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 1-11 were originally filed January 30, 2024.
Applicants submitted a claim set for the parent application (17/520,638) on July 30, 2024. Please note: applicants should only submit claims for the present application. Any claims submitted will be treated as a claim set for the present application by the Office.
The amendment received October 16, 2024 changed the status identifiers only.
The amendment received June 16, 2025 amended claims 4 and 6.
The amendment received January 22, 2026 cancelled claims 4-11 and added new claims 12-17.
Claims 1-3 and 12-17 are currently pending.
Claim 12 is currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group II (claims 4 and 6; now claims 12-14) in the reply filed on June 16, 2025 is acknowledged.
Claims 1-3, 5, 7-11, and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicants elected, without traverse, residues 830-851 of SEQ ID NO: 11 and cereblon in the reply filed on June 16, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2025.
Please note: cereblon is not a proper species for the “moiety that recruits the cellular enzyme E3 ubiquitin ligase” (see page 30 of the present specification; proper species would include pomalidomide, lenalidomide, etc.).
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 If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of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 CON of 17/520,638 filed November 6, 2021 (now U.S. Patent 11,897,925) which claims the benefit of 63/114,838 filed November 17, 2020.
Nucleotide and/or Amino Acid Sequence Disclosures
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 - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See pages 5, 7, and 25.
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.
Arguments and Response
Applicants contend that the specification was amended to include SEQ ID NOs:.
It is respectfully noted that the amendments to the specification received January 22, 2026 did not add the required SEQ ID NOs: to pages 5, 7, or 25.
Withdrawn Objections
The objection to the disclosure regarding the first line of the specification should be updated to include U.S. Patent 11,897,925 is withdrawn in view of the amendment received January 22, 2026.
The objection to claim 4 regarding “SEQ ID NO.” should read “SEQ ID NO:” is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
The objection to claim 4 regarding “or” between “d)” and “e)” should be deleted is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
The objection to claim 4 regarding “or” should be inserted between “e)” and “f)” (i.e. single conjunction within the Markush group) is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
Maintained Objections
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See pages 39, 41, 42, 43, and 44.
Arguments and Response
Applicants contend that the amendments received January 22, 2026 negate the objections.
The amendments do not negate the objections because hyperlinks are still present. Applicants should refer to the website by name and should not include hyperlinks.
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.
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 4 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 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 cancellation of the claim in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 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 cancellation of the claim in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 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 cancellation of the claim in the amendment received January 22, 2026.
The rejection of claims 4 and 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 cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 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 cancellation of the claim in the amendment received January 22, 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 cancellation of the claim in the amendment received January 22, 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 cancellation of the claim in the amendment received January 22, 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 cancellation of the claim in the amendment received January 22, 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 cancellation of the claim in the amendment received January 22, 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 cancellation of the claim in the amendment received January 22, 2026.
The rejection of claims 4 and 6 under 35 U.S.C. 101 because the claimed invention is directed to a fragment of a naturally occurring polypeptide without significantly more is withdrawn in view of the cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 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 is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
The rejection of claim 4 under 35 U.S.C. 102(a)(1) as being anticipated by Kumagai et al. U.S. Patent Application Publication 2008/0119685 published May 22, 2008 is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
The rejection of claim 4 under 35 U.S.C. 102(a)(1) as being anticipated by Kumagai et al. U.S. Patent 8,080,531 issued December 20, 2011 is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
The rejection of claims 4 and 6 under 35 U.S.C. 103 as being unpatentable over Kumagai et al. U.S. Patent 8,080,531 issued December 20, 2011 and Arap et al. WO 02/20769 published March 14, 2002 is withdrawn in view of the cancellation of the claims in the amendment received January 22, 2026.
The rejection of claim 4 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,897,925 is withdrawn in view of the cancellation of the claim in the amendment received January 22, 2026.
New Rejection Necessitated by Amendment
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.
Claim 12 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 presently claimed CIP2A-TOPBP1 inhibitor. For example, it is unclear how the CIP2A-TOPBP1 inhibitor can inhibit TOPBP1 when the peptide is only capable of binding to CIP2A.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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.
Claim 12 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 presently claimed CIP2A-TOPBP1 inhibitor. For example, it is unclear under what conditions the peptide is “capable of binding CIP2A”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mintz et al. U.S. Patent Application Publication 2007/0083334 published April 12, 2007 and Arap et al. WO 02/20769 published March 14, 2002.
For present claim 12, Mintz et al. teaches SEQ ID NOs: 744981, 744982, 744994, 744993, etc. which have 100% identity to residues 830-851 of present SEQ ID NO: 11, fusion polypeptides, and fragments (please refer to the entire specification particularly paragraphs 291, 292, 318, 319, 323).
For present claim 12, Arap et al. teach thalidomide (i.e. moiety that recruits the cellular enzyme E3 ubiquitin ligase) covalently attached to peptides (please refer to the entire specification particularly pages 6 and 7).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (i.e. making covalently attached therapeutics comprising more than one therapeutic) with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide) for another (i.e. fragments of SEQ ID NO: 11) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (e.g. making peptides covalently bound to thalidomide) 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Mintz et al. and Arap et al. for claim 12 were considered but are not persuasive for the following reasons.
Applicants contend that Mintz et al. and Arap et al. do not teach residues 830-851 of present SEQ ID NO: 11 covalently linked to a moiety that recruits an E3 ligase.
Applicants’ arguments are not convincing since the teachings of Mintz et al. and Arap et al. render the CIP2A-TOPBP1 inhibitor of the instant claims prima facie obvious.
Mintz et al. teaches SEQ ID NOs: 744981, 744982, 744994, 744993, etc. which have 100% identity to residues 830-851 of present SEQ ID NO: 11, fusion polypeptides, and fragments (please refer to the entire specification particularly paragraphs 291, 292, 318, 319, 323).
Arap et al. teach thalidomide (i.e. moiety that recruits the cellular enzyme E3 ubiquitin ligase) covalently attached to peptides (please refer to the entire specification particularly pages 6 and 7).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kumagai et al. U.S. Patent Application Publication 2008/0119685 published May 22, 2008 and Arap et al. WO 02/20769 published March 14, 2002.
For present claim 12, Kumagai et al. teach SEQ ID NO: 7 which have 100% identity to residues 830-851 of present SEQ ID NO: 11, fragments, peptidomimetics, and fusion polypeptides (please refer to the entire specification particularly paragraphs 15, 30, 31, 46, 48, 49, 55, 58, 69, 70, 87, 121, 130, 134, 225, 226, 261-268).
For present claim 12, Arap et al. teach thalidomide (i.e. moiety that recruits the cellular enzyme E3 ubiquitin ligase) covalently attached to peptides (please refer to the entire specification particularly pages 6 and 7).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (i.e. making covalently attached therapeutics comprising more than one therapeutic) with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide) for another (i.e. fragments of SEQ ID NO: 11) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (e.g. making peptides covalently bound to thalidomide) 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Kumagai et al. and Arap et al. for claim 12 were considered but are not persuasive for the following reasons.
Applicants contend that Kumagai et al. and Arap et al. do not teach residues 830-851 of present SEQ ID NO: 11 covalently linked to a moiety that recruits an E3 ligase.
Applicants’ arguments are not convincing since the teachings of Kumagai et al. and Arap et al. render the CIP2A-TOPBP1 inhibitor of the instant claims prima facie obvious.
Kumagai et al. teach SEQ ID NO: 7 which have 100% identity to residues 830-851 of present SEQ ID NO: 11, fragments, peptidomimetics, and fusion polypeptides (please refer to the entire specification particularly paragraphs 15, 30, 31, 46, 48, 49, 55, 58, 69, 70, 87, 121, 130, 134, 225, 226, 261-268).
Arap et al. teach thalidomide (i.e. moiety that recruits the cellular enzyme E3 ubiquitin ligase) covalently attached to peptides (please refer to the entire specification particularly pages 6 and 7).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,897,925 in view of Arap et al. WO 02/20769 published March 14, 2002.
U.S. Patent No. 11,897,925 claims CIP2A-TOPBP1 inhibitors.
Arap et al. teach thalidomide (i.e. moiety that recruits the cellular enzyme E3 ubiquitin ligase) covalently attached to peptides (please refer to the entire specification particularly pages 6 and 7).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (i.e. making covalently attached therapeutics comprising more than one therapeutic) with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide) for another (i.e. fragment of present SEQ ID NO: 11) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (e.g. making peptides covalently bound to thalidomide) 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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,897,925 in view of Arap et al. for claim 12 were considered but are not persuasive for the following reasons.
Applicants contend that since U.S. Patent No. 11,897,925 claims a method and the present claims are drawn to a product that a double patenting rejection is not proper.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,897,925 in view of Arap et al. renders obvious the CIP2A-TOPBP1 inhibitor of the instant claims. The present application is a CON, therefore a double patenting rejection may be made (i.e. present application is not a DIV). Furthermore, the restriction was withdrawn in the Notice of Allowance mailed on October 4, 2023. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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
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/AMBER D STEELE/Primary Examiner, Art Unit 1658