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/Restrictions
Applicant's election with traverse of Group I (claims 1-3 and 17) in the reply filed on 01/30/2026 is acknowledged. The traversal is on the ground(s) that the Office Action has not shown that a serious burden would be required to examine all of the claims. This argument is not persuasive because issues of burden in restrictions are addressed in applications filed under 35 USC 111(a). The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a). Applicants further argue that the reference of Brandenberger et al. used to break unity is improper because claim 1 is drawn to a peptide consisting of the amino acid sequence of SEQ ID NO:2 or an amino acid sequence showing 95% or more sequence homology thereto. Applicants argue that the mRNA transcript of Brandenberger is much larger than the encoded 105 peptides of Claim 1 which does not teach or suggest the claims. This argument has been considered but is not found persuasive as Claim 4, drawn, to a polynucleotide comprising a nucleotide sequence encoding the peptide of Claim 1, was used to illustrate that unity of invention was lacking. Further, the mRNA transcript is larger because it comprises three codons for every amino acid sequence.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-19 are currently pending. Claims 4-16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3 and 17 are currently pending and under consideration.
Information Disclosure Statement
The IDS filed 06-09-2023 was considered in part. In particular, the International Search Report and Written Opinion in PCT/KR2021/018751 could not be considered as it was not in English.
Claim Objections
Claim 17 is objected to because the pharmaceutical composition encompasses non-elected subject matter (items ii-iv) such as polynucleotides and vectors. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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(s) 1-2, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Accession Number CN431578, EST database, February 4, 2011, two pages (PTO-892).
The accession number reveals a 105 amino acid peptide encoded by a 526 basepair mRNA from embryonic stem cells. The encoded peptide has 95% or more sequence homology to SEQ ID NO:2.
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Although the reference does not specifically teach that the peptide activates innate immunity and adaptive immunity, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure as claimed, the properties applicant discloses and/or claims are necessarily present. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The same rationale also applies to Claim 17 as the only structure present in the pharmaceutical composition is the claimed peptide(s) and the specification does not provide a limiting definition of what constitutes a “pharmaceutical” composition. Further, the intended use “for preventing or treating cancer” is not given patentable weight. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). The preamble recitation of pharmaceutical composition is merely suggestive of an intended use and is not given weight for purposes of comparing the claims with the prior art. When the claim is directed to a product, the preamble or intended use is generally nonlimiting if the body of the claim is directed to an old composition and the preamble merely recites a property inherent in the old composition. [Kropa v. Robie, 88 USPQ 478, 480 - 81 (CCPA 1951); see also MEP. 2111.02]. The claims read on the active ingredients per se, which only comprise the peptide(s).
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 1-3, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. Claim 1 recites “A peptide consisting of the amino acid sequence of SEQ ID NO: 2 or an amino acid sequence showing 95% or more sequence homology thereto”. Claim 2 ascribes functional activity to all of the peptides of claim 1 stating “wherein the peptide activates innate immunity and adaptive immunity”. Claim 3 reiterates that the peptide can consist of SEQ ID NO:2 or it can consist of SEQ ID NO:3. Claim 17 is drawn to a pharmaceutical composition comprising the peptides of claim 1. Thus, the claims are drawn to amino acid sequences which are products of nature. A sequence comparison of SEQ ID NO:2 (Qy) and SEQ ID NO:3(Db) is shown below. The peptides are each 105 amino acids long and are 99% similar. Each peptide comprises naturally occurring amino acids derived from cysteineyl-tRNA [0009].
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The specification teaches [0009] that the present inventors have found that a fragment peptide of cysteineyl-tRNA synthetase (hereinafter referred to as ‘CRS’) has anticancer activity. The specification further teaches that the novel fragmented CRS peptide consists of the amino acid sequence of SEQ ID NO: 2. Regarding variants, the specification teaches [0081] as an example of the variant, whether it occurs naturally or non-naturally, it may exist as a splice variant or contain one or more point mutations. Further, [0084] the variant is one in which an arbitrary change has occurred in the amino acid sequence of the ‘peptide’, and may include one or more substitutions, deletions, additions and/or insertions. Such variants may be naturally occurring. Thus, the claimed peptides do not sufficiently distinguish over peptides as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See MPEP 2106.04(b).
Further, the human intervention required by the claims is limited to isolating the natural CRS products into a composition. However, in Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. See MPEP 2106.04(c). Therefore, here, like Myriad, the composition comprising an isolated natural product is not markedly different from the natural product itself because there is no difference in the CRS in its natural and isolated state. This judicial exception is not integrated into a practical application because there are no additional elements that could integrate the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements.
No claim is allowed.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cho et al. (Jnl. Immunotherapy Cancer;8(1), May 2020). See Figure 2. UNE-C1 consists of amino acids 106-228 of human cysteinyl-tRNA synthetase 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643