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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the filler (d)" in line 1. There is insufficient antecedent basis for this limitation in the claim. As currently written, independent claim 1 includes two recitations of a “filler (d)”-one as a component of composite resin (X) and the other as a component of composite resin (Y). It is unclear whether the recitation “the filler (d)” in claim 2 is intended to refer to only one of the two fillers (d) recited in the parent claim (and if so, which one) or if it is intended to refer to the combined total of filler (d)-i.e., the combination of filler (d) in resin (X) and filler (d) in resin (Y) is present in an amount in the recited range.
Claim 7 recites the limitation "the photopolymerization initiator (c-1)" in line 2. There is insufficient antecedent basis for this limitation in the claim. As written, the claimed invention comprises two components referred to as “photopolymerization initiator (c-1)”-one in composite resin (X) (see parent claim 6) and one in composite resin Y (see independent claim 1). It is unclear if claim 7 is intended to require that only one of the two initiators (c-1) has the recited water solubility (and if so, which one) or if it is intended to require that both initiators (c-1) have the recited water solubility.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1, 3-6, and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Takei et al, JP5271764.
A machine translation of Takei was used to prepare this Action.
Example 10 (¶0121-0122) of Takei discloses a dental filling kit (for claim 1) comprising a dental adhesive (A-6) and composite resin (B-1).
Regarding claimed composite resin (X): Dental adhesive (A-6) (¶0122) comprises the acid containing monomer MDP (¶0095), corresponding to claimed monomer (a) for claim 1); Bis-GMA as a monomer having no acidic group (¶0097), corresponding to claimed monomer (b) (for claim 1); photopolymerization initiator CQ (¶0099), corresponding to claimed initiator (c) which comprises a photopolymerization initiator (c-1) (for claims 1, 6); and filler R 972 (¶0100), corresponding to claimed filler (d) (for claim 1).
Regarding claimed composite resin (Y): Composite resin B-1 (¶0108) comprises Bis-GMA as a monomer having no acidic group (¶0097), corresponding to claimed monomer (b) (for claim 1); photopolymerization initiator CQ (¶0099), corresponding to claimed initiator (c) comprising a photopolymerization initiator (c-1) (for claim 1); and silica powder, corresponding to claimed filler (d) (for claim 1). Composite B-1 does not contain an acid-containing monomer (for claim 1); the prior art composite B-1 therefore corresponds to claimed composite resin (Y) (for claim 1).
Regarding claim 5: As noted above, dental adhesive (A-6) comprises MDP, which is 10-methacryloxydecyl dihydrogen phosphate (¶0095). This compound has the structure shown below, corresponding to the claimed monomer having a phosphoric acid group.
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Regarding claim 8: As noted above, composite B-1 comprises Bis-GMA, which is 2, 2-bis[4-(3-methacryloyloxy)-2-hydroxypropoxyphenyl] propane (¶0097). This compound has the structure shown below.
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Note that this structure is a methacrylate ester that contains an aromatic ring and hydroxyl group; Bis-GMA therefore corresponds to claimed monomer (b-5).
Takei is silent regarding the depth of cure (for claim 1), and flexural modulus properties (for claims 3, 4); however, it is reasonably expected that these properties are met by the prior art.
As noted above, prior art Example 10 comprises dental adhesive (A-6) and composite resin (B-1). Dental adhesive (A-6) comprises 10 parts MDP and 35 parts Bis-GMA; note that applicant’s specification teaches the use of the same compounds in the same amounts as monomers (a) and (b) of claimed composite resin (X) (specification ¶0016, 0025, 0040, 0045). Similarly, composite resin (B-1) comprises Bis-GMA; applicant’s specification teaches that this compound is suitable for use as the monomer (b) in resin (Y) (specification ¶0119).
“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…" as that required with respect to product-by-process claims; see In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (MPEP § 2112).
As discussed above, the prior art dental filling kit comprises the same components combined in the same amounts as used to define the claimed invention. As the prior art dental kit appears to be identical to the claimed invention, it is reasonably expected that its properties would necessarily be the same as claimed and inherently be not different from those of the claimed invention. The burden is therefore shifted to the applicant to provide evidence that the properties used to define the claimed dental kit would not be present in the prior art dental kit (for claims 1, 3-4).
Claim Rejections - 35 USC § 103
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) 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Takei et al, JP5271764, as applied to claims 1, 3-6, and 8 above, and further in view of Nojiri et al, WO2019/044815.
The examiner notes that Nojiri et al, US2020/0206091, has been used as an equivalent English translation of WO2019/044815.
As discussed earlier in this Action, Example 10 of Takei discloses a two part dental filling kit comprising a dental adhesive component, corresponding to claimed composite resin (X), and a composite resin component, corresponding to claimed composite resin (Y), wherein the adhesive component comprises a photopolymerization initiator.
Takei is silent regarding the use of photopolymerization initiator having a water solubility of 10 g/L or more at 25 °C.
Nojiri discloses a non-solvent dental adhesive comprising an acid-containing monomer, a monomer having no acid group, a photopolymerization initiator having a solubility of 10 g/L or more in water at 25 °C (for claim 7), and a filler (abstract, ¶0112). Nojiri teaches that the acid-containing monomer may be 10-methacryloxydecyl dihydrogen phosphate (¶0041) and the monomer that does not contain an acid group may be 2, 2-bis[4-(3-methacryloyloxy)-2-hydroxypropoxyphenyl] propane (¶0053); note that these are the same monomers as used in the dental adhesive of Takei. Said filler may be present in an amount in the range of 0 to 2000 parts per 100 parts monomer of the adhesive (¶0121), overlapping the claimed range (for claim 2). Nojiri discloses that the prior art adhesive is characterized by high initial bond strength and high bond durability (¶0018).
It has been held that the selection of a known material based on its suitability for its intended use is prima facie obvious; see Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Both Takei and Nojiri disclose the use of dental adhesives comprising an acid-containing monomer, a monomer that does not contain an acid group, a photopolymerization initiator, and a filler. Further note that Nojiri discloses the use of the same monomers in its adhesive as used by Takei. Given that
Takei and Nojiri both disclose the use of adhesives for dental applications, and
the adhesives of Takei and Nojiri are based on the same polymerizable monomers,
it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dental kit of Takei by substituting the adhesive of Nojiri as the dental adhesive component, with the reasonable expectation of that the adhesive would have the improved bonding properties taught by Nojiri.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY S LENIHAN whose telephone number is (571)270-5452. The examiner can normally be reached Mon.-Fri. 5:30-2:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Riviere Kelley can be reached at 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765
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