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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2025 has been considered by the examiner.
Status of the Claims
The response and amendment filed 10/28/2025 is acknowledged.
Claims 1-26 are pending.
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 10/28/2025 is acknowledged.
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Claim 11-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Claims 5, and 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 10/28/2025.
Claims 1-4, 6, 9, and 10 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 and 10 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 Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
Claim 9 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 9 recites such as 1 ng/day to 200 µg/day. Applicant may delete “such as” and instead include a wherein clause to overcome this rejection.
Clarification is required.
Claim 10 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 10 includes the recitation of such as a steroid or an NSAID, and 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.
Applicant may delete “such as” and instead include proper Markush language or wherein clauses to overcome this rejection.
Clarification is required.
Claim Rejections - 35 USC § 102
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 1-4, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lu, WO 2019140796 A1.
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 gel (natural polymer). 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 anticipates the subject matter of claims 1-4, 6, and 9.
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 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 above are reiterated here.
Lu teaches an endotracheal tube comprising an antimicrobial peptide which is effective to reduce biofilm formation and limit bacterial presence on the device (Lu, e.g., 0046).
Lu does 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 before the effective filing date of the presently claimed invention to modify an endotracheal tube comprising an antimicrobial coating containing an antimicrobial peptide 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 had a reasonable expectation of success because both references teach 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 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.
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 gel (natural polymer). 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 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 before the effective filing date of the presently claimed invention to modify antimicrobial coatings of Lu’s endotracheal tubes using techniques known from Miller to improve Lu’s 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 in the same way reported by Miller. The skilled artisan would have had a reasonable expectation of success because both references teach improvements to implantable medical devices for reducing device related microbial growth, e.g., biofilms.
Accordingly, the subject matter of claims 1-4, 6, and 9-10 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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.
The combined teachings of Lu 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 before the effective filing date of the presently claimed invention to modify antimicrobial coatings of endotracheal tubes suggested by Lu 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 in the same way reported by Miller. The skilled artisan would have had a reasonable expectation of success because each reference teaches improvements to implantable medical devices for reducing device related microbial growth, e.g., biofilms.
Accordingly, the subject matter of claims 1-4, 6, and 9-10 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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615