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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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
Applicant's arguments filed 9/18/2025 have been fully considered but they are not persuasive.
Priority
In the previous action, it was noted that there is a lack of support for peptides SEQ ID NO: 20, 8, 9, 11, and 19 within EP19192689.8, so the priority date had been set at 8/14/2020. This position is maintained. EP19192689.8 discloses SEQ ID NO: 1-5 and provides general teachings of modifications of SEQ ID NO: 1-5 without providing any specific examples (see Pg 9-10, “therapeutically effective variant” paragraph). Although the Examiner acknowledges that SEQ ID NO: 20, 9, and 19, are encompassed by SEQ ID NO: 3, EP19192689.8 provides no specific teachings or motivations that would lead one to assume that those fragments derived from SEQ ID NO: 3 would be desirable to isolate, have in a composition, or be useful in methods of promoting muscle growth or limiting muscle atrophy. Similarly, SEQ ID NO: 8 is most similar to SEQ ID NO: 1 set forth in EP19192689.8 but, again, the general teachings of substituting some amino acids for others, without specific details regarding the types of substitutions, the locations of the substitutions, etc., ultimately means that SEQ ID NO: 8 is not taught by EP19192689.8. There is also no support for SEQ ID NO: 11, which comprises SEQ ID NO: 3 and another N-terminal amino acid segment with unclear origins.
Further, applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Applicant’s election without traverse of Group I, claim(s) 1-7 and 12-14, drawn to isolated peptides, their variants, and compositions comprising the same and the species election by full sequence of the peptide SEQ ID NO: 3 in the reply filed on 1/30/2025 is acknowledged.
In the previous action, it was noted that the elected species was broadened to include SEQ ID NO: 20 along with previously elected SEQ ID NO: 3.
In this current action, the elected species have been broadened to include SEQ ID NO: 9 and 19.
Claim Status
Claims 1-3 and 7-21 are pending. Claims 8-11 and 15 are withdrawn. Claims 1-3 and 12-14 are currently amended. Claims 4-6 have been cancelled. Claims 16-21 are new.
Priority
The instant application is the 371 of PCT/EP2020/072937, filed 8/14/2020, which claims foreign priority to EP19192689.8 with a filing date of 8/20/2019.
In the previous action, it was noted that there is a lack of support for peptides SEQ ID NO: 20, 8, 9, 11, and 19 within EP19192689.8, so the priority date had been set at 8/14/2020.
EP19192689.8 does provide support for SEQ ID NO: 3. Thus, the priority date for
the current claim set is set at 8/20/2019 for SEQ ID NO: 3 in claims 1-2, 7, 12-13, and 16-21 and 8/14/2020 for SEQ ID NO: 9 and 19 in claims 3, 14, 18, and 21.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 13, line 25). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities: Both claims recite a sequence having 1 to 3 amino acid alterations that can be selected from insertions or additions. The claim is objected to because an addition can include an insertion, and, therefore, reciting both is redundant. Appropriate correction is required.
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, 7, 12-14, and 16-21 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 peptides, which are compositions of matter.
Regarding 2a), the peptide claimed is a product of nature.
The claims above recite the following peptides, which read on the following natural products:
SEQ ID NO: 3:
Legumin (UniProt ID Q43674_VICFA)
Legumin B (UniProt IDs A0A392P037_9FABA, A0A392N2Z5_9FABA, A0A2K3MUH9_TRIPR, A0A2K3MUE0_TRIPR)
Legumin type B (UniProt IDs A0AAV1A036_VICFA, A0AAV1A1Q2_VICFA, A0AAV0ZYS1_VICFA, A0AAV0ZY58_VICFA, and LEGB4_VICFA)
Others not listed here
SEQ ID NO: 3 with 3 amino acid alterations:
Extension-like protein (UniProt ID Q9M3S8_ARATH)
C2H2-type domain-containing protein (UniProt ID A0A165FXF0_9APHY)
DUF1583 domain-containing protein (UniProt ID A0A517VZ61_9PLAN)
Others not listed here
SEQ ID NO: 3 with 2 amino acid alterations:
Legumin storage protein 2 (UniProt ID B5U8K1_LOTJA)
Legumin storage protein 3 (UniProt ID B5U8K2_LOTJA)
Peptide/nickel transport system permease protein (UniProt ID A0A1X7G7H4_9BACL)
Other not listed here
SEQ ID NO: 3 with 1 amino acid alteration:
Minor legumin (UniProt ID Q41035_PEA)
Legumin type B (UniProt ID Q41703_VICSA)
Cupin type-1 domain containing protein (UniProt ID A0A9D5A4B1_PEA, A0A9D4W410_PEA, A0A9D5A2F4_PEA, and A0A9D4W585_PEA)
Others not listed here
SEQ ID NO: 9:
Legumin (UniProt ID Q43674_VICFA)
Gp14 (UniProt ID K9K981_9CAUD)
Os12g0141400 protein (UniProt ID A0A0P0Y745_ORYSJ)
Others not listed here
SEQ ID NO: 19:
Legumin (UniProt ID Q43674_VICFA)
Legumin B (UniProt ID A0A392P037_9FABA)
Legumin type B (UniProt ID A0AAV1A036_VICFA)
Others not listed here
Of note, the modified SEQ ID NO: 3 described above have only taken into consideration 1-3 amino acid substitutions relative to SEQ ID NO: 3. Other alterations, such as additions or deletions, have the potential to also read on natural products.
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 the above peptide into a practical application. At most, the claims recite the peptides in a composition or as a comestible powder (claims 1 and 7, respectively) but without significantly more. As such, they 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.
Claim Rejections - 35 USC § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7, 12, 13, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wong et al. (US 2008/0305212 A1, published 12/11/2008).
Wong teaches protein hydrolysate compositions, processes of making, and food products generally comprising polypeptide fragments (Abstract). Wong teaches SEQ ID NO: 77, which is 13 residues in length, and shown below aligned to the instant SEQ ID NO: 3:
PNG
media_image1.png
176
628
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Greyscale
Thus, Wong anticipates claims 1, 2, 12, 13, 16, and 19.
Wong also teaches that the protein hydrolysate can be derived from plants powders, including soy, maize, barley, potato, rice, white, egg, and milk ([0029, 0035, 0036]). Thus, Wong also anticipates claim 7.
Claim(s) 1, 2, 12, 13, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kern et al. (US 2018/0340933 A1, published 11/29/2018).
Kern teaches soybean allergy related epitopes (Title, Abstract). Kern teaches SEQ ID NO: 558, which is 15 residues in length, and shown below aligned to the instant SEQ ID NO: 3:
PNG
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178
632
media_image2.png
Greyscale
Thus, Kern anticipates claims 1, 2, 12, 13, 16, and 19.
Conclusion
No claim is allowed.
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