DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant's amendment and argument filed 01/16/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-19 and 21 are pending and are being examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/26/2023, 07/29/2024, 11/25/2024, 01/29/2025, 04/30/2025, 08/22/2025, 12/03/2025, 02/23/2023, 01/24/2023, 01/13/2026 and 01/14/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-19 and are rejected under 35 U.S.C. 103 as being unpatentable over Eva Berkes and Nicholas Monsul (WO2012118535A1), hereinafter Berkes.
Berkes’s general disclosure is to materials and methods for treating conditions associated with pathogenic biofilms (see abstract).
Regarding claim 1, 12 and 14, Berkes teaches wherein the invention comprises one or more probiotic organisms, anti-microbial honey and other ingredients (see abstract).
Berkes teaches wherein “During preparation of the invention, various samples comprised of hive products such as honey, propolis, royal jelly, bee bread or bee pollen may be processed using various methods and/or may remain unprocessed. Processing may include fractionation of proteins, sugars, pollens, polyphenols or other constituents via chemical means, high performance liquid chromatography, physical (filter) ultrafiltration, gel electrophoresis, heat treatment, enzymatic treatment, micronization, ultrasonication, crystallization, dehydration or lyophilization” (see page 34, lines 4-10).
Berkes teaches “Biofilms have broad-ranging clinical relevance in all areas of medicine. Bacterial biofilms such as those commonly associated with Pseudomonas and Staphylococcus are known to be a cause of intractable infection as well as chronic low-grade inflammation. They consist of colonies of bacterial organisms that collectively secrete and form a protective layer of extracellular matrix material. The bacterial colonies in bacterial biofilms appear to be very resistant to the hosts' natural defenses as well as antibiotic treatments. Biofilms colonize virtually any surface in or on the human body to which these colonies can adhere. They often colonize biomaterials such as urinary catheters, transcutaneous intravenous lines and prosthetic heart valves” (see bottom of page 4 and top of page 5). Berkes also teaches wherein the composition is delivered through catheters (see page 25, lines 17-20, claim 19 and 28). This would at least indicate introducing to a closed water system a composition comprising a fractionated honey in an amount effective for disrupting a biofilm in the closed water system, because with the broadest reasonable interpretation a catheter would be the closed water system as urine is made up of water as its main component and the catheter would need to be closed off to inhibit introduction of any microorganisms.
Berkes also teaches the reasons for the antimicrobial effects of the honey has been shown to be from a polysaccharide known as methylglyoxal and from Leptospermum scoparium (see page 31, lines 24-25).
Berke also teaches filtering and ultrafiltration of the honey (see page 34, lines 8) and specifically teaches filtering through 0.2 microns Millipore filters (see page 40, line 11). Berkes also includes teachings of ways in which to extract extracellular DNA from the biofilm matrix and includes a reference for doing so (see page 27, lines 14-15).
Regarding claim 3, Berkes teaches “In one embodiment, biosurfactants useful according to the subject invention are released by probiotics including non-lactic acid and lactic acid producing bacteria (LAB). In one embodiment, biosurfactants useful according to the subject invention are released by probiotics including, but not limited to, Bacteroides, Bifidobacterium, and Lactobacillus (see page 34, lines 27-31) and this indicates at least gram negative and gram-positive bacteria.
Regarding claims 4-6 and 15-18, Berkes teaches Honey may be used between 10 and 90% volume/volume (hive product/invention) and in varying concentrations of 0.001% to 100% (see page 33, lines 16-17 and lines 19-20). Berkes teaches wherein if honey is to be included as part of the anti-microbial it needs to be characterized like antibiotics are via standardized validated tests such as with MIC and teaches wherein anti-viral activity may be determined for particular viruses such as RSV and other known viruses via certain procedures. Standardization of the honey needs to be standardized via biofilm inhibitory concentration (see page 32, lines 15-30).
Regarding claim 10-11, Berkes teaches “however, microbial biofilms may be grown on relatively non-porous media, such as spheres, in a rotating-tube reactor system. This non-porous media may be represented by sterile 5 mm glass spheres. The reactor vessel may be a sterile 50 ml tube polystyrene Falcon tube or a similar column placed on a rotating shaker. The tube or column may have watertight tops such that rotations on a mechanical rotator do not result in spillage of vessel contents (i.e., contents are secured via screw-top, rubber or cork plug). The spheres may be immobilized at one end of the tube or column by an open mesh, autoclavable plastic plug. Each tube or column may contain sufficient open space such that as the device is mechanically rotated, a flushing action is generated to provide shear force to the cellular organisms adhering to the sphere surfaces without generating vacuum or static effect upon the media within the enclosed system” (see page 17, lines 9-19). Here Berkes teaches flushing to remove the composition from a closed system.
Regarding claim 12, Berkes teaches wherein honey has been shown to have antimicrobial properties as well as anti-inflammatory effects due to the polysaccharide known as methyl glyoxal, MGO and teaches that this is learned from an article which discusses the origin of the honey is from Leptospemum (see page 31, lines 20-25).
Regarding claim 13, Berkes teaches inhibiting biofilms on cochlear and middle ear implants (see page 23, lines 18-20 also see page 25, line 20-22).
Regarding claim 19, Berkes teaches the composition in the form of a spray (see page 24, lines 29-30).
Regarding claim 20, Berkes teaches “the compositions of the subject invention can prevent or inhibit the formation of pathogenic biofilms, and/or reduce, control or eliminate existing pathogenic biofilms via variety of mechanisms, including preventing, inhibiting, and/or disrupting the deposition, adhesion, and/or anchoring of biofilms or pathogenic microorganisms to biological or nonbiological surfaces (seepage 20, lines 14-17).
Berkes does not particularly teach that the honey is to be fractionated among the other components such as jelly, propolis, royal jelly, bee bread or bee pollen, however this selection is rendered obvious given that the invention is directed to compositions comprising honey and with the knowledge of the anti-film forming properties discussed about honey (see the above rejection). Particularly, Berkes teaches in that during the preparation process the honey, among the other components may be processed through fractionation of proteins, sugars, pollens, polyphenols (see above) thus, selecting for the honey to be fractionated would have been prima facie obvious.
Berkes does not particularly teach that the honey is within the % by weight of composition however Berkes teaches compositions by volume and the percentage of honey per composition optimizing the honey in order to have a standard biofilm inhibitory concentration.
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to optimize the amount of honey to be within the amount being claimed because Berkes teaches optimizing the honey to have a standard biofilm inhibitory concentration. Honey is the active ingredient and therefore is the optimizable parameter for inhibiting biofilm formation, thus this optimization is well within the purview of any skilled artisan, especially since the activity is already described in the prior art. It would have also been obvious to remove any DNA markers from Manuka pollen as Berkes teaches filtering and ultrafiltering the honey with pore sizes smaller than pollen grains and includes references to extraction of extracellular DNA.
It would have also been obvious to remove the composition from the system once the biofilm is disrupted as Berkes teaches flushing out the system in order to remove the cells producing the biofilm however this action would also remove the composition. Leaving the composition and maintaining the composition in the closed water system for an amount of time and wherein that time is for 60 minutes would have been obvious for reasons of having the active ingredients in contact with microbial surfaces long enough to inactivate/destroy pathogens.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Eva Berkes and Nicholas Monsul (WO2012118535A1) and W. Russell Markesbery and Eugene J. Pancheri (JP2019517900A).
Berkes teaches wherein the invention comprises one or more probiotic organisms, anti-microbial honey and other ingredients (see abstract).
Berkes teaches wherein “During preparation of the invention, various samples comprised of hive products such as honey, propolis, royal jelly, bee bread or bee pollen may be processed using various methods and/or may remain unprocessed. Processing may include fractionation of proteins, sugars, pollens, polyphenols or other constituents via chemical means, high performance liquid chromatography, physical (filter) ultrafiltration, gel electrophoresis, heat treatment, enzymatic treatment, micronization, ultrasonication, crystallization, dehydration or lyophilization” (see page 34, lines 4-10).
Berkes teaches “Biofilms have broad-ranging clinical relevance in all areas of medicine. Bacterial biofilms such as those commonly associated with Pseudomonas and Staphylococcus are known to be a cause of intractable infection as well as chronic low-grade inflammation. They consist of colonies of bacterial organisms that collectively secrete and form a protective layer of extracellular matrix material. The bacterial colonies in bacterial biofilms appear to be very resistant to the hosts' natural defenses as well as antibiotic treatments. Biofilms colonize virtually any surface in or on the human body to which these colonies can adhere. They often colonize biomaterials such as urinary catheters, transcutaneous intravenous lines and prosthetic heart valves” (see bottom of page 4 and top of page 5). Berkes also teaches wherein the composition is delivered through catheters (see page 25, lines 17-20, claim 19 and 28). This would at least indicate introducing to a closed water system a composition comprising a fractionated honey in an amount effective for disrupting a biofilm in the closed water system, because with the broadest reasonable interpretation a catheter would be the closed water system as urine is made up of water as its main component and the catheter would need to be closed off to inhibit introduction of any microorganisms.
Berkes also teaches the reasons for the antimicrobial effects of the honey has been shown to be from a polysaccharide known as methylglyoxal and from Leptospermum scoparium (see page 31, lines 24-25).
Berkes does not specifically teach that the closed water system is a metal vat and the biofilm is formed on a surface of the metal vat.
Markesbery teaches “the present disclosure relates to a method and system for disinfecting a surface in a volumetric space by forming a peracid in the reaction layer directly in situ on the surface to be disinfected. In particular, the peroxide compound and the organic acid compound are sequentially dispersed in the volume space to prevent the formation of peracid until the two reactants contact each other at the surface to be disinfected. The peracid reactant compound can be dispersed as electrostatically charged droplets or as a vapor. In particular, a system is provided for sequentially dispersing the peracid reactant compounds by electrostatic spray” (see abstract). Markesbery teaches “ in other embodiments, at least one of the first aqueous composition or the second aqueous composition further comprises one or more natural biocidal compounds commonly found in Manuka honey and essential oils. In a further embodiment, the natural biocidal compounds are methylglyoxal, carvacrol, eugenol, linalool, thymol, p-cymene, myrcene, borneol, camphor, caryophilin, cinnamaldehyde, geraniol, nerol, citronerol, and menthol thereof It is selected from the group consisting of combinations and the like. In still further embodiments, the aqueous composition comprises about 0.001 to about 1% by weight of the natural biocidal compound” (see page 8, 8th para.).
Markesbery teaches that methylglyoxal can be used to enhance the peracid on surfaces being disinfected as it has been known for its antimicrobial properties and is effective against multiple drug-resistant bacteria (see page 16, para. 4).
Markesbery teaches applying the compositions to the inside and outside of metal transport containers and teaches where it can be applied to various surfaces including metal (see page 21, para. 5-6). With the broadest reasonable interpretation of metal vat, a metal shipping container can also be considered a metal vat as a common definition for a metal vat is a large industrial container used for storing.
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to recognize the potential for using fractionated honey in amounts effective to disrupt biofilm formation in a closed water system which is also a metal vat. Berkes and Markesbery teach that honey, specifically Manuka honey comprises of methylglyoxal which is a known antimicrobial against multiple resistant bacteria. Berkes teaches using it in closed water systems however does not specifically teach using it on metal surfaces of closed water systems. Markesbery teaches compositions including the active components from Manuka honey to spray onto metal containers so including them would also have been prima facie obvious. Therefore it can be appreciated that the honey applied to closed water systems of Berkes could also be useful for closed water systems including metal vats. The honey contains active components known to disrupt biofilm formations in closed water systems and using it on metal vats would have been prima facie obvious.
Conclusion
Currently 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655