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 .
Applicants' arguments, filed August 6, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Election/Restrictions
The subject matter of claim 33 was not elected in the response filed March 21, 2025 and therefore claim 33 is withdrawn from consideration.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The mole fractions of each ingredient listed in claim 24 have been amended although all the amounts are still preceded by the word “about”. ¶ [0096] of the PGPub of the instant application discloses the numerical values for the mole fractions present in amended claim 24. However, only the mole fractions for Ta2O5 and B2O3 in this paragraph are preceded by the word “about” and the amounts for SiO2, Na2O and BaO are not preceded by the word “about”, indicating that these are exact values for the amount of each of SiO2, Na2O and BaO. This results in amended claim 24 containing new matter as all of the amounts including those for SiO2, Na2O and BaO are preceded by the word “about”.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to page and line number wherein support may be found for the instant invention.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 8, 12 – 16, 18, 22 – 24, 34, 39 and 45 were rejected under 35 U.S.C. 103 as being unpatentable over Dahlmann et al. (US 2018/0029925) in view of Stark et al. (US 8,658,188). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 7, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that the radiopaque glass compositions of Dahlmann are lead free and have a relatively low refractive index (¶ [0031]) while also noting that arbitrarily increasing radiopacity has the deleterious effect of increasing the refractive index. As such, Applicants disagree that it would have been obvious to add 5 – 50 wt% Ta2O5 to the materials of Dahlmann. The optional additional radiopaque components in Dahlmann may be present at 0 to 2 wt% (¶ [0061] with claim 9 also being mentioned). This would dissuade a skilled person considering Dahlmann to add more than 2 wt% Ta2O5 since doing so would be contrary to the explicit teachings in Dahlmann by rendering the glass unsatisfactory for its intended purpose by deleteriously increasing the refractive index of the glass. The composition in cited ¶ [0035] contains additional required ingredients that ultimately affect the wt% of the other components.
These arguments are unpersuasive. Dahlmann discloses a desired refractive index range of 1.48 – 1.56 with the radiopacity being provided by the combination of BaO, Cs2O and SnO2 (¶ [0040]). Stark et al. discloses various opacifiers including tin, caesium (Cs) along with BaO and Ta2O5 (col 4, ln 25 onward). Applicants’ arguments have not established that the selection of the combination of radiopacifiers (e.g., to reduce and/or replace the Cs2O and SnO2 in Dahlmann with another ingredient such as Ta2O5) would result in a material whose refractive index lies outside the range disclosed by Dahlmann. Arguments without factual support are mere allegations and are not found persuasive. That a composition with additional required ingredients was cited does not render the instant claims unpatentable as the claims use the open language of “comprising” that permits the presence of additional ingredients, the presence of lead is not required by the instant claims and the disclosed compositions in Dahlmann do not require LiO2 and reasons to limit the amount of this ingredient are explicitly discussed (e.g., ¶ [0020]) so the instant claim limitation of less than 0.01 mole fraction of LiO2 is met.
Applicants also argue that it is only by considering the working examples and transforming the wt% to mole fraction that one can determine if the glasses of Dahlmann fall within the scope of the claims. A particular example is set forth and the calculations redone by the addition of 0.05 mole fraction Ta2O5 to that specific example, which is stated to result in 23.1 wt%Ta2O5 which is over 10x the maximum amount contemplated by Dahlmann and the skilled person would not obviously think that such a large amount of Ta2O3 (the Examiner believes this is a typographical error for Ta2O5 in the very last line on p 10 of the August 6, 2025 response) would still provide a glass of suitable refractive index.
These arguments are unpersuasive. The teachings of a reference are not limited to the examples and the entirety of the teachings of the reference must be considered. As discussed in greater detail on p 10 of the Office Action mailed May 7, 2025, one of ordinary skill would select from known radiopacifiers and their combinations to provide the desired radiopacity without adversely affecting other properties of the final material which does not limit the options to merely adding Ta2O5 to a specific formulation in the primary reference and concluding without any evidence that the formulation would not have a suitable refractive index. Applicants do not present the assumptions made for not changing the amounts of any other ingredients are/or why the only other ingredient whose amount was altered was the SiO2 (looking at the mole fraction line of the second table on p 10). The Ta2O5 amount calculated by Applicants still fall within the range of 5 – 50% explicitly disclosed by Stark. Applicants have not provided evidence that the claimed compositions could not have been arrived at through routine experimentation as indicated by Stark and/or that the claimed compositions demonstrated unexpected results.
Claim(s) 1 – 8, 12 – 16, 18, 22 – 24, 34, 39 and 45 were rejected under 35 U.S.C. 103 as being unpatentable over Hoescheler et al. (WO 2005/060921) in view of Stark et al. (US 8,658,188). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 7, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that Hoescheler teaches glass fillers for use in dental composites and the statement regarding the need of dental composites to meet requirements such as X-ray opacity, dialectical properties, biocompatibility and a certain refractive index is modified by the statement that the materials have a desirable translucency in the visible light and have a refractive index close to that of the polymerizable resin (p 5, lines 1 - 4). The statements from Dahlmann that radiopacity cannot be increased arbitrarily and satisfactorily without too great an increase in the refractive index are repeated to indicate that the skilled person would have the same considerations discussed above, dissuading the skilled person from using sufficient Ta2O5 to arrive at a composition with at least 0.05 mole fraction Ta2O5. Multiple options are taught for several of the components in the formulations on p 7 and only Example 2 of Table 1 includes components recited in claim1 with some examples lacking ingredients such as Y2O3, BaO, Na2O or K2O. Reduction in the amounts of other components in example 2 to include 0.05 mole fraction Ta2O5 results in 23.2 wt% Ta2O5 in the resulting compositions. The desire of Hoescheler for glass filler materials having a refractive index close to the refractive index of polymerizable resin would dissuade the skilled person from using Ta2O5 in the amounts necessary to provide 0.05 mole fraction Ta2O5.
These arguments are unpersuasive. One possible use of the glass filler material disclosed by Hoescheler et al. is as dental composite but that is not the only use (e.g., p 1, ¶ 1) and therefore the statements regarding the need to have a refractive index close to that that of the polymerizable resin is not required for every single glass filler material. This rejection does not rely on Dahlmann and as discussed above, the evidence of record does not establish the routine optimization of the amount of radiopacifier that can be varied within the wide range of 5 – 50 wt% discussed by Stark et al. that is part of this rejection would not result in the claimed compositions and/or that the claimed compositions demonstrate unexpected results. The number of options for each component in the formulations on p 7 are generally quite small and that not al of the claimed components are present in all of the formulations exemplified does not rise to the level of teachings away from the use of materials that are not included in all of the example formulations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 8, 12 – 16, 18, 22 – 24, 34, 39 and 45 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 28 and 36 of copending Application No. 18/038,933 (reference application). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 7, 2025 and those set forth herein.
Applicants request reconsideration of this rejection in view of the amendment to instant claims requiring at least 0.01 as the lower limit for the amount of Na2O and/or K2O while the claims of US’933 require less than 0.01 mole fraction of Na2O and less than 0.01 mole fraction of K2O.
These arguments are unpersuasive. “Less than 0.01 mole fraction” and “at least 0.01 mole fraction” are ranges or amounts that do not overlap but are merely close to one another but a prima facie case of obviousness still exists as one skilled in the art would have expected them to have the same properties (see MPEP 2144.05(I)). Additionally, the value in the instant claims is for Na2O only, K2O only or the combination of Na2O and K2O while those in US’933 are for each ingredient separately. Mole fractions 0.009 for each of Na2O and K2O individually meet the limitations of the claims of US’933 of less than 0.01 mole fraction for each of Na2O and K2O while the sum of those mole fractions (0.018) falls squarely within the range of the instant claims of at least 0.01 and up to about 0.23 mole fraction of Na2O and/or K2O. Therefore the instant claims are not patentably distinguished over the claims of US’933.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618