DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-15 and 30, in the reply filed on 2/23/2026 is acknowledged. However, no arguments were set forth regarding Applicants traversal. 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 still deemed proper and is therefore made FINAL.
Applicant’s election of the species SEQ ID NO: 26 in the reply filed on 2/23/2026 is 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)).
Upon further search and examination, the species election was broadened to include SEQ ID NO: 29 and 33 in addition to the elected species of SEQ ID NO: 26.
Claim Status
Claims 1-15 and 26-30 are pending. Claims 26-29 are hereby withdrawn as a non-elected invention. Claims 4-6 and 8-15 are currently amended. Claims 26-30 are new.
Priority
The instant application is the 371 national stage entry of PCT/GB2021/052621, filed 10/11/2021, which claims priority to the foreign application GB2016022.2, 10/9/2020. The priority date of 10/9/2020 is acknowledged.
Information Disclosure Statement
The IDS submitted on 4/8/2023 is under consideration. Any strikethrough is owed to a lack of a copy of the document in the file wrapper.
Drawings
The drawings are objected to because Figure 12e is a color photograph shown in grayscale. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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:
1. 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.
See Abstract; Pg 2, line 9; Pg 8, lines 2 and 16; Pg 27, line 6; and Tables 1-4.
2. 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.
See Figures 1 and 10; SEQ ID NO’s can be included in either the Drawings themselves or in the Brief Description of the Drawings.
3. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 incorporation-by-reference paragraph, 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Pg 22, four different weblinks). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www, or other browser-executable code. See MPEP § 608.01.
The use of the terms SYTOX (Pg 14, line 22; Pg 18, line 28; Pg 19, lines 1, 4, 8; Pg 32 line 13); Sartorius (Pg 19, line 18; Pg 21, line 17); and Slide-A-Lyzer (Pg 20, lines 9-10), 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 a proper symbol 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
Claims 1, 2 and 9 are objected to because of the following informalities: The claims list an amino acid sequence with 4 or more specifically defined and enumerated residues and therefore requires a SEQ ID NO. However, no SEQ ID NO is listed in the claims. See MPEP 2422 and 37 C.F.R. 1.821. Appropriate correction is required.
Claim Interpretation
Claims 10, 14, and 15 each recite functional features of the claimed peptides rather than structural elements. As such, the claim is being interpreted based upon the structural limitation (a peptide comprising the motif GLLxLLxLLLxAAG), where the functional limitation is a property endowed by the structure.
Claim Rejections - 35 USC § 112
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.
Claims 10, 12, and 14 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.
Regarding claim 10, the claim recites that the one or more peptides are neutral or anionic. The scope of this claim is indefinite because it is unclear what conditions (i.e., pH, temperature, etc.) are required for the one or more peptides to be neutral or anionic.
Regarding claim 12, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “a diameter of from about 1-200nm”, and the claim also recites “about 5-100nm”, “about 10-50nm” or “about 20nm” which are narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 14, the claim recites that the one or more peptides form an alpha helical assembly. The scope of this claim is indefinite because it is unclear what conditions (i.e., solvent, temperature, etc.) are required that would result in the formation of an alpha helical assembly.
Claim Rejections - 35 USC § 103
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 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, 3, 8-15, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018165655 A1, published 9/13/2018; cited on IDS filed 4/8/2023 and ISR) in view of Gao et al. (Nanoparticle-based local antimicrobial drug delivery. Adv Drug Deliv Rev. 2018 Mar 1;127:46-57.).
Chen teaches rationally designed pore forming membrane-active, antimicrobial peptides (AMPs; Abstract). Chen teaches the peptide SEQ ID NO: 3, which consists of the sequence GLLDLLKLLLKAAG ([0009]; Sequence Listing). This meets the limitations of claim 1, wherein the peptide has a motif GLLxLLxLLLxAAG and the first x is D, the second x is K and the third x is K; SEQ ID NO: 3 of Chen corresponds to the instant SEQ ID NO: 33.
Chen also teaches the peptide SEQ ID NO: 4, which consists of the sequence GLLDLLHLLLKAAG ([0009]; Sequence Listing). This meets the limitations of claim 1, wherein the peptide has the motif GLLxLLxLLLxAAG and the first x is D, the second x is H, and the third x is K; SEQ ID NO: 4 of Chen corresponds to the instant SEQ ID NO: 29.
Chen does not teach a nanoparticle comprising the above peptides.
Gao teaches that local antimicrobial treatment has gained increasing attention owing to its benefit of minimizing systemic drug exposure and potentially reducing resistance development. While local antimicrobial delivery still faces many obstacles, nanoparticle drug delivery has significantly impacted medicine and healthcare. Nanoparticle delivery systems enhance drug solubility, offer stealth for immune evasion, modulate drug release characteristics, target drug molecules to desired sites, and delivery multiple drugs simultaneously. Additionally, several nanoparticle-based drug delivery systems have been approved for clinical use and many are under various stages of pre-clinical and clinical testing (Pg 2, “1. Introduction,” first and second paragraphs).
In summary, Chen teaches AMPs consisting of the motif GLLxLLxLLLxAAG, and Gao teaches nanoparticles can improve local delivery of antimicrobial agents. Based on these teachings, regarding claim 1, it would be prima facie obvious to incorporate the AMPs taught by Chen into nanoparticles. One skilled in the art would be motivated to do so in order to take advantage of the benefits described by Gao. One would have a reasonable expectation of success as Gao teaches that nanoparticle delivery is a viable means to delivery antimicrobial agents to treat infections.
Regarding claim 3, as described above, Chen teaches both the instant SEQ ID NO: 29 and 33 ([0009; Sequence Listing).
Regarding claim 8, as described above, the AMPs taught by Chen are 13 amino acids in length ([0009; Sequence Listing).
Regarding claim 9, as described above, the peptides taught by Chen consist of GLLxLLxLLLxAAG ([0009; Sequence Listing).
Regarding claim 10, Chen teaches the instant SEQ ID NO: 29 and 33. The instant specification indicates that these peptides are neutral or anionic (Pg 29, lines 1-2).
Regarding claim 11, Chen teaches that the amino acids of the peptides can be in the L form ([0055]).
Regarding claim 12, Gao teaches small gold nanoparticles approximately 30 nm in diameter (Pg 10, first paragraph).
Regarding claim 13, Gao teaches PLGA-PEG nanoparticles (Pg 4, second paragraph; Figure 3).
Regarding claim 14, Chen teaches the AMPs are helical membrane-active peptides that form an alpha helical assembly (Figures 2-4 and [0019-0021]).
Regarding claim 15, as described above, Chen teaches that the AMPs are pore forming (Abstract).
Regarding claim 30, Chen teaches the addition of a C-terminal Trp (W) residue to AMPs ([0009]; Sequence Listing).
Claim(s) 1-15 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018165655 A1, published 9/13/2018; cited on IDS filed 4/8/2023 and ISR) and Gao et al. (Nanoparticle-based local antimicrobial drug delivery. Adv Drug Deliv Rev. 2018 Mar 1;127:46-57.), as applied to claims 1, 3, 8-15, and 30 above, and further in view of Summerton (US20060193775A1, published 8/31/2006).
The teachings of Chen and Gao have been set forth above. Chen and Gao do not teach a nanoparticle comprising a peptide with the motif GLLxLLELLLxAAG.
Summerton teaches embedder peptides and compositions thereof for detecting and killing cells in acidic areas of tumors (Abstract). Embedder peptides are designed such that at about pH 7.2 and above, the peptide is poly-anionic, soluble in aqueous solutions, and repels from negatively charged cell surfaces of normal cells; at a lower pH present in acidic areas of tumors, ranging from about pH 6-7, the embedder peptide converts to a largely non-ionic lipophilic form which is effective to embed into cell membranes ([0051]).
Compositionally, embedder peptides are composed of two types of amino acids: one type with a lipophilic side chain and another with a carboxylic acid side chain. Leucine is generally the preferred lipophilic amino acid based on its ease of assembly into peptides, commercial availability, and cost. Amino acids having a carboxylic acid side chain should be glutamic acid but not aspartic acid ([0060-0063]).
Summerton further teaches certain specific separations between two carboxylic acid side chains of a peptide existing in an alpha helical conformation; in aqueous solution under mildly acidic conditions, the two carboxylic acids can cooperatively deionize and form a non-ionic double-H-bonded acid pair structure which serves to mask the polar sites of the two carboxylic acids. Such carboxylic acid pairs are designated as “acid pairs” ([0064]). An “acid pair” is a pair of side chain carboxylic acids in a peptide sequence with 0-3 amino acids intervening in the peptide backbone between the side chains of the pair, and which under acidic conditions the carboxylic of the acid pair form a double-hydrogen-bonded carboxylic acid pair structure when the peptide is in an alpha helical conformation ([0047]). When a suitable number of such acid pairs are present and properly positioned along the peptide backbone, then in combination with intervening amino acids having appropriate lipophilic side chains, on acidification the resultant peptide can undergo a surprisingly sharp transition to a non-ionic lipophilic form at a pH up to about 2 pH units higher than the pH where typical carboxylic acids of peptides transition between their anionic and free-acid forms. It is the hydrogen-bond-mediated masking of the polarity of carboxylic acid moieties in these acid pairs which is essential for generating sufficient lipophilicity for entry of embedder peptides into membranes at a pH present or achievable in acidic areas of tumors. Because of constraints imposed by the structure of a peptide in its alpha helical form, such pairs of acids can only form three specific acid pair types, one of which is EXXE (where X is an amino acid other than glycine or proline), with two amino acids intervene in the peptide backbone between the carboxylic acid side chains forming the acid pair. The intervening amino acids must be lipophilic, and ELLE is a suitable acid pair for an embedder peptide ([0064]).
In summary, Chen and Gao teach a nanoparticle comprising an AMP consisting of the sequence GLLxLLxLLLxAAG, wherein the first x is D, the second x is H or K, and the third x is K. Summerton teaches embedder peptides that comprise the motif ELLE, which can facilitate peptide embedding into the plasma membrane in a more acidic tumor microenvironment. Based on these teachings, regarding claim 2, it would be prima facie obvious to substitute the D and H/K residues at the first and second x positions, respectively, in the motif taught by Chen and Gao with E residues as taught by Summerton, thereby arriving at the elected SEQ ID NO: 26. One skilled in the art would be motivated to do so in order to improve the ability of the AMP to engage the plasma membrane of cancerous cells. One would have a reasonable expectation of success as Summerton established that this motif could be used to improve the ability of similar helical peptides to embed into the membrane of cancerous cells.
Regarding claims 4-7, as stated above, Chen, Gao, and Summerton teach the elected SEQ ID NO: 26.
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, 3, 9-15, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,059,855 B2 in view of Gao et al. (Nanoparticle-based local antimicrobial drug delivery. Adv Drug Deliv Rev. 2018 Mar 1;127:46-57.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘855 recites a pore-forming, membrane-active peptide comprising the amino acid sequence GLLDLLKLLLKAAG (SEQ ID NO: 3), GLLDLLHLLLKAAGW-AMIDE (SEQ ID NO: 4), GLADLAKLLLKLLGW-AMIDE (SEQ ID NO: 5), GLLDLLKLLLKLAGW-AMIDE (SEQ ID NO: 6), GLDDLAKLLLKLAGW-AMIDE (SEQ ID NO: 7), GLDDLLKALLKAAGW-AMIDE (SEQ ID NO: 8), GLLDDAKLLAKLAGW-AMIDE (SEQ ID NO: 9), GLLDLPKALAKALGW-AMIDE (SEQ ID NO: 10), GLADAAKLLLKAAGW-AMIDE (SEQ ID NO: 11), or GLLDAAKLLAKAAGW-AMIDE (SEQ ID NO: 12), or a fusion polypeptide comprising an amino acid sequence of any of the above peptides. SEQ ID NO: 3 of US ‘855 is identical to the instant SEQ ID NO: 33, and SEQ ID NO: 4 comprises the instant SEQ ID NO 29.
The additional independent and dependent claims include additional species of the peptides (claims 2 and 3).
US ‘855 does not each a nanoparticle comprising the claimed peptides.
Gao teaches that local antimicrobial treatment has gained increasing attention owing to its benefit of minimizing systemic drug exposure and potentially reducing resistance development. Nanoparticle delivery systems enhance drug solubility, offer stealth for immune evasion, modulate drug release characteristics, target drug molecules to desired sites, and delivery multiple drugs simultaneously. Additionally, several nanoparticle-based drug delivery systems have been approved for clinical use and many are under various stages of pre-clinical and clinical testing (Pg 2, “1. Introduction,” first and second paragraphs).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Gao into US ‘855, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Gao teaches using nanoparticles to deliver antimicrobial agents. Thus, the claims are obvious in view of US ‘855.
Claims 1-15 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-30 and 33 of copending Application No. 17/767,859 (‘859 reference application; claim set filed 1/5/2026) in view of Gao et al. (Nanoparticle-based local antimicrobial drug delivery. Adv Drug Deliv Rev. 2018 Mar 1;127:46-57.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 18 of copending Application No. ‘859 recites a peptide having a sequence comprising the motif GLLxLLELLLxAAG (SEQ ID NO: 39), wherein each x is independently selected from arginine (R), histidine (H), lysine (K), aspartic acid (D), or glutamic acid (E). Claim 19 of copending Application No. '859 recites a peptide having a sequence comprising the motif GLLxLLxLLLxAAG (SEQ ID NO: 38), wherein each x is independently selected from arginine (R), histidine (H), lysine (K), aspartic acid (D), or glutamic acid (E) and wherein the sequence does not comprise SEQ ID NO: 29 or SEQ ID NO: 33. SEQ ID NO: 38 and SEQ ID NO: 39 of copending Application No. ‘859 are identical to the sequences recited in the instant claims 2 and 1, respectively.
Dependent claims further include species of the peptide, which are identical to the sequences in the instant claims (claims 20-22, 24), the motif further comprises a tryptophan (W) at the C-terminus (claim 23), the peptide is in the L form (claim 25), the peptide forms an alpha helical assembly (claim 26), the peptide forms a pore in the cancer cell membrane (claim 27), a kit comprising thereof (claims 28-30), and a pharmaceutically acceptable composition comprising thereof (claim 33).
Copending Application No. ‘859 does not each a nanoparticle comprising the claimed peptides.
Gao teaches that local antimicrobial treatment has gained increasing attention owing to its benefit of minimizing drug systemic exposure and potentially reducing resistance development. Nanoparticle delivery systems enhance drug solubility, offer stealth for immune evasion, modulate drug release characteristics, target drug molecules to desired sites, and delivery multiple drugs simultaneously. Additionally, several nanoparticle-based drug delivery systems have been approved for clinical use and many are under various stages of pre-clinical and clinical testing (Pg 2, “1. Introduction,” first and second paragraphs).
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Gao into copending Application No. ‘859, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Gao teaches using nanoparticles to deliver antimicrobial agents. Thus, the claims are obvious in view of copending Application No. ‘859.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art Cited but not Referenced
The NPL Chen et al., as cited in the IDS filed 4/8/2023, also discloses the instant SEQ ID NO: 33.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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