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 .
Election/Restriction
Applicant’s election without traverse of the species DOP, hydrazine, PNA-M1 and PNA-Z1 in the reply filed on 09/26/25 is acknowledged.
The species were search and found to be free of the art. The search was extended to the
full scope of the claims 1-8, 10-16 and 18, which were searched and found to be free of the art.
Claim 9 however, is unclear, and cannot be searched in full until the scope of the nucleophilic moiety is clarified, as will be discussed below.
Additionally, claim 17 was searched and art was found reading on the product. An Office action on the merits follows.
Allowable Subject Matter
Claims 1-8, 10-16 and 18 were searched and found to be free of the art. The closest prior art to the instant claims is WO2012/085279A2, which teaches similar methods of coupling two agents with the starting peptide formula:
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(p. 20). However, this reference does not teach couple 2 agents by reacting it with a hydrazine, aminosulfonyl, aminooxy or hydroxylamine group, and there is no teaching or motivation to suggest modifying the formula to a saturate 1, 4-dioxo moiety. As such the claims are novel and unobvious over the prior art.
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.
Claim 9 recites the limitation "wherein the nucleophilic moiety comprises a group having a structure of formula VII, VIII or IX." There is insufficient antecedent basis for this limitation in claim 1 because the only options provided in claim 1 are listed as a Markush grouping selected from hydrazine, aminosulfanyl, aminooxy and hydroxylamine moieties. While the formulas of claim 9 encompass these moieties, they have much broader structures that lack antecedent basis in the closed language of claim 1. Clarification of the claimed nucleophilic moieties and how they relate to the process of claim 1 is required.
Claim Rejections 35 USC 112 (D)
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.
Claim 9 is 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. The scope of claim 9 is broader than the scope of claim 1 with regard to the nucleophilic moieties. 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.
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.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more.
The claim(s) recite(s) a peptide comprising a 1, 4-dioxo moiety have a structure of formula 1A. This judicial exception is not integrated into a practical application because Zhou et al. (Front Mol Biosci. 2026 Feb 18;13:1768199) teach that succinylation plays essential roles in metabolic regulation, signal transduction, and cellular differentiation, and is of particular interest in the liver, where is undergoes the following schematic of regulation by succinylation and desuccinylation:
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(Fig. 1, p. 5).
With regard to natural products, the MPEP states: “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 11A F.3d at 760, 113 USPQ2d at 1244. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.” (MPEP 2106.04).
Here, the analysis is as follows:
1: Is the claim drawn to a composition of matter? Yes
2A: Is the claim drawn to a product of nature? Yes - a succinylated peptide.
2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No – The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed product is the naturally occurring result of metabolism in the liver, as taught by Zhou.
Therefore, claim 17 is rejected as a 101 judicial exception.
Claim Rejections 35 USC 102(A)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 17 is rejected under 35 U.S.C. 102(A) as being anticipated by Zhou et al. (Front Mol Biosci. 2026 Feb 18;13:1768199).
Zhou teaches, which teaches that following:
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This meets the limitations of claim 17 where Formula IA is connected to a peptide, and R12 is a C1 alkyl substituted by a hydroxyl group. As such, claim 16 is anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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