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 . 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.
Status of the Claims
The response and amendment filed 05/11/2026 is acknowledged.
Claims 1-24, and 26-27 are pending.
Claim 27 is new.
Applicant’s election without traverse of Species A – endotracheal tube and Species B – Lasioglossin III in the reply filed on 10/28/2025 is acknowledged.
Applicant has indicated claims 1-4, 6, 9, and 10 read on the elected species.
Claim 11-26 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Claims 5, and 7-8 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 10/28/2025.
Claims 1-4, 6, 9, 10 and 27 are treated on the merits in this action.
After a search of the prior art, Species B has been expanded to encompass the species Musca domestica cecropin. Claims 1-4, 6, 9, 10 and 27 read on this species. See, e.g., claim 6: “a cecropin.”
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claim 9 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
The rejection of claim 10 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 pre-AIA the applicant regards as the invention.
The rejection of claims 1-4, 6, and 9 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lu, WO 2019140796 A1 has been withdrawn because of Applicant’s amendment.
Claims 1-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Mishra, J Mater Chem B, 2014 has been withdrawn because of Applicant’s amendment.
Claims 1-4, 6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Miller, US 20120121665 has been withdrawn because of Applicant’s amendment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Mishra, J Mater Chem B, 2014 as applied to claims 1-4, 6, and 9 above, and further in view of Miller, US 20120121665 has been withdrawn because of Applicant’s amendment.
Rejections based on Lu have been modified to address Applicant’s amendment.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has argued that Miller works with ethylene vinyl acetate copolymer, which is in fact hydrophobic; however, for this very reason, its teachings could not be combined with those of Lu or Mishra. Applicant argues that if a proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious. In re Ratti, 270 F.2d 810, 813, 123 USPQ 349, 352 (CCPA 1959). Applicant argues any attempted combination of Miller with Lu would indeed change the principle of operation of the latter given that a switch from hydrophilic to hydrophobic polymer would result. Applicant reminds the examiner that one cannot 'pick and choose' only those portions of a supporting reference that are compatible with a primary reference while ignoring others. Rather, the supporting reference must be relied on as a whole. See MPEP §2141.02.
This argument is unpersuasive. When viewing Miller as a whole, it is evident that Miller is not limited to only teaching ethylene vinyl acetate copolymer as the matrix polymer. From Miller, the skilled artisan was free to choose ethylene vinyl acetate if a non-biodegradable matrix is desired (Miller, e.g., 0040), chitosan as selected by Lu for a biodegradable matrix (Miller, e.g., 0041), or polylactic acid, polyglycolic acid and copolymers thereof for a more hydrophobic degradable matrix (Miller, e.g., 0041-0042). From Miller it is evident the skilled artisan would have understood that either hydrophobic polymers, e.g., ethylene vinyl acetate copolymers, or hydrophilic polymers, e.g., chitosan or other polysaccharides, may be selected as a reservoir matrix polymer for antimicrobial active agents on implantable devices (Miller, e.g., 0055). Taking the teachings of Lu into consideration, it is clear the skilled artisan understood from the combined teachings of Lu and Miller that modifying the matrix polymer from chitosan to a more hydrophobic polymer, e.g., ethylene vinyl acetate would retain the principle of operation by achieving the desired result of forming a reservoir matrix for antimicrobial agents on the surfaces of the device.
Modified Rejections Addressing Applicant’s Amendment
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 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.
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 1-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Cruz, Nanotechnology, 2017.
Citations in this rejection refer to the English translation attached.
This rejection applies to the species Musca domestica cecropin. The rejected claims read on this species of antimicrobial peptide. See, e.g., claim 6: “a cecropin.”
Lu teaches an endotracheal tube (airway intervention device) comprising a coating comprising an antimicrobial peptide and a chitosan. See Lu, e.g.., Abstract, claims. Peptide is Musca domestica cecropin (Lu, e.g., claims). Applicable to claims 3 and 9: Lu teaches the peptide on the endotracheal tube in a sustained release chitosan matrix (Lu, e.g., 0016).
Lu does not expressly teach the coating including hydrophobic polymers wherein the hydrophobic polymers form pockets into which one or more AMPs are trapped.
Cruz teaches improving AMP effectiveness by encapsulating AMPs in a polymeric particle, wherein the polymer is PLA or PLGA (Cruz, e.g., Abstract). Applicable to claims 1 and 3: The polymers PLA or PLGA are considered to be hydrophobic polymers. Cruz teaches loading AMPs into a polymer particle improves stability against physiological conditions found in the body, e.g., pH, ionic strength, reduce degradation and toxicity, offer site specific release, biocompatibility with tissues and cells, and improved bioavailability (Cruz, e.g., pg. 2, ¶ 2). The particles are made by an emulsion technique whereby the hydrophobic polymer contains water pockets inside the polymer matrix containing the AMP (Cruz, e.g., pg. 3, 2.4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a coating on an endotracheal tube containing an antimicrobial polymer, Musca domestica cecropin, by incorporating the AMP encapsulated as an emulsion inside PLA or PLGA polymer matrix with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar antimicrobial peptide delivery techniques in the same way. The skilled artisan would have been motivated to make this modification for benefits including improved AMP stability and effectiveness noted by Cruz. The skilled artisan would have had a reasonable expectation of success since both documents teach techniques for delivery of AMPs.
Accordingly, the subject matter of claims 1-4, 6, and 9 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Cruz, Nanotechnology, 2017 and Mishra, J Mater Chem B, 2014.
Citations in this rejection refer to the English translation attached.
This rejection applies to the elected species lasioglossin III.
The teachings of Lu and Cruz above are reiterated here.
The combined teachings of Lu and Cruz teach an endotracheal tube comprising an antimicrobial peptide encapsulated in a hydrophobic polymer on a surface, which antimicrobial peptide is effective to reduce biofilm formation and limit bacterial presence on the device (Lu, e.g., 0046).
The combined teachings of Lu and Cruz do not expressly teach the coating comprising the elected species lasioglossin III.
Mishra teaches lasioglossin III was known and used as an antimicrobial peptide on catheters to reduce biofilm formation and catheter associated infection resulting from pathogens including E. coli, S. aureus, P. aeruginosa and E. faecalis (Mishra, entire document, e.g., Abstract, conclusion, pg. 1710 and fig. 1).
At least E. coli and S. aureus and P. aeruginosa are microbes reported in Lu as responsible for endotracheal intubation problems (Lu, e.g., 0002).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify an endotracheal tube comprising an antimicrobial coating containing an antimicrobial peptide as understood from Lu and Cruz by incorporating lasioglossin III in the coating to achieve predictable results. Since Lu teaches formulating the coating with antimicrobial peptides which inhibit biofilm formation, the skilled artisan would have been motivated to include other, art recognized antimicrobial peptides like lasioglossin III which was known as effective for reducing biofilm formation of the same bacteria on similar catheters. The skilled artisan may have seen this modification as combining known antimicrobial peptides, recognized in the art for reducing biofilm formation on similar catheters, to arrive at a catheter having the same desired properties. Alternatively, the skilled artisan may have seen this modification as a substitution of one art recognized biofilm reducing antimicrobial peptide for another to achieve similar results. See MPEP 2144.06. The skilled artisan would have been motivated to encapsulate lasioglossin III in hydrophobic polymer particles for the benefits reported by Cruz. The skilled artisan would have had a reasonable expectation of success because Mishra teaches antimicrobial peptides for reducing biofilm formation on in-dwelling medical device surfaces.
Accordingly, the subject matter of claims 1-4, 6, and 9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 10 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Cruz, Nanotechnology, 2017 as applied to claims 1-4, 6, and 9 above and further in view of in view of Miller, US 20120121665.
Citations in this rejection refer to the English translation attached.
This rejection applies to the species Musca domestica cecropin. The rejected claims read on this species of antimicrobial peptide. See, e.g., claim 6: “a cecropin.”
The combined teachings of Lu and Cruz teach an endotracheal tube (airway intervention device) according to claim 1.
The combined teachings of Lu and Cruz do not expressly teach the coating material further comprising an anti- inflammatory agent, e.g., a steroid or an NSAID, or an additional molecule that impairs a bacterial or viral agent, e.g., a protein that interferes with pathogen attachment, colonization, a protein that enhances immune clearance of said agent, or a conventional antibiotic, e.g., azithromycin, tobramycin, ciprofloxacin, erythromycin, and amoxicillin.
Miller teaches implantable medical devices such as catheters, or tracheal stents or esophageal stents (Miller, e.g., 0091-0092), which devices comprise a polymer matrix containing an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor (Miller, e.g., 0023-0030). Miller teaches preferred microbial attachment/biofilm synthesis inhibitors include, e.g., non-steroidal anti-inflammatory drugs (NSAIDs) or additional antibiotics (Miller, e.g., 0012, 0027, 0034-0037, 0049 and claim 14).
The presence of both an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor in a medical device in accordance with the present invention provides distinct advantages over the use of, for example, only an antimicrobial agent. The use of such a dual mechanism for preventing microbial colonization and attachment is believed to have a synergistic effect. The synergy is related to the different mechanism of action of each of the bioactive agents. The antimicrobial agent not only kills a large percentage of microbes approaching a surface of the device, it also reduces the burden of microbes upon which the microbial attachment/biofilm synthesis inhibitor must act. Moreover, microbes that have attached to a surface produce a protective biofilm barrier after attachment. This biofilm barrier prevents or reduces the ability of antimicrobial agents from reaching the microbes. The antimicrobial agent is thereby rendered substantially less effective upon formation of the biofilm barrier. Therefore, if microbial attachment is prevented, biofilm synthesis is inhibited and the antimicrobial agent is rendered more effective. See Miller, e.g., 0037.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify antimicrobial coatings of endotracheal tubes suggested by Lu and Cruz using techniques known from Miller to improve the devices in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to render the antimicrobial agents more effective against biofilms in the same way reported by Miller. The skilled artisan would have had a reasonable expectation of success because Miller teaches this modification for improving effectiveness of antimicrobial agents.
Accordingly, the subject matter of claims 1-4, 6, 9-10, and 27 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 10 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, WO 2019140796 A1 in view of Cruz, Nanotechnology, 2017 and Mishra, J Mater Chem B, 2014 as applied to claims 1-4, 6, and 9 above and further in view of in view of Miller, US 20120121665
The combined teachings of Lu, Cruz and Mishra enumerated above teach a device according to claim 1, but do not expressly teach the coating material further comprising an anti- inflammatory agent, such as a steroid or an NSAID, or an additional molecule that impair a bacterial or viral agent, such as a protein that interferes with pathogen attachment, colonization, a protein that enhances immune clearance of said agent, or a conventional antibiotic, such as azithromycin, tobramycin, ciprofloxacin, erythromycin, and amoxicillin.
Miller teaches implantable medical devices such as catheters, or tracheal stents or esophageal stents (Miller, e.g., 0091-0092), which devices comprise a polymer matrix containing an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor (Miller, e.g., 0023-0030). Miller teaches preferred microbial attachment/biofilm synthesis inhibitors include, e.g., non-steroidal anti-inflammatory drugs (NSAIDs) or additional antibiotics (Miller, e.g., 0012, 0027, 0034-0037).
The presence of both an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor in a medical device in accordance with the present invention provides distinct advantages over the use of, for example, only an antimicrobial agent. The use of such a dual mechanism for preventing microbial colonization and attachment is believed to have a synergistic effect. The synergy is related to the different mechanism of action of each of the bioactive agents. The antimicrobial agent not only kills a large percentage of microbes approaching a surface of the device, it also reduces the burden of microbes upon which the microbial attachment/biofilm synthesis inhibitor must act. Moreover, microbes that have attached to a surface produce a protective biofilm barrier after attachment. This biofilm barrier prevents or reduces the ability of antimicrobial agents from reaching the microbes. The antimicrobial agent is thereby rendered substantially less effective upon formation of the biofilm barrier. Therefore, if microbial attachment is prevented, biofilm synthesis is inhibited and the antimicrobial agent is rendered more effective. See Miller, e.g., 0037.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify antimicrobial coatings of endotracheal tubes suggested by Lu, Cruz, and Mishra using techniques known from Miller to improve the devices in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to render the antimicrobial agents more effective against biofilms in the same way reported by Miller. The skilled artisan would have had a reasonable expectation of success because Miller teaches this modification for improving effectiveness of antimicrobial agents.
Accordingly, the subject matter of claims 1-4, 6, 9-10 and 27 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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