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 .
Priority
This application is a 371 of PCT/KR2021/016051, filed on 11/05/2021, and claims foreign priority to KR10-2021-0011657 filed 01/27/2021. Applicant has claimed the effective filing date of 01/27/2021 based on KR10-2021-0011657 but no translation has been made of record.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/2024, 08/06/2024 and 07/03/2023, complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-11 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.
For claim 1, the claim limitation “a derivative thereof”, the embodiments of the instant specification discloses “derivative” as any one of amino acid sequences of SEQ ID NO: 5 to SEQ ID NO: 8, “in which some functional group(s) is/are added to the amino acid sequences of SEQ ID NO: 5 to SEQ ID NO: 8 or some amino acid sequence(S) is/are deleted, modified, substituted, or added but is not limited thereto” [0027]. Specifically, “derivative” is “any one or more selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 4” [0028]. The claim limitation “fragment thereof” as disclosed in the specification, is the partial sequence of a peptide having a specific sequence [0032]. Therefore, absent a clear definition for a partial sequence, an artisan of ordinary skill would be unable to ascertain the metes and bounds of the presently claimed invention with respect to the peptide composition.
For claim 2, which is dependent on claim 1, it is unclear as to what element the limitation “derivative thereof” is making reference to. In the instant case, it is unclear what fragment and partial sequence of SEQ ID 5-8 in claim 1 the limitation is making reference to. Here, the claim scope is not reasonably ascertainable by those skilled in the art.
Claims 3-11 are rejected because they are dependent upon the rejected claim and/or are indefinite in scope.
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)(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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hongmin, S et al., (WO2021247965; published 09/12/2021; claiming priority to 63/034,528 effectively filed 04/06/2020).
Hongmin, S et al., teaches antibacterial peptide inhibitors comprising a binding peptide linked to a cell wall-permeating peptide for treating bacterial infections. The sequence of the peptide inhibitors in Hongmin, S et al., matches 100% to the antimicrobial peptides in the instant claims.
Regarding claim 1, Hongmin, S et al., teaches an antibacterial peptide ([0024] line 3) that comprises a binding motif comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 4. SEQ ID NO: 1 is X1-X0-X2 -X3-X0-X0-X4-A-X0-X0-X0 wherein each X0 is any standard amino acid; Xi, X5, Xx and X14 are each independently selected from lysine (K), arginine (R) or histidine (H); X2 and X13 are each independently selected from tyrosine (Y) or phenylalanine (F); X3, Xe, and X10 are each independently selected from valine (V), leucine (L) or isoleucine (I); X4, X7, and Xu are each independently selected from valine (V), leucine (L), isoleucine (I), or alanine (A). Hongmin, S et al., teaches that binding motifs may be indirectly or directly connected with any cell wall-permeating peptides (CPP) known in the art to form an antibacterial peptide [0041].
With regard to claim limitations in claim 1, “fragment thereof” and “derivative thereof” in SEQ ID NO: 5 to SEQ ID NO: 8, Hongmin, S et al., specifically teaches antibacterial peptides of SEQ ID NO: 66 and SEQ ID NO: 75 (Table 3), that are formed from the binding motifs in combination with cell wall-permeating peptides. SEQ ID NO: 66 (KKLFKKILKYLKTYLAQAAATG) and SEQ ID NO: 75 (KKLFKKILKYLKTFVVRALAS) as taught by Hongmin, S et al., meet the limitations of the instant claim of matching SEQ ID NO: 5 to SEQ ID NO: 8 (see underlined sequence above).
Regarding claims 2, 3 and 4, Hongmin, S et al., teaches antimicrobial peptides wherein any one position selected from the group consisting of 1st, 2nd, 5th, 9th and 12th positions is substituted with a basic amino acid wherein the basic amino acid is lysine or arginine. In Table 2, SEQ ID NO: 21, SEQ ID NO: 16, SEQ ID NO: 13 and Table 3, SEQ ID NO: 66 and SEQ ID NO: 75 meet the claim limitations. Notably, SEQ ID NO: 66 (KKLFKKILKYLKTYLAQAAATG) and SEQ ID NO: 75 (KKLFKKILKYLKTFVVRALAS) is a 100% sequence match to SEQ ID NO: 1 in claim 4.
Regarding claim 5, Hongmin, S et al., teaches that antibacterial peptides can be used to decrease bacterial titer and/or bacterial infection [0069]. Target bacteria can be gram negative or gram-positive bacteria. For example, the bacteria can comprise Escherichia coli ATCC 35218 or Staphylococcus aureus [0074]. In Figure 2A, Hongmin, S et al., teaches that BP100-T61-25, which corresponds to SEQ ID NO: 66 [0085], markedly decreases Escherichia coli ATCC 35218 growth, compared to growth in the absence of the antimicrobial peptide.
Regarding claims 6 and 7, Hongmin, S et al., teaches that antibacterial peptides can be produced using known methods of protein engineering and recombinant DNA technology and variants generated according to general rules well known in the art [0057].
Regarding claim 8, the instant specification discloses, “carrier” as one that can support any substance or component and is exemplified by a composition, and may be used interchangeably with a carrying agent, an impregnating agent, or a mediator [0074]. Hongmin, S et al., teaches a composition comprising antibacterial peptide and a carrier and/or drug delivery agent [0058]. Hongmin, S et al., teaches a list of carriers [0062] that can be selected depending on the desired route of administration. Some examples of carriers include peanut oil, cottonseed oil, glycols such as propylene glycol, etc.
Regarding claim 9, Hongmin, S et al., teaches compositions containing one or more of the antibacterial peptides that are formulated for but not limited to (e.g., intravenous, intra-arterial, subcutaneous, rectal, subcutaneous, intramuscular, intraorbital, intracapsular, intraspinal, intraperitoneal, or intrasternal), topical (nasal, transdermal, intraocular), intravesical, intrathecal, enteral, pulmonary, intralymphatic, intracavital, vaginal, transurethral, intradermal, aural, intramammary, buccal, oral, orthotopic, intratracheal, intralesional, percutaneous, endoscopical, transmucosal, sublingual and intestinal administration [0060].
Regarding claim 10, the instant specification discloses “quasi-drug” as items with milder action than pharmaceuticals and may be prepared in formulations selected from the group consisting of body cleaners, foams, soaps, masks, ointments, creams, lotions, essences, and sprays, but is not limited thereto (page 19, line 10). Hongmin, S et al., teaches excipients such as cocoa butter, oils, perfuming agents, etc [0062], which can serve as pharmaceutically acceptable carriers in the compositions containing antimicrobial peptides.
Regarding claim 11, Hongmin, S et al., teaches pharmaceutical compositions [0060] containing one or more of the antibacterial peptides that can be formulated in any conventional manner according to the routes of administration. Routes of administration include topical delivery.
The disclosure of Hongmin, S et al., satisfies the claim limitations as recited in instant claims 1-11. Accordingly, the disclosure of Hongmin, S et al., anticipates instant claims 1-11.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18, 19, 22, 23, 24, 25, 26 (see claim listing filed on 07/02/2023) of copending Application No. 18/270,818 (reference application-1) and claims 27, 28, 29, 30, 31-42 (see claim listing filed on 05/22/2024) of copending Application No. 18/712,400 (reference application-2). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, copending Application No. 18/712,400, and copending Application No. 18/270,818 claim “a peptide consisting of any one of amino acid sequence of SEQ ID NO: 5 to SEQ ID NO: 8, a derivative thereof, or a fragment thereof”. See claim 27 in Application No. 18/712,400 and claims 18 and 19 in Application No. 18/270,818.
Regarding claim 2, copending Application No. 18/712,400, and copending Application No. 18/270,818 claim amino acid substitutions to any one position selected from the group consisting of positions 1, 2, 5, 6, 9 and 12 of SEQ ID NO: 5 to SEQ ID NO: 8 with another basic amino acid. See claim 28 in Application No. 18/712,400 and claim 22 in Application No. 18/270,818.
Regarding claim 3, copending Application No. 18/712,400, and copending Application No. 18/270,818 claim the basic amino acid is lysine or arginine. See claim 29 in Application No. 18/712,400 and claim 23 in Application No. 18/270,818.
Regarding claim 4, copending Application No. 18/712,400, and copending Application No. 18/270,818 claim the derivative is any one or more selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 4. See claim 30 in copending Application No. 18/712,400 and claim 24 in copending Application No. 18/270,818.
Regarding claim 5, copending Application No. 18/270,818 claims a bioactive material (see claim 18). The bioactive material in the specification is directed to a “composition including a skin-permeable peptide consisting of any one amino acid sequence of SEQ ID NO: 5 to SEQ ID NO: 8, a derivative thereof, or a fragment thereof (See ‘Technical Solution’ lines 13-16). The composition encompasses bacteriostats (page 21, line 25).
Regarding claim 5, copending Application No. 18/712,400 claims a ‘physiologically active substance’ (claim 27). The specification discloses ‘physiologically active substance’ comprising a composition for delivery of a physiologically active substance. (See ‘Technical Solution’ , paragraph 3). Composition, as disclosed in the specification, includes bacteriostatic agents.
Regarding claims 6 and 7, copending Application No. 18/712,400 claims SEQ ID NO: 5 to SEQ ID NO: 8, a derivative thereof, or a fragment thereof. See claim 28. The scope of the reference claim anticipates the instant claim since the generation of the peptides in SEQ ID NO: 5 to SEQ ID NO: 8 would require the polynucleotide sequence that would encode the said peptide sequences. See claim 24 in copending Application No. 18/270,818.
Regarding claim 8, copending Application No. 18/270,818 claims a carrier. See claim 26.
Regarding claims 9 -11, copending Application No. 18/270,818 claims a skin-permeable peptide. See claim 25. The specification of copending Application No. 18/270,818 discloses the skin-permeable peptide may be used as a pharmaceutical composition and a functional cosmetic composition that target skin tissues including mucous membranes. [See section ‘Advantageous Effects’, lines 28-31). Copending Application No. 18/270,818 refers to the composition for skin-permeation may be included in a pharmaceutical composition, quasi-drug composition or cosmetic composition, etc (Page 16, lines 18-20). Copending Application No. 18/712,400 refers to pharmaceutical compositions of the physiologically active substance (see claims 27-42). The specification defines ‘physiologically active substances’ consisting of any one of amino acid sequences of SEQ ID NO: 5 to SEQ ID NO: 8, a derivative thereof, or a fragment thereof. The pharmaceutical composition…consisting of amino acid sequences of SEQ ID NO: 5 to SEQ ID NO: 8, a derivative thereof, or a fragment thereof (See ‘Best mode for carrying out the invention’ paragraph 3).
The critical limitations, that is the peptide sequence, in all claims (1-11) are the same in the conflicting claims. The application depends on the inherent property of the peptide sequences. See MPEP § 2112. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See MPEP § 2001.06(b). The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. This may include providing the identification of pending or abandoned applications filed by at least one of the inventors or assigned to the same assignee as the current application that disclose similar subject matter that are not otherwise identified in the current application. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654