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 .
Claims 1-20 are cancelled.
Claims 21-42 are pending and under examination.
This is the First Office Action on the Merits of US Application 19/587268 filed on 02/26/2024 is a CON of 17/749,731 filed on 05/20/2022 (now US Patent 11951151) which is a DIV of 17/525,344 filed on 11/12/2021 (now US Patent 11998586) which is a CON of PCT/US2020/059415 filed on 11/06/2020 which claims US priority benefit of US Provisionals 63/028,636 filed on 05/22/2020 and 62/932,609 filed on 11/08/2019.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, PCT/US2020/059415, and Provisional application Nos. 62/932,609 and 63/028,636, each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ’609 and Prov recites WLBU-2 called SEQ ID NO:10 in Table 1 but the sequence for the ‘609 and ‘636 Provisionals disclose a SEQ ID NO:10 WLBU-2 which is: RRWVR RVRRV WRVV RVVRR WVRR (23aa) which differs from instant SEQ 10 which is: RRWVR RVRRV WRRVV RVVRR WVRR (24aa).
Thus, instant claims 21-42 receive an effective filing date to 17/525,344 filed on 11/12/2021.
Information Disclosure Statement
The IDS statements filed on 09/09/2025, 01/21/2025, and 03/22/2024 have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: In the Section of Example 1 (para 0061, lines 6-7) the dose amounts of the Cefazolin and WLBU2 are recited in mg/ml units. For example, the highest amount of the WLBU2 is recited at 500 mg/ml. However, this experiment described in para 0061 appears to correspond to FIG2A in the Drawings which recites µg/ml quantities for Cefazolin and WLBU2. For example, the highest amount of the WLBU2 in FIG2A is recited at 500 µg/ml. It appears that FIG2A is showing the correct amounts in µg/ml quantities. Also, a discrepancy is found in the last sentence of para 0064 which states that doses of 62-1000 ug/ml of WLBU-2 were used (and shown in FIG1B). The present Drawings do not have a FIG1B. Appropriate correction is required.
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.
Claims 37-42 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.
Claim 37 is indefinite because it depends from cancelled claim 1. Thus the scope of claim 37 cannot be determined. Claims 38-42 are indefinite because they depend from claim 37 and are not remedial.
Also, claim 40 lacks sufficient antecedent basis for the term “the outlet nozzle” because claim 40 depends from claim 37 which does not recite an outlet nozzle. Note claim 39 recites an outlet nozzle.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 22, and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 22, the claim recites a total ionic strength range of “about 0.8 M to about 0.16 M” which is outside of the range of base claim 21 which recites a range of “about 0.02 M to about 0.2 M”.
Regarding claim 30, the claim depends from claim 28 and recites a pH range from about 6.5 to about 8.0 which is outside of the range of claim 28 which recites a pH range from about 7 to about 11.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-33, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Montelaro & Mietzner (US2009/0099533).
Regarding base claim 21, Montelaro discloses a pharmaceutical composition comprising: a. a cationic antimicrobial peptide or pharmaceutically acceptable salt thereof, wherein the cationic antimicrobial peptide is the 24-residue WLBU-2 which is reference SEQ ID NO: 10 and is identical to instant SEQ ID NO: 10. (See para 50.)
Montelaro discloses SEQ ID NO: 10 in a pharmaceutically acceptable aqueous carrier; wherein the pharmaceutical composition is in the form of a liquid; and wherein the pharmaceutical composition has a total ionic strength from about 0.02 M to about 0.2 M. Montelaro discloses the peptide is active at physiological NaCl concentrations being 150 mM which meets the limitation of a total ionic strength from about 0.02 M to about 0.2 M. (See para 0012; para 0050; 0060; 0069; Table 3).
Regarding claim 22, Montelaro discloses that the pharmaceutical composition at physiological NaCl concentrations being 150 mM which meets the limitation of a total ionic strength of about 0.8 M to about 0.16 M. (See para 0012; para 0050; 0069).
Regarding claim 23, Montelaro discloses that the pharmaceutical composition is physiologically isotonic or physiologically hypotonic. (See para 0012, lines 2-3.)
Regarding claim 24, Montelaro discloses that the aqueous carrier comprises phosphate buffered saline (aka PBS). (See para 0153, line 4).
Regarding claims 25-26, Montelaro discloses that the aqueous carrier comprises phosphate buffered saline (aka PBS). (See para 0153, line 4).
Regarding claim 27, Montelaro discloses that the pharmaceutical composition further comprises a salt that is selected from the group consisting of sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate, calcium chloride, sodium lactate, copper chloride, copper sulfate, C11H22CuO14, ammonium hydroxide, magnesium hydroxide, sodium carbonate, and any combination thereof. (See para 0058-0060; Table 3.)
Regarding claims 28-33, Montelaro discloses that the pharmaceutical composition further has a pH of 7.2 which meets the limitations of a pH for each of claims 28-33 Regarding claim 29, Montelaro discloses that the pharmaceutical composition further has a pH from about 5.0 to about 8.0. Regarding claim 30, Montelaro discloses that the pH is from about 6.5 to about 8.0. Regarding claim 31, Montelaro discloses that the pH is from about 7.0 to about 8.0. Regarding claim 32, Montelaro discloses that the pH is from about 7.2 to about 8.0. Regarding claim 33, Montelaro discloses that the pH is from about 7.4 to about 8.0. (See para 0120.)
Regarding claim 35, Montelaro discloses that the cationic antimicrobial peptide is present at about 1 mg/mL to about 100 mg/mL. Montelaro recites a dosage for adult human can range from about 0.01 to about 100 mg per kilogram body weight which meets the limitation of about 10/mg/mL concentration. Montelaro states the peptide composition should be about 1mg/ml (See para 0113).
Regarding claim 36, Montelaro discloses that the cationic antimicrobial peptide is present at a concentration of about 10 mg/mL. (See para 0113). Montelaro recites a preferred dosage for adult human can range from about 0.5 to about 5.0 mg per kilogram body weight which meets the limitation of about 10/mg/mL concentration.
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 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro & Mietzner (US2009/0099533) as applied to claims 21-33, and 35-36 above, and further in view of WO-2021/130390 (published 07/01/2021; IDS ref) or Quay et al (US2010/0210506), or Baumhof (US2015/0118183).
Claims 21-33, and 35-36 are anticipated by Montelaro for reasons applied above.
However, regarding instant claim 34, Montelaro differs from claim 34 because although it does recite using physiologic salt concentrations, they do not explicitly recite a total osmolarity from about 50 mOsm/L to about 350 mOsm/L.
However, WO/2021/130390 discloses pharmaceutical compositions comprising cationic peptides with osmolarity between 225 and 275 mOsm/L which renders obvious the limitation of total osmolarity from about 50 mOsm/L to about 350 mOsm/L. For example, WO/2021/130390 recites the following on pages 152-153: The person skilled in the art will also acknowledge that the osmolarity of the low salt buffer will be in the range between 100 and 400 milli-osmoles/L (mOsm/L), preferably between 150 and 350 mOsm/L, more preferably between 200 and 300 mOsm/L, even more preferably between 225 and 275 mOsm/L.
Further, each of the references of Quay et al and Baumhof disclose that pharmaceutical compositions comprising cationic peptides generally are in the range of from about 50 mOsm/L to about 350 mOsm/L. (See Quay ref claims 73 and para 0173 and see Baumhof para 0057). Baumhof disclose that the osmolarity of the Ringer lactate solution is 273 mOsm/L. Baumhof discloses a preferred embodiment of cationic peptides (e.g., para 0001, 0129). Baumhof disclose antimicrobial peptides (para 0011).
Baumhof disclose that "The sodium, chloride, potassium and lactate typically come from NaCI (sodium chloride), NaC.sub.3H.sub.5O.sub.3 (sodium lactate), CaCl2 (calcium chloride), and Kill (potassium chloride)". (para 0057).
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art having the cited references before them would
have been motivated to use a pharmaceutical solution such as Ringer lactate solution of an NaCL solution having a total osmolarity from about 50 mOsm/L to about 350 mOsm/L, as evidenced by each of WO/2021/130390, Quay et al, and Baumhof for the rationale that this is the commonly used osmolarity for physiological pharmaceutical solutions for effective treatment of physiological conditions such as wound infections.
It would have been obvious to use this range of osmolarity because US2009/0099533 reference explicitly disclose to use a pharmaceutical composition comprising a cationic antimicrobial peptide comprising the instant SEQ ID NO: 10 for treating infection using physiological conditions, "under physiological salt concentrations".
In view of the high skill level in the art it is considered that one of ordinary skill in
the art having the cited references would have had a reasonable expectation of success to use the osmolarity range of about 50 mOsm/L to about 350 mOsm/L in the method of the US2009/0099533 reference to arrive at the presently claimed invention.
Thus, the claims as a whole are rendered obvious in view of the cited references.
Claims 21 and 37-42 are rejected under 35 U.S.C. 103 as being unpatentable over Montelaro & Mietzner (US2009/0099533) as applied to claim 21 above, and further in view of Niezgoda et al (US2013/0261534, published 10/03/2013) and Tumey et al (US2009/0198200 published 08/06/2009).
Please note present claim 37 depends from a cancelled base claim. In the interest of compact prosecution, claim 37 is interpreted as depending from present base claim 21. Regarding claims 37-42, Montelaro teach the composition of instant base claim 21 for reasons provided above. However, Montelaro does not teach a lavage system comprising such composition.
Regarding claim 37, each of the references of Tumey et al and Niezgoda et al disclose an irrigation actuator configured for washing or irrigating a wound in a patient with a pharmaceutical antimicrobial composition, fluidly-connected to a reservoir.
Each of Tumey et al and Niezgoda et al, disclose that it was known before the effective filing date of the presently claimed invention that infected wounds could be treated with a treatment solution, including an antimicrobial solution, using a lavage apparatus containing a reservoir. For example, Tumey et al, discloses a lavage system comprising: an irrigation actuator configured for washing or irrigating a wound in a patient with the pharmaceutical antibiotic composition, fluidly-connected to a reservoir. For example, in paragraph 0031, Tumey states:
[0031] FIG. 1 shows a NPWT system with wound irrigation, according to an embodiment. The NPWT system has a wound dressing, which is placed in a wound. The distal end portions of suction tube and irrigation tube are connected to the wound dressing in one of the manners described in greater detail below. A covering, such as a semi-permeable occlusive sheet or drape, covers the wound dressing. The covering, for example, can be made of polyurethane film such as that available under the trademark Tegaderm. TM.. The covering is sealed to the skin surrounding the wound by, for example, an adhesive. The proximal end portion of the suction tube is connected to a fluid collection canister. The fluid collection canister is connected to a suction source by tubing. The proximal end portion of the irrigation tube is connected to a reservoir that contains a solution, such as, by way of example, an aqueous topical antibiotic solution, isotonic saline, Dakin's solution, or a Sulfamide Acetate solution, for use in providing therapy to the wound. (emphasis added).
Also, Niezgoda et al disclose an apparatus containing a reservoir for a treatment solution, a mechanism for delivering the treatment solution to the wound site, and a mechanism for applying the solution to the wound, tissue, bone or surgical cavity for treatments. See Abstract. Niezgoda et al contemplates use of this apparatus for treating a wound infected with drug resistant bacteria. See Abstract. Niezgoda et al specifically disclose a disinfecting mechanism for treating a wound may be by infusing a wound treatment solution to a wound using irrigation, and by pulsed lavage such that the wound is irrigated and debrided of necrotic tissue and simultaneously disinfected. See para 0018. Niezgoda et al discloses the apparatus may deliver a solution that contains an antibiotic. (See para 0065, line 1).
Regarding claim 38, Niezgoda et al discloses that the lavage system is a high-pressure lavage or a pulse lavage system. (See para 0081.)
Regarding claim 39, Tumey and Niezgoda et al discloses that the irrigation actuator further comprises a suction nozzle, an outlet nozzle, a vacuum, one or more internal pumps, one or more tubes, one or more valves, one or more triggers, or any combination thereof. (See Tumey para 0004; 0031 just above Niezgoda et al para 0054.)
Regarding claim 40, Niezgoda et al discloses that the outlet nozzle is configured to pump the pharmaceutical composition through the outlet nozzle as a stream, a spray, a continuous jet, a pulsed jet, or any combination thereof. (See para 0054.)
Regarding claim 41, Niezgoda et al discloses that the lavage system is configured to use an external power supply or further comprises an internal battery. (para 0055.)
Regarding claim 42, Tumey and Niezgoda et al discloses that the reservoir is an intravenous (IV) bag or a bottle. (See Tumey Fig1 #20; Niezgoda et al para 0031).
One of ordinary skill in the art would have been motivated to administer the antimicrobial pharmaceutical composition of claim 21 using a lavage system comprising an irrigation actuator configured for washing or irrigating a wound in a patient with the pharmaceutical composition, fluidly-connected to a reservoir for the rationale of disinfecting an infection in an open wound.
It would have been prima facie obvious to combine the lavage systems of either of Tumey et al or Niezgoda et al because they suggest using their systems for disinfecting and suggest using their lavage systems with an antimicrobial (antibiotic) solution.
In view of the high skill level in the art, it is considered that one of ordinary skill in the art having the cited references before the effective filing date would have had a reasonable expectation of success to use a lavage system to irrigate a patient wound using a lavage system using the antimicrobial solution containing the antimicrobial cationic peptide solution comprising instant SEQ ID NO: 10 (WLBU-2) in a pharmaceutically acceptable aqueous carrier; the pharmaceutical composition being in the form of a liquid.
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 21-36 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 further view of Montelaro & Mietzner (US2009/0099533).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate or render obvious the instant claims in further view of Montelaro & Mietzner.
Regarding instant claim 21-22, patented claim 1 recites a pharmaceutical composition comprising: a. a cationic antimicrobial peptide or pharmaceutically acceptable salt thereof, wherein the cationic antimicrobial peptide is SEQ ID NO: 10; and b. a pharmaceutically acceptable aqueous carrier; wherein the pharmaceutical composition is in the form of a liquid.
Regarding claim 23, patented claim 3 discloses that the pharmaceutical composition is physiologically isotonic or physiologically hypotonic.
Regarding claim 24, patented claim 4 discloses that the aqueous carrier comprises water, normal saline, phosphate buffered saline, dextrose, glycerol, ethanol, buffered salt solutions, lactated Ringer's solution, or any combination thereof.
Regarding claim 25, patented claim 4 discloses that the aqueous carrier comprises buffered salt solutions.
Regarding claim 26, patented claim 4 discloses that the aqueous carrier comprises phosphate buffered saline.
Regarding claim 27, patented claim 7 discloses that the pharmaceutical composition further comprises a salt that is selected from the group consisting of sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate, calcium chloride, sodium lactate, copper chloride, copper sulfate, C11H22CuO14, ammonium hydroxide, magnesium hydroxide, sodium carbonate, and any combination thereof.
Regarding claim 28, patented claim 8 discloses that the pharmaceutical composition further has a pH from about 7 to about 11.
Regarding claim 29, patented claim 9 discloses that the pharmaceutical composition further has a pH from about 5.0 to about 8.0.
Regarding claim 30, patented claim 10 discloses that the pH is from about 6.5 to about 8.0.
Regarding claim 31, patented claim 11 discloses that the pH is from about 7.0 to about 8.0.
Regarding claim 32, patented claim 12 discloses that the pH is from about 7.2 to about 8.0.
Regarding claim 33, patented claim 13 discloses that the pH is from about 7.4 to about 8.0.
Regarding claim 34, patented claim 2 discloses that the pharmaceutical composition further has a total osmolarity from about 50 mOsm/L to about 350 mOsm/L.
Regarding claim 35, patented claim 1 discloses that the cationic antimicrobial peptide is present at about 1 mg/mL to about 100 mg/mL.
Regarding claim 36, patented claim 1 discloses that the cationic antimicrobial peptide is present at a concentration of about 10 mg/mL.
However, patented claims differ in that they do not recite wherein the pharmaceutical composition has a total ionic strength from about 0.02 M to about 0.2 M or regarding claim 22, a total ionic strength of about 0.8 M to about 0.16 M.
Montelaro discloses a pharmaceutical composition comprising: a. a cationic antimicrobial peptide or pharmaceutically acceptable salt thereof, wherein the cationic antimicrobial peptide is the 24-residue WLBU-2 which is reference SEQ ID NO: 10 and is identical to instant SEQ ID NO: 10. (See para 50.) Montelaro discloses SEQ ID NO: 10 in a pharmaceutically acceptable aqueous carrier; wherein the pharmaceutical composition is in the form of a liquid; and wherein the pharmaceutical composition has a total ionic strength from about 0.02 M to about 0.2 M. Montelaro discloses the peptide is active at physiological NaCl concentrations being 150 mM which meets the limitation of a total ionic strength from about 0.02 M to about 0.2 M. (See para 0012; para 0050; 0060; 0069; Table 3). Regarding claim 22, Montelaro discloses that the pharmaceutical composition at physiological NaCl concentrations being 150 mM which meets the limitation of a total ionic strength of about 0.8 M to about 0.16 M. (See para 0012; para 0050; 0069).
In view of the high skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art would have been motivated to have the pharmaceutical composition of instant claims have a total ionic strength from about 0.02 M to about 0.2 M or regarding claim 22, a total ionic strength of about 0.8 M to about 0.16 M for the rationale that Montelaro discloses that the pharmaceutical composition at physiological NaCl concentrations being 150 mM is effective concentration for maximum activity of instant SEQ ID NO: 10.
It would have been obvious to combine the elements of the patented claims with the ionic strength elements of Montelaro because both are in the same field of using instant SEQ ID NO: 10 as an antibiotic, antimicrobial, especially for killing biofilms.
In view of the high skill in the art it is considered that one of ordinary skill in the art would have a reasonable expectation of success to make the composition of the patented claims have a total ionic strength from about 0.02 M to about 0.2 M or regarding claim 22, a total ionic strength of about 0.8 M to about 0.16 M to arrive at the presently claimed invention.
Conclusion
No claim is allowed.
Related prior art which is not being applied in this office but which may be included in a rejection in a future office action if applicable: Mandell et al "Direct antimicrobial activity of cationic amphipathic peptide WLBU2 against Staphylococcus aureus biofilms is enhanced in physiologic buffered saline" (J Orthop Res. 2020 December; Vol 38, No. 12: pages 2657-2663; Epub June 9, 2020; IDS ref). Note that this reference is the inventors own work but cites two additional authors.
Also, note that the related prior art of Lashua et al (J Antimicrob Chemother 2016; Vol 71: pages 2200-2207; IDS ref) discloses WLBU2 antimicrobial cationic peptide having the sequence: RRWVR RVRRW VRRW RVVRR WVRR (WLBU2). However, this sequence is different than the instant SEQ ID NO: 10 sequence (note the W at position 10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
Prosecution Insights