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 November 4, 2025 is acknowledged.
New claim 10 has been added.
Claims 1-10 are pending in this application.
Priority
5. Applicant claims foreign priority to JP 2020-096288 (06/02/2020). 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 06/01/2021 until the foreign priority date is perfected.
Restriction
6. Applicant’s election without traverse of the second peptide VPAF (SEQ ID NO: 1) as the species of the peptide and 4 residues as the number of the residues in the reply filed on November 4, 2025 is acknowledged. The restriction is deemed to be proper and is made FINAL in this office action. The elected species, SEQ ID NO: 1 has been searched and a prior art was found. Claims 3-5 are withdrawn from further consideration as being drawn to nonelected species. Claims 1-2 and 6-10 are examined on the merits in this office action.
Objections
7. The drawings are objected to because the sequence identifiers are missing from the drawings (see Figs. 1 and 3-7). 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.
8. The specification is objected to for 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, Tables 5 and 7-11 of instant specification US 2023/0151057 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.
Rejections
U.S.C. 112(d)
9. 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.
10. Claim 10 is 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.
11. Claim 10 recites, “The lactic acid bacteria growth promoter according to claim 1, wherein the second peptide comprises at least one peptide having…VAPF…IPIQ (SEQ ID NO: 10)…and VPVG (SEQ ID NO: 12).” Claim 10 depends from claim 1. Claim 1 recites, “…a second peptide having a total number of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3.” The peptides recited in instant claim 10 is a tetrapeptide. Therefore, 4/9 is 0.44444, less than the 2/3 (i.e., 0.666666). Thus, claim 10 does not further limit instant claim 1. Additionally, the amino acid gln (Q) is not a hydrophobic amino acid. As evidenced by ThermoFisher Scientific (https://www.thermofisher.com/us/en/home/life-science/protein-biology/protein-biology-learning-center/protein-biology-resource-library/pierce-protein-methods/amino-acid-physical-properties.html, pp. 1-2, enclosed), the amino acid Q is a hydrophilic amino acid. Therefore, the tetrapeptide IPIQ (SEQ ID NO: 10) does not further limit instant claim 1.
U.S.C. 112(b)
12. 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.
13. Claim 10 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.
14. Claim 10 recites the limitation " the second peptide comprises at least one peptide having…VAPF (SEQ ID NO: 1)…IPIQ (SEQ ID NO: 10)…and VPVG (SEQ ID NO: 12)" in the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 10 depends from claim 1. Claim 1 recites, “…a second peptide having a total number of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3.” Claim 10 depends from claim 1. Claim 1 recites, “…a second peptide having a total number of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3.” The peptides recited in instant claim 10 is a tetrapeptide. Therefore, 4/9 is 0.44444, less than the 2/3 (i.e., 0.666666). Thus, the peptides recited in claim 10 lacks antecedent basis.
15. Claim 10 recites, “the second peptide comprises at least one peptide having…VAPF (SEQ ID NO: 1)…IPIQ (SEQ ID NO: 10)…and VPVG (SEQ ID NO: 12)." It is unclear how the tetrapeptide IPIQ is a second peptide having a total of residues of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3, wherein the amino acid Q is not a hydrophobic amino acid. As evidenced by ThermoFisher Scientific (https://www.thermofisher.com/us/en/home/life-science/protein-biology/protein-biology-learning-center/protein-biology-resource-library/pierce-protein-methods/amino-acid-physical-properties.html, pp. 1-2, enclosed), the amino acid Q is a hydrophilic amino acid. Therefore, it is unclear how the tetrapeptide IPIQ (SEQ ID NO: 10) comprising the amino acid Q is counted as a hydrophobic amino acid.
U.S.C. 112(a)
16. 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.
17. Claims 1-2 and 6-10 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 lactic acid bacteria growth promoter comprising at least one peptide selected from the group consisting of…a second peptide having a total number of residues of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3. The generic statement a second peptide having a total number of residues of not more than 9, wherein the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3 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. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form amide bonds, and make up the class of peptides. 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 different peptide sequence other than the ones provided. 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 SEQ ID NOs: 1-15. Example 1 describes the peptides effect on the growth promoting effect on Lactobacillus gasseri. Example 2 describes the peptides effect on the growth promoting effect on Lactobacillus acidophilus. Example 3 describes the peptides effect on the growth promoting effect on Lactobacillus amylovorus. Example 4 describes the peptides effect on the growth promoting effect on Lactobacillus curvatus. Example 5 describes the peptides effect on the growth promoting effect on Lactobacillus plantarum. Example 6 describes the peptides effect on the growth promoting effect on Lactobacillus brevis. The specification does not describe any other peptides having hydrophobic and proline residue peptides having not more than 9 residues, such as synthetic peptide or peptide-like molecule that can form peptide bonds. Description of SEQ ID NOs: 1-15 is not sufficient to encompass numerous other peptides that belong to the same genus. For example, there are varying lengths (up to 9), varying amino acid compositions, and numerous distinct qualities that make up the genus. For example, the unpredictability of the effect of amino acid substitution on the function and/or property of peptide is further confirmed and discussed in Yampolsky et al (Genetics, 2005, 170: 1459-1472). Yampolsky et al teach even conservative substitution can significantly affect the function of the protein/peptide, for example, page 1465, Table 3. 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.
New Matter Rejection
18. Claim 10 is rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contain 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(s), at the time of the application was filed, had possession of the claimed invention.
The claims are drawn to a process for restricting migration of migratory cells on a substrate. The claim in question recite a “VAPF (SEQ ID NO: 1)”.
Lack of Ipsis Verbis Support
19. The specification is void of any literal support for the “VAPF (SEQ ID NO: 1)” claimed. The SEQ ID NO: 1 in the sequence listing has the sequence VPAF (val-pro-ala-phe)
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.
Lack of Implicit or Inherent Support
20. “While there is not in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” See MPEP 2163. Thus support can be furnished implicitly or inherently for a specifically claimed limitation. However, the specification lacks any implicit or inherent support for the claimed “VAPF (SEQ ID NO: 1)”. As explained above, there is no support for any concept of “VAPF (SEQ ID NO: 1)” in the specification. The SEQ ID NO: 1 in the sequence listing has the sequence VPAF. Therefore, the VAPF (SEQ ID NO: 1) recited in the new claim 1 is a new matter.
U.S.C. 102
21. 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.
22. 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.
23. Claim(s) 1-2, 6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scholler et al (US Patent No. 10968269).
24. Scholler et al teach a peptide comprising instant SEQ ID NO: 1 (see SEQ ID NO: 31995, residues 1-4)
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. Scholler et al teach that the peptide at the C-terminal end is a Gly, which is a hydrophobic residue. The SEQ ID NO: 31995 is a 8mer residue peptide sequence, and the hydrophobic residue V, A, F, V, G, L, G and the proline residues are not less than 2/3, not less than 3/4 and composed of hydrophobic and proline residues, meeting the limitation of instant claims 1-2, 6 and 8-9. Since the SEQ ID NO: 31995 comprises instant SEQ ID NO: 1 (VAPF), this meets the limitation of instant claims 1-2, 6 and 8-10. Additionally, since Scholler et al teach a peptide comprising instant SEQ ID NO: 1, the peptide would inherently have all of the activity and properties of 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)).” Since the reference teaches ALL of the active components, the reference anticipates instant claims 1-2, 6 and 8-10.
25. Claims 1-2 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imperiali et al (JACS, 1992, 114: 3182-3188).
26. Imperiali et al teach a tetrapeptide Ac-Val-Pro-D-Ala-Phe-NH2 (see p. 3184, left column, top, and Table 1), meeting the limitation of instant SEQ ID NO: 1 and claims 1-2 and 6-10. Since the SEQ ID NO: 31995 comprises instant SEQ ID NO: 1 (VAPF), this meets the limitation of instant claims 1-2, 6 and 8-10. Since Imperiali et al teach a peptide of instant SEQ ID NO: 1, the peptide would inherently have all of the activity and properties of 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)).” Since the reference teaches ALL of the active components, the reference anticipates instant claims 1-2 and 6-10.
27. Claims 1-2, 6 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem (https://pubchem/ncbi.nlm.nih.gov/compound/Cys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH2, created date is 11/19/2009, pp. 1-9 enclosed).
28. Pubchem teaches the peptide sequence CYIQNCPLG-NH2 (see page 1). The peptide sequence in the PubChem is a 9 residue peptide having a glycine at the C-terminus and comprises hydrophobic residues C, Y, I, L, G and the residue P (see bold type above). Seven (7) residues out of 9 residues implies that 7/9 = 0.777778, meeting the limitation of instant claims 1-2, 6 and 8-9. Since PubChem teaches a peptide comprising no more than 9 residues comprising the ratio of the total number of hydrophobic amino acid residues and proline residues to the total number of residues is not less than 2/3, the peptide would inherently have all of the activity and properties of instant claim 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)).” Since the reference teaches ALL of the active components, the reference anticipates instant claims 1-2, 6 and 8-9.
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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/JULIE HA/Primary Examiner, Art Unit 1654
12/30/2025