DETAILED ACTION
Response to Amendment
Applicant's amendment filed 6/16/2026 has been entered. Currently, claims 1 and 3-15 are pending and claim 2 is canceled.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 14/075630 and 61/731767, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Please see 112(a) rejections in section 5 below.
Specification
The Abstract filed 6/16/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
In the Abstract the limitations of a "metal oxides thereof, metal nitrides thereof, carbides thereof" and leaving out the fact that these materials are “tenacious inorganic coating” do not find support in the parent application as originally filed. Please see 112(a) new matter rejections for claims 1 and 11 below for an explanation.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, the phrase “400 C and for a time period” are objected to grammatically (two instances). The objection can be overcome by changing the phrase to “400 C for a time period” at the two instances it appears in claim 1, which is how the claim will be interpreted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1 and 3-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1 and 11, the Examiner does not find support for the limitations of “metal oxides thereof, metal nitrides thereof, carbides thereof” in the specification as originally filed. The materials listed earlier in the Markush group are oxides, nitrides or carbides, and therefore saying “metal oxides thereof, metal nitrides thereof, carbides thereof” does not find support and does not make sense. Please also see 112(b) below.
In claim 1, the term “about 30 minutes” does not find support in the specification as originally filed. The closest support for this term is at [0175], but when it talks about the time for depyrogenation, it is listed as 30 minutes and not “about 30 minutes” as claimed.
In claims 6 and 8, the Examiner does not find support for the limitations “at least” 260 C or 280 C in the specification as originally filed. It is clear from at least [0166] that depyrogenaton is performed within a range of temperatures or at about certain specific temperatures, and is not disclosed as an open-ended temperature range.
Claims 1 and 3-15 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.
In claims 1 and 11, the limitations “metal oxides thereof, metal nitrides thereof, carbides thereof” renders the claim indefinite as it is unclear to what the thereof is referring. The materials listed earlier in the Markush group are oxides, nitrides or carbides, and therefore saying “metal oxides thereof, metal nitrides thereof, carbides thereof” does not make sense. This rejection can be overcome by changing the phrase to “a metal oxide, a metal nitride, a carbide” which is how the claims will be interpreted.
Claims 6 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claims 6 and 8, the limitations of “at least 260 C” and “at least 280 C” fail to limit claim 1 as these claims seek to broaden the range of heating that is set forth in claim 1. Claim 1 has a closed range and claims 6 and 8 propose to amend the range to be open ended.
Claim Rejections - 35 USC § 103
Claims 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bicker et al. (US 2009/0155490) as evidenced by "Schott Technical Glasses" acquired from (http://www.us.schott.com/tubing/english/download/schott-brochure-technical-glasses_us.pdf).
Please note that the term "lubricous coating" and how the "coefficient of friction" is measured is defined at [0173]-[0177].
With regard to claims 1 and 3-15, Bicker et al. teach the treatment of glass hollow containers on both the inside and outside for pharmaceutical packaging [0001], [0016], and [0029]. The glass can be Fiolax glass and the coating can be SiOx among other materials, which read on applicants' tenacious inorganic coating [0027] and [0044]. Applicants state at [0125] of their specification that "Schott Fiolax" is a known Type I borosilicate glass for pharmaceutical packaging. The coating can be deposited at thicknesses greater than 5 nanometers [0027]; however, Bicker et al. do not specifically teach using the Fiolax glass with SiO2 coatings having the properties claimed.
It would have been obvious to one having ordinary skill to have made a Fiolax glass container with SiO2 coatings on the surfaces of the container having the thickness claimed as these are known materials in Bicker et al. for forming pharmaceutical containers and the thickness of the coating overlaps with the claimed range; hence, a prima facie case of obviousness exists.
Given the fact that Bicker et al. teach a pharmaceutical container having a glass composition and a tenacious inorganic coating identical to that claimed, the coated container of Bicker et al. will intrinsically possess the coefficient of friction, the coefficient of friction difference, the coefficient of friction change after undergoing a depyrogenation cycle at the conditions claimed, the horizontal compression strength difference, the horizontal compression strength change after undergoing a depyrogenation cycle at the conditions claimed and light transmission after depyrogenation as claimed.
With specific regard to claims 1, 11 and 15, as evidenced by pages 29-30 of "Schott Technical Glasses", the Fiolax brand neutral borosilicate pharmaceutical glass will meet each of the ISO 695, ISO 719, and DIN 12116 requirements and meet the pharmacopoeia standards in Europe and various other nations.
Given all of this evidence, it is the position of the Examiner that the Schott Fiolax glass will meet the Type 1 chemical durability according to USP 660, the Type 1 glass composition standard according to ASTM E438-92, the alkali resistance according to ISO 695, the hydrolytic resistance according to ISO 719, and the acid resistance according to DIN 12116 absent objective evidence to the contrary.
Claims 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bicker et al. (US 2009/0155490) in view of Brix (US 2011/0098172).
Please note that the Examiner is interpreting the phrases "lubricous coating" and "coefficient of friction" as explained above.
With regard to claims 1 and 3-15, Bicker et al. teach the treatment of glass hollow containers on both the inside and outside for pharmaceutical packaging [0001], [0016], and [0029]. The glass can be coated with SiOx among other materials, which read on applicants' tenacious inorganic coating [0027] and [0044]. The coating can be deposited at thicknesses greater than 5 nanometers [0027]; however, Bicker et al. do not specifically teach using aluminosilicate glass with SiO2 coatings with properties claimed.
Brix teaches a boron-free, zinc-free, phosphorous-free neutral glass that may be used as a packaging container for pharmaceutical products [0002]. Specifically, see Example B2 of Table 3 [0073]. The material may be comprise Na2O, CaO, and MgO along with the bulk being silica and alumina [0027]. The glass may have class 1 hydrolytic resistance according to ISO 719, class 2 acid resistance according to DIN 12116, and class 2 alkali resistance according to ISO 695 [0027].
Since Bicker et al. and Brix are both drawn to glass containers for pharmaceuticals; it would have been obvious to one having ordinary skill in the art to have used the glass containers of Brix as the glass containers of Bicker et al. This would be mere substitution for a known material for a known purpose. Additionally, it would have been obvious to have made the thickness of the coating the same as that claimed as there is an overlap in the thickness of the prior art with the thickness claimed; hence, a prima facie case of obviousness exists.
Given the fact that Bicker et al. in view of Brix teach a pharmaceutical container having a glass composition, a tenacious inorganic coating and a barrier coating identical to that claimed, the coated container of Bicker et al. in view of Brix will intrinsically possess the coefficient of friction, the coefficient of friction difference, the coefficient of friction change after undergoing a depyrogenation cycle at the conditions claimed, the horizontal compression strength difference, the horizontal compression strength change after undergoing a depyrogenation cycle at the conditions claimed and light transmission after depyrogenation as claimed.
Terminal Disclaimer
The terminal disclaimer filed on 6/16/2016 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 10307333, 10023495 and 10117806 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/16/2026, with respect to the specification objection, the objection to claim 11, the scope of enablement 112(a) rejection, the previous new matter 112(a) rejections, the previous 112(b) and (d) rejections have been fully considered and are persuasive. The relevant objections/rejections have been withdrawn.
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive.
Applicants argue on pages 11-12 of their Remarks that not all silicon oxide layers of Bicker et al. are lubricous layers as they form SiO2 networks that “are fundamentally incompatible with lubricity”.
The Examiner respectfully disagrees and notes that if the composition is the same, it must have the same properties, please see MPEP 2112.01. The coating composition is the same composition as claimed, e.g. SiO2 or a metal oxide coating, and therefore it must necessarily have the same properties as was established in the rejections above.
Applicants’ arguments on page 12 of their Remarks seem to suggest that only polymers or silicone oil can generate lubricity, but this does not make sense as applicants are claiming tenacious inorganic compounds, such as silicon oxide that have these properties. It would not make sense to state that the materials claimed can be a lubricous coating having the coefficient of friction claimed, while also saying only organic materials, e.g. polymers and silicone oils, can provide a lubricous coating with the defined coefficient of friction.
Applicants argue that Bicker et al. do not recognize that the layers are lubricous layers.
The Examiner respectfully disagrees and notes that this argument is not persuasive as it has been held that the inherent feature, i.e. being a lubricous coating with a specific coefficient of friction, need not be recognized at the relevant time, but only that the subject matter is necessarily present in the prior art reference, please see MPEP 2112. The Examiner has set forth a proper prima facie rationale that Bicker et al. would necessarily possess the properties claimed, and therefore the rejection remains proper.
Applicants argue on page 13 of their Remarks that the plasma treatments of Bicker et al. “are unlikely to form a lubricous layer”.
The Examiner respectfully disagrees and notes that there is no evidence or rationale to support this contention. In fact, the evidence would point to the opposite because the plasma treatments form layers having materials, e.g. silicon oxide, that are the same as claimed, and will therefore intrinsically be lubricous. As such, applicants’ argument is unpersuasive and the Examiner maintains that his position is proper for all of the reasons noted above.
Applicants argue on page 14 of their Remarks that the Bicker et al. in view of Brix rejection refers to claims that do not exist in the application, and therefore the “Applicant cannot be certain precisely how the references are applied in this rejection”.
The Examiner respectfully disagrees and notes that the statement of grounds of rejection sets forth what claims are rejected, i.e. 1-15, and the body of the rejection has a typographical error. The statement of grounds of rejection including the claims being rejected and the references used along with the rationale in the body of the rejection provides sufficient notice to let applicants know how the references are being applied.
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 GERARD T HIGGINS whose telephone number is (571)270-3467. The examiner can normally be reached M-F 9:30-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Ruthkosky can be reached at (571) 272-1291. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerard Higgins/Primary Examiner, Art Unit 1785
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