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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Foreign Priority
Applicant’s arguments filed 12/5/2025 with respect to the foreign priority date have been fully considered and are persuasive. The updated priority date is noted below.
35 U.S.C. 101
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
Applicant’s position is that the amended claims are not directed to a patient-ineligible phenomenon because 1) they limit size and origin of SEQ ID NO: 1, which excludes naturally occurring peptides that encompass or contain SEQ ID NO: 1, 2) the synthetic peptide is laboratory-made and is therefore markedly different from corresponding products of nature and has no naturally-occurring counterpart, and 3) SEQ ID NO: 1 has a practical purpose, which makes it patent eligible.
Regarding 1), amending the claims to limit the size and origin from which SEQ ID NO: 1 is derived does not prevent it from reading on the naturally-occurring products recited in the prior Office Action and reiterated herein. While these naturally-occurring proteins may be longer than the limit imposed by the claims, in Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that fragments of a biopolymer still trigger this statute. Thus, the fact that these sequences are longer than those claimed does not make the rejection invalid, unless the fragment is significantly different from the full-length polypeptide; in the instant case, however, there is nothing markedly different about the instant SEQ ID NO: 1 compared to its natural counterparts.
Regarding 2), obtaining any protein, including SEQ ID NO: 1, from an artificial process does not preclude it from reading on a naturally-occurring product. For example, synthesizing peptides through artificial means, such as through solid phase peptide synthesis, can still lead to the production of naturally-occurring peptides that are structurally equivalent and indistinguishable from their nature-derived counterparts. As stated above, there is nothing in the structure of SEQ ID NO: 1, as derived from a laboratory setting, that makes it markedly different from the natural products recited in the previous Office Action and reiterated herein, which makes it indistinguishable from its naturally-occurring counterparts.
Regarding 3), the claims do not integrate SEQ ID NO: 1 into a practical application raising it to the level of significantly more that would make it markedly different from the natural counterparts. The recitation of functional limitations that would be endowed by the sequence, as described in the previous Office Action and reiterated herein, does not raise SEQ ID NO: 1 to the level of having significantly more than its natural counterparts.
For each of these reasons, and described again below, SEQ ID NO: 1 remains rejected under 35 U.S.C. 101, as described below.
35 U.S.C. 102
Applicant’s arguments, see Pg 10-14, have been fully considered. The Examiner agrees with the Applicant that the amended claims 1 and 2 overcome the prior rejections under 102(a)(1) and (a)(2) of Berka ‘798 and ‘393 simply because the claims have been amended to recite a peptide consisting of SEQ ID NO: 1 rather than comprising SEQ ID NO: 1.
However, on the other points raised by the Applicant - the peptides taught by Berka ‘798 and ‘393 do not amount to explicit disclosure of the claimed peptides and do not meet all elements of the claims - the Examiner disagrees.
The prior claim set required a peptide comprising an amino acid sequence represented by SEQ ID NO: 1. Berka ‘798 and ‘393 disclosed SEQ ID NO: 6237 and SEQ ID NO: 7192, respectively, which are peptides that comprise the amino acid sequence SEQ ID NO: 1. Therefore, Berka ‘798 and ‘393 did and do anticipate a peptide comprising an amino acid sequence as shown in SEQ ID NO: 1, and the references were appropriately applied to the prior claims as anticipatory references.
A peptide sequence imparts its function; therefore, a peptide comprising or consisting of SEQ ID NO: 1 would be expected to the functional limitations claimed as well. MPEP 2112(II) states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In other words, Berka ‘798 and ‘393 as anticipatory references did not need to also teach the functional attributes as claimed because disclosing the peptide sequence itself is sufficient.
Ultimately, claims 1 and 2 are sufficient to overcome the 102(a)(1) and (a)(2) rejections of Berka ‘798 and ‘393 based upon the amendments to the claims, but not because of the persuasiveness of the arguments set forth above.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, and the species of lung cancer cell, in the reply filed on 9/10/2025 is acknowledged.
Claim Status
Claims 1, 2, 9-12, and 20 are pending under examination. Claims 9-12 and 20 were previously withdrawn as non-elected inventions. Claims 1 and 2 are currently amended.
Priority
The instant application is the 371 national stage entry of PCT/KR2021/010657, filed 8/11/2021, which claims priority to KR10-2021-0105103, 8/10/2021, and KR10-2020-0100354, filed 8/11/2020. The prior Office Action incorrectly assigned the priority date of 8/10/2021; the priority date of 8/11/2020 is acknowledged herein. Please note that this does not materially change either the prior Office Action nor the current one.
It is still noted that KR10-2021-0105103 and KR10-2020-0100354 have been received but no translation has been made of record.
Nucleotide and/or Amino Acid Sequence Disclosures
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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specifically, Figures 3B and 3C recite sequences without SEQ ID NO’s that do not seem to be present in Table 1 of the specification; include the relevant SEQ ID NO’s in either the Drawings themselves or the Brief Description of the Drawings.
Claim Interpretation
Claim 1 recites the peptide SEQ ID NO: 1 “specifically binds to an exosome derived from a cancer cell”. This limitation describes a functional rather than a structural element of the instant invention. As such, the claim is being interpreted based upon the structural limitation (a synthetic peptide consisting of the amino acid sequence represented by SEQ ID NO: 1), where the functional limitation is a property endowed by the structure.
Similarly, claim 2 recites the peptide of claim 1, wherein the cancer cell-derived exosome is from a lung cancer cell, a breast cancer cell, or a pancreatic cancer cell. This limitation describes a functional rather than a structural element of SEQ ID NO: 1. As such, the claim is being interpreted based upon the structural limitation (a synthetic peptide consisting of the amino acid sequence represented by SEQ ID NO: 1), where the functional limitation is a property endowed by the structure.
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 and 2 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to a peptide, which is a composition of matter.
Regarding 2a), the peptide claimed is a product of nature.
Claim 1 recites a synthetic peptide consisting of the amino acid sequence represented by SEQ ID NO: 1, wherein the synthetic peptide specifically binds to an exosome derived from a cancer cell. This reads on many naturally-occurring proteins, such as:
Diacylglycerol glucosyltransferase N-terminal domain-containing protein, 88 amino acids, UniProt ID A0AAF0UAV8_SOLVR
Flavin reductase, 168 amino acids, UniProt ID A0A3D2TTJ2_9FIRM
AMP-binding protein, 218 amino acids, UniProt ID A0A925PMG1_UNCDE
Ferredoxin--NADP reductase, 263 amino acids, UniProt ID A0A2V8Y9B4_UNCAI
Electron transfer flavoprotein subunit beta, 275 amino acids, UniProt ID A0A354SME0_9PORP
Others not listed here
While some of these proteins may be longer than the limit imposed by the claims, in Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that fragments of a biopolymer still trigger this statute. Thus, the fact that these sequences are longer than those claimed does not make the rejection invalid, unless the fragment is significantly different from the full-length polypeptide.
Regarding 2b), none of the claims above integrate SEQ ID NO: 1 into a practical application that raises it to the level of being significantly more than the naturally-occurring products. At most, the claims recite functional attributes endowed by the structure of SEQ ID NO: 1 without significantly more. However, SEQ ID NO: 1 remains indistinguishable from the natural-products described above on a structural level as there is nothing significantly more added to SEQ ID NO: 1 itself that differentiates it. As such, the claims do not contain elements added to the judicial exception sufficient to render the claims significantly more than the exception.
Taken together, the claims are drawn to patent ineligible subject matter and are rejected here.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658