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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
Applicant’s position is that 1) Le Tourneau only relates to administration of anticancer molecules or agents and not the instant SEQ ID NO: 1 and, therefore, cannot render obvious the dose ranges claimed and 2) the combined references do not teach the specific time periods recited in claims 94 and 95, therefore, arriving at these timed periods based upon the cited references would require improper hindsight.
Regarding 1), per MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.).
In the instant case, the claims are drawn to a method of treating a bacterial infection comprising a biofilm in a subject wherein the biofilm is formed on a prosthetic joint implanted in the subject, the joint is exposed through proximal incising, and the joint is irrigated in vivo with a pharmaceutical composition comprising the instant SEQ ID NO: 1 and a pharmaceutically acceptable buffering agent. The claims are rendered obvious by prior art per the teachings of Krebs, Mandell, and Phadke. The only difference between the method claimed and the method taught by Krebs, Mandell, and Phadke is the claimed concentration range of about 1-10mg/mL. Le Tourneau remedies this by teaching that determining the dose or concentration of drug administered to an individual receiving treatment involves the consideration of many factors, such as, for instance, preclinical data, current disease-specific standard treatments, the expected control arm if a combination of drugs under evaluation may be benchmarked by future randomized trials, and/or empiricism (Pg 715, “Designs for trials of combinations of agents, second paragraph). In other words, Le Tourneau teaches that administering the appropriate dosage or concentration of a given drug to an individual or subject requires routine optimization. Although Le Tourneau focuses on anticancer drugs, optimization of the appropriate dosage of any given therapeutic, as taught by Le Tourneau, still applies to the instant application.
Regarding 2), in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, Krebs teaches the practitioner will irrigate the infected implants to ensure all the affected surfaces are covered with the irrigation fluid, confirming all surfaces, even the hard-to-reach surfaces, receive a minimum amount of debridement (irrigation; [0015]). Krebs further teaches developing an irrigation plan to guaranteed all surfaces of the prosthetic implant are irrigated, which includes factors such as range, speed and pressure of the irrigation tool. The pre-determined plan may be customized by a surgeon based on the actual characteristics of the patient's anatomy and on the infection state of the implant and/or surrounding tissues [(0055)].
Effectively, Krebs teaches routine optimization of irrigating a prosthetic joint to ensure the joint receives a minimum amount of debridement; therefore, through routine optimization, the time periods as claimed in claims 94 and 95 are obvious. As the prior art (Krebs) teaches routine optimization of this claimed limitation, the claim rejections under 35 U.S.C. 103 do not rely on improper hindsight.
Collectively, the arguments set forth in 1) and 2) above are insufficient to overcome the outstanding obviousness rejection, which has been maintained/modified herein.
Consequently, the double patenting rejections have also been modified/maintained herein.
Claim Status
Claims 81, 93-100, and 103-111 are pending and previously presented. Claim 112 is currently amended. Claims 1-80 and 82-92 were previously canceled.
Priority
The present application, filed 9/11/2020 is a National Stage entry of PCT/US2019/022115. PCT/US2019/022115 has an International Filing Date of 3/13/2019 and claims priority from Provisional Application 62/642,393 that was filed on 3/13/2018. The priority date o 3/13/2018 is acknowledged.
New - 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 - 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.
The file size must be listed in bytes, not kilobytes.
Maintained/Modified - 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.
Claims 81, 94-99, 103, and 105-112 are rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al. (US 2019/0216559A1; effectively filed 1/27/18) in view of Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages), Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293), and Le Tourneau et al. (Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20.).
Krebs teaches treating an implanted prosthetic device, such as a knee joint replacement or a hip joint replacement, by debriding the infected prosthesis and the surrounding tissue, such as by irrigation ([0014]). Krebs teaches that once implanted into the patient, a prosthetic device may become infected where a biofilm may infect the prosthetic implant by adhering to its surface. Krebs teaches that in the case of an early infection, the prosthetic implant does not necessarily have to be removed. Instead, a thorough debridement of the infected implant and surrounding tissue can be performed by, for example, irrigating the area using an irrigation fluid such as bactericidal solutions, nanoparticle solutions, biofilm inhibiting agents, and/or antibiotics, using an ultrasonic debridement tool, and/or using irradiation. Krebs teaches that the irrigation and debridement should penetrate and destroy, for example, biofilms adhered to the surface of the prosthetic implant, thereby disinfecting the implant ([0003]). Krebs further teaches that the surgeon makes incisions such that the practitioners can access the infected implant ([0018]).
Krebs does not teach 1) proximal incising of the subject to expose the prosthetic joint prior to irrigation of the prosthetic joint in vivo while the prosthetic joint is implanted, 2) the irrigation fluid comprises a polypeptide of sequence SEQ ID NO: 1 and a buffering agent, nor 3) the concentration of SEQ ID NO: 1 in the composition is between 1mg/mL to 10mg/mL.
Mandell teaches that the most common organism in surgical site infection and periprosthetic join infection is Staphylococcus aureus (Introduction, 1st paragraph). Mandell teaches the cationic amphipathic peptide WLBU2 can effective treat S. aureus biofilms formed by a variety of clinical MSSA and MRSA strains, and in a surgical implant infection animal model, WLBU2 decreased biofilm mass. Mandell teaches WLBU2 has sufficient efficacy in vivo with minimal systemic toxicity (Abstract).
Phadke teaches that the peptide WLBU2 is 100% identical to the instant SEQ ID NO: 1 (Figure 1). Phadke et al. also teach that WLBU2 is effective against S. aureus in phosphate buffered saline (disodium hydrogen phosphate; Table 2 and page 1291, first column, first paragraph).
Le Tourneau teaches dosage optimization of drugs or new combinations of drugs in phase I clinical trials for cancer (Title, Abstract). Le Tourneau explains that in rule-based phase I trials of drug combinations, the dose level of each drug may be based on several factors such as preclinical data, current disease-specific standard treatments, the expected control arm if a combination of drugs under evaluation may be benchmarked by future randomized trials, and/or empiricism (Pg 715, “Designs for trials of combinations of agents, second paragraph). All of these decisions impact the recommended schedules and dosages, which can determine the success or failure of a trial.
Thus, regarding claims 81 and 110-112, Krebs teaches a method of treating a prosthetic joint infected with a biofilm through irrigation with antibacterial compositions. Although Krebs does not explicitly teach proximal incising of the subject to expose the prosthetic joint prior to irrigation of the prosthetic joint in vivo while it is implanted, it would have been obvious to do so. One ordinary skill in the art would have recognized that in order to access the infected joint one would necessarily have to incise in close location, or proximal, to the joint in order to access it for debridement and irrigation.
Further, Mandell teaches that the cationic amphipathic peptide WLBU2 can effectively treat S. aureus biofilms formed in vivo. Phadke teaches that WLBU2, which is the same peptide as the instant SEQ ID NO: 1, can effectively treat S. aureus in phosphate buffered saline. Thus, it would be prima facie obvious to irrigate the infected prosthetic joint with a composition comprising WLBU2 (the instant SEQ ID NO: 1) in phosphate buffered saline in order to effectively target S. aureus biofilms. One skilled in the art would have a reasonable expectation of success as Mandell and Phadke established that WLBU2 is effective at treating S. aureus biofilms in buffer compositions in vivo.
Finally, although Krebs, Mandell, and Phadke do not explicitly teach the dosages claimed, it would have been prima facie obvious to one of ordinary skill in the art because Le Tourneau recognized that therapeutic dosages depends on a number of factors, as described above. Thus, it would have been obvious to optimize the dosages as claimed in order to effectively treat the infected prosthetic joint (MPEP 2144.05(II)).
Regarding claims 94-96, Krebs, Mandell, Phadke, and Le Tourneau do not explicitly teach that the irrigation last for at least 15 or at least 30 minutes, resulting in the biofilm being partially disrupted or destroyed, nor that the irrigation is performed at least 2 times. However, Krebs teaches the practitioner will irrigate the infected implants to ensure all the affected surfaces are covered with the irrigation fluid, confirming all surfaces, even the hard-to-reach surfaces, receive a minimum amount of debridement (irrigation; [0015]). Krebs further teaches developing an irrigation plan to guaranteed all surfaces of the prosthetic implant are irrigated, which includes factors such as range, speed and pressure of the irrigation tool. The pre-determined plan may be customized by a surgeon based on the actual characteristics of the patient's anatomy and on the infection state of the implant and/or surrounding tissues [(0055)]. Thus, although Krebs, Mandell, Phadke, and Le Tourneau do not explicitly teach the irrigation last for at least 15 minutes or at least 30 minutes, resulting in the biofilm being partially disrupted or destroyed, nor irrigating at least 2 times, it would have been obvious to one of ordinary skill because Krebs recognizes that the amount of irrigation required to treat a prosthetic joint is based on characteristics of the patient’s anatomy and infection state of the implant. Thus, it would have been obvious to optimize the speed of irrigation and, thus, the time spend irrigating to in order to achieve the desired coverage and debridement of the implant surface.
Regarding claims 97-99, Krebs teaches the procedure for irrigating is applicable to hip implants, knee implants, and shoulder implants ([0043)]).
Regarding claim 103, as stated above, Phadke teaches that WLBU2 is effective against S. aureus in a composition comprising disodium hydrogen phosphate (Table 2 and page 1291, first column, first paragraph).
Regarding claim 105, Mandell teaches WLBU2 can eliminate mature S. aureus implant biofilms (Pg 3, “WLBU2 eliminates S. aureus implant biofilms” and Figure 2).
Regarding claim 106, as stated above, both Mandell and Phadke teach that WLBU2 is effective against S. aureus (Mandell - Pg 3, “WLBU2 eliminates S. aureus implant biofilms” and Figure 2; Phadke - Table 2 and page 1291, first column, first paragraph).
Regarding claims 107 and 108, Mandell teaches the S. aureus strain can be a methicillin resistant strain (Abstract; Pg 5, Table 1).
Regarding claim 109, Mandell teaches that when administered to mice, the antibiotic rifampin showed comparable reduction in biofilms as compared to WLBU2 (Pg 5, “WLBU2 has comparable efficacy to cefazolin and rifampin in a periprosthetic joint infection murine model”). Although, Krebs, Mandell, Phadke, and Le Tourneau do not teach administering rifampin before, during or after irrigation, it would have been obvious to a person of ordinary skill in the art to do so. Mandell recognized that rifampin shows a similar reduction in biofilm as compared to WLBU2. One would expect that there would be an additive, if not synergistic, impact resulting from the consecutive or simultaneous administration of two equally potent therapies used together to affect the same outcome. Thus, it would have been obvious to combine the therapeutic effects of rifampin with those of WLBU2 through administration of rifampin before, during, or after irrigation with the composition comprising WLBU2.
Claims 81, 93-99, 103, and 105-112 are rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al. (US 2019/0216559A1; effectively filed January 27, 2018), Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages), Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293), and Le Tourneau et al. (Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20.), as applied to claims 81, 94-99, 103, and 105-112, in further view of Li et al. (“Effects of Cold Irrigation on Early Results after Total Knee Arthroplasty”, Medicine (Baltimore) 2016, 5 pages).
The teachings of Krebs, Mandell, Phadke, and Le Tourneau have been set forth above. Krebs, Mandell, Phadke, and Le Tourneau do not teach suturing the tissue around the exposed prosthetic joint subsequent to the irrigation of the prosthetic joint in vivo results in the biofilm being partially disrupted or destroyed.
Li teaches that suturing the joint capsule tissue following irrigation of the knee joint cavity can produce a longer lasting effect (Pg 4, 4th paragraph).
Thus, regarding claim 93, Krebs, Mandell, Phadke, and Le Tourneau teach a method of treating a bacterial infection comprising a biofilm formed on a prosthetic joint, wherein proximal incising exposes the prosthetic joint and the joint is irrigated with a composition comprising the instant SEQ ID NO: 1 and a buffering agent. Li teaches suturing the knee joint capsule tissue after irrigation to prolong the impact of the irrigation. Thus, it would have been prima facie obvious to suture the exposed prosthetic joint post-irrigation in order to prolong the impact of the irrigation with WLBU2. One of ordinary skill in the art would have a reasonable expectation of success as Li demonstrated that this step in such a method improved the outcome of other joints, such as knee joints.
Claims 81, 94-100, 103, and 105-112 are rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al. (US 2019/0216559A1; effectively filed January 27, 2018), Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages), Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293), and Le Tourneau et al. (Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20.), as applied to claims 81, 94-99, 103, and 105-112, in further view of Streubel et al. (“Infection in total elbow arthroplasty with stable components”, Bone Joint J, 2016, 976-83).
The teachings of Krebs, Mandell, Phadke, and Le Tourneau have been set forth above. Krebs, Mandell, Phadke, and Le Tourneau do not teach the prosthetic joint is an elbow joint. Krebs teaches that the methods are equally applicable to infected implants in other joints ([0016]).
Streubel teaches a protocol of irrigation and debridement with retention of the implant for the treatment of periprosthetic infection of a total elbow arthroplasty (TEA; Abstract). Streubel also teaches that the most common infection organism is Staphylococcus (Abstract; Table III; Pg 977, second column 4th paragraph).
Thus, regarding claim 100, Krebs, Mandell, Phadke, and Le Tourneau teach a method of treating a bacterial infection comprising a biofilm formed on a prosthetic joint, wherein proximal incising exposes the prosthetic joint and the joint is irrigated with a composition comprising the instant SEQ ID NO: 1 and a buffering agent. Streubel teaches a method of treating periprosthetic infection of the elbow joint infected with Staphylococcus. Thus, it would have been prima facie obvious to use the method of treatment taught by Krebs, Mandell, Phadke, and Le Tourneau to treat elbow joint Staphylococcus infections in order to treat a wider array of infected joints. One of ordinary skill in the art would have a reasonable expectation of success as Krebs indicated that the methods taught are equally applicable many types of joints and Mandell and Phadke demonstrate that WLBU2 is effective against Staphylococcus, which, according to Streubel, is a common infection that can impact elbow joints.
Claims 81, 94-99, 103-112 are rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al. (US 2019/0216559A1; effectively filed January 27, 2018), Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages), Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293), and Le Tourneau et al. (Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20.), as applied to claims 81, 94-99, 103, and 105-112, in further view of Brown et al. (US 2018/0243333A1; filed Feb. 2017)).
The teachings of Krebs, Mandell, Phadke, and Le Tourneau have been set forth above. Krebs, Mandell, Phadke, and Le Tourneau do not teach the buffering agent comprises sodium bicarbonate, potassium bicarbonate, sodium carbonate or magnesium carbonate.
Brown teaches bicarbonate potentiates the effect of antimicrobial agents (Title; Abstract; [0105]). Brown teaches compositions comprising sodium bicarbonate and an antimicrobial peptide ([0050]). Brown teach sodium bicarbonate as a modulator of antibiotics (0002]).
Thus, regarding claims 103 and 104, Krebs, Mandell, Phadke, and Le Tourneau teach a method of treating a bacterial infection comprising a biofilm formed on a prosthetic joint, wherein proximal incising exposes the prosthetic joint and the joint is irrigated with a composition comprising the instant SEQ ID NO: 1 and a buffering agent. Brown teaches compositions comprising an antimicrobial peptide and sodium bicarbonate, which itself has antimicrobial properties and also can potentiate antimicrobial peptides. Thus, it would have been prima facie obvious to use a composition comprising sodium bicarbonate and the instant SEQ ID NO: 1 in order to further increase the antibacterial properties of SEQ ID NO: 1 and the composition overall. One of ordinary skill in the art would have a reasonable expectation of success as Brown established that sodium bicarbonate alone and in conjunction with other antibiotic agents could treat bacterial infections.
Maintained/Modified - 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 81, 97-99, 106, 107, and 109-112 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 8, 12, 21, 28, 41, 43, 52, and 68 of copending Application No. 18/290,214 (claims filed 1/17/25). 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 copending Application No. ‘214 recites a method for treating or preventing periprosthetic joint infection in a patient in need thereof, wherein a prosthetic joint is implanted in said patient; the method comprising administering: (i) a pharmaceutical composition comprising: (a) a peptide of pharmaceutically acceptable salt thereof, wherein said peptide has at least 70% sequence identity to a polypeptide sequence of: SA-5 (SEQ ID NO: 1); LSA-5 (SEQ ID NO: 2); WLSA-5 (SEQ ID NO: 3); LBU-1 (SEQ ID NO: 4); LBU-2 (SEQ ID NO: 5); LBU-3 (SEQ ID NO: 6); LBU-3.5 (SEQ ID NO: 7); LBU-4 (SEQ ID NO: 8); WLBU-1 (SEQ ID NO: 9); WLBU-2 (SEQ ID NO: 10); WLBU-3 (SEQ ID NO: 11); WLBU-4 (SEQ ID NO: 12); WR6 (SEQ ID NO: 13); WR12 (SEQ ID NO: 14); WR18 (SEQ ID NO: 15); or WR 24 (SEQ ID NO: 16); and (b) an aqueous carrier; wherein said pharmaceutical composition is in a form of a liquid, wherein said pharmaceutical composition is locally administered to said prosthetic joint in vivo; and (ii) an antibiotic or pharmaceutically acceptable salt thereof; and wherein administration of said pharmaceutical composition and said antibiotic reduces a bacterial burden of said periprosthetic joint infection to a greater extent as compared to administering (i) or (ii) alone. SEQ ID NO: 10 of copending Application No. ‘214 is the same as the instant SEQ ID NO: 1.
Dependent claims include administration of the antibiotic relative to the pharmaceutical composition (claims 5 and 6), the periprosthetic joint infection further comprises a biofilm (claim 8); administering comprises irrigating said prosthetic joint with said pharmaceutical composition, wherein said prosthetic joint is exposed (claim 12); wherein said peptide or pharmaceutically acceptable salt is WLBU-2 (SEQ ID NO: 10) (claim 21); the concentration of the peptide (claim 28), the species of bacteria (claim 41), the location of the prosthetic joint within the body (claim 43), the bacteria is resistant to antibiotics (claim 68).
Additionally, independent claim 52 recites a pharmaceutical composition comprising: a) a peptide of pharmaceutically acceptable salt thereof, wherein said peptide has at least 70% sequence identity to a polypeptide sequence of: SA-5 (SEQ ID NO: 1); LSA-5 (SEQ ID NO: 2); WLSA-5 (SEQ ID NO: 3); LBU-1 (SEQ ID NO: 4); LBU-2 (SEQ ID NO: 5); LBU-3 (SEQ ID NO: 6); LBU-3.5 (SEQ ID NO: 7); LBU-4 (SEQ ID NO: 8); WLBU-1 (SEQ ID NO: 9); WLBU-2 (SEQ ID NO: 10); WLBU-3 (SEQ ID NO: 11); WLBU-4 (SEQ ID NO: 12); WR6 (SEQ ID NO: 13); WR12 (SEQ ID NO: 14); WR18 (SEQ ID NO: 15); or WR 24 (SEQ ID NO: 16); b) an aqueous carrier; and c) an antibiotic or pharmaceutically acceptable salt thereof; wherein said pharmaceutical composition is in a form of a liquid (claim 52).
This is a provisional nonstatutory double patenting rejection.
Claims 81, 103, 104, 106, and 110-112 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 19, 38, 43, 54, 56, 69, and 95 of copending Application No. 18/606,023 (claims filed 11/22/24) in view of Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages) and Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293). 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 copending Application No. ‘023 recites a pharmaceutical formulation comprising: (a) Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 15); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 16); Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 17); Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 18); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg (SEQ ID NO: 19); Arg-Arg-Trp-Trp-Arg-Arg-Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-ArgArg-Trp-Trp-Arg-Arg (SEQ ID NO: 20); Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-ValArg-
Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 21); Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 22); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 23); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-ArgVal-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 24);Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Arg-Val-Val (SEQ ID NO: 25), or any combination thereof; and(b) aqueous sodium bicarbonate at a concentration from about 50 mM to about 300 mM. SEQ ID NO: 1 of copending Application No. ‘023 is the same as the instant SEQ ID NO: 1.
Dependent claims include the peptide concentration (claim 7) and the peptide or salt thereof comprises the polypeptide sequence Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1) (claim 19).
Additional independent claim 38 recites a method of making a pharmaceutical formulation from a kit, wherein the kit comprises: (i) a first container comprising a peptide or pharmaceutically acceptable salt thereof comprising at least 70% sequence identity to a polypeptide sequence of: Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 15); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 16); Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 17); Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 18); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg (SEQ ID NO: 19); Arg-Arg-Trp-Trp-Arg-Arg-Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-ArgArg-Trp-Trp-Arg-Arg (SEQ ID NO: 20); Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 21); Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 22); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 23); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-ArgVal-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 24);Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Arg-Val-Val (SEQ ID NO: 25); (ii) a second container comprising aqueous sodium bicarbonate; (iii) a third container comprising water; and (iv) a mixing container; wherein method comprises adding the first container, the second container, and the third container into the mixing container, thereby resulting in the pharmaceutical formulation having sodium bicarbonate at a concentration from about 50mM to about 300mM.
Dependent claims include wherein the concentration (claim 43) and the peptide or salt thereof comprises the polypeptide sequence Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1) (claim 54).
Additional independent claim 56 recites a method of treating an infection in a subject in need thereof, wherein the method comprising locally administering of a pharmaceutical formulation to a site of infection, wherein administration comprises washing, irrigating, debriding, aspirating, or a combination thereof the site of infection, thereby preventing or treating the infection, wherein the pharmaceutical formulation comprises: (a) a peptide or pharmaceutically acceptable salt thereof comprising at least 70% sequence identity to a polypeptide sequence of: Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 15); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 16); Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 17); Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 18); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg (SEQ ID NO: 19); Arg-Arg-Trp-Trp-Arg-Arg-Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-ArgArg-Trp-Trp-Arg-Arg (SEQ ID NO: 20); Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 21); Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 22); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 23); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-ArgVal-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 24);Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Arg-Val-Val (SEQ ID NO: 25), or any combination thereof; and (b) sodium bicarbonate at a concentration from about 50mM to about 300mM, wherein the sodium bicarbonate provides a synergistic effect with the peptide or pharmaceutically acceptable salt thereof, wherein the synergistic effect comprises reduces a bacterial burden in the subject to a greater extent as compared to administering (a) or (b) alone.
Dependent claims include wherein the stage of the joint infection (claim 69) and the bacterial species (claim 95).
Copending Application No. ‘023 does not teach that the joint infection comprises a biofilm in a subject and is formed on the prosthetic joint implanted in the subject.
As referenced above, Mandell and Phadke teach that the WLBU2 (SEQ ID NO: 1) can effectively treat S. aureus biofilms formed by a variety of clinical MSSA and MRSA strains and in a surgical implant infection animal model.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Mandell and Phadke into copending Application No. ‘023, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Mandell and Phadke teach treating biofilms formed by S. aureus in surgical implant animal models using WLBU2. Thus, the claims are obvious in view of copending Application No. ‘203.
This is a provisional nonstatutory double patenting rejection.
Claims 81, 103, 104, and 106 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14, 15, and 27-29 of copending Application No. 19/072,538 (claims filed 5/13/25) in view of Mandell et al. (“Elimination of Antibiotic Resistant Surgical Implant Biofilm Using an Engineered Cationic Amphipathic Peptide WLBU2”, Scientific Reports, 2017, 9 pages), Phadke et al. (“Antimicrobial Peptides in Mucosal Secretions: The Importance of Local Secretions in Mitigating Infection”, American Society for Nutritional Sciences, 2015, pp. 1289-1293), and Le Tourneau et al. (Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20.). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Independent claim 1 of copending Application No. ‘538 recites a pharmaceutical formulation comprising: (a) a peptide or pharmaceutically acceptable salt thereof comprising at least 70% sequence identity to a polypeptide sequence of: Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 15); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 16); Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 17); Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Arg (SEQ ID NO: 18); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg (SEQ ID NO: 19); Arg-Arg-Trp-Trp-Arg-Arg-Trp-Arg-Arg-Trp-Trp-Arg-Arg-Trp-Trp-Arg-Trp-Trp-ArgArg-Trp-Trp-Arg-Arg (SEQ ID NO: 20); Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 21); Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 22); Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-ArgArg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 23); Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-ArgVal-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Arg-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Val-Val-Arg-Arg (SEQ ID NO: 24);Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Arg-Val-Val (SEQ ID NO: 25); and (b) at least one pharmaceutically acceptable excipient; wherein the pharmaceutical formulation has a pH of about 3.5 to about 5.5; and wherein the pharmaceutical formulation comprises at most 5% by weight of at least one impurity as measured by high-performance liquid chromatography (HPLC) when stored for at least 50 days at 40°C. SEQ ID NO: 1 of copending Application No. ‘538 is the same as the instant SEQ ID NO: 1.
Dependent claims include the concentration of the peptide (claim 12); peptide comprises at least about 90% to 100% sequence identity to a polypeptide sequence Arg-Arg-Trp-Val-Arg-Arg-Val-Arg-Arg-Val-Trp-Arg-Arg-Val-Val-Arg-Val-Val-Arg-Arg-Trp-Val-Arg-Arg (SEQ ID NO: 1) (claims 14 and 15).
Additional independent claim 25 of copending Application No. ‘538 recites a kit comprising (i) the pharmaceutical formulation of claim 1; (ii) an aqueous carrier, wherein the aqueous carrier is sterile water for injection; (iii) a mixing container; (iv) instructions for use. Dependent claim 25 includes wherein kit further comprises (v) a second aqueous carrier, wherein the second aqueous carrier is aqueous sodium bicarbonate.
Additional independent claim 27 of copending Application No. ‘538 recites a method of preventing or treating an infection in a subject in need thereof, wherein the method comprising locally administering the pharmaceutical formulation of claim 1 to a site of infection, wherein administration comprises washing, irrigating, debridement, or a combination thereof of the site of infection, thereby preventing or treating the infection.
Dependent claims include the infection is periprosthetic joint infection (claim 28) and the bacterial species (claim 29).
Copending Application No. ‘538 does not teach that the bacterial infection to be treated comprises a biofilm on a prosthetic joint, nor does it specify the concentration of SEQ ID NO: 1.
As referenced above, Mandell teaches that peptide WBLU2 can effectively treat S. aureus biofilms formed by a variety of clinical MSSA and MRSA strains and in a surgical implant infection animal model. Phadke teaches that WBLU2 is the aforementioned and instant SEQ ID NO: 1. Le Tourneau teaches that optimal dosages are influenced by a number of factors and require optimization.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Mandell, Phadke, and Le Tourneau into copending Application No. ‘538, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Mandell and Phadke teach treating biofilms formed by S. aureus in surgical implant animal models using WLBU2 and Le Tourneau teaches optimizing dosage concentrations for treatment of disease. Thus, the claims are obvious in view of copending Application No. ‘538.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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