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 .
Response to Election/Restriction filed on July 1, 2026 is acknowledged.
Claims 9-11 have been cancelled.
Claims 1-8 are pending in this application.
Priority
5. Applicant claims foreign priority to CHINA 202310062959.7 (1/18/2023). The certified copy has been received by the Office. However, a certified English translation has not been provided. Therefore, the foreign priority date has not been perfected. Thus, the effective filing date of instant application is 12/26/2023 until the foreign priority date is perfected.
Restriction
6. Applicant’s election without traverse of Group 3 (now claim 8) in the reply filed on July 1, 2026 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Applicant indicates claims 1-7 are withdrawn from consideration. A search was conducted on the invention of Group 3. Claims 1-2 are hereby rejoined only. Restriction between Groups 1 and 3 is hereby withdrawn. Restriction between Groups 2 and 3 are maintained. Claims 3-7 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 1-2 and 8 are examined on the merits in this office action.
Sequence Interpretation/Claim Interpretation
7. The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more (2 consecutive residues or more within SEQ ID NO: 1), “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5’/3’ ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid 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.
Please note that the Examiner is interpreting the scope of claim 1 as the any 2 or more consecutive residues within sequence of SEQ ID NO: 1 (the claim recites “an amino acid sequence as shown in SEQ ID NO: 1).
Objections
8. The specification is objected to for containing referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses peptide sequences, and these are missing their respective sequence identifiers. For example, paragraphs [0023]-[0025], [0028]-[0029], [0060], [0071], [0073], [0075], [0077], [0079], [0083] and “Embodiment 6” of instant specification US 2024/0239848 A1 disclose peptide sequences, but these are missing their sequence identifiers. The examiner would like to bring the applicant’s attention to the following excerpt from MPEP §2422.03:
37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application. This requirement is also intended to permit references, in both the description and claims, to sequences set forth in the "Sequence Listing" by the use of assigned sequence identifiers without repeating the sequence in the text of the description or claims. Sequence identifiers can also be used to discuss and/or claim parts or fragments of a properly presented sequence. For example, language such as "residues 14 to 243 of SEQ ID NO:23" is permissible and the fragment need not be separately presented in the "Sequence Listing." Where a sequence is embedded in the text of an application, it must be presented in a manner that complies with the requirements of the sequence rules.
The applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
9. The drawings are objected to because the figures are missing the sequence identifiers that correspond to the peptide sequences (please see FIG. 2, FIG. 3, FIG. 4A, and FIG. 4B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.10
10. Claim 1 is objected to for the following: Claim 1 recites “…shown in SEQ ID NO.1”. Applicant is required to correct the sequence identifier to “SEQ ID NO: 1”.
Rejections
U.S.C. 112(a)
11. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. Claims 1-2 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a holothurian-derived active peptide with immune activity, wherein an amino acid sequence of the holothurian-derived active peptide is shown in SEQ ID NO: 1 (claim 1), and a preparation of immunocomponent peptide, comprising the holothurian-derived peptide according to claim 1 (claim 2). The generic an amino acid sequence of the holothurian-derived active peptide is shown in SEQ ID NO: 1 does not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claim 1 is broad generics with respect all possible compounds encompassed by the claims. Instant SEQ ID NO: 1 is a 7mer peptide sequence comprising the sequence IIENAVQ. As indicated above in the sequence/claim interpretation, the Examiner is interpreting the scope of claim 1 as the any 2 or more consecutive residues within sequence of SEQ ID NO: 1 (the claim recites “an amino acid sequence as shown in SEQ ID NO: 1). Therefore, the peptide can be any fragment having 2 or more residues within instant SEQ ID NO: 1. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of derivatives.
The specification is limited to the SEQ ID NO: 1 having the sequence IIENAVQ. The sequence listing has total of 13 sequences. However, none of the other sequences read on a fragment of instant SEQ ID NO: 1. Wei et al (Foods, 2019, 8, 390, pp. 1-15) teach a tripeptide sequence AVQ (see abstract). Wei et al do not teach that the tripeptide having the fragment of instant SEQ ID NO: 1 (i.e., AVQ) has immune activity. Wei et al teach that the tripeptide AVQ is an angiotensin converting enzyme (ACE) inhibitory peptide (see abstract). There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
U.S.C. 102
13. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
14. 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.
15. Claim(s) 1-2 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al (20th Annual Meeting of Chinese Institute of Food Science and Technology (CIFST), October 24-25, 2023, pp. 1-2, filed with IDS) as evidenced by Think USA Dairy, (October 25, 2023, pp. 1-3, enclosed) and as evidenced by ATCC catalog for RAW 264.7 (RAW 264.7 TIB-71, pp. 1-7, enclosed, accessed 7/14/2026).
16. Yang et al teach the peptide sequence that is 100% identical to instant SEQ ID NO: 1 (IIENAVQ) (see [214] and [215] abstracts), meeting the limitation of instant claims 1-2. Yang et al teach that the high immune activity were screened based on RAW 264.7 cell phagocytosis (see for example, line 3 of [214] abstract; line 7 of [215] abstract). Yang et al ([215] abstract) teach that the peptide IIENAVQ could specifically interact with TLR2 to activate the immune response, reduce the phosphorylation and degradation (see lines 8-10), meeting the limitation of instant claim 8. As evidenced by Think USA Dairy, the CIFST meeting was held on October 24-25, 2023. And as evidenced by ATCC, the RAW 264.7 is an adherent cell line isolated from a mouse tumor that was induced by Abelson murine leukemia virus. This cell line, with macrophage differentiation, can be used in oxidative stress, inflammatory and antibacterial activity studies (see p. 1). Since Yang et al teach the same peptide as instant SEQ ID NO: 1, the Yang reference anticipates instant claims 1-2 and 8.
ART OF INTEREST
17. UniProt Accession No. A0ABQ4NCT8 is a protein sequence isolated from Paenibacillus cisolokensis (see UniProt Accession No. A0ABQ4NCT8, pp. 1-4, enclosed). UniProt Accession No. A0ABQ4NCT8 teaches a 135 residue protein sequence comprising instant SEQ ID NO: 1 (see residues 15-21). This sequence data was updated on 10/8/2025, therefore, is not a prior art sequence. Additionally, UniProt does not teach that the isolated protein has an immune activity.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/14/2026
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