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 .
Status of the Claims
Claims 1-67 were originally filed November 10, 2023.
The amendment received January 17, 2025 canceled claims 3, 7, 9-11, 13-20, 22-24, 26, 27, 29, 34, 35, 37-40, 42, 45, 46, 48-51, and 53-67; amended claims 4, 6, 12, 28, 36, and 41; and added new claim 68.
The amendment received May 26, 2026 amended claims 1, 25, 28, 36, 41, 44, 47, and 68 and canceled claim 52.
Claims 1, 2, 4-6, 8, 12, 21, 25, 28, 30-33, 36, 41, 43, 44, 47, and 68 are currently pending.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 4-6, 8, 12, 21, 25, 28, 30-33, 36, 41, 43, 44, 47, and 68) in the reply filed on May 26, 2026 is acknowledged.
Applicant’s election of a biofilm, human, SEQ ID NO: 10 (10 mg/ml), water, irrigation wherein SEQ ID NO: 10 is administered subsequently to antibiotic administration, cefazolin (10 mg/kg), implant bacterial burden, pH 7.3, knee joint, and no additional reagents and/or methods as the species in the reply filed on May 26, 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)).
Claims 5, 33, 41, and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
Priority
The present application is a 371 (National Stage) of PCT/US2022/028993 filed May 12, 2022 which claims the benefit of 63/245,419 filed September 17, 2021; 63/238,560 filed August 30, 2021; and 63/187,658 filed May 12, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 2, 2024 (2); May 1, 2025; and May 26, 2026 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the first line of the specification should refer to the complete PCT (i.e. PCT/US2022/028993 filed May 12, 2022).
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: the arbitrary name should be removed. The peptide should be referred to via SEQ ID NO: or SEQ ID NO: and the peptide sequence. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: spacing should be corrected in the claim. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: applicants should carefully review the claim to ensure that Trademarks are not utilized in the claim. Appropriate correction is required.
Claims 31 and 32 are objected to because of the following informalities: the antibiotics should not be capitalized as this may cause confusion as to whether or not the terms are Trademarks. Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
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, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if “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” wherein (i) is SEQ ID NO: 10 and (ii) is any antibiotic is simply a function of administration, if additional method steps are required (testing SEQ ID NO: 10 alone, an antibiotic alone, and the combination), etc. In addition, it is unclear if the wherein clause alters the antibiotic and/or infection (e.g. SEQ ID NO: 10 has broad antimicrobial activity but, as with most antimicrobials, will have some differences related to which infection is present particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection; every antibiotic is not effective for every infection particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection). For example, an antibiotic could be effective for one type of bacteria and SEQ ID NO: 10 could have no effect and the pharmaceutical composition would still read on the wherein clause. For example, an SEQ ID NO: 10 could be effective for one type of bacteria and an antibiotic could have no effect and the pharmaceutical composition would still read on the wherein clause.
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if claim 2 requires an additional method step or not (i.e. determining bacterial burden of SEQ ID NO: 1 alone, the antibiotic alone, and the combination) or if claim 2 is simply the function of administration. In addition, it is unclear if claim 2 alters the antibiotic and/or infection (e.g. SEQ ID NO: 10 has broad antimicrobial activity but, as with most antimicrobials, will have some differences related to which infection is present particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection; every antibiotic is not effective for every infection particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection). For example, an antibiotic could be effective for one type of bacteria and SEQ ID NO: 10 could have no effect and the pharmaceutical composition would still read on the wherein clause. For example, an SEQ ID NO: 10 could be effective for one type of bacteria and an antibiotic could have no effect and the pharmaceutical composition would still read on the wherein clause.
Claim 4 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if claim 4 requires an additional method step or not (i.e. determining bacterial burden of SEQ ID NO: 1 alone, the antibiotic alone, and the combination; in vitro CFU assay, etc.) or if claim 2 is simply the function of administration. In addition, it is unclear if claim 2 alters the antibiotic and/or infection (e.g. SEQ ID NO: 10 has broad antimicrobial activity but, as with most antimicrobials, will have some differences related to which infection is present particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection; every antibiotic is not effective for every infection particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection). For example, an antibiotic could be effective for one type of bacteria and SEQ ID NO: 10 could have no effect and the pharmaceutical composition would still read on the wherein clause. For example, an SEQ ID NO: 10 could be effective for one type of bacteria and an antibiotic could have no effect and the pharmaceutical composition would still read on the wherein clause.
Claim 6 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear how the pharmaceutical composition can be administered subsequent to antibiotic administration when the pharmaceutical composition comprises both the peptide and the antibiotic (i.e. pharmaceutical composition comprising (i)…SEQ ID NO: 10)…and (ii) an antibiotic. In addition, it is unclear how the pharmaceutical composition can be administered any other way than simultaneously. Please also see withdrawn claim 5.
Claim 21 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear what the scope of “is” is (e.g. open, closed, etc.).
Claim 44 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if claim 44 requires an additional method step or not (i.e. determining ESR of SEQ ID NO: 1 alone, the antibiotic alone, and the combination; in vitro ESR assay, etc.) or if claim 2 is simply the function of administration. In addition, it is unclear if claim 2 alters the antibiotic and/or infection (e.g. SEQ ID NO: 10 has broad antimicrobial activity but, as with most antimicrobials, will have some differences related to which infection is present particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection; every antibiotic is not effective for every infection particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection). For example, an antibiotic could be effective for one type of bacteria and SEQ ID NO: 10 could have no effect and the pharmaceutical composition would still read on the wherein clause. For example, an SEQ ID NO: 10 could be effective for one type of bacteria and an antibiotic could have no effect and the pharmaceutical composition would still read on the wherein clause.
Claim 47 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if claim 47 requires an additional method step or not (i.e. determining C-reactive protein expression levels of SEQ ID NO: 1 alone, the antibiotic alone, and the combination; in vitro C-reactive protein expression levels, etc.) or if claim 2 is simply the function of administration. In addition, it is unclear if claim 2 alters the antibiotic and/or infection (e.g. SEQ ID NO: 10 has broad antimicrobial activity but, as with most antimicrobials, will have some differences related to which infection is present particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection; every antibiotic is not effective for every infection particularly since the infection is not even limited broadly to bacteria, virus, fungal, etc. or to specific types of infection). For example, an antibiotic could be effective for one type of bacteria and SEQ ID NO: 10 could have no effect and the pharmaceutical composition would still read on the wherein clause. For example, an SEQ ID NO: 10 could be effective for one type of bacteria and an antibiotic could have no effect and the pharmaceutical composition would still read on the wherein clause.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mietzner et al. WO 2009/012143 published January 22, 2009.
For present claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47, Mietzner et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25, 50, 100, and 200 mM; 0.001-20% (w/v); or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; pages 1-16, 18, 22, 24-31; Table 3; Example 4; Figures 8, 11, 12; claims).
Therefore, the teachings of Mietzner et al. anticipate the presently claimed invention.
Claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montelaro et al. WO 02/066608 published August 29, 2002.
For present claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47, Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25, 50, 100, 128, 150, and 200 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; pages 5, 8-13, 15-24, 26-30; Tables 1, 2; Example 4; Figures 2, 8, 10-12; claims).
Therefore, the teachings of Montelaro et al. anticipate the presently claimed invention.
Claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montelaro et al. 2002/0188102 published December 12, 2002.
For present claims 1, 2, 4, 6, 8, 21, 25, 28, 36, 43, 44, and 47, Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Therefore, the teachings of Montelaro et al. anticipate the presently claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Mietzner et al. WO 2009/012143 published January 22, 2009 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
For present claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Mietzner et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25, 50, 100, and 200 mM; 0.001-20% (w/v); or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; pages 1-16, 18, 22, 24-31; Table 3; Example 4; Figures 8, 11, 12; claims).
For present claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro et al. WO 02/066608 published August 29, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
For present claims1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25, 50, 100, 128, 150, and 200 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; pages 5, 8-13, 15-24, 26-30; Tables 1, 2; Example 4; Figures 2, 8, 10-12; claims).
For present claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
For present claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
For present claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47, Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,371,463 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
U.S. Patent 12,371,463 claims a method of administering SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 10).
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,951,151 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
U.S. Patent 11,951,151 claims SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10) and a lavage system comprising SEQ ID NO: 10.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of U.S. Patent No. 11,998,586 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
U.S. Patent 11,998,586 claims a method of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10) to a prosthetic with an infection including a biofilm.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 6,887,847 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
U.S. Patent 6,887,847 claims SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10) as a peptide-cargo complex wherein the cargo increases the antimicrobial activity of the peptide.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/072,538 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
Copending Application No. 19/072,538 claims SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 10).
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 11, 13, 19, 20, 22, 38, 40, 43, 51-56, 69, 70, 95, and 96 of copending Application No. 18/606,023 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
Copending Application No. 18/606,023 claims a method of treating an infection via administering SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 10) wherein administration is irrigation.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 5, 7, 17, 18, 25, 29, 35, 42, 54, 61, 64, 113, and 125-129 of copending Application No. 18/447,414 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
Copending Application No. 18/447,414 claims methods of administering SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 10) to treat an infection.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 81, 93-100, and 103-112 of copending Application No. 16/980,295 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
Copending Application No. 16/980,295 claims methods of treating a bacterial infection via administering SEQ ID NO: 1 (100% identity and the same length as present SEQ ID NO: 10) to a biofilm in a prosthetic joint wherein administration is via irrigation and the prosthetic joint is a prosthetic knee joint in combination with at least one antibiotic.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6, 8, 12, 21, 25, 28, 30-32, 36, 43, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-42 of copending Application No. 18/587,268 in view of Montelaro et al. 2002/0188102 published December 12, 2002 and Van Erp et al., 2019 (epub 5/28/2019), Optimization of the empirical antibiotic choice during the treatment of acute prosthetic joint infections: a retrospective analysis of 91 patients, Acta Orthopaedica, 90(5): 455-459.
Copending Application No. 18/587,268 claims SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10) in a lavage system.
Montelaro et al. teach methods of administering SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 10), a cargo including an antibiotic, and an aqueous/liquid carrier to a prosthetic device including a prosthetic joint including a knee at concentrations of 25 mM; 0.001-20% (w/v); about 1 ng/ml to about 1 mg/ml; or about 0.01 to about 100 mg/kg, and a pH of 7.2 wherein a biofilm is present and intraarticular administration (please refer to the entire specification particularly the abstract; paragraphs 2-7, 11, 21, 23-25, 35, 37, 41, 51, 60, 62, 65, 67, 70-74; Tables 1, 2; Examples 2, 4, 5; Figures 2, 8, 10-12; claims).
Van Erp et al. teach methods of irrigating knee joint prosthetics with cefazolin, clavulanic acid, or flucoxacillin (please refer to the entire reference particularly the abstract; Introduction; Patients and Methods).
All the claimed elements were known in the prior art (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of knee joint prosthetics, cefazolin, clavulanic acid, or flucoxacillin) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. intraarticular administration is specifically irrigation; direct administration of antibiotic to knee joint prosthetic) and the combination would have yielded predictable results (i.e. decrease of infection in knee joint prosthetic) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of intraarticular administration; genus of antibiotic cargo) for another (i.e. irrigation; species of cefazolin, clavulanic acid, or flucoxacillin antibiotics) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. methods of administering present SEQ ID NO: 10 and an antibiotic to a prosthetic joint; irrigation of a knee joint prosthetic with antibiotics) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bedencic et al., 2016 (epub 8/8/2015), Does Preoperative Antimicrobial Prophylaxis Influence the Diagnostic Potential of Periprosthetic Tissues in Hip or Knee Infections?, Clin Orthop Relat Res, 474: 258-264.
U.S. Patent Application Publication 2019/0216559
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/AMBER D STEELE/ Primary Examiner, Art Unit 1658
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