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 April 13, 2026 is acknowledged.
Claims 1-9 are pending in this application.
Priority
Applicant claims foreign priority to JP 2021-050468 (03/24/2021). 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 priority date is March 24, 2022, until the foreign priority dates are perfected.
Restriction
Applicant's election with traverse of Group 1 and the election of SEQ ID NO: 1 as the species of the peptide sequence and food as the species of a type of composition in the reply filed on April 13, 2026 is acknowledged. The traversal is on the ground(s) that the species and groups of claims 1-9 all use the elected sequence. The products and compositions are highly related and should be examined together. This is found persuasive. The restriction requirement is hereby withdrawn.
Claims 1-9 are examined on the merits in this office action.
Sequence non-compliance
This application is sequence non-compliant because the amino acid sequences disclosed on paragraph [0004] of US 20240158440 are not associated with a sequence identifiers (a SEQ ID NO) and are not listed in the sequence listing. All sequences longer than four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422 and Notice to Comply.
Objections
The TITLE is objected to for the following: The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 [0004], [0017], [0022]-[0024], [0046], [0050], [0118], [0128]-[0129], [0131], [0132]-[0136], [0138]-[0139], [0142]-[0143], [0150]-[0152], [0154], [0156]-[0159] of instant specification US 2024/0158440 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).
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.
Claim 1 is objected to for the following: The preamble of claim 1 recites, “A peptide having the amino acid sequence of (a) or (b) below:” However, the body of the claim recites, “
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”. There is inconsistency with the preamble and the body of the claim. Because claims 2-9 depend from claim 1, these claims are also objected to.
Rejections
35 U.S.C. 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.
Claims 1-9 are 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 1 recites, “
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”. The metes and bounds of the claim is unclear. The preamble of the claim recites, “A peptide having (a) or (b)” and the body of the claim recites, “(a) and (b)”. Therefore, it is unclear if both peptide sequences are involved or either (a) or (b) is involved. Additionally, it is unclear the metes and bounds of the recitation “…one or several amino acids are substituted, deleted or added in the amino acid sequence of SEQ ID NO: 1.” It is unclear what peptide sequences are encompassed within “one or several amino acids are substituted, deleted…in the amino acid sequence of SEQ ID NO: 1”. Instant SEQ ID NO: 1 is a 6 residue peptide sequence. It is unclear what peptide sequences are encompassed within “one or several amino acids are substituted, deleted…” Claim 1(b) implies that ALL residues of instant SEQ ID NO: 1 (6 residues) can be deleted and/or substituted. Because claims 2-9 depend from indefinite claim 1 and do not clarify the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
Claims 6-9 recite, “A composition containing the peptide according to claim 1 as an active ingredient” (see claim 6) and “The composition according to claim 8 which is used for treating, preventing and/or improving depression…” (see claim 9). It is unclear what peptides of claim 1(b) are encompassed within the composition as an active ingredient. The structure/function relationship is not clearly defined by the recitation of “an amino acid sequence in which one or several amino acids are substituted, deleted or added in the amino acid sequence of SEQ ID NO: 1”. The metes and bounds of the claims are unclear. It is unclear what peptides are encompassed in the claims to have the same function to treat, prevent and/or improve the diseases and disorders recited in the claims. The specification has not clearly defined what peptides are encompassed within “an amino acid sequence in which one or several amino acids are substituted, deleted or added in the amino acid sequence of SEQ ID NO: 1”.
35 U.S.C. 112(a)
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.
Claims 1-9 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 peptide having the amino acid sequence (a) or (b)…(b) an amino acid sequence in which one or several amino acids are substituted, deleted or added in the amino acid sequence of SEQ ID NO: 1, and composition comprising the same. The generic statements an amino acid sequence in which one or several amino acids are substituted, deleted or added in the amino acid sequence of SEQ ID NO: 1 do 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. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form amide bonds. 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. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules, and other synthetic peptide or peptide-like molecule that can form amide bonds.
The specification is limited to only SEQ ID NO: 1. Instant SEQ ID NO: 1 is a hexapeptide sequence with a defined residues (NLPPLT). The working example describes instant SEQ ID NO: 1 only. The specification does not describe any other peptide sequences, as well as which amino acids are required to maintain the function of instant claims 2-5 and 9. Description of SEQ ID NO: 1 is not sufficient to encompass numerous other peptides belong to the same genus. For example, there are varying lengths (deletion and addition of one or several amino acids), varying amino acid compositions, and numerous distinct qualities that make up the genus. For example, Yampolsky et al (Genetics, August 2005, 170: 1459-1472) teach that even a single conservative amino acid substitution can have an affect to the activity of the peptide (see Table 3, for example). 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.
35 U.S.C. 102
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.
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) 1-6 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carr et al (US 2019/0346442).
Carr et al teach a peptide having the sequence GENLPPLTY (see SEQ ID NO: 21012). This sequence comprises 100% sequence identity of instant SEQ ID NO: 1 (see residues 3-8 of SEQ ID NO: 21012), meeting the limitation of instant claim 1. Carr et al teach a composition comprising the peptide (see for example, paragraphs [0004], [0037]-[0038] and so forth), meeting the limitation of instant claims 8-9. In regards to instant claims 2-5, the claims recite an inherent properties of the instant SEQ ID NO: 1. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
In regards to instant claim 9, the claim recites an intended use. With respect to the limitation “used for treating, preventing and/or improving…” in instant claim 9, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
Since the reference teaches ALL of the active components, i.e., instant SEQ ID NO: 1, the reference anticipates instant claims 1-6 and 8-9.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto et al (JP 2001136995, filed with IDS, Google patent English translation used and enclosed in the previous office action).
Yamamoto et al teach a hexapeptide sequence PPLTQT (see paragraph [0013]). Instant SEQ ID NO: 1 has the sequence NLPPLT. Yamamoto et al teach a peptide sequence that has the 2 N-terminal residues NL of instant SEQ ID NO: 1 deleted, and dipeptide QT added at the C-terminal end. This meets the limitation of instant claim 1(b). Yamamoto et al teach food or pharmaceutical materials, and may be used as a liquid, powder, granule, dairy products such as yogurt and dairy beverages, general foods and drinks, foods for specified health use, health foods, pharmaceuticals (see for example, paragraph [0033]), meeting the limitation of instant claims 6-9.
In regards to instant claims 2-5, the claims recite an inherent properties of the instant SEQ ID NO: 1. The MPEP § 2112 states: “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning tending to show inherency, the burden shifts to the Applicant to show an unobvious difference ‘[t]he PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)).”
In regards to instant claim 9, the claim recites an intended use. With respect to the limitation “used for treating, preventing and/or improving…” in instant claim 9, an intended use limitation does not impart patentability to product claims where the product is otherwise anticipated by the prior art.
Since the reference teaches ALL of the active components, i.e., an amino acid sequence in which one or several amino acids are substituted, deleted, or added to the amino acid sequence of SEQ ID NO: 1, the reference anticipates instant claims 1-9.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
4/27/2026
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