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 .
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-12, drawn to a method of preventing or treating infectious disease with a peptide and the species SEQ ID NO: 1, Acinetobacter baumannii and Candida albicans, and a method of treating infectious disease in the reply filed on 2/27/25 is acknowledged.
For clarity of the record, the Election/Restriction requirement asked Applicant to elect one microorganism species, either bacteria or fungus, and select a corresponding species (for example, if electing bacteria, select Acinetobacter baumannii or if electing fungus, select Candida albicans). In the response to Election/Restriction, Applicant elected both a bacteria and fungus and a corresponding species for each genus, as acknowledged above. Examiner accepts this election because, upon further search and examination, the elected species was broadened to include both Acinetobacter baumannii and Candida albicans.
Claim Status
Claims 1-12 are pending under examination. Claims 13-16 have been withdrawn by the Examiner as non-elected species.
Priority
The instant application claims priority to KR10-2022-0044711, filed on 4/11/22, and KR10-2022-0135153, filed on 10/19/22. The priority date of 4/11/22 is hereby acknowledged.
Information Disclosure Statement
The IDS filed on 2/27/25 is under consideration by the Examiner.
Drawings
The drawings are objected to because Figure 7 is missing the "F" of "Fig 7". See below:
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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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specifically, replace instances where “Octominin” is used in the specification with “SEQ ID NO: 1”, including in the Abstract.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specifically, replace instances where “Octominin” is used with “SEQ ID NO: 1” in either the Figures themselves or their corresponding legends.
Specification
The use of the terms Tween 80 ([0067]), Sartorius ([00123]), ThermoScientific ([000126] and [00151]), Malvern Panalytical ([00137]), Sigma-Aldrich ([00138], [00151], [00169], [00176]), Bio-Rad ([00151]), and Carl Zeiss ([00169]), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include proper symbols indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are 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 commercial marks.
Claim Objections
Claim 3 is objected to because of the following informality: As it is now, the claim recites “A method for inhibiting a biofilm, the method comprising a step of treating an antimicrobial peptide”. The claim instead should recite “A method for inhibiting a biofilm, the method comprising a step of treating an individual with an antimicrobial peptide”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-12 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.
Claims 1-12, either directly as independent claims or indirectly as dependent claims, recite the use of “SEQ ID NO: 1 or fragments thereof” in a method of treating microbial disease via inhibition of infection, biofilm formation, infectious disease, and bacteria or fungus. The instant specification discloses SEQ ID NO: 1 as the peptide GWLIRGAIHAGKAIHGLIHRRRH ([0043]). Within the context of the claim as a whole, a “fragment thereof,” without any other limitations or unique elements specified, would include any and all fragments SEQ ID NO: 1, including 1) fragments ranging from 1-23 amino acids in length and 2) the 19 naturally occurring amino acids occupying any position along the length of the sequence. The amount of possible fragments this entails substantially broadens the instant genus (i.e., for a 22 amino acid fragment of the instant SEQ ID NO: 1, wherein any of the 19 naturally-occurring amino acids could occupy any position within the 22-residue sequence, this would result in 1.36*1028 potential sequences (i.e., 19 potential amino acids at position 1, 19 amino acids at position 2, etc… to position 22)).
However, it is unclear and unknown whether such fragments would retain the structural, chemical, and/or physical properties required to be able to inhibit infection. Therefore, the instant specification does not provide adequate written description to possess the broad genus of SEQ ID NO: 1 or fragments thereof since the specification does not disclose a correlation between the necessary structure of the sequence – such as sequence, length, or other chemical or physical properties of said peptide fragments – and the claimed function to be maintained – treating infectious disease.
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, 5, and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims are drawn to methods of treating infectious disease through inhibition of infection, biofilms, and microorganism viability, comprising a step of treating an individual with an antimicrobial peptide consisting of an amino acid represented by SEQ ID NO: 1 or a fragment thereof. Although the claims are drawn to a method or process, which is a subject eligible category, they also recite a natural phenomenon, which is a judicial exception.
Claim 1 recites a method for inhibiting infection of an Acinetobacter sp. strain, the method comprising a step of treating an individual with an antimicrobial peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 or a fragment thereof. The instant SEQ ID NO: 1 is encompassed by the naturally occurring protein fragment chrysophsin-2, an antimicrobial peptide identified in the gills of red seam bream (Chrysophrys major, formerly Pagrus major; Iijima N, Tanimoto N, Emoto Y, Morita Y, Uematsu K, Murakami T, Nakai T. Purification and characterization of three isoforms of chrysophsin, a novel antimicrobial peptide in the gills of the red sea bream, Chrysophrys major. Eur J Biochem. 2003 Feb;270(4):675-86.). The differences between the instant SEQ ID NO: 1 and chrysophsin-2 include 1) two phenylalanine residues at the N-terminus, which are absent in the instant SEQ ID NO: 1, and 2) the presence of an amidated histidine, which is also absent in the instant SEQ ID NO: 1.
Claim 1 also specifies that the instant SEQ ID NO: 1 or fragments thereof are used in a method for inhibiting infection of an Acinetobacter sp. strain, the method comprising a step of treating an individual. Practicing such a method necessarily reads on red sea bream exposed to an Acinetobacter sp. strain in its natural habitat. The natural range and habitat of red sea bream spans the northeastern portion of the South China Sea and northward towards Japan, where they reside in the ocean from 10-50 meters deep as well as in reefs (Pagrus major, Temminck & Schlegel, 1843, Red seabream, archived 8/20/17). Acinetobacter sp. strains are found within coral reefs within the South China Sea (Cai, L., Tian, RM., Zhou, G. et al. Exploring coral microbiome assemblages in the South China Sea. Sci Rep 8, 2428 (2018).), specifically Acinetobacter johnsonii and guillauiae (Cai et al., Table S3). Red sea bream qualify as individuals per the instant specification, which discloses that “an individual” includes biological and non-biological objects (see [0052]). Consequently, this claim reads on red sea bream, which naturally possess the antimicrobial peptide chrysophsin-2 within their gills and reside in the South China Sea, filtering sea water through their gills as a way to practice inhibiting infection from Acinetobacter sp. strains within themselves.
Claim 3 recites a method for inhibiting a biofilm, the method comprising a step of treating an antimicrobial peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 or a fragment thereof. Acinetobacter johnsonii, identified by Cai et al. as a species of Acinetobacter found within the natural habitat of red sea bream, is capable of forming biofilms at surface-liquid interfaces (Martí S, Rodríguez-Baño J, Catel-Ferreira M, Jouenne T, Vila J, Seifert H, Dé E. Biofilm formation at the solid-liquid and air-liquid interfaces by Acinetobacter species. BMC Res Notes. 2011 Jan 11;4:5.). Thus, the instant claim 3 also reads on red sea bream filtering water from the South China Sea through their gills as a means to practice inhibiting biofilm formation from an Acinetobacter sp. strain. Dependent claim 5 further recites wherein the antimicrobial peptide SEQ ID NO: 1 or the fragment thereof has a biofilm formation inhibitory ability and biofilm eradication ability. Thus, claim 5 also reads on red sea bream filtering sea water through their gills as well.
Claim 6 recites a method for preventing or treating an infectious disease by an Acinetobacter sp. strain, the method comprising a step of treating an individual with an antimicrobial peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 or a fragment thereof. Again, this reads on the red sea bream filtering water through their gills in the South China Sea to prevent and treat Acinetobacter-induced infectious disease in themselves.
The judicial exceptions recited in claims 1, 3, 5, and 6 are all integrated into practical applications because there is a specific application of the method of treating an individual with the antimicrobial peptide SEQ ID NO: 1 or fragments thereof, namely, inhibition of infection, biofilm, or infectious disease caused by Acinetobacter sp. strain.
However, claims 1, 3, 5, and 6 do not include additional elements that amount to significantly more than the judicial exception. Again, claims 1, 3, 5, and 6 all read on red seam bream inhibiting infections, preventing the formation of biofilms, and treating infectious disease caused by Acinetobacter sp. strains simply by residing in their natural environment where Acinetobacter johnsonii can be found in coral reefs and filtering water through their gills that contain chrysophsin-2. As such, the claims do not contain additional elements that, when added to the judicial exception, sufficiently 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) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayathilaka et al. (Jayathilaka EHTT, Rajapaksha DC, Nikapitiya C, De Zoysa M, Whang I. Antimicrobial and Anti-Biofilm Peptide Octominin for Controlling Multidrug-Resistant Acinetobacter baumannii. Int J Mol Sci. 2021 May 19;22(10):5353.).
Jayathilaka teach that the antimicrobial peptide Octominin, the instant SEQ ID NO: 1, can be used to treat and improve infections caused by Acinetobacter baumannii (Abstract).
Jayathilaka et al. first demonstrate in vitro that Octominin (SEQ ID NO: 1) inhibits Acinetobacter baumannii growth and viability (Pg 3, “2.3 MIC and MBC of A. baumannii treated with Octominin” to “2.4 Time-kill kinetics and bacteria viability of A. baumannii upon Octominin treatment” and Figure 1). Next, Jayathilaka et al. demonstrate that zebrafish (an individual; per the instant specification, an individual is defined as a biological or non-biological object [0052]; an individual can also be a fish per the definition in [0061]) infected with Acinetobacter baumannii can be treated with Octominin (Pg 10, 2.11 "Efficiency of A. baumannii control by Octominin in a zebrafish model" and Figs. 8B and C). Zebrafish treated with 100µg of Octominin had a 54.1% relative percent survival at the end of the study, which was significantly higher than that of the PBS-treated (control) group, which had a rate of 16.6% (Fig. 8B). Additionally, the number of colony-forming units (CFUs) in both the spleen and kidney were reduced in the Octominin-treated group compared to those in the PBS-treated group (Fig. 8C). Further, the abdomen and gill area of the zebrafish displayed clinical signs of infection, observations that were supported by histological analysis demonstrating reduced inflammation and morphological changes in the gill, spleen and kidney of Octominin-treated zebrafish (Pgs 10-11 and Figures 8d-9). Collectively, this indicates that Octominin, or the instant SEQ ID NO: 1, functions as an antimicrobial peptide capable of inhibiting infection and treating infectious disease caused by of an Acinetobacter sp. strain, wherein the strain is Acinetobacter baumannii, thereby anticipating claims 1, 2, and 6.
Jayathilaka et al. further evaluate Acinetobacter baumannii biofilm formation inhibition and eradication upon treatment with Octominin (Pg 8, "2.9 Biofilm inhibition and biofilm eradication activities of Octominin," and Fig. 6A and B). As shown in Figure 6, Octominin is both capable of inhibiting biofilm formation (Fig. 6A) and eradicating biofilm (Fig. 6B) in a concentration-dependent manner. Therefore, Octominin, or the instant SEQ ID NO: 1, functions as an antimicrobial peptide with biofilm formation inhibitory and eradication ability that can inhibit formation and eradicate biofilms from Acinetobacter baumannii, thereby anticipating claims 3-5.
Thus, Jayathilaka et al. anticipate the aforementioned claims.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jayathilaka et al. (Jayathilaka EHTT, Rajapaksha DC, Nikapitiya C, De Zoysa M, Whang I. Antimicrobial and Anti-Biofilm Peptide Octominin for Controlling Multidrug-Resistant Acinetobacter baumannii. Int J Mol Sci. 2021 May 19;22(10):5353.), as applied to claims 1-6 above, and further in view of Piras et al. (Piras AM, Maisetta G, Sandreschi S, Gazzarri M, Bartoli C, Grassi L, Esin S, Chiellini F, Batoni G. Chitosan nanoparticles loaded with the antimicrobial peptide temporin B exert a long-term antibacterial activity in vitro against clinical isolates of Staphylococcus epidermidis. Front Microbiol. 2015 Apr 28;6:372.; cited on IDS filed 2/27/25).
The teachings of Jayathilaka et al. have been set forth above.
Jayathilaka et al. do not explicitly teach a method for inhibiting bacteria or fungi, inhibiting a biofilm, or treating an infectious disease caused by Acinetobacter baumannii, the method comprising a step of treating an individual using a nanoparticle in which an antibacterial peptide consisting of an amino acid sequence represented by SEQ ID NO: 1 is encapsulated with chitosan.
Piras et al. teach the generation chitosan nanoparticles (CS-NPs) loaded with the antimicrobial peptide AMP temporin B (TB or TB-CS-NPs when in chitosan nanoparticles; Abstract). Piras et al. note that while AMPs are potent drugs capable of treating a broad spectrum of microorganism infections, pharmaceutical development of AMPs has been hampered by their potential toxicity (Abstract). To circumvent this issue, Piras et al. tested the hypothesis that encapsulation of TB into CS-NPs could increase TB antibacterial activity while reducing its toxic potential. TB-CS-NPs were tested for their ability to inhibit Staphylococcus epidermis (Pg 3, “Bactericidal Assays”; Pgs 5-6; Figures 3 and 4). Piras et al. demonstrate that over time, TB-CS-NPs display effective antibacterial activity against multiple clinical isolates of Staphylococcus epidermidis (Figures 3 and 4).
Regarding claims 7-8 and 10-12, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the chitosan-nanoparticle compositions taught by Piras et al. in a method of inhibiting infectious disease caused by Acinetobacter baumannii as taught by Jayathilaka et al. One would be motivated to do so with a reasonable expectation of success as both references are drawn to treating infectious diseases caused by bacteria using antimicrobial peptides, and Piras et al. teach that the use of chitosan nanoparticles could increase antibacterial activity, while reducing toxic potential (see abstract). One of ordinary skill in the art would have recognized that applying the known technique of Piras et al. – namely, using a chitosan-nanoparticle composition to treat bacterial infections – would have yielded predictable results and resulted in an improvement of the technique from Jayathilaka et al. – namely, an improved ability to treat infections and infectious diseases caused the bacteria Acinetobacter baumannii (MPEP 2143).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jayathilaka et al. (Jayathilaka EHTT, Rajapaksha DC, Nikapitiya C, De Zoysa M, Whang I. Antimicrobial and Anti-Biofilm Peptide Octominin for Controlling Multidrug-Resistant Acinetobacter baumannii. Int J Mol Sci. 2021 May 19;22(10):5353.) and Piras et al. (Piras AM, Maisetta G, Sandreschi S, Gazzarri M, Bartoli C, Grassi L, Esin S, Chiellini F, Batoni G. Chitosan nanoparticles loaded with the antimicrobial peptide temporin B exert a long-term antibacterial activity in vitro against clinical isolates of Staphylococcus epidermidis. Front Microbiol. 2015 Apr 28;6:372.; cited on IDS filed 2/27/25), as applied to claims 1-8 and 10-12 above, and in further view of Nikapitiya et al (Nikapitiya C, Dananjaya SHS, Chandrarathna HPSU, De Zoysa M, Whang I. Octominin: A Novel Synthetic Anticandidal Peptide Derived from Defense Protein of Octopus minor. Mar Drugs. 2020 Jan 15;18(1):56.).
The teachings of Jayathilaka et al. and Piras et al. have been set forth above.
Jayathilaka et al. and Piras et al. do not explicitly teach a method for inhibiting bacteria or fungi, wherein the fungi is C. albicans.
Nikapitiya et al. teach that Octominin, or the instant SEQ ID NO: 1, can be used to inhibit fungi such as C. albicans (Abstract, Pgs 1-10, Figures 2-5).
Regarding claim 9, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Octominin encapsulated with chitosan nanoparticles to treat infectious disease caused by Candida albicans. One would be motivated to do so with a reasonable expectation of success as all references are drawn to methods of treating infectious diseases using antimicrobial peptides. It was known in the art that Octominin could treat and inhibit Candida albicans infections, as taught by Nikapitiya et al. Additionally, the teachings of Jayathilaka et al. and Piras et al. indicated that antimicrobial peptides encapsulated in chitosan-nanoparticles could effectively treat and inhibition infections and infectious diseases caused by other similar microorganisms. One of ordinary skill in the art would have recognized that applying the known technique of Nikapitiya et al. – namely, using Octominin to treat Candida albicans infections – would have yielded predictable results and resulted in an improvement of the technique from Jayathilaka et al. and Piras et al. – namely, an improved ability to treat a wider array of infections and infectious diseases using antimicrobial peptides encased in chitosan-nanoparticles (MPEP 2143).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 17/781669 (reference application) in view of Jayathilaka et al. (Jayathilaka EHTT, Rajapaksha DC, Nikapitiya C, De Zoysa M, Whang I. Antimicrobial and Anti-Biofilm Peptide Octominin for Controlling Multidrug-Resistant Acinetobacter baumannii. Int J Mol Sci. 2021 May 19;22(10):5353.). Although the claims at issue are not identical, they are not patentably distinct from each other because they claim overlapping subject matter.
Claim 1 of copending Application No. 17/781669 recites a method for preventing or treating inflammatory disease comprising administering a pharmaceutical composition containing, as an active ingredient, an antimicrobial peptide having five or more contiguous amino acid residues in the amino acid sequence of SEQ ID NO: 1: 1GWLIRGAIHAGKAIHGLIHRRRH23 (SEQ ID NO: 1) to a subject in need thereof. Dependent claim 4 recites the method of any one of claims 1 to 3, wherein the inflammatory disease is selected from the group consisting of atopy, psoriasis, arthritis, dermatitis, allergy, osteoarthritis, rhinitis, otitis media, sore throat, tonsillitis, periodontitis, gingivitis, inflammatory eye disease, cystitis, nephritis, rheumatoid arthritis, spondylitis, inflammatory bowel disease, hepatitis, sepsis, alcoholic liver disease, non-alcoholic fatty liver, various cancers, epilepsy, and disc degeneration.
Copending Application No. 17/781669 does not explicitly teach that the SEQ ID NO: 1 can be used to treat infectious disease caused by Acinetobacter baumannii.
As referenced above, Jayathilaka teaches that SEQ ID NO: 1 (Octominin) can be used to treat zebrafish (subject in need thereof). Examination of zebrafish after treatment indicates a reduction in the clinical signs of infection in the abdomen and gills, observations supported by histological analysis demonstrating reduced inflammation and morphological changes in the gill, spleen and kidney of Octominin-treated zebrafish (Pgs 10-11 and Figures 8d-9).
In view of these teachings, it would have been obvious to treat an individual with an inflammatory diseases with SEQ ID NO: 1 (Octominin). One of ordinary skill in the art prior to the effective filing date would have been motivated to do so in order to treat a wider array of diseases with a single therapeutic peptide, especially as it was known in the art that SEQ ID NO: 1 (Octominin) could treat infectious diseases and symptoms of infectious diseases, including inflammation. One of ordinary skill in the art would have had a reasonable expectation of success given that others such as Jayathilaka have treated inflammation associated with infectious disease with the same therapeutic peptide, SEQ ID NO: 1. Thus, the invention as a whole is prima facie obvious over the references.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/786152 (reference application) in view of Jayathilaka et al. (Jayathilaka EHTT, Rajapaksha DC, Nikapitiya C, De Zoysa M, Whang I. Antimicrobial and Anti-Biofilm Peptide Octominin for Controlling Multidrug-Resistant Acinetobacter baumannii. Int J Mol Sci. 2021 May 19;22(10):5353.). Although the claims at issue are not identical, they are not patentably distinct from each other because they claim overlapping subject matter.
Claim 1 recites an antiviral composition for fish viral diseases comprising a peptide having an amino acid sequence as set forth in SEQ ID NO: 1 as an active ingredient. Dependent claims 2 and 3 recite various viral species (viral hemorrhagic septicemia virus (VHSV), infectious hematopoietic necrosis virus (IHNV), and infectious pancreatic necrosis virus (IPNV)) and fish species (halibut, rockfish, red sea bream, rock bream, sea bass, gay mullet, bass, Gizzard shad, flounder, puffer fish, mackerel, greenling, tuna, croacker, yellowtail, horse, mackerel, salmon, rainbow trout, carp, leather carp, eel, catfish, loach, and crucian carp) that can be treated with the composition, respectively. Other embodiments of the invention include a composition for a fish feed additive having antiviral activity against fish diseases comprising a peptide having SEQ ID NO: 1 as the active ingredient (claim 4), wherein the virus species and fish species are those listed above (claims 5 and 7), and a method of preventing or treating a fish viral diseases, the method comprising administering to a fish a peptide having an amino acid sequence set forth in SEQ ID NO: 1 (claim 6), wherein the virus species and fish species are those listed above (claims 8 and 9).
Copending Application No. 18/786152 does not explicitly teach that the SEQ ID NO: 1 can be used to treat infectious disease caused by Acinetobacter baumannii.
As referenced above, Jayathilaka teaches that SEQ ID NO: 1 (Octominin) can be used to treat zebrafish (fish) infected with Acinetobacter baumannii. Examination of zebrafish after treatment indicates a reduction in the clinical signs of infection in the abdomen and gills, observations supported by histological analysis demonstrating reduced inflammation and morphological changes in the gill, spleen and kidney of Octominin-treated zebrafish (Pgs 10-11 and Figures 8d-9).
In view of these teachings, it would have been obvious to develop a composition and method thereof comprising SEQ ID NO: 1 (Octominin) as the active ingredient used to treat viral fish disease in several species of fish. One of ordinary skill in the art prior to the effective filing date would have been motivated to do so in order to treat a wider array of diseases with a single therapeutic peptide, especially as it was known in the art that SEQ ID NO: 1 (Octominin) could treat other microorganism-driven diseases. One of ordinary skill in the art would have had a reasonable expectation of success given that others such as Jayathilaka have treated infectious disease caused by other microorganisms, including Acinetobacter baumannii, previously with the same peptide therapy, SEQ ID NO: 1. Thus, the invention as a whole is prima facie obvious over the references.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SEKS/Examiner, Art Unit 1658 /Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658