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 .
DETAILED ACTION
Claims 2 and 4 are canceled. Claims 16-17 are new. Claims 1, 3, and 5-17 are pending.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-12) in the reply filed on 11/14/2025 is acknowledged. The traversal is on the ground(s) that a search for art drawn to a method for coating a substrate material (claims 1-12) is likely to reveal art drawn to the article of manufacture (claim 14) comprising the substrate material coated according to the method and vice versa, as both relate to substrate material from polymers and ferrous metals coated with a biosurfactant produced by at least one strain selected from the group consisting of Pseudomonas aeruginosa, Bacillus amyloliquefaciens and Serratia marcescens. See the remarks, specifically the paragraph bridging p. 6-7. This is not found persuasive because the instant application is filed under 35 U.S.C 371. Therefore, the restriction/election is based on a lack of unity analysis, such that search and examination burden are not criteria relied upon in that analysis. The Requirement for Restriction/Election, mailed 09/15/2025 demonstrated that Groups I, II and IV lack unity a priori; and Groups I and III lack unity a posteriori over Heyse (WO 96/38726). Applicant further argues that Heyse does not disclose the unifying technical features of the method of claims 1-12 and of claim 14 namely “a substrate material selected from polymers and ferrous metals coated with a biosurfactant produced by at least one strain selected from the group consisting of Pseudomonas aeruginosa, Bacillus amyloliquefaciens and Serratia marcescens”. See the remarks, p. 7 paragraph 1. This is not found persuasive because the argument is not germane to the mailed Requirement for Restriction/Election. The technical feature referenced by Applicant was added to claims 1 and 14 in the amendment filed 11/14/2025, such that the feature was not present in the independent claims at the time the Requirement for Restriction/Election was mailed, 09/15/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant has canceled claims 2 and 4, and added claims 16-17 in the amendment filed on 11/14/2025. Claims 16-17 depend from withdrawn claim 14, so claims 16-17 are withdrawn from further consideration. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/14/2025.
Applicant's election of polymers and ferrous metals (Genus I) and functionalizing the carboxylic group of the biosurfactant in the presence of N-hydroxysuccinimide under an anhydrous Steglich esterification reaction (Genus II) in the reply filed on 11/14/2025 is acknowledged. See the remarks p.7 last full paragraph Because applicant did not distinctly and specifically point out the supposed errors in this restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 7 and dependent claim 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
Accordingly, claims 1, 3, 5-6, and 9-12 are under consideration in this action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The instant claims are entitled to an effective filing date of 09/25/2020.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 recites “A coating method for coating” in line 1, which is redundant, and the term “material” in line 1, line 4 and line 6 is superfluous. Claim 1 preamble can be amended to: “A method for coating a surface of a substrate with a biosurfactant.
Claim 1 recites “covalently to bond” in line 5, which is grammatically incorrect and should be replaced with “covalently bonding”.
Claim 6 recites “N-Hydroxylsuccinimide” in line 4, which can be lowercased to “N-hydroxylsuccinimide”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 3, 5-6, and 9-12 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 1 recites “the biosurfactant” in line 5, which renders the claim indefinite because in one interpretation “the biosurfactant” refers to the modified biosurfactant, such that the modified biosurfactant is required to be covalently bound to the functionalized surface; and under an alternative interpretation “the biosurfactant” refers to the biosurfactant before it is modified. To obviate this rejection, “the biosurfactant” in line 5 can be replaced with “the modified biosurfactant”.
Claims 3, 5-6, and 9-12 depend from claim 1 and are rejected for the reason set forth above.
Claim 3 recites “wherein the polymer is high-density polyethylene, or polyvinyl chloride, and the ferrous metal is stainless steel”, which renders the claim indefinite because it is unclear whether one or two substrate materials are required. Claim 3 depends from claim 1. Claim 1 requires the substrate material to be selected from polymers and ferrous metals. Therefore, claim 3 can be interpreted as requiring one substrate material, such that if the substrate material is a polymer, then the polymer is high-density polyethylene or polyvinyl chloride; and if the substrate material is ferrous metal, then the ferrous metal is stainless steel. Under an alternative interpretation, claim 3 requires two substrate materials because claim 3 explicitly recites “the polymer is…and the ferrous metal is” such that the claim may require high-density polyethylene or polyvinyl chloride, and stainless steel.
Claim 6 recites “activated ester” in line 4, which renders the claim indefinite because the structural distinction between an activated ester and any other ester is unclear. An “activated ester” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. To obviate this rejection, “activated ester” can be amended to “ester”.
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, 3, 5, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zoysa (ACS Applied Materials & Interfaces, 2017, 9(2), 1373-1383.) in view of Chebbi (J Basic Microbiol 2017;57:364–375).
Relevant to the interpretation of instant claim 1: The instant specification discloses that polymers include silicone. See p. 50 lines 25-26.
Regarding claim 1, Zoysa teaches covalently immobilizing cysteinylated battacin lipopeptide on silicon and titanium. See p. 1380 left column last passage. Zoysa teaches synthesizing (i.e. modifying) cysteinylated versions of battacin lipopeptide GZ3.27. Zoysa discloses that the addition of cysteine is essential in order to achieve controlled immobilization. See p. 1374 left column last passage. These cysteine-modified lipopeptides include GZ3.163. See table 1. Zoysa teaches silanizing piranha-treated surfaces including silicon (i.e. polymer) wafers and titanium with APTES (i.e. silane linker 3-triethoxysilylpropan-1-amine), and stabilizing the APTES monolayer on the surfaces. See p. 1381 left column first full paragraph. The APTES coated surfaces are functionalized. See. p. 1381 left column paragraph 2. The cysteine-modified lipopeptide GZ3.163 is coupled to the functionalized surfaces. See p. 1381 left column paragraph 3. Zoysa discloses that the immobilization of the lipopeptide on a silicon or titanium surface prevents Pseudomonas aeruginosa biofilm formation. See p. 1380 right column first passage.
Zoysa does not teach a biosurfactant produced by at least one strain selected from the group consisting of Pseudomonas aeruginosa, Bacillus amyloliquefaciens and Serratia marcescens.
Chebbi teaches the ability of Pseudomonas aeruginosa W10 rhamnolipids (i.e. biosurfactant) to inhibit biofilm formation and disrupt biofouling on stainless steel surfaces. See p. 365 right column first full paragraph. Chebbi discloses that the rhamnolipid from P. aeruginosa W10 inhibits the formation of biofilm of P. aeruginosa W10. See p. 373 right column first passage.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Chebbi’s Pseudomonas aeruginosa W10 rhamnolipid biosurfactant for Zoysa’s battacin lipopeptide. One of ordinary skill in the art would have been motivated to do so because Chebbi suggests that the biosurfactant inhibits P. aeruginosa biofilm formation. There would have been a reasonable expectation of success because Zoysa demonstrates coating a polymer surface with a battacin lipopeptide (which is a biosurfactant) in order to prevent P. aeruginosa biofilm formation. Thus, Chebbi’s biosurfactant predictably serves the same function as Zoysa’s biosurfactant.
Regarding claim 3, Zoysa teaches covalently immobilizing cysteinylated battacin lipopeptide on silicon and titanium. See p. 1380 left column last passage. Zoysa discloses that the immobilization of the lipopeptide on a silicon or titanium surface prevents Pseudomonas aeruginosa biofilm formation. See p. 1380 right column first passage.
Zoysa does not teach a high-density polyethylene, polyvinyl chloride, or stainless steel as the substrate material.
Chebbi teaches the ability of Pseudomonas aeruginosa W10 rhamnolipids (i.e. biosurfactant) to inhibit biofilm formation and disrupt biofouling on stainless steel surfaces. See p. 365 right column first full paragraph.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute Chebbi’s stainless steel for Zoysa’s titanium. One of ordinary skill in the art would have been motivated to do so because Chebbi suggests that stainless steel is commonly used by industries and has an established record of biofilm formation responsible for deterioration and corrosion (see p. 365 left column first passage). There would have been a reasonable expectation of success because Zoysa demonstrates covalently immobilizing a biosurfactant on a titanium metal to prevent P. aeruginosa biofilm formation; and Chebbi teaches a rhamnolipid that inhibits P. aeruginosa biofilm formation of stainless steel.
Regarding claim 5, Zoysa teaches increasing the number of surface available hydroxyl groups essential for optimal silanization, by thoroughly cleaning the surfaces
with an oxidizing mixture consisting of H2O2 and H2SO4. See p. 1375 left column first paragraph. See scheme 1 for the hydroxylation of the surface using H2O2:H2SO4.
Regarding claim 9, Zoysa teaches using APTES as the linker. See p. 1374 right column last passage.
Regarding claim 10, Chebbi teaches that P. aeruginosa W10 isolate produces rhamnolipid (i.e. glycolipid) comprising a mixture of congeners with the Rh-Rh-C10-C10 di-rhamnolipid as the major component. See p. 371 the sentence bridging the left and right columns.
Regarding claim 11, Chebbi discloses that the rhamnolipid from P. aeruginosa W10 inhibits the formation of biofilm of P. aeruginosa W10. See p. 373 right column first passage.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zoysa (ACS Applied Materials & Interfaces, 2017, 9(2), 1373-1383.) and Chebbi (J Basic Microbiol 2017;57:364–375), as applied to claims 1, 3, 5, and 9-11 above, and further in view of Kerr (US 2019/0127411), with evidence from PubChem (Compound Summary for CID 5458394, Rha2 C10-C10).
Regarding claim 6, Chebbi teaches that P. aeruginosa W10 produces rhamnolipid comprises a mixture of congeners with Rh-Rh-C10-C10 di-rhamnolipid (i.e. biosurfactant that has a carboxylic group) as the major component. See p. 371 the sentence spanning the left and right columns. The instant specification discloses that the rhamnolipid produced by Pseudomonas aeruginosa includes a carboxylic group. See p. 16-18.
Zoysa and Chebbi do not teach the step of modifying the biosurfactant to promote its reactivity with the silane linker comprises functionalizing the carboxylic group of the biosurfactant by generating activated ester in the presence of N-hydroxysuccinimide under an anhydrous Steglich esterification reaction.
Kerr teaches purified biosurfactants that include a hydrophobic lipid component including a carboxyl end and a hydroxyl end, wherein a carbohydrate moiety is at the hydroxyl end of the lipid component. The acyl chain length of the lipid component can be C10 and the carbohydrate moiety can include a rhamnose. See [0005]. Kerr teaches scheme 4: which is the synthesis of the tridecanoic acid moiety (17). See p. 10. discloses that upon generating 3-(tert-bityldimethylsilyl)decanoic acid (15), the building block can be linked twice to 3-hydroxydecanoic acid (14) via Steglich esterification to generate silylated di- and tri-decanoic acid (16 and 17, respectively) and other glycolipids. In this approach, carboxylic acid 15 is activated as a N-hydroxysuccinimide ester prior to the addition of 14, obviating an additional protecting group for the carboxylic acid functionality of 14. See [0069]. Kerr suggests that the approach can be used to introduce modify the lipid portion of a glycolipopeptides. See [0070] Shown below is scheme 4. As disclosed in the caption of scheme 4, the reaction (g) takes place in the presence of NHS, which is an abbreviation for N-hydroxysuccinimide as stated in the instant specification (p. 4 line 14).
[AltContent: textbox ((left) structure of Rha C10-C10 from evidentiary reference PubChem; (right) scheme 4 on page 10 annotated for clarity.)]
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to apply the Kerr’s Steglich esterification to Chebbi’s Rh-Rh-C10-C10 di-rhamnolipid. One of ordinary skill in the art would have been motivated to do so because Kerr suggests that the approach can be used to modify the lipid portion of a biosurfactant. There would have been a reasonable expectation of success because Chebbi teaches Rh-Rh-C10-C10 di-rhamnolipid, and Kerr teaches modifying biosurfactants comprising a rhamnose carbohydrate and a C10 lipid.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zoysa (ACS Applied Materials & Interfaces, 2017, 9(2), 1373-1383.) and Chebbi (J Basic Microbiol 2017;57:364–375), as applied to claims 1, 3, 5, and 9-11 above, and further in view of Coutte (US 2015/0045290).
Regarding claim 12, Chebbi teaches the biosurfactant production from P. aeruginosa strain W10 on mineral salt medium and nutrient broth medium supplemented with glycerol over 5 days (i.e. growing bacteria cells of the at least one strain). See the paragraph spanning p. 365-366. For biosurfactant extraction, cell-free supernatants are obtained after centrifuging (i.e. removing a bulk of the bacterial cells) and adjusting the pH to 3.0 using diluted HCl (i.e. acidifying the supernatant, thereby to yield crude extract). It is then subjected to extractions and the organic phase is dried and evaporated. See p. 366 left column first full paragraph. Chebbi teaches collecting the partially purified biosurfactant, and allowing for the removal of impurities from the crude rhamnolipid extract using solid phase extraction. Chebbi the solid phase extraction uses a solvent mix of chloroform and methanol (i.e. solvent extraction) to elute mono-rhamnolipids, and CHCl3:CH4 (i.e. solvent extraction) for the di-rhamnolipids. All eluted fractions (i.e. fractionating) are collected. See p. 366 left column second paragraph.
Chebbi does not teach freeze drying the precipitate; and at least partially purifying the freeze-dried precipitate by solvent extraction, thereby to yield a purified crude extract of the biosurfactant compounds; recovering a mixture of the biosurfactant compounds from the purified crude extract of biosurfactant compounds by a liquid membrane process.
Coutte teaches increasing biosurfactant production yield. See [0022]. Coutte teaches a microorganism capable of producing a biosurfactant that may be chosen from the group comprising P. aeruginosa. See [0032]. Coutte teaches biosurfactant chosen from a group comprising lipopeptide, and glycolipid. The glycolipid may be rhamnolipid. See [0023]. Coutte teaches concentrating lipopeptides by evaporation. See [0251]. Coutte teaches freeze drying lipopeptides. The freeze-drying is performed directly on a concentrated solution from the evaporation. Coutte suggests that the freeze-drying step improves the preservation of the product. See [0252]. Furthermore, Coutte teaches ultrafiltration in the presence of methanol. See [0247]. Coutte discloses that the ultrafiltration step passes mycosubtilin monomers (e.g. biosurfactant) through the pores of a membrane. See [0248]. Couttes teaches combining air/liquid membrane contactor (i.e. liquid membrane) with the ultrafiltration. See [0060]. Coutte discloses that the [air/liquid membrane contactor] device comprises ultrafiltration means. Coutte suggests that the ultrafiltration means separate the liquid into several fractions. See [0235].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to apply Coutte’s freeze-drying to Chebbi’s evaporated biosurfactant extract; and to further apply Coutte’s liquid membrane process to the methanol solvent extract of Chebbi and Coutte. One of ordinary skill in the art would have been motivated to apply Coutte’s freeze-drying to Chebbi’s evaporated biosurfactant extract, because Coutte suggests that the step can improve preservation. There would have been a reasonable expectation of success because Chebbi demonstrates evaporating a biosurfactant containing organic phase; and Couttes suggests that the freeze-drying can be performed directly on a concentrated biosurfactant containing solution after evaporation. One would be further motivated to apply Coutte’s liquid membrane process to Chebbi and Coutte’s methanol solvent extract, because Coutte suggests that such liquid membrane process can increase biosurfactant production yield. There would have been a reasonable expectation of success because Chebbi demonstrates extracting mono-biosurfactant with methanol; and Coutte’s teaches a liquid membrane process in which a biosurfactant monomers in methanol passed through a membrane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/K.C.B./Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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