DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 7/17/2026 have been received and entered into the case. Claims 3, 6, 8, 13-16, 18-19, 21-28, 30-32, 34-35, 37-51, and 53-54 have been canceled, Claim 58 has been added. Claims 1-2, 4-5, 7, 9-12, 17, 20, 29, 33, 36, 52, and 55-58 are currently pending, Claims 2, 4-5, 9-12, 17, 20, 29, 33, 36, 52, and 55-57 have been withdrawn, and Claims 1, 7 and 58 have been considered on the merits, insofar as they read on the elected species of post-implantation infections associated with infection of tissues around a medical device implanted in the body or of a medical device implanted in the body, β-1,3-endoglucanase, and a gel. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of applicant’s amendments.
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1, 3 and 13 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Jain (US 9,867,871 B2; 1/16/2018.) are withdrawn in view of applicant’s amendments.
Rejections of Claims 1, 3 and 13 under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 7 under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.) and Tan et al (International Journal of Biological Macromolecules. 2018;108:942-946.) are withdrawn in view of applicant’s amendments.
Rejections of Claims 1, 3, 7, and 13 under nonstatutory double patenting are withdrawn in view of applicant’s amendments.
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 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 of this title, 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 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.).
The instant claims recite a method of treatment for post-implantation infections associated with infection of tissues around a medical device implanted in the body with a parapharmaceutical or pharmaceutical composition, the parapharmaceutical or pharmaceutical composition comprising at least one endoribonuclease enzyme selected from the group consisting of enzymes belonging to the enzyme classes EC 3.1.30 and EC 3.1.31 and mixtures thereof, and at least a glucanase to potentiate a microbicidal agent, comprising an antibiotic, an antifungal, or a disinfectant, the method comprising administering a therapeutically effective dose of the parapharmaceutical or pharmaceutical composition to human beings in the treatment of bacterial infections involving biofilm formation, the parapharmaceutical or pharmaceutical composition being in the form of a gel.
Siala teaches a method for treating, at an implantation site, post-implantation infections (para 0026) of mammalian bodies, in particular of the human body, with a composition comprising at least one enzyme and at least one microbicidal molecule (para 0052), comprising: administering, at an implantation site of an implantable medical device, of a composition comprising at least one enzyme and at least one microbicidal molecule (para 0053), breakdown, by action of said at least one enzyme of said administered composition, of a biofilm present at said implantation site of said implantable medical device (para 0054), and destruction of bacteria and/or inhibition of the growth of bacteria released from said biofilm, by action of said at least one microbicidal molecule of said administered composition (para 0055), wherein the at least one enzyme includes deoxyribonucleases (DNases), Dispersin B (at least a second enzyme) and cellulase (at least a glucanase to potentiate a microbicidal agent) (para 0037, 0062), and is supplied in a concentration between 0.01 and 1000 mg/L (para 0039), the at least one microbicidal molecule includes antibiotic (para 0027) and is supplied in a concentration between 0.01 and 1000 mg/L (para 0041). The administration may be carried out by means of a gel (para 0051, 0056).
Siala does not teach the method wherein the at least one enzyme comprises enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31 (claim 1).
However, Siala does teach the method comprising a composition comprises at least one enzyme including DNases for treating infections related to the presence of biofilms (para 0034-0035). Jain teaches a composition for the treatment of eye diseases associated with poor tear quality related to biofilm formation (col.2 line 14-17, col.14 line 9-10 & 61-62), wherein the composition comprising DNases and micrococcal nuclease (EC 3.1.31.1) (col.7 line 23-24).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31, since Siala and Jain both disclose a composition comprises enzymes useful for treating a condition related to the presence of biofilms, and Jain discloses that the composition comprises micrococcal nuclease (EC 3.1.31.1). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31, with a reasonable expectation for successfully treating, at an implantation site, post-implantation infections of mammalian bodies related to the presence of biofilms, in particular of the human body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Siala et al (US 2019/0192639 A1; 6/27/2019.) in view of Jain (US 9,867,871 B2; 1/16/2018.) as applied to claims 1 and 58, further in view of Woo et al (Food Chemistry. 2014;148:184-187.).
References cited above do not teach the method wherein the composition comprises an endo-β-1,3-glucanase and/or being an endoglucanase from the group EC 3.2.1.39 (claim 7).
However, Siala does teach the method for treating infections comprising a composition comprises at least one enzyme, wherein the infections may be caused by yeasts including Candida albicans (forms biofilms) (para 0047). Woo teaches that endo-β-1,3-glucanases can inhibit fungal growth and control fungal pathogens due to their ability to hydrolyze and degrade β-1,3-polysaccharides and thereby destroy fungal cell walls, and that endo-β-1,3-glucanases are demonstrated to have strong activities against Candida species (p.184 col right – para 1, p.187 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an endo-β-1,3-glucanase, since Siala discloses a method for treating infections that may be caused by Candida albicans comprises at least one enzyme, and Woo discloses that an endo-β-1,3-glucanase inhibits the growth of Candida albicans. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate an endo-β-1,3-glucanase with a reasonable expectation for successfully treating, at an implantation site, post-implantation infections of mammalian bodies, in particular of the human body.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 7 and 58 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No 12,364,738 B2 (referred to as the ‘738 patent) in view of Jain (US 9,867,871 B2; 1/16/2018.) and Woo et al (Food Chemistry. 2014;148:184-187.).
Claim 1 of the ‘738 patent recites a method of treatment for post-implantation infections of mammalian bodies, the method comprising: administering a therapeutically effective amount of a composition comprising a combination of an enzymatic cocktail of Dispersin B (at least a second enzyme), cellulase (at least a glucanase to potentiate a microbicidal agent), and DNase; and a fluoroquinolone microbicidal molecule (antibiotic), wherein the composition is effective to reduce by at least 1 Log 10 the number of viable bacteria in biofilms formed post-implantation to a mammalian body following implantation of an implantable medical device.
‘738 patent does not teach the enzymatic cocktail includes enzymes belonging to the enzyme classes EC 3.1.30 and/or EC 3.1.31, and the composition being in the form of a gel (claim 1).
Jain teaches a composition and a method for treating a disease (Abstract) that may be caused by biofilm (col.14 line 10-12, 62, 65-66), comprising administering a therapeutically effective dose of a nuclease composition (col.10 line 33-35; col.13 line 16-18, 36, 40-43, 45-48), wherein the nuclease composition comprises DNases and micrococcal nuclease (EC 3.1.31.1) (col.7 line 24). The nuclease composition may be in the form of a gel (col.11 line 45; col.12 line 42-43).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate enzymes belonging to the enzyme class EC 3.1.31, since ‘738 patent discloses a method of treating a condition caused by biofilm comprises administering enzymes, and Jain discloses a nuclease composition useful for treating a condition that may be caused by biofilm where the nuclease composition comprises micrococcal nuclease (EC 3.1.31.1). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate enzymes belonging to the enzyme class EC 3.1.31, with a reasonable expectation for successfully treating post-implantation infections of mammalian bodies.
References cited above do not teach the method comprises an endo-β-1,3-glucanase (claim 7).
Woo teaches that endo-β-1,3-glucanases can inhibit fungal growth and control fungal pathogens due to their ability to hydrolyze and degrade β-1,3-polysaccharides and thereby destroy fungal cell walls, and that endo-β-1,3-glucanases are demonstrated to have strong activities against Candida species (p.184 col right – para 1, p.187 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate an endo-β-1,3-glucanase, since ‘738 patent discloses a method of treating a condition caused by biofilm comprises administering enzymes, and Woo discloses that an endo-β-1,3-glucanase may be useful as an antibiofilm agent. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate an endo-β-1,3-glucanase with a reasonable expectation for successfully treating post-implantation infections of mammalian bodies.
Response to Arguments
Applicant argues that the Declaration submitted on 7/17/2026 using Applicants’ formulations showing unexpected results providing advantages of the gel formulation for a related, and close, enzyme composition, allowing a 5-Log10 reduction, and that there is no motivation for one skilled in the art to select the specific nuclease as claimed.
These arguments are not found persuasive because Exhibit B in the Declaration is postdated. In addition, the exact formulation disclosed in the Declaration is not recited in the rejected claims. Finally, Siala does teach a composition comprises enzymes useful for treating a condition related to the presence of biofilms, and Jain does teach a composition for the treatment of eye diseases associated with poor tear quality related to biofilm formation, wherein the composition comprises micrococcal nuclease (EC 3.1.31.1). Thus, a skill in the art would have been motivated by the cited reference to incorporate micrococcal nuclease (EC 3.1.31.1) in a method for treating a condition related to the presence of biofilms with a reasonable expectation of success, since micrococcal nuclease (EC 3.1.31.1) is incorporated in a composition for the treatment of diseases related to biofilm formation as evidenced by Jain.
Applicant argues that the nuclease for the present method of treatment has an optimum pH of activity of 9.2, which is exceedingly high, and is not compatible with a biological application. Siala teaches a working example at pH 7.5, which is the optimal for DNase I, and close to the physiological pH, and that such a high optimal pH of activity for the nuclease as claimed teaches away from a formulation with other enzymes.
These arguments are not found persuasive because applicant’s arguments regarding the pH appear to have no connection to the subject at issue. In addition, Siala does teach the composition comprising at least one enzyme (para 0052), wherein the at least one enzyme includes Dispersin B (at least a second enzyme) and cellulase (at least a glucanase to potentiate a microbicidal agent) (para 0037, 0062), as recited in the rejected claims 1 and 58.
Applicant argues that Jain is entirely silent regarding the nuclease as claimed to potentiate antibiotic effect. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
Prosecution Insights