Prosecution Insights
Last updated: May 29, 2026
Application No. 17/912,072

GLASS FOR PHARMACEUTICAL CONTAINER, GLASS TUBE FOR PHARMACEUTICAL CONTAINER, AND PHARMACEUTICAL CONTAINER

Final Rejection §102§103
Filed
Sep 16, 2022
Priority
Apr 30, 2020 — JP 2020-080013 +2 more
Examiner
BOLDEN, ELIZABETH A
Art Unit
1731
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Nippon Electric Glass Co., Ltd.
OA Round
2 (Final)
85%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allowance Rate
797 granted / 935 resolved
+20.2% vs TC avg
Strong +22% interview lift
Without
With
+22.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
19 currently pending
Career history
961
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
46.0%
+6.0% vs TC avg
§102
21.2%
-18.8% vs TC avg
§112
4.1%
-35.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 935 resolved cases

Office Action

§102 §103
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 112, 102, and 103 (or as subject to pre-AIA 35 U.S.C. 112, 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of the Claims Any rejections and or objections, made in the previous Office Action, and not repeated below, are hereby withdrawn. Claims 1-23 are currently pending. Claims 1-23 are currently rejected. Claims 1-3, 5, 8-10, 22-24, and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al., CN 101244889 A. Claim 4, 11, 12, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., CN 101244889 A. Claims 1, 3, 5, 7, 8, 10, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flannery et al., US 4,309,218. Claims 2, 4, 9, 11, 12, 22-24, 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Flannery et al., US 4,309,218. Claims 1, 3, 5, 7, 8, 10, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Flannery et al., US 4,309,218. Claim 6 has an objection for depending from a rejected claim. Claim Rejections - 35 USC § 102 and 35 USC § 103 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. 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. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1-7, 9, 11, and 20-23 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Yamamoto et al., U.S. Patent Application Publication US 2016/0107924 A1. Yamamoto et al. disclose a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4. See Abstract and the entire specification, specifically, paragraphs [0011]-[0016], [0035], and [0039]-[0051]. Yamamoto et al. disclose the glass has a class 1 hydrolytic resistance. See paragraphs [0017] and [0055]. Yamamoto et al. disclose the glass has a working point of at most 1260°C. See paragraph [0057]. Yamamoto et al. disclose the glass can be a tube. See paragraphs [0036] and [0058]. Yamamoto et al. disclose the glass tube can be used for pharmaceutical containers, such as, vials, ampoules, carpules, and syringes. See paragraphs [0002], [0036], and [0058]. The compositional ranges of Yamamoto et al. are sufficiently specific to anticipate the glass composition as recited in claims 1-7, 9, 11, and 20-23. See MPEP 2131.03. Specifically, as to claim 1, Yamamoto et al. disclose Examples 6, 24-31, 34, and 37 (see Tables 1-4), which reads on a glass comprising in terms of mol%: 70-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-18% of Li2O+Na2O+K2O, 0-10% of MgO+CaO+SrO+BaO, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 1, and the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, as recited in instant claim 1. As to claim 2, Yamamoto et al. disclose Examples 6, 24-31, 34, and 37 (see Tables 1-4), which reads on a glass comprising in terms of mol%: 0-8.1% of Li2O, 0.1-8% of Na2O, and 0.01-5% of K2O, as recited in instant claim 2. As to claim 3, Yamamoto et al. disclose Examples 6, 24-31, and 34 (see Tables 1-4), which reads on a glass comprising in terms of mol%: 0-5% of MgO+CaO+SrO+BaO, as recited in instant claim 3. As to claim 4, Yamamoto et al. disclose Examples 6, 25, and 26 (see Tables 1-4), which reads on a glass comprising in terms of mol%: 0-1.5% of MgO, 0-4% of CaO, 0-0.3% of SrO, and 0-0.3% of BaO, as recited in instant claim 4. As to claim 5, Yamamoto et al. disclose Examples 6, 24-31, 34, and 37 (see Tables 1-4), which reads on a glass comprising having a ratio of Li2O/(Li2O+Na2O+K2O) of at most 0.6, as recited in instant claim 5. As to claim 6, Yamamoto et al. disclose Examples 6, 25-31, and 34 (see Tables 1-4), which reads on a glass having a ratio of (Li2O+Na2O+K2O)/Al2O3 of at least 2, as recited in instant claim 6. As to claim 7, Yamamoto et al. disclose Example 6 (see Table 1), which reads on a glass having a ratio of CaO/(Li2O+Na2O+K2O+MgO+CaO+SrO+BaO) of less than 0.018, as recited in instant claim 7. As to claim 9, Yamamoto et al. disclose Examples 6, 24-31, 34, and 37 (see Tables 1-4), which reads on a glass comprising in terms of mol%: at least 90% of SiO2+Al2O3+Li2O+Na2O+K2O+MgO+CaO+SrO+BaO, as recited in instant claim 9. As to claim 11, Yamamoto et al. disclose Examples 6, 24-31, 34, and 37 (see Tables 1-4), which reads on a glass comprising in terms of mol%: 0-2% of ZrO2, as recited in instant claim 11. As to claim 20, Yamamoto et al. disclose Examples 6, 24-31, and 37 (see Tables 1-4), which reads on a glass having at least a class HGA1 in a hydrolytic resistance test according to ISO 720 as recited in claim 20. As to claim 21, Yamamoto et al. disclose Examples 6, 24-31, and 37 (see Tables 1-4), which reads on a glass having a working point of at most 1300°C, as recited in claim 21. As to claim 22, Yamamoto et al. disclose the glass is in the shape of a tube, (see paragraphs [0036] and [0058], which reads on a glass tube, as recited in instant claim 22. As to claim 23, Yamamoto et al. disclose the glass is used as a pharmaceutical container, (see paragraphs [0002], [0036], and [0058], which reads on a pharmaceutical container, as recited in instant claim 23. Claims 8, 10, and 12-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Yamamoto et al., U.S. Patent Application Publication US 2016/0107924 A1. Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4. See Abstract and the entire specification, specifically, paragraphs [0011]-[0016], [0035], and [0039]-[0051]. Yamamoto et al. teach the glass has a class 1 hydrolytic resistance. See paragraphs [0017] and [0055]. Yamamoto et al. disclose the glass has a working point of at most 1260°C. See paragraph [0057]. Yamamoto et al. teach the glass can be a tube. See paragraphs [0036] and [0058]. Yamamoto et al. teach the glass tube can be used for pharmaceutical containers, such as, vials, ampoules, carpules, and syringes. See paragraphs [0002], [0036], and [0058]. Yamamoto et al. fail to teach any examples or compositional ranges that are sufficiently specific to anticipate the compositional limitations of claims 8, 10, and 12-19. However, the mole percent ranges taught by Yamamoto et al. have overlapping compositional ranges with instant claims 8, 10, and 12-19. See paragraphs [[0011]-[0016], [0035], and [0039]-[0051] and the above 102 rejection. Overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05. It would have been obvious to one of ordinary skill in the art before the effective filing date to have selected from the overlapping portion of the ranges disclosed by Yamamoto et al. because overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05. One of ordinary skill in the art before the effective filing date would have considered the invention to have been obvious because the compositional ranges taught by Yamamoto et al. et al. overlap the instantly claimed ranges and therefore are considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, particularly in view of the fact that; “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”, In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also, In re Geisler 43 USPQ2d 1365 (Fed. Cir. 1997); In re Woodruff, 16 USPQ2d 1934 (CCPA 1976); In re Malagari, 182 USPQ 549, 553 (CCPA 1974) and MPEP 2144.05. Specifically, as to claim 8, Yamamoto et al. disclose 0.1-12% of Li2O and 0-4% of CaO (see paragraphs [0044] and [0048]), which reads on a glass comprising CaO and having a ratio of Li2O/CaO of at most 3.1, as recited in instant claim 8. See MPEP 2144.05. As to claim 10, Yamamoto et al. disclose 0-5% of B2O3 (see paragraph [0041]), which reads on a glass comprising 0.01-1 mol% of B2O3, as recited in instant claim 10. See MPEP 2144.05. As to claim 12, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4 (see paragraphs [0011]-[0016], [0035], and [0039]-[0051]), which reads on a glass comprising in terms of mol%: 70-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-<13.9% of Li2O+Na2O+K2O, 0-10% of MgO+CaO+SrO+BaO, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 2, the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, the ratio of Li2O/(Li2O+Na2O+K2O) being at most 0.5, and the ratio of CaO/(Li2O+Na2O+K2O+MgO+CaO+SrO+BaO) being less than 0.018, as recited in instant claim 12. See MPEP 2144.05. As to claim 13, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4 (see paragraphs [0011]-[0016], [0035], and [0039]-[0051]), which reads on a glass comprising in terms of mol%: 70-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-<13.9% of Li2O+Na2O+K2O, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 2, the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, the ratio of Li2O/(Li2O+Na2O+K2O) being at most 0.5, and the ratio of Li2O/CaO being at most 3.1, as recited in instant claim 13. See MPEP 2144.05. As to claim 14, Yamamoto et al. disclose 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO (see paragraphs [0044]- [0049]), which reads on a glass having a ratio of (MgO+CaO+SrO+BaO)/(Li2O+Na2O+K2O+MgO+CaO+ro+BaO) of at most 0.06, as recited in instant claim 14. See MPEP 2144.05. As to claim 15, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4 (see paragraphs [0011]-[0016], [0035], and [0039]-[0051]), which reads on a glass comprising in terms of mol%: 75-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-15% of Na2O, 0.01-5% of K2O, 0.11-<16% of Li2O+Na2O+K2O, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 2, the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, and the ratio of (MgO+CaO+SrO+BaO)/(Li2O+Na2O+K2O+MgO+CaO+SrO+BaO) being at most 0.06, as recited in instant claim 15. See MPEP 2144.05. As to claim 16, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, (see paragraphs [0045]-[0049]),which reads on a glass comprising in terms of mol% having a ratio of CaO/( MgO+CaO+SrO+BaO) being at least 0.5, as recited in instant claim 16. See MPEP 2144.05. As to claim 17, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4 (see paragraphs [0011]-[0016], [0035], and [0039]-[0051]), which reads on a glass comprising in terms of mol%: 70-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-15% of Na2O, 0.1-<16% of Li2O+Na2O+K2O, 0.1-5% of MgO+CaO+SrO+BaO, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 2, the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, and the ratio of CaO/( MgO+CaO+SrO+BaO) being at least 0.5, as recited in instant claim 17. See MPEP 2144.05. As to claim 18, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2 and 4-14% of Al2O3, (see paragraphs [0039] and [0040]),which reads on a glass comprising in terms of mol% having a ratio of SiO2/Al2O3 being at least 10, as recited in instant claim 18. See MPEP 2144.05. As to claim 19, Yamamoto et al. teach a glass composition comprising in terms of mole percentages: 69-81% of SiO2, 4-12% of Al2O3, 0-5% of B2O3, 0.1-12% of Li2O, 0-11% of Na2O, 0-5% of K2O, 5-20% of Li2O+Na2O+K2O, 0-9% of MgO, 0-4% of CaO, 0-4% of SrO, 0-4% of BaO, 0-10% of MgO+CaO+SrO+BaO, 0-2% of ZrO2, and 0-5% of refining agents: F, Cl, Sb2O3, As2O3, SnO2, and Na2SO4 (see paragraphs [0011]-[0016], [0035], and [0039]-[0051]), which reads on a glass comprising in terms of mol%: 70-85% of SiO2, 3-13% of Al2O3, 0-2% of B2O3, 0.1-10% of Li2O, 0.1-15% of Na2O, 0.01-5% of K2O, 0.21-<16% of Li2O+Na2O+K2O, 0-6% of MgO+CaO+SrO+BaO, the ratio of (Li2O+Na2O+K2O)/Al2O3 being at least 1, the ratio of (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO-Al2O3)/(SiO2+Al2O3) being at most 0.127, and the ratio of SiO2/Al2O3 being more than 13.2, as recited in instant claim 19. Response to Arguments Applicant’s arguments with respect to claims 1-23 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. Conclusion The additional references cited on the 892 have been cited as art of interest since they are considered to be cumulative to or less than the art relied upon in the rejections above. Specifically, US 2013/0101596 A1 by DeMartino et al., Examples 6, 8, and 9 read on at least claim 1, US 2017/0022093 A1 by DeMartino et al., Example 13 reads on at least claim 1, US 2017/008239 A1 by Schwall et al., Examples 10 and 11 read on at least claim 1, and US 2018/0147114 A1 by DeMartino et al., Examples 8, 10, 18, 20, 27-31, 55, and 56 read on at least claim 1. 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 Elizabeth A. Bolden whose telephone number is (571)272-1363. The examiner can normally be reached 10:00 am to 6:30 pm M-F. 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, Amber R. Orlando can be reached at 571-270-3149. 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. /Elizabeth A. Bolden/Primary Examiner, Art Unit 1731 EAB 19 March 2026
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Prosecution Timeline

Sep 16, 2022
Application Filed
Aug 27, 2025
Non-Final Rejection mailed — §102, §103
Dec 23, 2025
Response Filed
Mar 23, 2026
Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
85%
Grant Probability
99%
With Interview (+22.2%)
2y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
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