DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Responses to Election/Restriction filed on 8/7/2025, 10/9/2025 and 12/11/2025 are acknowledged.
4. Claim filed on 8/7/2025 is acknowledged.
5. Claims 3, 4, 12-15 and 23 have been cancelled.
6. Claims 1, 2, 5-11 and 16-22 are pending in this application.
7. Claims 18 and 19 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 5, 6, 11 and 22 are withdrawn from consideration as being drawn to non-elected species.
8. Claims 1, 2, 7-10, 16, 17, 20 and 21 are under examination.
Election/Restrictions
9. Applicant’s election of Group 1 (claims 1, 2, 5-11, 16, 17 and 20-22) and election of SEQ ID NO: 2 as species of peptide; a pharmaceutical composition comprising SEQ ID NO: 2 and tobramycin as species of pharmaceutical composition; and P.aeruginosa infection as species of bacterial infection in the replies filed on 8/7/2025, 10/9/2025 and 12/11/2025 are acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is made FINAL in this office action.
Group 1 is drawn to a peptide comprising amino acid sequence having at least 52% sequence identity to SEQ ID NO: 1, wherein said amino acid sequence comprises one or more of the following substitutions relative to SEQ ID NO: 1: i. K7R ii. K8R iii. K14R iv. K18R; a pharmaceutical composition comprising such peptide; and a peptide comprising amino acid sequence selected from SEQ ID NO: 2 or SEQ ID NO: 3 or SEQ ID NO: 4. A search was conducted on the elected species; and SEQ ID NO: 2 as the elected species of peptide and pharmaceutical composition comprising SEQ ID NO: 2 and tobramycin as the elected species of pharmaceutical composition appear to be free of prior art. However, prior art was found for P.aeruginosa infection as the elected species of bacterial infection. A search was extended to the genus in claims 1, 9 and 16; and the genus in claim 9 appears to be free of prior art. However, prior art was found for the genus in claims 1 and 16. Claims 5, 6, 11 and 22 are withdrawn from consideration as being drawn to non-elected species. Claims 1, 2, 7-10, 16, 17, 20 and 21 are examined on the merits in this office action.
Sequence Non-Compliance
10. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, instant specification discloses the peptide GWGSFFRRAA HAGRHAGRAALTHYL-NH2 on page 20, line 20 of instant specification. However, this peptide is not disclosed in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
11. The specification is objected to for the following minor informality: The specification discloses the peptide GWGSFFRRAAHAGRHAGRAALTHYL-NH2 on page 20, line 20 of instant specification. However, this peptide is not disclosed in the filed sequence listing; and it is missing the sequence identifier. Furthermore, the peptides disclosed in the Table on page 63 of instant specification miss their respective sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
12. The specification is objected to for the following minor informality: The peptides of SEQ ID NOs: 1 and 4-23 disclosed in Table P (page 9) and Table V (page 11) of the specification are inconsistent with the peptides of SEQ ID NOs: 1 and 4-23 in the sequence listing filed on 6/2/2022. None of the peptides of SEQ ID NOs: 1 and 4-23 in the sequence listing filed on 6/2/2022 has the C-terminal modification; and the amino acid sequences of SEQ ID NO: 4 in the sequence listing filed on 6/2/2022 is not the same as the peptide of SEQ ID NO: 4 recited in Table P of the instant specification.
13. The specification is objected to for the following minor informality: In the instant case, it appears to the Examiner the instant specification is a combination of multiple scientific publications. First, Applicant is required to amend the specification to a proper specification for US application based on the guidelines as set forth in MPEP § 601 I regarding “Arrangement and Contents of the Specification”. As an example, the “Acknowledgments” section on page 58 of instant specification should be deleted. Second, below is a list of various issues that have been noticed throughout the specification:
(a) The use of trademarks has been noted in this application, for example, Locilex® on page 2, line 17; and many others throughout instant specification. Each letter of the trademarks should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
(b) The specification recites many hyperlinks and/or other forms of browser-executable code throughout the specification, for example, www.rcsb.org on page 55, line 1 of instant specification. The embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. It is suggested that Applicant places a URL between these symbols “< >” to inactivate the hyperlinks.
(c) The specification recites various supplemental figures throughout pages 39-49 of instant specification. However, none of these figures are presented in instant drawings.
(d) The specifications recites 2 different Table 1 on pages 62-63 and 68-69 of instant specification.
(e) The quality of the table on page 69 of instant specification is extremely poor.
Applicant is required to address all these issues in response to this office action.
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 (see MPEP § 608.01).
14. The drawings are objected to for the following minor informality:
First, Applicant is required to amend the brief description of the drawings on pages 66-67 of instant specification based on the guidelines as set forth in MPEP § 608.01(f). As an example, “Figure 1 shows graphs and plots” is not a proper description of instant Figure 1.
Second, Applicant is suggested to renumber the figures in numerical order. For example, amend “Figure P1” as “Figure 6”.
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.
15. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A peptide comprising the amino acid sequence that is at least 52% identical to the amino acid sequence of SEQ ID NO: 1, wherein said amino acid sequence comprises one or more of the following substitutions relative to SEQ ID NO: 1: i) K7R, ii) K8R, iii) K14R, or iv) K18R”.
16. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…i) K7R; ii) K8R; iii) K14R; and iv) K18R”.
Furthermore, claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
17. Claim 7 is objected to for the following minor informality: Applicant is suggested to amend claim 7 as “…wherein said peptide comprises the amino acid sequence that is at least 76% identical to the amino acid sequence of SEQ ID NO: 1”.
18. Claim 9 is objected to for the following minor informality: Applicant is suggested to amend claim 9 as “A peptide comprising the amino acid sequence selected from SEQ ID NO: 2, 3 or 4”.
19. Claim 20 is objected to for the following minor informality: Applicant is suggested to amend claim 20 as “…wherein said antibiotic agent is one or more selected from the group consisting of colistin, tobramycin and rifampin”.
20. Claim 21 is objected to for the following minor informality: Claim 21 contains the acronyms “P.aeruginosa” and “A. baumannii”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, Pseudomonas aeruginosa (P.aeruginosa). The abbreviations can be used thereafter.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
21. 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.
22. Claims 9 and 21 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 pre-AIA the applicant regards as the invention.
23. Claim 9 recites “SEQ ID NO: 4”. However, the instant specification discloses peptide of instant SEQ ID NO: 4 with two different amino acid sequences, GWGSFF RRAAHVGRHVGRAALTHYL-NH2 on page 9, Table P and GWGSFFRRAAHAGRHAG RAALTHYL on page 17, line 29 of instant specification. Therefore, it is unclear what the amino acid sequence of instant SEQ ID NO: 4 recited in instant claim 9 is. Thus, the metes and bounds of instant claim 9 is vague and indefinite.
24. Claim 21 recites “The pharmaceutical composition according to claim 17, wherein the bacterial infection is P.aeruginosa infection or A. baumannii infection, suitably P.aeruginosa infection”. First, the limitation “bacterial infection” is not recited in instant claim 17. Therefore, there is insufficient antecedent basis for this limitation in the claim. It is not clear to what the said phrase is referring. Second, with regard to the recitation “suitably P.aeruginosa infection”, it is unclear whether such recitation further limits the bacterial infection to P.aeruginosa infection only. In the instant case, it appears such recitation is a preferred embodiment. Taken all these together, the metes and bounds of instant claim 21 is vague and indefinite.
Claim Rejections - 35 U.S.C. § 102(a)(1)
25. 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.
26. Claims 1, 7, 8 10 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou (CN 105968179 A, pages 1-18, filed with IDS).
The instant claims 1, 7, 8 10 and 16 are drawn to a peptide comprising amino acid sequence having at least 52% sequence identity to SEQ ID NO: 1, wherein said amino acid sequence comprises one or more of the following substitutions relative to SEQ ID NO: 1: i. K7R ii. K8R iii. K14R iv. K18R; and a pharmaceutical composition comprising such peptide.
Hou, throughout the patent, teaches a pleurocidin mutant consisting of the amino acid sequence GWGSFFKRAAHVGKHVGKAARTHYLN (SEQ ID NO: 1); and a composition comprising such pleurocidin mutant for the prevention and treatment of aquatic animal diseases, for example, page 3, paragraph [0009]; page 6, paragraph [0031]; and SEQ ID NO: 1 on page 9. The pleurocidin mutant of SEQ ID NO: 1 in Hou is 26 amino acids in length and comprises the amino acid sequence that is 92% identical to the amino acid sequence of instant SEQ ID NO: 1 with K8R and L21R substitutions. It meets the limitations of instant claims 1, 7, 8 10 and 16.
Since the reference teaches all the limitations of instant claims 1, 7, 8 10 and 16; the reference anticipates instant claims 1, 7, 8 10 and 16.
Claim Rejections - 35 U.S.C. § 103
27. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
28. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
29. Claims 1, 7, 8, 10, 16, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hou (CN 105968179 A, pages 1-18, filed with IDS) in view of Amos et al (Sci. Rep., 2016, 6, pages 1-13, filed with IDS) and Bulitta et al (Antimicrob Agents Chemother, 2015, 59, pages 2315-2327).
The instant claims 1, 7, 8, 10, 16, 17, 20 and 21 are drawn to a peptide comprising amino acid sequence having at least 52% sequence identity to SEQ ID NO: 1, wherein said amino acid sequence comprises one or more of the following substitutions relative to SEQ ID NO: 1: i. K7R ii. K8R iii. K14R iv. K18R; and a pharmaceutical composition comprising such peptide.
Hou, throughout the patent, teaches a pleurocidin mutant consisting of the amino acid sequence GWGSFFKRAAHVGKHVGKAARTHYLN (SEQ ID NO: 1), wherein the pleurocidin mutant exhibits enhanced antibacterial activity; and a composition comprising such pleurocidin mutant for the prevention and treatment of aquatic animal diseases, for example, page 2, paragraph [0006]; page 3, paragraph [0009]; page 6, paragraph [0031]; and SEQ ID NO: 1 on page 9. The pleurocidin mutant of SEQ ID NO: 1 in Hou is 26 amino acids in length and comprises the amino acid sequence that is 92% identical to the amino acid sequence of instant SEQ ID NO: 1 with K8R and L21R substitutions. It meets the limitations of instant claims 1, 7, 8 10 and 16.
The difference between the reference and instant claims 1, 7, 8, 10, 16, 17, 20 and 21 is that the reference does not teach P.aeruginosa infection as the elected species of bacterial infection; and the limitations of instant claims 17, 20 and 21.
However, Amos et al teach pleurocidin as an AMP for treating P.aeruginosa infection, for example, page 9, the 1st paragraph in Section “Discussion”.
In addition, Bulitta et al, throughout the literature, teach tobramycin as an antibiotic agent for treating P.aeruginosa infection, for example, Title; and Abstract.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Hou, Amos et al and Bulitta et al to develop a pleurocidin mutant consisting of the amino acid sequence GWGSFFKRAAHVGKHVGKAARTHYLN; and a pharmaceutical composition comprising such pleurocidin mutant and tobramycin for treating P.aeruginosa infection. It reads on P.aeruginosa infection as the elected species of bacterial infection.
One of ordinary skilled in the art would have been motivated to combine the teachings of Hou, Amos et al and Bulitta et al to develop a pleurocidin mutant consisting of the amino acid sequence GWGSFFKRAAHVGKHVGKAARTHYLN; and a pharmaceutical composition comprising such pleurocidin mutant and tobramycin for treating P.aeruginosa infection, because Amos et al teach pleurocidin as an AMP for treating P.aeruginosa infection. Bulitta et al, throughout the literature, teach tobramycin as an antibiotic agent for treating P.aeruginosa infection. Furthermore, the MPEP states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose...” (see MPEP § 2144.06 I).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Hou, Amos et al and Bulitta et al to develop a pleurocidin mutant consisting of the amino acid sequence GWGSFFKRAAHVGKHVG KAARTHYLN; and a pharmaceutical composition comprising such pleurocidin mutant and tobramycin for treating P.aeruginosa infection.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658