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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 9-10, and 17-20, drawn to an oligopeptide having an amino acid sequence shown in SEQ ID NO: 1 as well as an inhibitor and drug thereof in the reply filed on 7/30/2025 is acknowledged.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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
35 U.S.C. 101
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant’s position is that the oligopeptide consisting of SEQ ID NO: 1, as recited in new claims 21-24, does not read on naturally-occurring products as SEQ ID NO: 1 is obtained from an artificial process, the claims incorporate SEQ ID NO: 1 into practical applications, and the angiotensin-converting enzyme inhibitory function of SEQ ID NO: 1 is a markedly different characteristic.
Regarding 1), 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. Simply because SEQ ID NO: 1 can be obtained from bioactivity-guided isolation and purification from rice fermentation products, wherein enzymatic hydrolysis produces the peptide, is not enough to distinguish SEQ ID NO: 1 from other naturally-occurring peptides with the same amino acid sequence. Applicant appears to acknowledge this concept in Remarks, Pg 8, 3rd paragraph (“…the LIIPEH sequence may appear as a segment in the long-chain proteins of some environmental microorganisms (e.g. Burkholderia, Bradyrhizobium, Cyanobacteria)…”
Regarding 2), although the claims may incorporate SEQ ID NO: 1 into practical applications there is nothing substantially more on a structural level that would differentiate SEQ ID NO: 1 from the naturally-occurring peptides cited in the previous Office Action and reiterated herein below. In other words, the natural product in a composition or equivalent thereof is insufficient to demonstrate a marked difference between the peptide at hand and its counterpart as the composition does not structurally alter or add significantly more to the natural product itself.
Regarding 3), as recited in the prior Office Action and reiterated herein, the recited function of SEQ ID NO: 1 having “an inhibition effect on angiotensin converting enzyme” represents an inherent characteristics endowed by the amino acid sequence itself. Per MPEP 2106.04(c)II(c), “The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75 (emphasis added)…
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.” Consequently, because the functional limitation is an inherent characteristic of SEQ ID NO: 1, the threshold of markedly different characteristic has not been reached.
35 U.S.C. 101/112(b)
Applicant’s arguments, see Pg 9-10, with respect to claims 9 and 10 have been fully considered and are persuasive but are moot as claims 9 and 10 have been cancelled. Regarding claim 23, see below.
35 U.S.C. 102
Applicant’s arguments, see Pg 10-12, have been fully considered. The Examiner agrees with the Applicant that the amended claims 21-24 overcome the prior rejections under 102(a)(1) and (a)(2) of Malley simply because the claims have been amended to recite an oligopeptide consisting of SEQ ID NO: 1 rather than having SEQ ID NO: 1.
However, on the other points raised by the Applicant - 1) Malley is not anticipatory as it never isolated, identified, or characterized the fragment and 2) the data submitted in the Remarks, Pg 11-12, demonstrates that SEQ ID NO: 1 has a novel functional property not found in nature -, the Examiner disagrees.
Regarding 1), the prior claim set required an oligopeptide having an amino acid sequence as shown in SEQ ID NO: 1. Malley disclosed SEQ ID NO: 70, which is a peptide that has the amino acid sequence SEQ ID NO: 1. Therefore, Malley did and does anticipate an oligopeptide having an amino acid sequence as shown in SEQ ID NO: 1, and the reference was appropriately applied to the prior claims as an anticipatory reference.
Regarding 2), as described above, a peptide sequence imparts its function; therefore, a peptide comprising or consisting of SEQ ID NO: 1 would be expected to demonstrate the properties shown in the graph of the Remarks. 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, Malley as an anticipatory reference did not need to also teach the functional attribute demonstrated in the graph of the Remarks as disclosing the peptide sequence itself is sufficient.
Ultimately, the new claims 21-24 are sufficient to overcome the 102(a)(1) and (a)(2) rejections of Malley based upon the amendments to the claims, not because of the persuasiveness of the arguments set forth above.
Claim Status
Claims 4-8, 11-16, and 21-24 are pending. Claims 4-8, and 11-16 are withdrawn. Claims 1-3, 9-10, and 17-20 have been cancelled. Claims 21-24 are new.
Priority
The instant application is the national stage entry of PCT/CN2021/081215, filed 3/17/2021, which claims priority to CN202010245463.X, filed 3/31/2020. Applicants have claimed the effective date of 3/31/2020 based on CN202010245463.X although no translation has been made of record.
Claim Interpretation
Claim 21 recites “An oligopeptide… with an amino acid sequence being SEQ ID NO: 1” (emphasis added). This claim is being interpreted as an oligopeptide consisting of SEQ ID NO: 1, wherein a peptide or protein with the sequence of SEQ ID NO: 1 meets the limitation of the claim. Conversely, smaller fragments encompassed by SEQ ID NO: 1 are being interpreted as not meeting the limitations of the claim. Further, the limitation “with an inhibition effect on angiotensin converting enzyme” is being interpreted as a functional limitation endowed by the structure SEQ ID NO: 1.
Claim 23 recites “Use of the oligopeptide.. for treating hypertension, comprising administering the oligopeptide…” This claim is being interpreted as a method claim, wherein the active step is administering the oligopeptide.
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 22 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.
Claim 22 recites two limitations that renders it indefinite. The first is the limitation “many times” in line 3, which is a relative term. The term “many times” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, the number of times that the instant SEQ ID NO: 1 is subjected to separation and purification by reversed-phase liquid chromatography is unclear, thereby making the scope of the claim indefinite.
Claim 22 is also indefinite based on the limitation “under the guidance of angiotensin converting enzyme inhibitory activity” because the relationship between angiotensin converting enzyme inhibitory activity and SEQ ID NO: 1 is unclear, e.g., whether the inhibitory activity should increase or decrease relative to the separation and purification of SEQ ID NO: 1.
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 21, 22, and 24 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.
The above claims recite SEQ ID NO: 1, which reads on many naturally-occurring proteins, such as:
IS1595 family transposase, 68 amino acids, UniProt ID A0A562PMX5_9BURK
BgtTE-56123, 74 amino acids, UniProt ID A0A9X9MQV9_BLUGR
Type II toxin-antitoxin system RelE/ParE family toxin, 75 amino acids, UniProt ID A0A846D850_9CYAN
PAS domain S-box protein, 79 amino acids, UniProt ID A0A844SJV4_9BRAD
Integration host factor subunit beta, 96 amino acids, UniProt ID A0A2E7CS16_9FLAO
Plus 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 limitations whereby the natural product is obtained and a composition thereof. In each of these instances, SEQ ID NO: 1 remains indistinguishable from the natural-products described above as there is nothing significantly more added to SEQ ID NO: 1 itself to differentiate it. As such, the claims do not contain elements added to the judicial exception sufficient to render them significantly more than the exception.
Taken together, the claims are drawn to patent ineligible subject matter and are rejected here.
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658