DETAILED ACTION
Status of Application
Acknowledgement is made of amendments filed 07/13/2026. Upon entering the amendments, claims 27-28 are added and claims 1-2, 4, 10, 13, 15, 18, and 23 are amended. The claims 1-11, 13-16, 18, 23, and 27-28 are pending and presented for the examination.
Rejections Over USC 112 Withdrawn
Claims 1-2, 10, and 15 have been amended to overcome the indefiniteness rejections set forth in the previous office action. Therefore, these grounds of rejection are withdrawn.
Claim Rejections - 35 USC § 103
3. 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.
4. The factual inquiries 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.
5. Claims 1-11 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Nishida (JP 2015093820 A).
Regarding claim 1, Nishida teaches a chemically resistant glass composition used in medical containers wherein the ranges for contents of SiO2, Li2O+K2O+Na2O, TiO2, and ZrO2 each fall within or overlap the corresponding ranges of instant claims 1 and 4, and wherein the glass is free of Al2O3 and B2O3 (see paragraph 0036 and Table at paragraph 0046). The claim differs from the amended claim 1 in that there is not an exemplary embodiment taught containing 0.1-20 mol% TiO2-. However, Nishida teaches that the range for this component is 0-2 wt% (see paragraph 0036), and thus this range also overlaps the corresponding range of the amended claim. 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.
Furthermore, when general conditions are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by changing the size, the proportion, the shape, and/or the sequence of added ingredients through routine experimentation. See MPEP 2144.04 (IV)(A) - In re Rose, 105 USPQ 237 and MPEP 2144.04 (IV)(A) - In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
As such, one of ordinary skill in the art would have arrived at glasses meeting each compositional limitation of instant claim 1 through routine optimization and experimentation with the overlapping Nishida ranges.
Nishida does not specify the loss of mass as measured and classified by ISO 695 (199105-15). However, the Nishida glass is compositionally equivalent to that of the instant claims in as much as it meets the compositional limitations of claims 4-6, and as discussed above, is taught to be chemically resistant. The equivalent Nishida glass would necessarily also be equivalent to that of the instant claim in terms of loss of mass when tested according to ISO 695 (199105-15). It is well settled that when a claimed composition appears to be substantially the same as a composition disclosed in the prior art, the burden is properly upon the applicant to prove by way of tangible evidence that the prior art composition does not necessarily possess characteristics attributed to the CLAIMED composition. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Circ. 1990); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980); In re Swinehart, 439 F.2d 2109, 169 USPQ 226 (CCPA 1971).
Each claim limitation is therefore taught by the prior art of record, and claim 1 is obvious and not patentably distinct over Nishida.
Regarding claim 2, Nishida teaches that an object of the inventive glass is to minimize glass component elution. Nishida does not specify the total eluded cation mass QC in mg/dm2 when subject to an elution test. However, as discussed above, Nishida teaches a glass that is compositionally equivalent to that of the instant claims, and the glass is therefore also necessarily understood to be equivalent in terms of elution resistance properties. The further limitations of claim 2 are thus met by the teachings of the prior art of record.
Regarding claim 3, Nishida teaches that the consumption of hydrochloric acid upon testing should be minimized in the inventive glass, preferable to 0 mL/g. Nishida does not specify the classification of this property as tested according to ISO 720 (1985). However, as above, the Nishida glass is compositionally equivalent to that of the instant claims, and the glass is therefore also necessarily understood to be equivalent in terms of hydrochloric acid consumption property. Additionally, a consumption of 0 mL/g, as taught by Nishida, would presumably also be classified by the aforementioned ISO test at a level meeting the instant claim limitation. The further limitations of claim 3 are thus met by the teachings of the prior art of record.
Regarding claim 4, as discussed previously, Nishida teaches embodiment glasses wherein the contents of SiO2, Li2O+K2O+Na2O, and ZrO2 each fall within the corresponding ranges of instant claim 4, and wherein the glass is free of Al2O3 and B2O3 (see Table at paragraph 0046, examples 1 and 2). As further discussed above, Nishida teaches that the TiO2 content of the inventive glasses is 0-2 wt%. This range overlaps and thus renders obvious the corresponding range of the amended claim 4, and one would therefore have arrived at a glass meeting each compositional limitation through routine optimization and experimentation with the Nishida range.
Regarding claim 5, as discussed above, the Nishida exemplary embodiment glasses comprise 6.6 mol% Na2O.
Regarding claim 6, as discussed above, the Nishida exemplary embodiment glasses comprise 3.4 mol% K2O.
Regarding claim 7, the claim differs from Nishida as applied above because Nishida does not teach an exemplary embodiment wherein the content of MgO+CaO+SrO+BaO is in the range of 0.1-10 mol%. However, Nishida teaches ranges for the contents of these individual components such that the combined content of the four oxides could fall within the range of the instant claim. The MgO content is taught to be 1-5 wt% and the CaO content is 4-10 wt% (see paragraphs 0024-0025). The glasses do not contain SrO or BaO. Because the combined content range of MgO+CaO (5-15 wt%) overlaps the corresponding range of instant claim 7, routine optimization and experimentation by one of ordinary skill in the art would lead to glasses meeting the further limitations of said claim. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have selected from the overlapping portion of the ranges disclosed by the reference because overlapping ranges have been held to establish prima facie obviousness. See MPEP 2144.05. Claim 7 is therefore obvious and not patentably distinct over the prior art of record.
Regarding claim 8, Nishida teaches transmittance as measured at 400 nm through a 5 mm thickness rather than through 1 mm. However, as discussed above, the Nishida glass is compositionally equivalent to that of the instant claims, and as it is used in pharmaceutical container tubes, would be intended to be maximally light transmitting. The equivalent Nishida glass would necessarily also have an equivalent transmittance at a wavelength in the range of 400-800 nm through a 1 mm optical path. ). It is well settled that when a claimed composition appears to be substantially the same as a composition disclosed in the prior art, the burden is properly upon the applicant to prove by way of tangible evidence that the prior art composition does not necessarily possess characteristics attributed to the CLAIMED composition. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Circ. 1990); In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980); In re Swinehart, 439 F.2d 2109, 169 USPQ 226 (CCPA 1971). Each limitation of claim 8 is therefore met by the teachings of Nishida, and the claim is anticipated under USC 102.
Regarding claim 9, as discussed above, the equivalent Nishida glass would necessarily have an equivalent hydrochloric acid consumption to that of the instant claims, and also an equivalent cation mass elution (per the discussion of claims 2-3). The dependent value of the chemical resistance factor is thus also equivalent in the Nishida glasses, and the value would be 98.5 or less.
Regarding claims 10-11, the Nishida glasses is used in pharmaceutical packaging, and therefore teaches a packaging container prepared from a glass meeting the limitations of that of instant claim 1.
Regarding claim 27, Nishida teaches that the inventive glass is used in a vacuum blood collection tube that is sterilized by γ rays or electron beams. This tube and sterilization apparatus comprising the tube constitute a laboratory instrument meeting the further limitations of claim 27.
Regarding claim 28, the preamble limitation designation of a piping for chemical plants would include any tube having some degree of corrosion resistance. The compositionally equivalent Nishida tubing glass would have such resistance, and the tube would be usable as piping a chemical plant. The further limitations of the claim are therefore met by the Nishida teachings.
6. Claims 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kawamoto (JP 06157072 A).
Regarding claim 18, Kawamoto teaches a glass composition comprising 67.0 mol% SiO2, 4.5 mol% TiO2, 6.5 mol% ZrO2, 5.0 mol% BaO, 2.5 mol% CaO, 2.5 mol% SrO, 10.0 mol% Na2O, and 2.0 mol% Li2O (see Table at paragraph 0031, example 6). The glass is free of B2O3 and Al2O3. The alkaline earth oxide content is thus 10.0 mol%, and the value (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 is 0.33. While this value is greater than the range of the amended claim 18, the ranges taught by Kawamoto for the components Li2O, Na2O, K2O, MgO, CaO, SrO, BaO, and SiO2 are such that glasses having this ratio with a value of 0.24 or less are within the scope of the Kawamoto teachings. Kawamoto teaches a BaO+CaO+SrO content of 5-15 mol% and a Na2O+Li2O+K2O content of 7-15 mol%. The lower bounds of these ranges can be combined to give a lower bound of the numerator portion of the instant claim limitation formula – 12 mol%. Thus, with the SiO2 range of 60-70 mol% taught by Kawamoto, this would give a range of 0.17-0.2 for the (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2. It is therefore clear that the Kawamoto teachings cover glass compositions wherein the (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 value falls within the range of the amended claim 18. Per MPEP 2144.05, overlapping ranges have been held to establish prima facie obviousness.
Each limitation of the amended claim is thus met by the Kawamoto teachings, and the claim is obvious and not patentably distinct over the prior art of record.
Regarding claim 23, Kawamoto teaches a glass composition comprising 67.0 mol% SiO2, 4.5 mol% TiO2, 6.5 mol% ZrO2, 5.0 mol% BaO, 2.5 mol% CaO, 2.5 mol% SrO, 10.0 mol% Na2O, and 2.0 mol% Li2O (see Table at paragraph 0031, example 6). The glass is free of B2O3 and Al2O3. The alkaline earth oxide content is thus 10.0 mol%, and the value (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 is 0.33. While this value is greater than the range of the amended claim 18, the ranges taught by Kawamoto for the components Li2O, Na2O, K2O, MgO, CaO, SrO, BaO, and SiO2 are such glasses having this ratio with a value of 0.24 or less are within the scope of the Kawamoto teachings. Kawamoto teaches a BaO+CaO+SrO content of 5-15 mol% and a Na2O+Li2O+K2O content of 7-15 mol%. The lower bounds of these ranges can be combined to give a lower bound of the numerator portion of the instant claim limitation formula – 12 mol%. Thus, with the SiO2 range of 60-70 mol% taught by Kawamoto, this would give a range of 0.17-0.2 for the (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2. It is therefore clear that the Kawamoto teachings cover glass compositions wherein the (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 value falls within the range of the amended claim 23. Per MPEP 2144.05, overlapping ranges have been held to establish prima facie obviousness.
Allowable Subject Matter
7. Claims 13-16 are allowed. The prior art, either alone or in combination, fails to teach or suggest an alkali silicate glass comprising SiO2, K2O, CaO, TiO2, and ZrO2 in amounts falling within the ranges of the instant claim 13, and wherein the TiO2/(Li2O+Na2O+K2O+MgO+CaO+SrO+BaO) and K2O/ZrO2 ratio limitations are met, and wherein the glass is substantially free of B2O3 and Al2O3.
Response to Arguments
8. Applicant’s arguments filed 07/13/2026 have been fully considered but are not persuasive regarding the previously applied prior art to Nishida. Applicant argues that Nishida fails to teach the TiO2 content of the amended claims because the working examples contain TiO2 in amounts falling below the lower limit of this range. However, the Nishida teachings must be considered for all that they convey, and the scope of what is taught by Nishida is not limited to only the working examples. As discussed above, Nishida teaches a range for TiO2 of 0-2 wt%. This range overlaps the 0.1-20 mol% range of the instant claim. When considering the Nishida teachings, one of ordinary skill in the art would have had motivation to form glasses from within the inventive ranges. This would constitute routine optimization and experimentation stemming from the desire to create glasses having the features taught by Nishida. As this routine optimization and experimentation would lead to glasses having TiO2 contents falling within the range of the amended claim 1, this claim limitation is met by Nishida. Thus, the amended claims 1-11 are not distinct over Nishida; the new grounds of obviousness rejection for claims 1-6 and 8-11 are necessitated by the amendments.
The arguments are also not persuasive regarding the previously applied prior art to Kawamoto. Applicant contends that, because the working examples of Kawamoto have (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 ratios that are greater than the 0.24 upper bound of the amended claim 18, this new limitation is not taught or suggested by the prior art. However, as discussed above, Kawamoto teaches ranges for Li2O, Na2O, K2O, MgO, CaO, SrO, BaO, and SiO2 such that glasses having this ratio with a value of 0.24 or less are within the scope of the Kawamoto teachings. As such, one of ordinary skill in the art would have had motivation to form glasses from within the inventive ranges. This would constitute routine optimization and experimentation stemming from the desire to create glasses having the features taught by Kawamoto. As this routine optimization and experimentation would lead to glasses having (Li2O+Na2O+K2O+MgO+CaO+SrO+BaO)/SiO2 values falling within the range of the amended claim 18, this claim limitation is met by Kawamoto. Thus, the amended claims 18 and 23 are not distinct; the new grounds of obviousness rejection for claims 18 and 23 are necessitated by the amendments.
Applicant’s arguments regarding the amended claims and the previously applied prior art to Mori are persuasive. As such, these grounds of rejection for claims 13-16 are withdrawn.
Conclusion
9. Claims 1-11, 18, 23, and 27-28 are rejected. Claims 13-16 are allowed.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH S WIESE whose telephone number is (571)270-3596. The examiner can normally be reached on Monday-Friday, 7:30am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amber Orlando can be reached on 571-270-3149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH S WIESE/Primary Examiner, Art Unit 1731
NSW14 September 2026
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