DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejections made in a previous Office action and not repeated below are hereby withdrawn.
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 .
Drawings
The drawings were received on November 11, 2025. These drawings are acceptable.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-8, 11, 12, 14, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schaut et al. (US 2020/0048139).
Regarding claim 1, Schaut discloses a glass article, such as pharmaceutical packages, that may include SiO2, Al2O3, B2O3, at least one alkali oxide, and at least one alkaline earth oxide, see abstract & [0002]. The reference further discloses the glass pharmaceutical package as a glass vial, which corresponds to a glass container comprising a first and second surface wherein the first surface is the outer surface of a glass container [0029].
The glass article may include: greater than or equal to 72 mol. % and less than or equal to 82 mol. % SiO2; greater than or equal to 1 mol. % and less than or equal to 6 mol. % Al2O3; greater than or equal to 3 mol. % and less than or equal to 16 mol. % B2O3; greater than or equal to 5 mol. % and less than or equal to 12 mol. % Na2O; greater than or equal to 0.30 mol. % and less than or equal to 2.5 mol. % K2O; greater than or equal to 0.10 mol. % and less than or equal to 6.00 mol. % MgO; and greater than or equal to 0.50 mol. % and less than or equal to 4.0 mol. % CaO [0007 & 0054].
Note that the ranges for SiO2, B2O3, Na2O and K2O overlap the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP 2144.05 I. Although the reference does not specifically disclose the claimed sum of Al2O3, SiO2 and B2O3, the ranges for each component disclosed by the reference render obvious the claimed sum. Similarly, while the reference does not specifically disclose the claimed ratio of Na2O to Al2O3, the ranges disclosed for each component render obvious the claimed ratio.
The reference further discloses the glass composition has an acid resistance of Class S1 or Class S2, a base resistance of Class A1 or Class A2 and a Type HGA1 hydrolytic resistance [0083].
Regarding claim 2, the reference discloses the glass composition includes greater than or equal to about 5 mol% and less than or equal to about 12 mol% Na2O [0053]. Additionally, the reference discloses the amount of K2O is greater than or equal to about 0.1 mol% and less than or equal to about 2.5 mol% [0054]. Note that the values disclosed for Na2O and K2O render obvious a total amount of Na2O and K2O that is at least 6 mol%. Further note in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP 2144.05 I.
Regarding claim 3, Schaut discloses the glass composition includes greater than or equal to 0.10 mol. % and less than or equal to 6.00 mol. % MgO; and greater than or equal to 0.50 mol. % and less than or equal to 4.0 mol. % CaO [0007]. Note that the values disclosed for MgO and CaO render obvious a total amount of MgO and CaO that is at most 2 mol%. Further note in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP 2144.05 I.
Regarding claim 4, the reference discloses the glass composition includes greater than or equal to 3 mol. % and less than or equal to 16 mol. % B2O3, which overlaps the claimed range [0007]; see MPEP 2144.05 I.
Regarding claim 5, the reference discloses the glass composition includes greater than or equal to 0.1 mol% and less than or equal to 6 mol% MgO, which overlaps the claimed range [0057]; see MPEP 2144.05 I.
Regarding claim 6, the reference discloses the glass composition includes greater than or equal to 0.1 mol% and less than or equal to 4 mol% CaO, which overlaps the claimed range [0058]; see MPEP 2144.05 I.
Regarding claim 7, the reference discloses the glass composition includes greater than about 0 mol% and less than or equal to 1 mol% SnO2, which overlaps the claimed range [0060]; see MPEP 2144.05 I.
Regarding claim 8, while the reference does not specifically disclose the claimed liquidus viscosity and the claimed temperature at which the viscosity of the glass composition is 200 P, the reference renders obvious the claimed composition. As such, it is expected that the disclosed composition renders obvious a glass article with same properties as the claimed glass article; see above discussion, Applicant’s specification Tables 1 & 2 and MPEP 2112.01 II “if the composition is physically the same, it must have the same properties.”
Regarding claim 11, the reference discloses the glass composition includes greater than or equal to about 5 mol% and less than or equal to about 12 mol% Na2O [0053]. Additionally, the reference discloses the amount of K2O is greater than or equal to about 0.1 mol% and less than or equal to about 2.5 mol% [0054]. Note that the values disclosed for Na2O and K2O render obvious a total amount of Na2O and K2O that is at least 4 mol%. Further note in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP 2144.05 I.
Regarding claim 12, Schaut discloses the glass composition includes greater than or equal to 0.10 mol. % and less than or equal to 6.00 mol. % MgO; and greater than or equal to 0.50 mol. % and less than or equal to 4.0 mol. % CaO [0007]. Note that the values disclosed for MgO and CaO render obvious a total amount of MgO and CaO that is at most 5 mol%. Further note in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP 2144.05 I.
Regarding claim 14, the reference discloses the glass composition includes greater than about 0 mol% and less than or equal to 1 mol% SnO2, which overlaps the claimed range [0060]; see MPEP 2144.05 I.
Regarding claim 15, the reference discloses the glass composition may include fining agents such as Fe2O3 in amount less than or equal to about 1 mol%, which overlaps the claimed range [0047 & 0060]; see MPEP 2144.05 I.
Regarding claim 17, the reference discloses that the glass article may include: greater than or equal to 72 mol. % and less than or equal to 82 mol. % SiO2; greater than or equal to 1 mol. % and less than or equal to 6 mol. % Al2O3; greater than or equal to 3 mol. % and less than or equal to 16 mol. % B2O3; greater than or equal to 5 mol. % and less than or equal to 12 mol. % Na2O; greater than or equal to 0.30 mol. % and less than or equal to 2.5 mol. % K2O; greater than or equal to 0.10 mol. % and less than or equal to 6.00 mol. % MgO; and greater than or equal to 0.50 mol. % and less than or equal to 4.0 mol. % CaO [0007 & 0054]. Note that the ranges disclosed for B2O3 and Al2O3 overlap the claimed range; see MPEP 2144.05 I. Further note that the values disclose for Na2O, K2O, CaO and MgO render obvious a total amount of greater than or equal to 7 mol. %. Lastly note, that based on the values disclosed for SiO2, B2O3, Al2O3, Na2O, K2O, CaO and MgO, the reference is considered to render obvious a composition that satisfies the claimed relationships.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schaut et al. (US 2020/0048139) as applied to claim 1 above, and further in view of Bookbinder et al. (US 2017/0066677).
Schaut discloses glass compositions shaped into glass articles such as glass pharmaceutical packages, see above discussion. The reference, however, fails to disclose the composition includes P2O5 in the claimed amount.
Bookbinder discloses glass containers such as vials that include P2O5 in order to promote a more efficient ion-exchange of the glass [0134]. The reference further discloses the amount of P2O5 as ranging from 0 to 15 wt%, see Table 3.
It would have been obvious to one of ordinary skill in the art to include P2O5 in an amount of 0 to 15 wt% in the composition of Schaut in order to promote more efficient ion-exchange of the glass. Note that 0 to 15 wt% is considered to overlap the claimed range of up to 4 mol%; see MPEP 2144.05 I.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaut et al. (US 2020/0048139) as applied to claim 1 above, and further in view of Mangold et al. (US 2019/0283919).
Schaut discloses glass compositions shaped into glass articles such as glass pharmaceutical packages including vials, see above discussion and [0086]. The reference, however, fails to disclose the claimed coating, outer diameter, and wall thickness.
Mangold discloses containers made of glass and used for pharmaceutical packaging such as vials [0002]. The reference further discloses a functionalizing composition at least partially superimposing the wall of the glass container on the interior surface, the exterior surface or both [0025 & 0062]. Note that the functionalizing layer corresponds to the claimed coating. Additionally, the reference discloses the hollow body may be a vial of the type 2R according to ISO 8362 [0156]. The examples disclose a vial diameter of 15.92 mm and a thickness of 0.2 to 5 mm, see Table 2 and [0022]. Note that the disclosed diameter and thickness render obvious the claimed wall thickness of less than 0.7*s1 and less than 0.5*s1.
It would have been obvious to one of ordinary skill in the art at the time of the invention for the vial of Schaut to have the functionalizing composition applied to one or both of its surface in order to have a contact angle with water of at least 80° so as to increase the production rate of a filling line for pharmaceutical compositions, see Mangold [0001 & 0009-0011]. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention for the vial of Schaut to be of 2R type with the dimensions of Mangold as a known size for pharmaceutical packaging.
Response to Arguments
Applicant's arguments filed November 11, 2025 have been fully considered but they are not persuasive.
Applicant argues that Schaut broadly discloses glass articles formed from an ion exchangeable borosilicate glass composition, but the reference fails to disclose a glass article which contains the amounts of SiO2, B2O3, Na2O, K2O and Al2O3 recited in claim 1 and which also satisfy the claimed ratio of Na2O to Al2O3. According to Applicant, such a combination is not contemplated by Schaut, either in the disclosure or examples. As such, Applicant requests the withdrawal of the rejections over Schaut and over Schaut in view of Bookbinder and of Mangold. Examiner respectfully disagrees.
While Applicant is correct that the reference does not specifically disclose the claimed sum of SiO2, B2O3 and Al2O3, Examiner notes that based on the ranges disclosed by the reference, the reference is considered to render obvious a glass composition that satisfies the claimed sum, see above discussion. Additionally, based on the values disclosed for the R2O and RO metal oxides, the reference is considered to render obvious the claimed ratio and relationship. Further, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Given the reference discloses a composition that overlaps the claimed ranges for the individual components and satisfies the claimed sums, ratio and relationship and given Applicant has not provided evidence of criticality, Examiner respectfully maintains the rejections over Schaut and Schaut in view of Bookbinder and of Mangold; see MPEP 2144.05 II.
For the above reasons, the rejections are respectfully maintained.
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 LAURA A AUER whose telephone number is (571)270-5669. The examiner can normally be reached Monday - Friday 9 am - 4 pm EST.
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, M. Veronica Ewald can be reached at (571)272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA A AUER/ Primary Examiner, Art Unit 1783