody fragment that is a single-domain antibody and, accordingly, the identification/description is indefinite.
Claim 20 recites the limitation "sum of the respective effects of the reagents” in line 5. There is insufficient antecedent basis for "the reagents” in the claim.
Regarding claims 20, 26 and 27, the recitation of the phrase “Use of the antibody or antigen-binding fragment thereof” causes the meets and bound of the claims to become indefinite. MPEP 2173.05(q) states attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness. Recitation of a use without any active, positive steps delimiting how this use is actually practiced is indefinite.
Claim Rejections - 35 USC § 101
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 20, 26 and 27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to the “use” of the antibody or antigen-binding fragment thereof capable of specifically binding to human tumor necrosis factor receptor 2 (TNFR2). The claims are not directed toward a: 1) composition of matter; 2) machine; 3) manufacture; or 4) process, but rather a “use” of an antibody or antigen-binding fragment thereof capable of specifically binding to human tumor necrosis factor receptor 2 (TNFR2), wherein no active method steps are present to suggest a process is being claimed. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101 MPEP 2173.05(q).
Allowable Subject Matter
The antibody or antigen-binding fragment thereof capable of specifically binding to human tumor necrosis factor receptor 2 (TNFR2), wherein the antibody or antigen-binding fragment comprises heavy chains and light chains, and the heavy chain variable region comprises the heavy chain complementary determining regions CDR1, CDR2 and CDR3, and the light chain variable region comprises the light chain complementary determining regions CDR1, CDR2 and CDR3, wherein,
(01) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 58 and SEQ ID NO: 20, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(02) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 4, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 6, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(03) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 10, SEQ ID NO: 11 and SEQ ID NO: 12, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 14, SEQ ID NO: 15 and SEQ ID NO: 16, respectively; Attorney Docket No. 18210003US
(04) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 19 and SEQ ID NO: 20, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(05) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 10, SEQ ID NO: 11 and SEQ ID NO: 12, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 27, SEQ ID NO: 15 and SEQ ID NO: 16, respectively;
(06) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 55 and SEQ ID NO: 20, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(07) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 4, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 28, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(08) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 4, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 33, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(09) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 36, respectively, and CDR1, CDR2 Attorney Docket No. 18210003US and CDR3 of the light chain variable region consist of SEQ ID NO: 6, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(10) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 55 and SEQ ID NO: 61, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(11) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 55 and SEQ ID NO: 64, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(12) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 58 and SEQ ID NO: 61, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively;
(13) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 36, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 28, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(14) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 45, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 6, SEQ ID NO: 7 and SEQ ID NO: 8, respectively;
(15) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 2, SEQ ID NO: 3 and SEQ ID NO: 45, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 28, SEQ ID NO: 7 and SEQ ID NO: 48, respectively; and
(16) CDR1, CDR2 and CDR3 of the heavy chain variable region consist of the amino acid sequences SEQ ID NO: 18, SEQ ID NO: 58 and SEQ ID NO: 64, respectively, and CDR1, CDR2 and CDR3 of the light chain variable region consist of SEQ ID NO: 22, SEQ ID NO: 23 and SEQ ID NO: 24, respectively, are free of prior art.
Conclusion
No claims are allowed.
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/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642
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