DETAILED ACTION
This Office Action is responsive to the amendment filed on 3/6/2026.
The objections and rejections not addressed below are deemed withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
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. 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.
Specification
The substitute specification filed 3/6/2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: The submitted substitute specification includes the original claims; see pages 92-96 of the substitute specification. Note that 37 CFR 1.125(b) states that a substitute specification excludes the claims.
The disclosure is objected to because of the following informalities: On page 90 of the specification filed 6/21/2022, Table 8 shows that examples 1-10 were prepared using samples A-1 to A-5. The following text, however, says that examples 1-10 were prepared using samples A-1 to A-6..
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims 1-5 are rejected under 35 U.S.C. 103 as being obvious over Matsuo et al, JP2020-037534, in view of Dickens et al, WO2005/002531, and Neisse et al, US5078598.
A machine translation of Matsuo was used for the preparation of this rejection.
Matsuo discloses a dental restorative material made comprising a composite resin, wherein said composite resin is made from a curable composition, corresponding to the claimed first polymerization curable component (A) (for claim 1) (¶0002, 0017).
Regarding claimed condition (a1): Matsuo’s curable composition comprises a polymerizable monomer, corresponding to the claimed first polymerizable component (for claim 1); inorganic particles (for claim 1); and a polymerization initiator, corresponding to the claimed first polymerization initiator component (for claim 1) (¶0018, 0091).
Regarding claimed condition (a2)(i): The prior art inorganic particles are an aggregate of spherical particles which have an average diameter in the range of 100 to 1000 nm, with ≥ 90% of the particles within +/- 5% of the average diameter (¶0025).
Regarding claimed condition (a2)(ii): The prior art inorganic particles have a number of same-size spherical particle groups-referred to as a- is represented by G-PIDm, wherein m is 1 when a is 1 and m is a natural number from 1 to a when a is 2 or more and the average diameter of each G-PIDm varies by 25 nm or more (Matsuo claim 1).
Regarding claimed condition (a2)(iii): The refractive index of the matrix derived from polymerizing the monomer is less than the refractive index of G-PIDm at 25 °C (¶0025).
Regarding claimed condition (a3): The radial distribution function g(r) = {1/<p>} × {dn/da} (0029-0032), wherein the distance between the closest particles is 1 to 2 times the average particle diameter, corresponding to condition (I) (for claim 1), and the minimum value of g(r) between two adjacent particles is 0.56 to 1.10, corresponding to condition (II) (for claim 1) (Matsuo claim 1).
Regarding claim 2: the composition of Matsuo further comprises a superfine particle group G-SFP having an average diameter less than 100 nm, wherein the average diameter of G-SFP is at least 25 nm smaller than the average diameter of G-PID1 (¶0065).
Regarding claim 3: The composition of Matsuo is not required to comprise a colorant and therefore reads on compositions that do not contain such additional components.
Regarding claim 4: As noted above, number of same-size spherical particle groups in the prior art composition-referred to as a- may be 1. Furthermore, the prior art range of 100 to 1000 nm overlaps the claimed range.
It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed in the prior art, a prima facie case of obviousness exists; see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). 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; see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (" (MPEP § 2144.05). As the prior art range overlaps the claimed range, it would have been obvious to prepare a composition having the claimed particle size.
Matsuo is silent regarding the inclusion of claimed second polymerization curable component (B).
Dickens discloses a remineralizing dental cement comprising a resin monomer, corresponding to the second polymerizable monomer component (for claim 1); a polymerization initiator, corresponding to the claimed second polymerization initiator (for claim 1); and pigments, corresponding to the claimed colorant component (for claim 1) (abstract, ¶05, 48). The composition of Dickens therefore corresponds to claimed condition (b1) (for claim 1). Dickens teaches that the prior art composition can be applied as a protective cavity base/liner to prevent tooth decay and help repair damage prior to the addition of the permanent restoration (abstract, ¶24, 25, 29). Dickens further teaches that the cement is only partially removed, with a portion left behind to prevent pulp damage (¶29). The portion left in the cavity therefore corresponds to the claimed foundation layer (for claim 1).
Regarding the claimed condition (b2): As noted in the previous paragraph, the composition of Dickens comprises pigment(s). As taught by Neisse, it was known in the art to vary the color of dental restoration materials to simulate as close as possible the color(s) of the remaining tooth structure so that the restoration will look as natural as possible (Column 1: lines 20-28). Neisse further teaches that it was known that the color of the material was measured on the Munsell color system, and that the value (i.e., brightness) was evaluated on a numeric scale from black to white, with white pigments being added to adjust the brightness (Column 1: lines 39-50).
The applied references are all directed towards the field of dental restorative materials. As taught by Dickens, it was known in the art to use apply a remineralizing cement to a cavity prior to the application of the permanent restorative in order to prevent decay and promote repair of the demineralized dentin. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to one of ordinary skill in the art use the composition of Matsuo, corresponding to claimed component (A), in combination with the composition of Dickens, corresponding to claimed component (B), with the reasonable expectation of promoting remineralization and protection of the pulp prior to the addition of the permanent restoration (for claim 1).
Furthermore, with respect to the color value (V), Neisse teaches that it was known in the art to adjust the color of dental materials to match the adjacent tissue as much as possible so that the final product appears more natural, with 1) the color being evaluated on the Munsell system and 2) the value on the black-white scale being adjusted to change brightness. Barring a showing of evidence demonstrating unexpected results, it would have been obvious to one of ordinary skill in the art to vary the color of the composition of Dickens as needed to match the surrounding dental tissue and achieve a more natural appearance (for claim 1).
Regarding claim 5: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As discussed in the previous paragraphs, the prior art renders obvious a composition comprising the same components which is taught to be used for the same general field-i.e., cavity restoration-as the claimed invention; it is therefore reasonably expected that the composition rendered obvious by the prior art would be capable of performing the recited intended use. The burden is therefore shifted to applicant to provide evidence demonstrating that the prior art composition could not perform the required intended use.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive.
Regarding the availability of JP2020-037534 as prior art: The examiner notes the form paragraph indicating that JP2020-037534 was prior art under 35 U.S.C. 102(a)(2) was used in error in the previous Office Action, and apologizes to applicant for this mistake.
The reference JP2020-037534 was published on March 12, 2020. This date is between the filing date of foreign priority application and the filing date international application PCT/JP2020/044221. Furthermore, note that (a) the certified copy of the foreign priority application is not in English and (b) a translation of the foreign priority application has not been submitted. As such, applicant cannot rely on the certified copy of the foreign priority application to overcome a rejection over JP2020-037543; see MPEP § 215 and 216. JP2020-037534 is therefore an intervening reference available as prior art under 35 U.S.C. 102(a)(1).
As noted by applicant the instant application names Takuma Matsuo, Hiroshi Morisaki, and Hironobu Akizumi as inventors. In contrast, the translation of JP2020-037534 submitted by applicant with the 6/21/2022 information disclosure statement lists the following inventors.
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Note the evidence currently in the record states that the inventors of JP2020-037534 include Hitoshi Morisaki and Hironobu Akitsumi, not Hiroshi Morisaki and Hironobu Akizumi as stated by applicant. There is no evidence in the record that addresses these discrepancies; it is therefore unclear whether inventors Hitoshi Morisaki and Hironobu Akitsumi of JP2020-037534 are the same people as Hiroshi Moriskaki and Hironobu Akizumi of the instant application, or if they are different people with similar names. The evidence currently in the record therefore does not support the applicant’s statement that the instant application and JP2020-037534 list the same inventive entities.
Regarding applicant’s statement regarding the exception under 35 U.S.C.102(b)(2)(c): As noted above, the previous Office Action mistakenly stated that JP2020-037534 was only available as prior art under 35 U.S.C.102(a)(2). As an intervening reference published before the filing date of the corresponding application, JP2020-037534 qualifies as prior art under 35 U.S.C.102(a)(1). Applicant’s statement under 35 U.S.C. 102(b)(2)(c) therefore does not disqualify JP2020-037534, as the exception under 35 U.S.C. 102(b)(2)(c) does not apply to references available under 35 U.S.C. 102(a)(1).
Conclusion
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/JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765
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