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 .
Election/Restrictions
Applicant’s election without traverse of group I invention with species A2 (claim 1-9 and 12) in the reply filed on 03/09/2026 is acknowledged.
Claim 10-11 and 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and a non-elected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/09/2026.
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.
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.
Claim(s) 1-9 and 12 are rejected under 35 U.S.C. 103 as obvious over Berger (US 2019/0298621) in view of Klee (WO2021/122957) (for applicant’s convenience, equivalent US2023/0014155 has been used for citations) or in view of Sharma (US2018/0214247).
Berger teaches an anti-inflammatory filling composition comprising a radiopacifier (i.e. a radiopaque substance) wherein the radiopacifier most preferably being zirconium dioxide (para. [0018], [0021], [0038], [0040], [0041], claim 14). As for the claimed radiopaque substance can be absorbed within living tissue or inflammatory lesion, Berger teaches radiopacifier (i.e. a radiopaque substance) being zirconium dioxide, which is same or substantially the same as that of instantly claimed radiopaque substance, therefore, same or substantially the same property, i.e. such material can be absorbed within living tissue or inflammatory lesion as that of instantly claimed would be expected.
Regarding claim 1, Berger does not expressly each the radiopacifier having an average particle size being 0.1 to 1 micron.
Klee teaches a dental root canal filling composition comprising at least one radio-opaque particulate having an average particle size (i.e. D50) of from 0.005 to 100 μm, preferably of from 0.01 to 40 µm (para. [0111], [0112], claim 14).
It would have been obvious for one of ordinary skill in the art to adopt such average particle size of radio-opaque particulate as shown by Klee to modify the radiopacifier material of Berger because applying such known technique of average particle size of radio-opaque particulate to modify a known radiopacifier material for improvement would yield predictable results (See MPEP §2143 KSR rationale D).
Sharma teaches suitable radio contrast agents (noted radio contrast agents are radiopaque substance) including (without limitation) zirconium dioxide etc. can be included in a root canal filling composition and such radio contrast agents can have a mean particle size less than 200 nm (i.e. less than 0.2 µm) (para. [0107]-[0111], [0114], [0151]).
It would have been obvious for one of ordinary skill in the art to adopt such average particle size of radio-opaque particulate as shown by Sharma to modify the radiopacifier material of Berger because applying such known technique of average particle size of radio-opaque particulate to modify a known radiopacifier material for improvement would yield predictable results (See MPEP §2143 KSR rationale D).
Regarding claim 2-5, such limitations have been met as discussed above.
Regarding claim 6-8, as for the claimed absorption occurs within one year, or within 6 months or within 4 months after the composition has been applied to the living tissue or inflammatory lesion, Berger teaches already teaches a same or substantially the same radiopacifier (i.e. a radiopaque substance) being zirconium dioxide (while Klee and Sharma discloses radiopacifier material size range being well-known), which is same or substantially the same as that of instantly claimed radiopaque substance, therefore, same or substantially the same property, i.e. absorption occurs within one year, or 6 months or within 4 months after the composition has been applied to the living tissue or inflammatory lesion as that of instantly claimed would be expected.
Regarding claim 9, Berger further teaches anti-inflammatory filling composition comprising a premixed cement putty which includes about 20 to 95% by weight of calcium silicates and 0 to 50% by weight of radiopacifier (para. [0038], [0040], [0041]) and the cement putty can be included in the anti-inflammatory filling composition from 30-95% by weight (para. [0046], [0047]), therefore, the radiopacifier content in the total composition can be from 0 to 47.5% (50%x95%=47.5%) by weight, such content overlapping with that of instantly claimed amount thus renders a prima facie case of obviousness (See MPEP §2144. 05 I)
Regarding claim 12, such limitation has been met as discussed above.
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.
Claim 1-8 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. US 11517508 in view of Sharma (US2018/0214247). US’508 teaches a composition comprising a radiopaque material selected from zirconium oxide etc. (claim 1 and 6), it would have been obvious for one of ordinary skill in the art “obvious to try” zirconium oxide as radiopaque material because choosing zirconium oxide from a finite number of identified, predictable solutions of radiopaque materials would have a reasonable expectation of success(See MPEP §2143 KSR rationale E). Since US’508 teaches a same or substantially the same radiopaque material as that of instantly claimed radiopaque substance, therefore, same or substantially the same property, i.e. such material can be absorbed within living tissue or inflammatory lesion as that of instantly claimed would be expected. US’508 does not teach such radiopaque material having an average particle size of 0.1 to 1.0 micron.
Sharma has been described as above. It would have been obvious for one of ordinary skill in the art to adopt such average particle size of radio-opaque particulate as shown by Sharma to modify the radiopacifier material of US’508 because applying such known technique of average particle size of radio-opaque particulate to modify a known radiopacifier material for improvement would yield predictable results (See MPEP §2143 KSR rationale D).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. US11517508 in view of Sharma (US2018/0214247) as applied above, and further in view of Berger (US 2019/0298621). Regarding claim 9, US’508 does not expressly teach the radiopaque substance content as that of instantly claimed. Berger teaches such limitation as discussed above. It would have been obvious for one of ordinary skill in the art to adopt such well-known radiopaque substance content as shown by Berger to modify the endodontic filling composition of US’508 in view of Sharma because applying a known technique of such radiopaque substance material to a known endodontic filling composition (for root canal) for improvement would yield predictable results (See MPEP §2143 KSR rationale D).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. For example, Jang (US2019/0321267)- patented as US patent No. 11517508, also English equivalent to KR 2018/0071201, teaches A single-paste type hydraulic endodontic filling composition, comprising: a calcium silicate component; and dimethyl sulfoxide (DMSO) and radiopaque substance selected from barium titanate, bismuth titanate, barium zirconate, zirconium oxide, calcium tungstate, tantalum oxide, and mixtures of two or more of the foregoing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUN LI whose telephone number is (571)270-5858. The examiner can normally be reached IFP.
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/JUN LI/ Primary Examiner, Art Unit 1732
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