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 .
Claim Rejections - 35 USC § 112
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 2-3 and 12-13 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.
Regarding claims 2-3 and 13, these claims are unclear as it is not made clear how much reduction in bacterial growth is required to establish the claimed effectiveness in increasing shelf-life. For the purposes of this office action, any antimicrobial coating will be assumed to meet this limitation absent persuasive evidence to the contrary.
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.
Claim(s) 1-4, 7-8, 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2003/0091612 to Sabesan (Sabesan hereinafter) in view of KR 2003/0015593 to Chun et al. (Chun, copy and translation provided herewith) and WO 2015/107476 (the ‘476 publication hereinafter.
Regarding claim 1, Sabesan teaches an array of polyolefin articles having antimicrobial agents thereon. Sabesan specifically teaches bottles and closed-ended tubes (paragraph 28) may be made with the coating, either of which comprises a lumen and used to contain fluids (paragraph 29), including an antimicrobial coating (not illustrated, see examples beginning at paragraph 34) which is effective to inhibit the growth of microbes (paragraphs 16 and 30). Sabesan further teaches that metal salts, specifically including silver salts, may be used to enhance antimicrobial properties (paragraph 26). Sabesan does not teach the use of the recited silver oxide. Chun teaches a silver salt generally, and particularly teaches that the recited silver oxide may be used in medical applications (see third paragraph under TECH-SOLUTION in translation and first full paragraph of page 8, “Applications in the fourth aspect”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the recited compound in the article of Sabesan as an implementation of the silver salt desired by Sabesan. Regarding the application method, the ’476 publication teaches that ALD or PECVD techniques are known and inexpensive techniques for applying coatings. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use such techniques to apply the coating of Chun to the article of Sabesan.
Regarding claim 2, Sabesan teaches effectiveness at killing bacteria (see e.g. paragraph 47) and further teaches that the product may have medical applications involving sterile fluids (see e.g. paragraph 30, “IV tubing and bags).
Regarding claims 3-4, Sabesan teaches that applicators may be used (paragraph 29). Applicators are held herein to be susceptible to bacterial contamination. Furthermore, as best understood by the examiner, the coating of Sabesan is effective to extend shelf life after first use.
Regarding claim 7, Sabesan teaches the use of bottles and tips (paragraph 29 and claim 12).
Regarding claim 8, Sabesan teaches the use of sprayers (e.g. claim 26) and use in nasal applications (paragraph 29).
Regarding claims 10-11, the claimed fluids stored within the package are taught by Sabesan.
Regarding claim 13, as best understood by the examiner, the coating of Sabesan is effective to extend shelf life three months after first use.
Regarding claim 14, Sabesan teaches a cosmetics container (paragraph 29).
Regarding claim 15, Sabesan teaches cosmetics applicators (paragraph 29).
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabesan in view of Chun and WO 2015/107476 (the ‘476 publication hereinafter).
Regarding claim 28, Sabesan teaches the limitations of claim 1 from which claim 28 depends, but does not teach the use of zinc oxide, titanium dioxide, or silver oxide. The ‘476 publication relates to antimicrobial coatings generally and particularly teaches that zinc oxide or titanium dioxide may be used to enhance antimicrobial properties (paragraph 5). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a coating comprising zinc oxide or titanium dioxide as taught by the ‘476 publication to the article of Sabesan in order to enhance its antimicrobial properties.
Regarding claims 35 and 36, the ‘476 publication teaches zinc oxide and titanium dioxide may be applied with ALD techniques (paragraph 9).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabesan in view of KR 2003/0015593 to Chun et al. (Chun, copy and translation provided herewith) and the ‘476 publication.
Regarding claim 37, Sabesan teaches the limitations of claim 1 from which claim 28 depends, and further teaches that metal salts, specifically including the claimed composition (see below), may be used to enhance antimicrobial properties (paragraph 26). Sabesan does not teach the use of the recited silver oxide. Chun teaches a silver salt generally, and particularly teaches that the recited silver oxide may be used in medical applications (see third paragraph under TECH-SOLUTION in translation and first full paragraph of page 8, “Applications in the fourth aspect”). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the recited compound in the article of Sabesan as an implementation of the silver salt desired by Sabesan. Regarding the application method, the ’476 publication teaches that ALD or PECVD techniques are known and inexpensive techniques for applying coatings. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use such techniques to apply the coating of Chun to the article of Sabesan.
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Claim(s) 39, 41 and 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabesan in view of US Pre-Grant Publication 2015/0290080 to Weikart et al. (Weikart).
Regarding these claims together, Sabesan teaches the limitations of claim 1 as discussed above, but is silent to an oxygen barrier coating and a pH protective coating. Weikart teaches that an oxygen barrier and a pH protective coating may be applied to an article in order to protect the fluids therein (paragraph 6), specifically including a SiOxCy coating (288, see paragraphs 39, 144) and a pH protective layer (286). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide such coatings to the article of Sabesan in order to protect the fluids therein from oxygen, and to provide the antimicrobial coating next to the fluid in which microbes might be found.
Regarding claims 138 and 140-141, Sabesan teaches an array of polyolefin articles having antimicrobial agents thereon and which may include an eye dropper bottle (see e.g. paragraph 29 and claim 29, “dropper tip”). Sabesan specifically teaches bottles and closed-ended tubes (paragraph 28) may be made with the coating, either of which comprises a lumen and used to contain fluids (paragraph 29), including an antimicrobial coating (not illustrated, see examples beginning at paragraph 34) which is effective to inhibit the growth of microbes (paragraphs 16 and 30), but is silent to an oxygen barrier coating and a pH protective coating. Weikart teaches that an oxygen barrier and a pH protective coating may be applied to an article in order to protect the fluids therein (paragraph 6), specifically including a SiOxCy coating (288, see paragraphs 39, 144) and a pH protective layer (286). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide such coatings to the article of Sabesan in order to protect the fluids therein from oxygen, and to provide the antimicrobial coating next to the fluid in which microbes might be found. Regarding the functional limitations, these are presumed to be met as the compositions disclosed by the prior art have the same chemical structure and application as disclosed by the applicant. Regarding the multidose sizing of the dropper bottle, one of ordinary skill would expect this as a single dose unit would require neither the dropper nor the antimicrobial layer. See also MPEP 2144.04 IV. A. Finally, regarding the ophthalmic composition, given the generic nature of the limitation, the examiner takes Official Notice that such compositions have been known for the treatment of various conditions well before the effective filing date of the instant application, based on the commercial availability of products containing such in that timeframe.
Regarding claim 139, Weikart teaches the recited ranges (paragraph 39, “The same particular coating or layer can alternatively be characterized by XPS only, without accounting for hydrogen, and thus expressed by the formula SiOxCy, in which x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3”).
Response to Arguments
Applicant’s arguments, see page 8, filed 15 December 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chun and the ‘476 publication as discussed above.
With respect to the argument that one of ordinary skill in the art would not understand how to apply the anti-microbial coating of Gieraltowska (‘the 476 publication), the examiner is not persuaded. Processes of coating article interiors are well known in the art generally, including vapor deposition processes. Applicant has not provided evidence of any particular difficulty involved or that an innovative deposition process is used to form the invention. Accordingly, the teachings of the ‘476 publication are sufficient to establish a prima facie case of obviousness. Furthermore, with respect to applicant’s argument that the mode of operation of Sabesan would be changed, the examiner is not persuaded, since, as noted above, Sabesan is clearly cognizant of the use of antimicrobial silver compounds such as those in the claimed invention (paragraph 26). The examiner is therefore not persuaded that alternate manufacturing techniques directed towards similar materials to those contemplated by Sabesan should be considered to change the mode of operation in a non-obvious way.
In response to applicant’s arguments regarding the Weikart reference, the examiner has amended the rejection above and holds that the combination is properly considered obvious.
Conclusion
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 19 February 2026