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 Interpretation
MPEP § 2111.02 (III) says “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” The term “kit” in claims 1-11 and the phrase “a tooth restoration” of claim 12 is taken to be intended use of the composition and is not considered a positive limitation.
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 1-3, 6, 9-12 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.
Claims 1-3, 6, 9-12 use the phrases "one-pack type" and/or "separate-pack type", where the word "type" is approximate language. The addition of the word "type" to an otherwise definite expression extends the scope of the expression so as to render it indefinite. See MPEP § 2173.05 (b) III.
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.
Claims 1, 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ishino (US 20100036075 A1) in view of Yoshinaga (US 20180110683 A1).
Regarding claims 1, 4, and 6-11, Ishino teaches dental adhesive compositions including:
a self-adhesive dental composite resin (analogous to resin (X)) (Example 3, Table 4) comprising:
(a-1) 10-methacryloyloxydecyldihydrogenphosphate (MDP) as a monomer having a divalent phosphoric acid group with a backbone C8 to C16 alkyl group;
(b) 2-hydroxyethylmethacrylate (HEMA) as a monomer having no acidic group;
(c) camphor quinone (CQ) as a photoinitiator;
(d) 72 mass% of inorganic fillers 3 and 4 (where the mass% is of the total resin (X) mass.
a dental adhesive composition (analogous to adhesive (Y)) (Example 4, Table 5) that comprises:
A first part (A) that comprises:
(a) MDP;
(b) HEMA;
(d) Inorganic fillers 3 and 4;
(e) 1,1,3,3-tetramethylbutyl hydroperoxide (THP) or cumene hydroperoxide (CHP) as chemical polymerization initiators comprising organic peroxides;
(g) silane coupling agents, since inorganic fillers 3 and 4 comprise a silane surface treatment (paragraph [0144]; Table 4 legend).
A second part (B) comprising:
(b) HEMA;
(g) silane coupling agents, since inorganic fillers 3 and 4 comprise a silane surface treatment.
Ishino is silent on the flexural modulus of both compositions above.
Yoshinaga teaches dental adhesive compositions and kits (paragraph [0001]) and that flexibility is a key variable when considering the use of the composition in oral conditions where a restoration is prone to stresses like mastication (paragraph [0024]). Yoshinaga also teaches a three-point bending test (paragraph [0600]) for testing flexural modulus that is comparable to the three-point test of the instant application paragraph [0211]. Yoshinaga discloses dental compositions with flexural moduli ranging from 2.2-2.6 GPa with an average of 2.3 GPa (Table 3a).
A person having ordinary skill in the art as of the effective filing date of the instant application would have found it obvious to consider the teaching in Yoshinaga regarding kits comprising dental adhesives and resins, the importance of flexibility in dental applications and the appropriate ranges of flexural modulus taught, and, using methods known in the art, would apply these teachings to the compositions of Ishino and the results would be predictable.
Regarding claim 3, the compositions of Ishino in view of Yoshinaga would be expected to produce a flexural modulus ratio within the claimed range because the person of ordinary skill would apply the of flexural moduli as disclosed in Yoshinaga to yield compositions where the ratio of the flexural moduli of resin (X) and adhesive (Y) where (X)/(Y) range from 0.85 (when (X) = 2.2 GPa and (Y) = 2.6 GPa) and 1.2 (where (X) = 2.6 GPa and the (Y) = 2.2 GPa).
Regarding claim 5, the examiner notes that the instant specification paragraph [0019] describes the ratio of the flexural modulus of (X)/(Y) as a result-effective variable on the property of sorption in the component (X), further stating that the range of flexural modulus most preferred is between 0.85 and 2.75 for decreasing water sorption in the cured product. Since compositions of Ishino in view of Yoshinaga as described above would yield ratios of the flexural moduli of (X) and (Y) where (X)/(Y) = 0.85 to 1.2, the sorption of the cured product of component (X) is expected to fall within the claimed range.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ishino (US 20100036075 A1) in view of Yoshinaga (US 20180110683 A1) and further in view of Takahiro (WO 2013046648 A1).
Regarding claims 2 and 12, Ishino and Yoshinaga apply as described above regarding claim 1 and the claimed compositions for resin (X) and adhesive (Y) according to claim 12. Ishino further teaches a method of adhering the self-adhesive resin to dentin and that the self-adhesive resin was cured (paragraph [0188]). Ishino further teaches that the exemplified compositions could be used in various dental applications (paragraph [0202]) (meaning that the self-adhesive resin could be used functionally as a primer).
Ishino an Yoshinaga fail to teach a flexural modulus for the adhesive (Y) of 3-6 GPa and a method wherein the resin is first cured and then the adhesive is applied and then cured to the resin as in claim 12.
Takahiro discloses a dental adhesive kit comprising a pre-treatment material (analogous to resin (X)) and a two-part adhesive material (analogous to adhesive (Y)) where the two-part dental adhesive material has flexural moduli ranging from 5.0 to 7.8 GPa, with an average flexural modulus of 6.1 GPa (abstract; Tables 6, 7, 14, 15). Takahiro further teaches a method of adhering the composition to dentin where the pretreatment is applied to the dentin surface, dried (i.e. cured), and then the two-component adhesive is applied to the primer and then cured (pages 42 and 43).
A person having ordinary skill in the art as of the effective filing date of the instant application would have found it obvious to combine the teaching of Ishino regarding the application of the self-adhesive resin and the use of the resin as a primer, and the teachings of Takahiro regarding acceptable flexural moduli for dental adhesives and a method of application using a primer and the two-part composition, and to apply these teachings the composition of Ishino in view of Yoshinaga as a combination of prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kusakabe S, Tsuruta H, Uno M, Burrow MF, Nikaido T. “Clinical assessment of resin-coating technique applied to exposed dentin after crown preparation”.
Tsuruta H, Kusakabe S, Burrow MF, Toru N. “Clinical Assessment of Resin-coating Technique for Dentin after Cavity Preparation”.
Both references discuss the method known as the “resin-coating method” for temporary dental restoration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOLTON JONES whose telephone number is (571)272-9802. The examiner can normally be reached Generally Monday-Friday 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached at (517)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KOLTON JONES/Examiner, Art Unit 1763 /JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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