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
Claim 1, in page 45, lines 27-29, says, “the material comprises at least 50 % by weight of polyfunctional radically polymerizable monomers or monomers and oligomers, based on the total amount of radically polymerizable monomers and oligomers”. The phrase “or monomers and oligomers” has antecedent basis broadly as radically polymerizable monomers and oligomers in claim 1, page 44, line 10. For examination purposes, the limitation is interpreted as it reads to mean that the material comprises at least 50% by weight of both polyfunctional and monofunctional radically polymerizable monomers and/or oligomers based on the total weight of radically polymerizable monomers. Claim 12’s similar limitation is interpreted in the same manner.
Claim Objections
Claim 5, in page 48, line 1, says “glycol 400-dimeth¬acrylate”. This is taken to be a typo intended to read “glycol 400-dimethacrylate”. Appropriate correction is required.
Claim 6, in page 48, lines 5-10, it is unclear if the terms “CMP-1E”, “MA-836” are trade names in reference to their respective acrylate monomers. This does not constitute a rejection since the monomers these terms are in reference to are given concisely by their formulae. Appropriate correction is required.
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.
Claims 2-14 and 16 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.
Claims 2-7, 9-14 recite the limitation "the composition of claim 1" in the preamble of the claims. There is insufficient antecedent basis for this limitation in the claim because claim 1 is drawn to a dental material. Claims 8 and 16 are rejected as depending on claims 7 and 9.
Further regarding claim 2, the claim recites that R2, R3, and R5 of the dihydropyridine derivative of claim 1 are each an alkyl group that “can be interrupted” by different atoms and groups “and is not interrupted”. The phrase “can be interrupted” accounts for both instances of interruption and non-interruption of the alkyl group, but the phrase “and is not interrupted” appears to eliminate the possibility of interruptions, creating a contradiction. It is unclear if the applicant is allowing for interruptions of the alkyl groups, rendering the scope of the claim indefinite. For examination purposes, the claim is taken to mean that the alkyl groups can be either interrupted or not interrupted.
Further regarding claim 3, the claim recites that R1 is given as a phenyl group optionally substituted by one of a proceeding list of options with some being "preferably" one embodiment over another. The phrase "preferably" renders a claim indefinite because it is unclear whether the features following "preferably" are required limitations of the invention. For examination purposes, the term “preferably” is not considered as giving any additional weight to an optional substitution group.
Further regarding claim 5, the claim contains the trademark/trade name SR-348c (Sartomer). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an ethoxylated 3 bisphenol A dimethacrylate from Arkema (parent company to Sartomer) and, accordingly, the identification/description is indefinite. Additionally, it is unclear if the terms “PEG-200-DMA”, “PEG-400-DMA”, “ V-837”, and “V-380” are tradenames.
Additionally, claim 5 says that the polyfunctional monomer according to claim 1 may comprise V-380 which has the following structure:
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where the R groups are substitutions comprising a variety of options which include V-380, which according to the claim has unspecified R groups. Since V-380 may be substituted by V-380 without specified R groups, the claim is rendered indefinite. Additionally, the claim allows for V-380 which can be substituted by V-380 which can be substituted by V-380 and so on, rendering the claim further indefinite.
Further regarding claims 5-9, the claims impermissibly use open ended "comprising" language in addition to closed Markush language (i.e. “selected from”). The following is a quote from the MPEP: “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group ‘consisting of’ (rather than ‘comprising’ or ‘including’) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group ‘comprising’ or ‘consisting essentially of’ the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim” (MPEP 2173(h)(I)). For examination purposes, these claims are interpreted as containing open ended groups.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7,9,11, 13, 14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xie (US 20150361313 A1).
Regarding claims 1-7, 9, 11 and 16, Xie teaches a two-part acrylic adhesive that could be used in dental applications. The acrylic adhesive comprises an initiator part (analogous to the catalyst paste) and an activator part (analogous to the base paste). The adhesive parts comprise:
The initiator part comprising:
A copolymer referred to as MABS which comprises a monomer 1,3-butadiene (a polyfunctional radically polymerizable monomer without an acid group) (also teaches claimed polyfunctional monomers such as bis-GMA or UDMA suitable in paragraph [0019]);
Methyl methacrylate (a monofunctional radically polymerizable monomer without an acid group) (also teaches isobornyl methacrylate as suitable in paragraph [0012]);
Methacrylic acid (a radically polymerizable monomer with a carboxylic acid group);
Cumene hydroperoxide (an oxidizing agent);
An activator part comprising:
Ethylene glycol dimethacrylate (EGDMA) (a polyfunctional radically polymerizable monomer without an acid group) (also teaches claimed polyfunctional monomers such as bis-GMA or UDMA suitable in paragraph [0019]);
Methyl methacrylate (a monofunctional radically polymerizable monomer without an acid group) (also teaches isobornyl methacrylate as suitable in paragraph [0012]);
3,5-diethyl-1-phenyl-2-propyl-1,2 dihydropyridine (PDHP) (a dihydropyridine derivative) of the following formula:
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Copper (II) acetylacetonate;
Butylated hydroxyl toluene (BHT) (composite filler).
Where the amount of radically polymerizable monomers amount to 100% by weight of radically polymerizable monomers. (Abstract; Table 2, Examples 6-10; paragraphs [0012], [0019], [0025]).
Regarding claims 13 and 14, the acrylic adhesive of Xie could be used in the claimed therapeutic and non-therapeutic dental applications. Case law holds that 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kneafsey (US 5506326 A).
Regarding claim 15, Kneafsey teaches dihydropyridine derivatives as shown below:
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Both derivatives have a phenyl group in the R1 position that is substituted in the claimed manner, R4 and R6 are hydrogen atoms, and R2, R3 and R5 are C2-3 linear alkyl groups. (columns 7 and 8, formulae VII and VIII).
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.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ling (US 20200268615 A1) in view of Xie (US 20150361313 A1).
Regarding claims 1-12 and 16, Ling teaches a dual-curing dental material comprising a catalyst paste and a base paste. The pastes comprise:
A catalyst paste (amounts given as percent weight of the catalyst paste):
19.055 wt.% combined bis-GMA, GDMA, TMPTMA (polyfunctional radically polymerizable monomers without an acid group);
5.688 wt.% (optional) hydroxyethyl methacrylate (HEMA) (a monofunctional radically polymerizable methacrylate monomer without an acid group);
2.8844 wt.% 10-methacryloyloxydecyl dihydrogen phosphate (MDP) (a radically polymerizable monomer with an acid group);
1.500 wt.% cumene hydroperoxide (oxidizing agent);
0 wt.% photoinitiator (but is taught in paragraphs [0007] and [0021] and would be obvious to include);
60 wt.% BG-Sil (a filler);
0.060 wt.% Butylated hydroxyl toluene (BHT) (composite filler);
A base paste (amounts given as percent weight of the base paste):
26.247 wt.% combined bis-GMA, UDMA, EBPADMA, TEGDMA (polyfunctional radically polymerizable monomers without an acid group);
2.949 wt.% HEMA (optional) (a monofunctional radically polymerizable methacrylate monomer without an acid group);
0.002 wt.% Copper (II) acetylacetonate;
0.059 wt.% Bis(2, 4, 6-trimethyl benzoyl) phenyl phosphine oxide (BTPPO) (photoinitiator);
60 wt.% FAS-Sil (a filler); and
0.060 wt.% Butylated hydroxyl toluene (BHT) (composite filler).
(Table 1, paragraphs [0034]-[0065]).
Ling futher teaches reducing agents 3-(trifluoromethyl)phenyl]thiourea and 4-(trifluoromethyl)phenyl]thiourea but does not teach the claimed dihydropyridine derivative (Table 1).
Xie applies as referenced above in paragraph 5 and further teaches PDHP as a suitable reducing agent that would react with the free-radical initiator cumene hydroperoxide in an amount of 1 wt.% of the activator part (base paste) (paragraphs [0014] and [0017]).
A person having ordinary skill in the art as of the effective date of the instant application would have known that the PDHP of Xie is a suitable reducing agent for two-part radically polymerizable compositions, and could have substituted the reducing agents of Ling with the PDHP of Xie in the exemplified amounts according to Xie, to arrive at the predicable result of the claimed dental material comprising the dihydropyridine derivative in the claimed amount.
Further regarding claim 6, Ling does not teach the claimed monofunctional radically polymerizable monomers without an acid group. Xie teaches isobornyl methacrylate as a suitable methacrylate monomer (paragraph [0012]). It would have been obvious to one of ordinary skill in the art as of the effective filing date of the instant application to substitute Ling’s HEMA with Xie’s isobornyl methacrylate to arrive at the predictable result of the claimed dental material. The examiner notes that the monofunctional radically polymerizable monomers without an acid group according to claim 1 are optional, and that the limitations of claim 6 are optional as a result.
Regarding claims 13 and 14, Ling teaches the dental material referenced above for therapeutic and non-therapeutic use as claimed (paragraph [001]).
Conclusion
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/KOLTON JONES/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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