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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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).
Response to Arguments
Applicant's arguments filed on 07/29/2026 have been fully considered but they are not persuasive. In response to applicant’s arguments about Berger not disclosing controlling the average particle size of the radiaopaque substance within the claimed range, the examiner recognized such deficiencies, therefore, applied secondary reference Klee and Sharma as set forth in the rejections. In response to applicant’s arguments about Klee directed to dental chemical polymerization composition while Sharma directed to mechanical means for improving the efficiency of dental treatment, and both are different technical concept of the present invention, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Klee and Sharma disclose overlapping radiopaque material used in dental treatment composition, which is pertinent to the instantly claimed endeavor, a composition containing such size radiopaque material for dental treatment.
In response to applicant's argument that Klee or Sharma not teaching the particle size of radiopaque substance at 1.0 µm or less associated with inhibiting formation of normal tissue and recovery of an inflammatory site, 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). In this case, Berger already teaches using a composition comprising radiopaque substance of zirconium dioxide as anti-inflammatory filling composition, while Klee and Sharma disclose the claimed radiopaque substance size is well-known in the art. Therefore, adopting such size as shown by Klee or Sharma to modify the radiopaque substance of Berger for improved anti-inflammatory filling composition in dental treatment would have predictable results. Since the applied references suggest a same or substantially the same size radiopaque substance as that of instantly claimed, therefore, same or substantially the same function, i.e. inhibiting formation of normal tissue and recovery of an inflammatory site would be expected.
In response to applicant’s arguments about average particle size of a radiopaque substance and improved bioabsorbablility of a dental filling material, the examiner would like to kindly remind the applicant that evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range (see MPEP § 716.02(d) - § 716.02(e)). In the instant case, the instant claims-e.g. claim 1 recites “A composition comprising a radiopaque substance, wherein the radiopaque substance has an average particle size (D50 value) in a range of 0.1 to 1.0 micron and can be absorbed within living tissue or inflammatory lesion”, which directs to any composition containing any radiopaque substance having a D50 in a range of 0.1-1.0 µm. But comparative example using 50:50 weight ratio of calcium trisilicate together with zirconium oxide having size of 0.5 µm, while example 1 and 2 both using 50:50 weight ratio of calcium hydroxide with zirconium oxide having size of 0.5 µm while example 3 using 50:50 weight ratio of calcium trisilicate with zirconium oxide having size of 0.5 µm, even if assuming applicant alleged improved results of example 1-3 showing improved results over comparative example 1 being true, such data with only shows one data point of using zirconium oxide having size of 0.5 µm with 50:50 weight ratio of calcium trisilicate or calcium hydroxide, it is not readily apparent to one of ordinary skill in the art that such alleged improved results would occur over the entire claimed range, such as for any composition containing any other material, such magnesium oxide with any other radiopaque substance, such as tungsten oxide, niobium oxide, or zinc oxide etc. having any size range from 0.1 to 1 micron would have such alleged improved results: because in order to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP § 716.02(d) II).
Similar reasons for sustaining double patenting rejections.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
