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 4/9/2026is acknowledged.
Claims 1-10 and 36-37 have been cancelled.
Claims 33-35 and 38-43 are pending in this application.
Information Disclosure Statement
5. It is noted that Applicants have not filed an information disclosure statementunder § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicants dutyto disclose all information known to be material to patentability.
Restriction
6. Applicant’s election without traverse of Group 2 (claims 33-43) and the election of SEQ ID NO: 1 as the Ubiquitin monomer sequence species, SEQ ID NO: 2 as the Ubiquitin monomer variant, SEQ ID NO: 3 as the Ankyrin-1 fragment species, and pharmaceutical agent as the species of additional agent in the reply filed on April 9, 2026 is acknowledged. Please note: the election of SEQ ID NO: 3 as “ankyrin-1 peptide” and “pharmaceutical agent” are not a species election. Instant SEQ ID NO: 3 is a full length Ankyrin-1 sequence isolated from Homo sapiens.
Restriction is deemed to be proper and is made FINAL in this office action. Claims 33-35 and 38-43 are examined on the merits in this office action.
Objections
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.
7. Claim 1 is objected to for the following reason: Claim 1 recites, “A method for stimulating of the immune system, characterized because it comprises administering to a subject a peptide composition…” The claim is wordy and appears to have grammatical errors. Applicant is recommended to amend the claim to recite, for example, “A method for stimulating immune system, the method comprises administering to a subject a peptide…”
Rejections
U.S.C. 112(b)
8. 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.
9. Claims 34, 39 and 42 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.
10. Claim 34 recites, “The method according to claim 33, wherein the immune system is depressed.” Claim 34 depends from claim 33. Claim 33 recites, “A method for stimulating of the immune system, characterized because…” It is unclear if claim 34 is reciting an end result or if the patient’s immune system is depressed.
11. Claim 39 recites the limitation "the average content" (lines 1-2) and “the peptide composition with immunomodulatory effects” (lines 2-3) in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 39 depends from claim 33. Claim 33 does not recite “an average content “ and “immunomodulatory effects”. Therefore, there is lack of antecedent basis.
12. Claim 42 recites the limitation “the human Ankyrin-1 protein” in the claim (see line 2). There is insufficient antecedent basis for this l imitation in the claim. Claim 42 depends from claim 40. Claim 40 recites, “…wherein the composition additionally comprises Ankyrin-1”. Claim 40 does not recite that the Ankyrin-1 is human. Therefore, there is lack of antecedent basis.
13. Claim 42 recites, “…wherein each peptide fragment of the human Ankyrin-1 protein corresponds to a fragment of the amino acid sequence of SEQ ID NO: 3.” It is unclear what fragments of SEQ ID NO: 3 are encompassed within “fragment of the amino acid sequence of SEQ ID NO: 3.” Instant SEQ ID NO: 3 is a 1881 residue protein sequence. A “fragment” can be any dipeptide (i.e., two amino acids) up to 1880 residue protein sequence. It is unclear what “fragments” will have the structure function relationship as being an “ankyrin-1” protein. Thus, the metes and bounds of the claim is unclear.
U.S.C. 112(d)
14. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
15. Claims 41-42 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
16. Claim 41 recites, “The method according to claim 40, wherein the composition further comprises from 0.644 to 0.924% (w/w) of at least one Ankyrin-1 fragment.” Claim 41 depends from claim 40. Claim 40 recites, “The method according to claim 33, wherein the composition additionally comprises one peptide fragment of Ankyrin-1.” Claim 41 recites, “at least one Ankyrin-1 fragment”. Therefore, claim 41 having more than 1 Ankyrin-1 fragment is broader than instant claim 40.
17. Claim 42 recites, “The method according to claim 40, wherein each peptide fragment of the human Ankyrin-1 protein corresponds to a fragment of the amino acid sequence of SEQ ID NO: 3.” Claim 42 depends from claim 40. Claim 40 recites, “The method according to claim 33, wherein the composition additionally comprises one peptide fragment of Ankyrin-1.” Therefore, claim 42 having “each peptide fragment” is broader than instant claim 40.
U.S.C. 112(a)
18. 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.
19. Claims 40-42 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 method for stimulating the immune system comprising administering to a subject a peptide composition comprising…wherein the composition additionally comprises one peptide fragment of Ankyrin-1…wherein each peptide fragment of the human Ankyrin-1 protein corresponds to a fragment of the amino acid sequence of SEQ ID NO: 3. The generic statements “wherein the composition additionally comprises one peptide fragment of Ankyrin-1 “ and “each peptide fragment of the human Ankyrin-1 protein corresponds to a fragment of the amino acid sequence of SEQ ID NO: 3” 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 claims 40-42 are broad generics with respect all possible compounds encompassed by the claims. Instant SEQ ID NO: 3 is a 1881 residue protein sequence. A fragment of instant SEQ ID NO: 3 can be any peptide that is two residues (dipeptide) up to 1880 residues within instant SEQ ID NO: 3. For example, a fragment of instant SEQ ID NO: 3 can be ANY dipeptide within instant SEQ ID NO: 3. Therefore, there are vast amounts of possibilities. 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 fragments. The specification does not define what residues of instant SEQ ID NO: 3 are required to maintain function and/or activity of “Ankyrin-1”..
The specification is instant SEQ ID NO: 3. The specification has not clearly defined what residues are required to maintain function/activity as being an Ankyrin-1 protein. Description of a full length Ankyrin-1 protein isolated from human for Ankyrin-1 protein is not sufficient to encompass numerous other fragments that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. 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
20. 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.
21. 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.
22. Claim(s) 33-35 and 38-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vallejo-Castillo et al (Frontiers of Pharmacology, October 7, 2020, 11: 1-17), as evidenced by P16157 (from UniProt, pp. 1-16, October 7, 2020 cited in Valleho-Castillo et al, Frontiers of Pharmacology, October 7, 2020, 11: 1-17).
23. Vallejo-Castillo et al teach that “Transferon Oral” is a peptide-derived product with immunomodulatory properties obtained from the lysis and dialysis of human buffy coat. Its active pharmaceutical ingredient, generically known as Dialyzable Leucocyte Extract, is a mixture of peptide populations…used as a therapeutic auxiliary in inflammatory diseases…The most abundant peptides were the monomeric human Ubiquitin (Ub) and an Ub variant which lacks the two-terminal Gly (Ub-GG). Recombinant Ub prevented murine death when ORO administered in a herpes infection murine model…the biological properties of “Transferon Oral” are partially associated to the Ub content. They suggest that Ub may activate its extracellular receptor (CXCR-4) in the stomach eliciting immunomodulatory effects via vagus nerve. (see abstract). Vallejo-Castillo et al teach
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900
860
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(see Figure 8), meeting the limitation of instant claims 33-35. Additionally, the ratio of Ub to Ub(-GG) is 2:1, this meets the limitation of instant claim 39. Vallejo-Castillo et al further teach that the monomeric Ub has 8564.5 Da (i.e., 8.56 kDa) and lacking to terminal glycine [Ub(-GG)] has 8450.5 Da (i.e., 8.45 kDa) (see p. 5, right column, bottom and p. 6, left column), meeting the limitation of instant claim 35. Vallejo-Castillo et al teach the following:
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748
1404
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(see Table 1), meeting the limitation of instant claims 38 and 40-41. Vallejo-Castillo et al teach ankyrin-1 fragments (see throughout the reference), meeting the limitation of instant claim 40. Because the Vallejo-Castillo et al teach all of the active method steps of instant claims, the reference anticipates instant claims 33-35 and 38-43.. As evidenced by UniProt P16157, instant SEQ ID NO: 3 is exactly the same as the Ankyrin-1 sequence of UniProt P16157. Additionally, UniProt P16157 teaches fragments of Ankyrin-1, see throughout the reference, meeting the limitation of instant claims 40-42.
Furthermore, since Transferon Oral has other peptides and peptide fragments in as the components (see Table 1), this anticipates instant claim 43.
Please note: claim 33 does not clearly define a patient population. The active method step recites, “administering to a subject a peptide composition”. Thus, any subject being administered the same peptide composition would have the same end result of “stimulating immune system”
Because Vallejo-Castillo et al teach all of the active method steps of instant claims, the reference anticipates instant claims 33-35 and 38-43.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
6/8/2026
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